本文選題：多孔鈦 + 激光立體成形��； 參考：《第四軍醫(yī)大學》2014年碩士論文

【摘要】：目前臨床所使用的鈦種植體的彈性模量普遍高于人體骨組織，植入人體后承受載荷時可產生應力屏蔽引起種植體周圍骨吸收、萎縮。降低種植體的彈性模量有利于將種植體承受的咬合力均勻傳遞到骨組織中，消除應力屏蔽作用,對提高種植體的長期成功率具有重要意義。本研究采用激光立體成形方法對純鈦粉進行加工，制備出了多孔鈦材料，期望該材料的力學性能與人體骨組織相接近，增強種植體與骨組織的結合，并通過相關實驗對其進行生物學性能評價，為該材料的臨床應用提供必要的理論依據和實驗基礎。 方法： 1、按照相關行業(yè)標準和中華人民共和國國家標準GB/T16886《醫(yī)療器械生物學評價》中規(guī)定的一系列檢測方法和要求，進行了體外細胞毒性試驗（GB/T16886.5-2003）、口腔黏膜刺激試驗（YY/T0127.13-2009;GB/T16886.10-2005）、短期全身毒性試驗(GB/T16886.11-2011)和溶血試驗（YY/T0127.1-1993; GB/T16886.4-2003），對激光立體成形多孔鈦的生物安全性進行評價。 2、用組織塊培養(yǎng)法對SD大鼠仔鼠成骨細胞進行原代培養(yǎng)，選取第三代細胞接種于多孔鈦材料表面進行體外細胞培養(yǎng)，設表面經噴砂粗化處理的致密鈦材料為對照組。通過MTT法、SEM觀察等方法對新生SD大鼠成骨細胞在實驗材料表面的生長和功能表達情況進行評價，檢測內容包括成骨細胞的貼附、增殖、ALP活性表達以及細胞形態(tài)的觀察。 3、將多孔鈦種植體植入兔股骨，設表面經噴砂粗化處理的致密鈦種植體為對照組。種植術后4周和8周時分兩批處死實驗動物，通過肉眼觀察、X線觀察、SEM觀察、VG染色對種植體周圍骨組織的愈合、種植體-骨界面的結合以及新生骨組織在微孔內的生長情況進行評價。 結果： 1、激光立體成形多孔鈦材料無細胞毒性，對口腔黏膜無刺激性，無短期全身毒性，無溶血作用，顯示了良好的生物安全性。 2、成骨細胞在多孔鈦材料表面生長狀態(tài)良好，與致密鈦材料相比其粗糙多孔的表面更有利于成骨細胞的早期貼附、增殖以及ALP活性表達。 3、多孔鈦種植體在活體動物實驗中表現(xiàn)出良好的生物相容性，種植體周圍骨組織愈合良好，，種植體-骨界面形成骨結合，新生骨組織可以長入并充滿微孔。 結論： 激光立體成形多孔鈦材料的彈性模量和人體骨組織非常接近，具有良好的力學相容性。經過一系列實驗檢測，該材料顯示出優(yōu)良的生物安全性及生物相容性，結果同時顯示多孔鈦材料可以促進骨組織的生長愈合，新生骨組織可以長入并充滿孔隙。
[Abstract]:At present, the elastic modulus of titanium implants used in clinic is generally higher than that of human bone tissue. Reducing the elastic modulus of implants is conducive to the uniform transfer of bite force to the bone tissue and the elimination of stress shielding. It is of great significance to improve the long-term success rate of implants. In this study, the pure titanium powder was processed by laser stereoscopic forming, and the porous titanium material was prepared. The mechanical properties of the material were expected to be similar to that of human bone tissue, and the bonding between implant and bone tissue was enhanced. The biological performance was evaluated by related experiments. To provide the necessary theoretical and experimental basis for the clinical application of the material. Methods: 1. According to the relevant industry standards and the national standard GBT16886 of the people's Republic of China, a series of testing methods and requirements were provided. In vitro cytotoxicity test GB / T 16886.5-2003, oral mucosal irritation test YY / T0127.13-2009 GB / T 16886.10-2005, short-term systemic toxicity test GB / T 16886.11-2011) and hemolysis test YY / T 0127.1-1993and GB / T 16886.4-2003 were used to evaluate the biological safety of porous titanium by laser stereoscopic molding. 2. Tissue culture method was used to evaluate the biosafety of porous titanium in SD rats. Rat osteoblasts were cultured in primary culture. The third generation of cells were inoculated on the porous titanium surface for cell culture in vitro, and the dense titanium materials which were treated by sand blasting and coarsening were used as the control group. The growth and functional expression of neonatal SD rat osteoblasts on the surface of experimental materials were evaluated by MTT assay and SEM observation, including the attachment of osteoblasts. 3The porous titanium implants were implanted into the femur of rabbits, and the dense titanium implants on the surface were used as the control group. At 4 and 8 weeks after implantation, the experimental animals were killed in two batches, and the healing of bone tissue around the implant was observed by observing the bone tissue around the implant with VG staining. The combination of implant-bone interface and the growth of new bone tissue in the micropore were evaluated. Results: 1. Laser stereoscopic porous titanium material had no cytotoxicity, no irritation to oral mucosa, no short-term systemic toxicity and no hemolytic effect. The results showed that the osteoblasts grew well on the surface of porous titanium, and the rough and porous surface of osteoblasts was more favorable to the early attachment of osteoblasts than that of dense titanium. Proliferation and ALP activity expression. 3. The porous titanium implants showed good biocompatibility in vivo animal experiments. The bone tissue around the implants healed well and the implant-bone interface formed bone bonding. Conclusion: the elastic modulus of laser stereoscopic forming porous titanium material is very close to that of human bone tissue and has good mechanical compatibility. After a series of experiments, the material showed excellent biological safety and biocompatibility. The results also showed that porous titanium material could promote the growth and healing of bone tissue, and the new bone tissue could grow into and be filled with pores.
【學位授予單位】：第四軍醫(yī)大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：R783.6

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