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，用于治疗腰椎间盘退行性变，这种疾病是导致大部分下腰痛的原因。治疗包括使用治疗性超声波系统从椎间盘中移除退化组织，并用可注射的快速凝胶剂取代，这种凝胶模仿健康椎间盘的行为。这项工作将结合利兹大学和牛津大学的工程学、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、建造、优化和测试该系统，为临床试验和商业化做好准备。五分之四的成年人在一生中会遭受腰痛的痛苦，大约5%的患者会成为慢性残疾。这给社会带来了沉重的经济和社会负担，因为这种疾病影响到工作年龄的人和老年人，总成本估计超过英国国内生产总值的1%。下腰痛与椎间盘的退变密切相关，椎间盘是连接脊椎并允许脊柱关节的软组织。目前下腰痛的手术治疗是高度侵入性的，长期成功率相对较低。目前的工作旨在开发一种新的、微创的治疗方法，用于不需要手术切开的腰椎间盘置换。如果成功，它有可能彻底改变治疗背部疼痛的临床实践，从而提高生活质量，减少这种重大疾病的经济影响。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移除变性组织，使用相同的系统实时可视化这一过程。一种新的自组装多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。在这些发展的同时，将开展一项计算和实验模拟的综合计划，以评估治疗的机械性能，并根据典型患者群体中可能出现的椎间盘特性变化来优化其性能。工作计划预计将产生一种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被适应于其他脊柱治疗以及其他关节的骨科干预，从长远来看，增加进一步的影响，并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.