| Lumbar disc herniation(LDH)is a common disease in spinal surgery and the most common cause of Lumbar-leg pain.According to statistics 80 percent of adults in China suffer from back and leg pain,while 20 percent of them are diagnosed with lumbar disc herniation.Severe cases can include dysuria and paralysis of the lower limbs.Most patients can be cured or improved after conservative treatment,but those without any improvement after 1-2 months’ conservative treatment need surgical treatment.Traditional open surgery includes total laminectomy,half laminectomy,laminae fenestration and discectomy for the nucleus pulposus of lumbar dics.Although the removal of pathological intervertebral disc tissue can achieve the purpose of nerve decompression and pain relief,the trauma of traditional open surgery is relatively greater,which requires the paravertebral muscle dissection,partial lamina resection and articular process to achieve widely exposure.But those procedures may damage the stability of the spine,damage the paravertebral muscle,increase the formation of local scar,and affect the recovery of spinal function and long-term efficacy of patients.With the development of spinal surgery technique and surgical instruments,the treatment of lumbar disc herniation tends to be minimally invasive.In the late 1990 s the emergence of percutaneous endoscopic lumbar discectomy(Percutaneous Endoscopic Lumbar Discectomy,PELD)is of epoch-making significance.Compared with traditional surgery,due to its advantages of being able to operate under local anesthesia,smaller incision(about 7mm),less trauma,rapid recovery,fewer complications,and definite curative effect,it has been welcomed by spine surgeons and patients,and is soon widely carried out worldwide.PELD is always divided into YESS(Yeung endoscopic spine system)technology and TESSYS(transforaminal endoscopic spine system)technology,which are reported by professor Yeung and professor Hoogland respectively.Classic YESS operation is usually via foraminal approach.The first step is percutaneous puncture,inserting the needle,its tip reaching Kambin security triangle(triangular working zone),and then enterring the pathological intervertebral disc.Then working channel steps into Kambin security triangle over the guidewire,followed by intervertebral disc decompression.Firstly remove intervertebral disc,and then gradually retreat,using inside-out(inside-out)method to remove protruding intervertebral disc.It is difficult to remove prolapse intervertebral disc tissue and other issues,because it is a kind of indirect decompression method.2003 German professor Hoogland designed TESSYS technology,through trephine,or the endoscopic dynamic system to remove a part of articular process’ s ventrolateral bone,expand the intervertebral foramen,set the work channels directly into the spinal canal,use endoscopic outside-in(that is,outside-in)method to remove protruding or prolapsing disc.The pathological intervertebral disc tissue can be removed,and the intervertebral foramen and lateral recess can be enlarged simultaneously to treat the spinal stenosis or lateral recess stenosis,further expanding the surgical indications and making the surgery safer and more effective.However,PELD’s steep learning curve,accurate puncture,well-positioned working channels and microscopically operated techniques require a lot of practice,making the learning process difficult and lengthy,especially for young doctors and non-spine surgeons who have no experience in open surgery.No matter YESS technology or TESSYS,intervertebral foramen approach is often adopted,and the establishment of well-positioned working channels is the key to the length of surgery,whether the surgery process is smooth,and whether the operation effect is good or not.The position of the working channel is determined by the effect of intervertebral foramen puncture.Therefore,intervertebral foramen puncture has become the primary and key technique of PELD technology.However,at present,the puncture of the intervertebral foramen is performed by free hand,relying on the experience and hand feeling of the operator.Complex body surface positioning before surgery and repeated intraoperative fluoroscopy confirmation and correction are required by X-ray fluoroscopy.Because beginners often do not have good three-dimensional imagination and puncture operation experience,even if the puncture experienced senior surgeons are very difficult to successfully complete the puncture at one time.Repeating puncture failure and severe puncture deviation are ofen seen,which lead to performers and patients receiving more X-ray exposure,increased the operation time,especially for beginners and non-spine-surgeon(such as anesthesia,physiciotherapist),who are often unable to achieve rapid and accurate puncture.Repeating puncture failures often increase the operation time and operation difficulty,lead to operation failures or termination,undermining the performer’s self-confidence.At present,there is no simple and effective guide device available.Therefore,it is necessary to develop a percutaneous intervertebral puncture guide device to improve the success rate of puncture,shorten the operation time,reduce the X-ray exposure of doctors and patients during the operation,and improve the operation efficiency.This is of positive significance for reducing the difficulty of PELD technology learning,improving the efficiency of surgery and promoting the popularization of PELD technology.To this end,we designed an intervertebral foramen guide device,which can realize rapid and accurate intervertebral foramen puncture under the guidance of the guiding device,shorten the time of puncture and surgery,reduce The times of fluoroscopy,improve the efficiency of puncture,reduce the difficulty of learning of the puncture technique,and enhance the confidence of beginners.Based on the same principle,a invasive scheme and a noninvasive scheme are designed.We first proved the effectiveness of the invasive program through the cadaver experiment,and then further proved the safety and effectiveness of the non-invasive program in the clinical study.The first part is the design and patent application of a intervertebral foramen guidance device.The second part is a cadaver study of an intervertebral puncture guide device.The third part is a clinical study of intervertebral puncture guide device.The first part The design and patent application of an intervertebral foramen puncture guide deviceIntervertebral foramen puncture actually targets at the superior articular processes of the lesion.This target forms a triangle with its projection on the body surface and skin entry point of intervertebral foramen puncture,but this triangle is three-dimensional in the human body.The free hand intervertebral foramen puncture relies on the rich spatial imagination and clinical experience of the operator,and the process of puncture is often difficult,time-consuming,and with much radiation exposure.Based on the triangulation of these three points,we designed an intervertebral foramen puncture guide device with a single plane right triangle.The vertical distance from the facet joint to the skin can be measured by preoperative image data.Another leg of the right triangle is the distance from the projection of the facet on the body surface to the puncture site of the intervertebral foramen.When the two legs of a right triangle are established,the length and angle of the hypotenuse(the intervertebral foramen puncture path)of the right triangle are determined.In the lateral angle of the triangle(that is,the entry point of intervertebral foramen puncture)we design a needle sleeve which can be adjusted the direction and angle.According to the data of the previous measuring in vitro,we adjust each joint of the guide device,identify the length of the the two rods of the guide device,fixed the angle and the direction of the intervertebral foramen puncture needle sleeve,then perform guide percutaneous puncture.With the guidance of the process puncture needle,he intervertebral foramen puncture needle accurately reach the articular process(intervertebral foramen is located on its ventral side).If the puncture is not ideal at the beginning,we can remove the guide device,adjust the angle and direction of the guiding sleeve according to the result of fluoroscopy,and make the puncture needle closer to the target until the result of ideal effect is obtained.We first drew the sketch of th novel guide device by ourselves,then commissioned professional drawing engineers to draw the diagrammatic sketch and device explosive diagram,and gave it to a medical device manufacturer to produce the material object of stainless steel,and applied for the utility model patent and invention patent.The device was then used to perform cadaver and clinical trials.The second part A cadaver study of an intervertebral foramen puncture guide device。Objective to prove that the accuracy and efficiency of intervertebral puncture can be effectively improved by using a novel guid device of intervertebral foramen puncture.Methods four cadavers with 40 lumbar intervertebral foramen were treated by three puncture methods.In group A,free hand puncture was performed by an experienced senior surgeon;In group B,mannual puncture was performed by an inexperienced surgeon.In group C,the inexperienced junior surgeon performed intervertebral foramen puncture with the aid of the novel guidance device.The localization time,puncture time,fluoroscopy times,intervertebral foramen puncture times and severe deviation times were compared among the three groups.Results there were statistically significant differences among the three groups in locating time,puncture time,fluoroscopy times,intervertebral foramen puncture times,and severe deviation times.Conclusion the accuracy and efficiency of intervertebral puncture can be effectively improved by means of intervertebral foramen puncture guid device.The third part A clinical study of intervertebral foramen puncture guidance deviceObjective to prove that the accuracy and efficiency of intervertebral foramen puncture can be effectively improved by the aid of a novel guidance device through clinical randomized controlled experiment.Methods 90 cases of single segment lumbar disc herniation were randomly divided into three groups.In group A,free hand intervertebral puncture was performed by experienced senior surgeon;In group B,free hand puncture puncture was performed by a junior surgeon with no experience.In group C,the inexperienced junior surgeon performed foramen puncture with the aid of a novel guidance device.Localization time,puncture time,fluoroscopy times,severe deviation times,operation time,visual analogue score,Mac Nab score and incidence of complications were compared between three groups.Results there were statistically significant differences among the three groups in locating time,puncture time,fluoroscopy times,intervertebral foramen puncture times,severe deviation times and operation time.There was no significant difference between the three groups in visual analogue score,Mac Nab score and complication rate.Conclusion the accuracy and efficiency of intervertebral foramen puncture can be effectively improved by means of the novel puncture guidance device. |
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