Title of Invention

APPRATUS FOR NON-INVASIVE MECHANICAL VENTILATION

Abstract An apparatus (1) for non-invasive mechanical ventilation comprises a fan (2) of Bi-level type, or BiPAP, for generating an air flow according to a succession of inspiration steps, or IPAP, and exhalation steps, or EPAP. The flow is conveyed in the aerial ducts of a patient (25) by means of a flexible tube (3) connected to a nasal mask (4). A flexible air reservoir (5) is provided pneumatically connected to the duct (3) and the nasal mask (4) in order to subtract from the inspiration flow a certain air amount before that it reaches the patient (25) at the beginning of an IPAP step. During the exhalation EPAP step, since the air flow pressure decreases automatically, there is the emptying at least partial of the flexible air reservoir (5), whereas the air exhaled by the patient exits through an opening (14) made on the nasal mask (4). This way an air exchange occurs also in the most peripheral patient's aerial ducts and the amount of gaseous exchanges is increased, reducing at the same time the duration of the treatment.
Full Text WO 2004/101049 PCT/EP2004/005231
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TITLE
APPARATUS FOR NON-INVASIVE MECHANICAL VENTILATION
DESCRIPTION
The present invention relates to the medical field
and in particular it relates to an apparatus for non-
invasive mechanical ventilation.
Background of the invention
As known, the respiratory system, comprising lungs
and thoracic cage, works as a pump that rests on a muscle
called diaphragm, which coordinates air and oxygen
suction/exhalation actions. In natural ventilation a
contraction of the diaphragm produces a vacuum in the
lungs so that air is inspired. However, problems of
respiratory insufficiency caused by thoracic cage or
lungs pathologies, as well as problems of insufficient
ventilation revealed by the rise of carbon dioxide in
arterial blood beyond physiological values, can affect
the correct operation of the respiratory system. Then,
for increasing or restoring a natural ventilation in an
individual in poor health, a mechanical ventilation must
be applied that consists of delivering air in pressure in
the aerial ducts and then in the lungs of the patient by
means of a special apparatus.
A largely used technique for treatment of patients
with chronic pulmonary pathologies or with acute
respiratory insufficiency is Non-Invasive Mechanical
Ventilation {NIMV). NIMV assures a much lighter work to
CONFIRMATION COPY

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respiratory muscles, improves gaseous exchanges and in
most cases avoids the need of an intratracheal
intubation, which is much more invasive and can cause
lesions or infections of the respiratory system, as well
as it can be applied only in a hospital.
An apparatus for non-invasive mechanical
ventilation comprises usually a fan, which produces air
at a certain pressure, and a nasal mask, which is
connected to the fan by means of a flexible tube.
Furthermore, pneumatic instruments are provided that
control the air delivery on the basis of pressure data
measured in real time, which are responsive to the
respiration of the patient or are set in a predetermined
pressure program.
Non-invasive ventilation with positive pressure has
two particular approaches, one with fixed pressure (CPAP)
and another with two levels of pressure, or bi-level
(BiPAP) . In particular, the BiPAP is a kind of
ventilation characterized by two different levels of
pressure, which exchange with each other at a
predetermined interval and allow passive pulmonary
ventilation responsive to changes of intrapulmonary
pressure. At the same time the patient can breath
spontaneously at each step of the respiratory cycle
without any mechanical support. More in detail, the
apparatus for ventilation delivers an inspiration
positive air pressure (IPAP), by means of a fan when

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breathing in, and an exhalation positive air pressure
(EPAP) , which is also positive but less than the
previous. In other words, during he mechanical
ventilation, the apparatus accomplishes the respiratory
work necessary to ventilate the lungs. Usually, the EPAP
is only slightly more than the atmospheric pressure
whereas the IPAP is much higher.
However, in the existing apparatus the air pressure
supplied to the patient follows a predetermined profile
depending on a program, on the kind of fan and on the
kind of control chosen, and said profile hardly would fit
the peculiar needs of an individual. In fact, the set
limit values are IPAP and EPAP and only adjustable value
is the pressure of air supplied between the two limit
values, by a valve or alternatively by controlling the
fan power.
Furthermore, such apparatus can assure ventilation
and air exchange only to the main aerial ducts without
reaching the peripheral aerial ducts, and this fact could
lead to atrophy of the latter. This drawback has also the
consequence of a very long time before reaching a natural
respiration rate of the patient after a temporary trauma.
Summary of the invention
It is therefore object of the present invention to
provide an apparatus for non-invasive mechanical
ventilation that provides air exchange also in the most
peripheral a patient's aerial ducts.

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It is also object of the present invention to
provide an apparatus for non-invasive mechanical
ventilation that increases the amount of the gaseous
exchanges and reduces the duration of the treatment of
the fan.
These and other objects are achieved by the
apparatus for non-invasive mechanical ventilation,
according to the present invention, comprising:
- means for generating an air flow according to a
predetermined pressures cycle comprising a
succession of inspiration steps, or IPAP, and
exhalation steps, or EPAP, wherein each inspiration
step has its apex with a maximum pressure and each
exhalation step ends with a pressure of minimum;
- means for conveying said air flow to a patient's
aerial ducts;
whose main feature is to provide furthermore means
for subtracting a predetermined air amount from said flow
at the beginning of said inspiration step, said means for
subtracting being in pneumatic connection with said means
for conveying.
In particular, the subtraction of an air amount
from the inspiration flow causes a depression sufficient
for creating a vortex in a patient's aerial ducts, thus
allowing the air to reach the most peripheral aerial
ducts.
Advantageously, said means for subtracting air

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comprises at least one air reservoir suitable for filling
of air between the EPAP step and the following IPAP step,
thus subtracting said predetermined air amount from said
flow.
In particular, the reservoir can be a flexible
container suitable for filling of air in the IPAP step
and emptying at least in part in the EPAP step.
Alternatively, said means for subtracting can
comprise a calibrated opening made in the means for
conveying. In this case, the calibrated opening can be
operated automatically.
In an embodiment of the invention the means for
conveying comprises a duct and a nasal mask and said
means for subtracting a predetermined air amount are
connected to the nasal mask or to the duct by means of a
junction fitting.
Brief description of the drawings
Further characteristics and advantages of the
present invention will be made clearer with the following
description of a possible embodiment, exemplifying but
not limitative, with reference to the attached drawings,
wherein:
- figure 1 shows diagrammatically a perspective view of
an apparatus for non-invasive mechanical ventilation,
according to the invention, applied to a patient;
- figure 2A shows diagrammatically a perspective view of
a detail of the nasal mask of the mechanical ventilation

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apparatus of figure 1 during an IPAP step;
figure 2B shows diagraininatically a perspective view of
a detail of the nasal mask of the mechanical ventilation
apparatus of figure 1 during an EPAP step;
- figures from 3A to 3C show diagrammatically three
different air subtraction devices for an apparatus for
non-invasive mechanical ventilation according to
alternative embodiments to that shown in figure 1;
- figure 4 shows diagrammatically the pressure trend
versus time in the apparatus of figure 1 during a
pressures cycle comprising inspiration steps, or IPAP,
alternated to exhalation steps, or EPAP comparing it with
the trend of the apparatus of prior art.
Description of a preferred embodiment
In figure 1 a first embodiment is shown of a non-
invasive mechanical ventilation apparatus 1, according to
the present invention. It comprises a fan 2 for
generating an air flow according to a predetermined
pressures cycle, consisting of a succession of
inspiration steps, or IPAP, and exhalation steps, or
EPAP. The air flow generated by fan 2 is conveyed into
the aerial ducts of a patient 25 by a flexible tube 3
connected to a nasal mask 4 worn by patient 25. The main
feature of the non-invasive mechanical ventilation
apparatus 1, according to the invention, is to provide a
flexible air reservoir 5 arranged pneumatically connected
to duct 3 and nasal mask 4, in order to subtract from the

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inspiration flow a certain air amount before that it
reaches the aerial ducts of patient 25.
In particular, at the beginning of an IPAP step a
certain air amount of the flow generated by fan 2 enters
reservoir 5, for example a "balloon" of flexible
material, preventing said air amount from reaching
patient 25, who has already started the inspiration step
(figure 2A) . Then, during the exhalation step, when the
air flow pressure reduces automatically owing to the low
level pressure of the Bi-level fan, at least partially
balloon 5 empties, while the exhaled air from the patient
exits through an opening 14 made on nasal mask 4 (figure
2B). In fact, the higher pressure of IPAP step causes the
balloon to inflate, because this pressure exceeds the own
weight of the walls of the balloon. During the EPAP step,
instead, the lower pressure is not sufficient to exceed
the own weight of the balloon, which partially empties.
In figure 3A an air reservoir 5 is shown as an
alternative embodiment to that of figure 1. In this case
a device is used comprising an accordion-shaped reservoir
51 suitably sized in order to fill of air during the IPAP
step and to empty during the EPAP step, like in the
previous case. Obviously, the step of subtraction of the
air can also be carried out in another desired known way.
An important requirement is that the automatic operation
of the BiPAP fan is not affected. For example, a
calibrated valve 55 can be used delivering air in the

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atmosphere and whose closure/opening can be automatically
operated (figure 3B).
In a further alternative embodiment, a pneumatic
system can be provided of subtraction of air 56, where
the subtracted air amount can be set in synchronism with
the beginning of the IPAP step (figure 3C).
The above four possible exemplary embodiments have
a same result, as diagrammatically shown in the scheme of
figure 4. It shows the pressure trend (P) versus time (t)
that is achieved during a cycle where inspiration steps,
or IPAP, are alternated to exhalation steps, or EPAP. In
particular, in the apparatus of prior art the final
pressure P2 of an IPAP step is the same as the starting
pressure P2 of the following EPAP step (dotted line). On
the contrary, the apparatus 1 according to the invention
provides a light depression 30 between the final pressure
P2 of an IPAP step and the starting pressure P3 of the
following EPAP step. The light depression caused by the
difference between the pressures P2 and P3 is sufficient
for creating a vortex in the aerial ducts of patient 25
that causes the following IPAP air flow to reach the most
peripheral aerial ducts. This way, a non-invasive
mechanical ventilation is achieved that is more effective
with respect to that obtained with the apparatus of prior
art and that allows increasing gaseous exchanges as well
as reducing remarkably the duration of the treatment.
Furthermore, the apparatus 1 allows achieving a

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further therapeutic effect on pulmonary ventilation,
specifically improving ventilation in lower and more
peripheral lungs sections, whereas in ventilation induced
by traditional VMNI a reduction of the ventilation in
medium-apex lungs sections is observed.
The foregoing description of a specific embodiment
will so fully reveal the invention according to the
conceptual point of view, so that others, by applying
current knowledge, will be able to modify and/or adapt
for various applications such an embodiment without
further research and without parting from the invention,
and it is therefore to be understood that such
adaptations and modifications will have to be considered
as equivalent to the specific embodiment. The means and
the materials to realise the different functions
described herein could have a different nature without,
for this reason, departing from the field of the
invention. It is to be understood that the phraseology or
terminology employed herein is for the purpose of
description and not of limitation.

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CLAIMS
1. Apparatus for non-invasive mechanical ventilation
comprising:
- means for generating an air flow according to a
predetermined pressures cycle comprising a
succession of inspiration steps, or IPAP, and
exhalation steps, or EPAP, wherein each
inspiration step has its. apex with a maximum
pressure and each exhalation step ends with a
minimum pressure;
- means for conveying said air flow to a
patient's aerial ducts;
characterised in that. of providing means for
subtracting a predetermined air amount from said flow
at the beginning of said inspiration step, said means
for subtracting being in pneumatic connection with
said means for conveying.
2. Apparatus, according to claim 1, wherein said means
for subtracting comprise at least one air reservoir
suitable for filling of air between said EPAP step and
the following IPAP step, thus subtracting said
predetermined air amount to said flow.
3. Apparatus, according to claims 1 and 2, wherein said
reservoir is a flexible container suitable for filling
of air during the IPAP step and emptying at least in
part during the EPAP step.
4. Apparatus, according to claim 3, wherein said flexible
container is a bag or a balloon.
5. Apparatus, according to claim 3, wherein said flexible

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container is an accordion.
6. Apparatus, according to claim 1, wherein said means
for subtracting air comprise a pneumatic air
subtraction system suitable for adjusting the
subtracted air amount in synchronism with the
beginning of said IPAP step.
7. Apparatus, according to claim 1, wherein said means
for subtracting air comprise a calibrated opening made
in said means for conveying.
8. Apparatus, according to claim 7, wherein said
calibrated opening is opened/closed automatically.
9. Apparatus, according to claim 1, wherein said means
for conveying comprise a duct and a nasal mask, said
means for subtracting being operatively connected to
said nasal mask or to said duct by means of a junction
fitting.


An apparatus (1) for non-invasive mechanical ventilation comprises a fan (2) of Bi-level type, or BiPAP, for generating an air flow according to a succession of inspiration steps, or IPAP, and exhalation steps, or EPAP. The flow is conveyed in the aerial ducts of a patient (25) by means of a flexible tube (3) connected to a nasal mask (4). A flexible air reservoir (5) is provided pneumatically connected to the duct (3) and the nasal mask (4) in order to subtract from the inspiration flow a certain air amount before that it reaches the patient (25) at the beginning of an IPAP step. During the exhalation EPAP step, since the air flow pressure decreases automatically, there is the emptying at least partial of the flexible air reservoir (5), whereas the air exhaled by the patient exits through an opening (14) made on the nasal mask (4). This way an air exchange occurs also in the most peripheral patient's aerial ducts and the amount of gaseous exchanges is increased, reducing at the same time the duration of the treatment.

Documents:

02334-kolnp-2005-abstract.pdf

02334-kolnp-2005-claims.pdf

02334-kolnp-2005-description complete.pdf

02334-kolnp-2005-drawings.pdf

02334-kolnp-2005-form 1.pdf

02334-kolnp-2005-form 3.pdf

02334-kolnp-2005-form 5.pdf

02334-kolnp-2005-international publication.pdf

2334-KOLNP-2005-ABSTRACT-1.1.pdf

2334-KOLNP-2005-ABSTRACT.pdf

2334-KOLNP-2005-AMANDED CLAIMS.pdf

2334-KOLNP-2005-ASSIGNMENT.pdf

2334-KOLNP-2005-CANCELLED PAGES.pdf

2334-KOLNP-2005-CLAIMS.pdf

2334-KOLNP-2005-CORRESPONDENCE-1.1.pdf

2334-KOLNP-2005-CORRESPONDENCE-1.2.pdf

2334-KOLNP-2005-CORRESPONDENCE.pdf

2334-KOLNP-2005-DESCRIPTION (COMPLETE)-1.1.pdf

2334-KOLNP-2005-DESCRIPTION (COMPLETE).pdf

2334-KOLNP-2005-DRAWINGS-1.1.pdf

2334-KOLNP-2005-DRAWINGS.pdf

2334-KOLNP-2005-FORM 1-1.1.pdf

2334-KOLNP-2005-FORM 1.pdf

2334-KOLNP-2005-FORM 2-1.1.pdf

2334-KOLNP-2005-FORM 2.pdf

2334-KOLNP-2005-FORM 3.pdf

2334-KOLNP-2005-FORM-27.pdf

2334-KOLNP-2005-OTHERS-1.1.pdf

2334-KOLNP-2005-PA.pdf

2334-KOLNP-2005-PETITION UNDER RULE 137.pdf

2334-KOLNP-2005-REPLY TO EXAMINATION REPORT.pdf

abstract-02334-kolnp-2005.jpg


Patent Number 245226
Indian Patent Application Number 2334/KOLNP/2005
PG Journal Number 02/2011
Publication Date 14-Jan-2011
Grant Date 10-Jan-2011
Date of Filing 22-Nov-2005
Name of Patentee AZIENDA OSPEDALIERA PISANA
Applicant Address VIA ZAMENHOF, 1, I-56127 PISA ITALY
Inventors:
# Inventor's Name Inventor's Address
1 ALBERTELLI, ROBERTO VIA DELLE ERICHE 39, I-56018 TIRRENIA ITALY
PCT International Classification Number A61M 16/08
PCT International Application Number PCT/EP2004/005231
PCT International Filing date 2004-05-14
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 03425314.6 2003-05-15 EUROPEAN UNION