CN114796850A - Method for controlling the speed of a heart assist system - Google Patents
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
- A61M60/546—Regulation using real-time blood pump operational parameter data, e.g. motor current of blood flow, e.g. by adapting rotor speed
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/126—Implantable 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
- A61M60/135—Implantable 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 inside a blood vessel, e.g. using grafting
- A61M60/139—Implantable 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 inside a blood vessel, e.g. using grafting inside the aorta, e.g. intra-aortic balloon pumps
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/178—Implantable 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
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- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/515—Regulation using real-time patient data
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES 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
- A61M2230/00—Measuring parameters of the user
- A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
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Abstract
本申请涉及医疗器械领域,尤其涉及一种用于控制心脏辅助系统的速度的方法,心脏辅助系统包括动作系统,动作系统设定了第一目标范围和第二目标范围,至少确定动作系统的第一运行参数和测试环境中的第二运行参数,并测量动作系统的转速数值;当第一运行参数超出第一目标范围或第二运行参数超出第二目标范围时,根据第一运行参数与第二运行参数进行计算以获得调整系数,并且根据调整系数重新确定动作系统的转速。
The present application relates to the field of medical devices, and in particular, to a method for controlling the speed of a heart assist system. The heart assist system includes an action system. The action system sets a first target range and a second target range, and at least determines the first target range of the action system. an operating parameter and a second operating parameter in the test environment, and measure the rotational speed value of the action system; when the first operating parameter exceeds the first target range or the second operating parameter exceeds the second target range, according to the first operating parameter and the first operating parameter Two operating parameters are calculated to obtain an adjustment coefficient, and the speed of the action system is re-determined according to the adjustment coefficient.
Description
技术领域technical field
本申请涉及医疗器械领域,尤其涉及一种用于控制心脏辅助系统的速度的方法。The present application relates to the field of medical devices, and more particularly, to a method for controlling the speed of a cardiac assist system.
背景技术Background technique
目前,心衰的发病率和死亡率均比较高,是大多数心血管疾病患者死亡的重要原因,全世界将近有1.17亿人患有该疾病。心衰全称为心力衰竭,是指由于心脏的收缩功能或者舒张功能发生障碍,造成静脉的回心血不能充分排出体外,从而导致静脉系统血液淤积,动脉系统供血不足,最终引发心脏循环系统障碍,据估计,我国急性心肌梗死的发病率约为十万分之四十五到十万分之五十五,目前还呈现上升趋势。由于心衰的发展过程比较缓慢,大多数是由于患者各种病症日积月累很多年后,心脏逐渐失去泵血功能,各方面功能逐渐减弱,并伴有心脏扩大,以左心室扩大为主,给患者的生活质量和临床治疗带来很大的负面影响,现有的治疗方案包括药物治疗、辅助器械以及心脏移植,但是不同的治疗方法均面临很大的挑战。Currently, heart failure has high morbidity and mortality, and is an important cause of death for most cardiovascular disease patients, with nearly 117 million people worldwide suffering from the disease. The full name of heart failure is heart failure, which means that due to the dysfunction of the heart's systolic or diastolic function, the venous return blood cannot be fully discharged from the body, resulting in blood stasis in the venous system, insufficient blood supply in the arterial system, and ultimately lead to cardiac circulatory system disorders. It is estimated that the incidence of acute myocardial infarction in my country is about 45/100,000 to 55/100,000, and it is still on the rise. Because the development process of heart failure is relatively slow, most of it is due to the accumulation of various diseases in patients for many years, the heart gradually loses its pumping function, and the functions of all aspects gradually weaken, accompanied by cardiac enlargement, mainly the left ventricle. The existing treatment options include drug therapy, auxiliary devices and heart transplantation, but different treatment methods all face great challenges.
现阶段,治疗心源性休克和高危PCI主要有药物治疗和心衰辅助系统两种治疗方案。目前,市场上常见的泵类心衰辅助系统(如ECMO、Impella等)的关键参数(电机转速)许多都是通过手动设定进行调整,此种控制方式在实际操作过程中需要医务人员根据患者体征不断调整参数,操作较为复杂;部分已知的方法是在稳定状态的前提下以通过特性曲线静态描述的状态为基础的,即例如泵转速、泵的驱动功率和作用在沿轴向引导血液的转子上的力或相似量的相关性,这种方法的弱点一方面是血液粘度本身很难确定并且必须借助于对患者进行单独的干预来相应地进行测量的事实,并且这种模型不能描述泵在变化或转换状态下的行为。At this stage, there are two main treatment options for cardiogenic shock and high-risk PCI: drug therapy and heart failure assist system. At present, many of the key parameters (motor speed) of the common pump heart failure assistance systems (such as ECMO, Impella, etc.) on the market are adjusted by manual settings. This control method requires medical staff to adjust according to the patient's actual operation. The parameters are constantly adjusted by the signs, and the operation is more complicated; some known methods are based on the state described statically by the characteristic curve under the premise of steady state, i.e., for example, the pump speed, the driving power of the pump and the effect on guiding the blood in the axial direction. Correlation of forces on the rotor or similar quantities, the weakness of this approach is on the one hand the fact that blood viscosity itself is difficult to determine and must be measured accordingly with the aid of individual patient interventions, and this model cannot describe The behavior of the pump in changing or transitioning states.
专利CN201780040840.2公开了一种用于确定特别是用于估计血液泵(1)的操作参数的方法,所述血液泵包括输送血液的转子(5),其中,确定所述血液泵的彼此独立的至少一个第一操作参数和第二操作参数的行为变化,并且其中在确定流过所述血液泵的流量和/或所述血液泵两端的压力差和/或血液粘度时考虑至少两个所述操作参数的所确定的行为变化,该方案的技术缺陷在于:血液泵在运行过程中转速会不断变化,为调节血液泵的转速,血液泵的电机电流会增加或减少,但若不对电流值进行监测或者不对上限电流进行限制,会导致电机发热影响电机寿命,甚至烧坏电机,影响血液泵的使用稳定性与安全性。Patent CN201780040840.2 discloses a method for determining, in particular for estimating, operating parameters of a blood pump (1) comprising a rotor (5) delivering blood, wherein the determination of said blood pumps is independent of each other change in behavior of at least one of the first and second operating parameters of the blood pump, and wherein at least two of these are considered when determining the flow rate through the blood pump and/or the pressure difference across the blood pump and/or the blood viscosity In order to adjust the speed of the blood pump, the motor current of the blood pump will increase or decrease, but if the current value is not equal to the current value Monitoring or not limiting the upper limit current will cause the motor to heat up, affect the life of the motor, or even burn out the motor, affecting the stability and safety of the blood pump.
因此,针对市场现有同类产品在参数控制方面的局限性,本领域的技术人员致力于开发一种用于控制心脏辅助系统的速度的方法,主要解决以下问题:心脏辅助系统无法随着主动脉血液流量的变化与动作系统工作电流的变化进行自适应调整转速。Therefore, in view of the limitations of the existing similar products in the market in terms of parameter control, those skilled in the art are committed to developing a method for controlling the speed of a cardiac assistance system, mainly to solve the following problems: the cardiac assistance system cannot follow the aorta The change of blood flow and the change of the working current of the action system are used to adjust the speed adaptively.
发明内容SUMMARY OF THE INVENTION
鉴于以上以及其它更多的构思而提出了本申请。The present application has been made in view of the above and other more concepts.
本申请的目的之一是克服现有技术的不足,针对例如心脏辅助系统无法随着主动脉血液流量的变化与动作系统工作电流的变化进行自适应调整转速等问题提供了一种用于控制心脏辅助系统的速度的方法。One of the purposes of the present application is to overcome the deficiencies of the prior art. For example, the heart assist system cannot adjust the rotational speed adaptively with the change of the aortic blood flow and the change of the working current of the action system. A method of assisting the speed of the system.
根据本申请的另一方面,提供了一种用于控制心脏辅助系统的速度的方法,所述心脏辅助系统包括动作系统,其中,至少确定所述动作系统的第一运行参数和测试环境中的第二运行参数,并测量所述动作系统的转速数值,根据第一运行参数与第二运行参数进行计算以获得调整系数,且根据所述调整系数重新确定动作系统的转速。According to another aspect of the present application, there is provided a method for controlling the speed of a cardiac assist system, the cardiac assist system comprising a motion system, wherein at least a first operating parameter of the motion system and a test environment are determined The second operating parameter is measured, and the rotational speed value of the motion system is measured, an adjustment coefficient is obtained by calculation according to the first operating parameter and the second operating parameter, and the rotational speed of the motion system is re-determined according to the adjustment coefficient.
根据一实施例,所述动作系统设定了第一目标范围和第二目标范围,当所述第一运行参数超出所述第一目标范围或所述第二运行参数超出所述第二目标范围时,动作系统的转速会作出调整。According to an embodiment, the action system sets a first target range and a second target range, when the first operating parameter exceeds the first target range or the second operating parameter exceeds the second target range , the speed of the action system will be adjusted.
根据一实施例,所述动作系统设定了安全参数,若第一运行参数超过所述安全参数,所述动作系统随即关闭。According to an embodiment, the action system is set with a safety parameter, and if the first operating parameter exceeds the safety parameter, the action system is shut down immediately.
根据另一实施例,所述动作系统设定了安全参数,若第二运行参数超过所述安全参数,所述动作系统随即关闭。According to another embodiment, the motion system is set with a safety parameter, and if the second operating parameter exceeds the safety parameter, the motion system is shut down immediately.
根据一实施例,至少测量所述动作系统的工作电流值I作为第一运行参数;并且确定所述电流值I随时间的变化率。According to an embodiment, at least the operating current value I of the action system is measured as the first operating parameter; and the rate of change of the current value I with time is determined.
根据一实施例,至少测量所述测试环境中血液流量L作为第二运行参数;并且确定所述血液流量L随时间的变化率。According to an embodiment, at least the blood flow L in the test environment is measured as a second operating parameter; and the rate of change of the blood flow L over time is determined.
根据一实施例,所述动作系统还设定了安全电流,当所述动作系统的电流I超过 所述安全电流时,所述动作系统随即关闭。 According to an embodiment, the action system further sets a safety current , when the current I of the action system exceeds the safe current , the motion system is turned off immediately.
根据一实施例,所述第一目标范围为目标电流范围,所述目标电流范围包括上限 电流阈值与下限电流阈值,当工作电流值I超出所述目标电流范围时,所述动作系统的 转速随即进行调整。 According to an embodiment, the first target range is a target current range, and the target current range includes an upper current threshold with the lower current threshold , when the working current value I exceeds the target current range, the rotational speed of the motion system is adjusted immediately.
根据一实施例,所述第二目标范围为目标流量范围,所述目标流量范围包括上限 流量阈值与下限流量阈值,当血液流量L超出所述目标流量范围时,所述动作系统的 转速随即进行调整。 According to an embodiment, the second target range is a target flow range, and the target flow range includes an upper flow threshold with lower flow threshold , when the blood flow L exceeds the target flow range, the rotational speed of the action system is adjusted immediately.
根据一实施例,只有同时满足血液流量L在目标流量范围内、动作系统的工作电流值I在目标电流范围内两个条件,动作系统才会以当前的转速工作,从而完成自适应调整动作系统的转速的目的。According to an embodiment, only if the blood flow L is within the target flow range and the operating current value I of the action system is within the target current range at the same time, the action system will work at the current rotational speed, thereby completing the adaptive adjustment of the action system the purpose of the speed.
根据一实施例,为调整动作系统的转速,必须先确定调整系数t,所述调整系数t乘以所述动作系统当前的转速数值便是所述动作系统的新转速;并且,所述动作系统的转速在自适应调整后会稳定到某一固定值。According to an embodiment, in order to adjust the rotational speed of the action system, an adjustment coefficient t must be determined first, and the adjustment coefficient t multiplied by the current rotational speed value of the action system is the new rotational speed of the action system; and, the action system The rotational speed of the will be stabilized to a fixed value after adaptive adjustment.
根据一实施例,为确定调整系数,除了确定所述第一运行参数与所述第二运行参 数外,至少还需确定第一调整参数、第二调整参数、血液流量的上限流量阈值、血液 流量的下限流量阈值、与所述动作系统的上限电流。 According to an embodiment, in order to determine the adjustment coefficient, in addition to determining the first operating parameter and the second operating parameter, at least a first adjustment parameter needs to be determined , the second adjustment parameter , the upper flow threshold of blood flow , the lower flow threshold of blood flow , and the upper limit current of the action system .
根据一实施例,所述调整系数t的计算公式为。According to an embodiment, the calculation formula of the adjustment coefficient t is: .
根据一实施例,所述第一调整参数与所述第二调整参数满足以下条件:+=1。 According to an embodiment, the first adjustment parameter with the second tuning parameter The following conditions: + =1.
根据本申请的另一方面,提供了一种心脏辅助系统,包括动作系统、控制系统、反馈信号采集系统与人机交互系统,其中,所述反馈信号采集系统包括用于采集所述动作系统的电流值I的霍尔传感器、用于采集主动脉血液流量L的流量采集系统与用于采集患者心电信号的心电信号采集器,所述控制系统根据所述反馈信号采集系统的所述电流值I与血液流量L对动作系统的转速进行调整。According to another aspect of the present application, a cardiac assistance system is provided, including an action system, a control system, a feedback signal collection system and a human-computer interaction system, wherein the feedback signal collection system includes a system for collecting the action system. A Hall sensor with a current value I, a flow acquisition system for collecting aortic blood flow L, and an ECG signal collector for collecting a patient's ECG signal, the control system collects the current of the system according to the feedback signal The value I and the blood flow L adjust the rotational speed of the motion system.
根据一实施例,人机交互系统包括触摸显示屏、旋转编码器与按钮,所述触摸显示屏与旋转编码器配合以设定所述动作系统的初始速度,并且,在所述触摸显示屏上设置目标流量范围。According to an embodiment, the human-computer interaction system includes a touch display screen, a rotary encoder and buttons, the touch display screen cooperates with the rotary encoder to set the initial speed of the action system, and on the touch display screen Set the target flow range.
根据一实施例,所述心电信号采集器采集的心电图ECG信号显示在所述触摸显示屏上;当动作系统的转速以某一固定转速运行一段时间后且所述心电信号采集器采集的心电图ECG信号正常时,所述触摸显示屏会显示弹框信息以提示动作系统从体内撤出。According to an embodiment, the ECG signal collected by the ECG signal collector is displayed on the touch screen; when the rotation speed of the motion system runs at a fixed rotation speed for a period of time and the ECG signal collected by the ECG signal collector is When the ECG signal of the electrocardiogram is normal, the touch screen will display pop-up information to prompt the action system to withdraw from the body.
根据一实施例,所述动作系统包括电机、导管、支架与桨叶,桨叶转速由所述电机控制,所述控制系统控制所述电机的转速;并且,所述支架、所述导管与所述电机依次由远端朝近端布置,且所述支架套设在所述桨叶外。According to an embodiment, the action system includes a motor, a guide tube, a bracket and a paddle, the speed of the blade is controlled by the motor, and the control system controls the speed of the motor; The motors are sequentially arranged from the distal end to the proximal end, and the bracket is sleeved outside the paddle.
根据一实施例,所述流量采集系统包括压力传感器,所述压力传感器设置在所述导管上以测量主动脉压力,所述流量采集系统根据主动脉压力计算得出主动脉血液流量L。According to an embodiment, the flow acquisition system includes a pressure sensor disposed on the catheter to measure aortic pressure, and the flow acquisition system calculates the aortic blood flow L according to the aortic pressure.
根据一实施例,所述第一调整参数=0.5,所述第二调整参数=0.5。 According to an embodiment, the first adjustment parameter =0.5, the second adjustment parameter =0.5.
根据一实施例,所述第一调整参数=0.4,所述第二调整参数=0.6。 According to an embodiment, the first adjustment parameter =0.4, the second adjustment parameter =0.6.
根据一实施例,所述第一调整参数与所述第一调整参数由所述动作系统默 认设置。 According to an embodiment, the first adjustment parameter with the first tuning parameter Set by default by the action system.
根据一实施例,所述第一调整参数与所述第一调整参数在所述动作系统运 行期间不作调整。 According to an embodiment, the first adjustment parameter with the first tuning parameter No adjustments are made during operation of the motion system.
根据另一实施例,所述动作系统运行期间,可对所述第一调整参数与所述第一 调整参数作出调整。 According to another embodiment, during the operation of the action system, the first adjustment parameter can be adjusted with the first tuning parameter make adjustments.
根据另一实施例,为确定调整系数,还要测量血液黏度。According to another embodiment, blood viscosity is also measured in order to determine the adjustment factor.
根据另一实施例,为确定调整系数,还要确定所述动作系统的平均速度。According to another embodiment, in order to determine the adjustment factor, the average speed of the motion system is also determined.
根据一实施例,所述人机交互系统用于设置心脏辅助系统的相关参数,动作系统 进入心脏并固定在目标位置后,在所述触摸显示屏上设置血液流量的上限流量阈值、血 液流量的下限流量阈值与所述电机的初始转速。 According to an embodiment, the human-computer interaction system is used to set relevant parameters of the cardiac assistance system. After the action system enters the heart and is fixed at the target position, the upper limit flow threshold of blood flow is set on the touch display screen. , the lower flow threshold of blood flow with the initial speed of the motor.
根据一实施例,所述安全电流由所述动作系统默认设置。 According to an embodiment, the safe current Set by default by the action system.
根据一实施例,所述心电图ECG信号的波形可作为患者生理指标检测信息。According to an embodiment, the waveform of the electrocardiogram ECG signal can be used as patient physiological index detection information.
根据一实施例,所述动作系统一旦开始运行,所述流量采集系统便开始采集患者的主动脉血液流量与所述动作系统的工作电流;当采集到的主动脉血液流量超出所述目标流量范围,或者所述动作系统的工作电流高于动作系统的所述目标电流范围,控制系统会自适应地调整电机转速。According to an embodiment, once the action system starts to run, the flow collection system starts to collect the patient's aortic blood flow and the working current of the action system; when the collected aortic blood flow exceeds the target flow range , or the operating current of the action system is higher than the target current range of the action system, and the control system will adaptively adjust the motor speed.
根据一实施例,当所述动作系统工作电流高于所述上限电流时,所述电机立即做降速处理。According to an embodiment, when the operating current of the motion system is higher than the upper limit current, the motor immediately performs deceleration processing.
根据一实施例,当所述动作系统工作电流低于所述上限电流时,所述电机立即做提速处理。According to an embodiment, when the operating current of the motion system is lower than the upper limit current, the motor immediately performs speed-up processing.
根据一实施例,所述测试环境为主动脉瓣环处。According to an embodiment, the test environment is at the aortic valve annulus.
根据一实施例,所述测试环境为升主动脉处。According to one embodiment, the test environment is at the ascending aorta.
根据一实施例,所述测试环境为左心室。According to one embodiment, the test environment is the left ventricle.
与现有技术相比,本申请的技术方案的优点至少包括如下:Compared with the prior art, the advantages of the technical solution of the present application include at least the following:
1.与现有的控制人工心脏的方法相比,本发明介绍了一种用于控制心脏辅助系统的速度的方法,首先,至少确定动作系统的第一运行参数与测试环境中的第二运行参数,对于第一运动参数与第二运动参数的选择,本发明综合考虑了心脏辅助系统本身与测试环境二者的变化对于心脏辅助系统运动的影响,并且,为了启动动作系统转速的自适应调整,动作系统设定了第一目标范围和第二目标范围,当采集到的第一运行参数超出第一目标范围或者第二运动参数超出第二目标范围,控制系统会自动控制动作系统转速,不需要手动调节其转速,降低了设备操作的复杂程度,如此,实现了在保证动作系统稳定运行的前提下自动调节心脏辅助系统的速度的功能,并且这种调整方式能够使动作系统速度逐渐稳定到一个固定数值,有利于患者恢复,临床意义重大。1. Compared with the existing method for controlling the artificial heart, the present invention introduces a method for controlling the speed of the cardiac assist system. First, at least the first operating parameter of the action system and the second operating parameter in the test environment are determined. parameter, for the selection of the first motion parameter and the second motion parameter, the present invention comprehensively considers the influence of the changes of the cardiac assistance system itself and the test environment on the motion of the cardiac assistance system, and, in order to start the adaptive adjustment of the rotational speed of the motion system , the action system sets the first target range and the second target range. When the collected first operating parameter exceeds the first target range or the second motion parameter exceeds the second target range, the control system will automatically control the speed of the action system, and will not It needs to manually adjust its speed, which reduces the complexity of equipment operation. In this way, the function of automatically adjusting the speed of the heart assist system is realized on the premise of ensuring the stable operation of the action system, and this adjustment method can gradually stabilize the speed of the action system to A fixed value is beneficial to the patient's recovery and is of great clinical significance.
2.根据本申请的一个构思,本申请将动作系统的工作电流值I作为第一运行参数,将测试环境中的血液流量L作为第二运行参数,此时,第一目标范围为目标电流范围,第二目标范围为目标流量范围,当工作电流值I超出目标电流范围或者血液流量L超出目标流量范围时,动作系统的转速随即进行调整,并且,只有血液流量L与工作电流值I均未超出范围的情况下,动作系统的转速才会保持在某一固定值,动作系统的自适应机制保证了动作系统在心内的稳定运行,泵血效果佳,符合人体心脏的生理环境,有利于病患的恢复;另一方面,动作系统还设定了安全电流,动作系统的电流一旦超过安全电流,动作系统会立即关闭,有效防止了动作系统遭受破坏,保证了动作系统的稳定性与安全性。2. According to a concept of the present application, the present application takes the working current value I of the action system as the first operating parameter, and takes the blood flow L in the test environment as the second operating parameter. At this time, the first target range is the target current range. , the second target range is the target flow range. When the working current value I exceeds the target current range or the blood flow L exceeds the target flow range, the speed of the action system is adjusted immediately, and only the blood flow L and the working current value I are not When it exceeds the range, the rotational speed of the action system will remain at a certain fixed value. The adaptive mechanism of the action system ensures the stable operation of the action system in the heart, and the pumping effect is good, which is in line with the physiological environment of the human heart and is conducive to the disease. On the other hand, the action system also sets a safe current. Once the current of the action system exceeds the safe current, the action system will immediately shut down, which effectively prevents the action system from being damaged and ensures the stability and safety of the action system. .
3.根据本申请的一个构思,为调整转速,必须先确定调整系数t,调整系数t的计算 公式为,其中,为第一调整参数,为第二调整参数,为 血液流量的上限流量阈值,为血液流量的下限流量阈值,为所述动作系统的上限电流, 且、、、、均为设置好的定值,调整系数仅仅需要依据血液流量L与工作电流值I 的变化而变动,因此,获得调整系数较为简单、快速,而动作系统的新转速数值是通过调整 系数t乘以动作系统当前的转速数值获得的,故动作系统的转速调整反应也快,灵敏度高, 配合好,综上所述,动作系统的自适应调整转速的机制能够满足且非常适应复杂的心内环 境,临床价值高。3. According to a concept of the present application, in order to adjust the rotational speed, the adjustment coefficient t must be determined first, and the calculation formula of the adjustment coefficient t is: ,in, for the first tuning parameter, for the second tuning parameter, is the upper flow threshold of blood flow, is the lower flow threshold of blood flow, is the upper limit current of the action system, and , , , , are all set fixed values, and the adjustment coefficient only needs to be changed according to the changes of blood flow L and working current value I. Therefore, it is relatively simple and fast to obtain the adjustment coefficient, and the new speed value of the action system is multiplied by the adjustment coefficient t. The current speed value of the action system is obtained, so the speed adjustment response of the action system is also fast, the sensitivity is high, and the coordination is good. To sum up, the mechanism of the action system's self-adaptive adjustment of the speed can meet and be very adaptable to the complex inner environment. High clinical value.
4.根据本申请的一个构思,心脏辅助系统除了包括动作系统,还包括控制系统、反馈信号采集系统与人机交互系统,其中,反馈信号采集系统包括用于采集动作系统的电流值I的霍尔传感器、用于采集主动脉血液流量L的流量采集系统与用于采集患者心电信号的心电信号采集器,控制系统会根据反馈信号采集系统的电流值I与血液流量L对动作系统的的转速进行调整。4. According to a concept of the present application, in addition to the action system, the cardiac assistance system also includes a control system, a feedback signal collection system and a human-computer interaction system, wherein the feedback signal collection system includes a HU for collecting the current value I of the action system. The sensor, the flow acquisition system for collecting the aortic blood flow L, and the ECG signal collector for collecting the patient's ECG signal, the control system will collect the current value I of the system and the blood flow L according to the feedback signal. speed adjustment.
5.根据本申请的一个构思,心电信号采集器会采集患者的心电信号,且心电图ECG信号显示在触摸显示屏上,当动作系统的转速以某一固定转速运行一段时间后且心电信号采集器采集的心电图ECG信号正常时,触摸显示屏会显示弹框信息以提示动作系统从体内撤出,这种提醒模式更加客观智能、节约时间,且更加高效,避免了繁琐的判断过程,将人机协同进行得更加彻底,实现意义重大。5. According to a concept of the present application, the ECG signal collector will collect the ECG signal of the patient, and the ECG signal of the ECG is displayed on the touch screen. When the ECG signal collected by the signal collector is normal, the touch screen will display pop-up information to remind the action system to withdraw from the body. This reminder mode is more objective and intelligent, saves time, and is more efficient, avoiding the cumbersome judgment process. It is of great significance to carry out human-machine collaboration more thoroughly.
本申请的实施例能够实现其它未一一列出的有利技术效果,这些其它的技术效果在下文中可能有部分描述,并且对于本领域的技术人员而言在阅读了本申请后是可以预期和理解的。The embodiments of the present application can achieve other advantageous technical effects that are not listed one by one. These other technical effects may be partially described below, and can be expected and understood by those skilled in the art after reading the present application of.
附图说明Description of drawings
通过参考下文的描述连同附图,这些实施例的上述特征和优点及其他特征和优点以及实现它们的方式将更显而易见,并且可以更好地理解本申请的实施例,在附图中:The above-described features and advantages and other features and advantages of these embodiments, and the manner in which they are achieved, will be more apparent, and embodiments of the present application may be better understood, by reference to the following description in conjunction with the accompanying drawings, in which:
图1为本发明用于控制心脏辅助系统的速度的方法的控制逻辑示意图。FIG. 1 is a schematic control logic diagram of the method of the present invention for controlling the speed of a cardiac assist system.
图2a~2d为本发明人机交互系统与动作系统的是示意图2a to 2d are schematic diagrams of the human-computer interaction system and the action system of the present invention
附图中各数字所指代的特征如下:The features referred to by the numbers in the accompanying drawings are as follows:
1-心脏辅助系统,2-动作系统,21-电机,22-导管,23-支架,24-桨叶,3-人机交互系统。1-Heart assist system, 2-action system, 21-motor, 22-catheter, 23-stand, 24-paddle, 3-human-computer interaction system.
具体实施方式Detailed ways
在以下对附图和具体实施方式的描述中,将阐述本申请的一个或多个实施例的细节。从这些描述、附图以及权利要求中,可以清楚本申请的其它特征、目的和优点。The details of one or more embodiments of the application are set forth in the accompanying drawings and the detailed description below. Other features, objects and advantages of the present application will be apparent from the description, drawings and claims.
应当理解,所图示和描述的实施例在应用中不限于在以下描述中阐明或在附图中图示的构件的构造和布置的细节。所图示的实施例可以是其它的实施例,并且能够以各种方式来实施或执行。各示例通过对所公开的实施例进行解释而非限制的方式来提供。实际上,将对本领域技术人员显而易见的是,在不背离本申请公开的范围或实质的情况下,可以对本申请的各实施例作出各种修改和变型。例如,作为一个实施例的一部分而图示或描述的特征,可以与另一实施例一起使用,以仍然产生另外的实施例。因此,本申请公开涵盖属于所附权利要求及其等同要素范围内的这样的修改和变型。It should be understood that the illustrated and described embodiments are not limited in application to the details of construction and the arrangement of components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments are capable of other embodiments and of being implemented or carried out in various ways. The examples are provided by way of explanation and not limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made in the various embodiments of the present application without departing from the scope or spirit of the present disclosure. For example, features illustrated or described as part of one embodiment can be used with another embodiment to still yield a further embodiment. Accordingly, the present disclosure covers such modifications and variations as fall within the scope of the appended claims and their equivalents.
同样,可以理解,本文中所使用的词组和用语是出于描述的目的,而不应当被认为是限制性的。本文中的“包括”、“包含”或“具有”及其变型的使用,旨在开放式地包括其后列出的项及其等同项以及附加的项。Also, it is to be understood that the phraseology and phraseology used herein is for the purpose of description and should not be regarded as limiting. The use of "including", "including" or "having" and variations thereof herein is intended to be open-ended to include the items listed thereafter and their equivalents as well as additional items.
下面将参考本申请的若干方面的不同的实施例和示例对本申请进行更详细的描述。The present application will be described in more detail below with reference to various embodiments and examples of several aspects of the present application.
在本申请中,术语“近端”或“近侧”是指离手术操作者较近的一端或一侧,“远端”或“远侧”是指离手术操作者较远的一端或一侧。In this application, the term "proximal" or "proximal" refers to the end or side that is closer to the operator, and "distal" or "distal" refers to the end or side that is further away from the operator. side.
实施例一Example 1
如图1所示,图示了根据本申请一实施例的一种用于控制心脏辅助系统1的速度的方法,所述心脏辅助系统1包括动作系统2,其中,至少确定所述动作系统2的第一运行参数和测试环境中的第二运行参数,并测量所述动作系统2的转速数值,根据第一运行参数与第二运行参数进行计算以获得调整系数,且根据所述调整系数重新确定动作系统2的转速。As shown in FIG. 1 , a method for controlling the speed of a heart assistance system 1 according to an embodiment of the present application is illustrated. The heart assistance system 1 includes an
本实施例一中,所述动作系统2设定了第一目标范围和第二目标范围,当所述第一运行参数超出所述第一目标范围或所述第二运行参数超出所述第二目标范围时,动作系统2的转速会作出调整。In the first embodiment, the
本实施例一中,所述动作系统2设定了安全参数,若第一运行参数超过所述安全参数,所述动作系统2随即关闭。In the first embodiment, the
本实施例一中,至少测量所述动作系统2的工作电流值I作为第一运行参数;并且确定所述电流值I随时间的变化率。In the first embodiment, at least the working current value I of the
本实施例一中,至少测量所述测试环境中血液流量L作为第二运行参数;并且确定所述血液流量L随时间的变化率。In the first embodiment, at least the blood flow L in the test environment is measured as the second operating parameter; and the rate of change of the blood flow L with time is determined.
本实施例一中,所述动作系统2还设定了安全电流,当所述动作系统2的电流I超
过所述安全电流时,所述动作系统2随即关闭。
In the first embodiment, the
本实施例一中,所述第一目标范围为目标电流范围,所述目标电流范围包括上限
电流阈值与下限电流阈值,当工作电流值I超出所述目标电流范围时,所述动作系统2
的转速随即进行调整。
In the first embodiment, the first target range is a target current range, and the target current range includes an upper current threshold with the lower current threshold , when the working current value I exceeds the target current range, the rotational speed of the
本实施例一中,所述第二目标范围为目标流量范围,所述目标流量范围包括上限
流量阈值与下限流量阈值,当血液流量L超出所述目标流量范围时,所述动作系统2的
转速随即进行调整。
In the first embodiment, the second target range is a target flow range, and the target flow range includes an upper flow rate threshold with lower flow threshold , when the blood flow L exceeds the target flow range, the rotational speed of the
本实施例一中,只有同时满足血液流量L在目标流量范围内、动作系统2的工作电流值I在目标电流范围内两个条件,动作系统2才会以当前的转速工作,从而完成自适应调整动作系统2的转速的目的。In the first embodiment, only if the blood flow L is within the target flow range and the operating current value I of the
本实施例一中,为调整动作系统2的转速,必须先确定调整系数t,所述调整系数t乘以所述动作系统2当前的转速数值便是所述动作系统2的新转速;并且,所述动作系统2的转速在自适应调整后会稳定到某一固定值。In the first embodiment, in order to adjust the rotational speed of the
本实施例一中,为确定调整系数,除了确定所述第一运行参数与所述第二运行参
数外,至少还需确定第一调整参数、第二调整参数、血液流量的上限流量阈值、血液
流量的下限流量阈值、与所述动作系统2的上限电流。
In the first embodiment, in order to determine the adjustment coefficient, in addition to determining the first operating parameter and the second operating parameter, at least the first adjustment parameter needs to be determined , the second adjustment parameter , the upper flow threshold of blood flow , the lower flow threshold of blood flow , and the upper limit current of the
本实施例一中,所述调整系数t的计算公式为。 In the first embodiment, the calculation formula of the adjustment coefficient t is: .
本实施例一中,所述第一调整参数与所述第二调整参数满足以下条件:+=1。 In the first embodiment, the first adjustment parameter with the second tuning parameter The following conditions: + =1.
本实施例一中,包括动作系统2的心脏辅助系统1还包括控制系统、反馈信号采集系统与人机交互系统3,如图2a所示,其中,所述反馈信号采集系统包括用于采集所述动作系统2的电流值I的霍尔传感器、用于采集主动脉血液流量L的流量采集系统与用于采集患者心电信号的心电信号采集器,所述控制系统根据所述反馈信号采集系统的所述电流值I与血液流量L对动作系统2的转速进行调整。In the first embodiment, the cardiac assistance system 1 including the
本实施例一中,人机交互系统3包括触摸显示屏、旋转编码器与按钮,所述触摸显示屏与旋转编码器配合以设定所述动作系统2的初始速度,并且,在所述触摸显示屏上设置目标流量范围。In the first embodiment, the human-
本实施例一中,所述心电信号采集器采集的心电图ECG信号显示在所述触摸显示屏上;当动作系统2的转速以某一固定转速运行一段时间后且所述心电信号采集器采集的心电图ECG信号正常时,所述触摸显示屏会显示弹框信息以提示动作系统2从体内撤出。In the first embodiment, the ECG signal collected by the ECG signal collector is displayed on the touch screen; when the rotation speed of the
本实施例一中,所述动作系统2包括电机21、导管22、支架23与桨叶24,桨叶24转速由所述电机21控制,所述控制系统控制所述电机21的转速;并且,所述支架23、所述导管22与所述电机21依次由远端朝近端布置,且所述支架23套设在所述桨叶24外,如图2c和2d所示。In the first embodiment, the
本实施例一中,所述流量采集系统包括压力传感器,所述压力传感器设置在所述导管22上以测量主动脉压力,所述流量采集系统根据主动脉压力计算得出主动脉血液流量L。In the first embodiment, the flow collection system includes a pressure sensor, the pressure sensor is arranged on the
本实施例一中,所述第一调整参数=0.5,所述第二调整参数=0.5。 In the first embodiment, the first adjustment parameter =0.5, the second adjustment parameter =0.5.
本实施例一中,所述第一调整参数与所述第一调整参数由所述动作系统2默
认设置。
In the first embodiment, the first adjustment parameter with the first tuning parameter Set by default by the
本实施例一中,所述第一调整参数与所述第一调整参数在所述动作系统2运
行期间不作调整。
In the first embodiment, the first adjustment parameter with the first tuning parameter No adjustments are made during operation of the
本实施例一中,目标流量范围为3.8~4L/min,上限电流阈值为0.6A, 安全电流为0.7A,电机21转速为25000r/min,在动作系统2运行过程中,当实际测得流量值为3.9L/
min,电流值为0.65A时,计算调整系统t为0.96,重新设定转速为24000r/min,其中,动作系
统2转速最小调整步长为500r/min。
In the first embodiment, the target flow range is 3.8-4L/min, and the upper limit current threshold is 0.6A, safe current When the actual measured flow value is 3.9L/min and the current value is 0.65A, the calculation and adjustment system t is 0.96, and the speed is reset. It is 24000r/min, among which, the minimum adjustment step of the speed of the
本实施例一中,在动作系统2运行过程中,当实际测得流量值为3.7L/min,电流值为0.45A时,计算调整系统t为1.2,重新设定转速为30000r/min。In the first embodiment, during the operation of the
本实施例一中,在动作系统2运行过程中,当实际测得流量值为4L/min,电流值为
0.7A时,由于工作电流达到安全电流,直接关闭动作系统2电源,并在触摸显示屏上提示
发生故障。
In the first embodiment, during the operation of the
本实施例一的心脏辅助系统1的一个示范性的使用步骤及控制逻辑如下:An exemplary use procedure and control logic of the cardiac assistance system 1 of the first embodiment are as follows:
1.通过外科手术将所述动作系统2经股动脉、降主动脉、主动脉弓、升主动脉、主动脉瓣输送进入左心室,如图2b所示,所述支架23跨瓣支撑;1. The
2.连接心脏辅助系统1的电源,启动成功后,在所述触摸显示屏上设置电机21初始
速度与血液流量的上限流量阈值和下限流量阈值;
2. Connect the power supply of the cardiac assistance system 1, and after the startup is successful, set the initial speed of the
3.按下人机交互系统3的按钮以启动所述动作系统2的电机21,所述电机21通过所述导管22带动桨叶24转动,实现泵血功能;3. Press the button of the human-
4.动作系统2运行后,反馈信号采集系统开始工作,采集动作系统2的工作电流、患者主动脉血液流量与心电信号,并将采集到的数据传递给控制系统,控制系统对动作系统2的工作电流与主动脉血液流量进行判断,如图1所示;4. After the
5. 当主动脉血液流量处于设定的目标流量范围外时,所述控制系统对电机21的
转速进行调整;当动作系统2的工作电流I高于所述上限电流时,所述控制系统对电机21
作降速处理;
5. When the aortic blood flow is outside the set target flow range, the control system adjusts the rotational speed of the
6. 当患者主动脉血液流量达到设定的目标流量且所述动作系统2的工作电流低于上限电流阈值,所述电机21才会以当前设定的转速工作,进而达到自适应调整电机21转速的目的;6. When the patient's aortic blood flow reaches the set target flow and the operating current of the
7.当电机21以某一固定转速运行一段时间后且反馈信号采集系统采集到的心电信号正常,所述触摸显示屏会显示弹框信息以帮助医护人员判断动作系统2是否可以从体内撤出。7. When the
出于说明的目的而提出了对本申请的对若干个实施例的前文描述。所述前文描述并非意图是穷举的,也并非将本申请限于所公开的精确配置、构造和/或步骤,显然,根据上文的教导,可作出许多修改和变型。本发明的范围和所有的等同者旨在由所附权利要求限定。The foregoing description of several embodiments of the present application has been presented for purposes of illustration. The foregoing description is not intended to be exhaustive or to limit the application to the precise configurations, configurations and/or steps disclosed, obviously many modifications and variations are possible in light of the above teachings. The scope of the invention and all equivalents are intended to be defined by the appended claims.
Claims (17)
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