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Part II
The Odon device imitates the bottle trick. A double layer of plastic is inserted via the birth canal to surround the baby's head. Some air is then pumped into the bag, inflating a plastic chamber that gently grips the head around the chin (there is no obstruction to the baby's breathing because it does not breathe through the nose until birth). Then the baby can be pulled out through the birth canal, without causing damage or bleeding.
In 2008, Odon took his creation to Des Moines University in Iowa for extensive testing in a state-of-the-art birth simulator, with WHO experts observing closely. This was a turning point for Odon.
"I couldn't believe that they would believe in me. It was a special moment," he says.
The experts could see the potential for this cheap and simple device in developing countries, where prolonged or obstructed births are often fatal.
Animation showing how the Odon device works
Worldwide, about 5.6 million babies are stillborn or die soon after birth every year. Some 260,000 mothers die as well - 99% of all maternal deaths occur in developing countries. Mothers may bleed to death or die from infection, whereas newborns are in danger of suffocating. Where the mother survives, she may suffer serious complications such as fistula, where tearing links the vagina with the rectum or bladder.
Schvartzman says the most important thing is that the Odon device is easy to use - it could potentially be used by a midwife without a doctor present. It also reduces the risk of transmission from mother to baby of infections such as HIV. And, in developed countries, it could help bring down soaring rates of Caesarean births.
"These features combined make it a potentially revolutionary development in obstetrics," says Merialdi.
The next phase was to test the device in real-life situations.
"The first time I saw it used I promised that if it worked, I would shave off my moustache," Odon says. The moustache had to go.
Continue reading the main storyFind out more
"I am not sure I would be very comfortable letting my wife, the mother of my children, use some device that has never been tested," Odon says. "But all the women who have volunteered for these trials, they do it for the progress of science, which is something truly beautiful."
Mariana Macchiarola, a 35-year-old singing teacher, was one of 30 women who agreed to pioneer the device. Like the others, she had given birth before.
"To give birth to my first son was a good experience, but quite painful," she says. "I was very frightened and they ended up having to help me by giving me an episiotomy (a cut to the perineum). I suffered a little - it's labour, right?"
In the initial trials the bag was inserted using a spatula, but it wasn't easy. So Odon went home to work on the problem. By the fifth birth, he had invented an inserter, "a very ingenious instrument that permits us to introduce the bag in a very easy way," Schvartzman says.
Macchiarola was the first patient to benefit from the inserter, which was finished the night before she gave birth, in an unusually busy hospital ward.
"Jorge was there, as well as several midwives and obstetricians. There were people filming. It was something truly spectacular," she says. "I had no pain whatsoever. It was very quick and I got to enjoy watching the birth of my son. The first time, I hadn't managed to see it, given my desperation! This time around, I could enjoy it. And it wasn't necessary to get an episiotomy."
Patient No 5 - the inserter was invented the night before baby Leon was born
The inserter evolved still further, with Odon submitting three more patents over the course of 30 trial deliveries. Trials are now continuing on 100 healthy women in Argentina. The next phase of the study will see it tested in problem births in Africa, Asia and Europe.
If the trials go well, Merialdi predicts the device could be in clinical use in two or three years' time. The US company that will manufacture the device, Becton Dickinson and Company, says it will sell it cheaply to developing countries. This is very important to Odon.
"The important thing is that it's affordable so that it can reach everywhere," he says. "More than the economic side of this I have always wanted to save lives, to help people."
Schvartzman puts the success of the project down to two factors: "The genius of Jorge Odon - and the fact that we paid attention.
Continue reading the main story“Start Quote
"Maybe another doctor would have said goodbye, but we didn't, and that's what has led to this fantastic device," he says. "Doctors are very structured in their thinking and Jorge is a free mind, he can think of new things."
Merialdi agrees that it took an outsider to think of a new approach.
"Albert Einstein used to say that sometimes imagination is more important than knowledge and this is actually the case, because Jorge didn't have any knowledge of obstetrics," he says.
"It's also true that although delivery is a biological function, it's also a mechanical process and so it's not surprising that a mechanic found a way to solve the problem of protracted or obstructed labour. I doubt an obstetrician like me would have thought of a plastic bag with an air chamber in it."
Odon's life has changed completely since he developed his device, and he has handed over the running of the garage to his son.
"In the beginning I used to work in my mechanic workshop so every time there was a birth I had to change my clothes very quickly and go to the hospital, so it was quite crazy. Now I am just working 24/7 on this, otherwise my health would have deteriorated."
But he still can't quite believe that his dream is about to become reality.
"I woke up one night with this idea, it almost felt magical. What I cannot understand is how I came up with a solution to help babies be born. I'm moved by the potential of this invention and I'm especially grateful to the doctors who first believed in me."
Additional reporting by Marco Silva. Jorge Odon spoke to Outlook on the BBC World Service. Listen again on iPlayer or get the Outlook podcast.
- Chamberlen forceps (top) date back to the 16th Century
- The ventouse (above) has been widely used since the 1950s, when a metal cap was designed in Sweden by Professor Tage Malmstrom
The Odon device imitates the bottle trick. A double layer of plastic is inserted via the birth canal to surround the baby's head. Some air is then pumped into the bag, inflating a plastic chamber that gently grips the head around the chin (there is no obstruction to the baby's breathing because it does not breathe through the nose until birth). Then the baby can be pulled out through the birth canal, without causing damage or bleeding.
In 2008, Odon took his creation to Des Moines University in Iowa for extensive testing in a state-of-the-art birth simulator, with WHO experts observing closely. This was a turning point for Odon.
"I couldn't believe that they would believe in me. It was a special moment," he says.
The experts could see the potential for this cheap and simple device in developing countries, where prolonged or obstructed births are often fatal.
Animation showing how the Odon device works
Worldwide, about 5.6 million babies are stillborn or die soon after birth every year. Some 260,000 mothers die as well - 99% of all maternal deaths occur in developing countries. Mothers may bleed to death or die from infection, whereas newborns are in danger of suffocating. Where the mother survives, she may suffer serious complications such as fistula, where tearing links the vagina with the rectum or bladder.
Schvartzman says the most important thing is that the Odon device is easy to use - it could potentially be used by a midwife without a doctor present. It also reduces the risk of transmission from mother to baby of infections such as HIV. And, in developed countries, it could help bring down soaring rates of Caesarean births.
"These features combined make it a potentially revolutionary development in obstetrics," says Merialdi.
The next phase was to test the device in real-life situations.
"The first time I saw it used I promised that if it worked, I would shave off my moustache," Odon says. The moustache had to go.
Continue reading the main storyFind out more
- "If it works, I'll shave off my moustache"
- Odon spoke to Outlook on the BBC World Service
"I am not sure I would be very comfortable letting my wife, the mother of my children, use some device that has never been tested," Odon says. "But all the women who have volunteered for these trials, they do it for the progress of science, which is something truly beautiful."
Mariana Macchiarola, a 35-year-old singing teacher, was one of 30 women who agreed to pioneer the device. Like the others, she had given birth before.
"To give birth to my first son was a good experience, but quite painful," she says. "I was very frightened and they ended up having to help me by giving me an episiotomy (a cut to the perineum). I suffered a little - it's labour, right?"
In the initial trials the bag was inserted using a spatula, but it wasn't easy. So Odon went home to work on the problem. By the fifth birth, he had invented an inserter, "a very ingenious instrument that permits us to introduce the bag in a very easy way," Schvartzman says.
Macchiarola was the first patient to benefit from the inserter, which was finished the night before she gave birth, in an unusually busy hospital ward.
"Jorge was there, as well as several midwives and obstetricians. There were people filming. It was something truly spectacular," she says. "I had no pain whatsoever. It was very quick and I got to enjoy watching the birth of my son. The first time, I hadn't managed to see it, given my desperation! This time around, I could enjoy it. And it wasn't necessary to get an episiotomy."
Patient No 5 - the inserter was invented the night before baby Leon was bornThe inserter evolved still further, with Odon submitting three more patents over the course of 30 trial deliveries. Trials are now continuing on 100 healthy women in Argentina. The next phase of the study will see it tested in problem births in Africa, Asia and Europe.
If the trials go well, Merialdi predicts the device could be in clinical use in two or three years' time. The US company that will manufacture the device, Becton Dickinson and Company, says it will sell it cheaply to developing countries. This is very important to Odon.
"The important thing is that it's affordable so that it can reach everywhere," he says. "More than the economic side of this I have always wanted to save lives, to help people."
Schvartzman puts the success of the project down to two factors: "The genius of Jorge Odon - and the fact that we paid attention.
Continue reading the main story“Start Quote
Delivery is a mechanical process so it's not surprising a mechanic solved this problem”
Dr Mario MerialdiWHO"Maybe another doctor would have said goodbye, but we didn't, and that's what has led to this fantastic device," he says. "Doctors are very structured in their thinking and Jorge is a free mind, he can think of new things."
Merialdi agrees that it took an outsider to think of a new approach.
"Albert Einstein used to say that sometimes imagination is more important than knowledge and this is actually the case, because Jorge didn't have any knowledge of obstetrics," he says.
"It's also true that although delivery is a biological function, it's also a mechanical process and so it's not surprising that a mechanic found a way to solve the problem of protracted or obstructed labour. I doubt an obstetrician like me would have thought of a plastic bag with an air chamber in it."
Odon's life has changed completely since he developed his device, and he has handed over the running of the garage to his son.
"In the beginning I used to work in my mechanic workshop so every time there was a birth I had to change my clothes very quickly and go to the hospital, so it was quite crazy. Now I am just working 24/7 on this, otherwise my health would have deteriorated."
But he still can't quite believe that his dream is about to become reality.
"I woke up one night with this idea, it almost felt magical. What I cannot understand is how I came up with a solution to help babies be born. I'm moved by the potential of this invention and I'm especially grateful to the doctors who first believed in me."
Additional reporting by Marco Silva. Jorge Odon spoke to Outlook on the BBC World Service. Listen again on iPlayer or get the Outlook podcast.
Jorge Odon demonstrates the device on a dummy at Des Moines University
Bruising from forceps and scabs from ventouse
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