New Obstetric Forceps
Giving birth is one of the most natural of processes but assistance is sometimes required. Use of obstetric forceps was first reported in 1792 and this device has proved highly efficacious over the years, and is still seen as the best tool available for carrying out an assisted delivery. In 2009 for example there were 298,000 forceps assisted deliveries in the UK, Europe & US. The last improvements to the device were made 150 years ago so an obstetrician presented with a situation where an assisted delivery is required will use a device designed in Victorian times.
The idea originated from Dr Alexander Oboh, consultant obstetrician at Hull and East Yorkshire Hospitals NHS Trust who wanted to re-develop the obstetric forceps into an improved, patient friendly and safer device.
Dr. Oboh said that the concept for the project was inspired by the fact that the current device, made of metal, was intimidating for women and that despite advances in technology, had changed little in 150 years. “What we have done is to redesign the forceps so that when they have to be used it is much safer for the mother and the baby. Clinicians get real-time feedback about the levels of force that they are using. If too much traction force is used, then there is a real risk of causing serious injury to babies during the delivery process. Because there are no electronics involved, this device could be easily used anywhere in the world”.
The improved device is single use, has built in safety features to limit the traction force being applied to the head of the baby and is made of lightweight, recyclable, non-steel materials. This has environmental benefits and in low-resourced countries reduces the risk of cross-infection and the cost of sterilisation.
Status and Next Steps
A development phase, supported by Medipex, enabled a patent to be filed and grant of a community design right. During this phase the needs of obstetricians, nationally and globally, were considered and based on this a fully functional rapid prototype was developed and well-received by clinical key opinion leaders. The rapid prototype was used on a birthing simulator to effect a successful delivery using a consistent level of traction force at a level lower than that utilised by standard forceps (used as a comparison), thus showing proof of concept.
Manufacturing company input was required to develop and commercialise the forceps. Surgical Dynamics was identified and a licence agreement signed with the Trust. With Medipex assistance a TSB grant was obtained and Surgical Dynamics developed the design from rapid prototype through the advanced prototyping stages to CE Mark approval. A small clinical study will be conducted and the device then taken to market.