FEATURE u Medical Equipment & Devices
Mitral Valve (MV) replacement innovation
How Design Partners worked with the National University of Ireland Galway and Trinity College Dublin to develop a simple workflow that could aid surgeon success in delivering a bio-prosthetic heart valve. By Eugene Canavan, Medical Design Director
T
he Mitral Valve is a small flap in the heart that stops blood flowing the wrong way and is vital in how blood
flows throughout the whole body. Mitral Valve Regurgitation (MR), the most common heart Valve disease, results in the back-flow of blood when the valve is in its closed position. Over time, this can lead to heart failure, which requires interventional treatment in the form of valve repair or replacement. Together with the National University of
Ireland Galway (NUIG) and Trinity College Dublin (TCD), Design Partners was set the task of designing a method of successfully delivering a self-expandable, bio-prosthetic Mitral Valve into the annulus of a defunct valve, through minimally invasive percutaneous techniques. Their collaborative approach allowed them to invent simplified ways to solve this complex challenge. In essence, the goal of this project was to
develop a simple workflow that could aid surgeon success in delivering the bio-prosthetic.
MINIMALLY INVASIVE To address the large number of patients being denied open heart surgery due to health risks every year, developing a minimally invasive approach was crucial. In order to develop an innovative delivery system, which would require a completely new surgical workflow, it was essential to intimately understand the complex method of deployment. Working with NUIG & TCD’s team of cardio- vascular surgeons, bio-mechanical engineers and mechanical engineers, a real-time iterative process of testing and experimenting was undertaken. This involved the development of many ‘proof of principle’ test-rigs and models that enabled the team to ultimately create an intuitive surgical experience. This process was essential in streamlining the complicated user journey from first incision to successful valve deployment.
A USER-CENTRIC APPROACH We always encourage clients to come to us as early as possible before the solution requirements are set. This allows us to influence the approach and objectives and ensure the
18 June 2022 Irish Manufacturing
solution is user-centric and is optimised in a way that can elevate human potential. This is particularly pertinent in a collaborative project like this – with different specialists bringing necessary expertise – as it means all parties involved are aligned, eliminating any unnecessary processes or approaches we know won’t work from the offset. The agreement in this case was that usability was the most important part of this project, so the technology developed around that needed to be centred on the surgeon and the patient. It was essential for the device and surgical
procedure to be developed and designed by both teams in tandem. A smart user-centric approach, where each task correlated to each step of the surgical procedure, resulted in a complete, all-in- one system. This ultimately allowed the team to successfully deploy and secure the MiVaR device during the in-depth testing trials.
ITERATIVE COLLABORATION We believe collaboration with the most innovative minds is the way to create designs that empower and inspire people. Co-creation on this project was essential; we were creating a new surgical procedure and a device to enable it - one can’t exist without the other.
Fast and efficient progress is vital in competitive markets which is why we have invested in our research and development facility to enable quick set up of procedures for testing complex or rudimentary rigs, models and prototypes. We held regular brainstorming sessions with NUIG and TCD to develop iteratives in our workshops, which were then taken to the university labs to test on their porcine hearts. This meant everything we developed happened in real time – we would mock up an idea into a physical form and bring it to the lab to prove if and how it would work. Once we were given the green light from the surgical consultants and bio-engineers that the approach was feasible, we moved on to developing functional prototypes for testing. This meant we were able to remove anything that didn’t work instantly, making it easier for all experts involved to advise at every stage of the process. This approach of prototyping, testing, failing, and repeating was essential to the bio- prosthetic delivery project’s overall success.
Design Partners
www.designpartners.com
www.irish-manufacturing.com
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