Note: Descriptions are shown in the official language in which they were submitted.
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FLUID MIXING APPARATUS SUCH AS A VENTILATOR
Jeffrey Travis Dalton
Jordan Francis Clifford
Travis Andrew Dean
FIELD OF THE INVENTION
100011 The invention generally relates to a fluid mixing apparatus, and more
specifically
to fluid mixing apparatus such as ventilators usable for human patients
suffering from respiratory
symptoms of a disease such as COVID-19 or from chronic respiratory ailments,
and methods of
utilizing such ventilators.
BACKGROUND
100021 As of the filing date of this document, a pandemic of the COVID-19
virus is
sweeping Earth. COVID-19 includes a number of symptoms, but is primarily a
respiratory
disease. The majority of people exposed to the COVID-19 virus have mild
symptoms, if any,
and return to full health quickly. However, a significant minority of people
react extremely
badly to exposure to the COVID-19 virus. For those people, their lungs can
become infected and
inflamed, filling up the alveoli with pus or fluid, becoming clogged,
interfering with oxygen
transfer to the capillaries. The sickest patients, with the worst response to
the COVID-19 virus,
may suffer from Acute Respiratory Distress Syndrome (ARDS). Patients with ARDS
have lungs
that have been badly damaged by the COVID-19 virus, and their alveoli become
filled with fluid.
Naturally-occurring surfactant in the lungs, which helps the alveoli inflate
and deflate, breaks
down, making the lungs stiffer. In addition, inflammation from ARDS increases
the gap
between the alveoli inner surface and the adjacent capillaries, reducing
oxygen transfer to the
capillaries still further. Patients suffering from such extreme symptoms from
COVID-19
infection or other causes must be intubated, and connected to a ventilator, in
order to push
oxygen into their lungs and improve oxygen transfer to the blood.
100031 As much as intubation and ventilation may be the last line of defense
between life
and death for patients suffering from severe symptoms of COVID- l9 infection,
and other
patients with ARDS, ventilation is invasive and expensive; another step
between no help with
breathing at all and full intubated ventilation would be beneficial.
Additionally, current
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ventilators can exhaust droplets exhaled by the patient into the patient's
surroundings ¨ typically
a hospital room or an intensive care unit. These droplets typically carry the
COVID-19 virus
from infected patients, placing healthcare workers and other patients at risk.
[0004] Further, current ventilators rely on a continuous supply of compressed
oxygen in
order to function properly; operation of such current ventilators requires the
oxygen supply to be
continuously flowing. This continuous flow wastes oxygen and increases costs,
and makes
current ventilators unsuitable for remote locations, locations in less-
developed countries, or other
locations that lack access or only have minimal access to plentiful and
continuous oxygen
supplies. Similarly, existing ventilators rely on electronics to control the
ventilator, and on
electrical power to power the electronics. This need for electricity also
makes current ventilators
unsuitable for remote locations, locations in less-developed countries, or
other locations that lack
access or only have minimal access to continuous electricity.
[0005] Accordingly, there is a need for an improved ventilator that is less
invasive for
the patient and presents less risk of infection for people near the ventilated
patient
[0006] Moreover, healthcare inequities are prominent throughout the globe,
particularly
in low- to middle-income countries (LMIC) like India. Traditional ventilation
methods are costly
and create an economic burden in the billions of US dollars each year in
America alone. In
LMICs, access to respiratory care devices like ventilators is limited through
not only these high
costs, but also a lack of resources such as varied electricity. Traditional
ventilation methods are
limited in their capacity to provide treatment to the various respiratory
needs of people across the
globe because they are delicate and require high volumes of infrastructure to
operate including
the need for a clean space, an electricity source, and normal service and
maintenance to remain
in optimal performance condition.
100071 Additionally, it is expected that traditional ventilation systems
monitor both the
clinical performance of the device, as well as the patient system interaction
of the device. There
is a gap in the monitoring of patient compliance with orders from their
doctors for use of
respiratory therapy devices. Verifying compliance is an important step in
order for medical
device companies to receive reimbursement, if there is no way to verify, then
companies are not
reimbursed for costs to supply their equipment.
[0008] There is a need for a new approach to ventilation devices in the
medical field to
address, at least in part, the deficiencies associated with traditional
ventilation devices. In
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particular, it is desirable to provide a ventilation device that is able to
provide treatment to
patients in LMICs which lack infrastructure and electricity, as well as a
device that can monitor
patient compliance which is key for medical device companies to receive
reimbursement for
devices they supply to patients.
SUMMARY
100091 According to some embodiments, a ventilator, which may be mechanical,
relies
on the natural breathing of the patient to control the flow of air into a
respirator. The airflow
provided is at a slightly higher pressure than ambient air pressure, and can
also be oxygen
enriched to aid patients with breathing difficulties. According to some
embodiments, rather than
relying on electronics to control the flow of air, a simple and robust
mechanical valve is used to
shut off the flow of compressed air and/or oxygen into the venturi intake. The
valve is activated
by the slight pressure changes created when the patient is naturally
breathing. The valve can be
based on a simple diaphragm and flap valve system, bistable diaphragm system,
or spring loaded
shuttle system.
100101 According to an aspect of the present invention, there is provided a
ventilator
including a venturi nozzle for flow of a pressure-controlled fluid; an ambient
fluid aperture in
fluid communication with the venturi nozzle; a fluid port; a pressure force
multiplier in fluid
communication with the fluid port; and a valve moveable relative to the
venturi nozzle between a
start flow position and a stop flow position; where the pressure force
multiplier is configured
such that fluid forced into the fluid port actuates the valve relative to the
venturi nozzle; and
where the pressure force multiplier is configured such that fluid withdrawn
from the fluid port
actuates the valve relative to the venturi nozzle.
100111 According to an aspect of the present invention, there is provided a
ventilator
connectable to the airway of a living patient, comprising: a venturi,
comprising a throat,. a venturi
nozzle i a venturi opening in the venturi nozzle through which pressure-
controlled oxygen flows
outward, wherein said venturi opening opens to said throat, and wherein said
venturi opening and
said throat are substantially longitudinally aligned; an ambient air aperture
in fluid
communication with said venturi nozzle and with ambient air; a fluid port in
fluid
communication with the airway of the patient; a pressure force multiplier in
fluid communication
with said fluid port, wherein said pressure force multiplier includes at least
one opening defined
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therethrough; said pressure force multiplier comprising at least one flap
movable between an
open position and a closed position relative to said at least one opening; and
a valve moveable
along an axis of movement relative to said venturi opening in said venturi
nozzle between a start
flow position that causes entrainment of the ambient air by the flow of
pressure-controlled
oxygen within said throat, and a stop flow position that ceases entrainment of
the ambient air by
the flow of pressure-controlled oxygen within said throat; wherein said
pressure force multiplier
is configured wherein exhalation of the patient into said fluid port actuates
said valve along said
axis of movement relative to said venturi nozzle to close said venturi nozzle;
wherein said
pressure force multiplier is configured wherein inhalation of the patient
through said fluid port
actuates said valve along said axis of movement relative to said venturi
nozzle; and wherein said
axis of movement of said valve is substantially longitudinally aligned with a
longitudinal
direction of said throat.
100121 According to an aspect of the invention, there is provided a ventilator
connectable
to the airway of a living patient, comprising: a venturi, comprising a throat.
a venturi nozzle i a
venturi opening in the venturi nozzle through which pressure-controlled oxygen
flows outward,
wherein said venturi opening opens to said throat, and wherein said venturi
opening and said
throat are substantially longitudinally aligned; an ambient air aperture in
fluid communication
with said venturi nozzle and with ambient air; a fluid port in fluid
communication with the
airway of the patient; a pressure force multiplier in fluid communication with
said fluid port,
wherein said pressure force multiplier includes at least one opening defined
therethrough; said
pressure force multiplier comprising at least one flap movable between an open
position and a
closed position relative to said at least one opening; and a valve moveable
along an axis of
movement relative to said venturi opening in said venturi nozzle between a
start flow position
that causes entrainment of the ambient air by the flow of pressure-controlled
oxygen within said
throat, and a stop flow position that ceases entrainment of the ambient air by
the flow of
pressure-controlled oxygen within said throat; wherein said pressure force
multiplier is
configured wherein exhalation of the patient into said fluid port actuates
said valve along said
axis of movement relative to said venturi nozzle to close said venturi nozzle;
wherein said
pressure force multiplier is configured wherein inhalation of the patient
through said fluid port
actuates said valve along said axis of movement relative to said venturi
nozzle; wherein said axis
of movement of said valve is substantially longitudinally aligned with a
longitudinal direction of
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said throat; and comprising at least one of a sensor, measurement device, and
power-generation
device positioned between at least one of: the venturi nozzle and the ambient
air aperture; and
the pressure force multiplier and the fluid port; and wherein at least one of
the sensor,
measurement device, and power-generation device comprises at least one of a
pressure sensor,
oxygen sensor, carbon dioxide sensor, temperature sensor, humidity sensor,
piezo sensor, piezo
electrical generator, spirometer measurement device, pitot measurement probe,
and spirometer
electrical generator.
100131 It may be that at least one of the sensor, measurement device, and
power-
generation device is positioned between the venturi nozzle and the ambient air
aperture, and at
least one of the sensor, measurement device, and power-generation device is
positioned between
the pressure force multiplier and the fluid port.
100141 It may be that, for collecting differential data, at least one of the
sensor,
measurement device, and power-generation device is positioned between the
venturi nozzle and
the ambient air aperture, and the same type of at least one of a sensor,
measurement device, and
power-generation device is positioned between the pressure force multiplier
and the fluid port.
100151 The ventilator may comprise a central processing unit for packaging raw
data
collected by at least one of the sensor, measurement device, and power-
generation device.
100161 The ventilator may comprise a motion sensor.
100171 The ventilator may comprise exhalation windows for allowing fluid to
exit the
ventilator during exhalation, and a fluid flow restrictor for at least
selectively partially closing
the exhalation windows to set the Positive End Expiratory Pressure (PEEP) of
the patient. The
fluid flow restrictor allows the ventilator to restrict the volume of air that
exits the ventilator in a
set period, thereby lengthening the exhalation period and thereby allowing
PEEP of the patient to
be modified to a safer level to avoid collapsing of the lungs, for instance.
Additionally, intubated
patients often require further procedures such as CT scans which require a
patient to be
transferred from one breathing device to another. This process of transporting
mechanically
ventilated patients can create various issues for the patient's health. The
brief period of time in
which a patient is disconnected from ventilation results in the loss of
positive end expiratory
pressure (PEEP) and reduces the functional residual capacity (FRC). A
significant reduction in
FRC for patients with severe Acute Respiratory Distress Syndrome can cause a
worsening of
hypoxemia. This, in some cases, can take hours for the FRC to improve and the
hypoxia to
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resolve. The present invention addresses at least in part this issue found in
traditional methods of
transport ventilation by eliminating the reduction in PEEP while switching a
patient from a
critical care ventilator to a transport ventilator and back again, resulting
in a significant
improvement in patient care.
100181 According to another aspect, the invention contemplates an apparatus
suitable for
use with a respirator, comprising: a venturi, comprising: a throat, a venturi
nozzle, and; a venturi
opening in the venturi nozzle through which pressure-controlled fluid flows
outward, wherein
said venturi opening opens to said throat, and wherein said venturi opening
and said throat are
substantially longitudinally aligned; an ambient fluid aperture in fluid
communication with said
venturi nozzle and with an ambient fluid; a fluid port; a pressure force
multiplier in fluid
communication with said fluid port; and a valve moveable along an axis of
movement relative to
said venturi opening in said venturi nozzle between a start flow position that
causes entrainment
of the ambient fluid by the flow of pressure-controlled fluid within said
throat, and a stop flow
position that ceases entrainment of the ambient fluid by the flow of pressure-
controlled fluid
within said throat; wherein said pressure force multiplier is configured such
that fluid forced into
said fluid port actuates said valve along said axis of movement relative to
said venturi nozzle to
close said venturi nozzle; wherein said pressure force multiplier is
configured such that fluid
withdrawn from said fluid port actuates said valve along said axis of movement
relative to said
venturi nozzle; wherein said axis of movement of said valve is substantially
longitudinally
aligned with a longitudinal direction of said throat, wherein said pressure
force multiplier is
positioned between said venturi nozzle and said fluid port; and comprising at
least one of a
sensor, measurement device, and power-generation device positioned between at
least one of: the
venturi nozzle and the ambient fluid aperture; and the pressure force
multiplier and the fluid port;
and wherein at least one of the sensor, measurement device, and power-
generation device
comprises at least one of a pressure sensor, oxygen sensor, carbon dioxide
sensor, temperature
sensor, humidity sensor, piezo sensor, piezo electrical generator, spirometer
measurement
device, pitot measurement probe, and spirometer electrical generator.
100191 It may be that at least one of the sensor, measurement device, and
power-
generation device is positioned between the venturi nozzle and the ambient air
aperture, and at
least one of the sensor, measurement device, and power-generation device is
positioned between
the pressure force multiplier and the fluid port.
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100201 It may be that, for collecting differential data, at least one of the
sensor,
measurement device, and power-generation device is positioned between the
venturi nozzle and
the ambient air aperture, and the same type of at least one of a sensor,
measurement device, and
power-generation device is positioned between the pressure force multiplier
and the fluid port.
100211 The apparatus may comprise a central processing unit for packaging raw
data
collected by at least one of the sensor, measurement device, and power-
generation device.
100221 The apparatus may comprise a motion sensor.
100231 The apparatus may comprise at least one fluid gate for allowing fluid
to exit the
apparatus when fluid is forced into said fluid port, and a fluid flow
restrictor for at least
selectively partially closing the at least one fluid gate.
100241 The apparatus may further comprise a pressure regulator for regulating
the flow of
the pressure-controlled fluid, the pressure regulator comprising: a housing
formed to include a
bore therein; a piston moveably disposed within said bore, wherein said piston
comprises an
annular lip adjacent a first end thereof; a spring disposed within said bore,
and comprising a first
end and a second end; an adjustment cap moveably disposed in said bore,
wherein said
adjustment cap is formed to include a plurality of key slots formed therein;
wherein: said first
end of said spring is in physical contact with said annular lip; and said
second end of said spring
is in physical contact with said adjustment cap wherein: rotating said
adjustment cap in a first
direction causes said adjustment cap to compress said first spring; rotating
said adjustment cap in
a second and opposite direction causes said adjustment cap to decompress said
spring; rotating
said adjustment cap in said first direction increases the output pressure of
the pressure regulator;
rotating said adjustment cap in said second direction decreases the output
pressure of the
pressure regulator; said bore is defined by a cylindrical wall; said
cylindrical wall is formed to
include a first threading therein; said adjustment cap is formed to include a
second threading
formed on a periphery thereof; and said second threading is configured to mesh
with said first
threading.
100251 The pressure force multiplier may comprise a diaphragm.
100261 It may be that said valve includes a stem with a tapered end, wherein
said tapered
end enters said venturi opening in said venturi nozzle in said stop position
to substantially close
said venturi opening.
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100271 The apparatus may further comprise at least one filter detachably
connected to
said ambient fluid aperture.
100281 It may be that said pressure-controlled fluid is a liquid.
100291 In another aspect, the invention comprehends a method of using an
apparatus
suitable for a ventilator and collecting data from a patient, the method
comprising: providing a
pressure-controlled oxygen source; providing an apparatus suitable for a
ventilator, comprising: a
venturi, comprising a throat a venturi nozzle; a venturi opening in said
venturi nozzle through
which pressure-controlled oxygen flows outward, wherein said venturi opening
opens to said
throat, and wherein said venturi opening and said throat are substantially
longitudinally aligned,
an ambient air aperture in fluid communication with said venturi nozzle and
with ambient air; a
fluid port; a pressure force multiplier in fluid communication with said fluid
port, wherein said
pressure force multiplier includes at least one opening defined therethrough;
said pressure force
multiplier comprising at least one flap movable between an open position and a
closed position
relative to said at least one opening; and a valve moveable along an axis of
movement relative to
said venturi opening in said venturi nozzle between a start flow position that
causes entrainment
of the ambient air by the flow of pressure-controlled oxygen within said
throat, and a stop flow
position that ceases entrainment of the ambient air by the flow of pressure-
controlled oxygen
within said throat; placing said fluid port in fluid communication with an
airway of the patient; in
response to exhalation by the patient through said fluid port, causing said at
least one flap to
move to said closed position relative to said at least one opening, and
actuating said valve along
said axis of movement relative to said venturi nozzle to close said venturi
nozzle; and in response
to inhalation by the patient through said fluid port, causing said at least
one flap to move to said
open position relative to said at least one opening, and actuating said valve
along said axis of
movement relative to said venturi nozzle; and wherein said axis of movement of
the valve is
substantially longitudinally aligned with the longitudinal direction of the
throat; and comprising
at least one of a sensor, measurement device, and power-generation device
positioned between at
least one of: the venturi nozzle and the ambient air aperture; and the
pressure force multiplier
and the fluid port; and wherein at least one of the sensor, measurement
device, and power-
generation device comprises at least one of a pressure sensor, oxygen sensor,
carbon dioxide
sensor, temperature sensor, humidity sensor, piezo sensor, piezo electrical
generator, spirometer
measurement device, pitot measurement probe, and spirometer electrical
generator; and
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collecting raw data using the at least one of the sensor, measurement device,
and power-
generation device; packaging the collected raw data using a central processing
unit; transmitting
the packaged raw data to a receiving device using a wired or wireless
communication link;
receiving the packaged data on the receiving device; unpackaging the collected
raw data;
quantizing the unpackaged raw data; formatting the quantized data; analyzing
the formatted data;
distributing the analyzed data; and displaying the analyzed data using an
application.
100301 The method may comprise the step of coupling the central processing
unit to the
ventilator.
100311 It may be that using the wireless communication link comprises using at
least one
wireless protocol selected from Bluetooth, Wi-Fi, and Thread.
100321 It may be that using the wired communication link comprises using at
least one of
a USB, serial, 1-wire, and parallel.
100331 The method may comprise displaying the analyzed data using a smart
device.
100341 It may be that the smart device comprises at least one of a mobile
communication
device, a tablet, a patient interface display, a laptop computer, and a
desktop computer.
100351 According to another aspect, the invention envisages an active filter
comprising at
least one piezo element and at least one dielectric filter medium, wherein the
piezo element
generates electricity to induce a static charge in the dielectric filter
medium.
100361 The use of piezoelectricity in this device will be used to power
sensors for data
collection and data transmission disclosed herein. By placing a piezoelectric
crystal between the
metal walls in the device, electric charges are generated as mechanical
pressure driven by a
patient's breathing is applied to the metal. Essentially, this pressure
generates electricity by
throwing the crystal out of balance. This can produce power up to 2mW, similar
to that stored in
Lithium batteries, generating enough power in order for the device sensors to
collect and
transmit data. The limiter 72 and/or the ribs 74 shown in FIG. 2A, for
example, may be piezo
elements or covered with piezo elements that are capable of generating
electricity due to
actuation of ventilator, and particularly due to the flange 38 impacting the
limiter 72 (which goes
on to vibrate the ribs 74 on impact).
100371 It may be that the power generated by the at least one piezo element is
AC.
100381 The active filter may comprise at least one spirometer that generates
electricity to
induce a static charge in the at least one dielectric filter medium.
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100391 The active filter may comprise two spirometers that generates
electricity to induce
a static charge in the at least one dielectric filter medium.
100401 It may be that the power generated by the at least one spirometer is
DC.
100411 It may be that the inhalation of the patient through said fluid port
actuates said
valve relative to said venturi nozzle to open said venturi nozzle.
100421 It may be that the exhalation of the patient into said fluid port
causes said at least
one flap to move to said closed position relative to said at least one opening
in said pressure
force multiplier.
100431 It may be that the inhalation of the patient through said fluid port
causes said at
least one flap to move to said open position relative to said at least one
opening in said pressure
force multiplier.
100441 According to another aspect, the present invention contemplates an
apparatus
suitable for a ventilator, including a venturi nozzle for flow of a pressure-
controlled fluid; an
ambient fluid aperture in fluid communication with the venturi nozzle; a fluid
port; a pressure
force multiplier in fluid communication with the fluid port; and a valve
moveable relative to the
venturi nozzle between a start flow position and a stop flow position; where
the pressure force
multiplier is configured such that fluid forced into the fluid port actuates
the valve relative to the
venturi nozzle; and where the pressure force multiplier is configured such
that fluid withdrawn
from the fluid port actuates the valve relative to the venturi nozzle.
100451 According to another aspect, the present invention contemplates an
apparatus
suitable for use with a respirator, comprising: a venturi, comprising: a
throat, a venturi nozzle,
and; a venturi opening in the venturi nozzle through which pressure-controlled
fluid flows
outward, wherein said venturi opening opens to said throat, and wherein said
venturi opening and
said throat are substantially longitudinally aligned; an ambient fluid
aperture in fluid
communication with said venturi nozzle and with an ambient fluid; a fluid
port; a pressure force
multiplier in fluid communication with said fluid port; and a valve moveable
along an axis of
movement relative to said venturi opening in said venturi nozzle between a
start flow position
that causes entrainment of the ambient fluid by the flow of pressure-
controlled fluid within said
throat, and a stop flow position that ceases entrainment of the ambient fluid
by the flow of
pressure-controlled fluid within said throat; wherein said pressure force
multiplier is configured
such that fluid forced into said fluid port actuates said valve along said
axis of movement relative
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to said venturi nozzle to close said venturi nozzle; wherein said pressure
force multiplier is
configured such that fluid withdrawn from said fluid port actuates said valve
along said axis of
movement relative to said venturi nozzle; wherein said axis of movement of
said valve is
substantially longitudinally aligned with a longitudinal direction of said
throat; and wherein said
pressure force multiplier is positioned between said venturi nozzle and said
fluid port. Thus, the
present invention does not rely on the pressure-controlled fluid to be
continuously flowing as is
commonly the case with known constructions. Therefore, significant savings,
both economic
and environmental, can be made due to the present invention actuating the
valve to regulate the
flow of the pressure-controlled fluid which in effect makes the overall
process more efficient.
The apparatus may be particularly suitable for remote locations, locations in
less-developed
countries, or other locations that lack access or only have minimal access to
plentiful and
continuous fluid supplies.
100461 The pressure force multiplier may be configured such that the (any)
fluid forced
into the fluid port actuates the valve relative to the venturi nozzle to a
stop flow position; and the
pressure force multiplier may be configured such that the (any) fluid
withdrawn from the fluid
port actuates the valve relative to the venturi nozzle to a start flow
position.
100471 The pressure force multiplier may be configured such that the (any)
fluid forced
into the fluid port actuates the valve relative to the venturi nozzle to a
start flow position; and the
pressure force multiplier may be configured such that the (any) fluid
withdrawn from the fluid
port actuates the valve relative to the venturi nozzle to a stop flow
position. This may be
considered a reverse configuration, for instance.
100481 The pressure force multiplier may be configured such that the (any)
fluid forced
into the fluid port actuates the valve relative to the venturi nozzle to an
active flow position
between the start flow position and stop flow position; and the pressure force
multiplier may be
configured such that the (any) fluid withdrawn from the fluid port actuates
the valve relative to
the venturi nozzle to an active flow position between the start flow position
and stop flow
position. In such a configuration, both actions of a fluid being forced into
the fluid port and a
fluid being withdrawn from the fluid port can actuate the valve to an active
flow position. This
may be considered a point anywhere between the stop flow and start flow
positions. Hence, the
flow may be completely controlled and/or regulated from the stop flow to start
flow and all
positions therebetween.
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100491 The apparatus may be defined such that a pressure-controlled fluid
includes
oxygen, an ambient fluid includes ambient air, fluid forced into the fluid
port includes air
exhaled into an air port, and fluid withdrawn from the fluid port includes air
inhaled from an air
port.
100501 It may be that the pressure force multiplier is positioned between the
venturi
nozzle and the fluid port Such a positioning may provide enhanced actuation of
the valve.
100511 The venturi nozzle may be positioned between the pressure force
multiplier and
the fluid port. The inventors consider such a positioning may also provide
enhanced actuation of
the valve.
100521 It may be that the venturi nozzle is positioned between the ambient
fluid aperture
and the fluid port. The inventors found such a positioning may also provide
enhanced actuation
of the valve.
100531 The apparatus may comprise a pressure regulator for regulating the flow
of a
pressure-controlled fluid. It will be appreciated that at least one of many
different pressure
regulators suitable for the purpose of regulating the flow of the pressure-
controlled fluid may be
included.
100541 More particularly, the apparatus may comprise a pressure regulator (for
regulating the flow of the pressure-controlled fluid) comprising a housing
formed to include a
bore therein; a piston moveably disposed within the bore, wherein the piston
includes an annular
lip adjacent a first end thereof; a spring disposed within the bore, and
comprising a first end and
a second end; an adjustment cap moveably disposed in the bore, where the
adjustment cap is
formed to include a plurality of key slots formed therein; wherein: the first
end of the spring is in
physical contact with the annular lip; and the second end of the spring is in
physical contact with
the adjustment cap wherein: rotating the adjustment cap in a first direction
causes the adjustment
cap to compress the first spring, rotating the adjustment cap in a second and
opposite direction
causes the adjustment cap to decompress the spring; rotating the adjustment
cap in the first
direction increases the output pressure of the pressure regulator; rotating
the adjustment cap in
the second direction decreases the output pressure of the pressure regulator;
the bore is defined
by a cylindrical wall; the cylindrical wall is formed to include a first
threading therein; the
adjustment cap is formed to include a second threading formed on a periphery
thereof; and the
second threading is configured to mesh with the first threading. Such a
regulator may be
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particularly effective at regulating the flow of the pressure-controlled
fluid. The inventors have
found such a pressure regulator to have particularly good synergy with the
apparatus defined
herein. This synergy makes such a pressure regulator a specific selection
generating enhanced
performance of the apparatus.
100551 The pressure force multiplier may comprise a diaphragm. The diaphragm
may be
saucer-shaped to enhance its function.
100561 It may be that the pressure force multiplier is bi-stable. This may be
in an
inhalation configuration and an exhalation configuration. In this way, the
pressure force
multiplier expresses two stable states which is particularly beneficial in at
least some
embodiments of the present invention.
100571 The pressure force multiplier may be biased toward the stop flow
position. In
some embodiments, it may be preferred that the pressure force multiplier be
biased toward the
stop flow position, and such an arrangement makes this possible.
100581 The pressure force multiplier may be biased toward the start flow
position.
Conversely, or additionally, in some embodiments, it may be preferred that the
pressure force
multiplier be biased toward the start flow position, and such an arrangement
makes this possible.
100591 The pressure force multiplier may include at least one flap.
100601 It may be that the apparatus is solely mechanical. According to some
embodiments, the apparatus being solely mechanical provides the benefit of
simplicity of
manufacture and operation.
100611 The apparatus may be configured such that in the start flow position or
an active
flow position a mixture of pressure-controlled fluid and ambient fluid is
allowed to flow to the
fluid port. For example, it may be that the ambient fluid, such as ambient
air, becomes entrained
with the flow of the pressure-controlled fluid, such as oxygen, driving flow
and movement
towards the fluid port.
100621 The flow of the mixture may be modulated in real-time. 'Ile apparatus
may,
therefore, control, change, and/or regulate the flow of the fluid mixture in
an alternative or
additional way to the regulation of the flow of the pressure-controlled fluid
alone.
100631 It may be that the valve includes a flange that is connected to the
pressure force
multiplier.
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100641 The valve may include a stem with a tapered end, where the tapered end
enters a
venturi opening in the venturi nozzle in the stop position to substantially
close the venturi
opening. Such an arrangement may be particularly effective in operation of the
valve in relation
to the features of the apparatus defined herein,
100651 It may be that the stem is connected to the pressure force multiplier.
Such a
configuration may make the stem and force multiplier more robust during
operation.
100661 The valve may comprise a switch. This may be particularly effective
when a
binary system is desired, or binary states are desired.
100671 It may be that the valve includes a flap valve.
100681 The valve may comprise a spring-loaded shuttle system.
100691 The valve may be slidable.
100701 The valve may be solely mechanical.
100711 It may be that the ambient fluid aperture includes a fluid exhaust. The
ambient
fluid aperture may, therefore, have the dual function of allowing ingress and
egress of fluid.
Exhaustion of fluid from the apparatus may reduce contamination by used fluids
within the
apparatus, and may simplify the apparatus by eliminating the need to store
used fluid that is not
exhausted.
100721 The valve may be configured to be actuated relative to the venturi
nozzle while
simultaneously opening the fluid exhaust. Such a dual functionality may
improve the operational
efficiency of the apparatus.
100731 The apparatus may further comprise at least one filter detachably
connected to the
ambient fluid aperture. The filter may operate to filter incoming and/or
outgoing fluid to/from
the apparatus. Filtration of both incoming and outgoing fluid with a single
filter may improve
the operational efficiency of the apparatus.
100741 The at least one filter may comprise pores of about 3 pm. This pore
size is
particularly effective in removing contaminants such as viruses and bacteria
from fluid such as
air, for example.
100751 The apparatus may further comprise a respirator or similar apparatus
that
provides for fluid communication between the ventilator and the airway of a
patient. The
inventors have discovered that the respirator used in combination with the
apparatus or forming
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part of the apparatus may be particularly effective in treating respiratory
conditions such as
COVID-19.
100761 The respirator may be in fluid communication with the fluid port. The
fluid port
may be connected directly or indirectly to the respirator, for instance.
100771 The fluid described herein above may be a liquid. In various
applications, liquid
may pass through the apparatus. It will be appreciated that liquid such as
medicine may also be
administered using the apparatus. For instance, the apparatus may thus
function as an improved
nebulizer or vaporizer that can be used to administer medication in the form
of a liquid mist that
can be inhaled into the lungs by a patient suffering from a respiratory
disease or condition. It
will be appreciated, however, that any suitable liquid may be utilized with
the apparatus.
100781 The apparatus may be injection molded. The apparatus may thus be
quickly
reproduced in a cost-effective manner.
100791 It may be that the apparatus is fabricated by additive manufacturing,
such as a 3D
printing process. The apparatus may, therefore, be reproduced accurately and
in a cost-effective
manner, which makes it particularly attractive in less-developed countries.
100801 The apparatus may be configured to be mobile.
100811 The apparatus may be configured to be re-usable. Since the apparatus
may be
effectively be cleaned, it may be suitable for re-use. This is particularly
beneficial in less-
developed countries where availability of new apparatus are not readily
available.
100821 The apparatus described herein may be for use in controlling the flow
of air
and/or oxygen into a respirator.
100831 The apparatus described herein may be for use in controlling the flow
of scrubbed
air and/or oxygen into a respirator.
100841 The apparatus described herein may be for use in treating a respiratory
condition.
100851 The apparatus described herein may be for use in treating COVID-19.
100861 In another aspect, the present invention envisages a method of using an
apparatus
suitable for a ventilator, the method including providing a source of pressure-
controlled fluid;
providing an apparatus suitable for a respirator, including: a venturi nozzle
for receiving a flow
of the pressure-controlled fluid; an ambient fluid aperture in fluid
communication with the
venturi nozzle; a fluid port; a pressure force multiplier in fluid
communication with the fluid
port; and a valve moveable relative to the venturi nozzle between a start flow
position, in which
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the pressure-controlled fluid mixes with the ambient fluid, and a stop flow
position; actuating the
valve relative to the venturi nozzle in response to fluid forced into the
fluid port; and actuating
the valve relative to the venturi nozzle in response to fluid withdrawn from
the fluid port.
100871 In another aspect, the present invention envisages a method of using an
apparatus
suitable for a ventilator, the method comprising: providing a pressure-
controlled oxygen source;
providing an apparatus suitable for a ventilator, comprising: a venturi,
comprising a throat a
venturi nozzle; a venturi opening in said venturi nozzle through which
pressure-controlled
oxygen flows outward, wherein said venturi opening opens to said throat, and
wherein said
venturi opening and said throat are substantially longitudinally aligned, an
ambient air aperture
in fluid communication with said venturi nozzle and with ambient air; a fluid
port; a pressure
force multiplier in fluid communication with said fluid port, wherein said
pressure force
multiplier includes at least one opening defined therethrough; said pressure
force multiplier
comprising at least one flap movable between an open position and a closed
position relative to
said at least one opening; and a valve moveable along an axis of movement
relative to said
venturi opening in said venturi nozzle between a start flow position that
causes entrainment of
the ambient air by the flow of pressure-controlled oxygen within said throat,
and a stop flow
position that ceases entrainment of the ambient air by the flow of pressure-
controlled oxygen
within said throat, placing said fluid port in fluid communication with an
airway of the patient; in
response to exhalation by the patient through said fluid port, causing said at
least one flap to
move to said closed position relative to said at least one opening, and
actuating said valve along
said axis of movement relative to said venturi nozzle to close said venturi
nozzle; and in response
to inhalation by the patient through said fluid port, causing said at least
one flap to move to said
open position relative to said at least one opening, and actuating said valve
along said axis of
movement relative to said venturi nozzle; and wherein said axis of movement of
the valve is
substantially longitudinally aligned with the longitudinal direction of the
throat.100881 The
apparatus in such a method may be solely mechanical.
100891 It may be that at least a portion of said valve is movable, along said
axis of
movement, within said throat.
100901 The method may further comprise adjusting the pressure of the pressure-
controlled fluid.
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100911 It may be that the method includes that the pressure-controlled fluid
is pressure-
controlled oxygen, and where the fluid is air, the method including:
connecting the apparatus to a
respirator or similar apparatus; placing the ventilator in gaseous
communication with the patient
and with the source of pressure-controlled oxygen; in response to inhalation
by the patient,
starting oxygen flow into the ventilator, mixing the oxygen with ambient air
to generate enriched
air, and delivering the enriched air to the patient; in response to exhalation
by the patient,
stopping oxygen flow into the ventilator, and exhausting exhalation air from
the ventilator.
100921 The enriched air may have an Fi02 of at least 26%.
100931 It may be that the method includes that the pressure-controlled fluid
is pressure-
controlled filtered air, and where the fluid is air, the method including:
connecting the apparatus
to a respirator or similar apparatus; placing the ventilator in gaseous
communication with the
patient and with the source of pressure-controlled filtered air; in response
to inhalation by the
patient, starting oxygen flow into the ventilator, mixing the pressure-
controlled filtered air with
ambient air to generate scrubbed air, and delivering the scrubbed air to the
patient; in response to
exhalation by the patient, stopping oxygen flow into the ventilator, and
exhausting exhalation air
from the ventilator.
100941 The scrubbed air may have an Fi02 of at least 26%.
100951 The method may further include walking and/or running while utilizing
the
apparatus and a respirator or similar apparatus. This may involve use of the
apparatus while the
user is exercising, for instance.
100961 The method may further include initiating use of the apparatus and
respirator or
similar apparatus to treat allergies.
100971 The method may further include initiating use of the apparatus and
respirator or
similar apparatus to treat ARDS.
100981 The method may further include initiating use of the apparatus and
respirator or
similar apparatus to treat sleep apnea.
100991 The method may further include initiating use of the apparatus and
respirator or
similar apparatus to treat COPD.
101001 The method may further include initiating use of the apparatus and
respirator or
similar apparatus to treat infection by the COVID-19 virus.
101011 The method may further include filtering the ambient air.
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101021 The method may further include filtering exhaled breath from the
patient.
101031 In another aspect, the present invention encompasses a pressure force
multiplier
including a sealed end and an open end, where the sealed end is in fluid
communication with a
valve to define a fixed volume between the sealed end and the valve, where the
pressure force
multiplier is configured such that a change in pressure in the open end causes
a change in
pressure in the sealed end which actuates the valve. Such a force multiplier
may be particularly
effective for use with the apparatus defined herein. However, this pressure
force multiplier is
considered inventive in its own right.
101041 The pressure force multiplier may be configured such that a negative
pressure in
the open end causes a reduction in pressure in the sealed end which actuates
the valve.
101051 The pressure force multiplier may be configured such that a positive
pressure in
the open end causes an increase in pressure in the sealed end which actuates
the valve.
101061 It may be that the actuation of the valve activates a humidifier.
101071 The actuation of the valve may generate a change in a visual indicator.
The
visual indicator may be a change in color, for instance.
101081 The change in visual indicator may represent a change of pressure in
the open
end.
101091 It may be that the change of pressure in the open end is caused by
inhalation
and/or exhalation of a patient. The pressure force multiplier is, thus,
adaptable for many
different applications, which makes it a particularly useful accessory in many
different fields of
operation.
101101 The characteristics and utilities of the present invention described in
this
summary and the detailed description below are not all inclusive. Many
additional features and
advantages will be apparent to one of ordinary skill in the art given the
following description.
There has thus been outlined, rather broadly, the more important features of
the invention in
order that the detailed description thereof that follows may be better
understood, and in order that
the present contribution to the art may be better appreciated.
BRIEF DESCRIPTION OF THE DRAWINGS
101111 FIG. 1 is a perspective cutaway view of a ventilator in an inhalation
configuration.
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101121 FIG. 2 is a side cutaway view of the ventilator of FIG. 1 in the
inhalation
configuration.
[0113] FIG. 2A is a detail perspective cutaway of the ventilator of FIG. 1 in
the
inhalation configuration, showing a diaphragm in the inhalation configuration
[0114] FIG. 3 is a perspective cutaway view of the ventilator in an exhalation
configuration.
[0115] FIG. 3A is a detail perspective cutaway of the ventilator of FIG. 3 in
the
exhalation configuration, showing exhalation windows.
[0116] FIG. 3B is a detail perspective cutaway of the ventilator of FIG. 3 in
the
exhalation configuration, showing flaps.
[0117] FIG. 4 is a side cutaway view of the ventilator of FIG. 3 in the
exhalation
configuration.
[0118] FIG. 5 is a perspective cutaway view of another embodiment of the
ventilator.
[0119] FIG. 6 is a side cutaway view of the ventilator of FIG. 5.
[0120] FIG. 7 is a detail perspective cutaway view of a valve of the
ventilator of FIG. 5.
[0121] FIG. 8 is detail side cutaway view of a valve of the ventilator of FIG.
5.
[0122] FIG. 9 is a perspective view of one embodiment of a secondary regulator
500.
[0123] FIG. 10 is a cross-sectional view of the secondary regulator 500.
[0124] FIG. 11 is a cross-section view of another embodiment of a secondary
regulator 700.
101251 FIG. 12 is an exploded view of the secondary regulator 700.
[0126] FIG. 13 is a top view of an adjustment cap 750 disposed within the
secondary
regulator 700.
[0127] FIG. 14 is a perspective view of the adjustment cap 750.
[0128] FIG. 15 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention having a sensor in one position.
[0129] FIG. 16 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention having a sensor in another position.
101301 FIG. 17 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention having a sensors in multiple positions.
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[0131] FIG. 18 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention having a spirometer in one position.
[0132] FIG. 19 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention having a spirometer in another position.
[0133] FIG. 20 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention having a spirometers in multiple positions.
[0134] FIG. 21 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention having a pitot tube.
[0135] FIG. 22 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention having a piezo element.
[0136] FIG. 23 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention having a sensors, spirometers, a pitot tube and
piezo element in
multiple positions.
101371 FIG. 24 is a perspective cutaway view of the ventilator/apparatus of
FIG. 23.
[0138] FIG. 25 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention having an active filter.
[0139] FIG. 26 is a perspective cutaway view of the ventilator/apparatus of
FIG. 25.
[0140] FIG. 27 is a flow chart of the method according to an embodiment of the
invention.
[0141] FIG. 28 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention without a fluid flow restrictor.
[0142] FIG. 29 is a perspective cutaway view of the ventilator/apparatus of
FIG. 28.
[0143] FIG. 30 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention with a fluid flow restrictor in an open position.
[0144] FIG. 31 is a perspective cutaway view of the ventilator/apparatus of
FIG. 30.
[0145] FIG. 32 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention with a fluid flow restrictor in a restricted
position.
[0146] FIG. 33 is a perspective cutaway view of the ventilator/apparatus of
FIG. 30.
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101471 The use of the same reference symbols in different figures indicates
similar or
identical items.
DETAILED DESCRIPTION
101481 Referring to FIGS. 1-2, one embodiment of a fluid mixer 2 is shown. The
fluid
mixer 2 also may be referred to as a fluid mixing apparatus 2 or apparatus 2.
The fluid mixer 2
may be used in a variety of applications. For example, the fluid mixer 2 may
find use in medical
applications, automotive applications, racing applications, and other
applications. As seen in
FIGS. 1-2, the fluid mixer 2 is a ventilator 2. The term "ventilator," as used
in this document,
encompasses any and all medical applications in which the ventilator 2 may be
used, such as but
not limited to continuous positive airway pressure (CPAP) machines, and
bilevel positive airway
pressure (BiPAP) machines.
101491 Returning to FIGS. 1-2, an exemplary ventilator 2 is shown in an
inhalation
configuration, in which a patient is inhaling gas through the ventilator 2.
Advantageously, the
ventilator 2 is solely mechanical. As used in this document, the term -solely
mechanical" is
defined to mean a mechanism operable based on gas pressure changes controlled
by a patient's
breath, without electricity or electronics According to other embodiments, the
ventilator 2 may
be controlled, powered, or otherwise operated in whole or in part using
electricity and/or
electronics. The ventilator 2 includes an ambient fluid aperture 4, which may
be generally bell-
shaped, or which may have any other suitable shape The opening of the ambient
fluid aperture
4 may have any suitable shape, such as but not limited to circular, oval,
rectilinear, or polygonal,
and may be bilaterally and/or radially symmetrical, or asymmetrical. The
ambient fluid aperture
4 may be located at one end of the ventilator 2. The ventilator 2 also
includes a fluid inlet 6,
located in proximity to the ambient fluid aperture 4. The fluid inlet 6 may be
connected to a
source of pressure-controlled fluid, such as oxygen. As seen in FIG. 1, the
ambient fluid
aperture 4 and the fluid inlet 6 may be arranged generally perpendicular to
one another; however,
the ambient fluid aperture 4 and the fluid inlet 6 may be arranged relative to
one another in any
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other suitable manner. The fluid inlet 6 may include threads 8 defined on an
outer diameter
thereof, to facilitate the connection of oxygen or other pressure-controlled
fluid to the ventilator
2. Advantageously, the pressure entering the fluid inlet 6 is slightly above
ambient. The
pressure at the fluid inlet 6 may be adjusted as described in greater detail
below. As utilized in
the treatment of patients, the fluid inlet 6 may be an oxygen inlet, through
which oxygen enters
the ventilator 2.
101501 Air from the ambient fluid aperture 4 and oxygen from the fluid inlet 6
are mixed
in a venturi 10. According to some embodiments, passages 12 are defined in the
ventilator 2
radially outside the ambient fluid aperture 4, and oxygen from the fluid inlet
6 travels from the
fluid inlet 6 through the passages 12 to a venturi nozzle 14 and out the
venturi opening 16 in the
venturi nozzle 14. The specific path, cross-section and other details of the
passages 12 are not
critical to the invention; rather, as long as a sufficient amount of oxygen is
delivered to the
venturi opening 16, the passages 12 may be configured in any manner. An air
passage 18 allows
air to flow from the ambient fluid aperture 4 to the venturi nozzle 14. As
oxygen exits the
venturi opening 16 of the venturi nozzle 14, that oxygen flow entrains air
from the throat 19 of
the venturi 10 and mixes with that entrained air, which is oxygen-enriched
compared to ambient
air. Above the venturi nozzle 14, a central passage 17 extends upwards,
allowing oxygen-
enriched air to travel to the patient during inhalation, and allowing
exhalation air to travel
outward from the patient during exhalation. As is well understood in the art,
a venturi is typically
a short tubular section with a tapering constriction (throat 19) in the middle
that causes an
increase in the velocity of flow of a fluid passing therethrough. As can be
seen from FIGS. 1-2,
the venturi opening 16 in the venturi nozzle 14, through which pressure-
controlled oxygen (or
other pressure-controlled fluid for example) flows outward, opens to said
throat 19, and wherein
said venturi opening 16 and said throat 19 are substantially longitudinally
aligned.
101511 A valve 20 is positioned above the venturi nozzle 14. As used in this
document,
words of orientation such as -top," -bottom," -above," -below" and the like
refer to the
orientation of and relative location of parts shown in the Figures relative to
the page for ease of
description; the ventilator 2 can be used in any orientation, and such words
of orientation do not
limit use of the ventilator 2. The valve 20 includes a stem 22, which may
include a tapered end
24 according to some embodiments. The tapered end 24 may be tapered such that
a portion of
the tapered end 24 has a diameter less than the diameter of the venturi
opening 16 and can enter
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the venturi nozzle 14 through the venturi opening 16. In the open, inhalation
position shown in
FIG. 1 the tapered end 24 is spaced apart from the venturi opening 16 such
that oxygen can flow
out of the venturi opening 16 and entrain ambient air from the air passage 18
in the throat 19 of
the venturi 10. According to other embodiments, the stem 22 need not include a
tapered end 24,
and may instead include an end that grows wider in diameter closer to the
venturi nozzle 14, such
that the wider end is capable of blocking the venturi opening 16 in a closed
position without
substantially entering the venturi opening 16. A stem seat 21 may extend
laterally toward the
stem 22, and may include a stem aperture 23 configured to receive and guide
the stem 22 in its
longitudinal motion, while substantially restraining the stem 22 against
lateral motion. The stem
aperture 23 may have a shape similar to and slightly larger than the stem 22.
For example, where
the stem 22 is generally cylindrical, the outer diameter of the stem 22 may be
slightly smaller
than the diameter of the stem aperture 23, such that the stem aperture 23
allows the stem 22 to
slide relative to the stem aperture 23 while the stem aperture 23 also limits
the lateral motion of
the stem 22. The valve 20 may be free-floating, as seen in FIGS. 1-2.
Optionally, the valve 20
may be biased toward the inhalation configuration shown in FIGS. 1-2, such as
by a spring (not
shown) or other structure or mechanism. Alternately, the valve 20 may be
biased toward the
exhalation configuration, such as by a spring (not shown) or other structure
or mechanism.
101521 The stem 22 extends from the tapered end 24 to a vent ring 26. The vent
ring 26
may be generally cylindrical in shape, including a generally circular bottom
28 and a curved
body 30. One or more windows 32 may be defined through the curved body 30. The
vent ring
26 may be received by an aperture 34 in a vent ring seat 36. The aperture 34
may have a shape
similar to and slightly larger than the vent ring 26. For example, where the
vent ring 26 is
generally cylindrical, the outer diameter of the vent ring 26 may be slightly
smaller than the
diameter of the aperture 34, such that the aperture 34 of the vent ring seat
36 allows the vent ring
26 to slide relative to the aperture 34 while the aperture 34 also limits the
lateral motion of the
vent ring 26. At least one flange 38 may extend radially outward from the vent
ring 26. The
flange 38 may extend outward from an upper edge of the vent ring 26, or from
any other suitable
portion of the vent ring 26.
101531 The flange 38 may be connected to a pressure force multiplier 40 within
a
chamber 42; advantageously, the flange 38 is fixed to the pressure force
multiplier 40.
According to some embodiments, the pressure force multiplier 40 is a diaphragm
40. The
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diaphragm 40 extends radially between the vent ring 26 and the inner surface
44 of the chamber
42. The diaphragm 40 is flexible and durable, and may be fabricated from any
suitable material
such as rubber, latex, plastic or other material or materials. Because the
flange 38 is connected
to the diaphragm 40, downward motion of the diaphragm 40 causes the flange 38,
and thus the
valve 20 as a whole, to move downward; upward motion of the diaphragm 40
causes the flange
38, and thus the valve 20 as a whole, to move upward According to some
embodiments, the
diaphragm 40 may be biased toward its position in the inhalation
configuration. According to
other embodiments, the diaphragm 40 may be bistable, such that it is stable
both in its position in
the inhalation configuration and its position in the exhalation configuration.
In this embodiment,
the valve 20 is moveable along an axis of movement relative to said venturi
opening 16 in said
venturi nozzle 14 between a start flow position that causes entrainment of the
ambient fluid by
the flow of pressure-controlled fluid (for example, pressure-controlled
oxygen) within said throat
19, and a stop flow position that ceases entrainment of the ambient fluid by
the flow of pressure-
controlled fluid within said throat 19. For instance, in an embodiment of the
present invention,
said pressure force multiplier 40 is configured such that fluid forced into
said fluid port 54
actuates said valve 20 along said axis of movement relative to said venturi
nozzle 14 to close
said venturi nozzle 14; additionally, in an embodiment of the present
invention, said pressure
force multiplier 40 is configured such that fluid withdrawn from said fluid
port 54 actuates said
valve 20 along said axis of movement relative to said venturi nozzle 14. The
axis of movement
of said valve 20, in this embodiment, is substantially longitudinally aligned
with a longitudinal
direction of said throat 19. In this embodiment, at least a portion of said
valve 20 is movable,
along said axis of movement, within said throat 19.
101541 Referring also to FIG. 2A, in the inhalation configuration, an inlet
passage 41 is
in fluid communication with the central passage 17. The vent ring 26 is in an
upward position
relative to the venturi nozzle 14. As a result, the bottom 27 of the vent ring
26 may be
substantially even with the lower surface 37 of the vent ring seat 36, and the
inlet aperture 43 is
thus open, placing the central passage 17 in fluid communication with the
inlet passage 41. The
flange 38 may be configured as a grid or grate, such as the concentric grid
shown in FIG. 2A,
such that a plurality of flange openings 39 allow fluid to flow therethrough.
In the inhalation
configuration, both sides of the diaphragm 40 are thus in fluid communication
with one other via
the flange openings 39, those flange openings 39 place the inlet passage 41
and the fluid port 54
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in fluid communication in the inhalation configuration. Thus, in the
inhalation configuration, the
central passage 17, the inlet passage 41, and the fluid port 54 are in fluid
communication with
one another, such that enriched air flows freely from the venturi nozzle 14 to
the fluid port 54,
and then to the patient.
101551 Where the diaphragm 40 is bistable, the diaphragm 40 may be in one of
its two
bi stable configurations in the inhalation configuration, as seen in FIG. 2A.
Utilizing a bi stable
diaphragm 40 with a stable configuration in the inhalation configuration means
the patient need
not utilize any breathing force to maintain the inhalation configuration after
that inhalation
configuration has been reached, as a result, the ventilator 2 may be useful
for treating patients
with degraded breathing capability. Where the diaphragm 40 is stable in a
single configuration,
that configuration may be the inhalation configuration as shown in FIG. 2A.
101561 The pressure force multiplier 40 is in fluid communication with said
fluid port 54,
wherein said pressure force multiplier 40 includes at least one opening 39
defined therethrough;
said pressure force multiplier 40 comprising at least one flap 70 movable
between an open
position and a closed position relative to said at least one opening 39. One
or more flaps 70 may
be associated with the flange 38, referring also to FIG. 3B. The flaps 70 are
described in greater
detail below with regard to FIG. 3B. In the inhalation configuration, fluid
flow toward the fluid
port 54 causes the flaps 70 to be blown upward away from the flange 38 and its
(flange)
openings 39, allowing for the free flow of enriched air to the patient through
the (flange)
openings 39. In this embodiment, said pressure force multiplier 40 is
positioned between said
venturi nozzle 14 and said fluid port 54.
101571 A limiter 72 optionally may be positioned in the chamber 42 above the
flange 38.
According to some embodiments, the limiter 72 may be a ring having
substantially the same
diameter as the vent ring 26, where the limiter 72 is substantially coaxial
with the vent ring 26.
The limiter 72 may be connected to, fixed to, or integral with one or more
ribs 74 that extend
therefrom. The one or more ribs 74 may extend upward from the limiter 72;
alternately, one or
more ribs 74 may extend laterally from or downward from the limiter 72. The
ribs 74 may be
substantially rigid, such that they do not substantially undergo bending or
flexure during normal
usage of the ventilator 2. According to other embodiments, one or more ribs 74
may be flexible.
Each rib 74 is connected at one end to the limiter 72, and at the other end to
a portion of the
chamber 40. For example, one or more ribs 74 are connected to the upper wall
76 of the
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chamber 40. The ribs 74 may be fixed to or integral with the upper wall 76 of
the chamber 40.
For example, the upper wall 76 of the chamber 40, the ribs 74, and the limiter
72 may be
injection molded, fabricated by additive manufacturing, or fabricated in any
other manner as a
single integral piece. The limiter 72 prevents the vent ring 26, and thus the
valve 20, from
moving upward out of the vent ring seat 36 and/or the stem seat 21.
101581 According to some embodiments, the limiter 72 has another shape than a
ring.
For example, the limiter 72 may be a bar, a rod, an X-shape, a square, a
rectangle, an oval, or any
other suitable shape. The limiter 72 may have any shape, and be placed
relative to the vent ring
26 in any location, that both engages the vent ring 26 in the inhalation
configuration to limit its
travel upward to prevent the valve 20 and/or the vent ring 26 from becoming
unseated, and
allows for substantially unrestricted fluid flow out of the flange openings
39.
101591 At the upper end of the chamber 42, a fluid port 54 allows inhalation
air to flow
out of the ventilator 2 and exhalation air to flow into the ventilator 2. At
least one filter 56 may
be positioned adjacent to the fluid port 54, in order to filter both
inhalation and exhalation air.
The filter 56 advantageously is a 3 micron filter or other filter suitable for
removing viruses,
pollen and other airborne contaminants from the air. In this way, the filter
56 protects the patient
from ambient contaminants, and also protects others near the ventilator 2 from
infection from air
exhaled from the patient. The filter 56 is detachably connected to the
ventilator 2, so that the
filter 56 may be periodically replaced. The filter 56 may be a single-use
filter, or may be
cleanable and sterilizable such that it can be reused after cleaning and
sterilization. Alternately,
the filter 56 may be placed adjacent to the ambient fluid aperture 4, or at
another location on the
ventilator 2. For example, according to some embodiments, the filter 56 is
positioned adjacent to
the ambient fluid aperture 4, in order to filter both inhalation and
exhalation air. In this way, the
filter 56 protects the patient from ambient contaminants, and also protects
others near the
ventilator 2 from infection from air exhaled from the patient. Alternately,
more than one filter 56
may be utilized.
101601 The chamber 42 may be connected via the fluid port 54 to a respirator
(not
shown) that is worn by the patient. As typically used in the industry, the
term "respirator" refers
to a device that provides respirable air to a patient or other user, such as
by providing a supply of
breathable gas. However, as used in this document, the term "respirator" is
specifically defined
to exclude any requirement that the respirator itself filter anything from the
air provided to the
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patient, or exhaled by the patient. According to some embodiments, the
respirator is
substantially impermeable to fluid, whether gas or liquid. According to some
embodiments, the
respirator may be a mask provided with compliant sealing surfaces or other
seal or seals such
that a substantially airtight seal is created against the patients face.
According to some
embodiments, the respirator may be a helmet or other structure that engages a
different part of
the patient than the face; for example, the respirator may be a helmet that
substantially seals
against the patient's neck and does not touch the face. According to some
embodiments, all of
the respirator or a portion of the respirator may be positioned within the
patient's nose and/or
mouth, and the respirator is substantially sealed relative to the nose and/or
mouth. According to
some embodiments, such as those described above, the respirator is
substantially sealed relative
to the patient's airway. By substantially sealing the respirator relative to
the patient's airway,
slight pressure changes when the patient breathes cause the valve 20 to move,
as described in
greater detail below. In this way, the respirator and thus the patient are in
fluid communication
with the ventilator 2. Because the respirator is substantially impermeable to
gas, substantially all
of the patient's exhalation breath reaches the fluid port 54 of the ventilator
2, such that only a
small exhalation effort causes the valve 20 to move. Alternately, the
respirator and the patient
may be in fluid communication with the ventilator 2 in any other suitable
manner.
101611 Referring to FIGS. 3-4, a ventilator 2 is shown in an exhalation
configuration, in
which a patient is exhaling gas through the ventilator 2. As described in
greater detail below,
exhalation pressure from the patient flexes the center of the diaphragm 40
downward. As a
result, the flange 38, which is connected to the diaphragm 40, moves downward.
Downward
motion of the flange 38 may be limited by the vent ring seat 36, the upper
surface of which may
engage a lower surface of the flange 38, thereby preventing further downward
motion of the
flange 38. In the exhalation configuration, the valve 20 has moved downward
relative to the
venturi nozzle 14, and the tapered end 24 of the stem 22 substantially blocks
the venturi opening
16. In this way, oxygen flow from the fluid inlet 6 outward through the
venturi opening 16 is
substantially stopped. Advantageously, the length of the stem 22 is fabricated
such that the
tapered end 24 or other lower end of the stem 22 substantially blocks the
venturi opening 16
when the flange 38 engages the vent ring seat 36.
101621 Referring also to FIG. 3A, in the exhalation configuration, the inlet
passage 41 is
no longer substantially in fluid communication with the central passage 17.
The vent ring 26 is
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in an downward position relative to the venturi nozzle 14. As a result, the
bottom 27 of the vent
ring 26 is positioned below the lower surface 37 of the vent ring seat 36, and
the inlet aperture 43
is thus closed, substantially closing the central passage 17 in fluid
communication with the inlet
passage 41. An 0-ring or other seal (not shown) may extend radially outward
from the vent ring
seat 36 to facilitate closure of the inlet aperture 43 in the exhalation
configuration. Alternately,
the inlet aperture 43 need not be closed, in whole or in part, in the
exhalation configuration,
because exhalation air will still travel outward through the central passage
17 as described
below.
101631 In the exhalation configuration, the flange 38 has moved downward
relative to its
position in the inhalation configuration, and may be in contact with the vent
ring seat 36. In this
way, the vent ring seat 36 may act to limit downward motion of the vent ring
26. Alternately,
contact between the tapered end 24 of the stem 22 and the venturi nozzle 14
limits downward
motion of the vent ring 26. Where the flange 38 is in the exhalation
configuration and the flange
38 contacts the vent ring seat 36, that contact may block at least one of the
flange openings 39.
Referring also to FIG. 3B, in the exhalation configuration, fluid flow from
the fluid port 54
causes the flaps 70 to be pushed down onto the flange 38 and the flange
openings 39,
substantially stopping the free flow of fluid from the patient through the
flange openings 39. In
this way, because the flange openings 39 are substantially blocked by the
flaps 70, the inlet
aperture 43 may remain partly or even entirely open, and exhalation air still
cannot substantially
flow outward through the flange openings 39 and then outward through the inlet
aperture 43. In
the exhalation configuration, both sides of the diaphragm 40 may be blocked
from fluid
communication with one other via the flange openings 39. Thus, in the
inhalation configuration,
the inlet passage 41 and the fluid port 54 are not substantially in fluid
communication with one
another. The flaps 70 may be thin and lightweight, and generally impermeable
to fluid. For
example, the flaps 70 may be composed of latex, rubber, silicone or any other
suitable substance.
101641 Because the flange openings 39 are closed, exhalation by the patient
into the fluid
port 54 causes a pressure rise in the chamber 42 above the diaphragm 40. This
rise in pressure
pushes the flange 38 downward into contact with or into proximity to the vent
ring seat 36, to the
exhalation position of the flange 38. Where the diaphragm 40 is bistable, the
diaphragm 40 may
be in one of its two bistable configurations in the exhalation configuration,
as seen in FIG. 3A.
Utilizing a bistable diaphragm 40 with a stable configuration in the
exhalation configuration
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means the patient need not utilize any breathing force to maintain the
exhalation configuration
after that exhalation configuration has been reached; as a result, the
ventilator 2 may be useful
for treating patients with degraded breathing capability. Where the diaphragm
40 is stable in a
single configuration, that configuration may be the exhalation configuration
as shown in FIG.
3A.
101651 The vent ring 36 includes one or more exhalation windows 78 defined
through
the side of the vent ring 36. One or more exhalation windows 78 may be located
at or near the
bottom 27 of the vent ring 36. As the vent ring 36 moves downward, the
exhalation windows 78
move downward, below the lower surface 37 of the vent ring seat 36. The
central passage 17 is
located below the vent ring seat 36, such that when the exhalation windows 78
move below the
lower surface 37 of the vent ring seat 36, exhaled air can flow out of the
chamber 42 above the
diaphragm 40, through the exhalation windows 78 in the vent ring 26, into the
central passage
17, and then out of the ventilator 2 through the ambient fluid aperture 4.
Thus, in the exhalation
configuration, the fluid port 54 and the central passage are in fluid
communication with one
another.
Operation
101661 The operation of the ventilator 2 now will be described. The fluid port
54 of the
ventilator 2 is placed in fluid communication with a respirator, which is
attached to a patient.
The respirator is provided with compliant sealing surfaces such that a
substantially airtight seal is
created against the patients face. The patient inhales from and exhales into
the respirator. In
turn, the respirator is in fluid communication with the airway of the patient.
In this way, the
fluid port 54 of the ventilator 2 is placed in fluid communication with the
patient's airway.
According to other embodiments, the fluid port 54 may be any apparatus other
than a respirator
that places the fluid port 54 in fluid communication with the patient's
airway; the use of the
respirator to do so is not critical to the invention.
101671 Upon inhalation by the patient, pressure above the diaphragm 40 is
reduced
compared to ambient air pressure. As a result, the diaphragm 40 flexes upward
at and in
proximity to its center. Alternately, the diaphragm 40 may be biased upward,
at least in part,
independently from the patient's inhalation. The upward motion of the
diaphragm 40 moves the
flange 38 upward, because the flange 38 is connected to the diaphragm 40.
Because the flange
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38 is part of or connected to the valve 20, that upward motion of the
diaphragm 40 causes the
valve 20 to move upward. That upward motion of the valve 20 moves the stem 22
upward, thus
moving the tapered end 24 of the step out of the venturi opening 16 and away
from the venturi
nozzle 14. Because the tapered end 24 of the stem 22 has moved out of the
venturi opening 16,
oxygen is again free to escape from the venturi opening 16. Thus, in this
embodiment, oxygen
flow out of the venturi opening 16 restarts purely mechanically, powered by
inhalation by the
patient via the fluid port 54. Oxygen flows out of the venturi opening 16 as
long as the tapered
end 24 of the stem 22 is spaced apart from the venturi opening 16. This
position of the valve 20,
in which the stem 22 is spaced apart from the venturi opening 16 and fluid can
flow out of the
venturi opening 16, is the start flow position of the valve 20.
101681 Oxygen may be supplied to the fluid inlet 6 from any suitable source.
According
to some embodiments, high pressure oxygen is connected to a pressure
regulator, which drops
the pressure of that oxygen and outputs lower pressure oxygen to the fluid
inlet 6. In one
embodiment, the pressure regulator is the GovReg adjustable flow regulator of
Legacy US, Inc,
as described in U.S. Pat. App. Serial No. 15/488,319, filed April 14, 2017
(the "GovReg
document), which is hereby incorporated by reference in its entirety. That
U.S. Pat. App. Serial
No. 15/488,319 is a continuation-in-part of U.S. Pat. App. Serial No.
14/990,673. The U.S. Pat.
App. Serial No. 15/488,319 application also expressly incorporates by
reference therein the U.S.
Pat. App. Serial No. 14/990,673 application in paragraph [0001] of the U.S.
Pat. App. Serial No.
15/488,319 application as originally filed. Thus, the contents of the U.S.
Pat. App. Serial No.
14/990,673 application are incorporated by reference in the present
application and specifically
FIGS. 5A, 5B, 7A, 7B, 7C, and 7D and the associated text of U.S. Pat. App.
Serial No.
14/990,673. The use of the GovReg pressure regulator allows a healthcare
worker to set the
pressure for a patient and fix that pressure, such that it cannot be changed
without the use of an
adjustment key that only healthcare workers can change it. This provides
additional safety for
the patient. Further, multiple ventilators 2 can be connected to the same high
pressure oxygen
source, and each ventilator 2 can receive a different pressure of oxygen
depending on the setting
of the GovReg pressure regulator associated with that ventilator. As
described in the
"GovReg document, the pressure regulator may include a housing formed to
include a bore
within, and a piston movable within that bore, where the piston may include an
annular lip
adjacent to an end of the piston. A spring may be disposed within the bore,
where the spring has
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two ends, and an adjustment cap may be moveably disposed in the bore, where
the adjustment
cap may include key slots formed therein. A first end of the spring may be in
physical contact
with the annular lip, and a second end of the spring may be in physical
contact with the
adjustment cap. The bore may be defined by a cylindrical wall, and the
cylindrical wall may be
threaded. The adjustment cap may be threaded as well, such that its threading
meshes with the
threading of the cylindrical wall. Rotating the adjustment cap in one
direction may cause the
adjustment cap to compress the spring and increase the output pressure of the
pressure regulator,
and rotating the adjustment cap in the opposite direction may cause the
adjustment cap to
decompress the spring and decrease the output pressure of the pressure
regulator. The
adjustment key may be, or may be detachably connected to, the adjustment cap;
the adjustment
key may be detachable from the pressure regulator. Thus, in some embodiments,
rotation of the
adjustment cap allows a healthcare worker to set and fix the pressure for a
patient.
101691 Referring now to FIGS. 9-14, a pressure regulator 700 comprises housing
510,
piston 760 moveably disposed within housing 510 wherein piston 760 is formed
to include an
annular lip 762, compression spring 720, and adjustment cap 750. Spring 720 is
disposed
between annular lip 520 and adjustment cap 750.
101701 Referring now to FIGS. 12-14, adjustment cap 750 is formed to include
threading
adjacent a first end thereof. Threading 752 is configured to mesh with
internal threading 780
(FIG. 11).
101711 Compression spring 720 determines the regulated output pressure in
portion 740.
Rotating adjustment cap in a first direction compresses spring 720, and
increases the output
pressure in region 740 (FIG. 11) of regulator 700. Rotating adjustment cap in
a second and
opposite direction decompresses spring 720, and decreases the output pressure
in region 740
(FIG. 11) of regulator 700.
101721 Adjustment cap 750 is further formed to include key slots 754 and 756
which
extend inwardly in a second end thereof. Adjustment cap 750 is further formed
to include an
aperture 758 extending therethrough. Shaft 764 of piston 760 passes through
aperture 758.
101731 Oxygen travels through the fluid inlet 6 and then the passages 12, then
through
the venturi nozzle 14 and out of the venturi opening 16. The flow of oxygen
outward through
the venturi opening 16 entrains ambient air entering the ventilator 2 through
the ambient fluid
aperture 4, and draws ambient air into the throat 19 of the venturi 10, where
oxygen and ambient
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air are mixed. The venturi nozzle 14 may be sized and configured to create a
mixture of ambient
air and oxygen that delivers a 26% fraction of inspired oxygen (Fi02) to the
patient. This
percentage of Fi02 is a recommended oxygen concentration, but other fractions
may be used as
needed. Accuracy of the fraction of oxygen is not critical, and that fraction
may be adjusted by a
clinician or other healthcare worker as required. For example, the Fi02may be
adjusted to 40%
from 26% as needed by the patient; after the Fi02 has been adjusted to 40%, if
the patient needs
additional oxygen, the patient may then be removed from the ventilator 2,
intubated, and then
placed on a currently-known ventilator.
101741 The enriched air travels upward through the central passage 17 to the
inlet
aperture 43. In the inhalation configuration, the inlet passage 41 is in fluid
communication with
the central passage 17. As described above, in the inhalation configuration,
the vent ring 26 is in
an upward position relative to the venturi nozzle 14. In the inhalation
configuration, the lowered
pressure in the chamber 42 above the diaphragm 40, caused by inhalation by the
patient through
the fluid port 54, causes the diaphragm 40 to move upward. Inhalation
withdraws gas from the
chamber 42 above the diaphragm 40, decreasing the pressure and actuating the
valve 20 relative
to the venturi nozzle 14. The flange 38 may contact the limiter 72, such that
the flange 38 does
not move higher than the limiter 72 allows. Upward motion of the diaphragm 40
causes the
flange 38, which is attached to the flange 38, to move upward. Upward motion
of the flange 38
causes the valve 20, of which the flange 38 is a part, to move upward as well.
Such upward
motion of the valve 20 moves the stem 22 away from the venturi nozzle 14,
thereby unblocking
the venturi opening 16 and allowing gas to flow outward therefrom. The
diaphragm 40 is an
example of a pressure force multiplier 40, because the surface area of the
diaphragm 40 in
combination with the flange openings 39 allow for a small differential change
in pressure at the
fluid port 54 to actuate the valve 20 between closed and open states.
101751 As described above, in the inhalation configuration, the inlet aperture
43 is open,
placing the central passage 17 in fluid communication with the inlet passage
41, and both sides
of the diaphragm 40 are thus in fluid communication with one other via the
flange openings 39;
as a result, those flange openings 39 place the inlet passage 41 and the fluid
port 54 in fluid
communication in the inhalation configuration. Thus, in the inhalation
configuration, the central
passage 17, the inlet passage 41, and the fluid port 54 are in fluid
communication with one
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another, such that enriched air flows freely from the venturi nozzle 14 to the
fluid port 54, and
then to the patient.
101761 The patient inhales normally, or as normally as possible. The
ventilator 2 is a
simple, single-mode ventilator that does not deliver a specific, limited or
preselected volume or
flow rate of air to the patient; instead, it delivers air at a volume and flow
rate that are controlled
solely by the patient's own inhalation. Further, the ventilator 2 only
delivers enriched air to the
patient during the patient's inhalation, and momentarily afterward. As opposed
to continuous
positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP)
ventilation,
enriched air is only supplied to the patient during inhalation. In this way,
the ventilator 2 does
not apply pressure to the patient's nose or mouth while the patient is trying
to exhale, and oxygen
is not wasted by applying it to the patient's nose or mouth while the patient
is actively exhaling.
101771 After inhalation, the patient then exhales. Upon exhalation by the
patient,
pressure above the diaphragm 40 is increased compared to ambient air pressure.
Referring also
to FIG. 3B, in the exhalation configuration, fluid flow into the chamber 42
from the fluid port 54
causes the flaps 70 to be pushed down onto the flange 38 and the flange
openings 39,
substantially stopping the free flow of fluid from the patient through the
flange openings 39. In
this way, because the flange openings 39 are substantially blocked by the
flaps 70, the inlet
aperture 43 may remain partly or even entirely open, and exhalation air still
cannot substantially
flow outward through the flange openings 39 and then outward through the inlet
aperture 43. In
the exhalation configuration, both sides of the diaphragm 40 may be blocked
from fluid
communication with one other via the flange openings 39. Thus, in the
exhalation configuration,
the inlet passage 41 and the fluid port 54 are not substantially in fluid
communication with one
another.
101781 Because the flange openings 39 are closed, exhalation by the patient
into the fluid
port 54 causes a pressure rise in the chamber 42 above the diaphragm 40. That
is, exhalation
forces gas into the chamber 42 above the diaphragm 40, increasing the pressure
and actuating the
valve 20 relative to the venturi nozzle 14. This rise in pressure pushes the
flange 38 downward
into contact with or into proximity to the vent ring seat 36, to the
exhalation position of the
flange 38. Because the flange 38 is part of or connected to the valve 20, that
downward motion
of the diaphragm 40 causes the valve 20 to move downward. That downward motion
of the
valve 20 moves the stem 22 downward, thus moving the tapered end 24 of the
step toward from
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the venturi nozzle 14 and into the venturi opening 16. Because the tapered end
24 of the stem 22
has moved into the venturi opening 16, oxygen is substantially restricted from
escaping from the
venturi opening 16. Thus, oxygen flow out of the venturi opening 16 stops
purely mechanically,
powered by exhalation by the patient through the fluid port 54. Oxygen is
substantially restricted
from escaping out of the venturi opening 16 as long as the tapered end 24 of
the stem 22 plugs
the venturi opening 16. This position of the valve 20, in which the stem 22
plugs the venturi
opening 16 and fluid is substantially restricted from flowing out of the
venturi opening 16, is the
stop flow position of the valve 20.
101791 As the flange 38 and the vent ring 36 moves downward, the exhalation
windows
78 move downward, below the lower surface 37 of the vent ring seat 36. The
central passage 17
is located below the vent ring seat 36, such that when the exhalation windows
78 move below the
lower surface 37 of the vent ring seat 36, exhaled air can flow out of the
chamber 42 above the
diaphragm 40, through the exhalation windows 78 in the vent ring 26, into the
central passage
17, and then out of the ventilator 2 through the ambient fluid aperture 4.
Thus, in the exhalation
configuration, the fluid port 54 and the central passage are in fluid
communication with one
another. The exhaled breath then travels through the central passage 17 and
out of the ventilator
2 through the ambient fluid aperture 4. When the patient then inhales again,
the cycle of
operation described above repeats again.
101801 Because the ventilator 2 does not require electrical power to operate
according to
some embodiments, its form factor may be comparatively small, such that the
ventilator 2 may
be portable. The ventilator 2 may be carried on the user's back by a strap or
straps like a
backpack; may be carried by a strap over the shoulder like a purse, may be
wheeled and able to
be pulled behind a user like luggage, or may be otherwise portable. The
portability of the
ventilator 2 also allows the user to take the ventilator 2 home. Home use of
the ventilator 2 may
be advantageous for patients who have been diagnosed with COVID-19 or other
respiratory
disease, but whose symptoms have not advanced to the level of seriousness of
ARDS such that
they require intubated ventilation. In this way, during a pandemic such as the
2020 COVID-19
pandemic, patients who are infected with a virus that causes respiratory
problems can be treated
safely at home, without consuming hospital beds and other hospital resources
needed for patients
who are significantly sicker and closer to death.
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101811 Because the ventilator 2 is small and portable and noninvasive, and
simply
provides enriched air with a higher oxygen concentration to a user, the
ventilator 2 may find use
in other applications. As one example, the ventilator 2 may be useful in the
treatment of asthma
and/or seasonal allergies. The user wears a respirator as described above, and
the ventilator 2
works substantially as described above; a user utilizes it as a portable
device. The increased
oxygen concentration delivered by the ventilator 2 may be beneficial for
asthma sufferers, and
the filter(s) 56 may be useful for removing pollen and other allergens from
the air before they
can be inhaled by the user, thereby improving symptoms experienced by those
who suffer from
seasonal allergies. As another example, in extremely polluted cities, the air
may be unhealthy to
breathe. By utilizing the ventilator 2 as a portable device, clean oxygen is
delivered to the user at
a higher than ambient concentration, and the filter(s) 56 may be useful for
removing particulates
and/or other pollutants from the ambient air prior to inhalation by the user.
101821 The ventilator 2 described above with regard to FIGS. 1-4 may find
particular use
in the treatment of patients infected with the COV1D-19 virus, especially
prior to their
development of ARDS. It is believed that treatment of such patients utilizing
the ventilator 2
may prevent a portion of such patients from developing ARDS. It is expected
that the ventilator
2 would be classified as a Class II medical device by the FDA and would thus
require approval
by the FDA for use in treating patients. While the regulatory path for
approval by the FDA of
the ventilator 2 is unknown as of the filing date of this document, it is
expected that for use as a
medical device, the ventilator 2 would require at least one of an
Investigational Device
Exemption (IDE), an Emergency Use Authorization (EUA), and a Premarket
Approval (PMA).
The independent claims as filed are believed to cover embodiments of the
ventilator 2 that would
be subject to an applicable FDA approval.
101831 However, the ventilator 2 is not limited to use the treatment of
patients infected
with the COVID-19 virus; the ventilator 2 may be used to treat patients
suffering from other
ailments. Further, the ventilator 2 may find use in fields other than
healthcare in which control
of fluid flow is desired, and need not be used in conjunction with a human
being in such fields.
Further, the ventilator 2 is described above as having components in fluid
communication with
one another and with one or more external attachments, such as a respirator.
Where the
ventilator 2 is utilized to treat a patient, the fluid of that fluid
communication is a gas. However,
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where the ventilator 2 is utilized in other applications, the fluid may be a
liquid, or a mixture of
liquid and gas.
101841 While the embodiment of the invention described above arose in an
endeavor to
facilitate treatment of respiratory conditions associated with COVID-19, it
will be understood
that the fluid mixer 2 has various other uses and applications in other
fields, which include but
are not limited to the following. As one example, in Formula 1 racing and
other racing
applications, the fluid mixer 2 may be used to pre-spin turbochargers by
detecting pressure
changes, to actuate cam timing changes based on pressure, to actuate opening
of fuel/air and
exhaust ports based on pressure, to actuate aerodynamic dovvnforce adjustment
based on pressure
conditions at a sample site, to actuate fuel system pressure adjustment, and
to regulate
temperature in fluid. As another example, in standard automotive usage, the
fluid mixer 2 may
be used to actuate turbocharger pre-spin, to actuate cam timing changes, to
actuate opening of
fuel/air and exhaust ports based on pressure, to actuate fuel system pressure
adjustment, and to
regulate temperature in fluid As another example, in indoor agriculture
applications, the fluid
mixer 2 may be used to actuate gas mixing based on pressure, and/or to actuate
a pressure
communication system. In such applications, the fluid that flows through the
fluid mixer 2 may
be a liquid, a gas, or both.
101851 Referring also to FIGS. 5-8, another embodiment of the fluid mixer 2 is
shown.
Such an embodiment may be described as a "reverse configuration." Such an
embodiment may
be useful for automotive or racing applications, although the fluid mixer 2 of
FIGS. 5-8 is not
limited to use in such applications. Any embodiment may be used with liquid,
gas or both as the
fluid. As seen in FIGS. 5-8, the valve 20 is in a start flow position, in
which fluid can enter the
fluid mixer 2 through the fluid inlet 6. The valve 20 may include a tapered
end 24 or other
suitably-shaped end, which is received in a bore 80. A spring 82 may be
received in the bore 80
as well. One end of the spring 82 may engage an end of the bore 80, and the
other end of the
spring 82 may engage an end of the valve 20. The other end 84 of the valve 20
may be
substantially cylindrical, or have any other suitable shape. The end 84 of the
valve 20 is received
in a pipe 86 through which fluid can flow. The bore 80 is substantially
hollow, such that fluid
flows from the fluid inlet 6 through the bore 80 when the valve 20 is in the
start flow position,
and then into one or more passages 12. As described in the with regard to the
previous
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embodiment, fluid flows out of the one or more passages 12 through the venturi
opening 16 in
the venturi nozzle 14.
101861 In this embodiment, the pressure force multiplier 40 is substantially
sealed to the
chamber 42 to form a sealed plenum 88. Unlike the previous embodiment, fluid
does not
substantially cross the pressure force multiplier 40. When fluid flows into
the fluid mixer 2
through the fluid port 54, that fluid flows toward the ambient fluid aperture
4 through the central
passage 17. The chamber 42 is open to the central passage 17 through a chamber
opening 90.
The chamber opening 90 may have any suitable shape and size. The chamber
opening 90 allows
for fluid communication between the chamber 42 and the central passage 17.
When fluid is
forced into the central passage 17 through the fluid port 54, pressure in the
central passage 17
increases. Pressure in the chamber 42 on the side of the pressure force
multiplier 40 opposite the
plenum 88 increases as well due to fluid communication through the chamber
opening 90.
Because the pressure force multiplier 40 is substantially sealed to the
chamber 42 and fluid
substantially cannot cross the pressure force multiplier 40, pressure on the
pressure force
multiplier 40 increases, causing the pressure force multiplier 40 to move and
thus decrease the
volume of the plenum 88, increasing the pressure in the plenum 88 as well.
That increased
pressure in the plenum 88 is transmitted through the pipe 86 to the end 84 of
the valve 20. That
pressure drives the end 84 of the valve 20 toward the spring 82 in the bore
80, opening the valve
20 to the start flow position. In the start flow position, the tapered end 24
of the valve 20, or
otherwise-shaped end of the valve 20, moves apart from the aperture 92,
allowing fluid to flow
through the aperture 92 into the bore 80. It may be that the volume of the
plenum 88, along with
the volume of the pipe 86, remains substantially constant during this process.
This is because the
end 84 of the valve 20 in the bore 80 is movable, such that any momentary
increase in pressure
in and decrease in volume of the plenum 88 may be substantially matched by
movement of the
end 84 of the valve 20. In this way, a substantially fixed volume may be
defined on one side of
the pressure force multiplier 40.
101871 When fluid flows into the fluid mixer 2 through the ambient fluid
aperture 4, that
fluid flows toward the fluid port 54 through the central passage 17. When
fluid is withdrawn
through the fluid port 54, pressure in the central passage 17 decreases.
Pressure in the chamber
42 on the side of the pressure force multiplier 40 opposite the plenum 88
decreases as well due to
fluid communication through the chamber opening 90. Because the pressure force
multiplier 40
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is substantially sealed to the chamber 42 and fluid substantially cannot cross
the pressure force
multiplier 40, pressure on the pressure force multiplier 40 decreases, causing
the pressure force
multiplier 40 to move and thus increase the volume of the plenum 88,
decreasing the pressure in
the plenum 88 as well. That decreased pressure in the plenum 88 is transmitted
through the pipe
86 to the end 84 of the valve 20. The pressure applied to the end 84 of the
valve 20 in the bore
80 decreases, allowing the spring 82 to push the end 84 of the valve 20
further into the pipe 86.
The spring 82 may be a compression spring that biases the valve 20 toward the
stop flow
positions; motion of the valve 20 toward the pipe 86 closes the valve 20 to
the stop flow position.
In the stop flow position, the tapered end 24 of the valve 20, or otherwise-
shaped end of the
valve 20, moves toward and substantially blocks the aperture 92, substantially
stopping fluid
flow through the aperture 92 into the bore 80. According to some embodiments,
the start flow
position of the valve 20 is also the active flow position, allowing fluid to
flow while the valve is
in the start flow position. Alternately, the valve 20 may be positioned in a
different active flow
position, between the start flow and stop flow positions; such an active flow
position may be
determined by the level or duration of force with which fluid is forced into
the fluid port 54 or
withdrawn from the fluid port 54.
101881 Referring now to FIG. 15, there is shown a side cutaway view of the
ventilator/apparatus 2 according to an embodiment of the invention. The
ventilator/apparatus 2 is
that described herein, but having a sensor module 1550 positioned between the
pressure force
multiplier and the fluid port. The sensor module 1550 may comprise any of the
sensors described
herein, for instance, pressure sensor, oxygen sensor, carbon dioxide sensor,
temperature sensor,
humidity sensor et al. The sensor module 1550 also, in this embodiment,
comprises a central
processing unit.
101891 Referring now to FIG. 16, there is shown a side cutaway view of the
ventilator/apparatus 2 according to an embodiment of the invention. The
ventilator/apparatus 2 is
that described herein, but having a sensor module 1551 positioned between the
venturi nozzle
and the ambient air aperture. The sensor module 1551 may comprise any of the
sensors described
herein, for instance, pressure sensor, oxygen sensor, carbon dioxide sensor,
temperature sensor,
humidity sensor et al.
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101901 Referring now to FIG. 17, there is shown a side cutaway view of the
ventilator/apparatus 2 according to an embodiment of the invention. The
ventilator/apparatus 2 is
that described herein, but having a sensor module 1750 positioned between the
pressure force
multiplier and the fluid port and a sensor module 1751 positioned between the
venturi nozzle and
the ambient air aperture. The sensor modules 1750/1751 may comprise any of the
sensors
described herein, for instance, pressure sensor, oxygen sensor, carbon dioxide
sensor,
temperature sensor, humidity sensor et al.
101911 Referring now to FIG. 18 there is shown a side cutaway view of the
ventilator/apparatus 2 according to an embodiment of the invention. The
ventilator/apparatus 2 is
that described herein, but having a spirometer 1853 positioned between the
pressure force
multiplier and the fluid port.
101921 Referring now to FIG. 19 there is shown a side cutaway view of the
ventilator/apparatus 2 according to an embodiment of the invention. The
ventilator/apparatus 2 is
that described herein, but having a spirometer 1954 positioned between the
venturi nozzle and
the ambient air aperture.
101931 FIG. 20 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention having a multiple spirometers 2053 and 2054 in
multiple positions.
That is having a spirometer 2053 positioned between the pressure force
multiplier and the fluid
port and a spirometer 2054 positioned between the venturi nozzle and the
ambient air aperture.
101941 FIG. 21 is a side cutaway view of the ventilator/apparatus 2 according
to an
embodiment of the invention having a pitot tube 2155 between the pressure
force multiplier and
the fluid port.
101951 FIG. 22 is a side cutaway view of the ventilator/apparatus 2 according
to an
embodiment of the invention having a piezo element 2267 at the limiter 72.
101961 FIG. 23 is a side cutaway view of the ventilator/apparatus 2 according
to an
embodiment of the invention having a sensors, spirometers, a pitot tube and
piezo element in
multiple positions ¨ like numbers denote like features as shown in earlier
embodiments.
101971 FIG. 24 is a perspective cutaway view of the ventilator/apparatus 2 of
FIG. 23.
101981 FIG. 25 is a side cutaway view of the ventilator/apparatus 2 according
to an
embodiment of the invention having an active filter 2560 positioned adjacent
the ambient fluid
aperture.
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[0199] FIG. 26 is a perspective cutaway view of the ventilator/apparatus of
FIG. 25.
[0200] FIG. 27 is a flow chart of the method according to an embodiment of the
invention. Steps Sl-S12 correspond to the steps defined herein.
[0201] FIG. 28 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention without a fluid flow restrictor.
[0202] FIG. 29 is a perspective cutaway view of the ventilator/apparatus of
FIG. 28.
[0203] FIG. 30 is a side cutaway view of the ventilator/apparatus 2 according
to an
embodiment of the invention with a fluid flow restrictor 3070 in an open
position. The ventilator
2 comprising exhalation windows 3078 for allowing fluid to exit the ventilator
2 during
exhalation, and a fluid flow restrictor 3070 for at least selectively
partially closing the exhalation
windows 3078 to set the Positive End Expiratory Pressure (PEEP) of the
patient. The fluid flow
restrictor 3070 is in the shape of a collar and is positioned adjacent the
vent ring, and held in
place by a pair of pins 3071 so that it can be selectively adjusted linear to
select the extent that
the collar obstructs the exhalation windows 3078.
[0204] FIG. 31 is a perspective cutaway view of the ventilator/apparatus of
FIG. 30.
[0205] FIG. 32 is a side cutaway view of the ventilator/apparatus according to
an
embodiment of the invention with a fluid flow restrictor in a restricted
position.
[0206] FIG. 33 is a perspective cutaway view of the ventilator/apparatus of
FIG. 30 in
the open position.
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Clauses
[0207] It will be understood that the following clauses form part of the
specification and
disclosure of the invention defined herein More particularly, the invention
herein may be
defined by the combination of the features of the clauses as detailed below,
and such clauses may
be utilized to amend the combination of the features within the claims of this
application.
[0208] 1. A respirator apparatus including:
a venturi nozzle for flow of a pressure-controlled fluid;
an ambient fluid aperture in fluid communication with the venturi nozzle;
a fluid port;
a pressure force multiplier in fluid communication with the fluid port; and
a valve moveable relative to the venturi nozzle between a start flow position
and a stop
flow position;
where the pressure force multiplier is configured such that fluid forced into
the fluid port
actuates the valve relative to the venturi nozzle; and
where the pressure force multiplier is configured such that fluid withdrawn
from the fluid
port actuates the valve relative to the venturi nozzle.
[0209] 2. An apparatus suitable for a respirator, including:
a venturi nozzle for flow of a pressure-controlled fluid;
an ambient fluid aperture in fluid communication with the venturi nozzle;
a fluid port;
a pressure force multiplier in fluid communication with the fluid port; and
a valve moveable relative to the venturi nozzle between a start flow position
and a stop
flow position;
where the pressure force multiplier is configured such that fluid forced into
the fluid port
actuates the valve relative to the venturi nozzle; and
where the pressure force multiplier is configured such that fluid withdrawn
from the fluid
port actuates the valve relative to the venturi nozzle.
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[0210] 3. The apparatus of Clause 1 or Clause 2, where the pressure force
multiplier is
configured such that fluid forced into the fluid port actuates the valve
relative to the venturi
nozzle to a stop flow position; and
where the pressure force multiplier is configured such that fluid withdrawn
from the fluid port
actuates the valve relative to the venturi nozzle to a start flow position.
[0211] 4. The apparatus of Clause 1 or Clause 2, where the pressure force
multiplier is
configured such that fluid forced into the fluid port actuates the valve
relative to the venturi
nozzle to a start flow position, and
where the pressure force multiplier is configured such that fluid withdrawn
from the fluid port
actuates the valve relative to the venturi nozzle to a stop flow position.
[0212] 5. The apparatus of Clause 1 or Clause 2, where the pressure force
multiplier is
configured such that fluid forced into the fluid port actuates the valve
relative to the venturi
nozzle to an active flow position between the start flow position and stop
flow position; and
where the pressure force multiplier is configured such that fluid withdrawn
from the fluid port
actuates the valve relative to the venturi nozzle to an active flow position
between the start flow
position and stop flow position.
[0213] 6. The apparatus of any of Clauses 1 to 5, where a pressure-controlled
fluid includes
oxygen, an ambient fluid includes ambient air, fluid forced into the fluid
port includes air
exhaled into an air port, and fluid withdrawn from the fluid port includes air
inhaled from an air
port.
[0214] 7. The apparatus of any of Clauses 1 to 5, where the pressure force
multiplier is
positioned between the venturi nozzle and the fluid port.
[0215] 8. The apparatus of any of Clauses 1 to 5, where the venturi nozzle is
positioned between
the pressure force multiplier and the fluid port.
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[0216] 9. The apparatus of any of Clauses 1 to 5, where the yenturi nozzle is
positioned between
the ambient fluid aperture and the fluid port.
[0217] 10 The apparatus of any of Clauses 1 to 9, including a pressure
regulator for regulating
the flow of a pressure-controlled fluid, the pressure regulator including:
a housing formed to include a bore therein;
a piston moveably disposed within the bore, where the piston includes an
annular lip
adjacent a first end thereof;
a spring disposed within the bore, and including a first end and a second end;
an adjustment cap moveably disposed in the bore, where the adjustment cap is
formed to include
a plurality of key slots formed therein;
where:
the first end of the spring is in physical contact with the annular lip; and
the second end of the spring is in physical contact with the adjustment cap
where:
rotating the adjustment cap in a first direction causes the adjustment cap to
compress the first spring;
rotating the adjustment cap in a second and opposite direction causes the
adjustment
cap to decompress the spring;
rotating the adjustment cap in the first direction increases the output
pressure of the
pressure regulator;
rotating the adjustment cap in the second direction decreases the output
pressure of
the pressure regulator;
the bore is defined by a cylindrical wall;
the cylindrical wall is formed to include first threading therein;
the adjustment cap is formed to include second threading formed on a periphery
thereof;
the second threading is configured to mesh with the first threading.
[0218] 11. The apparatus of any of Clauses 1 to 10, where the pressure force
multiplier includes
a diaphragm.
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[0219] 12. The apparatus of any of Clauses 1 to 11, where the pressure force
multiplier is bi-
stable.
[0220] 13. The apparatus of any of Clauses 3 to 12, where the pressure force
multiplier is biased
toward the stop flow position.
[0221] 14. The apparatus of any of Clauses 3 to 12, where the pressure force
multiplier is biased
toward the start flow position.
[0222] 15. The apparatus of any of Clauses 1 to 10, where the pressure force
multiplier includes
at least one flap.
[0223] 16. The apparatus of any of Clauses 1 to 15, where the apparatus is
solely mechanical.
[0224] 17. The apparatus of any of Clauses 3 to 16, where in the start flow
position or an active
flow position a mixture of pressure-controlled fluid and ambient fluid is
allowed to flow to the
fluid port.
[0225] 18. The apparatus of Clause 17, where the flow of the mixture is
modulated in real-time.
[0226] 19. The apparatus of any of Clauses 1 to 18, where the valve includes a
flange that is
connected to the pressure force multiplier.
[0227] 20. The apparatus of any of Clauses 1 to 18, where the valve includes a
stem with a
tapered end, where the tapered end enters a venturi opening in the venturi
nozzle in the stop
position to substantially close the venturi opening.
[0228] 21. The apparatus of Clause 20, where the stem is connected to the
pressure force
multiplier.
[0229] 22. The apparatus of any of Clauses 1 to 18, where the valve includes a
switch.
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[0230] 23. The apparatus of any of Clauses 1 to 18, where the valve includes a
flap valve.
[0231] 24. The apparatus of any of Clauses 1 to 18, where the valve includes a
spring-loaded
shuttle system.
[0232] 25. The apparatus of any of Clauses 1 to 18, where the valve is
slidable.
[0233] 26. The apparatus of any of Clauses 1 to 25, where the valve is solely
mechanical.
[0234] 27. The apparatus of any of Clauses 1 to 26, where the ambient fluid
aperture includes a
fluid exhaust.
[0235] 28. The apparatus of Clause 27, where the valve is configured to be
actuated relative to the
venturi nozzle while simultaneously opening the fluid exhaust.
[0236] 29. The apparatus of any of Clauses 1 to 28, further including at least
one filter detachably
connected to the ambient fluid aperture.
[0237] 30. The apparatus of Clause 29, where the at least one filter includes
pores of about 31.1m.
[0238] 31. The apparatus of any of Clauses 1 to 30, further including a
respirator.
[0239] 32. The apparatus of Clause 31, where the respirator is in fluid
communication with the
fluid port.
[0240] 33. The apparatus of any of Clauses 1 to 32, where the fluid is a
liquid.
[0241] 34. The apparatus of any of Clauses 1 to 33, where the apparatus is
injection molded.
[0242] 35. The apparatus of any of Clauses 1 to 33, where the apparatus is 3D
printed.
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[0243] 36. The apparatus of any of Clauses 1 to 35, where apparatus is
configured to be mobile.
[0244] 37. The apparatus of any of Clauses 1 to 36, where apparatus is
configured to here-usable.
[0245] 38. The apparatus of any of Clauses 1 to 37 for use in controlling the
flow of air and/or
oxygen into a respirator.
[0246] 39. The apparatus of any of Clauses 1 to 38 for use in controlling the
flow of scrubbed
air and/or oxygen into a respirator.
[0247] 40. The apparatus of any of Clauses 1 to 39 for use in treating a
respiratory condition.
[0248] 41. The apparatus of any of Clauses 1 to 40 for use in treating COV1D-
19.
[0249] 42. A method of using an apparatus suitable for a respirator, the
method including:
providing a source of pressure-controlled fluid;
providing an apparatus suitable for a respirator, including:
a venturi nozzle for receiving a flow of the pressure-controlled fluid,
an ambient fluid aperture in fluid communication with the venturi nozzle;
a fluid port;
a pressure force multiplier in fluid communication with the fluid port; and
a valve moveable relative to the venturi nozzle between a start flow position,
in
which the pressure-controlled fluid mixes with the ambient fluid, and a stop
flow
position;
actuating the valve relative to the venturi nozzle in response to fluid forced
into the fluid
port; and
actuating the valve relative to the venturi nozzle in response to fluid
withdrawn from the
fluid port.
[0250] 43. The method of Clause 42, where the apparatus is solely mechanical.
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[0251] 44. The method of Clause 42 or Clause 43, further including adjusting
the pressure of the
pressure-controlled fluid.
[0252] 45. The method of any of Clauses 42 to 44, where the method is for
using the apparatus in
treating a living patient who inhales and exhales breath, where the pressure-
controlled fluid is
pressure-controlled oxygen, and where the fluid is air, the method including:
connecting the apparatus to a respirator;
placing the respirator in gaseous communication with the patient and with the
source of
pressure-controlled oxygen;
in response to inhalation by the patient, starting oxygen flow into the
respirator, mixing the
oxygen with ambient air to generate enriched air, and delivering the enriched
air to
the patient;
in response to exhalation by the patient, stopping oxygen flow into the
respirator, and
exhausting exhalation air from the respirator.
[0253] 46. The method of Clause 45, where the enriched air has an Fi02 of at
least 26%.
[0254] 47. The method of any of Clauses 42 to 44, where the method is for
using the apparatus in
treating a living patient who inhales and exhales breath, where the pressure-
controlled fluid is
pressure-controlled filtered air, and where the fluid is air, the method
including:
connecting the apparatus to a respirator;
placing the respirator in gaseous communication with the patient and with the
source of
pressure-controlled filtered air;
in response to inhalation by the patient, starting oxygen flow into the
respirator, mixing the
pressure-controlled filtered air with ambient air to generate scrubbed air,
and
delivering the scrubbed air to the patient;
in response to exhalation by the patient, stopping oxygen flow into the
respirator, and
exhausting exhalation air from the respirator.
[0255] 48. The method of Clause 47, where the scrubbed air has an Fi02 of at
least 26%.
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[0256] 49. The method of any of Clauses 42 to 48, further including walking
and/or running
while utilizing the apparatus and a respirator.
[0257] 50. The method of any of Clauses 42 to 49, further including initiating
use of the
apparatus and respirator to treat allergies.
[0258] 51. The method of any of Clauses 42 to 49, further including initiating
use of the
apparatus and respirator to treat ARDS.
[0259] 52. The method of any of Clauses 42 to 49, further including initiating
use of the
apparatus and respirator to treat sleep apnea.
[0260] 53. The method of any of Clauses 42 to 49, further including initiating
use of the
apparatus and respirator to treat COPD.
[0261] 54. The method of any of Clauses 42 to 49, further including initiating
use of the
apparatus and respirator to treat infection by the COVID-19 virus.
[0262] 55. The method of any of Clauses 42 to 54, further including filtering
the ambient air.
[0263] 56. The method of any of Clauses 42 to 55, further including filtering
exhaled breath
from the patient.
[0264] 57. A pressure force multiplier including a sealed end and an open end,
where the sealed
end is in fluid communication with a valve to define a fixed volume between
the sealed end and
the valve, where the pressure force multiplier is configured such that a
change in pressure in the
open end causes a change in pressure in the sealed end which actuates the
valve.
[0265] 58. The pressure force multiplier of Clause 57, configured such that a
negative pressure
in the open end causes a reduction in pressure in the sealed end which
actuates the valve.
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[0266] 59. The pressure force multiplier of Clause 57, configured such that a
positive pressure in
the open end causes an increase in pressure in the sealed end which actuates
the valve.
[0267] 60. The pressure force multiplier of any of Clauses 57 to 59, where the
actuation of the
valve activates a humidifier.
[0268] 61. The pressure force multiplier of any of Clauses 57 to 59, where the
actuation of the
valve generates a change in a visual indicator.
[0269] 62. The pressure force multiplier of Clause 61, where the change in
visual indicator
represents a change of pressure in the open end.
[0270] 63. The pressure force multiplier of Clause 62, where the change of
pressure in the open
end is caused by inhalation and/or exhalation of a patient.
[0271] As used in this document, both in the description and in the claims,
and as
customarily used in the art, the words "substantially," "approximately," and
similar terms of
approximation are used to account for manufacturing tolerances, manufacturing
variations, and
manufacturing imprecisions that are inescapable parts of fabricating any
mechanism or structure
in the physical world.
[0272] While the invention has been described in detail, it will be apparent
to one skilled
in the art that various changes and modifications can be made and equivalents
employed, without
departing from the present invention. It is to be understood that the
invention is not limited to
the details of construction, the arrangements of components, and/or the method
set forth in the
above description or illustrated in the drawings. Statements in the abstract
of this document, and
any summary statements in this document, are merely exemplary; they are not,
and cannot be
interpreted as, limiting the scope of the claims. Further, the figures are
merely exemplary and
not limiting. Topical headings and subheadings are for the convenience of the
reader only. They
should not and cannot be construed to have any substantive significance,
meaning or
interpretation, and should not and cannot be deemed to indicate that all of
the information
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relating to any particular topic is to be found under or limited to any
particular heading or
subheading. The purpose of the Abstract of this document is to enable the U.S.
Patent and
Trademark Office, as well as readers who are not familiar with patent or legal
terms or
phraseology, to determine quickly from a cursory inspection the nature and
essence of the
technical disclosure of the application. The Abstract is not intended to
define the invention, nor
is it intended to limit to the scope of the invention. The purpose of the
clauses of this document
is to provide support for claims in any later-file foreign patent applications
claiming priority to
this document. The clauses are not intended to define the invention, nor are
they intended to
limit to the scope of the invention. Therefore, the invention is not to be
restricted or limited
except in accordance with the following claims and their legal equivalents.
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