Odon device

Odón device is a medical device 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.^[1]

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).^[2] 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 complicated pregnancies in which common medical practice would have led to a cesarean section, the use of forceps to extract the newborn or the use of a ventouse vacuum device that attaches suction cups directly to the baby's scalp.^[1] By reducing contact between the baby's skull and the birth canal, the risk of infection is also reduced.^[3]

The concept behind the device was developed in 2006 by Jorge Odón, a car mechanic from Lanús, Argentina, 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.^[4] 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.^[1]

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 19 kilograms (42 lb) of force to pull out the head and allow for the delivery of the baby.^[5]

Tras realizar más pruebas, Odón fue presentado al jefe de obstetricia de un hospital de Buenos Aires , quien reconoció la utilidad del método y gestionó que el dispositivo fuera probado exhaustivamente en un laboratorio de Iowa que cuenta con simuladores diseñados para modelar los partos de forma más realista. Se habían realizado pruebas de seguridad en 20 mujeres en Argentina, todas ellas con antecedentes de partos y embarazos sin complicaciones, incluyendo una mujer que pudo dar a luz a un bebé de 4,1 kg (9 libras) con solo dos pujos. Se realizarán más pruebas en más de 250 mujeres en China , India y Sudáfrica , incluyendo mujeres embarazadas con partos normales y complicados. ^{[ 1 ]} 

Becton Dickinson ha acordado fabricar y distribuir la unidad y estima que el dispositivo Odón podría construirse por $50 por unidad, y se espera que pueda ser utilizado por parteras y obstetras que necesitarían una capacitación mínima para usar el dispositivo de manera efectiva. ^{[ 1 ]} La Organización Mundial de la Salud (OMS) emitió comentarios favorables sobre el dispositivo, que fue reconocido por su "potencial para salvar las vidas de madres y recién nacidos en el momento del parto". ^{[ 3 ]} El Dr. Mario Merialdi de la OMS calificó el dispositivo de "emocionante", diciendo que el parto es un área que ha tenido poco progreso recientemente. ^{[ 1 ]} La Dra. Margaret Chan , Directora General de la OMS, describió el dispositivo como "una forma simplificada y de bajo costo para dar a luz bebés y proteger a las madres [que] promete transferir capacidad para salvar vidas a los puestos de salud rurales, que casi nunca tienen las instalaciones y el personal para realizar una cesárea [como] la primera herramienta nueva y simple para el parto asistido desde que se introdujeron los fórceps y los extractores de vacío hace siglos". ^{[ 6 ]}

Un estudio de 2017 sobre un modelo de cabeza infantil indicó que el dispositivo Odon aplicaba menos presión y tracción a la cabeza del bebé antes de fallar que otros dispositivos cuando se usaba correctamente, así como menos presión y torsión según algunas métricas (más torsión en el cuello) cuando se insertaba intencionadamente de forma incorrecta alrededor del cuello del bebé que otras herramientas. ^{[ 7 ]}

A single set of tests of the device at Southmead Hospital, 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.^[8] 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.^[9]

As of 2023, no comprehensive summaries of efficacy and safety were available.