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Invazive and non-invazive medical devices of high-tech textile materials

Programme: CEEX – MATNANTECH

Project period : 30.10.2005 – 30.03.2008

Partners:
– Institutul national de Cercetare–Dezvoltare pentru Textile si Pielarie – Coordonator
– Universitatea Tehnica “ Gh.Asachi” – Iasi
– Universitatea de Medicina si Farmacie “Victor Babes” – Timisoara
– Institutul de Fizica si Inginerie Nucleara “ Horia Hulubei” – Magurele

Abstract of the project:
The target of the project was to obtain high tech textile materials destined to manufacture invasive and noninvasive medical devices having biomedical and biofunctional characteristics, which are specific to clinical fields, according to the level imposed by the international standards in the field, in order to create the premises for substantiation and extension of the free circulation of the Romanian products on the international market.
In order to achieve this target, the project have been completed with the omologation of the products.
Therefore, the project proposal was correlated to the objectives of the Technological European Platform for Textiles which provides for the development of strategic technological directions, identification of technological shortcomings and of the trading barriers. A special attention has been drawn on the aspects of the resources from the research and innovation strategical initiatives and interventions will be done in those cases where lacks of human resources, capital resources and knowledge resources will be an obstacle in getting technological and organizational progress necessary for a successful industrial transformation and for competitivity, i.e.: turning from fibers, filaments and woven materials of a large consumption to specialized products from high tech flexible processes; settling and extension of the textiles as raw materials, chosen in many industrial sectors and new fields of application; the end of an epoch of mass production in textiles and the transition to an epoch marked by logistic products and personalized, intelligent and customer-oriented distribution.
The results of the research have been materialized in new, competitive products that answer to the requirements of the external market from the perspective of the manufacturing technological conditions, of the level of the products performance parameters products, through technical, biofunctional, physical and chemical on water extract characteristics, biological and microbiological characteristics in conformity with admissibility limits stipulated by the international normatives in force for the medical devices of categories I, II, and III.

Scope of the project:
The future of the textile and garment industry could be build around the concept of a dynamic and innovative bussiness network based on mulidisciplinary knowledgments having the client as the main target. This development process will be concentrated on exploitation, research, innovation and orientation to gain knowledgments in activities from the subsectors of the industry, including all potential opportunities to develop new bussiness in the field of materials, production, processes based on fibres and textiles that leads to new application fields.
In this way, the project proposal was correlated with European Platform for Textile that has as main target the development of technological strategies, identification of the technological weaknesses and the commercialization barriers.
A special atention was paid to the issues regarding the strategic initaitives in research and innovation and will be done all the necessary adjustments in cases of leakage of the human resources or knowledgments that represent barriers in achieve the adanced technologies and organizational structures in order to eliminate all the elements that not allowed the succesfull transformation of the industry. These measures aim at: accomplishing the specialized products through flexible high-tech processes; enlarging the applications of the textiles in other field of activities; started a new age for flexible, inteligent, efficient, personalized products.
All these developments of the processes and technologies was orientated in order to assure the capability of the european textile and garment companies to produce and use high specialized fibres and high-tech textile materials. These products will be destinated to a targeted market with impact in gaining that segment of the market which now are invaded by Asiatic manufacturers. Taking into account the developments in technologies and researches in the textile field, this product’s category has a lot of applications in various domains such as: automotive, rail, aerospatial, buildings, health, defence etc. Nowadays, these products having as generic name “ technical textiles” represent 50% from the total textile production in: Germany, Belgium, Sweden, France, Spain, Portugal etc.

Plan of accomplishing the project:
Stage 1. Technical-scientific substantiation of technological solutions for the realization of high-tech textile materials usable as invasive and non-invasive medical devices in surgical applications
1.1 Complex analysis of methods, techniques & procedures of high-tech textile materials obtaining in view of acknowledging new advanced knowledge regarding the realization of invasive and non-invasive medical devices - result: documentary study
1.2 Designing of functional models for the invasive and non-invasive medical devices of high-tech textile materials - result: 4 technological schemes
1.3 Dissemination through communicating and publishing of obtained results at national level - result: article
Stage 2. Functional models realization, experimentation
2.1 Realization of functional models - result: 4 functional models
2.2 Participation in training and skills improving courses - result: 2 certificates
2.3. Functional models experimentation - result: 4 testing reports
2.4. Presentation & demonstration of functional models functionality & utility in view of their promotion - result: demonstration report
2.5. Elaboration of technical specifications projects/drafts for the manufacture - result: 4 technical projects
Stage 3. Realization, experimentation of testing batches
3.1 Realization of testing batches - result: 4 testing lots
3.2. Preclinical & clinical experimentation of testing batches - result: 4 reports of experimentation
3.3. Dissemination through communicating and publishing of obtained results at national level - result: article for specialized magazines
3.4. Participation in technical-scientific events in fields specific to the project - result: paper for specialized events
Stage 4. Technological Transfer
4.1 Consulting and technical assistance - result: technical document
4.2 Finalization of referential - result: 4 referentials
4.3 Products transfer to enterprises - result: document for technological transfer of the products
Stage 5. Review of technical documentation for products realization, elaboration of technical-economic analysis & homologation documentation
5.1 Design and elaboration of technical-economic analysis documentation - result: fezability study
5.2 Review of technical documentation for products - result: technical document
5.3 Identification and attribution of intellectual property rights over results - result: patent requested
5.4 Homologation of products - result: 4 homologated products
5.5 Elaboration of products presentation manual - result: 4 presentation manual for products
5.6 Presentation and demonstration of products functionality & utility for their promotion - result: demonstration report

Results obtained : products - stage of accomplishment: functional model; valorification: tehnological transfered; homologated products
- Nonresorbable tissular sutures - users: INCDTP/hospitals and clinics of general surgery
- Elastic bandages for orthopaedic surgery - users: INCDTP/ hospitals and clinics of orthopaedy
- Gastroeneterological Mesh - users: INCDTP/ hospitals and clinics of gastroeneterology
- Woven vascular prostheses with “Y” geometry - users: INCDTP/ hospitals and clinics of cardiovascular surgery
- Biomaterial for the reconstruction of the semirigid tissue of the thoracic cavity - users: INCDTP/ hospitals and clinics of thoracical surgery

Articles published in Romania:
"Medical absorbent products based on cotton nonwovens" - Zamfir Maria, Ene Alexandra, Sava Costică, Ciocoiu Mihai, CORTEP 2007 Conference, Iasi, October 18th-21st, 2007, Section: Functional Textiles and Related Processes Book of Abstract, ISBN 978-973-730-401-8
"Research regarding the nonwoven medical products obtained by thermally bonding technology" - Zamfir Maria, Farama Daniela, Ene Alexandra, Bulacu Romulus, Miu Gabriela, Ciocoiu Mihai, CORTEP 2007 Conference, Iasi, October 18th-21st, 2007, Section: Functional Textiles and Related Processes Book of Abstract, ISBN 978-973-730-401-8
"Knitted fabrics for bandages" - Ciobanu Luminita, Macovei Laura, Ene Alexandra, Ciocoiu Mihai, CORTEP 2007 Conference, Iasi, October 18th-21st, 2007, Section: Functional Textiles and Related Processes Book of Abstract, ISBN 978-973-730-401-8
"Warp knitted fabrics for medical products" - Macovei Laura, Ciobanu Luminita, Ene Alexandra, Ciocoiu Mihai, CORTEP 2007 Conference, Iasi, October 18th-21st, 2007, Section: Functional Textiles and Related Processes Book of Abstract, ISBN 978-973-730-401-8
"Materiale textile high-tech cu grad controlat de elasticitate pentru dispozitive medicale neinvazive utilizabile in ortopedie si tehnici medicale recuperatorii" - ing. Alexandra Ene- INCDTP, dr.ing.Carmen Mihai- INCDTP Revista Industria Textila
"Reconstructia peretelui toracic cu ajutorul dispozitivelor medicale invazive din materiale textile high-tech" - Prof.Dr.Alexandru Nicodin- Universitatea de Medicina si Farmacie „Victor Babes”, ing. Alexandra Ene - INCDTP, dr.ing.Carmen Mihai-INCDTP Revista Industria Textila

Papers presented at specialized events:
"Reaserches related to absorbent medical products made from cotton based nonwovens" - Maria Zamfir, Alexandra Ene, Mihai Ciocoiu, International Scientific Conference UNITECH’07, 23-24 November 2007, Technical University of Gabrovo, Bulgaria, Volume 2, ISSN 1313-230X
"Medical products for external end-uses made from nonwovens" - Maria Zamfir, Daniela Farima, Alexandra Ene, Romulus Bulacu, Mihai Ciocoiu, International Scientific Conference UNITECH’07, 23-24 November 2007, Technical University of Gabrovo, Bulgaria, Volume 2, ISSN 1313-230X
"Polymers for multifunctional Textiles" - dr.ing.Emilia Visileanu – INCDTP, ing.A.Ene – INCDTP, dr.ing.Carmen Mihai – INCDTP, Marek Kowalczuck – Centrul de Chimie a Polimerilor Polonia Journal Macromolecular Symposia

Brevet elaborat:
Title: Non resorbable surgical sutures and accomplishing procedure
Authors: Alexandra Ene; Carmen Mihai; Adriana Petrescu; Mirauta Viorica