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1、BSC彈簧圈系列BSC 彈簧圈技術(shù)可解脫彈簧圈推送彈簧圈0.0180.0350.0180.035Interlock 18VortX 鉆石,多環(huán)形VortX 2D HelicalInterlock 35BSC彈簧圈系列推送彈簧圈Pushable Coils3BSC推送彈簧圈一切彈簧圈都是鉑金圈一切的彈簧圈都有一樣的根底制造流程 根底和二次纏繞一切都兼容MRI一切纖毛彈簧圈都含有Dacron-滌綸纖維一切微彈簧圈都需求經(jīng)過(guò)彈簧圈推送器釋放4彈簧圈順應(yīng)范圍動(dòng)靜脈瘺-AVF動(dòng)脈瘤外傷血管封堵50.018 纖毛彈簧圈-復(fù)合Helical彈簧圈60.018 纖毛彈簧圈-復(fù)合Helical彈簧圈7Featu

2、res0.018 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8VORTX - 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- VortX 18 鉆石形彈簧圈特性利益VORTX鉆石形-尖端設(shè)計(jì)錨

3、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)90.018 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(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

4、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10110.018彈簧圈的釋放彈簧圈預(yù)置在塑料海波管中,平安軸芯將其鎖定;移除平安軸芯然后推入海波管頭端經(jīng)過(guò)RHV,使其與保送系統(tǒng)推送器接頭構(gòu)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保送系統(tǒng)中至少進(jìn)入30cm,然后撤出硬頭端,運(yùn)用軟頭端釋放彈簧圈 12.035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(zhǎng)度(10-60mm)和直徑(3-9

5、mm)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)13.035纖毛鉑金圈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 VortX纖毛鉑金圈15.035彈簧圈的釋放彈簧圈預(yù)置在塑料海波管中,平安軸芯將其鎖定;置入導(dǎo)管接頭運(yùn)用.035/.038導(dǎo)絲的硬頭端將彈簧圈推入導(dǎo)管中,運(yùn)用正常的任

6、務(wù)頭端繼續(xù)肝素沖洗導(dǎo)管,防止彈簧圈堵塞BSC Embolic Agents可控彈簧圈17Interlock Fibered IDC Occlusion SystemInterlocking可控彈簧圈鉑金資料獨(dú)特的Interlocking Arm-互鎖臂設(shè)計(jì)預(yù)裝系統(tǒng),直接保送HelicalIDC外形有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19Interlocking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

7、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Interlock Fibered IDC系統(tǒng)特性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Jamming23Product Offering:2D (Multi-Loop

8、): 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 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)推送彈簧圈的風(fēng)險(xiǎn)移位由于不恰當(dāng)?shù)膹椈扇﹂L(zhǎng)度和尺寸,導(dǎo)致不正

9、確釋放推送彈簧圈的風(fēng)險(xiǎn)26保送導(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(xiǎn)更好的準(zhǔn)確性和控制與推送圈不同,Interlocking Arms和保送導(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)械分別可回撤設(shè)計(jì)彈簧圈在釋放前堅(jiān)持鎖定Interlock Fibered IDC Occlus

10、ion System只用于外周血管的栓塞,不能用于神經(jīng)血管的栓塞- Page 10 -更自信的栓塞鉑金彈簧圈配合滌綸纖維,加速血栓構(gòu)成。纖毛陳列成流線束狀,提高填塞效果。Interlock Occlusion SystemONCM980 / 06/06 2006 Boston Scientific Corporation 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 促血栓構(gòu)成資料保送鞘的漸細(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 可靠的保送保送系統(tǒng)的漸細(xì)頭端提供更可靠的保送

11、。- Page 11 -Interlock Occlusion System添加手術(shù)的靈敏性提供多種長(zhǎng)度、直徑和外形的彈簧圈,滿(mǎn)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 8cm30Interlock Fibered IDC Occlusion System:VORTX-18VORTX -18鉆石型纖毛鉑金彈簧圈雙尖端外形具有兩個(gè)小頭端,提高經(jīng)過(guò)性和加速栓塞雙尖端外形設(shè)計(jì)改善彈簧圈緊縮 兩個(gè)小頭端設(shè)計(jì)于閉塞中心血流312D HELICAL 纖毛彈簧圈遠(yuǎn)

12、端直徑為主要直徑的75% (1st 1.5 loops) 協(xié)助釋放和減少創(chuàng)傷性錨定才干設(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Interlock Fibered IDC Occlusion System:2D HELICAL32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)辰取出彈簧圈尤其適用于臨近大動(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)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

13、彈簧圈的優(yōu)勢(shì)35pull back可控彈簧圈的優(yōu)勢(shì)push36dense packing可控彈簧圈的優(yōu)勢(shì)deliver37可控彈簧圈的順應(yīng)證38可控彈簧圈的順應(yīng)證39可控彈簧圈的順應(yīng)證40突出可控彈簧圈的順應(yīng)證41導(dǎo)絲突出回撤1-2cm,然后再推送可控彈簧圈的順應(yīng)證42可控彈簧圈的順應(yīng)證43可控彈簧圈的順應(yīng)證醫(yī)生對(duì)于Interlock臨床運(yùn)用的反響: 動(dòng)脈瘤、假性動(dòng)脈瘤、 AVF、AVM、PAVM、GI Bleed, “維護(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)?Confidential. For Bost

14、on Scientific Internal Use Only. Do Not Copy or Distribute.The Fibered IDC Occlusion System is indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.Interlock Occlusion System 操作和釋放要點(diǎn)ONCM980 / 06/06 2006 Boston Scientific

15、Corporation or its affiliates. All rights reserved.一旦微導(dǎo)管到達(dá)需求栓塞的部位,留意堅(jiān)持微導(dǎo)管頭端與血管方向平行,不能垂直于需求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形狀,悄然的轉(zhuǎn)動(dòng)保送鞘平安鎖定安裝以解鎖,兩邊同時(shí)轉(zhuǎn)動(dòng),逆時(shí)針旋轉(zhuǎn)近端2-3圈將保送系統(tǒng)推入微導(dǎo)管接頭近端的魯爾接頭內(nèi)開(kāi)場(chǎng)繼續(xù)的肝素化 (通常,從加壓包內(nèi)繼續(xù)的每1-3秒鐘注入1滴)操作和釋放要點(diǎn)- Page 19 -ONCM980 / 06/06 2006 Boston Scientific Corporation or its affiliates. A

16、ll rights reserved.翻開(kāi)RHV的螺釘,小心地將Interlock System推進(jìn),直到保送鞘的遠(yuǎn)端嚴(yán)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,以免擠壓到保送鞘而 不能推送導(dǎo)絲。堅(jiān)持延續(xù)的灌注壓力。平穩(wěn)、延續(xù)地推進(jìn)導(dǎo)絲,將彈簧圈和保送導(dǎo)絲從保送鞘推到微導(dǎo)管內(nèi)。確保保送鞘堅(jiān)持在微導(dǎo)管接頭內(nèi),以防彈簧圈過(guò)早的釋放。一旦保送導(dǎo)絲近端顯露部分缺乏10cm時(shí),悄然地回撤和移出保送鞘。不要丟掉保送鞘,以防在完全釋放前需求回收彈簧圈。- Page 20 -操作和釋放要點(diǎn)續(xù)上一頁(yè)ONCM980 / 06/06 2006 Boston Scientific Corporat

17、ion or its affiliates. All rights reserved.彈簧圈保送(1-微導(dǎo)管不透射線標(biāo)志): 在顯影下推送彈簧圈直到互鎖臂間隔微導(dǎo)管遠(yuǎn)端的不透射線標(biāo)志約1cm。假設(shè)需求重新定位,在顯影下悄然地收回;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)志。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)ONCM980 / 06/06 2006 Boston Scientific Corporation or its affiliates. All rights reserved.需求重點(diǎn)關(guān)注和思索的要素:為了獲得更好的栓塞并減少

18、血栓并發(fā)癥的風(fēng)險(xiǎn),必需保證繼續(xù)的肝素化當(dāng)將保送鞘推至微導(dǎo)管接頭中時(shí),不要運(yùn)用過(guò)大的力。保送鞘頭端的變形會(huì)導(dǎo)致彈簧圈無(wú)法推出0.018彈簧圈必需在顯影下經(jīng)過(guò)0.021內(nèi)徑的微導(dǎo)管保送,且微導(dǎo)管必需有1-2個(gè)不透射線標(biāo)志點(diǎn)- Page 22 -操作和釋放要點(diǎn)2個(gè)不透射線標(biāo)志點(diǎn)的微導(dǎo)管1個(gè)不透射線標(biāo)志點(diǎn)的微導(dǎo)管假設(shè)需求重新定位,悄然地回撤。假設(shè)覺(jué)得難以重新定位,撤出并放棄該彈簧圈。悄然地推送導(dǎo)絲直到互鎖臂到達(dá)近端標(biāo)志點(diǎn),但先不要越過(guò)。假設(shè)越過(guò)近端標(biāo)志點(diǎn),互鎖臂就曾經(jīng)處在微導(dǎo)管體外,然后解鎖 (Figure 6).將互鎖臂推至間隔近端標(biāo)志點(diǎn)約1cm處 (Figure 5). 為防止過(guò)早的釋放,在預(yù)備好

19、釋放前,不要再往前推送導(dǎo)絲。Maneuver the Interlock 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 repositionin

20、g is necessary, gently retract the 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 i

21、nterlocking arms pass microcatheters 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 P

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

23、 Use for complete instructions on how to use this medical device.- Page 23 -Interlock Occlusion System Product Dimensions (from Proximal End): Delivery Wire: 175cm Introducer Sheath: 95cm Distal Tapered End: 1.3cm Occlusion Coil: Main Diameter & Restrained Length 2D Helical 3 14mm 6 30cm VortX Diamo

24、nd 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 the sheath in case it is necessary to remove the Interlock System prior to de

25、ployment.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 instructions on how to use this medical device.- Page 24 -Interlock Occlusi

26、on System In order to achieve excellent performance of the Interlock System and reduce the risk of thromboembolic complications, 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 intra

27、luminal device. Continuous flushing may: Reduce retrograde blood flow into the microcatheter and introducer sheath during 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.繼續(xù)沖

28、洗ONCM980 / 06/06 2006 Boston Scientific Corporation or its affiliates. All rights reserved.Steps to Basic Continuous 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

29、 of an appropriate flush solution. In general, one drop of flush solution every 1-3 seconds from a pressure bag containing 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

30、 microcatheter hub. Tighten the RHV thumbscrew just enough to prevent retrograde flow but not so tight as to pinch the 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 2

31、5 -廣泛的順應(yīng)證 完好的栓塞系統(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 維護(hù)性栓塞 外傷 精索靜脈曲張 Compatible Renegade Microcatheter Fathom MicroguidewireInterlock - 35Fibered IDC Occlusion System外形和尺寸Interlock -

32、35彈簧圈立體3D設(shè)計(jì) 允許for circumfrential wall apposition 和良好包裹才干內(nèi)臟血管動(dòng)脈瘤2D 螺旋理想的錨定由于這個(gè)彈簧圈的構(gòu)造經(jīng)常堅(jiān)持與血管壁的接觸 鉆石閉塞才干源自首尾尖端的彈簧圈直徑, 最大截面阻塞數(shù)目最長(zhǎng)最大134020數(shù)目最長(zhǎng)最大174020數(shù)目最長(zhǎng)最大63012Interlock 35 彈簧圈運(yùn)用5Fr的Imager II 造影管釋放,替代微導(dǎo)管 Interlock - 35 Coil 立體外形立體外形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。順應(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 AVM2D螺旋外

33、形彈簧圈用于提供優(yōu)化的錨定才干,由于螺旋外形保證彈簧圈與直形或漸細(xì)血管壁的繼續(xù)不變的接觸和貼壁。順應(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螺旋外形鉆石外形彈簧圈設(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。順應(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 鉆石外形本卷須知彈簧圈直徑假設(shè)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

34、大的彈簧圈需求栓塞的血管形狀和直徑,以及臨近分支血管的情況,都會(huì)決議彈簧圈的直徑和長(zhǎng)度Interlock - 35 Coil 外形的選擇Interlock - 35Fibered IDC Occlusion System互鎖臂設(shè)計(jì)Interlock 35 Fibered IDC Occlusion System經(jīng)過(guò)簡(jiǎn)單的互鎖將推送導(dǎo)絲和彈簧圈銜接起來(lái)互鎖銜接是一種簡(jiǎn)單的銜接,當(dāng)互鎖臂堅(jiān)持在保送系統(tǒng)內(nèi)時(shí),就會(huì)堅(jiān)持鎖定形狀I(lǐng)nterlock - 35 Coil Interlocking Arms-互鎖臂本卷須知: 不要過(guò)快的回收,或頂著阻力回收。這能夠?qū)е聫椈扇旎蚧ユi臂損壞在保送過(guò)程中,不要旋

35、轉(zhuǎn)保送導(dǎo)絲超越一圈360。過(guò)度的旋轉(zhuǎn)會(huì)損壞保送系統(tǒng)或?qū)е禄ユi臂在導(dǎo)管內(nèi)的解脫Interlock - 35Fibered IDC Occlusion System纖毛/纖維特征每個(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)血栓構(gòu)成滌綸纖維的特顯左圖顯示纖毛的構(gòu)造是有組織的,也有空隙,可快速構(gòu)成血栓 Interlock - 35 Coil Dacron Fiber: 纖毛的作用40cm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I(xiàn)nterlock - 35 Coil Dacron Fiber: 長(zhǎng)度和密度由于滌綸纖維的存在,適宜流量的沖洗必需堅(jiān)持繼續(xù)任務(wù)繼續(xù)沖洗

36、可以減少血液逆流至導(dǎo)管,減少造影劑結(jié)晶構(gòu)成的風(fēng)險(xiǎn),或彈簧圈及管腔內(nèi)血塊構(gòu)成的能夠通常,引薦從加壓袋中每1-3秒鐘注入1滴沖洗液肝素化生理鹽水留意:繼續(xù)沖洗過(guò)程中,確保不會(huì)有氣體進(jìn)入導(dǎo)管Interlock - 35 Coil Dacron Fiber: 繼續(xù)沖洗0.021.012ID of 5F Imager II Catheter 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 35 CoilInterlock 18 Coil 0.024 of free space 0.009of free spaceID of Renegade STC Catheter 0.021O

37、D of Platinum Coil primary windInterlockDacron Fiber: 繼續(xù)沖洗Interlock - 35Fibered IDC Occlusion System保送系統(tǒng)兼容性Interlock 35彈簧圈需在顯影下經(jīng)過(guò) 5F (0.035 0.89mm 或0.038 0.97mm 內(nèi)腔) Imager II造影導(dǎo)管保送.Interlock - 35 Coil 導(dǎo)管兼容性 Per DFU*Note: Physicians should exercise their clinical judgment in selection and use of cath

38、eters. Boston Scientific Corporation provides no warranty for use of third party catheters with its products. The use of other diagnostic catheters may result in an inability to deliver, deploy, or recapture the device.本卷須知:切記不要運(yùn)用柔軟的導(dǎo)管保送Interlock - 35 ,比如Terumo Glidecath Catheter;當(dāng)運(yùn)用柔軟導(dǎo)管保送Interlock

39、35時(shí),會(huì)覺(jué)得明顯的阻力?;鶞?zhǔn)測(cè)試丈量經(jīng)過(guò)導(dǎo)管推進(jìn)彈簧圈時(shí)所需的力,Lower Number = Less Force.彈簧圈不能經(jīng)過(guò)Terumo Glidecath Catheter. 運(yùn)用Cook Slip-Cath Catheter時(shí),需求額外的力量推進(jìn)Interlock - 35 Coil 導(dǎo)管兼容性 阻力測(cè)試Data on file at Boston Scientific. Testing data represents an average measurement taken across the range of available catheters. Test result

40、s shown are for models deemed most typically selected for placement in peripheral vasculature. Bench test results may not necessarily be indicative of clinical performance. TM基準(zhǔn)測(cè)試丈量擠壓導(dǎo)管時(shí)所需的力量,Lower number = Softer CatheterTerumo Glidecath是最柔軟的,然后是Cook Slip-Cath Catheter.導(dǎo)管硬度的數(shù)據(jù)與摩擦力數(shù)據(jù)匹配,闡明最柔軟的導(dǎo)管即是在彈簧

41、圈釋放過(guò)程中阻力最大的導(dǎo)管。Interlock - 35 Coil 導(dǎo)管兼容性 摩擦和柔軟度Data on file at Boston Scientific. Testing data represents an average measurement taken across the range of available catheters. Test results shown are for models deemed most typically selected for placement in peripheral vasculature. Bench test results

42、may not necessarily be indicative of clinical performance. 基準(zhǔn)測(cè)試丈量彎折導(dǎo)管時(shí)的彎曲半徑,Lower number = More Kink ResistantAngiodynamics Soft-Vu導(dǎo)管是最容易彎折的 當(dāng)導(dǎo)管彎折時(shí),彈簧圈就無(wú)法往前推送Interlock - 35 Coil 導(dǎo)管兼容性 摩擦力和打折Data on file at Boston Scientific. Testing data represents an average measurement taken across the range of av

43、ailable catheters. Test results shown are for models deemed most typically selected for placement in peripheral vasculature. Bench test results may not necessarily be indicative of clinical performance. TMNo VoidVoidImager II CatheterImager II導(dǎo)管顯示了從導(dǎo)管接頭到導(dǎo)管腔的平滑過(guò)渡 平滑的過(guò)渡提高了彈簧圈從保送鞘到導(dǎo)管的過(guò)渡這種特性是消費(fèi)過(guò)程中的嚴(yán)厲監(jiān)視和

44、檢查決議的Competitive CatheterCordis Tempo導(dǎo)管的測(cè)試結(jié)果顯示,20%的導(dǎo)管其接頭到管腔的過(guò)渡存在明顯的空隙空隙的存在影響了彈簧圈從保送鞘到管腔的過(guò)渡Images property of Boston ScientificInterlock - 35 Coil 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(lèi)型兼容性?備注5F Imager II 造影管兼容我們控制規(guī)格!5F Cordis Tempo CatheterYes我們不能控制規(guī)格。5F Cordis Tempo Aqua CatheterYes我們不能控制規(guī)格。5F Angio

45、dynamics SoftVu CatheterYes我們不能控制規(guī)格。5F Cook Slip-Cath CathetersYes/No很難推動(dòng)5F Terumo Glidecath CatheterNoNever try!Imager II 造影管是最正確選擇123全線產(chǎn)品引薦,不要關(guān)注特定彈簧圈讓手術(shù)選擇彈簧圈猶疑時(shí),運(yùn)用0.018 準(zhǔn)確: 可解脫彈簧圈潛在的優(yōu)勢(shì) 力度: 濃密纖維和長(zhǎng)度的奉獻(xiàn) 精度: 多種外形,多種直徑,018 或 035系列 038: 運(yùn)用0.038 Imager II 造影管開(kāi)場(chǎng)手術(shù) 035: 假設(shè)診斷性造影管已導(dǎo)入,請(qǐng)運(yùn)用0.035彈簧圈 018: 假設(shè)未提早建立

46、通路,運(yùn)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(gè)原那么!Interlock - 35 Coil and Interlock 18 CoilWhat are the Differences?Platinum/DacronPlatinum/Dacron14mm/30cm20mm/40cm2D, Diamond2D, Diamond, Cube0.0165in, 175cm, Silicone coated0.0355in, 150cm, PTFE coatedOnly

47、 0.021in ID microcatheterOnly BSC 5F Imager II (0.035in or 0.038in GW compatible)直徑/長(zhǎng)度外形保送導(dǎo)絲Product GuideInterlock 18 CoilInterlock 35 Coil彈簧圈/纖毛導(dǎo)管兼容性?xún)?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(zhǎng)度,增加了輸送阻力使用5F Imager II,持續(xù)沖洗中等致血栓性?xún)?yōu)秀纖毛數(shù)量多50%,減少閉塞時(shí)間盡量減少?gòu)椈扇︶尫徘霸趯?dǎo)管外的時(shí)間中等錨定優(yōu)秀錨定徑向力高30倍左右不

48、推薦彈簧圈直徑超過(guò)血管直徑太多填充性能保送性能致血栓性能錨定性能產(chǎn)品特性Interlock 018 CoilInterlock 035 CoilKey Interlock - 35 Coil PointsInterlock 18CoilInterlock 35Coil40%60%90%10%75%25%35%65%60%40%10%90%30%70%30%70%60%40%產(chǎn)品銷(xiāo)售: 035 Focus?GI VaricesAVMHypogastricVaricoceleGI BleedGDASplenicPCSEndoleaks臨床病例80Interlock - 35 Coil Clinic

49、al Success Example Angiogram of Large (3cm) Splenic Artery Aneurysm located in the proximal third of Splenic Artery 11A long, angled 6F Cook Sheath was placed at the origin of the Celiac artery.22A C2 Cook Beacon Tip Catheter was used to obtain a selective angiogram of the splenic artery.3A 0.035 Gl

50、idewire Guidewire was advanced distal to the aneurysm.4The Beacon Tip Catheter was removed and a GlideCath Catheter was pushed over the wire distal to the aneurysm.345The Glidewire Guidewire and GlideCath Catheter combination was advanced as far distally as possible.56The 6F sheath was advanced into

51、 the proximal splenic artery, just proximal to the origin of the aneurysm.681Interlock - 35 Coil Clinical Success Example Coil Nest in distal splenic artery, occluding the outflow from a large 3cm aneurysm 11The GlideCath Catheter was removed and a 5F Imager II BERN was pushed over the wire into the

52、 distal splenic vasculature.22Four Interlock 35 Coils (two 10 x20, two 12x20 2D) were placed within and just proximal to the first major turn in the distal splenic artery. Continuous flush was utilized and no friction was encountered.3A number of short pushable coils were squirted into the scaffoldi

53、ng created by the Interlock Coils. Pushable coils were chosen because of the hosptials lack of inventory of Interlock 35 Coil. 4The final two units of Interlock 35 Coils (12x40) that the hospital had were used to loosely pack the aneurysm sac.3482Interlock - 35 Coil Clinical Success Example 11With n

54、o Interlock 35 Coils available, the account determined that the 6F sheath would be adequate to place an Amplatzer II Vascular Plug.22Although the vessel diameter was measured to be 8mm, the largest 6F compatible Plug that was on the shelf was a 10mm diameter.NOTE: The Amplatzer II Vascular Plug shou

55、ld be oversized by 30-50%.3When the Amplatzer II Vascular Plug was initially deployed, difficulty was encountered detaching it, as it requires adequate wall apposition to unscrew. 4After a number of attempts, the plug did detach, but did very little to disrupt flow into the aneurysm.34Coil Nest in d

56、istal splenic artery, occluding the outflow from a large 3cm aneurysm 83Interlock - 35 Coil Clinical Success Example Final angiogram of completed embolization of splenic artery aneurysm 11As a result of persistant forward flow, the Amplatzer II Vascular Plug was used as a distal backstop for additio

57、nal fibered coils.22An additional eight 0.035 fibered platinum pushable coils were injected into the proximal inflow.3Following deployment of the additional coils, forward flow was stopped within the aneurysm sac and beyond the distal outflow.4Arterial flow was diverted around the proximal splenic a

58、neurysm and into the parcreatic vascualture above.34Abbreviated StatementsInterlock - 35 Fibered IDC Occlusion SystemCAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.INTENDED USE/INDICATIONS FOR USE: The Interlock 35 Fibered IDC Occlusion System is a modifie

59、d interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.CONTRAINDICATIONS: None known.WARNING: Compatibility with Magnetic Resonance Imaging (MRI) has not been established, and the degree of im

60、aging distortion resulting from the coil has not been measured.ADVERSE EVENTS: Complications related to catheterization (e.g., hematoma at the site of entry, clot formation at the tip of the catheter and subsequent dislodgement, nerve and vessel dissection or perforation) Pain Hemorrhage Infection n

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