The sutures, or joints, between the bones of new-born babies’ skulls are normally open and not yet fused together, to make it possible for the head to grow. If one of the sutures fuses prematurely, the head cannot grow width, or it may grow crooked.
Treating children’s cranial (skull) malformations requires both multi-professional special expertise and fine-tuned precision instruments.
The field of cranial surgery is developing rapidly. New surgical applications and instruments are continuously being developed and refined. There are other distraction devices on the market, but they didn’t fully meet all the needs of our customer.
“If a child’s skull has remained too small, and there is not enough space for the brain, the distraction device is used to stretch the skull. A certain device would have been suitable for us, but it is no longer available,” says Professor Willy Serlo, Chief Physician in Pediatric Surgery of the Oulu Craniofacial Centre.
Help with the development of the device was found at Mectalent: “I gave the idea to Mectalent and described what we need, and they developed a solution", Serlo explains.
We developed the tool based on the idea of a pediatric surgeon
The skull is gradually expanded in the weeks following surgery. In this way, the shape of the skull can be slowly altered, increasing the volume of the head in proportion to how much the scalp stretches.
When the distraction device is placed under the skin on the skull, there needs to be an opening in the skin where the extension of the device exits. In this way, the device can be gradually adjusted by hand. In addition, the extension has to be removable.
“Mectalent developed a solution for this,” Willy Serlo says. “The other solution involved controls with which the distraction device can be guided as precisely as possible in the right direction.”
The solution exceeded expectations
The solution developed by Mectalent surprised the pediatric surgeon: “Mectalent’s finishing touch positively surprised me, Serlo says. “They exceeded all my expectations. They understood from beginning to end what we were doing, and they created the technical solutions quickly and with expertise.”
The largest significance of the high-precision device is for the little patients and their families.
“For them, it is crucial that such devices exist. And naturally, it’s a source of pride for us that such instruments can be made in Finland,” Serlo says.
At Mectalent, the design and production of health technology is based on the certified ISO 13485 quality system. It ensures compliance with regulatory safety requirements and risk management at various stages of a product's life cycle.
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