U.S. patent application number 14/519466 was filed with the patent office on 2015-06-18 for inhalation device for use in aerosol therapy.
This patent application is currently assigned to Vectura GmbH. The applicant listed for this patent is Vectura GmbH. Invention is credited to Tobias Hoffmann, Martin Huber, Tobias Kolb, Bernhard Mullinger.
Application Number | 20150165137 14/519466 |
Document ID | / |
Family ID | 47137595 |
Filed Date | 2015-06-18 |
United States Patent
Application |
20150165137 |
Kind Code |
A1 |
Mullinger; Bernhard ; et
al. |
June 18, 2015 |
INHALATION DEVICE FOR USE IN AEROSOL THERAPY
Abstract
An inhalation device having a base unit, a mouthpiece, and an
aerosol head is provided. The base unit has an air inlet, an air
outlet opening, a groove for receiving the mouthpiece, and key lock
member(s). The mouthpiece has two segments: a first segment which
is insertable into the groove of the base unit and has an air inlet
opening and a lateral opening for receiving an aerosol generator
and a second segment with an aerosol outlet. The aerosol head has
an aerosol generator, a liquid reservoir, and key lock member(s)
complementary to those of the base unit. The base unit, mouthpiece
and aerosol head are connectable with one another such that when
engaging the members of the key lock with the complementary
members, the aerosol generator is inserted into the lateral opening
of the mouthpiece.
Inventors: |
Mullinger; Bernhard;
(Munchen, DE) ; Kolb; Tobias; (Neuried, DE)
; Huber; Martin; (Furstenfeldbruck, DE) ;
Hoffmann; Tobias; (Gilching, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Vectura GmbH |
Gemunden |
|
DE |
|
|
Assignee: |
Vectura GmbH
Gemunden
DE
|
Family ID: |
47137595 |
Appl. No.: |
14/519466 |
Filed: |
October 21, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14063115 |
Oct 25, 2013 |
8910625 |
|
|
14519466 |
|
|
|
|
Current U.S.
Class: |
128/200.16 ;
128/200.23 |
Current CPC
Class: |
A61M 15/0021 20140204;
A61M 2016/003 20130101; A61M 2205/8206 20130101; A61M 2205/583
20130101; A61M 2205/3584 20130101; A61M 16/0003 20140204; A61M
2205/276 20130101; A61M 2016/0027 20130101; A61M 2205/6045
20130101; A61M 2205/3334 20130101; A61M 15/009 20130101; A61M
15/025 20140204; A61M 2205/52 20130101; A61M 2016/0033 20130101;
A61M 15/0071 20140204; A61M 15/0085 20130101; A61M 2205/584
20130101; A61M 16/201 20140204; A61M 15/0091 20130101; A61M 11/042
20140204; A61M 11/005 20130101; A61M 15/002 20140204; A61M 15/00
20130101; A61M 2205/27 20130101 |
International
Class: |
A61M 15/00 20060101
A61M015/00; A61M 16/20 20060101 A61M016/20; A61M 16/00 20060101
A61M016/00 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 26, 2012 |
EP |
12 19 0139.1 |
Claims
1.-15. (canceled)
16. A method of delivering aerosolized or nebulized drug formulas
comprising providing an inhalation device comprising a base unit, a
mouthpiece, and an aerosol, providing an active ingredient, wherein
the active ingredients may be dissolved, dispersed, or suspended in
a liquid to form an aerosolizable or nebulizable drug formulation,
and wherein the inhalation device enables oral inhalation of the
nebulized drug.
17. The method of claim 16 wherein the inhalation device may be
used as a mobile, stand-alone, or handset system.
18. The method of claim 16 wherein the aerosol is introduced
horizontally into the base unit.
19. The method of claim 16 wherein the inhalation device comprises
a sensor, the sensor capable of sensing air pressure or airflow
rate within the base unit to control the air pressure or airflow
rate.
20. The method of claim 16 wherein the inhalation device comprises
an electronic control unit, the electronic control unit capable of
controlling a valve to open and close air flow.
21. The method of claim 16 wherein a feedback system indicates to a
user a target flow rate.
22. The method of claim 16 wherein an airflow rate is configured to
be about 12 to about 18 L/min.
23. The method of claim 16 wherein an airflow rate is configured to
be about 15 L/min.
24. The method of claim 16 wherein the inhalation device is
lockable to restrict aerosolization or nebulization of the drug
formulation.
25. The method of claim 16 wherein usage information is transmitted
to an external storage device.
26. The method of claim 16 wherein a piezoelectric transducer
vibrates at about a range of 50-200 kHz.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation application of U.S.
patent application Ser. No. 14/063,115, filed Oct. 25, 2013, which
in turn claims priority to EP application no. 12 19 0139.1 filed
Oct. 26, 2012.
BACKGROUND
[0002] Inhalation devices which allow a patient to inhale an
aerosol are required for numerous medical applications, such as the
inhalative treatment of asthma, cystic fibrosis (CF), and a number
of other respiratory diseases. An aerosol is a dispersion of small
solid particles or liquid droplets in a continuous gas phase.
Typically, aerosols of fine droplets of a liquid formulation of a
bioactive agent or drug are required in medical inhalation
treatments; ideally reaching even the smallest branches of the
peripheral lungs, such as bronchioles and alveoli.
[0003] In order to achieve the desired homogeneous droplet
distribution in the gas phase, the liquid formulation in the
inhalation device is atomized by nebulizers, such as ultrasonic
nebulizers, jet nebulizers, or vibrating mesh nebulizers.
[0004] The individual components of currently available vibrating
mesh nebulizers, such as, for example, the liquid reservoir, the
aerosol generator comprising the vibrating mesh, the mixing chamber
and the mouthpiece, are typically assembled so that the nebulizer
membrane is either arranged approximately vertical or
horizontal.
[0005] With vertically arranged nebulizer membranes, the generated
aerosol is introduced horizontally into the air flow channel, and
the aerosol generator can be positioned at an angle to the
direction of the air flow, without thereby changing the vertical
arrangement of the membrane. Depending on the selected angle, it is
even possible to introduce the aerosol roughly in parallel with the
air flow. This approach is, for example, chosen by PARI (e.g. WO
2009/135871 A1) and may, in addition, be complemented with an
annular air stream surrounding the aerosol generator so that the
nascent aerosol is engulfed in air to avoid particle collision with
the inner walls of the mouthpiece. Thereby this "air jacket" as
well as the option to orient the aerosol generator at an angle to
the direction of the air flow eliminates the need for spacious
mixing chambers. However, since the liquid has to be supplied to a
vertically positioned nebulizer membrane, even minor handling
deviations such as tilting the device during inhalation lead to
distinct variations in liquid supply and consequently the volume
inhaled as an aerosol. Also, the residual volume remaining in the
reservoir at the end of the inhalation treatment is typically
higher than for inhalation devices with a horizontally arranged
nebulizer membrane. In addition, errors during assembly of the
inhalation device as well as the vertical arrangement of the
nebulizer membrane commonly create problems with providing
airtight, leak-proof connections between the aerosol generator and
the air flow channel.
[0006] Horizontally arranged nebulizer membranes allow for an
easier, gravity-driven and thus less variable supply of the liquid
from a reservoir above said membrane. However, the generated
aerosol is now introduced perpendicular into the air flow channel,
so that typically mixing chambers are required in order to avoid
particle collision with each other and/or the device's inner walls
and to homogeneously mix the aerosolized particles with the air
flow before inhalation by the user. Typically, these mixing
chambers are rather spacious and hence increase the dimensions of
the inhalation devices unfavorably. Furthermore, owing to longer
residence times of the aerosol in the mixing chamber and
turbulences within said mixing chamber sedimentation and impaction
of the aerosolized particles occur, thereby increasing wastage of
the aerosolized formulation as well as decreasing dose
reproducibility. Also, the vertically stacked arrangement of liquid
reservoir, aerosol generator (with horizontal membrane) and mixing
chamber, leads to devices which are rather high compared to their
width. This could lead to handling problems because devices may
easily fall on their side, especially upon filling of the reservoir
or in filled state.
[0007] Further problems may arise during the assembly of the
nebulizer, when patients put the individual components of the
inhalation device together incorrectly, for example, after cleaning
and/or disinfecting them as required. This could lead to
irreproducible dosing of active agents due to leakage of the
liquid, malfunctions such as pressure losses, reduced therapeutic
efficacy or even permanent damages to the device. Especially sick
and/or elderly users may become discouraged by complicated
dissembling and assembling routines and either stop to comply with
their therapy or stop to dissemble and clean their device
regularly. This provokes a worsening of symptoms and/or increases
the risk for infections of the respiratory tract from contaminated
devices.
[0008] WO 2008/050542 A1 discloses a portable inhalation device
comprising a main body, a detachable mouthpiece, an inkjet system
medicine cartridge and a slide-on cover. The main body comprises an
air flow path and two fitting portions where the medicine cartridge
and the mouthpiece can be inserted in such a way that they are in
fluid communication with the air flow path. The medicine cartridge
comprises a reservoir (as an integral or detachable part),
electrical connectors and an ejection head, preferably equipped
with a heater, from which medicine is ejected by thermal energy
using the principle of inkjet systems. As an alternative to such
electro-thermal ejection means electro-mechanical ejection means
are suggested, such as by piezo-electric devices. After its
insertion into the fitting portion, the medicine cartridge is fixed
to the main body by the slide-on cover.
[0009] WO 2008/050542 A1 does not describe key lock members or
similar features of the medicine cartridge or of the main body
which would ensure easy and correct assembly, i.e. the complete
insertion of the medicine cartridge in the right orientation, and
securely lock the components together. Furthermore, the first
segment of the mouthpiece in WO 2008/050542 A1 (i.e. the
communicating portion which is inserted into the main body) does
not comprise a lateral opening for receiving the ejection head of
the medicine cartridge. Therefore the aerosol is emitted directly
into the air flow path of the main body before entering the first
segment of the mouthpiece. In this manner, some aerosol will
inevitably be deposited within the main body. In consequence, this
does not only lead to an increased loss of aerosol, but is also
associated with the disadvantage that the user would have to clean
not only the detachable mouthpiece but also the air flow path in
the opened main body which houses the water-sensitive electronic
controls for the ejection head and further electrical
components.
[0010] WO 2006/083014 A1 describes a similar portable inhaling
apparatus comprising a main body provided with a fitting section
for removably fitting thereto a disposable liquid agent ejection
cartridge. The ejection cartridge comprises a storage tank for a
liquid agent, an ejection head with ejection means, an integral
mouthpiece (called suction port) and a flow path projecting from
the cartridge. The ejection head may be an inkjet head comprising a
heater or a piezoelectric element or one having a mesh structure
with a large number of pores. The mouthpiece is an integral part of
the ejection cartridge, as favored by the authors, and therefore
the mouthpiece must be discarded along with the cartridge every
time the storage tank is empty, as the storage tank cannot be
effectively cleaned and/or refilled by a user. Moreover, the
document is silent about key locks or any other features of this
type which would ensure easy, correct and complete assembly of the
device. Further, the device does not exhibit a mouthpiece having a
lateral opening for receiving an aerosol generator capable of
emitting an aerosol into the flow path of the mouthpiece.
[0011] It is thus the aim of the current invention to provide an
improved inhalation device comprising a low number of components
which ensure the fast and correct assembly and filling of the
device as well as to improve its air tightness and reduce pressure
losses and leakages by reducing the number of leak-prone
connections. Another aim of the current invention is to allow for
easier, safer cleaning operations. It is further the aim of the
current invention to facilitate effective customization by
providing inhalation devices comprising aerosol generators which
are tailor-made for specific therapies, wherein said aerosol
generators can be assembled only with its intended
counter-components.
SUMMARY OF THE INVENTION
[0012] The objectives of the invention are met by the inhalation
device according to the claims. Advantageous embodiments are also
provided in the dependent claims.
[0013] In particular, an inhalation device is provided which
comprises a base unit, a mouthpiece and an aerosol head which are
connectable with one another. The base unit comprises one or more
air inlet opening(s), an air outlet opening, a groove for receiving
the mouthpiece, and one or more key lock member(s) which may e.g.
be male or female. The mouthpiece comprises a first segment and a
second segment, the second segment being downstream of the first
segment. The first segment comprises an air inlet opening which may
be attachable to the air outlet opening of the base unit, and a
lateral opening for receiving an aerosol generator, and the second
segment comprises an aerosol outlet opening. The aerosol head
includes an aerosol generator, a reservoir for a liquid and one or
more key lock member(s) which may be male or female, and which are
complementary to the key lock member(s) of the base unit. The
aerosol generator is positioned in the aerosol head in such a way
that when engaging the male or female key lock member(s) of the
aerosol head with the complementary key lock member(s) of the base
unit, the aerosol generator is at least partially inserted into the
lateral opening of the first segment of the mouthpiece.
[0014] The groove in the base unit and the mouthpiece inserted
therein may have a horizontal orientation. Moreover, the groove may
extend from the air outlet opening of the base unit to the front
side of the base unit. It may not be the complete mouthpiece which
is accommodated in the groove, but only a portion thereof, e.g. the
proximal segment or first segment.
[0015] The lateral opening of the mouthpiece which receives the
aerosol generator may be positioned on the top side of the first
segment of the mouthpiece, so that the aerosol generator, which may
be of the vibrating mesh type, is inserted vertically into the
mouthpiece.
[0016] The first segment of the mouthpiece may comprise a
protrusion.
[0017] The base unit may comprise an indentation for receiving the
protrusion.
[0018] The protrusion as well as the indentation may be
asymmetric.
[0019] The base unit and the aerosol head may each comprise two key
lock members.
[0020] The key lock members may be positioned to form a key lock on
the left side and another key lock on the right side of the
inhalation device.
[0021] The key locks may be disengaged by squeezing the aerosol
head at the position of the key lock members.
[0022] The aerosol generator may have an upstream end positioned at
the top of the aerosol generator and a downstream end positioned at
the bottom of the aerosol generator.
[0023] The mesh of the aerosol generator may be located at or near
the downstream end of the aerosol generator.
[0024] The air outlet opening of the base unit may exhibit a
sealing member.
[0025] Alternatively, the lateral opening of the mouthpiece for
receiving the aerosol generator may exhibit a sealing member.
[0026] As a further alternative, the air outlet opening of the base
unit and the lateral opening of the mouthpiece for receiving the
aerosol generator may exhibit a sealing member.
[0027] The air outlet opening may, for example, be circular or
elliptical and may, for example, be positioned in a central region
of the base unit. Optionally, the base unit may exhibit more than
one air outlet opening.
[0028] The base unit and the aerosol head may comprise electrical
connectors positioned in such a way that when engaging the base
unit's member(s) of the key lock with the aerosol head's
complementary member(s) the electrical connectors of the base unit
are brought in contact with the electrical connections of the
aerosol head.
[0029] The base unit may comprise one or more sensor(s) for sensing
air pressure or air flow rate within the unit.
[0030] The base unit may comprise valve for opening or closing the
air flow within the unit.
[0031] The base unit may comprise an electronic control unit for
controlling the aerosol generator.
[0032] The base unit may comprise an electronic control unit for
controlling the valve.
[0033] Alternatively, the base unit may comprise one or more
sensor(s) for sensing air pressure or air flow rate within the
unit, and a valve for opening or closing the air flow within the
unit.
[0034] Alternatively, the base unit may comprise one or more
sensor(s) for sensing air pressure or air flow rate within the
unit, and an electronic control unit for controlling the aerosol
generator and/or the valve.
[0035] Alternatively, the base unit may comprise a valve for
opening or closing the air flow within the unit, and an electronic
control unit for controlling the aerosol generator and/or the
valve.
[0036] Further alternatively, the base unit may comprise (a) one or
more sensor(s) for sensing air pressure or air flow rate within the
unit, and a valve for opening or closing the air flow within the
unit, and an electronic control unit for controlling the aerosol
generator and/or the valve.
[0037] The inhalation device may further comprise a feedback
system.
[0038] The feedback system may comprise one or more sensor(s) for
sensing air pressure or air flow rate capable of generating a
sensor signal in response to an actual value of flow rate and/or
inhaled volume during the inhalation maneuver. The feedback system
may also comprise an electronic memory capable of storing one or
more target values and/or target ranges for flow rate and/or
inhaled volume. Furthermore, the feedback system may comprise one
or more feedback indicator(s) capable of emitting an output signal.
The feedback system may also comprise a controller capable of
receiving the sensor signal(s) generated by the sensor(s), reading
the electronic memory, and controlling the one or more feedback
indicator(s).
[0039] The feedback system may be is configured to indicate to a
user during an inhalation maneuver by means of the output signal(s)
whether the actual value of the flow rate and/or inhaled volume is
within a target range.
[0040] The one or more air inlet opening of the base unit may be
positioned at the rear side of the device or base unit.
[0041] The one or more air inlet opening(s) of the base unit may be
connected to a tube through which an air flow is received.
[0042] The tube optionally exhibits a first lumen for an air flow
and a second lumen holding an electrical wire.
[0043] The inhalation device may be configured as a mobile,
stand-alone device with the inspiratory flow being generated by the
user.
[0044] The inhalation device may further comprise a flow restrictor
configured to restrict, control and/or regulate the inspiratory air
flow of the patient, or to assist the patient to adopt a useful
inspiratory flow rate. The flow restrictor may be configured to
enable the patient or user to achieve a preset specific target
value, for example 15 L/min, or target range, such as from 12 to 18
L/min.
[0045] According to another aspect, the invention provides the use
of the inhalation device according to any of the above aspects and
features for inhalation therapy.
[0046] The invention allows easy assembly and disassembly of the
inhalation device by the user as well as easier, safer cleaning
routines and provides for increased product safety in that it
ensures that the device is assembled in a correct manner. Moreover,
the low number of components to be assembled requires very few
airtight connections so that the risk of leakage or pressure loss
is minimized.
[0047] Further advantageous embodiments, features, beneficial
effects and uses of the device are described below in more
detail.
DEFINITIONS
[0048] The following expressions as used herein should normally be
interpreted as outlined in this section, unless the description
provides a different meaning in a specific context.
[0049] "Lateral", or "laterally", means away from the middle,
center, or center axis of a device or device component.
[0050] "Front", such as in "front side", or "front face", as well
as all similar terms designating a position, orientation or
direction, such as left, right, rear, back, top, bottom, up, down
and the like, should be understood with reference to the
orientation of the inhalation device or its components under normal
operational conditions, and typically from the perspective of the
user. For the avoidance of any misunderstandings, it is clear that
a user may also hold the device in such a way that there is some
deviation from a normal operational orientation. For example, while
the device is designed to be held in an approximately horizontal
orientation with respect to the axis along which the air flow
within the device occurs, the user may also hold the device at an
angle of up to 45.degree. deviating from the horizontal
orientation, without negative impact on the device function.
Similarly, a user may, to some degree, rotate the device around
said axis, again without any substantial deterioration of device
performance.
[0051] "Key lock" is understood as a locking mechanism for
connecting parts or components mechanically in a detachable manner
using at least one pair of members with complementary shape such as
to engage with each other non-permanently. Click mechanisms, or
snap-fit mechanisms, are examples of key locks.
[0052] "Key lock member" is a member (e.g. a male member) having a
particular shape adapted for non-permanent mechanical engagement
with a complementary (e.g. a female member) member such as to
connect two devices in a detachable manner.
[0053] "Flow," such as in "air flow" or "inspiratory flow" refers
to the rate of flow.
[0054] "Comprise" or "comprising" with reference to any feature
means that the respective feature must be present, but without
excluding the presence of other features.
[0055] "A" or "an" does not exclude a plurality.
[0056] "Essentially", "about", "approximately" and the like in
connection with an attribute or value include the exact attribute
or the precise value, as well as any attribute or value typically
considered to fall within a normal range or variability accepted in
the technical field concerned.
[0057] Any reference signs in the claims should not be construed as
a limitation to the embodiments represented in any of the
drawings.
[0058] A single unit may fulfil the functions of several features
recited in the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0059] FIG. 1 shows an exploded view of a particular inhalation
device according to the invention according to one embodiment of
the invention in the dissembled state.
[0060] FIG. 2 shows an enlarged view of the base unit of FIG.
1.
[0061] FIG. 3 shows an enlarged view of the mouthpiece of FIG.
1.
[0062] FIG. 4 shows an enlarged view of the aerosol head of FIG.
1.
[0063] FIG. 5 shows a three-dimensional rear view of the inhalation
device of FIG. 1 in assembled form.
[0064] FIG. 6 shows a three-dimensional rear view of an alternative
embodiment of the inhalation device in assembled form.
[0065] FIG. 7 shows a top view of the inhalation device of FIG. 1
in assembled form.
[0066] FIG. 8 shows a cross-section of a particular embodiment of
the inhalation device in the assembled state.
[0067] FIG. 9 shows a cross section of the aerosol generator of
FIG. 8.
LIST OF NUMERICAL REFERENCES USED IN THE FIGURES
[0068] 100 Base unit [0069] 101 Air inlet opening [0070] 102 Air
outlet opening [0071] 103 Groove [0072] 104 Key lock member [0073]
105 Sealing member [0074] 106 Indentation [0075] 107 Indentation
[0076] 108 Electrical connector [0077] 109 Electrical connector
[0078] 110 Air channel [0079] 111 Power switch [0080] 112 On/off
indicator [0081] 113 Battery indicator [0082] 114 Connectivity
indicator [0083] 115 Inhalation time indicator [0084] 116 Flow
restrictor [0085] 117 Feedback indicator [0086] 118 Valve [0087]
119 Sensor [0088] 200 Mouthpiece [0089] 200a First segment of
mouthpiece [0090] 200b Second segment of mouthpiece [0091] 201 Air
inlet opening [0092] 202 Lateral opening [0093] 203 Aerosol outlet
opening [0094] 204 Protrusion [0095] 205 Sealing member [0096] 206
Step [0097] 207 Air channel [0098] 300 Aerosol head [0099] 301
Aerosol generator [0100] 302 Reservoir [0101] 303 Key lock member
[0102] 304 Lid [0103] 305 Protrusion [0104] 306 Piezoelectric
transducer body [0105] 306a Upstream end [0106] 306b Downstream end
[0107] 306c Stress concentration zone [0108] 306d Deformation
amplification zone [0109] 307 Cavity containing liquid to be
nebulized [0110] 308 Piezoelectric member [0111] 309 Mesh
DETAILED DESCRIPTION OF THE INVENTION
[0112] The invention provides, inter alia, an inhalation device
comprising a base unit, a mouthpiece, and an aerosol head. The base
unit (100) comprises one or more air inlet opening(s) (101), an air
outlet opening (102), a groove (103) for receiving the mouthpiece
(200), and one or more key lock member(s) (104), e.g. male or
female member(s). The mouthpiece (200) comprises a first segment
(200a), comprising an air inlet opening (201) which may be
attachable to the air outlet opening (102) of the base unit (100),
and a lateral opening (202) for receiving an aerosol generator
(301), the first segment (200a) being insertable into the groove
(103) of the base unit (100), and a second segment (200b)
downstream of the first segment (200a), comprising an aerosol
outlet opening (203). The aerosol head (300) comprises an aerosol
generator (301), a reservoir for a liquid (302), and one or more
male or female key lock member(s) (303) complementary to the male
or female key lock member(s) (104) of the base unit (100). The base
unit (100), the mouthpiece (200) and the aerosol head (300) are
connectable with one another.
[0113] The assembly of the base unit (100) with the mouthpiece
(200) and aerosol head (300) is easily achieved, e.g. by inserting
the first segment (200a) of the mouthpiece (200) into the groove
(103) in the base unit (100), then placing the aerosol head (300)
over said first segment (200a) of the mouthpiece (200) and engaging
the key lock member(s) (303) of the aerosol head (300) with the
complementary member(s) (104) of the base unit (100) by gentle
pressure on both the aerosol head and the base unit. These few
assembling steps will typically create airtight connections between
the base unit's (100) air outlet opening (102) and the air inlet
opening (201) of the mouthpiece's first segment (200a) as well as
between the aerosol generator (301) and the lateral opening (202)
in the mouthpiece's first segment (200a). Moreover, the aerosol
generator (301) is positioned in the aerosol head (300) in such a
way that when engaging the member(s) of the key lock with the
complementary member(s), the aerosol generator (301) is at least
partially inserted into the lateral opening (202) of the first
segment (200a) of the mouthpiece (200).
[0114] The inhalation device according to this invention is
designed to be useful for inhalation therapy. Specifically, it is
for delivering nebulized aerosols to individuals in need thereof.
Such devices are often referred to as nebulizers, which have in
common that they convert a liquid into an aerosol, i.e. into a
system having at least two phases, of which the continuous phase is
gaseous and comprises a dispersed liquid phase in the form of small
liquid droplets. Optionally, the liquid phase may itself represent
a liquid solution, dispersion, suspension, or emulsion.
[0115] Aerosols for inhalation therapy often, but not always,
comprise an active ingredient such as a drug substance useful in
the prevention, management, treatment or alleviation of a disease,
condition or symptom. The drug substance, often also referred to as
drug, active compound, pharmaceutical, active pharmaceutical
ingredient (API), or bioactive agent, may be dissolved, dispersed
or suspended in a liquid--typically aqueous--carrier such as to
form an aerosolizable, or nebulizable, drug formulation. Of course,
the formulation may also comprise two or more active
ingredients.
[0116] The inhalation device enables oral inhalation of the
nebulized aerosol, i.e. inhalation via the mouth, which is
typically the preferred route of administration of aerosols to the
lungs. Preferably, the inhalation device is designed as a
relatively small, hand-held device which may be used either as a
mobile, stand-alone nebulizer or as a handset for an inhalation
system comprising further hardware components such as a control
unit capable of providing a controlled air flow to the inhalation
device, such as to control the inspiratory flow rate and/or
inhalation volume of the individual receiving the aerosol
treatment. In contrast, with a mobile stand-alone device, the
inspiratory flow is normally generated by the user.
[0117] In one embodiment, the shape of the device according to this
invention is roughly cuboidal, optionally with rounded edges. Owing
to the omission of a spacious mixing chamber (as will be described
in further detail below), the dimensions of the device can be
chosen in such a way that the height of the device, with the
aerosol head (300) attached, is not greater, or only marginally
greater than its width when looked at from the front, i.e. the side
facing the user during inhalation. This prevents tilting or tipping
of the device during filling of the reservoir (302) or when put
down in the empty or filled state.
[0118] As mentioned, the inhalation device comprises three major
components which are connectable with one another, i.e. a base unit
(100), a mouthpiece (200) and an aerosol head (300). The base unit
(100) may also be understood as the basis or socket of the device
to which the other components are connected. According to the
invention, the base unit (100) comprises one or more air inlet
opening(s) (101) and an air outlet opening (102).
[0119] Through the outlet opening (102) of the base unit (100), air
flows into the mouthpiece (200) via the air inlet opening (201) of
its first segment (200a). The air outlet opening (102) may, for
example, be circular or elliptical and may, for example, be
positioned in a central region of the base unit (as e.g. shown in
FIG. 1). It may further exhibit a sealing member (105), for example
in form of a gasket, a sealing lip, gaiter, or any other type of
seal, which serves to provide an airtight connection with the air
inlet opening (201) of the mouthpiece (200). Optionally, the base
unit (100) may exhibit more than one air outlet opening.
[0120] The one or more air inlet opening(s) (101) may, for example,
be positioned at the rear side of the device or base unit (100),
e.g. in order to avoid their potential obstruction by the user's
hand during inhalation. As used herein, the rear--or rear
side--means the side or face of the device or device component
which is opposite to the front, or front side, which in turn is the
side or face of the device or device component that faces the user
during inhalation.
[0121] The air inlet opening(s) (101) and the air outlet opening
(102) are typically connected within the base unit (100) such as to
form an air channel (110) wherein, under operational conditions and
during the inspiratory phase of the breathing maneuver of a user,
air flows from the upstream end to the downstream end of the air
channel (110), i.e. from the air inlet opening(s) (101) to the air
outlet opening (102) of the base unit (100).
[0122] The base unit (100) further comprises a groove (103) (or
depression, or canal) which is suitable for receiving the
mouthpiece (200). For the avoidance of doubt, it is not the
complete mouthpiece (200) as such which is accommodated in the
groove (103), but only a portion thereof, e.g. the proximal segment
or first segment (200a). The groove (103) typically extends from
the air outlet opening (102) to the front of the base unit (100)
and preferably has a horizontal orientation.
[0123] The base unit (100) may further exhibit one or more
indentation(s) (106) whose position may be at or near the groove
(103), and which are shaped to receive one or more protrusion(s)
(204) of the mouthpiece (200). In this context, an indentation is a
depression (or recess, or pit, or cavity, or void, or notch) whose
"negative" shape is complementary to the "positive" shape of the
protrusion (or projection, or nose, or bulge). Together, such
indentations and protrusions act as positioning members or
positioning indicators. The indentation, as well as the protrusion,
may be asymmetrical such as to ensure that the component having the
protrusion can only be inserted into the component having the
indentation in one particular manner. In this way, the positioning
members ensure that the device is assembled in such a way that the
position and orientation of the components relative to each other
are correct.
[0124] The base unit (100) may comprise one or more further
indentation(s) (107), for example to receive one or more
protrusion(s) (305) of the aerosol head (300) and/or of the
mouthpiece (200). Such indentations may also function as
positioning members to ensure the correct assembly of the device.
The indentations as well as their complementary protrusions may
optionally be asymmetrical.
[0125] Moreover, the base unit (100) may exhibit one or more
electrical connector(s) (108) for electrically connecting it with
complementary connectors of the aerosol head (300) in the assembled
state. This is particularly important in case the aerosol head
(300) comprises an ultrasonic or piezoelectric aerosol generator
(301), such as a vibrating mesh-type aerosol generator (301).
[0126] The electricity powering the inhalation device may be
supplied, for example, from an internal battery housed within the
base unit (100) or from an external energy source connected to the
base unit (100) via a cable. If the inhalation device is used as a
mobile, stand-alone device, with the inspiratory air flow being
provided by the user, an internal battery is preferred. Optionally,
said internal battery is rechargeable. The recharge may be
performed, for example, via an electrical connector (109), such as
a USB-port, optionally during data transfer between the inhalation
device and an external computer, as will be described further
below. In a further embodiment, the device further comprises a
battery indicator (113) for indicating the status of the battery,
for example a control light, such as an LED. The status of the
battery may, for example, be displayed by a green light ("on" for
sufficient battery power, "off" for insufficient battery power) or
by lights of different wavelengths (green for sufficient battery
power, red for insufficient battery power, yellow indicating that
battery should be replaced or recharged).
[0127] Optionally, the battery indicator (113) as well as other
visual indicators of the inhalation device according to the
invention are LEDs and housed within the base unit (100) in a
"sunk-in" manner, such as not to protrude from the outer casing of
the base unit (100). For example, the outer casing of the base unit
(100) may cover the LEDs completely and may be prepared so as to be
transparent, opaque or translucent at positions where an LED is
placed beneath the casing.
[0128] If the inhalation device is designed as a handset for an
inhalation system comprising further hardware components such as an
external control unit capable of providing a controlled air flow,
the energy supply to the base unit (100) may be received from the
external control unit, for example via an electrical wire, or
cable, attached to the electrical connector (109). Optionally, said
electrical wire or cable, may be housed in a multi-luminal tube
with at least two lumina; a first lumen for an air flow and a
second lumen for holding an electrical wire. Such a multi-luminal
tube may be used advantageously to supply, via one and the same
tube, electrical energy as well as controlled air flow from the
external control unit.
[0129] As mentioned, the base unit (100) exhibits one or more
member(s) of a key lock (104), such as one or more male or female
key lock members. The member(s) are complementary to the key lock
member(s) (303) of the aerosol head (300). As used herein, a key
lock is a releasable mechanical connection formed by two specific
complementary members. Typically, the members are somewhat
flexible, and one of the members (often referred to as "male") is
inserted, clicked or hooked into, and/or caught by, the other
member (often referred to as "female"). Release is usually very
easy and achieved e.g. by slightly pressing the key lock, or one of
the key lock members, such as in the case of a snap-fit
connection.
[0130] Moreover, a key lock can be further customized in that based
on the same general connecting male-female-principle particular
shapes can be used for the key lock members which are only
compatible with specifically complementary members. For example,
there could be key locks of different width. In this manner, it can
be prevented that components are assembled which belong to
different devices or device versions. For example, an aerosol head
(300) with an aerosol generator (301) which is specifically adapted
for the delivery of a particular drug formulation (for example, by
incorporating a vibrating mesh with a specific pore size) cannot be
connected with a base unit (100) which is customized for the
delivery of a different medicine (which may, for example, require a
specific, preset flow rate), if the respective device versions
exhibit key locks with different shapes. Thus the key locks may
contribute not only to user convenience in terms of easy of device
assembly and disassembly, but also to drug safety and the avoidance
of medication errors.
[0131] Optionally, the approach of choosing key locks of different
particular shapes for different device versions may be complemented
by the use of different colors and/or patterns. For example, a
colored stripe may be printed horizontally around the base unit
(100) in such a way that said stripe is only complete, or not
interrupted, (i.e. running 360.degree. all around the inhalation
device) when the appropriate, complementary aerosol head (300) is
attached to the base unit (100) and key lock members are engaged.
Thus, different customized versions of the inhalation device, e.g.
one having a thick red stripe, the other having a thin, green
stripe, would also be easily distinguishable in a visual
manner.
[0132] Optionally, the base unit (100) has two key lock members
located at the two opposing left and right lateral vertical sides,
or faces, of the base unit. As used herein, lateral, or laterally,
means away from the middle, center, or center axis of the
respective device or device component. Left and right should be
understood from the perspective of the user holding the device
appropriately under operational conditions. Positioning the key
lock members on the opposing lateral vertical sides means that the
device can be easily and conveniently disassembled by exerting
gentle pressure on the key locks, holding the device between the
thumb and e.g. the forefinger or the middle finger.
[0133] Optionally, the two key lock members (104) located at two
opposing sides, or faces, of the base unit (100) are of identical
shape, for example female key lock members of the same width on
both left and right side. This allows for easier production of the
base unit (100). However, they may also have different shapes, for
example on one side a male, on the other a female member or a
different width on each side, in order to prevent the attachment of
the aerosol head (300) in a wrong orientation. Typically, the
correct orientation of the aerosol head (300) is also assured by
positioning members, such as e.g. an indentation (107) and a
protrusion (305), as described above.
[0134] In one embodiment, the base unit (100) further comprises a
means, such as a power switch (111), or button, to turn the
inhalation device on or off; in particular where the device is
designed as a mobile, stand-alone inhalation device where the user
generates the inspiratory flow. In this case, the device may also
comprise an on/off indicator (112), such as a control light, to
show the on/off status of the base unit (100). The control light
may be incorporated in the power switch (111), or button, or
positioned in close vicinity of the button or switch.
[0135] When the inhalation device according to the invention is
designed as a mobile, stand-alone device with the inspiratory flow
being generated by the user, the base unit (100) further comprises
an internal control unit which is capable of controlling or
limiting the inspiratory air flow with regard to flow rate and
inhalation volume, monitoring the patient's breathing pattern and
providing a feedback, optionally visually, to the patient during
inhalation.
[0136] Moreover, the control unit includes a storage means to store
data such as target values or target ranges for inhalation
parameters, records of a patient's breathing pattern during each
inhalation treatment, which may be used for later analysis, such as
compliance monitoring and/or therapy adjustments. All stored data
can further be transferred to an external data handling device, for
example a computer or a mobile phone, either wireless, e.g. via a
Bluetooth connection, or via a cable connection with the electrical
connector (109).
[0137] Optionally, the inhalation device is equipped with an
electrical connector (109) in the form of a USB-port to allow
attachment of a USB-cable which may serve as a data transfer means
and/or as a recharge means for the above mentioned internal battery
of the device.
[0138] As mentioned, the inhalation device may be equipped with a
Bluetooth connectivity. In this case, the device may also comprise
a connectivity indicator (114), such as a control light, for
example an LED, to indicate the active/inactive status of the
Bluetooth component. Such Bluetooth connections may be used to
transfer data from the inhalation device of the patient to the
computer of a caregiver, e.g. medicinal staff or doctor.
[0139] In a preferred embodiment, the device further comprises a
flow restrictor (116), e.g. as described in EP 2 283 887 B1 and
incorporated herein by reference, to restrict, control and/or
regulate the inspiratory air flow of the patient, or to assist the
patient to adopt a useful inspiratory flow rate. The flow
restrictor (116) is designed to enable the patient or user to
achieve a preset specific target value, for example 15 L/min, or
target range, such as from 12 to 18 L/min. These flow rates are
rather low compared to the inspiratory flow rates many patients use
intuitively, especially when accustomed to pressurized metered dose
inhalers and/or dry powder inhalers. Relatively low flow rates may
however increase the fraction of inhaled drug which is deposited in
the deeper, peripheral airways of the lungs, at the same time
reducing oropharyngeal side effects. Thus they are considered
beneficial in certain therapeutic settings.
[0140] The base unit (100) may further comprise a valve (118), such
as a ball valve, which may be positioned within the air channel
(110) of the base unit (100). Optionally, the valve (118) is
electrically operated and capable of opening and closing the air
channel (110). For example, the valve (118) may be adapted to close
the air channel (110) after a preset inhalation time. If the air
flow rate is controlled, the preset inhalation time would
correspond to a specific inhalation volume.
[0141] Optionally, the device may be used for performing
individual, patient-specific inhalation therapy using a preset
inhalation time and/or inhalation volume which takes
patient-specific parameters into account. For example, at the start
of inhalation therapy, the patient may be subjected to an
examination in order to assess the patient's forced expiratory
volume in one second (FEV1) or inspiratory capacity (IC), which may
then be used to calculate optimal treatment parameters for the
respective patient. In this context, the method described in EP 2
067 497 A1 may be used.
[0142] Once the inhalation volume is selected, the respective
inhalation time may be calculated in accordance with the preset
target flow rate, such as 15 L/min. Thus, an inhalation volume of 1
L would correspond to a preset inhalation time of 4 seconds, after
which the valve (118) shuts the air channel (110) off. The
preselected inhalation time (or the actually remaining inhalation
time) may be indicated to the patient by an inhalation time
indicator (115), such as a light, which may be positioned close to
the rear and/or at the top of the base unit (100). Optionally, a
plurality of inhalation time indicators (115), such as LEDs, may be
used whose number may correspond to a certain duration, for example
one LED for every second of inhalation time. Alternatively, a
particular indicator from a plurality of indicators may be used to
indicate a specific preselected inhalation time. For example, a
preset inhalation time of 6 seconds may be indicated by indicator
number 6 being on.
[0143] In a further embodiment, the inhalation device may further
comprise a feedback system to indicate to the user whether (or to
what extent) an inhalation maneuver is being performed in such a
way that a target parameter, such as a particular inspiratory flow
rate, is complied with. The feedback system may be designed and
configured as described in European Patent application 11195773.4,
which is incorporated herein by reference. This feedback system
will guide the user to perform inhalation maneuvers in an optimized
manner with respect to predetermined values and/or ranges for
inhalation parameters such as inspiratory flow rate, pressure,
inspiration time, and/or inhaled volume. At least one of said
inhalation parameters is selected from inspiratory flow rate and
inhaled volume. Optionally, the feedback provided to the patient is
acoustic, visual and/or tactile. One or more feedback signals may
be provided for different inhalation parameters. The feedback
system facilitates correction or adaptation of the inhalation
maneuver by the user by indicating to the user means of feedback
signal(s) whether the actual value of the inhalation parameter
matches the predetermined target value or range. This may help to
ensure the deposition of the inhaled aerosol in the target regions
of the respiratory system.
[0144] The feedback system may include one or more sensor(s) (119)
for sensing air pressure or air flow rate capable of generating a
sensor signal in response to an actual value of flow rate and/or
inhaled volume during the inhalation maneuver, an electronic memory
capable of storing one or more target values and/or target ranges
for flow rate and/or inhaled volume, one or more feedback
indicator(s) (117) capable of emitting an output signal, and a
controller capable of receiving the sensor signal(s) generated by
the one or more sensor(s) (119), reading the electronic memory, and
controlling the one or more feedback indicator(s) (117). The
feedback system is configured to indicate to a user during an
inhalation maneuver by means of the output signal(s) whether the
actual value of the flow rate and/or inhaled volume is within a
target range.
[0145] The one or more sensor(s) (119), for example pressure
sensor(s) and/or flow sensor(s), sense the actual value of an
inhalation parameter during inhalation and generate a signal
corresponding to this value. For example, one or more flow
sensor(s) may provide direct information on the flow rate which, by
means of the internal clock included in the control unit, can be
transferred into an indirect value for the inhaled volume. Flow
rate values may further be obtained indirectly from pressure values
provided by one or more pressure sensors, using calibration curves.
The sensor signal(s) are sent to the controller where they will be
compared to one or more predetermined target values and/or target
ranges stored in the electronic memory. The one or more sensor(s)
(119) are positioned within or in communication with an air channel
(110, 207) of the inhalation device, whether within the base unit
(100) or the mouthpiece (200). Accommodating the sensor(s) (119)
within the base unit (100) offers the advantage of better
protection and makes it easier to provide it/them with electrical
connections.
[0146] The controller of the feedback system operates, or controls,
the one or more feedback indicator(s) (117) in response to the
signal(s) received by the one or more sensor(s) (119). The
controller and its electronic memory are integral parts of the
internal control unit housed within the base unit (100) of the
mobile, stand-alone inhalation device according to the invention.
Same applies to the internal clock which is required to measure
inspiration time and/or to calculate indirect parameters, such as
the inhaled volume from the flow rate.
[0147] The one or more feedback indicators (117) may, for example,
comprise light sources, such as light-emitting diodes. For example,
a light could be switched on when the patient's inhalation flow
rate is within the preset target range of e.g. 12-18 L/min.
Preferably, the feedback signal(s) provide a gradual feedback, for
example, indicating i) whether the patient inhales at a flow rate
falling within a preset operational range of the device, such as
from 1-30 L/min; ii) whether the patient inhales at a flow rate
falling within a preset optimal target range such as 12-18 L/min
and/or iii) whether the patient inhales at a flow rate very close
to a preset target value such as 15 L/min. Optionally, this gradual
feedback is achieved visually by, for example, a green light of
different intensity, with the light intensity reaching its highest
value when the patient inhales at the most preferred flow rate
target value. Such a gradual feedback enables the patient
immediately, during each single inhalation, to adapt and correct
his inspirational flow rate whenever necessary.
[0148] The mouthpiece (200) receives the nascent aerosol from the
aerosol generator (301). In the mouthpiece (200), the aerosol is
mixed or diluted with air while being carried downstream, and from
the downstream end of the mouthpiece (200) the aerosol is
eventually emitted via the aerosol outlet opening (203) and
delivered to the mouth of the user. In the context of the
invention, the mouthpiece (200) is understood as having a first
segment (200a) which is insertable into the groove of the base unit
(100) and a second segment (200b), which is downstream of the first
segment (200a) and which extends from the base unit (100). For the
avoidance of doubt, it is not necessary that the first (200a) and
the second (200b) segments are separate parts. The first segment
(200a) and the second segment (200b) may be made from the same or
different materials. Optionally, they are made from an opaque or
translucent material, such as opaque or translucent
polypropylene.
[0149] The air channel (207) of the mouthpiece (200), which forms
the downstream segment of the air channel of the inhalation device,
extends from the air inlet opening (201) at the upstream end to the
aerosol outlet opening (203) at the downstream end of the
mouthpiece (200). The cross section of the air channel (207) may
have an elliptical or circular shape. Advantageously, the shape and
dimensions of the air inlet opening (201) match those of the air
outlet opening (102) of the base unit (100) in order to allow an
airtight connection. For this purpose, the air inlet opening (201)
may be connectable with, or insertable into the air outlet opening
(102), optionally via a sealing member (105), for example in form
of a gasket, a sealing lip, gaiter, or any other type of seal,
which serves to provide an airtight connection. The orientation of
the air inlet opening (201) may be approximately vertical
(.+-.10.degree.) and thus about perpendicular to the direction of
air flow. Optionally, the air inlet opening (201) may be covered
with a mesh or filter, which should preferably exhibit a low flow
resistance.
[0150] The mouthpiece (200) further comprises a lateral opening
(202) for receiving the aerosol generator (301). The lateral
opening (202) is preferably positioned at or near the upper side of
the first segment (200a) of the mouthpiece (200). The shape of the
lateral opening (202) may be circular. It may further comprise a
sealing member (205), for example in form of a gasket, a sealing
lip, gaiter, or any other type of seal, which serves to provide an
airtight contact with the aerosol head (300), or with the aerosol
generator (301), respectively. The orientation of the lateral
opening (202) may be approximately horizontal and perpendicular to
the plane of the air inlet opening (201).
[0151] As mentioned, the nascent aerosol from the aerosol generator
(301) is introduced into the air channel (207) where it is diluted,
or mixed, with the air flowing through the air channel (207). Thus,
the air channel (207), or the respective region of the air channel
(207) of the mouthpiece (200), may also be referred to as a mixing
channel. The shape and dimensions of the air channel (207), or
mixing channel, may be selected as described in European Patent
application 12158852.9, which is incorporated herein by reference.
Following the guidance provided in this document results in a
homogenous distribution of droplets in the nascent aerosol and a
reduced loss of aerosol droplets in the inhalation device due to
coalescence and/or deposition within the device by impaction and/or
sedimentation.
[0152] However, since deposition losses can never be completely
avoided, such depositions should be removed by cleaning regularly,
e.g. by thoroughly rinsing all affected parts with tap water. Since
the nascent aerosol enters directly into the first segment (200a)
of the mouthpiece (200) through the lateral opening (202) and
immediately gets carried downstream towards the aerosol outlet
opening (203) it does not come in contact with the base unit (100).
Hence, the base unit (100) stays free of undesirable aerosol
depositions. This advantageously avoids the need to rinse the base
unit (100) which houses the water-sensitive electronics.
[0153] In particular, the air channel (207), or mixing channel, may
be shaped to include a step (206) on its inner circumferential
surface. This step (206), which may be defined as an abrupt change
in the cross sectional area at a longitudinal locus or within a
short longitudinal section, creates a discontinuity in the
direction of the air flow. Preferably, the cross sectional area
decreases abruptly at the injection zone where the aerosol droplets
are introduced from the aerosol generator (301) into the air
channel (207). The step (206) is positioned adjacent to the
downstream end (306b) of the aerosol generator (301) which may
protrude into the air channel (207). Optionally, the step (206) may
also be formed by said downstream end (306b) of the aerosol
generator (301) itself. The abrupt decrease of the cross sectional
area within the injection zone will accelerate the air flow in the
narrowed, or constricted, region and cause turbulences. While the
turbulences ensure sufficient mixing of the nascent aerosol
droplets with air, the accelerated air flow reduces the density of
the nascent aerosol by increasing the distance between the
individual droplets in the direction of the air flow and thus
avoids undesirable coalescence. The magnitude of the turbulences
and the air flow acceleration correlates with the degree to which
the step (206) extends, or protrudes, into the air channel (207),
or mixing channel; a 50% decrease, for example, provides sufficient
mixing while at the same time avoiding aerosol particle impaction
and/or coalescence. Owing to this type of mixing channel, more
spacious mixing chambers can be avoided, thereby reducing the
dimensions of the inhalation device. Specifically, the height of
the device can now be chosen in way as to not exceed, or only
marginally exceed its width, when looking at the front side. It
should be noted that the step (206) in the inner circumferential
surface is independent of the air channel's (207) outer
circumferential surface; i.e. the outer walls of the air channel
(207) may not always reflect the step (206).
[0154] Downstream of the narrowed, or constricted, region within
the injection zone, the air channel (207) preferably widens like a
truncated cone in order to decelerate the air flow to a flow rate
at the aerosol outlet opening (203) which is suitable for
inhalation, and which helps to avoid or at least to reduce
deposition of the aerosol droplets on the inner wall of the air
channel (207). Such deposition may be further reduced by suitable
anti-static coatings on the inner wall. Again, the increasing cross
sectional inner surfaces of the truncated cone shaped air channel
(207) may not reflect in the cross sectional outer surfaces.
[0155] The mouthpiece (200) further has an aerosol outlet opening
(203), whose shape may be elliptical or circular, positioned in the
second segment (200b) at the downstream end of the air channel
(207). The orientation of the aerosol outlet opening (203) may be
approximately vertical in normal mode of use. The dimensions of the
downstream end of the second segment (200b) and of the aerosol
outlet opening (203) are chosen in such a way that the patient can
easily place this part of the mouthpiece (200) in his mouth while
ensuring that the mouth is opened widely enough for optimal aerosol
administration. Optionally, mouthpieces with a slightly smaller
downstream end of the second segment (200b) may be provided for
toddlers and children.
[0156] As mentioned before, the aerosol head (300) comprises an
aerosol generator (301), a reservoir for a liquid (302) and one or
more key lock member(s) (303) which may be male or female, and
which are complementary to the key lock member(s) (104) of the base
unit (100), so that the base unit (100) and the aerosol head (300)
are easily connectable via a simple key lock, or snap-fit,
connection. The aerosol head (300) may be shaped in such a way
that, in an assembled state of the inhalation device, it covers any
voids created by the groove (103) and/or indentations (106, 107)
which are not already covered by the inserted first segment (200a)
of the mouthpiece (200).
[0157] The aerosol head (300) comprises, at its upstream end, a
reservoir (302) for holding a liquid to be nebulized, which is in
fluid contact with the upper end of the aerosol generator (301).
The reservoir (302) is optionally shaped as a funnel, or truncated
cone, or a tapered cylinder, with the narrower end transitioning
into the upstream end (306a) of the aerosol generator (301), such
as to ensure easy, gravity-driven liquid flow from the reservoir
(302) into the aerosol generator (301). If the dimensions of the
inhalation device are chosen such that the height does not exceed,
or only marginally exceeds, the width (when looked at from the
front), tilting or tipping of the inhalation device during the
filling of the reservoir (302) are prevented. Spillage of the
liquid drug formulation during use, or its contamination, is
preferably prevented by a lid (304) which closes the upper end of
the reservoir (302). Preferably, the lid (304) is a removable cap,
such as a screw cap, a hinged flip-top lid or a removable snap-on
lid with sealing lips.
[0158] The aerosol head (300) further comprises an aerosol
generator (301) which may be positioned centrally in the aerosol
head (300) in such a way that when engaging the male or female key
lock member(s) (303) of the aerosol head (300) with the
complementary key lock member(s) (104) of the base unit (100), the
aerosol generator (301) is at least partially inserted, with its
downstream end (306b), into the lateral opening (202) of the first
segment (200a) of the mouthpiece (200). Preferably, the aerosol
generator (301) is a vibrating mesh-type aerosolizer comprising a
mesh (309), or micro-perforated membrane, capable of vibration
wherein a nebulized aerosol is generated.
[0159] An example of a particularly useful aerosol generator is
described in WO 2008/058941 A1, which is incorporated herein by
reference. This device is an ultrasonic liquid atomizer comprising
a piezoelectric transducer body (306), for example made of
stainless steel, titanium or aluminum, which encloses a cavity
(307) for containing the liquid to be atomized. The transducer body
(306) and the cavity (307) are symmetrical along the axis X. The
cavity (307) is arranged to be in fluid contact with the reservoir
(302) so as to receive liquid to be nebulized from the reservoir
(302).
[0160] The piezoelectric transducer body (306) further comprises a
piezoelectric member (308), preferably an annular single or
multilayer ceramic, which vibrates the piezoelectric transducer
body (306) in a longitudinal mode, at a frequency preferably in the
50 to 200 kHz range. As a result, micronic longitudinal
displacements, or deformations, occur in a direction parallel to
the transducer body's (306) symmetry axis X. The piezoelectric
transducer body (306) exhibits a region close to the piezoelectric
member (308) with a relatively large wall thickness, which serves
as a stress concentration zone (306c), and a region downstream
thereof with a relatively low wall thickness which serves as a
deformation amplification zone (306d). In this configuration, the
vibrations or deformations of the piezoelectric transducer body
(306) caused by the piezoelectric member (308) are amplified.
Preferably, the piezoelectric member (308) is located at the level
of, or adjacent to, the stress concentration zone (306c). The
internal diameter of the transducer body (306) at the deformation
amplification zone (306d) may be the same as at the stress
concentration zone (306c), so that the differences in wall
thickness correspond to different external diameters.
Alternatively, the external diameter of the transducer body (306)
may be constant, while the inner diameters differ at the position
of the two zones.
[0161] A mesh (309), or micro-perforated membrane, may be
positioned at the downstream end (306b) of the transducer body
(306). The micro-perforations may be formed by electroforming or by
laser drilling, with openings normally being in the range from
about 1 .mu.m to about 10 .mu.m. Without vibration of the mesh
(309), the balance of pressures, the shape of the holes and the
nature of the material used for the mesh (309) are such that the
liquid does not seep out through the mesh (309). However, vibration
of the mesh (309) leads to the formation and emission (or
extrusion) of aerosol droplets through the mesh (309). The mesh
(309) may be made of plastic, silicon, ceramic or more preferably
metal, and may be affixed to the downstream end (306b) of the
aerosol generator (301) by various means, such as gluing, brazing,
crimping or laser welding. Optionally, the mesh (309) at least
partially forms a dome in its central region, which causes the jet
of nascent aerosol droplets to diverge and hence reduces the risk
of droplet coalescence.
[0162] The aerosol head (300) may receive electrical power and
signals for operating and controlling the aerosol generator (301)
from the base unit (100) via electrical connectors which connect
with the electrical connectors (108) of the base unit in the
assembled state.
[0163] As described earlier, the aerosol head (300) further
comprises male or female key lock member(s) (303) which are
complementary to the key lock member(s) (104) of the base unit
(100). In one embodiment, the aerosol head (300) has two key lock
members (303) located at the two opposing left and right lateral
vertical sides, or faces, of the aerosol head (300). This offers
the advantage that base unit (100) and aerosol head (300) are
easily detachable from one another by gently pressing both sides
with e.g. thumb and index finger. With respect to the shapes,
dimensions and customization options of the key lock member(s)
(303), reference is made to the respective discussion in the
context of the key lock member(s) (104) of the base unit (100).
[0164] As explained above, the inhalation device of the invention
brings about substantial advantages. Due to the small number of
major components, it is easy for a user to assemble the device and
prepare it for an inhalation treatment session. This is convenient
and time-saving, but also adds to the coherence of patients to
their prescribed therapy. It reduces the risk that a patient who
might find it generally difficult to assemble a device, for example
an elderly or sick person, becomes discouraged with the device or
even discontinues the prescribed inhalation therapy. Quick and easy
disassembly is just as important as the user, or patient, will find
it easier to clean and disinfect the device regularly, as needed.
It is noted that patients who do not regularly clean and/or
disinfect their inhalation device are at an increased risk of
developing an infection or superinfection of the respiratory
system, or a part thereof.
[0165] Moreover, the inhalation device of the invention, in
particular with its preferred embodiments, ensures the correct
assembly of the device. For example, the special configuration of
the main components ensure that when the key locks are engaged, the
aerosolizer is automatically in the correct position, and all
important members of the device have the correct orientation. Thus,
the risk of major user errors potentially leading to device
malfunction or even lack of delivery of the aerosolized medicament
to the patient is greatly reduced.
[0166] Another advantage of the invention is that is provides an
excellent platform for efficient and cost-effective customization.
On the one hand, customization is a feature enhancing drug safety.
For example, a particular aerosol head adapted for the inhalation
therapy with a first medicament (e.g. with respect to the
dimensions of the reservoir or of the opening of its vibratable
mesh) may be customized by means of a special shape or geometry of
its key lock member(s) so that it can only be assembled with the
correct base unit which is also adapted (and e.g. programmed) for
the delivery of this medicament, and cannot be combined with a
different base unit adapted for the delivery of another medicament.
This is an important safety issue since it is of course possible
that the same patient, or another member of the same household, has
also a prescription for another inhalable medicament. On the other
hand, customization needs to be economically feasible, which is the
case with the present invention as the same device may be
manufactured in several customized versions which share many basic
device components.
[0167] Moreover, the low number of main components that must be
assembled for use requires that only few airtight connections must
be established during assembly, thus increasing the overall
airtightness of the assembled device, which in turn enhances it
reproducible functionality and delays the occurrence of air leaks
through wear over time.
[0168] Certain embodiments of the invention are now explained with
reference to FIGS. 1 to 7.
[0169] FIG. 1 shows an exploded view of a particular inhalation
device according to the invention, comprising a base unit (100), a
mouthpiece (200) and an aerosol head (300). The base unit (100) is
roughly shaped like a flat, rounded cuboid, exhibiting a groove
(103) for receiving the mouthpiece (200). An air outlet opening
(102) is positioned in a central region of the base unit (100).
From this perspective, no air inlet opening(s) (101) can be seen. A
female key lock member (104) is seen on the left hand side (seen
from the perspective of the user during inhalation), whereas
another key lock member on the right hand side is partially hidden.
The mouthpiece (200), which is partially insertable into the groove
(103) of the base unit (100), exhibits an air inlet opening (201)
at its upstream end and an elliptical aerosol outlet opening (203)
at its downstream end. In an upper position of the mouthpiece
(200), a lateral opening (202) is present. The aerosol head (300)
has two male key lock members (303), one on each of the left and
right hand side of the aerosol head (300). From the aerosol
generator (301), only the bottom part is visible. The reservoir
(302) is located in the upper region of the aerosol head (300). A
lid (304) is screwable onto the aerosol head (300) such as to cover
the reservoir (302). Correct assembly of the inhalation device is
easily and conveniently achievable by inserting the mouthpiece
(200) into the groove (103), which will cause the aerosol generator
(301) to be partially inserted into the lateral opening (202) of
the mouthpiece (200), and gently pressing the aerosol head (300)
onto the main body (100) in such a way that the male key lock
members (303) of the aerosol head (300) engage with the female key
lock members of the main body (100). After filling a liquid to be
aerosolized into the reservoir (302), the reservoir (302) may be
closed with the screw-on lid (304). For disassembly, the male key
lock members (303) are gently squeezed for disengagement, and the
aerosol head (300) may be lifted off from the main body (100).
[0170] FIG. 2 shows an expanded view of the base unit (100) of FIG.
1. It illustrates a ring-shaped sealing member (105) of the air
outlet opening (102) which ensures an airtight connection with the
mouthpiece. Moreover, indentations (106, 107) are shown which are
designed as positioning members in that they are shaped to receive
corresponding protrusions of the mouthpiece and of the aerosol
head. The base unit (100) further exhibits two electrical
connectors (108) for connecting the aerosol head to the base unit
(100).
[0171] FIG. 3 shows an expanded view of the mouthpiece (200) of
FIG. 1, having a first segment (200a) and a second segment (200b)
downstream of the first segment. The first segment (200a) is shaped
such as to be insertable into the groove of the base unit, whereas
the second segment (200b) is not insertable. The mouthpiece (200)
further exhibits a positioning member shaped as a protrusion (204),
which is complementary to an indentation of the base unit. The
circular lateral opening (202) is equipped with a ring-shaped
sealing member (205) to ensure a tight connection with the aerosol
generator.
[0172] FIG. 4 shows an expanded view of the aerosol head (300) of
FIG. 1, exhibiting a positioning member in the form of a protrusion
(305) which matches a corresponding indentation of the base
unit.
[0173] FIG. 5 shows a three-dimensional rear view of the inhalation
device of FIG. 1 in assembled form. In the rear of the device,
several air inlet openings (101) and an electrical connector (109),
here in the form of a USB port, can be seen.
[0174] FIG. 6 shows a three-dimensional rear view of an alternative
embodiment of the inhalation device, exhibiting multiple air inlet
openings (101) and an electrical connector (109) for connecting the
device with an external control unit or other hardware component
via a multi-luminal tube.
[0175] FIG. 7 gives a top view of the inhalation device of FIG. 1
in assembled form. It illustrates how a base unit (100) may be
equipped to have a power switch (111) with an integrated on/off
indicator (112) for manually switching the inhalation device on and
off and verifying the status of the device; a battery indicator
(113) for indicating the status of the battery; a connectivity
indicator (114) for indicating the availability and/or status of a
data connection e.g. to an external computer or mobile phone; eight
inhalation time indicators (115) for indicating the preset
inhalation time per breathing maneuver; two feedback indicators
(117) in the form of LEDs incorporated in the frontal part of the
base unit (100) to indicate to the user whether or to what extent
an ongoing inhalation maneuver conforms to a target parameter such
as a target inspiratory flow rate.
[0176] FIG. 8 shows a longitudinal, vertical cross-section of a
particular embodiment of the inhalation device in the assembled
state. It illustrates how the first segment (200a) of the
mouthpiece (200) is accommodated within the base unit (100),
whereas the second segment (200b) extends from it such that it can
be placed into the mouth of a user. The aerosol generator (301) is
partially inserted into the air channel (207) of the mouthpiece
(200) so that its downstream end (306b) reaches a position near the
longitudinal center axis (not shown) of the air channel (207)
within the first segment (200a). Upstream of the inserted portion
of the aerosol generator (301), the air channel (207) exhibits a
much larger cross-sectional area than downstream. Here, the
narrowing of the air channel (207) is abrupt in the form of a step
(206). Towards the downstream end of the mouthpiece (200), the air
channel (207) widens such as to form a tapered cylinder or
truncated cone. The air inlet opening (201) of the mouthpiece (200)
is connected to the air outlet opening (102) of the base unit
(100). The Figure also shows a sensor (119), such as a pressure or
flow sensor, which is positioned to be in communication with the
air channel (110) of the base unit (100). A valve (118), in this
case in the form of a ball valve, is positioned within the air
channel (110) of the base unit (100) such as to be able to shut off
any air flow within the air channel (110). Further upstream, a flow
restrictor (116) is positioned to restrict the air flow, which is
configured to prevent undesirably high flow rates and/or to make it
easier for a user to breathe slowly. Also shown is the position and
tapered shape of the reservoir (302) in the aerosol head (300),
which is closed by a screw-on lid (304).
[0177] FIG. 9 shows a cross section of the aerosol generator (301)
of FIG. 8, comprising a transducer body (306) having a stress
concentration zone (306c) and a deformation amplification zone
(306d), an upstream end (306a) and a downstream end (306b). The
wall thickness of the stress concentration zone (306c) is
considerably larger than that of the deformation amplification zone
(306d), and while the internal diameter is substantially the same
for both zones, their external diameters differ. A piezoelectric
member (308) is located in the position where the two zones meet.
The upstream end (306a) of the transducer body (306) is connected
to the reservoir (302) for holding the liquid to be nebulized.
Moreover, the longitudinal center axis (X) is shown.
* * * * *