Gerresheimer and JenaValve have teamed up on a delivery device to improve safety in heart valve insertion.
When heart valves get constricted or don’t close properly, putting a person’s life at risk, artificial heart valves can help. A minimally invasive approach is often taken with elderly patients who aren’t fit enough for open-heart surgery.
An artificial heart valve that can be compressed small enough to fit into a catheter is necessary for minimally invasive aortic valve implantation.
JenaValve uses a self-expanding Nitinol stent with a tissue prosthesis for this purpose. This material has an excellent shape memory. It is very elastic at low temperatures and does not revert to its original shape until it warms up.
The surgeon inserts the refrigerated artificial valve into the beating heart via the defective aortic valve. When it warms to body temperature it expands and immediately starts to perform its function.
For the launch of the second series of aortic valves, JenaValve needed an optimised delivery system that considerably simplified the surgical procedure. Gerresheimer item GmbH was requested to optimise the design of the operating handle in terms of its ergonomics.
Bearing in mind the time pressure during heart surgery, the product had to have a simple and intuitive operating concept. So the most elementary product requirement was easy handling without the assistance of a second person at all times.
Another requirement was a design that facilitated ergonomic operation. All controls had to be reliably operable, even with a slippery surface or if the user wears surgical gloves.
The number of operating elements also had to be reduced to the minimum to make processes as simple and plausible as possible, thereby preventing mistakes in time-critical situations.
During the process of positioning the artificial heart valve, the lock button is released by rotating it one position to the right so that the operating ring can be used. This rules out any uncertainty about operating sequences or incorrect use.