Blood circulation assistance system

Abstract

The application aims to provide a blood circulation assisting system capable of generating pulsating blood flow and guaranteeing body functions, comprising a first blood circulation supporting unit located in a heart chamber of a patient and a second blood circulation supporting unit located in a descending aorta of the patient, the first blood circulation supporting unit pumping blood in the heart chamber to the aorta, and the second blood circulation supporting unit generating pulsating blood flow by periodically contracting and expanding to squeeze blood, and partially blocking the blood vessel when expanding. When the second blood circulation supporting unit periodically expands to squeeze blood, it does not completely block the blood vessel, but leaves a part of the blood flow passage, so as to allow part of the blood to pass through, prevent the ascending aorta pressure from suddenly rising, and prevent the blood from flowing back to the left ventricle, and also prevent the second blood circulation supporting unit from moving, so as to guarantee the pulsating effect and prevent unnecessary damage to the inner wall of the blood vessel.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a blood circulation auxiliary system. BACKGROUND

[0002] In a normal human body, in a beating cycle, when the heart contracts, the aortic valve between the left ventricle and the aorta opens, the blood in the left ventricle flows into the aorta under the contraction pressure, so that the aorta supplies blood to the tissues and organs of the human body; at the same time, the pulmonary valve between the right ventricle and the pulmonary artery opens, the blood in the right ventricle flows into the pulmonary artery, so that the pulmonary artery supplies blood to the pulmonary veins and branch organs of the human body. When the heart relaxes, the aortic valve closes to prevent the blood in the aorta from flowing back to the left ventricle; at the same time, the pulmonary valve closes to prevent the blood in the pulmonary artery from flowing back to the right ventricle. The aorta of the human body is sequentially divided into ascending aorta, aortic arch and descending aorta along the direction of blood flow, and the ascending aorta, aortic arch and descending aorta are sequentially connected.

[0003] The occurrence of cardiovascular diseases can lead to heart failure, which is manifested as dysfunction of the contraction and / or diastolic function of the heart, which cannot fully discharge the venous return blood volume from the heart, resulting in blood stasis in the ventricle, insufficient blood perfusion of the arterial interventional heart-kidney combined auxiliary system, causing heart blood circulation disorder, and triggering organ failure and even shock and other life-threatening conditions. At present, mechanical circulation support devices, also known as blood pumps, can assist or replace the heart pumping function to provide blood flow-based life support for cardiogenic shock and acute heart failure. When the blood pump is working, blood flows from the left ventricle to the whole body organs via the aorta, but the constant flow mode of the blood pump will increase the peripheral resistance of the systemic circulation as the days of assistance increase. In addition, when the systemic circulation relies on constant flow perfusion support, the carotid baroreceptor receives a signal, and the body increases the release of catecholamines, activates renin-angiotensin, releases vasopressin and local tissue factor, and further increases peripheral vascular resistance. The constant flow mode of blood will also increase the risk of potential complications such as gastrointestinal arteriovenous malformations and acquired von Willebrand disease.

[0004] To address the aforementioned issues, Chinese patent application No. CN114259646A (hereinafter referred to as Document 1), entitled "Blood Circulation Assist Device and Control System," discloses the following technical solution: It includes a sheath and a first balloon installed within a blood vessel, and a pump located distal to the sheath. During the flow of blood from the ventricle into the blood vessel under the power of the pump, a controller intermittently inflates and deflates the first balloon, making the inflation and deflation of the first balloon periodic. This periodically blocks and opens the blood vessel, causing the blood to be periodically blocked and opened during flow, thereby generating a pulsatile blood flow that matches the periodic diastolic and systolic characteristics of the heart. It is well known that when the pump is inserted into the patient's left ventricle, the aortic valve is in a septal state. After blood flows into the aorta, based on hemodynamics, some blood flows back from the aorta to the left ventricle, partially offsetting the outflow and reducing the auxiliary efficiency of the heart pump assembly. When the first balloon in Reference 1 expands, it completely blocks the blood vessel and cuts off blood flow. This causes a sudden increase in left atrial pressure, which on the one hand aggravates the phenomenon of blood reflux into the left ventricle and further reduces the auxiliary efficiency of the heart pump assembly; on the other hand, the sudden increase in left atrial pressure can also cause the first balloon to shift, weaken the pulsating effect and cause unnecessary damage to the inner wall of the blood vessel. Summary of the Invention

[0005] The purpose of this invention is to provide a blood circulation support system that can generate pulsating blood flow and ensure various bodily functions.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: a blood circulation support system, comprising a first blood circulation support unit located in the ventricle of the patient and a second blood circulation support unit located in the descending aorta of the patient. The first blood circulation support unit pumps blood from the ventricle to the aorta. The second blood circulation support unit generates pulsatile blood flow by periodically contracting and expanding to squeeze the blood. When the second blood circulation support unit expands, it partially blocks the blood vessels.

[0007] The second blood circulation support unit includes at least two single balloons that are connected to each other by side. Each single balloon is independently sealed and connected to the same tubing through a connector. When the single balloons are inflated, the area between each single balloon forms a blood flow channel.

[0008] There are three single balloons in total, forming a gap between them. The catheter connected to the proximal end of the first blood circulation support unit passes through the gap and is fixedly connected to the single balloon.

[0009] The second blood circulation support unit comprises an integrated balloon and a constraint frame, an inner tube is arranged in the inner cavity of the integrated balloon, both ends of the inner tube extend to the outside of both ends of the integrated balloon and are connected with catheters, and the constraint frame limits the outward expansion of part of the integrated balloon when the integrated balloon expands, and the area of the outer periphery of the constrained integrated balloon constitutes a blood flow channel.

[0010] The constraint frame comprises a plurality of supports arranged along the circumferential direction of the inner tube, the supports are in an arch shape, both ends of the supports are fixed to the outer wall of the inner tube, the middle part of the supports is in an arch shape, the profile line of the middle part of the arch is smaller than the maximum outer periphery profile line of the integrated balloon when the integrated balloon expands, the outer wall of the support is fixedly connected with the inner wall of the integrated balloon, and the support is made of foldable material with shape memory function.

[0011] The constraint frame comprises a plurality of pull rod groups arranged along the circumferential direction of the inner tube, each pull rod group comprises a plurality of pull rods arranged along the axial direction, one end of the pull rod is fixed to the inner tube, the other end of the pull rod is connected with the inner wall of the integrated balloon, and the pull rod is woven from a nickel-titanium wire with shape memory function.

[0012] The constraint frame is arranged on the outer periphery of the integrated balloon and comprises a plurality of support bodies arranged along the circumferential direction of the integrated balloon, both ends of the support body are fixed to the outer wall of the inner tube protruding to the outside of the integrated balloon, the middle part of the support body is in an arch shape, and the profile line of the middle part of the arch is smaller than the maximum outer periphery profile line of the integrated balloon when the integrated balloon expands, and the support body is made of foldable material with shape memory function.

[0013] The catheter is of a segmented structure and comprises a first catheter segment between the first blood circulation support unit and the integrated balloon and a second catheter segment extending to the outside of the body from the proximal end of the integrated balloon, and the proximal end of the first blood circulation support unit is provided with a cleaning pipeline and a PCB cable, the cleaning pipeline and the PCB cable enter the lumen of the inner tube from the inner cavity of the first catheter segment and extend to the second catheter segment.

[0014] The single-balloon / integrated balloon is communicated with an external medium source through a pipeline, the medium is gas, and the control unit controls the single-balloon / integrated balloon to deflate at the end of diastole and to inflate at the end of systole / early diastole.

[0015] The first blood circulation support unit comprises a motor, the proximal end of the motor is connected with the catheter, the distal end of the motor is coaxially connected with an impeller, the outer periphery of the impeller is provided with a blood outflow cage, the distal end of the blood outflow cage is fixed with the proximal end of a blood inflow cage through a sleeve, and the distal end of the blood inflow cage is further connected with a pigtail tube.

[0016] An optical fiber pressure sensor is arranged on the motor, and an optical fiber pressure sensor is also arranged on the single-balloon / integrated balloon.

[0017] The two groups of blood circulation support units form a series pump group in the application, under the axial pumping action of the first blood circulation support unit, the blood flow can easily overcome the pressure difference between the left ventricle and the aorta, complete the blood flow discharge movement, and then rely on the second blood circulation support unit located in the descending aorta to periodically block and conduct the blood flow in the blood vessel, so as to generate pulsatile blood flow that matches the periodic diastolic and systolic characteristics of the heart, eliminate the adverse effects of the continuous blood flow generated by the traditional ventricular assist device, at the same time, improve the blood perfusion of the patient's coronary and distal organs, reduce the burden of the ventricle, be beneficial to the patient's stable signs during the operation and postoperative rehabilitation, and promote the recovery of the patient's heart.

[0018] More importantly, when the second blood circulation support unit periodically expands and extrudes the blood, it does not completely block the blood vessel, but leaves part of the blood flow passage, allowing part of the blood to pass while providing pulsatile blood flow, thereby preventing the left atrial pressure from rising sharply, causing the blood to flow back into the left ventricle, and preventing the second blood circulation support unit from shifting, thereby ensuring the pulsatile effect and not causing unnecessary damage to the inner wall of the blood vessel. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 It is a schematic diagram of the blood circulation auxiliary system in use state;

[0020] Figure 2 It is a schematic diagram of the structure of the blood circulation auxiliary system;

[0021] Figure 3 It is a schematic diagram of the structure of the second blood circulation support unit in Example 1;

[0022] Figure 4 It is a sectional view of the second blood circulation support unit in Example 1;

[0023] Figure 5 It is a sectional view of the second blood circulation support unit in Example 2;

[0024] Figure 6 It is a sectional view of the second blood circulation support unit in Example 3;

[0025] Figure 7 It is a sectional view of the second blood circulation support unit in Example 4;

[0026] Figure 8 It is a schematic diagram of the structure of the first blood circulation support unit;

[0027] Figure 9 It is a sectional view of the motor;

[0028] Figure 10 It is a schematic diagram of the structure of the integrated balloon;

[0029] Figure 11 for Figure 2 a sectional view along the line A-A in Fig. 1;

[0030] Figure 12 for Figure 2 a sectional view along the line B-B in Fig. 1. DETAILED DESCRIPTION

[0031] For the sake of convenience, first we define the orientation involved in the following: "proximal" and "proximally" refer to the side close to the operator / physician, "distal" and "distally" refer to the side away from the operator / physician, i.e. the side close to the heart, which will be described below in conjunction with Figures 1-12 The application is further described in detail.

[0032] The heart can be mainly divided into two phases, i.e. systole and diastole, in a cardiac cycle. In the diastole phase, the mitral valve is open, the arterial valve is closed, and blood flows from the atrium to the ventricle to achieve filling. In the systole phase, the arterial valve is open, the mitral valve is closed, and the ventricle contracts to pump the blood inside the ventricle to the arterial blood vessels. The heart mainly provides kinetic energy for blood by such working mode to achieve the circulation of blood in the whole body.

[0033] As shown in Figs. 1 and 2, a blood circulation assisting system includes a first blood circulation supporting unit 10 located in the ventricle of a patient and a second blood circulation supporting unit 20 located in the descending aorta of the patient. The first blood circulation supporting unit 10 pumps the blood in the ventricle to the aorta, and the second blood circulation supporting unit 20 generates pulsatile blood flow by periodically contracting and expanding to squeeze the blood. When the second blood circulation supporting unit 20 expands, part of the occluded blood vessels is unblocked. Figure 1 Figure 2 Therefore, in the present application, two groups of blood circulation supporting units form a series pump group. Under the action of the axial flow of the first blood circulation supporting unit 10, the blood flow can easily overcome the pressure difference between the left ventricle and the aorta to complete the blood flow discharge movement. Then, the second blood circulation supporting unit 20 located in the descending aorta periodically blocks and unblocks the blood flow in the blood vessels, so as to generate pulsatile blood flow which is adapted to the periodic diastole and systole characteristics of the heart. Thus, the adverse effects caused by the continuous blood flow of the traditional ventricular assist device are eliminated. At the same time, the blood perfusion of the coronary artery and the distal organs of the patient is improved, the burden of the ventricle is reduced, which is conducive to the stability of the patient's signs during the operation and the postoperative recovery, and promotes the recovery of the patient's heart.

[0034] Therefore, in the present application, two groups of blood circulation supporting units form a series pump group. Under the action of the axial flow of the first blood circulation supporting unit 10, the blood flow can easily overcome the pressure difference between the left ventricle and the aorta to complete the blood flow discharge movement. Then, the second blood circulation supporting unit 20 located in the descending aorta periodically blocks and unblocks the blood flow in the blood vessels, so as to generate pulsatile blood flow which is adapted to the periodic diastole and systole characteristics of the heart. Thus, the adverse effects caused by the continuous blood flow of the traditional ventricular assist device are eliminated. At the same time, the blood perfusion of the coronary artery and the distal organs of the patient is improved, the burden of the ventricle is reduced, which is conducive to the stability of the patient's signs during the operation and the postoperative recovery, and promotes the recovery of the patient's heart.

[0035] ​The second blood circulation support unit 20 imitates the real blood supply mode of the heart, which can periodically flush the inner wall surface of the blood vessel to reduce the formation of thrombus, and periodically contract and expand to press the blood, so that more blood flow can be preferentially ensured for the supply of main organs such as heart, brain and lung.

[0036] More importantly, when the second blood circulation support unit 20 periodically expands to press the blood, it does not completely block the blood vessel, but leaves part of the blood flow passage, so as to prevent the left atrial pressure from suddenly rising and the blood from flowing back to the left ventricle, and also prevent the second blood circulation support unit 20 from moving, so as to ensure the pulsation effect and prevent unnecessary damage to the inner wall of the blood vessel.

[0037] When the heart normally beats, it not only provides the blood flow with forward flow kinetic energy, but also provides the blood vessel with tension potential energy. The laminar perfusion can only provide the blood flow with forward flow kinetic energy, and almost no tension potential energy of the blood vessel. The opening and closing threshold of the capillary is 1.3-3.3 kpa (10-25 mmHg), and the laminar perfusion is difficult to reach this value. The second blood circulation support unit 20 generates pulsatile blood flow to imitate the real blood supply mode of the heart, so as to provide the blood flow with forward flow kinetic energy and provide the blood vessel with tension potential energy.

[0038] Meanwhile, the second blood circulation support unit 20 located in the descending aorta can realize secondary blood flow acceleration, so as to weaken the blood pumping requirement of the first blood circulation support unit 10, reduce the speed requirement of the first blood circulation support unit 10 in the ventricle, help to reduce hemolysis, reduce motor heating and non-physiological blood stress damage, improve the blood compatibility of the device, and help to reduce the load of the ventricle, improve the blood circulation of the descending aorta, effectively unload the ventricular pressure, increase the blood perfusion amount of terminal organs such as kidney, and improve the heart and kidney functions.

[0039] Embodiment 1

[0040] Preferably, the second blood circulation support unit 20 comprises at least two single balloons 21 connected with each other through the side surfaces. The single balloons 21 are respectively sealed and communicated with the same pipeline through the joints. When the single balloons 21 expand, the area between the single balloons 21 forms a blood flow passage. Since the side surfaces of the single balloons 21 are connected with each other, the connection part limits the expansion of the balloons around the connection part, which is equivalent to the constraint of the balloons. Therefore, the connection part between the single balloons 21 cannot be deformed too much, so as to form the blood flow passage to allow a small part of blood to pass through.

[0041] In order to facilitate the connection of the catheter 30, three single balloons 21 are provided, as shown in FIG. 2. Figure 3 、 Figure 4, the middle of the three single balloons 21 forms a gap a, the catheter 30 connected to the proximal end of the first blood circulation support unit 10 passes through the gap a and is fixedly connected with the single balloon 21. The three single balloons 21 are distributed in a triangular shape, the whole posture is more stable, and the middle of the three single balloons 21 leaves a gap a, which is just used as a passing path for the catheter 30, so as to facilitate the control system outside the body to control the first blood circulation support unit 10, and has no any influence on the structure of the second blood circulation support unit 20. The three single balloons 21 are preferably communicated with the same pipeline through the interface, and the control unit outside the body controls the three single balloons 21 to contract or expand at the same time, so as to improve the blood pulsation effect.

[0042] Unlike example 1, the second blood circulation support unit 20 comprises an integrated balloon 23 and a constraint frame 25, an inner tube 24 is arranged in the inner cavity of the integrated balloon 23, both ends of the inner tube 24 extend to the outside of both ends of the integrated balloon 23 and are connected with the catheter 30, when the integrated balloon 23 expands, the constraint frame 25 limits part of the integrated balloon 23 to expand outward, and the area of the outer periphery of the constrained integrated balloon 23 constitutes a blood flow passage. This structure is to constrain the deformation of the integrated balloon 23 by the additional constraint frame 25, the integrated balloon 23 will fluctuate when inflating and deflating, and is easy to shake, however, we hope that the position of the integrated balloon 23 is relatively fixed, therefore, the inner tube 24 is arranged, on the one hand, as a support for the integrated balloon 23, to limit the position of the integrated balloon 23, on the other hand, as a pipeline for the cleaning pipeline 17, the PCB cable 18 and the first signal line 19 to pass through, due to the existence of the inner tube 24, the cleaning pipeline 17, the PCB cable 18 and the first signal line 19 will not have any adverse effects on the inside, to ensure the normal work of the integrated balloon 23.

[0043] Among them, the structure and arrangement of the constraint frame 25 at least include but are not limited to the following three embodiments.

[0044] Example 2

[0045] The first one is Figure 5As shown, the constraint frame 25 comprises a plurality of supports 251 arranged along the circumferential direction of the inner tube 24, the supports 251 are in the shape of arch-shaped strips, the two ends of the supports 251 are fixed to the outer wall of the inner tube 24, and the middle part is in the shape of arch, and the profile of the middle arch is smaller than the maximum outer circumferential profile of the integrated balloon 23 when expanded, i.e. when expanded, the balloon at the position not constrained by the supports 251 is expanded to the maximum state (which can be tightly attached to the blood vessel wall or slightly expand the blood vessel), while the balloon at the position constrained by the supports 251 cannot be expanded to the maximum state like other parts, so there will be a gap between the position and the inner wall of the blood vessel for part of the blood to pass through. The outer wall of the support 251 is fixedly connected to the inner wall of the integrated balloon 23, and the support 251 is made of foldable material with shape memory function, which can be contracted before intervention and expanded in the inflated state after intervention.

[0046] Embodiment 3

[0047] The second is as shown in Figure 6 As shown, the constraint frame 25 comprises a plurality of pull rod groups arranged along the circumferential direction of the inner tube 24, each pull rod group comprises a plurality of pull rods 252 arranged along the axial direction, one end of the pull rod 252 is fixed to the inner tube 24, and the other end is connected to the inner wall of the integrated balloon 23, and the pull rod 252 is made of nickel-titanium wire woven with shape memory material. In this case, the constraint frame 25 can also be contracted before intervention and expanded in the inflated state after intervention, and the difference from the first case is that the pull rod group here is not a whole, but is composed of a plurality of pull rods 252 arranged at intervals.

[0048] Embodiment 4

[0049] The third is as shown in Figure 7 As shown, the constraint frame 25 is arranged on the outer circumference of the integrated balloon 23, and comprises a plurality of support bodies 253 arranged along the circumferential direction of the integrated balloon 23, the two ends of the support body 253 are fixed to the outer wall of the inner tube 24 which protrudes to the outside of the integrated balloon 23, and the middle part is in the shape of arch, and the profile of the middle arch is smaller than the maximum outer circumferential profile of the integrated balloon 23 when expanded, and the support body 253 is made of foldable material with shape memory function. Different from the first arrangement, the constraint frame 25 here constrains the integrated balloon 23 from the outside, and when expanded, the balloon at the position not constrained by the support body 253 is expanded to the maximum state (which can be tightly attached to the blood vessel wall or slightly expand the blood vessel), while the balloon at the position constrained by the support body 253 cannot be expanded to the maximum state like other parts, so there will be a gap between the position and the inner wall of the blood vessel for part of the blood to pass through.

[0050] In embodiments 2, 3, and 4, the catheter 30 has a segmented structure, including a first catheter segment 31 located between the first blood circulation support unit 10 and the integrated balloon 23, and a second catheter segment 32 located proximal to the integrated balloon 23 and extending outside the body. That is, the integrated balloon 23 is located in the middle section of the catheter, and to achieve connection with the integrated balloon 23, the catheter is divided into two parts: the first catheter segment 31 and the second catheter segment 32. Due to the special environment of the motor 11, blood can enter the motor 11 from the gap between the bearing and the shaft, causing thrombosis. Therefore, cleaning fluid needs to be injected into the motor 11 to prevent blood from entering and to remove the heat generated by the motor 11 during operation. A cleaning conduit 17 and a PCB cable 18 are provided proximal to the first blood circulation support unit 10. Figure 10 As shown, the cleaning pipe 17 and PCB cable 18 enter the lumen of the inner tube 24 from the inner cavity of the first conduit section 31 and extend into the second conduit section 32.

[0051] The single balloon 21 / integrated balloon 23 is connected to an external medium source via tubing 26. The medium is gas. The control unit controls the single balloon 21 / integrated balloon 23 to deflate at end-diastole and inflate at end-systole / early diastole. The inflation and deflation timing of the single balloon 21 / integrated balloon 23 coincides with the heart's diastolic and systolic timings. The pump used to control the inflation and deflation of the single balloon 21 / integrated balloon 23 needs to be ECG-gated, triggered by the rising R wave on the ECG. Exhaust (aspiration) begins during the early systole of the ventricle during the rising R wave phase, and inflation begins during the early diastole of the ventricle at the start of the T wave phase, when the arterial valve closes. This simulates and synchronizes the left ventricular systole process, assisting left ventricular pumping and reducing left ventricular preload. The preferred gas here is nitrogen, which is continuously cooled externally before inflation and deflation.

[0052] See Figure 8 , Figure 9 The first blood circulation support unit 10 includes a motor 11. The proximal end of the motor 11 is connected to the conduit 30, and the distal end is coaxially connected to an impeller 12. A blood outflow cage 13 is provided on the outer periphery of the impeller 12. The distal end of the blood outflow cage 13 is fixed to the proximal end of the blood inflow cage 15 through a sleeve 14. The distal end of the blood inflow cage 15 is also connected to a pig tail tube 16. The pig tail tube 16 abuts against the ventricular wall to play a positioning role. The motor 11 drives the impeller 12 to rotate, drawing blood from the ventricle into the blood inflow cage 15, which then enters the sleeve 14 and is discharged into the aorta from the proximal blood outflow cage 13, thus achieving auxiliary blood pumping.

[0053] The motor 11 is provided with an optical fiber pressure sensor for detecting the pressure of the blood flow in the ventricle, improving the effectiveness of physiological information monitoring. The first signal line 19 of the optical fiber pressure sensor is arranged in the same way as the cleaning pipeline 17 and the PCB cable 18, entering the lumen of the inner tube 24 from the lumen of the first catheter segment 31 and extending to the second catheter segment 32. The single balloon 21 / integral balloon 23 is also provided with an optical fiber pressure sensor for detecting the pressure of the blood flow in the descending aorta, improving the effectiveness of physiological information monitoring. The second signal line 27 of the optical fiber pressure sensor is arranged in the same way as the pipeline 26, as shown in Figure 11 、 Figure 12 A sensor protective shell can also be provided to protect the sensor probe from damage caused by the impact of the blood flow.

[0054] Of course, for those skilled in the art, the present application is not limited to the details of the above exemplary embodiments, but also includes the same or similar structures that can be implemented in other specific forms without departing from the spirit or essential characteristics of the present application. Therefore, the embodiments should be regarded as exemplary and non-limiting in any respect, and the scope of the present application is defined by the appended claims rather than the above description, and therefore all changes falling within the meaning and scope of the equivalent elements of the claims are intended to be included in the present application. Any reference signs in the claims should not be regarded as limiting the claims involved.

[0055] Furthermore, it should be understood that although the present specification is described in terms of embodiments, not every embodiment contains only one independent technical solution, and the description of the specification is only for the sake of clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can be appropriately combined to form other embodiments that those skilled in the art can understand.

Claims

1. A blood circulation assistance system comprising a first blood circulation support unit (10) located in a heart chamber of a patient and a second blood circulation support unit (20) located in a descending aorta of the patient, the first blood circulation support unit (10) pumping blood within the heart chamber to the aorta, the second blood circulation support unit (20) generating pulsatile blood flow by periodically contracting and expanding to squeeze blood, characterized in that: When the second blood circulation support unit (20) expands, part of the occluded blood vessel is expanded; The second blood circulation support unit (20) comprises an integrated balloon (23) and a constraint frame (25), an inner tube (24) is arranged in the inner cavity of the integrated balloon (23), both ends of the inner tube (24) extend to the outside of both ends of the integrated balloon (23) and are connected with a catheter (30), when the integrated balloon (23) expands, the constraint frame (25) is connected with the inner wall of the integrated balloon (23) to limit the outward expansion of part of the integrated balloon (23), and the region of the outer periphery of the constrained integrated balloon (23) constitutes a blood flow passage; The constraint frame (25) comprises a plurality of pull rod groups arranged along the circumferential direction of the inner tube (24), each pull rod group comprises a plurality of pull rods (252) arranged along the axial direction, one end of the pull rod (252) is fixed with the inner tube (24), and the other end is connected with the inner wall of the integrated balloon (23), and the pull rod (252) is a nickel-titanium wire woven with a shape memory material; The catheter (30) is of a segmented structure, comprising a first catheter segment (31) between the first blood circulation support unit (10) and the integrated balloon (23) and a second catheter segment (32) extending to the outside of the body from the proximal end of the integrated balloon (23), the first catheter segment (31) and the second catheter segment (32) are discontinuous and disconnected, and the inner tube (24) for supporting the integrated balloon (23) is arranged therebetween, the inner tube (24) does not belong to the catheter (30), both ends of the integrated balloon (23) and the pull rod (252) are connected with the inner tube (24), the inner tube (24) serves as a support for the integrated balloon (23), and the middle lines of the integrated balloon (23), the catheter and the pull rod group coincide; The proximal end of the first blood circulation support unit (10) is provided with a cleaning pipeline (17) and a PCB cable (18), the cleaning pipeline (17) and the PCB cable (18) extend into the lumen of the inner tube (24) from the inner cavity of the first catheter segment (31) and extend to the second catheter segment (32).

2. The blood circulation assist system according to claim 1, characterized by: The single balloon (21) / integrated balloon (23) communicates with an external medium source through a pipeline (26), the medium is a gas, and a control unit controls the single balloon (21) / integrated balloon (23) to deflate at the end of diastole and inflate at the end of systole / early diastole.

3. The blood circulation assistance system according to claim 1, characterized by: The first blood circulation support unit (10) comprises a motor (11), the proximal end of the motor (11) is connected with the catheter (30), the distal end is coaxially connected with an impeller (12), the outer periphery of the impeller (12) is provided with a blood outflow cage (13), the distal end of the blood outflow cage (13) is fixed with the proximal end of a blood inflow cage (15) through a sleeve (14), and the distal end of the blood inflow cage (15) is further connected with a pigtail (16).

4. The blood circulation assistance system according to claim 3, characterized by: An optical fiber pressure sensor is arranged on the motor (11), and an optical fiber pressure sensor is also arranged on the single balloon (21) / integrated balloon (23).

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