創(chuàng)傷文件-全部用戶指南

1、目錄前言11、產品特點及優(yōu)點22、相關適應癥及癥33、手術方法：43.1、一般原則43.2、手術步驟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、 選擇1-標準螺釘103.2.7.2、 選擇2-骨鎖定鏍釘103.2.7.3、 拔出鎖定墊圈113.2.8、第8步113.2.8.1、肌下鎖定技術124、產品訂購信息-植入物145、產品訂購信息-4.0毫米工具15前言AxSOSTM鎖定骨板系統(tǒng)用于治療肱骨近端，股骨遠端，脛骨近端和脛骨遠端的關節(jié)周圍的骨折和關節(jié)內骨折。該系統(tǒng)的設計基于經(jīng)驗

2、豐富的外科醫(yī)生組成的國際小組的臨床數(shù)據(jù)，參考各種文獻數(shù)據(jù)并通過實踐及生物力學實驗而成。鋼板的解剖塑形，螺釘?shù)慕嵌群蛢?yōu)質表面處理，都充分考慮了臨床醫(yī)師在合理固定，疲勞強度及最小軟組織挫傷方面的需求。本手冊講述如何通過簡單的步驟植入脛骨近端外側骨板。Proximal Lateral Tibial Plate脛骨近端外側骨板本手冊講述如何通過簡單的步驟植入脛骨近端外側骨板。Proximal Humeral Plate肱骨近端骨板Distal Lateral Femoral Plate股骨遠端外側骨板Distal Medial Tibial Plate脛骨遠端內側骨板Distal Anterolate

3、ral Tibial Plate脛骨遠前端外側骨板1產品特點及優(yōu)點系統(tǒng)工具適用范圍方法簡單，只需少量組件的簡便器械。較長骨板可覆蓋更廣范圍的骨折類型。脛骨近端外側骨板在設計上采用不同角度的固定螺釘，在力學上提供了最佳的穩(wěn)定性。有助于預防復位的丟失。采用工具設計，與MIPO技術（微創(chuàng)鋼板接骨術）兼容。單軸孔（5個）鉆套導向器允許軸向穩(wěn)定置入螺釘，使結構具有穩(wěn)定性。有助于鉆套定位。克氏針/復位/縫合孔初期/臨時鋼板及骨折固定軟組織復位解剖預塑型很少或無需彎板減少手術時間獨創(chuàng)式鎖定螺釘設計無螺紋孔鎖定螺釘引導入骨板減少潛在滑絲和冷焊接可能徒手安裝螺釘可使用拉力螺釘支撐螺釘為后內側骨折塊提供牢固的三角

4、形固定裝置“腰狀”鋼板形態(tài)均一的荷載傳遞桿部螺孔-或鎖定型雙向軸孔加壓型，中立型或支撐型固定裝置可以使用SPS的標準3.5/4.0mm螺釘可以放置軸向穩(wěn)定鎖定螺釘用的鎖定墊圈圓形&錐型鋼板尾部幫助減少不必要的軟組織損傷。2相關適應癥及癥相關適應癥這種內固定裝置適用于脛骨近端干骺端關節(jié)內外骨折治療。相關癥最合適裝置和治療方法的選擇必須依賴醫(yī)生的受教育及所接受培訓的程度和專業(yè)判斷力。醫(yī)生必手術區(qū)域軟組織覆蓋。須考慮到以下可能發(fā)生的相對或絕對：使用植入物可能干擾解剖結構或生理機能。區(qū)域里面或周圍任何主動潛伏型，疑術后護理中可能產生的令人難以接受的接骨似潛伏型或明顯的局部。固定失敗或產生并發(fā)癥風險的心

5、理或神經(jīng)肌肉。損傷可能會導致骨折處或受累區(qū)域的。排除其他不適合進行手術的臨床情況。由于疾病，或原先植入的內植物可能導致詳細信息可參見植入物所附的使用指南。骨量，從而不能夠提供足夠的支持或固定內植入物。請閱讀包裝內所附說明書，里面有關于潛在和并發(fā)癥方面的詳細。必要時醫(yī)生必須向病有的或可疑的金屬過敏反應。人講解所有相關風險，包括此類產品的最終使用。肥胖問題。超重或肥胖型可能對植入物產生過度負荷，導致無法對裝置進行固定或者裝置本身出現(xiàn)問題。注：骨螺釘不是用來附著或固定頸椎，胸椎或腰椎的螺釘。3手術方法一般原則位 置手 術 方 法： 仰臥，可選擇屈膝。： 外側入路工具/螺釘型號： 4毫米復位骨折解剖復

6、位可以通過經(jīng)皮夾進行直視下操作，或者利用橋接的外部固定裝置幫助間接復位。關節(jié)表面的骨折復位應當通過直視操作或操作進行確認。必要時使用克氏針暫時維持復位。折彎在通常情況下，骨板無需進一步折彎即可使用。但是，如果要求對骨板進行折彎（通常是在和干骺端的交接部位），應當使用折彎器（702756）。因為折彎在干骺端的鎖孔區(qū)域的骨板會影響鎖定螺釘?shù)闹踩?，所以不允許這樣做。在鋼板折彎應當被一般來說，平行關節(jié)面的克氏針不但可以支撐骨折復位，還能有助于看清和確認關節(jié)面。限制在釘孔之間的區(qū)域。骨板折彎可能影響折彎點附近的釘孔鎖定墊圈的植入。請?zhí)貏e注意那些不要干擾所需鋼板和螺釘定位的情況。必須考慮在安裝骨板之前將獨

7、立拉力螺釘進行定位，以確保其不會干擾計劃中的骨板位置或鎖定螺釘軌跡。如果出現(xiàn)任何大骨缺損情況，需采取植骨或使用替代材料進行填充。注：如果采用肌下技術，請參看本指南后面的相關章節(jié)。4手術方法一般原則鎖定螺釘長短測量如下圖所示，有四種可選方法測出正確的鎖定螺釘長度。Measure off K-Wire 克氏針測量Read off Calibration 閱讀校準Conventional direct 傳統(tǒng)直接測量Measure off drill 骨鉆測量軟組織復位位于兩個近端克式針孔相對的骨板背面的獨特的開槽，即使骨板固定后也易于穿過縫線進行簡單的半月板縫合復位。5手術方法Step 1 - Pr

8、e Operative Planning第1步-術前準備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-線模板（981091）或鋼板試模（702793），配合X-線，可以幫助將4毫米長的鎖定墊圈（370002）安裝到挑選尺寸適合的植入物（圖1）。鎖定墊圈植入器（7027602），并裝到鋼板骨分選定的釘（圖2）。確保正確安If the Plate Trial is moren 90mm away裝鎖定墊圈。隨后

10、取出植入器（圖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.如果鋼板試模離骨超過90mm,比如，肥胖病人，會有10%-15%的放大率，因此必須去除這一影響。為保證正確的植入物選擇，必須進行最終術中確認。Do not place Locking In

11、serts with the Drill Sleeve.不要用鉆套安裝將鎖定的墊圈。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：如果用臨時鋼板定位針進行初期遠端鋼板固定，則絕不能將鎖定墊圈放入臨時鋼板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-鉆套導向器/骨板安裝手柄定位針的同一（參見第5步）。如果為鋼板骨分選定了鎖定螺釘，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預先鎖定墊圈。itioning and sliding of long muscularly (Fig. 3).lateb-用扳手T15（702747）將合適的鉆套導向器（702728/702729）用螺釘固定。如果需要，骨板器（702778）柄可以固定到導向器上來幫助鋼板和較長鋼板肌下定位（圖3）。 6手術方法Step 3 - Plate Application第3步-骨板的應用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).切開皮膚，進行解剖復位后，放入骨板，以便使用關節(jié)面下大約5毫米的骨板近端支撐外側骨突（圖4）。This helps to ensuret the most proximalLocking Screws are directly supporting t

15、he jo surface.這樣有助于確保最近端的鎖定螺釘可以直接支撐關節(jié)面。圖4-AP視圖圖4-外側圖Step4-Primary Plate Fixation -Proximal第4步-首次鋼板內固定-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.骨板上的克氏針孔可以將臨時光板固定到干骺端和螺桿部分（圖5）?？梢詫㈩~外的克氏針克氏針，超過鎖孔，有助于將骨板與骨體進一步吻合，還能支持關節(jié)面凹下區(qū)域。Remove the Handle for Insertion by pressing themetal button atof the Handle.按住手柄端的金屬按鈕，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.不要取下該點的骨鉆套筒和克氏針套筒，因為這可能導致骨板位置的缺損。圖 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.配合骨鉆套筒（編碼702707）與克氏針套筒（編碼702702）一起使用，可以將尺寸為depthhe oblong hole of the plate.使用2.5毫米的骨鉆（編碼7003

19、55-230毫米或者700347-125mm）和雙頭導鉆（編碼 702418），在骨板橢圓孔的合適深度鉆出一個中心孔位。2.0 x230mm的克氏針尾端的鎖定螺釘孔（見圖6）。該步驟顯示后面與關節(jié)面有關的螺釘?shù)奈恢?，并確定螺釘不在內關節(jié)。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).然后用標準螺釘和測深器（編碼702879）測量圖 6長度，再用扳手（編碼702841）合適的3.5毫米的自攻皮質螺釘或4毫米的自攻松質骨螺釘。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-線找到最佳可以檢測該克氏針的位置，以便位置，并正確放入骨板。在這一如果松質骨螺釘，需使用骨螺釘絲攻（編步驟上，還應重新確定正確的遠端位置，確保骨板螺桿與脛骨螺桿的外側面對準。如果骨板的近端不能和軸對線達成一致，則需取出克氏針，重新調整接骨板，重復以上步驟直到后面的克氏針與骨板都能進入理想位置。碼702

23、805）和手柄（編碼702428）對附近的皮質層進行預穿刺。The distal K-Wire can now be removed.最后可以取下遠端克氏針。圖 77手術方法Step 5-Primary Plate Fixation - Distal第5步-首次鋼板固定-遠端The distal end of the plate must now be secured. This can be achieved through one of four methods:確保骨板遠端安全的安全性可以通過以下四種方法獲得：To help prevent thermal necrosis during

24、 thedrilling stage, it is device is inserted by hand.mendedt this鉆孔期間要幫助預防熱壞死，建議手動該裝置。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.遠端螺桿克氏孔位的克氏針A 3.5mm Cortical Screw using the standard technique.采用標準技術的3.5毫米骨皮質螺釘A 4.0mm Locking Screw wiLockingInsert (see Step 7-Shaft Locking).帶鎖定墊圈的4.0毫米類型骨鎖定螺釘（參見第7步-螺桿鎖定

26、）The Temporary Plate Holder (REF 702776).臨時鋼板架（編碼702776）穿過遠端皮質層該裝置后，按順時針方 向轉動穿過的外套筒/套夾，直到骨板與骨體相連（圖8）。該工具的中心直徑為2.4毫米，允許其后在同一螺桿孔位皮質骨螺釘。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：使用臨時鋼板支架的孔位處定墊圈和鎖定螺釘。除了提供臨時固定，這種裝置還可以將骨板推進到骨折處，有自鉆自攻尖頭方便快速插入皮質骨層。使用鎖Step 6 Metaphyseal Locking第6步-干骺端鎖定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，可以通過使用在后端鎖定設的克氏針啟動鋼板的干骺端部分固

29、定?？梢酝ㄟ^使用骨鉆/克氏針深度計（編碼702712）的克氏針面測出螺釘?shù)拈L度。（參見第7頁的鎖定螺釘測量指南）。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.撥出克氏針和針筒，將骨鉆套筒留在原位。ensuret it does noterfere with t

31、he givenLocking Screw trajectories.鎖定螺釘不能用作拉力螺釘。如果要求具有斷面間鋼板加壓效果，安放任何鎖定螺釘前，首先必須在無螺紋的干骺端鎖定孔位（圖9）放置4毫米的標準松質骨螺釘或3.5毫米的標準皮質骨螺釘。如果采用松質骨螺釘，用測量標準髓內骨螺釘?shù)臏y深器測量螺釘?shù)拈L度（編碼702879），并用骨螺釘絲攻（編碼702805）預先穿刺近處的骨皮質。給螺釘定位時還必須考慮，絕對不能干擾特定鎖定螺釘軌跡。A 3.1mm Drill (REF 702742) is then used to drill the core hole for the Locking Sc

32、rew (Fig. 10).隨后使用3.1毫米的骨鉆（編碼702742）為鎖定螺釘鉆出孔位（圖10）。Using Fluoroscopy, check the correct depth of the drill, and measure the length of the screw.利用設備檢查骨鉆到達的正確深度，測量螺釘?shù)拈L度。 8手術方法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).現(xiàn)在可以撥出骨鉆套筒，用T15螺釘起子（編碼702747）和螺桿套筒（編碼702732）送入正確長度為4毫米的骨螺釘（圖11）。其余近端骨鎖定螺釘按同一方法用或者不使用克氏針。，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.鉆骨鎖定孔時務必使用骨鉆套筒（編碼 702707）。為確保最佳穩(wěn)定性，建議所有鎖孔應配合使用合適長度的骨鎖定螺釘。為保證對線正確，最開始應手動螺釘。鎖定骨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.如果鎖定螺釘?shù)穆菁y不能馬上與骨板的螺紋吻合，將螺釘翻轉幾次，重新線成功。，直到對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，配合使用螺釘起子T15(編碼702753)和T-型手柄（編碼702427），用力矩限

37、制裝置（編碼702750）手動擰緊鎖定螺釘。（圖12）手動擰緊可防止鎖定螺釘過緊，還能保證這些螺釘?shù)牧貫?.0Nm。力矩達到4Nm，該設備會滴答作響提醒。 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，如果鎖定螺釘，一定注意要慢慢以免損壞螺釘界面/骨板界面，最后手動擰緊。 9手術方法Step 7- Sh

38、aft Fixation第7步-螺桿固定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.配合使用相應的鎖定裝置，骨板的擴髓鉆桿孔的設計可以接受3.5毫米的標準皮質骨螺釘，或者接受4毫米的鎖定螺釘。If a combination of Standard and LockingScrews is usedhe

39、shaft, then the StandardCortical Screws must be placed prior to the Locking Screws.如果擴髓鉆桿內要結合標準螺釘和鎖定螺釘一同使用，則必須先裝標準皮質骨螺釘，然后裝鎖定螺釘。 Option 1 - Standard Screws選擇1-標準螺釘3.5mm Standard Cortical Screws can be placedin neutral, compresor buttressitions asdesired using the relevant Drill Guide and the standar

40、d technique.可使用相關骨鉆，根據(jù)標準技術，安裝中立型，加壓型或支撐型3.5毫米標準皮質骨螺釘。Option 2 - Locking Screws選擇2-骨鎖定螺釘4.0mm Locking Screws can be placedheshaft holes provided there is a pre-placedLocking Inserthe hole. (See Step 1).如果預留鎖定墊圈，可將4毫米鎖定螺釘702753) and the Screw Holding Sleeve (REF 702732) together with the Torque Limiti

41、ng裝入擴髓鉆桿孔（參見第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).將骨鉆套筒（編碼702707）與鎖定墊圈穿在一起，確保鎖定墊圈在骨板上的首次固定。這還有助于以后的螺釘安裝。使用3.1毫米的骨鉆套筒（編碼702742）鉆通兩邊的皮質層（圖 13）。(REF 702427).um stability of the LockingInsert is achieved once the screw head is fully seated and tightened to 4.0Nm.用螺釘起子T15(編碼702753)和握釘套筒（編碼 702732）配合扭矩限制固定裝置（編碼702570）和T型手柄（編碼702427）送入正確尺寸的鎖定螺釘。一旦螺桿頭完

43、全鎖緊，扭矩達到4.0Nm，則鎖定墊圈可以獲得最大穩(wěn)定性。This procedure is repeated for all holes chosen for locked shaft fixation.對所有用來進行鎖定螺桿固定的孔位，重復該流程。Avoid anulation or ex sive force on thedrill, as this could dislodge the Locking Insert. The screw measurement is then taken.使用骨鉆時要避免角度，或不要過度用力，因 All provial plate fixation d

44、evi(K-Wires,Temporary Plate Holder, etc) can now be removed.現(xiàn)在可以取下所有臨時鋼板的固定裝置（克氏針，臨時鋼板支架等等）。為可能拉出鎖定墊圈。隨后對螺釘進量。The appropriate sized Locking Screw is then inserted using the Solid Screwdriver T15 (REF10此類螺釘還可用作拉力螺釘。手術方法Locking Insert Extraction拔出鎖定墊圈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)如因何種原因需要取出鎖定墊圈，請按下列步驟進行。將鎖定墊圈剝離器（編碼702767）的中心部位（A）穿到希望取出的鎖定墊圈里，直到完全吻合。然后順時針轉動外部套筒/筒夾（B）直到將鎖定墊圈拉出骨板。因為該墊圈不能再使用，必須丟掉。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-放置支撐螺釘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.傾斜的“支撐”交互鎖定螺釘（圖14）近端骨折中提供牢固的三角形固定作用。建議在熒光協(xié)助下將植入該螺釘，防止關節(jié)穿刺

48、和近端螺釘夾擊癥 （參見第6步）?，F(xiàn)在可以取走鋼板定位導向器。 11%手術方法Sub-Muscular Insertion Technique肌下鎖定技術When implanting longlates, a minimallyThe slot and markings on the Shaft Hole Locatorinvasive technique can be used.植入較長骨板時，可以采用微創(chuàng)技術。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.上的溝槽與標記是骨板各孔位的指南?？蓜澇鲆粋€小切口，通過該溝槽確定選擇植入螺釘?shù)目孜唬▓D17）。然后通過旋轉拔出The Soft Ti e Elevator (REF 702782) can be used to create a pathway for the implant (