椎体成形术

Presented by Meredith GaoKH BKP SPM,KH ESSENT Balloon Kyphoplasty Procedure (BKP)Guide,Oct , 2015,康辉BKP配包清单,2,3.0标准手术器械包2.6/3.0/3.6穿刺系统导针扩张器系统（含导针2+扩张器1+套管2）空心钻骨水泥注入系统（推杆1+套管1）钻头30ml 标准注射器康辉球囊,4.0快速通道手术器械包4.0穿刺系统空心钻骨水泥注入系统（推杆1+套管1）钻头4.0穿刺系统套管30ml 标准注射器康辉球囊,手术附加器械准备单标记笔刻度尺子手术刀/解剖刀锤子一次性手术室搅拌杯子一次性压舌板/一次性搅拌棒,手术骨水泥系统德国骨水泥10ml标准注射器骨水泥注入系统(推杆4+套管4),KH BKP Procedure Guide,3,Room Set-up Page 22Access, Biopsy, Drilling, Page 24 Transpedicular ApproachExtrapedicular ApproachEn Face ViewCreating a Void Page 45KH Balloon Kyphoplasty IBT SystemsIBT PlacementCementing . Page 53,1. Room set-up,KH BKP Procedure Guide,4,Room Set-Up,5,2. Access, biopsy, drilling,6,KH ESSENT BKP Procedure Guide,Osteo Introducer System,穿刺系统,钻头 Drill,扩张系统,KH BKP Access Tools,7,Access System,接近骨折部位标准穿刺点Assess landmarks considering fracture configuration 预测穿刺角度Planning the trajectory,8,Transpedicular椎弓根入路,Extrapedicular椎弓根外侧入路,两种术士我们力求都采用双侧手术方案Both approaches are intended to be bilateral,康辉标准手术入路Access Approaches for KH BKP,9,椎弓根入路Transpedicular ApproachAccess,X片定位椎弓根外侧缘。Use fluoroscopy to locate the lateral border of the pedicle定位穿刺点椎弓根外侧缘10-11点/2-3点位。Place a small incision lateral to the pedicle location 定位皮肤切口（切口点取决与手术阶段和骨折形态），一般腰椎建议穿刺点外2cm,上2cm点切开。 This will allow proper convergence through the tissues to the pedicle entry point(2cm upper ,2 cm lateral),10,椎弓根入路Transpedicular ApproachAccess,将穿刺针潜入穿刺部位Dock the access tool of choice on the lateral border of the pedicle to start between the “10 to 11 or 2 to 3 - oclock” positionC臂机下确认准确的穿刺点Exact starting location will vary with fracture and pedicle morphology侧位片确认进针角度Switch to a lateral view to verify needle trajectory and position穿刺针尖在椎弓根后方椎弓根外侧缘Tip of instrument should be on the posterior aspect of the pedicle in the lateral view,11,椎弓根入路Transpedicular Approach Access,回到正位片Return to the AP view穿刺针进入椎弓根，到达椎弓根内测缘Advance the instrument tip to the medial border of the pedicle侧位片针尖到达椎体后缘Confirm in the lateral view that the tip is at the posterior wall of the vertebral 继续穿刺，至套管进入椎体3-4mm。Advance the distal end of the working cannula 3-4mm past the posterior cortical margin转动把手，取出针芯Rotate the handle of the introducer tool counter-clockwise and pull straight out to remove inner stylet,12,FIVE STEPs in AP view,| MDT Confidential,13,1,2,3,4,5,FIVE STEPs in lateral View,| MDT Confidential,14,1,2,3,4,5,FIVE Steps of accessing,| MDT Confidential,15,1,2,3,4,5,椎弓根入路在上胸椎手术时不能达到理想穿刺终点In the upper thoracic spine, the transpedicular approach may not allow proper medial placement of the instruments and the IBT,椎弓根外侧入路Extrapedicular ApproachAccess Alternative,16,理想穿刺终点在椎弓根外侧以保证其他工具和球囊进入椎体的中间位置Entry point is outside the pedicles to ensure proper medial position of the tools and IBT,椎弓根外侧入路Extrapedicular Approach,手术入路的选择取决于胸椎是第几节段Depending on the level of the thoracic vertebra:穿刺点在横突和上关节突结合部的外侧Entry point is at lateral junction of transverse process and superior articular process在肋骨与横突之间，椎弓根外上缘Between rib and transverse process at superior lateral pedicle wall,From Clemente Anatomy Urban & Schwarzenberg Mnchen 1997,17,椎弓根外侧入路Extrapedicular Approach Access,扩张器进入椎体后缘后，可以看到通道建立的结果和X片终点和椎弓根入路相同After the introducer tool passes through the posterior cortex, the instrument sequence and image endpoints are identical to the transpedicular approach,PMD014302-1.0,18,| MDT Confidential,椎弓根外侧入路Extrapedicular Approach Access,穿刺点和皮肤切口比椎弓根入路偏外上。Entry point and incision may be more lateral and superior than TP approach 起始用3.0穿刺系统（10cm)Initial access with 10 gauge needle器械在椎弓根外侧缘Instrument may appear slightly outside of pedicle outline转到侧位片确定穿刺角度Switch to lateral view to confirm trajectory. The needle will appear midway down pedicle,19,椎弓根外侧入路Extrapedicular ApproachAccess,回到正位片观察Return to AP view穿刺系统进入椎弓根中点Advance the introducer tool to mid pedicle 侧位片调整扩张系统尖端进入到椎体后缘Check lateral view to verify that the tip of the introducer tool is at the posterior cortical wall of the vertebral body,20,FIVE STEPs in AP view,| MDT Confidential,21,1,2,3,4,5,FIVE STEPs in lateral View,| MDT Confidential,22,1,2,3,4,5,FIVE Steps of accessing,| MDT Confidential,23,1,2,3,4,5,斜位片-椎弓根正前位片En Face ViewAccess,将穿刺针尖锚在椎弓根上Dock instrument tip in center of pedicle 侧位片观察穿刺角度和深度Check lateral to address trajectory and instrument depth in the pedicle斜位片穿刺直达椎弓根根部，保持穿刺系统在椎弓根内。Return to the En Face view and advance directly down the barrel of the pedicle, keeping the instrument tip within the borders of the pedicle 正位片和侧位片确保穿刺针尖在穿过椎体后缘之前不穿出椎弓根。Use corresponding AP and lateral images to ensure the instrument tip does not cross the medial pedicle border without first crossing the posterior cortex,24,取活检Biopsy Technique,用空心钻插入扩张套管，轻轻旋转，深度不超过钻头Remove Bone Biopsy Device plunger, insert the Bone Biopsy Device cannula into the vertebral body using a slight twisting motion prior to using the precision drill取出空心钻，用推杆推出活检样本Remove the cannula from the vertebral body and push out the specimen by inserting the plunger,25,进入椎体ApproachDrilling,侧位片观察，钻头钻入椎体In the lateral view, advance the drill to the center of the vertebral body正位片钻头在椎弓根内侧缘和棘突之间In the A-P view, the drill should appear to be equidistant between the medial pedicle border and the spinous process侧位片，钻头到达距离椎体前缘3mm处。In the lateral view, advance the drill approximately 3 mm from the anterior cortex 正位片，钻头在棘突中线处In the A-P view, the drill should be approaching or at the midline of the spinous process顺时针旋转取出钻头Remove the drill while continuing to turn clockwise,26,3. Creating a void,27,KH ESSENT BKP Procedure Guide,KH ESSENT Balloon Kyphoplasty IBT SystemsIBT Placement,28,Creating a void,康辉球囊KH Balloon Kyphoplasty Platform,将提供3种型号：Expanded Portfolio: choose among more IBT size/volume options: size 10/2 (3cc), 15/2 (4cc), and 20/2 (5cc), provides more clinical solutions for different patients and pathologies附加物Additional Offerings: 标记线Radiopaque markers in the balloon, a identifier circle on the tube充盈装置 Balloon inflating syringe,29,康辉球囊特点 KH IBT features,产品配包简单球囊花生样扩张，且受力均匀标记线显示球囊在椎体内深度充盈后双侧球囊在中间形成对抗，并向上扩张，充分解剖复位球囊导管标记线表示球囊尖端已经到达扩张系统的前端,Please reference the device instructions for use for complete information on indications, contraindications, warnings, precautions, adverse events and instructions.,30,KH ESSENT Balloon Kyphoplasty IBA15,康辉球囊工具KH BKP Platform Components,31,Inflation Syringe (IS) 球囊充盈装置便于控制球囊的充盈容积和检测球囊扩张压力Easy monitoring of pressure and contrast volume allows for convenient visualization and control of balloon inflation endpoints.,Please reference the device instructions for use for complete information on indications, contraindications, warnings, precautions, adverse events and instructions.,球囊撑开关键点IBT Inflation Volumes1,充盈容积和压力Volume is the key operating characteristic of balloon控制球囊容积和监测球囊内压力Operator controls volume, and monitors pressure充盈量增加，球囊扩张程度也增大As volume increases, more opportunity to move bone to create cavity监测球囊内压力可以知道球囊扩张的情况Monitoring the IBT pressure gives operator feedback during inflation (i.e. higher pressures could mean hard bone, too close to cortical wall or IBTs “kissing” and working off one another)球囊总是倾向向着压力小的方向扩张IBTs tend to expand in the direction of least resistance (i.e., weakest bone) to create cavity实践过程中，球囊最终的扩张形态与使用方法相关In practice, final balloon shapes may vary, depending on IBT used,32,椎体后入路进入椎体Transpedicular Approach Inflatable Bone Tamp Placement,插入球囊Insert the IBT确认双侧球囊都标记想都在椎体内Ensure both radiographic markers exit the cannula注入with 0.5-1cc 显影剂Fix the balloon in place by inflating with 0.5-1cc of contrast可以去掉针芯更便于C臂机的移动The stylet may be removed to facilitate C-arm freedom of movement (optional),33,椎体后入路扩张Transpedicular Approach Inflatable Bone Tamp Inflation,插入对侧球囊Place contralateral tools and IBT双侧球囊同时再次增加0.25-0.5 cc 。Sequentially increase the volume in both IBTs in small (0.25-0.5 cc) increments正位和侧位片观察球囊充盈情况Assess IBT size and position in lateral and AP views继续使球囊扩张至终点Sequentially inflate until an inflation endpoint is reached,34,4. cementing,35,KH BKP Procedure Guide,Cementing,Cement Delivery SystemCement Placement,36,康辉骨水泥注入器械KH Cement Delivery System,康辉骨水泥注入系统: 10ml骨水泥注射器1.5cc骨水泥注入系统,Please reference the device instructions for use for complete information on indications, contraindications, warnings, precautions, adverse events and instructions.,37,38,主要成分Composition: PMMA 主要特点Key Features: 快速粘成牙膏状Quick-to-dough 高粘度High viscosity工作时间差较长Long working time 可以在X线下显影Radiopaque操作时间Handling: 30秒混合Mix for 30 seconds, 2-6分钟粘稠2-6min to dough, 16分钟工作时间窗16min working time包装规格Package: 20克/包+10毫升溶剂Cement 20g powder + 10ml liquid 保质期Shelf Life: 36个月36 months,Please reference the device instructions for use for complete information on indications, contraindications, warnings, precautions, adverse events and instructions.,38,德国水泥Heraeus Bone Cement23度 1度的环境下操作Handling Characteristics at 23 10C,德国水泥工作时间窗Hareaus Bone CementHandling Characteristics at 23 10C (25),39,* These times are based on cement prepared by KH Lab. Times may vary when other mixing methods, delivery devices and vacuum are used.,时间窗和研发确认,骨质疏松治疗VCF TreatmentCementing,取出球囊Deflate and remove IBTs 插入骨水泥注入系统，距椎体前缘2-3mm。Insert BFD, leaving 2-3mm of space between end of BFD and cortical wall缓慢注入，并观察影像学Using fluoroscopy, slowly inject the cement mix在注入=1.5cc骨水泥观察X片X片显示水泥主要椎体前缘Leave the anteriorly placed,40,骨质疏松治疗VCF Treatment1Cementing Lateral,继续推注骨水泥至距离椎体后缘5mm。Inject cement until wi