Cardiac Surgery Devices
Background
The client was developing a new minimally invasive method of treating Tricuspid Regurgitation of the heart by placing connected pledgets pairs into the posterior portion of the mitral valve annulus, and then tightening them so the heart valves would seal better. If required up to three pairs of pledgets could be implanted around the same valve. Access was via a catheter inserted in the groin (transjugular).
Problem
- Navigating a catheter into the correct chamber of the heart
- Placing guide wires through the annulus at a set spacing
- Following the guide wire and placing a pledget through the annulus
- Placing a locking device on the pledget sutures, plicating, monitor and then cut the suture
Each step required at least one specialized handle, that all had to work together as a system. Each handle had to be flushable with saline before the procedure, and often needed to be used with a single hand. Safety and usability was a huge factor in the design, with each device needing multiple safety interlocks before cutting the suture and releasing the pledgets.
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