CN106473836A - 一种多孔peek界面钉 - Google Patents
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Abstract
本发明公开了一种多孔PEEK界面钉，所述界面钉包括主体，所述主体由PEEK材料制成，在所述主体上设置有多个所述微孔，所述界面钉的孔隙率在20％到85％之间，所述微孔的直径在0.1mm到1mm之间，所述主体包括前端和后端，所述前端为圆锥形，所述前端和所述后端连接为一体，所述界面钉用于前交叉韧带手术中。本发明的多孔PEEK界面钉，具有较好的生物相容性，新骨生长效果好，在使用过程中不容易脱落，制造过程简单，成本低。
Description
技术领域
本发明涉及外科植入物，尤其涉及一种多孔PEEK界面钉。
背景技术
前十字韧带，又称前交叉韧带，位于膝关节内，连接股骨与胫骨，主要作用是限制胫骨向前过度移位，它与膝关节内其他结构共同作用，来维持膝关节的稳定性，是维持膝关节稳定的主要结构之一，使人体能完成各种复杂和高难度的下肢动作。
前交叉韧带撕裂引起膝关节不稳，治疗不当将引起膝关节功能严重障碍。由于损伤暴力较大，常合并其他主要结构损伤，诊断、处理不当将会延误治疗，同时由于前交叉韧带的力学功能日益得到重视，以及损伤后造成的功能性不稳定，造成的膝关节不能满足日常生活和运动的需要，并可导致膝关节一系列后遗病变，因此应该行手术治疗，重建韧带及其功能。
前交叉韧带断裂手术会使用界面螺钉或纽扣板进行对肌腱移植物进行固定，但是界面螺钉对肌腱移植物的切割作用，进一步影响了肌腱的抗拉强度和腱与骨愈合。而纽扣板固定伴随的“雨刷效应”和“蹦极效应”可能会破坏移植物在骨隧道内的生物学愈合过程。
而现有的金属界面钉的生物相容性差，容易产生排斥反应。而可吸收界面钉在不同人体内的吸收速度与可吸收程度都存在较大差异，因此手术效果不稳定。
因此，需要提供一种多孔PEEK界面钉以解决上述问题。
发明内容
为了解决该问题，本发明公开了一种多孔PEEK界面钉，所述界面钉包括主体，所述主体由PEEK材料制成，在所述主体上设置有多个所述微孔，所述界面钉的孔隙率在20％到85％之间，所述微孔的直径在0.1mm到1mm之间，所述主体包括前端和后端，所述前端为圆锥形，所述前端和所述后端连接为一体，所述界面钉用于前交叉韧带手术中。
较佳地，所述界面钉的孔隙率优选为30％到50％。更优选的孔隙率为40％。
较佳地，所述微孔的直径在0.4mm到0.6mm之间。更优选的，所述微孔的直径为0.5mm。
较佳地，所述主体的表面粗糙度在0.2微米至10微米之间。
较佳地，所述前端和所述后端上设置有外螺纹，所述外螺纹外沿平整。
较佳地，所述主体整体上设置为圆锥形。
较佳地，所述后端可以为圆柱体或长方体。
较佳地，所述界面钉通过激光烧结PEEK粉末，通过3D打印而制造。
本发明的多孔PEEK界面钉，具有较好的生物相容性，新骨生长效果好，在使用过程中不容易脱落，制造过程简单，成本低。
在发明内容部分中引入了一系列简化形式的概念，这将在具体实施方式部分中进一步详细说明。本发明内容部分并不意味着要试图限定出所要求保护的技术方案的关键特征和必要技术特征，更不意味着试图确定所要求保护的技术方案的保护范围。
以下结合附图，详细说明本发明的优点和特征。
附图说明
图1是根据本发明一个实施例的多孔PEEK界面钉的示意图。
具体实施方式
在下文的描述中，给出了大量具体的细节以便提供对本发明更为彻底的理解。然而，对于本领域技术人员来说显而易见的是，本发明可以无需一个或多个这些细节而得以实施。在其他的例子中，为了避免与本发明发生混淆，对于本领域公知的一些技术特征未进行描述。
为了彻底了解本发明，将在下列的描述中提出详细的结构。显然，本发明的施行并不限定于本领域的技术人员所熟习的特殊细节。本发明的较佳实施例详细描述如下，然而除了这些详细描述外，本发明还可以具有其他实施方式。
以下结合附图对本发明的实施例做详细描述。
参考图1，是根据本发明一个实施例的多孔PEEK界面钉的示意图。本发明的界面钉，采用PEEK(聚醚醚酮)制造。PEEK材料具有优异的生物相容性和力学性能，能够长期植入人体并且不引起人体排斥。PEEK材料密度低，而多孔的PEEK材料更能降低植入体的质量，另外，PEEK材料的弹性模量接近人体皮质骨，能够很好的刺激骨再生。
本发明的多孔PEEK界面钉包括主体1，主体1包括前端2和后端3。前端2为圆锥形，前端2和后端3连接为一体。上述多孔PEEK界面钉前端为锥形，进入骨隧道与肌腱移植物之间时阻力较小，并对肌腱移植物无切割作用。在一个例子中，后端3可以为圆柱体，以进一步减少阻力。在另一个例子中，后端3可以为长方体。另外，主体1也可以整体上设置为圆锥形。由于前端为锥形，进入骨隧道与肌腱移植物之间时阻力较小，并对肌腱移植物无切割作用。
较佳地，如图1所示，前端2和后端3上设置有外螺纹，外螺纹外沿平整，同样对肌腱移植物无切割作用。由于设置了螺纹，更加容易植入，并提高了结合的稳定性。
在主体1上设置有多个微孔4，本发明的多孔PEEK界面钉能够很好的诱导新骨在界面钉表面以及体内生长。
对于微孔的设置，如果设置的数量过多，会影响界面钉整体的强度，如果设置的数量过少，则会使新骨的产生效果不佳。因此，选择合适的孔隙率尤为重要。孔隙率即为孔隙总体积占产品体积的比例。其计算方式如下：
式中：P为孔隙率(％)，dr为材料实际密度(g/cm3)，dth为材料理论密度(g/cm3)。
经过试验，申请人发现，孔隙率的选择在25％-85％之间都可以获得较好的新骨生长。试验如下：
1.采用3D打印PEEK技术，利用激光烧结PEEK粉末，制造出本发明的多孔PEEK界面钉。界面钉的长度为25mm，螺纹处直径为8mm，无螺纹处直径为5mm，孔隙直径选择为0.5mm。在上述参数相同的参数下，分别制备孔隙率为25％、30％、40％、50％、85％的界面钉。
2.试验对象采用健康成年家犬，体重约为13公斤。分为五组，每组4只。其中A组采用孔隙率为25％的界面钉，B组孔隙率为30％，C组孔隙率为40％，D组孔隙率为50％，E组孔隙率为85％。
3.将上述试验对象在股骨外侧髁中心部位制造骨缺损，缺损区域和界面钉大小一致。植入界面钉完毕后缝合创口。
4.手术3个月后，取试验对象股骨外侧髁标本。对骨缺损处新生骨组织进行定量分析。计算方式为：
N＝骨组织面积/视野内总面积x 100％。
其中N为新生骨组织面积比。
在进行定量分析时，可以采用市场上的全自动显微镜进行图像采集，并通过图像分析软件(例如Image pro等)进行定量分析。结果如下：
| 组别 | N(平均值) |
| A组(孔隙率25％) | 10.33 |
| B组(孔隙率30％) | 14.87 |
| C组(孔隙率40％) | 19.23 |
| D组(孔隙率50％) | 27.70 |
| E组(孔隙率85％) | 52.86 |
从上述结果可以看出，孔隙率越高，则新骨的生长越好。因此，如不考虑强度等因素，可以选择孔隙率更高的界面钉。但是，如果孔隙率过高，则对强度有所影响。因此，较佳的，孔隙率选择在30％-50％。更优的选择为40％。
上述的微孔4的孔径可以选择在0.1mm-1mm之间。优选地，孔径为0.4mm-0.6mm。在另一个例子中，所述微孔的直径为0.5mm。
另外，为了促进血小板附着和纤维蛋白块的粘连，为早起骨形成提供初始的稳定环境，本发明中的界面钉的表面的粗糙度Ra选择大于0.2微米而小于10微米。
如上所述，本发明的界面钉的制备可以采用激光烧结3D打印PEEK技术，利用激光烧结PEEK粉末，“打印”出多孔PEEK界面钉。本发明的界面钉的制备只需用到PEEK粉末，相比于PEEK型材，粉末的成本大大降低，且损耗低。而且制备过程不需要添加造孔剂，因此不会出现清洁不干净造成的污染为题，且工艺简单，成本低。
本发明的多孔PEEK界面钉，具有较好的生物相容性，新骨生长效果好，在使用过程中不容易脱落，制造过程简单，成本低。
本发明已经通过上述实施例进行了说明，但应当理解的是，上述实施例只是用于举例和说明的目的，而非意在将本发明限制于所描述的实施例范围内。此外本领域技术人员可以理解的是，本发明并不局限于上述实施例，根据本发明的教导还可以做出更多种的变型和修改，这些变型和修改均落在本发明所要求保护的范围以内。本发明的保护范围由附属的权利要求书及其等效范围所界定。
Claims (10)
1.一种多孔PEEK界面钉，其特征在于，所述界面钉包括主体，所述主体由PEEK材料制成，在所述主体上设置有多个所述微孔，所述界面钉的孔隙率在20％到85％之间，所述微孔的直径在0.1mm到1mm之间，所述主体包括前端和后端，所述前端为圆锥形，所述前端和所述后端连接为一体，所述界面钉用于前交叉韧带手术中。
2.按照权利要求1所述的多孔PEEK界面钉，其特征在于，所述界面钉的孔隙率优选为30％到50％。
3.按照权利要求1所述的多孔PEEK界面钉，其特征在于，所述界面钉的孔隙率为40％。
4.按照权利要求1所述的多孔PEEK界面钉，其特征在于，所述微孔的直径在0.4mm到0.6mm之间。
5.按照权利要求1所述的多孔PEEK界面钉，其特征在于，所述微孔的直径为0.5mm。
6.按照权利要求1所述的多孔PEEK界面钉，其特征在于，所述主体的表面粗糙度在0.2微米至10微米之间。
7.按照权利要求1-6中任一项所述的多孔PEEK界面钉，其特征在于，所述前端和所述后端上设置有外螺纹，所述外螺纹外沿平整。
8.按照权利要求1-6中任一项所述的多孔PEEK界面钉，其特征在于，所述主体整体上设置为圆锥形。
9.按照权利要求1-6中任一项所述的多孔PEEK界面钉，其特征在于，所述后端可以为圆柱体或长方体。
10.根据权利要求1所述的多孔PEEK界面钉，其特征在于，所述界面钉通过激光烧结PEEK粉末，通过3D打印而制造。
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