Project: Research & Development of a non-metallic vascular neurosurgical device

An aneurysm is a localized, blood-filled dilation (balloon-like bulge) of a blood vessel caused by disease or weakening of the vessel wall (Fig.1, see annex). Aneurysms are dangerous because when they burst, they lead to heavy haemorrhages which can be life-threatening. Intracranial aneurysms most commonly occur in arteries at the base of the brain (the circle of Willis) and in the aorta. Aneurysm are treated by Aneurysm Clips: to stop blood flow at the aneurysm neck (open surgery), or by Endovascular Coils: to embolize the aneurysm with coils inserted via catheter. The aim of the InnoClip project is to develop a new aneurysm clip based on innovative processing of biomaterials._x000D__x000D_An aneurysm clip is used to clip and seal the bulge at its base, thus allowing the blood to flow through the vessel but not in the aneurysm (Fig.2, see annex). Often, after clipping, the aneurysm is ruptured and emptied thus eliminating the pressure and volume of the aneurysm on the surrounding tissues. _x000D__x000D_Currently, all intracranial aneurysm clips on the market, are metallic, and limit the visibility and visual monitoring possibilities of the post-operative site due to artefacts created in medical imaging techniques (CT-Scan and MRI) (Fig.3, see annex). Reducing artefact and simplifying patient follow-up would be a significant advantage in terms of patient welfare, hospitalisation costs and significantly reduce the risk of perilous incidents._x000D__x000D_The aneurysm clips market demands a huge portfolio of sizes (some companies offer up to 300 different sizes) which have small variations in shapes and in lengths of the clip arms (Fig.4 see annex). To be able to satisfy this demand in a cost-effective way, most companies manufacture their clips by manually or semi-manually. This of course increases manufacturing costs, and quality control costs. _x000D_Our goal is to develop a new aneurysm clip which solves some of the drawbacks of current solutions, namely artefacts in medical imaging, and complex manufacturing. Our aim is to increase patient welfare, by optimising the clip characteristics to help patient intervention and follow-up. _x000D__x000D_The project consortium is made up of two European R&D intensive SMEs: NEOS SURGERY S.L. (NEOS) from Spain, and ADETE® - Advanced Engineering & Technologies GmbH (ADETE) from Germany and a German Research Center, Institut für Verbundwerkstoffe GmbH (IVW). Neos Surgery is a technology-based start-up company founded in 2003. It has three neurosurgical products in the market, the BHID , the Cranial Loop and Cranial Loop L, and has an R&D portfolio which includes developments in cranial and spinal surgery. ADETE - Advanced Engineering & Technologies GmbH, Kaiserslautern, came into life as spin-off of the Technical University of Kaiserslautern. The company specializes in customized light weight design solutions for various industries, based on plastics with and without fibre reinforcement. IVW is a non-profit research institute of the state Rhineland-Palatinate in Germany, exploring and advancing applications and potential applications of composite materials, based on polymer matrix systems. _x000D__x000D_NEOS’ tasks within the project include the design and concept of the new aneurysm clip and its instrumentation. NEOS will harness the clinical input from its neurosurgeon collaborators who will validate specifications, designs and prototypes. NEOS will also perform testing (mechanical, in vitro and in vivo) aimed at proving implant patency and regulatory documentation. NEOS will launch the final device in the market. NEOS is the leader of the project and will deal with the project management. _x000D_ADETE’s task in the project is to work on the design, and materials selection of the device, applying its expertise in finding alternative material solutions for the industry. It will perform finite element simulation at the design, development and validation phases. IVW’s tasks within the project include the development of the processing of the device, taking automation and scale-up into account. IVW will also collaborate in the design of the clip and materials selection. All Ps will participate in project IPR management and exploitation issues._x000D_The InnoClip device will be aimed at the neurosurgical market. P NEOS aims to apply the knowledge and technology developed to other neurosurgical and vascular applications. Ps IVW and ADETE aim to gain experience and know-how in the specifications of the medical device field, improving their position in a market with enormous potential for polymeric and composite materials._x000D_

Acronym InnoClip (Reference Number: 7343)
Duration 01/11/2012 - 30/10/2015
Project Topic Research and Development of a non-metallic vascular neurosurgical device based on innovative processing of polymeric materials. The project includes finite element simulation to optimise device design , and research on reinforced polymeric processing and a biomechanical evaluation of the implant.
Project Results
(after finalisation)
It was achieved to create a design for a non-metallic aneurysm-clip. The closing force of this clip is within the desired target range. The simulation showed that the clip will stand the mechanical loads permanently._x000D_Furthermore, ADETE had the opportunity to get inside specifications of a medical applications the first time. ADETE now will have a better understanding of medical engineering and will be able to offer a better support for appropriate customers._x000D_On the engineering side i, ADETE gained a deeper understanding of the design of smallest (micro) structures and is also able now to offer numerical creep analyses for non- and fibre reinforced plastics.
Network Eurostars
Call Eurostars Cut-Off 8

Project partner

Number Name Role Country
4 Neos Surgery S.L. Coordinator Spain
4 ADETE-Advanced Engineering & Technologies GmbH Partner Germany
4 Institut für Verbundwerkstoffe GmbH Partner Germany
4 ADETE-Advanced Engineering & Technologies GmbH Partner Germany