心脏辅助器械发展中英文

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医疗设备英语中英对照

医疗设备英语中英对照1 Myo-electric potential /evoked potential meter肌电/诱发电位仪2 fetal monitor胎儿监护仪3 digital imaging colposcope 数字成像阴道镜4 patient monitoring system 监护系统5 Coblation Plasma Surgery System低温等离子消融治疗仪6 IF Interference currency therapeutic Unit中频干扰电治疗仪7 Central Monitoring System中央监护系统8 Portable multi-parameter monitor便携式多参数监护仪9 MRI(magnetic resonance imaging) system磁共振成像系统10 CT （Computed (axial) Tomography）计算机X线断层摄影术11 X-ray Machine X射线机12 Color Ultrasonic 彩色超声波13 permanent-magnet open MRI system永磁开放式磁共振成像装置14 non-eddy current magnet无涡流磁体15 dynamic ECG动态心电图16 Spiral CT Scanner螺旋CT扫描机17 Full-body CT 全身CT机18 Open bore MR开放口径磁共振19 super high-field MRI超导高场20 Rotating /Rotary Viscometer 旋转式粘度计21 medical testing instrument and equipments 医用检测仪器及设备22 Bechtop超净工作台23 hemorrheology血液流变学24 Platelet Aggregation/Coagulation Analyzer血小板聚集凝血因子分析仪25 Blood Cell Deformation/Aggregation Analyzer血细胞变形/聚集测试仪26 Urine Sediments Microanalyzer尿沉渣显微分析仪27 blood flow rheometer 血流变仪28 X-ray diagnostic equipment X射线诊断设备29 Dental units 牙科仪器30 large-scale angiocardiography system 大型血管造影31 intervention treatment system介入治疗系统32 HF digital Gastrointestinal diagnostic system高频数字胃肠诊断系统33 direct digital imaging system直接数字成像系统34 Doppler spectrum analyzer 多普勒频谱分析器35 Computed & Remote-controlled X-ray diagnostic machine程控遥控医用诊断X射线机36 Magnetic Resonance Imaging System磁共振成像系统37 Comprehensive Dental unit牙科综合治疗机38 Autogenous Blood Recovery Unit自体血液回收机39 remote sensing 遥感40 telemetering 遥测41 He & Ne Laser intravascular irradiation therapeutic unit氦氖激光血管内照射治疗仪42 disposable optical fiber needle一次性使用光纤针43 semiconductor laser therapeutic unit, 半导体激光治疗仪44 optical fiber couplers光纤耦合器45 Laser Sitz bath chair 激光坐浴机46 low- intensity He[-Ne laser intravascular irradiation therapeutic unit47 低强度氦氖激光血管内照射治疗仪48 dressing 敷料49 Disposable Sterile Injector一次性使用无菌注射器50 Disposable venous Needle一次性使用静脉输液针51 Disposable Delivery Kit(operation package ,induced abortion) 一次性使用产包（手术包，人流包）52 Disposable mask and cap一次性口罩，帽子53 Disposable Sterile Hypodermic Needle一次性使用无菌皮下注射针54 Disposable Infusion Set一次性使用输液器55 disposable surgical pad一次性手术洞巾56 disposable surgical gown一次性使用手术衣服57 Gauze Bandage纱布绷带58 medical cotton bud医用棉签59 Universal Operating Table多功能手术床60 intervention treatment介入诊疗手术床61 Catheterization Operating Table 导管手术台62 Microsurgical Operating Table显微外科手术床63 Orthopedics Operating Table骨科手术床64 Orthopedics Navigation Operating Table骨科导航手术床65 carbon fibre material碳纤维复合材料66 Catheterization table 导管台67 catheter guide 导尿管导引器，68 catheter introducing forceps 麻醉导管导引钳.69 catheterization 导管插入术.70 catheterization table 导管台.71 catheter mandrin 导尿管导引针.72 catheter needle 导管针73 go-cart 病人移送车74 360°Rotatory Digitalized Cradle 360度可旋转数字摇篮床75 digital perspective bed 数字透视床76 infrared mammary diagnostic device (portable) 红外乳腺检查仪轻便型77 Infrared, B-ultrasonic mammary diagnostic systems红外B超联合乳腺诊断系统78 medical image-processing system医学影像处理系统79 mammary treatment unit乳腺治疗仪80 Emission Computed Tomography发射体层成像81 Single Photon Emission Computed Tomography单光子断层造影SPECT82 Positron tomography正子断层造影设备83 transmission computed tomography透射式计算机断层（TCT/XCT）84 computerized cerebrovascular comprehensive therapeutic unit 电脑血管综合诊断仪85 line array线阵86 foldaway翻盖87 concave array凹阵88 convex array凸阵89 trolley推车90 Laser therapeutic unit激光治疗仪91 Injection Pump注射泵92 Insufflator气腹机93 single-lens photography/video system单镜片摄像系统94 halogen cold light source 卤素冷光源95 pulmonary function testing system肺功能测量系统96 automatic pulmonary function analyzer自动分析肺功能仪97 HF electrotome高频电刀98 Spirometers 肺活量计99 Spectrophotometer分光光度计100 vertical purified operating table垂直净化工作台101 disk polarimeter圆盘旋光仪102 refractometers折射仪103 Centrifuges离心机、104 spectrophotofluorometer荧光分光光度计105 Constant temperature &freezing microtome恒温冷冻切片机106 infrared elliptical polarized spectrograph红外椭圆偏振光谱仪107 Laser Hemacytometer 激光血球计数仪108 Fluorophotometer荧光光度计109 fluoroscope 荧光屏110 converted biological microscope倒置生物显微镜111 biological microscope with Color T V Screen彩色电视生物显微镜112 biological microscope生物显微镜113 Lab biological microscope实验室生物显微镜114 Transmitted Polarization Microscope透射偏光显微镜115 Metallurgical Phase Microscope大型金相显微镜光学系统116 biological microscope 生物显微镜117 cryostats低温控制器118 stereoscopic microscope立体显微镜119 aerial survey instruments 航测仪器120 Microwave Therapeutic Unit微波治疗仪121 Radionuclide activity measuring equipment放射性核素活度测量仪122 Battery Automatic Testing Equipment自动电池测试仪123 X-ray cassette X射线暗盒124 X-ray tube X射线球管125 X-ray protective clothes X射线防护衣126 Transparent protective screen 全透明型防护屏127 X-ray intensifying screen X射线增感屏128 automatic film-developing machine自动洗片机。

中英对照——心血管器械

---------------------------------------------------------------最新资料推荐------------------------------------------------------中英对照——心血管器械心血管器械心血管器械 Cardiovascular Devices 节号中译文原英文 A 亚部总则（General Provisions） 870.1 范围 Scope 870.3 有关上市前批准生效日期的要求Effective dates of requirement for premarket approval 870.9 联邦食品、药品和化妆品法（Federal Food, Drug, and Cosmetic Act， FDCA）第 510（k）节的豁免限制 Limitations of exemptions from section 510（k） of the Federal Food, Drug, and Cosmetic Act （the act）B 亚部心血管诊断器械（Cardiovascular Diagnostic Devices）870.1025 心律失常探测器和警报器（包括 ST段测量和警报）Arrhythmia detector and alarm （including ST-segment measurement and alarm） 870.1100 血压警报器 Blood pressure alarm 870.1110 血压计算机 Blood pressure computer 870.1120 血压袖带 Blood pressure cuff 870.1130 非侵入式血压测量系统Noninvasive blood pressure measurement system 870.1140 静脉血压计 Venous blood pressure manometer 870.1200 诊断用血管内导管 Diagnostic intravascular catheter 870.1210 连续式冲洗导管 Continuous flush catheter 870.1220 电极记录导管或电极记录探针 Electrode recording catheter or electrode recording probe 870.1230 光纤式血氧计导管Fiberoptic oximeter catheter 870.1240 导流导管 Flow-directed catheter 870.1250 经皮导管1 / 8Percutaneous catheter 870.1270 腔内心音导管系统Intracavitary phonocatheter system 870.1280 可操纵导管Steerable catheter 870.1290 可操纵导管控制系统Steerable catheter control system 870.1300 导管套管 Catheter cannula 870.1310 经皮插入导管用的血管扩张器Vessel dilator for percutaneous catheterization 870.1330 导管导线Catheter guide wire 870.1340 导管插入器 Catheter introducer 870.1350 导管球囊修理工具盒 Catheter balloon repair kit 870.1360 示踪微球体 Trace microsphere 870.1370 导管尖端封闭器 Catheter tip occluder 870.1380 导管探针 Catheter stylet 870.1390 套管针Trocar 870.1425 可编程的诊断用计算机Programmable diagnostic computer 870.1435 预编程的单功能诊断用计算机Single-function, preprogrammed diagnostic computer 870.1450 光密度计Densitometer 870.1650 血管造影注射器和注射管Angiographic injector and syringe 870.1660 指示剂注射器Indicator injector 870.1670 注射器的注射管制动器 Syringe actuator for an injector 870.1750 体外可编程起搏器脉冲发生器External programmable pacemaker pulse generator 870.1800 抽缩式输液泵Withdrawal-infusion pump 870.1875 听诊器Stethoscope 870.1915 热稀释探头 Thermodilution probe C 亚部心血管监测器械（Cardiovascular Monitoring Devices） 870.2050 生物电位放大器和信号调节器 Biopotential amplifier and signal---------------------------------------------------------------最新资料推荐------------------------------------------------------ conditioner 870.2060 传感器信号放大器和调节器 Transducer signal amplifier and conditioner 870.2100 心血管血液流量计Cardiovascular blood flowmeter 870.2120 血管外血流探头Extravascular blood flow probe 870.2300 心脏监测器（包括心率计和心率警报器） Cardiac monitor （including cardiotachometer and rate alarm） 870.2310 尖端心动描记器（心振动图仪） Apex cardiograph （vibrocardiograph）870.2320 心冲击描记器Ballistocardiograph 870.2330 超声波心动图仪Echocardiograph 870.2340 心电图仪Electrocardiograph 870.2350 心电图仪导线转换接合器 Electrocardiograph lead switching adaptor 870.2360 心电图仪电极 Electrocardiograph electrode 870.2370 心电图仪表面电极检测器Electrocardiograph surface electrode tester 870.2390 心音图仪 Phonocardiograph 870.2400 心电向量图仪 Vectorcardiograph 870.2450 医用阴极射线管显示器Medical cathode-ray tube display 870.2600 信号隔离系统Signal isolation system 870.2620 在线隔离监视器 Line isolation monitor 870.2640 便携式漏电流警报器 Portable leakage current alarm 870.2675 动脉搏动描记器Oscillometer 870.2700 光电血氧计Oximeter 870.2710 耳光电血氧计 Ear oximeter 870.2750 阻抗式静脉搏动描记器Impedance phlebograph 870.2770 阻抗式体积描记器3 / 8Impedance plethysmograph 870.2780 水压式、气动式或光电式体积描记器Hydraulic, pneumatic, or photoelectric plethysmographs 870.2800 医用磁带记录器Medical magnetic tape recorder 870.2810 纸质图表记录器 Paper chart recorder 870.2840 尖端心动描记传感器 Apex cardiographic transducer 870.2850 血管外血压传感器Extravascular blood pressure transducer 870.2860 心音传感器Heart sound transducer 870.2870 导管顶端压力传感器 Catheter tip pressure transducer 870.2880 超声式传感器 Ultrasonic transducer 870.2890 脉管闭塞传感器 Vessel occlusion transducer 870.2900 患者传感器和电极电缆（包括连接器） Patient transducer and electrode cable （including connector） 870.2910 射频生理信号发送器和接收器Radiofrequency physiological signal transmitter and receiver 870.2920 电话式心电图仪发送器和接收器Telephone electrocardiograph transmitter and receiver D 亚部心血管修复器械（Cardiovascular Prosthetic Devices） 870.3250 血管夹Vascular clip 870.3260 腔静脉夹 Vena cava clip 870.3300 动脉栓塞器械 Arterial embolization device 870.3375 心血管内过滤器 Cardiovascular intravascular filter 870.3450 血管移植假体Vascular graft prosthesis 870.3470 聚丙烯、聚对苯二甲酸乙酯或聚四氟乙烯制成的心内补片或纱布Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or---------------------------------------------------------------最新资料推荐------------------------------------------------------ polytetrafluoroethylene 870.3535 大动脉内球囊和控制系统Intra-aortic balloon and control system 870.3545 心室旁路（辅助）器械 Ventricular bypass （assist） device 870.3600 体外起搏器脉冲发生器External pacemaker pulse generator 870.3610 植入式起搏器脉冲发生器 Implantable pacemaker pulse generator 870.3620 起搏器导线接合器 Pacemaker lead adaptor 870.3630 起搏器发生器功能分析仪 Pacemaker generator function analyzer 870.3640 间接式起搏器发生器功能分析仪Indirect pacemaker generator function analyzer 870.3650 起搏器聚合体网袋Pacemaker polymeric mesh bag 870.3670 起搏器充电器Pacemaker charger 870.3680 心血管永久性或临时性起搏器电极Cardiovascular permanent or temporary pacemaker electrode 870.3690 起搏器测试磁铁 Pacemaker test magnet 870.3700 起搏器程序器 Pacemaker programmers 870.3710 起搏器修复或替换材料Pacemaker repair or replacement material 870.3720 起搏器电极功能检测器 Pacemaker electrode function tester 870.3730 起搏器维修工具 Pacemaker service tools 870.3800 瓣环成形术环Annuloplasty ring 870.3850 颈动脉窦神经刺激器 Carotid sinus nerve stimulator 870.3925 心脏瓣膜替代品 Replacement heart valve 870.3935 心脏瓣膜假体支架 Prosthetic heart valve holder 870.3945 心脏瓣膜假体筛选器 Prosthetic heart valve sizer E 亚5 / 8部心血管手术器械（Cardiovascular Surgical Devices） 870.4075 心肌膜炎活组织检查器械 Endomyocardial biopsy device 870.4200 心肺旁路附属设备 Cardiopulmonary bypass accessory equipment 870.4205 心肺旁路气泡探测器 Cardiopulmonary bypass bubble detector 870.4210 心肺旁路血管导管、套管或管路Cardiopulmonary bypass vascular catheter, cannula, or tubing 870.4220 心肺旁路心肺机控制台Cardiopulmonary bypass heart-lung machine console 870.4230 心肺旁路消泡器Cardiopulmonary bypass defoamer 870.4240 心肺旁路热交换器Cardiopulmonary bypass heat exchanger 870.4250 心肺旁路温度控制器 Cardiopulmonary bypass temperature controller 870.4260 心肺旁路动脉血过滤器 Cardiopulmonary bypass arterial line blood filter 870.4270 心肺旁路心切开术抽吸管路血液过滤器Cardiopulmonary bypass cardiotomy suction line blood filter 870.4280 心肺旁路前过滤器 Cardiopulmonary prebypass filter 870.4290 心肺旁路接合器、旋塞阀、汇流管或配件Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting 870.4300 心肺旁路气体控制装置 Cardiopulmonary bypass gas control unit 870.4310 心肺旁路冠状动脉压力计 Cardiopulmonary bypass coronary pressure gauge 870.4320 心肺旁路脉动流发生器Cardiopulmonary bypass pulsatile flow generator 870.4330 心肺旁路即时血气监测仪 Cardiopulmonary bypass on-line blood gas---------------------------------------------------------------最新资料推荐------------------------------------------------------ monitor 870.4340 心肺旁路液面自动检测监视器和/或控制器Cardiopulmonary bypass level sensing monitor and/or control 870.4350 心肺旁路氧合器 Cardiopulmonary bypass oxygenator 870.4360 非滚筒型心肺旁路血液泵Nonroller-type cardiopulmonary bypass blood pump 870.4370 滚筒型心肺旁路血液泵 Roller-type cardiopulmonary bypass blood pump 870.4380 心肺旁路泵速度控制器Cardiopulmonary bypass pump speed control 870.4390 心肺旁路泵管路 Cardiopulmonary bypass pump tubing 870.4400 心肺旁路血液储存器 Cardiopulmonary bypass blood reservoir 870.4410 心肺旁路内嵌式血气传感器Cardiopulmonary bypass in-line blood gas sensor 870.4420 心肺旁路心切开术返回吸管Cardiopulmonary bypass cardiotomy return sucker 870.4430 心肺旁路心脏内抽吸控制器Cardiopulmonary bypass intracardiac suction control 870.4450 血管夹 Vascular clamp 870.4475 外科手术血管扩张器 Surgical vessel dilator 870.4500 心血管手术器具Cardiovascular surgical instruments 870.4875 管腔内动脉剥离器 Intraluminal artery stripper 870.4885 体外静脉剥离器External vein stripper F 亚部心血管治疗器械（Cardiovascular Therapeutic Devices） 870.5050 患者照料吸引装置 Patient care suction apparatus 870.5150 栓子切除导管Embolectomy catheter7 / 8870.5175 房隔造口导管 Septostomy catheter 870.5200 体外心脏挤压器External cardiac compressor 870.5225 体外反搏装置External counter-pulsating device 870.5300 DC－除颤器（包括除颤板） DC。

人工心脏

1964年，美国国立卫生研
世界上第一例临床人工心脏
植入手术是在1969年，美国医生Cooley将LiottaCooley全人工心脏植入到一个行室壁瘤切除后不能脱离体外循环的患者体内。全人工心脏辅助了64小时，成功地进行了心脏移植。患者在移植的32小时后死于假单胞菌性肺炎。该TAH是一个气动，双心室辅助的泵，再没有应用于临床。
生物合成人工心脏”的法国Carmat公司 TAH被首次置入人体，Carmat心脏临床可行性研究纳入的第一例患者在术后75天死亡，第二例患者于2014年9月8日接受置入。彭铁尔（Alain Carpentier）収明，电动驱动，双心室完成射血，其形态和生理学对自然心脏的模拟度更高。使用牛心包等生物材料，降低了血栓栓塞幵収症和排斥反应风险；内置诸多传感器以感受心室压力变化，根据患者运动或安静状态调整相应心输出量。该器械预期使用寿命为5年，大小与自然心脏相当，但重量超过900g
这种极简设计带来的特殊优势包括：
① 微型，“可放入8岁儿童胸腔”； ②只有一个运动部件，最大程度降低故障风险； ③ 磁力学和流体力学悬浮式离心推进器，最大限度减少机械磨损，
持久耐用。BiVACOR可为双心室提供支持（BV Assist）或完全替
持续平流灌注，根据泵的流量和压
力的变化自动调节
1957年，荷兰医生科尔夫
（Willem Johan Kolff）与同事阿库苏（Tetsuzo Akutsu）将一颗水压式聚氯乙烯人工心脏置入狗体内，使之生存了近90分钟，首次将“人工心脏”概念带入现实。究院（NIH）成立人工心脏项目；国家心、肺和血液研究所（NHLBI）提出“到 1970年设计出TAH”的目标。

人工心脏的研究与发展

人工心脏的研究与发展人工心脏是一种用于治疗心脏疾病的医疗器械，它能够完全或部分代替人体自身心脏的功能。

近年来，随着科技的发展和人们对健康的日益关注，人工心脏的研究与发展取得了巨大的突破，并逐渐成为临床治疗心脏疾病的一种有效手段。

首先，人工心脏的研究与发展主要包括两个方面：一是机械式人工心脏的研究与开发，即利用机械装置代替心脏的机械功能；二是生物材料与心脏组织工程的研究，即利用生物材料或组织工程技术修复或替代受损的心脏组织。

机械式人工心脏是人工心脏发展的首要方向。

其中最为常见的是人工心脏辅助装置（Artificial Heart Assist Device, AHAD）。

AHAD可以分为心外循环支持和心内循环支持两种类型。

心外循环支持主要是在手术过程中将机械装置连接到患者的心脏和血管上，辅助血液循环。

心内循环支持则是将机械装置植入到患者体内，直接辅助心脏的机械功能。

目前，心外循环支持多用于心脏移植手术等特殊情况，而心内循环支持则已经广泛应用于心力衰竭患者的治疗。

在机械式人工心脏的研究和发展中，关键的问题之一是如何实现机械装置的长期稳定运行。

目前，大多数机械式人工心脏装置都使用电池供电，但电池寿命有限，需要经常更换，严重影响了患者的生活质量。

因此，研究人员正在努力开发无电池供电或长寿命电池的机械式人工心脏装置。

此外，机械装置与人体的相容性也是一个需要解决的问题，包括机械装置与人体心血管系统的适应性以及机械装置对血细胞等血液成分的影响等。

另一方面，生物材料与心脏组织工程的研究也是人工心脏发展的重要方向。

通过利用生物材料和组织工程技术，可以修复或替代受损的心脏组织，达到恢复心脏功能的目的。

目前，研究人员已经成功地开发出了一些生物材料，如生物支架和心脏细胞培养基质等，用于修复和重建受损的心脏组织。

同时，研究人员还在探索利用干细胞和生物打印等先进技术，实现心脏组织的再生与重建。

总的来说，人工心脏的研究与发展取得了显著的进展。

心血管内科器械词汇

心血管诊断器械（Cardiovascular Diagnostic Devices）心律失常探测器和警报器（包括ST段测量和警报）Arrhythmia detector and alarm （including ST-segment measurement and alarm）血压警报器Blood pressure alarm血压计算机Blood pressure computer血压袖带Blood pressure cuff非侵入式血压测量系统Noninvasive blood pressure measurement system静脉血压计Venous blood pressure manometer诊断用血管内导管Diagnostic intravascular catheter连续式冲洗导管Continuous flush catheter电极记录导管或电极记录探针Electrode recording catheter or electrode recording probe 光纤式血氧计导管Fiberoptic oximeter catheter导流导管Flow-directed catheter经皮导管Percutaneous catheter腔内心音导管系统Intracavitary phonocatheter system可操纵导管Steerable catheter可操纵导管控制系统Steerable catheter control system导管套管Catheter cannula经皮插入导管用的血管扩张器Vessel dilator for percutaneous catheterization导管导线Catheter guide wire导管插入器Catheter introducer导管球囊修理工具盒Catheter balloon repair kit示踪微球体Trace microsphere导管尖端封闭器Catheter tip occluder导管探针Catheter stylet套管针Trocar可编程的诊断用计算机Programmable diagnostic computer预编程的单功能诊断用计算机Single-function，preprogrammed diagnostic computer 光密度计Densitometer血管造影注射器和注射管Angiographic injector and syringe指示剂注射器Indicator injector注射器的注射管制动器Syringe actuator for an injector体外可编程起搏器脉冲发生器External programmable pacemaker pulse generator抽缩式输液泵Withdrawal-infusion pump听诊器Stethoscope热稀释探头Thermodilution probe心血管监测器械（Cardiovascular Monitoring Devices）生物电位放大器和信号调节器Biopotential amplifier and signal conditioner传感器信号放大器和调节器Transducer signal amplifier and conditioner心血管血液流量计Cardiovascular blood flowmeter血管外血流探头Extravascular blood flow probe心脏监测器（包括心率计和心率警报器）Cardiac monitor （including cardiotachometer and rate alarm）2310尖端心动描记器（心振动图仪）Apex cardiograph （vibrocardiograph）心冲击描记器Ballistocardiograph超声波心动图仪Echocardiograph心电图仪Electrocardiograph心电图仪导线转换接合器Electrocardiograph lead switching adaptor心电图仪电极Electrocardiograph electrode心电图仪表面电极检测器Electrocardiograph surface electrode tester心音图仪Phonocardiograph心电向量图仪Vectorcardiograph医用阴极射线管显示器Medical cathode-ray tube display信号隔离系统Signal isolation system在线隔离监视器Line isolation monitor便携式漏电流警报器Portable leakage current alarm动脉搏动描记器Oscillometer光电血氧计Oximeter耳光电血氧计Ear oximeter阻抗式静脉搏动描记器Impedance phlebograph阻抗式体积描记器Impedance plethysmograph水压式、气动式或光电式体积描记器Hydraulic，pneumatic，or photoelectric plethysmographs医用磁带记录器Medical magnetic tape recorder纸质图表记录器Paper chart recorder尖端心动描记传感器Apex cardiographic transducer血管外血压传感器Extravascular blood pressure transducer心音传感器Heart sound transducer导管顶端压力传感器Catheter tip pressure transducer超声式传感器Ultrasonic transducer脉管闭塞传感器Vessel occlusion transducer患者传感器和电极电缆（包括连接器）Patient transducer and electrode cable （including connector）射频生理信号发送器和接收器Radiofrequency physiological signal transmitter and receiver电话式心电图仪发送器和接收器Telephone electrocardiograph transmitter and receiver心血管修复器械（Cardiovascular Prosthetic Devices）血管夹Vascular clip腔静脉夹Vena cava clip动脉栓塞器械Arterial embolization device心血管内过滤器Cardiovascular intravascular filter血管移植假体Vascular graft prosthesis聚丙烯、聚对苯二甲酸乙酯或聚四氟乙烯制成的心内补片或纱布Intracardiac patch or pledget made of polypropylene，polyethylene terephthalate，or polytetrafluoroethylene大动脉内球囊和控制系统Intra-aortic balloon and control system心室旁路（辅助）医.学教.育网搜.集整理器械Ventricular bypass （assist）device体外起搏器脉冲发生器External pacemaker pulse generator植入式起搏器脉冲发生器Implantable pacemaker pulse generator起搏器导线接合器Pacemaker lead adaptor起搏器发生器功能分析仪Pacemaker generator function analyzer间接式起搏器发生器功能分析仪Indirect pacemaker generator function analyzer起搏器聚合体网袋Pacemaker polymeric mesh bag起搏器充电器Pacemaker charger心血管永久性或临时性起搏器电极Cardiovascular permanent or temporary pacemaker electrode起搏器测试磁铁Pacemaker test magnet起搏器程序器Pacemaker programmers起搏器修复或替换材料Pacemaker repair or replacement material起搏器电极功能检测器Pacemaker electrode function tester起搏器维修工具Pacemaker service tools瓣环成形术环Annuloplasty ring颈动脉窦神经刺激器Carotid sinus nerve stimulator心脏瓣膜替代品Replacement heart valve心脏瓣膜假体支架Prosthetic heart valve holder心脏瓣膜假体筛选器Prosthetic heart valve sizer心血管手术器械（Cardiovascular Surgical Devices）心肌膜炎活组织检查器械Endomyocardial biopsy device心肺旁路附属设备Cardiopulmonary bypass accessory equipment心肺旁路气泡探测器Cardiopulmonary bypass bubble detector心肺旁路血管导管、医学教.育网搜集套管或管路Cardiopulmonary bypass vascular catheter，cannula，or tubing心肺旁路心肺机控制台Cardiopulmonary bypass heart-lung machine console心肺旁路消泡器Cardiopulmonary bypass defoamer心肺旁路热交换器Cardiopulmonary bypass heat exchanger心肺旁路温度控制器Cardiopulmonary bypass temperature controller心肺旁路动脉血过滤器Cardiopulmonary bypass arterial line blood filter心肺旁路心切开术抽吸管路血液过滤器Cardiopulmonary bypass cardiotomy suction line blood filter心肺旁路前过滤器Cardiopulmonary prebypass filter心肺旁路接合器、旋塞阀、汇流管或配件Cardiopulmonary bypass adaptor，stopcock，manifold，or fitting心肺旁路气体控制装置Cardiopulmonary bypass gas control unit心肺旁路冠状动脉压力计Cardiopulmonary bypass coronary pressure gauge心肺旁路脉动流发生器Cardiopulmonary bypass pulsatile flow generator心肺旁路即时血气监测仪Cardiopulmonary bypass on-line blood gas monitor心肺旁路液面自动检测监视器和/或控制器Cardiopulmonary bypass level sensing monitor and/or control心肺旁路氧合器Cardiopulmonary bypass oxygenator非滚筒型心肺旁路血液泵Nonroller-type cardiopulmonary bypass blood pump滚筒型心肺旁路血液泵Roller-type cardiopulmonary bypass blood pump心肺旁路泵速度控制器Cardiopulmonary bypass pump speed control心肺旁路泵管路Cardiopulmonary bypass pump tubing心肺旁路血液储存器Cardiopulmonary bypass blood reservoir心肺旁路内嵌式血气传感器Cardiopulmonary bypass in-line blood gas sensor心肺旁路心切开术返回吸管Cardiopulmonary bypass cardiotomy return sucker 心肺旁路心脏内抽吸控制器Cardiopulmonary bypass intracardiac suction control 血管夹Vascular clamp外科手术血管扩张器Surgical vessel dilator心血管手术器具Cardiovascular surgical instruments管腔内动脉剥离器Intraluminal artery stripper体外静脉剥离器External vein stripper。

心脏病患者的体外人工心脏辅助系统

心脏病患者的体外人工心脏辅助系统心脏病是当前世界上最常见的致死性疾病之一。

随着医学技术的不断发展，体外人工心脏辅助系统逐渐成为治疗心脏病患者的重要手段。

本文将介绍什么是体外人工心脏辅助系统、其原理和分类、应用场景以及未来发展方向。

一、体外人工心脏辅助系统简介体外人工心脏辅助系统（Extracorporeal Heart Assist System，EHS）是一种通过机械装置辅助或替代受损或衰竭的自身心功能，维持血液循环正常运转的方法。

该系统由一个或多个具有泵功能的机械装置组成，能够将血液引流出左室或右室，然后通过泵送机构将血液重新注入到动脉循环中。

这样可以有效地维持全身器官供血，避免因心功能不全而引起的损伤和并发症。

二、体外人工心脏辅助系统原理与分类1. 原理体外人工心脏辅助系统通过机械泵浦或压力传感器等装置实现了血液的有效引流和注入。

通常情况下，该系统一般是由一个主泵、用于连接动脉的插管以及连接大静脉和右心室的引流管所组成。

当心脏无法正常工作时，主泵负责将血液从左室或右室中抽出，并将其输送至主动脉或肺动脉。

同时，引流管也起到了减压和引流的作用，使得血液能够有效地回流至全身循环。

2. 分类根据其使用位置和功效不同，体外人工心脏辅助系统可以分为左室辅助装置（LVAD）和对性操作帮助装置（RVSM）。

前者是指将血液从左室引出并注入主动脉以支持左心功能；而后者是通过引号来将血液从右房直接推向肺动脉。

三、体外人工心脏辅助系统应用场景1. 心脏手术前期支持在进行复杂心脏手术之前，医生可能会选择使用体外人工心脏辅助系统来帮助心脏减负。

这有助于患者的手术风险评估、准备和心功能的恢复，提高手术成功率。

2. 急性心力衰竭治疗当患者出现急性心力衰竭时，体外人工心脏辅助系统可以快速维持全身血流供应，并为停用自身呼吸机造成了一个缓冲区。

3. 长期心脏辅助某些患者因病情严重或等待器官捐赠而需要长期的心脏支持。

长期使用体外人工心脏辅助系统可以使患者长时间生存下去，并为他们争取到更好的治疗机会。

人工心脏泵的原理

人工心脏泵的原理人工心脏泵，也称为人工心脏辅助装置（Artificial Heart Assist Device），是一种用于维持心脏功能的医疗器械。

它的原理是通过模拟心脏的收缩和舒张，向身体输送血液，以维持机体的正常生理活动。

人工心脏泵的核心部分是由电动机驱动的泵，泵的作用是通过机械力将血液从心脏中吸入，并将其推送到主动脉中，从而实现血液的循环。

泵的设计遵循了心脏的结构和功能，分为左心室泵和右心室泵两种。

左心室泵是用于辅助左心室功能的装置，它通过一个连通左心室和主动脉的导管，将氧合血液从左心室中吸入，并将其推送到主动脉中。

右心室泵则是用于辅助右心室功能的装置，它通过一个连通右心室和肺动脉的导管，将从体循环中回流的静脉血吸入，并将其推送到肺动脉中进行氧合。

泵的工作原理基于压力差和流体力学原理。

通过电动机的驱动，泵内的叶轮迅速旋转，产生一个负压区域，使血液被吸入泵中。

随后，叶轮将血液推送到体内的血管系统中。

泵的运转周期和旋转速度可以根据患者的生理状况进行调节，以确保血液的正常循环。

人工心脏泵的优点在于可以有效地缓解心脏病患者的症状，提高他们的生活质量。

由于泵能够提供持续而稳定的血液供应，患者的体力活动能力得到了明显的改善。

此外，人工心脏泵还可以为患者提供足够的时间等待心脏移植手术，从而增加了手术的成功率。

然而，人工心脏泵也存在一些局限性。

一方面，泵的使用需要外部电源供应，这对患者的生活带来了一定的限制。

另一方面，由于泵与人体血液直接接触，存在着血栓形成、感染和出血等并发症的风险。

因此，在使用人工心脏泵时，医生需要密切监测患者的病情，并及时处理可能出现的并发症。

总的来说，人工心脏泵作为一种辅助治疗手段，对于心脏病患者来说具有重要的意义。

它通过模拟心脏的功能，为患者提供持续而稳定的血液供应，从而改善了他们的生活质量。

尽管存在一些局限性，但随着技术的不断进步，人工心脏泵无疑将在未来的临床实践中发挥更加重要的作用，为更多患者带来健康和希望。

(心血管)介入医疗行业中英文对照

15
右冠状动脉
Right Coronary Artery, RCA
16
后降支
Posterior Descending, PD
17
左室后支
Posterior branches of left ventricular, PL
2、手术：
序号
名称
英文
1
介入放射学
interventional radiology
冠状动脉支架植入术
(coronary stent implantation---CSI)
7
经皮冠状动脉腔内血管成形术
（Percutaneous transluminal coronary angioplasty）
PTCA
8
皮血管腔内血管成形术
（percutaneous transluminal angioplasty,PTA）
15
超声血管成形术
（ultrasonicangioplasty,angiosonoplasty）。
16
冠状动脉旁路移植术
coronary artery bypass graft(CABG)
2、：
序号
名称
英文
1
欧洲心脏病学会
（European Society of Cardiology , ESC）
2
（心血管）介入医疗行业中英文对照
1、血管：
序号
名称
英文
1
股动脉
femoral artery
2
桡动脉
radial artery
3
肱动脉
brachial artery
4
尺动脉
ulnar artery

心血管医疗器械中英文对照.doc

心血管医疗器械中英文对照A亚部--总则（General Provisions）870.1范围870.3Effective dates of requirement for premarket approval870.9Limitations of exemptions from section 510（k）of the Federal Food, Drug, and Cosmetic Act （the act）B亚部--心血管诊断器械（Cardiovascular Diagnostic Devices）870.1025心律失常探测器和警报器（包括ST段测量和警报）870.1100Blood pressure alarm870.1110Blood pressure computer870.1120Blood pressure cuff870.1130Noninvasive blood pressure measurement system 870.1140Venous blood pressure manometer870.1200Diagnostic intravascular catheter870.1210Continuous flush catheter870.1220Electrode recording catheter or electrode recording probe 870.1230Fiberoptic oximeter catheter870.1240Flow-directed catheter870.1250Percutaneous catheter870.1270Intracavitary phonocatheter system870.1280Steerable catheter870.1290Steerable catheter control system870.1300Catheter cannula870.1310Vessel dilator for percutaneous catheterization 870.1330Catheter guide wire870.1340Catheter introducer870.1350Catheter balloon repair kit870.1360Trace microsphere870.1370Catheter tip occluder870.1380Catheter stylet870.1390Trocar870.1425Programmable diagnostic computer870.1435Single-function, preprogrammed diagnostic computer 870.1450Densitometer870.1650Angiographic injector and syringe870.1660Indicator injector870.1670Syringe actuator for an injector870.1750External programmable pacemaker pulse generator 870.1800Withdrawal-infusion pump870.1875Stethoscope870.1915Thermodilution probeC亚部--心血管监测器械（Cardiovascular Monitoring Devices）870.2050生物电位放大器和信号调节器870.2060Transducer signal amplifier and conditioner870.2100Cardiovascular blood flowmeter870.2120Extravascular blood flow probe870.2300Cardiac monitor （including cardiotachometer and rate alarm）870.2310Apex cardiograph （vibrocardiograph）870.2320Ballistocardiograph870.2330Echocardiograph870.2340Electrocardiograph870.2350Electrocardiograph lead switching adaptor 870.2360Electrocardiograph electrode870.2370Electrocardiograph surface electrode tester 870.2390Phonocardiograph870.2400Vectorcardiograph870.2450Medical cathode-ray tube display 870.2600Signal isolation system870.2620Line isolation monitor870.2640Portable leakage current alarm 870.2675Oscillometer870.2700Oximeter870.2710Ear oximeter870.2750Impedance phlebograph870.2770Impedance plethysmograph870.2780Hydraulic, pneumatic, or photoelectric plethysmographs 870.2800Medical magnetic tape recorder870.2810Paper chart recorder870.2840Apex cardiographic transducer870.2850Extravascular blood pressure transducer870.2860Heart sound transducer870.2870Catheter tip pressure transducer870.2880Ultrasonic transducer870.2890Vessel occlusion transducer870.2900Patient transducer and electrode cable （including connector）870.2910Radiofrequency physiological signal transmitter and receiver 870.2920Telephone electrocardiograph transmitter and receiverD亚部--心血管修复器械（Cardiovascular Prosthetic Devices）870.3250Vascular clip870.3260Vena cava clip870.3300Arterial embolization device870.3375Cardiovascular intravascular filter870.3450Vascular graft prosthesis870.3470Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene870.3535Intra-aortic balloon and control system 870.3545。

医学常用医疗设备中英文名称翻译

医学常用医疗设备中英文名称翻译Medical devices play a critical role in the healthcare industry, providing essential tools and equipment for diagnosis, treatment, and monitoring of patients. With the advancements in global healthcare, it has become increasingly important to have accurate translations of medical device names from Chinese to English. In this article, we will explore some commonly used medical devices and their translations.1. 血压计 - Blood Pressure MonitorThe blood pressure monitor is a device used to measure the pressure of the blood in a person's arteries. It consists of an inflatable cuff that is wrapped around the upper arm and a gauge that measures the pressure. This device is commonly used in clinics, hospitals, and even for personal home use.2. 心电图机 - Electrocardiograph (ECG) MachineThe electrocardiograph machine, often referred to as an ECG machine, is used to measure the electrical activity of the heart. It records the heart's rhythm and can detect abnormal patterns, such as irregular heartbeats or signs of heart disease. The ECG machine is a vital tool for cardiologists and other healthcare professionals.3. 输液泵 - Infusion PumpThe infusion pump is a device used to deliver fluids, such as medication, nutrients, or blood, directly into a patient's bloodstream. It ensures precise control over the rate and volume of the infusion, allowinghealthcare providers to administer medications safely and accurately. Infusion pumps are commonly used in hospitals, especially in critical care units.4. 呼吸机 - VentilatorAlso known as a respirator, the ventilator is a life-saving device used to support patients who are unable to breathe adequately on their own. It assists in delivering oxygen to the lungs and removing carbon dioxide from the body. Ventilators are commonly used in intensive care units (ICUs), operating rooms, and emergency departments.5. 手术台 - Operating TableThe operating table is a specialized table used during surgical procedures. It provides a stable and adjustable platform for surgeons to perform operations comfortably and efficiently. Operating tables often have various positioning capabilities and can be adjusted to different heights, angles, and positions, depending on the surgical requirements.6. CT 扫描仪 - CT ScannerThe CT scanner, or computed tomography scanner, is a medical imaging device that creates detailed images of the body's internal structures. It uses a combination of X-rays and computer processing to produce cross-sectional images, allowing healthcare professionals to diagnose and evaluate various conditions accurately. CT scanners are commonly found in hospitals and diagnostic imaging centers.7. 超声波 - UltrasoundUltrasound, also known as sonography, is a non-invasive imaging technique that uses high-frequency sound waves to create real-time images of the body's internal organs and structures. It is widely used in obstetrics and gynecology for prenatal imaging, as well as in other specialties to diagnose and monitor conditions such as heart disease, liver abnormalities, and kidney stones.8. 磁共振成像 - Magnetic Resonance Imaging (MRI)Magnetic resonance imaging, often referred to as MRI, is a diagnostic imaging technique that uses powerful magnets and radio waves to generate detailed images of the body's internal structures. It provides valuable information about soft tissues, organs, and certain types of tumors. MRI scans are commonly used in the diagnosis and management of various medical conditions.9. 输血机 - Blood Transfusion SystemThe blood transfusion system is a set of equipment used to administer blood or blood products to patients who have lost blood due to surgery, trauma, or medical conditions. It ensures the safe and controlled delivery of blood components, such as red blood cells, plasma, or platelets, to the recipient.10. 心脏起搏器 - PacemakerThe pacemaker is a small electronic device implanted in the chest or abdomen to regulate the heart's electrical rhythm. It sends electrical impulses to the heart muscles, helping to maintain a regular heartbeat. Pacemakers are commonly used to treat conditions such as bradycardia and heart block.These are just a few examples of commonly used medical devices and their translations from Chinese to English. Accurate and standardized translations are crucial in the healthcare field to ensure effective communication and proper understanding of medical device names across different languages.。

医院各科室及常用医疗设备的中英文名称

医院各科室及常用医疗设备的中英文名称内分泌科Endocrinology Department胸外科Thoracic surgery消化内科Digestive System Department心血管内科Vasculocardiology Deparment心外科Cardial Surgery神经内科Neurology Department神经外科Neurological Surgery肿瘤外科Oncological Surgery肾内科Urology Department小儿外科Pediatric Surgery呼吸科Pneumology Department骨科Orthopedics Department小儿科Pediatrics Department整形科Plastic Surgery传统放射科TraditionalRadiology Department中医科Traditional Chinese Medicine Department 烧伤科Department of Burn高干病房Senior Officials inpatient Ward妇产科Obstetric and Gynecologic Department华侨病房Overseas Chinese Ward口腔科Stomatological Department康复科Rehabilitation Department保健科Medical Care Department for personnel 眼科Ophthalmologic Department针灸科Acupuncture and Moxibustion Deparment 耳鼻喉科Otorhinolaryngologic Department痔疮科Hemorrhoids Deparment按摩科Massage Department皮肤科Dermatology Department麻醉科Anesthesia Department普外科General Surgery肿瘤Oncology Department泌尿Urology Surgery整形外科Plastic Surgery,肺功能室Lung Function Laboratory泌尿外科Urological Surgery内科Department of internal medicine外科Department of surgery儿科Department of pediatrics妇科Department of obstetrics and gynecology输液泵infusion pump呼吸机ventilator麻醉机aneasthetic apparatus心电图机electrocardiography(ECG)脑电图机electroencephalophy（EEG）肌电图仪electromyography （EMG）血压计sphygmomanometer体温计thermometer听力计audiometer多道生理记录仪multi-channelphysiology recorder超声诊断仪ultrasonography计算机断层摄影computer tomograpy （CT）生化分析仪biochemical analyzer原子吸收分光光度计atomicabsorption spectrophotometer 除颤仪defibrillator色谱仪chromatography电解质分析仪electrolyte analyzer血气分析仪blood-gas analyzer尿液分析仪automatic urineanalyzer数字减影血管造影digital subtractionangiography（DSA）计算机摄影computer radiography (CR)数字化摄影digital radiography (DR)磁共振成像系统magmetic resonanceimagingγ相机γ camera单光子发射型计算机断层成像singlephoton emission computedtomograpy （SPECT）正电子发射型计算机断层成像positronemission computed tomograpy （PET）医用电子直线加速器linearaccelerator γ刀γ knifeX刀X knife心脏起搏器pacemaker验光仪refractometer眼压计eye pressure meter激光治疗仪laser treatmentinstrument血液透析hemo-dialysis高频电刀medical electrc knife心电监护仪electro cardiacmonitor常用的辅助科室及其它部门英文名称MR室MR Laboratory胃镜室Dndoscope LaboratorysCT室SCt Laboratory人工肾室Hemodialyses Room介入科Invasive TechnologyDepartment超声诊断科UItrasonic DiagnosisDeparment DSA室DSA Room超声多谱勒室UItrasonic DopplerLaboratory血液净化室Laminar Airflow(LAF) Room核医学科Isotopic Laboratory高压氧舱室Hyperbaric Chamber院内感染监控室Nosocomial Infection Monitory供应室Supply House血液成份分离室Cytopheresis Laboratory营养室Nutrition House体外反搏室Counter Extropulsative Room理疗科Physiotherapy Deparment介入Invasive Department影像Medical Imagery病理科Pathology Deparment脑电图室ECG Laboratory门诊部out-patient department住院部In-patient department护理部Nursing department住院处Admission office出院处Discharge office挂号处Registration office Reception room, 侯诊室waiting room诊察室Consultation room隔离室Isolation room分娩室Delivery room急诊室Emergency room病房Ward药房Pharmacy dispensary营养部Nutrition department配膳室Diet-preparation department治疗室Therapeutic department手术室Operating room/Theater血站Blood-bank供应室Supply-room消毒室Disinfection-room换药室Dressing room太平间Mortuary病案室Record room矫形外科Department of plastic surgery理疗科Department of physiotherapy电疗科electrotherapy room光疗科heliotherapy room蜡疗科wax-therapy room水疗科hydrotherapy room中心实验室central laboratory临床实验室clinical laboratory细菌实验室bacteriological laboratory生化实验室biochemical laboratory血清实验室serological laboratory医生办公室doctor’s office护士办公室nurse’s office省级重点学科Key Subjects at the Provincial Level省级医疗领先特色专业The Leading Subjects of Medicine at the Provincial Level医院特色专科Characteristic Professional Subjects of Union Hospital。

心血管器械(Cardiovascular Devices)

870.2120
血管外血流探头
Extravascular blood flow probe
870.2300
心脏监测器(包括心率计和心率警报器)
Cardiac monitor (including cardiotachometer and rate alarm)
870.2310
尖端心动描记器(心振动图仪)
起搏器修复或替换材料
Pacemaker repair or replacement material
870.3720
起搏器电极功能检测器
Pacemaker electrode function tester
870.3730
起搏器维修工具
Pacemaker service tools
870.3800
瓣环成形术环
870.9
联邦食品、药品和化妆品法（Federal Food, Drug, and Cosmetic Act，FDCA）第510（k）节的豁免限制
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)
B亚部——心血管诊断器械（Cardiovascular Diagnostic Devices）
870.1025
心律失常探测器和警报器(包括ST段测量和警报)
Arrhythmia detector and alarm (including ST-segment measurement and alarm)
心脏瓣膜假体筛选器
Prosthetic heart valve sizer
E亚部——心血管手术器械（Cardiovascular Surgical Devices）

【医学ppt课件】机械辅助装置(MAD)在心衰患者中的应用-PPT说课稿

ACC/AHA 推荐使用主动脉内球囊反搏治疗
“In virtually all shock-management strategies in which counterpulsation is used today, it acts as a stabilizing device or bridge to facilitate diagnostic angiography and revascularization.” 如今在休克的治疗中使用的主动脉内球囊反搏是保证循环稳定相再血管化治疗过渡的重要手段
VA-ECMO
VA-ECMO
避开了开胸手术的风险和并发症,缩短了手术时间
适用于：心脏衰竭或严重心肺衰竭的病人紧急心肺复苏急救时缺点：某些炎性介质和反馈反应,导致某些
脏器的损伤
ECMO 的类型
离心泵+微孔纤维膜式氧合器搏动泵+矽膜氧合器
离心泵+微孔纤维膜式氧合器
优点: 启动迅速, 肝素嵌入，溶血现象少，安全性高
血栓形成
离心式ECMO 泵血栓不易脱落进入人体造成栓塞
搏动泵则必须相对加强抗凝,否则可因血栓脱落造成严重后果
溶血
监测ACT、血小板计数、纤维蛋白原、血浆游离血红蛋白及尿镜检
回路凝结、动脉闭塞、回路压力> 300 mmHg 更换整个ECMO（泵和氧合器）
碱化尿液、保持尿量 > 3ml/kg/hr 、呋塞米或甘露醇
从升主动脉流出
通过减少左心室的工作，使心脏得到有效的休息，从而恢复功能
ECMO与CPB的区别
装置地点静脉贮血槽
凝血时间（秒）血液回收再输入低温溶血血液稀释动脉过滤器型式
CPB

心脏辅助器械发展-中英文课件

REMATCH Trial
Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure
Implant to Failure Time
Overall Mean Time 332 days (15-632) Inflow valve failure 408 days (240-632) Motor Malfunction 285 days (15-439)
PRIMARY CAP
6 mo: 87±3%
12 mo: 75±6%
Pagani et al AHA 2007
HeartMate II 临床试验移植后存活率
移植后30天存活率 150/157 (96%) 移植后一年存活率 117/128 (91%)
HeartMate II 临床研究致死因素 (56/281)
英文原版
The U.S. Experience with Total Artificial Hearts vs. Left Ventricular Assist Devices
Lyle D. Joyce, M.D., PhD. Division of Cardiovascular Surgery The Mayo Clinic, Rochester, MN,USA
1964
WILLEM J. KOLFF
首个左室辅助装置治疗下康复病例
1966
心脏支持辅助装置的发展历史
心脏移植前类脉动式装置完全人工或永久性支持设计
DeBakey VAD–1966
Liotta TAH–1969
Akutsu TAH –1981

心血管医疗器械中英文对照

A亚部——总则（General Provisions） 870.1 范围 Scope 870.3 有关上市前批准⽣效⽇期的要求 Effective dates of requirement for premarket approval 870.9 联邦⾷品、药品和化妆品法（Federal Food, Drug, and Cosmetic Act，FDCA）第510（k）节的豁免限制 Limitations of exemptions from section 510（k） of the Federal Food, Drug, and Cosmetic Act （the act） B亚部——⼼⾎管诊断器械（Cardiovascular Diagnostic Devices） 870.1025 ⼼律失常探测器和警报器（包括ST段测量和警报） Arrhythmia detector and alarm （including ST-segment measurement and alarm） 870.1100 ⾎压警报器 Blood pressure alarm 870.1110 ⾎压计算机 Blood pressure computer 870.1120 ⾎压袖带 Blood pressure cuff 870.1130 ⾮侵⼊式⾎压测量系统 Noninvasive blood pressure measurement system 870.1140 静脉⾎压计 Venous blood pressure manometer 870.1200 诊断⽤⾎管内导管 Diagnostic intravascular catheter 870.1210 连续式冲洗导管 Continuous flush catheter 870.1220 电极记录导管或电极记录探针 Electrode recording catheter or electrode recording probe 870.1230 光纤式⾎氧计导管 Fiberoptic oximeter catheter 870.1240 导流导管 Flow-directed catheter 870.1250 经⽪导管 Percutaneous catheter 870.1270 腔内⼼⾳导管系统 Intracavitary phonocatheter system 870.1280 可操纵导管 Steerable catheter 870.1290 可操纵导管控制系统 Steerable catheter control system 870.1300 导管套管 Catheter cannula 870.1310 经⽪插⼊导管⽤的⾎管扩张器 Vessel dilator for percutaneous catheterization 870.1330 导管导线 Catheter guide wire 870.1340 导管插⼊器 Catheter introducer 870.1350 导管球囊修理⼯具盒 Catheter balloon repair kit 870.1360 ⽰踪微球体 Trace microsphere 870.1370 导管尖端封闭器 Catheter tip occluder 870.1380 导管探针 Catheter stylet 870.1390 套管针 Trocar 870.1425 可编程的诊断⽤计算机 Programmable diagnostic computer 870.1435 预编程的单功能诊断⽤计算机 Single-function, preprogrammed diagnostic computer 870.1450 光密度计 Densitometer 870.1650 ⾎管造影注射器和注射管 Angiographic injector and syringe 870.1660 指⽰剂注射器 Indicator injector 注射器的注射管制动器 Syringe actuator for an injector 870.1750 体外可编程起搏器脉冲发⽣器 External programmable pacemaker pulse generator 870.1800 抽缩式输液泵 Withdrawal-infusion pump 870.1875 听诊器 Stethoscope 870.1915 热稀释探头 Thermodilution probe C亚部——⼼⾎管监测器械（Cardiovascular Monitoring Devices） 870.2050 ⽣物电位放⼤器和信号调节器 Biopotential amplifier and signal conditioner 870.2060 传感器信号放⼤器和调节器 Transducer signal amplifier and conditioner 870.2100 ⼼⾎管⾎液流量计 Cardiovascular blood flowmeter 870.2120 ⾎管外⾎流探头 Extravascular blood flow probe 870.2300 ⼼脏监测器（包括⼼率计和⼼率警报器） Cardiac monitor （including cardiotachometer and rate alarm） 870.2310 尖端⼼动描记器（⼼振动图仪） Apex cardiograph （vibrocardiograph） 870.2320 ⼼冲击描记器 Ballistocardiograph 870.2330 超声波⼼动图仪 Echocardiograph 870.2340 ⼼电图仪 Electrocardiograph 870.2350 ⼼电图仪导线转换接合器 Electrocardiograph lead switching adaptor 870.2360 ⼼电图仪电极 Electrocardiograph electrode ⼼电图仪表⾯电极检测器 Electrocardiograph surface electrode tester 870.2390 ⼼⾳图仪 Phonocardiograph 870.2400 ⼼电向量图仪 Vectorcardiograph 870.2450 医⽤阴极射线管显⽰器 Medical cathode-ray tube display 870.2600 信号隔离系统 Signal isolation system 870.2620 在线隔离监视器 Line isolation monitor 870.2640 便携式漏电流警报器 Portable leakage current alarm 870.2675 动脉搏动描记器 Oscillometer 870.2700 光电⾎氧计 Oximeter 870.2710 ⽿光电⾎氧计 Ear oximeter 870.2750 阻抗式静脉搏动描记器 Impedance phlebograph 870.2770 阻抗式体积描记器 Impedance plethysmograph 870.2780 ⽔压式、⽓动式或光电式体积描记器 Hydraulic, pneumatic, or photoelectric plethysmographs 870.2800 医⽤磁带记录器 Medical magnetic tape recorder 870.2810 纸质图表记录器 Paper chart recorder 870.2840 尖端⼼动描记传感器 Apex cardiographic transducer 870.2850 ⾎管外⾎压传感器 Extravascular blood pressure transducer 870.2860 ⼼⾳传感器 Heart sound transducer 870.2870 导管顶端压⼒传感器 Catheter tip pressure transducer 870.2880 超声式传感器 Ultrasonic transducer 870.2890 脉管闭塞传感器 Vessel occlusion transducer 870.2900 患者传感器和电极电缆（包括连接器） Patient transducer and electrode cable （including connector） 870.2910 射频⽣理信号发送器和接收器 Radiofrequency physiological signal transmitter and receiver 870.2920 电话式⼼电图仪发送器和接收器 Telephone electrocardiograph transmitter and receiver D亚部——⼼⾎管修复器械（Cardiovascular Prosthetic Devices） 870.3250 ⾎管夹 Vascular clip 870.3260 腔静脉夹 Vena cava clip 870.3300 动脉栓塞器械 Arterial embolization device 870.3375 ⼼⾎管内过滤器 Cardiovascular intravascular filter 870.3450 ⾎管移植假体 Vascular graft prosthesis 870.3470 聚丙烯、聚对苯⼆甲酸⼄酯或聚四氟⼄烯制成的⼼内补⽚或纱布 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene 870.3535 ⼤动脉内球囊和控制系统 Intra-aortic balloon and control system 870.3545 ⼼室旁路（辅助）器械 Ventricular bypass （assist） device 870.3600 体外起搏器脉冲发⽣器 External pacemaker pulse generator 870.3610 植⼊式起搏器脉冲发⽣器 Implantable pacemaker pulse generator 870.3620 起搏器导线接合器 Pacemaker lead adaptor 870.3630 起搏器发⽣器功能分析仪 Pacemaker generator function analyzer 870.3640 间接式起搏器发⽣器功能分析仪 Indirect pacemaker generator function analyzer 870.3650 起搏器聚合体袋 Pacemaker polymeric mesh bag 870.3670 起搏器充电器 Pacemaker charger 870.3680 ⼼⾎管永久性或临时性起搏器电极 Cardiovascular permanent or temporary pacemaker electrode 870.3690 起搏器测试磁铁 Pacemaker test magnet 870.3700 起搏器程序器 Pacemaker programmers 870.3710 起搏器修复或替换材料 Pacemaker repair or replacement material 870.3720 起搏器电极功能检测器 Pacemaker electrode function tester 870.3730 起搏器维修⼯具 Pacemaker service tools 870.3800 瓣环成形术环 Annuloplasty ring 870.3850 颈动脉窦神经刺激器 Carotid sinus nerve stimulator 870.3925 ⼼脏瓣膜替代品 Replacement heart valve 870.3935 ⼼脏瓣膜假体⽀架 Prosthetic heart valve holder ⼼脏瓣膜假体筛选器 Prosthetic heart valve sizer E亚部——⼼⾎管⼿术器械（Cardiovascular Surgical Devices） 870.4075 ⼼肌膜炎活组织检查器械 Endomyocardial biopsy device 870.4200 ⼼肺旁路附属设备 Cardiopulmonary bypass accessory equipment 870.4205 ⼼肺旁路⽓泡探测器 Cardiopulmonary bypass bubble detector 870.4210 ⼼肺旁路⾎管导管、套管或管路 Cardiopulmonary bypass vascular catheter, cannula, or tubing 870.4220 ⼼肺旁路⼼肺机控制台 Cardiopulmonary bypass heart-lung machine console 870.4230 ⼼肺旁路消泡器 Cardiopulmonary bypass defoamer 870.4240 ⼼肺旁路热交换器 Cardiopulmonary bypass heat exchanger 870.4250 ⼼肺旁路温度控制器 Cardiopulmonary bypass temperature controller 870.4260 ⼼肺旁路动脉⾎过滤器 Cardiopulmonary bypass arterial line blood filter 870.4270 ⼼肺旁路⼼切开术抽吸管路⾎液过滤器 Cardiopulmonary bypass cardiotomy suction line blood filter 870.4280 ⼼肺旁路前过滤器 Cardiopulmonary prebypass filter 870.4290 ⼼肺旁路接合器、旋塞阀、汇流管或配件 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting 870.4300 ⼼肺旁路⽓体控制装置 Cardiopulmonary bypass gas control unit 870.4310 ⼼肺旁路冠状动脉压⼒计 Cardiopulmonary bypass coronary pressure gauge 870.4320 ⼼肺旁路脉动流发⽣器 Cardiopulmonary bypass pulsatile flow generator ⼼肺旁路即时⾎⽓监测仪 Cardiopulmonary bypass on-line blood gas monitor 870.4340 ⼼肺旁路液⾯⾃动检测监视器和/或控制器 Cardiopulmonary bypass level sensing monitor and/or control 870.4350 ⼼肺旁路氧合器 Cardiopulmonary bypass oxygenator 870.4360 ⾮滚筒型⼼肺旁路⾎液泵 Nonroller-type cardiopulmonary bypass blood pump 870.4370 滚筒型⼼肺旁路⾎液泵 Roller-type cardiopulmonary bypass blood pump 870.4380 ⼼肺旁路泵速度控制器 Cardiopulmonary bypass pump speed control 870.4390 ⼼肺旁路泵管路 Cardiopulmonary bypass pump tubing 870.4400 ⼼肺旁路⾎液储存器 Cardiopulmonary bypass blood reservoir 870.4410 ⼼肺旁路内嵌式⾎⽓传感器 Cardiopulmonary bypass in-line blood gas sensor 870.4420 ⼼肺旁路⼼切开术返回吸管 Cardiopulmonary bypass cardiotomy return sucker 870.4430 ⼼肺旁路⼼脏内抽吸控制器 Cardiopulmonary bypass intracardiac suction control 870.4450 ⾎管夹 Vascular clamp 870.4475 外科⼿术⾎管扩张器 Surgical vessel dilator 870.4500 ⼼⾎管⼿术器具 Cardiovascular surgical instruments 870.4875 管腔内动脉剥离器 Intraluminal artery stripper 870.4885 体外静脉剥离器 External vein stripper F亚部 ——⼼⾎管治疗器械（Cardiovascular Therapeutic Devices）患者照料吸引装置 Patient care suction apparatus 870.5150 栓⼦切除导管 Embolectomy catheter 870.5175 房隔造⼝导管 Septostomy catheter 870.5200 体外⼼脏挤压器 External cardiac compressor 870.5225 体外反搏装置 External counter-pulsating device 870.5300 DC－除颤器（包括除颤板） DC。

用于治疗心力衰竭的首款微创按压式器械——EpicHeart

用于治疗心力衰竭的首款微创按压式器械——EpicHeart简讯10月26日，Bioportfolio公布了CorInnova开发的一款新型心力衰竭治疗器械----EpicHeart，这是用于治疗心力衰竭的首款微创按压式器械。

这是世界上第一个具有关于损伤最小的侵入式心脏功能支持装置的专利保护，也获得了来自Wellcome Trust基金的610万美元的资助。

CorInnova公司首席执行官William Altman说：“我们的EpicHeart 器械是极具创新性和突破性的。

我们相信它将会成为引领心衰治疗的新范例。

”心力衰竭心力衰竭是指心脏无法提供足够血液流动以满足身体需要，目前没有治愈手段。

美国约有600万人心力衰竭患者。

终末期充血性心力衰竭的预后极差（两年死亡率达40％），心脏移植是首选治疗方法，但全球仅有4500个可移植心脏。

越来越多的先进的左心室辅助装置（LVAD）被研发用于延长生命，但是它们的使用受到侵入性手术与对心脏和主动脉的侵入性附着以及血液接触的限制，这些因素可能导致不良事件的发生，如血栓形成或者中风，以及应用抗凝剂后的出血和血管损伤。

因此每年仅有约7,000至8,000例左心室辅助装置被植入。

EpicHeart 器械特点1.第一款可折叠和扩张的自动心脏辅助装置；2.具有快速微创植入的能力和简单输入的工具；3.对心脏和主动脉无切口和缝线；4.操作无需接触血液，与血液接触辅助装置相比，不良事件减少多达30-40％；5.双心室辅助能力；6.通过促进正确的心脏运动促进心脏康复；7.具有预防大多数心脏病发作后心力衰竭进展的潜力。

EpicHeart 器械使用方法该技术从左肋骨间的间隙，通过输送鞘管并释放薄膜支架，使薄膜支架包覆心室。

通过设置压力控制装置来设定压力大小以及压缩频率。

（压缩频率与患者的心律一致） Epicheart能够纠正心脏运动，促进心脏修复。

薄膜支架与心脏之间填充生理盐水，使薄膜支架具备心脏在舒张末期的形状，能够为心脏表面提供平缓、均匀的压力。