Improved obstetric forceps getting ready for the clinic
Giving birth is one of the most natural of processes having evolved over millions of years to allow the safe delivery of an offspring. However, assistance is sometimes required to affect a delivery. The use of obstetric forceps was first reported in 1792 and this device has proved highly efficacious over the years, and today is still seen as the best of the tools available for carrying out an assisted delivery. In 2009 for example there were 298,000 forceps assisted deliveries in the UK, Europe & US. However, the last recorded improvements to the obstetric forceps were made about 150 years ago. The modern obstetrician when presented with a situation where an assisted delivery is required is therefore using a device designed in Victorian times.
Medipex has been working with a consultant obstetrician at Hull and East Yorkshire Hospitals NHS Trust, Dr Alexander Oboh, to re-develop the obstetric forceps to provide a device that is single use, has built in safety features to prevent too much 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.
An initial development phase was successfully completed enabling Medipex to file a patent application on behalf of the Trust and obtain the granting of a community design right. The development phase also looked at the needs of obstetricians both nationally and globally (views from >150 clinicians outside the UK have been gathered) and based on this a fully functional rapid prototype was developed and well-received by a panel of clinical key opinion leaders. The rapid prototype was also used successfully 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.
Dr. Oboh who was a Yorkshire Enterprise Fellow supported by Medipex and a winner at the Medipex Innovation 2010 Awards for his improved design for obstetric forceps 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”.
A collaboration with a development & manufacturing company was necessary to develop and commercialise the forceps. A number of companies were considered by Medipex before NuSurgix Limited (Now Surgical Dynamics Limited) located in Consett was selected. Surgical Dynamics entered into a licence agreement with the Trust to develop and take the device to market. With the assistance of Medipex a TSB grant was successfully obtained and Surgical Dynamics has developed the rapid prototype through the advanced prototyping stages to a point where a CE Mark application is being prepared for submission.
Once the CE Mark submission has been approved a small clinical study will be conducted and the device then taken to market. The development of the new obstetrics forceps has been achieved as a result of a strong collaborative working relationship between the Trust, the inventor Dr Alexander Oboh, Surgical Dynamics and Medipex. Once the new device enters the market it will be protected by patent claims including those of the recently granted US patent.
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