What it does
The device supplies oxygen and nutrients to an organ suitable for transplantation during transport. This allows for preserving organs outside the body for extended periods, significantly enhancing the chances of successful transplantation.
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Organ transplantation is a life-saving treatment for end-stage organ failure. However, the scarcity of donor organs remains a major challenge in transplantation. The transportation of organs for transplantation is a critical part of the process, as the viability of the organ is directly related to how it is stored and transported. One potential solution to address this problem involves the use of a hypothermic oxygenated perfusion (HOPE) organ transport device. It extends preservation time and allows for exploration of wider geographical regions for potential matches, as it allows for longer distance transportation.
How it works
The organ is placed in an organ specific capsule that meets organ specific requirements. The inflow of the organ is connected to the lid of the organ capsule. The capsule is filled with perfusion fluid that is saturated with nutrients. The organ capsule is placed and connected to the transport device. This device houses all the technical components. The perfusion fluid is pumped from the organ capsule to the perfusion system. The fluid gets oxygenated and cooled via an oxygenator and heat exchanger. Temperature is measured and the and this data is used to control the Temperature Control System. A Peltier element is utilised to cool a cooling fluid. After oxygenation and cooling, the perfusion fluid flows towards the inflow of the organ. Pressure is measured and an algorithm ensures the organ is perfused at optimal perfusion rates. A Graphical User Interface (GUI) allows for monitoring and minimises human error with step-by-step guidance.
Design process
For the development of the HOPE device, a component-based design approach was used. This approach involves designing and developing each component of the system separately, with a focus on its individual functionality and performance. Once all necessary components were designed and tested, they were then combined into a single cohesive design. First, the Automated Controlled Perfusion System was developed. This system is responsible of delivering the oxygen and nutrients to the tissue via the perfusion fluid. Different pump were considered and tested to meet the design requirements. An algorithm was written to enable precise pressure-controlled perfusion. Then, the Temperature Cooling System was designed. A Peltier element was chosen because of its size and reliability. Custom parts were designed and 3D printed to ensure efficient heat transfer. A temperature sensor combined with an algorithm allows for optimal control over temperature. For the oxygenation, using compressed air was considered to keep a compact design. This was validated with an experiment with a porcine liver. A Heart Organ Capsule was CAD modelled and after different iteration 3D printed. Lastly, multiple iterations for the complete transport device were made, resulting in a complete functional prototype.
How it is different
The current method of organ transportation involves static cold storage (SCS). This concept utilises a technique offers several benefits over SCS. It offers better preservation and longer transport times. This allows for performing organ transplantation more often, since there is more time to find match, transport of the organ and preparation of the medical personnel. The unique thing about this concept is that it is completely modular. The separately designed components of the concept can easily be redesigned, upgraded or changed without affecting the whole system. The modular organ capsules meet organ specific requirements. This means that one device can be used for the transport of different organs. This results in a drastically cost-effective design, since there is only the development costs for one device that serves multiple organs. Also medical certification, production and maintenance cost can be reduced due to the modular design.
Future plans
The next step is to start validation studies. The prototype is able to cool and perfuse the organ, however studies are needed to assess the functionality of the device. For these studies, organs from slaughterhouses can be used to avoid the use of lab animals. If the studies show that the concept is effective, it can be further developed. After medical certification it can eventually go to market and can be used for clinical use cases, potentially saving countless lives.
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