SaeLink

ECMO is an external circulatory system that provides patients with life-sustaining cardiopulmonary support. Gradually, though, this support is compromised as clots accumulate within its circuit. Without timely intervention, critical complications arise such as: mechanical failure, pulmonary embolisms, and seizures. Typically, after 1-2 weeks, the circuit needs to be replaced since clotting occurs in the oxygenator which creates blocks and the system cannot function effectively. To deal with this, perfusionists disconnect their patients from ECMO to perform a notoriously tricky wet-to-wet connection. During the time the wet-to-wet connection is performed, the patient is off ECMO creating a delicate period of high stress.

The current solution is where one perfusionist joins the existing and new circuit’s lines, while another drizzles a finite amount of saline into them to ensure they’re air-free to prevent air embolism strokes. This overcrowded nature causes inefficient coordination and inconsistent results. The showering saline obstructs visibility, forcing air-checks to occur after the connection. If present, they restart the process.  Patients can be off ECMO from 30 seconds to multiple minutes. For perfusionists it’s an anxiety-provoking procedure.

Our device, the SaeLink, optimizes wet-to-wet connections into a 3-step, 1-person process in which half the current tasks can be performed without taking the patient off ECMO. 

First, the saline is filled into a pouch featuring sealed insertion ports. Perfusionists are able to insert the new circuit’s line and receive visual confirmation of air removal before taking the patient off life support. 

Second, when the patient is disconnected, the process is repeated with the existing line. As the perfusionists push the lines together, the base telescopes to guide the connection as the compressed pouch retains clear visibility.

Lastly, with the patient back on ECMO, the device is fully removed for easy visibility of the lines in the future.

I was a part of the complete design process of the device from its conception. I was responsible for the 3D designing, prototyping, FMEA, killer experiments and bench-top testing of the device. We first determined what the product and customer requirements of the device will be and what general mechanisms it will use to function. We then proposed various methodologies the device could use to function and put them to the test using killer experiments. With the few selected methods we began solution landscaping and arranging them in a MECE chart to cover all possible combinations. After selectively ranking and testing all of the solutions we began experimenting and prototyping the top 5 selected solutions. We systematically weighed the pros and cons of all the solutions and arrived at our finalized soultion, SaeLink. We created a detailed FMEA for the complete process and the environment where th device was going to be used.

We are currently in the process of securing funding to professionallly manufacture a high-fidelity prototype of the device for a more efficient bench-top validation testing and to eventually move towards pre-GLP animal testing.