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CN116328173A - Monitoring catheter, monitoring system and method for assisting heart in pumping blood - Google Patents

Monitoring catheter, monitoring system and method for assisting heart in pumping blood Download PDF

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Publication number
CN116328173A
CN116328173A CN202310222850.5A CN202310222850A CN116328173A CN 116328173 A CN116328173 A CN 116328173A CN 202310222850 A CN202310222850 A CN 202310222850A CN 116328173 A CN116328173 A CN 116328173A
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monitoring
catheter
sensor
blood
impeller
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李雨琦
高与番
郑李洋
胡登脉
李志刚
张坤
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Shanghai Weiqi Medical Instrument Co ltd
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Shanghai Weiqi Medical Instrument Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50Details relating to control
    • A61M60/508Electronic control means, e.g. for feedback regulation
    • A61M60/515Regulation using real-time patient data
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50Details relating to control
    • A61M60/508Electronic control means, e.g. for feedback regulation
    • A61M60/515Regulation using real-time patient data
    • A61M60/523Regulation using real-time patient data using blood flow data, e.g. from blood flow transducers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50Details relating to control
    • A61M60/508Electronic control means, e.g. for feedback regulation
    • A61M60/515Regulation using real-time patient data
    • A61M60/531Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/802Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804Impellers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3327Measuring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3365Rotational speed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3368Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00Anatomical parts of the body
    • A61M2210/12Blood circulatory system
    • A61M2210/125Heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/30Blood pressure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/50Temperature
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02EREDUCTION OF GREENHOUSE GAS [GHG] EMISSIONS, RELATED TO ENERGY GENERATION, TRANSMISSION OR DISTRIBUTION
    • Y02E10/00Energy generation through renewable energy sources
    • Y02E10/20Hydro energy

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
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Abstract

本申请涉及一种辅助心脏泵血的监测导管,其改进之处在于,所述监测导管包括:流入通道,为在管壁上设置通孔的管状体;流出通道,与流入通道的近端连接,为在管壁上设置通孔的管状体;叶轮装置,设置在流出通道内;传感器,设置于所述叶轮装置上;流体从流入通道进入,通过叶轮装置将流体从流出通道流出;当流体流出时,叶轮装置能够释放流体产生的回转压力,以便传感器能够感受到被测信息,进行数据信息输出。

Figure 202310222850

The present application relates to a monitoring catheter for assisting heart pumping. The improvement is that the monitoring catheter includes: an inflow channel, which is a tubular body with a through hole in the tube wall; an outflow channel, connected to the proximal end of the inflow channel , is a tubular body provided with a through hole on the pipe wall; the impeller device is arranged in the outflow channel; the sensor is arranged on the impeller device; the fluid enters from the inflow channel, and the fluid flows out from the outflow channel through the impeller device; When flowing out, the impeller device can release the rotary pressure generated by the fluid, so that the sensor can sense the measured information and output data information.

Figure 202310222850

Description

一种辅助心脏泵血的监测导管、监测系统及方法A monitoring catheter, monitoring system and method for assisting heart pumping

技术领域technical field

本发明涉及医疗器械技术领域,尤其涉及一种辅助心脏泵血的监测导管、监测系统及方法。The invention relates to the technical field of medical devices, in particular to a monitoring catheter for assisting heart pumping, a monitoring system and a method.

背景技术Background technique

心力衰竭主要是由于心脏收缩及舒张功能不全,使静脉血液泵出心脏动力不足,无法灌注足够的动脉血液,从而导致的心脏血循环异常。其中,以左心衰尤为普遍。在左心衰治疗前期时,通常采用药物进行治疗。在左心衰后期症状较重时,则需要通过手术植入起搏器进行干预。左心室辅助装置是缓解重症心衰的有效手段,将其经股动脉植入心脏,可将左心室内血液泵入主动脉中,辅助左心室完成血液循环。与临床中常用的经皮机械循环支持装置:例如主动脉内球囊反搏等。与体外膜氧合器相比,左心室辅助系统导管操作简单,风险低,创口小,可以在短时间内完成手术恢复心脏泵血。在大多数心脏介入手术中,多普勒超声是检测血流量的常用方法,以通过超声波的发射与接收去计算血流速度。Heart failure is mainly due to systolic and diastolic insufficiency, which makes the venous blood pump out of the heart insufficient power, unable to perfuse enough arterial blood, resulting in abnormal cardiac blood circulation. Among them, left heart failure is particularly common. In the early stage of left heart failure treatment, drugs are usually used for treatment. When the symptoms are severe in the late stage of left heart failure, surgical implantation of a pacemaker is required for intervention. The left ventricular assist device is an effective means to alleviate severe heart failure. It is implanted into the heart through the femoral artery, which can pump blood from the left ventricle into the aorta and assist the left ventricle to complete blood circulation. Compatible with percutaneous mechanical circulatory support devices commonly used in clinical practice: such as intra-aortic balloon counterpulsation. Compared with the extracorporeal membrane oxygenator, the left ventricular assist system catheter is easy to operate, with low risk and small wound, and can complete the operation in a short time to restore the heart pumping blood. In most cardiac interventional operations, Doppler ultrasound is a common method to detect blood flow, so as to calculate the blood flow velocity through the transmission and reception of ultrasound.

在左心室辅助系统导管泵血工作中,具体的血流量及血流速度仅能通过多普勒超声反映。使用超声检测血流需要经验丰富的超声医生,并且经多次操作才能得到较为准确的结果。当导管出现异常转动或停转时,由于心脏泵血时血流干扰较多,多普勒超声无法及时反馈当前导管的运转状态。In the blood pumping work of the left ventricular assist system catheter, the specific blood flow and blood flow velocity can only be reflected by Doppler ultrasound. The use of ultrasound to detect blood flow requires experienced sonographers, and more accurate results can only be obtained after repeated operations. When the catheter rotates or stalls abnormally, the Doppler ultrasound cannot provide timely feedback on the current operating status of the catheter due to more blood flow interference when the heart pumps blood.

发明内容Contents of the invention

本申请旨在解决现有技术中存在的技术问题。为此,本申请实施例提供了一种辅助心脏泵血的监测导管、监测系统及监测方法,能够通过与心脏辅助系统导管连接的监测装置实时监测心脏内血流变化,判断导管是否能够正常泵血,及时发现由导管高速转动导致的血栓或者使用寿命等其他原因引发的停转,显著提高了心衰手术的安全性和精准度。This application aims to solve the technical problems existing in the prior art. For this reason, the embodiment of the present application provides a monitoring catheter, a monitoring system and a monitoring method for assisting the heart to pump blood, which can monitor the blood flow changes in the heart in real time through the monitoring device connected to the heart assist system catheter, and judge whether the catheter can pump normally. Blood, timely detection of thrombus caused by high-speed rotation of the catheter or stall caused by other reasons such as service life, significantly improved the safety and accuracy of heart failure surgery.

本发明涉及一种辅助心脏泵血的监测导管,其改进之处在于,所述监测导管包括:The present invention relates to a monitoring catheter for assisting heart pumping. The improvement is that the monitoring catheter includes:

流入通道,为在管壁上设置通孔的管状体;The inflow passage is a tubular body provided with through holes on the pipe wall;

流出通道,与所述流入通道的近端连接,为在管壁上设置通孔的管状体;The outflow channel, connected to the proximal end of the inflow channel, is a tubular body with through holes provided on the tube wall;

叶轮装置,设置在所述流出通道内;an impeller device arranged in the outflow channel;

传感器,设置于所述叶轮装置上;a sensor arranged on the impeller device;

流体从所述流入通道进入,通过所述叶轮装置将流体从所述流出通道流出;当流体流出时,所述叶轮装置能够释放流体产生的回转压力,以便所述传感器能够感受到被测信息,进行数据信息输出。The fluid enters from the inflow channel, and the fluid flows out from the outflow channel through the impeller device; when the fluid flows out, the impeller device can release the rotary pressure generated by the fluid, so that the sensor can sense the measured information, Carry out data information output.

优选的,叶轮装置包括:Preferably, the impeller device includes:

基座,为圆柱体;The base is a cylinder;

轴芯,与所述基座同轴设置;the shaft core is arranged coaxially with the base;

叶片,设置于所述轴芯外表面;所述叶片的外接圆面积小于所述基座的横截面积;The blade is arranged on the outer surface of the shaft core; the circumscribed circle area of the blade is smaller than the cross-sectional area of the base;

叶轮外壁,为环状体;同轴连接至所述基座上;The outer wall of the impeller is an annular body; it is coaxially connected to the base;

在所述叶轮外壁上设置用于安装传感器的槽口。A notch for installing a sensor is provided on the outer wall of the impeller.

优选的,所述叶片包括在所述轴芯的外表面沿轴向旋转形成为螺旋形扇面。Preferably, the blade includes a helical sector formed by axially rotating on the outer surface of the shaft core.

优选的,所述辅助心脏泵血的监测导管还包括:连接管,用于连接所述流入通道与所述流出通道,所述连接管上设置显影环。Preferably, the monitoring catheter for assisting heart pumping further includes: a connecting tube for connecting the inflow channel and the outflow channel, and a developing ring is arranged on the connecting tube.

优选的,所述连接管为弯管。Preferably, the connecting pipe is an elbow.

优选的,在所述监测导管还包括:连接导管,为管状物,连接于所述叶轮装置近端。Preferably, the monitoring catheter further includes: a connecting catheter, which is a tube, connected to the proximal end of the impeller device.

优选的,所述连接导管包括:Preferably, the connecting conduit includes:

连接导管内腔,与叶轮装置同轴连接;Connect the inner cavity of the catheter and coaxially connect with the impeller device;

铰丝,设置于所述连接导管内腔中;A hinge wire is arranged in the lumen of the connecting catheter;

连接导管外腔,与所述连接导管内腔同轴设置;The outer cavity of the connecting catheter is arranged coaxially with the inner cavity of the connecting catheter;

传感器导线,设置于所述连接导管外腔的管壁内,用于与传感器连接。The sensor wire is arranged in the tube wall of the outer lumen of the connecting catheter, and is used for connecting with the sensor.

优选的,所述传感器包括:压力传感器、温度传感器、转速传感器和流量传感器。Preferably, the sensors include: pressure sensors, temperature sensors, rotational speed sensors and flow sensors.

本申请还涉及一种辅助心脏泵血的监测系统,其改进之处在于,所述监测系统包括:上述辅助心脏泵血的监测导管;The present application also relates to a monitoring system for assisting heart pumping, the improvement of which is that the monitoring system includes: the above-mentioned monitoring catheter for assisting heart pumping;

数据接收端口,与所述连接导管的近端连接,用于接收信号;A data receiving port, connected to the proximal end of the connecting catheter, for receiving signals;

监测装置,与所述辅助心脏泵血的监测导管电连接,用于监测信号的信息。本申请还涉及一种辅助心脏泵血的监测方法,用于上述的辅助心脏泵血的监测系统,其改进之处在于,所述监测方法包括:通过导引导丝将所述辅助心脏泵血的监测导管经股动脉放入至左心室;在所述叶轮装置启动前,所述监测装置获得监测数据阈值;当所述叶轮装置启动后,所述监测装置获得实际监测数据;将实际监测数据与监测数据阈值进行比较,当实际监测数据不在所述监测数据阈值的范围内时,则判断所述监测导管为非正常工作状态;当实际监测数据在所述监测数据阈值的范围内波动时,则判断所述监测导管为正常工作状态。The monitoring device is electrically connected with the monitoring catheter for assisting the heart to pump blood, and is used for monitoring signal information. The present application also relates to a method for monitoring blood pumping of the auxiliary heart, which is used in the above-mentioned monitoring system for pumping blood of the auxiliary heart. The monitoring catheter is placed into the left ventricle through the femoral artery; before the impeller device is started, the monitoring device obtains the monitoring data threshold; after the impeller device is started, the monitoring device obtains the actual monitoring data; the actual monitoring data is combined with When the actual monitoring data is not within the range of the monitoring data threshold, it is judged that the monitoring catheter is in an abnormal working state; when the actual monitoring data fluctuates within the range of the monitoring data threshold, then It is judged that the monitoring catheter is in a normal working state.

与现有技术相比,本发明的有益效果为:Compared with prior art, the beneficial effect of the present invention is:

本发明提供的辅助心脏泵血的监测导管其结构简单,操作方便,安全高效,尤其在进行基于辅助心脏泵血的压力监测时,不需要借助额外手段就可实现实时监测泵血工作中的血流血压,判断导管的运转状态。The monitoring catheter for assisting the heart to pump blood provided by the present invention has the advantages of simple structure, convenient operation, safety and high efficiency, especially when performing pressure monitoring based on assisting the heart to pump blood, real-time monitoring of the blood in the blood pumping work can be realized without additional means. Blood pressure, to judge the operation status of the catheter.

本申请提供的辅助心脏泵血的监测导管和监测系统,不仅可以实时监测心脏内血流变化,判断导管是否能够正常泵血,及时发现由导管高速转动导致的血栓或者使用寿命等其他原因引发的停转,显著提高心衰手术的安全性和精准度;还可以将压力传感器替换为温度传感器、转速传感器、流量传感器等,用于不同实施场景包括但不限于心脏、血管、肠道、肺静脉、肺动脉等人体不同组织部位。The monitoring catheter and monitoring system for assisting heart pumping provided by this application can not only monitor the change of blood flow in the heart in real time, judge whether the catheter can pump blood normally, but also detect in time the thrombus caused by the high-speed rotation of the catheter or other reasons such as service life. It can significantly improve the safety and accuracy of heart failure surgery; pressure sensors can also be replaced by temperature sensors, speed sensors, flow sensors, etc., for different implementation scenarios including but not limited to the heart, blood vessels, intestines, pulmonary veins, Pulmonary artery and other different tissue parts of the human body.

附图说明Description of drawings

构成本申请的一部分的说明书附图用来提供对本发明的进一步理解,本发明的示意性实施例及其说明用于解释本发明,并不构成对本发明的不当限定。其中:The accompanying drawings constituting a part of the present application are used to provide a further understanding of the present invention, and the schematic embodiments and descriptions of the present invention are used to explain the present invention, and do not constitute an improper limitation of the present invention. in:

图1为本发明一个实施例的监测导管示意图;Fig. 1 is a schematic diagram of a monitoring catheter according to an embodiment of the present invention;

图2为本发明一个实施例的监测系统示意图;Fig. 2 is a schematic diagram of a monitoring system according to an embodiment of the present invention;

图3为本发明一个实施例的流入通道示意图;Fig. 3 is a schematic diagram of an inflow channel according to an embodiment of the present invention;

图4为本发明一个实施例的流入通道主视示意图;Fig. 4 is a schematic front view of an inflow channel according to an embodiment of the present invention;

图5为本发明一个实施例的流出通道示意图;Fig. 5 is a schematic diagram of an outflow channel according to an embodiment of the present invention;

图6为本发明一个实施例的流出通道主视示意图;Fig. 6 is a schematic front view of an outflow channel according to an embodiment of the present invention;

图7为本发明一个实施例的流出通道左视示意图;Fig. 7 is a schematic left view of an outflow channel according to an embodiment of the present invention;

图8为本发明一个实施例的叶轮示意图;Fig. 8 is a schematic diagram of an impeller according to an embodiment of the present invention;

图9为本发明一个实施例的叶轮主视示意图;Fig. 9 is a schematic front view of an impeller according to an embodiment of the present invention;

图10为本发明一个实施例的叶轮左视示意图;Figure 10 is a schematic left view of an impeller according to an embodiment of the present invention;

图11为本发明一个实施例的叶轮装配示意图;Figure 11 is a schematic diagram of impeller assembly according to an embodiment of the present invention;

图12为本发明一个实施例的叶轮装配左视示意图;Fig. 12 is a schematic left view of impeller assembly according to an embodiment of the present invention;

图13为本发明一个实施例的连接导管示意图;Fig. 13 is a schematic diagram of a connecting conduit according to an embodiment of the present invention;

其中,流入通道10、跨瓣弯管20、显影环21、流出通道30、轴芯31、传感器32、叶轮装置33、连接导管40、连接导管外腔41、传感器导线42、连接导管内腔43、铰丝44、监测仪50、导管前段60、数据接收端口70、软管80。Among them, the inflow channel 10, the transvalvular elbow 20, the developing ring 21, the outflow channel 30, the shaft core 31, the sensor 32, the impeller device 33, the connecting catheter 40, the connecting catheter outer cavity 41, the sensor wire 42, the connecting catheter inner cavity 43 , hinge wire 44, monitor 50, catheter front section 60, data receiving port 70, hose 80.

具体实施方式Detailed ways

下面将对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明的一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员所获得的所有其他实施例,都属于本发明保护的范围。The technical solutions in the embodiments of the present invention will be clearly and completely described below, obviously, the described embodiments are only some of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by persons of ordinary skill in the art based on the embodiments of the present invention belong to the protection scope of the present invention.

在本发明的描述中,术语“纵向”、“横向”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明而不是要求本发明必须以特定的方位构造和操作,因此不能理解为对本发明的限制。本发明中使用的术语“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接;可以是直接相连,也可以通过中间部件间接相连,对于本领域的普通技术人员而言,可以根据具体情况理解上述术语的具体含义。In the description of the present invention, the terms "longitudinal", "transverse", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", " The orientations or positional relationships indicated by "top", "bottom", etc. are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and do not require that the present invention must be constructed and operated in a specific orientation, so they cannot be understood as Limitations on the Invention. The terms "connected" and "connected" used in the present invention should be understood in a broad sense, for example, it can be fixedly connected or detachably connected; it can be directly connected or indirectly connected through intermediate parts, for ordinary A skilled person can understand the specific meanings of the above terms according to specific situations.

在介入医疗器械领域,一般将植入人体或动物体内的医疗器械的距离操作者较近的一端称为“近端”,将距离操作者较远的一端称为“远端”,并依据此原理定义医疗器械的任一部件的“近端”和“远端”。“轴向”一般是指医疗器械在被输送时的长度方向,“径向”一般是指医疗器械的与其“轴向”垂直的方向,并依据此原理定义医疗器械的任一部件的“轴向”和“径向”。In the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end", and the end that is farther from the operator is called the "distal end". Principles define the "proximal" and "distal" ends of any component of a medical device. "Axial" generally refers to the length direction of the medical device when it is being transported, and "radial" generally refers to the direction perpendicular to the "axial" of the medical device, and the "axis" of any part of the medical device is defined according to this principle to" and "radial".

下面将参考附图并结合实施例来详细说明本发明。需要说明的是,在不冲突的情况下,本发明中的实施例及实施例中的特征可以相互组合。The present invention will be described in detail below with reference to the accompanying drawings and examples. It should be noted that, in the case of no conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other.

心力衰竭主要是由于心脏收缩及舒张功能不全,使静脉血液泵出心脏动力不足,无法灌注足够的动脉血液,从而导致的心脏血循环异常。其中,以左心衰尤为普遍。在左心衰治疗前期时,通常采用药物进行治疗。在左心衰后期症状较重时,则需要通过手术植入起搏器或者心脏移植进行干预,然而心脏移植供不应求,不能满足患者需求。因此通常采用左心室辅助装置作为缓解重症心衰的有效手段,将其经过股动脉植入心脏,可将左心室内血液泵入主动脉中,辅助左心室完成血液循环。与临床中常用的经皮机械循环支持装置:例如主动脉内球囊反搏、体外膜氧合器相比,左心室辅助系统导管操作简单,风险低,创口小,可以在短时间内完成手术恢复心脏泵血。在大多数心脏介入手术中,多普勒超声是检测血流量的常用方法,以通过超声波的发射与接收去计算血流速度。Heart failure is mainly due to systolic and diastolic insufficiency, which makes the venous blood pump out of the heart insufficient power, unable to perfuse enough arterial blood, resulting in abnormal cardiac blood circulation. Among them, left heart failure is particularly common. In the early stage of left heart failure treatment, drugs are usually used for treatment. When the symptoms are severe in the late stage of left heart failure, surgical implantation of a pacemaker or heart transplantation is required for intervention. However, the supply of heart transplants is in short supply and cannot meet the needs of patients. Therefore, a left ventricular assist device is usually used as an effective means to alleviate severe heart failure. It is implanted into the heart through the femoral artery, which can pump blood from the left ventricle into the aorta and assist the left ventricle to complete blood circulation. Compared with percutaneous mechanical circulatory support devices commonly used in clinical practice: such as intra-aortic balloon counterpulsation and extracorporeal membrane oxygenator, the left ventricular assist system catheter is easy to operate, with low risk and small wound, and the operation can be completed in a short time Resume heart pumping. In most cardiac interventional operations, Doppler ultrasound is a common method to detect blood flow, so as to calculate the blood flow velocity through the transmission and reception of ultrasound.

在左心室辅助系统导管泵血工作中,具体的血流量及血流速度仅能通过多普勒超声反映。使用超声检测血流需要经验丰富的超声医生,并且经多次操作才能得到较为准确的结果。当导管出现异常转动或停转时,由于心脏泵血时血流干扰较多,多普勒超声将无法及时反馈当前导管的运转状态。In the blood pumping work of the left ventricular assist system catheter, the specific blood flow and blood flow velocity can only be reflected by Doppler ultrasound. The use of ultrasound to detect blood flow requires experienced sonographers, and more accurate results can only be obtained after repeated operations. When the catheter rotates or stalls abnormally, the Doppler ultrasound will not be able to provide timely feedback on the current operating status of the catheter due to more blood flow interference when the heart pumps blood.

现有的心脏泵血辅助导管不具备实时监测泵血工作血压的能力。现有的用于测试血流量及血流速度的多普勒超声技术需要专业超声团队的支持,其操作复杂,培训周期长,测试结果不准确。因此,本发明提供的一种辅助心脏泵血的监测导管,其结构简单,操作方便,安全高效,在进行基于辅助心脏泵血的压力监测时,不需要借助额外手段就可实现实时监测泵血工作中的血流血压,判断导管的运转状态。能够实时监测心脏内血流变化,判断导管是否正常泵血,及时发现由导管高速转动导致的血栓或者使用寿命等其他原因引发的停转,显著提高了心衰手术的安全性和精准度。Existing heart pumping auxiliary catheters do not have the ability to monitor the working blood pressure of pumping blood in real time. The existing Doppler ultrasound technology for testing blood flow and blood velocity requires the support of a professional ultrasound team, and its operation is complicated, the training period is long, and the test results are inaccurate. Therefore, the monitoring catheter for assisting heart pumping provided by the present invention has simple structure, convenient operation, safety and high efficiency. When performing pressure monitoring based on assisting heart pumping, real-time monitoring of pumping blood can be realized without additional means. The blood flow and blood pressure during work can be used to judge the operation status of the catheter. It can monitor the blood flow changes in the heart in real time, judge whether the catheter is pumping blood normally, and timely detect the thrombus caused by the high-speed rotation of the catheter or the stall caused by other reasons such as service life, which significantly improves the safety and accuracy of heart failure surgery.

具体的,如图1所示,本发明涉及一种辅助心脏泵血的监测导管,其改进之处在于,所述辅助心脏泵血的监测导管包括,依次连接的流入通道10、跨瓣弯管20、流出通道30、和连接导管40。Specifically, as shown in FIG. 1 , the present invention relates to a monitoring catheter for assisting heart pumping. The improvement is that the monitoring catheter for assisting heart pumping includes an inflow channel 10 connected in sequence, a transvalvular elbow 20 , an outflow channel 30 , and a connecting conduit 40 .

具体的,流入通道10,为管状体,其长度不限;包括第一管壁,以及在所述第一管壁上设置的第一通孔,以便流体流入。Specifically, the inflow channel 10 is a tubular body, the length of which is not limited; it includes a first tube wall and a first through hole provided on the first tube wall for fluid to flow in.

具体的,第一通孔的形状和大小不限,可以为圆形、椭圆形、多边形、或者不规则形状,只要穿透管壁形成通孔即可;第一通孔的数量也不做限制,一个或者一个以上均可,可以达到让流体能够进入流入通道的功能即可。Specifically, the shape and size of the first through hole are not limited, and can be circular, elliptical, polygonal, or irregular in shape, as long as the through hole is formed through the pipe wall; the number of the first through hole is not limited , one or more than one can be used to achieve the function of allowing fluid to enter the inflow channel.

优选的,如图3和图4所示,在本申请的一个优选实施例中,为了增大流入通道10进入的血流量,因此将通孔设计为沿管状体轴向延伸的矩形槽口,且多个槽口均匀排列在第一管壁上。优选的,可以将矩形槽口的宽度边调整为弧形,使得槽口更加圆润,不伤害血管壁。Preferably, as shown in Figures 3 and 4, in a preferred embodiment of the present application, in order to increase the blood flow entering the inflow channel 10, the through hole is designed as a rectangular notch extending axially along the tubular body, And a plurality of notches are uniformly arranged on the first pipe wall. Preferably, the width side of the rectangular notch can be adjusted to be arc-shaped, so that the notch is more rounded and does not damage the blood vessel wall.

同时,为了便于将监测导管放置于血管内而不损伤血管壁,因此在流入通道10的远端端面设置倒角。优选的,将流入通道10的远端端口设计为小于其近端端口,以便更加便于监测导管的置入。At the same time, in order to facilitate the placement of the monitoring catheter in the blood vessel without damaging the blood vessel wall, chamfers are provided on the distal end surface of the inflow channel 10 . Preferably, the distal end port of the inflow channel 10 is designed to be smaller than its proximal end port, so as to facilitate the placement of the monitoring catheter.

如图1所示,在一些实施例中,流入通道10远端连接有弹性且自然弯曲的软管80。为了避免对组织器官造成伤害,软管80的远端采用柔性材料,远端在自然状态下成卷曲状,一般采用中空管状结构,通过导引导丝等将监测导管辅助进入人体,如心脏左心室,其卷曲的形状在左心室内通常情况下不会发生折叠、扭曲或滑脱的情况。As shown in FIG. 1 , in some embodiments, the distal end of the inflow channel 10 is connected with an elastic and naturally curved hose 80 . In order to avoid damage to tissues and organs, the distal end of the hose 80 is made of flexible material, and the distal end is curled in a natural state, and generally adopts a hollow tubular structure, and the monitoring catheter is assisted to enter the human body through a guide wire, such as the left ventricle of the heart , and its curled shape does not normally fold, twist, or slip within the left ventricle.

流出通道30,为管状体,其长度不限,与所述流入通道10的近端连接;包括第二管壁,以及在所述第二管壁上设置的第二通孔,以便血液流出;The outflow channel 30 is a tubular body, the length of which is not limited, and is connected to the proximal end of the inflow channel 10; it includes a second tube wall and a second through hole provided on the second tube wall for blood to flow out;

具体的,第二通孔的形状和大小不限,可以为圆形、椭圆形、多边形、或者不规则形状,只要穿透第二管壁形成通孔即可;第二通孔的数量也不做限制,一个或者一个以上均可,能够让血液从流出通道流出即可。Specifically, the shape and size of the second through hole are not limited, and can be circular, elliptical, polygonal, or irregular in shape, as long as the second through hole is penetrated to form a through hole; As restrictions, one or more than one can be used to allow blood to flow out from the outflow channel.

优选的,如图5至图7所示,在本申请的一个优选实施例中,为了增大从流出通道30流出的血流量,同时又为了避免后续因为血流量过大从而干扰传感器的运行状态,因此在流出通道30中部沿管状体轴向设置有矩形通孔,且多个通孔均匀排列在第二管壁上。为了令流出通道30表面光滑,上述矩形通孔应设置圆角。为了便于流出通道30与其他器件连接,流出通道30的远端端口小于其近端端口。Preferably, as shown in FIG. 5 to FIG. 7, in a preferred embodiment of the present application, in order to increase the blood flow flowing out from the outflow channel 30, and at the same time, in order to avoid subsequent interference with the operating state of the sensor due to excessive blood flow Therefore, a rectangular through hole is arranged in the middle of the outflow channel 30 along the axial direction of the tubular body, and a plurality of through holes are uniformly arranged on the second tube wall. In order to make the surface of the outflow channel 30 smooth, the above-mentioned rectangular through hole should be provided with rounded corners. In order to facilitate the connection of the outflow channel 30 with other devices, the distal port of the outflow channel 30 is smaller than its proximal port.

叶轮装置33,同轴设置在所述流出通道内;The impeller device 33 is coaxially arranged in the outflow channel;

叶轮装置包括:基座,叶片和轴芯。具体的,轴芯的形状不做限制,可视为与所述流出通道30同轴设置的旋转轴,为柱状体即可。如图8至图10所示在本申请的一个优选实施例中,采用的芯轴为条状体,其截面为三叉星结构,具体为假设一个整圆被同时以圆心出发的三条射线平均分割为三份,三叉星结构即为所述三条射线沿轴线延长形成的条状体结构。所述叶片的形状也不做限制,可以是沿轴芯表面的径向设置的多个均匀排列的扇叶状叶片,以2-4个为最佳,多个叶片可以是在径向共面的,也可以是在沿轴向分开排列的,只要能达到释放叶轮装置对血液施加的回转压力即可。The impeller device includes: a base, blades and a shaft core. Specifically, the shape of the shaft core is not limited, and it can be regarded as a rotation shaft coaxially arranged with the outflow channel 30 , which may be a columnar body. As shown in Figures 8 to 10, in a preferred embodiment of the present application, the mandrel used is a strip-shaped body, and its cross-section is a three-pointed star structure, specifically assuming that a full circle is equally divided by three rays starting from the center of the circle at the same time There are three parts, and the trident star structure is a strip structure formed by extending the three rays along the axis. The shape of the blades is also not limited, it can be a plurality of uniformly arranged fan-like blades arranged radially along the surface of the shaft core, preferably 2-4, and multiple blades can be coplanar in the radial direction They can also be arranged separately in the axial direction, as long as the rotational pressure exerted by the impeller device on the blood can be released.

其中,叶片在所述轴芯外表面围绕所述轴芯的轴线方向旋转而形成螺旋形扇面,当轴芯轴向旋转时,能带动叶片一起旋转,以便释放叶轮装置对血液施加的回转压力。具体的,所述叶片可以是单一叶片旋转而成的螺旋形扇面,也可以是多个叶片旋转形成的扇面。在本申请其中一个优选实施例中,两个叶片从不同的初始位置沿同一旋转方向在轴芯表面沿轴向延伸,由于轴芯具有三叉星结构,因此,叶片与轴芯呈现出相对卡接的效果,能够令叶片与轴芯的连接更加牢固。Wherein, the blade rotates around the axial direction of the shaft core on the outer surface of the shaft core to form a spiral sector, and when the shaft core rotates axially, it can drive the blades to rotate together so as to release the rotational pressure exerted by the impeller device on the blood. Specifically, the blade may be a helical fan surface formed by the rotation of a single blade, or a fan surface formed by the rotation of multiple blades. In one of the preferred embodiments of the present application, the two blades extend axially on the surface of the shaft core from different initial positions along the same rotation direction. Since the shaft core has a three-pointed star structure, the blades and the shaft core are relatively engaged. The effect can make the connection between the blade and the shaft core more firm.

叶轮装置还包括叶轮外壁,The impeller device also includes the outer wall of the impeller,

具体的,叶轮外壁为管状体,同轴连接于基座上的另一端,即设置于与叶片相反的方向。叶轮外壁直径需与基座直径相匹配,以保证能够将叶轮装置放入流出通道30内。在叶轮外壁上还设置有槽口,以便放入传感器。优选的,为了达到更好的获得感应数据,叶轮外壁尺寸与基座尺寸相同,以便传感器在使用时对外部环境更加敏锐,能够获得更精确的检测数据。传感器的设置位置以及个数不做限制,为了检测更精确,因此将传感器均匀排列在叶轮外壁上。Specifically, the outer wall of the impeller is a tubular body, which is coaxially connected to the other end of the base, that is, arranged in the direction opposite to the blade. The diameter of the outer wall of the impeller needs to match the diameter of the base, so as to ensure that the impeller device can be put into the outflow channel 30 . A notch is also provided on the outer wall of the impeller for placing the sensor. Preferably, in order to obtain better sensing data, the size of the outer wall of the impeller is the same as that of the base, so that the sensor is more sensitive to the external environment during use and can obtain more accurate detection data. The location and number of sensors are not limited. In order to detect more accurately, the sensors are evenly arranged on the outer wall of the impeller.

马达设置在叶轮外壁形成的空心部分内,与轴芯连接以提供叶轮装置的动力。The motor is arranged in the hollow part formed by the outer wall of the impeller, and is connected with the shaft core to provide the power of the impeller device.

如图11和12所示,在流出通道30与叶轮装置装配时,需保证传感器位于叶轮外壁内,流出通道30的第二通孔与叶片的径向配合,保证当血液流出时,传感器不会收到血液的干扰,同时又能监测到血液流出时的各项数据。As shown in Figures 11 and 12, when the outflow channel 30 is assembled with the impeller device, it is necessary to ensure that the sensor is located in the outer wall of the impeller, and the second through hole of the outflow channel 30 cooperates with the radial direction of the blade to ensure that when the blood flows out, the sensor will not It receives the interference of blood, and at the same time, it can monitor various data when the blood flows out.

如图13所示,监测导管还包括连接导管40,连接于所述叶轮装置33的近端,由连接导管外腔41,传感器导线42,连接导管内腔43和铰丝44组成。As shown in FIG. 13 , the monitoring catheter also includes a connecting catheter 40 , which is connected to the proximal end of the impeller device 33 and consists of a connecting catheter outer lumen 41 , sensor wires 42 , connecting catheter lumen 43 and hinge wire 44 .

具体包括连接导管内腔43,为一种长条空心软管,材质不限,与轴芯同轴连接;It specifically includes connecting the inner cavity of the catheter 43, which is a long hollow hose with any material, coaxially connected with the shaft core;

铰丝44,优选为延其自身轴线扭转的金属丝,设置于所述连接导管内腔43中,与马达连接至叶轮装置上以传递电能;The hinge wire 44, preferably a metal wire twisted along its own axis, is arranged in the inner cavity 43 of the connecting conduit, and is connected to the impeller device with the motor to transmit electric energy;

连接导管外腔41,为一种长条软管,材质不限,与所述连接导管内腔43同轴设置;The outer cavity 41 of the connecting catheter is a long flexible tube of any material, which is arranged coaxially with the inner cavity 43 of the connecting catheter;

传感器导线42,用于与传感器32连接,设置位置不做限制。在本申请的优选实施例中,传感器导线42沿连接导管外腔41的轴向置于所述连接导管外腔41的管壁内。The sensor wire 42 is used to connect with the sensor 32, and the setting position is not limited. In a preferred embodiment of the present application, the sensor wire 42 is placed in the tube wall of the outer lumen 41 of the connecting catheter along the axial direction of the outer lumen 41 of the connecting catheter.

为了达到让监测导管平稳进入心脏左室的效果,还在流入通道和流出通道的连接处设置一个连接管。并且将连接管设计为弯曲状,即作为跨瓣弯管20。其弯曲弧度不限,用以匹配左心室与股动脉的弧度。In order to achieve the effect of allowing the monitoring catheter to enter the left ventricle of the heart smoothly, a connecting tube is also provided at the junction of the inflow channel and the outflow channel. And the connecting tube is designed to be curved, that is, as the transvalvular elbow 20 . The curvature is not limited, and is used to match the curvature of the left ventricle and the femoral artery.

为了能够显示监测导管在心脏主动脉弓中的具体位置,还需在第二连接管上设置显影环21。In order to display the specific position of the monitoring catheter in the aortic arch of the heart, a developing ring 21 needs to be provided on the second connecting tube.

本发明提供的监测导管,可使用不同的传感器以便应用于不同的监测环境。The monitoring catheter provided by the present invention can use different sensors so as to be applied to different monitoring environments.

实施场景之一:One of the implementation scenarios:

如图1和图2所示,当传感器采用压力传感器时,本发明涉及的一种监测导管包括:流入通道10、跨瓣弯管20、显影环21、叶轮装置33、压力传感器、流出通道30和连接导管40。流入通道10设置在监测导管远端,并与跨瓣弯管20相连接;显影环21设置在所述跨瓣弯管20的后端,用于X光穿透显示所述跨瓣弯管上的显影环在主动脉弓中的具体位置,并记录此时监测仪50输出的压力监测数据。跨瓣弯管20与流出通道30相连接,同时与所述流入通道10连接组成导管前段60,即从远端至近端依次连接的流入通道10、跨瓣弯管20和流出通道30构成导管前段60。导管前段60需要通过导引导丝从流入通道10穿入至流出通道30。先将导引导丝经股动脉进入左心室,再将导管前段60通过上述导引导丝穿入送入左心室进行泵血工作。叶轮装置33设置在流出通道30内;流出通道30内壁上设置有三个以上等距分布的压力传感器,用于实时监测泵血血压,即血液流出流出通道30时的血压,并取数据的平均值减少测试误差。流出通道30与连接导管40相连接;连接导管包括连接导管外腔41和连接导管内腔43。连接导管外腔41,用于定位传感器导线42。传感器导线42与所述连接导管40近端的监测数据接收端口70连接,并通过数据接收端口连接外部监测仪50,显示泵血工作中实时血压值。连接导管内腔43,用于设置连接叶轮装置的铰丝44。铰丝也同时与设置在连接导管40近端的马达连接,通过马达驱动铰丝从而转动叶轮装置33,以辅助左心室血液泵入主动脉,并记录泵血稳定后压力监测仪的输出数据。所述连接导管内腔43,用于注射通过生理盐水和肝素,生理盐水用于手术前排出连接导管内气泡与降低叶轮装置工作时温度,肝素用于预防局部血栓引发的术中并发症。泵血后,将监测仪50监测到的实际压力数据与叶轮装置在泵血前的监测数据阈值进行比较,当压力监测数据出现明显波动,超出监测数据阈值的范围即叶轮装置运行时的安全值时,需要判断导管中叶轮装置运转状态。若叶轮装置转动异常,则应当及时撤出导管进行更换,保证辅助泵血的正常进行。因监测导管采用的叶轮装置的结构会有所不同,其所对应的泵血流量不同,产生的压力也不同,因此目前没有统一的监测范围,只需监测与到有较大波动发生,即可检查叶轮装置的运行状态。As shown in Figures 1 and 2, when the sensor adopts a pressure sensor, a monitoring catheter related to the present invention includes: an inflow channel 10, a transvalvular elbow 20, a developing ring 21, an impeller device 33, a pressure sensor, and an outflow channel 30 And connecting conduit 40. The inflow channel 10 is arranged at the distal end of the monitoring catheter and is connected with the transvalvular elbow 20; the developing ring 21 is arranged at the rear end of the transvalvular elbow 20 for X-ray penetration display on the transvalvular elbow The specific position of the developing ring in the aortic arch, and record the pressure monitoring data output by the monitor 50 at this time. The transvalvular elbow 20 is connected with the outflow channel 30, and at the same time, it is connected with the inflow channel 10 to form the front section 60 of the catheter, that is, the inflow channel 10, the transvalvular elbow 20 and the outflow channel 30 connected in sequence from the distal end to the proximal end constitute the catheter Front section 60. The catheter front section 60 needs to pass through the guide wire from the inflow channel 10 to the outflow channel 30 . Firstly, the guide wire enters the left ventricle through the femoral artery, and then the front section 60 of the catheter is passed through the guide wire and sent into the left ventricle for blood pumping. The impeller device 33 is set in the outflow channel 30; the inner wall of the outflow channel 30 is provided with more than three pressure sensors equidistantly distributed for real-time monitoring of pump blood pressure, that is, the blood pressure when blood flows out of the outflow channel 30, and the average value of the data is taken Reduce test errors. The outflow channel 30 is connected with a connecting conduit 40 ; the connecting conduit includes an outer cavity 41 of the connecting conduit and an inner cavity 43 of the connecting conduit. Catheter lumen 41 is attached for positioning sensor wire 42 . The sensor wire 42 is connected to the monitoring data receiving port 70 at the proximal end of the connecting catheter 40, and is connected to an external monitor 50 through the data receiving port to display the real-time blood pressure value during blood pumping. The inner cavity 43 of the connecting conduit is used for setting the hinged wire 44 connected to the impeller device. The hinge wire is also connected to the motor arranged at the proximal end of the connecting catheter 40, and the motor drives the hinge wire to rotate the impeller device 33 to assist the pumping of blood from the left ventricle into the aorta, and record the output data of the pressure monitor after the blood pump is stabilized. The lumen 43 of the connecting catheter is used for injecting normal saline and heparin. The normal saline is used to discharge air bubbles in the connecting catheter and reduce the temperature of the impeller device before operation, and the heparin is used to prevent intraoperative complications caused by local thrombus. After the blood is pumped, compare the actual pressure data monitored by the monitor 50 with the monitoring data threshold of the impeller device before pumping blood. When the pressure monitoring data fluctuates significantly, the range beyond the monitoring data threshold is the safe value of the impeller device during operation. , it is necessary to judge the running state of the impeller device in the duct. If the impeller device rotates abnormally, the catheter should be withdrawn in time for replacement to ensure the normal operation of the auxiliary blood pump. Because the structure of the impeller device used in the monitoring catheter will be different, the corresponding pump blood flow rate is different, and the pressure generated is also different. Therefore, there is no unified monitoring range at present. It only needs to be monitored when there is a large fluctuation. Check the operation of the impeller unit.

本申请将压力传感器与叶轮装置设置为一体,在使用时,压力传感器可以更加敏锐感受到血液在流动时作用于流出通道的侧压力,能够得到更加准确的血压监测数据,以便进而迅速反应心脏辅助泵血导管是否在正常工作。In this application, the pressure sensor and the impeller device are integrated. When in use, the pressure sensor can more sensitively feel the side pressure of the blood acting on the outflow channel when the blood is flowing, and can obtain more accurate blood pressure monitoring data, so as to quickly respond to cardiac assistance. Whether the blood pump catheter is working properly.

应用场景之二:Application scenario two:

当传感器采用温度传感器时,能够测量泵血时的血液温度。监测导管放置方式与应用场景一相同,对此不再进行冗余赘述。泵血后,通过监测仪50显示的泵血工作中实时温度值。温度监测数据阈值即人体心脏温度正常范围为36.9°到37.9°,记录泵血前温度数据,与泵血后实际监测的温度数据进行比较,判断心脏内血液温度是否正常。若实时温度在导管稳定运转10min后持续高于37.9°,需及时停止泵血。When the sensor adopts a temperature sensor, it is possible to measure the temperature of the blood when the blood is pumped. The placement method of the monitoring catheter is the same as that of the application scenario 1, and redundant description will not be repeated here. After the blood is pumped, the monitor 50 displays the real-time temperature value during the blood pumping operation. The temperature monitoring data threshold means the normal range of human heart temperature is 36.9° to 37.9°. Record the temperature data before pumping blood and compare it with the actual monitored temperature data after pumping blood to judge whether the blood temperature in the heart is normal. If the real-time temperature continues to be higher than 37.9° after 10 minutes of stable operation of the catheter, blood pumping should be stopped in time.

本申请将温度传感器与叶轮装置设置为一体,在使用时,温度传感器可以更加敏锐感受到人体心脏温度,能够得到更加准确的温度监测数据,以便进而迅速反应心脏辅助泵血导管是否在正常工作。In this application, the temperature sensor and the impeller device are integrated. When in use, the temperature sensor can sense the temperature of the human heart more sensitively, and can obtain more accurate temperature monitoring data, so as to quickly reflect whether the heart-assisted blood pump catheter is working normally.

应用场景之三:The third application scenario:

当传感器采用转速传感器时,能够测量泵血时的叶轮装置的转速。监测导管放置方式与应用场景一相同,对此不再进行冗余赘述。通过监测仪50显示叶片在泵血工作中叶轮的实时转速。记录叶轮装置实时转速,与监测数据阈值即马达实际转速进行比较,判断导管中叶轮装置运转状态。若叶轮装置转速异常,则监测到实际监测的转速数据与马达实际转速不匹配,应及时撤出导管进行更换,保证辅助泵血的正常进行。When a rotational speed sensor is used as the sensor, the rotational speed of the impeller device during blood pumping can be measured. The placement method of the monitoring catheter is the same as that of the application scenario 1, and redundant description will not be repeated here. The monitor 50 displays the real-time rotational speed of the impeller when the blade is pumping blood. Record the real-time speed of the impeller device, compare it with the monitoring data threshold, that is, the actual speed of the motor, and judge the operation status of the impeller device in the duct. If the speed of the impeller device is abnormal, it is detected that the actual monitored speed data does not match the actual speed of the motor, and the catheter should be withdrawn in time for replacement to ensure the normal operation of the auxiliary blood pump.

本申请将转速传感器与叶轮装置设置为一体,在使用时,转速传感器能够得到更加准确的叶轮装置的转速数据,以便进而迅速反应心脏辅助泵血导管是否在正常工作。In this application, the rotational speed sensor and the impeller device are integrated. When in use, the rotational speed sensor can obtain more accurate rotational speed data of the impeller device, so as to quickly reflect whether the heart-assisted blood pumping catheter is working normally.

应用场景之四:The fourth application scenario:

当传感器采用流量传感器时,能够测量泵血时的血液流量。导管放置方式与应用场景一相同,对此不再进行冗余赘述。通过监测仪50显示叶轮装置在泵血工作中泵出血液实时流量。监测装置获得实际监测数据,记录泵血时血液的实时流量,并与泵血前监测数据阈值进行比较,判断导管中叶轮装置是否正常泵血。若泵血流量异常,则判断监测导管为非正常工作状态,应当及时撤出导管进行更换,保证辅助泵血的正常进行。具体为,假设在叶轮装置转动前先记录人心脏泵血流量X L/min,如果叶轮装置本身的最大泵血流量是2.0-2.5L/min(不包括人心脏泵血流量),则泵血流量记为2.Y L/min,此时正常工作的泵血流量阈值为X+2.Y L/min。当泵血后的实际监测数据出现较大波动时,即监测流量从初始流量X+2.Y L/min突然下降到X L/min左右时,此时可视为此时叶轮装置停止转动,应及时更换导管。When the sensor adopts a flow sensor, it can measure the blood flow when pumping blood. The way of placing the catheter is the same as that of the application scenario 1, and redundant description will not be repeated here. The monitor 50 displays the real-time flow of blood pumped by the impeller device during the blood pumping work. The monitoring device obtains actual monitoring data, records the real-time flow of blood during blood pumping, and compares it with the threshold value of the monitoring data before pumping to judge whether the impeller device in the catheter is pumping blood normally. If the pump blood flow is abnormal, it is judged that the monitoring catheter is not in normal working condition, and the catheter should be withdrawn in time for replacement to ensure the normal operation of the auxiliary blood pump. Specifically, assuming that the human heart pump blood flow X L/min is recorded before the impeller device rotates, if the maximum pump blood flow of the impeller device itself is 2.0-2.5L/min (excluding the human heart pump blood flow), the pump blood flow It is recorded as 2.Y L/min, and the blood flow threshold of the normal pump at this time is X+2.Y L/min. When the actual monitoring data after pumping blood fluctuates greatly, that is, when the monitored flow rate suddenly drops from the initial flow rate X+2.Y L/min to about X L/min, it can be regarded as that the impeller device stops rotating at this time, and it should be timely Replace catheter.

本申请将流量传感器与叶轮装置设置为一体,在使用时,流量传感器可以更加敏锐接收到血液流出流出通道的血流量,从而能够得到更加准确的流量监测数据,以便进而迅速反应心脏辅助泵血导管是否在正常工作。In this application, the flow sensor and the impeller device are integrated. When in use, the flow sensor can more sensitively receive the blood flow of the blood flowing out of the outflow channel, so that more accurate flow monitoring data can be obtained, so as to quickly respond to the heart-assisted blood pumping catheter Is it working properly.

以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均在本发明待批权利要求保护范围之内。The above descriptions are only preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of the present invention are within the scope of the pending rights of the present invention. within the scope of protection.

Claims (10)

1. A monitoring catheter for assisting cardiac pumping, the monitoring catheter comprising:
the inflow channel is a tubular body with a through hole on the pipe wall;
the outflow channel is connected with the proximal end of the inflow channel and is a tubular body with a through hole on the pipe wall;
an impeller device disposed within the outflow channel;
the sensor is arranged on the impeller device;
fluid enters from the inflow channel and flows out of the outflow channel through the impeller device; when the fluid flows out, the impeller device can release the rotary pressure generated by the fluid, so that the sensor can sense the detected information and output the data information.
2. The cardiac pump assisted monitoring catheter of claim 1, wherein the impeller means comprises: the base is a cylinder;
the shaft core is coaxially arranged with the base;
the blade is arranged on the outer surface of the shaft core; the area of the circumcircle of the blade is smaller than the cross-sectional area of the base;
the outer wall of the impeller is an annular body; coaxially connected to the base;
and a notch for installing a sensor is arranged on the outer wall of the impeller.
3. The cardiac pumping-assist monitoring catheter as recited in claim 2 in which the blade comprises a spiral sector formed by axial rotation on an outer surface of the hub.
4. The cardiac assist pump monitoring catheter of claim 1, further comprising: and the connecting pipe is used for connecting the inflow channel and the outflow channel, and a developing ring is arranged on the connecting pipe.
5. The cardiac pump assisted monitoring catheter of claim 4, wherein the connecting tube is an elbow.
6. The monitoring catheter for assisting cardiac pumping according to claim 1, further comprising, in the monitoring catheter: a connecting conduit, which is a tubular object, is connected to the proximal end of the impeller device.
7. The cardiac pump assisted monitoring catheter of claim 6, wherein the connecting catheter comprises:
the connecting catheter inner cavity is coaxially connected with the impeller device;
the reaming wire is arranged in the inner cavity of the connecting catheter;
the connecting catheter outer cavity is coaxially arranged with the connecting catheter inner cavity;
and the sensor wire is arranged in the pipe wall of the outer cavity of the connecting catheter and used for being connected with the sensor.
8. A monitoring catheter for assisting cardiac pumping according to claim 3, wherein the sensor comprises: pressure sensor, temperature sensor, rotational speed sensor and flow sensor.
9. A monitoring system for assisting cardiac pumping, the monitoring system comprising: a monitoring catheter for assisting cardiac pumping according to any one of claims 1-8;
a data receiving port connected with the proximal end of the connecting catheter for receiving signals;
and the monitoring device is electrically connected with the monitoring catheter for assisting the heart to pump blood and is used for monitoring information of signals.
10. A method of monitoring assisted heart pumping, for use in a system for monitoring assisted heart pumping as in claim 9, the method comprising: placing the monitoring catheter for assisting the heart to pump blood into the left ventricle through the femoral artery by a guide wire; before the impeller device is started, the monitoring device obtains a monitoring data threshold value; when the impeller device is started, the monitoring device obtains actual monitoring data; comparing the actual monitoring data with a monitoring data threshold value, and judging that the monitoring catheter is in an abnormal working state when the actual monitoring data is not in the range of the monitoring data threshold value; and when the actual monitoring data fluctuates within the range of the monitoring data threshold value, judging that the monitoring catheter is in a normal working state.
CN202310222850.5A 2023-03-09 2023-03-09 Monitoring catheter, monitoring system and method for assisting heart in pumping blood Pending CN116328173A (en)

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CN114984444A (en) * 2022-05-24 2022-09-02 苏州心岭迈德医疗科技有限公司 Catheter intervention heart pump
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Publication number Priority date Publication date Assignee Title
US20180250456A1 (en) * 2017-03-02 2018-09-06 White Swell Medical Ltd Systems and methods for reducing pressure at an outflow of a duct
CN110237327A (en) * 2019-06-14 2019-09-17 湖南埃普特医疗器械有限公司 A kind of external profile shaft stream ventricular assist device of driving
CN111437449A (en) * 2020-05-06 2020-07-24 广州弘大医疗科技有限公司 Right heart auxiliary device
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