Overcoming the Challenges of Specialized Heart Valve Manufacturing 

 

A medical device manufacturer wanted to produce a specialized heart valve made with bovine tissue. The valve would offer two key advantages to patients with vascular disease: unlike mechanical valves, tissue valves do not require blood thinners, and they can be inserted into a patient via transcatheter, eliminating the need for open heart surgery. 

 

THE CHALLENGES

The valve is very small, about the size of a quarter, and has difficult geometry. IMPACT’s engineers created a prototype with a steel rule die (SRD) on an acrylic base that was able to successfully cut the tissue. SRD dies are made with multiple pieces—and this application required 10 total blade segments. Adjusting one spot affected all other dimensions. While the prototype delivered an impressive 70 percent success rate, the tolerances were difficult to keep consistent and the die’s lifespan was short due to corrosion from contact with the biomaterial over time. IMPACT looked for ways to improve.

 

SOLUTION

Undaunted by the challenge, IMPACT’s engineers developed another die with a different approach. An Eagle die is a one-piece machined part, which holds tighter tolerances and has a significantly longer lifespan than the SRD prototype. It was the right solution for the job.

 

RESULTS

The Eagle die has a 100 percent success rate, with 100 percent of parts produced within tolerance. The medical device manufacturer had its solution and the valve earned FDA approval. Thanks to this product, patients can have replacement heart valves inserted through the leg—a transcatheter procedure where a balloon-like device opened the artery and inserted the new valve—instead of open-heart surgery.

 

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