Left ventricle auxiliary device and implantation assembly

Abstract

The invention relates to a left ventricle auxiliary device and an implantation assembly. The left ventricle auxiliary device comprises a small and special electric machine and a housing with a blood channel, the small and special motor comprises a shell and a pump machine body, the pump machine body is provided with a motor shaft, pump blades are arranged on the motor shaft, and the motor shaft extends out of the shell and extends into the housing; the shell is provided with a rear cover, the inner end of the wire penetrates through the rear cover to be electrically connected with the pump machine body, and the outer end of the wire is electrically connected with an external power supply control device. The housing comprises a pumping-in cover, a transition pipe and a pumping-out cover, the pumping-in cover is provided with a blood suction hole, and the pumping-out cover is provided with a blood discharge hole; a first suction cup and a second suction cup are arranged outside the shell, and a third suction cup and a fourth suction cup are arranged outside the transition pipe. The left ventricle auxiliary device can be implanted into a body through the implantation assembly. The left ventricle auxiliary device is simple and small in structure, implantation can be completed through percutaneous puncture by means of the implantation assembly, blood can be pumped into the ascending aorta from the left atrium through a blood channel, and the left ventricle auxiliary function is achieved.

Description

Technical Field

[0001] This invention relates to a left ventricular assist device and its implantable components, belonging to the field of medical device technology. Background Technology

[0002] In recent years, the incidence of cardiovascular diseases has increased. According to a survey by the World Health Organization, cardiovascular diseases currently account for about 30% of all diseases. Many of these diseases ultimately affect left ventricular function, leading to left ventricular failure, cardiogenic shock, and other left ventricular dysfunction disorders. To address left ventricular dysfunction, scholars both domestically and internationally have proposed new treatment methods. Left ventricular assist devices (LVADs) are designed for patients with left ventricular dysfunction, diverting blood from the left ventricle to the aorta to provide circulatory support. LVADs are classified as implantable or para-invasive based on whether they are implanted in the body, and as pulsatile or axial based on the blood flow pattern.

[0003] Traditional left ventricular assist devices (LVAP) are surgically implanted by creating a channel through holes in the left ventricle and aorta, with a pump inserted between them. Surgical implantation is highly invasive. Currently, the most commonly used percutaneous LVAP devices in clinical practice include Extracorporeal Membrane Oxygenation (ECMO), Intra-aortic Balloon Counterpulsation (IABP), Tandem Heart, and Impella. ECMO involves implanting two catheters in the femoral artery and femoral vein respectively. The catheter in the femoral vein connects to an external artificial lung, which is then connected to an axial flow pump or pulsatile pump, and finally to the catheter in the femoral artery. Disadvantages include the need for an external artificial lung, complex structure, interruption of pulmonary circulation, increased risk of pulmonary thrombosis, and a high risk of massive bleeding. Intra-aortic Balloon Counterpulsation involves inserting a long balloon into the aorta. The balloon inflates and deflates with the heartbeat, enhancing myocardial blood supply. Disadvantages include dependence on ventricular function and instability. The Tandem Heart system consists of an inflow tube inserted into the left atrium via the femoral vein, an external central pump, and an outflow tube inserted into the left ventricle via the femoral artery, establishing a drainage channel from the left atrium to the femoral artery. Its disadvantages are that the tubing is complex, requires an external central pump, and does not utilize the body's oxygenation system. The Impella system contains a catheter inserted into the left ventricle via the femoral artery. The catheter tip has a cage-like blood inlet, and the outlet is located in the ascending aorta. An axial flow pump is located between the inlet and outlet to drain blood from the left ventricle into the aorta. However, it has the following disadvantages: (1) It is non-implantable and requires repeated punctures, increasing costs and risks; (2) The device passes through the aortic valve, affecting valve function; (3) The device requires an external power source and cannot be carried around.

[0004] A search revealed that patent applications CN20101055360.3 and CN102475923A disclose a ventricular circulation device, comprising an external drive device, a pump, a catheter, and an interventional cannula. The catheter, connected before the pump and made of a biocompatible polymer material, serves to drain blood from the ventricle to the pump, passing over the aortic valve during insertion. The catheter tip for left ventricular assist is beveled to facilitate passage over the aortic valve. The interventional cannula, used for interventional procedures, is inserted into the pump to its position and positions it after insertion. It is made of a biocompatible polymer material tube, with a stainless steel spring tube supporting the inner wall to provide both rigidity and flexibility. This technical solution utilizes a catheter to directly pump blood from the left ventricle into the aorta; however, the catheter's passage over the aortic valve can affect valve function and hinder normal blood flow within the heart.

[0005] Utility model patent application CN201920562887.1 and CN210020563U discloses a percutaneous left ventricular assist system, including a dual-chamber blood pump and a main controller for controlling the operation of the dual-chamber blood pump; the dual-chamber blood pump includes an inflow chamber, an outflow chamber connected to the inflow chamber, and a blood pump power system; the inflow chamber is connected to a blood inlet tube, and the end of the blood inlet tube away from the dual-chamber blood pump is inserted into the left atrium; the outflow chamber is connected to a blood outflow tube, and the end of the outflow tube away from the dual-chamber blood pump is inserted into the aorta from one or both femoral arteries; a one-way mechanical valve is provided between the outflow chamber and the blood outflow tube. In this technical solution, the main controller sends control commands to the pump power system in the dual-chamber blood pump based on the electrocardiogram (ECG) signal, and controls the pump power system to operate accordingly. A blood inlet tube facilitates the dual-chamber blood pump to draw oxygenated blood from the left atrium. An inflow chamber stores the oxygenated blood drawn from the left atrium. An outflow chamber, connected to the inflow chamber, pumps the stored oxygenated blood into the outflow chamber, and then pumps the oxygenated blood out of the outflow chamber into a blood outflow tube. The blood outflow tube then delivers the oxygenated blood to the aorta. However, this technical solution primarily provides temporary circulatory support during clinical surgical treatment of patients with cardiogenic shock. The main components are located outside the patient's body, making them difficult to carry and restricting patient movement; therefore, they are not suitable for patients with left ventricular dysfunction.

[0006] Patent application CN201980050062.4 and publication number CN112533662A discloses an intravascular pump with proximal and distal pressure or flow sensors and distal sensor tracking, including a pump assembly without flow guides or diffusers, and proximal and distal flow or pressure sensors. This intravascular pump crosses the aortic valve to deliver blood. However, because the intravascular pump passes through the aortic valve, it can affect valve function and hinder normal blood flow within the heart. Summary of the Invention

[0007] The main objective of this invention is to overcome the problems existing in the prior art and provide a left ventricular assist device with a simple and compact structure that can be implanted via percutaneous puncture with minimal trauma during implantation; since it does not need to cross the valves, it will not affect normal blood flow within the heart. Corresponding implantation components are also provided.

[0008] The technical solution of this invention to solve its technical problem is as follows:

[0009] A left ventricular assist device includes a motor and a housing; characterized in that the motor is a micro motor; the housing has a blood channel; the micro motor includes a housing and a pump body located within the housing, the pump body having a motor shaft with pump blades, the motor shaft extending out of the housing and into the housing; the housing of the micro motor has a rear cover with a connection hole for an external delivery cable; the micro motor also has a wire, the inner end of which passes through the rear cover and is electrically connected to the pump body, and the outer end of which is electrically connected to an external power supply control device; the housing includes a pump inlet shroud and a transition tube sequentially connected and interconnected. The system includes a pump inlet hood, which is fixedly connected to the housing of the micro-motor. The side wall of the pump inlet hood has a set of blood suction holes, and the side wall of the pump outlet hood has a set of blood discharge holes. The blood channel is composed of the blood suction holes, the hollow space of the pump inlet hood, the hollow pipe of the transition tube, the hollow space of the pump outlet hood, and the blood discharge holes. A one-way valve is provided inside the pump outlet hood. The outer side of the housing of the micro-motor is provided with a first suction cup and a second suction cup located on both sides of a first longitudinal plane. The outer side of the transition tube is provided with a third suction cup and a fourth suction cup located on both sides of a second longitudinal plane. The first and second longitudinal planes are parallel to each other and perpendicular to the axis of the micro-motor.

[0010] The left ventricular assist device has the following implantation state: the housing of the micro motor passes through the interatrial septum, the pump inlet shroud is located in the left atrium, the transition tube passes through the interatrial septum between the ascending aorta and the left atrium, the pump outlet shroud is located in the ascending aorta, the first suction cup is located on the right atrial side of the interatrial septum and is attached to the inner wall of the right atrium, the second suction cup is located on the left atrial side of the interatrial septum and is attached to the inner wall of the left atrium, the third suction cup is located on the left atrial side of the interatrial septum between the ascending aorta and the left atrium and is attached to the inner wall of the left atrium, and the fourth suction cup is located on the ascending aortic side of the interatrial septum between the ascending aorta and the left atrium and is attached to the inner wall of the ascending aorta;

[0011] The left ventricular assist device also has the following working state: when implanted, the power supply control device supplies power to the micro motor, and the micro motor, under the control of the power supply control device, pumps blood from the left atrium into the ascending aorta through the blood channel.

[0012] This device utilizes a micro-motor, effectively reducing its overall size (down to a length of 3.5cm). Implantation can be performed percutaneously with minimal trauma. The first to fourth suction cups securely fix the entire device in a preset position. After implantation, under the control of an external power supply, the micro-motor pumps blood from the left atrium into the ascending aorta via a blood channel, thereby reducing the workload of the left ventricular myocardium, reducing myocardial oxygen consumption, improving hemodynamics, and improving peripheral blood supply. Simultaneously, the one-way valve effectively prevents backflow of blood.

[0013] The technical solution for further improving the above-mentioned device is as follows:

[0014] Preferably, one end of the pump inlet shroud is fixedly connected to the housing of the micro motor, and the other end is open; both ends of the transition tube are open; one end of the pump outlet shroud is open and the other end is closed; the other end of the pump inlet shroud is fixedly connected to and communicates with one end of the transition tube, and the other end of the transition tube is fixedly connected to and communicates with the open end of the pump outlet shroud. This further optimizes the connection structure of the various components of the shroud.

[0015] More preferably, the one-way valve of the pump shroud includes a spherical piston and a spring, one end of the spring being fixedly connected to the spherical piston and the other end being fixedly connected to the inner wall of the closed end of the pump shroud; the spherical piston blocks the open end of the pump shroud under the action of the spring. This further optimizes the structure of the one-way valve. When the micro motor is running, the pumped blood can push open the spherical piston and enter the pump shroud, continuing to enter the ascending aorta through the blood discharge hole.

[0016] More preferably, a metal marker ring is provided on the outer side of the closed end of the pump cover, which facilitates monitoring the position of the entire device head within the body during implantation. Furthermore, the diameter of the blood discharge port is 1±0.5 mm.

[0017] Preferably, the first, second, third, and fourth suction cups are all coated suction cups with tension wires; the third and fourth suction cups each have retaining barbs. This further optimizes the specific structure of each suction cup, and the retaining barbs help achieve a better fixing effect.

[0018] Preferably, the housing of the micro motor also has a front cover, through which the motor shaft extends into the housing. This further optimizes the specific structure of the micro motor housing.

[0019] More preferably, the micro motor is a coreless motor; the pump body of the micro motor also includes a commutation circuit board, a bracket, an arc-shaped plate, a coil winding, a magnetic inner cylinder, and a bushing; the arc-shaped plate, the coil winding, the magnetic inner cylinder, the bushing, and the motor shaft are arranged coaxially; the arc-shaped plate is located circumferentially outside the coil winding, the coil winding is located circumferentially outside the magnetic inner cylinder, the magnetic inner cylinder is located circumferentially outside the bushing, and the bushing is located circumferentially outside the motor shaft; one end of the bushing is located inside the housing, and its other end passes through the front cover and is located outside the housing; the other end of the bushing is rotatably and sealed to the motor shaft. The bushing is sealed to the housing; the magnetic inner cylinder is rotatably connected to the motor shaft via a connecting bearing, one side of which has a gasket, and the other side of which contacts one end of the bushing; the magnetic inner cylinder is located inside the housing and is fixedly connected to it; the motor shaft, arc plate, and coil winding are located inside the housing and are respectively fixedly connected to the bracket, together forming the rotor; the commutation circuit board is located inside the housing and on one side of the bracket, while the arc plate and coil winding are on the other side of the bracket; the commutation circuit board has conductive contacts, which maintain electrical connection with the coil winding during rotor rotation. This further optimizes the specific structure of the pump body of the micro-motor.

[0020] This invention also provides:

[0021] An implantable assembly for implanting a left ventricular assist device (LVAD), characterized by comprising a guidewire, an adjustable-bend sheath, an inner sheath, a puncture needle, a delivery sheath, a delivery cable, a power supply control device, and the aforementioned LVAD device; wherein the delivery sheath has an exhaust valve and a hemostatic valve, the hemostatic valve of the delivery sheath having a fixing device that matches the adjustable-bend sheath; the adjustable-bend sheath is a tear-off sheath; the power supply control device has a battery and a controller, the battery being electrically connected to the controller, and the controller having an interface for electrical connection to the leads of the LVAD device.

[0022] This implantable component can effectively complete the implantation of a left ventricular assist device, thereby enabling it to perform left ventricular assist function.

[0023] The technical solutions for further improving the above-mentioned implanted components are as follows:

[0024] Preferably, the implanted component has the following specific states:

[0025] The guidewire is located inside the inner sheath, which is located inside the adjustable bending long sheath. The tip of the adjustable bending long sheath is located in the right atrium and at the orifice of the inferior vena cava in the first state.

[0026] Based on the first state, the puncture needle is in the second state after the inner sheath and guidewire are withdrawn from the adjustable curved long sheath;

[0027] Based on the second state, after the puncture needle punctures the interatrial septum at the center of the fossa ovalis and enters the left atrium, the tip of the adjustable long sheath enters the left atrium in the third state.

[0028] Based on the third state, after the puncture needle is withdrawn from the adjustable curved long sheath and the guidewire is inserted into the pulmonary vein along the adjustable curved long sheath, the tip of the adjustable curved long sheath is moved to the fourth state, which is located in the middle of the left atrium.

[0029] Based on the fourth state, after the guidewire is withdrawn from the adjustable curved sheath, the tip of the adjustable curved sheath is rotated toward the ascending aorta and contacts the septum between the ascending aorta and the left atrium, and the puncture needle is located inside the adjustable curved sheath in the fifth state.

[0030] Based on the fifth state, the sixth state is reached after the puncture needle enters the ascending aorta, the tip of the adjustable long sheath enters the ascending aorta and reaches the preset position.

[0031] Based on the sixth state, after the puncture needle is withdrawn from the adjustable curved sheath, the left ventricular assist device is fixedly connected to the delivery cable, the left ventricular assist device is inserted into the adjustable curved sheath along the delivery sheath, and the metal marker ring is located at the head end of the adjustable curved sheath. The lead of the left ventricular assist device is located inside the delivery sheath and the adjustable curved sheath, and the outer end of the lead is exposed outside the body. The fixing device of the adjustable curved sheath and the delivery sheath is fixedly connected in an integrated manner in the seventh state.

[0032] Based on the seventh state, the adjustable curved sheath of the left ventricular assist device pump hood and transition tube is released. The pump hood is located inside the ascending aorta, the transition tube passes through the septum between the ascending aorta and the left atrium, the third suction cup is released and located on the left atrial side at the septum between the ascending aorta and the left atrium, and the third suction cup is attached to the inner wall of the left atrium. The fourth suction cup is released and located on the ascending aortic side at the septum between the ascending aorta and the left atrium, and the fourth suction cup is attached to the inner wall of the ascending aorta, which is the eighth state.

[0033] Based on the eighth state, the adjustable curved sheath of the pump inlet hood, micro motor and housing of the left ventricular assist device is released. The pump inlet hood is located in the left atrium. The housing of the micro motor passes through the interatrial septum. The first suction cup is released and located on the right atrial side of the interatrial septum. The first suction cup is attached to the inner wall of the right atrium. The second suction cup is released and located on the left atrial side of the interatrial septum. The second suction cup is attached to the inner wall of the left atrium.

[0034] Based on the ninth state, after removing the delivery cable from the adjustable bending sheath and the delivery sheath, separating the delivery sheath from the adjustable bending sheath, and removing the adjustable bending sheath, the left ventricular assist device remains in the body. The outer end of the lead wire of the left ventricular assist device is electrically connected to the power supply control device. The control parameters of the power supply control device on the micro motor are determined by testing the speed of the micro motor and monitoring the hemodynamic parameters. The tenth state is when the part of the lead wire exposed outside the body and the power supply control device are placed in the subcutaneous pouch.

[0035] This allows for the optimization of the specific states of the implanted components, thereby improving the efficiency of implanting left ventricular assist devices in the body.

[0036] More preferably, when testing the speed of the micromotor, the speed adjustment range of the micromotor is 20,000-30,000 rpm. This satisfies the blood pumping requirements while reducing damage to red blood cells.

[0037] Compared with the prior art, the left ventricular assist device of the present invention has a simple and compact structure, can be implanted through percutaneous puncture, and has less trauma during implantation; since it does not need to cross the valve, it will not affect the normal blood flow in the heart; after the left ventricular assist device is implanted in the body using the above-mentioned implantation components, the micro motor can pump blood from the left atrium into the ascending aorta through the blood channel, thereby reducing the work of the left ventricular myocardium, reducing myocardial oxygen consumption, improving hemodynamics, and improving peripheral blood supply. Attached Figure Description

[0038] Figure 1 This is a schematic diagram of the left ventricular assist device according to Embodiment 1 of the present invention.

[0039] Figure 2 This is a schematic diagram of the pump body of Embodiment 1 of the present invention.

[0040] Figure 3 This is a schematic diagram of the left ventricular assist device in working state according to Embodiment 1 of the present invention.

[0041] Figures 4 to 16 These are schematic diagrams illustrating a series of specific implementations of the implanted component in Embodiment 2 of the present invention.

[0042] Figure 17 This is a schematic diagram of the implanted component in Embodiment 2 of the present invention being delivered to the adjustable curved sheath tip of the left ventricular assist device.

[0043] Figures 18 to 21 This is a series of specific implementation diagrams showing the release of each suction cup one by one in Embodiment 2 of the present invention. Detailed Implementation

[0044] The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. However, the present invention is not limited to the examples given.

[0045] Example 1

[0046] This embodiment is a left ventricular assist device 01 (such as...) Figure 1As shown, it includes a micro motor 02 and a housing with a blood channel; the micro motor 02 has a housing 03 and a pump body 04 located inside the housing 03, the pump body 04 has a motor shaft 05, and a pump blade 06 is provided on the motor shaft 05. The motor shaft 05 extends out of the housing 03 and into the housing; the housing includes a pump inlet hood 07 and a pump outlet hood 08 that are connected to each other. The pump inlet hood 07 is fixedly connected to the pump outlet hood 08 via a transition pipe 09; the side wall of the pump inlet hood 07 has a set of blood suction holes 10, and the side wall of the pump outlet hood 08 has a set of blood discharge holes 11 (with a diameter of about 1 mm); the blood suction holes 10, the hollow space of the pump inlet hood 07, the hollow pipe of the transition pipe 09, the hollow space of the pump outlet hood 08, and the blood discharge holes 11 together constitute the blood channel. One end of the pump inlet cover 07 is fixedly connected to the housing 03 of the micro motor, and the other end is open; both ends of the transition pipe 09 are open; one end of the pump outlet cover 08 is open and is the open end, and the other end is closed and is the closed end; the other end of the pump inlet cover 07 is fixedly connected to one end of the transition pipe 09 and is in communication, and the other end of the transition pipe 09 is fixedly connected to the open end of the pump outlet cover 08 and is in communication.

[0047] The pump discharge shroud 08 is equipped with a one-way valve; the one-way valve includes a ball piston 12 and a spring 13. One end of the spring 13 is fixedly connected to the ball piston 12, and the other end is fixedly connected to the inner wall of the closed end of the pump discharge shroud 08. Under the action of the spring 13, the ball piston 12 blocks the open end of the pump discharge shroud 08. In addition, a metal marker ring 14 is provided on the outside of the closed end of the pump discharge shroud 08.

[0048] The outer side of the housing 03 of the micro-motor is provided with a first suction cup 15 and a second suction cup 16, located on both sides of the first longitudinal plane; the outer side of the transition tube 09 is provided with a third suction cup 17 and a fourth suction cup 18, located on both sides of the second longitudinal plane; the first and second longitudinal planes are perpendicular to the axial direction of the micro-motor 02, and the first longitudinal plane is parallel to the second longitudinal plane. The first suction cup 15, the second suction cup 16, the third suction cup 17, and the fourth suction cup 18 are all coated suction cups with tension steel wires. In addition, the third suction cup 17 and the fourth suction cup 18 are each provided with fixing barbs 19.

[0049] The micro motor 02 is a coreless motor. The housing 03 of the micro motor has a front cover 20 and a rear cover 21; the motor shaft 05 passes through the front cover 20 and extends into the housing; the rear cover 21 has a connection hole (not shown in the figure) for matching with the external conveying steel cable 22; the micro motor 02 also has a wire 23, the inner end of the wire 23 passes through the rear cover 21 and is electrically connected to the pump body 04, and the outer end of the wire 23 is electrically connected to the external power supply control device 35.

[0050] like Figure 2As shown, the pump body 04 also includes a reversing circuit board 24, a bracket 25, an arc plate 26, a coil winding 27, a magnetic inner cylinder 28, and a bushing 29; the arc plate 26, coil winding 27, magnetic inner cylinder 28, bushing 29, and motor shaft 05 are arranged coaxially; the arc plate 26 is located circumferentially outside the coil winding 27, the coil winding 27 is located circumferentially outside the magnetic inner cylinder 28, the magnetic inner cylinder 28 is located circumferentially outside the bushing 29, and the bushing 29 is located circumferentially outside the motor shaft 05; one end of the bushing 29 is located inside the housing 03, and the other end passes through the front cover 20 and is located outside the housing 03; the other end of the bushing 29 is rotatably and sealed to the motor shaft 05, and the bushing 29 is sealed to the housing 03. Connection: The magnetic inner cylinder 28 is rotatably connected to the motor shaft 05 via the connecting bearing 30. A gasket 31 is provided on one side of the connecting bearing 30, and the other side of the connecting bearing 30 is in contact with one end of the bushing 29. The magnetic inner cylinder 28 is located inside the housing 03 and is fixedly connected to the housing 03. The motor shaft 05, the arc plate 26, and the coil winding 27 are located inside the housing 03 and are fixedly connected to the bracket 25 respectively, and together they constitute the rotor. The reversing circuit board 24 is located inside the housing 03 and is located on one side of the bracket 25. The arc plate 26 and the coil winding 27 are located on the other side of the bracket 25. The reversing circuit board 24 has conductive contacts (not shown in the figure). The conductive contacts are electrically connected to the coil winding 27 during the rotation of the rotor.

[0051] In terms of size, the device in this embodiment can be made quite compact. For example, along the axial direction of the micromotor 02, the length of the micromotor housing 03 is 7mm, the length of the pump inlet cover 07 is 5mm, the length of the transition tube 09 is 1cm, and the length of the pump outlet cover 08 is 1.3cm, for a total overall length of 3.5cm. This minimizes the trauma caused when implanting the device in this embodiment.

[0052] The left ventricular assist device in this embodiment has the following specific states:

[0053] (1) The housing 03 of the micro motor passes through the interatrial septum, the pump inlet cover 07 is located in the left atrium, the transition tube 09 passes through the interatrial septum between the ascending aorta and the left atrium, the pump outlet cover 08 is located in the ascending aorta, the first suction cup 15 is located on the right atrium side of the interatrial septum and is attached to the inner wall of the right atrium, the second suction cup 16 is located on the left atrium side of the interatrial septum and is attached to the inner wall of the left atrium, the third suction cup 17 is located on the left atrium side of the interatrial septum between the ascending aorta and the left atrium and is attached to the inner wall of the left atrium, and the fourth suction cup 18 is located on the ascending aorta side of the interatrial septum between the ascending aorta and the left atrium and is attached to the inner wall of the ascending aorta.

[0054] (2) The power supply control device 35 supplies power to the micro motor 02, and the micro motor 02, under the control of the power supply control device 35, pumps blood from the left atrium through the blood channel into the ascending aorta (e.g., the working state of the micro motor 02 pumping blood from the left atrium into the ascending aorta through the blood channel). Figure 3 (As shown).

[0055] It should be noted that all components in the device of this embodiment that come into direct contact with or may come into contact with human tissue are made of biocompatible materials.

[0056] Example 2

[0057] This embodiment is an implantation component for implanting a left ventricular assist device, including a guidewire 32, an adjustable bendable sheath 39, an inner sheath, a puncture needle 33, a delivery sheath 34, a delivery cable 22, a power supply control device 35, and the left ventricular assist device 01 of Embodiment 1; wherein, the delivery sheath 34 has an exhaust valve 36 and a hemostatic valve 37, and the hemostatic valve 37 of the delivery sheath 34 has a fixing device 38 that matches the adjustable bendable sheath 39; the adjustable bendable sheath 39 is a tear-off sheath; the power supply control device 35 has a battery and a controller, the battery is electrically connected to the controller, and the controller has an interface (not shown in the figure) that is electrically connected to the lead wire 23 of the left ventricular assist device 01.

[0058] The specific implementation process of the implanted component in this embodiment and the specific states it has in sequence are as follows:

[0059] (1) After puncturing the axillary vein and establishing a venous access, guidewire 32 is advanced along the venous access to the right atrium. Figure 4 ), and insert the adjustable curved long sheath 39 and inner sheath along the guidewire 32 to the inferior vena cava orifice in the right atrium ( Figure 5 ).

[0060] At this time, the implanted component has the following first state: the guidewire 32 is located inside the inner sheath, the inner sheath is located inside the adjustable bending long sheath 39, and the tip of the adjustable bending long sheath 39 is located in the right atrium and at the inferior vena cava orifice.

[0061] (2) Remove the inner sheath and guidewire 32, and insert the puncture needle 33. Figure 6 ).

[0062] At this time, the implanted component has a second state in which the puncture needle 33 is located inside the adjustable curved sheath 39 after the inner sheath and guidewire 32 have been withdrawn.

[0063] (3) Under the guidance of right anterior oblique fluoroscopy, align the tip of the adjustable curved sheath 39 with the fossa of the ovum, and rotate the puncture needle 33 into the center of the fossa of the ovum. Figure 7 ), and insert the puncture needle 33 to puncture the interatrial septum and enter the left atrium ( Figure 8 ), inject contrast agent to confirm penetration into the left atrium; push the puncture needle 33 and the adjustable bending sheath 39 into the left atrium ( Figure 9 ).

[0064] At this point, the implanted component has a third state: after the puncture needle 33 punctures the interatrial septum at the center of the fossa ovalis and enters the left atrium, the tip of the adjustable long sheath 39 enters the left atrium.

[0065] (4) Withdraw the puncture needle 33 and insert the guidewire 32 into the pulmonary vein along the adjustable curved sheath 39. Figure 10 The tip of the adjustable bendable sheath 39 is moved along the guidewire 32 to the middle of the left atrium. Figure 11 ).

[0066] At this time, the implanted component has a fourth state in which the tip of the adjustable bending sheath 39 is moved to the middle of the left atrium after the puncture needle 33 is withdrawn from the adjustable bending sheath 39 and the guidewire 32 is inserted into the pulmonary vein along the adjustable bending sheath 39.

[0067] (5) Withdraw the guidewire 32, turn the adjustable bendable sheath 39 toward the ascending aorta, and gently press it against the septum between the ascending aorta and the left atrium. Figure 12 Insert the puncture needle.

[0068] At this time, the implanted component has the following fifth state: after the guidewire 32 is withdrawn from the adjustable bending sheath 39, the tip of the adjustable bending sheath 39 is rotated toward the ascending aorta and contacts the septum between the ascending aorta and the left atrium, and the puncture needle 33 is located inside the adjustable bending sheath 39.

[0069] (6) Insert the puncture needle 33 for puncture and inject contrast agent to confirm that the aorta has been penetrated. Figure 13 After the puncture needle 33 is inserted into the ascending aorta, the puncture needle 33 and the adjustable curved sheath 39 are pushed into the ascending aorta. Angiography is used to adjust the adjustable curved sheath 39 to a depth in the ascending aorta at least to its preset mark. Figure 14 ).

[0070] At this time, the implanted component has a sixth state: after the puncture needle 33 punctures into the ascending aorta, the tip of the adjustable bending sheath 39 enters the ascending aorta and reaches a preset position.

[0071] (7) Withdraw the puncture needle 33; connect the delivery cable 22 to the left ventricular assist device 01 of Example 1, and then assemble it into the delivery sheath 34; insert the left ventricular assist device 01 from the delivery sheath 34 into the adjustable bendable sheath 39 until the metal marker ring 14 of the left ventricular assist device 01 is delivered to the head end of the adjustable bendable sheath 39, retract the adjustable bendable sheath 39 and fix it integrally with the delivery sheath 34. Figures 15 to 17 ).

[0072] At this time, the implanted component has the following seventh state: after the puncture needle 33 is withdrawn from the adjustable bending sheath 39, the left ventricular assist device 01 is fixedly connected to the delivery cable 22, the left ventricular assist device 01 is inserted into the adjustable bending sheath 39 along the delivery sheath 34 and the metal marker ring 14 is located at the head end of the adjustable bending sheath 39, the lead wire 23 of the left ventricular assist device 01 is located inside the delivery sheath 34 and the adjustable bending sheath 39 and the outer end of the lead wire 23 is exposed outside the body, and the adjustable bending sheath 39 and the fixing device 38 of the delivery sheath 34 are fixedly connected as an integral unit.

[0073] (8) Gradually retract the adjustable bending sheath 39 and the delivery sheath 34 to release the left ventricular assist device 01; the fourth suction cup 18 is automatically released first. The fourth suction cup 18 is located on the ascending aortic side at the septum between the ascending aorta and the left atrium. The fourth suction cup 18 is adsorbed and fixed to the inner wall of the ascending aorta and clearly defined by angiography. Figure 18 As the adjustable bending sheath 39 gradually retracts within the left atrium, the third suction cup 17 is automatically released. The third suction cup 17 is located on the left atrial side at the septum between the ascending aorta and the left atrium. The third suction cup 17 is adhered and fixed to the inner wall of the left atrium and clearly defined by angiography. Figure 19 Continue to gradually retract the adjustable curved sheath 39 until the transition tube 09 of the left ventricular assist device 01 is completely released; observe under fluoroscopy to ensure that the third suction cup 17 and the fourth suction cup 18 are stably fixed at the septum between the left atrium and the ascending aorta.

[0074] At this time, the implanted component has the following eighth state: the pump shroud 08 and transition tube 09 of the left ventricular assist device 01 are released from the adjustable curved sheath 39, the pump shroud 08 is located in the ascending aorta, the transition tube 09 passes through the septum between the ascending aorta and the left atrium, the third suction cup 17 is released and located on the left atrial side of the septum between the ascending aorta and the left atrium, the third suction cup 17 is adsorbed and fixed to the inner wall of the left atrium, and the fourth suction cup 18 is released and located on the ascending aortic side of the septum between the ascending aorta and the left atrium, the fourth suction cup 18 is adsorbed and fixed to the inner wall of the ascending aorta.

[0075] (9) Continue to gradually retract the adjustable curved sheath 39. The second suction cup 16 is automatically released. The second suction cup 16 is located on the left atrial side at the interatrial septum. The second suction cup 16 is adsorbed and fixed to the inner wall of the left atrium and clearly defined by angiography. Figure 20 The adjustable bendable sheath 39 continues to gradually retract into the right atrium, and the first suction cup 15 is automatically released. The first suction cup 15 is located on the right atrial side at the interatrial septum. The first suction cup 15 is adhered and fixed to the inner wall of the right atrium and clearly visible on angiography. Figure 21 Continue to retract the adjustable curved sheath 39 until the housing 03 of the micro motor of the left ventricular assist device 01 is fully released; observe under fluoroscopy to ensure that the first suction cup 15 and the second suction cup 16 are stably fixed at the interatrial septum.

[0076] At this time, the implanted component has the following ninth state: the pump shroud 07, micro motor 02, and housing 03 of the left ventricular assist device 01 are released from the adjustable curved sheath 39, the pump shroud 07 is located in the left atrium, the housing 03 of the micro motor passes through the interatrial septum, the first suction cup 15 is released and located on the right atrial side of the interatrial septum, the first suction cup 15 is adsorbed and fixed to the inner wall of the right atrium, and the second suction cup 16 is released and located on the left atrial side of the interatrial septum, the second suction cup 16 is adsorbed and fixed to the inner wall of the left atrium.

[0077] (10) Connect the outer end of the lead wire 23 of the left ventricular assist device 01 to the power supply control device 35. Test the speed of the micro motor 02 through the power supply control device 35, and monitor the patient's hemodynamic parameters at the same time. After obtaining satisfactory hemodynamic parameters, disconnect the lead wire 23 from the power supply control device 35. Rotate the delivery cable 22 counterclockwise to remove it from the left ventricular assist device 01. Remove the delivery cable 22 from the adjustable bending sheath 39 and the delivery sheath 34. Rotate the hemostatic valve 37 of the delivery sheath 34 counterclockwise to remove the fixing device 38 from the adjustable bending sheath 39. Tear open the adjustable bending sheath 39. The left ventricular assist device (LVAD) was then removed from the patient's body, leaving only the LVAD 01 inside the body, with the lead 23 protruding from the axillary vein puncture site. The pectoralis major fascia was separated, and a pouch was created. The outer end of the lead 23 was electrically connected to the power supply control device 35 again. The speed of the micromotor 02 was tested, and hemodynamic parameters were monitored. After obtaining satisfactory hemodynamic parameters, the control parameters of the power supply control device 35 for the micromotor 02 were determined. The protruding portion of the lead 23 and the power supply control device 35 were placed into the pouch, the lead 23 and the power supply control device 35 were fixed, and the layers were sutured until the skin was intact. The implantation was completed.

[0078] At this time, the implanted component has the following state: after the delivery cable 22 is removed from the adjustable bending sheath 39 and the delivery sheath 34, the delivery sheath 34 is removed from the adjustable bending sheath 39, and the adjustable bending sheath 39 is removed, the left ventricular assist device 01 remains in the body, the outer end of the lead 23 of the left ventricular assist device 01 is electrically connected to the power supply control device 35, the control parameters of the power supply control device 35 on the micro motor 02 are determined by testing the speed of the micro motor 02 and monitoring the hemodynamic parameters, and the part of the lead 23 exposed outside the body and the power supply control device 35 are placed in the subcutaneous pouch.

[0079] In addition, during testing, the speed adjustment range of the micro motor 02 was 20,000-30,000 rpm, which could meet the requirements of blood pumping volume while reducing damage to red blood cells.

[0080] After this, by controlling the left ventricular assist device 01, blood in the left atrium can be diverted into the ascending aorta, reducing the workload of the left ventricular myocardium, reducing myocardial oxygen consumption, improving hemodynamics, and improving peripheral blood supply.

[0081] As can be seen from the above embodiments, the present invention does not require devices such as artificial lungs, has a relatively simple structure, can be implanted into the body by percutaneous puncture, and the power supply control device 35 can be buried under the skin, making it easy to carry; the control parameters of the power supply control device 35 can be adjusted to adapt to different human needs for pumping blood volume.

[0082] In addition to the embodiments described above, the present invention may have other implementations. All technical solutions formed by equivalent substitution or equivalent transformation fall within the protection scope claimed by the present invention.

Claims

1. A left ventricular assist device, comprising a motor and a housing; characterized in that, The motor is a micro motor; the housing has a blood channel; the micro motor includes a housing and a pump body located inside the housing, the pump body has a motor shaft with pump blades, the motor shaft extends out of the housing and into the housing; the housing of the micro motor has a rear cover with a connection hole for an external delivery cable; the micro motor also has a wire, the inner end of which passes through the rear cover and is electrically connected to the pump body, and the outer end of which is electrically connected to an external power supply control device; the housing includes a pump inlet shroud, a transition pipe, and a pump outlet shroud that are sequentially fixed and interconnected. The housing of the micro motor is fixedly connected; the side wall of the pump inlet shroud has a set of blood suction holes, and the side wall of the pump outlet shroud has a set of blood discharge holes; the blood channel is composed of the blood suction holes, the hollow space of the pump inlet shroud, the hollow pipe of the transition tube, the hollow space of the pump outlet shroud, and the blood discharge holes; a one-way valve is provided inside the pump outlet shroud; the outer side of the housing of the micro motor is provided with a first suction cup and a second suction cup located on both sides of the first longitudinal plane, and the outer side of the transition tube is provided with a third suction cup and a fourth suction cup located on both sides of the second longitudinal plane; the first longitudinal plane and the second longitudinal plane are parallel to each other and perpendicular to the axis of the micro motor respectively; The left ventricular assist device has the following implantation state: the housing of the micro motor passes through the interatrial septum, the pump inlet shroud is located in the left atrium, the transition tube passes through the interatrial septum between the ascending aorta and the left atrium, the pump outlet shroud is located in the ascending aorta, the first suction cup is located on the right atrial side of the interatrial septum and is attached to the inner wall of the right atrium, the second suction cup is located on the left atrial side of the interatrial septum and is attached to the inner wall of the left atrium, the third suction cup is located on the left atrial side of the interatrial septum between the ascending aorta and the left atrium and is attached to the inner wall of the left atrium, and the fourth suction cup is located on the ascending aortic side of the interatrial septum between the ascending aorta and the left atrium and is attached to the inner wall of the ascending aorta; The left ventricular assist device also has the following working state: when implanted, the power supply control device supplies power to the micro motor, and the micro motor, under the control of the power supply control device, pumps blood from the left atrium into the ascending aorta through the blood channel.

2. The left ventricular assist device according to claim 1, characterized in that, One end of the pump inlet shroud is fixedly connected to the housing of the micro motor, and the other end is open; both ends of the transition tube are open; one end of the pump outlet shroud is open and is the open end, and the other end is closed and is the closed end; the other end of the pump inlet shroud is fixedly connected to and communicates with one end of the transition tube, and the other end of the transition tube is fixedly connected to and communicates with the open end of the pump outlet shroud.

3. A left ventricular assist device according to claim 2, characterized in that, The one-way valve of the pump hood includes a spherical piston and a spring. One end of the spring is fixedly connected to the spherical piston and the other end is fixedly connected to the inner wall of the closed end of the pump hood. The spherical piston blocks the open end of the pump hood under the action of the spring.

4. A left ventricular assist device according to claim 2, characterized in that, A metal marker ring is provided on the outer side of the closed end of the pump cover; the diameter of the blood discharge hole is 1±0.5mm.

5. A left ventricular assist device according to claim 1, characterized in that, The first suction cup, the second suction cup, the third suction cup, and the fourth suction cup are all coated suction cups with tension steel wires; the third suction cup and the fourth suction cup are each equipped with fixed barbs.

6. A left ventricular assist device according to claim 1, characterized in that, The housing of the micro motor also has a front cover, through which the motor shaft extends into the housing.

7. A left ventricular assist device according to claim 6, characterized in that, The micro motor is a coreless motor; the pump body of the micro motor also includes a commutation circuit board, a bracket, an arc-shaped plate, a coil winding, a magnetic inner cylinder, and a bushing; the arc-shaped plate, coil winding, magnetic inner cylinder, bushing, and motor shaft are arranged coaxially; the arc-shaped plate is located circumferentially outside the coil winding, the coil winding is located circumferentially outside the magnetic inner cylinder, the magnetic inner cylinder is located circumferentially outside the bushing, and the bushing is located circumferentially outside the motor shaft; one end of the bushing is located inside the housing, and the other end passes through the front cover and is located outside the housing; the other end of the bushing is rotatably and sealed to the motor shaft. The sleeve is sealed to the housing; the magnetic inner cylinder is rotatably connected to the motor shaft via a connecting bearing, one side of which is provided with a gasket, and the other side of which is in contact with one end of the bushing; the magnetic inner cylinder is located inside the housing and is fixedly connected to the housing; the motor shaft, the arc plate, and the coil winding are located inside the housing and are respectively fixedly connected to the bracket, and together constitute the rotor; the commutation circuit board is located inside the housing and on one side of the bracket, while the arc plate and the coil winding are located on the other side of the bracket; the commutation circuit board has conductive contacts, which remain electrically connected to the coil winding during rotor rotation.

8. An implantable component for implanting a left ventricular assist device, characterized in that, The device includes a guidewire, an adjustable bendable sheath, an inner sheath, a puncture needle, a delivery sheath, a delivery cable, a power supply control device, and the left ventricular assist device as described in any one of claims 1 to 7; wherein the delivery sheath has an exhaust valve and a hemostatic valve, and the hemostatic valve of the delivery sheath has a fixing device that matches the adjustable bendable sheath; the adjustable bendable sheath is a tear-off sheath; the power supply control device has a battery and a controller, the battery being electrically connected to the controller, and the controller having an interface for electrical connection to the wires of the left ventricular assist device.

9. The implantable component according to claim 8, characterized in that, The implanted component has the following specific states: The guidewire is located inside the inner sheath, which is located inside the adjustable bending long sheath. The tip of the adjustable bending long sheath is located in the right atrium and at the orifice of the inferior vena cava in the first state. Based on the first state, the puncture needle is in the second state after the inner sheath and guidewire are withdrawn from the adjustable curved long sheath; Based on the second state, after the puncture needle punctures the interatrial septum at the center of the fossa ovalis and enters the left atrium, the tip of the adjustable long sheath enters the left atrium in the third state. Based on the third state, after the puncture needle is withdrawn from the adjustable curved long sheath and the guidewire is inserted into the pulmonary vein along the adjustable curved long sheath, the tip of the adjustable curved long sheath is moved to the fourth state, which is located in the middle of the left atrium. Based on the fourth state, after the guidewire is withdrawn from the adjustable curved sheath, the tip of the adjustable curved sheath is rotated toward the ascending aorta and contacts the septum between the ascending aorta and the left atrium, and the puncture needle is located inside the adjustable curved sheath in the fifth state. Based on the fifth state, the sixth state is reached after the puncture needle enters the ascending aorta, the tip of the adjustable long sheath enters the ascending aorta and reaches the preset position. Based on the sixth state, after the puncture needle is withdrawn from the adjustable curved sheath, the left ventricular assist device is fixedly connected to the delivery cable, the left ventricular assist device is inserted into the adjustable curved sheath along the delivery sheath, and the metal marker ring is located at the head end of the adjustable curved sheath. The lead of the left ventricular assist device is located inside the delivery sheath and the adjustable curved sheath, and the outer end of the lead is exposed outside the body. The fixing device of the adjustable curved sheath and the delivery sheath is fixedly connected in an integrated manner in the seventh state. Based on the seventh state, the adjustable curved sheath of the left ventricular assist device pump hood and transition tube is released. The pump hood is located inside the ascending aorta, the transition tube passes through the septum between the ascending aorta and the left atrium, the third suction cup is released and located on the left atrial side at the septum between the ascending aorta and the left atrium, and the third suction cup is attached to the inner wall of the left atrium. The fourth suction cup is released and located on the ascending aortic side at the septum between the ascending aorta and the left atrium, and the fourth suction cup is attached to the inner wall of the ascending aorta, which is the eighth state. Based on the eighth state, the adjustable curved sheath of the pump inlet hood, micro motor and housing of the left ventricular assist device is released. The pump inlet hood is located in the left atrium. The housing of the micro motor passes through the interatrial septum. The first suction cup is released and located on the right atrial side of the interatrial septum. The first suction cup is attached to the inner wall of the right atrium. The second suction cup is released and located on the left atrial side of the interatrial septum. The second suction cup is attached to the inner wall of the left atrium. Based on the ninth state, after removing the delivery cable from the adjustable bending sheath and the delivery sheath, separating the delivery sheath from the adjustable bending sheath, and removing the adjustable bending sheath, the left ventricular assist device remains in the body. The outer end of the lead wire of the left ventricular assist device is electrically connected to the power supply control device. The control parameters of the power supply control device on the micro motor are determined by testing the speed of the micro motor and monitoring the hemodynamic parameters. The tenth state is when the part of the lead wire exposed outside the body and the power supply control device are placed in the subcutaneous pouch.

10. The implantable component according to claim 9, characterized in that, When testing the speed of the micro motor, the speed adjustment range of the micro motor is 20,000-30,000 rpm.

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