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BSC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,多環(huán)形VortX?2DHelicalInterlock?35BSC彈簧圈系列推送彈簧圈PushableCoils

BSC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彈簧圈推送器釋放彈簧圈適應(yīng)范圍動靜脈瘺-AVF動脈瘤外傷血管封堵0.018”纖毛彈簧圈-復(fù)合Helical彈簧圈0.018”纖毛彈簧圈-復(fù)合Helical彈簧圈Features0.018”纖毛彈簧圈-復(fù)合Helical彈簧圈特性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血管尺寸VORTX?-0.018’’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)外周栓塞-

VortX18鉆石形彈簧圈特性利益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)0.018”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創(chuàng)地進(jìn)入微導(dǎo)管和血管0.021”直徑的初級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)帶有兩個小頭端,以快速閉塞血管減少移位/伸長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0.018”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(CoilPusher16)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

.035”纖毛鉑金圈形狀螺旋形-Helical材料鉑金纖毛致密聚酯纖維尺寸多種長度(10-60mm)和直徑(3-9mm)特性利益鉑金結(jié)構(gòu)可視性更佳兼容MRI致密纖毛組成促進(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VORTX35:Available

2mm/4mmApex/Basis3mm/5mmApex/Basis3mm/6mmApex/Basis3mm/7mmApex/Basis.035”VortX纖毛鉑金圈.035”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BSCEmbolicAgents可控彈簧圈

InterlockFiberedIDCOcclusionSystemInterlocking可控彈簧圈鉑金材料獨(dú)特的InterlockingArm-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;Controlleddeployment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)過渡到微導(dǎo)管Interlocking可控彈簧圈Interlocking可控彈簧圈Interlocking可控彈簧圈特性利益鉑金結(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)管的過渡Interlock?

FiberedIDC系統(tǒng)特性利益鉑鎢合金彈簧圈兼容MRI,磁場強(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)管的過渡多種尺寸可選2D:直徑(3-14mm),長度(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JammingProductOffering:2D(Multi-Loop):

3mmx6cm 3mmx12cm 4mmx8cm 4mmx15cm 5mmx8cm 5mmx15cm 6mmx10cm 6mmx20cm 8mmx20cm10mmx20cm 10mmx30cm 12mmx20cm 12mmx30cm 14mmx20cm 14mmx30cm VortX?

DiamondCoil: 2mm/3mmx2.3cm 2mm/4mmx4.1cm 2mm/5mmx5.8cm 2mm/6mmx8.0cm Interlock?

FiberedIDC系統(tǒng)推送彈簧圈的風(fēng)險移位由于不恰當(dāng)?shù)膹椈扇﹂L度和尺寸,導(dǎo)致不正確釋放推送彈簧圈的風(fēng)險輸送導(dǎo)管的不穩(wěn)定,導(dǎo)致的不正確釋放推送彈簧圈的風(fēng)險更好的精確性和控制與推送圈不同,InterlockingArms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?OcclusionSystemONCM980/06/06 2006BostonScientificCorporationoritsaffiliates.Allrightsreserved. INTERLOCKINGARM-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InterlockFiberedIDCOcclusionSystem只用于外周血管的栓塞,不能用于神經(jīng)血管的栓塞-Page10-更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?OcclusionSystemONCM980/06/06 2006BostonScientificCorporationoritsaffiliates.Allrightsreserved. FIBERBUNDLING

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):

減少過早的釋放、彈簧圈打折貨堵塞改善推送性

可靠的輸送輸送系統(tǒng)的漸細(xì)頭端提供更可靠的輸送。-Page11-

Interlock?OcclusionSystem增加手術(shù)的靈活性提供多種長度、直徑和形狀的彈簧圈,滿足不同血管和手術(shù)的需求。MainRestrained

Diameter

Length2DHelical:3–14mm6–30cm

VortXDiamond:3–6mm2.3–8cmInterlock?FiberedIDCOcclusionSystem:VORTX-18VORTX?-18鉆石型纖毛鉑金彈簧圈雙尖端形狀具有兩個小頭端,提高通過性和加速栓塞雙尖端形狀設(shè)計(jì)改善彈簧圈壓縮兩個小頭端設(shè)計(jì)于閉塞中心血流2DHELICAL纖毛彈簧圈遠(yuǎn)端直徑為主要直徑的75%(1st1.5loops)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Interlock?FiberedIDCOcclusionSystem:2DHELICAL可控彈簧圈的優(yōu)勢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)險必要時可重新進(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)時刻取出彈簧圈尤其適用于鄰近大動脈的病灶如重要動脈的假性動脈瘤

可控彈簧圈的優(yōu)勢完全可控的釋放

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pullback可控彈簧圈的優(yōu)勢pushdensepacking可控彈簧圈的優(yōu)勢deliver可控彈簧圈的適應(yīng)證可控彈簧圈的適應(yīng)證可控彈簧圈的適應(yīng)證突出可控彈簧圈的適應(yīng)證導(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)證可控彈簧圈的適應(yīng)證醫(yī)生對于Interlock臨床應(yīng)用的反饋:

動脈瘤、假性動脈瘤、AVF、AVM、PAVM、GIBleed,“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?OcclusionSystem–

可用在哪些手術(shù)?Confidential.ForBostonScientificInternalUseOnly.DoNotCopyorDistribute.TheFiberedIDCOcclusionSystemisindicatedtoobstructorreducerateofbloodflowintheperipheralvasculature.Thisdeviceisnotintendedforneurovascularuse.Interlock?OcclusionSystem

操作和釋放要點(diǎn)ONCM980/06/06 2006BostonScientificCorporationoritsaffiliates.Allrightsreserved. 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)沒有損傷并且互鎖臂還處于鎖定狀態(tài),輕輕的轉(zhuǎn)動輸送鞘安全鎖定裝置以解鎖,兩邊同時轉(zhuǎn)動,逆時針旋轉(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)開始持續(xù)的肝素化(通常,從加壓包內(nèi)持續(xù)的每1-3秒鐘注入1滴)

操作和釋放要點(diǎn)-Page19-ONCM980/06/06 2006BostonScientificCorporationoritsaffiliates.Allrightsreserved. 打開RHV的螺釘,小心地將InterlockSystem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),以防彈簧圈過早的釋放。一旦輸送導(dǎo)絲近端露出部分不足10cm時,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。-Page20-

操作和釋放要點(diǎn)(續(xù)上一頁)ONCM980/06/06 2006BostonScientificCorporationoritsaffiliates.Allrightsreserved. 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,緩慢地推進(jìn)導(dǎo)絲直到互鎖臂越過微導(dǎo)管的遠(yuǎn)端不透射線標(biāo)記。最后,將整個系統(tǒng)從微導(dǎo)管中移出-Page21-

操作和釋放要點(diǎn)(續(xù)上一頁)ONCM980/06/06 2006BostonScientificCorporationoritsaffiliates.Allrightsreserved. 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,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,不要使用過大的力。輸送鞘頭端的變形會導(dǎo)致彈簧圈無法推出0.018”彈簧圈必須在顯影下通過0.021”內(nèi)徑的微導(dǎo)管輸送,且微導(dǎo)管必須有1-2個不透射線標(biāo)記點(diǎn)-Page22-

操作和釋放要點(diǎn)2個不透射線標(biāo)記點(diǎn)的微導(dǎo)管1個不透射線標(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。如果越過近端標(biāo)記點(diǎn),互鎖臂就已經(jīng)處在微導(dǎo)管體外,然后解鎖(Figure6).將互鎖臂推至距離近端標(biāo)記點(diǎn)約1cm處(Figure5).為防止過早的釋放,在準(zhǔn)備好釋放前,不要再往前推送導(dǎo)絲。ManeuvertheInterlockSystemunderfluoroscopyuntilthecoildetachmentzoneisapproximately1cmproximaltothemicrocatheterradiopaquetipmarker(Figure7).Thispositionstheinterlockingarmsapproximately1cmproximaltothemicrocathetertip.IfInterlockSystemrepositioningisnecessary,gentlyretracttheInterlockSystemunderfluoroscopy.Ifrepositioningisdifficulttoimpossible,removeanddiscardtheInterlockSystem(seeInterlockSystemRemovalProcedureforfurtherinstructions).Todeploythecoil,slowlyadvancethedeliverywireunderfluoroscopyuntilinterlockingarmspassmicrocatheter’stipmarker(Figure8).Figure5:AdvancingInterlockOcclusionSystemtoPre-ReleasePosition(2-ROmarkermicrocatheter)Figure6:DeliveringInterlockOcclusionSystemcoil(2-ROmarkermicrocatheter)Figure7:AdvancingInterlockOcclusionSystemtoPre-ReleasePosition(1-ROmarkermicrocatheter)Figure8:DeliveringInterlockOcclusionSystemcoil(1-ROmarkermicrocatheter)Interlock?OcclusionSystem

不透射線標(biāo)記ONCM980/06/06 2006BostonScientificCorporationoritsaffiliates.Allrightsreserved. RefertoInterlockFiberedIDCOcclusionSystemDirectionsforUseforcompleteinstructionsonhowtousethismedicaldevice.-Page23-Interlock?OcclusionSystem

ProductDimensions(fromProximalEnd):DeliveryWire:175cmIntroducerSheath:95cmDistalTaperedEnd:1.3cmOcclusionCoil:MainDiameter&RestrainedLength 2DHelical 3–14mm6–30cm VortX?Diamond3–6mm2.3–8cmRemovingIntroducerSheath:Gentlywithdrawandremovetheintroducersheathfromthemicrocatheteroncetheproximalendofthedeliverywireiswithin10cmoftheproximalendofthesheath.DonotdiscardthesheathincaseitisnecessarytoremovetheInterlockSystempriortodeployment.ProductDimensions&IntroducerSheathRemovalONCM980/06/06 2006BostonScientificCorporationoritsaffiliates.Allrightsreserved. RefertoInterlockFiberedIDCOcclusionSystemDirectionsforUseforcompleteinstructionsonhowtousethismedicaldevice.-Page24-Interlock?OcclusionSystem

InordertoachieveexcellentperformanceoftheInterlockSystemandreducetheriskofthromboemboliccomplications,itiscriticalthatacontinuousflowofappropriateflushsolutionbemaintainedbetweena)themicrocatheterandguidingcatheter,andb)themicrocatheterandanyintraluminaldevice.Continuousflushingmay:Reduceretrogradebloodflowintothemicrocatheterandintroducersheathduringcoildelivery.Reducecontrastcrystalformationand/orthrombosisonthedeliverywireandintheguidingcatheterandmicrocatheterlumens.Reduceprematurecoilthrombosis.持續(xù)沖洗ONCM980/06/06 2006BostonScientificCorporationoritsaffiliates.Allrightsreserved. StepstoBasicContinuousFlush(refertoInterlockFiberedIDCOcclusionSystemDirectionsforUse):AttachtheincludedRHVtotheproximallueradapteronthehubofthemicrocatheter.Begincontinuousflowofanappropriateflushsolution.Ingeneral,onedropofflushsolutionevery1-3secondsfromapressurebagcontainingtheflushsolutionisrecommended.OpenthethumbscrewoftheRHVandcarefullyinserttheInterlockSystemuntilthedistaltipoftheintroducersheathisfirmlyseatedinthemicrocatheterhub.TightentheRHVthumbscrewjustenoughtopreventretrogradeflowbutnotsotightastopinchtheintroducersheathandinhibitforwardmovementofthedeliverywire.Maintainin-linepressureofthecontinuousflushtopreventretrogradeflowoncethesheathisremoved.-Page25-廣泛的適應(yīng)證

完整的栓塞系統(tǒng)

Interlock?OcclusionSystemONCM980/06/06 2006BostonScientificCorporationoritsaffiliates.Allrightsreserved.

動脈瘤、假性動脈瘤AVF,AVM,肺部AVMGIBleed

保護(hù)性栓塞

外傷

精索靜脈曲張

CompatibleRenegade?MicrocatheterFathom?MicroguidewireInterlock?-35FiberedIDC?OcclusionSystem形狀和尺寸Interlock?-35彈簧圈立體3D設(shè)計(jì)

允許forcircumfrentialwallapposition和良好包裹能力內(nèi)臟血管動脈瘤2D螺旋理想的錨定

因?yàn)檫@個彈簧圈的結(jié)構(gòu)經(jīng)常保持與血管壁的接觸

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)目最長最大134020數(shù)目最長最大174020數(shù)目最長最大63012Interlock–35彈簧圈使用5Fr的ImagerII造影管釋放,替代微導(dǎo)管

Interlock?-35Coil

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:

脾動脈瘤

腎動脈瘤

髂內(nèi)動脈栓塞AVM2D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脈栓塞

近端脾動脈瘤栓塞Interlock?-35Coil

2D螺旋形狀鉆石形狀彈簧圈設(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)臟動脈瘤GIBleedsInterlock?-35Coil

鉆石形狀注意事項(xiàng)彈簧圈直徑如果選小了,就會產(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,都會決定彈簧圈的直徑和長度Interlock?-35Coil

形狀的選擇Interlock?-35FiberedIDC?OcclusionSystem互鎖臂設(shè)計(jì)Interlock35FiberedIDC?OcclusionSystem通過簡單的互鎖將推送導(dǎo)絲和彈簧圈連接起來互鎖連接是一種簡單的連接,當(dāng)互鎖臂保持在輸送系統(tǒng)內(nèi)時,就會保持鎖定狀態(tài)Interlock?-35Coil

InterlockingArms-互鎖臂注意事項(xiàng):

不要過快的回收,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過程中,不要旋轉(zhuǎn)輸送導(dǎo)絲超過一圈(360°)。過度的旋轉(zhuǎn)會損壞輸送系統(tǒng)或?qū)е禄ユi臂在導(dǎo)管內(nèi)的解脫Interlock?-35FiberedIDC?OcclusionSystem纖毛/纖維特征每個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?-35Coil

Dacron?Fiber:纖毛的作用40cm長度的彈簧圈的纖毛總長度近6000cm每個彈簧圈的每個地方都有纖毛I(xiàn)nterlock?-35Coil

Dacron?Fiber:長度和密度因?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,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秒鐘注入1滴沖洗液(肝素化生理鹽水)注意:持續(xù)沖洗過程中,確保不會有氣體進(jìn)入導(dǎo)管Interlock?-35Coil

Dacron?Fiber:持續(xù)沖洗0.021”.012”IDof5FImagerIICatheter≈0.045”還有將近3倍的空間存在讓血液進(jìn)入逆流導(dǎo)管內(nèi)Interlock–35CoilInterlock–18Coil≈0.024”offreespace≈

0.009”offreespaceIDofRenegade?STCCatheter≈0.021”O(jiān)DofPlatinumCoilprimarywindInterlock?

Dacron?Fiber:持續(xù)沖洗Interlock?-35FiberedIDC?OcclusionSystem輸送系統(tǒng)兼容性Interlock–35彈簧圈需在顯影下通過5F(0.035”[0.89mm]或0.038”[0.97mm]內(nèi)腔)Imager?II造影導(dǎo)管輸送.Interlock?-35Coil

導(dǎo)管兼容性–PerDFU*Note:Physiciansshouldexercisetheirclinicaljudgmentinselectionanduseofcatheters.BostonScientificCorporationprovidesnowarrantyforuseofthirdpartycatheterswithitsproducts.Theuseofotherdiagnosticcathetersmayresultinaninabilitytodeliver,deploy,orrecapturethedevice.注意事項(xiàng):切記不要使用柔軟的導(dǎo)管輸送Interlock-35,比如TerumoGlidecath?Catheter;當(dāng)使用柔軟導(dǎo)管輸送Interlock–35時,會感覺明顯的阻力?;鶞?zhǔn)測試測量通過導(dǎo)管推進(jìn)彈簧圈時所需的力,LowerNumber=LessForce.彈簧圈不能通過TerumoGlidecath?Catheter.使用CookSlip-Cath?Catheter時,需要額外的力量推進(jìn)Interlock?-35Coil

導(dǎo)管兼容性–阻力測試DataonfileatBostonScientific.Testingdatarepresentsanaveragemeasurementtakenacrosstherangeofavailablecatheters.Testresultsshownareformodelsdeemedmosttypicallyselectedforplacementinperipheralvasculature.

Benchtestresultsmaynotnecessarilybeindicativeofclinicalperformance.TM????基準(zhǔn)測試測量擠壓導(dǎo)管時所需的力量,Lowernumber=SofterCatheterTerumoGlidecath?是最柔軟的,然后是CookSlip-Cath?Catheter.導(dǎo)管硬度的數(shù)據(jù)與摩擦力數(shù)據(jù)匹配,表明最柔軟的導(dǎo)管即是在彈簧圈釋放過程中阻力最大的導(dǎo)管。Interlock?-35Coil

導(dǎo)管兼容性–摩擦和柔軟度DataonfileatBostonScientific.Testingdatarepresentsanaveragemeasurementtakenacrosstherangeofavailablecatheters.Testresultsshownareformodelsdeemedmosttypicallyselectedforplacementinperipheralvasculature.

Benchtestresultsmaynotnecessarilybeindicativeofclinicalperformance.基準(zhǔn)測試測量彎折導(dǎo)管時的彎曲半徑,Lowernumber=MoreKinkResistantAngiodynamicsSoft-Vu?導(dǎo)管是最容易彎折的

當(dāng)導(dǎo)管彎折時,彈簧圈就無法往前推送Interlock?-35Coil

導(dǎo)管兼容性–摩擦力和打折DataonfileatBostonScientific.Testingdatarepresentsanaveragemeasurementtakenacrosstherangeofavailablecatheters.Testresultsshownareformodelsdeemedmosttypicallyselectedforplacementinperipheralvasculature.

Benchtestresultsmaynotnecessarilybeindicativeofclinicalperformance.TM????NoVoidVoidImager?IICatheterImagerII導(dǎo)管顯示了從導(dǎo)管接頭到導(dǎo)管腔的平滑過渡

平滑的過渡提高了彈簧圈從輸送鞘到導(dǎo)管的過渡這種特性是生產(chǎn)過程中的嚴(yán)格監(jiān)督和檢查決定的CompetitiveCatheterCordisTempo?導(dǎo)管的測試結(jié)果顯示,20%的導(dǎo)管其接頭到管腔的過渡存在明顯的空隙空隙的存在影響了彈簧圈從輸送鞘到管腔的過渡ImagespropertyofBostonScientificInterlock?-35Coil

導(dǎo)管兼容性–Hub的區(qū)別Interlock?-35彈簧圈

導(dǎo)管兼容導(dǎo)管類型兼容性?備注5FImagerII造影管兼容我們控制規(guī)格!!5FCordisTempoCatheterYes我們不能控制規(guī)格。5FCordisTempoAquaCatheterYes我們不能控制規(guī)格。5FAngiodynamicsSoftVuCatheterYes我們不能控制規(guī)格。5FCookSlip-Cath?CathetersYes/No很難推動5FTerumoGlidecathCatheterNoNevertry!!ImagerII造影管是最佳選擇123全線產(chǎn)品推薦,不要關(guān)注特定彈簧圈讓手術(shù)選擇彈簧圈猶豫時,使用0.018”

精確:

可解脫彈簧圈潛在的優(yōu)勢

力度:

濃密纖維和長度的貢獻(xiàn)

精度:

多種形狀,多種直徑,018或035系列038:使用0.038”ImagerII造影管開始手術(shù)

035:如果診斷性造影管已導(dǎo)入,請使用0.035”彈簧圈

018:

如果未提前建立通路,使用STC微導(dǎo)管和0.018”彈簧圈

同軸定位:5Fr造影管/微導(dǎo)管,定位輕松

填充:5Fr造影管更易填實(shí)

PE成籃:PE成籃,易處多Interlock?35:3個原則!Interlock?-35CoilandInterlock18Coil

WhataretheDifferences?Platinum/Dacron?Platinum/Dacron14mm/30cm20mm/40cm2D,Diamond2D,Diamond,Cube0.0165in,175cm,Siliconecoated0.0355in,150cm,PTFEcoatedOnly0.021inIDmicrocatheterOnlyBSC5FImager?II(0.035inor0.038inGWcompatible)直徑/長度形狀輸送導(dǎo)絲ProductGuideInterlock–18CoilInterlock–35Coil彈簧圈/纖毛導(dǎo)管兼容性優(yōu)秀適度-更大的基本纏繞,而順應(yīng)性更低-允許合適的空間以釋放彈簧圈最小摩擦力中等摩擦力更大的纖毛密度,更高的徑向力和彈簧圈長度,增加了輸送阻力使用5FImager?II,持續(xù)沖洗中等致血栓性優(yōu)秀纖毛數(shù)量多50%,減少閉塞時間盡量減少彈簧圈釋放前在導(dǎo)管外的時間中等錨定優(yōu)秀錨定徑向力高30倍左右不推薦彈簧圈直徑超過血管直徑太多填充性能輸送性能致血栓性能錨定性能產(chǎn)品特性Interlock?–018CoilInterlock–035CoilKeyInterlock-35CoilPointsInterlock?–18CoilInterlock–35Coil40%60%90%10%75%25%35%65%60%40%10%90%30%70%30%70%60%40%產(chǎn)品銷售:035Focus?GIVaricesAVMHypogastricVaricoceleGIBleedGDASplenicPCSEndoleaks臨床病例Interlock?-35Coil

ClinicalSuccessExample

AngiogramofLarge(>3cm)SplenicArteryAneurysmlocatedintheproximalthirdofSplenicArtery11Along,angled6FCookSheathwasplacedattheoriginoftheCeliacartery.22AC2CookBeacon?TipCatheterwasusedtoobtainaselectiveangiogramofthesplenicartery.3A0.035”Glidewire?Guidewirewasadvanceddistaltotheaneurysm.4TheBeaconTipCatheterwasremovedandaGlideCath?Catheterwaspushedoverthewiredistaltotheaneurysm.345TheGlidewireGuidewireandGlideCathCathetercombinationwasadvancedasfardistallyaspossible.56The6Fsheathwasadvancedintotheproximalsplenicartery,justproximaltotheoriginoftheaneurysm.6Interlock?-35Coil

ClinicalSuccessExample

CoilNestindistalsplenicartery,occludingtheoutflowfromalarge>3cmaneurysm11TheGlideCath?Catheterwasremovedanda5FImager?IIBERNwaspushedoverthewireintothedistalsplenicvasculature.22FourInterlock35Coils(two10x20,two12x202D)wereplacedwithinandjustproximaltothefirstmajorturninthedistalsplenicartery.Continuousflushwasutilizedandnofrictionwasencountered.3AnumberofshortpushablecoilsweresquirtedintothescaffoldingcreatedbytheInterlockCoils.Pushablecoilswerechosenbecauseofthehosptial’slackofinventoryofInterlock–35Coil.4ThefinaltwounitsofInterlock–35Coils(12x40)thatthehospitalhadwereusedtolooselypacktheaneurysmsac.34Interlock?-35Coil

ClinicalSuccessExample

11WithnoInterlock–35Coilsavailable,theaccountdeterminedthatthe6FsheathwouldbeadequatetoplaceanAmplatzer?IIVascularPlug.22Althoughthevesseldiameterwasmeasuredtobe8mm,thelargest6FcompatiblePlugthatwasontheshelfwasa10mmdiameter.NOTE:TheAmplatzerIIVascularPlugshouldbeoversizedby30-50%.3WhentheAmplatzerIIVascularPlugwasinitiallydeployed,difficultywasencountereddetachingit,asitrequiresadequatewallappositiontounscrew.4Afteranumberofattempts,theplugdiddetach,butdidverylittletodisruptflowintotheaneurysm.34CoilNestindistalsplenicartery,occludingtheoutflowfromalarge>3cmaneurysmInterlock?-35Coil

ClinicalSuccessExample

Finalangiogramofcompletedembolizationofsplenicarteryaneurysm11Asaresultofpersistantforwardflow,theAmplatzer?IIVascularPlugwasusedasadistalbackstopforadditionalfiberedcoils.22Anadditionaleight0.035”fiberedplatinumpushablecoilswereinjectedintotheproximalinflow.3Followingdeploymentoftheadditionalcoils,forwardflowwasstoppedwithintheaneurysmsacandbeyondthedistaloutflow.4Arterialflowwasdivertedaroundtheproximalsplenicaneurysmandintotheparcreaticvascualtureabove.34AbbreviatedStatementsInterlock?-35FiberedIDC?OcclusionSystemCAUTION:Federallaw(USA)restrictsthisdevicetosalebyorontheorderofaphysician.INTENDEDUSE/INDICATIONSFORUSE:TheInterlock–35FiberedIDCOcclusionSystemisamodifiedinterlockingdetachablecoilindicatedtoobstructorreducerateofbloodflowintheperipheralvasculature.Thisdeviceisnotintendedforneurovascularuse.CONTRAINDICATIONS:Noneknown.WARNING:CompatibilitywithMagneticResonanceImaging(MRI)hasnotbeenestablished,andthedegreeofimagingdistortionresultingfromthecoilhasnotbeenmeasured.ADVERSEEVENTS:?Complicationsrelatedtocatheterization(e.g.,hematomaatthesiteofentry,clotformationatthetipofthecatheterandsubsequentdislodgement,nerveandvesseldissectionorperforation)?Pain?Hemorrhage?Infectionnecessitatingmedicalintervention?Foreignbodyreactionsnecessitatingmedicalintervention?Emboli?Ischemia?Vasospasm?Tissuenecrosis?Undesirableclotformationofthevasculature?Claudication?Recanalization?Death?Temporaryneurologicaldeficit.Priortouse,pleaseseethecomplete“DirectionsforUse”formoreinformationonIndications,Contraindications,Warnings,precautions,Adverseeventsandoperatorsinstructions.IMAGER?IIANGIOGRAPHICCATHETERDEVICEDESCRIPTION:TheImagerIIAngiographicCathetersaresterile,single-usediagnosticintravascularcatheters.Thesecathetersareavailableinavarietyofflushandselectiveshapeswithlengthsof40cm,65cm,90cmand100cm.Thedistalsegmentofthecatheterisradiopaquetoaidinvisualizationofthedeviceunderfluoroscopy.Clinically,flushcathetersareusedtodeliverabolusofcontrasttoapatientwhenobtaininganimageofalargearea(aorta,legrunoff,etc.).Sideholesarealsoaddedtodispersethecontrast.Selectivecathetersareusedtocreateimagesofspecificareasofinterest.INTENDEDUSE/INDICATIONSFORUSE:TheImagerIIAngiographicCathetersaredesignedtoprovideapathwayfordeliveringcontrastmediatoselectedsitesinthevascularsystem,includingthecarotidarteries.CONTRAINDICATIONS:Noknowncontraindications.WARNINGS:Angiographiccathetersaredesignedforusebyphysiciansengagedinthepracticeofaspecializedbranchofmedicine.Useofthesedevicesshouldberestrictedtothosespecialiststrainedtoperformtheprocedure.Athoroughunderstandingofthetechnicalprinciples,clinicalapplicationsandrisksassociatedwithdiagnosticangiographyisnecessarybeforeperformingthisprocedure.Accordingly,theImagerIIAngiographicCathetersshouldonlybeusedbyphysicianswithathoroughunderstandingofangiographicprocedures.?Duetothevarioussizesandshapes,andtherelativestiffnessofangiographiccatheters,extremecaremustbetakenwhenselectingandusingtheImagerIIAngiographicCatheterstoavoiddamagetothevesselwallsthroughwhichthiscatheterpasses.?ContentssuppliedSTERILEusinganethyleneoxide(EO)process.Donotuseifsterilebarrierisdamaged.Ifdamageisfound,callyourBostonScientificrepresentative.?Forsinglepatientuseonly.Donotreuse,reprocessorresterilize.Reuse,reprocessingorresterilizationmaycompromisethestructuralintegrityofthedeviceand/orleadtodevicefailure,which,inturn,mayresultinpatientinjury,illnessordeath.Reuse,reprocessingorresterilizationmayalsocreateariskofcontaminationofthedeviceand/orcausepatientinfectionorcross-infection,including,butnotlimitedto,thetransmissionofinfectiousdisease(s)fromonepatienttoanother.Contaminationofthedevicemayleadtoinjury,illnessordeathofthepatient.?Afteruse,disposeofproductandpackaginginaccordancewithhospital,administrativeand/orlocalgovernmentpolicy.?Donotexceedthepressureratingsprintedonthedevicelabeling.Catheterintegritymaybecompromisedifpressurelimitsareexceeded.?TheriskassociatedwithImagerIIAngiographicCathetersoutsidetheintendeduseisnotknown.PRECAUTIONS:Carefullyinspectthecatheterpriortousetoverifythatthesizeandshapearesuitableforth

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