Passive ventricular auxiliary circulation device

Abstract

The invention relates to the technical field of heart blood pumps, in particular to a passive ventricular auxiliary circulation device. Comprising a motor body shell, a stator and a rotor are arranged in the motor body shell, and one of the stator and the rotor comprises a coil; the axial flow channel shell is sleeved; the upper end of the axial flow channel shell is configured to face the aortic valve to the lower part of the ventricle, and a power supply configured to be operably coupled to the coil; and the controller is configured to be operated and coupled to the power supply to select and control the power supply to change the rotor to a certain rotating speed in a manual selection mode, then the rotor keeps working in a certain rotating speed mode, and corresponding auxiliary pressure output by the fluid outlet interface is configured at a different rotating speed. The device is controlled to be in a rotating speed state, and when systolic pressure smaller than normal systolic pressure is provided for cardiac pulsation of a heart failure patient, the normal systolic pressure is provided when the systolic pressure and auxiliary pressure are overlapped together, so that the heart failure patient maintains the normal systolic pressure.

Description

Technical Field

[0001] The present invention relates to the technical field of cardiac blood pumps, and particularly to a passive ventricular assist circulation device. Background Art

[0002] Generally, patients with heart failure will present with low blood pressure, which is a relatively common blood pressure manifestation in heart failure. Due to the decline in cardiac function, the heart is unable to effectively pump out blood, resulting in a decrease in blood pressure. This may cause symptoms such as dizziness, fatigue, and even fainting.

[0003] To solve the problem of low blood pressure, the general prior art is to set up a cardiac blood pump as a ventricular assist circulation device. There are two types of designs for cardiac blood pumps. One type is connected in parallel to the cardiac passage, and the other type is connected in series to the cardiac passage. Currently, regardless of which type of cardiac blood pump, the control method adopted is the active pumping mode. The so-called active pumping mode means: collecting the cardiac beating rhythm, and then controlling the blades of the pump to pump blood following the cardiac beating rhythm. The pump operates in a mode of switching between high power and low power. For example, in CN104168932B, the controller of the pump is programmed to use the star sensor to determine the natural cardiac rhythm and control the rotation speed of the rotor in response to the natural cardiac rhythm. That is, the rotation speed of the rotor of the pump is fast and slow following the cardiac rhythm.

[0004] There is a response time between the rhythm of the pump in this mode and the natural cardiac rhythm. Therefore, a very high responsiveness is required. Consequently, a very high stability requirement is imposed on the controller. Once a delay occurs, there will be a large conflict with the cardiac rhythm. Its stability and safety pose serious challenges. Summary of the Invention

[0005] The purpose of the present invention is to provide a passive ventricular assist circulation device. In the ventricular assist circulation pump device of this device, the rotation speed of the rotor is controlled by the controller at a certain rotation speed state, and this rotation speed provides an auxiliary pressure smaller than the normal cardiac systolic pressure. When the heart of a heart failure patient beats to provide a systolic pressure smaller than the normal cardiac systolic pressure, when the systolic pressure and the auxiliary pressure are jointly superimposed, a normal cardiac systolic pressure is provided. The superimposed pressure can prompt the tricuspid valve to open, thereby enabling the heart to pump blood externally, so that the heart failure patient can maintain a normal cardiac systolic pressure. This rotation speed can be constant.

[0006] On the one hand, the present invention provides a passive ventricular assist circulation device, including: a ventricular assist circulation pump device, and the ventricular assist circulation pump device includes: Axial flow pump, the axial flow pump includes a motor body housing, a stator and a rotor are arranged in the motor body housing, the rotor is connected to a hub, and a second impeller is circumferentially connected to the hub. One of the stator and the rotor includes a field magnet and the other of the stator and the rotor includes a coil; an axial flow channel housing coaxially sleeved outside the motor body housing; the upper end of the axial flow channel housing is configured as a fluid outlet interface, and the lower end is configured as a fluid inlet interface. The second impeller is arranged in the lower region of the axial flow channel housing. The upper end of the axial flow channel housing is arranged below the aortic valve facing the ventricle. The axial flow channel housing is configured to be connected in series with the aortic tube; Power supply, configured to be operatively coupled to the coil; Controller, configured to be operatively coupled to the power supply to manually select a mode to control the power supply to change the rotor to a certain speed. After the rotor operates at a certain speed mode, the rotor maintains operation at a certain speed. Different certain speeds are configured with corresponding auxiliary pressures output at the fluid outlet interface. The manual selection criterion for the auxiliary pressure is: Auxiliary pressure = (Normal cardiac systolic pressure - Current measured cardiac systolic pressure of the heart failure patient) ± Calibration compensation pressure.

[0007] To achieve the above passive assist function, the controller of the present invention controls the rotor to a certain speed. This certain speed can be a constant speed, that is, the axial flow pump provides a constant auxiliary pressure. At the same time, it is also necessary to connect the axial flow channel housing in series with the aortic tube to avoid pressure relief and ensure that the aortic tube is in a pre-pressurized state. Only when the cardiac systolic pulsation provides a supplementary pressure, the two are superimposed to provide a normal pressure. At the same time, it is also necessary to arrange the axial flow channel housing below the aortic valve facing the ventricle in the aortic tube, that is, below the tricuspid valve. The tricuspid valve is equivalent to a valve. The auxiliary pressure is not sufficient to open the tricuspid valve. That is, the function of the axial flow pump of the present invention is to provide a passive auxiliary pressure, which will not cause the tricuspid valve to open and it has been in a waiting state. When the cardiac itself contracts to provide a pulsation pressure, the two are superimposed, so as to superimpose and generate a pressure, and this superimposed pressure is sufficient to open the tricuspid valve.

[0008] The axial flow pump provided by the present invention does not detect the cardiac rhythm, but provides a constant speed and a constant pressure. The freely changing rhythm of the heart, that is, the heartbeat, triggers the opening of the tricuspid valve, thereby generating pulsation. The present invention does not affect the heartbeat rhythm, and the pulse in the human body system remains the natural rhythm of the human body. The present invention does not need to respond to the cardiac rhythm, and the reliability requirements for the corresponding product are low, and the safety performance is greatly improved.

[0009] Preferably, the power supply is configured to be operatively coupled to the coil by wire or wirelessly.

[0010] Preferably, the calibration compensation pressure is set and determined according to physiological parameters such as blood viscosity state or / and stator-rotor loss state or / and ventricular systolic pressure or / and ventricular diastolic pressure or / and cardiac output.

[0011] Preferably, the controller controls the power supply to change the rotor to a certain rotational speed in a constant-current variable-voltage manner, a constant-voltage variable-current manner, or a variable-voltage variable-current manner.

[0012] Preferably, the controller includes: a key-in module for obtaining the normal cardiac systolic pressure, a key-in module for obtaining the currently measured cardiac systolic pressure of a heart failure patient, a key-in module for confirming the calibration compensation pressure, a module for calculating the auxiliary pressure, where the auxiliary pressure = (normal cardiac systolic pressure - currently measured cardiac systolic pressure of a heart failure patient) ± calibration compensation pressure; an output module for matching a control signal corresponding to a certain rotational speed according to the auxiliary pressure, where the control signal is a driving signal for driving the power supply to operate in a constant-current variable-voltage manner, a constant-voltage variable-current manner, or a variable-voltage variable-current manner.

[0013] Preferably, the controller includes: a key-in module for obtaining the auxiliary pressure, where the auxiliary pressure = (normal cardiac systolic pressure - currently measured cardiac systolic pressure of a heart failure patient) ± calibration compensation pressure; an output module for matching a control signal corresponding to a certain rotational speed according to the auxiliary pressure, where the control signal is a driving signal for driving the power supply to operate in a constant-current variable-voltage manner, a constant-voltage variable-current manner, or a variable-voltage variable-current manner.

[0014] On the other hand, the present invention provides a passive ventricular assist circulation device, which further includes a first blade. The spiral outer edge line of the blade surface of the first blade is fixedly connected along the inner wall surface of the axial flow channel housing, and the spiral inner edge line of the blade surface of the first blade is fixedly connected along the outer peripheral surface of the motor body housing; the spiral outer edge line of the blade surface of the second blade has a free rotation gap with the inner wall surface of the axial flow channel housing, and the spiral inner edge line of the blade surface of the second blade is fixedly connected along the circumferential direction of the hub. Preferably, the number of the first blade and the second blade is at least 1, and their arrangement can be that the first blade is on the upper side and the second blade is on the lower side, or vice versa. When the first blade is on the upper side and the second blade is on the lower side, the spiral direction of the first blade is opposite to that of the second blade. New spiral directions can also be determined according to the number and arrangement.

[0015] The upper end of the axial flow channel housing is provided with a radially outward flanging portion, and a suture body is pre-installed or temporarily assembled on the upper surface and / or lower surface of the flanging portion. The suture body located on the upper surface is an upper suture body for suturing with the lower surface of the aortic valve root, and the suture body located on the upper surface is a lower suture body for suturing with the inner surface of the aortic tube.

[0016] The flanging part is provided with a plurality of assembly holes, the axial direction of the assembly holes is the same as the axial direction of the axial flow channel housing, and the upper suture body or / and the lower suture body are pre-assembled or temporarily assembled on the upper or / and lower sides of the flanging part after the suture thread passes through the assembly holes.

[0017] The outer diameter dimension of the outer edge of the flanging part is preset as the inner diameter dimension of the aortic tube.

[0018] The suture body is an annular medical polyester braided body or an annular polytetrafluoroethylene braided body or an annular artificial blood vessel or artificial valve.

[0019] The upper end of the motor body housing extends out from the upper end of the axial flow channel housing.

[0020] The upper surface or / and the lower surface of the flanging part has a concave structure in the axial direction, and the upper suture body or / and the lower suture body is embedded in the concave structure.

[0021] The axial flow channel housing or / and the first fan blade or / and the motor body housing are all made of high thermal conductivity material.

[0022] The sum of the lengths of the spiral inner edges of all the first fan blades is greater than or equal to the outer circumference of the motor body housing, and the sum of the lengths of the spiral outer edges of all the first fan blades is greater than or equal to the inner circumference of the axial flow channel housing.

[0023] The thickness of the first fan blade on the side close to the motor body housing is greater than the thickness on the side close to the axial flow channel housing.

[0024] The existing series ventricular assist circulation device includes: a motor body housing, an axial flow channel housing coaxially sleeved outside the motor body housing, a hub connected to the lower end of the motor body housing, a second fan blade circumferentially connected to the hub, a first fan blade that is not in contact connection with the motor body housing, is only arranged on one side of the inner wall of the axial flow channel housing, and only functions to eliminate the rotational movement of the blood caused by the second fan blade, a support rod that suspends the motor body housing on the central axis of the axial flow channel housing, the motor body housing extends through the aortic valve, and a connecting rod and a fixing ring for fixing the upper end of the motor body housing are arranged at the upper end of the motor body housing. The heat dissipation path of this device only depends on the motor body housing, and the size of the motor body housing is increased upward, thereby improving the heat dissipation effect. The overall weight of this device is relatively large. The support path I of this device includes the motor body housing, the support rod, and the axial flow channel housing connected in sequence, and the support path II of this device includes the motor body housing, the connecting rod, and the fixing ring connected in sequence.

[0025] In the present invention, the first fan blade is bridged between the motor body housing and the axial flow channel housing, thereby introducing the heat of the motor body housing into the first fan blade and the axial flow channel housing, so that the first fan blade and the axial flow channel housing can also serve as heat dissipation surfaces, increasing the heat dissipation area in contact with the blood. At the same time, the length of the motor housing does not need to be increased, and even the diameter of the motor housing can be further reduced, increasing the blood flow area. The present invention constructs a new heat dissipation path: the motor body housing, the first fan blade, and the axial flow channel housing. The first fan blade is a fixed structure and does not rotate. One side is fixed to the motor body housing and the other side is fixed to the axial flow channel housing. This greatly increases the heat dissipation area. At the same time, the first fan blade also plays a role in supporting the motor body housing, eliminating the support rod, connecting rod, and fixing ring in the prior art. A new support path is constructed: the motor body housing, the first fan blade, and the axial flow channel housing. The support path coincides with the heat dissipation path, playing a dual function. The spiral direction of the first fan blade is opposite to that of the second fan blade, which plays a role in eliminating the rotational movement of the blood caused by the second fan blade. Therefore, the first fan blade in the present invention plays three roles: support, heat dissipation and heat conduction, and anti-blood rotation. The traditional first fan blade is only a guide vane connected to the inner wall of the axial flow channel housing on one side, which only plays the role of anti-blood rotation. In contrast, the present invention can prevent the accumulation of the motor body housing without relying on the method of increasing the area by extending the length or diameter of the motor body housing, but proposes a new technical method of using the axial flow channel housing for heat dissipation. The device can be provided with a shorter motor body housing and a smaller diameter motor body housing.

[0026] On the other hand, the present invention provides a passive ventricular assist circulation device, which further includes a ventricular assist circulation valve device; the ventricular assist circulation valve device has a tubular metal stent body, and the metal stent body includes a plurality of longitudinal struts; the upper end of the axial flow channel housing is provided with a radially outward flanging portion, and the lower end of the longitudinal strut of the longitudinal strut is assembled and fixed in contact with the flanging portion.

[0027] The lower end of the longitudinal strut of the longitudinal strut is directly welded to the upper surface of the flanging portion.

[0028] The flanging portion is provided with a plurality of assembly holes, the axial direction of the assembly holes is the same as the axial direction of the axial flow channel housing, and the lower end of the longitudinal strut of the longitudinal strut is inserted into the interior of the assembly holes.

[0029] After the lower end of the longitudinal strut is inserted into the assembly hole with the same diameter and welded into an integral structure, or the lower end of the longitudinal strut is press-fitted into the assembly hole to form an integral structure.

[0030] The upper surface and / or the lower surface of the flanging part is pre-mounted or temporarily assembled with a suture body. The suture body located on the upper surface is an upper suture body for suturing with the lower surface of the aortic valve root of the aortic valve in the aortic tube and for suturing with the circumferential annular membrane of the ventricular assist circulation pump device. The circumferential annular membrane of the ventricular assist circulation pump device is also used for suturing with the aortic valve root. The suture body located on the lower surface is a lower suture body for suturing with the inner surface of the aortic tube.

[0031] The upper suture body and / or the lower suture body is pre-mounted or temporarily assembled on the upper and / or lower sides of the flanging part after the suture thread passes through the assembly holes.

[0032] The assembly holes include assembly holes with a first diameter and assembly holes with a second diameter. The assembly holes with the first diameter and the assembly holes with the second diameter are arranged at intervals. The assembly holes with the first diameter are used for assembling the lower end of the longitudinal strut or the suture thread, and the assembly holes with the second diameter are used for assembling the lower end of the longitudinal strut or the suture thread; the diameter of the assembly holes with the first diameter is greater than or equal to the diameter of the assembly holes with the second diameter.

[0033] The ventricular assist circulation valve device is an artificial valve with longitudinal struts.

[0034] The axial flow channel housing is connected in series with the heart aorta. The axial flow channel housing is sutured to the heart aorta through the flanging part. Blood can only flow out from the axial flow channel housing. The driving motor provides kinetic energy. When the valve leaf of the upper ventricular assist circulation valve device opens, blood flows from the ventricle into the artery. The driving motor will continue to work, resulting in heat accumulation. If the heat accumulation is not reduced, it will cause thermal damage to the blood. In order not to increase the structural area of the driving motor itself to increase the heat dissipation area, the present invention uses a heat conducting sheet to guide the heat of the motor body housing of the driving motor to the axial flow channel housing, and uses the axial flow channel housing to increase the heat dissipation area. In order to further improve the heat dissipation effect, the present invention constructs the flanging part on the basis of the axial flow channel housing, and directly welds and assembles the upper ventricular assist circulation valve device on the basis of the flanging part or constructs assembly holes and assembles the upper ventricular assist circulation valve device through the assembly holes (the lower end of the longitudinal strut of the longitudinal strut of the ventricular assist circulation valve device is inserted into the interior of the assembly hole). The longitudinal strut is integrally connected with the axial flow channel housing, and the heat can be transferred to the longitudinal strut. Due to the large number of longitudinal struts, large extension range, large surface area in contact with blood, and being washed, the effect of dispersed heat dissipation can be achieved, greatly reducing the problem of heat accumulation of the driving motor. At the same time, due to the integral connection between the longitudinal strut and the axial flow channel housing, during its assembly, it can rely on the suture fixation of the axial flow channel housing and the aortic tube, solving the problem of insufficient fixation force of the traditional ventricular assist circulation valve device relying on expansion support.

[0035] The beneficial effects of the present invention are: The pump of the present invention is located below the tricuspid valve, the pump is connected in series with the aorta, and the pump is configured to work in a constant speed and constant pressure mode, so as to passively wait for the arrival of cardiac contraction pressure and open the tricuspid valve after superimposing the cardiac contraction pressure, so as to maintain the natural heart beat of the human body system, without the need to detect the cardiac beat rhythm, and without the need to respond to the cardiac beat rhythm. The pump does not start and stop, and the speed does not change. It is in a constant state, and the safety and stability of the pump are improved, and it will not cause rhythm disorders in the human blood supply system. It should be noted that the so-called constant speed of the present invention is not a point value, but a speed in a range area, which can be within a controllable error range, generally within a certain ideal point value attachment fluctuation range.

[0036] The present invention constructs a support system and a heat dissipation system as the same set of path structures, thereby increasing the heat dissipation effect on the basis of reducing the structure.

[0037] The present invention constructs a suture body in the form of a groove on the aortic tube, which is inserted into the flange portion, and even when the suture fails, a stable assembly effect is still achieved.

[0038] The present invention uses sutures to fix the device and the suture body, which increases the stability of the device and eliminates the risk of slipping. The sutures are up-and-down sutures and do not need to be exposed in the flow channel, thus avoiding the formation of thrombus. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 This is a cross-sectional schematic diagram of Example 1.

[0040] Figure 2 for Figure 1 , Figure 6 Schematic diagram of the enlarged area FD in the middle.

[0041] Figure 3 This is a top view of Example 1.

[0042] Figure 4 This is a three-dimensional diagram of Example 1 from a bottom-up angle.

[0043] Figure 5 This is a three-dimensional diagram from a top view of Example 1.

[0044] Figure 6 It is a cross-sectional schematic diagram of Example 2 of the present invention.

[0045] Figure 7 This is a cross-sectional schematic diagram of Example 3.

[0046] Figure 8 for Figure 7 Schematic diagram of the enlarged area FD in the middle.

[0047] Figure 9 This is a top view of Example 3.

[0048] Figure 10 It is an upward view perspective view of Embodiment 3.

[0049] Figure 11 It is a top view perspective view of Embodiment 3.

[0050] Figure 12 It is a schematic structural view of Embodiment 4.

[0051] The reference numerals in the figure are respectively: 1, motor body housing; 2, hub; 3, axial flow channel housing; 5, aorta; 6, aortic valve; 7, suture; 11, first blade; 21, second blade; 31, flanging portion; 32, assembly hole; 41, lower suture body; 42, upper suture body; 61, aortic valve root; 62, artificial aortic valve body; 100, metal stent body; 101, lower end of longitudinal strut; 10, controller; 20, power supply. Specific Embodiments

[0052] The present invention will be further described in detail below in conjunction with the embodiments and the accompanying drawings, but the embodiments of the present invention are not limited thereto.

[0053] Embodiment 1 As Figures 1-5 shown, the present invention provides a passive ventricular assist circulation device, including: a motor body housing 1, an axial flow channel housing 3 coaxially sleeved outside the motor body housing, a hub 2 connected to the lower end of the motor body housing 1, a second blade 21 circumferentially connected to the hub 2, and further including a first blade 11. The spiral outer edge line of the blade surface of the first blade 11 is fixedly connected along the inner wall surface of the axial flow channel housing 3, and the spiral inner edge line of the blade surface of the first blade 11 is fixedly connected along the outer peripheral surface of the motor body housing 1; the spiral outer edge line of the blade surface of the second blade 21 has a free rotation gap with the inner wall surface of the axial flow channel housing 3, and the spiral inner edge line of the blade surface of the second blade 21 is fixedly connected circumferentially along the hub 2; the spiral direction of the first blade 11 is opposite to that of the second blade 21.

[0054] As Figure 1 shown, the motor body housing 1 extends and passes through the aortic valve 6. The hub 2 and the second blade 21 form an impeller. The motor body housing 1 and the impeller are separately designed with the aortic valve 6 as the boundary. The main part of the motor is located in the upper region of the aortic valve 6, and the hub 2 and the second blade 21 are located in the lower region of the aortic valve 6. The axial flow channel housing 3 is sleeved outside the motor body housing 1. The area between the axial flow channel housing 3 and the motor body housing 1 forms a blood flow channel. The motor body housing 1 extends, and its diameter can be reduced to make the blood flow channel as large as possible. The second blade rotates in the blood flow channel to drive the blood upward to form pressure. When the aortic valve 6 opens, the blood is sprayed from the ventricle into the aorta.

[0055] AsFigure 3 As shown, there is a free rotation gap between the spiral outer edge line of the fan surface of the second fan blade 21 and the inner wall surface of the axial flow channel housing 3, while the spiral outer edge line of the fan surface of the first fan blade 11 is fixedly connected along the inner wall surface of the axial flow channel housing 3, and the spiral inner edge line of the fan surface of the first fan blade 11 is fixedly connected along the outer peripheral surface of the motor body housing 1. In the design, while considering preventing the blood rotation caused by the second fan blade 21, in order to increase the supporting effect on the motor body housing 1 as well as the heat conduction and heat dissipation effects, the spiral inner edge line should increase the line contact length with the motor body housing 1 as much as possible. In Figure 3 it, the seemingly horizontal spiral inner edge line is actually a line spiraling downward, and its length is much greater than the projected length in the top view direction.

[0056] Among them, the number of the second fan blades 21 is 2, 3 or multiple. The number of the first fan blades 11 can generally be the same as or different from that of the second fan blades 21.

[0057] Such as 1, Figure 2 and Figure 3 , the outer diameter dimension of the axial flow channel housing 3 is slightly equal to that of the aortic tube 5. The upper port of the axial flow channel housing 3 adopts a flanging process to form a flanging part 31. The flanging part should not be too wide, and the size of the assembly hole 32 with the up-down axis can be formed on the flanging part. The flanging part can be a horizontal straight type or an edge-bending type flanging, and at least one upper and lower plane is provided with a suture body as a medium to be sutured and connected with the aortic valve root 61 or / and the aortic tube 5 by a suture 7. The assembly hole 32 is also used for the suture 7 to pass through. In the present invention, the axial flow channel housing 3 is hoisted by means of the aortic valve root 61. The aortic valve root 61 is the root part of the aortic valve 6, and this part generally grows horizontally perpendicular to the aortic tube 5 and is relatively thick. The aortic valve root 61 has stronger toughness, can bear heavier devices, and is more beneficial to the convenience of suture operation, the subsequent safety in use, and the suture area. Compared with the traditional method of directly suturing on the inner wall of the aortic tube, the damage to the aortic tube is smaller. Such as Figure 2 shown, the suture lines in the present invention all adopt vertically oriented suture lines and will not appear on the inner wall of the axial flow channel housing 3, avoiding the risk of thrombosis.

[0058] Such as Figure 2 shown, the suture body includes a lower suture body 41 and an upper suture body 42. Among them, the lower suture body 41, the flanging part, and the upper suture body 42 are stacked up and down to form a stacked combination body. Among them, the aortic valve root 61 is also a horizontal human tissue structure, and the aortic valve root 61, the lower suture body 41, the flanging part, and the upper suture body 42 are stacked up and down to form a stacked combination body. It forms a hanging mode, and the flanging part is equivalent to being embedded in the stacked combination body.

[0059] Such as Figure 4 shown, Figure 4The aortic valve 6, aortic valve root 61, and upper suture body 42 are not shown. The axial flow channel housing 3 is sleeved on the inner wall of the aortic tube 5. The axial direction of the axial flow channel housing 3, the axial direction of the aortic tube 5, and the axial direction of the motor body housing are all in the up and down direction.

[0060] The design principle of the present invention is as follows: The existing passive ventricular assist circulation device includes: a motor body housing, an axial flow channel housing 3 coaxially sleeved outside the motor body housing, a hub connected to the lower end of the motor body housing, a second fan blade circumferentially connected to the hub, a first fan blade that is not in contact with and connected to the motor body housing and is only disposed on one side of the inner wall of the axial flow channel housing 3 and only serves to eliminate the rotational movement of the blood caused by the second fan blade, a support rod that suspends the motor body housing 1 on the axis of the axial flow channel, the motor body housing 1 extends through the aortic valve, and a connecting rod and a fixing ring for fixing the upper end of the motor body housing 1 are provided at the upper end of the motor body housing 1. The heat dissipation path of this device only depends on the motor body housing 1, and the size of the motor body housing 1 is increased upward, thereby improving the heat dissipation effect. The overall weight of this device is relatively large. The support path I of this device includes the motor body housing, the support rod, and the axial flow channel housing connected in sequence, and the support path II of this device includes the motor body housing, the connecting rod, and the fixing ring connected in sequence.

[0061] In the present invention, the first fan blade is bridged between the motor body housing and the axial flow channel housing, thereby introducing the heat of the motor body housing into the first fan blade and the axial flow channel housing, so that the first fan blade and the axial flow channel housing can also serve as heat dissipation surfaces, increasing the heat dissipation area in contact with the blood. At the same time, the length of the motor housing does not need to be increased, and even the diameter of the motor housing can be further reduced, increasing the blood flow area. The present invention constructs a new heat dissipation path: the motor body housing, the first fan blade, and the axial flow channel housing. The first fan blade is a fixed structure and does not rotate. One side is fixed to the motor body housing and the other side is fixed to the axial flow channel housing. This greatly increases the heat dissipation area. At the same time, the first fan blade also plays a role in supporting the motor body housing, eliminating the support rod, connecting rod, and fixing ring in the prior art. A new support path is constructed: the motor body housing, the first fan blade, and the axial flow channel housing. The support path coincides with the heat dissipation path, playing a dual function. The spiral direction of the first fan blade is opposite to that of the second fan blade, playing a role in eliminating the rotational movement of the blood caused by the second fan blade. Therefore, the first fan blade in the present invention plays three roles: support, heat dissipation and heat conduction, and anti-blood rotation. The traditional first fan blade is only a guide vane connected to the inner wall of the axial flow channel housing on one side, which only plays the role of anti-blood rotation. In contrast, the present invention can prevent the accumulation of the motor body housing without relying on the method of increasing the area by extending the length or diameter of the motor body housing, but proposes a new technical method of using the axial flow channel housing for heat dissipation. The device can be provided with a shorter motor body housing and a smaller diameter motor body housing. The heat generation of the motor body housing can be controlled at 38 degrees Celsius. In the case of increasing the length and diameter of the traditional design, the temperature can generally only be controlled at 40 degrees Celsius. Therefore, there is a problem of thermal injury.

[0062] Preferably, the upper end of the axial flow channel housing 3 is provided with a radially outward flanging portion 31, and a suture body is pre-installed or temporarily assembled on the upper surface and / or lower surface of the flanging portion 31. The suture body located on the upper surface is an upper suture body 42 for suturing with the lower surface of the aortic valve root (human structure), and the suture body located on the upper surface is a lower suture body 41 for suturing with the inner surface of the aortic tube. The aortic valve root is the area adjacent to the aortic tube.

[0063] Preferably, the flanging portion 31 is provided with a plurality of assembly holes 32, and the axial direction of the assembly holes 32 is the same as the axial direction of the axial flow channel housing. The upper suture body 42 and / or the lower suture body 41 are pre-installed or temporarily assembled on the upper and / or lower sides of the flanging portion 31 after the suture line 7 passes through the assembly holes 32.

[0064] In the existing installation technology of the axial flow channel shell 3, for example, in CN1253837A, the general approach is to sleeve a suture body on the circumferential surface of the axial flow channel shell 3, and then suture and connect it to the inner wall of the aorta through the suture body. However, generally, the suture body is not firmly sleeved on the circumferential surface of the axial flow channel shell 3, and there is a risk of slippage. The general approach is to set a wire-passing hole in the horizontal direction of the shaft hole, and suture the suture body to the circumferential surface through the wire-passing hole in the horizontal direction of the shaft hole. However, when setting the wire-passing hole in the horizontal direction of the shaft hole, the suture line will pass through the wire-passing hole and be exposed on the inner side wall of the axial flow channel shell 3. Therefore, the suture line will be exposed in the blood flow channel. Experimental studies have found that this will cause blood to form thrombus based on the suture line and accumulate in the flow channel. Therefore, CN1253837A does not adopt the wire-passing hole in the horizontal direction of the shaft hole, but adopts the mortise and tenon concept. The circumferential surface of the axial flow channel shell 3 is recessed radially inward, so that the suture body is clamped into the inner recess to form a clamping connection. However, since the suture body is a braided structure and has high flexibility and easy deformation characteristics. Therefore, there is still a risk of slippage in this way. In order not to adopt the mortise and tenon concept that is prone to slippage, but to adopt the suture connection concept, and at the same time avoid the problem that the suture line will be exposed in the blood flow channel, the present invention adopts the flanging concept, that is, a radial (horizontal) flanging is performed at the upper end of the axial flow channel shell 3 to form a horizontally extended flanging part 31, and then the suture body is lapped on the upper surface and / or lower surface of the flanging part 31. Further, an assembly hole 32 with the same axial direction as the axial direction of the axial flow channel shell is provided on the flanging part 31, and the suture line is wound up and down through the assembly hole 32 to fix the suture body on the upper surface and / or lower surface of the flanging part 31, and the suture line will not appear in the flow channel of the axial flow channel shell 3. The assembly steps of the present invention are generally as follows: 1. In vitro, cut a suture body with the same width and inner diameter as the flanging part, place the suture body on the upper surface and / or lower surface of the flanging part 31, and use the suture line to wind up and down through the assembly hole 32 to fix the suture body on the upper surface and / or lower surface of the flanging part 31. The formed structure is called an assembly. 2. In vivo, suture the suture body to the aorta tube with a suture line.

[0065] In the present invention, since the suture body is fixed on the upper surface and / or lower surface of the flanging part 31, among which, the upper suture body 42 is sutured to the lower surface of the aortic valve root, which can facilitate increasing the suture area. Form a downward force to avoid suturing with the aorta tube and form an oblique force. Among them, the lower suture body 41 is sutured to the aorta tube to form a supporting force, which is equivalent to constructing a clamping groove in the aorta tube, and then inserting the flanging part into the clamping groove to increase the installation stability of the device.

[0066] Preferably, the outer diameter dimension of the flanging part 31 is preset as the inner diameter dimension of the aorta tube.

[0067] Preferably, the suture body is an annular medical polyester braid or an annular polytetrafluoroethylene braid or an artificial blood vessel or an artificial valve.

[0068] Preferably, the upper end of the motor body housing 1 extends out from the upper end of the axial flow channel housing 3 and is located below or above the aortic valve.

[0069] Preferably, the upper surface or / and the lower surface of the flanging portion 31 has a concave structure in the axial direction, and the upper suture body 42 or / and the lower suture body 41 is embedded in the concave structure.

[0070] Preferably, the axial flow channel housing 3, the first fan blades 11, and the motor body housing 1 are all made of high thermal conductivity material bodies.

[0071] The sum of the lengths of the spiral inner edges of all the first fan blades 11 is greater than or equal to the outer circumference of the motor body housing 1, and the sum of the lengths of the spiral outer edges of all the first fan blades 11 is greater than or equal to the inner circumference of the axial flow channel housing 3. The thickness of the first fan blades 11 on the side close to the motor body housing 1 is greater than the thickness on the side close to the axial flow channel housing 3.

[0072] Among them, the high thermal conductivity material bodies are all metal materials. The axial flow channel housing 3 serves as the base, the second fan blades 21 serve as the connecting bodies, and the motor body housing 1 serves as the object to be supported. It constructs a new support system and heat dissipation system. Among them, in order to increase the support stability and heat dissipation effect, the lengths of the spiral inner edges and spiral outer edges of the first fan blades 11 are subject to the above constraints, which can further increase the above effects. Since the first fan blades 11 are in a spiral rising structure, both sides of them are connected by lines rather than points. At the same time, the thickness of the first fan blades 11 on the side close to the motor body housing 1 can be further made greater than the thickness on the side close to the axial flow channel housing 3 to increase its thermal conductivity.

[0073] Embodiment 2: As Figure 6 shown, the motor body housing 1 does not extend and does not pass through the aortic valve 6. The hub 2 and the second fan blades 21 form an impeller. The motor main body is located in the lower region of the aortic valve 6, and the hub 2 and the second fan blades 21 are also located in the lower region of the aortic valve 6. The axial flow channel housing 3 is sleeved outside the motor body housing 1. The rest of the structure is the same as that in Embodiment 1, see the attached Figure 2 For Figure 6 the schematic diagram of the enlarged area FD in

[0074] Embodiment 3: As Figures 7-11As shown, a passive ventricular assist circulation device includes: a ventricular assist circulation pump device and a ventricular assist circulation valve device; the ventricular assist circulation pump device has an axial flow channel housing 3 and a power unit disposed within the axial flow channel housing 3; the ventricular assist circulation valve device has a tubular metal stent body 100 and an artificial aortic valve body 62, and the metal stent body includes a plurality of longitudinal struts; the upper end of the axial flow channel housing 3 is provided with a radially outward flanging portion 31, and the lower end 101 of the longitudinal strut of the longitudinal strut is assembled and fixed in contact with the flanging portion 31.

[0075] A preferred assembly contact implementation method is: One assembly method of the lower end 101 of the longitudinal strut is: The lower end 101 of the longitudinal strut of the longitudinal strut is directly welded to the upper surface of the flanging portion 31. Figure 7 This direct welding method is not shown.

[0076] A preferred assembly contact implementation method is: One assembly method of the lower end 101 of the longitudinal strut is: The flanging portion 31 is provided with a plurality of assembly holes 32, the axial direction of the assembly holes 32 is the same as the axial direction of the axial flow channel housing, and the lower end 101 of the longitudinal strut of the longitudinal strut is inserted into the interior of the assembly holes 32. See Figure 7 and Figure 8 . In Figure 8 , the lower end 101 of the longitudinal strut has not been inserted into the assembly hole 32 yet, and after assembly, the lower end 101 of the longitudinal strut needs to be inserted into the assembly hole 32.

[0077] The ventricular assist circulation valve device is an artificial valve having longitudinal struts, such as a balloon-expandable valve or a self-expanding valve or a mechanical valve.

[0078] Such as Figure 7 and Figure 8, the ventricular assist circulation pump device includes an axial flow channel housing 3 and a power unit disposed within the axial flow channel housing 3. Among them, the power unit mainly includes: a drive motor and an impeller mounted on the motor. The axial flow channel housing 3 is connected in series with the aorta, and the axial flow channel housing 3 is sutured to the heart artery through a flanging portion. Blood can only flow out from the axial flow channel housing 3. The drive motor provides kinetic energy. When the valve leaf of the upper ventricular assist circulation valve device opens, blood flows from the ventricle into the artery. The drive motor continuously operates, resulting in heat accumulation. If the heat accumulation is not reduced, it will cause blood thermal damage. In order not to increase the structural area of the drive motor itself to increase the heat dissipation area, the present invention uses a heat conducting fin to guide the heat of the motor body housing 1 of the drive motor to the axial flow channel housing 3, and uses the axial flow channel housing 3 to increase the heat dissipation area. In order to further improve the heat dissipation effect, the present invention constructs a flanging portion 31 on the basis of the axial flow channel housing 3, and directly welds and assembles the upper ventricular assist circulation valve device on the flanging portion 31 or constructs an assembly hole 32 and assembles the upper ventricular assist circulation valve device through the assembly hole 32 (the lower end 101 of the longitudinal pillar of the longitudinal pillar of the ventricular assist circulation valve device is inserted inside the assembly hole 32). The longitudinal pillar is integrally connected to the axial flow channel housing 3, and heat can be transferred to the longitudinal pillar. Due to the large number of longitudinal pillars, large extension range, large surface area in contact with blood, and being washed, the effect of dispersed heat dissipation can be achieved, greatly reducing the problem of heat accumulation of the drive motor. At the same time, since the longitudinal pillar is integrally connected to the axial flow channel housing 3, during its assembly, it can rely on the suture fixation of the axial flow channel housing 3 and the aorta to solve the problem of insufficient fixing force of the traditional ventricular assist circulation valve device relying on expansion support.

[0079] As Figure 7 and Figure 8 , the ventricular assist circulation pump device includes: a motor body housing 1, an axial flow channel housing 3 coaxially sleeved outside the motor body housing, a hub 2 connected to the lower end of the motor body housing 1, and a second fan blade 21 circumferentially connected to the hub 2. The motor body housing 1, the hub 2, and the second fan blade 21 form a power unit. It further includes a first fan blade 11. The first fan blade 11 functions as a heat conducting fin to conduct the heat of the motor body housing 1 to the axial flow channel housing 3. The spiral outer edge line of the fan surface of the first fan blade 11 is fixedly connected along the inner wall surface of the axial flow channel housing 3, and the spiral inner edge line of the fan surface of the first fan blade 11 is fixedly connected along the outer peripheral surface of the motor body housing 1; there is a free rotation gap between the spiral outer edge line of the fan surface of the second fan blade 21 and the inner wall surface of the axial flow channel housing 3, and the spiral inner edge line of the fan surface of the second fan blade 21 is fixedly connected along the circumference of the hub 2; the spiral direction of the first fan blade 11 is opposite to the spiral direction of the second fan blade 21.

[0080] As Figure 7As shown, the outer shell 1 of the motor body extends and passes through the valve leaflets of the ventricular assist circulation valve device. The valve leaflets are not shown in the figure. The hub 2 and the second fan blades 21 form an impeller. The outer shell 1 of the motor body and the impeller are designed as separate bodies with the aortic valve root 61 as the boundary. The main part of the motor is located in the upper region of the aortic valve root 61, and the hub 2 and the second fan blades 21 are located in the lower region of the aortic valve root 61. The axial flow channel housing 3 is sleeved outside the outer shell 1 of the motor body. The region between the axial flow channel housing 3 and the outer shell 1 of the motor body forms a blood flow channel. The extension of the outer shell 1 of the motor body can reduce its diameter, making the blood flow channel as large as possible. The second fan blades rotate in the blood flow channel, driving the blood upward to form pressure. When the valve leaflets of the ventricular assist circulation valve device open, the blood is sprayed from the ventricle into the aortic tube 5.

[0081] As Figure 9 shown, there is a free rotation gap between the spiral outer edge line of the fan blade surface of the second fan blade 21 and the inner wall surface of the axial flow channel housing 3, while the spiral outer edge line of the fan blade surface of the first fan blade 11 is fixedly connected along the inner wall surface of the axial flow channel housing 3, and the spiral inner edge line of the fan blade surface of the first fan blade 11 is fixedly connected along the outer peripheral surface of the outer shell 1 of the motor body. In the design, while considering preventing the blood rotation caused by the second fan blade 21, in order to increase the supporting effect on the outer shell 1 of the motor body and the heat conduction and heat dissipation effects, the spiral inner edge line should increase the line contact length with the outer shell 1 of the motor body as much as possible. In Figure 9 it, the seemingly horizontal spiral inner edge line is actually a spiral downward line, and its length is much greater than the projected length in the top view direction.

[0082] Among them, the number of the second fan blades 21 is 2, 3 or multiple. The number of the first fan blades 11 can generally be the same as or different from that of the second fan blades 21.

[0083] As shown in FIGS. 7, Figure 8 and Figure 9 , the outer diameter dimension of the axial flow channel housing 3 is slightly equal to that of the aortic tube 5. The upper port of the axial flow channel housing 3 adopts a flanging process to form a flanging part 31. The flanging part should not be too wide, and the size of the assembly hole 32 along the up-and-down axis can be formed on the flanging part. The flanging part can be a horizontal straight type or an edge-bending type flanging. At least one upper and lower plane of it is provided with a suture body as a medium and is sutured and connected to the aortic valve root 61 and / or the aortic tube 5 by a suture 7. The assembly hole 32 is also used for the suture 7 to pass through. In the present invention, the axial flow channel housing 3 is hoisted by means of the aortic valve root 61. The aortic valve root 61 is the root part of the aortic valve. This part generally grows horizontally perpendicular to the aortic tube 5 and is relatively thick. The aortic valve root 61 has stronger toughness and can bear a heavier device, which is more beneficial to the convenience of the suture operation, the safety of subsequent use, and the suture area. Compared with the traditional method of directly suturing on the inner wall of the aortic tube, the damage to the aortic tube is smaller. As Figure 8As shown, the sutures in the present invention all adopt vertical sutures and will not appear on the inner wall of the axial flow channel housing 3, avoiding the risk of thrombosis.

[0084] As Figure 8 shown, a suture body is pre-installed or temporarily assembled on the upper surface and / or lower surface of the flanging portion 31. The suture body located on the upper surface is the upper suture body 42 for suturing with the lower surface of the aortic root 61 and for suturing with the circumferential annular membrane of the ventricular assist circulation pump device. The circumferential annular membrane of the ventricular assist circulation pump device ( Figure 8 not shown in the figure) is also used for suturing with the aortic root 61. The suture body located on the lower surface is the lower suture body 41 for suturing with the inner surface of the aortic tube. The suture body includes the lower suture body 41 and the upper suture body 42. Among them, the lower suture body 41, the flanging portion, and the upper suture body 42 are stacked vertically to form a stacked combination. Among them, the aortic root 61 is also a horizontal human tissue structure. The aortic root 61, the lower suture body 41, the flanging portion, and the upper suture body 42 are stacked vertically to form a stacked combination. In its composition and suspension mode, the flanging portion is equivalent to being embedded in the stacked combination. The upper suture body 42 and / or the lower suture body 41 are pre-installed or temporarily assembled on the upper and / or lower sides of the flanging portion 31 through the suture 7 passing through the assembly hole 32.

[0085] The assembly hole 32 includes an assembly hole with a first diameter and an assembly hole with a second diameter. The assembly holes with the first diameter and the second diameter are arranged at intervals. The assembly hole with the first diameter is used for assembling the lower end 101 of the longitudinal strut or the suture 7, and the assembly hole with the second diameter is used for assembling the lower end 101 of the longitudinal strut or the suture 7; the diameter of the assembly hole with the first diameter is greater than or equal to the diameter of the assembly hole with the second diameter. In the present invention, the assembly hole 32 is divided into two categories, one is a large-diameter hole and the other is a small-diameter hole. The large-diameter hole is used for assembling the lower end 101 of the longitudinal strut, and the small-diameter hole is used for assembling the suture 7.

[0086] As Figure 10 shown, the axial flow channel housing 3 is sleeved on the inner wall of the aortic tube 5. The axial direction of the assembly hole 32, the axial direction of the axial flow channel housing 3, the axial direction of the aortic tube 5, and the axial direction of the motor body housing are all in the up and down direction.

[0087] In the present invention, the first fan blade is bridged between the motor body housing and the axial flow channel housing, thereby introducing the heat of the motor body housing into the first fan blade and the axial flow channel housing, so that the first fan blade and the axial flow channel housing can also serve as heat dissipation surfaces, increasing the heat dissipation area in contact with the blood. At the same time, the length of the motor housing body does not need to be increased, and even the diameter of the motor housing body can be further reduced, increasing the blood flow area. The present invention constructs a new heat dissipation path: the motor body housing, the first fan blade, and the axial flow channel housing. The first fan blade is a fixed structure and does not rotate. One side is fixed to the motor body housing and the other side is fixed to the axial flow channel housing. This greatly increases the heat dissipation area. At the same time, the first fan blade also plays a role in supporting the motor body housing, eliminating the support rods, connecting rods, and fixing rings in the prior art. A new support path is constructed: the motor body housing, the first fan blade, and the axial flow channel housing. The support path coincides with the heat dissipation path, serving a dual function. The spiral direction of the first fan blade is opposite to that of the second fan blade, which serves to eliminate the rotational movement of the blood caused by the second fan blade. Therefore, the first fan blade in the present invention plays three roles: support, heat dissipation and heat conduction, and anti-blood rotation. The traditional first fan blade is only a guide vane connected to the inner wall of the axial flow channel housing on one side, which only plays the role of anti-blood rotation. In contrast, the present invention can prevent the accumulation of the motor body housing without relying on the method of increasing the area by extending the length or diameter of the motor body housing, but proposes a new technical method of using the axial flow channel housing for heat dissipation. The device can be provided with a shorter motor body housing and a smaller diameter motor body housing. The heat conduction path of the present invention includes: the motor body housing, the first fan blade, the axial flow channel housing, and the longitudinal strut of the ventricular assist circulation valve device.

[0088] In the existing installation technology of the axial flow channel shell 3, for example, in CN1253837A, the general approach is to sleeve a suture body on the circumferential surface of the axial flow channel shell 3, and then suture and connect it to the inner wall of the aorta through the suture body. However, generally, the suture body sleeved on the circumferential surface of the axial flow channel shell 3 is not firm, and there is a risk of slippage. The general method is to set a wire-passing hole in the horizontal direction of the shaft hole, and suture the suture body to the circumferential surface through the wire-passing hole in the horizontal direction of the shaft hole. However, when setting the wire-passing hole in the horizontal direction of the shaft hole, the suture line will pass through the wire-passing hole and be exposed on the inner side wall of the axial flow channel shell 3. Therefore, the suture line will be exposed in the blood flow channel. Experimental studies have found that this will cause blood to form thrombus based on the suture line and accumulate in the flow channel. Therefore, CN1253837A does not adopt the wire-passing hole in the horizontal direction of the shaft hole, but adopts the mortise and tenon concept. The circumferential surface of the axial flow channel shell 3 is recessed radially inward, so that the suture body is clamped into the inner recess to form a snap connection. However, since the suture body is a braided structure and has high flexibility and easy deformation characteristics. Therefore, there is still a risk of slippage in this way. In order not to adopt the mortise and tenon technology concept that is prone to slippage, but to adopt the suture connection technology concept, and at the same time avoid the problem that the suture line will be exposed in the blood flow channel, the present invention adopts the flanging technology concept, that is, a radial (horizontal) flange is formed at the upper end of the axial flow channel shell 3 to form a horizontally extended flange portion 31, and then the suture body is lapped on the upper surface and / or lower surface of the flange portion 31. Further, an assembly hole 32 with the same axial direction as the axial direction of the axial flow channel shell is provided on the flange portion 31, and the suture line passes through the assembly hole 32 in a way of winding up and down to fix the suture body on the upper surface and / or lower surface of the flange portion 31, and the suture line will not appear in the flow channel of the axial flow channel shell 3. The assembly steps of the present invention are generally as follows: 1. In vitro, cut a suture body with the same width and inner diameter as the flange portion, place the suture body on the upper surface and / or lower surface of the flange portion 31, and pass the suture line through the assembly hole 32 in a way of winding up and down to fix the suture body on the upper surface and / or lower surface of the flange portion 31. The formed structure is called an assembly. 2. In vivo, suture the suture body to the aorta tube with a suture line.

[0089] In the present invention, due to the suture body fixed on the upper surface and / or lower surface of the flange portion 31, among which, the upper suture body 42 is sutured to the lower surface of the aortic valve root, which can facilitate increasing the suture area. Form a downward force to avoid suturing with the aorta tube and form an oblique force. Among them, the lower suture body 41 is sutured to the aorta tube to form a supporting force, which is equivalent to constructing a clamping groove in the aorta tube, and then inserting the flange portion into the clamping groove to increase the installation stability of the device.

[0090] Preferably, the outer diameter dimension of the flange portion 31 is preset as the inner diameter dimension of the aorta tube.

[0091] Preferably, the suture body is an annular medical polyester braid or an annular polytetrafluoroethylene braid or an annular artificial blood vessel.

[0092] Preferably, the upper end of the motor body housing 1 extends out from the upper end of the axial flow channel housing 3 and is located below or above the aortic valve.

[0093] Preferably, the upper surface or / and the lower surface of the flanging portion 31 has a concave structure in the axial direction, and the upper suture body 42 or / and the lower suture body 41 is embedded in the concave structure.

[0094] Preferably, the longitudinal struts, the axial flow channel housing 3, the second fan blades 21, and the motor body housing 1 are all made of high thermal conductivity material bodies.

[0095] The sum of the lengths of the spiral inner edges of all the first fan blades 11 is greater than or equal to the outer circumference of the motor body housing 1, and the sum of the lengths of the spiral outer edges of all the first fan blades 11 is greater than or equal to the inner circumference of the axial flow channel housing 3. The thickness of the first fan blade 11 on the side close to the motor body housing 1 is greater than the thickness on the side close to the axial flow channel housing 3.

[0096] Among them, the high thermal conductivity material bodies are all metal materials. The axial flow channel housing 3 serves as a base, the second fan blades 21 serve as connectors, and the motor body housing 1 serves as the object to be supported. A new support system and heat dissipation system are constructed. Among them, in order to increase the support stability and heat dissipation effect, the lengths of the spiral inner edge and the spiral outer edge of the first fan blade 11 are subject to the above constraints, which can further increase the above effects. Since the first fan blade 11 has a spiral rising structure, both sides of it are line-connected rather than point-connected. At the same time, the thickness of the first fan blade 11 on the side close to the motor body housing 1 can be further made greater than the thickness on the side close to the axial flow channel housing 3 to increase its thermal conductivity.

[0097] Embodiment 4 As Figure 12 shown, this embodiment provides a passive ventricular assist circulation device, including: a ventricular assist circulation pump device, and the ventricular assist circulation pump device includes: An axial flow pump, the axial flow pump includes a motor body housing 1, a stator and a rotor ( Figure 12 not shown in the figure) are arranged inside the motor body housing 1, the rotor (for example, the lower end) is connected to the hub 2, the hub 2 is circumferentially connected with the second fan blades 21, one of the stator and the rotor includes a field magnet and the other of the stator and the rotor includes a coil; an axial flow channel housing 3 coaxially sleeved outside the motor body housing; the upper end of the axial flow channel housing 3 is configured as a fluid outlet interface, the lower end is configured as a fluid inlet interface, the second fan blades 21 are arranged in the lower region of the axial flow channel housing 3, the upper end of the axial flow channel housing 3 is arranged below the aortic valve 6 (the tricuspid valve of the heart) facing the ventricle, and the axial flow channel housing 3 is configured to be connected in series with the aortic tube 5; As Figure 12As shown, an axial flow pump may adopt the corresponding structures in Embodiment 1, Embodiment 2, and Embodiment 3. This Embodiment 4 is implemented on the basis of Embodiments 1, 2, and 3. The core technical problem to be solved is to propose a new control mode for Embodiments 1, 2, and 3.

[0098] As Figure 12 shown, a power supply 20 is configured to be operatively coupled to the coil; a controller 10 is configured to be operatively coupled to the power supply to manually select a mode to control the power supply to change the rotor to a certain rotational speed (for example, a constant rotational speed), and after the rotor maintains operation in a certain rotational speed mode, different certain rotational speeds are configured with corresponding auxiliary pressures output at the fluid outlet interface. The manual selection criterion for the auxiliary pressure is: Auxiliary pressure = (Normal systolic pressure - Current measured systolic pressure of the heart failure patient) ± Calibration compensation pressure.

[0099] To achieve the above passive assist function, the controller 10 of the present invention controls the rotor to a certain constant rotational speed, that is, to achieve that the axial flow pump provides a constant auxiliary pressure. At the same time, it is also necessary to connect the axial flow channel housing 3 in series with the aortic tube 5 to avoid pressure relief and ensure that the aortic tube 5 is in a pre-pressurized state. Only when the cardiac systolic pulsation provides a supplementary pressure, the two are superimposed to provide a normal pressure. At the same time, it is also necessary to arrange the axial flow channel housing 3 below the aortic valve 6 facing the ventricle in the aortic tube 5, that is, below the tricuspid valve. The tricuspid valve is equivalent to a valve, and the auxiliary pressure is not sufficient to open the tricuspid valve. That is, the function of the axial flow pump of the present invention is to provide a passive auxiliary pressure, which will not cause the tricuspid valve to open and it has been in a waiting state. When the cardiac itself contracts to provide a pulsation pressure, the two are superimposed, so as to superimpose and generate a pressure, and this superimposed pressure is sufficient to open the tricuspid valve.

[0100] The axial flow pump provided by the present invention does not detect the cardiac rhythm, but provides a constant rotational speed and a constant pressure. The freely changing rhythm of the heart, that is, the heartbeat, triggers the opening of the tricuspid valve, thereby generating pulsation. The present invention does not affect the heartbeat rhythm, and the pulse in the human body system remains the natural rhythm of the human body. The present invention does not need to respond to the cardiac rhythm, and the reliability requirements for the corresponding product are low, and the safety performance is greatly improved.

[0101] Preferably, the power supply 20 is configured to be operatively coupled to the coil by wired or wireless means.

[0102] Preferably, the calibration compensation pressure is determined according to the blood viscosity state or / and the stator-rotor loss state.

[0103] Preferably, the controller 10 controls the power supply to change the rotor to a certain rotational speed in a constant current variable voltage manner, or a constant voltage variable current manner, or a variable voltage variable current manner.

[0104] Preferably, the controller 10 includes: A key-in module for obtaining the normal cardiac systolic pressure A key-in module for obtaining the currently measured cardiac systolic pressure of the heart failure patient A key-in module for confirming the calibration compensation pressure A module for calculating the auxiliary pressure, where the auxiliary pressure = (normal cardiac systolic pressure - currently measured cardiac systolic pressure of the heart failure patient) ± calibration compensation pressure; An output module for matching a control signal corresponding to a certain rotational speed according to the auxiliary pressure, where the control signal is a driving signal for the driving power supply to operate in a constant current variable voltage mode, or a constant voltage variable current mode, or a variable voltage variable current mode.

[0105] Specifically, a special user (doctor) collects and confirms the currently measured cardiac systolic pressure of the heart failure patient before the operation, confirms the calibration compensation pressure, and then calculates the required auxiliary pressure according to the normal cardiac systolic pressure. For example, the normal cardiac systolic pressure is 90 - 120 mmHg, the special user (doctor) determines the normal cardiac systolic pressure target to be 100 mmHg according to the patient's condition, confirms the calibration compensation pressure to be -10 mmHg, and measures that the currently measured cardiac systolic pressure of the heart failure patient is 70 mmHg, then the auxiliary pressure can be confirmed to be 40 mmHg. Therefore, the special user (doctor) enters the above parameters into the controller 10 through the interaction interface of the controller 10. Among them, the controller 10 calculates that the auxiliary pressure = 40 mmHg, and at the same time, the controller 10 confirms the corresponding rotational speed according to the auxiliary pressure - rotational speed correspondence table, and then outputs a driving signal adapted to the rotational speed. Through this driving signal, the power supply is controlled to output power parameters adapted to the rotational speed to supply power to the motor, so as to achieve the purpose of outputting the corresponding rotational speed. At this rotational speed, the axial flow pump in this embodiment rotates at a stable current rotational speed, providing a pressure adapted to 40 mmHg below the inner aortic valve 6 (the heart tricuspid valve). At this time, waiting for the cardiac contraction action, the cardiac contraction generates a pressure adapted to 70 mmHg, and the two pressures are superimposed to reach a pressure corresponding to 100 mmHg, so as to provide a pulsating pressure of 100 mmHg for the blood passage after the inner aortic valve 6 (the heart tricuspid valve) opens. The axial flow pump in this embodiment has no rhythm and does not require responsiveness, and only relies on the natural rhythm of the human body for control in the system.

[0106] Preferably, the controller 10 includes: A key-in module for obtaining the auxiliary pressure, where the auxiliary pressure = (normal cardiac systolic pressure - currently measured cardiac systolic pressure of the heart failure patient) ± calibration compensation pressure; An output module that matches a control signal corresponding to a certain rotational speed according to the auxiliary pressure, where the control signal is a driving signal for the driving power supply to operate in a constant current variable voltage manner, a constant voltage variable current manner, or a variable voltage variable current manner.

[0107] Specifically, the control provided in this embodiment may also only require obtaining the auxiliary pressure input. The auxiliary pressure needs to be calculated externally and then manually input into the controller, and the controller only needs to match the driving signal.

[0108] It should be noted that: Embodiment 1 is an auxiliary circulation device containing only a pump, that is, the auxiliary circulation device is the pump itself. The core problems it needs to solve are: constructing a new heat path to solve the problem of equipment heat damage, and constructing a new assembly position and assembly structure to solve the problem of equipment assembly stability, providing a structural basis for the waiting-for-heart-contraction control mode of Embodiment 4, where the aortic valve 6 (tricuspid valve) in Embodiment 1 is a healthy human structure. Embodiment 3 is an auxiliary circulation device containing a combination of a pump and an artificial valve. The core problems it needs to solve are: constructing a new heat path to solve the problem of equipment heat damage, and constructing a new assembly position and assembly structure to solve the problem of equipment assembly stability, providing a structural basis for the waiting-for-heart-contraction control mode of Embodiment 4, where the aortic valve 6 (tricuspid valve) in Embodiment 3 is replaced by an artificial aortic valve body 62, and any artificial aortic valve body 62 can be used. Among them, the metal stent body 100 of the artificial aortic valve body 62 is integrally connected to the pump to construct a new heat dissipation path.

[0109] Based on Embodiments 1, 2, and 3, Embodiment 4 provides a new solution for the control mode, aiming to solve the problem of forming a new control on the basis of the above system, and solving the existing control mode that relies on collecting the cardiac rhythm and then actively pumping in a responsive mode. It adopts a passive response, without collecting the rhythm and without calculating the rhythm periodicity. The control mode provided by the present invention is more stable and safe.

[0110] It can be understood that the above embodiments are merely exemplary embodiments adopted to illustrate the principle of the present invention / invention. However, the present invention / invention is not limited thereto. For those of ordinary skill in the art, various modifications and improvements can be made without departing from the spirit and essence of the present invention / invention, and these modifications and improvements are also regarded as the protection scope of the present invention / invention.

Claims

1. A passive ventricular assist circulatory device, characterized in that: include: A ventricular assist circulatory pump device, the ventricular assist circulatory pump device comprising: An axial flow pump, the axial flow pump comprising a motor housing (1), a stator and a rotor arranged inside the motor housing (1), the rotor connected to a hub (2), the hub (2) circumferentially connected to a second fan blade (21), one of the stator and the rotor comprising a field magnet and the other of the stator and the rotor comprising a coil; an axial flow channel shell (3) coaxially sleeved outside the motor housing; the upper end of the axial flow channel shell (3) being configured as a fluid outlet interface and the lower end being configured as a fluid inlet interface, the upper end of the axial flow channel shell (3) being configured below the aortic valve (6) facing the ventricle, and the axial flow channel shell (3) being configured to be connected in series with the aortic tube (5); a power source (20) configured to be operatively coupled to the coil; The controller (10) is configured to be operatively coupled to the power supply to select and control the power supply to change the rotor to a certain speed in an artificially selected mode, and the rotor keeps working in a certain speed mode. Different speeds are configured with corresponding auxiliary pressures output by the fluid outlet interface. The artificially selected standard of the auxiliary pressure is: auxiliary pressure = (normal cardiac systolic pressure - currently measured cardiac systolic pressure of heart failure patients) ± adjusted compensation pressure.

2. The passive ventricular assist circulation device according to claim 1, characterized in that: The power source (20) is configured to be coupled to the coil via a wired or wireless operation.

3. The passive ventricular assist circulation device according to claim 1, characterized in that: The adjustment compensation pressure is determined according to the blood viscosity state and / or the stator rotor loss state and / or the ventricular systolic pressure and / or the ventricular diastolic pressure and / or the cardiac output physiological parameter setting.

4. The passive ventricular assist circulation device according to claim 1, characterized in that: The controller (10) controls the power supply to change the rotation speed of the rotor to a certain value in a constant current to voltage mode, a constant voltage to current mode, or a variable voltage to current mode.

5. The passive ventricular assist circulation device according to claim 1, characterized in that: The controller (10) comprises: A keying module to obtain normal systolic pressure, Get the input module of the current measurement of cardiac systolic pressure of the heart failure patient, Confirm the input module for adjusting the compensation pressure, A module for calculating auxiliary pressure, auxiliary pressure = (normal cardiac systolic pressure - currently measured cardiac systolic pressure of heart failure patients) ± adjusted compensation pressure; An output module for matching a control signal corresponding to a certain rotation speed according to the auxiliary pressure, wherein the control signal is a driving signal for driving the power supply to operate in a constant current to voltage mode, a constant voltage to current mode, or a variable voltage to current mode.

6. The passive ventricular assist circulation device according to claim 1, characterized in that: The controller (10) comprises: A keying module for obtaining auxiliary pressure, where auxiliary pressure = (normal cardiac systolic pressure - currently measured cardiac systolic pressure of heart failure patients) ± adjusted compensation pressure; An output module for matching a control signal corresponding to a certain rotation speed according to the auxiliary pressure, wherein the control signal is a driving signal for driving the power supply to operate in a constant current to voltage mode, a constant voltage to current mode, or a variable voltage to current mode.

7. The passive ventricular assist circulatory device according to any one of claims 1 to 6, characterized in that: It also includes a first blade (11), wherein the spiral outer edge of the blade surface of the first blade (11) is fixedly connected along the inner wall surface of the axial flow channel shell (3), and the spiral inner edge of the blade surface of the first blade (11) is fixedly connected along the outer peripheral surface of the motor body shell (1); there is a free rotation gap between the spiral outer edge of the blade surface of the second blade (21) and the inner wall surface of the axial flow channel shell (3), and the spiral inner edge of the blade surface of the second blade (21) is fixedly connected along the circumference of the hub (2).

8. The passive ventricular assist circulatory device according to any one of claims 1 to 6, characterized in that: The upper end of the axial flow channel shell (3) is provided with a radially outward flange portion (31), and the upper surface or / and the lower surface of the flange portion (31) are pre-installed or temporarily assembled with a suture body, the suture body located on the upper surface is an upper suture body (42) used for suturing with the lower surface of the aortic valve root, and the suture body located on the upper surface is a lower suture body (41) used for suturing with the inner surface of the aortic tube.

9. The passive ventricular assist circulation device according to claim 8, characterized in that: The flange portion (31) is provided with a plurality of assembly holes (32), the axial direction of the assembly holes (32) being the same as the axial direction of the axial flow channel shell, and the upper suture body (42) and / or the lower suture body (41) are pre-installed or temporarily assembled on the upper and / or lower sides of the flange portion (31) after the suture thread (7) passes through the assembly holes (32).

10. The passive ventricular assist circulation device according to claim 8, characterized in that: The outer diameter size of the flange portion (31) is preset to be the inner diameter size of the aorta tube.

11. The passive ventricular assist circulation device according to claim 8, characterized in that: The suture body is a circular medical polyester braided body or a circular polytetrafluoroethylene braided body or a circular artificial blood vessel or artificial valve.

12. The passive ventricular assist circulation device according to claim 8, characterized in that: The upper end of the motor body shell (1) extends out from the upper end of the axial flow channel shell (3).

13. The passive ventricular assist circulation device according to claim 8, characterized in that: The upper surface and / or the lower surface of the flange portion (31) has an axially concave structure, and the upper suture body (42) and / or the lower suture body (41) are embedded in the concave structure.

14. The passive ventricular assist circulation device according to claim 7, characterized in that: The axial flow channel shell (3) and / or the first fan blade (11) and / or the motor body shell (1) are all made of a material with high thermal conductivity.

15. The passive ventricular assist circulation device according to claim 7, characterized in that: The sum of the lengths of the spiral inner edges of all the first blades (11) is greater than or equal to the outer circumference of the motor housing (1), and the sum of the lengths of the spiral outer edges of all the first blades (11) is greater than or equal to the inner circumference of the axial flow channel housing (3).

16. The passive ventricular assist circulation device according to claim 7, characterized in that: The thickness of the first fan blade (11) on a side close to the motor body shell (1) is greater than the thickness of the side close to the axial flow channel shell (3).

17. The passive ventricular assist circulation device according to any one of claims 1 to 6, characterized in that: Also included is a ventricular assist circulatory valve device; the ventricular assist circulatory valve device has a tubular metal stent body (100), the metal stent body comprising a plurality of longitudinal struts; the upper end of the axial flow channel shell (3) is provided with a radially outward flange portion (31), and the longitudinal strut lower end (101) of the longitudinal strut is assembled, contacted and fixed to the flange portion (31).

18. The passive ventricular assist circulation device according to claim 17, characterized in that: The longitudinal support lower end (101) of the longitudinal support is directly welded to the upper surface of the flange portion (31).

19. The passive ventricular assist circulation device according to claim 17, characterized in that: The flange portion (31) is provided with a plurality of assembly holes (32), the axial direction of the assembly holes (32) is the same as the axial direction of the axial flow channel shell, and the longitudinal support lower ends (101) of the longitudinal supports are inserted into the assembly holes (32).

20. The passive ventricular assist circulation device according to claim 17, characterized in that: The lower end (101) of the longitudinal support is inserted into the assembly hole (32) with equal diameter and then welded to form an integrated structure, or the lower end (101) of the longitudinal support is inserted into the assembly hole (32) with interference fit to form an integrated structure.

21. The passive ventricular assist circulation device according to claim 19, characterized in that: The upper surface or / and the lower surface of the flange portion (31) are pre-installed or temporarily assembled with a suture body, the suture body located on the upper surface is an upper suture body (42) used for suturing with the lower surface of the aortic valve root (61) of the aortic valve (6) and for suturing with the circumferential annulus of the ventricular assist circulation pump device, the circumferential annulus of the ventricular assist circulation pump device is also used for suturing with the aortic valve root (61), and the suture body located on the lower surface is a lower suture body (41) used for suturing with the inner surface of the aortic tube.

22. The passive ventricular assist circulation device according to claim 21, characterized in that: The upper suture body (42) and / or the lower suture body (41) are pre-installed or temporarily assembled on the upper and / or lower sides of the flange portion (31) after the suture thread (7) passes through the assembly hole (32).

23. The passive ventricular assist circulation device according to claim 22, characterized in that: The assembly holes (32) include an assembly hole of a first diameter and an assembly hole of a second diameter, the assembly holes of the first diameter and the assembly holes of the second diameter are arranged at intervals, the assembly hole of the first diameter is used to assemble the lower end (101) of the longitudinal support or the suture (7), and the assembly hole of the second diameter is used to assemble the lower end (101) of the longitudinal support or the suture (7); the diameter of the assembly hole of the first diameter is greater than or equal to the diameter of the assembly hole of the second diameter.

24. The passive ventricular assist circulation device according to claim 17, characterized in that: The ventricular assist valve device is an artificial valve with longitudinal struts.

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