Proceedings of the 2010 Design of Medical Devices Conference

DMD2010
April 13-15, 2010, Minneapolis, MN, USA

DMD2010-3845

Design and Prototyping of a Low-cost Portable Mechanical

Ventilator

Abdul Mohsen Al Husseini1, Heon Ju Lee1, Justin Negrete1, Stephen Powelson1, Amelia Servi1,
Alexander Slocum1, Jussi Saukkonen2
1
Massachusetts Institute of Technology, Department of Mechanical Engineering
2
Boston University, School of Medicine

Abstract
This paper describes the design and prototyping of a low-cost portable mechanical ventilator for
use in mass casualty cases and resource-poor environments. The ventilator delivers breaths by
compressing a conventional bag-valve mask (BVM) with a pivoting cam arm, eliminating the
need for a human operator for the BVM. An initial prototype was built out of acrylic, measuring
11.25 x 6.7 x 8 inches (285 x 170 x 200 mm) and weighing 9 lbs (4.1 kg). It is driven by an
electric motor powered by a 14.8 VDC battery and features an adjustable tidal volume up to a
maximum of 750 ml. Tidal volume and number of breaths per minute are set via user-friendly
input knobs. The prototype also features an assist-control mode and an alarm to indicate over-
pressurization of the system. Future iterations of the device will include a controllable
inspiration to expiration time ratio, a pressure relief valve, PEEP capabilities and an LCD screen.
With a prototyping cost of only $420, the bulk-manufacturing price for the ventilator is
estimated to be less than $200. Through this prototype, the strategy of cam-actuated BVM
compression is proven to be a viable option to achieve low-cost, low-power portable ventilator
technology that provides essential ventilator features at a fraction of the cost of existing
technology.
Keywords: Ventilator, Bag Valve Mask (BVM), Low-Cost, Low-Power, Portable and Automatic

1. Introduction which are on the rise in developing countries 1,2

Respiratory diseases and injury-induced
respiratory failure constitute a major public
health problem in both developed and less
developed countries. Asthma, chronic
obstructive pulmonary disease and other chronic
respiratory conditions are widespread. These
conditions are exacerbated by air pollution,
smoking, and burning of biomass for fuel, all of
Patients with underlying lung disease may
develop respiratory failure under a variety of
challenges and can be supported mechanical
ventilation. These are machines which
mechanically assist patients inspire and exhale,
allowing the exchange of oxygen and carbon
dioxide to occur in the lungs, a process referred
to as artificial respiration3. While the ventilators
used in modern hospitals in the United States are

Abdul Mohsen Al Husseini, Heon Ju Lee, Justin Negrete, Stephen Powelson, Amelia Servi, Alexander Slocum, Jussi Saukkonen
 1 Reprinted with permission of

Abdul Mohsen Al Husseini, Heon Ju Lee, Justin Negrete, Stephen Powelson, Amelia Servi, Alexander Slocum, Jussi Saukkonen
highly functionally and technologically
sophisticated, their acquisition costs are
correspondingly high (as much as $30,000).
High costs render such technologically
sophisticated mechanical prohibitively
expensive for use in resource-poor countries.
Additionally, these ventilators are often fragile
and vulnerable during continued use, requiring
costly service contracts from the
manufacturer. In developing countries, this has
led to practices such as sharing of ventilators
among hospitals and purchasing of less reliable
refurbished units. Since medical resources in
these countries are concentrated in major urban
centers, in some cases rural and outlying areas
have no access at all to mechanical ventilators.
The need for an inexpensive transport ventilator
is therefore paramount.
In the developed world, where well-stocked
medical centers are widely available, the
problem is of a different nature. While there are
enough ventilators for regular use, there is a lack
of preparedness for cases of mass casualty such
as influenza pandemics, natural disasters and
massive toxic chemical releases. The costs of
stockpiling and deployment of state-of-the-art
mechanical ventilators for mass casualty settings
in developed countries are prohibitive.
According to the national preparedness plan
issued by President Bush in November 2005, the
United States would need as many as 742,500
ventilators in a worst-case pandemic. When
compared to the 100,000 presently in use, it is
clear that the system is lacking 4. One example
of this shortage occurred during Hurricane
Katrina, when there were insufficient numbers
of ventilators 5 , and personnel were forced to
resort to manual BVM ventilation6. Measures to
improve preparedness have since been enacted;
most notably the Center for Disease Control and
Prevention (CDC) recently purchased 4,500
portable emergency ventilators for the strategic
national stockpile 7 . However, considering the
low number of stocked ventilators and their
currently high cost, there is a need for an
Electric ventilators are
capable of operating
2
inexpensive portable ventilator for which
production can be scaled up on demand.
1.1. Prior Art
While many emergency and portable ventilators
are on the market, an adequate low-cost
ventilator is lacking. A cost-performance
distribution is depicted in Figure 1 with
manually operated BVMs on the low end of cost
and performance, and full-featured hospital
ventilators on the other extreme. The middle
section of the chart includes the existing portable
ventilators which can be broadly categorized as
pneumatic and electric. Pneumatic ventilators
are actuated using the energy of compressed gas,
often a standard 50 psi (345 kPa) pressure
source normally available in hospitals. These
ventilators have prices ranging from $700-1000.
This category includes products such as the
VORTRAN Automatic Resuscitator (VAR™), a
single patient, disposable resuscitator, and the
reusable Lifesaving Systems Inc.'s Oxylator, O-
Two CAREvent® Handheld Resuscitators and
Ambu® Matic. However, these systems cost an
order of magnitude more than our target price
and depend on external pressurized air, a
resource to which our target market may not
have access.
Figure 1: Cost-performance distribution of ventilators
anywhere, and thus are not
bound by this constraint.
Ventilators of this type such
as CareFusion LTV® 1200
were the choice device was patented environment. of mechanical,
of the CDC for by JHU/APL, and medical,
the Strategic licensed to 1.2. Medical Device
economic, user-
National AutoMedx. The Requirements
interface and
Stockpile. The commercial device In light of the
aforementioned repeatability
LTV® 1200 features single-knob functional
constraints, a set
weighs 13.9 lbs operation. Its requirements were
(6.3 kg) and simplicity comes with developed. These
includes standard a compromise, as the include the ASTM
features as well as tidal volume, breath F920-93 standard
the capability to rate and other requirements9, and
slowly parameters cannot be are summarized in
discontinue or adjusted by the user, Table 1.
wean off making it not suitable
mechanical for many patients - User-specified
ventilator who cannot tolerate insp./exp ratio,
support. Its the fixed tidal - Assist control
complexity volume, rate or - Positive end-ex
elevates its cost minute ventilation. It pressure (PEEP
Medical
to several also cannot be
- Maximum pres
thousands of operated for long
- Humidity exch
dollars, an order periods in a resource-
- Infection contr
of magnitude poor environment.
- Limited dead-s
above our target Additionally, with a
- Portable
retail price. price tag over $2000,
- Standalone ope
it costs several times
- Robust mechan
The United States more than our target
Mechanical electrical and s
Department of price. Another device,
systems
Defense has also the FFLSS, weighs
- Readily source
developed several 26.5 lbs (12 kg) and
repairable parts
rugged, portable is capable of one hour
electric of operation powered - Minimal power
ventilators. One by a battery. It also - Battery-powere
such ventilator is includes additional Economic - Low-cost (<$5
the Johns physiologic sensors, - Alarms for lo
Hopkins and fits in a standard loss of breat
University (JHU) U.S. Army backpack 8 User- integrity, hi
Applied Physics . While these devices interface pressure and
Laboratory (APL) are functionally life
Mini Ventilation adequate, their - Display of s
Unit (JAMU), compressors require status
which weighs 6.6 high power which - Standard conne
lbs (3.0 kg), limits battery life. In - Indicators with
measures 220 addition, their many Repeatability correct reading
cubic inches pneumatic - Breath frequenc
(3,600 cubic cm) components are to one breath p
and can operate costly and are not Table 1: Device functional
requirements
up to 30 minutes easily repairable in a
on a battery. This resource-poor
3
 main patient’s lungs by over space. Other
strategies compression of the compression
2. Device were bag. Our methodology, techniques were
Design identified for therefore, was to sought to take
the design a mechanical advantage of the
2.1. Air ventilator’s device to actuate the
Delivery cylindrical BVM
air delivery BVM. This approach shape. However,
Technique
system. One results in an since BVMs were
Two
strategy inexpensive machine designed for
uses a constant embodiment of a providing the basic manual operation,
pressure source to volume-displacement functionality required their compressible
intermittently ventilator. Due to the by mechanical outer surface is
deliver air while simplicity of their ventilator standards. made from high-
the other delivers design and their friction material to
2.2. Compression
breaths by production in large maintain hand-
Mechanism
compressing an volumes, BVMs are contact with
The most obvious
air reservoir. The very inexpensive minimal slippage.
means to actuate a
latter approach (approximately $10) This eliminates the
BVM is to mimic the
was adopted as it and are frequently option of
hand motion for which
eliminates the used in hospitals and tightening a strap
the bag was designed.
need for the ambulances. They are wrapped around
This requires the use of
continuous also readily available the bag as a means
linear actuation
operation of a in developing of actuation. To
mechanisms (e.g. lead
positive pressure countries. Equipped avoid the problems
screw or rack and
source. This with an air reservoir associated with
pinion) which despite
reduces power and a complete valve high surface
being simple to
requirements and system, they friction, the two
implement, require
the need for inherently provide the main candidates
linear bearings and
expensive and basic needs required for actuation were
extra
difficult to repair for a ventilator. a roller chain and
pneumatic cam compression.
components. The main drawback These options
with BVMs is their employ rolling
Where most manual operation contact with the
emergency and requiring continuous bag rather than
portable operator engagement sliding contact,
ventilators are to hold the mask on eliminating losses
designed with all the patient and due to kinetic
custom squeeze the bag. This friction between
mechanical operating procedure the actuator and
components, we induces fatigue the bag.
chose to take an during long
orthogonal operations, and 2.2.1. Roller-chain
approach by effectively limits the Concept
building on the usefulness of these The roller-chain
inexpensive bags to temporary concept utilizes
BVM, an existing relief. Moreover, an roller-chains with
technology which untrained operator roller diameters
is the simplest can easily damage a larger than link
4
width. for breath more space efficient
(Figure delivery.
2) The
chain
wraps Figure 2: Sketch
around of roller-chain
the device
circumfe
rence of While this
the bag, idea seemed
and as a initially
result is feasible,
very preliminary
space experiments and yield higher
efficient. revealed that angular resolution for Figure 3: Sketch of
radial compression, bag cam based device
A
sprocket compression crumpling becomes an operation. By controlling
connects of a BVM issue. On the other the angle of the cam’s shaft,
to the requires hand, a higher the amount of air volume
motor significantly pitch/roller-diameter delivered can be accurately
shaft; its higher force chain overcomes controlled. The cam
clockwis than the crumpling but takes up mechanism was found to be
e/anticlo vertical more space and more space efficient and
ckwise compression decreases angular have a lower power
rotation for which resolution. In either requirement than the roller
compres the bag was case, the use of roller chain concept, and was
sing and designed. chains added a therefore the method of
expandin Additionally, significant amount of choice.
g the bag its weight to the system
suggesting the need for
operation was accurate and a more effective
noisy, and the bag repeatable tidal mechanism needing a
smaller contact area.

2.2.2. CAM Concept

The cam concept
utilizes a crescent-
shaped cam to
compress the BVM,
which allows smooth,
repeatable deformation
to ensure constant air
delivery (Figure 3). As
crumpled under volume from being
it rotates, the cam
radial delivered.
makes a rolling contact
compression,
along the surface of the
inhibiting the A trade-off was
bag and unlike the
desired pure encountered; while
roller-chain, achieving
rolling motion, small pitch/roller-
low-noise of
and preventing an diameter chains are
5
3. Prototype is easily laser
Design cut and
allows for
3.1. First visibility of
Prototype the internal
Design components.
With the The two inner
cam sections experiment rate (and volume,
concept (ribs) have U- was by integrating over
selected shaped slots conducted on time), a hand
as the made to the first dynamometer to
best conform to prototype to measure force
method BVM’s determine exerted on the
for BVM surface performance cam, a rotary
compress contour, characteristics motion sensor to
ion, an while the end . Data was measure cam
initial sections collected angular
prototype feature using our displacement, and
was built openings to prototype's a pressure sensor
to accommodate cam to measure internal
measure the BVM’s mechanism to air pressure. The
force and valve neck compress an experimental setup
power and oxygen adult sized is depicted in
requirem reservoir. The Ambu® Figure 4 and 5.
ents. The pivoting cam BVM. The
enclosure assembly was test apparatus
’s frame mounted on included a
consists top of the Figure 4: Sketch of
spirometer to experiment setup
of four hinged measure flow-
vertically aluminum lid, by integrating the flow
mounted and consisted rate over time. Results
sections of two 2.5" indicated that the
of ½” (63.5 mm) volume delivered versus
(12.5 radius cam angle relation is
mm) crescent- approximately linear
clear shaped pieces (Figure 6). Data
acrylic, attached to a analysis showed that the
each 5/16" (8 mm) peak power required
mounted aluminum was 30 W, and
on the shaft maximum torque was
bottom mounted with 1.5 Nm. The maximum
Figure 5:
section of nylon Actual volume delivered per
the frame bushings. experiment stroke was
with setup
approximately 750 mL.
interlocki 3.2. First
Prototype The target tidal volume
ng The air volume
Experiment is 6-8 ml/kg for adult
mates. delivered was
A bench human use, so this is
The measured as a
level adequate for most
material function of cam angle
clinical situations.
6
 of acrylic, and prototype operator selects the
tidal volume
appropriate to the
4. Control patient, usually 6-8
Implementation mL/kg of ideal body
weight and a
4.1. Control design minimum
This respiratory rate.
ventilator This provides a
provides assured minimum assured
tidal volumes minute ventilation
using an assist- (Ve). If the patient is
hinges from control (AC) breathing above the
Figure 6:
the side of the mode. The set
Volume vs.
Cam angle unit to better
constrain the rate, negative hemodynamic and gas
top of the bag. inspiratory pressure exchange consequences.
The support that exceeds 2 cmH20 However, these issues are
3.3. Second vacuum triggers the commonly handled with
Prototype ribs inside the
enclosure also ventilator to deliver the reductions in respiratory
Design
serve as set tidal volume. rate and sedation as needed.
A second
mounting AC mode, one of the most
prototype was
blocks for widely utilized mechanical
built in which The advantage of AC
camshaft ventilator modes, is
all the moving mode is that the patient
bushings. A adequate for the
components has an assured minute
potentiometer management of the majority
were moved ventilation to meet
was coupled of most clinical respiratory
inside the physiologic needs for
to the end of failure scenarios. This
enclosure. adequate gas
the shaft for ventilator can be used for
Enclosure exchange. A
use as a patients who are intubated
dimensions were disadvantage is that if
position with an endotracheal tube
increased to the patient is
feedback or who would receive non-
accommodate tachypneic or
sensor. An invasive mechanical
the cam arm’s breathing too fast,
isometric ventilation through a mask
range of motion, respiratory alkalosis
view of the that is commonly used for
and to make may develop or, for
second provision of continous
space for the those with obstructive
prototype’s positive airway pressure
motor, lung disease, air
CAD model is (CPAP).
microcontroller trapping may occur,
and battery shown in raising intra- thoracic
pack. The Figure 7, and pressure with adverse
enclosure’s lid the built
was made device in
Figure 8.

Figure 7: Second
prototype CAD
model

Figure 8: Second

7
4.3. Controller initiated at outside of the
An off- the ventilator. The
the-shelf beginning of prototype has a range
Arduino the loop. of 200-750 mL tidal
Duemila Once the volume and 5-30
nove prescribed breaths per minute
microco tidal volume (bpm). This yields a
ntroller is reached, maximum minute Figure 9: Ventilator
board the actuator ventilation (Ve) of 21L control loop
was returns the and a minimum Ve of
selected cam back to 1.5L. However, these 4 Motor
to its initial values do not reflect .
control position and the limits of the final 4
our holds until design only the .
device. the next settings of the According to initial
The breath. The prototype. experiments, a maximum
microco loop then Theoretically, the torque of 1.5 Nm
ntroller repeats to ventilator is able to was required for
runs a deliver deliver anywhere from maximum volume
simple intermittent 0L minute volume to delivery. A PK51
control breaths. If 60L minute volume. DC gearmotor with
loop to the loop is However, this has not a stall torque of 2.8
achieve interrupted been fully tested. I:E Nm was selected
user- by a breath ratio was not for the prototype.
prescribe attempt by implemented on the Despite the lower
d the patient prototype but torque value
performa (sensed theoretically could measured in our
nce. through the have any desired range experiment, we
pressure within the limits found that this
sensor), the determined by the other motor did not
The
ventilator parameters. The ranges provide quite
control
immediately on the final design will enough torque to
loop is
delivers a be determined in effectively drive
triggere
breath, consultation with the cam at the
d by the
interrupting respiration specialists slower inhalation
internal
the loop and to allow for the cycle rates
timer set
resetting the broadest range of safe prescribed to some
by user
timer. A settings. patients. While a
inputs,
diagram larger motor will
with the
showing this be necessary to
inspirat
loop is achieve better
ory
found in speed control, this
stroke
Figure 9. motor functioned
acceptably
4.2. Parameters in to expiratory time at the proof-of-concept required range of 50-70
The operator sp ratio using three phase. It was desirable rpm.
adjusts tidal ira continuous for its gear reduction
volume, breath to analog knobs ratio of 51:1, and an 4.5. Motor Driver
rate, and ry mounted to the operating speed in the The motor driver comprises

8
of two H-Bridge iterations of the the ventilator hours and thirty-
circuits. These device will include can run off of five minutes at
circuits direct the addition of an any battery which point the
current through LCD display to show capable of battery was
the motor in the input settings as delivering 12- depleted. Based on
opposite well as airway 15 volt at least the battery
directions, pressure level and 3.5 Amps. For capacity and
depending on battery power status. the prototype, voltage, the
which set of we used a 14.8 electrical power
switches on the 4.7. Safety
volt, four-cell consumption
circuits are Features
Li- Ion battery during this test
energized. Speed To ensure that the
pack capable averages to only 9
of the motor is patient is not injured,
of 4.2 Amps Watts (this
signaled with a the airway pressure is
(limited by includes the
pwm pin. The monitored with a
protective inactive time
power is supplied pressure sensor
circuitry), between breaths).
directly from the connected to a sensor
with a
battery, so the output on the BVM.
capacity of
only limit is the The same pressure 6. Conclusions
2200 mA-hr.
current capability sensor used for
initiation of assist A working
of the chip and
control also triggers prototype that can
battery. 5. Analysis and be operated on a
an alarm if the
Testing test lung has been
We opted to use pressure rises too
high, alerting the developed. The
the Solarbotics® 5.1. Battery-life Test
physician to attend to prototype has user-
motor driver, The battery
the patient. As a controlled breath
which is capable life for the
further safety measure rate and tidal
of supplying 5 second
to prevent over- volume. It features
amps of current prototype was
inflation, future assist control and
to the two tested by
iterations of the an over-pressure
circuits. The running the
device will include a alarm. It has low
PK51 motor's ventilator on
mechanical pressure power
stall current is the test lung
relief valve. requirements,
rated at 5.2 amps until the running for 3.5
which means the battery
4.8. Power hours on one
motor driver will voltage
Delivery battery charge at
be able to handle dropped to a
An AC/DC converter its most
the requirements level
can be used to power demanding setting.
for the system. insufficient
the ventilator directly It is portable,
for operation.
from a wall outlet or weighing 9 lbs (4.1
4.6. User The device
Interface a vehicle inverter. kg) and measuring
was set at
The three user When external power 11.25 x 6.7 x 8
maximum
inputs (tidal is unavailable, inches (285 x 170
volume and
volume, bpm and x 200 mm) , and
BPM rate (30
I:E ratio) are set has a handle and
breaths/minute
via three easy to use latches.
). The overall
potentiometer The prototype can
duration of the
knobs. Future display settings
test was three
9
and our the use of the most guidance for the project.
status on prototype efficient rolling contact We are also thankful to Dr.
a testing. It embodiment. An LCD Barbara Hughey for her
computer will screen will be help with instrumentation
screen. incorporate included, and alarms for our bench level
an adjustable programmed for loss experiments. The authors
Further inspiratory to of power, loss of would also like to thank
develop expiratory breathing circuit SolidWorks Corporation for
ment of ratio, an integrity and low providing the solid model
this option battery life. Extensive software used to
proof-of- missing in testing of the
concept this ventilator's
is prototype repeatability will be
planned. due to its conducted. Finally, we
Future underpowere will test the ventilator
iterations d motor. We on a lung model to
will will meet ventilator
incorpora investigate standards and market
te the effects the product.
changes that
prompted changing the
by the motor will 7. Acknowledge
results of cause to cost, ments
weight The design and
and battery life. valves can be placed fabrication of this
We will also at the patient end of device was a term
incorporate add- the tubing. In later project in MIT Course
on features iterations we hope to 2.75: Precision
including a PEEP be independent from Machine Design. We
valve, a humidity Laerdal® by are grateful to Lynn
exchanger and a manufacturing our Osborn and Dr. Tom
blow-off valve. own bags or Brady of The Center
Since BVM contracting their for Integration of
infrastructure production. The Medicine and
already supports design will be Innovative Technology
commercial add- changed to be www.cimit.org for
ons, these injection molded such providing support for
components can that the mass- course 2.75 and this
be easily produced a version project; and the VA
purchased and would cost less than Medical Center-West
incorporated. $200 to produce. Roxbury. CIMIT
Ways to Weight will be support comes from
minimize minimized and DOD funds with FAR
deadspace will be battery-life extended. 52.277-11. Special
explored, Consideration to a thanks are due to Prof.
including the pediatric version will Alex Slocum, Nevan
option of using a also be given. Cam Hanumara, Conor
Laerdal® brand arm shape will be Walsh and Dave
BVM whose optimized to ensure Custer for continuous
1
create the models respir Africa. ventilat
for this project. atory Int J ors if
disea Tuberc bird flu
ses in Lung Dis. hits,
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