ULTRASPINE: Ultrasound-Enabled Minimally Invasive Disc Replacement

The aim of this programme of work is to develop a new minimally invasive treatment system for spinal disc degeneration, the condition responsible for the majority of low back pain. The treatment involves removal of degenerated tissue from the disc using a therapeutic ultrasound system and replacement with an injectable fast-setting gel that mimics the behaviour of the healthy disc. This work will combine engineering, basic science and clinical expertise at the Universities of Leeds and Oxford. We aim to design, build, optimise and test the system in readiness for clinical trials and commercialization by the end of the funding period.
Four out of five adults will suffer from low back pain during their lifetime and around 5% of sufferers become chronically disabled. This imposes a high economic and social burden on society because the disorder affects people of working age as well as the elderly, with the total cost being estimated to be over 1 % of the UK's GDP. Low back pain is strongly associated with degeneration of the intervertebral discs, the soft tissues that connect the spinal vertebrae and allow the spine to articulate. Current surgical treatments for low back pain are highly invasive and have relatively low long term success rates. The present work aims to develop a novel, minimally invasive therapy for disc replacement without the need for surgical incision. If successful, it has the potential to revolutionise clinical practice for the treatment of back pain, thus improving quality of life and reducing the economic impact of this major disease.
The work will include the development of a novel high intensity focussed ultrasound system for the removal of the degenerated tissue from a highly controllable location, employing the same system to visualise the procedure in real time. A new class of self assembling peptide gels will also be developed and optimised for minimally invasive insertion into the cavity to restore the disc's mechanical function. In parallel with these developments, a combined programme of computational and experimental modelling will be undertaken to evaluate the mechanical performance of the treatment and optimise its performance across the likely variance in disc properties seen in a typical patient population.
The programme of work is expected to yield a complete novel spinal therapy system ready for clinical trial and commercialization. The processes employed will have potential to be adapted for other spinal treatments as well as for orthopaedic interventions in other joints, adding further impact in the longer term and benefitting both healthcare providers and the patients themselves.

The unique and complementary facilities in two of the country's largest biomedical engineering research centres will provide highly multidisciplinary training for the post-doctoral researchers and related PhD students involved through our respective Doctoral Training Centres. The proposal will enhance the interactions between engineers and clinicians through joint training and laboratory exchanges, demonstrating the significance of biomedical engineering to orthopaedic surgeons and providing the researchers with a greater appreciation of the clinical application and challenges. A further training opportunity will be provided for the PDRAs to develop a public engagement event and write a bid to the PIs for the allocated funding, in order to foster their grant-writing, creative thinking and public communication skills.
The proposed work will demonstrate the possibility of using HIFU applications near and in bone, opening up a new range of applications such as meniscal replacement. The novel treatment would introduce inexpensive non-surgical disc intervention strategies for the NHS, and provide new opportunities for the UK to lead in this aspect of healthcare provision. Following recent high profile clinical failures, there is a current move towards improved regulatory pathways. The processes developed through this proposal will improve the robustness of pre-clinical testing for spinal interventions, allowing optimization at an earlier stage in the design cycle and shortening the time to successful clinical adoption. By capturing the variance of real patients through use of clinical data during design, this proposal will demonstrate how patient variation can be incorporated into pre-clinical evaluation and provide more rigorous evidence of the efficacy of the treatment than current standardized tests. The models and methodology will provide a platform that can be used for the evaluation of other treatments and provide future co-development opportunities with industry and academic partners.
Last but not least, the proposal is expected to yield a complete novel spinal therapy system ready for clinical trial and commercialization. There is considerable expertise in bench-to-bedside translation at both institutions, including the EPSRC Innovation Knowledge Centre in Medical Technologies at Leeds and ISIS Innovation and the NIH Biomedical Research Centre at Oxford. Their resources will be employed to maximize commercial impact through creation of a spin-out company or licensing to a major orthopaedic industrial partner. The processes employed here also have opportunities to be adapted for other spinal treatments as well as for orthopaedic interventions in other joints, adding further impact in the longer term and benefitting both healthcare providers and the patients themselves.