ULTRASPINE: Ultrasound-Enabled Minimally Invasive Disc Replacement

这项工作计划的目的是开发一种新的微创治疗系统，用于椎间盘退变，这是大多数腰痛的原因。治疗包括使用治疗性超声系统从椎间盘中去除变性组织，并用一种模仿健康椎间盘行为的可注射速凝凝胶代替。这项工作将结合利兹大学和牛津大学的工程、基础科学和临床专业知识。我们的目标是在资助期结束前设计、构建、优化和测试该系统，为临床试验和商业化做好准备。五分之四的成年人一生中会遭受腰痛的折磨，大约5%的患者会成为慢性残疾。这给社会带来了很高的经济和社会负担，因为这种疾病影响到工作年龄的人以及老年人，总成本估计超过英国GDP的1%。腰痛与椎间盘退变密切相关，椎间盘是连接脊椎骨并使脊柱连接的软组织。目前的手术治疗腰痛是高度侵入性的，长期成功率相对较低。目前的工作旨在开发一种新的，微创治疗椎间盘置换术，而不需要手术切口。如果成功，它有可能彻底改变背部疼痛治疗的临床实践，从而提高生活质量并减少这一主要疾病的经济影响。这项工作将包括开发一种新型的高强度聚焦超声系统，用于从高度可控的位置去除变性组织，采用相同的系统实时可视化过程。一种新的自组装肽凝胶也将被开发和优化，用于微创插入腔内，以恢复椎间盘的机械功能。与这些进展并行，将进行计算和实验建模的组合方案，以评估治疗的力学性能，并在典型患者群体中可能出现的椎间盘特性差异中优化其性能。该工作计划预计将产生一个完整的新型脊柱治疗系统，为临床试验和商业化做好准备。所采用的过程将有可能适用于其他脊柱治疗以及其他关节的矫形干预，从长远来看，增加进一步的影响，使医疗保健提供者和患者本身受益。

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.