1、1FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*S2AI 骶髂固定螺钉 2FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or com
2、mercial use in any market.*仅供内部使用*简介SAI螺钉是第一款根据骶骨翼解剖设计。用于骶盆融合手术的内植物。目前。由于腰骶部复杂的解剖结构，独特的生物力学机制。以及疏松的骨质等原因。腰骶部的融合依旧是脊柱手术面临着挑战。现有腰骶及骶盆融合技术以及相应的内植物系统均有各自的优缺点。SAI技术是对现有技术的最新发展。通过螺钉置入，能为腰骶部提供稳定固定。将假关节形成风险最小化。偏角设计万向钉图光滑杆区域及强力把持的四种特性。而SAI螺钉在术中的植入。中线对线的固定方式也使其不仅能重建骨盆稳定，同时能有效矫正骨盆在失状位或冠状位的畸形。3FOR INTERNAL USE
3、ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*Expedlium 家族现有骶髂固定方式方式一2枚髂骨螺钉+2个横连方式二2枚 SAI螺钉4FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available
4、for sale or commercial use in any market.*仅供内部使用*常见骨盆固定方式选择S1 椎弓根螺钉髂骨螺钉SAI 螺钉S2-ala 螺钉将固定延伸至髂骨皮质是最佳选择腰骶轴心点腰椎和骶骨的连接点，位于L5S1椎间盘后缘5FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*常见骨盆固定方式选择6F
5、OR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*Why SAI （Sacral-Alar-lliac ）?S1 Screws 经椎弓根，皮质骨把持少S2 Screws 短，不经过腰骶重心 Iliac Screws 并发症多，术后翻修率高* Supported by data其他固定方式SAI 固定7FOR INTERNAL US
6、E ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*潜在技术优势适应症手术操作8FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in
7、any market.*仅供内部使用*设计者Dr. Kebaish ( 成人脊柱侧弯 ) Dr. Sponseller ( 儿童脊柱侧弯 ) Johns Hopkins University Hospital9FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*SAI 优势v中线入路减少软组织损伤，降低术后切口并发症，感染及出血有
8、助于关闭切口时保留完整的肌肉筋膜层开放手术与微创手术均可使用v骨进钉点低于髂后上棘15mm, 切迹明显低于其他方式无需损伤髂后上棘，减少术后疼痛，减少钉头突出带来的不适感v路线髂后上棘-髂前下棘，把持更多皮质骨通常达80-90mm,经过腰骶重心，稳定性令人满意v同轴结构符合生物学稳定理念保证L4，L5，S1，S2钉维持在一条线上，便于棒的安放无需特殊连接装置，有助于骨盆矫形10FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available
9、 for sale or commercial use in any market.*仅供内部使用*SAI 适应症目标领域：1：复杂的成人脊柱侧弯病患2：神经肌肉源性脊柱侧弯的病患4：复杂微创手术的一种选择3：少量复杂肿瘤和骨盆骨折的病患融合至骶骨的长节段手术严重的椎体滑脱（三度以上）复杂的腰骶部畸形需行截骨矫形的平背畸形远端腰椎后凸矫形骨盆倾斜矫形骨质不良的畸形11FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for
10、sale or commercial use in any market.*仅供内部使用*SAI 特性特点利益偏角设计可与棒直接连接易于对线及放棒不需要使用横连可显著减小切迹6.35系统中的持钉器在螺钉置入过程中提供更大扭矩，方便螺钉植入光滑杆降低螺钉螺纹对骶髂关节的刺激，拉力螺钉空心螺钉 适用于使用VIPER, EXPEDIUM的微创手术、开放手术或混合手术 T27持钉器偏角设计光滑杆设计空心螺钉12FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance.
11、Not available for sale or commercial use in any market.*仅供内部使用*SAI 规格 螺钉直径 : 8, 9, 10mm 螺钉长度 : 65, 70, 80, 90, 100, 110mm; 常用规格80， 90mm; T27 上钉器， T25 上螺帽 适用于5.5系统，可以和Expedium / Viper进行连用 不同长度的螺钉，螺纹的长度不同:13FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance
12、. Not available for sale or commercial use in any market.*仅供内部使用*病人体位及切口病人需要在透视手术床上保持俯卧位，使用单平面或双平面X线或CT透视前后位及侧位，使用体位垫帮助支撑髂嵴，保持骨盆中立位，例如无旋转，良好的失状位，同时摆放完成后可触及大转子。延长皮肤中线切口，暴露骶骨背侧，尤其是S1S2的背孔，使用SAI技术将不再需要显露髂嵴，不再使用连接杆。14FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA c
13、learance. Not available for sale or commercial use in any market.*仅供内部使用*SAI 手术技术1：确认进钉点：qS1与S2的背侧孔是确认进钉点的解剖标志；q找到S1与S2背侧孔间横向中线与其外侧缘连线的交点；q交点即是进钉点q该点需与S1的椎弓根螺钉保持对线guq骨盆在横断面不对称，进钉点在中外侧平面需要调整。15FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not availab
14、le for sale or commercial use in any market.*仅供内部使用*2：SAI 螺钉路径q髂后上棘-髂前下棘 连线方向；q朝尾端倾斜20-30 夹角；q与水平面呈40-50 夹角；q对准髂前下棘，可以通过大粗隆顶部的触诊获得；q路径穿过坐骨切迹之上；16FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供
15、内部使用*螺钉置入 使用尖头探针或2.5毫米钻头。 所选轨迹应横向向外约40 50度，指向髂后上棘并向尾侧倾斜20 - 30。 这个轨迹将随骨盆倾斜和腰椎前凸改变 位于坐骨切迹上方2cm17FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*2：SAI 螺钉路径q透视有助于帮助术中定位，C臂透视能帮助调整置钉方向q将C臂机置于进钉
16、点上方q调整C臂机角度（尾端20-30，水平40-50）q指向髂前下棘q此时，AP位透视显示泪滴状图样18FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*泪滴19FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending F
17、DA clearance. Not available for sale or commercial use in any market.*仅供内部使用*2：SAI 技术螺钉路径q在开路器开口后，可以使用导针q在透视下确认导针方向q攻丝（关键），攻丝与螺钉的直径一致，并保证攻丝时导针位置不前移q由于骨盆翼是皮质骨，更长距离的攻丝（全部钉道）有利于减少螺钉所受的扭力20FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for
18、sale or commercial use in any market.*仅供内部使用*选择直径和长度适宜的螺钉，沿导针置入螺钉在螺钉完全植入前，移除导针21FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*Teardrop View附：C-arm定位22FOR INTERNAL USE ONLY. NOT FOR USE W
19、ITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*23FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*24FOR INTERNAL
20、 USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*25FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any marke
21、t.*仅供内部使用*26FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*27FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or com
22、mercial use in any market.*仅供内部使用*放棒选择长度合适的棒，在放棒之前按正常生理弧度预弯棒即可，无需额外调整。28FOR INTERNAL USE ONLY. NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION.Pending FDA clearance. Not available for sale or commercial use in any market.*仅供内部使用*v 2017 Johnson & Johnson Services. All rights reserved. 063858-161129 Thank Thank YouYou ! !
