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Case Study

RUA Medical Devices + University of Strathclyde

Enable identification of the platform technology strategy for ElastEon, for the in-house development of medical devices.

Awards and Achievements

KTP Final Grade: A ⭐⭐⭐⭐⭐

The project was awarded the grade of "Outstanding" by the KTP Grading Panel for its achievement in meeting KTP's objectives.

RUA Medical Devices

RUA Medical is an experienced full-service medical device contract developer, contract manufacturer and implantable fabric specialist.

What was the need?

The Challenge

The requirements for materials used in prosthetic heart valves are numerous and demanding, and the most challenging of all are placed on the moving leaflets. This critical component of a valve must fulfil many requirements: it must be sufficiently flexible to open under low pressure but robust enough to resist high back pressure on closing. It must be biocompatible to allow implantation, and biostable so it can safely be in contact with the bloodstream over many years. It should have a very long fatigue life of many hundreds of millions of cycles under operational conditions. If it does begin to fail, the mechanism(s) of failure must be slow to allow the valve deterioration to be diagnosed by physicians and for appropriate steps taken to mitigate. The valve and all its materials should also be robust, to withstand the rigours of surgical implantation.

 In this project, the challenge was to meet all of the described criteria using entirely synthetic polymer materials. The primary material was to be ElastEon™, RUA’s proprietary polymer, due to its proven track record for biocompatibility and biostability in long-term implanted devices.

What did we do?

The Solution

A solution was developed by incorporating RUA’s expertise in textile manufacture alongside the processing of the ElastEon polymer. A novel textile was designed to provide strength and stability, without sacrificing the flexibility of the finished material. A set of processes were then designed to add an ElastEon coating to this textile, ultimately creating a thin and flexible composite material that was dimensionally consistent. The product name for the new composite developed is AurTex. The material was tested extensively within the scope of the KTP to demonstrate that its properties were suitable for use as leaflet material in a valve prosthetic. This included demonstrating its tensile strength, fatigue life, resistance to tearing and maintenance of properties following relevant chemical ageing. A separate work package undertook finite element testing, creating a virtual material model for use in design optimisation. Physical testing by colleagues within the wider project team showed that AurTex functioned successfully when used in prototype valve frame designs, meeting the opening, closing and regurgitation requirements of the relevant standard. Long-term durability was also demonstrated using model prototype valves.

What changed?

The Impacts and Benefits

Impacts for the Company

Through the partnership, the company have benefitted in a number of areas which have directly attributed to the successful development of AurTex. As a business, RUA specialise in implantable medical textiles, but this is the first time the business has looked to develop a composite material combining textile with their proprietary Elast-Eon™ polymer.

Having access to expert, technical knowledge within the Academic team has proven invaluable through the development process, allowing greater understanding of AurTex as a material. The collaboration has been key to supporting the identification of critical parameters and developing appropriate test methods to enable material characterisation and modelling, as well as increasing the understanding of how material processing could impact manufacturing process and final product design specifications.

The partnership has also provided the company with access to laboratories within the university campus; this will continue after the partnership comes to an end, via the visiting researcher scheme.

 

Impacts for the Academic Team

The partnership with a company with an internationally-recognised market position in biomedical  devices has further enhanced the credibility of the University's strategic vision to be A Place of Useful Learning, and to support the application of its research expertise to issues of commercial, industrial and societal importance. It provided an opportunity for the Academic Team  to apply their technical skills to structurally complex materials. Identifying the combination of parameters affecting its processing and end-use application  of the AurTex materials has been a scientific challenge in its own right, with the additional challenging constraint of working to commercial and regulatory realities.

The project led to the creation of new inter-departmental academic collaboration between Dr Oliveira and Prof Liggat, and this new working relationship has since yielded a new funded PhD position.

Two company-sponsored UG student projects were run, one in Mechanical and Aerospace Engineering and one in Pure and Applied Chemistry, with the latter subsequently enrolling in a PhD at the University.

 

Impacts for the KTP Associate

Both Associates in this 2-Associate project benefited significantly. They gained insight into the medical device industry particularly relating to the design process. They also gained significant knowledge of both native heart valves and prosthetic devices, from the perspective of engineers and designers as well as surgeons and the wider medical device industry. They also learned about various textile manufacturing techniques and the uses of medical textiles in devices.

Through the research undertaken they expanded their skills and expertise regarding numerous aspects of material testing, both physical and chemical, and the modelling of complex hyperelastic materials.

The training opportunities, including the KTP modules and courses in project management, provided significant benefits to the Associates that will be invaluable to their ongoing careers.

The Impacts and Benefits

The People

Meet the Team

Peter Jenkins

KTP Associate

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Dr Guillermo Idarraga Alarcon

KTP Associate

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Professor John Liggat

Knowledge Base Supervisor

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Dr Monica Oliveira

Knowledge Base Supervisor

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Simon Rosendale

Company Supervisor

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