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​PEEK人工关节
​重构骨科植入物新生态

Discover the future of joint replacement with our innovative PEEK biomaterial solutions

1962年John Charnley 发明人工关节

金属植入物与人体骨骼差异

01.

强度不匹配

02.

金属磨损离子

03.

关节假体松动

04.

​假体周围骨者

05.

无法CT/MRI显影

我们试图寻找与人体骨骼更接近仿生关节材料

​全新PEEK人工关节产品管线

世界级PEEK注塑平台技术
释放PEEK作为人工关节潜力

专注关节颠覆性创新产品材料技术和工艺

全球发明及实用新型专利获批50余项

覆盖中国、美国、英国、德国、法国、意大利、西班牙、澳大利亚

ZL201510070528.0, US10918763B2, EP3257476B1, AU2015383055B2 etc.

完成了千万次磨损试验、疲劳试验、老化试验、生物相容性、动物实验,以及多中心注册临床实验,证明了PEEK在人工关节使用的安全性、有效性和可及性

精确控制PEEK的结晶度

突破了高温注塑对流动性、成型时间、对饱满度、对成型结晶度等严苛要求。调整和控制结晶度涉及对注塑成型工艺参数的精确控制,包括温度、速度、位置、压力、时间周期、冷却、注射

高精异形模具设计与制造

膝关节假体的形状复杂,对接触面的精度要求极高,要求模具设计和制造必须达到极高的精度,对于在极短时间、极高温度、极差流动性下一次性注塑成型工作状态下的综合要求

PEEK高温注塑流动控制

PEEK的高熔点和高粘度在高温注塑过程中导致其流动性较差,苏州中科通过优化注塑机和模具设计,特定比例增塑剂和流动促进剂,经过精确工艺突破了植入剂PEEK颗粒高温注塑流动性差的局限

高精度镜面抛光工艺

关节面的光洁度是决定植入器械成功与否的关键因素之一,因为它直接影响到植入器械的磨损性能和患者的舒适度,通过模具设计和注塑参数优化,实现PEEK关节面光洁度≤0.5μm

全球第一家
系统化科研证据和临床数据
证明了PEEK关节的可行性

PEEK人工关节生物相容性体外细胞实验

1.Du Z, Wang S, Wang Y. Preferential CD8 rather than CD4 T-cell response to wear particles of polyether-ether-ketone and highly cross-linked polyethylene. RSC Adv., 2018, 8, 1866. 

2.Du Z, Wang S, Yue B, Wang Y, Wang Y. Effects of wear particles of polyether-ether-ketone and cobalt-chromium-molybdenum on CD4- and CD8-T-cell responses. Oncotarget. 2017 Dec 29;9(13):11197-11208. 

PEEK人工关节动物实验

1.Du Z, Zhu Z, Yue B, Li Z, Wang Y. Feasibility and Safety of a Cemented PEEK-on-PE Knee Replacement in a Goat Model: A Preliminary Study. Artif Organs. 2018 Aug;42(8):E204-E214. doi: 10.1111/aor.13101. Epub 2018 Feb 13. PMID: 29435992.

2.Meng X, Du Z and Wang Y. Characteristics of wear particles and wear behavior of retrieved PEEK-on-HXLPE total knee implants: a preliminary study. 30330. RSC Adv., 2018, 8, 30330–30339. 

PEEK全膝关节假体减少了应力屏蔽

1.Zhao G, Luo J, Ma J, Wang J. Decreased stress shielding with poly-ether-ether-ketone tibial implant for total knee arthroplasty - A preliminary study using finite element analysis. Heliyon. 2024 Feb 29;10(5):e27204. 

2.De Ruiter L, Janssen D, Briscoe A, Verdonschot N. A preclinical numerical assessment of a polyetheretherketone femoral component in total knee arthroplasty during gait. J Exp Orthop. 2017 Dec;4(1):3.

PEEK关节磨损性能评价

1.ZHANG X, ZHANG T, CHEN K, XU H, FENG C, ZHANG D. Wear mechanism and debris analysis of PEEK as an alternative to CoCrMo in the femoral component of total knee replacement. Friction 11(10): 1845–1861 (2023)

2.Cowie, R.M.; Pallem, N.M.; Briscoe, A.; Jennings, L.M. Third Body Wear of UHMWPE-on-PEEK-OPTIMA™. Materials 2020, 13, 1264

PEEK植入物-骨水泥界面

Zhao, G., Yao, S., Sun, X. Ma J., Wang J. Consequences of using poly-ether-ether-ketone versus traditional implant on tibial cement penetration and short-term clinical outcomes during total knee arthroplasty: a randomized controlled trial. J Orthop Surg Res 18, 589 (2023). 

磁共振成像、CT和X射线对PEEK人工关节体内评估  

Cai Z, Qu X, Zhao Y, Yuan Z, Zheng L, Long T, Yao Q, Yue B, Wang Y. Preliminary Study on Immediate Postoperative CT Images and Values of the Modular Polyetheretherketone Based Total Knee Arthroplasty: An Observational First-in-Human Trial. Front Surg. 2022 Feb 14;9:809699. doi: 10.3389/fsurg.2022.809699. 

髋关节、表面修复等其他部位研究

Meng X, Zhang W, Yuan Z, Chen J, Lyu Z, Wang Y. A partial hemi-resurfacing preliminary study of a novel magnetic resonance imaging compatible polyetheretherketone mini-prosthesis for focal osteochondral defects. J Orthop Translat. 2020 Mar 20;26:67-73. doi: 10.1016/j.jot.2020.02.010. 

 

表面改性:骨生成、抗菌、耐摩擦

1.Huo S, Meng X, Zhang S, Yue B, Zhao Y, Long T, Nie B, Wang Y, Hydrofluoric acid and nitric acid cotreatment forbiofunctionalization of polyetheretherketone in M2macrophage polarization and osteogenesis, J Biomed Mater Res.2021;109:879–892. 

2.Meng X., Zhang J., Chen J., Nie B., Yue B., Zhang W., Lyu Z., Long T., Wang Y., KR-12 coating of polyetheretherketone (PEEK) surface via polydopamine improves osteointegration and antibacterial activity in vivo. J. Mater. Chem. B, 2020,8, 10190-10204

3.Wu T, Zhang X, Chen K, Chen Q, Yu Z, Feng C, Qi J,Zhang D,The antibacterial and wear-resistant nano-ZnO/PEEK composites were constructed by a simple two-step method, Journal of the Mechanical Behavior of Biomedical Materials, Volume 126, February 2022, 104986

4.Feng C, Cao Y, Wu T, Cen J, Chen K, Li X, Zhang D, Friction and wear mechanism of artificial joint composite material PEEK/ZnO under different decomposition motion modes of knee joint, Tribology International, Volume 189, November 2023, 108917

5.Scholes SC, Unsworth A. The wear properties of CFR-PEEK-OPTIMA articulating against ceramic assessed on a multidirectional pin-on-plate machine. Proc Inst Mech Eng H. 2007 Apr;221(3):281-9. doi: 10.1243/09544119JEIM224. 

产品价值

500%

提高骨骼力学匹配度

0

金属离子腐蚀

​a l l

CT & MRI影像学检查

1:1

骨骼重量匹配度

30+

预期终身使用

让我们一起帮助每一个

遭受关节炎及退化困扰的患者

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