Personalised Stent Graft Manufacturing for Endovascular Intervention

Vascular disease is a major contributor to cardiovascular deaths in the Western world. The incidence of abdominal aortic aneurysms increases significantly with age - by over 300% for those at age 70 compared to those at age 50. With the demographic shift associated with the ageing population, there is a pressing need for early intervention and minimally invasive surgery. Endovascular therapy avoids major trauma associated with open operation, with clear advantages in terms of reduced morbidity and mortality, especially in patients unable to withstand traditional open surgery. It, however, has certain technical and anatomical constraints which are currently not addressed by the current manufacturing methods. Stent design and placement have a direct implication on the reintervention rate, which for endovascular repair is often higher than open repair. Side branches to the main artery require bespoke openings on the graft, which are expensive and time consuming to produce. The long delay in customised graft manufacturing can subject patients to the risk of aneurysm rupture and precludes treatment to patients with acute symptoms. Improved manufacturing of personalised stent-grafts is therefore an unmet clinical demand that requires innovative manufacturing solutions. This project aims to develop a novel robotic platform for personalised stent-graft manufacturing. It includes the development of a new stent graft sewing robot combined with a fully personalised aortic mould printed with the latest 3D printing technologies using patient-specific imaging data. It improves consistency, speed and quality of customised manufacturing of stent graft with complex geometries and represents an ideal example of the innovative use of robotics, additive manufacturing, and machine vision for small run, 'batch'-of-one personalised medical devices. The project is to be carried out by a multidisciplinary team with complementary research skills in robotics, sensing, imaging, and endovascular intervention, alongside two major industrial partners in medical devices and surgical robotics.

The proposed work aims to improve the manufacturing of stent grafts through the use of robotics, imaging and vision. A summary of the impact produced by this proposed project is below, and a full description of the Pathways to Impact is in Annex II. The impact activity milestones include: 1) Staff training and development; 2) IP generation; 3) Public engagement activities; 4) Sustainability of the project team through different exploitation routes and leverage funding from other sources.

Knowledge and academic impact
Significant focuses of the project include knowledge transfer and clinical translation with measurable healthcare impact. The academic beneficiaries will be in the fields of medical device manufacturing, robotics, imaging and endovascular interventions. The pathways to impact will be through academic publications, and presenting at international conferences in the relevant fields with due consideration of IP implications. The knowledge gained from this project will be put to use by forming collaborations with technical and clinical research groups in these research fields.

Clinical impact
The proposed project will have significant clinical impact to society through the provision of better healthcare, particularly in endovascular intervention. The current method of personalised stent graft manufacturing is expensive and time consuming. The proposed work aims to make personalised stent graft manufacturing more efficient, scalable and cost-effective, and thus making the stent graft technology available to many more patients. The national AAA screening programme provides an ideal vehicle for clinical and patient engagement of the proposed project and we will also engage with national and international professional vascular surgery societies.

Commercial exploitation and economic benefit
The technologies developed in this project could have significant commercial impact, particularly in high value, small-run medical device manufacturing, as well as a wider application in other manufacturing sectors. In linking to academic dissemination, IPR will be reviewed at each milestone stage and any intellectual property arising will be protected and exploited via Imperial Innovations in full coordination with the Research Steering Group, which will provide IP management recommendations, as well as critical review and management and technical recommendations to the research team, and to establish effective dissemination routes to both academic and industrial communities. Our strong relationship with industrial partners (Medtronic and Hansen Medical) will ensure the IP generated will have strong industrial relevance and tangible exploitation routes.

People development
We will actively encourage new academic staff (Co-Is) and PDRAs to spearhead and take ownership of blue sky idea generation with direct clinical/industrial interaction, thus stimulating creative and adventurous approaches that underpin the project objectives. For staff development, we will work closely with the Learning and Development Centre at Imperial College London to offer a series of interlinked programmes to meet individual needs regarding research and management skills, covering research organisation, professional development and public engagement of cross-disciplinary research. The team will be encouraged to lead public dissemination activities and develop the necessary managerial, vocational and entrepreneurial skills for career progression.

Communication and engagement
The multidisciplinary team will ensure close collaboration between clinical and engineering researchers as well as continuous two-way communication between clinical and non-clinical partners. Annual project workshops and clinical seminars will also be organised. We aim to engage with patients and the public through conferences, science fairs and open days. A project website will be set up to disseminate the details of the project and its progress to the public.