SYNTHAFLEECE

"Creation of a synthetic, absorbable, haemostatic fleece for delivery of active agents into healing wounds"

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 Obiettivo del progetto (Objective)

'The SME Participants in the SynthaFleece project (NANOVAL, BBS, ASTERIE, STERIPACK) aim to create a new, totally synthetic medical device based on a poly-lactide (PLA) polymer platform that is capable of the sustained release of ionic silver, antibiotics and bone morphogenetic proteins (BMPs) whist stimulating haemostasis and encouraging bone growth and healing. With such a device we can target the market for healing of potentially infected wounds arising from bone and joint surgery worth in excess of €220 million in 2007. To achieve our objective we need to develop new scientific knowledge in: PLA polymer technology and in particular the creation of high density fleece materials for the release of active agents; how the variation of polymer density in a spun-bonded fleece can modify the release characteristics of silver ions, antibiotics and BMPs; the basis for physical and/or chemical induction of haemostasis; and to translate this knowledge into creation of PLA-based micro-fibres to be spun-bonded into a fleece that can bind silver ions, antibiotics and BMPs and release them over a period from seven days to two weeks. The fleece should degrade in the wound bed and be absorbed over the same time period whilst causing immediate and long-lasting haemostasis. Whilst the SMEPs form a complete supply chain for the manufacture of the ultimate fleece product we have neither the facilities nor the resources to undertake the necessary R&D. The Research for SMEs funding instrument provides the ideal solution allowing us to outsource the R&D to three RTD Performers – FhG, HERI and IMM-recherche. The Foreground Intellectual Property (FGIP) generated in the SynthaFleece project will be owned by the SMEPs and exploited in partnership with a large enterprise (BIOMET) which will provide a route to the global market for wound-healing devices. The SMEPs will benefit from sales and licensing of the FGIP to the tune of €XXX million over a ten year period.'

Introduzione (Teaser)

Research is looking into ways of treating wounds that become infected following bone or joint surgery. A slow-release mix through fleece appears to be a promising solution.

Descrizione progetto (Article)

The 'Creation of a synthetic, absorbable, haemostatic fleece for delivery of active agents into healing wounds' (Synthafleece) project proposed the development of a synthetic, absorbable and haemostatic fleece to deliver active healing agents into wounds. The entirely synthetic medical device would be based on a polylactide (PLA) polymer platform releasing ionic silver, antibiotics and bone morphogenetic proteins. This has the aim of stimulating haemostasis and promoting the healing and growth of bones.

To achieve this, Synthafleece first had to acquire new knowledge in PLA polymer technology, the creation of high-density fleece materials for releasing healing agents and the degree of density needed for optimal release, and the basis for physically or chemically inducing haemostasis.

This knowledge is necessary for creating PLA-based microfibres to be spun-bonded into the fleece for release in the wound bed over the period of 7 to 14 days, during which time the fleece degrades and is absorbed.

Market research and study of customer-supplier requirements helped establish the optimal settings for producing a totally synthetic fleece material. A melt-blown process was revealed to be best for manufacturing the non-woven fleece.

Synthafleece project partners delivered a set of sterilised fleece samples for testing and to set the proper parameters of the polymer material requirements. The non-woven medical device was characterised and specified, prototype integration was investigated and materials were examined for degradability and process ability.