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The degradation and local tissue effects of collagen hydrogel and sponge implants in muscle
Institution:1. National Engineering Research Center for Biomaterials, Sichuan University, 29 Wangjiang Road, Chengdu, China;2. Sichuan Testing Center for Biomaterials and Medical Devices, Sichuan University, 29 Wangjiang Road, Chengdu, China;1. MMRI/ CAPPA-D, Department of Chemical Engineering, McMaster University, Hamilton, Ontario L8S 4L7, Canada;2. 3M Canada Company, London, Ontario, Canada;1. College of Materials Science and Engineering, Shenzhen Key Laboratory of Polymer Science and Technology, Guangdong Research Center for Interfacial Engineering of Functional Materials, Nanshan District Key Lab for Biopolymers and Safety Evaluation, Shenzhen University, Shenzhen 518060, PR China;2. Key Laboratory of Optoelectronic Devices and System of Ministry Education and Guangdong Province, College of Optoelectronic Engineering, Shenzhen University, Shenzhen 518060, PR China;1. CIMJECT Laboratory, Department of Mechanical Engineering, Federal University of Santa Catarina, 88040-900 Florianópolis, SC, Brazil;2. Biomechanics Engineering Laboratory, University Hospital (HU), Federal University of Santa Catarina, 88040-900 Florianópolis, SC, Brazil;3. Dipartimento di Chimica, Materiali ed Ingegneria Chimica “G. Natta”, Politecnico di Milano, Edificio 6, Piazza L. da Vinci 32, 20133 Milano, Italy;1. School of Mechanical, Aerospace and Civil Engineering, United Kingdom;2. North West Composites Centre, School of Materials, The University of Manchester, Manchester M13 9PL, United Kingdom;1. State Key Laboratory of Pulp and Paper Engineering, South China University of Technology, Guangzhou, 510640, China;2. Pearl River Water Resources Institute, Pearl River Water Resources Commission, Guangzhou, 510640, China;3. National Paper Products Quality Supervision Inspection Center, Dongguan, 523080, China;1. Technische Universität Dresden, Institut für Leichtbau und Kunststofftechnik, 01062 Dresden, Germany;2. Technische Universität Dresden, Institut für Magnetofluiddynamik, Mess- und Automatisierungstechnik, 01062 Dresden, Germany;3. Anton Paar GmbH, Ostfildern-Scharnhausen, 73760, Germany
Abstract:Collagen products will degrade and evoke certain local tissue reaction after being implanted. ISO 10993.6 is the international standard to evaluate local tissue reaction for biomaterials. However, even in the present version, it does not define the specific view fields for scoring local tissue reaction in the sections, which may influence the fair evaluation for the degradable polymer, such as collagen. In this study, 4 kinds of collagens and 2 kinds of bio-inert products were implanted into the rabbit muscle for 26 weeks, and two different scoring methods (uniform distribution scoring method and area locating scoring method) were applied to evaluate the local tissue reaction for each implant. The results showed that the tissue reaction on the interface was active, but the various scores in the implant and surrounding areas could help us to understand the differences of the degradation process. An area locating scoring method which selected the fields in the implant, interface and surroundings respectively showed a higher total score and offered more detailed information compared to the uniform distribution scoring method. Since the degradation and tissue reaction degree in the different areas are ever changing for the degradable implants, this area locating scoring method is sensitive, effective and applicable for the semi-quantitative evaluating system of ISO 10993.6.
Keywords:ISO 10993 standard  Collagen  Local tissue reaction  In vivo degradation  Biological evaluation
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