创伤文件-全部用户指南

1、目录前言11、产品特点及优点22、相关适应症及症33、手术方法：43.1、一般原则43.2、手术步骤63.2.1、第1步63.2.2、第2步63.2.3、第3步73.2.4、第4步73.2.5、第5步83.2.6、第6步83.2.7、第7步103.2.7.1、 选择1-标准螺钉103.2.7.2、 选择2-骨锁定镙钉103.2.7.3、 拔出锁定垫圈113.2.8、第8步113.2.8.1、肌下锁定技术124、产品订购信息-植入物145、产品订购信息-4.0毫米工具15前言AxSOSTM锁定骨板系统用于治疗肱骨近端，股骨远端，胫骨近端和胫骨远端的关节周围的骨折和关节内骨折。该系统的设计基于经验

2、丰富的外科医生组成的国际小组的临床数据，参考各种文献数据并通过实践及生物力学实验而成。钢板的解剖塑形，螺钉的角度和优质表面处理，都充分考虑了临床医师在合理固定，疲劳强度及最小软组织挫伤方面的需求。本手册讲述如何通过简单的步骤植入胫骨近端外侧骨板。Proximal Lateral Tibial Plate胫骨近端外侧骨板本手册讲述如何通过简单的步骤植入胫骨近端外侧骨板。Proximal Humeral Plate肱骨近端骨板Distal Lateral Femoral Plate股骨远端外侧骨板Distal Medial Tibial Plate胫骨远端内侧骨板Distal Anterolate

3、ral Tibial Plate胫骨远前端外侧骨板1产品特点及优点系统工具适用范围方法简单，只需少量组件的简便器械。较长骨板可覆盖更广范围的骨折类型。胫骨近端外侧骨板在设计上采用不同角度的固定螺钉，在力学上提供了最佳的稳定性。有助于预防复位的丢失。采用工具设计，与MIPO技术（微创钢板接骨术）兼容。单轴孔（5个）钻套导向器允许轴向稳定置入螺钉，使结构具有稳定性。有助于钻套定位。克氏针/复位/缝合孔初期/临时钢板及骨折固定软组织复位解剖预塑型很少或无需弯板减少手术时间独创式锁定螺钉设计无螺纹孔锁定螺钉引导入骨板减少潜在滑丝和冷焊接可能徒手安装螺钉可使用拉力螺钉支撑螺钉为后内侧骨折块提供牢固的三角

4、形固定装置“腰状”钢板形态均一的荷载传递杆部螺孔-或锁定型双向轴孔加压型，中立型或支撑型固定装置可以使用SPS的标准3.5/4.0mm螺钉可以放置轴向稳定锁定螺钉用的锁定垫圈圆形&锥型钢板尾部帮助减少不必要的软组织损伤。2相关适应症及症相关适应症这种内固定装置适用于胫骨近端干骺端关节内外骨折治疗。相关症最合适装置和治疗方法的选择必须依赖医生的受教育及所接受培训的程度和专业判断力。医生必手术区域软组织覆盖。须考虑到以下可能发生的相对或绝对：使用植入物可能干扰解剖结构或生理机能。区域里面或周围任何主动潜伏型，疑术后护理中可能产生的令人难以接受的接骨似潜伏型或明显的局部。固定失败或产生并发症风险的心

5、理或神经肌肉。损伤可能会导致骨折处或受累区域的。排除其他不适合进行手术的临床情况。由于疾病，或原先植入的内植物可能导致详细信息可参见植入物所附的使用指南。骨量，从而不能够提供足够的支持或固定内植入物。请阅读包装内所附说明书，里面有关于潜在和并发症方面的详细。必要时医生必须向病有的或可疑的金属过敏反应。人讲解所有相关风险，包括此类产品的最终使用。肥胖问题。超重或肥胖型可能对植入物产生过度负荷，导致无法对装置进行固定或者装置本身出现问题。注：骨螺钉不是用来附着或固定颈椎，胸椎或腰椎的螺钉。3手术方法一般原则位 置手 术 方 法： 仰卧，可选择屈膝。： 外侧入路工具/螺钉型号： 4毫米复位骨折解剖复

6、位可以通过经皮夹进行直视下操作，或者利用桥接的外部固定装置帮助间接复位。关节表面的骨折复位应当通过直视操作或操作进行确认。必要时使用克氏针暂时维持复位。折弯在通常情况下，骨板无需进一步折弯即可使用。但是，如果要求对骨板进行折弯（通常是在和干骺端的交接部位），应当使用折弯器（702756）。因为折弯在干骺端的锁孔区域的骨板会影响锁定螺钉的植入，所以不允许这样做。在钢板折弯应当被一般来说，平行关节面的克氏针不但可以支撑骨折复位，还能有助于看清和确认关节面。限制在钉孔之间的区域。骨板折弯可能影响折弯点附近的钉孔锁定垫圈的植入。请特别注意那些不要干扰所需钢板和螺钉定位的情况。必须考虑在安装骨板之前将独

7、立拉力螺钉进行定位，以确保其不会干扰计划中的骨板位置或锁定螺钉轨迹。如果出现任何大骨缺损情况，需采取植骨或使用替代材料进行填充。注：如果采用肌下技术，请参看本指南后面的相关章节。4手术方法一般原则锁定螺钉长短测量如下图所示，有四种可选方法测出正确的锁定螺钉长度。Measure off K-Wire 克氏针测量Read off Calibration 阅读校准Conventional direct 传统直接测量Measure off drill 骨钻测量软组织复位位于两个近端克式针孔相对的骨板背面的独特的开槽，即使骨板固定后也易于穿过缝线进行简单的半月板缝合复位。5手术方法Step 1 - Pr

8、e Operative Planning第1步-术前准备Use of the X-Ray Template (REF 981091) or Plate Trial (REF 702793) in assotion withA 4.0mm Locking Insert (REF 370002) is attached to the Locking Insert Inserter (REF702762) and placedo the chosen holes influoroscopy can assisthe selection of anthe shaft portion of the pl

9、ate (Fig. 2). Ensure t the Locking Insert is properly placed. TheInserter should then be removed (Fig. 2A).appropria y sized implant (Fig. 1).利用X-线模板（981091）或钢板试模（702793），配合X-线，可以帮助将4毫米长的锁定垫圈（370002）安装到挑选尺寸适合的植入物（图1）。锁定垫圈植入器（7027602），并装到钢板骨分选定的钉（图2）。确保正确安If the Plate Trial is moren 90mm away装锁定垫圈。随后

10、取出植入器（图2A）from the bone, e.g. with obese patients, a magnification factor of 10-15% will occur and must be compensated for. Final raoperative verification should be made to ensure correct implant selection.如果钢板试模离骨超过90mm,比如，肥胖病人，会有10%-15%的放大率，因此必须去除这一影响。为保证正确的植入物选择，必须进行最终术中确认。Do not place Locking In

11、serts with the Drill Sleeve.不要用钻套安装将锁定的垫圈。Note:It is important to notet if a TemporaryPlate Holder is to be used for primary distal plate fixation, then a Locking Insert must not be placedhe same hole as the Temporary PlateHolder (See Step 5).注：如果用临时钢板定位针进行初期远端钢板固定，则绝不能将锁定垫圈放入临时钢板Step 2 - Aiming Blo

12、ck/Plate In-sertion Handle AssemblyIf Locking Screws are chosen for the plate shaft, pre-operative insertion of Locking Inserts is required.第2步-钻套导向器/骨板安装手柄定位针的同一（参见第5步）。如果为钢板骨分选定了锁定螺钉，需要Screw the appropriate Aiming Block (REF 702728/ 702729) to the plate using the Screwdriver T15 (REF 702747). If d

13、esired, the Handle for Plate Insertion (REF 702778) can now be attached to help facili e plate预先锁定垫圈。itioning and sliding of long muscularly (Fig. 3).lateb-用扳手T15（702747）将合适的钻套导向器（702728/702729）用螺钉固定。如果需要，骨板器（702778）柄可以固定到导向器上来帮助钢板和较长钢板肌下定位（图3）。 6手术方法Step 3 - Plate Application第3步-骨板的应用After skin inc

14、iand anatomical reductionis achieved, apply the plate sot the lateralcondyle ipported, with the proximal endof the plate approxima y 5mm below the articular surface (Fig. 4).切开皮肤，进行解剖复位后，放入骨板，以便使用关节面下大约5毫米的骨板近端支撑外侧骨突（图4）。This helps to ensuret the most proximalLocking Screws are directly supporting t

15、he jo surface.这样有助于确保最近端的锁定螺钉可以直接支撑关节面。图4-AP视图图4-外侧图Step4-Primary Plate Fixation -Proximal第4步-首次钢板内固定-近端The K-Wire hole just distal to the oblong holeAdditional K-Wires can be insertedheallows temporary plate fixation (Fig. 5).he metaphysisK-Wire holeperior to the locking holes tofurther help secure

16、 the plate to the bone and also support depressed areas he articular surface.骨板上的克氏针孔可以将临时光板固定到干骺端和螺杆部分（图5）。可以将额外的克氏针克氏针，超过锁孔，有助于将骨板与骨体进一步吻合，还能支持关节面凹下区域。Remove the Handle for Insertion by pressing themetal button atof the Handle.按住手柄端的金属按钮，取下手柄。Do not remove the Drill Sleeve and K-Wire Sleeve at thi

17、s poas it will cause a loss of theUsing the K-Wire Sleeve (REF 702702) in conjunction with the Drill Sleeve (REF 702707), a 2.0 x230mm K-Wire can now be inserted o theplateition.不要取下该点的骨钻套筒和克氏针套筒，因为这可能导致骨板位置的缺损。图 5mostterior Locking Screw hole (Fig. 6). Thisstep shows theition of the screwteriorlyUs

18、ing a 2.5mm Drill (REF 700355 -230mm or 700347-125mm) and Double Drill Guide (REF 702418), drill a core hole to the appropriateand in relation to the josurface and confirms the screw will not bera articular.配合骨钻套筒（编码702707）与克氏针套筒（编码702702）一起使用，可以将尺寸为depthhe oblong hole of the plate.使用2.5毫米的骨钻（编码7003

19、55-230毫米或者700347-125mm）和双头导钻（编码 702418），在骨板椭圆孔的合适深度钻出一个中心孔位。2.0 x230mm的克氏针尾端的锁定螺钉孔（见图6）。该步骤显示后面与关节面有关的螺钉的位置，并确定螺钉不在内关节。Using fluoroscopy, theition of this K-WireThe length is then measured using the Depth Gauge for Standard Screws (REF 702879) andcan be checked until the optimal achieved and the pla

20、te is correctlyition is itioned.an appropriate Self-Tap3.5mm CorticalCorrect distal placement should also be re- confirmed at this po to make sure the plate shaft is properly aligned over the lateral surface of the Tibial shaft (Fig. 5). If the proximal and axial alignment of the plate cannot be ach

21、ieved, the K-Wires should be removed, the plate readjusted, and the above procedure repeated until both the terior K-Wire and the plateScrew or a 4.0mm Cancellous Screw is then inserted using Screwdriver(REF702841)(Fig. 7).然后用标准螺钉和测深器（编码702879）测量图 6长度，再用扳手（编码702841）合适的3.5毫米的自攻皮质螺钉或4毫米的自攻松质骨螺钉。If ins

22、erting a cancellous screw, the near cortex must be pre-tapped using the Tap(REF 702805), and the Teardrop Handle (REF 702428).arehe desiredition.使用X-线找到最佳可以检测该克氏针的位置，以便位置，并正确放入骨板。在这一如果松质骨螺钉，需使用骨螺钉丝攻（编步骤上，还应重新确定正确的远端位置，确保骨板螺杆与胫骨螺杆的外侧面对准。如果骨板的近端不能和轴对线达成一致，则需取出克氏针，重新调整接骨板，重复以上步骤直到后面的克氏针与骨板都能进入理想位置。码702

23、805）和手柄（编码702428）对附近的皮质层进行预穿刺。The distal K-Wire can now be removed.最后可以取下远端克氏针。图 77手术方法Step 5-Primary Plate Fixation - Distal第5步-首次钢板固定-远端The distal end of the plate must now be secured. This can be achieved through one of four methods:确保骨板远端安全的安全性可以通过以下四种方法获得：To help prevent thermal necrosis during

24、 thedrilling stage, it is device is inserted by hand.mendedt this钻孔期间要帮助预防热坏死，建议手动该装置。A K-Wire inserted hole.he distal shaft K-WireOnce the device has been inserted through the far cortex, the threaded outer sleeve/collet is turned clockwise until the plate is in contact with the bone (Fig. 8). The

25、core diameter of this instrument is 2.4mm to allow a 3.5mm Cortical Screw to be subsequently inserted in the same shaft hole.远端螺杆克氏孔位的克氏针A 3.5mm Cortical Screw using the standard technique.采用标准技术的3.5毫米骨皮质螺钉A 4.0mm Locking Screw wiLockingInsert (see Step 7-Shaft Locking).带锁定垫圈的4.0毫米类型骨锁定螺钉（参见第7步-螺杆锁定

26、）The Temporary Plate Holder (REF 702776).临时钢板架（编码702776）穿过远端皮质层该装置后，按顺时针方 向转动穿过的外套筒/套夹，直到骨板与骨体相连（图8）。该工具的中心直径为2.4毫米，允许其后在同一螺杆孔位皮质骨螺钉。3.5毫米的In addition to providing temporary fixation, thisdevice pushes the plate to the bone. Also, isNote: A Locking Insert and Locking Screwa self drilling, self tap o

27、 cortical bone.tip for quick insertionshould not be usedhe hole where theTemporary Plate Holder is used.注：使用临时钢板支架的孔位处定垫圈和锁定螺钉。除了提供临时固定，这种装置还可以将骨板推进到骨折处，有自钻自攻尖头方便快速插入皮质骨层。使用锁Step 6 Metaphyseal Locking第6步-干骺端锁定Fixation of the metaphyseal portion of the plateLocking Screws cannot aLag Screws.can be st

28、arted using the preset K-WireheShould anerfragmentary compresterior locking hole as described in Step 4. The length of the screw can be taken by using the K-Wire side of the Drill/ K-Wire Depth Gauge (REF 702712) (See Locking Screw Measurement Guidelines on Page 7).如第4步所述，可以通过使用在后端锁定设的克氏针启动钢板的干骺端部分固

29、定。可以通过使用骨钻/克氏针深度计（编码702712）的克氏针面测出螺钉的长度。（参见第7页的锁定螺钉测量指南）。effect be required, a 4.0mm StandardCancellous Screw or a 3.5mm Standard CortexScrew mustbe placedhe unthreadedmetaphyseal plate holes (Fig. 9) prior to the placement of any Locking Screws.Measure the length of the screw using the Depth Gauge

30、for Standard Screws (REF 702879), and pre-tap the near cortex with the Tap (REF 702805) if a cancellous screw is used. Consideration mustalso be taken when itioning this screw to Remove the K-Wire and K-Wire Sleeve leaving the Drill Sleeve in place.拨出克氏针和针筒，将骨钻套筒留在原位。ensuret it does noterfere with t

31、he givenLocking Screw trajectories.锁定螺钉不能用作拉力螺钉。如果要求具有断面间钢板加压效果，安放任何锁定螺钉前，首先必须在无螺纹的干骺端锁定孔位（图9）放置4毫米的标准松质骨螺钉或3.5毫米的标准皮质骨螺钉。如果采用松质骨螺钉，用测量标准髓内骨螺钉的测深器测量螺钉的长度（编码702879），并用骨螺钉丝攻（编码702805）预先穿刺近处的骨皮质。给螺钉定位时还必须考虑，绝对不能干扰特定锁定螺钉轨迹。A 3.1mm Drill (REF 702742) is then used to drill the core hole for the Locking Sc

32、rew (Fig. 10).随后使用3.1毫米的骨钻（编码702742）为锁定螺钉钻出孔位（图10）。Using Fluoroscopy, check the correct depth of the drill, and measure the length of the screw.利用设备检查骨钻到达的正确深度，测量螺钉的长度。 8手术方法The remaining proximal Locking Screws are inserted following the same technique with or without the use of a K-Wire.The Drill

33、Sleeve should now be removed, and the correct length 4.0mm Locking Screw is inserted using the Screwdriver T15 (REF 702747) and Screw Holding Sleeve (REF 702732) (Fig. 11).现在可以拨出骨钻套筒，用T15螺钉起子（编码702747）和螺杆套筒（编码702732）送入正确长度为4毫米的骨螺钉（图11）。其余近端骨锁定螺钉按同一方法用或者不使用克氏针。，可以使Always use the Drill Sleeve (REF 702

34、707)whendrilling for locking holes. To ensureumstability, it ismendedt all locking holesare filled wi length.Locking Screw of the appropriateLocking Screws should initially be inserted manually to ensure proper alignment.钻骨锁定孔时务必使用骨钻套筒（编码 702707）。为确保最佳稳定性，建议所有锁孔应配合使用合适长度的骨锁定螺钉。为保证对线正确，最开始应手动螺钉。锁定骨If

35、 the Locking Screw thread does not immedia y engage the plate thread, reverse thescrew turns and re-insert the screw onceit is properly aligned.如果锁定螺钉的螺纹不能马上与骨板的螺纹吻合，将螺钉翻转几次，重新线成功。，直到对Final tightening of Locking Screws should always be performed manually using theTorque Limiting Attaent (REF 702750)

36、together with the Solid Screwdriver T15 (REF702753) andndle (REF 702427) (Fig.12). This helps to prevent over-tightening ofLocking Screws, and also ensurest theseScrews are tightened to a torque of 4.0Nm. The device will click when the torque reaches 4Nm.最后，配合使用螺钉起子T15(编码702753)和T-型手柄（编码702427），用力矩限

37、制装置（编码702750）手动拧紧锁定螺钉。（图12）手动拧紧可防止锁定螺钉过紧，还能保证这些螺钉的力矩为4.0Nm。力矩达到4Nm，该设备会滴答作响提醒。 If inserting Locking Screws undower,make sure to use a low speed to avoid damage to the screw/plate erface, and perform final tightening by hand, as described above.如上所述，如果锁定螺钉，一定注意要慢慢以免损坏螺钉界面/骨板界面，最后手动拧紧。 9手术方法Step 7- Sh

38、aft Fixation第7步-螺杆固定The shaft holes of this plate have been designed to accept either 3.5mm Standard Cortical Screws or 4.0mm Locking Screws together with the corresponding Locking Inserts.配合使用相应的锁定装置，骨板的扩髓钻杆孔的设计可以接受3.5毫米的标准皮质骨螺钉，或者接受4毫米的锁定螺钉。If a combination of Standard and LockingScrews is usedhe

39、shaft, then the StandardCortical Screws must be placed prior to the Locking Screws.如果扩髓钻杆内要结合标准螺钉和锁定螺钉一同使用，则必须先装标准皮质骨螺钉，然后装锁定螺钉。 Option 1 - Standard Screws选择1-标准螺钉3.5mm Standard Cortical Screws can be placedin neutral, compresor buttressitions asdesired using the relevant Drill Guide and the standar

40、d technique.可使用相关骨钻，根据标准技术，安装中立型，加压型或支撑型3.5毫米标准皮质骨螺钉。Option 2 - Locking Screws选择2-骨锁定螺钉4.0mm Locking Screws can be placedheshaft holes provided there is a pre-placedLocking Inserthe hole. (See Step 1).如果预留锁定垫圈，可将4毫米锁定螺钉702753) and the Screw Holding Sleeve (REF 702732) together with the Torque Limiti

41、ng装入扩髓钻杆孔（参见第1步）。Attaent (REF 702750) and thendleThe Drill Sleeve(REF 702707) is threaded o the Locking Insert to ensure initial fixation of the Locking Insert o the plate. This will also facili e subsequent screw placement. A 3.1mm Drill Bit (REF 702742) is used to drill through both corti . (Fig.

42、13).将骨钻套筒（编码702707）与锁定垫圈穿在一起，确保锁定垫圈在骨板上的首次固定。这还有助于以后的螺钉安装。使用3.1毫米的骨钻套筒（编码702742）钻通两边的皮质层（图 13）。(REF 702427).um stability of the LockingInsert is achieved once the screw head is fully seated and tightened to 4.0Nm.用螺钉起子T15(编码702753)和握钉套筒（编码 702732）配合扭矩限制固定装置（编码702570）和T型手柄（编码702427）送入正确尺寸的锁定螺钉。一旦螺杆头完

43、全锁紧，扭矩达到4.0Nm，则锁定垫圈可以获得最大稳定性。This procedure is repeated for all holes chosen for locked shaft fixation.对所有用来进行锁定螺杆固定的孔位，重复该流程。Avoid anulation or ex sive force on thedrill, as this could dislodge the Locking Insert. The screw measurement is then taken.使用骨钻时要避免角度，或不要过度用力，因 All provial plate fixation d

44、evi(K-Wires,Temporary Plate Holder, etc) can now be removed.现在可以取下所有临时钢板的固定装置（克氏针，临时钢板支架等等）。为可能拉出锁定垫圈。随后对螺钉进量。The appropriate sized Locking Screw is then inserted using the Solid Screwdriver T15 (REF10此类螺钉还可用作拉力螺钉。手术方法Locking Insert Extraction拔出锁定垫圈Should removal of a Locking Insert be required for

45、any reason, then the following procedure should be used. Thread the central portion (A) of the Locking Insert Extractor (REF 702767)如因何种原因需要取出锁定垫圈，请按下列步骤进行。将锁定垫圈剥离器（编码702767）的中心部位（A）穿到希望取出的锁定垫圈里，直到完全吻合。然后顺时针转动外部套筒/筒夹（B）直到将锁定垫圈拉出骨板。因为该垫圈不能再使用，必须丢掉。o the Locking Insertt you wish to removeuntil it is f

46、ully seated. Then turn the outer sleeve/ collet (B) clockwise until it pulls the Locking Insert out of the plate. The Locking Insert must then be discarded, as it cannot be reused.$Step 8 - Kick-Stand Screw Placement第8步-放置支撑螺钉The oblique Kick-Stand Locking Screw (Fig. 14) provides strong triangular

47、fixation tothe proximal fragments. It is advisedt thisscrew is placed with the assistance of fluoroscopyto prevent jopenetration and imementwith the proximal Screws (See Step 6 for insertion guidelines). The Aiming Block should now be removed.倾斜的“支撑”交互锁定螺钉（图14）近端骨折中提供牢固的三角形固定作用。建议在荧光协助下将植入该螺钉，防止关节穿刺

48、和近端螺钉夹击症 （参见第6步）。现在可以取走钢板定位导向器。 11%手术方法Sub-Muscular Insertion Technique肌下锁定技术When implanting longlates, a minimallyThe slot and markings on the Shaft Hole Locatorinvasive technique can be used.植入较长骨板时，可以采用微创技术。aa guide to the respective holeshe plate.A small stab incican then be made throughthe slot to locate the hole selected for screw placement (Fig. 17). The Shaft Hole Locator can then be ro ed out of the way or removed.上的沟槽与标记是骨板各孔位的指南。可划出一个小切口，通过该沟槽确定选择植入螺钉的孔位（图17）。然后通过旋转拔出The Soft Ti e Elevator (REF 702782) can be used to create a pathway for the implant (