Titanium fiber metal as a biomaterial implanted for spine fusion

钛纤维金属作为生物材料植入脊柱融合

• 批准号: 01480370
• 负责人: YAMAMOTO Hiroshi
• 金额: $ 4.16万
• 依托单位: Kochi Medical School
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for General Scientific Research (B)
• 财政年份: 1989
• 资助国家: 日本
• 起止时间: 1989 至 1991
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-01480370/
• 关键词: Biomaterial; Titanium; Porous Material; Mechanical Property; Biomechanics; implant; Spine Fusion; Biotolerance

Since 1985, we have developed a favorable biomaterial of titanium fiber metal implant (T. F. M. I.) for anterior spine fusion. The material is made of pure titanium wire of 250 mum diameter woven into mesh and sintered. Compression testing showed that failure stress and modulus of elasticity of this implant more closely resemble those of cancellous bone of vertebrae. And that this material showed reversible strain to the compression stress. Titanium fiber metal implants (8mmx 8mm x5mm) were implanted anteriorly into the lumbar intersegmental space of 16 adult dogs. To provide enough initial fixation, anterior tension band wiring was added at the time of surgery. A periodic observation of the radiological change at the interface of the implant and the bone were carried out. Toluidine-blue stained hard tissue specimens of the implant and the bone were made, and the biological fixation of the implant was evaluated at 1, 3, 6, 9 and 12 months post implantation. Biomechanical fixation of the enplant was measured by the push-out test. After the implantation, radiolucent zone appeared around the implant in all dogs. It was a wide and fuzzy zone, and its margin was unclear. Until the postoperative 3 months, radiolucent zone was noticed around the implant. Then, the abnormal shadow gradually disappeared. One hundred) lm hard tissue specimen by toluidine-blue staining of the animal without any radiolucent area revealed travecular bone formation in the space of the titanium wire. As time passes, the new travecular bone had been gradually growing into the enplants. And at post operative 12 months, the maximum depth of the bone ingrowth was 2.35mm. As time passes, the force to push out had increased. And at 9 months after the implantation, the maximum shearing force of the bone-implant interface was 49.2 kgf/cm_2. These favorable experimental results give us an assurance of the clinical use of this implant as an excellent biomaterial for spine fusion.

自1985年以来，我们开发了一种良好的生物材料钛纤维金属植入物（T。F. M.（一）脊柱前路融合术该材料由编织成网并烧结的直径为250 μ m的纯钛丝制成。压缩测试表明，该植入物的失效应力和弹性模量更接近于椎骨松质骨的失效应力和弹性模量。这种材料表现出对压缩应力的可逆应变。将钛纤维金属植入物（8 mm × 8 mm × 5 mm）植入16只成年犬的腰椎节段间间隙。为了提供足够的初始固定，在手术时增加了前路张力带钢丝。定期观察种植体与骨界面的放射学变化。制作甲苯胺蓝染色的种植体和骨的硬组织标本，并在植入后1、3、6、9和12个月评价种植体的生物学固定。通过推出试验测量植入物的生物力学固定。植入后，所有犬的植入物周围均出现放射性显影带。这是一个广阔而模糊的区域，边缘不清。直到术后3个月，在种植体周围观察到放射性显影带。然后，那道诡异的影子渐渐消失。甲苯胺蓝染色的100 μ m硬组织标本显示钛丝间隙内有横分子骨形成。随着时间的推移，新的横骨已经逐渐长入了植入物中。术后12个月，骨长入最大深度为2.35mm。随着时间的推移，这股推力越来越大。术后9个月骨-种植体界面最大剪切力为49.2kgf/cm_2。这些良好的实验结果为该植入物作为脊柱融合的优良生物材料的临床应用提供了保证。

项目成果

中内 睦郎: "脊椎固定術に対するtitanium fiber metal implantに関する実験的研究" 中部日本整形外科災害外科学会雑誌. 34. 1773-1783 (1991)

Mutsuo Nakauchi：“用于脊柱融合手术的钛纤维金属植入物的实验研究”日本中部整形外科和灾难外科学会杂志 34。1773-1783（1991）。

H. Yamamoto, et al.: "Anterior lumbar body fusion with our Titanium Fiber Metal Implant system" The Central Japan Journal of Orthopaedic Surgery & Traumatology. 34(1). 93-94 (1991)

H. Yamamoto 等人：“使用我们的钛纤维金属植入系统进行前路腰椎融合” 日本中部骨科外科杂志

中内睦郎: "脊椎椎体固定術に対するTitanium Fiber Metal Implantに関する実験的研究(第四報)" 日本整形外科学会雑誌. 63. 995 (1989)

Mutsuo Nakauchi：“用于脊柱融合的钛纤维金属植入物的实验研究（第四次报告）”日本骨科学会杂志 63. 995（1989）。

中内 睦郎: "脊椎固定術に対するTitanium Fiber Metal Implantに関する実験的研究(第5報)" 日本整形外科学会雑誌. 64. 1102 (1990)

Mutsuo Nakauchi：“用于脊柱融合的钛纤维金属植入物的实验研究（第5次报告）”日本骨科学会杂志64. 1102（1990）。

山本 博司: "Titanium Fiber Metal Implantシステムによる腰椎前方固定術" 中部日本整形外科災害外科学会雑誌.

Hiroshi Yamamoto：“使用钛纤维金属植入系统的前路腰椎融合”日本中部骨科和灾难外科学会杂志。