New baby vacuum can help ease vaginal births

It turns out, what the birth injury world needed was a mechanic with a penchant for wine who doesn’t mind playing with his daughter’s dolls.  After watching a video on how to gently fish a cork out of a wine bottle, an Argentine mechanic went to bed and had a dream about delivering a baby using the decades-old vacuum extractor.  In the dream, however, the dangerous cup of the vacuum that attaches to the baby’s head was gone.  Instead, the baby’s head had a plastic bag around it.  Contrary to what one might think, the plastic bag is what makes the device so safe.  The device, named the Odon device after its creator, Jorge Odon, created excitement in the obstetrics world the instant it was introduced to a few obstetricians at a local hospital.  The Odon has since been promoted by the World Health Organization, and it has won numerous awards.

Eight years ago when Odon watched a YouTube video on how to retrieve a cork from a wine bottle, he had no idea it would lead to an invention that would gain worldwide recognition.   In fact, the only reason Odon watched the video was so he could win a bet with his friend by performing a very entertaining bar trick.

The trick is this:  when a cork is in an empty bottle, you stuff a plastic bag down the neck of the bottle and blow into the opening of the bag.  The bag will balloon in the bottle, wrapping the plastic tightly around the cork.  Then all you have to do is yank on the bag to make the bag and cork pop right out.

Happily falling asleep after winning the bet, Odon suddenly woke up at 4 a.m.  It occurred to Odon that the concept behind the bar trick could be applied to delivering babies.  After his wife called him crazy, Odon grabbed his daughter’s doll, raced into the kitchen, and stuffed the doll into a glass bottle.  He was able to easily pull the doll out with a bag in a manner similar to the bar trick.  The doll recovered, and Odon has since been funded by a Fortune 500 company, patenting every new development in his groundbreaking device.

Realizing that the Odon device could save lives – and do it very cheaply – the WHO has been touting it for over two years.

“Obstructed labor is a major killer of young women and adolescent girls,” WHO director general Dr. Margaret Chan said at the World Health Assembly in May, 2012. “If approved, the Odon device will be the first simple new tool for assisted delivery since forceps and vacuum extractors were introduced centuries ago.”

The problem the Odon device hopes to solve is massive: every day, approximately 800 women die from preventable causes relating to pregnancy and childbirth, according to the WHO.  The vast majority of maternal deaths occur in developing countries and many are caused by prolonged or obstructed labors, which can cause mothers to have sudden and rapid bleeding (hemorrhages) and babies to be oxygen deprived while in the womb.  When babies are oxygen deprived, severe brain damage can occur, such as hypoxic ischemic encephalopathy (HIE) and cerebral palsy.

When a baby is in trouble, the safest method of delivery is almost always a C-section.  In third world countries, this surgical delivery technique is often not available.  Devices to facilitate delivery, such as forceps and vacuum extractors, have been around for centuries.  These devices, which have parts that attach to the baby’s head, can cause severe injuries, such as bleeding under the scalp, brain bleeds and skull fractures.  The cup on the vacuum extractor that attaches to a baby’s head is especially dangerous because it poses a significant risk of a life-threatening brain bleed called a subgaleal hemorrhage, which is when a vein ruptures and bleeds into the space between the scalp and the skull.  Furthermore, a vacuum extractor greatly increases the risk that a baby will suffer a stroke during delivery.  Stroke is one of the most common causes of cerebral palsy in term and near-term babies.

 

In addition to saving lives of women in third world countries, it is hoped that the Odon will be a potentially safer alternative to forceps and the vacuum extractors.

On Friday, the Becton Dickinson Company and the WHO announced plans for testing and manufacturing the Odon device.   The device works in the following manner:

The inserter is applied on the head of the baby.  A soft plastic bell assures perfect adaptation to the fetal head and prevents damage.The inserter progressively positions the Odon device around the head of the baby.  Positioning occurs as the inserter gently produces sliding of the two surfaces of the folded sleeve along the birth canal and around the baby’s head.

The inserter progressively positions the Odon device around the head of the baby.  Positioning occurs as the inserter gently produces sliding of the two surfaces of the folded sleeve along the birth canal and around the baby’s head.

When positioned properly, a marker on the Odon insertion handle becomes cleary visible on the reading window.  A minimal and self-limited amount of air is pumped into an air chamber in the inner surface.

Step # 3 produces a secure grasp around the head of the baby that fixes the inner surface and allows for traction.  The inserter is removed.

The baby’s head is delivered, taking advantage of the sliding effect of the two surfaces of the folded sleeve.  Lubrication of the surfaces further facilitates the extraction process.  If necessary, traction can be applied up to 19 kg, which is equivalent to the force applied with the metal vacuum extractor.

The Odon device is an exciting alternative to forceps and vacuum extractors.  The device won the first prize at the competition for technological innovation at INNOVAR 2011, and was also a winner in the “Saving Lives at Birth: a Grand Challenge for Development” global competition.

ALTERNATIVES TO VACUUM EXTRACTOR AND FORCEPS DELIVERY

Given the potential for severe injury when forceps and vacuum extractors are used, it is important for physicians to be knowledgeable about operative delivery alternatives.

Alternatives to forceps and vacuum extractors include the following:

  •  C-section.  A C-section is performed when a vaginal delivery would put the baby’s or mother’s life or health at risk.  Some conditions that require the baby to be delivered immediately include fetal distress, uterine rupture and cord prolapse.  Sometimes physicians fail to perform an emergency C-section when one is indicated, or they wait too long to perform one.  Other times, the C-section may be ordered, but the physician lacks skill in the procedure, or the hospital is ill-equipped for it.  Delay in performing a C-section can lead to permanent injuries in the baby, such as cerebral palsy and HIE.  Indeed, in many cases, a C-section is the safest way to deliver the baby.  Thus it is critical that physicians be skilled and prepared for the procedure.
  • Expectant management.  This involves non-intervention by the physician and allowing the pregnancy to progress.  When expectant management is utilized, very close monitoring of the mother and baby is essential.  Expectant management can include delayed pushing, maternal rest, change in maternal position, reduction in anesthesia, and emotional support.
  • Use of Pitocin (oxytocin).  This is a labor induction drug that is used to induce or speed up labor.  In some instances, Pitocin is effective, and the baby is born without complications.  In other cases, this drug can be very dangerous.  There is no way to predict the effects the drug will have on the mother and baby; its effects vary from person to person.  Pitocin can cause a condition called hyperstimulation of the uterus, which means that the mother’s contractions are very strong and frequent.  When hyperstimulation occurs, the uterus is in an almost constant state of contraction.  Contractions push or impinge on the blood vessels that deliver oxygen-rich blood to the baby through the umbilical cord.  When contractions are almost constant, the vessels cannot recharge with a fresh supply of oxygen-rich blood for the baby.  This can cause severe oxygen deprivation and fetal distress.  Pitocin can be helpful during delivery, but due to its risky nature, it must only be used in very select circumstances, and the mother and baby must be closely monitored.

DELIVERY DEVICES AND A SAFE BIRTH

In certain situations and when properly used, delivery devices can be helpful during birth.  Due to the risks involved with delivery devices, it is imperative that physicians be very skilled in using them, and understand which device is the most appropriate for each situation.  Physicians must be aware and skilled in alternatives to device-assisted delivery, and standards of care must be followed at all times.  Failure to act skillfully and in a timely manner during delivery is negligence.  If negligence leads to injury of the mother or baby, it is medical malpractice.

If your baby suffered any birth complications and has been diagnosed with injuries such as HIE and cerebral palsy, please contact the nationally recognized birth injury attorneys at Reiter & Walsh ABC Law Centers.  For decades, we have been helping families in Michigan and throughout the nation whose children have birth injuries.  We have numerous multi-million dollar verdicts that attest to our success, and we will fight to obtain the compensation you and your family deserve.  We will evaluate your case to determine if your child suffered injuries due to the negligence of the physician or medical staff, and you never pay any money until we win your case.  Email or call us at 888-419-2229.

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