Case Study

Operations to reduce back pain by stabilising or replacing worn out spinal discs can often fail because the implant is not tailored to the patient with sufficient accuracy. The IKC provided proof of concept funding to help Leeds researchers address this problem through a partnership with 3D image processing company Simpleware.

The aim of the project was to develop sophisticated modelling software that can predict how an implant will perform.

Companies manufacturing spinal implants cannot yet produce bespoke devices for each individual. Instead, they produce stratified designs, in a range of sizes and shapes that are tailored to particular patient groups.

The key is to work out the parameters within which each device can work effectively. Getting this right will mean a better outcome for the patient and will also mean devices can be designed and manufactured more efficiently.

Researchers at Leeds have created and stored a databank of 3D spinal images, using human donations, but also museum specimens to build in as much variety as possible. The resulting computer models could be manipulated to show the effects of spinal implants and, from this, a set of design parameters could be produced for use by implant manufacturing companies.

Through the partnership with Simpleware, the team was then able to develop modelling software that uses this data to predict the behaviour of devices within a variety of patients of different age, weight and physical condition. Guidance from the IKC enabled the team to navigate the IP issues and commissioning agreements to ensure that the partnership progressed smoothly.

“The technology we’re using is called finite element analysis, and it’s already used widely in industries such as automotive or aerospace engineering,” explains Ruth Wilcox, Professor of Biomedical Engineering at Leeds. “Its use in the medical field is growing, but where this work differs is that the variation from one patient to another is included in the analysis.

“Our aim is to ensure that companies – and clinicians – understand the types of patients that would benefit from a particular design of implant. Any company designing an implant, can run it though our software to see how it will perform and whether sufficient design variations have been produced to meet patient need.”

Follow on funding from the IKC has enabled the team to work on validating the software further, before seeking commercial clients. The techniques are also feeding back into fundamental research at the University as they are being applied to other devices, such as implants for hips and knees.