A method and device for testing the stability of magnetic levitation performance of an artificial heart

Abstract

The present invention discloses a method and a testing device for the stability of the magnetic levitation performance of an artificial heart. The testing method comprises adjusting the relative position of the artificial heart and the swing arm; applying a first force to the rotor of the artificial heart by simulating the pulsation of blood through an external extracorporeal pulsation circulation loop; applying a second force to the rotor of the artificial heart through an external pendulum swinging motion; and testing the stability of the rotor of the artificial heart by adjusting the first force and the second force. The present invention can more comprehensively reflect the complex dynamic environment of various physiological and non-physiological states that the artificial heart may encounter in actual use by simultaneously simulating the fluid force and external acceleration generated by ventricular pulsation, so as to more accurately predict and evaluate the performance and stability of the magnetic levitation performance of the artificial heart in actual life, improve the accuracy of the artificial heart test, and further improve the service life and reliability of the artificial heart, and improve the treatment effect.

Description

Technical Field

[0001] The invention relates to the field of medical devices, and in particular to a method and equipment for testing the stability of magnetic suspension performance of an artificial heart. Background Art

[0002] The magnetic levitation artificial heart is a medical device that uses magnetic levitation technology to reduce the contact between blood and mechanical parts, thereby reducing the risk of thrombosis and improving the reliability of the equipment and the comfort of patients. The magnetic levitation artificial heart includes a blood pump installed in the patient's ventricle. The blood pump is connected to the controller and mobile power supply placed outside the patient's body through a pipeline. After the blood pump is powered on, it rotates at high speed to restore the blood circulation necessary to maintain life. The blood pump uses magnetic levitation technology inside, that is, through a sophisticated magnetic field design, the rotor that drives the impeller to rotate does not contact the stator in the radial and axial directions, which can avoid blood cell damage caused by direct mechanical contact between the stator and the rotor. In the blood pump of the magnetic levitation artificial heart, the rotor is the core component to realize the blood pumping function. The stability of the rotor is directly related to the working efficiency and safety of the entire artificial heart. Therefore, for the magnetic levitation artificial heart, it is necessary to test the magnetic levitation stability of the rotor.

[0003] At present, the research on the rotor stability test of the magnetically levitated artificial heart mainly focuses on static testing, which fails to fully simulate the dynamic environment in daily life, resulting in incomplete testing. This not only affects the use of the magnetically levitated artificial heart, but also is not convenient for the design and optimization of the magnetically levitated artificial heart. Summary of the invention

[0004] In view of the above technical problems, the purpose of the present invention is to provide a method and equipment for testing the stability of the magnetic levitation performance of an artificial heart, which can more comprehensively reflect the dynamic mechanical environment of the magnetic levitation artificial heart under various physiological and non-physiological conditions that may be encountered in actual use, such as rapid turns, turning in a vehicle, playing golf and other sports activities with large torsional acceleration, so as to more accurately predict and evaluate the performance and stability of the artificial heart in real life.

[0005] In order to achieve the above object, the present invention provides a method for testing the stability of magnetic levitation performance of an artificial heart, comprising:

[0006] Adjust the relative position of the artificial heart and the swing arm;

[0007] Applying a first force to the rotor of the artificial heart by simulating the pulsation of blood through an external extracorporeal pulsation circulation loop;

[0008] Applying a second force to the rotor of the artificial heart through an external pendulum swinging motion;

[0009] By adjusting the first acting force and the second acting force, the stability of the rotor of the artificial heart is tested.

[0010] In some embodiments, applying a second force to the rotor of the artificial heart through an external pendulum swinging motion specifically includes:

[0011] During the start and stop phases of the swinging motion, a tangential force and a centripetal force are applied to the rotor of the artificial heart, wherein the second force is a resultant force of the tangential force and the centripetal force.

[0012] In some embodiments, applying a second force to the rotor of the artificial heart through an external pendulum swinging motion further comprises:

[0013] During the uniform motion phase of the swinging motion, a centripetal force is applied to the rotor of the artificial heart, wherein the second force is the centripetal force.

[0014] In some embodiments, testing the stability of the rotor of the artificial heart by adjusting the first force and the second force specifically includes:

[0015] By adjusting the first acting force, testing the axial stability of the rotor of the artificial heart;

[0016] By adjusting the second force, the radial and / or axial stability of the rotor of the artificial heart is tested.

[0017] In some embodiments, the adjustment of the first force is achieved by changing any one or more of the pulsating flow, pulsating duty cycle, and pulsating frequency.

[0018] In some embodiments, the adjustment of the second force is achieved by changing any one or both of the start / stop acceleration and the uniform speed of the swing motion.

[0019] According to another aspect of the present invention, the present invention further provides an artificial heart magnetic levitation performance stability test device, which is used to perform the artificial heart magnetic levitation performance stability test method described in any of the above embodiments, comprising:

[0020] A pulsation simulation device, used for applying a first force to the rotor of the artificial heart;

[0021] A swing device for applying a second force to the rotor of the artificial heart;

[0022] A control device for adjusting the relative positions of an artificial heart and a swing arm, and for controlling the pulsation simulation device and the swing device to test the stability of the rotor of the artificial heart by adjusting the first acting force and the second acting force.

[0023] In some embodiments, the control device includes:

[0024] A first adjustment module for adjusting any one or more of the pulsation flow rate, pulsation duty cycle, and pulsation frequency of the pulsation simulation device.

[0025] In some embodiments, the control device further includes:

[0026] A second adjustment module for adjusting the start-stop acceleration and uniform speed of the swing device.

[0027] In some embodiments, the control device further includes:

[0028] A detector for detecting the state of the rotor of the artificial heart;

[0029] A controller for controlling the first adjustment module and the second adjustment module according to the feedback of the detector.

[0030] Compared with the prior art, the artificial heart magnetic levitation performance stability test method and test device provided by the present invention can more comprehensively reflect the complex dynamic environment in various physiological and non-physiological states that the magnetic levitation artificial heart may encounter during actual use by simultaneously simulating the fluid force generated by internal ventricular pulsation and external acceleration, so as to more accurately predict and evaluate the performance and stability of the magnetic levitation artificial heart in real life, improve the accuracy of artificial heart testing, and further improve the service life and reliability of the magnetic levitation artificial heart and the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The following will further illustrate the above-mentioned characteristics, technical features, advantages and their implementation manners of the present invention in a clear and understandable manner in combination with the drawings of the preferred embodiments.

[0032] Figure 1 is a flowchart of an embodiment of a method for testing the magnetic levitation performance stability of an artificial heart according to the present invention;

[0033] Figure 2 is a schematic structural diagram of a device for testing the magnetic levitation performance stability of an artificial heart according to the present invention;

[0034] Figure 3 is a schematic diagram of the placement position of the artificial heart and the swing arm provided by the present invention under one example;

[0035] Figure 4It's an artificial heart. Figure 3 The test schematic diagram under the placement shown;

[0036] Figure 5 is a schematic diagram of the placement of the artificial heart and the swing arm provided by the present invention in another example;

[0037] Figure 6 It's an artificial heart. Figure 5 The test schematic diagram under the placement shown;

[0038] Figure 7 is a schematic diagram of the placement of the artificial heart and the swing arm provided by the present invention in another example;

[0039] Figure 8 It's an artificial heart. Figure 7 The test schematic diagram under the placement shown;

[0040] Fig. 9 The present invention is a schematic structural diagram of an artificial heart magnetic suspension performance stability testing device. DETAILED DESCRIPTION

[0041] In the following description, specific details such as specific system structures, technologies, etc. are provided for the purpose of illustration rather than limitation, so as to provide a thorough understanding of the embodiments of the present invention. However, it should be clear to those skilled in the art that the present invention may be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to prevent unnecessary details from obstructing the description of the present invention.

[0042] It should be understood that when used in this specification and the appended claims, the term "comprising" indicates the presence of the described features, integers, steps, operations, elements and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components and / or collections.

[0043] In order to simplify the drawings, only the parts related to the present invention are schematically shown in each figure, and they do not represent the actual structure of the product. In addition, in order to simplify the drawings and facilitate understanding, in some figures, only one of the parts with the same structure or function is schematically drawn or marked. In this article, "one" not only means "only one", but also means "more than one".

[0044] It should be further understood that the term "and / or" used in the present description and the appended claims refers to any and all possible combinations of one or more of the associated listed items, and includes these combinations.

[0045] In addition, in the description of the present invention, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0046] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the specific implementation methods of the present invention will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings and other implementation methods can be obtained based on these drawings without creative work.

[0047] At present, research has found that due to the continuous beating and relaxation of the ventricles of the human heart, the pulsating blood produces a periodic positive and negative force on the impeller and rotor of the artificial heart (the force from the entrance to the exit of the artificial heart), which is an internal factor affecting the stability of the rotor of the magnetic levitation artificial heart. In addition, patients with artificial hearts will experience various acceleration scenarios in their daily lives, such as sudden stops, sudden turns, jumping, driving in cars and airplanes at high speeds, playing golf, etc. The accelerations generated by various human activities outside the artificial heart may affect the stability of the magnetic levitation artificial heart and are important external factors. However, the existing test methods mostly focus on static testing and fail to fully simulate the dynamic environment in daily life, such as the multi-directional acceleration and pressure changes that the magnetic levitation artificial heart is subjected to during sports activities or daily rapid movement. That is, the existing evaluation methods lack a comprehensive evaluation of the stability and functionality of the magnetic levitation artificial heart under the simultaneous action of multiple internal and external factors.

[0048] In view of the above problems, the present invention provides a test method for comprehensively evaluating the stability of a magnetically suspended artificial heart by simulating the effects of internal factors and external dynamic factors in a near-physiological state. This test method can better simulate the environment of a magnetically suspended artificial heart in actual use, improve the test reliability, and provide more accurate data to support the design and optimization of a magnetically suspended artificial heart, thereby improving the limitations of the existing technology.

[0049] like Figure 1 As shown, the present invention provides a method for testing the stability of artificial heart magnetic levitation performance, comprising:

[0050] S100 adjusts the relative position of the artificial heart and the swing arm;

[0051] like Figure 2As shown, first, the artificial heart 10 is fixed to the swing arm 21, and the relative positional relationship between the artificial heart 10 and the swing arm 21 is adjusted to test the stability of the rotor of the artificial heart 10 in certain directions. For example, the axial direction of the rotor of the artificial heart 10 can be set parallel to the axial direction of the swing arm 21, or the axial direction of the rotor of the artificial heart 10 can be set perpendicular to the axial direction of the swing arm 21; by changing the relative positional relationship between the rotor of the artificial heart 10 and the swing arm 21, the first acting force and the second acting force in steps S200 and S300 can be decomposed into various directions of the rotor of the artificial heart 10 to test the stability of the rotor of the artificial heart 10 in different directions.

[0052] S200 pulsates the simulated blood through an externally connected extracorporeal pulsatile circulation circuit to apply a first acting force to the rotor of the artificial heart.

[0053] In the embodiment of the present invention, for the internal pulsatile motion, it is realized by constructing a pulsation simulation device. As Figure 2 shown, the pulsation simulation device includes an extracorporeal pulsatile circulation circuit and a power mechanism. The extracorporeal pulsatile circulation circuit includes a simulated ventricle cavity 11, a simulated aorta cavity 12, a simulated atrium cavity 13, a simulated vein cavity 14, and simulated human valves. These simulated cavities are used to simulate the corresponding physiological structures of the human body, thereby providing an experimental environment (simulating a physiological pulsatile environment) for the effectiveness of the magnetic levitation artificial heart 10. The power mechanism 15 can be a linear motor. The linear motor drives a diaphragm to push and suck the liquid in the simulated ventricle cavity through a linear reciprocating motion. Since no one-way valve is provided, no one-way flow is generated, and the liquid reciprocates and reverses between the inlet and outlet of the artificial heart 10 with the rotor as the center, thereby realizing the application of a periodic (axial direction of the rotor) acting force to the rotor.

[0054] S300 applies a second acting force to the rotor of the artificial heart through the swinging motion of an external pendulum.

[0055] In the embodiment of the present invention, for the external swinging motion, it can be realized by constructing a swinging device. As Figure 2 shown, the swinging device includes a swing arm 21 and a power mechanism 22. The power mechanism 22 drives the swing arm with a length of R to move. The swing arm 21 reciprocates within a range of plus or minus 45 degrees or a larger angle with respect to the equilibrium position of the swing arm 21 at an angular velocity w. The artificial heart 10 is fixed to the end of the swing arm 21. The swinging motion of the swing arm 21 is used to simulate various acceleration scenarios that a patient will experience in daily life, and the angular velocity and the length of the swing arm 21 are used to determine the magnitude of the acceleration at the position of the measured artificial heart 10.

[0056] S400 tests the stability of the rotor of the artificial heart by adjusting the first acting force and the second acting force.

[0057] In an embodiment of the present invention, after constructing a pulsation simulation device and a swinging device and fixing the relative positions of the rotor of the artificial heart 10 and the swing arm 21, the first force generated by the pulsation simulation device on the rotor and the second force generated by the swinging device on the rotor are adjusted by a control device provided in the console 40, so as to comprehensively evaluate the stability of the rotor of the artificial heart 10 in this direction. When it is necessary to test the stability of the artificial heart 10 in other directions, the relative positions of the rotor of the artificial heart 10 and the swing arm 21 are changed, and then the first force and the second force are adjusted for stability testing. Among them, the adjustment of the first force is achieved by changing any one or more of the pulsation flow rate, pulsation duty cycle, and pulsation frequency of the pulsation motion.

[0058] During the test, by adjusting the first force and the second force, it can be tested at what magnitudes of the first force and the second force the rotor of the artificial heart 10 deviates from its predetermined suspension position, including the deviation in the axial direction and / or the radial direction. And according to the magnitudes of the first force and the second force when the rotor of the artificial heart 10 deviates from the predetermined position, it is judged whether the stability of the rotor of the artificial heart 10 meets the usage requirements. Or the first force and the second force are adjusted to preset values to test whether the rotor of the artificial heart 10 deviates from its predetermined suspension position. If so, it is determined that the stability of the rotor of the artificial heart 10 does not meet the usage requirements. If not, it is determined that the stability of the rotor of the artificial heart 10 meets the usage requirements.

[0059] When detecting whether the rotor of the artificial heart 10 deviates from the predetermined position, it can be detected by a vibration meter whether the rotor of the artificial heart 10 collides with the inner wall of the artificial heart 10. Or the deviation of the rotor from the predetermined position can be detected by detecting the change in the electrical signal of the three-phase power supply of the artificial heart 10. Or it can be detected by the magnetic induction intensity of a Hall element. For example, first, the influence of the displacement change of the permanent magnet ring on the magnetic induction intensity at a certain point in space is analyzed by simulation to establish a mathematical relationship, and then a Hall sensor is used to detect the displacement of the rotor. The above detection methods for detecting whether the rotor of the artificial heart 10 deviates from the predetermined position can be used alone or in combination to ensure the accuracy of the detection and guarantee the safety of the patient when using the artificial heart 10.

[0060] The present invention can more comprehensively reflect the dynamic environment of various physiological and non-physiological states that the artificial heart may encounter in actual use by simultaneously simulating the fluid force and external acceleration generated by the internal ventricular beating, so as to more accurately predict and evaluate the performance and stability of the artificial heart in real life; in addition, through this comprehensive test, the design deficiencies of the artificial heart can be more accurately identified, and then the design can be optimized to reduce potential mechanical failures and blood damage, increase the service life and reliability of the artificial heart, improve the treatment effect, reduce complications, reduce maintenance and replacement costs caused by failures or inefficiency, and reduce long-term medical expenses, thereby saving patients a lot of money.

[0061] In some embodiments, the above S300 applies the second force to the rotor of the artificial heart through the external pendulum swinging motion specifically includes:

[0062] S310: applying a tangential force and a centripetal force to the rotor of the artificial heart during the start and stop phases of the swinging motion, wherein the second force is a resultant force of the tangential force and the centripetal force;

[0063] S320: During the uniform motion phase of the swinging motion, a centripetal force is applied to the rotor of the artificial heart, wherein the second force is the centripetal force.

[0064] Specifically, after the artificial heart 10 is fixed on the swing arm 21, there are tangential acceleration and centripetal acceleration in the start and stop stages of the swing of the swing arm 21. The tangential acceleration generates a tangential force on the rotor of the artificial heart 10, and the centripetal acceleration generates a centripetal force on the rotor of the artificial heart 10. That is, in the swinging motion, there are both tangential force and centripetal force, and the second force acting on the rotor of the artificial heart 10 is the resultant force of the tangential force and the centripetal force. In the intermediate uniform motion stage of the swing arm 21, there is no tangential acceleration, that is, there is no tangential force, and there is only a centripetal force. At this time, the second force acting on the rotor of the artificial heart 10 is only the centripetal force.

[0065] Therefore, during actual testing, the magnitude of the second force acting on the rotor of the artificial heart 10 can be adjusted by changing the start and stop acceleration of the swing arm 21 during swinging motion and / or the uniform speed during uniform motion.

[0066] Among them, after the blood flow is processed into a sinusoidal reciprocating motion, the first force The calculation formula is:

[0067] ;

[0068] Where ρ is the blood fluid density, A is the cross-sectional area of ​​the pipe, and V 0is the blood flow velocity, and ω is the periodic reciprocating frequency.

[0069] The rotor of the artificial heart is subjected to centripetal force due to the swing of the swing arm. , tangential force The calculation formulas are:

[0070] ;

[0071] ;

[0072] In the formula, m is the mass of the stator itself, L is the length of the swing arm, and g is the acceleration due to gravity. It is the angle-time expression of the artificial heart moving on the swing arm.

[0073] The resultant force on the rotor of the artificial heart is:

[0074]

[0075] In the formula, is the resultant force on the rotor of the artificial heart, is the pulsating pressure (i.e. the first force); is the centripetal force, is the start-stop acceleration (i.e. tangential force), and the resultant of these two forces is the second force.

[0076] In some embodiments, the step of testing the stability of the rotor of the artificial heart by adjusting the first force and the second force in S400 specifically includes:

[0077] S410 tests the axial stability of the rotor of the artificial heart by adjusting the first acting force;

[0078] In this embodiment, the blood inlet of the artificial heart 10 is arranged at the top of the blood pump, the blood outlet is arranged on the side of the blood pump, and the axial direction of the rotor is arranged along the top to the bottom direction of the artificial heart 10, that is, the blood inlet is located in the axial direction of the rotor, and the blood outlet is located in the radial direction of the rotor. When the artificial heart 10 is performing internal beating motion, when the liquid reciprocates between the blood inlet and the blood outlet, an axial thrust (first force) is applied to the rotor, and the axial stability of the rotor can be tested by adjusting the thrust.

[0079] S420: Testing the radial and / or axial stability of the rotor of the artificial heart by adjusting the second acting force.

[0080] In this embodiment, the artificial heart 10 is fixed to the end of the swing arm 21. When the swing arm 21 swings, a second force can be applied to the artificial heart 10, wherein the second force includes a tangential force and / or a centripetal force. When the tangential force and / or the centripetal force are adjusted, the radial and / or axial stability of the rotor of the artificial heart 10 can be tested.

[0081] The fixed position of the artificial heart 10 on the swing arm 21 is adjustable. When the axial direction of the rotor of the artificial heart 10 is parallel to the axial direction (extension direction) of the swing arm 21, the start-stop acceleration (tangential force) of the reciprocating swing arm 21 can test the radial magnetic suspension stability of the rotor of the artificial heart 10; the centripetal force applied during the uniform motion stage during the swinging process can test the axial magnetic suspension stability of the rotor of the artificial heart 10. When the axial direction of the rotor of the artificial heart 10 is perpendicular to the axial direction of the swing arm 21 and is located in the swinging plane of the swing arm 21, the start-stop acceleration (tangential force) of the reciprocating swing arm 21 can test the axial magnetic suspension stability of the rotor of the artificial heart 10; the centripetal force applied during the uniform motion stage during the swinging process can test the radial magnetic suspension stability of the rotor of the artificial heart 10. This embodiment does not specifically limit the fixed position of the artificial heart 10 on the swing arm 21. In actual testing, the placement direction of the artificial heart 10 can be adjusted according to the test requirements, or the magnetic suspension stability of the artificial heart 10 in different placement directions can be tested.

[0082] For example, Figure 3 and Figure 4 As shown, Figure 3 is the placement position of the artificial heart 10 on the swing arm 21, Figure 4 The middle arrow a indicates the blood flow direction of the artificial heart 10, and the arrow b indicates the swing direction of the swing arm 21. Assuming that the radial direction of the swing arm 21 is the z-axis direction, the axial direction (z-axis direction) of the rotor of the artificial heart 10 is fixedly parallel to the radial direction of the swing arm 21; assuming that the tangential direction of the swing arm 21 is the x-axis direction.

[0083] By adjusting the start and stop acceleration of the swing arm 21, the force of the rotor of the artificial heart 10 in the x direction can be adjusted. By adjusting the swing arm 21 uniform swing stage speed, the force acting on the rotor of the artificial heart 10 in the Z direction can be adjusted ; By adjusting the pulsating flow and / or pulsating frequency of the pulsating motion, the z-axis force can be adjusted .

[0084] For example, Figure 5 and Figure 6 As shown, Figure 5 is the placement position of the artificial heart 10 on the swing arm 21, Figure 6The middle arrow a indicates the blood flow direction of the artificial heart 10, and the arrow b indicates the swing direction of the swing arm 21. Assuming that the radial direction of the swing arm 21 is the x-axis direction, the axial direction of the rotor of the artificial heart 10 is fixed parallel to the tangent direction (z-axis direction) of the swing arm 21; assuming that the tangent direction of the swing arm 21 is the z-axis direction.

[0085] By adjusting the start and stop acceleration of the swing arm 21, the force of the rotor of the artificial heart 10 in the z direction can be adjusted. By adjusting the swing arm 21 uniform swing stage speed, the force on the rotor of the artificial heart 10 in the x direction can be adjusted ; By adjusting the pulsating flow and / or pulsating frequency of the pulsating motion, the z-axis force can be adjusted .

[0086] For example, Figure 7 and Figure 8 As shown, Figure 7 is the placement position of the artificial heart 10 on the swing arm 21, Figure 8 The middle arrow a indicates the blood flow direction of the artificial heart 10, and the arrow b indicates the swing direction of the swing arm 21. Assuming that the radial direction of the swing arm 21 is the y-axis direction, the axial direction (z-axis direction) of the rotor of the artificial heart 10 is fixed perpendicular to the plane of the swing arm 21; assuming that the tangential direction of the swing arm 21 is the x-axis direction.

[0087] By adjusting the start and stop acceleration of the swing arm 21, the force of the rotor of the artificial heart 10 in the x direction can be adjusted. By adjusting the swing arm 21 uniform swing stage speed, the force on the rotor of the artificial heart 10 in the y direction can be adjusted ; By adjusting the pulsating flow and / or pulsating frequency of the pulsating motion, the z-axis force can be adjusted .

[0088] In addition to the relative positioning of the swing arm 21 and the artificial heart 10 in this example, the relative positioning of the swing arm 21 and the artificial heart 10 can also be adjusted according to actual needs, for example, the axial direction of the artificial heart 10 is parallel to the x or y direction of the swing arm 21 (or any angle).

[0089] Through the above-mentioned adjustments, the magnetic levitation stability test of the rotor of the artificial heart 10 in three dimensions and six directions can be realized, so as to more accurately simulate and evaluate the complex dynamic environment that the rotor of the artificial heart 10 may encounter in actual operation, improve the test reliability, and provide patients with a more stable and safe implantable heart device.

[0090] The present invention also provides an embodiment of an artificial heart magnetic levitation performance stability test device, which is applied to the artificial heart magnetic levitation performance stability test method described in the above embodiment, such as Fig. 9 As shown, the artificial heart magnetic levitation performance stability test equipment includes:

[0091] The pulsation simulation device 100 is used to apply a first force to the rotor of the artificial heart;

[0092] The swing device 200 is used to apply a second force to the rotor of the artificial heart;

[0093] The control device 300 is used to adjust the relative position of the artificial heart and the swing arm, and to control the pulsation simulation device and the swing device, so as to test the stability of the rotor of the artificial heart by adjusting the first force and the second force.

[0094] Specifically, the artificial heart 10 is first fixed on the swing arm 21, and the relative position relationship between the artificial heart 10 and the swing arm 21 is adjusted to test the stability of the rotor of the magnetically suspended artificial heart 10 in certain directions. For example, the axial direction of the rotor of the artificial heart 10 can be set to be parallel to the axial direction of the swing arm 21, or the axial direction of the rotor of the artificial heart 10 can be set to be perpendicular to the axial direction of the swing arm 21; by changing the relative position relationship between the rotor of the artificial heart 10 and the swing arm 21, the first force and the second force can be decomposed into various directions of the rotor of the artificial heart 10 to test the stability of the rotor of the artificial heart 10 in different directions.

[0095] The pulsation simulation device 100 can adopt an existing simulation device. Exemplarily, the pulsation simulation device 100 includes an extracorporeal pulsation circulation circuit and a power mechanism. The extracorporeal pulsation circulation circuit includes a simulated ventricular cavity 11, a simulated aortic cavity 12, a simulated atrial cavity 13, a simulated venous cavity 14 and a simulated human valve. The blood flow inlet of the artificial heart 10 is connected to the simulated left ventricular cavity, and the blood flow outlet of the artificial heart 10 is connected to the simulated aortic cavity. These simulated chambers are used to simulate the corresponding physiological structure of the human body, thereby providing an experimental environment (simulated physiological pulsation environment) for the effectiveness of the artificial heart 10, thereby simulating the pulsation environment of different heart failure patients (cardiogenic shock, heart failure, healthy). The power mechanism 15 can be a linear motor, which drives the diaphragm to push and suck the liquid in the simulated ventricular cavity through linear reciprocating motion. Since no one-way valve is provided, no one-way flow is generated, so that the liquid reciprocates and switches between the blood flow inlet and outlet with the rotor as the center in the artificial heart 10, thereby exerting a periodic lateral (rotor radial) force on the rotor. In addition, the pulsation simulation device also includes various sensors arranged in the in vitro simulated circulation loop, such as pressure sensors, flow sensors and temperature sensors, so as to detect the fluid pressure, flow rate and temperature in the circulation loop through these sensors.

[0096] The swing device 200 includes a swing arm 21 and a power mechanism 22. The power mechanism drives the swing arm to reciprocate within a range of plus or minus 45 degrees or more from the balance position of the swing arm. The end of the swing arm 21 is fixed with an artificial heart 10. By the swinging motion of the swing arm 21, various acceleration scenarios that a patient may experience in daily life are simulated, and the angular velocity and the length of the swing arm 21 are used to determine the magnitude of the acceleration at the position of the measured artificial heart 10. In addition, the swing device 200 further includes various acceleration sensors disposed on the swing arm 21 to detect the acceleration and angular velocity information of the swing arm 21 during the test.

[0097] The control device 300 disposed on the console 40 controls the power mechanism of the pulsation simulation device 100 and the power mechanism of the swing device 200 through electrical connection, so as to adjust the first force exerted on the rotor by the pulsation simulation device 100 and the second force exerted on the rotor by the swing device 200, thereby realizing the stability test of the rotor of the artificial heart 10. When it is necessary to test the stability of the artificial heart 10 in other directions, change the relative position between the rotor of the artificial heart 10 and the swing arm 21, and then adjust the first force and the second force for the stability test.

[0098] Wherein, during the start and stop stages of the swinging motion, a tangential force and a centripetal force are applied to the rotor of the artificial heart. Wherein, the second force is the resultant force of the tangential force and the centripetal force. During the uniform motion stage of the swinging motion, a centripetal force is applied to the rotor of the artificial heart. Wherein, the second force is the centripetal force.

[0099] By simultaneously simulating the fluid forces generated by the internal ventricular pulsation and the external acceleration, the present invention can more comprehensively reflect the dynamic environments in various physiological and non-physiological states that the artificial heart may encounter during actual use, so as to more accurately predict and evaluate the performance and stability of the artificial heart in actual life. In addition, through this comprehensive test, the deficiencies in the design of the artificial heart can be more accurately identified, and then the optimization design can be carried out to reduce potential mechanical failures and blood damage, improve the service life and reliability of the artificial heart, improve the treatment effect, reduce complications, reduce the maintenance and replacement costs caused by failures or inefficiencies, and reduce long-term medical expenses, thereby saving a large amount of expenses for patients.

[0100] In some embodiments, the control device 300 includes a first adjustment module for adjusting the pulsation flow rate and pulsation frequency of the pulsation simulation device. The first adjustment module can adjust any one or more of the pulsation flow rate, pulsation duty cycle, and pulsation frequency by controlling the power mechanism of the pulsation simulation device. For example, the pulsation flow rate and pulsation frequency are adjusted by adjusting the rotation speed of the motor. Or an electronically controlled valve is provided on the pulsation simulation device, and the pulsation flow rate is adjusted by controlling the opening and closing of the valve.

[0101] In some embodiments, the control device 300 further includes a second regulating module for regulating the start / stop acceleration and the uniform speed of the swing device. The second regulating module can adjust the start / stop acceleration and the uniform speed of the swing arm 21 by controlling the rotation speed of the power mechanism of the swing device.

[0102] In some embodiments, the control device 300 further includes:

[0103] A detector, used to detect the state of the rotor of the artificial heart;

[0104] A controller is used to control the first regulating module and the second regulating module according to feedback from the detector.

[0105] During the test, the first adjustment module and the second adjustment module can be controlled by the control module to adjust the first force and the second force applied to the rotor. The detector is used to detect the state of the rotor, for example, it can detect whether the rotor deviates from the predetermined position, and then feed back the detection result to the controller, and then the controller controls the first adjustment module and the second adjustment module to continue to adjust the first force and / or the second force, or stop the test. Exemplarily, when it is detected that the rotor has deviated from the predetermined position, the controller can control the first adjustment module and the second adjustment module to make the first force and the second force applied to the rotor zero, and then stop the test. When it is detected that the rotor has not deviated from the predetermined position, the controller can control the first adjustment module and the second adjustment module to continue to increase the first force and the second force applied to the rotor to continue the test.

[0106] Specifically, this embodiment is a device embodiment corresponding to the above method embodiment. For specific technical effects, please refer to the above method embodiment, which will not be described in detail here.

[0107] Those skilled in the art can clearly understand that, for the convenience and simplicity of description, only the division of the above-mentioned program modules is used as an example for illustration. In actual applications, the above-mentioned functions can be assigned to different program modules as needed, that is, the internal structure of the device can be divided into different program units or modules to complete all or part of the functions described above. The program modules in the embodiment can be integrated into a processing unit, or each unit can exist physically separately, or two or more units can be integrated into a processing unit. The above-mentioned integrated unit can be implemented in the form of hardware or in the form of a software program unit. In addition, the specific names of the program modules are only for the convenience of distinguishing each other, and are not used to limit the scope of protection of the present invention.

[0108] It should be understood that, although the steps in the flowchart of the accompanying drawings are displayed in sequence as indicated by the arrows, these steps are not necessarily executed in sequence in the order indicated by the arrows. Unless otherwise specified herein, there is no strict order restriction on the execution of these steps, and they can be executed in other orders. Moreover, at least a part of the steps in the flowchart of the accompanying drawings may include multiple sub-steps or multiple stages, and these sub-steps or stages are not necessarily executed at the same time, but can be executed at different times, and their execution order is not necessarily sequential, but can be executed in turn or alternately with other steps or at least a part of the sub-steps or stages of other steps.

[0109] It should be noted that the above embodiments can be freely combined as needed. The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered as the protection scope of the present invention.

Claims

1. A method for testing the stability of artificial heart magnetic levitation performance, characterized in that: include: Adjust the relative position of the artificial heart and the swing arm; Applying a first force to the rotor of the artificial heart by simulating the pulsation of blood through an external extracorporeal pulsation circulation loop; Applying a second force to the rotor of the artificial heart through an external pendulum swinging motion; By adjusting the first acting force and the second acting force, the stability of the rotor of the artificial heart is tested.

2. The method for testing the stability of the magnetic levitation performance of an artificial heart according to claim 1, characterized in that: The step of applying the second force to the rotor of the artificial heart through the external pendulum swinging motion specifically includes: During the start and stop phases of the swinging motion, a tangential force and a centripetal force are applied to the rotor of the artificial heart, wherein the second force is the resultant force of the tangential force and the centripetal force.

3. The method for testing the stability of the magnetic levitation performance of an artificial heart according to claim 2, characterized in that: The step of applying a second force to the rotor of the artificial heart through the external pendulum swinging motion further comprises: During the uniform motion phase of the swinging motion, a centripetal force is applied to the rotor of the artificial heart, wherein the second force is the centripetal force.

4. The method for testing the stability of the magnetic levitation performance of an artificial heart according to claim 3, characterized in that: The step of testing the stability of the rotor of the artificial heart by adjusting the first acting force and the second acting force specifically includes: By adjusting the first acting force, testing the axial stability of the rotor of the artificial heart; By adjusting the second force, the radial and / or axial stability of the rotor of the artificial heart is tested.

5. A method for testing the stability of magnetic levitation performance of an artificial heart according to any one of claims 1 to 4, characterized in that: The adjustment of the first force is achieved by changing any one or more of the pulsating flow, pulsating duty cycle and pulsating frequency.

6. A method for testing the stability of magnetic levitation performance of an artificial heart according to any one of claims 1 to 4, characterized in that: The adjustment of the second force is achieved by changing any one or both of the start / stop acceleration and the uniform speed of the swing motion.

7. An artificial heart magnetic levitation performance stability test device, used to perform the artificial heart magnetic levitation performance stability test method according to any one of claims 1 to 6, characterized in that: include: A pulsation simulation device, used for applying a first force to the rotor of the artificial heart; A swing device for applying a second force to the rotor of the artificial heart; The control device is used to adjust the relative position of the artificial heart and the swing arm, and is used to control the pulsation simulation device and the swing device, so as to test the stability of the rotor of the artificial heart by adjusting the first force and the second force.

8. The artificial heart magnetic suspension performance stability testing device according to claim 7, characterized in that: The control device comprises: The first regulating module is used to regulate any one or more of the pulsation flow, pulsation duty cycle and pulsation frequency of the pulsation simulation device.

9. The artificial heart magnetic suspension performance stability testing device according to claim 8, characterized in that: The control device also includes: The second regulating module is used to regulate the start / stop acceleration and the uniform speed of the swing device.

10. The artificial heart magnetic suspension performance stability testing device according to claim 9, characterized in that: The control device also includes: A detector, used to detect the state of the rotor of the artificial heart; A controller is used to control the first regulating module and the second regulating module according to feedback from the detector.

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