WO2024109422A1 - Système et procédé d'estimation de la position d'une pompe à sang interventionnelle - Google Patents

Système et procédé d'estimation de la position d'une pompe à sang interventionnelle Download PDF

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Publication number
WO2024109422A1
WO2024109422A1 PCT/CN2023/126158 CN2023126158W WO2024109422A1 WO 2024109422 A1 WO2024109422 A1 WO 2024109422A1 CN 2023126158 W CN2023126158 W CN 2023126158W WO 2024109422 A1 WO2024109422 A1 WO 2024109422A1
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WO
WIPO (PCT)
Prior art keywords
blood pump
induced current
pump system
interventional
periodic
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Application number
PCT/CN2023/126158
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English (en)
Chinese (zh)
Inventor
吕骁
吕世文
古珮瑶
Original Assignee
上海炫脉医疗科技有限公司
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Filing date
Publication date
Application filed by 上海炫脉医疗科技有限公司 filed Critical 上海炫脉医疗科技有限公司
Publication of WO2024109422A1 publication Critical patent/WO2024109422A1/fr

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Classifications

    • 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
    • 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
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/35—Medical purposes thereof other than the enhancement of the cardiac output for specific surgeries, e.g. for Fontan procedure
    • 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/865—Devices for guiding or inserting pumps or pumping devices into the patient's body
    • A61M60/867—Devices for guiding or inserting pumps or pumping devices into the patient's body using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter

Definitions

  • the present application relates to the field of medical devices, for example, to a system and method for estimating the position of an invasive blood pump.
  • interventional cardiac treatment surgery is a common treatment option, which uses a stable hemodynamic assist device in conjunction with the surgery.
  • the heart pump also known as an interventional blood pump
  • the position of the heart where the interventional blood pump is located during operation determines whether the surgery is successful.
  • the positioning of the interventional blood pump usually uses the image positioning method, but image positioning is not accurate in some cases and has the defect of unclear imaging.
  • the use of dedicated sensors for positioning is also a common method, but such sensors are easily damaged and have high costs, and are not easy to maintain in the later stage, which poses certain risks to the surgery.
  • the present application provides an interventional blood pump system and a method for estimating the position of an interventional blood pump system for situations where it is difficult to determine the position of a blood pump using, for example, imaging or ultrasound technology, and where it is difficult to determine the position of a blood pump when a sensor fails.
  • a method for estimating the position of an interventional blood pump system includes: receiving an induced current generated by the interventional blood pump system due to the action of intracardiac blood; wherein the magnitude and/or direction of the induced current changes with the operation of the interventional blood pump system, and the induced current forms a time-varying periodic diagram relative to time; and determining the position of the interventional blood pump system in the patient based on at least one of the magnitude, direction, and valley value of the induced current in the time-varying periodic diagram.
  • an invasive blood pump system including a blood pump, a catheter, and a controller, wherein the controller is configured to execute the aforementioned method for estimating the position of the invasive blood pump system.
  • FIG1 is a control logic diagram of a method for estimating the position of an invasive blood pump system according to an embodiment of the present application.
  • FIG. 2 a is a schematic diagram of the position of a blood pump in the heart when the blood pump has not reached the target position according to an embodiment of the present application.
  • FIG. 2 b is a waveform diagram of the first cycle when the blood pump does not reach the target position according to an embodiment of the present application.
  • FIG. 3 a is a schematic diagram of the position of the blood pump in the heart when it reaches the target position according to an embodiment of the present application.
  • FIG. 3 b is a waveform diagram of the second cycle when the blood pump reaches the target position according to an embodiment of the present application.
  • FIG. 4 a is a schematic diagram of the position of the blood pump in the heart when the blood pump exceeds the target position according to an embodiment of the present application.
  • FIG. 4 b is a waveform diagram of the third cycle when the blood pump exceeds the target position according to an embodiment of the present application.
  • FIG. 5 a is a schematic diagram of the overall structure of a blood pump according to an embodiment of the present application.
  • FIG. 5 b is another schematic diagram of the overall structure of a blood pump according to an embodiment of the present application.
  • FIG. 5 c is a schematic diagram of an integrated structure of a blood pump according to an embodiment of the present application.
  • FIG. 6 is a schematic diagram of the connection between a blood pump and a controller according to an embodiment of the present application.
  • proximal end or “proximal side” refers to an end or a side closer to a surgical operator
  • distal end or “distal side” refers to an end or a side farther from a surgical operator
  • FIG. 1 a method for estimating the position of an invasive blood pump system according to an embodiment of the present application is shown.
  • the method may be executed by the invasive blood pump system, for example, by a controller in the invasive blood pump.
  • the natural cardiac ejection of the human body can drive the motor and blades in the blood pump to rotate; the rotation of the blades generates an induced current; the sensor in the motor measures the induced current; the controller in the blood pump receives the induced current and determines the curve characteristics of the induced current; the controller presents the induced current in the form of visual data on the operating end of the medical staff; the controller determines the position of the blood pump based on the curve characteristics of the induced current; the system program of the controller combines with a specific algorithm to display corresponding adjustment measures on the operating end of the medical staff for the medical staff to perform the next surgical operation.
  • the method for estimating the position of an interventional blood pump system includes: during the operation of the interventional blood pump system in a patient, receiving an induced current generated by the interventional blood pump system due to the action of intracardiac blood, wherein the magnitude and/or direction of the induced current changes with the operation of the interventional blood pump system, and the induced current forms a time-varying periodic diagram relative to time, and determining the position of the interventional blood pump system in the patient based on at least one of the magnitude, direction, and valley value of the induced current in the time-varying periodic diagram.
  • the induced current is received from a controller on the interventional blood pump system; and the time-varying periodic diagram is a waveform diagram, and the lowest value of the induced current in each cycle is the trough of each fluctuation cycle; when the trough is in the time-varying cycle When the lowest point is reached in the period graph, the induced current reaches a valley value, and the interventional blood pump system reaches the target position.
  • the interventional blood pump system when the lowest value of the induced current is a negative value and the direction of the induced current alternates between a positive direction and a reverse direction, the interventional blood pump system is located at the target position, as shown in FIGS. 3a and 3b .
  • At least a first periodic waveform diagram and a second periodic waveform diagram appear in the time-varying periodic diagram; and, when the first periodic waveform diagram appears, the interventional blood pump system has not reached the target position, as shown in Figures 2a and 2b, and when the second periodic waveform diagram appears, the interventional blood pump system reaches the target position, as shown in Figures 3a and 3b.
  • the time-varying periodic diagram further includes a third periodic waveform diagram; and when the third periodic waveform diagram appears, the invasive blood pump system has exceeded the target position, as shown in FIGS. 4a and 4b .
  • the interventional blood pump system includes a blood inlet 6 and a blood outlet 7, as shown in Figure 5a; and, when the blood inlet 6 and the blood outlet 7 are both located in the aorta, as shown in Figure 2a, the time-varying periodic diagram is a first periodic waveform diagram, as shown in Figure 2b; when the blood inlet 6 is located in the left ventricle and the blood outlet 7 is located in the aorta, as shown in Figure 3a, the time-varying periodic diagram is a second periodic waveform diagram, as shown in Figure 3b; when the blood inlet 6 and the blood outlet 7 are both located in the left ventricle, as shown in Figure 4a, the time-varying periodic diagram is a third periodic waveform diagram, as shown in Figure 4b.
  • the lowest value of the induced current of the second periodic waveform is smaller than the lowest value of the induced current of the third periodic waveform, and the lowest value of the induced current of the third periodic waveform is smaller than the lowest value of the induced current of the first periodic waveform; and the highest value of the induced current of the second periodic waveform is the smallest among the highest values of the induced current of the three periodic waveforms.
  • a maximum value of the induced current in the first periodic waveform diagram is close to a maximum value of the induced current in the third periodic waveform diagram.
  • the invasive blood pump system when the blood inlet 6 is located in the left ventricle and the blood outlet 7 is located in the aorta, the invasive blood pump system is located at the target position.
  • the variation amplitude of the induced current of the first periodic waveform is the smallest among the variation amplitudes of the three periodic waveforms.
  • the time-varying periodogram visually presents real-time data, waveform and current characteristic values of the induced current, wherein the current characteristic values include peak value, valley value, amplitude, frequency, rate of change, first-order derivative and second-order derivative.
  • the method provided by the present application is particularly important when the effect of determining the position of the interventional blood pump using medical images is not obvious, or when other sensors used to determine the position of the interventional blood pump fail.
  • the variation amplitude of the induced current generated when the blood inlet 6 and the blood outlet 7 are located in the left ventricle of the patient is greater than the variation amplitude of the induced current generated when the blood inlet 6 and the blood outlet 7 are located in the aorta of the patient.
  • an invasive blood pump system including a blood pump 1, a catheter 8 (the catheter 8 may be an elongated catheter) and a controller 9 (as shown in FIG. 6 ).
  • the blood pump 1 includes a blade 2, a housing 3 and a motor 4.
  • the motor 4 includes a rotating shaft 41, an inner magnetic pole 42, a coil 43 and an outer magnetic pole 44.
  • the coil 43 and the outer magnetic pole 44 are fixed to the housing 3; and the blade 2, the rotating shaft 41 and the inner magnetic pole 42 are fixed together to form an integrated structure.
  • the interventional blood pump system when the interventional blood pump system enters the human body, when the blood pump is not driven by current, the blood fluid generated by the natural heart pumping of the human body impacts the blade 2, the integrated structure 5 rotates, and the rotation of the inner magnetic pole 42 changes the direction of the magnetic field formed by the inner magnetic pole 42 and the outer magnetic pole 44.
  • the magnetic field and the coil 43 produce a cutting motion, and the coil 43 generates an induced current.
  • the controller has a built-in analog-to-electric conversion device, which converts the collected induced current into a digital signal and stores it in the memory of the controller.
  • the blade 2 is disposed at the distal end of the rotating shaft 41 .
  • the blood inlet 6 is arranged at the distal end of the blade 2
  • the blood outlet 7 is arranged at the proximal end of the blade 2 .
  • the controller determines the current curve characteristics of the induced current and presents the current curve and its characteristics on an operation interface of medical personnel so that the medical personnel can observe the physiological characteristics of the patient.
  • the controller has a determination function to programmatically determine the position of the interventional blood pump using the induced current curve and its characteristic value to reduce the number of determination steps for medical personnel; the system program of the controller combines with a specific algorithm to display corresponding adjustment measures at the operating end for medical personnel to perform the next surgical operation.
  • the motor has a built-in high-precision current sensor, and the current sensor is configured to collect the driving current of the motor and the induced current caused by the blood fluid impact generated by the natural heart pumping of the human body.
  • the controller has an automatic determination function, and monitors the patient in real time and determines the surgical status of the patient through the collected current data and the calculated multiple characteristic values, and executes the corresponding alarm function.
  • An exemplary use procedure and control logic of the heart assist system 1 are as follows:
  • the blood pump 1 is delivered to the ascending aorta through the femoral artery, the descending aorta, and the aortic arch through a surgical operation, as shown in FIG2a , and the blood drives the blades 2 of the blood pump 1 to rotate, and the controller receives the induced current and displays a first cycle waveform, as shown in FIG2b ;
  • the controller shows a second period waveform, the direction of the induced current in the second period waveform alternates between positive and reverse directions, and the blood pump 1 reaches the vicinity of the target position;
  • the blood pump 1 is started, and the motor 4 drives the blade 2 to rotate to achieve the blood pumping function;
  • the controller collects the current data of the motor 4 and stores it in the controller memory.
  • Artificial interventional blood pumps in related technologies generally determine the position of the blood pump body in the human body through image positioning or by setting a positioning sensor outside the motor.
  • Image positioning is not accurate in some cases and has the defect of unclear imaging.
  • Setting a positioning sensor not only increases the difficulty of the process, but also easily scratches the blood vessels during movement, reducing the safety of the operation and easily causing damage and failure of the sensor.
  • This application avoids the above situation and discloses a method for estimating the position of the blood pump body in the human body.
  • a method for calculating the position of an interventional blood pump system First, the natural ejection of blood by the human body will drive the motor and blades of the blood pump to rotate. According to the electromagnetic induction phenomenon, the blood pump system can generate an induced current.
  • the controller in the blood pump determines the curve characteristics of the induced current and presents the induced current in the form of visualized data on the operating end of the medical staff.
  • the controller can determine the position of the blood pump in the patient according to at least one of the magnitude, direction, and valley value of the induced current. Therefore, the operator can determine whether the blood pump system is located at the target position by observing the induced current curve characteristics at the operating end. This judgment method not only saves the need for additional positioning sensors, but also saves equipment production costs and increases the safety factor of the operation.
  • the time-varying periodic diagram of the present application is a waveform diagram.
  • the position and shape of the induced current curve of the time-varying periodic diagram are different.
  • the lowest value of the induced current is a negative value, and the direction of the induced current alternates between positive and reverse directions, the interventional blood pump system is located at the target position, and the determination principle is as follows: during the systolic period of the human heart, the aortic valve opens, and the left ventricular blood is connected to the aortic blood.
  • the blood flow direction is positive, and the direction of the generated induced current is also positive; during the diastolic period of the heart, the aortic valve closes, but because the blood pump crosses the aortic valve, the aortic valve cannot be completely closed.
  • the aortic blood pressure is greater than the left ventricular blood pressure, and the blood fluid flows from the high-pressure area to the low-pressure area, causing a slight reflux phenomenon that causes the blades to reverse.
  • the induced current corresponding to the blood pump motor is in the reverse direction. Therefore, for multiple consecutive and complete cardiac cycles, the direction of the induced current alternates between positive and reverse directions.
  • the interventional blood pump system includes a blood inlet and a blood outlet, and when the blood inlet and the blood outlet are both located in the aorta, the time-varying periodic diagram is a first periodic waveform diagram; when the blood inlet is located in the left ventricle and the blood outlet is located in the aorta, the time-varying periodic diagram is a second periodic waveform diagram; when the blood inlet and the blood outlet are both located in the left ventricle, the time-varying periodic diagram is a third periodic waveform diagram.
  • the controller can determine the first periodic waveform diagram, the second periodic waveform diagram, or the third periodic waveform diagram based on the amplitude, peak, trough, or other current characteristic values of the induced current in the time-varying periodic diagram, thereby determining the position of the blood pump in the heart, and the basis for determination is also very intuitive and simple.
  • the blood pump system is percutaneously intervened and passes through the aortic arch.
  • the first cycle waveform appears first.
  • the peaks and troughs of the first cycle waveform are both positive numbers with a small amplitude.
  • the second cycle waveform appears, the lowest value of the induced current is a negative value, and the direction of the induced current alternates between positive and reverse directions, which means that the target position has been reached.
  • the target position has been exceeded and the interventional blood pump system needs to be pulled proximally.
  • a time-varying periodogram visually presents the real-time data, waveform and current characteristic values of the induced current.
  • the current characteristic values include peak value, valley value, amplitude, frequency, rate of change, first-order derivative and second-order derivative.
  • the blood pump of the interventional blood pump system includes blades, a casing and a motor
  • the motor includes a rotating shaft, an inner magnetic pole, a coil and an outer magnetic pole
  • the blades, the rotating shaft and the inner magnetic pole are fixed together to form an integrated structure.
  • the rotation of the inner magnetic pole changes the direction of the magnetic field formed by the inner magnetic pole and the outer magnetic pole, and the magnetic field and the coil produce a cutting motion, and the coil generates an induced current, thereby utilizing the natural blood pumping of the human body without setting up other structures.
  • the blood pump generates an induced current, thereby determining the position of the blood pump.
  • the design is ingenious and has high clinical promotion value.
  • the controller has a built-in analog-to-electric conversion device, which converts the collected induced current into a digital signal and stores it in the controller's memory. The data is backed up, and the humanization level is high.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne une pompe à sang interventionnelle et un procédé d'estimation de la position d'un système de pompe à sang interventionnelle. Pendant le fonctionnement du système de pompe à sang interventionnelle à l'intérieur d'un patient, un courant induit, généré par le système de pompe à sang interventionnelle sous l'action du sang dans le cœur, est reçu. L'amplitude et/ou la direction du courant induit change à mesure que le système de pompe à sang interventionnelle fonctionne. Le courant induit forme un motif périodique variant dans le temps par rapport au temps. Sur la base de l'amplitude, de la direction et/ou des points de vallée du courant induit dans le motif périodique variant dans le temps, la position du système de pompe à sang interventionnelle à l'intérieur du patient est déterminée.
PCT/CN2023/126158 2022-11-24 2023-10-24 Système et procédé d'estimation de la position d'une pompe à sang interventionnelle WO2024109422A1 (fr)

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CN202211484638.8A CN115779260A (zh) 2022-11-24 2022-11-24 用于估计介入式血泵位置的系统和方法
CN202211484638.8 2022-11-24

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Families Citing this family (4)

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Publication number Priority date Publication date Assignee Title
CN115779260A (zh) * 2022-11-24 2023-03-14 上海炫脉医疗科技有限公司 用于估计介入式血泵位置的系统和方法
CN117018434B (zh) * 2023-10-07 2023-12-26 心擎医疗（苏州）股份有限公司 介入泵位置确定方法、装置、控制设备及心室辅助装置
CN117298443B (zh) * 2023-11-27 2024-03-12 安徽通灵仿生科技有限公司 一种iabp控制方法及装置
CN117919584B (zh) * 2024-03-22 2024-05-24 生命盾医疗技术(苏州)有限公司 介入式心脏泵异常预警方法、装置、存储介质及电子设备

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US5527159A (en) * 1993-11-10 1996-06-18 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Rotary blood pump
CN1222863A (zh) * 1997-04-02 1999-07-14 激励心脏技术有限公司 心脏内的血液泵
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CN217246252U (zh) * 2022-04-13 2022-08-23 上海微创心力医疗科技有限公司 经皮介入式血泵与医疗装置
CN115779260A (zh) * 2022-11-24 2023-03-14 上海炫脉医疗科技有限公司 用于估计介入式血泵位置的系统和方法

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Publication number Priority date Publication date Assignee Title
US5527159A (en) * 1993-11-10 1996-06-18 The United States Of America As Represented By The Administrator Of The National Aeronautics And Space Administration Rotary blood pump
CN1222863A (zh) * 1997-04-02 1999-07-14 激励心脏技术有限公司 心脏内的血液泵
CN112088022A (zh) * 2018-03-16 2020-12-15 阿比奥梅德公司 用于估计心脏泵的位置的系统和方法
CN114588530A (zh) * 2022-03-14 2022-06-07 丰凯利医疗器械(上海)有限公司 泵血导管在人体内位置的检测方法和系统
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