WO2024131262A1 - Method and device for measuring blood pressure at outlet of blood pump - Google Patents

Method and device for measuring blood pressure at outlet of blood pump Download PDF

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Publication number
WO2024131262A1
WO2024131262A1 PCT/CN2023/126204 CN2023126204W WO2024131262A1 WO 2024131262 A1 WO2024131262 A1 WO 2024131262A1 CN 2023126204 W CN2023126204 W CN 2023126204W WO 2024131262 A1 WO2024131262 A1 WO 2024131262A1
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fluid
pressure
motor
outlet
blood
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PCT/CN2023/126204
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French (fr)
Chinese (zh)
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吕骁
吕世文
古珮瑶
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上海炫脉医疗科技有限公司
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Publication of WO2024131262A1 publication Critical patent/WO2024131262A1/en

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    • Y—GENERAL 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
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Definitions

  • the present application relates to the field of medical device technology, for example, to a method and device for measuring blood pressure at an outlet of a blood pump.
  • interventional cardiac treatment surgery is a common treatment scheme, which uses a stable hemodynamic assist device in conjunction with the surgery, and a blood pump assists the patient's heart to eject blood.
  • the blood pressure of ejection is an important indicator, and its fluid pressure needs to be accurately monitored.
  • the related technology discloses an intravascular blood pump with an outflow hose.
  • the technical defects of this design are: first, the second pressure sensor is also flushed by the blood while measuring the blood pressure of the outflowing blood. Under long-term blood flow flushing, the pressure sensor is prone to damage or displacement, resulting in inaccurate received pressure values or directly affecting the blood pumping function of the blood pump; secondly, during the process of blood flowing from the outflow hose into the aorta, it rubs against the outflow hose and the discharge port, and the blood pressure inside the outflow hose is actually different from the blood pressure in the aorta, making it difficult to obtain accurate aortic blood pressure.
  • the setting of the pressure sensor increases the implants in the patient's body, increasing the surgical risk; second, the pressure sensor is easily damaged by long-term blood flow impact during operation, and the error of the long-term implant measurement value is large; third, the measurement position of the aortic blood pressure is inaccurate.
  • the present application provides a method for measuring blood pressure at the outlet of a blood pump in order to address situations such as the placement of a pressure sensor in the body and inaccurate pressure measurement results.
  • the present application provides a method for measuring blood pressure at an outlet of a blood pump, wherein the blood pump comprises a motor and a delivery tube, a fluid enters the motor through the delivery tube, and the outlet is located in the aorta or the pulmonary artery after the blood pump is implanted, comprising: retrieving a reference data set obtained from a test environment, wherein the reference data set comprises the following reference data: a pressure difference of the fluid before and after flowing through the motor and a fluid flow rate in the delivery tube under conditions of different working parameters and different driving parameters; wherein the working parameters comprise a first working parameter, and the driving parameters comprise a first driving parameter; after the blood pump is placed in a patient, measuring or calculating the fluid flow rate under conditions of the first working parameter and the first driving parameter, And obtain the corresponding fluid pressure difference through the benchmark data set; measure the fluid pressure flowing in front of the motor, thereby obtaining the fluid pressure flowing after the motor, wherein the fluid pressure flowing after the motor is the sum of the fluid pressure flowing in front of the motor and the
  • a device for measuring blood pressure at the outlet of a blood pump which executes the above method, includes: a power unit, a retrieval unit, a control unit and a calculation unit; wherein the power unit is configured to drive the motor of the blood pump and adjust the motor speed; the retrieval unit is configured to retrieve a reference data set obtained from a test environment, thereby obtaining a fluid pressure difference corresponding to the fluid flow rate; the control unit includes a fluid drive device and a pressure sensor, the drive device is configured to control the flow rate and pressure of the fluid, and the pressure sensor is configured to measure the fluid pressure before flowing through the motor; the calculation unit is configured to obtain the fluid pressure difference of the retrieval unit and the fluid pressure of the control unit, and obtain the fluid pressure after flowing through the motor through calculation.
  • FIG. 1 a is a schematic diagram of a blood pump according to an embodiment of the present application, wherein the solid arrows and the hollow arrows respectively indicate the flow path of the cleaning fluid and the flow path of the blood.
  • FIG1 b is a schematic diagram of components for measuring blood pressure at the outlet of a blood pump according to an embodiment of the present application, wherein hollow arrows indicate the flow path of blood.
  • FIG. 2 is a schematic diagram of multiple components when measuring P, N, and Q under a test environment in an embodiment of the present application.
  • FIG. 3 a shows data at a first fluid concentration according to an embodiment of the present application.
  • FIG. 3 b is a schematic diagram of a first curve at a first fluid concentration according to an embodiment of the present application.
  • FIG. 4 a shows data at a second fluid concentration according to an embodiment of the present application.
  • FIG. 4 b is a schematic diagram of a second curve at a second fluid concentration according to an embodiment of the present application.
  • FIG5 is a method for measuring blood pressure at the outlet of a blood pump provided in an embodiment of the present application.
  • 1-blood pump 11-motor, 111-first bearing, 112-second bearing, 12-delivery tube, 13-blade, 14-housing, 141-inlet, 142-outlet, 2-fluid driving device, 21-speed measuring motor, 22-push pump, 3-pressure sensor, 4-flow meter, 5-cleaning box.
  • proximal or “proximal side” refers to the end or side closer to the operator
  • distal or “distal side” refers to the end or side closer to the operator. It refers to the end or side that is farther away from the operator.
  • FIG. 1a a schematic diagram of a blood pump is shown, wherein the solid arrows and the hollow arrows respectively indicate the flow path of the cleaning fluid and the flow path of the blood.
  • FIG. 1b a schematic diagram of the components for measuring the blood pressure at the outlet of the blood pump is shown, wherein the hollow arrows indicate the flow path of the blood.
  • FIG. 1b a schematic diagram of the components for measuring the blood pressure at the outlet of the blood pump is shown, wherein the hollow arrows indicate the flow path of the blood.
  • Step 1 retrieve a benchmark data set obtained from a test environment, wherein the benchmark data set includes the following benchmark data: Under the conditions of different working parameters including a first working parameter and different driving parameters including a first driving parameter, the pressure difference H of the fluid flowing before and after the motor 11 and the pressure difference H of the fluid located at the outlet 142 of the blood pump 1 The fluid flow Q in the delivery tube 12; Step 2: after the blood pump 1 is placed in the patient, measure or calculate the fluid flow Q1 under the conditions of the first working parameter and the first driving parameter, and obtain the corresponding fluid pressure difference H1 through the reference data set; Step 3: measure the fluid pressure N before flowing through the motor 11, thereby obtaining the fluid pressure
  • the working parameter is fluid concentration
  • the driving parameter is the rotation speed of the motor
  • the fluid is a cleaning fluid
  • the cleaning fluid includes heparin, glucose and sodium bicarbonate solution.
  • several groups of fluid pressure differences H and fluid flow rates Q in the benchmark data set form different curves; and, when the concentration of the fluid is a first fluid concentration and the speed of the motor is a first speed, several groups of fluid pressure differences H1 and fluid flow rates Q1 in the benchmark data set form a first curve.
  • the first fluid concentration is 5%
  • the first rotational speed is 24000 r/min
  • several groups of fluid pressure differences H1 before and after the motor 11 and the fluid flow rate Q1 in the delivery pipe 12 are measured in a test environment, and a first curve is formed, as shown in Figures 3a and 3b.
  • factors affecting the shape of the curve formed by the fluid pressure difference H and the fluid flow rate Q include the resistance formed by the delivery tube and its tortuous shape and the transmission loss caused by the resistance formed by the blood pump structure.
  • H-Q curves of different shapes can be obtained by changing the fluid concentration.
  • H-Q curves of different shapes can be obtained by changing the rotation speed of the motor.
  • the reference data set includes the pressure difference H of the fluid before and after flowing through the motor and the fluid flow rate Q in the delivery pipe under several fluid concentration conditions.
  • the reference data set includes the pressure difference H of the fluid before and after the motor and the fluid flow rate Q in the delivery pipe under several motor speed conditions.
  • the fluid flows in front of the motor 11 from entering the delivery tube 12 to entering the motor 11; and, the measuring position for measuring the fluid pressure N in front of the motor 11 is outside the patient's body, that is, the pressure sensor 3 for measuring the fluid pressure N in front of the motor 11 is outside the body, as shown in Figure 1b.
  • the fluid flow rate Q1, the fluid pressure difference H1, and the fluid pressure N are real-time data, and the calculated fluid pressure P is also real-time data; and, as the pressure P at the outlet 142 of the blood pump 1 increases, the fluid flow rate Q1 decreases, and the fluid pressure N and the fluid pressure difference H1 before flowing through the motor 11 increase.
  • the pressure of the fluid is greater than the blood pressure at the outlet 142 ; and the pumping direction of the blood at the outlet 142 is perpendicular to the center line of the motor 11 .
  • the function of preventing blood from entering the motor 11 of the blood pump 1 can be achieved, so that the blood is ejected to the outside of the motor 11 of the blood pump 1.
  • the blood pump 1 further includes a paddle 13 and a housing 14, wherein the paddle 13 is connected to the motor 11, and the housing 14 is sleeved outside the paddle 13; and, an inlet 141 is provided at the first end (distal end) of the housing 14, and an outlet 142 is provided at the second end (proximal end) of the housing 14, as shown in FIG. 1a.
  • the fluid pressure P after flowing through the motor 11 and the fluid pressure N before flowing through the motor 11 are both measured by a pressure sensor 3, and the fluid flow Q in the delivery pipe 12 is measured by a flow meter 4; and the fluid pressure difference H before and after flowing through the motor 11 is obtained by subtracting P from N.
  • the test environment simulates a human blood vessel or organ and, therefore, substantially simulates a blood pump 1 in the human body.
  • the blood pressure in the ventricle changes, the pressure at the outlet 142 of the blood pump 1 changes, and then the pressure of the fluid after the motor 11 changes, and the pressure of the fluid before the motor 11 changes, and the fluid flow Q1 changes.
  • the pressure difference H1 of the fluid before and after the motor 11 can be obtained through the reference data set.
  • the cleaning fluid is stored in the cleaning box 5, and the cleaning box 5 can adjust the concentration of the cleaning fluid.
  • the device for executing the above-mentioned measurement method includes: a power unit, a retrieval unit, a control unit and a calculation unit; wherein the power unit is configured to drive the motor 11 of the blood pump 1 and adjust the rotation speed of the motor 11; the retrieval unit is configured to retrieve a reference data set obtained from a test environment, thereby obtaining a fluid pressure difference H corresponding to the fluid flow rate Q; the control unit includes a fluid drive device 2 and a pressure sensor 3, the drive device is configured to control the flow rate and pressure of the fluid, and the pressure sensor 3 is configured to measure the fluid pressure N before flowing through the motor 11; the calculation unit is configured to obtain the fluid pressure difference H of the retrieval unit and the fluid pressure N of the control unit, and obtain the fluid pressure P after flowing through the motor 11 through calculation.
  • the power unit is configured to drive the motor 11 of the blood pump 1 and adjust the rotation speed of the motor 11
  • the retrieval unit is configured to retrieve a reference data set obtained from a test environment, thereby obtaining a fluid pressure difference
  • the pressure sensor 3 is arranged at one end (distal end) of the driving device, and the pressure sensor 3 and the driving device are both located outside the body when the blood pump 1 is running; and the pressure sensor 3 is located at one end (proximal part) of the delivery tube 12.
  • the motor 11 includes a first bearing 111 (also called a proximal bearing) and a second bearing 112 (also called a distal bearing), and the fluid forms a dynamic seal after flowing through the second bearing 112; and the fluid pressure after passing through the second bearing 112 is greater than the blood pressure at the outlet 142.
  • the internal gap of the motor 11 is extremely small, and the pressure of the fluid increases after flowing through the motor 11.
  • the fluid pressure P after the motor 11 is greater than the fluid pressure N before flowing through the motor 11 .
  • the fluid driving device 2 includes a speed measuring motor 21 and a push pump 22
  • the push pump 22 includes a piston
  • the fluid flow rate Q is calculated by the cross-sectional area of the piston and the rotation speed of the speed measuring motor 21 .
  • the cleaning box 5 is operated to perfuse the blood pump 1 with a cleaning solution with a concentration of 5%, and the control unit is operated to make the speed of the motor 24000 r/min, thereby determining a first curve adapted to the cleaning solution concentration and the speed of the motor;
  • the control unit automatically calculates the fluid flow rate Q1 as 10 ml/hr based on the rotation speed of the speed measuring motor 21 and the cross-sectional area of the piston. At this time, H1 is 792 mmHg according to the first curve;
  • the calculation unit calculates the pressure value at the outlet 142 of the blood pump 1 in real time according to the surgical situation and presents the result visually to the operator.
  • Another embodiment of the present application is substantially the same as the aforementioned embodiment, except that the concentration of the cleaning liquid is different from the motor speed.
  • a method for measuring blood pressure at an outlet 142 of a blood pump 1, wherein the blood pump 1 comprises a motor 11 and a delivery tube 12, wherein a fluid enters the motor 11 through the delivery tube 12, and wherein the outlet 142 is located in the aorta or the pulmonary artery after the blood pump 1 is implanted comprises the following steps: Step 1: Retrieve a benchmark data set obtained from a test environment, wherein the benchmark data set comprises the following benchmark data: under different working parameters including a first working parameter and different driving parameters including a first driving parameter, the pressure difference H of the fluid flowing before and after the motor 11 and the pressure difference H at the outlet 142 The fluid flow Q in the delivery tube 12; Step 2: after the blood pump 1 is placed in the patient, measure or calculate the fluid flow Q1 under the conditions of the first working parameter and the first driving parameter, and obtain the corresponding fluid pressure difference H1 through the reference data set; Step 3: measure the fluid pressure N before flowing through the motor 11, thereby obtaining the fluid pressure P after flowing
  • the several groups of fluid pressure differences H and fluid flow rates Q in the reference data set form different curves; and when the concentration of the fluid is a second fluid concentration and the motor speed is a second speed, the several groups of fluid pressure differences H2 and fluid flow rates Q2 in the reference data set form a second curve. Second curve.
  • the concentration of the second fluid is 10%, and the rotation speed of the motor is 20000 r/min.
  • the fluid flow rate Q2 decreases, and the fluid pressure N and the fluid pressure difference H2 before flowing through the motor 11 increase.
  • the blood pressure in the ventricle changes, the pressure at the outlet 142 of the blood pump 1 changes, and then the pressure of the fluid after passing through the motor 11 changes.
  • the pressure of the fluid before passing through the motor 11 changes, and the fluid flow rate Q2 changes.
  • the pressure difference H2 of the fluid before and after passing through the motor 11 can be obtained through the second curve.
  • a pressure sensor is generally connected to a blood pump or a delivery tube to measure the blood pressure at the aorta.
  • the pressure sensor is prone to malfunction or even detachment under the flushing of blood flow, causing harm to the patient.
  • the present application avoids the above situation and discloses a method for measuring the blood pressure at the outlet of a blood pump. By experimentally measuring the ejection pressure of the blood pump and several data of an extracorporeal device, the relationship between the data is obtained, which can be expressed as a function or a curve graph.
  • the ejection pressure of the blood pump can be obtained through the above function or curve graph, thereby realizing the function of measuring human blood pressure by an extracorporeal sensor.
  • the specific principle of obtaining the aortic pressure without implanting a sensor is as follows: By measuring the blood pressure at the outlet of the blood pump in a test environment, the blood pressure at the outlet of the blood pump can be measured. The ejection pressure at the outlet is measured. First, since the fluid after flowing through the motor is also located at the outlet, the measured blood pressure is equivalent to the fluid pressure flowing out of the motor.
  • the fluid pressure in the delivery tube outside the body is comprehensively measured to obtain the fluid pressure difference H before and after flowing through the motor.
  • the data relationship between the fluid pressure difference H and the fluid flow rate Q is obtained. This relationship is expressed as an H-Q curve.
  • H is obtained through the fluid flow rate Q, and the real-time fluid pressure N is measured at the position where the extracorporeal fluid pressure is measured in the test environment.
  • the sum of N and H is the blood pressure at the outlet of the blood pump.
  • the data acquisition is simple. While reducing the number of mechanical devices implanted in the patient's body, it also reduces the burden of blood pump processing and reduces the economic pressure of medical institutions and patients to a certain extent.
  • the measuring position when measuring the fluid pressure N flowing in front of the motor is located outside the patient's body, and the pressure sensor for measuring the fluid pressure N flowing in front of the motor is located at the proximal end of the delivery tube.
  • changes in the working parameters and driving parameters will affect the shape of the HQ curve.
  • several groups of fluid pressure differences H and fluid flow rates Q in the reference data set form different curves. If the cleaning fluid concentration is changed during the operation of the blood pump, the retrieval unit will confirm a certain HQ curve based on the adjusted cleaning fluid concentration and the real-time motor speed, and then obtain the fluid pressure difference H based on the real-time fluid flow rate Q. If the motor speed is changed during the operation of the blood pump, the retrieval unit will confirm a certain HQ curve based on the adjusted motor speed and the real-time cleaning fluid concentration, and then obtain the fluid pressure difference H based on the real-time fluid flow Q.
  • the coupling efficiency of multiple units is high, the data is updated in real time, and the data obtained by medical workers is accurate and efficient.
  • the power unit automatically determines different motor speeds and transmits them to the retrieval unit, and is combined with specific algorithms and devices to determine the applicable HQ curve described in this method based on the cleaning fluid concentration and motor speed set by medical personnel, thereby obtaining the required blood pressure at the ejection point of the blood pump.
  • the operation is simple, the response is rapid, and the clinical value is great.

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Abstract

The present application relates to a method and a device for measuring blood pressure at an outlet of a blood pump. The method comprises: retrieving a benchmark data set obtained from a test environment, wherein the benchmark data set comprises the following benchmark data: under the conditions of different working parameters and different driving parameters, a pressure difference of a fluid before and after flowing through a motor and a fluid flow rate in a delivery tube, wherein the working parameters comprise a first working parameter, and the driving parameters comprise a first driving parameter; after a blood pump is placed in a patient, measuring or calculating fluid flow rates under the conditions of the first working parameter and the first driving parameter, and obtaining a corresponding pressure difference of the fluid through the benchmark data set; and measuring a pressure of the fluid before flowing through the motor to obtain a pressure of the fluid after flowing through the motor, wherein the pressure of the fluid after flowing through the motor is the sum of the pressure of the fluid before flowing through the motor and the corresponding fluid pressure difference obtained through the benchmark data set; the fluid after flowing through the motor is located at the outlet, and the blood pressure at the outlet is the pressure of the fluid after flowing through the motor.

Description

用于测量血泵出口处血压的方法、设备Method and device for measuring blood pressure at the outlet of a blood pump
本申请要求在2022年12月20日提交中国专利局、申请号为202211642321.2的中国专利申请的优先权，该申请的全部内容通过引用结合在本申请中。This application claims priority to the Chinese patent application filed with the China Patent Office on December 20, 2022, with application number 202211642321.2, the entire contents of which are incorporated by reference into this application.
技术领域Technical Field
本申请涉及医疗器械技术领域，例如涉及一种用于测量血泵出口处血压的方法、设备。The present application relates to the field of medical device technology, for example, to a method and device for measuring blood pressure at an outlet of a blood pump.
背景技术Background technique
目前，心血管疾病在中国的发病率和死亡率逐渐上升，严重的心血管疾病例如心肌梗死及其并发症等疾病直接威胁患者的生命安全，需要紧急手术治疗。对于相关技术中的心脏外科手术治疗方案上，介入式心脏治疗手术是常见的治疗方案，运用稳定的血液动力辅助装置配合手术，血泵辅助患者心脏射血，其中，射血的血液压力是一项重要指标，需要精确监测其流体压力。At present, the incidence and mortality of cardiovascular diseases in China are gradually increasing. Severe cardiovascular diseases such as myocardial infarction and its complications directly threaten the life safety of patients and require emergency surgical treatment. Regarding the cardiac surgical treatment scheme in related technologies, interventional cardiac treatment surgery is a common treatment scheme, which uses a stable hemodynamic assist device in conjunction with the surgery, and a blood pump assists the patient's heart to eject blood. Among them, the blood pressure of ejection is an important indicator, and its fluid pressure needs to be accurately monitored.
针对左心室手术的血泵技术中，常见在血泵的机械外壳上附着压力传感器以测量心脏主动脉压或左心室压，这不可避免地导致患者体内植入较多的机械器件或材料，有潜在的生理性风险；此外，在手术进行中时由于血泵在患者心脏内部，若其压力传感器故障则需要更换血泵，步骤比较繁琐且严格，这对患者的生命也构成了一定的威胁，同时，通常该类高精度压力传感器价格昂贵，维护费用高，一定程度下增加了产品生产成本。In the blood pump technology for left ventricular surgery, it is common to attach a pressure sensor to the mechanical housing of the blood pump to measure the aortic pressure or left ventricular pressure of the heart, which inevitably leads to the implantation of more mechanical devices or materials in the patient's body, posing potential physiological risks. In addition, during the operation, since the blood pump is inside the patient's heart, if its pressure sensor fails, the blood pump needs to be replaced, and the steps are relatively cumbersome and strict, which also poses a certain threat to the patient's life. At the same time, this type of high-precision pressure sensor is usually expensive and has high maintenance costs, which increases the product production cost to a certain extent.
相关技术公开了一种具有流出软管的血管内血泵，这样设计的技术缺陷在于：首先，第二压力传感器在测量流出血液血压的同时，也受到了血液的冲刷，在长期的血流冲刷下，压力传感器容易发生损坏或位移，导致接收的压力值不准确或者直接影响血泵泵血功能；其次，血液从流出软管流入主动脉的过程中与流出软管、排出端口摩擦，流出软管内侧的血压实质上是与主动脉中的血压并不相同，难以获得准确的主动脉血压压力。The related technology discloses an intravascular blood pump with an outflow hose. The technical defects of this design are: first, the second pressure sensor is also flushed by the blood while measuring the blood pressure of the outflowing blood. Under long-term blood flow flushing, the pressure sensor is prone to damage or displacement, resulting in inaccurate received pressure values or directly affecting the blood pumping function of the blood pump; secondly, during the process of blood flowing from the outflow hose into the aorta, it rubs against the outflow hose and the discharge port, and the blood pressure inside the outflow hose is actually different from the blood pressure in the aorta, making it difficult to obtain accurate aortic blood pressure.
综上所述，相关技术中存在以下情况：第一，压力传感器的设置增加了患者体内的植入物，增大了手术风险；第二，压力传感器工作时受到长期血流冲击易受损，长期植入测量值的误差大；第三，主动脉血压压力测量位置不准确。To sum up, the following situations exist in the relevant technology: first, the setting of the pressure sensor increases the implants in the patient's body, increasing the surgical risk; second, the pressure sensor is easily damaged by long-term blood flow impact during operation, and the error of the long-term implant measurement value is large; third, the measurement position of the aortic blood pressure is inaccurate.
发明内容Summary of the invention
本申请针对例如压力传感器在体内的设置与压力测量结果不准确等情况，提供了一种用于测量血泵出口处血压的方法。The present application provides a method for measuring blood pressure at the outlet of a blood pump in order to address situations such as the placement of a pressure sensor in the body and inaccurate pressure measurement results.
本申请提供一种用于测量血泵出口处血压的方法，所述血泵包括电机和输送管，流体通过所述输送管进入所述电机，所述出口处在所述血泵植入后位于主动脉或肺动脉内，包括：检索从测试环境中获得的基准数据集合，所述基准数据集合包括以下基准数据：在不同工作参数和不同驱动参数的条件下，流经所述电机前后的流体压差和位于所述输送管内的流体流量；其中，所述工作参数包括第一工作参数，所述驱动参数包括第一驱动参数；在所述血泵放置在患者中之后，测量或计算处于所述第一工作参数和第一驱动参数的条件下的流体流量， 并通过所述基准数据集合获得对应的流体压差；测量流经所述电机前的流体压力，由此获得流经所述电机后的流体压力，其中，流经所述电机后的流体压力为流经所述电机前的流体压力与通过所述基准数据集合获得对应的流体压差之和；流经所述电机后的流***于出口处，出口处的血压为流经所述电机后的流体压力。The present application provides a method for measuring blood pressure at an outlet of a blood pump, wherein the blood pump comprises a motor and a delivery tube, a fluid enters the motor through the delivery tube, and the outlet is located in the aorta or the pulmonary artery after the blood pump is implanted, comprising: retrieving a reference data set obtained from a test environment, wherein the reference data set comprises the following reference data: a pressure difference of the fluid before and after flowing through the motor and a fluid flow rate in the delivery tube under conditions of different working parameters and different driving parameters; wherein the working parameters comprise a first working parameter, and the driving parameters comprise a first driving parameter; after the blood pump is placed in a patient, measuring or calculating the fluid flow rate under conditions of the first working parameter and the first driving parameter, And obtain the corresponding fluid pressure difference through the benchmark data set; measure the fluid pressure flowing in front of the motor, thereby obtaining the fluid pressure flowing after the motor, wherein the fluid pressure flowing after the motor is the sum of the fluid pressure flowing in front of the motor and the corresponding fluid pressure difference obtained through the benchmark data set; the fluid flowing after the motor is located at the outlet, and the blood pressure at the outlet is the fluid pressure after the motor.
在另一方面中，一种用于测量血泵出口处血压的设备，执行上述的方法，包括：动力单元、检索单元、控制单元与计算单元；其中，所述动力单元设置为驱动所述血泵的电机并调整所述电机转速；所述检索单元设置为检索从测试环境中获得的基准数据集合，从而获得与流体流量对应的流体压差；所述控制单元包括流体驱动装置与压力传感器，所述驱动装置设置为控制流体的流速和压力，所述压力传感器设置为测量流经所述电机前的流体压力；所述计算单元设置为获取所述检索单元的流体压差与所述控制单元的流体压力，经过计算获得流经所述电机后的流体压力。On the other hand, a device for measuring blood pressure at the outlet of a blood pump, which executes the above method, includes: a power unit, a retrieval unit, a control unit and a calculation unit; wherein the power unit is configured to drive the motor of the blood pump and adjust the motor speed; the retrieval unit is configured to retrieve a reference data set obtained from a test environment, thereby obtaining a fluid pressure difference corresponding to the fluid flow rate; the control unit includes a fluid drive device and a pressure sensor, the drive device is configured to control the flow rate and pressure of the fluid, and the pressure sensor is configured to measure the fluid pressure before flowing through the motor; the calculation unit is configured to obtain the fluid pressure difference of the retrieval unit and the fluid pressure of the control unit, and obtain the fluid pressure after flowing through the motor through calculation.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1a为本申请一实施例的血泵示意图其中实心箭头与空心箭头分别示意清洗液的流动路径与血液的流动路径。FIG. 1 a is a schematic diagram of a blood pump according to an embodiment of the present application, wherein the solid arrows and the hollow arrows respectively indicate the flow path of the cleaning fluid and the flow path of the blood.
图1b为本申请一实施例的测量血泵出口处血压时的部件示意图，其中空心箭头示意血液的流动路径。FIG1 b is a schematic diagram of components for measuring blood pressure at the outlet of a blood pump according to an embodiment of the present application, wherein hollow arrows indicate the flow path of blood.
图2为本申请一实施例测试环境下测量P、N、Q时的多个部件示意图。FIG. 2 is a schematic diagram of multiple components when measuring P, N, and Q under a test environment in an embodiment of the present application.
图3a为本申请一实施例的第一流体浓度下的数据。FIG. 3 a shows data at a first fluid concentration according to an embodiment of the present application.
图3b为本申请一实施例的第一流体浓度下的第一曲线示意图。FIG. 3 b is a schematic diagram of a first curve at a first fluid concentration according to an embodiment of the present application.
图4a为本申请一实施例的第二流体浓度下的数据。FIG. 4 a shows data at a second fluid concentration according to an embodiment of the present application.
图4b为本申请一实施例的第二流体浓度下的第二曲线示意图。FIG. 4 b is a schematic diagram of a second curve at a second fluid concentration according to an embodiment of the present application.
图5为本申请一实施例提供的一种用于测量血泵出口处血压的方法。FIG5 is a method for measuring blood pressure at the outlet of a blood pump provided in an embodiment of the present application.
附图中附图标记如下：The reference numerals in the accompanying drawings are as follows:
1-血泵，11-电机，111-第一轴承，112-第二轴承，12-输送管，13-桨叶，14-外壳，141-进口处，142-出口处，2-流体驱动装置，21-测速马达，22-推送泵，3-压力传感器，4-流量计，5-清洗盒。1-blood pump, 11-motor, 111-first bearing, 112-second bearing, 12-delivery tube, 13-blade, 14-housing, 141-inlet, 142-outlet, 2-fluid driving device, 21-speed measuring motor, 22-push pump, 3-pressure sensor, 4-flow meter, 5-cleaning box.
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。The details of one or more embodiments of the present application are set forth in the following description of the drawings and detailed description.
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。Likewise, it is understood that the phrases and terms used herein are for descriptive purposes and should not be considered restrictive. The use of "include," "comprise," or "have" and variations thereof herein is intended to openly include the items listed thereafter and their equivalents and 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 different 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 side" refers to the end or side closer to the operator, and the term "distal" or "distal side" refers to the end or side closer to the operator. It refers to the end or side that is farther away from the operator.
如图1a所示，图中示了一种的血泵示意图，其中实心箭头与空心箭头分别示意清洗液的流动路径与血液的流动路径。如图1b所示，图中示了一种的测量血泵出口处血压时的部件示意图，其中空心箭头示意血液的流动路径。图5示出了一种用于测量血泵1出口处142血压的方法，所述血泵1包括电机11和输送管12，流体通过所述输送管12进入所述电机11，所述出口处142在所述血泵1植入后位于主动脉或肺动脉内，包括以下步骤：步骤1：检索从测试环境中获得的基准数据集合，所述基准数据集合包括以下基准数据：在包括第一工作参数在内的不同工作参数和包括第一驱动参数在内的不同驱动参数的条件下，流经所述电机11前后的流体压差H和位于所述输送管12内的流体流量Q；步骤2：在所述血泵1放置在患者中之后，测量或计算处于所述第一工作参数和第一驱动参数的条件下的流体流量Q1，并且，通过所述基准数据集合获得对应的流体压差H1；步骤3：测量流经所述电机11前的流体压力N，由此获得流经所述电机11后的流体压力P，其中，P为N与H1之和；并且，流经所述电机11后的流***于血泵1出口处142，血泵1出口处142的血压为流经所述电机11后的流体压力P。As shown in FIG. 1a, a schematic diagram of a blood pump is shown, wherein the solid arrows and the hollow arrows respectively indicate the flow path of the cleaning fluid and the flow path of the blood. As shown in FIG. 1b, a schematic diagram of the components for measuring the blood pressure at the outlet of the blood pump is shown, wherein the hollow arrows indicate the flow path of the blood. FIG. 5 shows a method for measuring the blood pressure at the outlet 142 of the blood pump 1, wherein the blood pump 1 includes a motor 11 and a delivery tube 12, wherein the fluid enters the motor 11 through the delivery tube 12, and the outlet 142 is located in the aorta or the pulmonary artery after the blood pump 1 is implanted, comprising the following steps: Step 1: Retrieve a benchmark data set obtained from a test environment, wherein the benchmark data set includes the following benchmark data: Under the conditions of different working parameters including a first working parameter and different driving parameters including a first driving parameter, the pressure difference H of the fluid flowing before and after the motor 11 and the pressure difference H of the fluid located at the outlet 142 of the blood pump 1 The fluid flow Q in the delivery tube 12; Step 2: after the blood pump 1 is placed in the patient, measure or calculate the fluid flow Q1 under the conditions of the first working parameter and the first driving parameter, and obtain the corresponding fluid pressure difference H1 through the reference data set; Step 3: measure the fluid pressure N before flowing through the motor 11, thereby obtaining the fluid pressure P after flowing through the motor 11, wherein P is the sum of N and H1; and the fluid after flowing through the motor 11 is located at the outlet 142 of the blood pump 1, and the blood pressure at the outlet 142 of the blood pump 1 is the fluid pressure P after flowing through the motor 11.
根据一实施例，所述工作参数为流体浓度，所述驱动参数为所述电机的转速；并且，所述流体为清洗液，所述清洗液包括肝素、葡萄糖和碳酸氢钠溶液。According to one embodiment, the working parameter is fluid concentration, the driving parameter is the rotation speed of the motor; and the fluid is a cleaning fluid, and the cleaning fluid includes heparin, glucose and sodium bicarbonate solution.
根据一实施例，在不同的流体浓度和/或不同的电机转速的条件下，所述基准数据集合内的若干组流体压差H和流体流量Q形成不同曲线；并且，所述流体的浓度为第一流体浓度、所述电机的转速为第一转速时，所述基准数据集合内的若干组流体压差H1和流体流量Q1形成第一曲线。According to one embodiment, under the conditions of different fluid concentrations and/or different motor speeds, several groups of fluid pressure differences H and fluid flow rates Q in the benchmark data set form different curves; and, when the concentration of the fluid is a first fluid concentration and the speed of the motor is a first speed, several groups of fluid pressure differences H1 and fluid flow rates Q1 in the benchmark data set form a first curve.
根据一实施例，所述第一流体浓度为5％，所述第一转速为24000r/min，在测试环境中测得的若干组流经所述电机11前后的流体压差H1和位于所述输送管12内的流体流量Q1，并且，形成第一曲线，如图3a和3b所示所示。According to one embodiment, the first fluid concentration is 5%, the first rotational speed is 24000 r/min, and several groups of fluid pressure differences H1 before and after the motor 11 and the fluid flow rate Q1 in the delivery pipe 12 are measured in a test environment, and a first curve is formed, as shown in Figures 3a and 3b.
根据一实施例，流体压差H和流体流量Q形成的曲线形状的影响因素包括所述输送管及其曲折形态所形成的阻力以及血泵结构所形成的阻力所带来的传递损失。According to one embodiment, factors affecting the shape of the curve formed by the fluid pressure difference H and the fluid flow rate Q include the resistance formed by the delivery tube and its tortuous shape and the transmission loss caused by the resistance formed by the blood pump structure.
根据一实施例，改变流体浓度即可得到不同形状的H-Q曲线。According to one embodiment, H-Q curves of different shapes can be obtained by changing the fluid concentration.
根据一实施例，改变所述电机的转速即可得到不同形状的H-Q曲线。According to one embodiment, H-Q curves of different shapes can be obtained by changing the rotation speed of the motor.
根据一实施例，所述基准数据集合包括若干个流体浓度条件下的流经所述电机前后的流体压差H和位于所述输送管内的流体流量Q。According to one embodiment, the reference data set includes the pressure difference H of the fluid before and after flowing through the motor and the fluid flow rate Q in the delivery pipe under several fluid concentration conditions.
根据一实施例，所述基准数据集合包括若干个电机转速条件下的流经所述电机前后的流体压差H和位于所述输送管内的流体流量Q。According to an embodiment, the reference data set includes the pressure difference H of the fluid before and after the motor and the fluid flow rate Q in the delivery pipe under several motor speed conditions.
根据一实施例，流体从进入所述输送管12至进入电机11前均为流经所述电机11前；并且，测量流经所述电机11前的流体压力N的测量位置在患者体外，即测量流经所述电机11前的流体压力N的压力传感器3在体外，如图1b所示。 According to one embodiment, the fluid flows in front of the motor 11 from entering the delivery tube 12 to entering the motor 11; and, the measuring position for measuring the fluid pressure N in front of the motor 11 is outside the patient's body, that is, the pressure sensor 3 for measuring the fluid pressure N in front of the motor 11 is outside the body, as shown in Figure 1b.
根据一实施例，所述流体流量Q1、所述流体压差H1、所述流体压力N为实时数据，经计算得到的所述流体压力P也是实时数据；并且，随着血泵1出口处142的压力P的增大，所述流体流量Q1减小，流经所述电机11前的流体压力N和流体压差H1增大。According to one embodiment, the fluid flow rate Q1, the fluid pressure difference H1, and the fluid pressure N are real-time data, and the calculated fluid pressure P is also real-time data; and, as the pressure P at the outlet 142 of the blood pump 1 increases, the fluid flow rate Q1 decreases, and the fluid pressure N and the fluid pressure difference H1 before flowing through the motor 11 increase.
根据一实施例，流体流经所述电机11后，流体的压力大于所述出口处142的血液压力；并且，血液在出口处142的泵出方向与所述电机11的中心线垂直。According to one embodiment, after the fluid flows through the motor 11 , the pressure of the fluid is greater than the blood pressure at the outlet 142 ; and the pumping direction of the blood at the outlet 142 is perpendicular to the center line of the motor 11 .
根据一实施例，当清洗液的压力大于血液压力时，即可实现阻止血液进入血泵1电机11内部的功能，使血液向血泵1电机11外侧射出。According to one embodiment, when the pressure of the cleaning fluid is greater than the blood pressure, the function of preventing blood from entering the motor 11 of the blood pump 1 can be achieved, so that the blood is ejected to the outside of the motor 11 of the blood pump 1.
根据一实施例，所述血泵1还包括桨叶13和外壳14，所述桨叶13与所述电机11连接，所述外壳14套设在所述桨叶13外；并且，所述外壳14的第一端(远端)设置进口处141，所述外壳14的第二端(近端)设置出口处142，如图1a所示。According to one embodiment, the blood pump 1 further includes a paddle 13 and a housing 14, wherein the paddle 13 is connected to the motor 11, and the housing 14 is sleeved outside the paddle 13; and, an inlet 141 is provided at the first end (distal end) of the housing 14, and an outlet 142 is provided at the second end (proximal end) of the housing 14, as shown in FIG. 1a.
根据一实施例，在测试环境下，如图2所示，流经所述电机11后的流体压力P和流经所述电机11前的流体压力N均通过压力传感器3测量，位于所述输送管12内的流体流量Q通过流量计4测量；并且，流经所述电机11前后的流体压差H由P、N相减得到。According to one embodiment, under a test environment, as shown in FIG2 , the fluid pressure P after flowing through the motor 11 and the fluid pressure N before flowing through the motor 11 are both measured by a pressure sensor 3, and the fluid flow Q in the delivery pipe 12 is measured by a flow meter 4; and the fluid pressure difference H before and after flowing through the motor 11 is obtained by subtracting P from N.
根据一实施例，测试环境模拟人体血管或器官，并且，因此，基本上模拟在人类身体中的血泵1。According to an embodiment, the test environment simulates a human blood vessel or organ and, therefore, substantially simulates a blood pump 1 in the human body.
根据一实施例，在所述血泵1植入过程中与血泵1植入后，心室内血液压力变化，血泵1出口处142的压力变化，随即流经所述电机11后的流体压力变化，同时流经所述电机11前的流体压力改变，同时流体流量Q1发生改变，此时通过基准数据集合便能得到流经所述电机11前后的流体压差H1。根据一实施例，清洗液存储在清洗盒5中，并且，所述清洗盒5能调整清洗液的浓度。According to one embodiment, during and after the implantation of the blood pump 1, the blood pressure in the ventricle changes, the pressure at the outlet 142 of the blood pump 1 changes, and then the pressure of the fluid after the motor 11 changes, and the pressure of the fluid before the motor 11 changes, and the fluid flow Q1 changes. At this time, the pressure difference H1 of the fluid before and after the motor 11 can be obtained through the reference data set. According to one embodiment, the cleaning fluid is stored in the cleaning box 5, and the cleaning box 5 can adjust the concentration of the cleaning fluid.
根据一实施例，执行上述测量方法的设备，包括：动力单元、检索单元、控制单元与计算单元；其中，所述动力单元设置为驱动所述血泵1的电机11并调整所述电机11转速；所述检索单元设置为检索从测试环境中获得的基准数据集合，从而获得与流体流量Q对应的流体压差H；所述控制单元包括流体驱动装置2与压力传感器3，所述驱动装置设置为控制流体的流速和压力，所述压力传感器3设置为测量流经所述电机11前的流体压力N；所述计算单元设置为获取所述检索单元的流体压差H与所述控制单元的流体压力N，经过计算获得流经所述电机11后的流体压力P。According to one embodiment, the device for executing the above-mentioned measurement method includes: a power unit, a retrieval unit, a control unit and a calculation unit; wherein the power unit is configured to drive the motor 11 of the blood pump 1 and adjust the rotation speed of the motor 11; the retrieval unit is configured to retrieve a reference data set obtained from a test environment, thereby obtaining a fluid pressure difference H corresponding to the fluid flow rate Q; the control unit includes a fluid drive device 2 and a pressure sensor 3, the drive device is configured to control the flow rate and pressure of the fluid, and the pressure sensor 3 is configured to measure the fluid pressure N before flowing through the motor 11; the calculation unit is configured to obtain the fluid pressure difference H of the retrieval unit and the fluid pressure N of the control unit, and obtain the fluid pressure P after flowing through the motor 11 through calculation.
根据一实施例，所述压力传感器3设置在所述驱动装置的一端(远端)，所述压力传感器3与驱动装置在血泵1运行时均位于体外；并且，所述压力传感器3位于所述输送管12的一端(近端部分)。According to one embodiment, the pressure sensor 3 is arranged at one end (distal end) of the driving device, and the pressure sensor 3 and the driving device are both located outside the body when the blood pump 1 is running; and the pressure sensor 3 is located at one end (proximal part) of the delivery tube 12.
根据一实施例，所述电机11包括第一轴承111(也可称为近端轴承)和第二轴承112(也可称为远端轴承)，所述流体流经所述第二轴承112后形成动密封；并且，通过第二轴承112后的流体压力大于出口处142的血液压力。According to one embodiment, the motor 11 includes a first bearing 111 (also called a proximal bearing) and a second bearing 112 (also called a distal bearing), and the fluid forms a dynamic seal after flowing through the second bearing 112; and the fluid pressure after passing through the second bearing 112 is greater than the blood pressure at the outlet 142.
根据一实施例，所述电机11的内部缝隙极小，流体流经电机11后压力增大，流经所述 电机11后的流体压力P大于流经所述电机11前的流体压力N。According to one embodiment, the internal gap of the motor 11 is extremely small, and the pressure of the fluid increases after flowing through the motor 11. The fluid pressure P after the motor 11 is greater than the fluid pressure N before flowing through the motor 11 .
根据一实施例，所述流体驱动装置2包括测速马达21和推送泵22，所述推送泵22包括活塞。According to an embodiment, the fluid driving device 2 includes a speed measuring motor 21 and a push pump 22 , and the push pump 22 includes a piston.
根据一实施例，所述流体流量Q通过所述活塞的横截面积与测速马达21的转速计算得出。According to one embodiment, the fluid flow rate Q is calculated by the cross-sectional area of the piston and the rotation speed of the speed measuring motor 21 .
本申请的具体操作步骤如下所示：The specific steps of this application are as follows:
1.手术过程中，操作所述清洗盒5朝所述血泵1灌注浓度为5％的清洗液，操作所述控制单元使得所述电机的转速为24000r/min，由此通过清洗液浓度和所述电机的转速确定相适应的第一曲线；1. During the operation, the cleaning box 5 is operated to perfuse the blood pump 1 with a cleaning solution with a concentration of 5%, and the control unit is operated to make the speed of the motor 24000 r/min, thereby determining a first curve adapted to the cleaning solution concentration and the speed of the motor;
2.所述控制单元根据测速马达21的转速与所述活塞的横截面积自动计算处所述流体流量Q1为10ml/hr，此时根据所述第一曲线得到H1为792mmHg；2. The control unit automatically calculates the fluid flow rate Q1 as 10 ml/hr based on the rotation speed of the speed measuring motor 21 and the cross-sectional area of the piston. At this time, H1 is 792 mmHg according to the first curve;
3.所述压力传感器3测量流经所述电机11前的流体压力N为78mmHg，由此得到了血液在所述出口出的压力P＝H1+N＝870mmHg；3. The pressure sensor 3 measures the fluid pressure N before the motor 11 to be 78 mmHg, thereby obtaining the pressure of the blood at the outlet P=H1+N=870 mmHg;
4.术者继续调整所述血泵1的位置，所述血泵1出口处142的压力发生变化，此时测得流体流量Q1为14ml/hr，此时根据所述第一曲线得到H1为679mmHg；4. The operator continues to adjust the position of the blood pump 1, and the pressure at the outlet 142 of the blood pump 1 changes. At this time, the fluid flow rate Q1 is measured to be 14 ml/hr. At this time, H1 is obtained according to the first curve to be 679 mmHg;
5.所述压力传感器3测量流经所述电机11前的流体压力N为72mmHg，由此得到了血液在所述出口出的压力P＝H1+N＝751mmHg；5. The pressure sensor 3 measures the fluid pressure N before the motor 11 to be 72 mmHg, thereby obtaining the pressure of the blood at the outlet P=H1+N=751 mmHg;
6.所述计算单元根据手术情况实时计算出血泵1出口处142的压力数值并将结果可视化呈现给术者。6. The calculation unit calculates the pressure value at the outlet 142 of the blood pump 1 in real time according to the surgical situation and presents the result visually to the operator.
本申请另一实施例与前述实施例大体上相同，不同之处在于清洗液浓度与电机转速大小的不同。Another embodiment of the present application is substantially the same as the aforementioned embodiment, except that the concentration of the cleaning liquid is different from the motor speed.
根据本申请一实施例的一种用于测量血泵1出口处142血压的方法，所述血泵1包括电机11和输送管12，流体通过所述输送管12进入所述电机11，所述出口处142在所述血泵1植入后位于主动脉或肺动脉内，包括以下步骤：步骤1：检索从测试环境中获得的基准数据集合，所述基准数据集合包括以下基准数据：在包括第一工作参数在内的不同工作参数和包括第一驱动参数在内的不同驱动参数的条件下，流经所述电机11前后的流体压差H和位于所述输送管12内的流体流量Q；步骤2：在所述血泵1放置在患者中之后，测量或计算处于所述第一工作参数和第一驱动参数的条件下的流体流量Q1，并且，通过所述基准数据集合获得对应的流体压差H1；步骤3：测量流经所述电机11前的流体压力N，由此获得流经所述电机11后的流体压力P，其中，P为N与H1之和；并且，流经所述电机11后的流***于血泵1出口处142，血泵1出口处142的血压为流经所述电机11后的流体压力P。According to an embodiment of the present application, a method for measuring blood pressure at an outlet 142 of a blood pump 1, wherein the blood pump 1 comprises a motor 11 and a delivery tube 12, wherein a fluid enters the motor 11 through the delivery tube 12, and wherein the outlet 142 is located in the aorta or the pulmonary artery after the blood pump 1 is implanted, comprises the following steps: Step 1: Retrieve a benchmark data set obtained from a test environment, wherein the benchmark data set comprises the following benchmark data: under different working parameters including a first working parameter and different driving parameters including a first driving parameter, the pressure difference H of the fluid flowing before and after the motor 11 and the pressure difference H at the outlet 142 The fluid flow Q in the delivery tube 12; Step 2: after the blood pump 1 is placed in the patient, measure or calculate the fluid flow Q1 under the conditions of the first working parameter and the first driving parameter, and obtain the corresponding fluid pressure difference H1 through the reference data set; Step 3: measure the fluid pressure N before flowing through the motor 11, thereby obtaining the fluid pressure P after flowing through the motor 11, wherein P is the sum of N and H1; and, the fluid after flowing through the motor 11 is located at the outlet 142 of the blood pump 1, and the blood pressure at the outlet 142 of the blood pump 1 is the fluid pressure P after flowing through the motor 11.
根据一实施例，在不同的流体浓度和不同的电机转速的条件下，所述基准数据集合内的若干组流体压差H和流体流量Q形成不同曲线；并且，所述流体的浓度为第二流体浓度、所述电机转速为第二转速时，所述基准数据集合内的若干组流体压差H2和流体流量Q2形成第 二曲线。According to one embodiment, under the conditions of different fluid concentrations and different motor speeds, the several groups of fluid pressure differences H and fluid flow rates Q in the reference data set form different curves; and when the concentration of the fluid is a second fluid concentration and the motor speed is a second speed, the several groups of fluid pressure differences H2 and fluid flow rates Q2 in the reference data set form a second curve. Second curve.
根据一实施例，所述第二流体浓度为10％，所述电机的转速为20000r/min。According to one embodiment, the concentration of the second fluid is 10%, and the rotation speed of the motor is 20000 r/min.
根据一实施例，在测试环境中测得的若干组流经所述电机11前后的流体压差H2和位于所述输送管12内的流体流量Q2，并且，形成第二曲线，如图4a和4b所示。According to one embodiment, several groups of fluid pressure differences H2 before and after the motor 11 and fluid flow rates Q2 in the delivery pipe 12 are measured in a test environment, and a second curve is formed, as shown in FIGS. 4a and 4b .
根据一实施例，随着血泵1出口处142的压力P的增大，所述流体流量Q2减小，流经所述电机11前的流体压力N和流体压差H2增大。According to one embodiment, as the pressure P at the outlet 142 of the blood pump 1 increases, the fluid flow rate Q2 decreases, and the fluid pressure N and the fluid pressure difference H2 before flowing through the motor 11 increase.
根据一实施例，在所述血泵1植入过程中与血泵1植入后，心室内血液压力变化，血泵1出口处142的压力变化，随即流经所述电机11后的流体压力变化，同时流经所述电机11前的流体压力改变，同时流体流量Q2发生改变，此时通过第二曲线便能得到流经所述电机11前后的流体压差H2。According to one embodiment, during and after the implantation of the blood pump 1, the blood pressure in the ventricle changes, the pressure at the outlet 142 of the blood pump 1 changes, and then the pressure of the fluid after passing through the motor 11 changes. At the same time, the pressure of the fluid before passing through the motor 11 changes, and the fluid flow rate Q2 changes. At this time, the pressure difference H2 of the fluid before and after passing through the motor 11 can be obtained through the second curve.
本申请实施例中的相关构造和构思类似，因此在这里不再重复描述。The relevant structures and concepts in the embodiments of the present application are similar, so they will not be described again here.
相关技术中，一般将压力传感器连接在血泵或输送管上以测量主动脉处的血压，但是压力传感器在血流冲刷下容易导致功能失效甚至脱离的情况，对患者造成伤害，本申请则避免了以上情况，本申请公开了一种用于测量血泵出口处血压的方法，通过实验测量血泵射血压力与体外装置的其中几项数据，得出数据之间的关系，该关系可表示为函数或曲线图，在血泵的实际应用中，即可仅测量体外装置的数据通过上述函数或曲线图得出血泵射血压力，实现由体外传感器测量人体血压的功能，无需在人体植入压力传感器，极大地降低了手术风险；其中，不植入传感器而获得主动脉压力的具体原理如下：通过在测试环境中测量血泵出口处的射血压力，首先，由于流经电机后的流体也位于出口处，测量所得的血液压力相当于从电机流出的流体压力，然后综合测量体外在输送管内的流体压力，即可得到流经电机前后的流体压差H，其次，再结合测量位于输送管内的流体流量Q，得到流体压差H与流体流量Q的数据关系，该关系表现为H-Q曲线图，继而在血泵的实际运行过程中，通过流体流量Q获得H，并且，在测试环境中测量体外流体压力的位置处测量实时的流体压力N，N、H相加所得即为血泵出口处的血液压力，数据获取简单，在减少了植入患者体内的机械器件的数量的同时，还减轻了血泵加工负担，一定程度降低了医疗机构和患者的经济压力。In the related art, a pressure sensor is generally connected to a blood pump or a delivery tube to measure the blood pressure at the aorta. However, the pressure sensor is prone to malfunction or even detachment under the flushing of blood flow, causing harm to the patient. The present application avoids the above situation and discloses a method for measuring the blood pressure at the outlet of a blood pump. By experimentally measuring the ejection pressure of the blood pump and several data of an extracorporeal device, the relationship between the data is obtained, which can be expressed as a function or a curve graph. In the actual application of the blood pump, only the data of the extracorporeal device can be measured, and the ejection pressure of the blood pump can be obtained through the above function or curve graph, thereby realizing the function of measuring human blood pressure by an extracorporeal sensor. There is no need to implant a pressure sensor in the human body, which greatly reduces the risk of surgery. The specific principle of obtaining the aortic pressure without implanting a sensor is as follows: By measuring the blood pressure at the outlet of the blood pump in a test environment, the blood pressure at the outlet of the blood pump can be measured. The ejection pressure at the outlet is measured. First, since the fluid after flowing through the motor is also located at the outlet, the measured blood pressure is equivalent to the fluid pressure flowing out of the motor. Then, the fluid pressure in the delivery tube outside the body is comprehensively measured to obtain the fluid pressure difference H before and after flowing through the motor. Secondly, combined with the measurement of the fluid flow rate Q in the delivery tube, the data relationship between the fluid pressure difference H and the fluid flow rate Q is obtained. This relationship is expressed as an H-Q curve. Then, in the actual operation of the blood pump, H is obtained through the fluid flow rate Q, and the real-time fluid pressure N is measured at the position where the extracorporeal fluid pressure is measured in the test environment. The sum of N and H is the blood pressure at the outlet of the blood pump. The data acquisition is simple. While reducing the number of mechanical devices implanted in the patient's body, it also reduces the burden of blood pump processing and reduces the economic pressure of medical institutions and patients to a certain extent.
根据本申请的一个构思，血泵植入后，测量流经电机前的流体压力N时测量位置位于患者体外，且测量流经电机前的流体压力N的压力传感器位于输送管的近端部分，这样设计，一方面由于压力传感器设置在了体外而非血液环境中，降低了对传感器电路的要求，简化了装配流程、降低了加工难度；另一方面，压力传感器设置在体外更易于检查更换，极大增加了产品的安全系数；再一方面，体外传感器可重复使用，无需随着血泵更换，一定程度降低了医疗机构与患者的经济压力。According to one concept of the present application, after the blood pump is implanted, the measuring position when measuring the fluid pressure N flowing in front of the motor is located outside the patient's body, and the pressure sensor for measuring the fluid pressure N flowing in front of the motor is located at the proximal end of the delivery tube. With this design, on the one hand, since the pressure sensor is set outside the body rather than in the blood environment, the requirements for the sensor circuit are reduced, the assembly process is simplified, and the processing difficulty is reduced; on the other hand, the pressure sensor is set outside the body, which is easier to check and replace, greatly increasing the safety factor of the product; on another hand, the in vitro sensor is reusable and does not need to be replaced with the blood pump, which reduces the economic pressure on medical institutions and patients to a certain extent.
根据本申请的一个构思，工作参数和驱动参数的变动会影响H-Q曲线的形状，在不同的流体浓度和不同的电机转速的条件下，基准数据集合内的若干组流体压差H和流体流量Q形成不同曲线，若在血泵运行过程中，改变清洗液浓度，检索单元会根据调整后的清洗液浓度和实时的电机转速确认到某一H-Q曲线，再根据实时得到的流体流量Q得到流体压力差H； 若在血泵运行过程中，改变电机的转速，检索单元会根据调整后的电机转速和实时的清洗液浓度确认到某一H-Q曲线，再根据实时得到的流体流量Q得到流体压力差H，综上所述，多个单元耦合效率高，数据实时更新，医疗工作者获得的数据准确、高效。According to an idea of the present application, changes in the working parameters and driving parameters will affect the shape of the HQ curve. Under the conditions of different fluid concentrations and different motor speeds, several groups of fluid pressure differences H and fluid flow rates Q in the reference data set form different curves. If the cleaning fluid concentration is changed during the operation of the blood pump, the retrieval unit will confirm a certain HQ curve based on the adjusted cleaning fluid concentration and the real-time motor speed, and then obtain the fluid pressure difference H based on the real-time fluid flow rate Q. If the motor speed is changed during the operation of the blood pump, the retrieval unit will confirm a certain HQ curve based on the adjusted motor speed and the real-time cleaning fluid concentration, and then obtain the fluid pressure difference H based on the real-time fluid flow Q. In summary, the coupling efficiency of multiple units is high, the data is updated in real time, and the data obtained by medical workers is accurate and efficient.
根据本申请的一个构思，动力单元自动判断不同电机转速并输送至检索单元，并且结合特定算法及装置，实现根据医疗人员所设定的清洗液浓度和电机转速判断本方法所述的适用H-Q曲线，从而得出所需血泵射血处血压，操作简单，反应迅速，临床价值大。 According to an idea of the present application, the power unit automatically determines different motor speeds and transmits them to the retrieval unit, and is combined with specific algorithms and devices to determine the applicable HQ curve described in this method based on the cleaning fluid concentration and motor speed set by medical personnel, thereby obtaining the required blood pressure at the ejection point of the blood pump. The operation is simple, the response is rapid, and the clinical value is great.

Claims (14)

  1. 一种用于测量血泵出口处血压的方法，所述血泵包括电机和输送管，流体通过所述输送管进入所述电机，所述出口处在所述血泵植入后位于主动脉或肺动脉内，所述方法包括：A method for measuring blood pressure at an outlet of a blood pump, the blood pump comprising a motor and a delivery tube, a fluid entering the motor through the delivery tube, the outlet being located in the aorta or the pulmonary artery after implantation of the blood pump, the method comprising:
    检索从测试环境中获得的基准数据集合，所述基准数据集合包括以下基准数据：在不同工作参数和不同驱动参数的条件下，流经所述电机前后的流体压差和位于所述输送管内的流体流量；其中，所述工作参数包括第一工作参数，所述驱动参数包括第一驱动参数；Retrieving a benchmark data set obtained from a test environment, the benchmark data set comprising the following benchmark data: a pressure difference of a fluid before and after the motor and a fluid flow rate in the delivery pipe under conditions of different operating parameters and different driving parameters; wherein the operating parameters include a first operating parameter, and the driving parameters include a first driving parameter;
    在所述血泵放置在患者中之后，测量或计算处于所述第一工作参数和所述第一驱动参数的条件下的流体流量，并通过所述基准数据集合获得对应的流体压差；After the blood pump is placed in a patient, measuring or calculating the fluid flow rate under the conditions of the first working parameter and the first driving parameter, and obtaining a corresponding fluid pressure difference through the reference data set;
    测量流经所述电机前的流体压力，以获得流经所述电机后的流体压力，其中，流经所述电机后的流体压力为流经所述电机前的流体压力与通过所述基准数据集合获得对应的流体压差之和；流经所述电机后的流***于所述出口处，所述出口处的血压为流经所述电机后的流体压力。Measure the fluid pressure before flowing through the motor to obtain the fluid pressure after flowing through the motor, wherein the fluid pressure after flowing through the motor is the sum of the fluid pressure before flowing through the motor and the corresponding fluid pressure difference obtained through the reference data set; the fluid after flowing through the motor is located at the outlet, and the blood pressure at the outlet is the fluid pressure after flowing through the motor.
  2. 根据权利要求1所述的用于测量血泵出口处血压的方法，其中，所述工作参数为流体浓度，所述驱动参数为所述电机的转速。The method for measuring blood pressure at the outlet of a blood pump according to claim 1, wherein the operating parameter is fluid concentration and the driving parameter is the rotational speed of the motor.
  3. 根据权利要求1所述的用于测量血泵出口处血压的方法，其中，在不同的流体浓度和/或不同的电机转速的条件下，所述基准数据集合内的多组流体压差和流体流量形成不同曲线；所述流体的浓度为第一流体浓度、所述电机的转速为第一转速时，所述基准数据集合内的多组流体压差和流体流量形成第一曲线。According to the method for measuring the blood pressure at the outlet of a blood pump according to claim 1, under the conditions of different fluid concentrations and/or different motor speeds, the multiple groups of fluid pressure differences and fluid flow rates in the benchmark data set form different curves; when the concentration of the fluid is a first fluid concentration and the speed of the motor is a first speed, the multiple groups of fluid pressure differences and fluid flow rates in the benchmark data set form a first curve.
  4. 根据权利要求1所述的用于测量血泵出口处血压的方法，其中，所述流经所述电机前包括：所述流体从进入所述输送管至进入所述电机前；其中，测量流经所述电机前的流体压力的测量位置在患者体外。The method for measuring blood pressure at the outlet of a blood pump according to claim 1, wherein the flow in front of the motor includes: the fluid from entering the delivery tube to entering in front of the motor; wherein the measurement position for measuring the pressure of the fluid flowing in front of the motor is outside the patient's body.
  5. 根据权利要求2或3所述的用于测量血泵出口处血压的方法，其中，所述流体流量、所述流体压差、所述流体压力为实时数据，经计算得到的所述流体压力为实时数据；随着所述出口处的压力的增大，所述流体流量减小，流经所述电机前的流体压力和流体压差增大。According to the method for measuring blood pressure at the outlet of a blood pump according to claim 2 or 3, the fluid flow rate, the fluid pressure difference, and the fluid pressure are real-time data, and the fluid pressure obtained by calculation is real-time data; as the pressure at the outlet increases, the fluid flow rate decreases, and the fluid pressure and fluid pressure difference before flowing through the motor increase.
  6. 根据权利要求1所述的用于测量血泵出口处血压的方法，其中，所述流体为清洗液，所述清洗液包括肝素、葡萄糖和碳酸氢钠溶液。The method for measuring blood pressure at an outlet of a blood pump according to claim 1, wherein the fluid is a cleaning fluid comprising heparin, glucose and sodium bicarbonate solution.
  7. 根据权利要求1所述的用于测量血泵出口处血压的方法，其中，流体流经所述电机后，所述流体的压力大于所述出口处的血液压力；所述血液在所述出口处的泵出方向与所述电机的中心线垂直。The method for measuring blood pressure at the outlet of a blood pump according to claim 1, wherein, after the fluid flows through the motor, the pressure of the fluid is greater than the blood pressure at the outlet; and the pumping direction of the blood at the outlet is perpendicular to the center line of the motor.
  8. 根据权利要求1所述的用于测量血泵出口处血压的方法，其中，所述血泵还包括桨叶和外壳，所述桨叶与所述电机连接，所述外壳套设在所述桨叶外；所述外壳的第一端设置进口处，所述外壳的第二端设置所述出口处。According to the method for measuring blood pressure at the outlet of a blood pump according to claim 1, the blood pump further comprises a paddle and a housing, the paddle is connected to the motor, and the housing is sleeved outside the paddle; the first end of the housing is provided with an inlet, and the second end of the housing is provided with the outlet.
  9. 根据权利要求1或6所述的用于测量血泵出口处血压的方法，其中，在所述测试环境下，流经所述电机后的流体压力和流经所述电机前的流体压力分别通过压力传感器测量，位于所述输送管内的流体流量通过流量计测量；流经所述电机前后的流体压差由流经所述电机后的流体压力和流经所述电机前的流体压力相减得到。 According to the method for measuring the blood pressure at the outlet of a blood pump according to claim 1 or 6, wherein, under the test environment, the pressure of the fluid after the motor and the pressure of the fluid before the motor are respectively measured by pressure sensors, and the fluid flow in the delivery pipe is measured by a flow meter; the pressure difference of the fluid before and after the motor is obtained by subtracting the pressure of the fluid after the motor from the pressure of the fluid before the motor.
  10. 一种用于测量血泵出口处血压的设备，执行根据权利要求1-9中任一项所述的方法，包括：动力单元、检索单元、控制单元与计算单元；其中，所述动力单元设置为驱动所述血泵的电机并调整所述电机的转速；所述检索单元设置为检索从测试环境中获得的基准数据集合，以获得与流体流量对应的流体压差；所述控制单元包括流体驱动装置与压力传感器，所述驱动装置设置为控制流体的流速和压力，所述压力传感器设置为测量流经所述电机前的流体压力；所述计算单元设置为获取所述检索单元的流体压差与所述控制单元的流体压力，经过计算获得流经所述电机后的流体压力。A device for measuring blood pressure at the outlet of a blood pump, executing the method according to any one of claims 1 to 9, comprising: a power unit, a retrieval unit, a control unit and a calculation unit; wherein the power unit is configured to drive the motor of the blood pump and adjust the speed of the motor; the retrieval unit is configured to retrieve a reference data set obtained from a test environment to obtain a fluid pressure difference corresponding to the fluid flow rate; the control unit includes a fluid drive device and a pressure sensor, the drive device is configured to control the flow rate and pressure of the fluid, and the pressure sensor is configured to measure the fluid pressure before flowing through the motor; the calculation unit is configured to obtain the fluid pressure difference of the retrieval unit and the fluid pressure of the control unit, and obtain the fluid pressure after flowing through the motor through calculation.
  11. 根据权利要求10所述的用于测量血泵出口处血压的设备，其中，所述压力传感器设置在所述驱动装置的一端，所述压力传感器与所述驱动装置在所述血泵运行时分别位于体外；所述压力传感器位于所述输送管的一端。According to the device for measuring blood pressure at the outlet of a blood pump according to claim 10, the pressure sensor is arranged at one end of the driving device, and the pressure sensor and the driving device are respectively located outside the body when the blood pump is running; the pressure sensor is located at one end of the delivery tube.
  12. 根据权利要求10所述的用于测量血泵出口处血压的设备，其中，所述电机包括第一轴承和第二轴承，所述流体流经所述第二轴承后形成动密封；通过所述第二轴承后的流体压力大于所述出口处的血液压力。According to the device for measuring blood pressure at the outlet of a blood pump according to claim 10, the motor includes a first bearing and a second bearing, and the fluid forms a dynamic seal after flowing through the second bearing; the fluid pressure after passing through the second bearing is greater than the blood pressure at the outlet.
  13. 根据权利要求10所述的用于测量血泵出口处血压的设备，其中，所述流体驱动装置包括测速马达和推送泵，所述推送泵包括活塞。The device for measuring blood pressure at the outlet of a blood pump according to claim 10, wherein the fluid driving device includes a speed measuring motor and a push pump, and the push pump includes a piston.
  14. 根据权利要求13所述的用于测量血泵出口处血压的设备，其中，所述流体流量通过所述活塞的横截面积与所述测速马达的转速计算得出。 The device for measuring blood pressure at the outlet of a blood pump according to claim 13, wherein the fluid flow rate is calculated by the cross-sectional area of the piston and the rotational speed of the speed measuring motor.
PCT/CN2023/126204 2022-12-20 2023-10-24 Method and device for measuring blood pressure at outlet of blood pump WO2024131262A1 (en)

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