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基于计算机辅助设计与3D打印技术的新型横突牵开器的研制与临床应用

[Development and clinical application of a new transverse process retractor based on computer-aided design and 3D printing technology].

作者信息

Liu Tao, Niu Guo-Qi, Zhou Gong, Liu Lu-Tan, Nie Hu

机构信息

Department of Orthopaedics, the Second Affiliated Hospital of Bengbu Medical College, Bengbu 233002, Anhui, China.

出版信息

Zhongguo Gu Shang. 2022 May 25;35(5):454-9. doi: 10.12200/j.issn.1003-0034.2022.05.009.

Abstract

OBJECTIVE

To manufacture a new type of transverse process retractor by using computer-aided design(CAD) combined with 3D printing technology and investigate its clinical application effect.

METHODS

A new type of transverse protrusion retractor was developed by CAD combined with 3D printing technology. From September 2018 to September 2019, the new transverse process retractor was applied in clinic. Sixty patients with lumbar single segment lesions who needed treatment by pedicle screw fixation, bone grafting and interbody fusion were divided into new transverse process retractor group and control group, with 30 cases in each group. There were 14 males and 16 females in new type transverse process retractor group, the age was (68.0±4.3) years old on average; lesion segment of 8 cases were L, 9 cases were L, 13 cases were LS;5 cases of lumbar disc herniation, 20 cases of lumbar spinal stenosis, 5 cases of degenerative lumbar spondylolisthesis;new transverse process retractor was used to pedicle screw placement. While there were 15 males and 15 females in control group, with an average age of (69.2±4.5) years old;lesion segment of 8 cases were L, 10 cases were L, 12 cases were LS;5 cases of lumbar disc herniation, 21 cases of lumbar spinal stenosis, 4 cases of degenerative lumbar spondylolisthesis;the traditional lamina retractor was used for soft tissue pulling and finished pedicle screw placement by freehand. The length of surgical incision, the time required for inserting a single screw, fluoroscopy times, the times of adjusting the positioning needle or screw in insertion process, and the visual analogue scale (VAS) of surgical incision 72 hours after operation were compared between two groups.

RESULTS

Using CAD and 3D printing technology, a new type of transverse protrusion retractor was developed quickly. The length of surgical incision, the time required for inserting a single screw, fluoroscopy time, and the times of adjusting the positioning needle or screw in insertion process in new transverse process retractor group were less than those in control group(<0.05). There was no significant difference in VAS of lumbar incision pain at 72 hours after operation between two groups(>0.05).

CONCLUSION

Using CAD combined with 3D printing technology to develop a new transverse protrusion retractor has the advantages of convenient design, short development cycle and low cost. It provides a new idea for the research and development of new medical devices. The new transverse process retractor has the advantages of easy operation, reliable fixation, less damage to paravertebral muscle, convenient pedicle screw placement, reducing fluoroscopy time and so on.

摘要

目的

采用计算机辅助设计(CAD)结合3D打印技术制造一种新型横突牵开器,并探讨其临床应用效果。

方法

通过CAD结合3D打印技术研制新型横突牵开器。2018年9月至2019年9月,将新型横突牵开器应用于临床。将60例需要行椎弓根螺钉固定、植骨融合治疗的腰椎单节段病变患者分为新型横突牵开器组和对照组,每组30例。新型横突牵开器组男14例,女16例,平均年龄(68.0±4.3)岁;病变节段L₄ 8例,L₅ 9例,L₅S₁ 13例;腰椎间盘突出症5例,腰椎管狭窄症20例,退变性腰椎滑脱症5例;使用新型横突牵开器辅助椎弓根螺钉置入。对照组男15例,女15例,平均年龄(69.2±4.5)岁;病变节段L₄ 8例,L₅ 10例,L₅S₁ 12例;腰椎间盘突出症5例,腰椎管狭窄症21例,退变性腰椎滑脱症4例;采用传统椎板牵开器牵拉软组织,徒手完成椎弓根螺钉置入。比较两组手术切口长度、单枚螺钉置入所需时间、透视次数、置入过程中调整定位针或螺钉的次数以及术后72小时手术切口视觉模拟评分(VAS)。

结果

利用CAD和3D打印技术快速研制出新型横突牵开器。新型横突牵开器组手术切口长度、单枚螺钉置入所需时间、透视时间及置入过程中调整定位针或螺钉的次数均少于对照组(P<0.05)。两组术后72小时腰椎切口疼痛VAS评分比较差异无统计学意义(P>0.05)。

结论

采用CAD结合3D打印技术研制新型横突牵开器具有设计方便、研发周期短、成本低等优点,为新型医疗器械的研发提供了新思路。新型横突牵开器具有操作简便、固定可靠、对椎旁肌损伤小、椎弓根螺钉置入方便、减少透视时间等优点。

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