Aspects of Chemical Characterisation of Leachables Profile from Ultra-Light Knitting Textiles for Uses as Medical Implants in Urogynaecology and General Surgery

• Autorzy: Jóźwicka J. , Gzyra-Jagieła K , Struszczyk M. H. , Gutowska A. , Ciechańska D. , Krucińska I

Warianty tytułu

PL

Aspekty charakterystyki chemicznej substancji wymywalnych z ultralekkich dzianin o potencjalnym zastosowaniu jako implantowalne wyroby medyczne stosowane w urologinekologii i chirurgii ogólnej

• Języki publikacji: EN

Abstrakty

EN

Ultra-light textiles (knitwear) designed as implantable medical devices for potential uses in urogynaecology (treatment procedures in women incontinence and vagina reconstructions) and general surgery (hernia treatments) are a response to the increasing demand for advanced medical devices in medicine. Chemical profile characterisation of leachable substances is an important factor in the use of the materials influencing their biocompatibility. The implant is made of undesired chemical substances in the main raw-material, and penetration into the tissue may cause local and/or systemic inflammation in the patient’s body. The characterisation and analysis of such substances is therefore essential to secure the safe use of implants. Most important is the characterisation of the matter that is extractable from the designed medical devices. To serve these purpose, ultra-light textile implants designed for potential use in urogynaecology and general surgery were examined concerning the chemical analysis of the undesired substance contained in the main material which constitutes the base of the implant. It was a goal of the work to set optimal parameters for the examination of chemical characterisation of the leachable implant’s material, bearing in mind their safe clinical use. Analysis of the chemical leachable profile was made in accordance with directives of standard PN-EN ISO 10993-18:2008 and some Polish and European testing procedures.

PL

Artykuł przedstawia innowacyjne ultra-lekkie implanty włókiennicze w postaci dzianiny z przeznaczeniem na implanty do potencjalnego zastosowania w urologinekologii i chirurgii ogólnej (procedury zaopatrywania przepuklin nietrzymania moczu u kobiet i plastyki pochwy). Badano własności?? charakterystyki substancji wymywalnych z projektowanych implantów. Ultralekkie dzianiny poddano ocenie czystości chemicznej pod kątem wpływu ewentualnych substancji wymywalnych na ich bezpieczeństwo kliniczne. Wyznaczono optymalne parametry badań czystości chemicznej implantowalnych wyrobów medycznych. Oceny czystości chemicznej wyselekcjonowanych dzianin dokonano w oparciu o metody badawcze opracowane na podstawie wytycznych normy PN-EN ISO 10993-18:2008: „Biologiczna ocena wyrobów medycznych – Część 18: Charakterystyka chemiczna materiałów” (ISO 10993-18:2009) oraz opracowanych procedur badawczych na bazie normatywów polskich i europejskich.

Słowa kluczowe

EN

ultra-light textile implants for urogynaecology; evaluation of chemical leachable profile; physical-chemical parameters

PL

substancje wymywalne z ultralekkich dzianin; wyroby medyczne; implanty w urologii

• Wydawca: Sieć Badawcza Łukasiewicz - Łódzki Instytut Technologiczny
• Czasopismo: Fibres & Textiles in Eastern Europe
• Rocznik: 2012
• Tom: Vol. 20, no. 6B (96)
• Strony: 128--134
• Opis fizyczny: Bibliogr. 22 poz., rys., tab., wykr.

Twórcy

autor

Jóźwicka J.

• Poland, Łódź, Institute of Biopolymers and Chemical Fibres

autor

Gzyra-Jagieła K

• Poland, Łódź, Institute of Biopolymers and Chemical Fibres

autor

Struszczyk M. H.

• Poland, Łódź, Lodz University of Technology, Faculty of Material Technologies and Textile Design, Department of Material and Commodity Sciencs and Textile Metrology

autor

Gutowska A.

• Poland, Łódź, Institute of Biopolymers and Chemical Fibres

autor

Ciechańska D.

• Poland, Łódź, Institute of Biopolymers and Chemical Fibres

autor

Krucińska I

• Poland, Łódź, Lodz University of Technology, Faculty of Material Technologies and Textile Design, Department of Material and Commodity Sciencs and Textile Metrology

Bibliografia

• 1. Górecki R. Treatment of urinary incontinence. Current state and directions of development (in Polish). Przegląd Urologiczny 2006; 7/2: 36.
• 2. Incontinence: causes, management and provision of services, Royal College of Physicians of London, 1995.
• 3. Jolleys JV. Incontinence. Royal College of General Practitioners London, 1994.
• 4. Cody J, et al. Systematic review of the clinical effectiveness and cost-effectiveness of tension-free vaginal tape (TVT) for treatment of urinary stress incontinence. Report commissioned by NHS R&D HTA, Programme on behalf of the national Institute for Clinical Excellence 2002, http://www.hta.ac.uk/pdfexecs/summ721.pdf [2011-12-10].
• 5. Struszczyk MH, Olejnik M. Present and future demand for textile medical devices (in Polish). Techniczne Wyroby Włókiennicze 2010; 18, 3/4: 19-25.
• 6. Baranowski W. Implant as a lift. Żyjmy Dłużej 2007; 11: 18-19.
• 7. Anton F. et al. The phenomenon of infection with abdominal wall reconstruction.Biomaterials 2007; 28: 2314-2327.
• 8. Klosterhalfen B., et al. The lightweight and large porous mesh concept for hernia repair. Expert Rev. Devices 2005; 2(1): 1-15.
• 9. Welty G., et al. Functional impairment and complaints following incisional hernia repair with different polypropylene meshes. Hernia 2001; 5: 142-147.
• 10. Struszczyk MH, Gutowska A, Kowalski K, Kopias K, Pałys B, Komisarczyk A, Krucińska I. Ultra-light knitted structures for application in urologynaecology and general surgery – Optimisation of structure in the aspect of physical parameters. Fibres & Textiles in Eastern Europe 2011; 19, 5(8): 92-98.
• 11. Wintermantel E., Mayer J. Anisotropicbiomaterials strategies and developments for bone implants. In: Wise DL, Trantola DJ, Actobelli DE, Yaszeniski JD, Gresser JD, Schwarz ER (eds) Encyclopaedic Handbook of Biomaterials and Bioenerineering, Prat-B New York, Marcel Dekker, 1995, 3-42.
• 12. PN-EN ISO 14155:2011: Clinical investigation of medical devices for human subjects - Good clinical practice (in Polish).
• 13. PN-EN ISO 14155:2011: Clinical investigation of medical devices for human subjects - Clinical investigation plans (in Polish).
• 14. PN-EN ISO 10993-18:2009: Biological evaluation of medical devices - Part 18: Chemical characterization of materials (in Polish).
• 15. PN-EN ISO 10993-12:2009: Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (in Polish).
• 16. PN-EN ISO 14630:2009: Non-active surgical implants. General requirements (in Polish).
• 17. Struszczyk MH, Kopias K, Kowalski K, Golczyk A. Trójwymiarowy, dziany implant do rekonstrukcji ubytków tkanki łącznej. PL P-394623, 2011.
• 18. Struszczyk MH. Introduction of chitin and its derivatives for the design of medical devices based on the requirements of EU Derivative 93/42/EWG. In: Senel S, Varum KM, Sumnu M, HinncalA (eds) Proceedings of the 8th International Conference of the European Chitin Society. ISBN 978-975-491-250-0, 2007, 186-192.
• 19. Struszczyk MH, Rogaczewska A, Dobrowolska A, Majcherek Z. The elaboration of optimal structure of flat implants for hernia treatments. Fibres & Textiles in Eastern Europe 2009; 17, 1(72), 103-110.
• 20. Laboratory of Paper Quality of Institute of Biopolymers and Chemical Fibres.
• 21. Struszczyk MH, Kowalski K, Kopias K, Komisarczyk A. Aspects of the risk analysis in designing of textile medical devices for use in urogynaecology and general surgeries. In: Proceedings of IXth International Conference Knitt Tech 2010, Rydzyna/Poland, 17 - 19.06.2010.
• 22. Struszczyk MH, Komisarczyk A, Krucinska I, Kowalski K, Kopias K. Ultra-light knitted structures for application in urologynaecology and general surgery – optimisation of structure. In: Talvenmaa P (ed) FiberMed11 Proceedings, ISBN 978-952-15-2607-15-2607-7, 2011.