LifeBox

What it does

The inability to move hearts from donor to recipient is the primary cause for an abysmal heart transplant rate in India. LifeBox tackles this problem with a system that extends preservation time of the heart to allow for increased travel time and distances.

Your inspiration

The project has its genesis at IISc Bangalore, with a vision to explore drones as a transport channel for organs. Extensive stakeholder interactions and literature study quickly helped us realize that without active preservation techniques, drones will not do much to improve the rate of heart transplants in India. This led to a shift in focus: A portable system that can extend the out-of-body viable time of the heart. The idea of the novel cooling method (the device consists of two sub-systems: perfusion/flushing and cooling) was inspired by the inner workings of a simple convection over.

How it works

There are two sub-systems within the device: cooling and perfusion/flushing. A peristaltic pump drives the preservation fluid from a reservoir to the heart which is housed within a chamber. It is equipped with multiple sensors that track biomarkers which are indicative of heart health. Waste fluid from the heart is then collected via a waste reservoir pump. The heart in this setup is only intermittently perfused and does not beat. The cooling sub-system utilizes a refrigerant, over which air is blown to cool it. The system is feedback controlled using temperature sensors and maintain hypothermic temperatures (4-8 degree Celsius). This impedes heart metabolism which in turn prevents damage. The user can control and monitor all necessary parameters via a touchscreen mounted on the device. This also serves to inform the user in case of any alerts/warnings. Data is also transmitted in real time to the recipient site so that the surgeon can prepare accordingly.

Design process

The project has adopted a user-in-the-loop approach to engineering design. It began with an extensive literature review, user discussions, and empathy exercises. Multiple interviews were conducted with stakeholders across the spectrum, including policymaking, transplant experts, clinicians etc. Insights gained from these immersion activities led to realignment of priorities: making an active preservation device that extends the out-of-body viable time of the heart. At the end of each design stage, stakeholders were revisited and based on their feedback course corrections, if necessary, were made. Conceptually, multiple ideas were brainstormed, leading to development of several prototypes and a novel cooling system that allows for significant reduction in weight and power requirement. Fluid delivery and cooling sub-systems were iteratively improved via experiments. The current prototype, however, is larger than the planned size, which is attributed to limitations of additive manufacturing as a prototyping method. The team is currently undertaking efforts for transitioning to conventional manufacturing methods, standardization of tolerances among other items. These efforts are expected to address the issue of device size.

How it is different

LifeBox utilizes intermittent flushing of the heart with a preservation fluid to extend its out-of-body viable time. It has been designed to be portable, with corresponding innovations to overcome challenges of power and weight. Hypothermic temperatures (4 to 8 degree Celsius) are maintained using a novel patent-pending cooling system which uses a refrigerant, fans, and sensors for temperature regulation. This reduces the weight of the system by an order of magnitude as compared to traditional thermoelectric cooling methods. Additionally, the heart chamber is equipped with multiple sensors that continuously capture biomarker data, which serves as an indicator of heart health. This data allows the surgeon at the recipient site to take critical decisions, potentially leading to improved chances of success. Conceptually, the system can also be extended for preservation of other organs which rely on active flushing as a means of preservation.

Future plans

A clinical investigation of the device is planned, and necessary approvals for this are being sought. The novel cooling system is also being evaluated for vaccine storage. Eventually, parts of the device designs will be made available open source, allowing multiple players the freedom to operate and test the device independently. This can create a community around the device and lead to multiple contributions by independent innovators. Commercial systems that can preserve organs are globally limited in number and prohibitively expensive. An open-source platform can spur rapid development leading to affordable solutions in the market.

Awards

The project has been awarded the PACE grant by the Department of Biotechnology, Government of India. The mandate of the grant is to further develop the device and conduct a clinical investigation. The project outcomes have also been published in reputed international conferences and covered by multiple media outlets.