DEVELOPMENT OF HYBRID-TYPE ARTIFICIAL LIGAMENT COMPOSED OF BIOABSORBABLE SYNTHETIC FIBERS AND HUMAN COLLAGEN BIBER BUNDLES

由生物可吸收合成纤维和人体胶原蛋白束组成的混合型人工韧带的开发

• 批准号: 10558124
• 负责人: YASUDA Kazunori
• 金额: $ 7.36万
• 依托单位: HOKKAIDO UNIVERSITY
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (B)
• 财政年份: 1998
• 资助国家: 日本
• 起止时间: 1998 至 2001
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-10558124/
• 关键词: Artificial ligament; Hybrid-type material; Bioabsorption; Collagen; Ligament reconstruction; Biomaterial; 人工靭帯; 靭帯再建術

1. The natural healing phenomenon occurs in the human-derived collagen fiber bundle portion of the hybrid-type artificial ligament (Hyb-AL) which was implanted within the bone tunnel. This part was bonded to the body wall with fibrous connective tissue. The bonding strength of this part was inferiorto that of the bone tendon autograft at 3 weeks, but equivalent at 6 weeks.2. In ACL reconstruction using the Hyb-AL composed of bioabsorbable Polydioxanone fibers having a diameter of 0.01 mm, foreign body reaction occurred More significantly within the bone tunnel. Subsequently, the tunnel was enlarged to a greater degree in comparison with the Hyb-AL using 0.6-mm Polydioxanone (PD) fibers. In tensile testing, there were no significant differences in the maximum load between these two types of artificial ligament. The diameter and the volume of bioabsorbable synthetic fibers significantly affect intraosseous healing of the Hyb-AL.3. The hybrid-type artificial ligament involving Polyglactin … More e (PG) fibers was commonly pulled out from the tunnel. In gross observation of the specimens after pull-out testing, the PG fibers were always melt. These results were extremely different from those in the other artificial ligaments. The PG fiber is not appropriate as a component of the Hyb-AL.4. There were no significant differences in the failure mode and the maximum load among the Hyb-ALs involving absorbable Polylactic acid (PL) fibers, PD fibers, and non-absorbable Polyester (PE) fibers. The Hyb-AL involving PL fibers or PD fibers is expected to have the same ability as that involving PE fibers, at least, for 6 weeks.5. Around PL fibers and PE fibers, new bone formation richly occurred within the bone tunnel so that the tunnel became narrow.6. Based on these results, the hybrid-type artificial ligament composed of bioabsorbable PL fibers and human-derived collagen fiber bundles is considered to useful for clinical application.7. Finally, we designed 2 types of Hyb-AL for clinical use in ACL- and PCL-reconstruction surgeries. We also developed surgical procedures to implant these ligaments. Less

1. 在骨隧道内植入的混合型人工韧带（Hyb-AL）中，人源性胶原纤维束部分出现自然愈合现象。这部分通过纤维结缔组织与体壁结合。该部分的结合强度在3周时低于自体骨肌腱，但在6周时相当。使用直径为0.01 mm的生物可吸收聚二恶酮纤维组成的Hyb-AL重建前交叉韧带时，骨隧道内发生的异物反应更为明显。随后，与使用0.6 mm聚二氧环酮（PD）纤维的Hyb-AL相比，隧道扩大到更大的程度。在拉力测试中，两种人工韧带的最大载荷无显著差异。生物可吸收合成纤维的直径和体积对hyb - al骨内愈合有显著影响。累及聚乳酸蛋白（PG）纤维的混合型人工韧带通常从隧道中拔出。拔试后大体观察，PG纤维始终处于熔融状态。这些结果与其他人工韧带的结果截然不同。PG纤维不适合作为Hyb-AL.4的组成部分。可吸收聚乳酸（PL）纤维、PD纤维和不可吸收聚酯（PE）纤维的hyb - al在失效模式和最大载荷方面没有显著差异。涉及PL纤维或PD纤维的Hyb-AL预计至少在6周内具有与涉及PE纤维相同的能力。在PL纤维和PE纤维周围，骨隧道内大量新骨形成，使隧道变窄。基于这些结果，认为由生物可吸收聚乳酸纤维和人源性胶原纤维束组成的混合型人工韧带具有临床应用价值。最后，我们设计了2种Hyb-AL用于ACL和pcl重建手术的临床应用。我们还开发了外科手术来植入这些韧带。少

项目成果

遠山晴一: "負荷増大がIn situ凍結処理後膝蓋腱の力学的特性に与える影響"日本臨床バイオメカニクス学会誌. 20. 123-128 (1999)

Haruichi Toyama：“原位冷冻治疗后负荷增加对髌腱机械性能的影响”日本临床生物力学学会杂志 20. 123-128 (1999)。

安田和則: "成長因子TGF-βおよびEGFの混合投与が凍結処理前十字靭帯の力学的特性に与える効果,---投与畤期による効果の差異---"第12回バイオエンジニアリング講演会講演論文集. 99. 11-12 (2000)

安田和典：“混合施用生长因子TGF-β和EGF对冷冻前交叉韧带机械性能的影响，---根据施用时间不同效果的差异---”第12届生物工程会议演讲论文集99。 11-12（2000）

原則行: "膝屈筋腱-ハイブリッド代用材料を用いた膝前十字靭帯再建術後における脛骨骨孔径の変化"臨床整形外科. 34. 1097-1102 (1999)

原理：“使用膝关节屈肌腱混合替代材料重建前交叉韧带后胫骨隧道直径的变化”《临床骨科》34。1097-1102（1999）。

Kimura S: "The degradation of the bioabsorbable polydioxanone fiber depends on the implantation site and the diameter"Trans Orthop Res Soc. 23. 322-322 (1998)

Kimura S：“生物可吸收聚二氧环己酮纤维的降解取决于植入部位和直径”Trans Orthop Res Soc。

Tohyama H: "Anterior drawer test for acute anterior talofibular ligament injuries of the ankle. How much load should be applied during the test?"J Bone Joint Surg, Orthop. Trans. 21. 1207-1207

Tohyama H：“踝关节急性前距腓韧带损伤的前抽屉试验。试验期间应施加多少负载？”J Bone Joint Surg，Orthop。