Development and verification of a novel bone collector with automatic size separating function for orthopedics surgery.

Expert review of medical devices Pub Date : 2024-07-01 Epub Date: 2024-06-17 DOI:10.1080/17434440.2024.2367688
Kin-Weng Wong, Hsuan-Wen Wang, Chi-Sheng Chien, Chia-Hsuan Li, Cun-Bin Li, Chun-Li Lin
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Abstract

Background: Autologous bone dust can be filled in bone defects to promote effective bone healing but typically it is lost when using suction during surgery. The aim of this study was to develop a novel bone collector that can be used to collect bone chips/dust of varying sizes without changing current surgical procedures.

Research design and methods: This collector was designed to connect to a surgical continuous suction system and comprised a plate filter with a 3 mm hole and featured a taper filter with a mesh size of 0.27 mm for the separation and collection of both coarse and fine bone chips/dust. The bone collector was manufactured using nylon 3D printing and plastic injection with biocompatible materials.

Results: The bone collector functional test revealed high bone chip collection efficiency (93%) with automatic size separation function. Low (3.42%) filtration errors showed that most of the water can be drained smoothly from the bone collector. In clinical usability testing, bone collectors can provide functions demonstrated in in vivo spinal fusion and femoral fracture surgeries with different bone grafting size requirements.

Conclusions: The novel bone collector has been validated as a viable and effective surgical device, offering surgeons an additional option to enhance patient outcomes.

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开发并验证用于矫形外科手术的具有尺寸自动分离功能的新型骨收集器。
背景:自体骨粉可填充在骨缺损处,以促进有效的骨愈合,但在手术过程中使用抽吸器时通常会丢失自体骨粉。本研究旨在开发一种新型骨收集器,可用于收集不同大小的骨屑/骨粉,而无需改变当前的手术程序:该收集器设计用于连接外科连续抽吸系统,由一个孔径为 3 毫米的板式过滤器和一个网眼尺寸为 0.27 毫米的锥形过滤器组成,用于分离和收集粗细骨屑/粉尘。骨收集器采用尼龙三维打印和塑料注塑技术制造,并使用了生物相容性材料:结果:骨收集器功能测试显示,骨屑收集效率高(93%),并具有自动尺寸分离功能。过滤误差低(3.42%),表明大部分水都能从骨收集器中顺利排出。在临床可用性测试中,骨收集器可在不同植骨尺寸要求的活体脊柱融合和股骨骨折手术中提供功能:结论:新型骨收集器已被证实是一种可行且有效的手术设备,为外科医生提供了提高患者疗效的额外选择。
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