CN117379681A - transapical split cardiac assist device - Google Patents

Abstract

The invention relates to the technical field of medical devices and discloses a transapical split heart assist device, which includes an axial flow drive system and a diversion module. 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, which are arranged spirally around the outer circumference of the hub; the diversion module includes a hollow sleeve, the impeller is located inside the inlet end of the sleeve, a spiral guide vane is fixed on the inner wall of the outlet end of the sleeve, and the drive module extends in a direction away from the sleeve . The invention can be placed at the apex of the heart, and forms a series structure with the heart after installation. The generated blood pressure waveform is closer to the arterial pulse waveform under physiological conditions. The systolic pressure is large, which is beneficial to tissue and organ perfusion; the separation of the motor and the paddle increases blood pressure. In the flow space, the required blade speed is reduced, reducing the risk of thrombus and damage to coagulation; the drive module is extended to the outside of the apex of the heart, which can reduce the adverse effects on the blood caused by the heat generated by the operation of the drive module.

Description

transapical split cardiac assist device

Technical field

The present invention relates to the technical field of medical devices, and in particular to a transapical split heart assist device.

Background technique

Heart failure (heart failure) is the terminal course of all cardiovascular diseases. It is specifically characterized by: impairment of the systolic and/or diastolic function of the heart, and a reduction in the amount of blood pumped by the heart. On the one hand, this will cause insufficient blood perfusion in all important organs of the body, causing dysfunction of various organs; on the other hand, the heart cannot pump blood in time, causing obstruction of the venous return of blood to the heart, blood stasis in the venous system, and organ edema, further aggravating tissue and organ Metabolic disorders, eventually leading to systemic organ failure and death. Heart transplantation is generally considered the best treatment option for patients with end-stage heart failure, but due to the extreme shortage of heart donors, only a small number of heart failure patients are expected to receive heart transplantation.

When heart donors are in extremely short supply, mechanical circulatory support (MCS) devices bring new hope for survival to patients with end-stage heart failure. The basic principle is to pump blood from the failing heart into the aortic system. The cardiac assist devices currently used clinically have an inlet at the apex of the left ventricle, an artificial blood vessel connected to an artificial auxiliary pump, and an outlet located at the ascending aorta. Blood flowing through the failing left ventricle is reached by the artificial auxiliary pump bypassing the aortic valve. The aorta forms a bypass circulation and forms a parallel structure with the heart to continuously deliver blood flow to the systemic arterial system for circulatory support. However, due to the design of the device, the following clinical problems still need to be solved: 1) The parallel structure causes hemodynamic changes and cannot produce physiological-like systolic and diastolic blood pressures, and the pulse pressure difference is small, as shown in Figure 5 (left) ) as shown (LVP: left ventricular pressure; AOP: intra-aortic pressure; LAP: left atrial pressure). Because the pulse pulsation is extremely small, patients with this type of pump are also called "pulseless people." However, physiological pulsation is extremely important to the human body: the alternation of systolic blood pressure and diastolic blood pressure is the main driving force for capillary opening. When this power is lost, capillary opening is difficult, resulting in insufficient perfusion of tissues and organs, and patients will suffer from a series of complications. Such as liver and kidney failure; 2) There is pump-ventricular competition in blood flow, which leads to a series of complications such as poor organ perfusion and thrombosis; 3) The pump speed is difficult to control to an appropriate level, and pump stall or blood flow may occur. Stop; or the pump speed is too fast, which will aggravate the destruction of red blood cells and increase the risk of bleeding.

US 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 cardiac assist devices to a certain extent. However, the blood flow inlet of this patent is located on the aortic valve, which inevitably requires diversion of the coronary opening, which increases the difficulty of the operation and the risks associated with coronary artery reimplantation. The left ventricular outflow tract and aorta are thin, long, straight channels, and the aortic root space is small. How to ensure sufficient blood flow channels and effective pulse volume will become a difficult problem in clinical applications.

Contents of the invention

In order to solve the above-mentioned deficiencies in the prior art, the present invention provides a miniaturized transapical split-type cardiac assist device.

In order to achieve the above technical objectives, the technical solutions adopted by the present invention are:

A transapical split heart assist device includes an axial flow drive system and a flow diversion module. 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 an impeller blade. The impeller blade surrounds The outer circumference of the hub is spirally arranged; the diversion module includes a hollow sleeve, the impeller is located inside the inlet end of the sleeve, and the inner wall of the outlet end of the sleeve is fixed with spiral guide vanes; the drive module extends away from the sleeve.

Further, the driving module includes a power section and a connecting section. The connecting section is in the shape of an elongated shaft, and the transmission shaft passes through the connecting section.

Further, a support rod is connected between the connecting section of the driving module and the sleeve.

Preferably, there are three support rods, which are evenly distributed around the connection section of the drive module.

Further, a connecting portion is provided on the outer periphery of the outlet end of the sleeve.

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

In another preferred embodiment, the connecting portion is in an annular corrugated shape.

Further, the drive module includes a casing, an annular motor is arranged in the casing of the power section, an annular permanent magnet is coaxially arranged inside the annular motor, the transmission shaft penetrates inside the annular permanent magnet, and both ends of the transmission shaft pass through the annular magnet respectively. At both ends of the permanent magnet, one end of the transmission shaft extends to the connecting section and passes through the casing. Bearings are provided at both ends of the casing. Both ends of the transmission shaft are respectively installed in the bearings. The opening of the connecting section of the casing is connected to the transmission shaft. There is a sealing ring between them.

Furthermore, it also includes a wire, one end of which is connected to the ring motor, and the other end of the wire extends out of the housing and is connected to an external power supply.

The beneficial effects of the present invention include:

The transapical split-type heart assist device of the present invention is installed in a series structure with the heart, which can achieve a pulsating effect. The blood pressure waveform generated by the series structure is closer to the pulsating waveform under physiological conditions, with a higher pulse pressure difference and pulsed blood flow. It makes organ perfusion better, and the pump-heart competition relationship becomes a synergistic relationship, so that all blood passes through the heart-pump-aorta. The abundant blood flow avoids thrombosis in the pump. Therefore, the series structure can effectively prevent A series of related complications caused by the parallel structure such as renal function damage, stroke, etc.

The transapical split cardiac assist device of the present invention is easy to operate and does not require surgeries related to the aortic valve area such as coronary artery opening diversion, thereby reducing the difficulty of surgery and reducing surgery-related complications.

In the transapical split heart assist device of the present invention, the separation of the motor and the paddle greatly increases the blood flow space, resulting in a decrease in the required paddle speed, thereby reducing blood damage and damage to coagulation; at the same time, there is no need to increase the diameter and It achieves the auxiliary function and is suitable for installation at the left ventricular apex; the drive module of the axial flow drive system extends to the outside of the apex, which can reduce the adverse effects on the blood caused by the heat generated by the operation of the drive module.

In the transapical split heart assist device of the present invention, the sleeve outlet end of the flow diversion module is provided with a spiral guide vane, which can eliminate the rotational movement of blood driven by the impeller, causing the pumped blood to move axially, reducing blood flow. Kinetic energy loss.

Description of the drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required to be used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present application and therefore do not It should be regarded as a limitation of the scope. For those of ordinary skill in the art, other relevant drawings can be obtained based on these drawings without exerting creative efforts.

Figure 1 is a schematic structural diagram of an embodiment of the present invention;

Figure 2 is a schematic cross-sectional view of the drive module;

Figure 3 is a schematic diagram of the connection between the drive module and the sleeve;

Figure 4 is a schematic structural diagram of the present invention in application state;

Figure 5 is a schematic diagram comparing the blood pressure waveforms after installation of the prior art (left) and the present application (right).

Reference signs: 1-drive module, 13-casing, 14-annular motor, 15-annular permanent magnet, 2-impeller, 21-hub, 22-impeller blade, 3-drive shaft, 4-sleeve, 41- Guide vane, 42-connection part, 5-aorta, 6-support rod, 7-aortic valve, 8-coronary artery, 9-seal ring.

Detailed ways

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 These are part of the embodiments of this application, but not all of them. The components of the embodiments of the present application generally described and illustrated in the figures herein may be arranged and designed in a variety of different configurations. Accordingly, the following detailed description of the embodiments of the application provided in the appended drawings is not intended to limit the scope of the claimed application, but rather to represent selected embodiments of the application. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of this application.

The transapical split heart assist device, as shown in Figures 1, 2, 3, and 4, includes an axial flow drive system and a diversion module. The axial flow drive system includes a drive module 1 and an impeller 2. The drive The transmission shaft 3 of the module 1 is connected to the impeller 2. The impeller 2 includes a hub 21 and impeller blades 22. The impeller blades 22 are spirally arranged around the periphery of the hub 21; the flow guide module includes a hollow sleeve 4, and the impeller 2 is located inside the inlet end of the sleeve 4. , the inner wall of the outlet end of the sleeve 4 is fixed with a spiral guide vane 41; the drive module 1 extends in a direction away from the sleeve 4. During installation, the sleeve 4 is sutured and connected under the aortic valve 7 at the root of the aorta 5, and the driving module 1 passes through the apex of the heart and is fixed on the myocardium.

The impeller blades 22 have a first helical direction around the hub 21, and the guide vanes 41 have a second helical direction around the sleeve 4. The first helical direction is opposite to the second helical direction. The outlet end of the guide vane 41 has a partial area extending along the axial direction of the sleeve 4, so that the direction of the blood at the outlet end of the guide vane 41 is consistent with the axial direction of the sleeve 4, ensuring that the outflow direction of the blood is consistent with the direction of the central axis of the blood vessel. Reduce the rotational movement after blood flow out and reduce energy loss.

Preferably, a connecting portion 42 is provided on the outer periphery of the outlet end of the sleeve 4. The connecting portion 42 is in the shape of an annular groove or a ridge, which facilitates fixation with the aorta during suturing.

Further, the driving module 1 includes a power section and a connecting section. The connecting section is in the shape of an elongated shaft, and the transmission shaft 3 passes through the connecting section. When installed, the power segment is located outside the heart, and the connecting segment runs through the apex of the heart and is fixedly connected to the myocardium. A support rod 6 is connected between the connecting section of the drive module 1 and the sleeve 4. As shown in Figure 3, the support rod 6 fixes the drive module 1 and the sleeve 4 to ensure that the connection between the drive module 1 and the sleeve 4 is A coaxial relative positional relationship is always maintained between the two support rods 6. At least two support rods 6 are provided, and they are evenly distributed around the connecting section of the drive module 1. Preferably, two, three or four support rods 6 are provided; so The longitudinal section of the support rod 6 is circular or elliptical, which reduces resistance when blood flow passes through.

As shown in Figure 2, the drive module 1 includes a housing 13. An annular motor 14 is provided in the inner cavity of the housing 13. An annular permanent magnet 15 is coaxially provided inside the annular motor 14. The transmission shaft 3 is passed through the annular permanent magnet 15. Inside, the two ends of the transmission shaft 3 pass through the two ends of the annular permanent magnet 15 respectively. One end of the transmission shaft 3 extends toward the connecting section and passes through the housing 13. Bearings are respectively provided at both ends of the housing 13. The two ends of the transmission shaft 3 respectively pass through the two ends of the annular permanent magnet 15. Passing through the bearing, a sealing ring 9 is provided between the opening of the connecting section of the housing 13 and the transmission shaft 3 . It also includes a wire, one end of which is connected to the ring motor 14, and the other end extends out of the housing 13 and is connected to an external power supply. The external power supply is turned on to supply power to the ring motor 14. The ring motor 14 is energized to generate a magnetic field, which causes the ring permanent magnet 15 to rotate. The rotation of the ring permanent magnet 15 drives the transmission shaft 3 to rotate. The transmission shaft 3 then drives the impeller 2 to rotate, pumping blood into the sleeve. Inside the barrel 4, it flows into the aorta through the sleeve 4.

During installation, the sleeve 4 of the flow diversion module is fixedly installed under the aortic valve 7 at the root of the aorta 5. The power section of the drive module 1 is located outside the heart, and the connecting section penetrates the apex of the heart and is fixedly connected to the myocardium. The installation diagram is shown in Figure 4. shown. The transapical split-type heart assist device of the present invention is installed in a series structure with the heart, which can achieve a pulsating effect. The blood pressure waveform generated by the series structure is closer to the pulsating waveform under physiological conditions, and the average arterial pressure is larger, which is beneficial to tissues and organs. During perfusion, the blood pressure waveform is shown in Figure 5 (right) (LVP: left ventricular pressure; AOP: intra-aortic pressure; LAP: left atrial pressure). Therefore, the series structure can effectively avoid a series of related complications caused by the parallel structure, such as stroke, renal function damage, etc.

In the transapical split heart assist device of the present invention, the blood flow inlet is located at the aortic valve 7, which avoids coronary ischemia without the need for diversion of the coronary artery 8 opening, reduces the difficulty of surgery, and reduces stenosis and damage after coronary artery reimplantation. The risks associated with coronary artery surgery are avoided. The separate structure adopted by the present invention not only makes surgical installation more convenient, but also avoids bleeding caused by aorta replacement.

In the transapical split heart assist device of the present invention, the separation of the motor and the paddle greatly increases the blood flow space, resulting in a decrease in the required paddle speed, thereby reducing blood damage and damage to coagulation; at the same time, there is no need to increase the diameter and It achieves the auxiliary function and is suitable for installation in the left ventricular outflow tract and aorta; the drive module of the axial flow drive system extends to the outside of the apex of the heart, which can reduce the adverse effects on the blood caused by the heat generated by the operation of the drive module.

In the transapical split-type heart assist device of the present invention, the sleeve outlet end of the flow diversion module is provided with a spiral guide vane, which can eliminate the rotational movement of blood driven by the impeller and change it to the axial movement along the aorta, reducing blood flow. Flow energy loss.

Of course, the present invention can also have various other embodiments. Without departing from the spirit and essence of the present invention, those skilled in the art can make various corresponding changes and modifications according to the present invention. However, these corresponding changes All modifications and variations shall fall within the protection scope of the appended claims of the present invention.

Claims (9)

1. Transapical split cardiac assist device, characterized by: including an axial flow drive system and a flow diversion module. 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 a flow guide module. The impeller blades are arranged spirally around the outer circumference of the hub; the diversion module includes a hollow sleeve, the impeller is located inside the inlet end of the sleeve, and a spiral guide vane is fixed on the inner wall of the outlet end of the sleeve; the drive module moves in the direction away from the sleeve extend. 2. The transapical split cardiac assist device according to claim 1, wherein the driving module includes a power section and a connecting section, the connecting section is in the shape of an elongated shaft, and the transmission shaft runs through the connecting section. 3. The transapical split cardiac assist device according to claim 2, characterized in that: a support rod is connected between the connecting section of the driving module and the sleeve. 4. The transapical split-type cardiac assist device according to claim 3, characterized in that: there are three support rods, which are evenly distributed around the connecting section of the driving module in the circumferential direction. 5. The transapical split cardiac assist device according to claim 1, wherein a connecting portion is provided on the outer periphery of the outlet end of the sleeve. 6. The transapical split cardiac assist device according to claim 5, wherein the connecting portion is in the shape of an annular groove. 7. The transapical split cardiac assist device according to claim 5, wherein the connecting portion is in an annular convex shape. 8. The transapical split cardiac assist device according to claim 2, wherein the drive module includes a housing, a ring motor is provided in the housing of the power section, and an annular permanent magnet is coaxially provided inside the ring motor. The transmission shaft passes through the interior of the annular permanent magnet. Both ends of the transmission shaft pass through the two ends of the annular permanent magnet. One end of the transmission shaft extends toward the connecting section and passes through the housing. Bearings are provided at both ends of the housing. The two ends of the transmission shaft They are respectively installed in the bearings, and a sealing ring is provided between the opening of the connecting section of the housing and the transmission shaft. 9. The transapical split cardiac assist device according to claim 8, further comprising a wire, one end of the wire is connected to the ring motor, and the other end of the wire extends out of the housing and is connected to an external power supply.