BSC彈簧圈系列

1、1Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally BSC彈簧圈系列彈簧圈系列BSC 彈簧圈技術(shù)可解脫彈簧圈推送彈簧圈0.018”0.035”0.018”0.035”Interlock 18VortX 鉆石，鉆石，多環(huán)形多環(huán)形VortX 2D HelicalInterlock 352Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or D

2、istribute Externally BSC彈簧圈系列推送彈簧圈Pushable Coils3Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 3BSC推送彈簧圈推送彈簧圈 所有彈簧圈都是鉑金圈 所有的彈簧圈都有相同的基礎(chǔ)制造流程 基礎(chǔ)和二次纏繞 所有都兼容MRI 所有纖毛彈簧圈都含有Dacron-滌綸纖維 所有微彈簧圈都需要通過(guò)彈簧圈推送器釋放4Boston Scientific Confidential - For Internal

3、Use Only. Do Not Copy, Display or Distribute Externally 4彈簧圈適應(yīng)范圍彈簧圈適應(yīng)范圍 動(dòng)靜脈瘺-AVF 動(dòng)脈瘤 外傷 血管封堵5Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 50.018” 纖毛彈簧圈纖毛彈簧圈-復(fù)合復(fù)合Helical彈簧圈彈簧圈6Boston Scientific Confidential - For Internal Use Only. Do Not Copy,

4、 Display or Distribute Externally 60.018” 纖毛彈簧圈纖毛彈簧圈-復(fù)合復(fù)合Helical彈簧圈彈簧圈7Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Features0.018” 纖毛彈簧圈纖毛彈簧圈-復(fù)合復(fù)合Helical彈簧圈彈簧圈特性特性利益利益鉑金材料可視性佳兼容MRI滌綸纖維促進(jìn)血栓形成兩頭都是圓的更易在微導(dǎo)管內(nèi)推送漸細(xì)的導(dǎo)入鞘減少血管壁損傷更容易將彈簧圈導(dǎo)入微導(dǎo)管接頭多種尺寸和形狀適用多種

5、血管尺寸8Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 8VORTX - 0.018 鉆石形彈簧圈鉆石形彈簧圈VORTX鉆石形: 2mm/3mm/2.5mm (Apex/Basis/UL) 2mm/4mm/4.0mm (Apex/Basis/UL) 2mm/5mm/5.5mm (Apex/Basis/UL) 2mm/6mm/6.5mm (Apex/Basis/UL)尖端設(shè)計(jì)9Boston Scientific Confidential -

6、 For Internal Use Only. Do Not Copy, Display or Distribute Externally 外周栓塞外周栓塞- VortX 18 鉆石形彈簧圈鉆石形彈簧圈特性特性利益利益VORTX鉆石形-尖端設(shè)計(jì)錨定圈最小化移位減少尾端形成致密纖毛組成在血管中間形成更多彈簧圈和纖毛促進(jìn)血栓形成鉑金成分可視性更佳兼容MRI減少血管損傷兩頭都是圓的減少血管損傷降低導(dǎo)管內(nèi)的摩擦0.021”直徑的初級(jí)線圈提高輸送性改良的漸細(xì)彈簧圈導(dǎo)入鞘更容易導(dǎo)入至導(dǎo)管接頭內(nèi)10Boston Scientific Confidential - For Internal Use Only.

7、 Do Not Copy, Display or Distribute Externally 0.018” 推送彈簧圈推送彈簧圈特性利益合成纖維促進(jìn)血栓形成鉑鎢合金彈簧圈提高可視性圓形球狀焊接頭端無(wú)創(chuàng)地進(jìn)入微導(dǎo)管和血管0.021”直徑的初級(jí)線圈提高輸送性改良的漸細(xì)彈簧圈導(dǎo)入鞘更容易導(dǎo)入至導(dǎo)管接頭內(nèi)多種形狀和尺寸提供多種手術(shù)選擇方案VortX -18鉆石型纖毛鉑金圈VortX -18纖毛鉑金圈復(fù)合形Helical-18纖毛鉑金圈8字形-18纖毛鉑金圈多環(huán)形-18纖毛鉑金圈直形-18纖毛鉑金圈雙尖端設(shè)計(jì)帶有兩個(gè)小頭端，以快速閉塞血管減少移位/伸長(zhǎng)圓錐形狀形成快速閉塞首先使用尖端形狀以減少移位可能三

8、葉草形狀形成快速閉塞8字形形成快速閉塞傳統(tǒng)形狀形成快速閉塞11Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 110.018”彈簧圈的釋放彈簧圈的釋放 彈簧圈預(yù)置在塑料海波管中，安全軸芯將其鎖定； 移除安全軸芯然后推入海波管頭端通過(guò)RHV，使其與輸送系統(tǒng)（推送器）接頭形成自然的貼合 彈簧圈推送器（Coil Pusher 16）的硬頭端用于將彈簧圈很好的推入輸送系統(tǒng)中（至少進(jìn)入30cm），然后撤出硬頭端，使用軟頭端釋放彈簧圈 12Boston

9、 Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 12.035”纖毛鉑金圈纖毛鉑金圈形狀形狀螺旋形螺旋形-Helical材料鉑金纖毛致密聚酯纖維尺寸多種長(zhǎng)度（10-60mm）和直徑（3-9mm）13Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 特性特性利益利益鉑金結(jié)構(gòu)可視性更佳兼容MRI致密纖毛組成

10、促進(jìn)血栓形成兩頭都是圓的減少血管損傷更容易推進(jìn)彈簧圈多種尺寸和形態(tài)可治療多種血管改良的漸細(xì)彈簧圈導(dǎo)入鞘更容易導(dǎo)入至導(dǎo)管接頭內(nèi).035”纖毛鉑金圈纖毛鉑金圈14Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 14VORTX 35:Available 2 mm/ 4 mm Apex/ Basis 3 mm/ 5 mm Apex/ Basis 3 mm/ 6 mm Apex/ Basis 3 mm/ 7 mm Apex/ Basis.035” V

11、ortX纖毛鉑金圈纖毛鉑金圈15Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 15.035”彈簧圈的釋放彈簧圈的釋放 彈簧圈預(yù)置在塑料海波管中，安全軸芯將其鎖定； 置入導(dǎo)管接頭 使用.035/.038導(dǎo)絲的硬頭端將彈簧圈推入導(dǎo)管中，使用正常的工作頭端 持續(xù)肝素沖洗導(dǎo)管，防止彈簧圈堵塞16Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display

12、or Distribute Externally BSC Embolic Agents可控彈簧圈可控彈簧圈17Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 1718Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlocking可控彈簧圈可控彈簧圈 鉑金材料 獨(dú)特的Interl

13、ocking Arm-互鎖臂設(shè)計(jì) 預(yù)裝系統(tǒng)，直接輸送 Helical（IDC）形狀有18種尺寸，VotrX（纖毛I(xiàn)DC）有19種尺寸，直徑從2mm到14mm；Controlled deployment 在完全釋放前，可以重新定位或回撤 易于將彈簧圈預(yù)裝系統(tǒng)過(guò)渡到微導(dǎo)管19Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 19Interlocking可控彈簧圈可控彈簧圈20Boston Scientific Confidential - For

14、 Internal Use Only. Do Not Copy, Display or Distribute Externally Interlocking可控彈簧圈可控彈簧圈21Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlocking可控彈簧圈可控彈簧圈特性特性利益利益鉑金結(jié)構(gòu)和不透射線標(biāo)記可視性更佳兼容MRI獨(dú)特的互鎖臂設(shè)計(jì)可控的釋放完全釋放前可以重新定位或回撤預(yù)裝輸送系統(tǒng)便于使用易于從輸送系統(tǒng)到微導(dǎo)管的過(guò)渡22Bost

15、on Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlock Fibered IDC系統(tǒng)系統(tǒng)特性特性利益利益鉑鎢合金彈簧圈兼容MRI，磁場(chǎng)強(qiáng)度可至1.5T獨(dú)特的互鎖臂設(shè)計(jì)可控的釋放完全釋放前可以重新定位或回撤豐富的纖毛纏繞便于使用易于從輸送系統(tǒng)到微導(dǎo)管的過(guò)渡多種尺寸可選2D：直徑(3-14mm)，長(zhǎng)度(6-30cm)VortX 鉆石型2D：增加手術(shù)靈活性VortX 鉆石型：雙尖端設(shè)計(jì)兩個(gè)小頭端的設(shè)計(jì)用以快速閉塞改善鞘-遠(yuǎn)端減少在接頭內(nèi)的Jam

16、ming23Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 23Product Offering:2D (Multi-Loop): 3mm x 6cm 3mm x 12cm 4mm x 8cm 4mm x 15cm 5mm x 8cm 5mm x 15cm 6mm x 10cm 6mm x 20cm 8mm x 20cm10mm x 20cm10mm x 30cm 12mm x 20cm12mm x 30cm 14mm x 20cm14mm

17、 x 30cm VortX Diamond Coil: 2mm/3mm x 2.3cm2mm/4mm x 4.1cm 2mm/5mm x 5.8cm2mm/6mm x 8.0cmInterlock Fibered IDC系統(tǒng)系統(tǒng)24Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 推送彈簧圈的風(fēng)險(xiǎn)推送彈簧圈的風(fēng)險(xiǎn)移位移位25Boston Scientific Confidential - For Internal Use Only. Do N

18、ot Copy, Display or Distribute Externally 由于不恰當(dāng)?shù)膹椈扇﹂L(zhǎng)度和尺寸，導(dǎo)致不正確釋放推送彈簧圈的風(fēng)險(xiǎn)推送彈簧圈的風(fēng)險(xiǎn)26Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 26 輸送導(dǎo)管的不穩(wěn)定，導(dǎo)致的輸送導(dǎo)管的不穩(wěn)定，導(dǎo)致的不正確釋放不正確釋放推送彈簧圈的風(fēng)險(xiǎn)推送彈簧圈的風(fēng)險(xiǎn)27Boston Scientific Confidential - For Internal Use Only. Do No

19、t Copy, Display or Distribute Externally 更好的精確性和控制更好的精確性和控制與推送圈不同，Interlocking Arms和輸送導(dǎo)絲的設(shè)計(jì)允許在彈簧圈完全釋放前可以回撤 ，提供更多的控制，而不僅僅是釋放！Interlock Occlusion SystemONCM980 / 06/06 2006 Boston Scientific Corporation or its affiliates. All rights reserved.INTERLOCKING ARM-互鎖臂作用加強(qiáng)機(jī)械分離可回撤設(shè)計(jì)彈簧圈在釋放前保持鎖定Interlock Fibere

20、d IDC Occlusion System只用于外周血管的栓塞，不能用于神經(jīng)血管的栓塞只用于外周血管的栓塞，不能用于神經(jīng)血管的栓塞- Page 10 -28Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 更更自信的栓塞自信的栓塞鉑金彈簧圈配合滌綸纖維，加速血栓形成。纖毛排列成流線束狀，提高填塞效果。Interlock Occlusion SystemONCM980 / 06/06 2006 Boston Scientific Corpor

21、ation or its affiliates. All rights reserved.FIBER BUNDLING 流線方向 優(yōu)秀的密度和數(shù)量提高致填塞作用 促血栓形成材料輸送鞘的漸細(xì)頭端設(shè)計(jì): 減少過(guò)早的釋放、彈簧圈打折貨堵塞改善推送性 可靠的輸送可靠的輸送輸送系統(tǒng)的漸細(xì)頭端提供更可靠的輸送。- Page 11 -29Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlock Occlusion System增加手術(shù)的靈活性增

22、加手術(shù)的靈活性提供多種長(zhǎng)度、直徑和形狀的彈簧圈，滿足不同血管和手術(shù)的需求。 Main Restrained Diameter Length2D Helical: 3 14mm 6 30cm VortXDiamond: 3 6mm 2.3 8cm30Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 30Interlock Fibered IDC Occlusion System:VORTX-18VORTX -18鉆石型纖毛鉑金彈簧圈鉆石型纖毛鉑

23、金彈簧圈雙尖端形狀具有兩個(gè)小頭端，提高通過(guò)性和加速栓塞雙尖端形狀設(shè)計(jì)改善彈簧圈壓縮 兩個(gè)小頭端設(shè)計(jì)于閉塞中心血流31Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 31 2D HELICAL 纖毛彈簧圈纖毛彈簧圈 遠(yuǎn)端直徑為主要直徑的75% (1st 1.5 loops) - 幫助釋放和減少創(chuàng)傷性 錨定能力設(shè)計(jì)使得該彈簧圈成為理想的第一個(gè)彈簧圈（成欄技術(shù)） 優(yōu)秀的纖維束- 纖維束數(shù)量- 纖維束的位置- 20cm和30cm彈簧圈的近端纖維化I

24、nterlock Fibered IDC Occlusion System:2D HELICAL32Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 32可控彈簧圈的優(yōu)勢(shì)可控彈簧圈的優(yōu)勢(shì) 完全可控的釋放 可回撤，防止不充分釋放或構(gòu)型最小化誤放的風(fēng)險(xiǎn) 必要時(shí)可重新進(jìn)入或重構(gòu) 優(yōu)化彈簧圈的構(gòu)型和獲得理想填塞 當(dāng)尺寸不當(dāng)時(shí)刻取出彈簧圈33Boston Scientific Confidential - For Internal Use Only.

25、Do Not Copy, Display or Distribute Externally 尤其適用于鄰近大動(dòng)脈的病灶 如重要?jiǎng)用}的假性動(dòng)脈瘤可控彈簧圈的優(yōu)勢(shì)可控彈簧圈的優(yōu)勢(shì)34Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 34 完全可控的釋放 多種選擇:- 回撤- 重新定位- 再成形- 交換- 致密填塞可控彈簧圈的優(yōu)勢(shì)可控彈簧圈的優(yōu)勢(shì)35Boston Scientific Confidential - For Internal Use

26、Only. Do Not Copy, Display or Distribute Externally 35pull back可控彈簧圈的優(yōu)勢(shì)可控彈簧圈的優(yōu)勢(shì)push36Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 36dense packing可控彈簧圈的優(yōu)勢(shì)可控彈簧圈的優(yōu)勢(shì)deliver37Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Disp

27、lay or Distribute Externally 37可控彈簧圈的適應(yīng)證可控彈簧圈的適應(yīng)證38Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 38可控彈簧圈的適應(yīng)證可控彈簧圈的適應(yīng)證39Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 39可控彈簧圈的適應(yīng)證可控彈簧圈的適應(yīng)證40B

28、oston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 40突出突出可控彈簧圈的適應(yīng)證可控彈簧圈的適應(yīng)證41Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 41導(dǎo)絲突出回撤1-2cm，然后再推送可控彈簧圈的適應(yīng)證可控彈簧圈的適應(yīng)證42Boston Scientific Confidential -

29、 For Internal Use Only. Do Not Copy, Display or Distribute Externally 42可控彈簧圈的適應(yīng)證可控彈簧圈的適應(yīng)證43Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 43可控彈簧圈的適應(yīng)證可控彈簧圈的適應(yīng)證44Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Dist

30、ribute Externally 醫(yī)生對(duì)于醫(yī)生對(duì)于Interlock臨床應(yīng)用的反饋：臨床應(yīng)用的反饋： 動(dòng)脈瘤、假性動(dòng)脈瘤、 AVF、AVM、PAVM、GI Bleed, “保護(hù)性” 栓塞：GDA內(nèi)漏：AAA外傷性出血 脾臟、肝臟、腎臟 盆腔Interlock Occlusion System 可用在哪些手術(shù)可用在哪些手術(shù)？Confidential. For Boston Scientific Internal Use Only. Do Not Copy or Distribute.The Fibered IDC Occlusion System is indicated to obstruc

31、t or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.45Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlock Occlusion System 操作和釋放要點(diǎn)操作和釋放要點(diǎn)46Boston Scientific Confidential - For Inte

32、rnal Use Only. Do Not Copy, Display or Distribute Externally ONCM980 / 06/06 2006 Boston Scientific Corporation or its affiliates. All rights reserved.一旦微導(dǎo)管到達(dá)需要栓塞的部位，注意保持微導(dǎo)管頭端與血管方向平行，不能垂直于需要釋放彈簧圈位置的血管壁.檢查確認(rèn)沒(méi)有損傷并且互鎖臂還處于鎖定狀態(tài)，輕輕的轉(zhuǎn)動(dòng)輸送鞘安全鎖定裝置以解鎖，兩邊同時(shí)轉(zhuǎn)動(dòng)，逆時(shí)針旋轉(zhuǎn)近端2-3圈將輸送系統(tǒng)推入微導(dǎo)管接頭近端的魯爾接頭內(nèi)開(kāi)始持續(xù)的肝素化 (通常，從加壓包內(nèi)持續(xù)的

33、每1-3秒鐘注入1滴)操作和釋放要點(diǎn)操作和釋放要點(diǎn)- Page 19 -47Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally ONCM980 / 06/06 2006 Boston Scientific Corporation or its affiliates. All rights reserved.打開(kāi)RHV的螺釘，小心地將Interlock System推進(jìn)，直到輸送鞘的遠(yuǎn)端緊密的固定在微導(dǎo)管接頭內(nèi)。收緊RHV的螺釘防止逆流，但不要太

34、緊，以免擠壓到輸送鞘而 不能推送導(dǎo)絲。保持連續(xù)的灌注壓力。平穩(wěn)、連續(xù)地推進(jìn)導(dǎo)絲，將彈簧圈和輸送導(dǎo)絲從輸送鞘推到微導(dǎo)管內(nèi)。確保輸送鞘保持在微導(dǎo)管接頭內(nèi)，以防彈簧圈過(guò)早的釋放。一旦輸送導(dǎo)絲近端露出部分不足10cm時(shí)，輕輕地回撤和移出輸送鞘。不要丟掉輸送鞘，以防在完全釋放前需要回收彈簧圈。- Page 20 -操作和釋放要點(diǎn)（續(xù)上一頁(yè)）操作和釋放要點(diǎn)（續(xù)上一頁(yè)）48Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally ONCM980 / 06/06 2

35、006 Boston Scientific Corporation or its affiliates. All rights reserved.彈簧圈輸送(1-微導(dǎo)管不透射線標(biāo)記): 在顯影下推送彈簧圈直到互鎖臂距離微導(dǎo)管遠(yuǎn)端的不透射線標(biāo)記約1cm。如果需要重新定位，在顯影下輕輕地收回；重新釋放時(shí)，緩慢地推進(jìn)導(dǎo)絲直到互鎖臂越過(guò)微導(dǎo)管的遠(yuǎn)端不透射線標(biāo)記。 最后，將整個(gè)系統(tǒng)從微導(dǎo)管中移出- Page 21 -操作和釋放要點(diǎn)（續(xù)上一頁(yè)）操作和釋放要點(diǎn)（續(xù)上一頁(yè)）49Boston Scientific Confidential - For Internal Use Only. Do Not Copy

36、, Display or Distribute Externally ONCM980 / 06/06 2006 Boston Scientific Corporation or its affiliates. All rights reserved.需要重點(diǎn)關(guān)注和考慮的因素：為了獲得更好的栓塞并減少血栓并發(fā)癥的風(fēng)險(xiǎn)，必須保證持續(xù)的肝素化 當(dāng)將輸送鞘推至微導(dǎo)管接頭中時(shí)，不要使用過(guò)大的力。輸送鞘頭端的變形會(huì)導(dǎo)致彈簧圈無(wú)法推出 0.018”彈簧圈必須在顯影下通過(guò)0.021”內(nèi)徑的微導(dǎo)管輸送，且微導(dǎo)管必須有1-2個(gè)不透射線標(biāo)記點(diǎn)- Page 22 -操作和釋放要點(diǎn)操作和釋放要點(diǎn)50Boston Sci

37、entific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 2個(gè)不透射線標(biāo)記點(diǎn)的微導(dǎo)管1個(gè)不透射線標(biāo)記點(diǎn)的微導(dǎo)管如果需要重新定位，輕輕地回撤。如果感覺(jué)難以重新定位，撤出并放棄該彈簧圈。輕輕地推送導(dǎo)絲直到互鎖臂到達(dá)近端標(biāo)記點(diǎn)，但先不要越過(guò)。如果越過(guò)近端標(biāo)記點(diǎn)，互鎖臂就已經(jīng)處在微導(dǎo)管體外，然后解鎖 (Figure 6).將互鎖臂推至距離近端標(biāo)記點(diǎn)約1cm處 (Figure 5). 為防止過(guò)早的釋放，在準(zhǔn)備好釋放前，不要再往前推送導(dǎo)絲。Maneuver the Interloc

38、k System under fluoroscopy until the coil detachment zone is approximately 1cm proximal to the microcatheter radiopaque tip marker (Figure 7). This positions the interlocking arms approximately 1cm proximal to the microcatheter tip. If Interlock System repositioning is necessary, gently retract the

39、Interlock System under fluoroscopy. If repositioning is difficult to impossible, remove and discard the Interlock System (see Interlock System Removal Procedure for further instructions).To deploy the coil, slowly advance the delivery wire under fluoroscopy until interlocking arms pass microcatheter

40、s tip marker (Figure 8).Figure 5: Advancing Interlock Occlusion System to Pre-Release Position (2-RO marker microcatheter)Figure 6: Delivering Interlock Occlusion System coil (2-RO marker microcatheter)Figure 7: Advancing Interlock Occlusion System to Pre-Release Position (1-RO marker microcatheter)

41、Figure 8: Delivering Interlock Occlusion System coil (1-RO marker microcatheter)Interlock Occlusion System 不透射線標(biāo)記不透射線標(biāo)記ONCM980 / 06/06 2006 Boston Scientific Corporation or its affiliates. All rights reserved.Refer to Interlock Fibered IDC Occlusion System Directions for Use for complete instruction

42、s on how to use this medical device.- Page 23 -51Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlock Occlusion System Product Dimensions (from Proximal End): Delivery Wire: 175cm Introducer Sheath: 95cm Distal Tapered End: 1.3cm Occlusion C

43、oil: Main Diameter & Restrained Length 2D Helical 3 14mm 6 30cm VortX Diamond 3 6mm 2.3 8cmRemoving Introducer Sheath:Gently withdraw and remove the introducer sheath from the microcatheter once the proximal end of the delivery wire is within 10cm of the proximal end of the sheath. Do not discard th

44、e sheath in case it is necessary to remove the Interlock System prior to deployment.Product Dimensions & Introducer Sheath RemovalONCM980 / 06/06 2006 Boston Scientific Corporation or its affiliates. All rights reserved.Refer to Interlock Fibered IDC Occlusion System Directions for Use for complete

45、instructions on how to use this medical device.- Page 24 -52Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlock Occlusion System In order to achieve excellent performance of the Interlock System and reduce the risk of thromboembolic complic

46、ations, it is critical that a continuous flow of appropriate flush solution be maintained between a) the microcatheter and guiding catheter, and b) the microcatheter and any intraluminal device. Continuous flushing may: Reduce retrograde blood flow into the microcatheter and introducer sheath during

47、 coil delivery. Reduce contrast crystal formation and/or thrombosis on the delivery wire and in the guiding catheter and microcatheter lumens. Reduce premature coil thrombosis.持續(xù)沖洗持續(xù)沖洗ONCM980 / 06/06 2006 Boston Scientific Corporation or its affiliates. All rights reserved.Steps to Basic Continuous

48、Flush (refer to Interlock Fibered IDC Occlusion System Directions for Use): Attach the included RHV to the proximal luer adapter on the hub of the microcatheter. Begin continuous flow of an appropriate flush solution. In general, one drop of flush solution every 1-3 seconds from a pressure bag conta

49、ining the flush solution is recommended. Open the thumbscrew of the RHV and carefully insert the Interlock System until the distal tip of the introducer sheath is firmly seated in the microcatheter hub. Tighten the RHV thumbscrew just enough to prevent retrograde flow but not so tight as to pinch th

50、e introducer sheath and inhibit forward movement of the delivery wire. Maintain in-line pressure of the continuous flush to prevent retrograde flow once the sheath is removed.- Page 25 -53Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 廣泛的適應(yīng)證 完整的

51、栓塞系統(tǒng) Interlock Occlusion SystemONCM980 / 06/06 2006 Boston Scientific Corporation or its affiliates. All rights reserved. 動(dòng)脈瘤、假性動(dòng)脈瘤 AVF, AVM, 肺部AVM GI Bleed 保護(hù)性栓塞 外傷 精索靜脈曲張 Compatible Renegade Microcatheter Fathom Microguidewire54Boston Scientific Confidential - For Internal Use Only. Do Not Copy, D

52、isplay or Distribute Externally Interlock - 35Fibered IDC Occlusion System形狀和尺寸形狀和尺寸55Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlock - 35彈簧圈彈簧圈立體立體3D設(shè)計(jì) 允許for circumfrential wall apposition 和良好包裹能力內(nèi)臟血管動(dòng)脈瘤2D 螺旋螺旋理想的錨定 因?yàn)檫@個(gè)彈簧圈的結(jié)構(gòu)經(jīng)常保持與血管壁的

53、接觸 鉆石鉆石閉塞能力 源自首尾尖端的彈簧圈直徑, 最大截面阻塞數(shù)目數(shù)目最長(zhǎng)最長(zhǎng)最大最大134020數(shù)目數(shù)目最長(zhǎng)最長(zhǎng)最大最大174020數(shù)目數(shù)目最長(zhǎng)最長(zhǎng)最大最大63012Interlock 35 彈簧圈彈簧圈使用使用5Fr的的Imager II 造影管釋放，替代微導(dǎo)管造影管釋放，替代微導(dǎo)管 56Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlock - 35 Coil 立體形狀立體形狀立體形狀的彈簧圈用于提供圓周式的貼壁作用和出

54、色的填充性能，適用于內(nèi)臟血管瘤。適應(yīng)證包括但不限于以下: 脾動(dòng)脈瘤 腎動(dòng)脈瘤 髂內(nèi)動(dòng)脈栓塞 AVM57Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 2D螺旋形狀彈簧圈用于提供優(yōu)化的錨定能力，因?yàn)槁菪螤畋ＷC彈簧圈與直形或漸細(xì)血管壁的持續(xù)不變的接觸和貼壁。適應(yīng)證包括但不限于以下: 精索靜脈曲張栓塞盆腔淤血綜合征栓塞胃十二指腸動(dòng)脈栓塞 近端脾動(dòng)脈瘤栓塞Interlock - 35 Coil 2D螺旋形狀螺旋形狀58Boston Scienti

55、fic Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 鉆石形狀彈簧圈設(shè)計(jì)用于提供最大化的閉塞作用，它具有漸細(xì)的近端和遠(yuǎn)端，最大化血流的阻斷作用。適應(yīng)證包括但不限于以下: 精索靜脈曲張栓塞 盆腔淤血綜合征栓塞 內(nèi)臟動(dòng)脈瘤 GI BleedsInterlock - 35 Coil 鉆石鉆石形狀形狀59Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute

56、 Externally 注意事項(xiàng)注意事項(xiàng) 彈簧圈直徑如果選小了，就會(huì)產(chǎn)生移位； 彈簧圈的選擇取決于醫(yī)生的偏好和臨床情況，但通常都要求醫(yī)生根據(jù)病灶的情況選擇尺寸偏大的彈簧圈 需要栓塞的血管形態(tài)和直徑，以及鄰近分支血管的情況，都會(huì)決定彈簧圈的直徑和長(zhǎng)度Interlock - 35 Coil 形狀的選擇形狀的選擇60Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlock - 35Fibered IDC Occlusion System

57、互鎖臂設(shè)計(jì)互鎖臂設(shè)計(jì)61Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlock 35 Fibered IDC Occlusion System通過(guò)簡(jiǎn)單的互鎖將推送導(dǎo)絲和彈簧圈連接起來(lái)互鎖連接是一種簡(jiǎn)單的連接，當(dāng)互鎖臂保持在輸送系統(tǒng)內(nèi)時(shí)，就會(huì)保持鎖定狀態(tài)Interlock - 35 Coil Interlocking Arms-互鎖臂互鎖臂注意事項(xiàng)注意事項(xiàng): 不要過(guò)快的回收，或頂著阻力回收。這可能導(dǎo)致彈簧圈拉伸或互鎖臂損壞 在輸送

58、過(guò)程中，不要旋轉(zhuǎn)輸送導(dǎo)絲超過(guò)一圈（360）。過(guò)度的旋轉(zhuǎn)會(huì)損壞輸送系統(tǒng)或?qū)е禄ユi臂在導(dǎo)管內(nèi)的解脫62Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally Interlock - 35Fibered IDC Occlusion System纖毛纖毛/纖維特征纖維特征63Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute E

59、xternally 每個(gè)彈簧圈都含有許多致密滌綸纖維，它們可以結(jié)合血細(xì)胞并促進(jìn)血栓形成滌綸纖維的特顯（左圖）顯示纖毛的結(jié)構(gòu)是有組織的，也有空隙，可快速形成血栓 Interlock - 35 Coil Dacron Fiber: 纖毛的作用纖毛的作用64Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 010002000300040005000600070004102040纖毛總長(zhǎng)度(CM)彈簧圈長(zhǎng)度彈簧圈長(zhǎng)度(CM)Total Fiber (

60、CM)40cm長(zhǎng)度的彈簧圈的纖毛總長(zhǎng)度近長(zhǎng)度的彈簧圈的纖毛總長(zhǎng)度近6000cm 每個(gè)彈簧圈的每個(gè)地方都有纖毛每個(gè)彈簧圈的每個(gè)地方都有纖毛I(xiàn)nterlock - 35 Coil Dacron Fiber: 長(zhǎng)度和密度長(zhǎng)度和密度65Boston Scientific Confidential - For Internal Use Only. Do Not Copy, Display or Distribute Externally 因?yàn)闇炀]纖維的存在，合適流量的沖洗必須保持持續(xù)工作持續(xù)沖洗可以減少血液逆流至導(dǎo)管，減少造影劑結(jié)晶形成的風(fēng)險(xiǎn)，或彈簧圈及管腔內(nèi)血塊形成的可能通常，推薦從加壓袋中每1-3秒