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生物相容性材料兼具金属和聚合物的特性 - China Medical Device Manufacturer
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Fri, January 19th, 2018

2007年1/2月CMDM电子快讯 » 技术新知
生物相容性材料兼具金属和聚合物的特性

一种用于植入器械的复合材料兼具金属的强度以及聚合物的生物相容性和成像性。

随着植入器械需求的增加,人们对于何种材料最适合此类体内应用的争论日益激烈。生物材料供应商Invibio公司(美国南卡罗来纳州,Greenville)研制出一种用于植入器械的复合材料,该材料兼具金属合金的强度以及聚合物的成像特性和生物相容性。

Endolign复合材料是一种碳加固热塑材料,由该公司的拳头产品PEEK-Optima聚合物基质与高强度连续碳纤维融合而成。据Invibio公司总裁Michael Callahan介绍,该产品使用的是连续碳纤维,而非通常使用的短切纤维,而且碳纤维比例高达5060%,因此,与纤维比例较低的材料相比,该产品具有更好的强度、硬度和抗疲劳性。

在某些应用领域,标准聚合物只能提供一定的强度, Callahan说。我们的核心产品PEEK-Optima能够满足一部分的市场需求,但是,如果产品将要用于高负荷的领域,对强度或硬度有极高的要求,而且要考虑负重性和抗疲劳性,市场上很难找到像我们这样的产品。

据该公司介绍,通过向PEEK-Optima中添加高强度碳纤维,其模制单向杆材的的挠曲强度从150MPa增大至1000MPa以上,硬度从3.5GPa增大至150GPa。

除强度增大外,该材料另一个复合特性就是它的成像性。尽管Endolign具有钴铬合金、钛和不锈钢等金属的机械特性,但由于产品为聚合物成分,因而可与MRI兼容。由于该复合材料允许射线通过,因而可采用CT和X射线等方法进行清晰成像,不会产生伪迹。

Callahan先生补充道: 该产品的另一个优点在于,使用金属材料时,有时会发生金属离子过敏,产生过敏反应;而我们没有这种担心。

Endolign以预浸渍卷带的形式提供,可模制成杆材等形状。产品除高强度外,另一个特点就是可耐受蒸汽、伽马射线和环氧乙烷等方法的重复消毒,而不受损害。

该复合材料适合与血液、骨骼或组织接触超过30天的负重产品,可用于骨片针、脊柱固定架、骨折接骨板和髓内钉等器械。该材料具有CE标志,并通过FDA认证。

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