All Ventilators are NOT Created Equal

In these recent months of the COVID-19 crisis, many companies and institutions have taken on ventilator design and manufacturing for the first time. With our long history of involvement with researchers and ventilator manufacturers, Michigan Instruments has played a role in many of these recent efforts, providing our calibrated lung simulators (TTL and PneuView) to auto manufacturers, electronics companies, Universities, and even NASA to support their development and manufacturing efforts. One of the things that we know at Michigan Instruments, as do most medical professionals involved in mechanical ventilation, is that not just any ventilator can be used on any patient.

Ventilators range in complexity from very simple emergency units that are meant for short-term use in the pre-hospital or field setting, to long-term care ventilators that are used in homes or institutions to support patients with chronic breathing issues, to critical care ventilators used in ICU’s to deal with acute illness, severe trauma, or post-surgical cases. These units can have very different features and capabilities. All ventilators are not created equal, and that’s intentional.

The virus that causes COVID-19 is designated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The major morbidity and mortality from COVID-19 is largely due to acute viral pneumonitis that evolves to acute respiratory distress syndrome (ARDS). Patients that develop ARDS will often end up on a ventilator in the ICU. These patients can be difficult to ventilate, requiring high levels of oxygen and relatively high ventilating pressures to move adequate breath volumes in and out of the lungs. And that’s the issue. Not just any ventilator will meet the needs of these patients.

As mentioned above, Michigan Instruments has been involved in many of these recent efforts to ramp up ventilator production in response to the COVID-19 pandemic. Our lung simulators are being used all over the world. We wouldn’t presume to know exactly what kinds of ventilators will work best to treat these COVID-19 patients, but we believe there are some reasonable basic features and minimal capabilities that should be incorporated into the ventilators being developed and built to deal with this crisis.

  • Oxygen %: Adjustable from 21 to 100%  (either built-in or adjustable external O2/Air blender)
  • Respiratory Rate: Up to 40 breaths per minute (BPM)
  • Tidal Volume: 100 to 1000mL
  • Pressure Limit:  Up to 60 cmH2O
  • PEEP:  Up to 15 cmH2O
  • Alarms:  Low Pressure, Disconnect, High Pressure, Loss of O2 Source
  • Other Features:  Synchronized to patient effort; high sensitivity to patient effort; sine or decelerating flow waveform; dual-limb breathing circuit with adequate filtration of inhaled and exhaled gases

Note: These features are the opinion of the technical specialists at Michigan Instruments and should not be taken as official guidelines or requirements. In an emergency situation, we believe that almost any mechanical ventilator will be superior to no support or prolonged use of a manual resuscitator.

The Michigan Instruments TTL Training Test Lungs and PneuView Systems have played an invaluable role in the effort to meet the need for reliable, tested mechanical ventilators. Our products and our expertise have been called upon by old and new partners around the world during this pandemic crisis. Whether your role is in development, design, or manufacture of ventilators, we’ve got the lung simulator products that are tried, trusted, and often specified to meet your testing needs. 

Learn more about our Lung Simulator Devices here or contact us today for more information!

Michigan Instruments delivers unprecedented number of lung simulators to aid in ventilator research and development amid shortage

Michigan Instruments, a leading manufacturer in Lung Simulation, has delivered an unprecedented number of lung simulators to organizations around the world to help in respiratory technology research and critical ventilator development and manufacturing to combat the shortages caused by the COVID-19 pandemic.

Many countries, including the United States, are continuing to see a rise in COVID-19 cases, which brings to light the extreme lack of medical resources like ventilators available to hospitals and critical care facilities.

In response, the world has seen an incredible response in the development and manufacturing of ventilators as researchers attempt to create a cost-effective and efficient lifesaving solution. Michigan Instruments has been at the forefront of this response by working with organizations to deliver Lung Simulators designed for validating and testing these ventilators. 

Organizations like NASA, Ford Motor Company, Cornell University, Michigan Technological University, University of California San Diego, OperationAir, and the Royal Women’s Hospital, Monash University and the Alfred Hospital in Australia have all used Michigan Instruments lung simulators to aid in the development and discovery of several potential ventilator solutions.

  • A group of engineers from NASA’s Jet Propulsion Laboratory have developed a high-pressure ventilator that can mechanically breathe for patients with the most severe cases of COVID-19.
  • Students and faculty from Cornell University, Michigan Technological University, and the University of California San Diego have all developed versions of effective, low-cost ventilator systems created using inexpensive materials or materials readily available.
  • OperationAir has also developed a prototype called the AIRone, an easily producible emergency ventilator that can be used when shortages occur due to the pandemic. Production has already started on the device and its design is open source and available globally.
  • A team of researchers from the Royal Women’s Hospital, Monash University and Alfred Hospital have successfully tested, in a simulated environment, the potential to ventilate two lungs of different compliances from a single ventilator using only commonly available hospital equipment.

These lung simulators provide developers with cutting edge technology that can aid in the design, engineering, testing and manufacturing of devices like ventilators by replicating hundreds of healthy and diseased lung conditions to evaluate a ventilator’s performance with accurate measurement and data reporting.

Based in Grand Rapids, Michigan, Michigan Instruments continues to produce and ship Lung Simulators. The increased demand in production allowed Michigan Instruments to utilize qualified workers from other manufacturers forced to close during the Michigan shut down, as well as existing employees working extended hours.

Chris Blanker, President & Owner of Michigan Instruments shared, “In a time when many manufacturers were forced to lay off employees and slow production, we were blessed to be able to remain open, provide work for our employees and utilize very talented workers from local companies forced to close. Sadly, this is due to the Pandemic, but our team is proud to know that our devices are helping with the development and supporting the production of ventilators and other devices that help save lives.”The ventilator’s modularity, that it can function as a transport or an ICU ventilator, running with a desktop or laptop, is one of the key innovations of Ivy’s design. By running multiple instances of the clinician software, a single tablet or computer can govern multiple ventilators remotely, so nurses can monitor many patients without having to enter their rooms.

Chris Blanker shared, “We are very proud to have been able to quickly ramp up production and delivery of our lung simulators for the organizations that are developing and manufacturing critical ventilators and other devices to help save lives. The production ramp up was challenging, but our team rose to the task.  We’ve worked closely with developers and manufacturers of all backgrounds and we look forward to continued partnerships like this. ”

Cornell ECE Ph.D. student Landon Ivy assembled a team to work on a new project: produce a safe, simple and reliable ICU mechanical ventilator.

Landon Ivy started his Ph.D. work with Professor Amit Lal’s SonicMEMS Lab, developing new processes for micro electrostatic linear actuators which will eventually drive the locomotion of a microbot. He had cultivated an affinity for working on hardware during his undergraduate studies, and when he got to Cornell he spent as much time as he could in the Cornell NanoScale Facility (CNF).

Then the pandemic forced Ivy along with all of his SonicMEMS Lab colleagues off campus. “A few days later, Dr. Lal got the word that there would be a ventilator shortage, so he encouraged the group to brainstorm,” Ivy said. Since he wouldn’t be able to resume work in the CNF for the foreseeable future, Ivy assembled a team to work on a new project: produce a safe, simple and reliable ICU mechanical ventilator.

“I had never produced any medical equipment before,” Ivy said. “I took a bunch of clinician training classes online and read through a couple of textbooks on ventilator design.” User manuals from existing ventilators were also helpful, he said.

Typically, ventilators are made almost entirely of custom parts, some of which are sourced from various vendors around the world. That’s one reason why companies had such a hard time ramping up ventilator production as the pandemic began, and why most ventilators are quite expensive ($25 to $50 thousand for a high-end ICU ventilator). 

“My goal was to make an emergency response ventilator capable of safely ventilating a COVID-19-induced ARDS patient using inexpensive and readily available components,” Ivy said. He wanted to use parts that could be quickly and easily sourced and assembled by people with limited funds. The final version cost only $2750 to make.

Ivy detailed the ventilator project and construction in a video produced in his home lab—his bedroom. 

“The patient circuit is a single-limb which is optimized for cleanliness,” he said. “The inspiration line doesn’t get contaminated during expiration like in a dual-limb ventilator.” 

He used a non-rebreathing valve normally used for a bag valve mask (sometimes known by the proprietary name Ambu bag, a hand-held breathing-assistance device) to further isolate the patient from contaminating the rest of the system. ”This is something I haven’t seen on any other ventilator,” Ivy said. 

The ventilator’s modularity, that it can function as a transport or an ICU ventilator, running with a desktop or laptop, is one of the key innovations of Ivy’s design. By running multiple instances of the clinician software, a single tablet or computer can govern multiple ventilators remotely, so nurses can monitor many patients without having to enter their rooms.

Ivy hopes that the progress and findings he was able to demonstrate with his home build might garner the support necessary for animal testing, or at the very least lead to further innovations within the health science community.

View original article here.

Our first functional prototype is a fact: the AIRone. Last week the AIRone has been a subject to various tests. Using a mechanical phantom of the lungs we were able to do the functional tests that determine if the prototype meets our requirements. The documents are submitted to the Ministry of Health, Welfare and Sports, as the start of the clinical tests are required to be authorized by them. Clinical approval is obliged before our ventilator can be used during the coronavirus pandemic. If clinical approval is granted, the Ministry of Health, Welfare and Sports can instruct production of our ventilators.

We have started a cooperation with an assembly facility in the region to be able to start the production as soon as possible when we receive clinical approval. Furthermore, we have close contact with suppliers of the different parts of the AIRone. When the Ministry of VWS instructs us to start production of our ventilators, we can start immediately with our partners. Our ambition is to be able to produce 500 ventilators in total by producing 100 ventilators a week. If the demand for ventilators increases, we could possibly decide to scale up. We have close contact with the Dutch Intensive Care Society and the Dutch National Consortium of Clinical Supplies to stay up-to-date on the demand for ventilators in the Netherlands. For now, though, our main focus is getting clinical approval.

When clinical approval is granted and the production has started, OperationAIR will continue operating. The team will focus on implementation, service and further improvement. A training plan regarding our ventilator is set up for medical professionals in the hospital. Furthermore, a team is assembled that will be ready to provide assistance when the ventilator is implemented in a hospital. The clinically approved design will be publicly available on our website, so other countries can make use of it as well.

View original article here.

A team of engineers and physicians at the University of California San Diego has developed a low-cost, easy-to-use emergency ventilator for COVID-19 patients that is built around a ventilator bag usually found in ambulances.

The team built an automated system around the bag and brought down the cost of an emergency ventilator to just $500 per unit. The device’s components can be rapidly fabricated  and the ventilator can be assembled in just 15 minutes. The device’s electronics and sensors rely on a robust supply chain from fields not related to healthcare that are unlikely to be affected by shortages. 

The UCSD MADVent Mark V is also the only device offering pressure-controlled ventilation equipped with alarms that can be adjusted to signal that pressure is too low or too high. This is especially important because excessive pressure can cause lung injury in COVID-19 patients that often experience rapid decreases in lung capacity as the disease progresses.  

Most ventilators measure the volume of air that is being pumped into the patient’s lungs, which requires expensive airflow sensors. By contrast, the UCSD MADVent Mark V measures pressure and uses that data to deduct and control the airflow to the lungs. This was key to lowering the device’s price. 

The team from tUC San Diego and industry partners will be seeking approval for the device from the Food and Drug Administration. They detail their work in an upcoming issue of Medical Devices and Sensors. 

The device’s plans and specifications are available at

“The MADVent can safely meet the diverse requirements of COVID-19 patients because it can adjust over the broad ranges of respiration parameters needed to treat acute respiratory distress syndrome,” said James Friend, a professor at the UC San Diego Jacobs School of Engineering and one of the paper’s two corresponding authors. “The combination of off-the-shelf components and readily machined parts with mechanically driven pressure control makes our design both low cost and rapidly manufacturable.” 

 Researchers also wanted to make sure that the device could be used by healthcare workers with limited experience with ventilators and no experience with this type of system, said Dr. Casper Petersen, co-author of the study and a project scientist in the Department of Anesthesiology at the UC San Diego School of Medicine. As a result, the MADVent Mark V is safe to use, easy to assemble and easy to repair.

“This device could be a great option for use in situations where materials are scarce, such as when  the normal supply chain breaks down, or in developing nations and hard-to-reach rural areas,” Dr. Casper Petersen said. 

The device is not meant as a substitute for the highly complex ventilators used in Intensive Care Units.

“Rather, our low-cost ventilator is meant to bridge an urgent gap in situations of a large surge in patients where we may not have enough life sustaining equipment”, said Dr. Lonnie Petersen, an assistant professor at the Jacobs School of Engineering, adjunct professor at UC San Diego Health and the paper’s other corresponding author. “Safety is our main priority; while the MADVent is a low-tech and low-cost device, it actually offers robust and patient tailored ventilationThis really increases the safety for the patients suffering from the complex pulmonary infection and respiratory distress associated with COVID-19”. 

The UCSD MADVent Mark V

The UC San Diego team built their device around a ventilator bag usually found in ambulances and designed to be manually squeezed to help patients breathe. In the UCSD MADvent Mark V, a machined paddle squeezes the bag instead. The paddle is controlled by a series of pressure sensors to make sure the patients get the appropriate flow of air into their lungs. The team deliberately integrated as many standard hospital items as possible into the design because those have already undergone rigorous testing for safety, longevity and compatibility. 

To measure pressure, the researchers developed an algorithm that deduces how much the bag was compressed based on how many turns the device’s motor has made and calculates the volume of air sent into the patient’s lungs as a result.

“The elasticity of the lungs changes very quickly, so it’s important to be able to sense the feedback from the patient,” said Dr. Lonnie Petersen.

Researchers tested their system more than 200 times and for days on end on a lung simulator, adhering to standards for the International Standards Organization and FDA guidelines to ensure it functioned correctly. The device was also tested on a medical mannequin simulator.

One of the keys for cost savings was developing computer models of the volume of air delivered through the ambulance bag when it is compressed. This allowed researchers to do away with expensive airflow sensors and the complex algorithms that control them.

The materials on the ventilator can be sanitized with conventional disinfectants such as 1.5% hydrogen peroxide and 70% ethanol.  

“The system, in its current state of development, can easily accommodate new modules that enable more sophisticated features, such as flow monitoring, which can enable additional ventilation modes and provide healthcare operators more information regarding a patient’s breathing,” said Aditya Vasan, a Ph.D. student in Friend’s research group and the paper’s first author. 

Collaboration across disciplines

A close collaboration between clinicians and engineers enabled the team to put together a crude prototype in just three days. They then spent countless hours refining and testing the ventilator.  A lot of work went into making sure it was safe and could be manufactured with simple parts at a large scale.

Engineers with the UC San Diego Qualcomm Institute Prototyping Lab provided engineering design and fabrication support.  Electrical engineer Mark Stambaugh stepped in to work on the microcontroller and help adjust the stroke cycle and control the speed and volume of the compressions to help patients breathe. Mechanical engineer Alex Grant provided design support and guidance.

Seed funding for the project came from several organizations: San Diego-based Kratos Defense & Security Solutions, Inc., which develops fields systems, platforms and products for national security and communications needs; the US Office of Naval Research in the Department of Defense; and the Catalyst initiative at the UC Institute for Global Conflict and Cooperation.

MADVent: A low-cost ventilator for patients with COVID-19

Corresponding authors: James Friend, Dr. Lonnie Petersen

UC San Diego Jacobs School of Engineering: Medically Advanced Devices Laboratory: James Friend, Aditya Vasan, Reiley Weekes, William, Connacher.

UC San Diego School of Medicine: Dr. Casper Petersen, Dr. Sidney Merritt, Dr. Preetham Suresh, Dr. Daniel E. Lee, Dr. William Mazzei, Theodore Vallejos, Jeremy Sieker. 

Qualcomm Institute: Mark Stambaugh, Alex Grant.

Eric Schlaepfer, independent researcher

View original article here.

Engineers at NASA’s Jet Propulsion Laboratory (JPL) in Pasadena, California, have come up with a design for a high-pressure ventilator that can mechanically breathe for patients with the most severe cases of COVID-19 (coronavirus)—and they did it in just 37 days. View original article from Popular Mechanics here.

“We specialize in spacecraft, not medical device manufacturing. But excellent engineering, rigorous testing and rapid prototyping are some of our specialties,” JPL Director Michael Watkins said in a prepared statement. “When people at JPL realized they might have what it takes to support the medical community and the broader community, they felt it was their duty to share their ingenuity, expertise and drive.”

The lab joins various other ventilator-making efforts, as the U.S. faces a shortage on the order of 300,000 to 700,000 units. Tesla has retrofitted some of its Model 3 car parts to build the life-saving breathing machines, while Ford and General Motors have restructured assembly lines for ventilator manufacturing. Dyson pivoted from vacuums to ventilators in just 10 days, and even CERN, home to the Large Hadron Collider, has shifted from particle physics to ventilators.

Although all of these firms design and engineer technical devices, none of them are specialized to the effort. Not only do ventilators contain sophisticated hardware—from pressure generators, to patient circuits, to filters, and valves—but the software is also sensitive. If even one component is faulty, the entire machine shuts down.

NASA submitted its prototype to a renowned medical facility in New York City, where the virus is raging, for feedback. At Mount Sinai Hospital, researchers at the Human Simulation Lab in the Department of Anesthesiology, Perioperative, and Pain Medicine conducted further testing.

“The NASA prototype performed as expected under a wide variety of simulated patient conditions,” Matthew Levin, M.D., director of innovation for the Human Simulation Lab, said in the statement. “The team feels confident that the VITAL ventilator will be able to safely ventilate patients suffering from COVID-19 both here in the United States and throughout the world.”

Because its made of fewer parts, NASA says that VITAL can be built faster, and be maintained more easily, than traditional ventilators. Since the design is relatively flexible, health care workers can even modify VITAL for use in makeshift hospitals popping up in convention centers and hotels across the U.S. as brick-and-mortar hospitals reach max capacity.

VITAL machines aren’t meant to permanently replace expensive hospital ventilators. Those are meant to last for years and have various modes to meet a range of medical issues. Rather, the NASA ventilator is specifically meant to treat COVID-19 patients and has an expected lifespan of about three or four months.

“Intensive care units are seeing COVID-19 patients who require highly dynamic ventilators,” J.D. Polk, M.D., chief health and medical officer for NASA, said in the statement. “The intention with VITAL is to decrease the likelihood patients will get to that advanced stage of the disease and require more advanced ventilator assistance.”

Currently, NASA is seeking emergency use authorization from the U.S. Food and Drug Administration. That process ensures the government agency can approve critical medical devices in days, rather than years. Once complete, Caltech’s tech transfer office, which manages JPL, will offer a free license for VITAL.

The university is currently looking for manufacturing partners to bring the design to life.

A team of researchers from the Royal Women’s Hospital, Monash University and the Alfred Hospital has successfully tested, in a simulated environment, the potential to ventilate two lungs of different compliances from a single ventilator using only commonly available hospital equipment. While the authors do not condone the practice of ventilator splitting and say the findings must be interpreted and applied with caution, the experiments demonstrate the hope of simultaneously ventilating two test lungs of different compliances and modify the pressure, flow and volume of air in each lung, in case of extreme emergencies.

“Patients with COVID-19 may develop progressive viral pneumonitis leading to severe respiratory failure,” said lead author Dr. Alexander Clarke, a researcher in the Department of Anaesthesia at the Royal Women’s Hospital.

“The combination of unprecedented disease burden and global supply chain disruption has resulted in worldwide shortages of medical equipment.”

“Despite our advances in the practical application of ventilator splitting, the practice is unregulated and under tested. But as the COVID-19 pandemic continues to grow, some countries, like the USA, may consider ventilator splitting on compassionate grounds. The U.S. FDA has passed emergency use authorization for the splitting of ventilators.”

“While ventilator splitting has, at face value, validity in addressing ventilator shortages, we agree that on sober reflection, it is a solution that needs to be weighed up carefully as it may cause more harm than good.”

The basic principle of ventilator splitting is simple — two or more patients are connected to one ventilator and both are exposed to the same circuit dynamics.

This presents many challenges including ventilator and patient synchronicity — ventilation requirements are different for a 100 kg male and a 50 kg female, cross-infection from inter-patient gas exchange, oxygen concentration, and the lack of monitoring for individual tidal volume, flow and pressure. Irregularly pressurized air supply can kill patients.

To counter this, Dr. Clarke and colleagues connected a flow restrictor apparatus, which consisted of a Hoffman clamp and tracheal tube, to the inspiratory limb of the ventilator to the high compliance test lungs.

The breathing circuit ran from the humidifier to a hospital-commodity Y-connector splitter.

From the splitter, two identical limbs were created, simulating the ventilation of two pairs of patient lungs.

The resistance was modified to achieve end-tidal volumes of 500 ml ± 20 ml.

“The addition of the flow restrictor was critical to the way this setup works — without the restrictor, we weren’t able to control air flow to each simulated patient,” said co-author Dr. Shaun Gregory, a scientist in the Department of Mechanical and Aerospace Engineering at Monash University.

While the findings are exciting for crisis and trauma medicine, they need to be interpreted and applied with caution.

“Our experiment has demonstrated that in order to deliver a safe tidal volume and airway pressure, a resistance mechanism is required on at least one inspiratory limb of the circuit,” Dr. Gregory said.

“One way of achieving this is through the use of a tracheal tube and Hoffman clamp — common, practical items found in hospitals.”

“While the discovery is promising, the use of this method in the clinical context has not been validated and we don’t recommend its wider use without further trials.”

“We are hopeful of one day being able to get great surety with this approach to ventilator splitting so we can help save lives in dire cases of emergency.”

The team’s paper was published in the journal Anaesthesia.

View SciNews Article HERE.

HOUGHTON — As COVID-19 cases have surged, the shortage of working ventilators has become one of the biggest obstacles in treating patients.

A Michigan Technological University professor is one of the people working on a solution. Joshua Pearce, Richard Witte Endowed Professor of Materials Science and Engineering and a professor of electrical and computer engineering, is co-editor in chief of HardwareX, an open-source scientific hardware journal. It is now accepting submissions for an issue with proposals for making ventilators and other necessary equipment, such as non-contact thermometers and N95 respirators. Those can be through 3-D printing, or with materials and tools readily available at hardware stores. 

Several previous authors have indicated they will submit papers, Pearce said. One South American researcher is testing an open-source ultraviolet sterilization method that can be used for entire rooms. 

“He had done it for biological research, but he’s adapted it for a hospital setting as well,” Pearce said. 

Submissions will be taken until June 1, then posted online within a week of their acceptance. HardwareX is making the issue available to all to ensure a fast peer review. 

Michigan Tech is also tackling the problem. Pearce runs the Michigan Tech Open Sustainability Technology (MOST) Lab. He is also part of Tech’s Open Source Initiative. 

One approach they are working on is recreating a low-cost ventilator used by a Tech Enterprise team that was deployed in Africa. 

“That is slightly challenging because we only have access to one of the labs on campus,” Pearce said. 

Testing is using artificial lungs from Michigan Instruments to simulate the ventilators’ effect on humans. 

“No one is quite there yet,” Pearce said. “It’s very, very challenging on the software side to control the pressures so you don’t damage people’s lungs.”

COVID-19 closures have already caused problems with access to some places. One of the most promising leads was a paper published in 2019 by a research team in Pakistan, with whom Pearce had been working. The team had access to an artificial lung and could run tests immediately. However, their university was shut down due to the pandemic. 

“The last version of the code is stuck on some computer at the university, and nobody can get access to it,” Pearce said. 

Other researchers are looking at converting a CPAP machine to assist people in breathing. 

All of this is taking place when teams are restricted to what Pearce calls “the absolute worst way to do designing”: limits on how many can be in a lab, limited access to equipment and disrupted supply chains. Before the next pandemic, Pearce said, there should be government-funded open-source designs pre-tested and ready to put into place when the need arises.

“That would relieve a lot of the costs associated with having stockpiles, and really help the countries that don’t have the capital to build 10,000 ventilators,” he said. 

In March, Pearce conducted a review of open-source ventilators. While promising, he said, the systems that had been tested and peer-reviewed did not have full documentation. Those that were documented were either early designs or had not finished testing. 

“With the considerably larger motivation of an ongoing pandemic, it is assumed these projects will garner greater attention and resources to make significant progress to reach a functional and easily replicated open source ventilator system,” he said. 

A $1,500 ventilator system being developed by the Innovative Global Solutions Enterprise team at Tech had been one of the furthest along, Pearce said. However, it could not reach its fundraising goal through Superior Ideas, Michigan Tech’s crowdfunding platform. 

“If it had been funded, we’d probably have the solution already and we could shop it out,” Pearce said.

See The Daily Mining Gazette Article HERE.