An artificial heart pump device and a preparation method of a magnetic diaphragm pump

Abstract

The present invention provides an artificial heart pump device and a preparation method of a magnetic diaphragm pump, belonging to the field of medical devices. The artificial heart pump device includes a magnetic diaphragm pump system and a magnetic field generating system; the magnetic diaphragm pump includes a magnetic diaphragm and a non-magnetic pump body; after the magnetic diaphragm is magnetized radially, it deforms under a uniform magnetic field; the non-magnetic pump body cooperates with the magnetic diaphragm to generate elastic deformation, and realizes the function of pumping blood by changing the volume of the magnetic diaphragm pump; a hose connects each artery or vein where the magnetic diaphragm pump is connected to the human heart to complete the transportation and circulation of blood in the human blood vessels and the magnetic diaphragm pump; a one-way valve controls the one-way flow of blood; the magnetic field generating system generates a uniform magnetic field along the axial direction of the magnetic diaphragm. The artificial heart pump device provided by the present invention has higher operation reliability and longer service life.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and more specifically, relates to an artificial heart pump device based on magnetic torque and a preparation method of a magnetic diaphragm pump. Background Art

[0002] The incidence and mortality rates of heart failure are both relatively high, and it is recognized as the last battlefield in the field of cardiovascular diseases. With the gradual deepening of the aging degree, the incidence of cardiovascular diseases is expected to continue to increase, which greatly endangers human health and natural lifespan. Heart failure refers to the disorder of the contraction and relaxation functions of the heart, which cannot fully pump out the blood returning to the heart through veins, and the arterial blood perfusion in the heart is insufficient, thus causing blood circulation disorders in the heart.

[0003] For heart failure, single drug treatment often cannot achieve good results. At present, heart transplantation surgery is recognized as the only effective means for treating patients with end-stage heart failure. However, the shortage of heart donors is severe and it is difficult to meet the needs of a large number of heart failure patients. Therefore, using surgical treatment to implant an artificial heart pump device to assist or even replace the damaged heart function and improve the quality of life of heart failure patients will become the key to future heart failure treatment.

[0004] At present, the research on artificial hearts has gone through three generations of product iterations. The first-generation artificial heart is a circulatory assist device that simulates the principle of natural heart contraction and relaxation. The product structure is complex, the surgical difficulty is high, and it is easy to cause mechanical failures and thrombus formation, which greatly affects the survival rate of patients. The second-generation artificial heart does not use the change in the volume of the heart blood chamber to drive blood circulation, but uses a centrifugal pump or an axial flow pump to drive blood flow, and has been widely used clinically at present. The third-generation artificial heart is based on the second generation and uses technologies such as magnetic liquid suspension, magnetic suspension, and pure water suspension to avoid direct contact between blood and bearings, further reducing thrombus formation. For the second-generation and third-generation artificial heart devices mainly used clinically at present, their main principle is to install a pump body on the patient's heart and use the pump body to achieve blood circulation. This treatment method will have some problems: the heart assist device implanted in the body must be connected to the external functional device in a wired manner, which will not only affect the daily activities of patients, but may also cause infections, thrombi, and even a series of complications; in addition, mechanical pump blood devices may experience mechanical failures and wear during use, which greatly affects the service life of the heart assist device. Summary of the Invention

[0005] Aiming at the defects of the prior art, the purpose of the present invention is to provide an artificial heart pump device and a preparation method of a magnetic diaphragm pump. The drive of this device is based on the principle of magnetic torque, aiming to solve the problems of large drive magnetic fields, complex drive devices, high control difficulty, and low precision required by existing heart assist devices based on the principle of magnetic gradient force.

[0006] To achieve the above object, on the one hand, the present invention provides an artificial heart pump device, comprising: a magnetic diaphragm pump system and a magnetic field generating system;

[0007] The magnetic diaphragm pump system is used to perform three-dimensional deformation actions under a uniform magnetic field after radial magnetization, and complete the functions of pumping blood into and out of the heart by the heart;

[0008] The magnetic diaphragm pump system includes a magnetic diaphragm pump, a hose and a check valve;

[0009] The magnetic diaphragm pump includes a magnetic diaphragm and a non-magnetic pump body; the magnetic diaphragm is located on both sides above and below the non-magnetic pump body, and the magnetic diaphragm is used to deform under a uniform magnetic field after radial magnetization; the non-magnetic pump body is used to cooperate with the magnetic diaphragm to generate elastic deformation, and realize the function of pumping blood by changing the volume of the magnetic diaphragm pump; the magnetic diaphragm includes magnetic particles and a non-magnetic pump body; the magnetic particles are permanent magnetic particles magnetized under a magnetic field in the radial direction; the non-magnetic pump body is made of a flexible substrate material;

[0010] The hose is used to connect the magnetic diaphragm pump to each artery or vein connected to the human heart, and complete the transportation and circulation of blood in the human blood vessels and the magnetic diaphragm pump;

[0011] The check valve is installed inside the hose and is used to control the one-way flow of blood and prevent blood backflow;

[0012] The magnetic field generating system is used to generate a uniform magnetic field along the axial direction of the magnetic diaphragm.

[0013] Further preferably, the flexible material is polydimethylsiloxane resin or silica gel; the magnetic particles are one or a mixture of several materials of NdFeB, SmCo and AlNiCo materials.

[0014] Further preferably, there are two groups of magnetic diaphragm pump systems. The first group includes a systolic first magnetic diaphragm pump and a diastolic first magnetic diaphragm pump that replace the left ventricle and left atrium, a first hose and a first check valve; the inlet side of the diastolic first magnetic diaphragm pump is connected to the pulmonary vein by the first hose, and its outlet side is connected to the inlet side of the systolic first magnetic diaphragm pump, and the outlet end of the systolic first magnetic diaphragm pump is connected to the aorta; a first check valve is provided at the first hose between the systolic first magnetic diaphragm pump and the diastolic first magnetic diaphragm pump, and a first check valve is provided at the first hose between the systolic first diaphragm pump and the aorta;

[0015] The second group includes a systolic second magnetic diaphragm pump and a diastolic second magnetic diaphragm pump that replace the right ventricle and the right atrium, a second hose, and a second one-way valve; the inlet side of the diastolic second magnetic diaphragm pump is connected to the superior and inferior vena cava through the second hose, and its outlet is connected to the inlet end of the systolic second magnetic diaphragm pump; the outlet end of the systolic second magnetic diaphragm pump is connected to the pulmonary artery; a second one-way valve is added at the second hose between the systolic second magnetic diaphragm pump and the diastolic second magnetic diaphragm pump; a second one-way valve is provided at the second hose between the systolic second magnetic diaphragm pump and the pulmonary artery.

[0016] Further preferably, the uniform magnetic field is an externally applied magnetic field with an amplitude of 10 mT to 100 mT and a magnetic field gradient of 0 T / m to 0.2 T / m (no magnetic field gradient or weak gradient); when the magnetization direction of the magnetic diaphragm is along the axis from the center to the periphery, the uniform magnetic field is directed inward along the axis, then the magnetic diaphragm bulges outward, and the volume of the magnetic diaphragm pump increases, realizing the pumping of external blood into the magnetic diaphragm pump; when the uniform magnetic field is directed outward along the axis, the magnetic diaphragm sinks inward, and the volume of the magnetic diaphragm pump decreases, realizing the pumping of blood out of the magnetic diaphragm pump.

[0017] On the other hand, the present invention provides a method for preparing a magnetic diaphragm pump, including the following steps:

[0018] S1: Customize a thin plate mold, an inner mold of the pump body, and an outer mold of the pump body according to the preset size of the actual magnetic diaphragm pump;

[0019] S2: Mix a certain mass ratio of magnetic particles and a flexible substrate material evenly with a mixer and then perform defoaming treatment to obtain a magnetic mixture;

[0020] S3: Inject the magnetic mixture into the thin plate mold using a syringe, place the thin plate mold in an environment of 70°C to 80°C and heat for 100 min to 120 min, demold after the magnetic mixture is cured to obtain a rough magnetic diaphragm;

[0021] S4: Place the rough magnetic diaphragm under a pulsed magnetic field for radial magnetization to obtain a magnetized magnetic diaphragm;

[0022] S5: Place the magnetized magnetic diaphragm in the outer mold of the pump body, then place and fix the inner mold of the pump body, and then pour the flexible substrate material into the gap between the inner mold and the outer mold using a syringe. After the gap is filled, place another magnetic diaphragm on the top and then place it in an environment of 70°C to 80°C and heat for 100 min to 120 min for curing, so that the non-magnetic pump body made of the flexible substrate material and the magnetic diaphragm form an integral body to form a magnetic diaphragm pump;

[0023] S6: Demold the entire magnetic diaphragm pump.

[0024] Further preferably, in S1, a thin plate mold, an inner mold of the pump body, and an outer mold of the pump body are prepared by 3D printing; the material of the inner mold of the pump body is blue wax; the outer mold of the pump body and the thin plate mold are resin.

[0025] Further preferably, the magnetic particles are one or a mixture of several materials of NdFeB, Fe, and FeC materials; the flexible substrate material is polydimethylsiloxane or silicone rubber.

[0026] Further preferably, after obtaining the demolded rough magnetic diaphragm in S3, the surface of the rough magnetic diaphragm is cleaned with ethanol or isopropanol, and the cleaned rough magnetic diaphragm is placed in a nitrogen stream for drying.

[0027] Further preferably, S4 is specifically as follows:

[0028] The rough magnetic diaphragm is placed in a draw plate for fixing, and then the entire draw plate is placed under a pulsed magnetic field greater than 1 T to radially magnetize the rough magnetic diaphragm to obtain a magnetized magnetic diaphragm.

[0029] Generally speaking, compared with the prior art by the above technical solution conceived by the present invention, the following

[0030] Advantages are as follows:

[0031] The present invention provides an artificial heart pump device based on magnetic torque. Among them, after being radially magnetized, the magnetic diaphragm deforms under a uniform magnetic field, and elastic deformation occurs in cooperation with a non-magnetic pump body. By changing the volume of the magnetic diaphragm pump, blood pumping is realized, and the artificial heart pump device is driven by a wireless magnetic field, solving the problems of wound infection, thrombosis, and complications generated during the wired operation of traditional artificial heart assist devices, as well as the problems of easy mechanical damage and inconvenient life for patients when wearing. Compared with traditional ventricular assist devices, the artificial heart pump device provided by the present invention has higher operating reliability and longer service life.

[0032] The artificial heart pump device provided by the present invention is based on the principle of magnetic torque and can realize the deformation of the magnetic diaphragm under a low-intensity uniform magnetic field, thereby completing the pumping in and pumping out actions of the entire heart pump, and thus assisting the damaged heart function of heart failure patients. The specific principle of magnetic torque is as follows: after the magnetic diaphragm is radially magnetized by a pulsed magnetic field, the magnetic particles exhibit radial magnetization characteristics. When a uniform magnetic field is applied to it and the magnetic field direction is inconsistent with the magnetic moment direction of the magnetic particles, the magnetic particles will be subjected to a magnetic torque force to make the magnetic moment direction as consistent with the external magnetic field direction as possible, thereby causing the magnetic diaphragm to generate three-dimensional deformation (including outward protrusion and inward depression). The present invention utilizes the principle of magnetic torque and can drive the device to work under a uniform magnetic field with a lower intensity, solving the problems of large driving magnetic field intensity, high energy consumption, and uncontrollable deformation under the principle of gradient magnetic field force.

[0033] The artificial heart device provided by the present invention can comprehensively assist the heart in promoting blood circulation, and can perform two three-dimensional deformations, namely outward protrusion and inward depression. It not only meets the function of the ventricle in the heart to pump out blood, but also can meet the function of the atrium to pump blood outside the heart into the heart, solving the problem that existing heart assist devices can only assist in pumping out blood but not promoting blood inflow. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a schematic diagram of the preparation steps of the magnetic diaphragm provided by an embodiment of the present invention;

[0035] Figure 2 It is a schematic diagram of the entire manufacturing process of the magnetic diaphragm pump provided by an embodiment of the present invention;

[0036] Figure 3 It is a schematic diagram of the magnetization and deformation principle of the magnetic diaphragm pump provided by an embodiment of the present invention;

[0037] Figure 4 It is a schematic diagram of the external working process of the magnetic diaphragm pump provided by an embodiment of the present invention;

[0038] Figure 5 It is a schematic diagram of the in-vivo deformation process of the magnetic diaphragm pump provided by an embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0039] In order to make the objectives, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0040] On the one hand, the present invention provides a magnetically controlled artificial heart pump device, including a magnetic diaphragm pump system and a magnetic field generation system for driving the magnetic diaphragm pump; the magnetic diaphragm pump system can perform three-dimensional deformation actions under the uniform magnetic field generated by the magnetic field generation system, so as to complete the functions of pumping blood into and out of the heart, providing assistance for the heart treatment of heart failure patients;

[0041] The magnetic diaphragm pump system includes a magnetic diaphragm pump, a hose and a one-way valve;

[0042] The magnetic diaphragm pump includes a magnetic diaphragm at the top and a non-magnetic pump body; among them, the magnetic diaphragm is the main component for movement, and after being radially magnetized, it will deform under a uniform magnetic field; the main function of the non-magnetic pump body is to cooperate with the magnetic diaphragm to generate elastic deformation, so as to change the volume of the entire pump body to achieve the function of pumping blood; the magnetic diaphragm includes magnetic particles and a non-magnetic pump body; the magnetic particles are permanent magnetic particles magnetized under a radial magnetic field; the non-magnetic pump body is composed of a flexible base material;

[0043] The hose is used to connect the magnetic diaphragm pump to each artery or vein connected to the human heart, so as to complete the transportation and circulation of blood in the human blood vessels and the magnetic diaphragm pump;

[0044] The one-way valve is installed inside the hose to control the one-way flow of blood and prevent blood backflow;

[0045] The magnetic field generating system is used to generate a uniform magnetic field along the axial direction of the magnetic diaphragm. Its function is to drive the implanted magnetic diaphragm pump in the human body after radial magnetization. Under the drive of the uniform magnetic field, the magnetic diaphragm part in the magnetic diaphragm pump makes outward convex and inward concave movements, driving the entire magnetic diaphragm pump to perform the pumping in and pumping out of blood; among them, the direction of the uniform magnetic field is the axial direction of the entire magnetic diaphragm pump.

[0046] Further preferably, the flexible material is polydimethylsiloxane resin or silica gel; the magnetic particles are one or a mixture of several materials of NdFeB, SmCo and AlNiCo materials.

[0047] The present invention solves the problems existing in the wired power supply in the existing cardiac assist devices, such as wire entanglement, easy infection and mechanical failures. And compared with the technical solution of the cardiac assist device driven by magnetic gradient force, the present invention has the advantages of low driving magnetic field intensity, low energy consumption and high control precision, and can achieve two effects of pumping in and pumping out of blood, and has a good effect on assisting the cardiac function of heart failure patients.

[0048] On the other hand, the present invention provides a preparation method for the corresponding magnetic diaphragm pump, which specifically includes the following steps:

[0049] S1: Customize the mold according to the actual requirements, including: a thin plate mold, an inner mold of the pump body and an outer mold of the pump body;

[0050] More specifically, in S1, in order to ensure the accuracy of the magnetically controlled artificial heart pump device, it is necessary to manufacture the mold by 3D printing. The material of the inner mold of the pump body is selected as blue wax, while the outer mold of the pump body and the thin plate mold are selected as resin;

[0051] Further preferably, in S1, the overall size of the magnetically controlled diaphragm pump can be determined according to the patient's own physiological data and the degree of heart function loss, so as to achieve the best assisting effect;

[0052] S2: Mix a certain mass ratio of magnetic particles and flexible substrate materials, and mix them evenly with a mixer, and perform defoaming treatment to obtain a magnetic mixture;

[0053] Further preferably, in order to facilitate demolding, a mold release agent should be applied to the surface of the customized mold;

[0054] Further preferably, in S2, the magnetic particles can be selected from one or several of NdFeB, Fe, and FeC materials; the flexible substrate material can be selected from polydimethylsiloxane and silicone rubber, etc.;

[0055] Further preferably, in S2, in order to fully and uniformly mix the magnetic particles and the flexible material, the two materials can be mixed and stirred and defoamed using a degassing machine. Among them, the stirring time can be set to 1.5 min, the rotation speed is controlled at 800 r / min to 1000 r / min, and after the stirring process ends, the uniformly mixed magnetic particles and flexible material are subjected to degassing treatment, with the time controlled at about 1 min and the rotation speed controlled at 1000 r / min to 1200 r / min;

[0056] S3: As Figure 1 shown, the magnetic mixture prepared in S2 is injected into the thin plate mold in S1 using a syringe, and it is placed in an environment of 70 °C to 80 °C and heated for 100 min to 120 min to be cured, and then demolded to obtain a crude magnetic diaphragm;

[0057] Further preferably, in S3, when using a syringe to extract the magnetic mixture and inject it into the thin plate mold, the extraction speed and injection speed should be controlled to avoid a large number of bubbles in the sample; after the injection molding is completed, a scraper should be used to scrape off the excess mixture on the surface of the mold to ensure that the surface of the sample is smooth and flat and conducive to demolding after curing;

[0058] Further preferably, after obtaining the demolded crude magnetic diaphragm in S3, its surface can be cleaned with ethanol or isopropanol, and it is placed in a nitrogen stream for drying to prepare for the next magnetization process;

[0059] S4: The crude magnetic diaphragm prepared in S3 is placed under a pulsed magnetic field for radial magnetization to obtain a magnetized magnetic diaphragm;

[0060] Further preferably, in S4, the processed crude magnetic diaphragm can be placed and fixed in a drawplate, and then the entire drawplate is placed under a pulsed magnetic field greater than 1 T for radial magnetization of the crude magnetic diaphragm to prevent the sample from moving and being damaged under the strong pulsed magnetic field;

[0061] S5: As Figure 2 shown, the magnetic diaphragm prepared in S4 is placed inside the outer mold of the pump body, and the inner mold is placed and fixed. Then, a syringe is used to pour the flexible substrate material into the gap between the inner and outer molds. After the gap is filled, it is placed in an environment of 70 °C to 80 °C again and heated for 100 min to 120 min for curing, so that the non-magnetic pump body made of the flexible substrate material and the magnetic diaphragm form a whole;

[0062] S6: Demold the entire magnetic diaphragm pump.

[0063] Since the magnetic diaphragm pump changes the pressure inside the pump through the deformation of the top magnetic diaphragm to complete the blood pumping action, it is necessary to ensure that the entire pump body is a complete sealed container except for the inlet and outlet. When performing S6 demolding, the integrity of the pump body must be ensured. Therefore, the material of the inner mold in the pump body is selected as wax; and the heating temperature for curing the pump body in S5 has reached the melting point of wax. Therefore, the liquid blue wax formed by melting the inner mold after heating can be directly poured out from the inlet and outlet of the pump body to demold it.

[0064] The reason for radially magnetizing the magnetic diaphragm is as follows: It can make the magnetic diaphragm have a radial magnetization direction inside. After magnetization, it can generate deformation under the drive of an external uniform magnetic field; the external uniform magnetic field can be a uniform magnetic field with an amplitude of 10 mT to 100 mT and a magnetic field gradient of 0 T / m to 0.2 T / m (no magnetic field gradient or weak gradient) according to the required action amplitude of the magnetic diaphragm pump. Among them, the magnetic field direction is the axial direction of the magnetic diaphragm; the principle of magnetization and deformation of the magnetic diaphragm pump is as Figure 3 shown. The driving principle of the external magnetic field on the magnetic diaphragm pump is: When an axial uniform magnetic field is applied to the magnetically diaphragm pump that has been radially magnetized with central symmetry, the torque of the magnetic particles inside the diaphragm will tend to deflect in the direction of the external magnetic field, thereby driving the entire magnetic diaphragm to generate elastic deformation. Taking the deformation of the magnetic diaphragm with the magnetization direction along the axis from the center to the periphery as an example, when the external uniform magnetic field is along the axis inward, the diaphragm bulges outward, and the volume of the entire diaphragm pump increases, so the pressure decreases, and thus the external blood is pumped into it; when the external uniform magnetic field is along the axis outward, the diaphragm sinks inward, and the volume of the entire diaphragm decreases and the pressure increases, so the internal blood is pumped out. Therefore, the functions of the atrium and ventricle in the heart are realized.

[0065] Further preferably, four magnetic diaphragm pumps should be set in the magnetic diaphragm pump system. Two of them replace the functions of the left atrium and the right atrium, and are used to suck the external blood into the pump and present an expanded state under the action of the magnetic field; the remaining two replace the functions of the left ventricle and the right ventricle, and are used to pump the blood in the pump out and present a contracted state under the action of the magnetic field.

[0066] Further preferably, the magnetic field generated by the magnetic field generating system can be upward or downward. Taking the upward magnetic field direction as an example, the deformation mechanism of the diaphragm pump replacing the atrial and ventricular functions is analyzed respectively. The magnetization directions of the magnetic diaphragm sheets on both sides of the diaphragm pump are opposite: for the diaphragm pump replacing the atrial function, the magnetization direction of the upper magnetic diaphragm is from the edge to the center, while the magnetization direction of the lower diaphragm pump is from the center to the edge; the diaphragm pump replacing the ventricular function is the opposite, with the upper magnetization direction from the center to the edge and the lower direction from the edge to the center. When the magnetic field direction is downward, the deformation of the diaphragm pump is opposite. The schematic diagram of the external operation of the magnetic diaphragm pump device replacing the atrial function when the magnetic field direction is upward is as Figure 4 shown;

[0067] In order to replace the function of the human heart and thus achieve human blood circulation, the entire magnetic diaphragm pump system is divided into two parts: The first part consists of a contraction and relaxation magnetic diaphragm pump, a hose, and a one-way valve that replace the functions of the left ventricle and left atrium. The inlet side of the relaxation magnetic diaphragm pump is connected to the pulmonary vein by a hose, and the outlet side is connected to the inlet side of the contraction diaphragm pump. Finally, the outlet end of the contraction diaphragm pump is connected to the aorta, and one-way valves should be added at the hoses between the two diaphragm pumps and between the contraction diaphragm pump and the aorta to simulate the functions of the mitral valve and the aortic valve. The second part consists of a contraction and relaxation diaphragm pump, a hose, and a one-way valve that replace the functions of the right ventricle and right atrium. The inlet side of the relaxation diaphragm pump is connected to the superior and inferior vena cava through a hose, the outlet is connected to the inlet end of the contraction diaphragm pump, and the outlet end of the contraction diaphragm pump is connected to the pulmonary artery. One-way valves should be added at the hoses between the two diaphragm pumps and between the contraction diaphragm pump and the pulmonary artery to simulate the functions of the tricuspid valve and the pulmonary valve. The schematic diagram of the entire device working in the body is as Figure 5 shown.

[0068] In summary, compared with the prior art, the present invention has the following advantages:

[0069] The present invention provides an artificial heart pump device based on magnetic torque. Among them, the magnetic diaphragm deforms under a uniform magnetic field after being magnetized radially, and produces elastic deformation with the cooperation of a non-magnetic pump body. By changing the volume of the magnetic diaphragm pump, blood pumping is realized, and the artificial heart pump device is driven by a wireless magnetic field, solving the problems of wound infection, thrombosis, and complications generated during the wired operation of traditional artificial heart assist devices, as well as the problems of easy mechanical damage and inconvenience in patients' lives when wearing. Compared with traditional ventricular assist devices, the artificial heart pump device provided by the present invention has higher operation reliability and longer service life.

[0070] The artificial heart pump device provided by the present invention is based on the principle of magnetic torque, and can achieve the deformation of the magnetic diaphragm under a low-intensity uniform magnetic field, thereby completing the pumping-in and pumping-out actions of the entire heart pump, so as to assist the damaged heart function of heart failure patients. The magnetic torque principle is specifically as follows: after the magnetic diaphragm is radially magnetized by a pulsed magnetic field, the magnetic particles exhibit radial magnetization characteristics. When a uniform magnetic field is applied to it and the magnetic field direction is inconsistent with the magnetic moment direction of the magnetic particles, the magnetic particles will be subjected to the action of magnetic torque to make their magnetic moment directions as consistent with the external magnetic field direction as possible, thereby causing the magnetic diaphragm to generate three-dimensional deformation (including bulging outwards and sinking inwards). By using the magnetic torque principle, the present invention can drive the device to work under a uniform magnetic field with a relatively low intensity, and solves the problems such as large driving magnetic field intensity, high energy consumption and uncontrollable deformation under the gradient magnetic field force principle.

[0071] The artificial heart device provided by the present invention can comprehensively assist the heart in promoting blood circulation, and can perform two kinds of three-dimensional deformations, namely bulging outwards and sinking inwards. It not only meets the function of the ventricle in the heart to pump out blood, but also can meet the function of the atrium to pump in blood outside the heart, and solves the problem that the existing heart assist device can only assist in pumping out blood but cannot promote blood pumping in.

[0072] It is easy for those skilled in the art to understand that the above are only the preferred embodiments of the present invention, and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. An artificial heart pump device, characterized in that, Comprising: A magnetic diaphragm pump system and a magnetic field generating system; The magnetic diaphragm pump system is used to perform three-dimensional deformation actions under a uniform magnetic field after radial magnetization to complete the functions of pumping blood into and out of the heart; The magnetic diaphragm pump system includes a magnetic diaphragm pump, a hose, and a one-way valve; The magnetic diaphragm pump includes a magnetic diaphragm and a non-magnetic pump body; the magnetic diaphragm is located on both the upper and lower sides of the non-magnetic pump body, and the magnetic diaphragm is used to deform under a uniform magnetic field after radial magnetization; the non-magnetic pump body is used to cooperate with the magnetic diaphragm to generate elastic deformation and realize the function of pumping blood by changing the volume of the magnetic diaphragm pump; the magnetic diaphragm includes magnetic particles and a non-magnetic pump body; the magnetic particles are permanent magnetic particles magnetized under a magnetic field in the radial direction; the non-magnetic pump body is a flexible substrate material; The hose is used to connect the magnetic diaphragm pump to each artery or vein connected to the human heart to complete the transportation and circulation of blood in the human blood vessels and the magnetic diaphragm pump; The one-way valve is installed in the hose to control the one-way flow of blood and prevent blood backflow; The magnetic field generating system is used to generate a uniform magnetic field along the axial direction of the magnetic diaphragm; The uniform magnetic field is an externally applied magnetic field with an amplitude of 10 mT to 100 mT and a magnetic field gradient of 0 T / m to 0.2 T / m; when the magnetization direction of the magnetic diaphragm is from the center to the periphery along the axis, the uniform magnetic field is inward along the axis, then the magnetic diaphragm bulges outward, and the volume of the magnetic diaphragm pump increases to realize the pumping of blood outside the magnetic diaphragm pump; when the uniform magnetic field is outward along the axis, the magnetic diaphragm sinks inward, and the volume of the magnetic diaphragm pump decreases to realize the pumping of blood inside the magnetic diaphragm pump.

2. The artificial heart pump device according to claim 1, characterized in that, The flexible substrate material is polydimethylsiloxane resin or silica gel; the magnetic particles are one or a mixture of several materials of NdFeB, SmCo, and AlNiCo materials.

3. The artificial heart pump device according to claim 1 or 2, characterized in that, There are two groups of magnetic diaphragm pump systems. The first group includes a systolic first magnetic diaphragm pump and a diastolic first magnetic diaphragm pump that replace the left ventricle and left atrium, a first hose, and a first one-way valve; the inlet side of the diastolic first magnetic diaphragm pump is connected to the pulmonary vein by the first hose, and its outlet side is connected to the inlet side of the systolic first magnetic diaphragm pump. The outlet end of the systolic first magnetic diaphragm pump is connected to the aorta; a first one-way valve is provided at the first hose between the systolic first magnetic diaphragm pump and the diastolic first magnetic diaphragm pump, and a first one-way valve is provided at the first hose between the systolic first diaphragm pump and the aorta; The second group includes a systolic second magnetic diaphragm pump and a diastolic second magnetic diaphragm pump that replace the right ventricle and right atrium, a second hose, and a second one-way valve; the inlet side of the diastolic second magnetic diaphragm pump is connected to the superior and inferior vena cava through the second hose, and its outlet is connected to the inlet end of the systolic second magnetic diaphragm pump; The outlet end of the systolic second magnetic diaphragm pump is connected to the pulmonary artery; a second one-way valve is added at the second hose between the systolic second magnetic diaphragm pump and the diastolic second magnetic diaphragm pump; a second one-way valve is provided at the second hose between the systolic second magnetic diaphragm pump and the pulmonary artery.

4. A method for preparing a magnetic diaphragm pump of the artificial heart pump device according to claim 1, characterized in that, Including the following steps: S1: Customize a thin plate mold, an inner mold of the pump body, and an outer mold of the pump body according to the preset size of the actual magnetic diaphragm pump; S2: Mix magnetic particles and a flexible substrate material in a certain mass ratio evenly with a blender and then perform defoaming treatment to obtain a magnetic mixture. S3: Inject the magnetic mixture into a thin plate mold using a syringe, place the thin plate mold in an environment of 70°C - 80°C and heat it for 100 min - 120 min, demold after the magnetic mixture is cured to obtain a rough magnetic diaphragm. S4: Place the rough magnetic diaphragm under a pulsed magnetic field for radial magnetization to obtain a magnetized magnetic diaphragm. S5: Place the magnetized magnetic diaphragm in the outer mold of the pump body, then place and fix the inner mold of the pump body, and then pour the flexible substrate material into the gap between the inner mold and the outer mold with a syringe. After the gap is filled, place another magnetic diaphragm on the top and then place it in an environment of 70°C - 80°C again and heat it for 100 min - 120 min for curing, so that the non-magnetic pump body made of the flexible substrate material and the magnetic diaphragm form an integral body to form a magnetic diaphragm pump. S6: Demold the whole magnetic diaphragm pump.

5. The preparation method according to claim 4, characterized in that, In S1, the thin plate mold, the inner mold of the pump body and the outer mold of the pump body are prepared by 3D printing; the material of the inner mold of the pump body is blue wax; the outer mold of the pump body and the thin plate mold are resin.

6. The preparation method according to claim 4 or 5, characterized in that, The magnetic particles are one or a mixture of several materials of NdFeB, Fe, FeC; the flexible substrate material is polydimethylsiloxane or silicone rubber.

7. The preparation method according to claim 6, characterized in that, After obtaining the demolded rough magnetic diaphragm in S3, clean the surface of the rough magnetic diaphragm with ethanol or isopropanol, and place the cleaned rough magnetic diaphragm in a nitrogen stream for drying.

8. The preparation method according to claim 4 or 7, characterized in that S4 specifically is: Place the rough magnetic diaphragm in a draw plate for fixation, and then place the whole draw plate under a pulsed magnetic field greater than 1 T to perform radial magnetization on the rough magnetic diaphragm to obtain a magnetized magnetic diaphragm.

Images