脊柱导航手术机器人上胸椎（T1-T3）置针实验研究
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摘要
背景：
近年来,经椎弓根穿刺或置入内固定的各种手术方式如椎体成形术、脊柱骨折内固定、脊柱侧弯矫形术等,在临床上得到了越来越广泛的应用。上胸椎(T1-T3)由于椎弓根直径细小,其与硬膜之间缺乏硬膜外空间与毗邻的脊髓接触紧密,且术中侧位X线透视受肩关节的阻挡无法显示,正位透视锁骨、肋骨、胸骨、肺组织等组织投影重叠影响观察,因此置入方向稍有偏差,即有可能突破皮质造成脊髓损伤导致瘫痪等严重后果,这就使上胸椎的经椎弓根置入极具挑战性。
目前用于T1-T3椎弓根置入的方法主要有人工置入和计算机辅助导航系统(computer aided surgery navigation system,CASNS)。人工置入主要根据解剖标志和医生“手感”,缺乏有效的监测措施,文献报道其失误率6%-41%。CASNS可显著提高腰椎椎弓根置入准确率,但需要借助昂贵的设备和特殊的器械,还存在影像易漂移、追踪系统易受干扰、不能动态实时监测等因素的影响,有学者研究发现CASNS并不能有效提高T1-T3经椎弓根置入的准确率。
因此,探索精度更高、更为安全的T1-T3椎弓根置入方法,是亟待解决的重要课题之一。
目的：
探索自主研制的脊柱导航手术机器人确定T1-T3椎骨后表面两椎弓根中心轴线置入点(简称为中置点),结合体内体外“十”配准,确定椎弓根中心轴线,从而为T1-T3这一复杂手术部位建立一种精度更高、可靠易行的椎弓根置入方法。
方法：
1.将双导针置入两中置点：按术前测量a及α值双置入机器手导针,这样控制了进针点的内外方向；同时在X线正位透视下,以b,b’进行“轨迹对比”在头尾方向控制进针点。
2.设置体内外双“十”字配准：将依据CT测量值设置双“十”字。
3.定位中心点：调整X射线透视设备,使其中心投照线先后与两枚导针的中心轴线一致进行体外、体内“十”字配准,中心点即被精确定位,中置点与中心点的连线即椎弓根中心轴线。
4.置入导针：旋入导针并实时动态监测,即保持导针的投影始终呈点状并沿体外“十”字投影交叉点的中心下降,这样导针即能沿椎弓根中心轴线准确置入。
5.实验后C-ARM和CT辅助测量及统计学分析：CT扫描评估实际进针点与术前设计的进针点上下或内外侧偏移的最短距离,以及实际SSA、TSA与实验前测量值之间的差值比较。
结果：
1.所选6具脊柱T1-T3标本(18个人胸椎干燥标本36个椎弓根)中椎弓根标准轴位清晰投照并置入导针,术后椎体轴位、侧位X像观察导针均居椎弓根中部,准确率为100%。
2.术后CT扫描测量：进针点与术前预先设计进针点之间头尾与内外侧垂直最短的距离偏差分别为0.09±0.29mm (p=0.058)和0.01±0.31mm (p=0.874)。
3. T1-T3实验前TSA测量值分别为：32.1±3.2°；20.2±3.3°；14.1±3.6°；T1-T3实验后TSA测量值分别为：32.4±3.3°；19.9±3.3°；14.6±3.8°。同一阶段术前与术后相差最大不超过2.0°,各节段术前与术后无统计学意义(p>0.05)。
4. T1-T3实验前SSA测量值分别为：11.2±2.7°；10.9±3.5°；9.8±2.6°；T1-T3实验后SSA测量值分别为：11.5±3.0°；11.3±3.3°；9.9±2.3°。同一阶段术前与术后相差最大不超过2.0°,各节段术前与术后无统计学意义(p>0.05)。
结论：
脊柱导航手术机器人可准确确定T1-T3中置点,结合体外、体内“十”字配准,能准确进行经椎弓根中心轴线或规划路径置入,为T1-T3这一复杂手术部位建立一种新的、理想的经椎弓根置入方法。
Background:
In recent years, transpedicular placement or insertion surgical method is widely used in percutaneous vertebroplasty(PVP), spine Fracture, scoliosis, and so forth. The width of Upper thoracic veterbra pedicle is short, and the relationship between thoracic pedicle inner cortex and dura mater is tight and no space at all, so the possibility of thoracic transpedicular placement penetrating the bone cortex is large. And paralysis is the most serious complication. Furthermore, X-ray's anteroposterior and lateral projection cannot satisfy the real requirements. Anteroposterior image was blocked by clavicle, ribs, mesosternum and lung and lateral by shoulder, so it's difficult to observe the images clearly. Upper thoracic spine of T1-T3 transpedicular placement or insertion is a great challenge.
The current method of upper thoracic T1-T3 transpedicular placement or insertion is depending on CASNS or by hand. Due to anatomic marker and the doctors'experience, it is reported that the failure rate of transpedicular placement is 6%-41% because of lacking of effective monitoring. The CASNS can significantly improve the accuracy of transpedicular placement of lumbar spine, but has many disadvantages. Furthermore, it is reported that CASNS can't improve the accuracy rate of the upper thoracic spine of T1-T3.So it is meaningful to explore a novel method for improving the accuracy and safety of thoracic transpedicular placement,
and it is a critical issue to be solved.
Method:
1. According to the data measured on CT scanning, the distance a and angle a of the two guide wires of the manipulator were set, and its needlepoint locating at the two pedicle central axis(PCA) entry points (EP)were confirmed through trajectory matching(b,b') and the anteroposterior fluoroscopy.
2. Register external "十"and internal "十"coincide with each other.
3. After the two central axis of guide wire and central view axis of C-Arm were coincided respectively, the pedicle axis view was acquired via C-arm, the external "十"is adjusted to register with the internal"十", then the centre of pedicle isthmus(CPI) is confirmed. EP and CPI making a line is the pedicle central axis(PCA).
4. The insertion along the PC A was achieved by the robot's guide wire under monitoring.
5. The deviation between post/preoperative TSA, SSA was analyzed by statistic method respectively. And the excursion of the medical/lateral and superior /inferior shortest distance from EP to the planned was done similarly.
Results:
1. All the specimens,36 pedicle centre axis view was acquired and the accuracy of the inserting trajectory is 100%.The guide-wire trajectory was supervised and right in the middle of the lateral and axis image.
2. On postoperative CT scanning images, the deviation distance between the medical/lateral and superior/inferior shortest distance from EP to the planned was 0.09±0.29mm (p=0.058) and 0.01±0.31mm (p=0.874) seperatively.
3. Preoperation TSA measurement from T1to T3 were32.1±3.2°; 20.2±3.3°; 14.1±3.6°. Postoperation TSA measurement from T1 to T3 were 32.4±3.3°,19.9±3.3°,14.6±3.8°。There were no statistic difference between them (p>0.05).
4. Preoperation SSA measurement from T1 to T3 were 11.2±2.7°;10.9±3.5°; 9.8±2.6°. Postoperation TSA measurement from T1 to T3 were 11.5±3.0°; 11.3±3.3°; 9.9±2.3°. There were no statistic difference between them(p> 0.05).
conclusion:
The spine navigation surgery robot can confirm the thoracic spine of T1-T3 EP accurately. And combined with the internal and the external"十" registration, the robot can insert along the PCA or the planned trajectory accurately, which provides a novel and efficient method of improving the accuracy for the upper thoracic spine of T1-T3.
近年来,经椎弓根穿刺或置入内固定的各种手术方式如椎体成形术、脊柱骨折内固定、脊柱侧弯矫形术等,在临床上得到了越来越广泛的应用。上胸椎(T1-T3)由于椎弓根直径细小,其与硬膜之间缺乏硬膜外空间与毗邻的脊髓接触紧密,且术中侧位X线透视受肩关节的阻挡无法显示,正位透视锁骨、肋骨、胸骨、肺组织等组织投影重叠影响观察,因此置入方向稍有偏差,即有可能突破皮质造成脊髓损伤导致瘫痪等严重后果,这就使上胸椎的经椎弓根置入极具挑战性。
目前用于T1-T3椎弓根置入的方法主要有人工置入和计算机辅助导航系统(computer aided surgery navigation system,CASNS)。人工置入主要根据解剖标志和医生“手感”,缺乏有效的监测措施,文献报道其失误率6%-41%。CASNS可显著提高腰椎椎弓根置入准确率,但需要借助昂贵的设备和特殊的器械,还存在影像易漂移、追踪系统易受干扰、不能动态实时监测等因素的影响,有学者研究发现CASNS并不能有效提高T1-T3经椎弓根置入的准确率。
因此,探索精度更高、更为安全的T1-T3椎弓根置入方法,是亟待解决的重要课题之一。
目的：
探索自主研制的脊柱导航手术机器人确定T1-T3椎骨后表面两椎弓根中心轴线置入点(简称为中置点),结合体内体外“十”配准,确定椎弓根中心轴线,从而为T1-T3这一复杂手术部位建立一种精度更高、可靠易行的椎弓根置入方法。
方法：
1.将双导针置入两中置点：按术前测量a及α值双置入机器手导针,这样控制了进针点的内外方向；同时在X线正位透视下,以b,b’进行“轨迹对比”在头尾方向控制进针点。
2.设置体内外双“十”字配准：将依据CT测量值设置双“十”字。
3.定位中心点：调整X射线透视设备,使其中心投照线先后与两枚导针的中心轴线一致进行体外、体内“十”字配准,中心点即被精确定位,中置点与中心点的连线即椎弓根中心轴线。
4.置入导针：旋入导针并实时动态监测,即保持导针的投影始终呈点状并沿体外“十”字投影交叉点的中心下降,这样导针即能沿椎弓根中心轴线准确置入。
5.实验后C-ARM和CT辅助测量及统计学分析：CT扫描评估实际进针点与术前设计的进针点上下或内外侧偏移的最短距离,以及实际SSA、TSA与实验前测量值之间的差值比较。
结果：
1.所选6具脊柱T1-T3标本(18个人胸椎干燥标本36个椎弓根)中椎弓根标准轴位清晰投照并置入导针,术后椎体轴位、侧位X像观察导针均居椎弓根中部,准确率为100%。
2.术后CT扫描测量：进针点与术前预先设计进针点之间头尾与内外侧垂直最短的距离偏差分别为0.09±0.29mm (p=0.058)和0.01±0.31mm (p=0.874)。
3. T1-T3实验前TSA测量值分别为：32.1±3.2°；20.2±3.3°；14.1±3.6°；T1-T3实验后TSA测量值分别为：32.4±3.3°；19.9±3.3°；14.6±3.8°。同一阶段术前与术后相差最大不超过2.0°,各节段术前与术后无统计学意义(p>0.05)。
4. T1-T3实验前SSA测量值分别为：11.2±2.7°；10.9±3.5°；9.8±2.6°；T1-T3实验后SSA测量值分别为：11.5±3.0°；11.3±3.3°；9.9±2.3°。同一阶段术前与术后相差最大不超过2.0°,各节段术前与术后无统计学意义(p>0.05)。
结论：
脊柱导航手术机器人可准确确定T1-T3中置点,结合体外、体内“十”字配准,能准确进行经椎弓根中心轴线或规划路径置入,为T1-T3这一复杂手术部位建立一种新的、理想的经椎弓根置入方法。
Background:
In recent years, transpedicular placement or insertion surgical method is widely used in percutaneous vertebroplasty(PVP), spine Fracture, scoliosis, and so forth. The width of Upper thoracic veterbra pedicle is short, and the relationship between thoracic pedicle inner cortex and dura mater is tight and no space at all, so the possibility of thoracic transpedicular placement penetrating the bone cortex is large. And paralysis is the most serious complication. Furthermore, X-ray's anteroposterior and lateral projection cannot satisfy the real requirements. Anteroposterior image was blocked by clavicle, ribs, mesosternum and lung and lateral by shoulder, so it's difficult to observe the images clearly. Upper thoracic spine of T1-T3 transpedicular placement or insertion is a great challenge.
The current method of upper thoracic T1-T3 transpedicular placement or insertion is depending on CASNS or by hand. Due to anatomic marker and the doctors'experience, it is reported that the failure rate of transpedicular placement is 6%-41% because of lacking of effective monitoring. The CASNS can significantly improve the accuracy of transpedicular placement of lumbar spine, but has many disadvantages. Furthermore, it is reported that CASNS can't improve the accuracy rate of the upper thoracic spine of T1-T3.So it is meaningful to explore a novel method for improving the accuracy and safety of thoracic transpedicular placement,
and it is a critical issue to be solved.
Method:
1. According to the data measured on CT scanning, the distance a and angle a of the two guide wires of the manipulator were set, and its needlepoint locating at the two pedicle central axis(PCA) entry points (EP)were confirmed through trajectory matching(b,b') and the anteroposterior fluoroscopy.
2. Register external "十"and internal "十"coincide with each other.
3. After the two central axis of guide wire and central view axis of C-Arm were coincided respectively, the pedicle axis view was acquired via C-arm, the external "十"is adjusted to register with the internal"十", then the centre of pedicle isthmus(CPI) is confirmed. EP and CPI making a line is the pedicle central axis(PCA).
4. The insertion along the PC A was achieved by the robot's guide wire under monitoring.
5. The deviation between post/preoperative TSA, SSA was analyzed by statistic method respectively. And the excursion of the medical/lateral and superior /inferior shortest distance from EP to the planned was done similarly.
Results:
1. All the specimens,36 pedicle centre axis view was acquired and the accuracy of the inserting trajectory is 100%.The guide-wire trajectory was supervised and right in the middle of the lateral and axis image.
2. On postoperative CT scanning images, the deviation distance between the medical/lateral and superior/inferior shortest distance from EP to the planned was 0.09±0.29mm (p=0.058) and 0.01±0.31mm (p=0.874) seperatively.
3. Preoperation TSA measurement from T1to T3 were32.1±3.2°; 20.2±3.3°; 14.1±3.6°. Postoperation TSA measurement from T1 to T3 were 32.4±3.3°,19.9±3.3°,14.6±3.8°。There were no statistic difference between them (p>0.05).
4. Preoperation SSA measurement from T1 to T3 were 11.2±2.7°;10.9±3.5°; 9.8±2.6°. Postoperation TSA measurement from T1 to T3 were 11.5±3.0°; 11.3±3.3°; 9.9±2.3°. There were no statistic difference between them(p> 0.05).
conclusion:
The spine navigation surgery robot can confirm the thoracic spine of T1-T3 EP accurately. And combined with the internal and the external"十" registration, the robot can insert along the PCA or the planned trajectory accurately, which provides a novel and efficient method of improving the accuracy for the upper thoracic spine of T1-T3.
引文
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[29]Amoit LP, Labelle H, DeGuise JA, et al. Computer-assisted pedicle screw fixation, a feasibility study [J]. spine,1995,20:1208-1212
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[31]Muto M, Muto E, Lzzo R, et al. Vertebroplasty in the treatment of back pain[J]. Radiol Med,2005,109(3):208-219.
[32]王黎明,喻忠,桂鉴超,等.计算机导航辅助下经皮椎体成形术[J].中华骨科杂志,2006,26(10)：676-681.
[33]van de Kraats EB, van Walsum T, Verlaan JJ, et al. Three-dimensional rotational X-ray navigation for needle guidance in percutaneous vertebroplasty:an accuracy study[J]. Spine,2006,31:1359-1364.
[34]Belmont Jr PJ, Klemme WR, Dhawan A, Polly Jr DW. In vivo accuracy of thoracic pedicle screws [J]. Spine 2001,26(12):2340-2346
[35]Choi WW, Green BA, Levi AD.Computer-assisted fluoroscopic targeting system for pedicle screw insertion [J]. Neurosurgery,2000,47(4):872-878
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[37]Youkilis AS,Quint DJ, McGillicuddy JE, et al. Stereotactic navigation for placement of pedicle screws in the thoracic spine[J]. Neurosurg,2001,48(6):771-781.
[38]海涌,邹德威,邵水霖,等.电磁导航技术在胸腰椎手术的应用[J].中国脊柱脊髓杂志,2003,13(11)：660-662.
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[41]Barzilay Y, Liebergall M. Fridlander A, et al. Miniature robotic guidance for spine surgery-introduction of a novel system and analysis of challenges encountered during the clinical development phase at two spine centres [J]. Int J Med Robot,2006,2(2):146-153
[42]Sukovich W, Brink DS, Hardenbrook M, et al. Miniature robotic guidance for pedicle screw placement in posterior spinal fusion:early clinical experience with the SpineAssist [J]. Int J Med Robot,2006,2(2):114-122
[43]Lieberman IH, Togawa D, Kayanja MM, et al. Bone-mounted miniature robot for pedicle screw and translaminar facetscrew placement:Part 1-technical development and a test case result [J]. Neurosurg,2006,59(3):641-650
[44]Togawa D, Kayanja MM, Reinhardt MK, et al. Bone-mounted miniature robot for pedicle screw and translaminar facet screw placement:Part Ⅱ—evaluation of system's accuracy [J]. Neutosurgery,2007,60(2):129-139
[45]Chung G B, Kim S, Lee S G, et al. An image-guided robotic surgery system for spinal fusion [J]. International Journal of Control Automation and Systems,2006,4(1):30
[46]Chung G B, Kim S, Yi* BJ, et al.Cadaver Study for Spinal Fusion Surgery Using an Image-guided Surgical Robotic System [J]. International Journal of Control Automation and Systems,2010,8(3):564-573
[47]Lee F,Hwang I,Kim K,et al. Cooperative robotic assistant with drill-by-wire end-effector for spinal fusion surgery[J].Industrial Robot:An international Journal,2009,1(36):60-72
[48]Zemiti N,Morel G,Ortmaier T,et al.Mechatronic Design of a New Robot for Force Control in Minimally Invasive Surgery [J].Ieee/asme Transactions On Mechatronics,2007,11(12): 143-147
[49]Hussong A,S.Rau T,Ortmaier T,et al.An automated insertion tool for cochlear implants:another step towards atraumatic cochlear implant surgery [J]. Int JCARS,2010,5: 163-171
[50]Ortmaier T, Weiss H, Dobele S, et al. Experiments on robot-assisted navigated drilling and milling of bones for pedicle screw placement. [J]. Int J Med Robot,2006,2(4):350-363
[51]Kim, Sungmin, Chung, Jaeheon, Yi, Byung-Ju, et al. An Assistive Image-Guided Surgical Robot System Using O-Arm Fluoroscopy for Pedicle Screw Insertion:Preliminary and Cadaveric Study [J].Neurosurgery,2010,67(6):1757-1767
[52]Schizas C, Theumann N,Kosmopoulos V. Insening pedicle screws in the upper thoracic spine without the out of fluoroscopy or image guidance. Is it safe? Eur Spine J,2007, 16(5):625-629
[53]Rajasekaran S,Vidyadhara S, Ramesh P, et al.Randomized clinical study to compare the accuracy of navigated and non- navigated thoracic pedicle screws in deformity correction surgeries. Spine,2007,32(2):56-64
[54]Lu S, Xu YQ, Li YB, et al. Anew digital template as navigation in spinal pedicle instrumentation. Chin J Orthop Trauma,2008,10(2):128-131
[55]Lu S, Xu YQ, Zhang YZ, et al. Rapid prototyping drill guide template for lumbar pedicle screw placement. Chin J Orthop Trauma 2009,12(3):171-177
[56]陈玉兵,陆声,徐永清.快速成型个体化导航模板辅助胸椎椎弓根螺钉置入可行性研究[J].中国矫形外科杂志,2009,17(20)：1557-1561
[57]Shoham M, Lieberman IH, Benzel EC, et al. Robotic assisted spinal surgery-from concept to clinical practice [J]. Computer Aided Surgery,2007,12(2):105-115
[58]Eric L. Lin, Daniel K. Park, Peter G. Whang, et al. O-Arm Surgical Imaging System [J]. Seminars in Spine Surgery,2008,20(3):209-213
[59]鞠浩,张建勋,安刚,等.机器人辅助脊柱微创手术系统设计与实现[J].南开大学学报：自然科学版,2008,41(4)：31-35
[60]田伟,刘亚军,刘波,等.计算机导航系统和C臂机透视引导颈椎椎弓根螺钉内固定技术的临床对比研究[J].中华外科杂志,2006,44(20)：1399-1402
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