| BackgroundPercutaneous transforaminal endoscopic discectomy(PTED) is a surgery which perceived difficult, long learning-time, intraoperative localization should be quite accurate, meanwhile the puncture location is the key to successful operation. But for the new doctor to the technology, especially a young doctor, maybe usually rather difficult in the process. Due to the anatomical features of intervertebral foramen and variation factors will seriously affect the surgical puncture, leads to increase operation difficulty, increase number of surgical complications, accept more amount radiation of patient and doctor, even need to be changed to open surgery. These problems will hinder the further development of the technology. Because of this reason, how to make good puncture and positioning is one of the hot spots of the technology to be explored.ObjectiveTo develop an arc positioning biopsy device for assist surgery biopsy and it’s method. And then observed its result of application in clinical,which aims to improve puncture accuracy, decrease the time of intraoperative biopsy, reduce patient and doctor radiation.Methods1. Fundamental research:(1) Research of equipment According to the principle of the globe, that is to said, the distance of any point on asphere to ball center was equal to the radius(puncture depth), an arc target biopsy device was developed, which was composed of two same axises and radius circleses, puncturing with the preoperatively measured puncture angle and puncture path. This device was drawn by CAD software and was revised and modeled by 3DS-MAX software. Then it was processed and manufacture by Sanyo company and Mingyi production company.(2)Methods formulation:a.Preoperative imaging measurement:The traditional PTED puncture angle was divided into abduction angle and sagittal view angle, preoperative horizontal plane data of MRI imaging was measured in patients with lumbar intervertebral disc herniation, which determine the distance d with target to the midline and angle a between puncture face and median sagittal plane, called abduction angle a;preoperative coronal plane data of X-ray, CT or MRI imaging was measured in patients with lumbar intervertebral disc herniat ion, which determine the angle βbetween puncture face and horizontal plane, called sagittal view angle β. The puncture depth was controled by arc positioning biopsy device. The perpendicular distance OA(0 for intervertebral disc herniation, A point was the locating point of intervertebral disc targets projected on the posterior surface.) from intervertebral disc herniation to skin which was measured by midst sagittal plane of the MRI results, b. Intraoperative display of target puncture method:The method was used 3DS MAX-simulation to display the surgery scene,first determine surface anchor point A and B(A point determined by preoperative measuring d value and grid location, B point was the locating point of intervertebral disc targets projected on the lateral surface, determined by the distance of the OA). After that using target puncture device’s mesogun aimed at A and B two points, and target puncture according to the measurement of abduction angle and sagittal view angle, then clinical operation steps was in accordance with the three-dimensional figures showd in 3ds MAX.(3) Clinical research:121 cases received PTED in orthopedics department of FSTCM were single segment disc herniation.61 cases with L4/5 disc herniation were randomly divided into 2 groups by random number table. Experimental group A (30 cases) was the same doctor punctured and established channels who used target puncture method combined arc positioning biopsy device to puncture, while the control group B(31 cases) was the same doctor punctured and established channels who used the conventional puncture method with THESSYS technique.61 cases with L5/1 disc herniation were randomly divided into 2 groups by random number table. Experimental group C(30 cases) did the same as experimental group A, while the control group D(30 cases) used the same method as control group B. Then respectively compared A, B and C, D groups’puncture indicators included:success rate of a puncture, positioned and punctured time, channel establishment time and accepted the X-ray times (front and lateral films for twice); Observed four groups’intraoperative complications and respectively compared A, B and C, D groups’postoperative rehabilitation indicators included:Visual Analog Scale (VAS),ODI index and developed Macnab grade.Result1. Fundamental research:Successful developed a new arc positioning biopsy device and improved target puncture method to puncture assisted PTED.2. Clinical research:All cases successfully received PTED and got the follow-up.(1)Puncture indicators comparison Experimental group A’ssuccess rate of a puncture was 66.67%, positioned and punctured time was (4.90±.63) minutes, channel establishment time was (5.20±1.92) min, accepted the X-ray times were (12.17±1.46) and the comfort of puncturing and establishing channels showed 1 cases were excellent,22 cases good,6 cases better and 1 cases poor, the excellent rate was 76.67%;control group B’ssuccess rate of a puncture was 29.03%, positioned and punctured time was (6.87±1.91) minutes, channel establishment time was (6.74±1.71)min and accepted the X-ray times were (13.16±1.98). All the results of two groups showed statistically significant each other (P<.0.05); Experimental group C’ssuccess rate of a puncture was 53.33%, positioned and punctured time was (5.90±1.92) minutes, channel establishment time was (6.90±1.99) min, accepted the X-ray times were (13.10±1.88) and the comfort of puncturing and establishing channels showed 0 cases were excellent,20 cases good,10 cases better and 0 cases poor, the excellent rate was 66.67%;control group D’ssuccess rate of a puncture was 20.00%, positioned and punctured time was (7.47±2.22) minutes, channel establishment time was (8.20±1.94)min and accepted the X-ray times were (14.60±2.54).All the results of two groups showed statistically significant each other (P<0.05);(2) Intraoperative complications comparison Experimental group A appeared 1 case (3.33%) and control group B also appeared 2 cases (6.45%) of transient neurological injury, which both of their nerve roots were milded in the time of establishing channels and could be settled by conservative therapy. The incidence of complications was not statistically significant (P≥05);Experimental group C appeared 1 case(3.33%) and control group B appeared 2 cases (6.67%) of transient neurological injury, which both of their nerve roots were also milded in the time of establishing channels and could be settled by conservative therapy. The incidence of complications was not statistically significant (P≥0.05);(3)Postoperative rehabilitation indicators comparison:In L4/5 segments, Experimental group A’s VAS, ODI index respectively dropped from preoperative(7.70±1.39)/(68.20±3.84)topostoperative (2.33±1.49)/(13.67±3.97). The postoperative one showed differences statistically significant compared to Preoperative(P<0.05). The Macnab grade showed 20 cases were excellent,6 cases good,4 cases better and 0 cases poor, the excellent rate was 86.67%.Control group B’s VAS, ODI index respectively dropped from preoperative (7.71±1.42)/(67.16±4.41) to postoperative (2.23±1.43)/(14.32±4.38). The postoperative one also showed differences statistically significant compared to Preoperative (P<0.05), The Macnab grade showed 19 cases wereexcellent,7 cases good,5 cases better and 0 cases poor, the excellent rate was 83.87%. There was no statistically significant between two groupsinVAS, ODI index and Macnab grade (P≥0.05); In L5/1 segments, Experimentalgroup C’s VAS, ODI index respectively dropped from preoperative (7.53±1.48)/(67.33±4.85) to postoperative (2.17±1.46) /(13.53±3.95). The postoperative one showed differences statistically significant compared to Preoperative (P<0.05).The Macnab grade showed 19 cases were excellent,6 cases good,4 cases better and 0 cases poor, the excellent rate was 83.33%. Control group D’s VAS, ODI index respectively dropped from preoperative (7.60±1.38)/(68.07±4.50) to postoperative (2.13±1.36) /(15.47±4.87). The postoperative one also showed differences statistically significant comparedto Preoperative(P<0.05).The Macnab grade showed 18 cases were excellent,6 cases good,6 cases better and 0 cases poor, the excellent rate was 80.00%. There was no statistically significant between two groups in VAS and ODI index Macnab grade (P≥0.05)Conclusion1. PTED target puncture device has a reasonable design, proper method, simple installation and high precision.It makes the puncture depth and targets in a fixed, which can effective assist PTED puncture and has an advantage in control ing angle and depth compare to the unarmed puncture method.2. Improved PTED targets puncture method can pay attention to individual differences, dividing the puncture angle into the abduction angle and sagittal view angle and imaging measurement, which Effective to quantify the puncture angle and ensure the PTED targets puncture device for Accurately puncturing.3. PTED targets puncture device and its’method not only can get a good postoperative effect assisting PTED surgery, but also can improve ssuccess rate of a puncture, reduce the punctured and established channels time and lower the radiation. |