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.混合型人工韧带(Hyb-AL)的人源性胶原纤维束部分发生自然愈合现象，植入骨隧道内。这部分用纤维结缔组织粘合在体壁上。结果：1.3周时，该部分的粘接强度低于自体骨肌腱，6周时与自体骨腱的粘接强度相当。在使用由直径为0.01 mm的可生物吸收的聚二氧六环酮纤维组成的Hyb-AL重建前交叉韧带时，异物反应在骨隧道内发生得更明显。随后，与使用0.6 mm聚二氧杂环己酮(PD)纤维的Hyb-AL相比，隧道扩大到了更大的程度。在拉伸试验中，两种类型的人工韧带的最大载荷没有显著差异。生物可吸收合成纤维的直径和体积对Hyb-AL.3的骨内愈合有显著影响。含聚乳酸…的混合型人工韧带更多的E(PG)纤维通常从隧道中拔出。在拔出试验后的大体观察中，PG纤维总是融化的。这些结果与其他人工韧带的结果有很大的不同。PG纤维不适合作为Hyb-AL.4的组件。可吸收聚乳酸(PL)纤维、PD纤维和不可吸收聚酯(PE)纤维的Hyb-ALS在失效模式和最大载荷方面没有显著差异。含有PL纤维或PD纤维的Hyb-AL有望与含有PE纤维的Hyb-AL具有相同的能力，至少6周。在PL纤维和PE纤维周围，新骨形成丰富，使骨隧道变窄。基于这些结果，生物可吸收PL纤维和人源性胶原纤维束组成的杂交型人工韧带被认为是有临床应用价值的。最后，我们设计了两种Hyb-AL用于前交叉韧带和后交叉韧带重建手术的临床应用。我们还开发了植入这些韧带的手术程序。较少

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。