ULTRASPINE: Ultrasound-Enabled Minimally Invasive Disc Replacement

Lead Research Organisation: University of Oxford
Department Name: Engineering Science

Abstract

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.

Planned Impact

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.

Publications

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Elbes D (2014) Ultrasound-induced fractionation of the intervertebral disk in The Journal of the Acoustical Society of America

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Gray MD (2018) Diffraction Effects and Compensation in Passive Acoustic Mapping. in IEEE transactions on ultrasonics, ferroelectrics, and frequency control

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Qiao S (2014) Simulations of ultrasound propagation in a spinal structure in The Journal of the Acoustical Society of America

 
Description - Minimally invasive removal of the spinal nucleus pulposus is feasible by ultrasound-mediated fractionation

-The required ultrasound intensities can be delivered to the intravertebral disc even in the presence of bone.

- Complete replacement of the intervertebral disc nucleus through a 22-gauge needle is possible without damage to the annulus.

- Biomechanical testing of the replaced disc reveals restoration of its mechanical properties to a level comparable to that preceding disc degeneration.
Exploitation Route Development of a new product for spinal surgery through Oxford University spinout OrthoSon
Sectors Healthcare

 
Description The research carried out under this award contributed to the creation of University spin-out OrthoSon, which has received both private investor funding and an Innovate UK primer award to develop a clinical prototype for ultrasonically mediated minimally invasive replacement of the intervertebral disc.
First Year Of Impact 2016
Sector Healthcare
Impact Types Societal,Economic

 
Title Intervertebral disc treatment apparatus 
Description A new method of replacing the intervertebral disc without the need for surgery. 
IP Reference WO2012131383 
Protection Patent application published
Year Protection Granted 2011
Licensed Yes
Impact Being incorporated within a novel medical device being developed by the licensee
 
Title Modular Ultrasound Apparatus and Methods 
Description This application describes a new type of modular, 'lego-like', therapeutic ultrasound array, consisting of individual 'tiles' of 16 elements each that can be configured to optimally cover an acoustic window for diagnosis or therapy. Non-invasive and invasive methods for achieving optimal focusing of such arrays have also bee described. 
IP Reference GB1617255.3 
Protection Patent application published
Year Protection Granted 2016
Licensed Yes
Impact None yet.
 
Company Name www.orthoson.com 
Description Therapeutic ultrasound technologies for minimally invasive orthopaedic and particularly spinal surgery 
Year Established 2016 
Impact The company successfully raised £1m of external investor capital and recently received a further £1.2m Primer Award from Innovate UK to develop a clinical prototype.
Website http://www.orthoson.com