Flexible membrane dynamic magnetic drive blood pump

Abstract

The application discloses a flexible membrane moving-magnetic driving type blood pump, which comprises a pump shell, a moving-magnetic driving device and a wave transmission assembly arranged in the pump shell, wherein the moving-magnetic driving device comprises a stator assembly and a rotor assembly; the wave transmission assembly comprises a flow channel component forming a wave transmission flow channel, and a flexible membrane arranged in the wave transmission flow channel is connected with the rotor assembly through a rigid diaphragm, so that the rotor assembly drives the flexible membrane to vibrate in the wave transmission flow channel under the electromagnetic driving effect of the stator assembly, and the flexible membrane generates a wave motion, thereby making the blood flowing into the pump shell and the flow channel component to have a wave pumping effect with physiological characteristics. The application realizes the wave transmission of the blood, makes the blood flow have the pulsation physiological characteristics, is stable and reliable in operation, is not prone to faults, is low in cost and is suitable for promotion.

Description

TECHNICAL FIELD

[0001] The present application relates to a flexible membrane dynamic magnetic drive blood pump, belonging to the technical field of blood pump. BACKGROUND

[0002] At present, the number of heart failure patients in China is increasing year by year, and one of the effective means for treating heart failure is to implant a mechanical ventricular assist device, and mainly left ventricular assist device. However, the standard blood pump that can be used in clinic is mainly divided into axial flow pump and centrifugal pump, which belong to rotary pump. The high-speed rotation of the rotor will cause damage to the blood components, resulting in hemolysis, thrombosis and bleeding complications. In addition, they are operated at a single pump speed, which will cause the patient's pulse pressure to decrease, and then the complications related to continuous non-physiological blood pumping will occur, such as gastrointestinal bleeding, aortic valve dysfunction or stroke.

[0003] At present, some blood pump products that can better improve the pulsatility have appeared. For example, the HeartMate 3 product developed by Abbott Company periodically changes the speed through program setting, so as to change the flow and then produce pulsatile blood flow. Although this flow change is not according to the physiological cycle of the heart, it can also produce a certain pulse pressure difference, maintain vascular elasticity, and reduce gastrointestinal bleeding. For another example, the EVAHEART product developed by Yongren Heart Medical Technology Company relies on a unique open impeller design to achieve part of the function of simulating physiological pulsatile blood flow, so that the ejection during systole is increased and the ejection during diastole is reduced, thereby maintaining a pulse pressure difference of 20-30mmHg and producing pulsatile blood flow. However, from the actual use aspect, the actual clinical effect of the above two products is not good, and they cannot well restore physiological pulse.

[0004] Chinese patent application with publication number CN110636873A discloses an implantable system with a rectangular flexible membrane, which proposes a thin film that can move up and down to push blood flow. The thin film has less damage to blood cells in blood and can produce pulsatile blood flow similar to normal physiology, produce a higher pulse pressure difference, and well solve the above-mentioned shortcomings. However, it uses an electromagnetic actuator to drive the thin film to move up and down, and the driving force is limited. The limited force density will cause significant temperature rise of the coil and local hot spot, and the motion stability is not good. In addition, the reciprocating mover inside is a coil, which is prone to failure and is not suitable as a power source for blood pump.

[0005] The Chinese invention patent application with the publication number CN114712700A discloses a flexible membrane magnetic resistance driving type implantable blood pump and artificial blood pump system, which well solves the problems of the Chinese invention patent application with the publication number CN110636873A, but the components thereof are more, especially the vibration assembly for driving the flexible membrane to make up-and-down movement needs to be installed on the linear guide assembly of the hybrid magnetic resistance actuator, the assembly of the two needs high matching, otherwise the movement effect of the flexible membrane will be affected, so it can be seen that the manufacturing and assembly are difficult, and faults are prone to occur in the movement process. SUMMARY

[0006] The flexible membrane dynamic magnetic driving type blood pump of the present application realizes the fluctuation delivery of blood, makes the blood flow have the pulsatile physiological characteristics, is stable and reliable in operation, is not prone to faults, is low in cost, and is suitable for promotion.

[0007] In order to achieve the above-mentioned purpose, the present application adopts the following technical solutions:

[0008] The flexible membrane dynamic magnetic driving type blood pump is characterized in that it comprises a pump shell, a dynamic magnetic driver and a fluctuation transmission assembly are arranged in the pump shell, wherein the dynamic magnetic driver comprises a stator assembly and a rotor assembly; the fluctuation transmission assembly comprises a flow channel component forming a fluctuation transmission flow channel, and a flexible membrane arranged in the fluctuation transmission flow channel is connected with the rotor assembly through a rigid diaphragm, so that the rotor assembly drives the flexible membrane to vibrate in the fluctuation transmission flow channel to produce wave motion under the electromagnetic driving action of the stator assembly, thereby making the blood flowing into the pump shell and entering the flow channel component have the fluctuation pumping effect with physiological characteristics.

[0009] The present application has the following advantages:

[0010] On the one hand, the flexible membrane and the flow channel component form the effects of the upper and lower liquid bags, realize the fluctuation delivery of blood based on the fluid-structure interaction, make the blood flow have the pulsatile physiological characteristics, reduce the damage to blood to the minimum, and reduce the risk of complications such as hemolysis and thrombosis; on the other hand, the dynamic magnetic driver has high force density, strong driving performance and reliability, provides protection for the stable fluctuation of the flexible membrane; on the other hand, the dynamic magnetic driver for driving the flexible membrane to make up-and-down movement is easy to assemble, is not prone to faults, ensures the movement effect of the flexible membrane, is low in cost, has good blood compatibility, and is suitable for clinical promotion. BRIEF DESCRIPTION OF DRAWINGS

[0011] Figure 1 is a perspective sectional view of the first preferred embodiment of the flexible membrane dynamic magnetic driving type blood pump of the present application.

[0012] Figure 2is the exploded view of the first preferred embodiment of the flexible membrane moving magnetic drive blood pump of the present application.

[0013] Figure 3A is the schematic diagram of the moving magnetic drive principle of the first preferred embodiment of the flexible membrane moving magnetic drive blood pump of the present application (rigid diaphragm moving upward).

[0014] Figure 3B is the schematic diagram of the moving magnetic drive principle of the first preferred embodiment of the flexible membrane moving magnetic drive blood pump of the present application (rigid diaphragm moving downward).

[0015] Figure 4 is the schematic diagram of the connection structure of the flexible membrane and the rigid diaphragm.

[0016] Figure 5 is the schematic diagram of the structure of the rigid diaphragm.

[0017] Figure 6 is the schematic diagram of the structure of the flow channel component.

[0018] Figure 7 is the schematic diagram of the structure of the pump shell.

[0019] Figure 8A is the schematic diagram of the flexible membrane in the fluctuation state of the first preferred embodiment of the flexible membrane moving magnetic drive blood pump of the present application (rigid diaphragm moving upward).

[0020] Figure 8B is the schematic diagram of the flexible membrane in the fluctuation state of the first preferred embodiment of the flexible membrane moving magnetic drive blood pump of the present application (rigid diaphragm moving downward).

[0021] Figure 9 is the schematic diagram of the second preferred embodiment of the flexible membrane moving magnetic drive blood pump of the present application (the pump shell is not shown).

[0022] Figure 10 is the exploded view of Figure 9 .

[0023] Figure 11 is the schematic diagram of the installation structure of the moving magnetic drive and the flexible membrane of the second preferred embodiment of the flexible membrane moving magnetic drive blood pump of the present application.

[0024] Figure 12 is the schematic diagram of the structure of the pump shell. DETAILED DESCRIPTION

[0025] As Figures 1 to 12As shown, the flexible membrane dynamic magnetic drive blood pump of the present application comprises a pump shell 10, a dynamic magnetic drive 80 and a wave transmission assembly 90 are arranged in the pump shell 10, wherein: the dynamic magnetic drive 80 comprises a stator assembly and a rotor assembly; the wave transmission assembly 90 comprises a flow channel component 50 forming a wave transmission flow channel 53, and a flexible membrane 60 arranged in the wave transmission flow channel 53 is connected with the rotor assembly through a rigid diaphragm 70, that is, the dynamic magnetic drive 80 provides a reliable power source for the flexible membrane 60, so that the rotor assembly drives the flexible membrane 60 to vibrate in the wave transmission flow channel 53 through the rigid diaphragm 70 under the electromagnetic driving action of the stator assembly of the dynamic magnetic drive 80, so that the flexible membrane 60 generates wave motion, thereby making the blood flowing into the pump shell 10 and into the flow channel component 50 generate a wave pumping effect with physiological characteristics and be sent out.

[0026] As Figure 1 and Figure 2 , and Figure 3A and Figure 3B , the stator assembly comprises an annular upper wire shaft 21 and an annular lower wire shaft 22 opposite to each other, the upper wire shaft 21 and the lower wire shaft 22 are respectively provided with an upper wire groove 210 and a lower wire groove 220, the upper wire groove 210 and the lower wire groove 220 are respectively wound with an upper electromagnetic coil 23 and a lower electromagnetic coil 24, the upper wire groove 210 and the lower wire groove 220 are separated by a non-magnetic separation piece 25, the upper wire groove 210 wound with the upper electromagnetic coil 23 forms an upper stator, the lower wire groove 220 wound with the lower electromagnetic coil 24 forms a lower stator, and the space between the upper wire groove 210 and the lower wire groove 220 without the separation piece 25 forms a vibration space 41, the vibration space 41 is communicated with the wave transmission flow channel 53 formed by the flow channel component 50, the center holes of the upper wire shaft 21 and the lower wire shaft 22 and the space between the two center holes jointly form a vibration cavity 40, and the rotor assembly is installed in the vibration cavity 40, wherein:

[0027] The mover assembly comprises the upper magnet 31, the lower magnet 32, the upper magnet 31 is the upper mover, the lower magnet 32 is the lower mover, the upper magnet 31 and the lower magnet 32 are connected through the I-shaped fixing part 35, the top of the upper magnet 31 is connected with the upper elastic assembly 33 fixedly installed in the center hole of the upper wire shaft 21, the bottom of the lower magnet 32 is connected with the lower elastic assembly 34 fixedly installed in the center hole of the lower wire shaft 22, from the height direction of the pump shell 10, the upper magnet 31 and the lower magnet 32 are correspondingly arranged with the upper wire shaft 21 and the lower wire shaft 22 respectively, the I-shaped fixing part 35 is correspondingly arranged with the partition sheet 25, the non-magnetic rigid diaphragm 70 is connected with the I-shaped fixing part 35 after penetrating into the vibration space 41, here, the partition sheet 25 plays a structural isolation role for the upper stator and the lower stator, and the partition sheet 25 plays a good electromagnetic isolation role for the upper stator and the lower stator together with the rigid diaphragm 70, so that a shorter magnetic flux loop is obtained, wherein the upper magnet 31 and the lower magnet 32 together with the I-shaped fixing part 35 make up-and-down vibration in the vibration cavity 40 under the electromagnetic driving action of the upper electromagnetic coil 23 and the lower electromagnetic coil 24 and the elastic limiting action of the upper elastic assembly 33 and the lower elastic assembly 34, and drive the rigid diaphragm 70 to make up-and-down vibration in the vibration space 41, and then the rigid diaphragm 70 drives the flexible diaphragm 60 to make up-and-down vibration in the fluctuation transmission flow channel 53, so that the flexible diaphragm 60 generates wave motion.

[0028] As Figure 2 and Figure 10 , the partition sheet 25 is shown in the U-shaped case, so that the space opposite to the opening of the partition sheet 25 forms the vibration space 41 for the extension of the rigid diaphragm 70, and in the present application, the partition sheet 25 plays a good electromagnetic isolation role for the upper stator and the lower stator together with the rigid diaphragm 70.

[0029] As Figure 3A and Figure 3B , the upper elastic assembly 33 comprises the upper base 331 fixed in the center hole of the upper wire shaft 21, the upper base plate 333 fixed on the top of the upper magnet 31, and the upper spring 332 connected between the upper base 331 and the upper base plate 333. Further, the lower elastic assembly 34 comprises the lower base 341 fixed in the center hole of the lower wire shaft 22, the lower base plate 343 fixed on the bottom of the lower magnet 32, and the lower spring 342 connected between the lower base 341 and the lower base plate 343.

[0030] In actual design, a plurality of upper protruding columns 3310 can be arranged on the upper base 331, the upper protruding columns 3310 are used for firm connection with the upper spring 332, and similarly, a plurality of lower protruding columns 3410 can be arranged on the lower base 341, the lower protruding columns 3410 are used for firm connection with the lower spring 342.

[0031] As Figure 3A and Figure 3BThe I-shaped fixing member 35 comprises a fixing plate 351 fixed on the bottom of the upper magnet 31 and a reverse T-shaped fixing base 352 fixed on the top of the lower magnet 32, wherein the rigid diaphragm 70 is provided with a clamping hole 71; and the rigid diaphragm 70 is connected with the I-shaped fixing member 35 by the clamping hole 71 clamping on the fixing base 352 and the fixed connection between the fixing plate 351 and the fixing base 352.

[0032] As Figure 5 Preferably, the rigid diaphragm 70 extends a connecting piece 72 for fixed connection with the flexible film 60, and the flexible film 60 is combined with the connecting piece 72 into an integral whole by means of adhesion or plastic dipping, wherein the connecting piece 72 is provided with a plurality of reinforcing holes 721 for improving the bonding strength.

[0033] In the present application, the flexible film 60 is designed as a soft, deformable and elastic, biocompatible sheet made of organic silicon or polyurethane composite material, and the shape, thickness and mounting mode (such as epoxy resin pouring adhesion, screw fixing, etc.) of the flexible film 60 are not limited, as long as it can produce large deformation wave effect in the blood pumping direction under the comprehensive action of vibration force, fluid force, etc.

[0034] Further, the flexible film 60 should have a small density, so that compared with the material with higher density, it not only reduces the mass of the flexible film, increases the sensitivity and improves the response speed, but also reduces the required rigidity of the rigid diaphragm 70. At the same time, the flexible film 60 needs to have a low elastic modulus to produce large deformation wave effect. In actual production, the flexible film 60 can be designed to have a specific modulus less than 8500 Pa / (kg / m 3 ), wherein the specific modulus of the material is equal to the elastic modulus / density, and also equal to the stress / strain of the material. In addition, the modulus of the material constituting the flexible film 60 can be isotropic or anisotropic, and is not limited.

[0035] In the present application, the magnetism of the upper magnet 31 and the lower magnet 32, the current direction flowing through the upper electromagnetic coil 23 and the lower electromagnetic coil 24 are not limited, as long as the moving direction of the upper rotor under the electromagnetic driving action of the upper stator is consistent with the moving direction of the lower rotor under the electromagnetic driving action of the lower stator.

[0036] Referring to Figure 3A and Figure 3B , it can be understood that the current direction flowing through the upper electromagnetic coil 23 and the lower electromagnetic coil 24 is synchronous switching control, wherein:

[0037] When the current flowing through the upper electromagnetic coil 23 and the lower electromagnetic coil 24 is in the same direction: if the upper magnet 31 and the lower magnet 32 ​​are both composed of a single permanent magnet, then the magnetism of the upper magnet 31 and the lower magnet 32 ​​is the same; if the upper magnet 31 and the lower magnet 32 ​​are both composed of multiple permanent magnets with different magnetic properties stacked alternately, that is, the magnetism of adjacent permanent magnets is opposite, then from the top to the bottom, the magnetic arrangement of the upper magnet 31 and the lower magnet 32 ​​is the same, that is, the magnetic arrangement of each permanent magnet in the upper magnet 31 from top to bottom is consistent with the magnetic arrangement of each permanent magnet in the lower magnet 32 ​​from top to bottom;

[0038] When the current flowing through the upper electromagnetic coil 23 and the lower electromagnetic coil 24 is in opposite directions: if the upper magnet 31 and the lower magnet 32 ​​are both composed of a single permanent magnet, then the magnetism of the upper magnet 31 and the lower magnet 32 ​​is opposite; if the upper magnet 31 and the lower magnet 32 ​​are both composed of multiple permanent magnets with different magnetic properties stacked alternately, that is, the magnetism of adjacent permanent magnets is opposite, then from the top to the bottom, the magnetic arrangement of the upper magnet 31 and the lower magnet 32 ​​is opposite, that is, the magnetic arrangement of each permanent magnet in the upper magnet 31 from top to bottom is opposite to the magnetic arrangement of each permanent magnet in the lower magnet 32 ​​from top to bottom. In other words, the magnetic arrangement of the upper magnet 31 and the lower magnet 32 ​​is symmetrical about the I-shaped fixing member 35.

[0039] Furthermore, when both the upper magnet 31 and the lower magnet 32 ​​are composed of multiple permanent magnets with different magnetic properties stacked in an alternating manner (i.e., the magnetic properties of adjacent permanent magnets are opposite), an upper reinforcing plate 310 can be provided between the upper and lower adjacent permanent magnets of the upper magnet 31, and a lower reinforcing plate 320 can be provided between the upper and lower adjacent permanent magnets of the lower magnet 32. The function of the upper reinforcing plate 310 and the lower reinforcing plate 320 is to resist the interference of the induced magnetic field.

[0040] like Figure 3A and Figure 3B The figure shows the magnetism of the upper magnet 31 and the lower magnet 32, and the preferred design of the current direction in the upper electromagnetic coil 23 and the lower electromagnetic coil 24. As shown, the current directions in the upper electromagnetic coil 23 and the lower electromagnetic coil 24 are opposite. Both the upper magnet 31 and the lower magnet 32 ​​are composed of two permanent magnets with different magnetic properties. From top to bottom, the magnetic arrangement of the upper magnet 31 and the lower magnet 32 ​​is opposite. That is, for the upper magnet 31, the magnetic properties of its upper and lower permanent magnets 311 and 312 are S and N, respectively, while for the lower magnet 32, the magnetic properties of its upper and lower permanent magnets 321 and 322 are N and S, respectively. In particular, an upper reinforcing plate 310 is provided between the upper and lower permanent magnets 311 and 312, and a lower reinforcing plate 320 is provided between the upper and lower permanent magnets 321 and 322.

[0041] by Figure 3A and Figure 3B As shown in the example, when the upper electromagnetic coil 23 and the lower electromagnetic coil 24 are energized...Figure 3A When the current flows in the direction shown, the induced magnetic field generated by the upper electromagnetic coil 23 and the induced magnetic field generated by the lower electromagnetic coil 24 act on the upper magnet 31 and the lower magnet 32, so that the upper magnet 31 and the lower magnet 32 are attracted and pulled upward or downward. Thus, under the action of the alternating current flowing through the upper electromagnetic coil 23 and the lower electromagnetic coil 24, the rigid diaphragm 70 is moved up and down, or vibrates up and down, and then the rigid diaphragm 70 transmits the vibration effect to the flexible diaphragm 60, i.e. drives the flexible diaphragm 60 to vibrate, and then the flexible diaphragm 60 generates a fluctuation effect in the blood pumping direction.

[0042] In actual design, the upper wire shaft 21 and the lower wire shaft 22 for constraining the upper electromagnetic coil 23 and the lower electromagnetic coil 24 respectively can be made of soft iron, A3 steel, ferrite or soft magnetic alloy, etc. In addition, in order to avoid the problem of blood compatibility caused by contact with blood, a protective layer made of non-magnetic material (such as titanium alloy material and other well-known materials) can be covered on the outer wall of the upper wire shaft 21 and the lower wire shaft 22.

[0043] The upper electromagnetic coil 23 and the lower electromagnetic coil 24 are made of copper or aluminum wire, and adopt a bread-type winding. The number of turns is not limited. The cable led out from the upper electromagnetic coil 23 is stretched out through the corresponding hole on the upper wire shaft 21 and the pump housing 10 to connect with the external power supply device. Similarly, the cable led out from the lower electromagnetic coil 24 is stretched out through the corresponding hole on the lower wire shaft 22 and the pump housing 10 to connect with the external power supply device.

[0044] The partition sheet 25 and the rigid diaphragm 70 can be made of non-magnetic material (such as titanium alloy material and other well-known materials). In addition, the thickness of the partition sheet 25 limits the vibration amplitude of the rigid diaphragm 70. Preferably, the thickness of the partition sheet 25 should be not less than 3.0 mm.

[0045] In actual design, the upper magnet 31 and the lower magnet 32 can also be a single or multiple magnetic bodies combined to form a magnet which can attract iron, cobalt or nickel.

[0046] In actual design, the upper base 331, the upper substrate 333, the lower base 341, the lower substrate 343, the I-shaped fixing piece 35, the upper reinforcing sheet 310 and the lower reinforcing sheet 320 can be made of soft iron, A3 steel, ferrite or soft magnetic alloy, etc.

[0047] As shown in FIG. 1, the blood pump 1 comprises a pump housing 10, a rigid diaphragm 70, a flexible diaphragm 60, an upper electromagnetic coil 23, a lower electromagnetic coil 24, an upper magnet 31, a lower magnet 32, an upper wire shaft 21, a lower wire shaft 22 and a partition sheet 25. Figure 6The rectangular flow channel component 50 is formed by the upper flow channel 51 and the lower flow channel 52 which are coupled together. The upper flow channel 51 and the lower flow channel 52 are respectively provided with the upper flow channel groove 510 and the lower flow channel groove 520 on the opposite inner surfaces. The upper flow channel groove 510 and the lower flow channel groove 520 form the wave transmission flow channel 53. In the longitudinal section of the flow channel component 50 cut along the length direction of the pump shell 10, the wave transmission flow channel 53 is composed of the rectangular body-shaped inlet flow channel 531, the longitudinal section of the lying trapezoidal transition flow channel 532, the flat plate-shaped main flow channel 533 and the lying round table body-shaped outlet flow channel 534 which are sequentially communicated. The outlet of the inlet flow channel 531 is contracted into the inlet of the main flow channel 533 through the transition flow channel 532. The outlet of the outlet flow channel 534 is larger than the inlet thereof. The rigid diaphragm 70 extends into the inlet flow channel 531 and is connected with one end of the flexible diaphragm 60. The other end of the flexible diaphragm 60, i.e. the end not connected with the rigid diaphragm 70, is located in the main flow channel 533.

[0048] As shown in Figure 8A and Figure 8B , a liquid bag is formed between the upper flow channel 51 and the flexible diaphragm 60. Another liquid bag is formed between the lower flow channel 52 and the flexible diaphragm 60.

[0049] In the present application, the above structure of the wave transmission flow channel 53 aims at accelerating the flow speed of the blood flowing into the inlet flow channel 531 through the contraction design of the transition flow channel 532, and then flowing into the main flow channel 533, so that the blood produces the wave pumping effect with physiological characteristics under the wave motion of the flexible diaphragm 60 in the main flow channel 533, and the blood also produces the accelerated flow effect through the outlet flow channel 534.

[0050] In the actual design, as shown in Figure 1 , only one moving magnet type driver 80 can be arranged in the pump shell 10. The one moving magnet type driver 80 and one wave transmission assembly 90 are arranged along the length direction of the pump shell 10, so that the wave transmission flow channel 53 is arranged along the length direction of the pump shell 10. The inlet flow channel 531 of the wave transmission flow channel 53 extends along the width direction perpendicular to the length direction of the pump shell 10 and is provided with the flow inlet 54 which is opposite to the pump inlet 11 on the pump shell 10, so that the blood flows into the wave transmission flow channel 53 through the flow inlet 54. The outlet flow channel 534 of the wave transmission flow channel 53 is directly opposite to the pump outlet 12 on the pump shell 10 along the length direction of the pump shell 10, so that the blood is sent out through the wave transmission flow channel 53.

[0051] In addition, as shown in Figures 9 to 11To understand, two moving-magnetic type drivers 80 are provided in the pump housing 10 in parallel and separated along the width direction of the pump housing 10, and a wave transmission assembly 90 is provided between the two moving-magnetic type drivers 80. The rigid diaphragms 70 respectively extending from the vibration spaces 41 of the two moving-magnetic type drivers 80 are connected into one body after penetrating the flow passage member 50 and connected with the flexible diaphragm 60. Preferably, the two rigid diaphragms 70 are connected into one body and jointly extend a connecting piece 72 for connecting with the flexible diaphragm 60. The wave transmission flow passage 53 formed by the flow passage member 50 is arranged along the length direction of the pump housing 10. The inlet flow passage 531 of the wave transmission flow passage 53 extends a flow inlet 54 along the length direction of the pump housing 10 and is opposite to the pump inlet 11 on the pump housing 10 via the flow inlet 54, so that blood flows into the wave transmission flow passage 53 via the flow inlet 54. The outlet flow passage 534 of the wave transmission flow passage 53 is directly opposite to the pump outlet 12 on the pump housing 10 along the length direction of the pump housing 10, so that blood is sent out via the wave transmission flow passage 53. The current direction into the two moving-magnetic type drivers 80 is synchronously switched and controlled. Here, the part of the two rigid diaphragms 70 connected into one body has the function of flow separation.

[0052] In actual design, the flow inlet 54 is usually designed as a lying round table body, and the inlet of the flow inlet 54 is preferably designed to be larger than the outlet.

[0053] Here, the amount of blood flowing from the wave transmission flow passage 53 into the vibration space 41 is extremely small and can be ignored. Of course, a protective measure for avoiding blood compatibility problem can be designed at the position between the wave transmission flow passage 53 and the vibration space 41, which is not described in detail here.

[0054] In addition, as Figure 10 , the wave transmission flow passage 53 can also be designed with a containing passage 55 for containing the rigid diaphragm part extending from the vibration space 41 and penetrating the flow passage member 50.

[0055] Of course, for the case that two moving-magnetic type drivers 80 and one wave transmission assembly 90 are designed in the pump housing 10, the two moving-magnetic type drivers 80 and the wave transmission assembly 90 can also be arranged along the length direction of the pump housing 10. In summary, the number and arrangement of the moving-magnetic type drivers 80 and the wave transmission assembly 90 are not limited.

[0056] In the present application, the shape of the pump housing 10 is not limited. As Figure 1 , the pump housing 10 is usually in the shape of a rectangular body, which can be composed of a lower housing 102 and an upper cover 101, and the height, width and length directions are shown in the figure. Further, for Figure 9 the blood pump of the present application shown in the figure, the pump inlet 11 and the pump outlet 12 of the pump housing 10 are oppositely arranged along the length direction of the pump housing 10 (as Figure 12 ), but for Figure 1The pump inlet 11 and the pump outlet 12 of the pump shell 10 are not arranged oppositely along the length direction of the pump shell 10 (for example, as shown in Figure 7 ) in the blood pump.

[0057] In the blood pump, the blood pumping direction is defined along the length direction of the pump shell 10, i.e. the direction of the wave transmission of the blood via the flexible membrane 60, and the height direction of the pump shell 10, i.e. the up-down direction, is defined as the direction of the up-down movement or vibration of the rigid diaphragm 70.

[0058] For example, in the blood pump shown in Figure 1 , the moving-magnetic type driver 80 and the wave transmission assembly 90 are arranged along the length direction of the pump shell 10, the upper stator and the lower stator of the moving-magnetic type driver 80 are arranged along the height direction of the pump shell 10, the upper mover and the lower mover are arranged along the height direction of the pump shell 10, the upper electromagnetic coil 23 and the lower electromagnetic coil 24 are wound along the height direction of the pump shell 10, the moving direction of the mover, the vibration direction of the rigid diaphragm 70 and the flexible membrane 60 driven by the rigid diaphragm 70 are along the height direction of the pump shell 10, the vibration space 41 and the wave transmission flow channel 53 are formed along the length direction of the pump shell 10, and the wave transmission of the flexible membrane 60 is along the length direction of the pump shell 10, more precisely, the blood flows into the wave transmission flow channel 53 along the width direction of the pump shell 10 and then flows out along the length direction of the pump shell 10.

[0059] In the blood pump, the pump shell 10 and the flow channel component 50 can be made of stainless steel, cobalt-based alloy, titanium-based alloy or other rigid materials with biocompatibility.

[0060] In the blood pump, the flow of the blood can be regulated by designing the vibration frequency and the vibration amplitude of the rigid diaphragm 70 and adjusting the pressure gradient in the inlet flow channel 531 and the transition flow channel 532. In the actual design, preferably, the vibration amplitude of the rigid diaphragm 70 is set to 1.2 mm and the vibration frequency is set to 60 Hz, wherein the average flow of the blood flowing through the wave transmission flow channel 53 is between 2.3 L / min and 3.8 L / min (pulsating physiological flow) to satisfy the pressure difference of the blood entering and exiting the pump shell 10 of 60 mmHg. Of course, the vibration frequency of the rigid diaphragm 70 can be between 0 Hz and 120 Hz, and of course, other vibration frequencies can also be designed.

[0061] In the blood pump, the components in contact with the blood should be made of materials with excellent blood compatibility, such as titanium alloy materials.

[0062] The blood pump is realized based on the principles of electromagnetic induction, mechanical vibration and fluid-structure coupling. The working process and driving principle of the blood pump shown in Figure 1 will be described below. The blood pump has the advantages of Figure 9The working process and driving principle of the second preferred embodiment of the blood pump of the present application shown in the dynamic magnetic driver 80 are basically the same as those of the first preferred embodiment of the blood pump of the present application shown in the dynamic magnetic driver 70, and thus will not be described in detail. Figure 1 The working process and driving principle of the second preferred embodiment of the blood pump of the present application shown in the dynamic magnetic driver 80 are basically the same as those of the first preferred embodiment of the blood pump of the present application shown in the dynamic magnetic driver 70, and thus will not be described in detail.

[0063] As shown in FIG. 6, when no current is passed through the upper electromagnetic coil 23 and the lower electromagnetic coil 24, the moving element (the upper magnet 31 and the lower magnet 32) is in the middle position of the vibration cavity 40 under the elastic limiting action of the upper elastic assembly 33 and the lower elastic assembly 34, and thus the rigid diaphragm 70 is in the middle position of the vibration space 41 in the up-down direction, i.e., in the balanced state. Figure 3A Figure 3B As shown in FIG. 7, when the current in the direction shown in the figure is passed through the upper electromagnetic coil 23 and the lower electromagnetic coil 24, the upper magnet 31 is attracted upward under the action of the induced magnetic field generated by the upper electromagnetic coil 23, and the lower magnet 32 is also attracted upward under the action of the induced magnetic field generated by the lower electromagnetic coil 24, and thus the rigid diaphragm 70 moves upward under the rigid driving of the moving element.

[0064] As shown in FIG. 8, when the current in the direction shown in the figure is passed through the upper electromagnetic coil 23 and the lower electromagnetic coil 24, the upper magnet 31 is attracted downward under the action of the induced magnetic field generated by the upper electromagnetic coil 23, and the lower magnet 32 is also attracted downward under the action of the induced magnetic field generated by the lower electromagnetic coil 24, and thus the rigid diaphragm 70 moves downward under the rigid driving of the moving element. Figure 3A As shown in FIG. 8, when the current in the direction shown in the figure is passed through the upper electromagnetic coil 23 and the lower electromagnetic coil 24, the upper magnet 31 is attracted downward under the action of the induced magnetic field generated by the upper electromagnetic coil 23, and the lower magnet 32 is also attracted downward under the action of the induced magnetic field generated by the lower electromagnetic coil 24, and thus the rigid diaphragm 70 moves downward under the rigid driving of the moving element.

[0065] Figure 3B As shown in FIG. 8, when the current in the direction shown in the figure is passed through the upper electromagnetic coil 23 and the lower electromagnetic coil 24, the upper magnet 31 is attracted downward under the action of the induced magnetic field generated by the upper electromagnetic coil 23, and the lower magnet 32 is also attracted downward under the action of the induced magnetic field generated by the lower electromagnetic coil 24, and thus the rigid diaphragm 70 moves downward under the rigid driving of the moving element.

[0066] Thus, by constantly switching the current direction passed through the upper electromagnetic coil 23 and the lower electromagnetic coil 24, the rigid diaphragm 70 can realize the up-down vibration effect, so that the rigid diaphragm 70 drives the flexible diaphragm 60 to vibrate up and down, and then the flexible diaphragm 60 generates the undulating wave motion, and the blood is pumped by the wave motion.

[0067] Figure 8A As shown in FIG. 9, which shows a state of the rigid diaphragm 70 at a certain moment during the upward movement, the blood flows into the space between the rigid diaphragm 70 and the flexible diaphragm 60 and the inner bottom wall of the inlet flow channel 531, and spreads with the undulation of the flexible diaphragm 60, and pushes the blood toward the outlet flow channel 534, at this time, the liquid bag A is formed between the upper flow channel 51 and the flexible diaphragm 60, and the liquid bag B is formed between the lower flow channel 52 and the flexible diaphragm 60, and the liquid bag A and the liquid bag B show the tendency of flowing toward the outlet flow channel 534 to push the blood out of the pump shell 10.

[0068] Figure 8B ​​As shown in the state of the rigid diaphragm 70 moving downward at a certain moment, blood flows into the space between the rigid diaphragm 70 and the flexible diaphragm 60 and the top wall of the inlet flow channel 531, and spreads with the fluctuation of the flexible diaphragm 60, and pushes the blood towards the outlet flow channel 534, at this time, the liquid bag A gradually becomes smaller and disappears, and is replaced by the liquid bag C formed between the lower flow channel 52 and the flexible diaphragm 60, similarly, the liquid bag B gradually becomes smaller and disappears, and is replaced by the liquid bag D formed between the upper flow channel 51 and the flexible diaphragm 60, the liquid bag C and the liquid bag D show a trend of flowing towards the outlet flow 534 to push the blood out of the pump shell 10.

[0069] Preferably, the speed of the fluctuation of the flexible diaphragm 60 in spreading the blood is preferably controlled between 1.0 m / s and 2.0 m / s, of course, not limited.

[0070] The advantages of the present application are:

[0071] The present application forms the effects of the upper and lower liquid bags by the flexible diaphragm and the flow channel component, realizes the fluctuation and fluctuation of the blood based on the fluid-structure interaction, makes the blood flow have the pulsatility with physiological characteristics, reduces the damage to the blood to the minimum, reduces the risk of complications such as hemolysis and thrombosis, on the other hand, the dynamic magnetic driver provides high force density, strong driving performance and reliability, provides guarantee for the stable fluctuation of the flexible diaphragm, on the other hand, the present application has simple structure, especially the dynamic magnetic driver driving the flexible diaphragm to move easily, is not easy to malfunction, ensures the movement effect of the flexible diaphragm, has low cost, good blood compatibility, and is suitable for clinical promotion.

[0072] The above describes the preferred embodiments of the present application and the technical principles used, for those skilled in the art, any equivalent transformation, simple replacement and other obvious changes based on the technical solutions of the present application without departing from the spirit and scope of the present application, all belong to the protection scope of the present application.

Claims

1. A flexible membrane magnetically driven blood pump, characterized in that: It includes a pump housing, within which a moving magnetic drive and a wave transmission assembly are housed, wherein: The moving magnetic actuator includes a stator assembly and a mover assembly; the wave transmission assembly includes a flow channel component forming a wave transmission channel. A flexible membrane disposed in the wave transmission channel is connected to the mover assembly through a rigid diaphragm, so that the mover assembly, under the electromagnetic drive generated by the stator assembly, drives the flexible membrane to vibrate in the wave transmission channel by the rigid diaphragm to generate wave motion, thereby generating a wave pumping effect with physiological characteristics to deliver the blood flowing into the pump housing and entering the flow channel component. The stator assembly includes an annular upper shaft and an annular lower shaft facing each other. The upper and lower shafts are respectively provided with upper and lower grooves. An upper electromagnetic coil and a lower electromagnetic coil are wound in the upper and lower grooves, respectively. The upper and lower grooves are separated by a non-magnetic separator. The space between the upper and lower grooves without the separator forms a vibration space, which is connected to the wave transmission channel. The central holes of the upper and lower shafts and the space between the two central holes together form a vibration cavity. The mover assembly is installed inside the vibration cavity, wherein: The moving part assembly includes an upper magnet and a lower magnet, which are connected by an I-shaped fastener. The top of the upper magnet is connected to an upper elastic component fixedly installed in the center hole of the upper spool, and the bottom of the lower magnet is connected to a lower elastic component fixedly installed in the center hole of the lower spool. The non-magnetic rigid diaphragm extends through the vibration space and is connected to the I-shaped fastener. Under the electromagnetic driving action of the upper and lower electromagnetic coils and the elastic limiting action of the upper and lower elastic components, the upper magnet, the lower magnet, and the I-shaped fastener vibrate up and down in the vibration cavity and drive the rigid diaphragm to vibrate up and down in the vibration space.

2. The flexible membrane magnetically driven blood pump as described in claim 1, characterized in that: The upper elastic component includes an upper base fixed in the central hole of the upper spool, an upper base plate fixed on the top of the upper magnet, and an upper spring connected between the upper base and the upper base plate. The lower elastic component includes a lower base fixed in the central hole of the lower spool, a lower base plate fixed on the bottom of the lower magnet, and a lower spring connected between the lower base and the lower base plate.

3. The flexible membrane magnetically driven blood pump as described in claim 1, characterized in that: The I-shaped fastener includes a fixing plate fixed to the bottom of the upper magnet and an inverted T-shaped fixing seat fixed to the top of the lower magnet, wherein: the rigid diaphragm is provided with a locking hole; when the rigid diaphragm is fitted onto the fixing seat through the locking hole, the connection between the rigid diaphragm and the I-shaped fastener is realized through the fixed connection between the fixing plate and the fixing seat.

4. The flexible membrane magnetically driven blood pump as described in claim 3, characterized in that: The rigid diaphragm extends with a connecting piece for fixed connection with the flexible diaphragm. The flexible diaphragm is bonded to the connecting piece by adhesive bonding or dip coating. The connecting piece has multiple reinforcing holes to improve the bonding strength.

5. The flexible membrane magnetically driven blood pump as described in claim 1, characterized in that: The directions of the current flowing through the upper electromagnetic coil and the lower electromagnetic coil are synchronously switched, wherein: When the current flowing through the upper electromagnetic coil and the lower electromagnetic coil is in the same direction: if the upper magnet and the lower magnet are both made of a single permanent magnet, then the upper magnet and the lower magnet have the same magnetism; if the upper magnet and the lower magnet are both made of multiple permanent magnets with different magnetic properties stacked alternately, then from the top to the bottom, the upper magnet and the lower magnet have the same magnetic arrangement. When the current flowing through the upper electromagnetic coil and the lower electromagnetic coil is in opposite directions: if the upper magnet and the lower magnet are both composed of a single permanent magnet, then the magnetism of the upper magnet and the lower magnet are opposite; if the upper magnet and the lower magnet are both composed of multiple permanent magnets with different magnetic properties stacked alternately, then from the top to the bottom, the magnetic arrangement of the upper magnet and the lower magnet is opposite.

6. The flexible membrane magnetically driven blood pump as described in claim 1, characterized in that: The rectangular flow channel component is formed by the upper flow channel and the lower flow channel being interlocked. The inner surfaces of the upper and lower flow channels are respectively recessed with an upper flow channel groove and a lower flow channel groove, which together form the wave transmission flow channel. The wave transmission flow channel consists of a rectangular inlet flow channel, a transition flow channel with a longitudinal section of an inverted trapezoid, a flat plate-shaped main flow channel, and an inverted frustum-shaped outlet flow channel connected in sequence. The outlet of the inlet flow channel narrows into the inlet of the main flow channel via the transition flow channel, and the outlet of the outlet flow channel is larger than its own inlet. The rigid diaphragm extends into the inlet flow channel and connects to one end of the flexible membrane, while the other end of the flexible membrane is located in the main flow channel.

7. The flexible membrane magnetically driven blood pump as described in claim 6, characterized in that: The pump housing contains only one moving magnetic actuator. This moving magnetic actuator and one wave transmission component are arranged along the length of the pump housing, so that the wave transmission channel is arranged along the length of the pump housing. The inlet channel of the wave transmission channel extends along the width of the pump housing and has an inlet, which is opposite to the pump inlet on the pump housing, so that blood flows into the wave transmission channel through the inlet. The outlet channel of the wave transmission channel is directly opposite to the pump outlet on the pump housing, so that blood is delivered out through the wave transmission channel.

8. The flexible membrane magnetically driven blood pump as described in claim 6, characterized in that: Two moving magnetic actuators are arranged side-by-side along the width of the pump housing. A wave transmission component is provided between these two moving magnetic actuators. The rigid diaphragms extending from the vibration space of each of the two moving magnetic actuators pass through the flow channel component and are connected to a single unit and connected to the flexible diaphragm. The wave transmission flow channel formed by the flow channel component is arranged along the length of the pump housing. The inlet flow channel of the wave transmission flow channel extends along the length of the pump housing and has an inlet that is opposite to the pump inlet on the pump housing, so that blood flows into the wave transmission flow channel through the inlet. The outlet flow channel of the wave transmission flow channel is directly opposite to the pump outlet on the pump housing, so that blood is sent out through the wave transmission flow channel. The direction of the current supplied to the two moving magnetic actuators is synchronously switched.

9. The flexible membrane magnetically driven blood pump as described in any one of claims 6 to 8, characterized in that: The vibration amplitude of the rigid diaphragm is set to 1.2 mm and the vibration frequency is set to 60 Hz, so that the average blood flow rate through the wave transmission channel is between 2.3 L / min and 3.8 L / min, so as to satisfy the blood pressure difference between entering and exiting the pump housing is 60 mmHg.

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