Novel Functional Nanocomposite Engineering of Stents

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

Abstract

We propose a four-party collaborative research programme that combines the expertise of the materials science, engineering, and surface science and cell biology from four leading universities. We wish to continue our highly successful Flagship Grant programme in the development of Abdominal Aortic Aneurysm (AAA) stent graft and coronary stent whereby stainless steel and shape memory alloy (SMA) are coated with nanocomposite (NC) polymer. Our preliminary work has demonstrated excellent blood and tissue biocompatibility and we have attributed this property to the preferential adsorption of fibrinogen followed by its conformational deactivation. Further work is required for mechanical and haemodynamic testing in vitro and in vivo. We intend to complete the deployment and positioning studies to allow an animal study to take place, leading to commercialisation. To achieve these aims we will use a novel packaging technique to fold the stent into a small and uniform diameter avoiding geometric incompatibility. The folding is achieved by generating a set of folds onto the surface of a graft using origami-based techniques. We will make the graft from either SMA with NC coated or entirely from a radio-opaque SMNC. Coating will be achieved using electrohydrodynamic spray deposition (ESD). Spectroscopic ellipsometry (SE) and neutron reflection (NR) will be utilised to determine how durable these materials are in vitro and how they achieve biocompatibility. Successful delivery of the programme will lead to the development of a stent that has significant advantages over existing devices including geometric simplicity, a more reliable expansion mechanism, higher radial strength, the ability to shape the structure to the artery, and better biocompatibility with both blood and tissue. With engineering, materials, surface science and biological groups in close collaboration, structural design and novel manufacturing concepts can be applied to new materials development and stent fabrication, simplifying the regulatory pathway and acceptance to the marketplace. The proposal is highly likely to succeed as it has a unique integrated structure and approach. All the applicants have international reputations in their own fields, have established records in integrated adventurous projects and have recognised track records for commercialising concepts and products and as a team are well suited for carrying out the proposed research.

Publications

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Bakhshi R (2011) Polymeric coating of surface modified nitinol stent with POSS-nanocomposite polymer. in Colloids and surfaces. B, Biointerfaces

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Desai M (2010) AAA stent-grafts: past problems and future prospects. in Annals of biomedical engineering

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YOU Z (2009) Origami 4

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Zhou X (2007) A numerical study of helix-shaped Nitinol stent in Proceedings of International Conference of Shape Memory and Superelastic Technologies

 
Description The project resulted in a new stent graft for treating thoracic aortic aneurysm. Unlike the conventional stent grafts, the new stent graft has a curved profile, which fits better to the descending aorta. This is important to overcome the problem of stent graft migration and endoleak.

Since the end of the project, my team have done further work and we are now working on a chimney-like concept to deal with blood vessel branches. To date, the analytical work has attracted much attention from communities that perform numerical simulation. We aim to create a tool that can be used for design of such devices.
Exploitation Route We are undertaking pre-clinical trials and hope to commercialise this concept, but this is a rather long process as the device has to pass all the regulatory hurdles.

In addition, the concept of folding the stentgraft actually leads to the development of a tube with negative Poisson's ratio. This is a sought-after feature in material science. My team is actively explore this concept at present trying to create meta-materials using the idea.
Sectors Healthcare

URL http://www.eng.ox.ac.uk/deployable/research/medical-foldables
 
Description The stent graft concept was used by a company for further development. In addition, the concept and skills developed and during this project has been further developed to create a novel cerebral flow diverter for direct treatment of cerebral aneurysms. This new device has attracted £2 million investment in 2015 and a university spin-off company has been set up here in Oxford to take this idea to clinical use.
First Year Of Impact 2011
Sector Healthcare
Impact Types Economic

 
Title Curved stent graft assembly 
Description This is about the curved stent graft for treating thoracic aortic aneurysm 
IP Reference GB1018869.6 
Protection Patent application published
Year Protection Granted 2014
Licensed Yes
Impact This idea is very different from current stent graft. It was licensed to a company which is undertaking pre-clinical trials.
 
Title TAA Stent Graft 
Description The product was undergoing pre-clinical trials. It was licensed to a start-up company. 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Refinement. Non-clinical
Year Development Stage Completed 2013
Development Status Under active development/distribution
Impact None 
 
Company Name Oxford Endovascular 
Description The company was an Oxford University spin-off aimed to commercialise a novel flow diverter for direct treatment of cerebral aneurysms. The company has successfully raised £2 million to carry out product finalisation and clinical trials. The EPSRC funded project enabled me to start research on stents and flow diversion stent. Though my technology used by the company does not directly come from the outcome of this project, but the principles were the same. The project enabled the PI to think beyond aortic aneurysms, and later the PI carried on research on cerebral aneurysms and came up with the idea that led to the creation of the company. 
Year Established 2015 
Impact The company has a novel approach which is vastly different from existing devices. Its success will greatly enhance the treatment to cerebral aneurysms that cannot be effectively dealt with by existing devices.
Website http://oxfordendovascular.com/?i=1
 
Description Conference/Exhibition: • Designers' Open, Leipzig, Germany, October 2013 (the leading design festival in Germany) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact I was invited to take part in this event. I gave a talk on a specialised conference and exhibited some of my models.
Year(s) Of Engagement Activity 2013
URL http://www.designersopen.com/
 
Description Exhibitions: Techfest 2007 Mumbai, India 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? Yes
Geographic Reach International
Primary Audience Public/other audiences
Results and Impact We spent quite a few days there to show the work in our group carried out with EPSRC funding.

There have been quite an interest in pursuing study opportunities in the UK.
Year(s) Of Engagement Activity 2007
 
Description Incoming talk at Sir William Borlase's Grammar School 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Schools
Results and Impact I have been invited to give a talk on my research activities at Sir William Borlase's Grammar School on 24th April 2017. I accepted the invitation as I thought it was good to talk to young pupils who may choose engineering as their university subject. They are the future of this country and I would like to encourage more and more youngsters to be engineers. In the talk, I shall highlight my work supported by this grant.
Year(s) Of Engagement Activity 2017
 
Description Presentation at IMechE Oxford 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Industry/Business
Results and Impact I was invited to give a talk at IMechE Oxford. The talk was open to general public. In my talk, I mentioned that the grant that I received from EPSRC to develop TAA stent graft using origami has prompted me to work on origami structures. It has enabled many activities. In fact, my research on origami structures has received world-wide recognition.
Year(s) Of Engagement Activity 2017
URL http://nearyou.imeche.org/eventdetail?id=12501
 
Description Talk organised by Didcot First 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact I have been invited to give a talk at Didcot First, an independent organisation that promotes science in and around Oxford. Since there are quite a few science parks in Oxford surrounding areas, this talk will enable professionals and general public to interact.
Year(s) Of Engagement Activity 2017