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1、文件更改号更改申请人更改后版本日 期X12013-05-091.0 Purpose 目的The purpose of this protocol is to establish a test method and acceptance criteria to verify the design of thrombus retriever. Through testing all of the samples whether comply with the enterprise standard, to approve the design rationality of product char
2、acteristics.该方案的目的是建立取栓器验证设计的测试方法和接收标准。通过测试样品是否满足企业标准的要求来验证取栓器产品设计是否合理。2.0 Scope 范围This protocol just covers the retriever shaped section samples manufactured by Laserage and the assembled finish product thereout.该方案仅覆盖由Laserage加工的取栓网架及由此组装的取栓器成品。3.0 User Needs用户需求根据DDD1001000取栓器设计描述文件中对于用户需求中关于功能要求
3、、性能要求和可靠性要求等方面的规定来制定本验证测试方案。Catalog 项目User Need 用户需求Design Input 设计要求1. 功能要求功能需求定义了产品的性质和用途产品尺寸：取栓网架正常状态下的直径应能适合血管的内径根据血管直径设计取栓网架标准直径，分别涵盖3,4,5,6mm的血管直径取栓网架自膨胀后的长度应能包含血栓的整体根据血栓长度，将取栓网架可用长度设计成15-30mm 等几个规格取栓网架压缩状态下的直径应能放入输送导管内取栓网架压缩后的直径小于0.017”或0.021”取栓器应能将血栓顺利取出取栓网架的网孔尺寸设计成适中取栓网架远端应封闭，使用过程中应不使血栓碎块逃逸
4、整个产品的长度应能使取栓网架到达病灶区产品整体长度设计成180cm以上取栓器应具有推送性能推送金属丝具有一定的支撑力，近端直径设计成0.4mm取栓器应能抗折推送金属丝具有一定强度，远端直径设计成渐变推送金属丝采用镍钛丝等不易折弯的材料2. 性能要求性能要求指定多少或有设备必须履行它的功能。取栓网架应能轻易通过弯曲的血管设计采用0.02-0.1mm直径的镍钛丝或以上壁厚的镍钛管以增加柔顺性取栓网架在取栓过程中应对血管壁产生尽可能小的损伤设计对取栓网架进行电解抛光，去除毛刺设计对取栓网架表面涂覆亲水涂层，减少对血管壁的磨损设计取栓网架的径向支撑力应适中取栓网架在X光下应能清晰的显影取栓网架远端和近
5、端设计3-4个铂金金属环取栓网架推出微导管后应能自膨胀采用超弹性材料镍钛合金制作取栓网架外观要求：产品应整洁，无污渍应在进货检验或半成品检验中加入外观检验要求金属件表面应无锈蚀痕迹金属材料均采用镍钛，不锈钢等材料要求：材料应满足生物相容性要求取栓网架采用镍钛合金推送金属丝设计采用镍钛合金盘管设计采用PE材料显影环设计采用铂金材料保护套设计采用PTFE材料运动要求：取栓器使用时在微导管内前后运动应灵活取栓器尺寸应与微导管匹配取栓器应与其他公司的微导管尺寸匹配，在其中运动应无阻力7. 可靠性要求取栓器产品在使用过程中不允许失效，也不允许遗落任何异物在人体血管内取栓支架与远端显影弹簧圈的连接力需大于
6、3N取栓支架与近端显影环的连接力需大于3N推送金属丝与近端显影环的连接力需大于3N支撑弹簧圈与推送金属丝的连接力应大于3N支架本身镍钛丝的连接力强度需满足企业标准要求应能承受极限工作条件而不断裂4.0 Reference Documents参考文献Listed below are the supporting documents applicable to the preparation of this protocol, as well as procedures to follow during execution of the protocol.Q/TFOV 5-2013 Enterpr
7、ise Standard of Presgo Thrombus retrieverDDD1001000 Design Description Document for Thrombus retrieverFMEA1001000 Failure Mode and Effect Analysis for Thrombus retrieverPPL1001000 Instructions for Use of Thrombus retrieverLHR Lot History Record of Thrombus retrieverMPI1001001 Flow Chart for Thrombus
8、 Retriever5.0 Acceptance Criteria接收标准All samples for this verification test should meet the predetermined specifications and the requirement specified in the enterprise standard.本次测试方案的所有样品应满足预设的规格及企标中指定的要求。6.0 Material & Equipment物料设备Scale卷尺Micro caliper 千分尺Tensile test machine 拉力测试机Micro catheter
9、微导管0.017”Simulation aneurysm model 动脉瘤模型7.0 Samples to be tested 测试样品规格The specification tested in this verification is FG1001800-0420, the detailed information is shown as below: the retriever shaped section is open, the diameter is 4mm and the effective length is 20mm, the total length of thrombus
10、 retriever is 180cm.本次测试的样品规格为FG1001800-0420，表示取栓网架为远端开放式的，取栓网架的直径为4mm，可用长度为20mm，取栓器的整体长度为180cmThe samples used in this test are the most representative product; the diameter and effective length of retriever shaped section are the median among the whole specifications.此次的测试样品为最具代表性的规格，其取栓网架的直径和可用长度
11、均为整个规格的中值。Refer to the requirement of Flow chart MPI1001000 and Lot history record to make the samples, and test after sterilization.按取栓器流程图草案MPI1001001和LHR草案的规定制作此次样品，经灭菌后用于本次测试。8.0 Verification Test Processing验证测试方法This verification test protocol will include following contents:本测试方案包含以下内容8.1 Phys
12、ical dimension measurement of retriever shaped section and other components取栓网架和其他部件的物理尺寸测量The purpose of this test is to ensure that the dimension of the samples comply with the enterprise standard or the predetermined specifications. The testing items and criteria refer to the Figure 1 & table 1本项
13、测试的目的是为了确认样品的尺寸是否满足企业标准和预设的规格的要求，测试项目和接收标准参见图1和表1 Fig. 1 Presgo Thrombus RetrieverTable 1 Dimension test items and acceptance criteriaDimension test itemsAcceptance criteriaTotal length of Thrombus Retriever (L1)18010cmTotal length of Retriever shaped section (L2)322mmEffective length of Retriever s
14、haped section (L3)202mmStruts width of Retriever shaped section (L4)0.0550.01mmDistance from proximal marker to detachment zone (L5)311mmDetachment zone (L6)0.30.1mmOuter diameter of Retriever shaped section D1)4.00.5mmInternal diameter of Retriever shaped section (D2)3.80.5mmOuter diameter of Push
15、wire (D3)0.40.05mmOuter diameter of proximal marker (D4)0.0155Note: The inspection method of the Retriever shaped section dimension shall be complied with the requirement as below:注：取栓网架的尺寸测量方法应满足以下要求：Use non-contact measuring equipment which resolution is 0.1mm or more higher to inspect the dimensi
16、on of the Retriever shaped section as listed in table 1: the dimension of L2, L3, L4, L5, L6, D1, D2 and D4. Inspector shall measure both sides and middle of the Retriever shaped section and in two directions perpendicular to each other, each dimension shall be measured 3 times and take the average.
17、通过分辨率达0.1mm或更高的非接触性仪器测量取栓网架表1中所列的如下尺寸：L2, L3, L4, L5, L6, D1, D2 和 D4。测量时，应选择取栓网架的两端及中部，并在相互垂直的两个方向上测量，每个值应测量3次，并取其平均值。8.2 Visual inspection 外观检测The purpose of this test is to observe the surface of the components of Thrombus Retriever to meet the enterprise standard. The testing items and criteria
18、refer to table 2本项测试的目的是观察取栓器各部件的外观是否满足企业标准的要求，测试项目和接收标准参见表2Table 2 Visual inspection items and acceptance criteriaTest itemsAcceptance criteriaAppearance of Retriever shaped section取栓网架内外表面无毛刺，无焦痕，连接处无断裂 No burrs and scorch on inside and outside surface, no disrupt at jointAppearance of metal compo
19、nents各金属件表面无油污、锈迹等 No grease and rust on surface of metal componentsAppearance of plastic components各塑料件表面应透明并无黑点等异物 No black spot and any foreign bodies on surface of plastic components8.3 Flexibility 柔顺性The purpose of this test is to verify the flexibility of the delivery system and the performanc
20、e when the thrombus retriever going through the curved vessel.本项测试的目的是考察输送系统和取栓器介入手术时在血管内的弯曲能力，通过弯曲血管结构的能力。Curve the 0.017” Micro catheter to six tangent circles, each circle diameter is 50mm, and connect the rotating hemostatic valve to Luer lock connector of Micro catheter. Push forward the thromb
21、us retriever into Micro catheter, and it can pass through Micro catheter smoothly, or the maximum resistance force should be similar to the competitors. The acceptance criteria refer to Table 3.将0.017”的微导管弯曲成6个相切的直径为50mm的圆圈，在微导管鲁尔接头上连接旋转止血阀，导入取栓器样品，应能顺利通过微导管。其最大推送力应和竞争对手产品的相差不大，接收标准见表3Table 3 Flexib
22、ility of delivery into Micro catheterTest itemsAcceptance criteria取栓器在通过弯曲的微导管时的最大阻力 Maximum resistance force when the Thrombus retriever going through the curved Micro catheter取栓器推进过程中应无阻力或与竞争对手产品的相差不大 Feel small resistance force during delivery thrombus retriever or the force is similar to the com
23、petitors8.4 Recoil ratio 回缩率The purpose of this test is to verify the performance of adherence to the vessel wall.本测试项目的目的是考察取栓网架的贴壁性。Measure the diameter (D before) of retriever shaped section before withdraw it into the Protective tube, and after place three days stretch it out of the Protective t
24、ube, then measure the diameter (D after) again, the measurement method refer to 7.1; After that, calculate the recoil ratio refer to the following formulaRecoil Ratio（%）= (D before D after ) / D before X 100%The acceptance criteria refer to Table 4.先测量取栓网架回缩入保护套管前的直径D before，然后将取栓网架缩入保护套管，放置3天后取出再测量
25、其直径Dafter，测量方法参照7.1，计算其前后的变化率。接收标准见表4.Table 4 Recoil ratio before and after in Protective tubeTest itemsAcceptance criteria取栓网架放置在保护套管前后的直径变化The diameter variation of retriever shaped section before and after placement in Protective tube回缩率值小于10%Recoil ratio 10%8.5 Compression force 压缩力The purpose o
26、f this test is to measure the pulling force when the retriever shaped section withdrawn into Protective tube, to reckon up the force to vessel wall when it self-expanding.本测试项目的目的是考察取栓网架压入保护套管的拉力，推算其在血管中扩张的弹力。Fix the proximal of Push wire on the test-head of tensile test machine, place Protective tu
27、be in the distal of Push wire, and smoothly withdraw the The shaped section into Protective tube, record the maximum pulling force as well during this process.将推送金属丝的近端固定在拉力测试机的测试头上，保护套管放置在推送金属丝的远端，将取栓网架慢慢地拉入保护套管，记录在此过程中的最大拉力。接收标准见表5Table 5 Compression force during withdrawing into Protective tubeTe
28、st itemsAcceptance criteria将取栓网架拉入保护套管的最大拉力The maximum pulling force withdraw the retriever shaped section into Protective tube小于1NCompression force1N与竞争对手的产品比较Compare with the competitors product8.6 Radoipacity 射线可探测性The purpose of this test is to observe whether the radiopacity components displaye
29、d under DSA is clear or not.本测试项目的目的是为了考察取栓器前后两端显影部件在数字减影造影机（DSA）的照射下的显影是否清晰可辨。Place the distal 60-100mm portion of Thrombus retriever within the scope of DSA, and observe the radiopacity components on the DSA display, compare clarity with the competitors.将取栓器远端约60-100mm部分置于DSA照射范围内，在显示器上观察其显影情况，与竞争
30、对手的产品比较其清晰度。接收标准见表6Table 6 Radiopacity under DSATest itemsAcceptance criteriaDSA下显影部件的显影情况The situation of radiopacity components under DSA与竞争对手的产品比较Compare with the competitors product8.7 Joint strength 连接强度The purpose of this test is to verify the joint strength of every connecting components to p
31、revent the Thrombus retriever from falling off or device shift.本测试项目的目的是为了考察各连接部分的结合强度，防止取栓器在使用过程中脱落或移位。Fix the following connector of Thrombus retriever separately on the test-head of tensile test machine: the joint of The shaped section and Radiopacity coil, the joint of The shaped section and Rad
32、iopacity ring, the joint of Radiopacity ring and Push wire, test the samples with the speed of 100mm/min and record the maximum pulling off force.将取栓器的以下各连接部分：显影弹簧圈与取栓网架的连接处、取栓网架与显影环的连接处、显影环与推行金属丝的连接处，将其分别夹紧在拉力测试机的测试头上，以100mm/min的速率测试，记录其拉脱的力。接收标准见表7Table 7 Joint strengthTest itemsAcceptance criteri
33、a显影弹簧圈与取栓网架的连接力Joint strength of The shaped section and Radiopacity coil3.0N取栓网架与显影环的连接力Joint strength of The shaped section and Radiopacity ring3.0N显影环与推行金属丝的连接力Joint strength of Radiopacity ring and Push wire3.0N8.8 Corrosion resistance 耐腐蚀性The purpose of this test is to evaluate the corrosion ris
34、k of each metal component in human body.本测试项目的目的是为了评估取栓器的各金属部件在人体液中的腐蚀情况。Immerse the metal components into the Nacl solution and after 5 hours placement, furthermore drop into boiling distilled water for 30 minutes, after that, cool them to 37 and keep for 48 hours, take out the metals and dry at th
35、e room temperature, then inspect the corrosion condition by naked eyesight.将金属部件浸入氯化钠溶液中，室温下放置5小时后，再浸入沸腾的蒸馏水中持续30分钟，再将蒸馏水和金属件冷却至37，保持48小时，取出金属件在室温下干燥后，以目力检查金属件的腐蚀痕迹。接收标准见表8Table 8 Corrosion resistance of metal componentsTest itemsAcceptance criteria按YY 0450.1中附录B的方法试验Test according to the method in
36、YY 0450.1 Annex B无腐蚀痕迹，或有腐蚀痕迹但经擦拭可除去No rust, or have corrosion pit but can be removed by wiping8.9 Delivery system kink test 输送系统的抗折测试The purpose of this test is to verify the kink resistance of delivery system during advanced and withdrawn in Micro catheter.本测试项目的目的是为了考察取栓器输送系统在导管中前进后退时是否会出现打折现象。Cu
37、rve an ID 0.017” Micro catheter to a 5mm circle, refer to Fig.2, and advance the distal 60-100mm portion of Thrombus retriever through the circle and observe whether kink exit or not.将一根内径为0.017”的微导管远端弯曲成直径为5mm的圈，参见附图2，然后将取栓器远端约60-100mm部分通过此圈，取出后查看其有无打折情况。接收标准见表9Fig. 2 Curve the Micro catheter to a
38、circleTable 9 Kink resistance of delivery systemTest itemsAcceptance criteria输送系统的抗折测试Delivery system kin test无打折现象No kink8.10 Torque and Tensile durability 抗扭矩测试The purpose of this test is to measure the torsion angle of the delivery system of Thrombus Retriever when the distal of retriever shaped
39、section rotate to a certain angle, and ensure that no friction should be found during torsion.本测试项目的目的是为了确定取栓器远端旋转特定角度时，近端需要旋转的角度值，并确认在扭转过程中取栓器任何部件未发生断裂。Fill the tortuous simulation aneurysm model with 37 2 saline, and advance an ID 0.017” Micro catheter to the position which ID is about 3mm, then c
40、lockwise rotate Push wire to make retriever shaped section rotate 90 degrees, record the rotation angle of Push wire.将37 2的生理盐水注入弯曲的动脉瘤模型，然后将微导管推到内径为3mm左右的弯曲程度比较大的位置，顺时针扭转输送金属丝使远端取栓网架旋转90，测量此时输送金属丝旋转的角度。接收标准见表10Table 10 Torque and tensile durabilityTest itemsAcceptance criteria抗扭矩测试Torque and tensil
41、e durability使取栓网架旋转90时，输送金属丝需要旋转的角度Record the rotation angle of Push wire when the retriever shaped section rotate 90 degrees8.11 Delivery friction test in Micro catheter 微导管内输送摩擦力测量The purpose of this test is to evaluate the delivery performance by smoothly advancing the Thrombus retriever through
42、the relative Micro catheter.本测试项目的目的是为了确认取栓器是否能在相应的微导管内顺利地被输送。Advance the Thrombus retriever into an ID 0.017” Micro catheter at a speed of 100mm/min, and verify whether it can be moved smoothly, meanwhile, record the maximum friction during this process, and compare with the competitors.将取栓器以100mm/
43、min的速率推入内径为0.017”的微导管，验证其是否可以顺利地输送，并记录在此过程中的最大摩擦力，并与竞争对手样品比较。接收标准见表11Table 11 Delivery friction testTest itemsAcceptance criteria输送摩擦力测量Delivery friction test最大摩擦力小于3NMaximum friction 3.0N与竞争对手的产品比较Compare with the competitors product8.12 Delivery performance in simulation aneurysm model 动脉瘤模型中的输送性能
44、测试The purpose of this test is to evaluate the delivery performance by advancing Thrombus retriever to the appointed position of simulation aneurysm model.本测试项目的目的是为了确认取栓器是否能在动脉瘤模型内被顺利地输送到指定位置。Fill the tortuous simulation aneurysm model with 37 2 saline, and advance an ID 0.017” Micro catheter to the
45、 position which ID is about 3mm and a little tortuous, draw and pull Thrombus retriever for 10 times.将37 2的生理盐水注入弯曲的动脉瘤模型（Fig.3），然后将微导管推到内径为3mm左右的弯曲程度比较大的位置，随后将取栓器在微导管中前后抽拉10次。接收标准见表12。Fig.3 Simulation aneurysm modelTable 12 Delivery performance in simulation aneurysm modelTest itemsAcceptance crite
46、ria抽拉10次后取栓器是否有打结Knot inspection after 10 times drawing and pulling未发现打结No knot can be found抽拉10次后是否有部件脱落Fall off inspection after 10 times drawing and pulling无任何部件No fallen component can be found8.13 Simulation thrombectomy test in vitro 体外模拟取栓测试The purpose of this test is to evaluate the performan
47、ce of Thrombus retriever by operating simulation thrombectomy in vitro.本测试项目的目的是为了验证取栓器体外模拟取栓的效果。Procedure of simulation thrombectomy in vitro as below:1) Use thrombin to make thrombus in vitro: take 2mL fresh venous blood to inject into a cuvette, and add low （25u/ml）concentration of thrombin-containing solution, after vortex, place it in water bathes at 37 for 3hours，then the thrombus will be formed by coagulation process; then use different spec syringe needle to make various of diameter and le
