| Research backgroundIn the past 10 years, percutaneous endoscopic lumbar discectomy (PELD) in the treatment of lumbar disc herniation is a hot research topic in the field of minimally invasive spinal surgery. Compared with micro-endoscopic discectomy (MED) and spinal minimally invasive technique of Quadrant expandable channel system in the treatment of lumbar disc herniation, percutaneous transforaminal endoscopic lumbar discectomy (PELD) is a more minimally invasive spinal surgery technique and its operation effect is significantly theoretically. PELD poses little effect on the structure on spinal canal, does not affect spinal stability, forms slight scar adhesion, thus possesses the features and advantages of minimally invasive treatment, such as extremely small incision, very light damage, very little bleeding, rapid recovery, low recurrent etc. Percutaneous endoscopic lumbar discectomy (PELD) has become the developmental trend of minimally invasive spinal surgery, and is gradually accepted by more and more minimally invasive spine surgeons in the treatment of lumbar disc herniation.At present, percutaneous transforaminal full endoscopic lumbar Discectomy has mainly two kinds of operation modes. One method is TESSYS delegeted by Hoogland (Transforaminal endoscopic spine system) technology (decompression technology from outside to inside). TESSYS technology is resection the part of the facet joint bone and expansion of intervertebral foramen through the posterolateral lumbar spine via percutaneous transforaminal approach. Spinal endoscopy was inserted into lumbar intervertebral disc protrusion in vertebral canal, the intervertebral disc protrusion was removed, thus the nerve root was decompressed. The nerve roots and dural sac can be clearly observed in endoscopy, and decompression of the nerve root effect is good, this operation is also known as percutaneous transforaminal full endoscopic lumbar discectomy (PTELD). PTELD technology is widely adapted to patients with all types of lumbar disc herniation with or without spinal stenosis, intervertebral foramen stenosis and cauda equina syndrome. The working sleeve was can easily be inserted after the expansion of the lumbar intervertebral foramen, so there is no need to go through the Kambin security triangle, which can avoid the injury of the nerve root and ganglion. But, during the process of clinical application of TESSYS technology, injury of nerve root and spinal dural membrane is more common. To a certain extent, it affects the effect of surgery, because the puncture location is more difficult and less accurate and X-ray exposure dose increased. Another technique is to Antony Yeung as the representative of the YESS (Yeung Endoscopic Spine System) technology from the inside to the outside decompression technique(In-Outside). YESS technology is that the spinal endoscope is inserted into Lumbar intervertebral disc space through Kambin security triangle approach, and intervertebral disc nucleus pulposus is removed and decompressed. In fact, this technology is indirect decompression of spinal nerve roots. Its indications are relatively narrow,and mainly for inclusive disc herniation or part of the posterior longitudinal ligament type herniated intervertebral disc. It cannot remove intraspinal prolapse and free disc fragment, can not expand the intervertebral foramen or foraminoplasty. Treatment of lumbar spinal stenosis, lateral recess stenosis and L5-S1 disc herniation with high iliac crest is difficult. Nerves are vulnerable to stimulation and damage in the process of puncture and intubation through the narrow Kambin safety triangle.Because TESSYS technology has more advantages than YESS technology in the wide indication and good operation effect., Percutaneous Transforaminal Endoscopic Lumbar Discectomy is more concerned by the minimally invasive surgeons. PTELD technology has many advantages, but there are many problems. Mainly exists in the following aspects:Surgical field of vision is small under the microscope. Video image quality is not good because of scope lens is easily blocked by water. The operation proficiency, experience, hand feeling and eye hand coordination ability of surgeons are different. It is difficult to identify the anatomical structure under the microscope. Applications in some important blood vessels and nerve sites are often restricted. On the other hand, Operation should be operated under X-ray fluoroscopy. Both the operator and patient will suffer from plenty of X-ray radiation, Surgical risk is increased. It is more important that the PTELD targeted puncture technique is a difficult problem. Ihe percutaneous puncture of the location of the lumbar disc protrusion the spinal canal through the narrow intervertebral foramen directly determines the success of the operation.Li Changqing put forward a new concept of targeted puncture technology for the selection of TESSYS and YESS technology. He believes that the technology is characterized by the location of different intervertebral disc protrusion. the appropriate target puncture is determined by the lumbar spine X-ray, CT and MRI imag. Establishing target should take into account the spinal canal and intervertebral disc degeneration and protrusion of the intervertebral disc tissue. Then with the mobile C arm X-ray fluoroscopy monitoring, after free-hand and manual blind targeted puncture sucessfully, expanded sleeve and working sleeve are inserted into the spinal canal. By rotating the working sleeve and using of a curved nucleus pulposus clamp, the spinal canal and intervertebral disc degeneration and protrusion of the intervertebral disc tissues are removed completely. Li Feng et al also proposed that the so-called targeted puncture is to use CT scann to locate, to select ideal puncture direction, angle, and needle point avoid nerve root. After confirming that there is enough space for expansion, the puncture needle safely reaches the target area.. A method of puncture under the blind spot in the area of the target point of safety. This technique is also a method of blind and free-hand puncture.In recent years, computer assisted surgical navigation system technology (also called image guided surgical navigation system, or image guided surgery) has begun to be applied in the field of minimally invasive spinal surgery. This technique is mainly used in the spinal vertebral pedicle screw insertion, artificial intervertebral disc replacement surgery, spinal tumor surgery. The key technology of computer assisted surgical navigation system is image mapping technology and spatial location technology. Space positioning technology mainly has 4 kinds of positioning methods, such as mechanical hand positioning, optical method positioning, ultrasonic positioning, electromagnetic positioning and so on. Optical positioning system is the most accurate and widely used method. The positioning accuracy can be less than 0.5mm. The application of this navigation technology can make the operation more accurate, more minimally invasive, less radiation exposure. But there is little experience in clinical application. The operator needs to carry out preoperative planning and manual registration in the operation. The registration process is cumbersome and easy to fail. And the equipment price is expensive, waits for the further development and the research.. There is no report on the application of computer navigation technology to the targeted puncture of the intervertebral foramen.At present, the domestic and foreign PTELD operator with their own feel and experience puncture. Target puncture technique is also the biggest problem in the early learners. Multiple times of X-ray fluoroscopy are needed to confirm the locations of puncture needle tip and sleeve’s front end and to repetitively adjust the angle of puncture needle. Therefore, both the operator and patient will suffer from plenty of X-ray radiation, which is increased tissue damage, significantly prolonged the operation time, increased the risk of infection. There are reports in the literature the number of X-ray fluoroscopy performed for targeted puncture and sleeve insertion can be as high as 32 times and 1.6-4.5 minutes, and the X-ray exposure dose for new operator can be even more. Few physicians around the world are willing to master the technology. If the puncture deviation is large, it is very easy to damage the important blood vessels, nerves, intestines and other tissues, and even lead to serious adverse consequences. Even if the position angle of the puncture needle is adjusted repeatedly, the intervertebral disc tissue can not be effectively removed and the compression nerve can not be effectively removed. The nerve decompression is not complete, resulting in a significant reduction in the effect of surgery. The postoperative effects of different patients were significantly different. And the learning curve of percutaneous transforaminal endoscopic lumbar discectomy is long and steep. To master this technology is difficult. Because there is a steep learning curve in the technique of percutaneous transforaminal endoscopic lumbar discectomy, the complications of early surgery were higher. Li Changqing et al [23] reported its incidence was 6.61%, Zhang Shufang et al reported as 7.2%. Analysis shows that the operation experience and skills of familiarity, surgical indications, preoperative preparation and postoperative postprocessing methods are associated with surgical complications. However, on the basis of strict indications of the operation, with the increase of the number of cases of operation, the operation experience and skills to improve, the incidence of surgical complications will be significantly reduced.In order to break through the difficult problem of PTLED’s targeted puncture technique, we have developed a lumbar disc herniation target collimator and a new scientific methodology to guide the targeted puncture (In 2015, it was awarded the national invention patent, patent number:CN103767791B). Target collimator can guide the puncture needle through the narrow intervertebral foramen, puncture to the tiny lesions of the intervertebral disc protrusion. This technology is expected to reduce the amount of human being X ray radiation, to reduce the complications of surgery, to alleviate the suffering of patients, shorten the operation time, improve the surgical effect and shortening master transforaminal endoscopic technology learning curve.Research purpose1. To develop a special kind of the lumbar disc herniation target collimator and to innovate a scientific targeted puncture methodology in clinical practice.2. To explore the application effect of the lumbar disc herniation target collimator and the innovative targeted puncture methodology in percutaneous transforaminal endoscopic lumbar discectomy.3. To explore the methods to reduce X-ray exposure dose, protect spine surgeons effectively and avoid targeted puncture complications in percutaneous transforaminal endoscopic lumbar discectomy.4. To explore the surgry effect of the individualized design of approach of the targeted puncture operation in the patients subjected to percutaneous transforaminal endoscopic lumbar discectomy.5. System evaluation and analysis of the effect of lumbar discectomy using the transforaminal and interlaminar approaches in the treatment of lumbar disc herniation (LDH).Research contents1. Close combination with human waist anatomy, the location of the lumbar intervertebral disc protrusion (target spot) was determined, on the basis of the lumbar X-ray fluoroscopy, CT and MRI imaging of patient with lumbar disc herniation. According to the PTLED technical requirements, establish path from puncture point to the target point in the waist post-lateral skin in the angle and distance on the lumbar transverse and sagittal, determine the relationship principle between the surface and point in the puncture target spot and puncture path, conceive the idea of lumbar disc herniation target aiming instrument function component composition.2. The lumbar disc herniation target collimator is produced using mechanical model of three dimensional graphics software and 3D printing technology.3. Design a scientific and operable method of targeted puncture in combination with the X ray, CT and MRI image of patient with the lumbar disc herniation.4. A prospective controlled study was conducted in accordance with the principle of random control in clinical application. Target collimator to guide the targeted puncture for PTELD was the experimental group and free-hand target puncture for PTELD was the blank control group. The accuracy of target puncture, the number of X-ray fluoroscopy, surgical complications, and VAS, ODI and modified MacNab scale were compared to gain evidence based medical support for the clinical application effect of target collimator.Research methods1. In the theoretical basis for the targeted puncture of PTLED surgery in patients with lumbar disc herniation, the target spot position on the perspective of the lumbar intervertebral disc is Determined. The vertical projection point of the target point on the skin of the waist and the connection of the target point to the vertical projection point are Marked. Avoiding the blocking of the transverse process and the nerve root, The puncture path through the intervertebral foramen to the target is marked. This forms a right angle triangle. Angle alpha in the tail section of the puncture needle, the angle of the needle to the medial sagittal plane are marked. The lumbar disc herniation target collimator is mainly composed of an alpha angle locator and a beta angle locator which are connected by a telescopic rod is Determined.2. Making of the lumbar disc herniation target collimator. PTC/PROE ENNGRED Creo Elements/Pro5.0 system 3D graphics software is started. The three-dimensional image of each functional part of the an alpha angle locator and a beta angle locator is designed and drawn out. The three-dimensional map data file of the function component of the instrument is input to the computer system of the SPS600B laser rapid prototyping machine (3D printer) and 3D map data files are converted into STL files. Under the ultraviolet laser beam of the SPS600B laser rapid prototyping machine, the liquid SOMOS DSM 14120 photosensitive resin material of the scanned area is rapidly solidified and formed. The light cured resin prototype of the functional component is manufactured. And then through the prototype to support, cleaning, polishing processing, high precision function parts is made and assembled into a complete umbar disc herniation target collimator.3. To design innovation of targeted puncture methodology. On the workstation of the image viewing system(Huayi regional medical image archiving and communication system diagnostic workstation, GreatAPACS), on the basis of close combination of human waist and on the lumbar X-ray fluoroscopy, CT and MRI imaging of patient with lumbar disc herniation, the location of the lumbar intervertebral disc protrusion (target spot) was determined. To avoid bone and nerve, intestinal and other important organizations, the best way to personalize the puncture path is formulated and marked. The alpha angle and beta angle of the target puncture, and the vertical projection point distance d from the target point to the waist skin are accurately measured. According to the principle of right angle trigonometric function, distance dl of alpha angle locator of the circle to the beta angle locator center, and distance d2 of targets to beta angle locator center is calculated. Putting the lumbar disc herniation target collimator on the waist of the skin and Setting the actual measured angle and distance, the puncture needle can puncture to the target point through a personalized setting path guiding by the guide tube.4. A prospective randomized controlled study on the clinical application of the lumbar disc herniation target collimator.Between January and September of 2014, A total of 66 patients with lumbar disc herniation who met the inclusion and exclusion criteria were included. According to the time of hospitalization of patients, the patients were divided into experimental group and control group according to the odevity of their dates of birth. Patients whose dates of birth were even numbers were assigned to the experimental group and underwent percutaneous transforaminal endoscopic lumbar discectomy using a new targeted puncture technique with application of a lumbar disc herniation target collimator, while patients whose dates of birth were odd numbers were assigned to the control group and underwent free-hand targeted puncture percutaneous transforaminal endoscopic lumbar discectomy.Surgical method of experimental group:the lumbar disc herniation tissue location (target spot) was determined based on lumbar X-ray radiographs, CT and MRI images based on the downward displacement of lumbar disc herniation tissue shown on sagittal images of CT or MRI. The personalized optimal target puncture approach path is designed and formulated. Alpha angle and beta angle, and the vertical projection point distance from the target point to the waist of the skin are accurately measured. distance of alpha angle locator of the circle to the beta angle locator center, and distance of targets to beta angle locator center is calculated. The patient was asked to lie in prostrate position on the operating table, and the position was adjusted to lumbar over-flexion so that the waist plane was parallel to the floor and the patient was kept immobilized. A roentgen opaque positioning grid was flatly placed over the waist skin and locted under X ray fluoroscopy, then the lumbar disc’s parallel line and the vertical projection point of target spot were marked on the skin. Disinfection was frequently performed on the skin surface around the surgical area, The a angle locator was horizontally placed on the waist skin so that the circle center of a angle locator was on the vertical projection point B and the diameter of a angle locator was on the lumbar’s disc’s parallel line.The angle of a angle locator was adjusted to the measured α value, the length of the connecting telescopic rod was adjusted so that the distance between the circle center of α angle locator and circle center of β angle locator. The puncture needle was then inserted into the guide wire and slowly pushed through skin-muscle tissues to pass through the narrow intervertebral foramen and enter into the target spot inside the spinal canal. The mobile C-arm X-ray machine was used for fluoroscopy to confirm the puncture needle tip was at the target spot. Local subcutaneous infiltration anesthesia was performed for the puncture point. The puncture needle’s stylet was removed and guide wire was inserted. Expanding sleeves were placed step-by-step under the guidance of guide wire and at last, the working sleeve was inserted.Full endoscope was placed inside the working sleeve and the nerve-compressing lumbar disc herniation tissue was directly removed under the monitoring of video camera,.Surgical method of control group:The patient was asked to lie in prostrate position on the operating table, and the position was adjusted to lumbar over-flexion so that the waist plane was parallel to the floor. The center line of lumbar vertebrae and a parallel line passing through the upper margin of lumbar disc were marked under lumbar anteroposterior fluoroscopy using a mobile C-arm X-ray machine, as well as a lateral line through the upper posterior margin of lower vertebrae along the direction of intervertebral tilt under lumbar lateral fluoroscopy. The intersection of the lateral line and the parallel line passing through the upper margin of lumbar disc was the puncture point. For the L5/S1 lumbar disc, the connecting line between the peak points of iliac crests and parallel line passing through the upper margin of L5/S1 lumbar disc were marked under lumbar anteroposterior fluoroscopy, as well as a lateral line from superior articular process of S1 to upper posterior margin of S1 under lateral fluoroscopy, the intersection of the lateral line and connecting line between the peak points of iliac crests was the puncture point. The puncture was performed from the upper posterior margin of S1, usually at an angle between 30°～40° for L4/L5 lumbar disc abduction, and between 40°～50° for L5/S1 lumbar disc abduction.Disinfection was frequently performed on the skin surface around the surgical area. The puncture needle was pushed free-hand through skin-muscle and the front edge of superior articular process to enter into the location of target spot in spinal canal. The mobile C-arm X-ray machine was used for fluoroscopy to confirm the puncture needle tip was at the target spot. Local subcutaneous infiltration anesthesia was performed for the puncture point. The puncture needle’s stylet was removed and guide wire was inserted. Expanding sleeves were placed step-by-step under the guidance of guide wire and at last, the working sleeve was inserted.Full endoscope was placed inside the working sleeve and the nerve-compressing lumbar disc herniation tissue was directly removed under the monitoring of video camera.The number of X-ray fluoroscopy performed during puncturing and sleeve inserting, puncture angle and depth, distance from the target point to the vertical projection point of waist skin,and number of puncture needle adjustment was recorded. The targeted puncture accuracy was observed. The degree of patient’s pain response during sleeve inserting was assessed and categorized into mild, moderate and severe. Mild pain represents the patient did not moan or perform reactive body movement to pain, with blood pressure<140 mmHg, respiration rate<22 min-1 and heart rate<100 min-1. Moderate pain represents the patient moaned and performed slight reactive body movement to pain, with blood pressure<140 mmHg, respiration rate<22 min-1 and heart rate<100 min-1. Severe pain represents the patient shouted with both hands fisted and lumbar muscle being noticeably tense, performed obvious reactive body movement to pain, with blood pressure>140 mmHg, respiration rate> 22 min-1 and heart rate>100 min-1. The complications of surgery were observe, the average follow-up period was 12.6 months,The surgical effect was evaluated according to VAS, ODI and MacNab scores.The results were statistically analyzed by t test using SPSS 21, P value< 0.01 indicates statistical significance.5. We searched the Pubmed, Ovid, full text database of Wanfang Data, and Chinese National Knowledge Infrastructure databases for all studies related to cohort studies on transforaminal and interlaminar lumbar discectomy that were published before August 1,2014. The systematic review and meta analysis were conducted in the control study which met the inclusion criteria.Research results1. The lumbar disc herniation target collimator includes two parts, the a angle locator and the β angle locator, which are connected by a telescopic rod, and thus constitute the target collimator together. The a angle locator is a semi circle structure, and the β angle locator is a 1/4 circular structure. Alpha angle locator comprises a sector a angle ruler. The telescopic rod passes through the center of the a angle ruler and can rotate around it. The gear is rotated by a rotary knob, to make the telescopic rod move in a circular direction of the alpha angle ruler, so as to set the a angle. The a angle locator comprises a guide cylinder shaped beta angle ruler and guide tube passing through the center. The gear can be rotated by a rotary knob, to set the β angle.2. Methodology of the lumbar disc herniation target collimator guided target to puncture is established on the basis of lumbar spine X-ray, CT and MRI images of patients with lumbar disc herniation. The location of the disc herniation in the lumbar spinal canal was identified as the target. The connection from the target point to the vertical projection points of the waist skin form the bottom edge of a triangle. In the waist skin level plane, through the target as a vertical projection, the bottom edge of the vertical line is marked lateral to the skin as a puncture. Puncture angle (complementary angle of right angle triangle) is determined, and form a right angle triangle. Hypotenuse is the puncture strength of the way. According to the principle of right angle trigonometric function, the angle and depth of the puncture can be. measured and calculated scientifically and accurately.3. The number of X-ray fluoroscopy performed was 5.4516±0.85005 in the experimental group and 33.5714±8.73561 in the control group, showing a significant statistical difference (P<0.01). As for puncture accuracy, the experimental group had 27 cases (87.1%) succeeded in the first attempt and 4 cases (12.9%) succeeded in the second attempt, the control group had 3 cases (8.6%) succeeded in the first attempt,2 cases (5.7%) succeeded in the second attempt,6 cases (17.1%) succeeded in the third attempt,7 cases (20.0%) succeeded in the fourth attempt,7 cases (20.0%) succeeded in the fifth attempt,2 cases (5.7%) succeeded in the sixth attempt,2 cases (5.7%) succeeded in the eighth attempt,1 case (2.9%) succeeded in the ninth attempt and 5 cases (14.3%) succeeded in the tenth attempt or more. The puncture accuracy of the experimental group was clearly higher than that of the control group. As for patient’s pain response during sleeve insertion under local anesthesia, experimental group had 25 mild cases (80.6%),5 moderate cases (16.1%) and 1 severe case (3.2%), while control group had 5 mild cases (14.3%),19 moderate cases (54.3%) and 11 severe cases (31.4%). The overall pain response of the experimental group was obviously milder than that of the control group.The control group had 5 cases lower limb radiating pain during puncturing and 7 cases buttock pain. As the patients informed the surgeon in time, and the latter stopped puncturing immediately, pulled out the puncture needle and re-punctured after adjusted the angle. No symptom of nerve root damage was observed. In the control group,1 case of severe systemic bloodstream infection occurred, which was suspected to be caused by the large deviation during free-hand puncture, the puncture needle that entered the patient’s intestinal canal was pulled out and reused, thus carried intestinal bacteria into lumbar vertebra and caused severe infection. Fortunately, the patient’s condition was effectively controlled by applying intravenous drip of antibiotic imipenem cilastin sodium. Both groups had no nerve injury, major blood vessel damage or dural sac tearing complications. Postoperative follow-up was conducted for 9-15 months with an average of 12.6 months, the modified MacNab score of the experimental group and the control group was statistically significant (P<0.01).4.11 cohort studies and 3 RCT papers met the inclusion criteria, a total of 2110 patients (cohort study 1922 patients, randomized control study 188 patients) were included in the study. Meta-analysis results showed that transforaminal lumbar discectomy had better visual analog scale (VAS) score for low back pain and Oswestry Disability Index scores than the interlaminar approach. However, the transforaminal approach required longer operation time than the interlaminar approach. No significant differences were observed in complications, incomplete removal of herniated lumbar disc tissue, LDH recurrence rate score, reoperation rate, leg pain VAS, Japanese Orthopaedic Association score, or modified MacNab evaluation.Research conclusions1.The accuracy of the lumbar disc herniation target collimator is high, and the target puncture method is scientific.2.Personalized formulate the puncture path of percutaneous transforaminal full endoscopic lumbar Discectomy, and use the new targeted puncture technique guided by lumbar disc herniation target collimator can significantly reduce X-ray exposure dose in PTELD, effectively protect the surgeon from more X ray radiation, reduce the technical difficulty of the target puncture technique and the surgical risk, relieve the pain of patients and improve the excellent rate of surgery. This new puncture technique will greatly help new learners to master PTELD.3.Compared with the interlaminar approaches, percutaneous transforaminal full endoscopic lumbar discectomy for lumbar soft tissue injury is the lightest, very small influence on the spinal tissue, rehabilitation of lumbar function quickly. But PTELD technical difficulty is high and long learning curve. Further technical innovation to reduce the technical difficulty of PTELD operation is required. |
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