When Islip obstetrician Dr. Scott Berlin couldn't find a better incision-making tool to deliver babies by Caesarean section, he got a piece of cardboard and a pair of scissors and started making mock-ups of a new kind of scalpel -- one that wouldn't nick babies.
For centuries, infants born by C-section have often had to endure nicks and cuts, because traditional scalpels -- and back in the day, butcher's knives -- cut too deeply.
"There has been a full spectrum of injuries, from small scratches to cutting into a baby's lungs," Berlin said, referring to cases in the medical literature.
Some incisions, other experts say, have been worse.
Berlin, who runs a private practice in obstetrics and gynecology and is on staff at Southside Hospital in Bay Shore, where for several years he was chief of OB-GYN, said it was time to end the agony.
Doctor takes the initiative
He had never before attempted inventing anything until a half-dozen years ago when he began development of a new type of scalpel.
His knife, which was recently approved by the U.S. Food and Drug Administration, is new to medicine. It looks more like a box cutter than a medical tool. But because it has a rounded, plasticized edge, the blade does not reach deeply into the uterus and cannot nick a baby.
"When I did my initial patent search, I couldn't believe no one had ever done anything like this," Berlin said.
Before inventing the scalpel, which he has named C-Safe, Berlin searched medical catalogs for a tool that could be adapted, but he couldn't find anything.
By the time he developed a prototype, he was even more surprised to discover there had never been a tool such as his in the history of modern medicine.
Rates of C-sections have been rising worldwide. In this country, the number of C-sections has risen in recent years following a decline in the 1990s. About one-third of U.S. births are C-section deliveries, according to the Centers for Disease Control and Prevention. In China, about half of all deliveries are by C-section.
Doctors at North Shore-Long Island Jewish Health System, of which Southside Hospital is a member, are testing the scalpel in deliveries, he said.
The American Pregnancy Association estimates that one to two babies out of every 100 gets nicked or scratched when delivered by C-section.
Federal data suggest about 45,000 babies of the 1.3 million delivered by C-section nationwide suffer minor injuries annually. Most nicks and scratches occur in emergency procedures, especially when the baby is in a difficult position.
Jeanne Flood, a registered nurse who specializes in obstetrics at Southside, said she's thrilled that a doctor at her hospital had the ingenuity to develop a new medical instrument.
"Doctors are cutting through the abdominal wall before they reach the uterus," Flood said, "so they are cutting through more than one layer on the mother. But the uterus is very thin, and the baby is right there."
A drive to help babies
Berlin said he first got interested in developing a better scalpel after his father, Dr. Melvin Berlin, a veteran Long Island obstetrician/gynecologist, nicked a baby in a C-section seven years ago. "At the time, he had been in practice for 35 years and had never cut a baby," Scott Berlin said. "He got sued and fought it.
"It was an emergency C-section. The baby was . . . [breeched] and the back of the scalp was accidentally cut. It was less than an inch long," the son said.
The elder Berlin retired four years ago.
"When you cut a baby, that's bad and it's sad for everyone involved -- the baby, the parents and the doctor -- because the doctor feels bad, too," his son said.
"It was at that point when I said there has to be a better way," Scott Berlin said.
"I also hired a design team and did animal studies, which had to be submitted to the FDA because any medical device has to be approved before it can be used on an actual patient," he said.
He tested his scalpel on cow and pig wombs to satisfy FDA regulatory requirements and raised $1.3 million from friends, family and other investors to meet safety and efficacy conditions demanded by the agency.
The scalpel also is approved in Britain, where it is referred to as a superknife and used in deliveries throughout the system of hospitals run by nationalized health service, he said.
Berlin hopes to introduce it in other countries, including China, which has the highest C-section rate in the world.