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Car Mechanic Dreams up a Tool to Ease Births


By Donald McNeil, Jr., Nov 13, 2013, NY Times


    The idea came to Jorge Odon as he slept.
    Somehow, he said, his unconscious made the leap from a YouTube
    video he had just seen on extracting a lost cork from a wine bottle
    to the realization that the same parlor trick could save a baby stuck
    in the birth canal.
    Mr. Odon, 59, an Argentine car mechanic, built his first prototype
    in his kitchen, using a glass jar for a womb, his daughter’s doll
    for the trapped baby, and a fabric bag and sleeve sewn by his wife
    as his lifesaving device.
    Unlikely as it seems, the idea that took shape on his counter
    has won the enthusiastic endorsement of the World Health
    Organization and major donors, and an American medical
    technology company has just licensed it for production.  
    With the Odon Device, an attendant slips a plastic bag inside
    a lubricated plastic sleeve around the head, inflates it to grip
    the head and pulls the bag until the baby emerges.
     
    Doctors say it has enormous potential to save babies in poor
    countries, and perhaps to reduce cesarean section births
    in rich ones.
    “This is very exciting,” said Dr. Mario Merialdi, the W.H.O.’s chief
    coordinator for improving maternal and perinatal health and
    an early champion of the Odon Device.
    “This critical moment of life is one in which there’s been
    very little advancement for years.”
    About 10 percent of the 137 million births worldwide each year
    have potentially serious complications, Dr. Merialdi said.
    About 5.6 million babies are stillborn or die quickly,
    and about 260,000 women die in childbirth.
    Obstructed labor, which can occur when a baby’s head is too large
    or an exhausted mother’s contractions stop, is a major factor.
    In wealthy countries, fetal distress results in a rush
    to the operating room.
    In poor, rural clinics, Dr. Merialdi said,
    “if the baby doesn’t come out, the woman is on her own.”
    The current options in those cases are forceps —
    large, rounded pliers — or suction cups attached to
    the baby’s scalp. In untrained hands, either can cause hemorrhages,
    crush the baby’s head or twist its spine.
    Although more testing is planned on the Odon Device,
    doctors said it appeared to be safe for midwives with
    minimal training to use.
    Along the way, it has won research grants from the United States
    Agency for International Development and from
    Grand Challenges Canada.
    “We’ve given out $32 million for 61 different innovations,
    and this one is the farthest along,” said Dr. Peter A. Singer,
    the chief executive of Grand Challenges Canada.  
    The device will be manufactured by Becton, Dickinson and Company,
    or BD, of Franklin Lakes, N.J., which is better known for making
    syringes.
    “My first reaction, as soon as I saw it, was positive,” said
    Gary M. Cohen, the company’s executive vice president
    for global health. It was at the World Economic Forum in Davos,
    Switzerland, that Dr. Merialdi asked him to consider taking it on.  
    “Many inventions get to the prototype stage, but
    that’s maybe 15 percent of what needs to be done,” Mr. Cohen said.
    “There’s finalizing the design for manufacture, quality control,
    the regulatory work and clinical studies.
    Absent that, they don’t see the light of day.”
    So far, the device has been safety-tested only on 30 Argentine
    women, all of whom were in hospitals, had given birth
    before and were in normal labor.
    “I was glad they asked me, because it was for a good cause,”
    said Luciana Valle, a kindergarten teacher who was 31
    two years ago when her son, Matteo, was one of the first babies
    extracted with the device.
    Because Matteo weighed almost nine pounds,
    “it really helped,” she said in a telephone interview.
    “His head came out on my second push.”
    The W.H.O. will now oversee tests on 100 more women
    in normal labor in China, India and South Africa,
    and then on 170 women in obstructed labor.  
    In a telephone interview from Argentina, Mr. Odon described
    the origins of his idea.
    He tinkers at his garage, but his previous inventions
    were car parts.
    Seven years ago, he said, employees were imitating a video
    showing that a cork pushed into an empty bottle can be retrieved
    by inserting a plastic grocery bag, blowing
    until it surrounds the cork, and drawing it out.
    That night, he won a dinner bet on it.  
    At 4 a.m., he woke his wife and told her the idea that
    had just come to him.
    (His own children were born without problems, he said, but
    he has an aunt who suffered nerve damage from birth.)
    His wife, he recalled, “said I was crazy and went back to sleep.”
    The next morning, a somewhat skeptical friend introduced him
    to an obstetrician.
    “You can imagine these two guys in suits in a waiting room full of
    pregnant ladies,” he said. The doctor was encouraging,
    so he kept working.
    Polyethylene replaced the bag his wife had sewn, and
    the jar was replaced by a plastic uterus.
    With the help of a cousin, Mr. Odon met the chief of obstetrics
    at a major hospital in Buenos Aires.
    The chief had a friend at the W.H.O., who knew Dr. Merialdi,
    who, at a 2008 medical conference in Argentina, granted Mr. Odon
    10 minutes during a coffee break.
    The meeting instead lasted two hours.
    At the end, Dr. Merialdi declared the idea “fantastic” and
    arranged for testing at the Des Moines University simulation lab,
    which has mannequins more true-to-life than a doll and a jar.  
    Since then, Mr. Odon has continued to refine the device,
    patenting each change so he will eventually earn royalties on it.
    “My daughter said, ‘And now I can have my doll back,’ ” he said.
    It is too early to know what BD will charge, Mr. Cohen said, but
    each device should cost less than $50 to make.
    While the company expects to profit on all sales,
    it will charge poor countries less.
    Dr. Merialdi said he endorsed a modest profit motive because
    he had seen other lifesaving ideas languish for lack of it.
    He cited magnesium sulfate injections, which
    can prevent fatal eclampsia, and corticosteroids,
    which speed lung development in premature infants.  
    “But first, this problem needed someone like Jorge,” he said.
    “An obstetrician would have tried to improve the forceps or
    the vacuum extractor, but obstructed labor needed a mechanic.
    And 10 years ago, this would not have been possible.
    Without YouTube, he never would have seen the video.”
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