Flexible Membrane Magnetoresistive Drive Implantable Blood Pump and Artificial Blood Pump System

Abstract

The present invention discloses a flexible film magnetoresistive drive type implantable blood pump and an artificial blood pump system. The implantable blood pump includes a pump housing, and a pump assembly is installed inside the pump housing, wherein: the pump assembly includes a hybrid magnetoresistive actuator, a vibration assembly is installed on a linear guiding assembly of the hybrid magnetoresistive actuator, the vibration assembly is connected to a flexible film, an upstream flow channel assembly and a downstream flow channel assembly are respectively arranged above and below the flexible film, and the vibration assembly makes a vertical vibration along the linear guiding assembly under the hybrid magnetoresistive drive of the hybrid magnetoresistive actuator, so as to drive the flexible film to make a vertical vibration between the upstream flow channel assembly and the downstream flow channel assembly and generate a wave motion. The implantable blood pump of the present invention realizes pulsatile transportation of blood, enables the blood flow to have pulsatile physiological characteristics, has small damage to blood, is stable and reliable in operation, has a small volume, and is suitable for popularization.

Description

Technical Field

[0001] The present invention relates to a flexible membrane magnetoresistive drive implantable blood pump and an artificial blood pump system, belonging to the technical field of implantable artificial blood pumps. Background Art

[0002] At present, the number of heart failure patients in China is increasing year by year. One of the effective means for the treatment of advanced heart failure is the artificial implantation of a mechanical ventricular assist device, and mainly a left ventricular assist device. However, most of the existing left ventricular assist devices are large in size and require highly invasive and high-risk surgical implantation, so they are usually only used for end-stage heart failure patients. For heart failure patients who have not reached the end stage, it is considered to implant a smaller pump to avoid the above problems and reduce the morbidity during the operation period. The US patent application with the publication number US2019069898A1 discloses a collaborative micro pump, which is implanted in the bypass from the left atrium to the subclavian artery. The pump will be located in the subclavian fossa like a pacemaker. The pump is about the size of a No. 5 battery and can directly transport up to 3L / min of oxygenated blood from the left atrium to the left subclavian artery. However, in this application document, the pump structure is not specifically described.

[0003] Currently, the standard blood pumps available for clinical use are mainly divided into axial flow pumps and centrifugal pumps. They both belong to rotary pumps. The high-speed rotation of their rotors will damage blood components, causing hemolysis, thrombosis and bleeding complications. In addition, they operate at a single pump speed, which will cause a decrease in the patient's pulse pressure during clinical use, and then complications related to continuous non-physiological blood pumping will occur, such as gastrointestinal bleeding, aortic valve insufficiency or stroke. Therefore, researchers have developed a pulsation algorithm for this type of rotary pump in order to improve the flushing situation and thus reduce the formation of thrombus and the like. However, the actual clinical effect is not good, and the developed pulsation algorithm cannot well restore the physiological pulse.

[0004] The Chinese patent application with the publication number CN110636873A discloses an implantable system with a rectangular flexible membrane, which proposes a film that can undulate, well solving the above-mentioned disadvantages. However, the driver for driving the film to undulate is a Lorentz actuator (a current-carrying coil winding located in a magnetic field), its driving force is limited, and the limited force density will cause significant heating of the coil and local hot spots, and the motion stability is not good, which needs to be improved. Summary of the Invention

[0005] The purpose of the present invention is to provide a flexible membrane magnetoresistive drive implantable blood pump and an artificial blood pump system. The implantable blood pump realizes the pulsatile transportation of blood, makes the blood flow have pulsatile physiological characteristics, has little damage to blood, is stable and reliable in operation, small in size, and is suitable for popularization.

[0006] To achieve the above object, the present invention adopts the following technical solutions:

[0007] A flexible membrane magnetoresistive drive type implantable blood pump, characterized in that: it includes a pump housing, and a pump assembly is installed in the pump housing, wherein: the pump assembly includes a hybrid magnetoresistive actuator, a vibration assembly is installed on the linear guiding assembly of the hybrid magnetoresistive actuator, the vibration assembly is connected to the flexible membrane, an upstream flow channel assembly and a downstream flow channel assembly are respectively arranged above and below the flexible membrane, and the vibration assembly makes a reciprocating up and down vibration along the linear guiding assembly under the hybrid magnetoresistive drive of the hybrid magnetoresistive actuator, so as to drive the flexible membrane to make a reciprocating up and down vibration between the upstream flow channel assembly and the downstream flow channel assembly and generate a wave motion.

[0008] An artificial blood pump system, characterized in that: it includes the flexible membrane magnetoresistive drive type implantable blood pump, the pump inlet of the flexible membrane magnetoresistive drive type implantable blood pump is connected to an inlet sleeve and the pump outlet is connected to an outlet sleeve, the cable port of the flexible membrane magnetoresistive drive type implantable blood pump is connected to a controller via a cable, the controller is connected to a computer in a wired or wireless manner, a battery device transmits power to the controller in a wired or wireless manner, and wireless communication can be carried out between the controller and a mobile terminal.

[0009] The advantages of the present invention are:

[0010] On the one hand, the present invention respectively forms upper and lower flow channels with a fluid bag effect between the flexible membrane and the upstream and downstream flow channel assemblies. Based on the fluid-structure interaction, the undulating transportation of blood is realized, the flow of blood generates pulsatility with physiological characteristics, the damage to blood is minimized, and the risk of complications such as hemolysis and thrombosis is reduced. On the other hand, the hybrid magnetoresistive actuator provides a high force density, strong and reliable driving performance, and guarantees the stable fluctuation of the flexible membrane. In addition, the present invention is small in size, light in weight, simple in structure, low in cost, good in blood compatibility, and suitable for clinical promotion. Description of the Drawings

[0011] Figure 1 is a schematic diagram of the first preferred embodiment of the implantable blood pump of the present invention.

[0012] Figure 2A is a schematic diagram of a preferred embodiment of the pump housing.

[0013] Figure 2B is a schematic diagram of another preferred embodiment of the pump housing.

[0014] Figure 3 is a cross-sectional schematic diagram of the first preferred embodiment of the implantable blood pump of the present invention.

[0015] Figure 4 is a three-dimensional schematic diagram of the pump assembly of the first preferred embodiment of the implantable blood pump of the present invention (the upstream and downstream flow channel assemblies are not shown).

[0016] Figure 5 It is a schematic diagram of the connection structure between the vibration component and the linear guide component.

[0017] Figure 6 It is a schematic diagram of the magnetoresistive drive principle of the first preferred embodiment of the implantable blood pump of the present invention.

[0018] Figure 7A It is a schematic diagram of the first embodiment of the flexible membrane.

[0019] Figure 7B It is a schematic diagram of the second embodiment of the flexible membrane.

[0020] Figure 7C It is a schematic diagram of the third embodiment of the flexible membrane.

[0021] Figure 7D It is a schematic diagram of the fourth embodiment of the flexible membrane.

[0022] Figure 8 It is a schematic diagram of a preferred embodiment of the upstream and downstream channel components.

[0023] Figure 9 It is a schematic diagram of the flexible membrane of the first preferred embodiment of the implantable blood pump of the present invention in a fluctuating state (the vibrating part moves downward).

[0024] Figure 10 It is a cross-sectional schematic diagram of the second preferred embodiment of the implantable blood pump of the present invention.

[0025] Figure 11 It is a three-dimensional schematic diagram of the pump assembly of the second preferred embodiment of the implantable blood pump of the present invention (the upstream and downstream channel components are not shown).

[0026] Figure 12 It is a three-dimensional schematic diagram of the pump assembly of the second preferred embodiment of the implantable blood pump of the present invention.

[0027] Figure 13 It is Figure 12 exploded schematic diagram of.

[0028] Figure 14 It is a schematic diagram of the flexible membrane of the second preferred embodiment of the implantable blood pump of the present invention in a fluctuating state (the vibrating part moves upward).

[0029] Figure 15 It is a schematic diagram of the composition of the artificial blood pump system of the present invention.

[0030] Figure 16 It is a structural diagram of the controller.

[0031] Figure 17 It is a block diagram of the circuit composition of the controller.

[0032] Figure 18It is a structural diagram of a battery device. Detailed implementation mode

[0033] As Figures 1 to 14 shown, the flexible film magnetoresistive drive type implantable blood pump 200 of the present invention includes a pump housing 10, and a pump assembly is installed in the pump housing 10, wherein: the pump assembly includes a hybrid magnetoresistive actuator 20, a vibration assembly 26 is installed on a linear guiding assembly 25 of the hybrid magnetoresistive actuator 20, the vibration assembly 26 is connected to a flexible film 27, an upper flow channel assembly 281 and a lower flow channel assembly 282 are respectively arranged above and below the flexible film 27, and the vibration assembly 26 makes a vertical vibration along the linear guiding assembly 25 under the hybrid magnetoresistive drive of the hybrid magnetoresistive actuator 20, so as to drive the flexible film 27 to make a vertical vibration between the upper flow channel assembly 281 and the lower flow channel assembly 282 and generate a wave motion, thereby making the blood flowing into the pump housing 10 produce a wave pumping effect with physiological characteristics.

[0034] As Figure 4 and Figures 11 to 13 shown, the hybrid magnetoresistive actuator 20 includes a plate-shaped upper frame 211 and a plate-shaped lower frame 212 that are symmetric up and down. An electromagnetic assembly and a linear guiding assembly 25 are arranged between the upper frame 211 and the lower frame 212, wherein: the electromagnetic assembly includes a block-shaped iron core 221 fixed between the upper frame 211 and the lower frame 212, an upper electromagnetic coil 222 and a lower electromagnetic coil 223 are wound around the iron core 221 separately, usually, the separated upper electromagnetic coil 222 and lower electromagnetic coil 223 are respectively arranged close to the upper frame 211 and the lower frame 212; the current directions passed through the upper electromagnetic coil 222 and the lower electromagnetic coil 223 are the same; a plurality of linear guiding assemblies 25 arranged at intervals in a straight line are installed between the opposite edges of the upper frame 211 and the lower frame 212; a magnet assembly 24 is fixed on the iron core 221, the magnet assembly 24 is located between the upper electromagnetic coil 222 and the lower electromagnetic coil 223, and the magnet assembly 24 is located between the iron core 221 and the linear guiding assembly 25; the magnet assembly 24 includes two magnets 241 and 242 with opposite magnetic polarities arranged side by side, wherein, one side of a magnet 241 is fixed on the iron core 221 and the other side is fixed to the other magnet 242 arranged close to the linear guiding assembly 25.

[0035] In actual design, the magnet assembly 24 can be a permanent magnet, or a magnet formed by combining one or more magnetic bodies that can attract substances such as iron, cobalt or nickel.

[0036] Preferably, the upper electromagnetic coil 222 and the lower electromagnetic coil 223 are covered by a coil cover (not shown in the figure) made of a non-magnetic material (such as well-known materials such as titanium alloy). The coil cover can not only play a role in restricting and fixing the movement of the upper and lower electromagnetic coils, but also reduce the possibility of the upper and lower electromagnetic coils made of copper or aluminum wires coming into contact with blood, avoiding blood compatibility problems.

[0037] In addition, the iron core 221 can be made of materials such as soft iron, A3 steel, ferrite, or soft magnetic alloy with good magnetic conductivity. Further, the iron core 221 can act as a magnetic yoke.

[0038] Such as Figure 4 and Figure 13 , flanges are provided at the edges of the upper frame 211 and the lower frame 212 to form an L shape, that is, the upper frame 211 is provided with a flange 2110, and the lower frame 212 is provided with a flange 2120. The linear guide assembly 25 is disposed between the flange 2110 of the upper frame 211 and the flange 2120 of the lower frame 212. Such a structural design facilitates the linear guide assembly 25 to perform a vibration motion in a relatively narrow upper and lower space.

[0039] In actual design, such as Figure 5 , the vibration assembly 26 includes a vibrating member 261, and the linear guide assembly 25 includes a linear column 251 fixed between the flange 2110 of the upper frame 211 and the flange 2120 of the lower frame 212. Two springs 252 and a vibrating member 261 such as a block or a sheet are sleeved on the linear column 251, and the vibrating member 261 is located between the two springs 252, wherein: the flexible membrane 27 is directly connected to the vibrating member 261, or the flexible membrane 27 is connected to the vibrating member 261 through a connecting member 262.

[0040] Refer to Figure 13 to understand that in actual design, the vibrating member 261 is provided with a through hole 260 for movably passing through the linear column 251. Refer to Figure 9 and Figure 14 , when the vibrating member 261 deviates from the middle position, the spring 252 provides an elastic force to it, so that the vibrating member 261 can quickly return, thereby generating a high-quality vibration effect.

[0041] In the present invention, the flexible membrane 27 includes a rectangular flexible sheet body 271, and one end of the flexible sheet body 271 is provided with a fixing portion 272, wherein: the fixing portion 272 is fixed to the vibrating member 261 via the connecting member 262 ( Figure 4 shows the situation where the strip-shaped fixing portion 272 is inserted into the U-shaped connecting member 262 and then bonded and fixed to the connecting member 262 through an adhesive), or, after the fixing portion 272 is embedded in the embedding groove 263 of the vibrating member 261, it is fixed via a bolt (not shown in the figure) or an adhesive (not limited); the other end of the flexible sheet body 271 is provided with or without a fixing hole 270 (for the situation without the fixing hole 270, refer to Figure 7A and Figure 7D ), wherein, when the flexible sheet body 271 is provided with the fixing hole 270, the fixing hole 270 is directly provided on the flexible sheet body 271 (such as Figure 7B ) or the fixing hole 270 is provided on a fixing piece 273 extending outward from the flexible sheet body 271 (such asFigure 7C and Figure 13 , two corners of the flexible sheet body 271 each extend outwards by a fixing piece 273); the thickness of the flexible sheet body 271 remains consistent (such as Figures 7A to 7C ), or the thickness of the flexible sheet body 271 gradually decreases from the end provided with the fixing portion 272 to the other end (such as Figure 7D ).

[0042] In the present invention, the flexible film 27 is a soft, deformable, elastic, and biocompatible thin sheet made of, for example, a silicone or polyurethane composite material. The shape, thickness, and installation method (such as bonding with epoxy resin glue, fixing with screws, etc.) of the flexible film 27 are not limited, as long as it can produce a large-deformation fluctuation effect along the direction of the upper flow channel 291 or the lower flow channel 292 under the combined action of vibration force, fluid force, etc.

[0043] Such as Figure 3 , Figure 4 and Figure 9 , only one hybrid magnetoresistive actuator 20 is provided in the pump housing 10, and the vibrating part 261 of the strip-shaped vibrating assembly 26 is installed on the linear guiding assembly 25 of the hybrid magnetoresistive actuator 20, wherein: an inlet 2210 is provided on the iron core 221, the inlet 2210 is opposite to and close to the pump inlet 12 of the pump housing 10, and a flow dividing sheet 23 that divides the inlet 2210 into two upper and lower parts is fixed in the inlet 2210, and the flow dividing sheet 23 is horizontally opposite to the magnet assembly 24.

[0044] Such as Figures 10 to 14 , two hybrid magnetoresistive actuators 20 are symmetrically provided in the pump housing 10, and both sides of the rectangular sheet-shaped vibrating assembly 26 (vibrating part 261) are respectively installed on the linear guiding assemblies 25 of the two hybrid magnetoresistive actuators 20, wherein: the vibrating part 261 of the vibrating assembly 26 with a flow dividing function is opposite to and close to the pump inlet 12 of the pump housing 10; the current directions in the upper electromagnetic coil 222 and the lower electromagnetic coil 223 of the two hybrid magnetoresistive actuators 20 are the same and the switching of the current direction is synchronously controlled.

[0045] In the present invention, the upper flow channel assembly 281 and the lower flow channel assembly 282 are symmetrically arranged above and below the flexible film 27, referring to Figure 3 , Figure 8 and Figure 13, the upstream flow channel assembly 281 and the downstream flow channel assembly 282 include a rectangular plate body 280. One end of the plate body 280 facing the vibration assembly 26 is provided with an inclined slope 2801, and the other end of the plate body 280 is provided with a flow guiding outlet 284. The flow guiding outlet 284 is opposite to and close to the pump outlet 13 of the pump housing 10. The inclined slope 2801 is arranged on the inner side surface of the plate body 280 facing the flexible membrane 27, and a flow guiding groove 283 is also arranged on the inner side surface of the plate body 280. The flow guiding groove 283 communicates with the flow guiding outlet 284. An upper flow channel 291 is formed between the upstream flow channel assembly 281 and the flexible membrane 27, and a lower flow channel 292 is formed between the downstream flow channel assembly 282 and the flexible membrane 27. Wherein: the flow guiding groove 283 gradually converges and narrows from the inclined slope 2801 to the flow guiding outlet 284; along the direction from the end where the flexible membrane 27 is fixed to the vibration assembly 26 to the other end of the flexible membrane 27, that is, along the direction from the pump inlet 12 to the pump outlet 13, the heights of the upper flow channel 291 and the lower flow channel 292 first gradually decrease and then remain unchanged, that is, the part of the plate body 280 provided with the inclined slope 2801 produces the effect of gradually decreasing height, while the part of the plate body 280 without the inclined slope 2801 produces the effect of unchanged height. This design enables blood to flow rapidly towards the pump outlet 13.

[0046] Furthermore, if the flexible membrane 27 arranged between the upstream flow channel assembly 281 and the downstream flow channel assembly 282 is provided with a fixing hole 270, then corresponding assembly holes 285 are further provided on the inner side surfaces of the upstream flow channel assembly 281 and the downstream flow channel assembly 282 facing the flexible membrane 27. The double-headed screw 289 passes through the fixing hole 270 of the flexible membrane 27 and is fixed between the upstream flow channel assembly 281 and the downstream flow channel assembly 282. The flexible membrane 27 can move up and down on the double-headed screw 289. Refer to Figure 13 for understanding.

[0047] Such as Figure 1 , the pump housing 10 includes a housing 11. The two ends of the housing 11 are respectively provided with a pump inlet 12 and a pump outlet 13. Wherein: the pump inlet 12 and the pump outlet 13 are arranged oppositely, and the caliber of the pump outlet 13 is smaller than that of the pump inlet 12 to promote the flow of blood towards the pump outlet 13; a cable port 14 is further provided on the housing 11. The cables led out from the upper electromagnetic coil 222 and the lower electromagnetic coil 223 of the hybrid reluctance actuator 20 are connected to the external cable 60 via the cable port 14.

[0048] In the present invention, the shape of the housing 11 of the pump housing 10 is not limited. For example, the housing 11 can be Figure 1 in the shape of a rectangular body as shown, the housing 11 can also be Figure 2A in the shape with one end wide and one end narrow as shown, or can also be Figure 2B in the shape with one end in an arc shape as shown.

[0049] In the present invention, screw holes 213 for fixing to the pump housing 10 by screws may be provided on the upper and lower frames 211 and 212, and screw holes 288 for fixing to the pump housing 10 by screws may be provided on the upper flow channel assembly 281 and the lower flow channel assembly 282. Additionally, the upper and lower frames 211 and 212, the upper flow channel assembly 281, and the lower flow channel assembly 282 may also be welded inside the pump housing 10, and their specific installation methods are not limited.

[0050] In the present invention, the pump housing 10 may be made of stainless steel, cobalt-based, titanium-based alloy, or other rigid materials with biocompatibility. The upper and lower frames 211 and 212 may be made of materials such as soft iron, A3 steel, ferrite, or soft magnetic alloy with good magnetic conductivity to ensure better magnetic field line transmission effect in the magnetic circuit. Additionally, the upper and lower frames 211 and 212 may also be yokes (or magnetic yokes) made of stacked silicon steel sheets, which can play a role in restricting the outward diffusion of electromagnetic induction, improving the induction efficiency, and can also play a role in magnetic shielding and reducing the heat generation of metal components. The linear guide assembly 25 and the vibration assembly 26 (especially the vibrating part 261) may be made of the same material as the upper and lower frames 211 and 212.

[0051] In the present invention, all components that need to come into contact with blood, such as the iron core 221, the linear guide assembly 25, the vibration assembly 26, the upper and lower frames 211 and 212, the flexible membrane 27, the upper and lower flow channel assemblies 281 and 282, etc., are made of materials with excellent blood compatibility, such as titanium alloy material.

[0052] The following takes Figure 3 the implantable blood pump of the present invention shown as an example to illustrate the hybrid reluctance drive principle. Figure 10 The hybrid reluctance drive principle of the implantable blood pump of the present invention shown is the same as that shown in Figure 3 so it will not be elaborated here.

[0053] It is assumed that the magnet 241 fixed on the iron core 221 has an S magnetic property, and the other magnet 242 has an N magnetic property, and the magnetic field lines generated by them are as shown by the center dash-dotted arrows in Figure 6 .

[0054] When no current is passed through the upper and lower electromagnetic coils 222 and 223, the magnetic forces on the vibrating part 261 exerted by the two magnets 241 and 242 are equal in strength and opposite in direction. Thus, the vibrating part 261 is in the middle position of the linear column 251, that is, in a balanced state.

[0055] When current is passed through the upper electromagnetic coil 222 and the lower electromagnetic coil 223 in the Figure 6 direction shown, Figure 6The electromagnetic wire shown by the solid arrow in the figure. Therefore, the magnetic flux after a part of the magnetic force lines is cancelled by the electromagnetic wire in the upper part of the linear guiding component 25 is less than the magnetic flux after the superposition of the electromagnetic wire and the magnetic force lines in the lower part of the linear guiding component 25. Therefore, the vibrating part 261 moves downward along the linear column 251 under the combined action of the electromagnetic force and the magnetic force.

[0056] Conversely, when the upper electromagnetic coil 222 and the lower electromagnetic coil 223 are energized with currents in the Figure 6 opposite direction to that shown in the figure, the magnetic flux after the superposition of the electromagnetic wire and the magnetic force lines in the upper part of the linear guiding component 25 is greater than the magnetic flux after a part of the magnetic force lines is cancelled by the electromagnetic wire in the lower part of the linear guiding component 25. Therefore, the vibrating part 261 moves upward along the linear column 251 under the combined action of the electromagnetic force and the magnetic force.

[0057] Thus, by continuously switching the current directions applied to the upper electromagnetic coil 222 and the lower electromagnetic coil 223, the vibrating part 261 can achieve an up-and-down vibration effect on the linear column 251. As a result, the vibrating part 261 drives the flexible membrane 27 to perform up-and-down vibrations, and then the flexible membrane 27 generates undulating wave motions to pump the blood entering from the pump inlet 12 in a fluctuating manner to the pump outlet 13.

[0058] Figure 9 Compared with Figure 14 the implantable blood pump of the present invention shown in the figure, the difference lies in:

[0059] For Figure 9 the implantable blood pump 200 of the present invention shown in the figure, after the blood flows into the pump inlet 12 of the pump housing 10, it is first shunted up and down by the shunt piece 23 and then enters the upper and lower flow channels 291 and 292 through the up-and-down shunting of the magnet assembly 24 and the vibrating part 261. Please refer to Figure 9 the blood flow direction shown by the arrow in the figure for understanding. For Figure 14 the implantable blood pump 200 of the present invention shown in the figure, after the blood flows into the pump inlet 12 of the pump housing 10, it directly enters the upper and lower flow channels 291 and 292 through the up-and-down shunting of the vibrating part 261. Please refer to Figure 14 the blood flow direction shown by the arrow in the figure for understanding.

[0060] In addition, for Figure 9 the implantable blood pump 200 of the present invention shown in the figure, the vibrating part 261 generates a vibrating motion under the hybrid magnetic resistance driving action of a hybrid magnetic resistance actuator 20, while for Figure 14 the implantable blood pump 200 of the present invention shown in the figure, the vibrating part 261 generates a vibrating motion under the combined hybrid magnetic resistance driving action of two hybrid magnetic resistance actuators 20.

[0061] Figure 9 The similarities with Figure 14 the implantable blood pump of the present invention shown in the figure are:

[0062] After the blood enters the upper and lower flow channels 291 and 292, due to the design that the upper and lower flow channels 291 and 292 gradually narrow, the pressure of the blood gradually increases without relying on other effects, thereby achieving the effect of accelerating blood flow. When the blood flows out of the upper and lower flow channels 291 and 292, it will converge and then flow out from the pump outlet 13.

[0063] The present invention also proposes an artificial blood pump system, which includes the flexible membrane magnetoresistive drive implantable blood pump 200 of the present invention. The pump inlet 12 of the flexible membrane magnetoresistive drive implantable blood pump 200 of the present invention is connected to an inlet cannula 40, and the pump outlet 13 is connected to an outlet cannula 50. The cable port 14 of the flexible membrane magnetoresistive drive implantable blood pump 200 of the present invention is connected to a controller 70 via a cable 60. The controller 70 is connected to a computer 90 by wire or wirelessly. The battery device 80 transmits power to the controller 70 by wire or wirelessly, and wireless communication can be performed between the controller 70 and the mobile terminal 100.

[0064] Specifically, the flexible membrane magnetoresistive drive implantable blood pump 200 of the present invention is used to be implanted in a pocket area under the subcutaneous or muscle layer in front of the right pectoralis major muscle and below the right subclavian artery in the patient's body. The inlet cannula 40 is used to be inserted into the first heart chamber or body cavity of the human body (such as Figure 1 the left atrium LA of the heart H shown) through the right subclavian vein SV. The outlet cannula 50 is used to be connected to the second heart chamber or body cavity of the human body (such as Figure 1 the right subclavian artery SA shown). The blood enters the flexible membrane magnetoresistive drive implantable blood pump 200 of the present invention from the inlet cannula 40, and then is pumped out through the flexible membrane magnetoresistive drive implantable blood pump 200 of the present invention and enters the outlet cannula 50.

[0065] The controller 70 and the battery device 80 are usually installed outside the patient's body, for example, they can be placed on a belt (such as Figure 15 ) or a backpack. The controller 70 and the battery device 80 can be designed independently or integrally. In addition, the controller 70 and the battery device 80 can also be implanted under the patient's skin.

[0066] The cable 60 connected to the controller 70 can penetrate into the human body through the right lower abdomen position of the human body (such as the position of the circle in Figure 1 ) and be connected to the flexible membrane magnetoresistive drive implantable blood pump 200 of the present invention.

[0067] Such as Figure 16 and Figure 17, the controller 70 includes a housing 71, on which there are a pump signal interface 72, an external signal interface 73, a power supply interface 74, an indicator light 75, a status light 76, a display 78 and a button 77. Inside the housing 71, there is a microprocessor 31. The signal ports of the pump signal interface 72, the external signal interface 73, the power supply interface 74, the indicator light 75, the status light 76, the display 78, the button 77, the memory 32 and the transceiver 33 are respectively connected to the corresponding signal ports of the microprocessor 31.

[0068] The pump signal interface 72 is used to connect with the cable port 14 of the flexible membrane magnetoresistive drive implantable blood pump 200 of the present invention to provide current signals to the upper and lower electromagnetic coils 222 and 223. The external signal interface 73 is used for wired connection with the computer 90. When there is a wireless connection between the controller 70 and the computer 90, the external signal interface 73 can be omitted. The power supply interface 74 is used to connect with the battery device 80 to receive power. When the controller 70 and the battery device 80 are integrated and the battery device 80 transmits power to the controller 70 wirelessly, the power supply interface 74 can be replaced by a wireless charging device that can sense power. The indicator light 75 is used to display information related to system operations (such as remaining battery power, system error alarms, etc.), the status light 76 is used to display whether the controller 70 is in an operating state, etc., the button 77 is used to wake up the display 78 and set relevant parameters, and the display 78 is used to display relevant data and alarm information, etc. The transceiver 33 is used to realize wireless communication between the microprocessor 31 and the computer 90, and between the microprocessor 31 and the mobile terminal 100.

[0069] The computer 90 is used for program design to control and monitor the operation of the controller 70, modify the control parameters of the controller 70, etc. The computer 90 can be a laptop computer, a desktop computer or a smart phone, etc.

[0070] The mobile terminal 100 can be a movable device such as a laptop computer, a smart phone, a tablet computer or a smart watch, etc. Usually, the mobile terminal 100 can be authorized for use by the patient or the patient's family member. The user can send instructions to the controller 70 through the mobile terminal 100 to adjust the operation of the pump. In addition, the user can view the operation of the pump and alarm information, etc. from the display screen 101 of the mobile terminal 100.

[0071] The battery device 80 is used to provide power to the controller 70 and the implantable blood pump 200 of the present invention. Such as Figure 18, the battery device 80 may include a battery case 81, one or more batteries are disposed inside the battery case 81, a power interface 83 and a power quantity display device 84 are provided on the battery case 81. Additionally, a charging interface 82 may also be provided on the battery case 81. The power interface 83 is used to connect to the power interface 74 of the controller 70 via a cable, the power quantity display device 84 is used to display the remaining power of the battery, and the charging interface 82 is used to charge the battery. Of course, the battery can also be charged wirelessly.

[0072] The advantages of the present invention are:

[0073] On the one hand, the present invention forms upper and lower flow channels with a fluid bag effect with the upstream and downstream channel components through the flexible membrane respectively. Based on the fluid-structure interaction, the undulating transportation of blood is realized, making the blood flow pulsatile with physiological characteristics, minimizing the damage to the blood, and reducing the risk of complications such as hemolysis and thrombosis. On the other hand, the hybrid reluctance actuator provides a high force density, strong and reliable driving performance, which guarantees the stable fluctuation of the flexible membrane. In addition, the present invention is small in volume, light in weight, simple in structure, low in cost, and good in blood compatibility, and is suitable for clinical promotion.

[0074] The above is the preferred embodiment of the present invention and the technical principles applied. For those skilled in the art, any obvious changes such as equivalent transformation and simple substitution based on the technical solution of the present invention without departing from the spirit and scope of the present invention shall fall within the protection scope of the present invention.

Claims

1. A flexible membrane magnetoresistive drive type implantable blood pump, characterized in that: It includes a pump housing, and a pump assembly is installed inside the pump housing, where: The pump assembly includes a hybrid reluctance actuator, a vibration assembly is installed on the linear guiding assembly of the hybrid reluctance actuator, the vibration assembly is connected to a flexible membrane, an upper flow channel assembly and a lower flow channel assembly are respectively arranged above and below the flexible membrane, and the vibration assembly makes a vertical vibration along the linear guiding assembly under the hybrid reluctance driving action of the hybrid reluctance actuator, so as to drive the flexible membrane to make a vertical vibration between the upper flow channel assembly and the lower flow channel assembly and generate a wave motion, where: The hybrid reluctance actuator includes a plate-shaped upper frame and a lower frame which are symmetric up and down, an electromagnetic assembly and the linear guiding assembly are arranged between the upper frame and the lower frame, where: The electromagnetic assembly includes an iron core fixed between the upper frame and the lower frame, an upper electromagnetic coil and a lower electromagnetic coil are wound on the iron core separately; the current directions passed through the upper electromagnetic coil and the lower electromagnetic coil are the same; a plurality of the linear guiding assemblies arranged in a linear and spaced manner are installed between the opposite edges of the upper frame and the lower frame; a magnet assembly is fixed on the iron core, the magnet assembly is located between the upper electromagnetic coil and the lower electromagnetic coil, and the magnet assembly is located between the iron core and the linear guiding assembly; the magnet assembly includes two magnets with opposite magnetic polarities arranged side by side, where, one side of a magnet is fixed on the iron core and the other side is fixed to another magnet arranged close to the linear guiding assembly; the vibration assembly includes a vibrating part, the linear guiding assembly includes a linear column fixed between the upper frame and the lower frame, two springs and the vibrating part are sleeved on the linear column, and the vibrating part is located between the two springs, where: The flexible membrane is directly connected to the vibrating part, or the flexible membrane is connected to the vibrating part through a connecting piece; flanges are arranged on the edges of the upper frame and the lower frame to form an L shape, and the linear guiding assembly is arranged between the flange of the upper frame and the flange of the lower frame.

2. The flexible membrane reluctance-driven implantable blood pump according to claim 1, characterized in that: The flexible membrane includes a rectangular flexible sheet body, and a fixing part is arranged at one end of the flexible sheet body, where: The fixing part is fixed to the vibrating part via the connecting piece, or, the fixing part is fixed after being embedded in the slot of the vibrating part; a fixing hole is provided or not provided at the other end of the flexible sheet body, where, when the flexible sheet body is provided with a fixing hole, the fixing hole is directly arranged on the flexible sheet body or the fixing hole is arranged on a fixing piece extending outward from the flexible sheet body; the thickness of the flexible sheet body is kept consistent, or the thickness of the flexible sheet body gradually decreases from the end provided with the fixing part to the other end.

3. The flexible membrane reluctance-driven implantable blood pump according to claim 1, characterized in that: One said hybrid reluctance actuator is provided inside the pump housing, and the strip-shaped vibration assembly is installed on the linear guiding assembly of the hybrid reluctance actuator, where: An inlet is provided on the iron core, the inlet is opposite to the pump inlet of the pump housing and is arranged close to the pump inlet, and a flow dividing sheet that divides the inlet into two parts up and down is fixed in the inlet, and the flow dividing sheet is horizontally opposite to the magnet assembly.

4. The flexible membrane reluctance-driven implantable blood pump according to claim 1, characterized in that: Two of the hybrid magnetoresistive actuators are symmetrically arranged inside the pump housing. Both sides of the vibration assembly in the shape of a rectangular sheet are respectively mounted on the linear guiding assemblies of the two hybrid magnetoresistive actuators, wherein: the vibration assembly with a shunting function faces and is close to the pump inlet of the pump housing; the current directions in the upper electromagnetic coil and the lower electromagnetic coil of the two hybrid magnetoresistive actuators are the same and the switching of the current directions is synchronously controlled.

5. The flexible membrane magnetoresistive drive implantable blood pump according to claim 1, wherein: The upstream flow channel assembly and the downstream flow channel assembly include rectangular plate bodies. One end of the plate body facing the vibration assembly is provided with an inclined slope surface, and the other end of the plate body is provided with a diversion outlet. The diversion outlet faces and is close to the pump outlet of the pump housing. The inclined slope surface is arranged on the inner side surface of the plate body facing the flexible membrane, and a diversion groove is further arranged on the inner side surface of the plate body. The diversion groove is communicated with the diversion outlet. An upper flow channel is formed between the upstream flow channel assembly and the flexible membrane, and a lower flow channel is formed between the downstream flow channel assembly and the flexible membrane, wherein: the diversion groove gradually converges and narrows from the inclined slope surface to the diversion outlet; along the direction from the end where the flexible membrane is fixed to the vibration assembly to the other end of the flexible membrane, the heights of the upper flow channel and the lower flow channel first gradually decrease and then remain unchanged.

6. The flexible membrane magnetoresistive drive implantable blood pump according to claim 1, wherein: The pump housing includes a housing. A pump inlet and a pump outlet are respectively arranged at both ends of the housing, wherein: the pump inlet and the pump outlet are arranged opposite to each other, and the diameter of the pump outlet is smaller than that of the pump inlet; a cable port is further arranged on the housing, and the cables led out from the upper electromagnetic coil and the lower electromagnetic coil of the hybrid magnetoresistive actuator are connected to the external cables through the cable port.

7. An artificial blood pump system, characterized in that: It includes the flexible membrane magnetoresistive drive implantable blood pump according to any one of claims 1 to 6. The pump inlet of the flexible membrane magnetoresistive drive implantable blood pump is connected to an inlet sleeve, and the pump outlet is connected to an outlet sleeve. The cable port of the flexible membrane magnetoresistive drive implantable blood pump is connected to a controller through a cable. The controller is connected to a computer in a wired or wireless manner. The battery device transmits power to the controller in a wired or wireless manner, and wireless communication can be carried out between the controller and the mobile terminal.

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