U.S. patent application number 14/266145 was filed with the patent office on 2014-10-02 for inhalation therapy device with a nozzle nebuliser.
This patent application is currently assigned to Pari GmbH Spezialisten fur effektive Inhalation. The applicant listed for this patent is Pari GmbH Spezialisten fur effektive Inhalation. Invention is credited to Vera KREUTZMANN, Frank KUMMER, Markus MORNHINWEG, Sven ROSENBEIGER, Titus SELZER.
Application Number | 20140291888 14/266145 |
Document ID | / |
Family ID | 34442023 |
Filed Date | 2014-10-02 |
United States Patent
Application |
20140291888 |
Kind Code |
A1 |
KREUTZMANN; Vera ; et
al. |
October 2, 2014 |
INHALATION THERAPY DEVICE WITH A NOZZLE NEBULISER
Abstract
The invention relates to an inhalation therapy device with a
nozzle nebuliser, in particular with a nozzle nebuliser having a
nozzle element which is easy to clean and is thereby simple and
reliable to handle so that the nozzle is not damaged and the
geometry of the nozzle is not affected during cleaning. The aerosol
generator comprises a nozzle element, said nozzle consisting of at
least a first part and a second part, said first part of the nozzle
element being made of a more resilient material than said second
part of the nozzle element, and said first part of the nozzle
element being attached to said second part of the nozzle element.
Owing to the resilient material, the nozzle can deform during
cleaning and can return to the original shape without altering its
initial geometry.
Inventors: |
KREUTZMANN; Vera; (Seefeld,
DE) ; KUMMER; Frank; (Oberschleissheim, DE) ;
MORNHINWEG; Markus; (Diessen, DE) ; ROSENBEIGER;
Sven; (Starnberg, DE) ; SELZER; Titus;
(Munich, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Pari GmbH Spezialisten fur effektive Inhalation |
Starnberg |
|
DE |
|
|
Assignee: |
Pari GmbH Spezialisten fur
effektive Inhalation
Starnberg
DE
|
Family ID: |
34442023 |
Appl. No.: |
14/266145 |
Filed: |
April 30, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10575933 |
Nov 15, 2006 |
8739777 |
|
|
PCT/EP2004/010140 |
Sep 10, 2004 |
|
|
|
14266145 |
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Current U.S.
Class: |
264/250 |
Current CPC
Class: |
B05B 7/0012 20130101;
B05B 15/528 20180201; A61M 15/009 20130101; A61M 2206/14 20130101;
B05B 7/2435 20130101; A61M 15/0021 20140204; A61M 11/06 20130101;
A61M 11/002 20140204 |
Class at
Publication: |
264/250 |
International
Class: |
A61M 15/00 20060101
A61M015/00 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 16, 2003 |
DE |
103 48 237.7 |
Claims
1. A method for making an inhalation therapy device, the method
comprising: forming a nebulizing chamber; forming an aerosol
generator arranged to release an aerosol into the nebulizing
chamber with a medicament, the aerosol generator comprising a
nozzle and an outer member; forming the nozzle from a first part
and a second part, said first part of the nozzle comprising a
resilient deformable material, and including a deformable tip
having a nozzle outlet with a nozzle edge configured to deliver a
reproducible droplet spectrum of said aerosol through the nozzle
outlet; forming the second part of the nozzle; molding the first
part of the nozzle on the second part of the nozzle; the first part
of the nozzle tapering from the second part with a cross-section of
the first part converging to the deformable nozzle tip; and placing
a removable outer member in the nebulizing chamber to define at
least one medicament channel extending between the nozzle and an
outer member and in fluid communication with the nozzle outlet.
2. The method according to claim 1, comprising forming the first
part of the nozzle of a reversible deformable material, wherein the
nozzle outlet widens in dependence on flow through the nozzle
outlet so that a stable state is established between flow and
medicament sucked into the flow.
3. The method according to claim 1, wherein the first part of the
nozzle is produced with the second part of the nozzle in a
two-component method, comprising molding the first part of the
nozzle on the second part of the nozzle.
4. The method according to claim 3, comprising making said first
part of the nozzle from a more resilient material than the second
part.
5. The method according to claim 1, comprising making said first
part of the nozzle from a more resilient material than the second
part.
6. The method according to claim 1, comprising molding the first
part and the second part from two different materials.
7. The method according to claim 1, wherein the forming of the
nozzle comprises injection molding the first part and attaching to
the second part to form a nozzle assembly.
8. The method according to claim 7, comprising fixedly connecting
the first and second parts so that the transitions between the
first part and the second part are free of steps, indentations or
gaps.
9. The method according to claim 1, wherein the first part of the
nozzle is silicone rubber or a thermoplastic elastomer (TPE).
10. The method according to claim 1, wherein the second part of the
nozzle comprises polyethylene or polypropylene.
11. The method according to claim 1, comprising making the first
part of the nozzle with a cross-section which tapers further than a
cross-section of the second part of said nozzle.
12. The method according to claim 1, wherein the first part of the
nozzle consists of a resilient material resuming original geometry
following deformation.
13. The method according to claim 1, comprising molding the nozzle
edge so as to be reversibly deformable.
Description
[0001] This application is a continuation of U.S. application Ser.
No. 10/575,933, filed 15 Nov. 2006, which is a national stage
application of PCT/EP2004/010140, filed 10 Sep. 2004, which claims
benefit of Ser. No. 103 48 237.7, filed 16 Oct. 2003 in Germany,
and which applications are incorporated herein by reference. To the
extent appropriate, a claim of priority is made to each of the
above disclosed applications.
[0002] The invention relates to an inhalation therapy device with a
nozzle nebuliser, in particular with a nozzle nebuliser having a
nozzle element which is easy to clean and is thereby simple and
reliable to handle.
[0003] Inhalation therapy devices are used to administer suitable
medicaments in the form of an aerosol to patients suffering from
disorders of the respiratory tract. By adjusting the droplet size
owing to a corresponding design of a nebuliser, it is possible to
control those sites (pharynx, bronchi, lungs) at which the
medicament is supposed to be deposited. The patient inhales the
nebulised medicament through his mouth via a mouthpiece in order to
adapt the inhalation therapy device to the patient to an optimum
extent.
[0004] In order to generate the aerosol with a desired droplet
spectrum, it is necessary to precisely realise the geometry of the
nebuliser or aerosol generator in order to avoid deviations and
modifications over the lifespan of the inhalation therapy device.
The geometry of the nozzle element has an essential role in this
regard, the nozzle element being part of the aerosol generator. By
manufacturing the nozzle element in a precise manner, it is thus
ensured that the aerosol has a reproducible droplet spectrum.
[0005] In an inhalation therapy device, the aerosol generator and
the nozzle are normally exposed to contamination caused by residual
medicament, sputum (saliva) and exhalation condensate. To comply
with hygiene requirements, especially if the inhalation therapy
device is being used by several patients, the components of the
nebuliser must therefore be cleaned regularly in order to free them
of residual medicament, exhalation condensate and sputum residue.
For this purpose, the components of the nebuliser should be
designed so that they can be cleaned thoroughly in a simple manner.
An inhalation therapy device is normally configured such that it
can be cleaned and sterilised in order to remove residual
medicament, sputum residue or other such contaminations. For this
purpose, the inhalation therapy device can normally be opened or
dismantled in such a manner that cleaning and/or sterilisation is
possible without any problems.
[0006] The nozzle of a nebuliser or an aerosol generator often
comprises sharp, precisely manufactured edges, which are necessary
to achieve a reproducible droplet spectrum and a good yield, i.e.
efficiency of the nebuliser. These geometries of the edges are very
sensitive, particularly during cleaning of the nozzle, and they can
thus only be cleaned with great care and effort. Finally, it is
virtually impossible to prevent damage to the geometry of the
nozzle in the medium to long term.
[0007] Cleaning of the nebuliser components or the nozzle must,
however, be made possible for the reasons already cited above. It
must be possible for a patient who is generally unaware of the
problem of the sensitive geometry of the nozzle to nevertheless
carry out this cleaning without any problems, in particular
patients suffering from physical impairments as a consequence of
their respiratory disease.
[0008] Inhalation therapy devices having nebulisers or aerosol
generators are known from the prior art, for example from EP 0 786
263, which can be dismantled such that they can be cleaned, for
instance, under running water or sterilised in an autoclave. For
this purpose, the inhalation therapy device can be opened such that
the nozzle of the aerosol generator is freely accessible and can
thus be reached by a cleaning fluid. However, in the case of
tightly adhering particles, rinsing with a cleaning fluid is
generally not sufficient and therefore mechanical cleaning of the
nozzle possibly has to be carried out. This inevitably leads to the
use of a cleaning tool, for example a brush or cloth. This
considerably increases the risk of damaging the sensitive geometry
of the edges of the nozzle and of consequently modifying the
desired droplet spectrum of the aerosol generator of the inhalation
therapy device. The inhalation therapy device having a nebuliser or
an aerosol generator would become ineffective in many cases since
the droplet spectrum is essential for the type of therapy.
[0009] The object of the present invention is to eliminate the
disadvantages of the inhalation therapy devices of the prior art
and to provide an inhalation therapy device having an aerosol
generator with a nozzle that is easy to clean owing to its
construction and is thereby simple and reliable to handle so that
the nozzle is not damaged and the geometry of the nozzle is not
affected during cleaning.
[0010] This object is solved by means of an inhalation therapy
device having a nebulising chamber and an aerosol generator which
is arranged such that it releases an aerosol into the nebulising
chamber, said aerosol generator comprising a nozzle element, with
the nozzle consisting of at least a first part and a second part,
said first part of the nozzle element being made of a more
resilient material than the second part of the nozzle element, and
the first part of the nozzle element being attached to the second
part of the nozzle element.
[0011] The first part of the nozzle element advantageously has a
cross-section which tapers further than that of the second part of
the nozzle element.
[0012] The first part of the nozzle is advantageously made of
silicone rubber or a thermoplastic elastomer (TPE). The first part
of the nozzle element is advantageously produced together with the
second part of the nozzle element in a two-component method, the
first part of the nozzle element thereby being moulded on the
second part of the nozzle element.
[0013] The first part of the nozzle element advantageously contains
the nozzle outlet.
[0014] According to a further embodiment, the nozzle advantageously
comprises a third part, which contains the nozzle outlet.
[0015] The third part of the nozzle element advantageously has a
cross-section which tapers further than that of the first part of
the nozzle element.
[0016] The third part of the nozzle element is preferably produced
together with the first part of the nozzle element in a
two-component method.
[0017] The third part of the nozzle element is advantageously made
of a less resilient material than the first part of the nozzle
element.
[0018] The object of the present invention is furthermore solved by
means of an inhalation therapy device having a nebulising chamber
and an aerosol generator which is arranged such that it releases an
aerosol into the nebulising chamber, said aerosol generator
comprising a nozzle element, with the nozzle element consisting of
at least a first part, said first part of the nozzle element being
made of a more resilient material than a member of the inhalation
therapy device on which the nozzle element is moulded or to which
the nozzle element is attached.
[0019] The invention will be described in more detail below by
means of embodiments and with reference to the drawings. In the
drawings:
[0020] FIG. 1 shows an inhalation therapy device with an aerosol
generator having a nozzle according to a first embodiment of the
present invention;
[0021] FIG. 2 shows a nozzle element according to the first
embodiment of the present invention;
[0022] FIG. 3 shows a nozzle element according to a second
embodiment of the present invention;
[0023] FIG. 4 shows a nozzle element according to a third
embodiment of the present invention; and
[0024] FIG. 5 shows a nozzle element according to a fourth
embodiment of the present invention.
[0025] FIG. 1 shows an inhalation therapy device 1 according to a
first embodiment of the present invention. The inhalation therapy
device comprises a nebulising chamber 2, attached to which is, for
example, a mouthpiece 21 via which the patient can inhale the
nebulised medicament in the form of an aerosol 4.
[0026] The inhalation therapy device can furthermore be provided
with inhalation and exhalation valves (not shown here) such that a
flow of respiratory air can be guided so as to achieve the optimum
supply of an aerosol 4 to the patient. An aerosol generator 3 is
provided in the nebulising chamber 2, which is able to generate an
aerosol 4.
[0027] The aerosol generator 3 comprises a nozzle element 5,
through which compressed air is guided in the present embodiment.
The aerosol generator 3 furthermore comprises one or more channels
32, via which a medicament can be guided out of a storage container
6 and into the vicinity of the nozzle outlet 55 through which the
compressed air guided by the nozzle element 5 escapes. The channels
can, for example, be formed by means of a suitable member 31, which
is designed such that one or more channels 32 are formed between
the nozzle element 5 or the nozzle parts 51, 52 and the member 31.
Owing to an injection or venturi effect, the medicament is sucked
through the channels 32 and entrained by the compressed air which
flows out of the nozzle outlet 55, such that a mixture of
compressed air and medicament passes through the opening 35 of the
member 31 and is released into the nebulising chamber 2.
[0028] In this embodiment, an impact baffle 38 is disposed in front
of the opening 35 of the aerosol generator 3, said impact baffle
having the object of controlling the air flow with the medicament
such that when the medicament droplets collide with the impact
baffle 38, an aerosol 4, 42 having a desired droplet spectrum is
obtained. The droplets of the medicament 4, 41 exiting the aerosol
generator 3 collide with the baffle 38, thereby resulting in a
splitting of the aerosol droplets and making it possible to provide
smaller aerosol droplets 4, 42. As a result of a corresponding air
flow, which is generated by means of respiratory air supplied from
the outside through a possibly present inhalation valve, the
aerosol 4, 42 is entrained therewith and inhaled by the patient via
the mouthpiece 21.
[0029] In the embodiment shown here, the nozzle body 5 of the
aerosol generator 3 consists of a first part 51 and a second part
52, with the first part 51 of the nozzle element 5 having a
cross-section which tapers further than that of the second part 52
of the nozzle element 5. The cross-section of the nozzle body is
tapered further by the first part 51 of the nozzle element so that
the cross-section decreases in the direction of the nozzle tip. In
the embodiment shown here, the first part 51 of the nozzle element
5 comprises the nozzle rim or nozzle edge having the nozzle outlet
55. The first part 51 of the nozzle element 5 is made of a more
resilient material than the second part 52 of the nozzle element 5
in this embodiment.
[0030] Within the meaning of the invention, resilience is to be
understood as a material property which causes an element made from
the material to resume its original shape of its own accord
following deformation. This may, for example, be a silicone rubber
or an elastomer that has this property, namely advantageously even
in the case of a scratching stress, without incurring morphological
damage, and resumes its original shape. A material is described as
more resilient if, as compared to a less resilient material, it
resumes its original form to a greater extent, virtually without
any remaining deformation.
[0031] For cleaning of the aerosol generator 3, the member 31 can
generally be removed so that the channels 32 for supplying the
medicament are exposed, which improves the possibility for
cleaning. Furthermore, the removal of the member 31 exposes the
nozzle body such that it can be cleaned by a rinsing or cleaning
liquid. Owing to the fact that the first part 51 of the nozzle
element 5 is configured so as to be more resilient than the second
part 52 of the nozzle element 5, the upper, first part 51 of the
nozzle element 5 can deform in a resilient manner during
cleaning.
[0032] Since the resilient deformation of part 52 of the nozzle
element 5 is a virtually completely reversible deformation, the
first part 51 of the nozzle element 5 resumes the original shape
following cleaning such that the original geometry of the nozzle is
maintained, without damage occurring to the nozzle geometry. The
first part 51 of the nozzle element 5 is attached to or moulded on
the second part 52 of the nozzle element 5.
[0033] The at least two nozzle parts 51, 52 are fixedly connected
to one another, as can be seen in the embodiment shown in FIG. 1,
in order to prevent them from becoming detached from one another
and to ensure a low friction or friction-free and low turbulence or
turbulence-free transition.
[0034] In terms of production, the so-called two-component method
(two-component injection moulding method), for example, is
available for this purpose, with which it is possible for two or
more suitable, albeit different materials, from which parts of an
assembly are made, to be produced in injection moulding as a single
part in an assembly. The parts of the assembly are then fixedly
connected together and the transitions between one another can be
connected almost without steps or indentations and essentially also
without gaps. This ensures a low friction or friction-free and low
turbulence or turbulence-free transition in the present case.
[0035] The second part 52 of the nozzle element 5 is made of a less
resilient material than the first part 51 of the nozzle element 5,
such that the deformability of the first part ensures a yielding
during mechanical cleaning of the nozzle element 5, which
essentially lowers the risk of damaging the nozzle element. The
resilient material can thereby be a silicone rubber or a
thermoplastic elastomer (TPE). The latter can be readily processed
with less resilient materials, such as polyethylene (PE) or
polypropylene (PP), in the two-component injection moulding method,
such that the TPE parts and the PE or PP parts are fixedly
connected together.
[0036] FIG. 2 shows an embodiment of the present invention in which
the nozzle element 5 consists of a first part 51 and a second part
52. In this embodiment, the first part 51 contains the nozzle
outlet 55. On account of the more resilient part 51 of the nozzle
element 5 as compared to the less resilient part 52 of the nozzle
element 5, the nozzle outlet 55 or the nozzle edge is reversibly
deformable such that in the case of cleaning and a resulting
deformation, part 51 of the nozzle element 5 can resume its
original shape again as soon as the mechanical effect of cleaning
no longer exists.
[0037] In a further advantageous embodiment, the part 51 of the
nozzle element 5 can be designed such that by selecting a
corresponding resilient material, the nozzle outlet 55 is widened
in dependence on the flow of compressed air through said nozzle
outlet 55, such that a stable state between the air flowing through
and the medicament sucked through the channels 32 can be
established in the aerosol generator 3. This embodiment is
particularly advantageous if particles, which may possibly block
the outlet 55, are already added to the compressed air during
supply, so that the nozzle outlet is widened by the accumulated
compressed air such that blocking of the nozzle outlet can be
prevented. A further advantage of a part 51 designed in a resilient
manner, which contains the nozzle outlet 55, is the simplified
possibility of removing solid contaminating particles tightly
adhering to or in the nozzle tip, which become detached when the
resilient material is deformed. An improved cleaning is thus
ensured. Owing to a resilient deformation of the nozzle outlet 55,
solid particles blocking the nozzle outlet 55 can thus also be
removed, without the geometry of the nozzle suffering lasting
damage.
[0038] FIG. 3 shows an embodiment in which the nozzle body 5
comprises a third part 53. The third part 53 is again less
resilient than the first part 51 of the nozzle element 5. In this
embodiment, the third part 53 of the nozzle element 5 contains the
nozzle outlet 55. The advantage of such an embodiment is that the
nozzle outlet 55, or the rim surrounding the nozzle outlet, can be
produced from a more dimensionally stable material, however owing
to the more resilient part 51, can yield under pressure or as a
result of other mechanical influences such that damage cannot occur
to the upper part, in this case the third part 53, of the nozzle
element 5. When cleaning the nozzle, the resilient part 51 of the
nozzle element 5 deforms in the shown embodiment and, once the
mechanical influence no longer exists, resumes the original shape
again such that the dimensional stability of the nozzle is
retained.
[0039] The demands on handlability, the mechanical effects to be
endured and the stresses to be expected determine the selection of
the material for the respective parts 51, 52 and 53, with it being
assumed that the person skilled in the art will select suitable
materials with suitable resiliences.
[0040] In the present invention, the boundary between the first
part 51 of the nozzle element 5 and the second part of the nozzle
element does not necessarily have to be in the top part of the
nozzle element 5, as is shown in FIG. 4. The connecting region
between the first part 51 of the nozzle element 5 and the second
part 52 of the nozzle element 5 can rather also be in the bottom
region of the nozzle element, which is attached, for example, to a
housing part 11, without departing from the application area of the
invention.
[0041] According to a further embodiment, the nozzle element can
also be completely produced from a more resilient material than a
component 11 of the inhalation therapy device on which the nozzle
element 5 is formed or to which the nozzle element is attached. As
shown in FIG. 5, the nozzle element can, for example, be configured
as a plug-in type element which is inserted into a provided opening
15 during production. Production is thereby simplified and the
nozzle element 5 can possibly be exchanged in the case of damage.
Furthermore, the nozzle element 5 can take on sealing functions,
for example in case of an attached tube supply 18.
[0042] The nozzle element 5 can thereby advantageously be made of a
resilient material such as, for example, silicone rubber or a
thermoplastic elastomer (TPE). The dimensional stability when in
use is ensured by the member 31. When the member 31 is removed, the
nozzle element 5 is exposed and, owing to its resilience, is not
greatly exposed to a risk of damage during cleaning.
* * * * *