The Ex-Vivo Organ Support System (EVOSS) is a medical device created to facilitate the transplant of human lungs. The EVOSS is the first organ support system to provide conditions almost identical to that of a healthy human body for donor lungs during transport. With EVOSS, donated human lungs en route to recipients remain warm, alive and breathing. Donated organs are the ultimate gift, the EVOSS system seeks to honor this gift by maximizing the potential for successful transplants.
The system was designed from the lungs outward to create an environment as similar to the human body as possible. This a dramatic departure from the current standard of care which is cold, static storage in which organs are transported on ice with no blood-flow or respiration.
Body-like conditions are created through the perfusion (circulation) of a blood-like, therapeutic solution at normal body temperatures and breathing via mechanical ventilation. The lungs expand and contract using negative pressure ventilation which closely mimics the body's natural means of respiration. This is more physiologic and far less damaging than inflating lungs using positive pressure as with traditional ventilators. Operating in the same natural way human bodies do, EVOSS provides the ideal vehicle for lungs and the ability for transplant teams to monitor and evaluate lungs in transit.
As we emerge from the Covid-19 pandemic, its effects will remain for years to come. Although over 100 million people have survived Covid-19 infections, many will face lasting effects and potentially debilitating lung disease. EVOSS provides the ideal platform for the study of targeted lung therapies and in the most severe cases, increased opportunities for lung transplants. This innovative system dramatically raises the standard for organ preservation; it can and will make more donor lungs available for transplant. This is not a theoretical or hopeful outcome. Using a prototype featuring the device's underlying warm perfusion/negative pressure technology, twelve human transplants have been conducted using donor lungs that would have been discarded. All twelve double lung transplants were successful and all recipients are alive and thriving. These are twelve lives saved that would have been lost.
Organ transplantation is a difficult and audacious undertaking with everything conspiring against successful outcomes. Millions of patients are in need. While donors are abundant, willing, and registered, as few as three in one thousand organs offered begin the journey from donor to recipient. Throughout this journey, challenges are plentiful. They include the tyranny of time, the chemistry of death, distance, logistics, coordination, potential organ damage, and a notable lack of information detailing organ condition. Many of these shortcomings can be attributed to the traditional means of organ transportation: a consumer-grade cooler containing an organ wrapped in plastic, packed in ice, and accompanied by paper documents and stickers. The greatest limitation is that this method offers no opportunity to understand the dynamics of the organ while in transit. There's no information on organ condition or way to inform subsequent transplant decisions. EVOSS was designed to address these challenges while providing organs with a better ride.
The system's design considers the people and infrastructure that comprises our transplant system. Its appearance is intended to convey a serious, integrated and purposeful aesthetic while remaining sensitive to donor and recipient families who may encounter the device.
Everything and everyone must work together, from air ambulance pilots to transplant coordinators, to surgeons and EMTs. The roles and needs of every contributor were considered in the design of the system. Contextual research was carried out for all major workflows and use cases. Initial set-up was designed to be simple and efficient, reducing decision points and accommodating existing protocols, such as those established to maintain sterility.
Like many medical devices, the EVOSS system has a reusable, durable component and single-use, consumables that come into contact with biological materials. Sensors and instrumentation built into the consumables monitor lung function locally or remotely and without the need for additional equipment. All pertinent information is organized and presented on a dockable tablet operated using an intuitive touch screen interface.
While procedures for keeping an organ functioning and viable in clinical settings are established, solutions to provide that same level of care and functional support in mobile settings do not currently exist. Furthermore, traditional methods fail to replicate the natural way in which organs function. This can lead to compromises in who receives a particular donor organ, how it's transported and how well it may perform post-transplant.
Each functional element of the EVOSS lung device is intended to replicate crucial functions of the human body to provide the most natural respiratory process for the organ while in transit. The system is comprised of a consumable assembly that includes a double-sealed chamber to provide a sterile environment for the lungs and supporting sub-systems. This single-use component is replaced between patients requiring limited effort and coordination as a means to mitigate potential errors. Lungs breathe using negative pressure ventilation which acts on them by modulating chamber pressure to replicate how the body's diaphragm works. A supplemental airway ventilator works in tandem to maintain a constant minimum pressure through the trachea as a failsafe. A closed-circuit perfusion system circulates a blood-based, therapeutic solution to provide the lungs with the necessary dissolved gasses to maintain function. This system is packed with sensors that provide real-time information on lung performance, as well as trend data to aid transplant teams in decision making.
To keep the lungs healthy, elastic, and protected from environmental changes in transit, a blood contact heater was designed to regulate the system's temperature within normothermic ranges. Once an organ transport is complete, the entire consumables assembly is removed and the system can be reset for the next organ procurement in a matter of minutes.
The durable, reusable base of the system was designed for the realities and rigors of organ transport in a variety of vehicles, including full-size ambulances, constrained air ambulances, jets, taxis, and rideshare vehicles. Between these various modes, organs are often carried or carted by one or two members of a transplant team. The size, shape, and touchpoints of the device were developed in response to these complex use cases. The EVOSS was designed to be small enough to fit through the doorways of the smallest jets to provide the greatest range of aircraft compatibility.
Handles were placed in multiple, strategic locations to provide the most useful and ergonomic handling options for different situations. Folding handles facilitate two-person, tandem carrying for transit through hospital corridors and doorways. Strategically placed grips and grab points allow for handling in tight quarters. Lash points allow for the use of tie-downs in vehicles. All of these details were informed by contextual research with transplant teams and respond to the unique challenges of transplant coordination. Every element of the system is designed to support donor lungs as well as the dedicated people who make organ transplant possible. The EVOSS system will increase the number of donor lungs available for transplant and will save lives.