Ecomed Solutions announced the release of its SureGlide Cesarean scalpel at the 37th annual Society for Maternal-Fetal Medicine this week. The scalpel is meant to prevent fetuses from getting cut during C-sections.
Ecomed had engineers and OB-GYNs design the scalpel so that it eliminate fetuses getting cut during C-sections, according to the Mundelein, Illinois–based company.
The SureGlide’s design eliminates fetal exposure to a blade during incision, regardless of uterine wall thickness or the number of times the blade has to pass through, according to Ecomed Solutions. It features a protected blade that cuts up and away from the fetus to eliminate exposure to the blade by surgical staff. There’s an ergonomically designed handle that offers greater control with the same feel as a traditional scalpel and a line of sight to the incision, and there are raised ribs for a better grip to create “a unique safety device specifically designed for C-sections,” said CEO of Ecomed Solutions David Yurek.
“How do you have a scalpel that essentially prevents exposure to a surgical blade and still deliver on the look, feel and performance requirements for surgeons?” said Yurek.
To be able to reduce the risk of fetal injury from nicks, cuts or lacerations during C-section deliveries, the scalpel design team had to overcome a major design challenge: The scalpel had to be safe for surgeons, doctors and other personnel from sharps injury while protecting the fetus at the same time.
In-house engineers and in-house designers posed Yurek’s question to OB-GYNs and together they took a collaborative approach to generating new concepts for a new scalpel. The concepts were developed into clay models and transferred to a 3D CAD modeling software to use 3D printing technology to create a prototype.
The design team and OB-GYNs were able to give feedback on the 3D printed prototype which allowed the designers to make cost-effective changes.
In the early development stages, Yurek said that using the 3D CAD and 3D printing technology allowed them to reiterate the design models.
“The most stressful aspect of a delivery for every doctor is getting the baby out safely,” said Dr. Andrea Wolfe, a Grand Rapids, Mich.-based OB-GYN practitioner and medical consultant for Sureglide. “Just like the mother and father, we invest nine months in preparing for the most precious moment of a family’s life. With Sureglide, a doctor is assured that every risk is managed right up to the last moment in pregnancy.”
The scalpel works by applying slight downward pressure to the handle while moving the tip along striations in the tissue. The tip of the scalpel will essentially get caught on one of the striations or a ripple in the uterine wall. The surgeon tries to tent the interior uterine wall upwards to swipe across the lower segment. The tip of the scalpel cuts through the tissue and allows the incision to be continued transversely. The tip and blade move up and away from the baby.
More than 30% of births are by C-section in the U.S., a 7% increase from 2000. According to the National Institutes of Health (NIH) about 3% of all pregnancies have resulted in fetal injury during C-section deliveries. The face, cheek and ears of the fetus are often in the way during the hysterectomy incision.
The CDC reports that there are about 385,000 sharps-related injuries among healthcare workers. Injuries in surgical settings increased 6.5% from 2001 to 2006.
“From the moment the pregnancy test comes back as positive, parents plan for just about everything from prenatal care to the outfit the baby will leave the hospital in,” said Yurek. “If a Cesarean delivery is part of the plan, parents and physicians now have an option to make sure the baby is protected during the delivery. Scars should be left for memories of learning to ride a bike, not childbirth.”
|
Where is a controlled randomized trial showing that this scalpel significantly reduces the incidence of fetal lacerations?
That’s a great question, Dr. Mays. I’ve sent an email to Ecomed’s public relations person. I’ll post whatever they tell me.