Design and Prototyping of a Low-cost Portable

Mechanical Ventilator
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
overpressurization 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

Introduction:
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 which are on the rise
in developing countries1,2 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 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 lacking4 . 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 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,
OTwo 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.

Electric ventilators are capable of operating anywhere, and thus are not bound by this constraint.
Ventilators of this type such as CareFusion LTV® 1200 were the choice of the CDC for the Strategic
National Stockpile. The LTV® 1200 weighs 13.9 lbs (6.3 kg) and includes standard features as well as the
capability to slowly discontinue or wean off mechanical ventilator support. Its complexity elevates its
cost to several thousands of dollars, an order of magnitude above our target retail price. The United
States Department of Defense has also developed several rugged, portable electric ventilators. One such
ventilator is the Johns Hopkins University (JHU) Applied Physics Laboratory (APL) Mini Ventilation Unit
(JAMU), which weighs 6.6 lbs (3.0 kg), measures 220 cubic inches (3,600 cubic cm) and can operate up to
30 minutes on a battery. This device was patented by JHU/APL, and licensed to AutoMedx. The
commercial device features single-knob operation. Its simplicity comes with a compromise, as the tidal
volume, breath rate and other parameters cannot be adjusted by the user, making it not suitable for
many patients who cannot tolerate the fixed tidal volume, rate or minute ventilation. It also cannot be
operated for long periods in a resource-poor environment. Additionally, with a price tag over $2000, it
costs several times more than our target price. Another device, the FFLSS, weighs 26.5 lbs (12 kg) and is
capable of one hour of operation powered by a battery. It also includes additional physiologic sensors,
and fits in a standard U.S. Army backpack 8 . While these devices are functionally adequate, their
compressors require high power which limits battery life. In addition, their many pneumatic components
are costly and are not easily repairable in a resource-poor environment.

2. Device Design :

2.1. Air Delivery Technique Two main strategies were identified for the ventilator’s air delivery system.
One strategyuses a constant pressure source to intermittently deliver air while the other delivers
breaths by compressing an air reservoir. The latter approach was adopted as it eliminates the need for
the continuous operation of a positive pressure source. This reduces power requirements and the need
for expensive and difficult to repair pneumatic components. Where most emergency and portable
ventilators are designed with all custom mechanical components, we chose to take an orthogonal
approach by building on the inexpensive BVM, an existing technology which is the simplest embodiment
of a volume-displacement ventilator. Due to the simplicity of their design and their production in large
volumes, BVMs are very inexpensive (approximately $10) and are frequently used in hospitals and
ambulances. They are also readily available in developing countries. Equipped with an air reservoir and a
complete valve system, they inherently provide the basic needs required for a ventilator. The main
drawback with BVMs is their manual operation requiring continuous operator engagement to hold the
mask on the patient and squeeze the bag. This operating procedure induces fatigue during long
operations, and effectively limits the usefulness of these bags to temporary relief. Moreover, an
untrained operator can easily damage a patient’s lungs by over compression of the bag. Our
methodology, therefore, was to design a mechanical device to actuate the BVM. This approach results in
an inexpensive machine providing the basic functionality required by mechanical ventilator standards.
Attribute:

The realistic budget of low cost ventilator is approximately US$450.

Conclusions :
A working prototype that can be operated on a test lung has been developed. The prototype has user-
controlled breath rate and tidal volume. It features assist control and an over-pressure alarm. It has low
power requirements, running for 3.5 hours on one battery charge at its most demanding setting. It is
portable, weighing 9 lbs (4.1 kg) and measuring 11.25 x 6.7 x 8 inches (285 x 170 x 200 mm) , and has a
handle and easy to use latches. The prototype can display settings and status on a computer screen.
Further development of this proof-of-concept is planned. Future iterations will incorporate changes
prompted by the results of our prototype testing. It will incorporate an adjustable inspiratory to
expiratory ratio, an option missing in this prototype due to its underpowered motor. We will investigate
the effects that changing the motor will cause to cost, weight and battery life. We will also incorporate
addon features including a PEEP valve, a humidity exchanger and a blow-off valve. Since BVM
infrastructure already supports commercial addons, these components can be easily purchased and
incorporated. Ways to minimize deadspace will be explored, including the option of using a Laerdal®
brand BVM whose valves can be placed at the patient end of the tubing. In later iterations we hope to
be independent from Laerdal® by manufacturing our own bags or contracting their production. The
design will be changed to be injection molded such that the mass-produced a version would cost less
than $200 to produce. Weight will be minimized and battery-life extended. Consideration to a pediatric
version will also be given. Cam arm shape will be optimized to ensure the use of the most efficient
rolling contact embodiment. An LCD screen will be included, and alarms programmed for loss of power,
loss of breathing circuit integrity and low battery life. Extensive testing of the ventilator's repeatability
will be conducted. Finally, we will test the ventilator on a lung model to meet ventilator standards and
market the product.