Transaortic split-type heart assist device and assistance method

By adopting a transaortic split cardiac assist device, using the tandem structure of the axial flow drive system and the diversion module to work in concert with the heart, the problems of different design and physiology of the existing cardiac assist device are solved, and periodic cardiac pulsation ejaculation and appropriate blood flow perfusion are achieved.

WO2025123825A1PCT designated stage expired Publication Date: 2025-06-19WEST CHINA HOSPITAL SICHUAN UNIV
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Patent Information

Application Number
PCT/CN2024/118853
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-12-11
Filing Date
2024-09-13
Publication Date
2025-06-19

AI Technical Summary

Technical Problem

The design of existing cardiac assist devices is very different from physiology, resulting in problems such as right heart failure, hemodynamic changes, poor organ perfusion, thrombosis, etc., and it is difficult to achieve appropriate pump speed control.

Method used

A transaortic split cardiac assist device, including an axial flow drive system and a diversion module, is adopted to work in concert with the heart through a tandem structure to form periodic pulsating ejaculation, provide right ventricular ejaculation support, and eliminate rotating blood flow through spiral guide lobes.

Benefits of technology

Periodic cardiac pulsation ejaculation is achieved, which avoids right heart failure and insufficient organ perfusion, reduces the risk of thrombosis, and simplifies the difficulty of surgery and pump speed control.

✦ Generated by Eureka AI based on patent content.

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Abstract

A transaortic split-type heart assist device and an assistance method. The transaortic split-type heart assist device comprises an axial flow driving system and a flow guide module, wherein one end facing a heart ventricle is defined as the proximal end, and the other end of is defined as the distal end; the axial flow driving system comprises a driving module (1) and an impeller (2), a transmission shaft (3) of the driving module (1) is connected to the impeller (2), the impeller (2) comprises a hub (21) and impeller blades (22), and the impeller blades (22) are spirally arranged around the periphery of the hub (21); the flow guide module comprises a hollow sleeve (4), the impeller (2) is arranged at the proximal end of the sleeve (4), and spiral guide vanes (41) are fixedly arranged on the inner wall of the distal end of the sleeve (4); the driving module (1) is located in the center of the device and extends towards and penetrates out of the distal end of the sleeve (4), and the driving module (1) is connected to the sleeve (4) by means of the spiral guide vanes (41); and a connecting portion (42) is provided on the periphery of the distal end of the sleeve (4).
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Description

Transaortic split cardiac assist device and assist method Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a transaortic split cardiac assist device and an assist method. Background Art

[0002] Heart failure (HF), the terminal course of all cardiovascular diseases, manifests itself as impaired systolic and / or diastolic function, resulting in reduced blood pumping. This, on the one hand, leads to insufficient blood perfusion to vital organs throughout the body, causing organ dysfunction. On the other hand, the heart's inability to pump blood promptly obstructs venous return to the heart, leading to blood congestion in the venous system and organ edema, further exacerbating metabolic disorders in tissues and organs, ultimately leading to systemic organ failure and death. Heart transplantation is generally considered the best treatment option for patients with end-stage HF, but due to the extreme shortage of donor hearts, only a small number of HF patients are eligible for heart transplantation.

[0003] In the face of an extremely limited supply of donor hearts, mechanical circulatory support (MCS) devices offer new hope for survival for patients with end-stage heart failure. Their basic principle is to pump blood from the failing heart into the aortic system. Currently used CADs all have an inlet located at the left ventricular apex, connected to an artificial pump via a prosthetic blood vessel. The outlet is located in the ascending aorta. Blood flows through the failing left ventricle, bypassing the aortic valve, and then into the aorta via the artificial pump, creating a bypass circuit. This parallel circuit with the heart continuously delivers blood to the systemic arterial system for circulatory support. However, because the device's design and operating principles differ significantly from physiology, the following clinical challenges remain unresolved: 1) Continuous left ventricular pumping causes leftward shift of the ventricular septum, depriving the ventricular septum of support during right ventricular contraction and ejection, leading to right heart failure. 2) The parallel circuit design alters hemodynamics, preventing the generation of physiological systolic and diastolic pressures. Consequently, pulse pressure differences are minimal, and patients fitted with these pumps are often referred to as "pulseless patients." However, physiological pulsation is extremely important to the human body: the alternation of systolic and diastolic blood pressure is the main driving force for the opening of capillaries. When this power is lost, it is difficult for capillaries to open, resulting in insufficient perfusion of tissues and organs, and patients will develop a series of complications, such as liver and kidney failure; 3) There is pump-ventricular competition in blood flow, which leads to a series of complications such as poor organ perfusion and thrombosis; 4) Right heart assist cannot be implemented; 5) The pump speed is difficult to control to an appropriate level, and the pump may stop or blood flow may stop; or if the pump speed is too fast, it will aggravate red blood cell destruction and increase the risk of bleeding.

[0004] U.S. invention patent application US20150231318A1 discloses a trans-aortic artificial heart assist device. The device is installed in the aorta and forms a series structure with the heart, which helps to avoid the defects of parallel heart assist devices to a certain extent. However, the blood flow inlet of this patent is located on the aortic valve. Since the coronary artery is located at the root of the aorta, the biggest problem with placing it in this position is that with the suction action of the pump, the pressure at the root of the aorta decreases, leading to myocardial ischemia. Therefore, it is inevitable to divert the coronary artery opening, making coronary bypass surgery inevitable, increasing the difficulty of the operation, and the coronary bypass is short in patency. Once the bypass vessel is blocked, it will lead to the risk of sudden death of the patient.

[0005] Chinese invention patent application CN1253837A (publication date: May 24, 2000) discloses a method and apparatus for ventricular assist circulation, which performs left (or right) ventricular assist circulation in series. The apparatus comprises a pump body and a separate controller, with the pump body positioned anterior or posterior to the heart valve, and the controller positioned externally in the anterior or posterior cardiac region. When the permanent magnet in the controller rotates rhythmically, the resulting rotating magnetic field drives an impeller with a permanent magnet inside the pump body to rotate rhythmically. The impeller's blades propel blood, drawing blood from the left or right ventricle through the valve and injecting it into the aorta or pulmonary artery. This patent application suffers from the following problems: 1. The micropump is small. Because the left ventricular outflow tract is a thin, long channel (approximately 2 cm in diameter and approximately 0.8-1 cm in length), the micropump has a maximum diameter of less than 2 cm and a length of less than 1 cm. The requirement to provide sufficient power for the replacement heart while maintaining a sufficient blood flow path within such a small pump volume is difficult to implement. When the outer diameter of the micro pump is determined, the larger the motor (motor + permanent magnet), the stronger the power it provides, but the space of the outflow channel will be squeezed and narrowed; vice versa. According to calculations, in a space with a diameter of 2 cm (area of ​​3.14 cm 2 ), install the permanent magnet, motor, and blade (i.e. outflow channel) at the same time. The permanent magnet and motor need to occupy at least 2.3cm 2 The area is sufficient to provide sufficient power, which means that the remaining space is only 0.9cm 2 , which is equivalent to the pathological characteristics of moderate to severe aortic stenosis. 2 In a space of 1000 square meters, if the normal blood flow of the human body (5-6L / min) is to be achieved, the speed of the blade needs to reach 25,000 revolutions per minute, at which time the shear force is as high as 350Pa (3500dyne / cm 2 ), there will be a lot of hemolysis (<150Pa, no hemolysis; >300Pa, there will be a lot of hemolysis). Obviously, this is simply not achievable in practical applications.

[0006] Another shortcoming of Chinese invention patent application CN1253837A (publication date: May 24, 2000) is the lack of a blood diversion device. The high-speed rotation of blood generated by the pump body will cause the valve to be severely distorted and damaged.

[0007] Therefore, given that the left ventricular outflow tract and the aorta are thin, long, and straight channels, and the aortic root space is relatively small, how to generate sufficient power while ensuring sufficient blood flow channels, effective pulse volume, and non-rotating blood flow will become a difficult problem faced in clinical applications.

[0008] Summary of the Invention

[0009] In order to address the above-mentioned deficiencies in the prior art, the present invention provides a miniaturized transaortic split cardiac assist device and an assist method.

[0010] In order to achieve the above technical objectives, the technical solution adopted by the present invention is:

[0011] A trans-aortic split cardiac assist device includes an axial flow drive system and a diversion module, with one end facing the heart ventricle being defined as the proximal end and the other end being defined as the distal end; the axial flow drive system includes a drive module and an impeller, the drive module transmission shaft is connected to the impeller, the impeller includes a hub and impeller blades, and the impeller blades are spirally arranged around the outer circumference of the hub; the diversion module includes a hollow sleeve, the impeller is placed at the proximal end of the sleeve, and spiral guide vanes are fixedly provided on the inner wall of the distal end of the sleeve; the drive module is located in the center of the device, extending to and passing through the distal end of the sleeve, and the drive module and the sleeve are connected by spiral guide vanes; a connecting portion is provided on the outer circumference of the distal end of the sleeve.

[0012] Preferably, the outer periphery of the driving module is connected to a fixing ring via a connecting rod.

[0013] Preferably, the connecting portion is in the shape of an annular groove.

[0014] In another preferred embodiment, the connecting portion is in the shape of an annular convex ridge.

[0015] Preferably, at least two connecting rods are provided and arranged circumferentially around the driving module.

[0016] Furthermore, the driving module includes a shell, an annular motor is provided in the inner cavity of the shell, an annular permanent magnet is coaxially provided on the inner side of the annular motor, a transmission shaft is passed through the inside of the annular permanent magnet, two ends of the transmission shaft respectively pass through the two ends of the annular permanent magnet, the proximal end of the transmission shaft passes through the shell, bearings are respectively provided at both ends of the shell, two ends of the transmission shaft are respectively passed through the bearings, and a sealing ring is provided between the proximal opening of the shell and the transmission shaft.

[0017] Furthermore, it also includes a wire, one end of which is connected to the ring motor, and the other end of which extends out of the shell along the connecting rod and is connected to an external power supply.

[0018] Preferably, the housing of the driving module includes a rugby-shaped distal end and a slender shaft-shaped proximal end, and the annular motor and the annular permanent magnet are arranged inside the distal end of the housing.

[0019] In another embodiment, the distal end and the proximal end of the housing of the driving module have the same diameter, and the annular motor and the annular permanent magnet are evenly arranged inside the housing.

[0020] A method for assisting cardiac circulation utilizes the aforementioned transaortic split-type cardiac assist device. During installation, the sleeve of the diversion module is fixedly installed below the aortic valve at the aortic root without affecting coronary blood flow. The drive shaft of the drive module passes through the aortic valve. The drive module is located within the aorta and secured to the aortic valve annulus via a retaining ring. When the drive module is turned on, the drive shaft drives the impeller to rotate, creating a pressure differential between the proximal and distal ends. During diastole, the pressure generated by the impeller rotation is lower than the aortic pressure, preventing ejection, and the aortic valve closes. When the left ventricle contracts, the pressure generated by the impeller increases, exceeding the pressure within the aorta. This causes blood within the left ventricle to flow through the diversion module, opening the aortic valve and ejecting it into the aorta. As the heart periodically contracts and relaxes, the aortic valve periodically opens and closes, manifesting as pulsatile blood flow in the aorta. Blood flows through arterial and venous branches, completing systemic circulation, and then returns to the right atrium, thus providing serial cardiac circulation assistance.

[0021] The beneficial effects of the present invention are:

[0022] The transaortic split cardiac assist device of the present invention is in series with the heart after installation, which can make the heart beat and eject blood periodically, and make the ventricular septum move similarly to a normal heart, thereby providing support for the right ventricle when ejecting blood, and avoiding right heart failure; the blood pressure waveform generated by the series structure is closer to the pulsating blood flow under physiological conditions, with a high pulse pressure difference and better organ perfusion, thereby avoiding failure caused by insufficient perfusion of the liver and kidneys; the pump-heart flow competition relationship is transformed into a cooperative relationship, so that all blood passes through the heart-pump-aorta, and the abundant blood flow avoids thrombosis in the pump, thereby avoiding the blood stasis caused by the parallel structure. Thrombosis and stroke, etc.; a guide vane is set at the distal end of the cylindrical structure to avoid the damage of the aortic valve and the internal structure of the aorta by the rotating blood flow; the drive system is designed so that the motor and the permanent magnet are closely connected, thereby avoiding energy consumption caused by distance; the transmission shaft of the power source is directly connected to the impeller, making the power transmission more reliable; the power source part makes full use of the narrow, long and straight space of the outflow tract and the aorta, so that it extends from the left ventricular outflow tract through the aortic valve into the aorta, thereby making the driving power source system (including the permanent magnet and the motor) become slender, while providing sufficient energy for ejection, retaining a large enough blood flow channel.

[0023] The transaortic split heart assist device of the present invention has a blood flow inlet located in the left ventricular outflow tract and an outlet located under the aortic valve. Therefore, there is no need for coronary artery opening diversion, thereby avoiding coronary artery transplantation surgery, reducing the difficulty of surgery, and avoiding the occurrence of risks related to coronary artery surgery.

[0024] The present invention adopts a separate structure, which not only makes surgical installation more convenient, but also makes the surgical method similar to aortic valve replacement, thereby avoiding bleeding caused by aortic valve replacement.

[0025] In the present invention, the motor is slender and the blades are wide, which greatly increases the blood flow space, resulting in a decrease in the required blade speed, thereby reducing blood damage and damage to coagulation; thus, it is suitable for installation in the left ventricular outflow tract and aorta; the motor and the permanent magnet are fitted together and positioned in the middle of the blood flow. The advantage of this is that the efficiency of converting electrical energy into kinetic energy is greatly improved. Even if heat is generated, it will be carried away by the rapid blood flow, will not damage the myocardium, and will not cause coagulation events.

[0026] In the transaortic split cardiac assist device of the present invention, spiral guide vanes are provided in the sleeve of the diversion module, which can eliminate the rotational motion of the blood driven by the impeller and convert it into axial motion along the aorta, reducing the loss of blood flow energy without damaging the valves and blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0028] FIG1 is a schematic structural diagram of an embodiment of the present invention;

[0029] FIG2 is a schematic diagram of the connection between the drive module and the fixing ring;

[0030] FIG3 is a schematic cross-sectional view of the driving module in the embodiment shown in FIG1 .

[0031] FIG4 is a schematic structural diagram of another embodiment;

[0032] FIG5 is a schematic cross-sectional view of the driving module in the embodiment shown in FIG4 ;

[0033] FIG6 is a schematic diagram of the present invention in an application state;

[0034] FIG7 is a schematic diagram of a blood pressure waveform after installation of the device of the present invention.

[0035] Figure numerals: 1-driving module, 11-connecting rod, 12-fixing ring, 13-housing, 14-ring-shaped motor, 15-ring-shaped permanent magnet, 2-impeller, 21-hub, 22-impeller blade, 3-transmission shaft, 4-sleeve, 41-guide vane, 42-connecting part, 5-aorta, 6-support rod, 7-aortic valve, 8-coronary artery, 9-sealing ring. DETAILED DESCRIPTION

[0036] In order to make the purpose, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application generally described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the application for protection, but merely represents the selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0037] The transaortic split cardiac assist device, as shown in Figures 1 to 6, includes an axial flow drive system and a flow guide module, with one end facing the heart ventricle being the proximal end and the other end being the distal end. The axial flow drive system includes a drive module 1 and an impeller 2. The drive shaft 3 of the drive module 1 is connected to the impeller 2. The impeller 2 includes a hub 21 and impeller blades 22, which are spirally arranged around the circumference of the hub 21. The flow guide module includes a hollow sleeve 4, with the impeller 2 located within the proximal end of the sleeve 4. The distal end of the sleeve 4 is fixedly provided with spiral guide vanes 41. The drive module 1 is located in the center of the device, extending toward and protruding from the distal end of the sleeve 4. The drive module 1 and the sleeve 4 are connected by spiral guide vanes 41. A connection portion 42 is provided on the outer periphery of the distal end of the sleeve 1. During installation, the sleeve 4 is sutured to the aorta via the connection portion 42 on the outer periphery of the sleeve 4, and the drive module 1 passes through the aortic valve and enters the aorta.

[0038] Preferably, the outer periphery of the driving module 1 is connected to a fixing ring 12 via a connecting rod 11 . During installation, the fixing ring 12 of the driving module 1 is supported on the inner wall of the aorta 5 to limit the driving module 1 from shaking significantly.

[0039] The impeller blades 22 have a first spiral direction around the hub 21, and the guide vanes 41 have a second spiral direction around the sleeve 4, with the first spiral direction and the second spiral direction being opposite. A portion of the outlet end of the guide vanes 41 extends along the axial direction of the sleeve 4, aligning the direction of blood flow at the outlet end of the guide vanes 41 with the axial direction of the sleeve 4. This ensures that the blood outflow direction is aligned with the central axis of the blood vessel, reduces rotational motion of the blood after outflow, and reduces energy loss.

[0040] Preferably, a connecting portion 42 is provided on the outer periphery of the sleeve 4, and the connecting portion 42 is in the shape of an annular groove or a ridge, so as to facilitate fixation with the aorta during suturing.

[0041] At least two connecting rods 11 are provided and arranged circumferentially around the driving module 1. Preferably, as shown in Figure 2, three connecting rods 11 are provided. The longitudinal cross-section of the connecting rod 11 is circular or elliptical, so that blood flows smoothly with little resistance.

[0042] Furthermore, a support rod 6 is connected between the drive module 1 and the sleeve 4. One end of the support rod 6 is connected to the drive module 1, and the other end is connected to the spiral guide vane 41 in the sleeve 4. The support rod 6 secures the drive module 1 and the sleeve 4 to ensure that the drive module 1 and the sleeve 4 always maintain a coaxial relative position. At least two support rods 6 are provided, evenly distributed around the circumference of the drive module 1. Preferably, two, three, or four support rods 6 are provided. The longitudinal cross-section of each support rod 6 is circular or elliptical, reducing resistance to blood flow.

[0043] As shown in FIG3 , the drive module 1 comprises a housing 13. An annular motor 14 is disposed within the housing 13. An annular permanent magnet 15 is coaxially disposed within the annular permanent magnet 15. A drive shaft 3 extends through the interior of the annular permanent magnet 15. The drive shaft 3 extends proximally through the housing 13. Bearings are disposed within the housing 13 at both ends, and the drive shaft 3 extends proximally through the bearings. A sealing ring 9 is disposed between the proximal opening of the housing 13 and the drive shaft 3. The drive module 1 also comprises a wire, one end of which connects to the annular motor 14 and the other end of which extends out of the housing 13 along a connecting rod 11 and connects to an external power source. Preferably, the connecting rod 11 has a hollow passageway disposed therein, through which the wire extends. When the external power source is activated, the annular motor 14 is powered, generating a magnetic field that rotates the annular permanent magnet 15. This rotation of the annular permanent magnet 15 drives the drive shaft 3, which in turn drives the impeller 2, pumping blood into the sleeve 4 and into the aorta.

[0044] In one embodiment, as shown in Figures 1 and 3, the housing 13 of the drive module 1 includes a distal end in the shape of a rugby ball and a proximal end in the shape of an elongated shaft. The annular motor 14 and annular permanent magnet 15 are disposed within the distal end of the housing 13, and the drive shaft 3 passes through the proximal end and is connected to the impeller. In another embodiment, as shown in Figures 4 and 5, the housing 13 of the drive module 1 is generally in the shape of an elongated cylinder, with the proximal end of the housing 13 abutting the hub of the impeller. The annular motor 14 and annular permanent magnet 15 are disposed within the housing 13, and the distal end of the housing 13 is in the shape of a semi-ellipsoidal convergence.

[0045] During installation, the sleeve 4 of the flow diversion module is sutured and installed below the aortic valve 7 at the root of the aorta 5 via the connection portion 42. The driver module 1 passes through the aortic valve 7, and the retaining ring 12 is supported on the inner wall of the aorta 5. The installation diagram is shown in Figure 6. When the driver module is turned on, the drive shaft drives the impeller to rotate. The impeller rotates, drawing blood from the left ventricle. Blood flows through the flow diversion module and the aortic valve into the aorta, where it is then circulated through the arteries and veins before returning to the right atrium, achieving series cardiac circulation assistance. The transaortic split-type cardiac assist device of the present invention, when installed, is in series with the heart, achieving a pulsatile effect. The blood pressure waveform generated by the series configuration is closer to the pulsatile waveform under physiological conditions, resulting in a higher mean arterial pressure, which is beneficial for tissue and organ perfusion. The blood pressure waveforms are shown in Figure 7 (LVP: left ventricular pressure; AOP: intra-aortic pressure; LAP: left atrial pressure). As can be seen in the latter half of Figure 7, the intra-aortic pressure fluctuation is significantly increased. Therefore, the series configuration effectively avoids a series of complications associated with parallel configurations, such as stroke and renal impairment.

[0046] The present invention's transaortic split-type cardiac assist device utilizes the anatomical structure of the left ventricular outflow tract and the ascending aorta in a straight line. The motor part (permanent magnet, motor) is made into a slender structure and inserted deep into the ascending aorta. This not only solves the problem of strong motor power and stability, but also solves the problem of insufficient blood outflow tract capacity. The blood flow space is as high as 2.6cm 2 The speed can be reduced to 2500 rpm, providing a blood flow of 6L / min and a shear force of <100Pa (1000dyne / cm 2 ), no hemolysis.

[0047] The transaortic split-type heart assist device of the present invention has a blood flow outlet located at the aortic valve 7, eliminating the need for coronary artery 8 rerouting and preventing coronary ischemia. This reduces surgical difficulty, lowers the risk of stenosis and injury after coronary reimplantation, and avoids the risks associated with coronary surgery. The present invention's split structure not only facilitates surgical installation, with the surgical procedure similar to aortic valve replacement, but also avoids the bleeding associated with aortic valve replacement.

[0048] In this invention, the separation of the motor and the blades significantly increases blood flow space, resulting in a lower required blade speed, thereby reducing blood damage and disruption to coagulation. Furthermore, the need for increased diameter to achieve auxiliary functions is eliminated, making it suitable for installation in the narrow, long, and straight left ventricular outflow tract and aorta. The motor and permanent magnet are bonded together and positioned in the center of the blood flow, significantly improving the efficiency of converting electrical energy into kinetic energy. Even if heat is generated, it is carried away by the rapid blood flow, preventing myocardial damage and coagulation events.

[0049] The present invention also provides a method for assisting cardiac circulation, using the aforementioned transaortic split-type cardiac assist device. During installation, the sleeve of the diversion module is sutured to the aortic valve at the aortic root, without affecting coronary blood flow. The drive shaft of the drive module passes through the aortic valve. The drive module is located within the aorta and supported on the inner wall of the aorta by a fixing ring. When the drive module is turned on, the drive shaft drives the impeller to rotate. The rotation of the impeller creates a pressure differential between the proximal and distal ends. When the heart is in diastole, the pressure generated by the impeller rotation is lower than the aortic pressure, preventing ejection, and the aortic valve closes. When the left ventricle contracts, the pressure generated by the impeller increases, exceeding the pressure in the aorta. This causes blood in the left ventricle to flow through the diversion module, opening the aortic valve and ejecting it into the aorta. As the heart contracts and relaxes periodically, the aortic valve opens and closes periodically, manifesting as pulsatile blood flow in the aorta. Blood flows through arterial and venous branches, completing systemic circulation, and then returns to the right atrium, thus providing serial cardiac circulation assistance.

[0050] Of course, the present invention may have many other embodiments. Without departing from the spirit and essence of the present invention, those skilled in the art may make various corresponding changes and modifications based on the present invention, but these corresponding changes and modifications should all fall within the scope of protection of the claims attached to the present invention.

Claims

1. A transaortic split cardiac assist device, characterized in that: It includes an axial flow drive system and a guide module, and one end facing the heart ventricle is defined as the proximal end, and the other end is defined as the distal end; the axial flow drive system includes a drive module and an impeller, the drive shaft of the drive module is connected to the impeller, the impeller includes a hub and impeller blades, and the impeller blades are spirally arranged around the outer circumference of the hub; the guide module includes a hollow sleeve, the impeller is placed at the proximal end of the sleeve, and the inner wall of the distal end of the sleeve is fixedly provided with spiral guide vanes; the drive module is located in the center of the device, extends to and passes through the distal end of the sleeve, and the drive module is connected to the sleeve through spiral guide vanes; a connecting portion is provided on the outer circumference of the distal end of the sleeve.

2. The transaortic split heart assist device according to claim 1, characterized in that: The outer periphery of the driving module is connected with a fixing ring via a connecting rod.

3. The transaortic split heart assist device according to claim 2, characterized in that: The connecting portion is in the shape of an annular groove.

4. The transaortic split heart assist device according to claim 2, characterized in that: The connecting portion is in the shape of an annular convex ridge.

5. The transaortic split heart assist device according to claim 1, characterized in that: At least two connecting rods are provided and arranged circumferentially around the driving module.

6. The transaortic split heart assist device according to claim 1, characterized in that: The driving module includes a shell, an annular motor is provided in the inner cavity of the shell, an annular permanent magnet is coaxially provided on the inner side of the annular motor, a transmission shaft is passed through the inside of the annular permanent magnet, two ends of the transmission shaft respectively pass through two ends of the annular permanent magnet, a proximal end of the transmission shaft passes through the shell, bearings are respectively provided at two ends in the shell, two ends of the transmission shaft are respectively passed through the bearings, and a sealing ring is provided between the proximal end opening of the shell and the transmission shaft.

7. The transaortic split heart assist device according to claim 6, characterized in that: The invention also includes a wire, one end of which is connected to the annular motor, and the other end of which extends out of the housing along the connecting rod and is connected to an external power source.

8. The transaortic split heart assist device according to claim 6, characterized in that: The shell of the driving module comprises a rugby-shaped distal end and a slender shaft-shaped proximal end, and an annular motor and an annular permanent magnet are arranged inside the distal end of the shell.

9. The transaortic split heart assist device according to claim 6, characterized in that: The distal end and the proximal end of the shell of the driving module have the same diameter, and the annular motor and the annular permanent magnet are evenly arranged inside the shell.

10. A method for assisting cardiac circulation, characterized in that: The transaortic split cardiac assist device according to any one of claims 1 to 9 is used. During installation, the sleeve of the diversion module is sutured and installed below the aortic valve at the root of the aorta without affecting the coronary blood flow. The transmission shaft of the driving module passes through the aortic valve. The driving module is arranged in the aorta and supported on the inner wall of the aorta by a fixing ring. When the driving module is turned on, the impeller is driven to rotate via the transmission shaft, and the rotation of the impeller forms a pressure difference between the proximal and distal ends. When the heart is in diastole, the pressure formed by the rotation of the impeller is lower than the aortic pressure and does not cause ejection. At this time, the aortic valve is closed. When the pressure generated by the contraction of the left ventricle is pressurized by the rotation of the impeller, the distal outlet pressure increases and exceeds the pressure in the aorta, so that the blood in the left ventricle flows through the diversion module and the aortic valve is opened and ejected into the aorta. With the periodic contraction and relaxation of the heart, the aortic valve opens and closes periodically, which is manifested as pulsating blood flow in the aorta. The blood flows back to the right atrium after completing the systemic circulation through the arterial and venous branches, forming a series cardiac circulation assistance.

Citation Information

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