Medical Device Prototype & Manufacture Unit

医疗设备原型

• 批准号: EP/R042721/1
• 负责人: Jonathan Jeffers
• 金额: $ 214.93万
• 依托单位: Imperial College London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2018
• 资助国家: 英国
• 起止时间: 2018 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=EP%2FR042721%2F1
• 关键词: Medical; Device; Prototype; Manufacture; Unit

One hundred and fifty ago, life expectancy in the UK was about 43 years. Improvements in nutrition, medicine and public health have dramatically increased this such that those born today can expect to live for over 80 years. This 150 year period is but the blink of an eye in evolution terms, and the evolution of our musculoskeletal system has not caught up with the increased life expectancy. It is therefore no surprise that musculoskeletal disorders are one of the biggest expenditures in the annual NHS budget (about £5.4bn). Our vision is for lifelong musculoskeletal health. We consider the only way to achieve this is to identify musculoskeletal problems early in life, then make small interventions to correct them before they become chronic. This preventative approach needs new technology which we will create using the equipment in the Medical Device Prototype & Manufacture Unit. We seek to manufacture early intervention implants using material that is tailored to make the surrounding bone stronger by controlling the bone strain experienced. We want to make smart instruments and implants that can measure biomarkers in synovial fluid to provide objective measures of joint health. We want to deploy new biomaterials like nanoneedles that can bypass the membrane of bacteria cells and provide anti-infection coatings on our implantable devices. We will manufacture ligament, tendon and capsule repair patches using a soft tissue 'velcro' fixation combined with functionalised surfaces that adhere to soft tissues on one side, yet provide a low friction sliding surface on the other side. We also want to better understand the ageing process of osteoporosis and the effects of bisphosphonate theory. Finally we want to perform higher fidelity laboratory testing of musculoskeletal tissues, both to understand better the pathology, but also the response of tissue to our proposed treatments.The proposed Medical Device Prototype & Manufacture Unit would enable breakthroughs in all these interrelated research themes. The powder bed fusion additive manufacture (AM) machine and 2-photon lithography AM machine allow manufacturing of porous lattice materials at the range of scales we need to create stiffness matched implants with 150 micron features down to microfluidic channels for our sensing technology and nanoneedles with sub-micron features. The nano CT scanner has a higher resolution (sub-micron) than currently available and the 3D microscope is equipped with confocal profiler with 100 nanometre resolution - these imaging instruments will allow unprecedented surface and internal imaging of pathological tissues and the response of tissues to our interventions. Our research will be conducted in an environment that will strongly encourage translation. The Prototype & Manufacture Unit will be set up with all the regulatory approval and quality control to enable us to manufacture devices from first off prototypes through to small batch production parts for early clinical safety studies. This combination of cutting edge AM and imaging equipment in an environment with strong emphasis on translation would enable us to break new ground in all our research themes and also bridge the gap between exciting laboratory testing and clinical practice.

150年前，英国人的预期寿命约为43岁。营养、医学和公共卫生的进步极大地增加了这一点，以至于今天出生的人预计可以活到80岁以上。从进化的角度来看，这150年的时间只是一眨眼的功夫，我们肌肉骨骼系统的进化还没有赶上预期寿命的增加。因此，肌肉骨骼疾病是NHS年度预算(约54亿GB)中最大的支出之一也就不足为奇了。我们的愿景是终身肌肉骨骼健康。我们认为实现这一目标的唯一方法是在生命早期识别肌肉骨骼问题，然后在它们变得慢性之前进行小的干预来纠正它们。这种预防性的方法需要新的技术，我们将使用医疗器械原型和制造单位的设备来创造这些技术。我们寻求使用量身定做的材料制造早期干预性植入物，通过控制所经历的骨应变使周围的骨骼更坚固。我们希望制造能够测量滑液中生物标记物的智能仪器和植入物，以提供关节健康的客观衡量标准。我们希望部署新的生物材料，如纳米针，它可以绕过细菌细胞膜，并在我们的可植入设备上提供抗感染涂层。我们将制造韧带、肌腱和关节囊修复补片，使用软组织‘尼龙搭扣’固定结合功能化表面，粘连在一侧的软组织上，同时在另一侧提供低摩擦的滑动表面。我们也想更好地了解骨质疏松症的衰老过程和双膦酸盐理论的影响。最后，我们希望对肌肉骨骼组织进行更高保真度的实验室测试，这既是为了更好地了解病理，也是为了更好地了解组织对我们建议的治疗方法的反应。拟议的医疗器械原型和制造单位将使所有这些相互关联的研究主题取得突破。粉末床熔合添加剂制造(AM)机和双光子光刻AM机允许在我们需要的范围内制造多孔晶格材料，我们需要创建具有150微米特征的硬度匹配植入物，直到用于我们的传感技术的微流体通道，以及具有亚微米特征的纳米针。纳米CT扫描仪具有比目前可用的更高的分辨率(亚微米)，3D显微镜配备了100纳米分辨率的共焦剖面仪-这些成像仪器将允许前所未有的病理组织的表面和内部成像以及组织对我们干预的反应。我们的研究将在一个强烈鼓励翻译的环境中进行。样机和制造部门将获得所有监管部门的批准和质量控制，使我们能够制造从最初的样机到小批量生产部件的设备，用于早期临床安全性研究。在一个强调翻译的环境中，这种尖端AM和成像设备的结合将使我们能够在所有研究主题上开辟新的天地，并弥合令人兴奋的实验室测试和临床实践之间的差距。

项目成果

Quantifying 3D Strain in Scaffold Implants for Regenerative Medicine.

• DOI: 10.3390/ma13173890
• 发表时间: 2020-09-03
• 期刊: Materials (Basel, Switzerland)
• 作者: Clark JN;Tavana S;Heyraud A;Tallia F;Jones JR;Hansen U;Jeffers JRT
• 通讯作者: Jeffers JRT

Exploratory Full-Field Mechanical Analysis across the Osteochondral Tissue-Biomaterial Interface in an Ovine Model.

• DOI: 10.3390/ma13183911
• 发表时间: 2020-09-04
• 期刊: Materials (Basel, Switzerland)
• 作者: Clark JN;Heyraud A;Tavana S;Al-Jabri T;Tallia F;Clark B;Blunn GW;Cobb JP;Hansen U;Jones JR;Jeffers JRT
• 通讯作者: Jeffers JRT

Vacuum heat treatments of titanium porous structures

• DOI: 10.1016/j.addma.2021.102262
• 发表时间: 2021-11-01
• 期刊: ADDITIVE MANUFACTURING
• 影响因子: 11
• 作者: Ghouse, Shaaz;Oosterbeek, Reece N.;Jeffers, Jonathan R. T.
• 通讯作者: Jeffers, Jonathan R. T.

Automating the customization of stiffness-matched knee implants using machine learning techniques

• DOI: 10.1007/s00170-023-11357-6
• 发表时间: 2023-04-10
• 期刊: INTERNATIONAL JOURNAL OF ADVANCED MANUFACTURING TECHNOLOGY
• 影响因子: 3.4
• 作者: Burge, Thomas A.;Munford, Maxwell J.;Myant, Connor W.
• 通讯作者: Myant, Connor W.

Controlling and testing anisotropy in additively manufactured stochastic structures

• DOI: 10.1016/j.addma.2021.101849
• 发表时间: 2021-03-01
• 期刊: ADDITIVE MANUFACTURING
• 影响因子: 11
• 作者: Hossain, Umar;Ghouse, Shaaz;Jeffers, Jonathan R. T.
• 通讯作者: Jeffers, Jonathan R. T.