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具有超弹性结构 Nitinol 锚固元件的螺钉植入物的功能化。

Functionalization of screw implants with superelastic structured Nitinol anchoring elements.

机构信息

Fraunhofer Institute for Machine Tools and Forming Technology IWU, 01187, Dresden, Germany.

Asklepios Orthopädische Klinik Hohwald, 01844, Neustadt in Sachsen, Germany.

出版信息

Biomed Eng Online. 2022 Jan 11;21(1):3. doi: 10.1186/s12938-021-00975-4.

Abstract

BACKGROUND

Demographic change is leading to an increase in the number of osteoporotic patients, so a rethink is required in implantology in order to be able to guarantee adequate anchoring stability in the bone. The functional modification of conventional standard screw implants using superelastic, structured Ti6Al4V anchoring elements promises great potential for increasing anchoring stability.

METHODS

For this purpose, conventional screw implants were mechanically machined and extended so that structured-superelastic-positionable-Ti6Al4V anchoring elements could be used. The novel implants were investigated with three tests. The setup of the anchoring elements was investigated in CT studies in an artificial bone. In a subsequent simplified handling test, the handling of the functional samples was evaluated under surgical conditions. The anchorage stability compared to standard screw implants was investigated in a final pullout test according to ASTM F543-the international for the standard specification and test methods for metallic medical bone screws.

RESULTS

The functionalization of conventional screw implants with structured superelastic Ti6Al4V anchoring elements is technically realizable. It was demonstrated that the anchoring elements can be set up in the artificial bone without any problems. The anchorage mechanism is easy to handle under operating conditions. The first simplified handling test showed that at the current point of the investigations, the anchoring elements have no negative influence on the surgical procedure (especially under the focus of screw implantation). Compared to conventional standard screws, more mechanical work is required to remove the functional patterns completely from the bone.

CONCLUSION

In summary, it was shown that conventional standard screw implants can be functionalized with Ti6Al4V-structured NiTi anchoring elements and the new type of screws are suitable for orthopedic and neurosurgical use. A first biomechanical test showed that the anchoring stability could be increased by the anchoring elements.

摘要

背景

人口结构的变化导致骨质疏松症患者的数量增加,因此需要对植入物进行重新思考,以便能够保证在骨骼中具有足够的锚固稳定性。使用超弹性、结构化 Ti6Al4V 锚固元件对传统标准螺钉植入物进行功能改性,有望极大地提高锚固稳定性。

方法

为此,对传统的螺钉植入物进行机械加工和扩展,以便使用结构化的超弹性可定位 Ti6Al4V 锚固元件。新型植入物通过三项测试进行了研究。在人工骨中的 CT 研究中研究了锚固元件的设置。在随后的简化处理测试中,根据 ASTM F543(金属医用骨螺钉的标准规范和试验方法的国际标准)评估了在手术条件下处理功能样本的情况。最后根据 ASTM F543 进行了拔出试验,以研究与标准螺钉植入物相比的锚固稳定性。

结果

用结构化的超弹性 Ti6Al4V 锚固元件对传统螺钉植入物进行功能化在技术上是可行的。结果表明,锚固元件可以在人工骨中无任何问题地进行设置。锚固机制在手术条件下易于处理。第一个简化的处理测试表明,在目前的研究点,锚固元件不会对手术过程(尤其是在植入螺钉的重点)产生任何负面影响。与传统的标准螺钉相比,需要更多的机械功才能将功能图案从骨骼中完全移除。

结论

综上所述,结果表明可以用 Ti6Al4V 结构的 NiTi 锚固元件对传统标准螺钉植入物进行功能化,新型螺钉适合用于矫形和神经外科。初步的生物力学测试表明,锚固元件可以提高锚固稳定性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e522/8751162/64cdee0851ab/12938_2021_975_Fig1_HTML.jpg

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