Odón device is a

medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...

that is designed to assist during a difficult birth. The device consists of a plastic sleeve that is inflated around the baby's head and is used to gently pull and ease the head of the infant through the

birth canal In mammals and other animals, the vagina (: vaginas or vaginae) is the elastic, muscular reproductive organ of the female genital tract. In humans, it extends from the vulval vestibule to the cervix (neck of the uterus). The vaginal int ...

.McNeil, Donald G, Jr
"Car Mechanic Dreams Up a Tool to Ease Births"
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The New York Times ''The New York Times'' (''NYT'') is an American daily newspaper based in New York City. ''The New York Times'' covers domestic, national, and international news, and publishes opinion pieces, investigative reports, and reviews. As one of ...

'', November 13, 2013. Accessed November 14, 2013.

Need

Worldwide, more than 13 million births each year face serious complications, and every day about 800 women die from preventable causes related to pregnancy and childbirth (about 300,000 annually). The use of forceps and other mechanical devices in the extraction of a baby in a difficult delivery can cause internal bleeding in the mother or may result in injuries to the baby's head or spine. The Odón device has the potential to allow for

vaginal delivery In mammals and other animals, the vagina (: vaginas or vaginae) is the elastic, muscular sex organ, reproductive organ of the female genital tract. In humans, it extends from the vulval vestibule to the cervix (neck of the uterus). The #Vag ...

in complicated pregnancies in which common medical practice would have led to a

cesarean section Caesarean section, also known as C-section, cesarean, or caesarean delivery, is the surgical procedure by which one or more babies are delivered through an incision in the mother's abdomen. It is often performed because vaginal delivery would ...

, the use of forceps to extract the newborn or the use of a

ventouse Vacuum extraction (VE), also known as ventouse, is a method to assist delivery of a baby using a vacuum device. It is used in the second stage of labor if it has not progressed adequately. It may be an alternative to a forceps delivery and cae ...

vacuum device that attaches suction cups directly to the baby's scalp. By reducing contact between the baby's skull and the birth canal, the risk of infection is also reduced.

Conception

The concept behind the device was developed in 2006 by Jorge Odón, a car mechanic from

Lanús Lanús () is the capital of Lanús Partido, Buenos Aires Province in Argentina. It lies just south of the capital city Buenos Aires, in the Greater Buenos Aires conurbation, metropolitan area. The List of cities in Argentina, city has a populati ...

Argentina Argentina, officially the Argentine Republic, is a country in the southern half of South America. It covers an area of , making it the List of South American countries by area, second-largest country in South America after Brazil, the fourt ...

, who had seen a video describing a method to extract a loose cork from inside an empty wine bottle by inserting a plastic bag into the bottle, inflating the bag once it has enveloped the cork and then pulling out the inflated bag together with the cork; Odón conceived of the use of this same technique that evening in bed and spoke with an obstetrician who encouraged him to move ahead with the idea. The first model of the device was created by sewing a sleeve onto a cloth bag and was tested using a doll inserted into a glass jar to simulate the use of the device in the delivery process. In complicated deliveries, the device is positioned against the baby's scalp and the lubricated sleeve is gently inserted around the baby's head. Once a marker on the device indicates that it has been properly positioned, the sleeve's inner compartment is inflated, providing a strong grip on the baby's head. The inserter is taken away and the sleeve can be pulled with up to of force to pull out the head and allow for the delivery of the baby.

Testing and development

After further testing, Odón was introduced to the chief of obstetrics at a hospital in

Buenos Aires Buenos Aires, controlled by the government of the Autonomous City of Buenos Aires, is the Capital city, capital and largest city of Argentina. It is located on the southwest of the Río de la Plata. Buenos Aires is classified as an Alpha− glob ...

who saw the benefit of the method and arranged to have the device tested more thoroughly at an Iowa laboratory that has simulators designed to model delivery methods more realistically. Safety testing had been performed on 20 women in Argentina, all of whom had previously given birth and were experiencing uncomplicated pregnancies, including a woman who was able to deliver a baby weighing with only two pushes. Further testing will be conducted on more than 250 women in

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India India, officially the Republic of India, is a country in South Asia. It is the List of countries and dependencies by area, seventh-largest country by area; the List of countries by population (United Nations), most populous country since ...

and

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, with a mix of pregnant women experiencing normal and complicated labor.

Becton Dickinson Becton, Dickinson and Company (BD; also Becton Dickinson or Becton) is an American multinational medical technology company that manufactures and sells medical devices, instrument systems, and reagents. BD also provides consulting and analytic ...

has agreed to manufacture and distribute the unit and estimates that the Odón device could be constructed for $50 per unit, and it is expected that it could be used by

midwives A midwife (: midwives) is a health professional who cares for mothers and newborns around childbirth, a specialisation known as midwifery. The education and training for a midwife concentrates extensively on the care of women throughout their ...

as well as

obstetrician Obstetrics is the field of study concentrated on pregnancy, childbirth and the postpartum period. As a medical specialty, obstetrics is combined with gynecology under the discipline known as obstetrics and gynecology (OB/GYN), which is a surgi ...

s who would need minimal training to use the device effectively. The

World Health Organization The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...

(WHO) offered favorable notices regarding the device, which was recognized for its "potential to save the lives of mothers and newborns at the time of birth".New, low-cost instrument for assisted vaginal delivery
,

. Accessed November 14, 2013. The WHO's Dr. Mario Merialdi called the device "exciting", saying that childbirth is an area that has had little recent progress. Dr.

Margaret Chan Margaret Chan Fung Fu-chun (born 21 August 1947) is a Chinese-Canadian physician, who served as the Director-General of the World Health Organization (WHO) delegating the People's Republic of China from 2006 to 2017. Chan previously served a ...

, Director-General of the WHO, described the device as "a low-cost simplified way to deliver babies, and protect mothers

hat A hat is a Headgear, head covering which is worn for various reasons, including protection against weather conditions, ceremonial reasons such as university graduation, religious reasons, safety, or as a fashion accessory. Hats which incorpor ...

promises to transfer life-saving capacity to rural health posts, which almost never have the facilities and staff to perform a C-section sthe first simple new tool for assisted delivery since forceps and vacuum extractors were introduced centuries ago." A 2017 study on a model infant head indicated that the Odon device applied less pressure and traction to the infant's head before failing than some other devices when used correctly, as well as less pressure and torsion by some metrics (more torsion on the neck) when purposely inserted incorrectly around the neck of the infant than other tools. A single set of tests of the device at

Southmead Hospital Southmead Hospital is a large public National Health Service hospital, situated in the area of Southmead, though in Horfield ward, in the northern suburbs of Bristol, England. It is part of the North Bristol NHS Trust. The 800-bed Brunel Buil ...

, Bristol, UK in 2021 during births where an assistive method was deemed to be required allowed 19 of 40 births to be completed with the Odon device alone. In four of the cases in which an additional method was required, manufacturing defects were identified in the devices afterwards. Women's qualitative experiences and opinions of the device's use during delivery were also gathered during this study. In all but one case, women had positive reactions to the device. As of 2023, no comprehensive summaries of efficacy and safety were available.

References

{{DEFAULTSORT:Odon device Argentine inventions Equipment used in childbirth Medical equipment Obstetrical procedures