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Novel zinc alloys for biodegradable surgical staples

World Journal of Clinical Cases 2020年第3期8卷 504-516页

作者： Hizuru Amano Koichi Miyake Akinari Hinoki Kazuki Yokota Fumie Kinoshita Atsuko Nakazawa Yujiro Tanaka Yasuhiro Seto Hiroo Uchida Department of Pediatric Surgery Graduate School of MedicineThe University of TokyoTokyo 113-8655Japan Mitsui Mining and Smelting Co. Ltd.Tokyo 141-0032Japan Department of Pediatric Surgery Nagoya University Graduate School of MedicineNagoya 466-8550Japan Department of Advanced Medicine Nagoya University HospitalNagoya 466-8560Japan Department of Clinical Research Saitama Children’s Medical CenterSaitama 330-8777Japan

BACKGROUND The development of biodegradable surgical staples is desirable as non-biodegradable Ti alloy staples reside in the human body long after wound healing, which can cause allergic/foreign-body reactions, adhesion, or other adverse effects. In order to develop a biodegradable alloy suitable for the fabrication of surgical staples, we hypothesized that Zn, a known biodegradable metal, could be alloyed with various elements to improve the mechanical properties while retaining biodegradability and biocompatibility. Considering their biocompatibility, Mg, Ca, Mn, and Cu were selected as candidate alloying elements, alongside Ti, the main material of clinically available surgical *** To investigate the in vitro mechanical properties and degradation behavior and in vivo safety and feasibility of biodegradable Zn alloy *** Tensile and bending tests were conducted to evaluate the mechanical properties of binary Zn alloys with 0.1–6 wt.% Mg, Ca, Mn, Cu, or Ti. Based on the results,three promising Zn alloy compositions were devised for staple applications(wt.%): Zn-1.0Cu-0.2Mn-0.1Ti(Zn alloy 1), Zn-1.0Mn-0.1Ti(Zn alloy 2), and Zn-1.0Cu-0.1Ti(Zn alloy 3). Immersion tests were performed at 37℃ for 4 wk using fed-state simulated intestinal fluid(Fe SSIF) and Hank’s balanced salt solution(HBSS). The corrosion rate was estimated from the weight loss of staples during immersion. Nine rabbits were subjected to gastric resection using each Zn alloy staple, and a clinically available Ti staple was used for another group of nine rabbits. Three in each group were sacrificed at 1, 4, and 12 wk *** Additions of ≤1 wt.% Mn or Cu and 0.1 wt.% Ti improved the yield strength without excessive deterioration of elongation or bendability. Immersion tests revealed no gas evolution or staple fracture in any of the Zn alloy staples. The corrosion rates of Zn alloy staples 1, 2, and 3 were 0.02 mm/year in HBSS and 0.12, 0.11, and 0.13 mm/year, respective

关键词： Zinc alloy Surgical staple Gastric resection biodegradability,biocompatibility Mechanical Strength

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