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 NUIG, National University of Ireland Galway and TCD, Trinity College Dublin, Design Partners were 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.
In essence, the goal of this project was to develop a simple workflow in order to aid surgeon success in delivering the bio-prosthetic.
Developing a minimally invasive approach is the ideal platform to address the large number of patients being denied open heart surgery due to health risks every year.
In order to develop a delivery system, which required a completely new surgical workflow, it was essential to intimately understand the complex method of deployment the client had initially conceptualised.
Design > Test > Iterate > Develop > Repeat
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 through the development of ‘proof of principle’ test-rigs and models.
This process was essential in streamlining the complicated user step journey from first incision to successful valve deployment.
The industrial design of the delivery system was dictated by the design and development of a completely new and previously unknown surgical procedure workflow.
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-1 system, ultimately allowing the team to successfully deploy and secure the MiVaR device during test trials.
Regular group sessions with the client allowed for ‘real-time design’ where procedures could be quickly set up and tested using rudimentary test rigs and models, whilst being edited, improved and developed on the go. This was essential to the projects overall success.