The goals of this proposal is to develop industrial scale surface modification of materials used in extra corporeal circuitry to enhance haemocompatibility, and reduce negative impact on patient. Unless current proposed approaches, the program will take a novel approach, by addressing the various mechanisms involved in contact activation, platelet activation, and complement activation.
The methodology used is to combine natural inhibitors to know surface modification by hydrogels, minimising protein adsorption and therefore contact and platelet activation. A number of blood protein inhibitors have been identified as good candidates, and another aim will be to identify in these inhibitors the key inhibitory substance to allow use of peptidic equivalents that could be produced industrially. To maintain feasibility, various coating technologies are envisaged, including physical solution coating which is currently used and acceptable from a cost perspective. Spacer technology is another key element of this proposal, as proper active element presentation is crucial. Validation of in-vivo testing will allow the minimisation of animal studies, and reduce evaluation time. Last, the targeted started market will benefit from a 1 billion ECU reduction of healthcare budget by avoiding unnecessary hospital stay.
The partnership has been selected on the basis of complementarity of expertise, and practically by including clinicians as well as basic research to the industrial expertise of the other partners. The project aims to develop an integrated system that allows a more efficient design of personalised implants and surgical tools in a medical imaging environment and cost effective manufacturing techniques.
The generic system named DDOSS, medical Device Design and Operation Simulation System, enables presurgical planning, taking aspects in account such as bone quality, the presence of soft tissue or the effects of an osteotomy. DDOSS will integrate bio mechanical design principles in the design and dimensioning process of the personalised implants and surgical aids.
The major advantage of the system to be developed in the project over state of the art systems is the integration of CAD and medical imaging. This integration overcomes the limitations of the inevitable link Medical Imagiting to CAD which is usually obtained by segmenting the data, resulting in the preservation of the outer object shape data only. With the generic system, both custom implants and custom surgical aids will be designed. The custom surgical aid fits perfectly on an internal structure of the patient and guides (e.g. with a hole) the surgeon during the operation. They help the surgeon in the exact positioning of his instruments or bone cuts. They enable the operation to be performed exactly as planned and are essential for optimal use of off the shelf and personalised implants. As such they help to solve the image to patient registration problem and are in several situations competitive to robot assisted surgery.
The parts will be produced by rapid prototyping and may occasionally directly be used as personalised surgical aids. In most applications they will be used as masters for subsequent processes as precision casting, ionomeric cement casting, titanium hydroforming or sintering of bio compatible materials to result in surgical tools, or functional implants. Optimisation of these processes should enable to convert the prototyping techniques into reliable, cost effective and fast one of a kind production methodologies for medical devices. Patient specific surgical tools and personalised implants manufactured using the procedure obtained in the PISA project should improve the quality of the surgical intervention and reduce its duration. It may even reduce the number of revision interventions required thus enhancing the patient's quality of life and saving costs to the patient and the community.
The applicability and validity of the products developed in the project will be investigated in applications of oral, craniofacial, orthopaedic and spinal surgery. Cadaver studies, simulators and finally limited trials on patients will be performed by a group of experienced surgeons from these fields. Together with Health Care authorities they establish the Validation Group within the Consortium.
Funding SchemeCSC - Cost-sharing contracts
LS11 8DT Leeds
5680 DA Best
LS16 6QB Leeds