中国组织工程研究

中国组织工程研究 ›› 2024, Vol. 28 ›› Issue (30): 4795-4799.doi: 10.12307/2024.650

• 数字化骨科 digital orthopedics • 上一篇    下一篇

构建“等效模型”快速验证个性化骨模型的精确度

张爱丽1，黄家峥1，樊  文1，李沂桓2，李  爽2，甘学文1，熊  鹰1   

  1. 1昆明医科大学附属延安医院，云南省昆明市   650051；2昆明霂恩医疗科技有限公司，云南省昆明市   650000
  • 收稿日期:2023-07-21 接受日期:2023-09-22 出版日期:2024-10-28 发布日期:2023-12-25
  • 通讯作者: 熊鹰，昆明医科大学附属延安医院，云南省昆明市 650051
  • 作者简介:张爱丽，女，1989年生，云南省昆明市人，土家族，2018年昆明医科大学毕业，硕士，主管药师，主要从事医疗器械产品转化方面的研究。
  • 基金资助:
    云南省科技厅重大科技专项计划(202102AA310040)，项目负责人：熊鹰

Establishing equivalent model to verify the precision of personalized bone model rapidly

Zhang Aili1, Huang Jiazheng1, Fan Wen1, Li Yihuan2, Li Shuang2, Gan Xuewen1, Xiong Ying1   

  1. 1Yan’an Hospital Affiliated to Kunming Medical University, Kunming 650051, Yunnan Province, China; 2Kunming Mu’en Medical Technology Co., Ltd., Kunming 650000, Yunnan Province, China
  • Received:2023-07-21 Accepted:2023-09-22 Online:2024-10-28 Published:2023-12-25
  • Contact: Xiong Ying, Yan’an Hospital Affiliated to Kunming Medical University, Kunming 650051, Yunnan Province, China
  • About author:Zhang Aili, Master, Pharmacist-in-charge, Yan’an Hospital Affiliated to Kunming Medical University, Kunming 650051, Yunnan Province, China
  • Supported by:
    Major Science and Technology Plan (Special Program) of Yunnan Province, No. 202102AA310040 (to XY)

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摘要：


文题释义：

等效模型：是一种用于评价个性化产品与其临床预期使用情况的数值和物理模型，该模型与预期使用于临床的个性化产品的几何结构、形貌、材料属性、固定方式、力学环境和生物整合机制等性能相等效，可作为一种快速而精准的验证个性化产品安全性和有效性的方法。
个性化骨模型：是由高分子材料聚乳酸线材，依据影像学设备生成的患者数据，经数据转换和三维立体重建设计，利用3D打印机将重建后的三维立体图打印为等比例的骨模型。


背景：目前个性化骨模型精确度的验证通常是通过配对t检验或组内相关系数等方法来进行，但这类方法往往需要制作大批量模型，不能满足个性化模型即时使用的需求。

目的：探讨构建“等效模型”快速验证个性化骨模型精确度的可行性。
方法：随机获取3例成年人骨骼CT影像并进行重建，运用3D打印制作个性化骨模型，再将个性化骨模型进行CT扫描并重建，使用Mimics对比重建模型和骨骼CT影像。运用Geomagic Studio对个性化骨模型CT影像的重建模型与骨骼CT影像的重建模型进行拟合偏差分析。对照骨骼CT影像的重建模型上所标注的测量位置和尺寸，对3D打印的个性化骨模型进行实物测量，并计算误差。

结果与结论：①通过对比骨骼CT影像的重建模型与骨骼CT图像，二者在解剖结构和形态上相符，轮廓几乎重合；②通过拟合偏差分析，标准偏差依次为0.176，0.226，0.143 mm，所有结果均< 0.25 mm；③通过实物测量并计算，相对误差均数依次为0.44%，0.21%，0.13%，所有结果均在5%的误差范围之内；④通过骨骼CT影像重建的模型符合制作个性化骨模型的基本条件；所构建的等效模型是符合临床需求和设计要求的，使用等效模型方法快速验证个性化骨模型精确度是可行的；⑤此方法可为个性化骨模型精确度的验证提供针对性强、验证迅速的途径，与常规配对t检验或组内相关系数等方法相比可缩短验证时间，能够达到提供临床即时使用的目的。

https://orcid.org/0009-0006-7666-2766 (张爱丽) 

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

关键词: 等效模型, 3D打印, 个性化骨模型, 熔融沉积制造, 聚乳酸, 医工交互, 精准医疗

Abstract: BACKGROUND: Currently, the verification of the precision of personalized bone models is usually performed by methods such as paired t-tests or intraclass correlation coefficient, but such methods often require the production of large batches of models, which do not satisfy the need for immediate use of personalized models.
OBJECTIVE: To study the feasibility of establishing the equivalent model to verify the precision of the personalized bone model rapidly.
METHODS: Bone CT images of three adults were randomly obtained for reconstruction. 3D printing was used to create personalized bone models, and then the personalized bone models were scanned using CT and reconstructed. Mimics was used to compare the reconstructed models of bone CT images with the bone CT images. Geomagic Studio was used to analyze the fitting deviation between the reconstruction model of personalized bone model CT image and the reconstruction model of skeletal CT image. The 3D-printed personalized bone model was measured against the measurement positions and dimensions marked on the reconstruction model of skeletal CT image, and the error was calculated.
RESULTS AND CONCLUSION: (1) By comparing the reconstructed bone CT image model with the bone CT scan image, the two were compatible in terms of anatomical structure and morphology, and the contours almost overlapped. (2) By fitting bias analysis, the standard bias was 0.176, 0.226, and 0.143 mm in order, and all the results were < 0.25 mm. (3) By measuring and calculating the model, the mean relative errors were 0.44%, 0.21%, and 0.13%, and all the results were within 5% error. (4) The constructed equivalent model was in line with the basic conditions for making personalized bone models. The established equivalent model met the clinical needs and design requirements, and it was feasible to use the method of the equivalent model to verify the precision of the personalized bone model quickly. (5) This method could provide a targeted and rapid way to verify the precision of personalized bone models. It could achieve the goal of providing immediate clinical use without the need to produce large batches of models compared to conventional methods such as paired t-tests or intraclass correlation coefficient. 

Key words: equivalent model, 3D printing, personalized bone model, fused deposition modeling, polylactic acid, medical-industrial interaction, precision medicine

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