Ventricular assist pump blood apparatus and system

Abstract

The application provides a ventricular assist pump blood instrument and system, and relates to the technical field of medical instruments.The ventricular assist pump blood instrument comprises an in-vivo component, the in-vivo component comprises a support cover and an impeller mechanism; the in-vivo component has a folded state and an unfolded state, when being arranged at a position where the aorta is connected with the left ventricle or in the left ventricle, the in-vivo component is arranged in the unfolded state, a blood flow channel is formed by the covering film and the support cover, the impeller mechanism is rotated to increase the pressure of the blood in the blood flow channel, and then the in-vivo component can be used as a blood pump to promote the blood flow in the left ventricle to the aorta; meanwhile, the in-vivo component has a folded state, in the folded state, the impeller mechanism and the support cover are folded, the volume is small, the in-vivo component can be implanted into the position where the aorta is connected with the left ventricle or the left ventricle through a catheter, and a thoracotomy operation is not needed, so that the operation time is short, the trauma is small, and the patient recovers quickly.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a ventricular assist pump device and system. Background Technology

[0002] The heart is a vital organ that powers the body's blood circulation. It is divided into two parts, left and right, each containing a ventricle and an atrium. The left and right ventricles are separated by the ventricular septum, and the left and right atria are separated by the atrial septum. The direction of blood flow between the left atrium and left ventricle is regulated by the mitral valve. A healthy mitral valve ensures that oxygen-rich blood flows from the left atrium to the left ventricle, and is then pumped by the left ventricle to the arteries throughout the body. The direction of blood flow between the right atrium and right ventricle is regulated by the tricuspid valve. The tricuspid valve ensures that carbon dioxide-rich venous blood flows from the right atrium to the right ventricle, and is then pumped by the right ventricle to the pulmonary artery.

[0003] Patients undergoing high-risk cardiac surgery and those with heart failure experience a decline in their heart's pumping capacity, which can easily lead to insufficient blood supply to other organs, such as the brain and kidneys, resulting in systemic organ damage. Heart failure, in particular, is a life-threatening disease; approximately one-fifth of heart disease patients worldwide eventually develop heart failure each year, and the current incidence rate in my country is 0.9%, with a 5-year mortality rate exceeding 60%. For a long time to come, the number of patients with advanced heart failure will far exceed the number of available heart transplant donors. Left ventricular assist devices (LVADs) not only save lives but also greatly assist patients in finding suitable donors or gaining valuable time for surgery.

[0004] Since its clinical application in the 1960s, after years of research and clinical use, the application of left ventricular assist devices (LVAP) has expanded from post-cardiovascular surgery resuscitation and heart transplant transition or replacement to the recovery of myocardial function and even the permanent treatment of heart failure. LVAP not only serves as a bridge before heart transplantation and a vessel for myocardial recovery, but it can also improve the quality of life of heart failure patients and is used in their treatment. Currently, the main LVAP devices establish an extra-cardiac pathway at the apex of the left ventricle and the aorta, using a centrifugal pump to draw blood from the left ventricle to the aorta. Because this pathway is located outside the heart, the procedure requires open-chest surgery. Open-chest surgery is highly invasive, and many elderly heart failure patients cannot tolerate the trauma, resulting in poorer prognoses. Summary of the Invention

[0005] The purpose of this invention is to provide a ventricular assist pump device and system to solve the problems of current ventricular assist devices requiring open-chest surgery, which is time-consuming and highly invasive.

[0006] The ventricular assist pump device provided by the present invention includes an internal component, wherein the internal component includes a support cover and an impeller mechanism;

[0007] The support cover includes a hollow cover body and a film, the film covering the hollow cover body, the impeller mechanism being disposed inside the hollow cover body, and the impeller mechanism including a rotating shaft and blades connected to the rotating shaft;

[0008] The internal components have a folded state and an unfolded state. In the folded state, the support cover is folded inward onto the impeller mechanism, and the blades are folded onto the rotating shaft. In the unfolded state, the support cover is unfolded outward to form a blood flow channel, and the blades are unfolded relative to the rotating shaft within the support cover for rotating and pumping blood to promote the delivery of blood from the left ventricle to the aorta.

[0009] The in vivo component is configured to be implanted via catheter into the junction of the aorta and the left ventricle or into the left ventricle in a folded state, and is configured to be in an unfolded state, with the support cover disposed at the junction of the aorta and the left ventricle or into the left ventricle.

[0010] Furthermore, the hollowed-out cover includes a main frame, the cross-section of which is annular and the main frame is hollowed out in a grid pattern. The two ends of the main frame in the axial direction converge inward in opposite directions, and the blades are correspondingly arranged in the main frame.

[0011] Furthermore, the middle part of the main frame is covered with the membrane, and the two ends of the main frame form the blood inlet and outlet, respectively.

[0012] Furthermore, the hollow cover also includes a connecting frame. In the unfolded state, the inner diameter of the connecting frame is smaller than the inner diameter of the hollow cover. The cross-section of the connecting frame is annular. The connecting frame is connected to the side of the main frame near the aorta, and the end of the connecting frame away from the main frame is used to be placed inside the aorta.

[0013] The connecting frame is arranged in a perforated mesh, and the main frame and the connecting frame are covered with the membrane. The end of the main frame away from the connecting frame is exposed to form a blood inlet, and the membrane located at the end of the connecting frame away from the main frame forms a blood outlet; or, the connecting frame is arranged in a hollow tube shape, the main frame is covered with the membrane, and the end of the main frame away from the connecting frame is exposed to form a blood inlet, and the end of the connecting frame away from the main frame is open to form a blood outlet.

[0014] Furthermore, the connecting frame includes a first section and a second section, wherein the first section is connected between the second section and the main frame body;

[0015] The outer diameter of the first segment is smaller than that of the second segment, and the first segment is used to correspond to the aortic valve setting.

[0016] Furthermore, the outlet includes a central hole, the axis of which is aligned with the axis of the connecting frame; or, the outlet includes multiple through holes, the axes of which are aligned with the axis of the connecting frame, and the multiple through holes are arranged in a honeycomb pattern.

[0017] Furthermore, a first support sleeve and a third support sleeve are respectively provided at both ends of the main frame;

[0018] The rotating shaft passes through the main frame, the first support sleeve, and the second support sleeve, and the first support sleeve and the third support sleeve are used to support the rotating shaft.

[0019] Furthermore, the ventricular assist pump device also includes a pressure measuring mechanism, which is used to monitor the pressure in the left ventricle corresponding to the inlet, the pressure in the aorta corresponding to the outlet, and / or the pressure in the blood flow channel;

[0020] The pressure measuring mechanism is located inside the body; or, the pressure measuring mechanism is located outside the body and is connected to the pressure measurement location via a conductive tube.

[0021] Furthermore, the number of blades is one or more, the blades are fixedly connected to the rotating shaft, and the blades are made of shape memory alloy so that the blades can be folded or unfolded;

[0022] and / or

[0023] The blade is hinged to the rotating shaft, and a reset member is provided between the blade and the rotating shaft. Under the action of external force, the blade can compress the reset member to make the blade folded. The reset member makes the blade tend to unfold relative to the rotating shaft.

[0024] Furthermore, the ventricular assist pump device also includes a drive assembly connected to the rotating shaft. The drive assembly is configured to be disposed within a support cover, or the drive assembly is configured to be disposed outside the body and connected to the rotating shaft via a transmission component.

[0025] Furthermore, the impeller mechanism includes a plurality of impeller mechanisms arranged sequentially, each impeller mechanism including blades and a rotating shaft, the rotating shafts of the plurality of impeller mechanisms being configured to be fixedly connected, or the rotating shafts of the plurality of impeller mechanisms being configured to be rotatably connected relative to each other.

[0026] Furthermore, there are two impeller mechanisms, and the rotating shafts of the two impeller mechanisms are rotatably connected so that the two impeller mechanisms can rotate independently.

[0027] The number of drive components is two, and the two drive components are respectively connected to the two rotating shafts one-to-one, and the two drive components are respectively connected to the two opposite ends of the two rotating shafts.

[0028] Furthermore, one or both ends of the support cover are connected to a sheath tube, and the curvature of the sheath tube is adjustable.

[0029] Furthermore, the ventricular assist pump device also includes a control box, which is connected to the pressure measuring mechanism and the drive assembly that drives the impeller mechanism to rotate via a signal transmission unit.

[0030] Furthermore, the hollow cover is made of shape memory alloy, and the coating is a plastic film or a biological tissue membrane.

[0031] The present invention provides a ventricular assist pump device, which includes an internal component, the internal component including a support cover and an impeller mechanism;

[0032] The support cover includes a hollow cover body, and the impeller mechanism is disposed in the hollow cover body. The impeller mechanism includes a rotating shaft and blades connected to the rotating shaft.

[0033] The internal components have a folded state and an unfolded state. In the folded state, the support cover is folded inward onto the impeller mechanism, and the blades are folded onto the rotating shaft. In the unfolded state, the support cover is unfolded outward, and the blades are unfolded relative to the rotating shaft within the support cover for rotating and pumping blood to promote the delivery of blood from the left ventricle to the aorta.

[0034] The in vivo component is configured to be implanted into the aorta via a catheter in a folded state, and configured to be in an unfolded state, with the support cover interference-fitted into the aorta.

[0035] The ventricular assist pumping system provided by the present invention includes an ECG and the ventricular assist pumping device provided by the present invention.

[0036] The ventricular assist pump device provided by this invention includes an internal component, which includes a support cover and an impeller mechanism. The support cover includes a perforated cover body and a membrane, with the membrane covering the perforated cover body. The impeller mechanism is disposed within the perforated cover body and includes a rotating shaft and blades connected to the rotating shaft. The internal component has a folded state and an unfolded state. In the folded state, the support cover is folded inward onto the impeller mechanism, and the blades are folded onto the rotating shaft. In the unfolded state, the support cover unfolds outward to form a blood flow channel, and the blades unfold relative to the rotating shaft within the support cover for rotating and pumping blood to promote the delivery of blood from the left ventricle to the aorta. The internal component is configured to be implanted via a catheter into the junction of the aorta and the left ventricle or within the left ventricle in the folded state, and is configured such that in the unfolded state, the support cover is disposed at the junction of the aorta and the left ventricle or within the left ventricle. The internal components of the ventricular assist pump device of the present invention have a folded state and an unfolded state. When placed at the connection between the aorta and the left ventricle or within the left ventricle, the internal components are in the unfolded state, with the diaphragm and support cover forming a blood flow channel. The rotation of the impeller mechanism can increase the blood pressure within the blood flow channel, thereby enabling the internal components to be used as a blood pump to promote blood flow from the left ventricle to the aorta. At the same time, the internal components have a folded state, in which the impeller mechanism and support cover are folded up, resulting in a smaller volume. It can be implanted through a catheter at the connection between the aorta and the left ventricle or within the left ventricle, without the need for open-chest surgery, resulting in a short operation time, minimal trauma, and rapid patient recovery.

[0037] The present invention provides a ventricular assist pump device, comprising an internal component, which includes a support cover and an impeller mechanism. The support cover includes a perforated cover body, and the impeller mechanism is disposed within the perforated cover body. The impeller mechanism includes a rotating shaft and blades connected to the rotating shaft. The internal component has a folded state and an unfolded state. In the folded state, the support cover is folded inward onto the impeller mechanism, and the blades are folded onto the rotating shaft. In the unfolded state, the support cover is unfolded outward, and the blades are unfolded relative to the rotating shaft within the support cover for rotating and pumping blood to promote the delivery of blood from the left ventricle to the aorta. The internal component is configured to be implanted into the aorta via a catheter in the folded state, and configured to have the support cover interference fit within the aorta in the unfolded state. The internal components of the ventricular assist pump device of the present invention have a folded state and an unfolded state. When installed at the connection between the aorta and the left ventricle or within the left ventricle, the internal components are in the unfolded state. The support cover, together with the blood vessels of the aorta, forms a blood flow channel. The rotation of the impeller mechanism can increase the blood pressure in the blood flow channel, thereby enabling the internal components to be used as a blood pump to promote the flow of blood from the left ventricle to the aorta. At the same time, the internal components have a folded state. In this folded state, the impeller mechanism and the support cover are folded up, resulting in a smaller volume. It can be implanted through a catheter at the connection between the aorta and the left ventricle or within the left ventricle, without the need for open-chest surgery. The operation time is short, the trauma is minimal, and the patient recovers quickly.

[0038] The ventricular assist pumping system provided by the present invention includes an ECG and a ventricular assist pumping device provided by the present invention, and has the same beneficial effects as the ventricular assist pumping device provided by the present invention. Attached Figure Description

[0039] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0040] Figure 1 This is a schematic diagram of the ventricular assist pump device provided in Embodiment 1 of the present invention in its usage state;

[0041] Figure 2 This is a schematic diagram of the ventricular assist pump device provided in Embodiment 1 of the present invention;

[0042] Figure 3 This is a partial schematic diagram of the impeller mechanism of the ventricular assist pump device provided in Embodiment 1 of the present invention in a folded state from one direction.

[0043] Figure 4 for Figure 3 A diagram showing another direction;

[0044] Figure 5 for Figure 3 A schematic diagram of the impeller mechanism in its deployed state;

[0045] Figure 6 This is a schematic diagram of the in vivo components of the ventricular assist pump device provided in Embodiment 1 of the present invention;

[0046] Figure 7 This is a schematic diagram of a membrane structure for a ventricular assist pump device provided in Embodiment 1 of the present invention.

[0047] Figure 8 This is a schematic diagram of another structure of the membrane of the ventricular assist pump device provided in Embodiment 1 of the present invention;

[0048] Figure 9 This is a schematic diagram of the first form of the hollow cover of the ventricular assist pump device provided in Embodiment 1 of the present invention;

[0049] Figure 10 This is a schematic diagram of a second form of the hollowed-out cover of the ventricular assist pump device provided in Embodiment 1 of the present invention;

[0050] Figure 11This is a schematic diagram of a third form of the perforated cover of the ventricular assist pump device provided in Embodiment 1 of the present invention;

[0051] Figure 12 This is a schematic diagram of an installation configuration of the drive assembly of the ventricular assist pump device provided in Embodiment 1 of the present invention;

[0052] Figure 13 This is a schematic diagram of another installation configuration of the drive assembly of the ventricular assist pump device provided in Embodiment 1 of the present invention;

[0053] Figure 14 This is a schematic diagram illustrating a usage state of the ventricular assist pump device provided in Embodiment 2 of the present invention;

[0054] Figure 15 A schematic diagram of another usage state of the ventricular assist pump device provided in Embodiment 2 of the present invention;

[0055] Figure 16 This is a schematic diagram of the ventricular assist pump device provided in Embodiment 2 of the present invention;

[0056] Figure 17 This is a schematic diagram illustrating a usage state of the ventricular assist pump device provided in Embodiment 3 of the present invention;

[0057] Figure 18 This is a schematic diagram illustrating another usage state of the ventricular assist pump device provided in Embodiment 3 of the present invention;

[0058] Figure 19 This is a schematic diagram illustrating a usage state of the ventricular assist pump device provided in Embodiment 4 of the present invention;

[0059] Figure 20 This is a schematic diagram of another usage state of the ventricular assist pump device provided in Embodiment 4 of the present invention.

[0060] Icons: 1-Left ventricle; 2-Aorta; 100-In vivo component; 101-Outlet; 102-Inlet; 103-Central orifice; 104-Through hole; 110-Support cover; 111-Hollow cover; 1111-Main frame; 1112-Connecting frame; 1113-First section; 1114-Second section; 112-Covering membrane; 113-First support sleeve; 114-Second support sleeve; 115-Third support sleeve; 116-Sheath; 200-Impeller mechanism; 210-Blade; 220-Rotating shaft; 221-Mounting hole; 222-Slot; 300-Drive assembly; 310-Transmission component; 400-Controller; 500-Signal box; 600-Catheter; 700-Wire; 800-ECG. Detailed Implementation

[0061] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0062] Currently, the main ventricular assist devices are located at the apex of the left ventricle (1) and the aorta (2), establishing an extracardiac pathway. A centrifugal pump then draws blood from the left ventricle (1) to the aorta (2). Because this pathway is located outside the heart, the procedure requires open-chest surgery. Open-chest surgery is traumatic for patients, and many elderly patients with heart failure cannot tolerate the trauma, resulting in a poor prognosis.

[0063] This invention provides a transcatheter implantable device that can be implanted via the femoral artery, resulting in minimal surgical trauma, short procedure time, and minimal patient injury.

[0064] Example 1

[0065] like Figures 1 to 13 As shown, this embodiment provides a ventricular assist pump device, including an in vivo component 100. The in vivo component 100 includes a support cover 110 and an impeller mechanism 200. The support cover 110 includes a perforated cover body 111 and a membrane 112, with the membrane 112 covering the perforated cover body 111. The impeller mechanism 200 is disposed inside the perforated cover body 111 and includes a rotating shaft 220 and blades 210 connected to the rotating shaft 220. The in vivo component 100 has a folded state and an unfolded state. In the folded state, the support cover 110 is folded inward onto the impeller mechanism 200, and the blades 210 are folded onto the rotating shaft 220. In the unfolded state, the support cover 110 unfolds outward to form a blood flow channel, and the blades 210 unfold relative to the rotating shaft 220 within the support cover 110 for rotating and pumping blood to promote the delivery of blood from the left ventricle 1 to the aorta 2. The in vivo component 100 is configured to be implanted via catheter into the connection between the aorta 2 and the left ventricle 1 or into the left ventricle 1 in a folded state, and is configured to have a support cover 110 disposed at the connection between the aorta 2 and the left ventricle 1 or into the left ventricle 1 in an unfolded state.

[0066] The membrane 112 can cover either the inner or outer surface of the perforated cover 111. The membrane 112 is made of a soft material, specifically a soft plastic film, i.e., a polymer material, such as PET (a condensation polymer of phthalic acid and ethylene glycol) or eTFP (ethylene-tetrafluoroethylene copolymer); it can also be a biological tissue membrane, such as one or more materials used in animal pericardial membranes. The membrane 112 is fused to the perforated cover 111 through processes such as suturing, bonding, or heat fusion. When the impeller mechanism 200 rotates, a pressure drop is created inside the membrane 112, thereby drawing blood from the left ventricle 1 to the aorta 2, thus providing auxiliary blood flow to the left ventricle.

[0067] In this embodiment, the internal component 100 of the ventricular assist pump device has a folded state and an unfolded state. When installed at the connection between the aorta 2 and the left ventricle 1 or within the left ventricle 1, the internal component 100 is in the unfolded state. The diaphragm 112 and the support cover 110 form a blood flow channel. The rotation of the impeller mechanism 200 increases the blood pressure within the blood flow channel, thereby enabling the internal component 100 to function as a blood pump, promoting blood flow from the left ventricle 1 to the aorta 2. Simultaneously, the internal component 100 has a folded state. In this folded state, the impeller mechanism 200 and the support cover 110 are folded, resulting in a smaller volume. It can be implanted via catheter at the connection between the aorta 2 and the left ventricle 1 or within the left ventricle 1, eliminating the need for open-chest surgery. This results in a shorter operation time, less trauma, and faster patient recovery.

[0068] The hollow cover 111 can be made of shape memory alloy, such as nickel-titanium alloy, and the shape memory and self-expansion properties of the shape memory alloy can be used to realize the changes in the folded state and unfolded state of the hollow cover 111.

[0069] The number of blades 210 can be one or more. When there are multiple blades 210, they are spaced apart circumferentially or axially along the rotation shaft 220. The blades 210 can switch between a folded state and an unfolded state. Specifically, the blades 210 are made of shape memory alloy and are fixedly connected to the rotation shaft 220 so that they can be folded or unfolded. Specifically, one end of the blade 210 is fixedly connected to the rotation shaft 220. The blade 210 is made of shape memory alloy. The rotation shaft 220 is provided with a slot 222. The blade 210 is set corresponding to the slot 222. In the folded state, the blade 210 is folded into the slot 222. In the unfolded state, the end of the blade 210 that is fixedly connected to the rotation shaft 220 extends outward away from the rotation shaft 220. The blade 210 is finally set at an acute angle or a right angle with the rotation shaft 220, that is, the blade 210 can be used as a drive plate.

[0070] The switching between the folded and unfolded states of the blade 210 can also be mechanically driven. For example, the blade 210 is hinged to the rotating shaft 220, and a reset member is provided between the blade 210 and the rotating shaft 220. Under the action of external force, the blade 210 can compress the reset member, so that the blade 210 is in the folded state, and the reset member makes the blade 210 tend to unfold relative to the rotating shaft 220. Specifically, such as... Figure 3 , Figure 4 or Figure 5 As shown, one end of the blade 210 is hinged to the rotating shaft 220. A reset member is provided between the blade 210 and the rotating shaft 220. Under the action of external force, the blade 210 can compress the reset member to make the blade 210 folded. The reset member makes the blade 210 tend to unfold relative to the rotating shaft 220. The reset member can be a torsion spring, which can be set in the mounting hole 221. When the blade 210 is in the folded position, the torsion spring is compressed, and the elastic force of the torsion spring can keep the blade 210 stable in the unfolded state. It can be understood that in this form, the rotating shaft 220 can still be provided with a slot 222. The blade 210 is hinged in the slot 222. The side wall of the slot 222 corresponding to the hinged end of the blade 210 can serve as a limit when the blade 210 is opened. In this way, when the blade 210 is opened, the blade 210 can be locked onto the side wall of the slot 222 under the action of the torsion spring.

[0071] Furthermore, the perforated cover 111 includes a main frame 1111 and a connecting frame 1112. The main frame 1111 has a ring-shaped cross-section and a grid-like perforated design. The two ends of the main frame 1111 converge inward in opposite directions. In the unfolded state, the inner diameter of the connecting frame 1112 is smaller than the inner diameter of the perforated cover 111. The connecting frame 1112 has a ring-shaped cross-section and is connected to the side of the main frame 1111 closest to the aorta 2. The end of the connecting frame 1112 away from the main frame is used to be installed inside the aorta 2.

[0072] The main frame 1111 forms a relatively large radial space, and the impeller mechanism 200 is disposed within the main frame 1111 to allow the blades 210 to have a larger blade area, which is beneficial for improving blood delivery capacity at the same rotational speed. The connecting frame 1112 is mainly used to drain blood into the aorta 2, and the end of the connecting frame 1112 away from the main frame 1111 passes through the aortic valve and is disposed within the aorta 2. The connecting frame 1112 can have various forms; for example, in the first form, such as... Figure 9As shown, the connecting frame 1112 is a straight rod with a perforated mesh design. A membrane 112 covers both the main frame and the connecting frame 1112. The end of the main frame away from the connecting frame 1112 is exposed, forming a blood inlet 102. The membrane 112, located at the end of the connecting frame 1112 away from the main frame, forms a blood outlet 101. For example, in the second form, such as... Figure 10 As shown, the connecting frame 1112 is cylindrical, that is, it is set in a hollow tube shape. The main frame is covered with a membrane 112, and the end of the main frame away from the connecting frame 1112 is exposed to form a blood inlet 102. The end of the connecting frame 1112 away from the main frame opens to form a blood outlet 101.

[0073] The connecting frame 1112 can also be a variable cross-section with different cross-sections. Typically, the outer diameter of the connecting frame 1112 corresponding to the position of the aortic valve is set to be smaller. For example... Figure 9 The first form shown can be transformed into Figure 11 The third form is shown. In this third form, the connecting frame 1112 includes a first segment 1113 and a second segment 1114. The first segment 1113 connects the second segment 1114 to the main frame body. The outer diameter of the first segment 1113 is smaller than that of the second segment 1114. The first segment 1113 is used to correspond to the aortic valve setting. It is understandable that the aortic valve gap is often small. The smaller outer diameter of the connecting frame 1112 located at the aortic valve position can ensure the normal operation of the aortic valve and prevent damage to the aortic valve. The second segment 1114, with a larger outer diameter, is located behind the aortic valve. When the outer diameter of the second segment 1114 increases, the inner diameter can often also increase accordingly, which can slow down the blood flow and reduce energy loss.

[0074] It should be noted that the connecting frame 1112 needs to pass through the aorta 2, so the diameter of the connecting frame 1112 should not be too large. In this embodiment, the diameter (outer diameter) of the connecting frame 1112 is in the range of 2-10mm.

[0075] like Figure 1 As shown, in this embodiment of the ventricular assist pump device, the main frame 1111 is installed inside the left ventricle 1 and is used to protect the blades 210. The connecting frame 1112 is connected between the aorta 2 and the main frame 1111, so that the blood flow channel formed by the membrane 112 extends from the left ventricle 1 to the aorta 2. Thus, when the impeller mechanism 200 rotates, the blood in the left ventricle 1 enters the blood flow channel from the inlet 102 of the main frame 1111, and enters the aorta 2 along the blood flow channel under the driving action of the impeller mechanism 200, thereby assisting in the pumping of blood.

[0076] It is understood that the ventricular assist pump device of this embodiment can pump blood in real time without being affected by the aortic valve. For example, when the aortic valve fails pathologically and cannot maintain automatic opening or closing, or when the left ventricle 1 fails, the ventricular assist pump device of this embodiment can still pump blood in real time through the blood flow channel.

[0077] When blood flows into the aorta 2, the large cross-sectional change easily leads to high-speed blood flow, but also to significant fluid energy loss. In this embodiment, the connecting frame 1112 increases the outflow cross-section. That is, the connecting frame 1112 acts as a spreading mechanism, increasing the blood flow channel to the aorta 2, increasing the pipe area when blood flows out, and reducing the flow velocity. This reduces pressure and energy loss. When the same pumping volume is required, the rotational speed of the impeller mechanism 200 can be reduced, thereby reducing the possibility of excessive rotational speed of the impeller mechanism 200 generating large shear forces that could damage the blood.

[0078] To improve the directionality of blood delivery, the blood outlet 101 includes a central hole 103, the axis of which is aligned with the axis of the connecting frame 1112; or, the outlet 101 includes multiple through holes 104, the axes of which are aligned with the axis of the connecting frame 1112, and the through holes 104 are arranged in a honeycomb pattern. That is, the outflow end structure of the membrane 112 can be as follows... Figure 7 As shown, a central hole 103 is provided, and this central hole 103 is a through hole structure. Alternatively, it can be as follows: Figure 8 As shown, multiple through holes 104 are provided, forming a honeycomb structure, and the normal direction of each through hole 104 is parallel to the axial direction of the coating 112.

[0079] Understandably, since the blood is agitated by the rotation of the blade 210, there is a lot of rotation and uneven flow rate. The honeycomb design of the multiple through holes 104 can rectify the fluid delivered to the aorta 2 and play a role in stabilizing the flow field. Therefore, the honeycomb design of multiple through holes 104 is usually a preferred form.

[0080] Since the support cover 110 of the ventricular assist pump device in this embodiment is a hollow structure, the space it creates is often quite large. When the rotating shaft 220 is placed inside the support shaft, instability may occur. To solve this problem, in this embodiment, a first support sleeve 113 and a third support sleeve 115 are respectively provided at both ends of the main frame 1111. The first support sleeve 113 is located at the end of the main frame 1111 closer to the connecting frame 1112, and the connecting frame 1112 is connected to the first support sleeve 113. A second support sleeve 114 is provided at the end of the connecting frame 1112 away from the main frame. The rotating shaft 220 passes through the main frame 1111, the first support sleeve 113, the connecting frame 1112, and the second support sleeve 114, and the first support sleeve 113, the second support sleeve 114, and the third support sleeve 115 are used to support the rotating shaft 220.

[0081] like Figure 2 or Figure 9 As shown, the diameters of the first support sleeve 113, the second support sleeve 114, and the third support sleeve 115 are smaller than the diameter of the connecting frame 1112 or the main frame 1111. That is, the support cover 110 is recessed inwards at the positions of the first support sleeve 113, the second support sleeve 114, and the third support sleeve 115, so that the first support sleeve 113 and the second support sleeve 114 can support the rotating shaft 220. The first support sleeve 113, the second support sleeve 114, and the third support sleeve 115 act as bushings, allowing the rotating shaft 220 to rotate relative to the support cover 110 and providing good stability during rotation. It should also be noted that the structure of the film 112 is adapted to the perforated cover 111, such as... Figure 2 As shown, the membrane 112 smoothly transitions to the position of the first support sleeve 113 and is spaced apart from the first support sleeve 113 so that a blood flow channel is formed between the membrane 112 and the first support sleeve 113, so that blood can flow smoothly from the main frame 1111 into the connecting frame 1112 without blood flow resistance.

[0082] Furthermore, the ventricular assist pump device in this embodiment also includes a pressure measuring mechanism, which is used to monitor the pressure in the left ventricle 1 corresponding to the inlet 102, the pressure in the aorta 2 corresponding to the outlet 101, and / or the pressure in the blood flow channel.

[0083] Understandably, the pressure measuring mechanism can assess the working status of the blood pump formed by the impeller mechanism 200 and the blood flow channel by monitoring the pressure at various points. By monitoring the pressure in the left ventricle 1 corresponding to inlet 102, the pressure of blood at inlet 102 can be understood; by monitoring the pressure in the aorta 2 corresponding to outlet 101, the pressure of blood flowing out can be understood. By monitoring the pressure within the blood flow channel, the pressure within the blood flow channel can be determined. These pressure measurement locations can be selected and set as needed. In this embodiment, multiple pressure measurement points are set within the blood flow channel, such as... Figure 2 As shown, a first measuring point P1 is set on the first support sleeve 113, a second measuring point P2 is set at one end of the connecting frame 1112 near the outlet 101, and a third measuring point P3 is set at the outlet 101. The first measuring point P1 allows us to know the inlet pressure of the blood entering the blood flow channel formed by the connecting frame 1112 and the membrane 112 under the action of the impeller mechanism 200. This pressure can then be used to determine whether the driving pressure from the impeller mechanism 200 is appropriate. The second measuring point P2 and the third measuring point P3, combined with the area A of the blood flow channel formed by the connecting frame 1112 and the membrane 112 (that is, the inner cross-sectional area of ​​the blood flow channel formed by the connecting frame 1112 and the membrane 112), are used to determine the appropriateness of the driving pressure. Figure 2 The cross-sectional area at point aa (as shown) can be used to calculate the blood flow rate assisted by the device, thus allowing for the assessment of the real-time flow rate of the pumping device. The formula for calculating the blood flow rate assisted by the ventricular assist pumping device is as follows:

[0084] Formula 1: The pressure difference ΔP is equal to the pressure value p2 at the second measuring point P2 minus the pressure value p3 at the third measuring point P3, that is, ΔP = p2 - p3;

[0085] Formula 2: The pressure difference ΔP equals 4 multiplied by the square of the blood flow velocity V, that is, ΔP = 4 * V 2 ;

[0086] Formula 3: Blood flow rate Q equals blood velocity V multiplied by area A, that is, Q = V * A.

[0087] Among them, the pressure values ​​p2 at the second measurement point P2 and p3 at the third measurement point P3 are obtained through measurement. Therefore, the blood flow velocity V can be calculated by combining Formula 1 and Formula 2. The area A is a known quantity that has been measured or calculated in advance. Therefore, after obtaining the blood flow velocity V, the blood flow rate can be calculated using Formula 3.

[0088] This embodiment can monitor the working flow rate of the ventricular assist pump device in real time, thereby determining the output flow rate of the device based on the patient's heart failure level, and then controlling the rotation speed of the blade 210 through the control box to adjust it to the ideal flow rate.

[0089] It should be noted that the pressure measuring mechanism includes a pressure sensor. The pressure measuring mechanism can be installed inside the body, in which case the pressure sensor is directly connected to the corresponding pressure measurement point. Alternatively, the pressure measuring mechanism can be installed outside the body, in which case it is connected to the location to be measured, i.e., the corresponding pressure measurement point, through a conductive tube.

[0090] Furthermore, the ventricular assist pump device in this embodiment also includes a sheath 116, which is fixedly connected to the support cover 110. The sheath 116 is provided with corresponding functional holes, which allow the conduction tube, transmission component 310, wire 700, etc. to pass through.

[0091] The sheath 116 can be configured as an adjustable-bend sheath, meaning that in addition to its flexibility to bend with the blood vessel, the sheath 116 can also have its curvature manually adjusted. For example... Figure 2 As shown, a guide wire is provided on the sheath 116, and the curvature of the sheath 116 can be manually adjusted by pulling the guide wire. The curvature of the sheath 116 is adjustable, which can be used to adjust the position of the support cover 110 and the impeller mechanism 200 located in the left ventricle 1, as well as the straightness of the rotating shaft 220.

[0092] The sheath 116 can also be connected to the catheter 600 to facilitate the connection between the internal component 100 and the external component, and to facilitate the setting of the connector between the internal component 100 and the external component.

[0093] Furthermore, the ventricular assist pump device of this embodiment also includes a drive assembly 300, which is connected to the rotating shaft 220. The drive assembly 300 is configured to be disposed inside the support cover 110, or the drive assembly 300 is configured to be disposed outside the body and connected to the rotating shaft 220 through a transmission member 310.

[0094] Specifically, in this embodiment, the impeller mechanism 200 of the ventricular assist pump device can be a single unit. The number of blades 210 in an impeller mechanism 200 can be one or more. Multiple blades 210 can be arranged sequentially along the circumference of the rotation shaft 220 or sequentially along the axial direction of the rotation shaft 220. The rotation shaft 220 of the impeller mechanism 200 is connected to a drive assembly 300, which is typically a motor. The motor can be a micro motor, and in this case, the motor can be located inside one end of the support cover 110 or at both ends of the support cover 110. Alternatively, the drive assembly 300 can be located externally. In this case, the drive assembly 300 is connected to the rotation shaft 220 via a transmission member 310 formed by a drive wire, and the drive wire rotatably passes through the functional hole of the sheath 116.

[0095] The impeller mechanism 200 of the ventricular assist pump device in this embodiment can also include multiple impeller mechanisms arranged sequentially. In one embodiment, the rotation shafts 220 of the multiple impeller mechanisms 200 are configured to be fixedly connected, and each impeller mechanism 200 can be driven by a drive assembly 300, so that the multiple impeller mechanisms 200 rotate synchronously. In another embodiment, the rotation shafts 220 of the multiple impeller mechanisms 200 are configured to be rotatably connected relative to each other, and in this case, the impeller mechanisms 200 can be driven separately. This embodiment provides a specific implementation of this form.

[0096] like Figure 12 or Figure 13 As shown, there are two impeller mechanisms 200, and their rotating shafts 220 are rotatably connected. Specifically, the two rotating shafts 220 are rotatably connected by a connecting shaft, allowing each impeller mechanism 200 to rotate independently. There are also two drive assemblies 300, each connected to one of the two rotating shafts 220, and each drive assembly is connected to the opposite ends of the two rotating shafts 220. The ends of the two rotating shafts 220 that are close to each other have slots 222. The blades 210 of the two impeller mechanisms 200 are respectively located at the opposite ends of the slots 222. The two ends of the connecting shaft are fitted into the two rotating shafts 220 through the slots 222. The two rotating shafts 220 are clearance-fitted with the connecting shaft, and the connecting shaft has a limiting part to restrict the axial movement of the two rotating shafts 220.

[0097] Among them, two impeller mechanisms 200 are arranged sequentially at intervals along the blood flow direction, located upstream of the blood flow direction (wherein, Figure 1 and Figure 6 The middle arrow indicates the direction of blood flow; the upstream direction of blood flow is... Figure 1 As shown below, Figure 6 The blade 210 (shown on the left) serves to blow blood between the two impeller mechanisms 200. The blade 210 located downstream in the direction of blood flow ( Figure 1 The area above is shown. Figure 6 The right side shown serves to draw blood between the two impeller mechanisms 200.

[0098] like Figure 12 As shown, two drive components 300 can be simultaneously installed in the body. In this case, the two drive components 300 are installed one-to-one inside the two ends of the support cover 110, and each drive component 300 is connected to the rotation shaft 220 near that drive component 300. Figure 13As shown, the two drive components 300 can also be installed outside the body at the same time. In this case, the two ends of the support cover 110 are respectively connected to the sheath tube 116. The drive components 300, drive wire and sheath tube 116 are set one-to-one. The drive wire passes through the functional hole of the sheath tube 116. Any drive component 300 drives the corresponding rotating shaft 220 to rotate through the drive wire it is connected to.

[0099] It is understandable that the two impeller mechanisms 200 are driven independently and can both generate a pressure difference. The upstream impeller mechanism 200 ( Figure 2 The impeller mechanism 200 on the left side (shown in the diagram) mainly blows fluid into the membrane 112, while the downstream impeller mechanism 200 ( Figure 2 The impeller mechanism 200 on the right side (shown in the diagram) is used to draw fluid inward. The two impeller mechanisms 200 work together to achieve a large flow rate using a low rotational speed. Simultaneously, the operation of both blades 210 can be selected as needed; for example, the upstream impeller mechanism 200 can be retained for blowing blood in, while the downstream impeller mechanism 200 can be retained for drawing blood in, increasing the pumping adjustment range of the ventricular assist pump device. Furthermore, if one impeller mechanism 200 fails, the other impeller mechanism 200 can still function normally, improving the reliability of the ventricular assist pump device. At the same time, the two drive components 300 can intermittently alternate and operate independently, improving the overall lifespan of the ventricular assist pump device. Further, using the rotation of both impeller mechanisms 200 to pressurize the blood, compared to using a single impeller mechanism 200 rotating at high speed, avoids the problem of large shear forces from high-speed rotating blades 210 that could damage blood cells. Additionally, the two impeller mechanisms 200 are connected as one unit by a connecting shaft, providing better support stability at the ends where they are close to each other.

[0100] It should be noted that when there are multiple impeller mechanisms 200, one or more blades 210 can also be provided on the same rotating shaft 220, preferably two. The connecting shaft and the two rotating shafts 220 are coaxially arranged to improve the operational stability of the device when delivering blood. The two impeller mechanisms 200 can rotate in the same direction or in opposite directions, and the rotation of the two impeller mechanisms 200 in the same direction or in opposite directions can be controlled by the controller 400.

[0101] like Figure 1 As shown, the ventricular assist pump device of this embodiment also includes a control box. The control box is connected to the pressure measuring mechanism and the drive assembly 300 that drives the impeller mechanism 200 to rotate via a signal transmission unit. The control box is typically located externally, and the signal transmission unit can be a separately installed signal box 500 or a signal transmission module integrated within the control box.

[0102] The signal transmission unit collects pressure data at corresponding measurement points via a pressure measuring mechanism and feeds it back to the control box. The control box is equipped with a controller 400 and control knobs to control and adjust the pressurization and blood flow of the ventricular assist pump device. Specifically, the controller 400 can automatically adjust the rotation speed of the drive component 300 based on the built-in program settings and feedback from the signal transmission unit. Alternatively, the rotation speed of the drive component 300 can be manually adjusted as needed, referring to the feedback from the signal transmission unit, to regulate the pressurization.

[0103] It should also be noted that when the drive assembly 300 is located externally, it can also be integrated into the control box, which facilitates the integrated design of the external part of the ventricular assist pump device and improves the problem of inconvenience caused by scattered parts.

[0104] In summary, the ventricular assist pump device of this embodiment is a catheter-guided ventricular assist device that can be used to treat patients with heart failure. It can increase the controlled flow rate, reduce the pressure or pumping burden on the heart, allow the myocardium to gradually recover, and contribute to cardiac recovery. The impeller mechanism 200 and the support cover 110 form a blood pump. This blood pump has a vane pump structure, and the vanes 210 are foldable. They can be self-expanding using nickel-titanium alloy or using a mechanical spring-loaded device. The speed of the vane pump can be controlled by adjusting the control box, thereby achieving flow rate regulation. Furthermore, the blood pump can achieve high flow rate delivery at a lower speed. The signal box 500 is used to detect the real-time flow rate and speed of the blood pump and feed it back to the control box. The control box is used to adjust the speed of the blood pump, thereby achieving the purpose of flow rate regulation. The device is equipped with three pressure measurement points, which can be used to monitor the pressure changes inside and around the device. At the same time, the flow rate of the device can be monitored based on the pressure values ​​of the first measurement point P2 and the second measurement point P3. The device employs a dual-motor, dual-impeller structure. One impeller propels fluid into the blood flow channel, while the other aspirates it. Each impeller can operate independently and perform a pumping function. The dual-motor design enhances the overall reliability of the system. The motors can be implanted internally or externally via a drive wire. The blood flow channel comprises a support cover 110 and a membrane 112. Both ends of the membrane 112 are perforated, with the outflow end either straight or designed as a honeycomb structure with round holes for effective flow rectification. The support cover 110 includes a main frame 1111 and a connecting frame 1112. The main frame 1111 protects the impellers, while the connecting frame 1112 increases the cross-sectional area of ​​the blood outlet 101, improving the device's delivery efficiency. The device also features an adjustable sheath 116 for bending adjustment, facilitating implantation through the aortic arch.

[0105] Example 2

[0106] like Figures 14-16 As shown, this embodiment provides a ventricular assist pump device. The only difference between this ventricular assist pump device and the first embodiment is that the support cover 110 includes a main frame 1111. The main frame 1111 is not connected to the connecting frame 1112. The middle part of the main frame 1111 is covered with a membrane 112. The membrane 112 has openings at both ends to form a blood inlet 102 and an outlet 101 at both ends of the main frame 1111.

[0107] This embodiment of the ventricular assist pump device can be implanted via the femoral artery or through the apex of the heart. The principle of this ventricular assist pump device is primarily to pump blood from the bottom of the ventricle towards the outflow tract near the aorta 2 during cardiac contraction, thereby increasing the blood flow to the aortic valves. Specifically, the device detects the patient's ECG800 (ECG, or electrocardiogram) signal to determine the heart's systolic or diastolic state. The control box receives the ECG800 signal to determine the heart's state. When the heart is in a systolic state, the control box sends a pulse signal, causing the motor to rotate and enabling the ventricular assist pump device to pump blood. When the heart begins to diastole, the motor is immediately shut off.

[0108] It should be noted that, Figure 14 and Figure 15 The arrows in the image represent blood flow. Figure 14 The demonstration shows the femoral artery implantation method. Figure 15 The demonstration shows the apical implantation method.

[0109] The configuration of other components of the ventricular assist pump device in this embodiment can be implemented with reference to Embodiment 1. The ventricular assist pump device in this embodiment has the beneficial effects of the ventricular assist pump device in Embodiment 1.

[0110] Example 3

[0111] like Figures 17-18 As shown, this embodiment provides a ventricular assist pump device, which is the same as that in Embodiment 2, except that the support cover 110 is inserted through the connection between the aorta 2 and the left ventricle 1, or it can be understood as being inside the aorta 2. That is, the support cover 110 passes through the aortic valve, and one end of the main frame 1111 exposed outside the diaphragm 112 communicates with the left ventricle 1, forming a blood inlet 102, while the other end of the main frame 1111 exposed outside the diaphragm 112 communicates with the aorta 2, forming a blood outlet 101.

[0112] This embodiment of the ventricular assist pump device can be equipped with two pressure measurement points. One pressure measurement point, P4, is located at the end of the main frame 1111 exposed outside the diaphragm 112 and connected to the left ventricle 1. The other pressure measurement point, P5, is located at the other end of the main frame 1111 exposed outside the diaphragm 112 and connected to the aorta 2. By measuring the pressure at both points, the status of the blood pump can be understood. Simultaneously, based on the pressure values ​​at the two measurement points and the inner cross-sectional area of ​​the main frame 1111 (since the main frame 1111 is interfering with the aorta 2, this cross-sectional area is also the cross-sectional area of ​​the aorta 2), the blood flow rate of the ventricular assist pump device can be calculated, thereby adjusting the blood flow rate according to the patient's heart failure level. The specific calculation method for the blood flow rate of this embodiment of the ventricular assist pump device can be found in the description of Embodiment 1.

[0113] Similarly, the ventricular assist pump device in this embodiment can be implanted via the femoral artery, such as... Figure 17 As shown; that is, implanted via the apex of the heart, such as Figure 18 As shown.

[0114] The other components of the ventricular assist pump device in this embodiment can be implemented with reference to Embodiment 1 or Embodiment 2. The ventricular assist pump device in this embodiment has the beneficial effects of the ventricular assist pump device in Embodiment 1. Furthermore, the blood pump composed of the support cover 110 and the impeller mechanism 200 of the ventricular assist pump device in this embodiment can directly replace the aortic valve, not only treating heart failure but also replacing the left ventricle 1 to achieve pumping function. Since many heart failure patients may have aortic 2 calcification or regurgitation, the ventricular assist pump device in this embodiment can be used to treat such patients. That is, the internal component 100 of the device directly replaces the aortic valve, achieving fixation at the aorta 2 position. The suction function of the device replaces the function of the aortic valve, ensuring unidirectional blood flow and also treating heart failure.

[0115] Example 4

[0116] like Figure 19 or Figure 20 As shown, this embodiment provides a ventricular assist pump device. The difference from the first embodiment is that the ventricular assist pump device in this embodiment is configured in the aorta 2. The blood vessel wall of the aorta 2 and the main frame 1111 form a blood flow channel, without the need to set up a diaphragm 112.

[0117] Specifically, the ventricular assist pump device of this embodiment includes an in vivo component 100, which includes a support cover 110 and an impeller mechanism 200. The support cover 110 includes a hollow cover 111, and the impeller mechanism 200 is disposed inside the hollow cover 111. The impeller mechanism 200 includes a rotating shaft 220 and blades 210 connected to the rotating shaft 220. The in vivo component 100 has a folded state and an unfolded state. In the folded state, the support cover 110 is folded inward onto the impeller mechanism 200, and the blades 210 are folded onto the rotating shaft 220. In the unfolded state, the support cover 110 is unfolded outward, and the blades 210 are unfolded relative to the rotating shaft 220 within the support cover 110 for rotating and pumping blood to promote the delivery of blood from the left ventricle 1 to the aorta 2. The in vivo component 100 is configured to be implanted into the aorta 2 via a catheter in the folded state, and configured to have the support cover 110 press-fitted into the aorta 2 in the unfolded state.

[0118] In this embodiment, the internal component 100 of the ventricular assist pump device can be placed at the location of the aorta 2, specifically at the connection point between the aorta 2 and the outflow tract of the left ventricle 1, and the device is fixed through the aorta 2. The device can utilize the blood vessels of the aorta 2 and the circular channel at the outflow tract location to create a pressure drop within the channel, thereby perfusing blood into the aorta 2.

[0119] Similarly, the ventricular assist pump device of this embodiment can be implanted via the femoral artery, such as... Figure 19 As shown; that is, implanted via the apex of the heart, such as Figure 20 As shown.

[0120] The configuration of other components of the ventricular assist pump device in this embodiment can be implemented with reference to Embodiment 1. The ventricular assist pump device in this embodiment has the beneficial effects of the ventricular assist pump device in Embodiment 1.

[0121] Example 5

[0122] This embodiment provides a ventricular assist pumping system, including ECG800 and the ventricular assist pumping device provided in any of the embodiments one to four.

[0123] The ECG800 connects to the control box of the ventricular assist pump device. Existing conventional equipment can be used with the ECG800. This ventricular assist pump system uses the ECG800's signal receiving module to monitor the patient's electrocardiogram (ECG) and receive signals. The received ECG signals are sent to the control box, which converts them into digital signals, determines the heart's systolic and diastolic states, and then converts the converted digital signals into control commands, sending them to the drive assembly 300. The drive assembly 300 drives the impeller mechanism 200 to rotate, thereby assisting the left ventricle 1 in pumping blood into the aorta 2.

[0124] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A ventricular assist pumping apparatus, comprising: The in-vivo component (100) comprises a support cover (110) and an impeller mechanism (200); The support cover (110) comprises a hollow cover body (111) and a film (112), the hollow cover body (111) comprises a main frame body and a connecting frame (1112); the film (112) is coated on the hollow cover body (111), the impeller mechanism (200) comprises a rotating shaft (220) and a blade (210) connected with the rotating shaft (220); the blade (210) is correspondingly arranged in the main frame body (1111); The connecting frame (1112) comprises a first section (1113) and a second section (1114), the first section (1113) is connected between the second section (1114) and the main frame body (1111); the outer diameter of the first section (1113) is smaller than that of the second section (1114), the first section (1113) is used for corresponding aortic valve arrangement; the end of the main frame body (1111) away from the connecting frame (1112) is exposed to form a blood inlet (102), the film (112) at the end of the connecting frame (1112) away from the main frame body (1111) forms a blood outlet (101); the outlet (101) comprises a plurality of through holes (104), the axes of the plurality of through holes (104) are consistent with the axis of the connecting frame (1112), and the plurality of through holes (104) are arranged in a honeycomb shape; the in-vivo component (100) has a folded state and an unfolded state, in the folded state, the support cover (110) is folded inward on the impeller mechanism (200), and the blade (210) is folded on the rotating shaft (220); in the unfolded state, the support cover (110) is unfolded outward to form a blood flow channel, and the blade (210) is unfolded relative to the rotating shaft (220) in the support cover (110) for rotating blood pumping to promote the blood in the left ventricle (1) to the aorta (2), while in the unfolded state, the inner diameter of the connecting frame (1112) is smaller than that of the hollow cover body (111), the cross section of the connecting frame (1112) is arranged in a ring shape, the connecting frame (1112) is connected to the side of the main frame body (1111) close to the aorta (2), and the end of the connecting frame (1112) away from the main frame body (1111) is used for arrangement in the aorta (2); The in-vivo component (100) is configured to be implanted into the connection between the aorta (2) and the left ventricle (1) or the left ventricle (1) through a catheter in the folded state, and the support cover (110) is arranged in the connection between the aorta (2) and the left ventricle (1) or the left ventricle (1) in the unfolded state.

2. The ventricular assist pumping apparatus according to claim 1, wherein, The hollow cover (111) comprises a main frame (1111), the main frame (1111) is arranged in a ring shape in cross section, and the main frame (1111) is arranged in a grid shape and is hollow, and the two ends of the main frame (1111) are respectively folded inward in directions away from each other.

3. The ventricular assist pumping apparatus of claim 1 or 2, wherein, The two ends of the main frame (1111) are respectively provided with a first support sleeve (113) and a third support sleeve (115). The rotating shaft (220) is arranged in the main frame (1111), the first support sleeve (113), and the second support sleeve (114), and the first support sleeve (113) and the third support sleeve (115) are used for supporting the rotating shaft (220).

4. The ventricular assist pumping apparatus according to claim 1, wherein, The ventricular assist pump blood instrument further comprises a pressure measuring mechanism for monitoring the pressure in the left ventricle (1) corresponding to the inlet (102), the pressure in the aorta (2) corresponding to the outlet (101), and / or the pressure in the blood flow channel. The pressure measuring mechanism is arranged in the body, or the pressure measuring mechanism is arranged outside the body and communicates with the position to be measured through a lead-through tube.

5. The ventricular assist pumping apparatus according to claim 1, wherein, The number of the blades (210) is one or more, the blades (210) are fixedly connected with the rotating shaft (220), and the blades (210) are made of a memory alloy, so that the blades (210) can be folded or unfolded. And / or The blades (210) are hingedly connected with the rotating shaft (220), and a reset member is arranged between the blades (210) and the rotating shaft (220). Under the action of an external force, the blades (210) can compress the reset member, so that the blades (210) are in a folded state, and the reset member makes the blades (210) have a tendency to unfold relative to the rotating shaft (220).

6. The ventricular assist pumping apparatus according to claim 1, wherein, The ventricular assist pump blood instrument further comprises a driving assembly (300) connected with the rotating shaft (220). The driving assembly (300) is arranged in the support cover (110), or the driving assembly (300) is arranged outside the body and connected with the rotating shaft (220) through a transmission member (310).

7. The ventricular assist pumping apparatus of claim 6, wherein, The plurality of impeller mechanisms (200) are arranged in sequence, and the rotating shafts (220) of the plurality of impeller mechanisms (200) are fixedly connected or rotatably connected.

8. The ventricular assist pumping apparatus of claim 7, wherein, The number of the impeller mechanisms (200) is two, and the rotating shafts (220) of the two impeller mechanisms (200) are rotatably connected, so that the two impeller mechanisms (200) can rotate independently. The number of the driving assemblies (300) is two, and the two driving assemblies (300) are respectively connected with the two rotating shafts (220) one by one, and the two driving assemblies (300) are connected with the two ends of the two rotating shafts (220) away from each other.

9. The ventricular assist pumping apparatus according to claim 1, wherein, One end or both ends of the support cover (110) is connected with a sheath (116), and the sheath (116) is adjustable in bending degree.

10. The ventricular assist pumping apparatus according to claim 4, wherein, The ventricular assist pumping device further comprises a control box connected with the pressure measuring mechanism and a driving assembly (300) driving the impeller mechanism (200) to rotate respectively through a signal transmission unit.

11. The ventricular assist pumping apparatus according to claim 1, wherein, The material of the hollow cover body (111) is a memory alloy, and the film (112) is a plastic film or a biological tissue film.

12. A ventricular assist pump blood system, characterized by, The ventricular assist pumping device of any one of claims 1-11. The ventricular assist pumping device of any one of claims 1-11.

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