摘要
下颌骨缺损是颌面外科临床常见的疾病。缺损的原因常见于外伤、感染、肿瘤切除手术等,也可见于某些先天性畸形。理想的颌骨缺损重建不光要求恢复正常的面部外形,更需要恢复咬合功能。这便要求恢复骨性的牙槽嵴,以利植入种植体修复牙列。目前,临床上最常用的下颌骨缺损修复方法是骨移植,包括单纯游离骨移植和血管化骨瓣移植。不过这两种骨移植方法均完全依靠手术过程中术者对骨块进行手工塑形,耗费手术时间,且难以获得理想的形态修复。过去的十年中,一种工程制造的新技术——快速成形技术被引进到医学领域。快速成形技术善于精确制造复杂实体,能够制造出结构与形状精确匹配的颌面骨替代物,尤其对于临床上常规方法难以完成的复杂的面部缺损重建,具有重要意义。在颌面畸形与缺损的整复中,可针对不同个体,快速而准确地设计并制作出个体化的修复体。利用快速成形技术可以在术前完成修复体的设计制作,因而术中无需对修复体塑形,且精确的制作能使修复体快速准确就位,在获得良好的面部外形重建的同时,可以有效缩短手术时间[1]。如果能够将快速成形制造的修复体和骨移植结合相结合,则有望实现外形和功能兼得的仿生学修复。
本研究通过一系列的实验,设计、应用并改进了快速成形植骨支架:利用计算机辅助设计与快速成形技术,制作个体化的骨移植托槽,用于松质骨移植恢复下颌骨的骨连续性,期望植骨成活后,作为牙种植体的骨性支持,最终修复咀嚼功能,从而实现功能修复。在动物实验和临床初步应用中发现快速成形植骨支架最主要的问题:应力屏蔽效应。并最终通过优化植骨托槽的设计方案,使之减少刚性,而使咬合应力能够传导到植骨块,从而有利于植骨的改建和代谢。
本研究共分为五个实验。
实验一:利用快速成形支架结合自体松质骨移植修复下颌骨缺损:动物实验研究
本实验利用快速成形支架结合自体骨移植修复下颌骨节段性缺损,期望实现功能和形态兼顾的理想修复效果。并探讨应用核医学方法监测钛支架内部移植骨的转归情况。以10只杂种犬作为实验动物。通过螺旋CT采集犬头颅CT图像,建立CAD模型,在模型上制造一侧下颌骨4cm长的节段性缺损,并利用镜像对称重构缺损区域,设计完全匹配的个体化的植入支架,通过快速成形技术获得树脂模型,再铸造得到钛支架。然后手术制造下颌骨缺损,植入钛支架,并在支架内充填碎髂松质骨。术后2、4、8、12及24周进行核素骨显像检查,连续观察移植骨的核素分布情况,判断植骨是否成活。结果发现术后植骨区域较对侧正常下颌骨有明显的核素浓聚。核素计数比值半定量分析发现术后2周时,植骨区和对照侧核素计数比值最大,此后呈逐渐下降趋势。实验说明快速成形支架结合自体骨移植植入下颌骨缺损区后,植骨块能够成活。利用核素骨显像监测金属支架内移植骨成活的方法是可行的。
实验二:利用快速成形技术精确重建下颌骨间断性缺损的临床研究
本实验中,利用个体制造的钛支架结合自体髂松质骨移植,修复6例因为外伤或者肿瘤截除的下颌骨。个体制造的钛支架是应用RE/CAD/RP技术制造而得。通过螺旋CT扫描获得数字三维模型,在模型中,通过镜像对称方法,将正常侧下颌骨的镜像图像覆盖缺损区,以恢复良好的面部对称性。基于镜像图像设计骨移植支架,并通过快速成形制造出支架模型,模型包埋后利用和铸钛方法得到个体化的钛支架。利用该个体化的支架,结合自体髂骨移植,重建下颌骨缺损。在其中一例中,试行种植义齿,以恢复咬合。结果在6例患者中,利用快速成形技术制作的钛支架和各自的下颌骨残端精确匹配。使下颌骨重建手术很容易,而且节省时间,术后获得了满意的面部对称性。经过平均4年的随访,在5例未进行种植修复的患者中,均无严重并发症发生。而在随访病例复查X线片时发现,植骨槽内呈现低密度影,提示骨移植到植骨槽内,并没有完成骨改建形成良好的骨修复。而且在一例进行咬合重建的病例中,咬合重建只持续了一年,终因骨吸收和感染而告失败。实验说明,通过快速成形技术制作的个体化支架应用于下颌骨修复,能够获得满意的面部外形。快速成形技术为临床下颌骨重建提供非常实用的技术支持。然而,铸造的钛支架的刚性可能对支架内填充的移植骨块产生严重的应力遮挡,这可能导致植骨的废用性萎缩。因此,需要对支架做进一步的改进以利下颌骨的功能性重建。
在进一步的研究中,我们致力于通过改变植骨支架的设计,而促进植骨的成活和改建。在改进支架设计过程中,我们主要从两个方面入手:1、减小支架的体积。对于外形而言,仅修复完好的颊面形态,即可满足医生和患者对面部外形的要求。现有的快速成形支架体积巨大,形成血供阻挡,不利于植骨的成活和改建,因而,在保证足够强度的基础上,设法减少植骨支架的体积和面积,理论上可以增进骨改建。因此我们考虑,仅通过RP技术设计植骨槽的颊面,通过贴附式植骨,将植骨块固定在修复体的舌侧。如此,植骨块只有颊侧存在金属支架对血运的阻挡,而舌侧仍然可以与周围软组织很好的接触,增强了血液供应并有利于肌肉的附着。2、通过结构优化设计,降低铸造钛支架的刚性,以期减少支架对内部游离植骨的应力屏蔽和血运阻挡等不利影响。通过改进植骨支架的曲面结构,使对于其中的植骨的应力屏蔽效应达到最小化。
实验三:个体化快速成形钛重建板应用于下颌骨缺损的修复
通过减小支架的面积,只保留托槽支架的颊侧面,结合块状自体髂松质骨块,修复下颌骨缺损。通过犬动物实验发现,固定在在颊面板支架舌侧的有软组织附着则有良好的骨块形成,植骨块的颊侧紧邻重建板,被重建板阻挡了血运,因而成骨不佳,发生骨吸收、纤维化,甚至于形成死骨。结果说明,应用颊面板形式的个体化重建板尚不能完全解决血运阻挡的问题,因为颊面板无法承载颗粒状植骨,只能以大块骨固定在颊面板上,而块状的植骨不利于血供的渗透,加上支架的阻挡,所以容易坏死。
实验四:下颌骨植骨支架的优化设计
通过三维有限元分析方法分析正常下颌骨的受力和应变分布。运用ANSYS软件对下颌修复体进行CAD建模和力学分析研究,在常规托槽型钛下颌植骨支架的基础上对下颌修复体体部进行柔性结构优化设计。引入骨应力重建理论作为理论依据,对骨移植托槽支架进行优化设计。以使支架能够在保证安全,不至于折断的条件下,更多的植骨能够处于有利于成骨的应变范围。通过综合比较一系列的柔性化设计,我们选择了一种体部开槽的弹簧状支架。
实验五:柔性化快速成形下颌骨植骨支架应用于下颌骨缺损重建的动物实验研究
进一步通过以杂种犬的动物实验,验证了实验四得出的柔性植骨支架对促进移植骨成骨的作用。以9只杂种犬作为实验动物,应用优化设计后的支架作为假体,修复犬下颌骨体部40mm长的节段性缺损。修复术后通过核医学方法检测支架内部填充游离自体移植骨的成活状态,取材后通过大体标本观察和三点弯曲试验,评价支架内植骨改建后的形态和强度。并和托槽型支架结果进行比较。术后核医学检测结果发现,柔性支架内部的自体移植骨具有更高的活性。取材后见实验组各个标本成骨良好,移植骨改建后不同程度地将支架包裹。有1例在术后1月左右发生支架折断,但取材后发现成骨良好,完全将支架包裹。实验说明经结构优化设计后的快速成形支架能够有效的降低钛支架对内部植骨的应力屏蔽及其它不利影响,相对常规孔槽状支架更有利于内部植骨的成活。
Mandible reconstruction poses a vast challenge to maxillofacial surgeons. There is no ideal method that can achieve satisfactory esthetic and functional results. Free bone grafting, including non-vascularized and vascularized bone grafting, is the most commonly used method for reconstruction of mandibular defects. However, for the non-vascularized bone grafting, resorption of the block bone graft remains unsolved, and it’s not suitable for the large defects. Moreover, it is difficult to achieve ideal aesthetic reconstruction, because of that the bone grafts were manually shaped and fixed intraoperatively. Success rates of over 90% have been achieved with vascularized bone grafting. However, harvesting a vascularized graft requires complicated operative techniques and takes lots of time during the operation. And to reconstruct symmetrical facial appearance is extremely difficult.
The reverse engineering (RE), CAD/CAM, and rapid prototyping (RP) technologies, originated in the field of industrial fabrication, have been employed to construct craniofacial prostheses. Their feasibility and efficiency have been well demonstrated. However, mandibular segmental defects reconstruction demands not only appearance reconstruction, but also bony continuity to facilitate prosthetic dental rehabilitation. In this study, a customized bone grafting tray was manufactured using the RE-CAD-RP technology, aiming to reconstruct the mandibular shape and the bony continuity at one time. Preshaped titanium mesh tray has been demonstrated to be feasible to carry the autologous cancellous bone grafts to restore bone defects. Thus the bone grafts in the tray was expected to be remodeled and serve as a bony support for the further implant dental implantation.
This study includes 5 experiments:
Experiment 1. Reconstruction of Mandibular Defects with the Combination of Rapid Prototyped Tray and Autologous Iliac Bone Grafting: Animal Experiment in Hybrid Dogs.
The purpose of this experiment is to repair a mandibular discontinous defect using Computer-Aided Design (CAD) and Rapid Prototyping (RP) technique,for satisfactory aesthetic and functional restoration. 10 hybrid dogs were used for this experiment. Helical CT scanning was performed for each subject, and 3D digital model of the skulls of the dogs was constructed with the CT slices in Mimics. After that, segmental mandible dissection was simulated on the model in Geomagic, and individualized bone grafting tray was designed based on the digital. A prototyped tangible resin model was then obtained using the Stereolithography technology. A custom titanium tray was then cast for each animal, and then an operation was done on the each subject. A Discontinous defect in the mandibular body was created according to the CAD proposal. The defect was restored immediately using the tray combining autologous iliac cancellous bone grafting. Sequential radionuclide bone imaging was performed in 2nd,4th,8th,12th,24th week to evaluate the bone graft. Semi-quantitative analysis was done by comparing the ratio of activity between the grafted and the host left mandible. The radionuclide tracer uptake greatly increased in the grafted mandible over a follow-up period of 24 week. the mean activity ratio between the grafted and the contralateral host mandible was greatest at 2 week. The results suggested that the bone graft survived and active modification occurred. The study demonstrates that customized CAD-RP titanium tray combining autologous cancellous bone grafting is feasible for the reconstruction of mandibular discontinuous defect. And radionuclide bone imaging is a sensitive and efficient means for evaluating the bone graft in the Titanium tray. [1]
Experiment 2. Accurate Reconstruction of Discontinuous Mandible Using a Rapid Prototyped Tray in Combination with Autologous Bone Grafting: A Preliminary Clinical Study
Six patients who had undergone various block resection of the mandible were restored using a custom titanium tray combining autogenous iliac grafts. The custom titanium tray was fabricated using the rapid prototyping technique. A CAD model of the mandible was constructed in MIMICS with the CT scanning data. The opposite side (unaffected side) of the mandible was mirrored to cover the defect area. A bone grafting tray was designed from the mirrored image. Rapid prototyped model was then obtained and used for casting to get a titanium tray. The mandibular defects were restored using the custom titanium trays in combination of autologous iliac grafting. For 1 of the 6 patients, an implant denture was made to rehabilitate the occlusion, at 24 weeks postoperatively. Results revealed that the prototyped trays fit well in all 6 patients. Satisfactory mandibular symmetries were restored for all of the 6 patients. The reconstructive procedures were straight, simple and time saving. No severe complications ware noted in the other 5 patients without occlusion rehabilitation during a mean 50-month follow-up period. The reconstruction in the patient with occlusion rehabilitation lasted only 1 year and failed eventually due to bone resorption and infection. This case was restored after another 6 months, using vascularized bone grafting. This study suggested that the Rapid Prototyping technique facilitated the clinical mandibular reconstruction and secured satisfactory esthetic reconstruction. However, the rigidity of the cast titanium tray could cause severe stress shielding to the grafts filled in the tray, which could lead to disuse atrophy. Therefore, some modification is needed for better functional reconstruction.[2]
Experiment 3. customized grafting plate for mandibular defects.
To reduce the area of the grafting tray, we cut off the lingual and bottom wall of the U shaped tray. A customized tray that only has a buccal wall, which we called“customized grafting plate”, was computer-aided designed and rapid prototyped. A titanium plate was used to reconstruct discontunous mandible, by combining with autologous iliac grafting in dogs. The results revealed that, the grafted bone which is opposite to the plate survived and got corticalized, while the bone graft close to the plate was observed absorbed or osteonecrosis formed. These results suggested that, the customized grafting plate could increase the blood supply of the lingual side but not the buccal side. Furthermore, the plate can’t carry the crushed iliac bone graft, thus iliac cancellous bone block was attached onto the plate, which is not good for nutrient penetration.
Experiment 4. Optimum Designed Rapid Prototyping Tray for Reconstruction of Mandibular Defects.
To diminish the stress shield that the tray affect to the inner bone graft,the rapid prototyping tray was optimum designed to decrease the rigidity of the cast titanium tray. ANSYS 6.0 was used to construct the CAD model of the mandible and the Titanium prosthesis,and mechanical simulation investigation was done. Optimum design in the body part of the prosthesis was made on the base of the routine tray.
Experiment 5. Reconstruction of Mandibular Defects with the Optimum Rapid Prototyped Tray. Animal experiments were done to compare the advantages of the optimum designed tray to the routine U shaped tray in reconstruction of mandibular defects. Nine hybrid dogs were used to investigate the difference between the optimumized tray and the routine tray. 3D digital model was made through helical CT scanning for each subject. Segmental mandible dissection was simulated on the model. And individualized Titanium bone grafting tray was made utilizing CAD-RP technique. Optimumize tray for the 9 subjects in the experimental group,routine tray for the control group. And then an operation was done on the each subject. Discontinuity defect in the mandibular body was created in accordance with the CAD proposal. The defect was restored immediately using the tray combining autologous iliac cancellous bone graft. Sequential radionuclide bone imaging was performed in 2nd,4th,8th,12th,24th week to evaluate the bone graft. And quantitative analysis was done by comparing the ratio of activity between the grafted and the contralateral host mandible. Gross observation and Three-point bending test was done for each sample after sacrifice and harvesting. The radionuclide bone imaging revealed that the bone graft in the optimumized tray has a higher activity than that in the routine tray. The optimumized tray fractured in one of the 10 subjects at about 1 month postoperatively,while the gross observation of the bone sample showed that the bone grafted survived and the rebuilt in a good condition. Infection and osteonecrosis occurred in 2 subjects after the breakage of the alveolar mucosa. Partly osteonecrosis occurred in the inner part of bone graft in the tray,and the bone block covered on the top the tray survived in 2 subjects. Fibrous connective tissue was observed between the bone and the tray in 3 samples. The rest 3 samples were found good. The optimum designed trays could effectively diminish the stress shield and other adverse effect to the in-filled bone graft.
They are more profit for the survival and remolding of the bone graft comparing to the routine trays.
引文
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