The mitral valve is one of four valves in the heart that keep blood flowing in the right direction. Mitral regurgitation is when the mitral valve (between the left atrium, and the left ventricle) does not close properly when the heart is beating. There are many causes (Cardiomyopathy, heart attack, mitral valve prolapse, etc) and as the regurgitation gets worse, the heart must work harder to pump blood to the body.
Developing a new surgical procedure to treat health problems like this is a long and difficult process. Over a decade we helped Mitralign with developing new medical instruments to help make their novel approach for treating Mitral Regurgitation with the use of surgical implants directly into the mitral annulus by means of a catheter. The implants are cinched together, thus reducing the size of the mitral valve annulus and the valve opening.
It is often assumed that the term ‘Medical Product’ means a machine that sits next to a patient silently monitoring their vital signs, or administers a treatment, but there is another important part of medical products – surgical instruments.
Mitralign needed a series of devices to help with throughout their procedure for treating Mitral Regurgitation, from implanting the device, to setting the amount of adjustment. They asked us to help with designing and engineering the tools a surgeon would use during the procedure, which were attached to special catheters they were developing at the same time.
Developing products that are used in an operating theater, and that need to function reliably when covered in blood, is a challenge that we’re familiar with, and happy to help you with.
With medical device development for Mitralign, the top requirements were for reliability and ease of use, while meeting relevant medical device regulations.
All through the development process we worked with Mitralign and their trainers to test prototypes in their development lab, and in training facilities. We got the chance to observe the entire procedure, and work with surgeons as they learned how to use the equipment.
For placing the pledgeted suture (pledget) they needed a lightweight handle that would easily slide along the drapes, and then tighten the pledget with a known torque. We developed a molded torque limiting spool that was the heart of the handle, along with a method for retracting the catheter a specific distance with a safety interlock and emergency ‘bailout’. Everything was designed to be molded in plastics that would be easy to sterilize.
The most complicated device built on what we learned with the pledget delivery handle, and had a number of spools that the suture could be wound onto, again with torque limiters, and a safety to prevent premature deployment of the lock. Even though there was a lot going on inside the handle, we designed the outside to be simple to operate, and used color coding and clear iconography to make sure operation was easy to use.
Finally we got to design the guide system for navigating a wire from the groin into the left ventricle of the heart, via the aorta, that would then be used by all the other devices as a guide. This involved two new handles, along with a rail and carriages, that would allow each handle to rotate 360 degrees so the catheter tip could be easily steered while everything was monitored via echocardiography and x-ray imaging.
