CN114642827A - Ventricular Assisted Blood Pumping Devices and Systems - Google Patents

Abstract

The invention provides a ventricular auxiliary blood pumping device and system, and relates to the technical field of medical devices. The ventricular auxiliary blood pumping device includes an internal component, and the internal component includes a support cover and an impeller mechanism; the internal component has a folded state and an unfolded state, and is arranged in a When the aorta is connected to the left ventricle or in the left ventricle, the in-vivo components are set in the unfolded state, and the membrane and the support cover form a blood flow channel. It can be used as a blood pump to promote the blood flow in 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, the volume is small, and can be implanted into the aorta and the aorta through the catheter. The connection position of the left ventricle or the left ventricle does not require thoracotomy, the operation time is short, the trauma is small, and the patient recovers quickly.

Description

Ventricular Assisted Blood Pumping Devices and Systems

technical field

The invention relates to the technical field of medical devices, in particular to a ventricular auxiliary blood pumping device and a system.

Background technique

The heart is an important organ that provides power for human blood circulation. The heart is divided into two parts, left and right, each of which contains a ventricle and an atrium. The left ventricle and the right ventricle are blocked by the interventricular septum, and the left atrium and the right atrium are blocked 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, where it is pumped to the arteries throughout the body. The direction of blood flow between the right atrium and the right ventricle is regulated by the tricuspid valve, which indeed contains carbon dioxide-rich venous blood, which flows from the right atrium to the right ventricle, which pumps it to the pulmonary artery.

In high-risk cardiac surgery patients and patients with heart failure, the ability of the heart to pump blood is reduced, which can easily lead to insufficient blood supply to other organs, such as the brain and kidneys, resulting in systemic organ damage. In particular, heart failure is a disease that seriously threatens human life. About 1/5 of heart disease patients in the world will eventually develop heart failure every year. At present, the incidence of heart failure in my country is 0.9%. And the 5-year mortality rate exceeds 60%. Over a long period of time, the number of patients with advanced heart failure will be far greater than the number of donors who can provide heart transplantation, and left ventricular assist devices can not only save patients' lives, but also find suitable donors for patients, or buy surgery time to provide a huge help.

Since its clinical application in the 1960s, after years of research and clinical application, the application of left ventricular assist devices has expanded from resuscitation after cardiovascular surgery, transition or replacement of heart transplantation, to the recovery of myocardial function and even the permanent treatment of heart failure. treat. The left ventricular assist device can not only serve as a bridge before heart transplantation, a boat leading to myocardial recovery, but also can improve the quality of life of patients with heart failure and be used for the treatment of patients with heart failure. At present, the main left ventricular assist device is to establish a passage outside the heart at the apex of the left ventricle and the aorta, and use a centrifugal pump to pump blood from the left ventricle to the aorta. Because the access is outside the heart, the procedure requires a thoracotomy to complete. Thoracotomy is more traumatic for patients, and many elderly patients with heart failure cannot tolerate the trauma caused by surgery, and the prognosis is poor.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide a ventricular assisting blood pumping device and system, so as to solve the problems that the current ventricular assisting device needs to open the chest, the operation time is long and the trauma is large.

The ventricular assisted blood pumping device provided by the present invention includes an in-vivo component, and the in-body component includes a support cover and an impeller mechanism;

The support cover includes a hollow cover body and a film, the cover film is wrapped on the hollow cover body, the impeller mechanism is arranged in the hollow cover body, and the impeller mechanism includes a rotating shaft and is connected with the rotating shaft. the leaves;

The in-body assembly has a folded state and an unfolded state, in which the support cover is folded inward on the impeller mechanism, and the blade is folded on the rotating shaft; in the unfolded state, the The support cover is expanded outward to form a blood flow channel, and the blade is expanded in the support cover relative to the rotating shaft to rotate and pump blood, so as to promote the delivery of blood from the left ventricle to the aorta;

The in vivo assembly is configured to be implanted transcatheterly into the junction of the aorta and the left ventricle or within the left ventricle in a collapsed state, and is configured in a deployed state with the support cap disposed between the aorta and the left ventricle. junction or within the left ventricle.

Further, the hollow cover body includes a main frame body, the cross section of the main frame body is annularly arranged, and the main frame body is hollowed out in a grid shape, and the axial ends of the main frame body are respectively Folded inward in directions away from each other, the blades are correspondingly arranged in the main frame body.

Further, the middle part of the main frame body is covered with the coating film, and the two ends of the main frame body respectively form an inlet and an outlet for blood.

Further, the hollow cover body further 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 body, the cross section of the connecting frame is annular, and the connecting frame is connected On the side of the main frame body close to the aorta, one end of the connecting frame away from the main frame body is used to be arranged in the aorta;

The connecting frame is arranged in a hollow grid, the main frame body and the connecting frame are covered with the coating film, and the end of the main frame body away from the connecting frame is exposed to form an inlet for blood, which is located at the end of the connecting frame. The film at one end of the connecting frame away from the main frame forms an outlet for blood; or, the connecting frame is arranged in a hollow tubular shape, the main frame is covered with the film, and the main frame is covered with the film. One end of the frame body away from the connection frame is exposed to form an inlet for blood, and one end of the connection frame away from the main frame body is opened to form an outlet for blood.

Further, the connecting frame includes a first section and a second section, and the first section is connected between the second section and the main frame body;

The outer diameter of the first section is smaller than the outer diameter of the second section, and the first section is configured to correspond to the aortic valve.

Further, the outlet includes a central hole, and the axis of the central hole is consistent with the axis of the connecting frame; or, the outlet includes a plurality of through holes, and the axes of the plurality of through holes are consistent with the axis of the connecting frame Consistent, and a plurality of through holes are arranged in a honeycomb shape.

Further, both ends of the main frame body are respectively provided with a first support sleeve and a third support sleeve;

The rotating shaft passes through the main frame body, 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.

Further, the ventricular auxiliary blood pumping device further includes a pressure measuring mechanism, and the pressure measuring mechanism 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 left ventricle corresponding to the inlet. pressure within the blood flow channel;

The pressure measuring mechanism is arranged inside the body; or, the pressure measuring mechanism is arranged outside the body, and the pressure measuring mechanism is communicated with the position to be pressure measured through a conducting pipe.

Further, the number of the blades is one or more, the blades are fixedly connected with the rotating shaft, and the material of the blades is memory alloy, so that the blades can be folded or unfolded;

and / or

The blade is hingedly connected with the rotating shaft, and a reset piece is arranged between the blade and the rotating shaft. Under the action of an external force, the blade can compress the reset piece, so that the blade is in a folded state, The reset member causes the blade to have a tendency to expand relative to the rotational axis.

Further, the ventricular auxiliary blood pumping device further comprises a drive assembly, the drive assembly is connected with the rotating shaft, the drive assembly is configured to be disposed in the support cover, or the drive assembly is configured to be disposed outside the body, and is connected with the rotating shaft through a transmission member.

Further, the impeller mechanisms include a plurality of impeller mechanisms arranged in sequence, each of the impeller mechanisms includes a blade and a rotating shaft, and the rotating shafts of the multiple impeller mechanisms are configured to be fixedly connected, or, a plurality of the impeller mechanisms The rotating shafts are configured to be rotatably connected relative to each other.

Further, the number of the impeller mechanisms is two, and the rotating shafts of the two impeller mechanisms are configured to be rotatably connected, so that the two impeller mechanisms can rotate independently respectively;

The number of the driving components is two, and the two driving components are respectively connected with the two rotating shafts in a one-to-one correspondence, and the two driving components are respectively connected with the two ends of the two rotating shafts that are away from each other. .

Further, a sheath tube is connected to one or both ends of the support cover, and the curvature of the sheath tube is adjustable.

Further, the ventricular auxiliary blood pumping device further includes a control box, and the control box is respectively connected with the pressure measuring mechanism and the driving assembly for driving the rotation of the impeller mechanism through a signal transmission unit.

Further, the material of the hollow cover body is memory alloy, and the covering film is a plastic film or a biological tissue film.

The ventricular auxiliary blood pumping device provided by the present invention includes an in-body component, and the in-body component includes a support cover and an impeller mechanism;

The support cover includes a hollow cover body, the impeller mechanism is arranged in the hollow cover body, and the impeller mechanism includes a rotating shaft and a blade connected with the rotating shaft;

The in-body assembly has a folded state and an unfolded state, in which the support cover is folded inward on the impeller mechanism, and the blade is folded on the rotating shaft; in the unfolded state, the The support cover is expanded outward, and the blade is expanded in the support cover relative to the rotating shaft, and is used for rotating pumping blood, so as to promote the delivery of blood from the left ventricle to the aorta;

The in-vivo assembly is configured for transcatheter implantation into the aorta in a collapsed state, and is configured in a deployed state with the support shield interference sleeved within the aorta.

The ventricular assisting blood pumping system provided by the present invention includes an ECG and the ventricular assisting blood pumping device provided by the present invention.

The ventricular auxiliary blood pumping device provided by the present invention includes an internal component, and the internal component includes a support cover and an impeller mechanism; the support cover includes a hollow cover body and a film, the cover film is wrapped on the hollow cover body, and the impeller mechanism is arranged in the hollow cover body. , the impeller mechanism includes a rotating shaft and a blade connected to the rotating shaft; the internal assembly has a folded state and an unfolded state. In the folded state, the support cover is folded inward on the impeller mechanism, and the blades are folded on the rotating shaft; in the unfolded state, the support cover Expand outward to form a blood flow channel, and the blades are expanded relative to the rotating shaft in the support cover for rotating pumping to promote the delivery of blood from the left ventricle to the aorta; the in-body assembly is configured to be implanted into the aorta through a catheter in a folded state At the junction with or within the left ventricle, and configured in the deployed state, the support shield is positioned at the junction of the aorta with the left ventricle or within the left ventricle. The in-vivo component of the ventricular auxiliary blood pumping device of the present invention has a folded state and an unfolded state. When set in the connection position between the aorta and the left ventricle or in the left ventricle, the in-vivo component is set in the unfolded state, and the membrane and the support cover form a blood flow channel , the rotation of the impeller mechanism can promote the pressure of the blood in the blood flow channel to increase, and then the internal component can be used as a blood pump to promote the blood flow in the left ventricle to the aorta; at the same time, the internal component has a folded state, in this folded state, The impeller mechanism and support cover are closed, and the volume is small. It can be implanted through the catheter into the connection position of the aorta and the left ventricle or in the left ventricle without thoracotomy. The operation time is short, the trauma is small, and the patient recovers quickly.

The ventricular auxiliary blood pumping device provided by the present invention includes an internal component, and the internal component includes a support cover and an impeller mechanism; the support cover includes a hollow cover body, the impeller mechanism is arranged in the hollow cover body, and the impeller mechanism includes a rotating shaft and an impeller mechanism. The blade connected by the rotating shaft; the internal assembly has a folded state and an unfolded state. In the folded state, the support cover is folded inward on the impeller mechanism, and the blade is folded on the rotating shaft; in the unfolded state, the support cover is unfolded outward, and the blade is relative to the rotating shaft. Deployed within the support cap for rotational pumping to facilitate the delivery of blood from the left ventricle to the aorta; the in-vivo component is configured to be implanted into the aorta via the catheter in a collapsed state, and configured to be in an expanded state with an interference fit of the support cap Set in the aorta. The internal components of the ventricular auxiliary blood pumping device of the present invention have a folded state and an unfolded state. When set at the connection position between the aorta and the left ventricle or in the left ventricle, the internal components are set in the unfolded state, and the support cover cooperates with the blood vessels of the aorta to form blood In the flow channel, the rotation of the impeller mechanism can promote the pressure of the blood in the blood flow channel to increase, and then the internal component can be used as a blood pump to promote the blood flow in the left ventricle to the aorta; at the same time, the internal component has a folded state, in this folded state The impeller mechanism and support cover are closed, and the volume is small. It can be implanted through the catheter into the connection between the aorta and the left ventricle or in the left ventricle. It does not require thoracotomy, the operation time is short, the trauma is small, and the patient recovers quickly.

The ventricular assisted blood pumping system provided by the present invention, including the ECG and the ventricular assisted blood pumping device provided by the present invention, has the same beneficial effects as the ventricular assisted blood pumping device provided by the present invention.

Description of drawings

In order to illustrate the specific embodiments of the present invention or the technical solutions in the prior art more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the specific embodiments or the prior art. Obviously, the accompanying drawings in the following description The drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without creative efforts.

FIG. 1 is a schematic diagram of the use state of the ventricular assisted blood pumping device provided in the first embodiment of the present invention;

2 is a schematic diagram of a ventricular assisted blood pumping device provided in Embodiment 1 of the present invention;

FIG. 3 is a partial schematic diagram of one direction of the impeller mechanism of the ventricular auxiliary blood pumping device provided in the first embodiment of the present invention in a folded state;

Fig. 4 is the schematic diagram of another direction of Fig. 3;

FIG. 5 is a schematic view of the impeller mechanism of FIG. 3 in a deployed state;

6 is a schematic diagram of the in-vivo components of the ventricular assisted blood pumping device provided in Embodiment 1 of the present invention;

FIG. 7 is a schematic structural diagram of a membrane covering of a ventricular assisted blood pumping device provided in Embodiment 1 of the present invention;

FIG. 8 is another structural schematic diagram of the membrane of the ventricular assisted blood pumping device provided in Embodiment 1 of the present invention;

9 is a schematic diagram of the first form of the hollowed-out cover of the ventricular assisted blood pumping device provided in the first embodiment of the present invention;

10 is a schematic diagram of the second form of the hollowed-out cover of the ventricular assisting blood pumping device provided in the first embodiment of the present invention;

11 is a schematic diagram of a third form of the hollowed-out cover of the ventricular assisted blood pumping device provided in the first embodiment of the present invention;

12 is a schematic diagram of an installation form of the drive assembly of the ventricular assisted blood pumping device provided in Embodiment 1 of the present invention;

13 is a schematic diagram of another installation form of the drive assembly of the ventricular assisting blood pumping device provided in the first embodiment of the present invention;

FIG. 14 is a schematic diagram of a use state of the ventricular assisted blood pumping device provided in Embodiment 2 of the present invention;

15 is a schematic diagram of another use state of the ventricular assisted blood pumping device provided in the second embodiment of the present invention;

16 is a schematic diagram of a ventricular assisted blood pumping device provided in Embodiment 2 of the present invention;

FIG. 17 is a schematic diagram of a use state of the ventricular assisted blood pumping device provided in Embodiment 3 of the present invention;

FIG. 18 is a schematic diagram of another use state of the ventricular assisted blood pumping device provided in Embodiment 3 of the present invention;

FIG. 19 is a schematic diagram of a use state of the ventricular assisted blood pumping device provided in Embodiment 4 of the present invention;

FIG. 20 is a schematic diagram of another use state of the ventricular assisted blood pumping device provided in Embodiment 4 of the present invention.

Icons: 1-left ventricle; 2-aorta; 100-body components; 101-outlet; 102-inlet; 103-central hole; 104-through hole; 1112-connecting frame; 1113-first segment; 1114-second segment; 112-film; 113-first support sleeve; 114-second support sleeve; 115-third support sleeve; 116- Sheath tube; 200-impeller mechanism; 210-vane; 220-rotating shaft; 221-installation hole; 222-notch; 300-drive assembly; 310-transmission part; 400-controller; 500-signal box; 600-duct ; 700-lead; 800-ECG.

Detailed ways

The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

At present, the main ventricular assist devices are mainly located at the apex of the left ventricle 1 and the aorta 2 to establish a pathway outside the heart, and use a centrifugal pump to pump blood from the left ventricle 1 to the aorta 2 . Because the access is outside the heart, the procedure requires a thoracotomy to complete. Thoracotomy is traumatic for patients, and many elderly patients with heart failure cannot tolerate the trauma caused by surgery, and the prognosis is poor.

The invention provides a device implanted through a catheter, which can be implanted through the femoral artery, and the operation process is less traumatic, the time is short, and the trauma caused to the patient is small.

Example 1

As shown in FIGS. 1 to 13 , this embodiment provides a ventricular assisting blood pumping device, including an in-vivo assembly 100 , and the in-vivo assembly 100 includes a support cover 110 and an impeller mechanism 200 . The support cover 110 includes a hollow cover body 111 and a cover film 112 , the cover film 112 is covered on the hollow cover body 111 , the impeller mechanism 200 is arranged in the hollow cover body 111 , and the impeller mechanism 200 includes a rotating shaft 220 and a rotating shaft 220 . Blade 210. The in-body assembly 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 blades 210 are folded on the rotating shaft 220; in the unfolded state, the support cover 110 is unfolded outward to form a blood flow channel , the blade 210 is unfolded in the support cover 110 relative to the rotating shaft 220 , and is used to rotate and pump blood, so as to promote the delivery of the blood of the left ventricle 1 to the aorta 2 . The in vivo assembly 100 is configured to be implanted transcatheterly at the junction of the aorta 2 and the left ventricle 1 or into the left ventricle 1 in the collapsed state, and is configured to be in the deployed state with the support cap 110 disposed at the junction of the aorta 2 and the left ventricle 1 or in the left ventricle 1.

The film 112 may cover the inner surface of the hollow cover body 111 or the outer surface of the hollow cover body 111 . The covering film 112 is prepared from a soft material, specifically a soft plastic film, that is, a polymer material, such as PET (polycondensation polymer of phthalic acid and ethylene glycol), eTFP (ethylene-tetrafluoroethylene copolymer) It can also be a biological tissue membrane, such as an animal pericardial coating of one or more materials, and the coating 112 is fused on the hollow cover body 111 by sewing, bonding or hot melting. When the impeller mechanism 200 rotates, a pressure drop is formed inside the membrane 112 , so that the blood flow is sucked from the left ventricle 1 to the aorta 2 , thereby forming an auxiliary function for the left ventricle.

The in-vivo assembly 100 of the ventricular assisting blood pumping device in this embodiment has a folded state and an expanded state. When placed at the connection position between the aorta 2 and the left ventricle 1 or in the left ventricle 1, the in-vivo assembly 100 is set in the expanded state, and the membrane 112 and The support cover 110 forms a blood flow channel, the rotation of the impeller mechanism 200 can increase the pressure of the blood in the blood flow channel, and the in-vivo component 100 can be used as a blood pump to promote the blood flow in the left ventricle 1 to the aorta 2 . Meanwhile, the in-body assembly 100 has a folded state, in which the impeller mechanism 200 and the support cover 110 are folded, the volume is small, and can be implanted into the connection position of the aorta 2 and the left ventricle 1 or into the left ventricle 1 through the catheter, There is no need for thoracotomy, the operation time is short, the trauma is small, and the patient recovers quickly.

The material of the hollow cover body 111 can be a memory alloy, such as nickel-titanium alloy, and the memory and self-expansion properties of the memory alloy can be used to realize the change of the folded state and the unfolded state of the hollow cover body 111 .

The number of the blades 210 is one or more, and when there are multiple blades 210 , the multiple blades 210 are arranged at intervals along the circumferential direction or the axial direction of the rotating shaft 220 . The blade 210 is switched between the folded state and the unfolded state. The blade 210 may be a memory alloy, and the blade 210 is fixedly connected with the rotating shaft 220 so that the blade 210 can be folded or unfolded. Specifically, one end of the blade 210 is fixedly connected with the rotating shaft 220, the material of the blade 210 is memory alloy, the rotating shaft 220 is provided with a slot 222, the blade 210 is arranged corresponding to the slot 222, and in the folding posture, the blade 210 is folded in the slot 222; in the unfolded state, the end of the blade 210 away from its fixed connection with the rotating shaft 220 expands outward away from the rotating shaft 220, and the blade 210 is finally arranged at an acute or right angle with the rotating shaft 220, that is, the blade 210 can be used as a driving piece.

The switch between the folded state and the unfolded state of the blade 210 can also be mechanically driven. For example, the blade 210 is hingedly connected 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 is capable of compressing the restoring member, so that the blade 210 is in a folded state, and the restoring member makes the blade 210 have a tendency to expand relative to the rotating shaft 220 . Specifically, as shown in FIG. 3 , FIG. 4 or FIG. 5 , one end of the blade 210 is hingedly connected 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 In order to make the blade 210 in the folded position, the restoring member makes the blade 210 have a tendency to unfold relative to the rotation axis 220 . Wherein, the reset member may be a torsion spring, and the torsion spring may be arranged in the installation 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 notch 222, the blade 210 is hinged in the notch 222, and the side wall of the notch 222 corresponding to the hinged end of the blade 210 can be used as a limit when the blade 210 is opened. position, so that when the blade 210 is opened, the blade 210 can be clamped on the side wall of the slot 222 under the action of the torsion spring.

Further, the hollow cover body 111 includes a main frame body 1111 and a connecting frame 1112. The cross section of the main frame body 1111 is annular, and the main frame body 1111 is hollowed out in a grid shape. Gather inwards in directions away from each other. In the unfolded state, the inner diameter of the connecting frame 1112 is smaller than the inner diameter of the hollow cover body 111 , the cross-section of the connecting frame 1112 is annular, the connecting frame 1112 is connected to the side of the main frame body 1111 close to the aorta 2 , and the connecting frame 1112 is far away from the main frame One end of the body is intended to be placed within the aorta 2 .

Among them, the radial space formed by the main frame body 1111 is larger, and the impeller mechanism 200 is arranged in the main frame body 1111, so that the blades 210 can have a larger blade area, which is beneficial to improve the blood transportation under the same rotation speed. ability. The connecting frame 1112 is mainly used to drain blood into the aorta 2 , and one end of the connecting frame 1112 away from the main frame body 1111 is disposed in the aorta 2 through the aortic valve. The connecting frame 1112 can have various forms. For example, in the first form, as shown in FIG. 9 , the connecting frame 1112 is a straight rod, which is arranged in a hollow grid, and the main frame body and the connecting frame 1112 are covered with a cover. The membrane 112 is exposed, and the end of the main frame away from the connection frame 1112 is exposed to form the blood inlet 102 , and the membrane 112 is located at the end of the connection frame 1112 away from the main frame to form the blood outlet 101 . For another example, in the second form, as shown in FIG. 10 , the connecting frame 1112 is a straight cylinder, that is, a hollow tubular shape, the main frame body is covered with a film 112 , and the end of the main frame body is far from the connecting frame 1112 The inlet 102 for blood is formed bare, and one end of the connecting frame 1112 away from the main frame is opened to form the outlet 101 for blood.

Wherein, the connecting frame 1112 may also be in the form of variable cross-section with different cross-sections, and generally, the outer diameter of the connecting frame 1112 at the position corresponding to the aortic valve is set to be smaller. For example, the first form shown in FIG. 9 can be transformed into the third form shown in FIG. 11 . In the third form, the connecting frame 1112 includes 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; the outer diameter of the first section 1113 is smaller than the second section 1114 The outer diameter of the first segment 1113 is used to correspond to the aortic valve setting. It can be understood that the aortic valve often has a small gap, and the outer diameter of the connecting frame 1112 arranged at the position of the aortic valve is small, which can ensure the normal operation of the aortic valve, and is not easy to damage the aortic valve, and is behind the aortic valve. A second section 1114 with a larger outer diameter is set at the position of the second section 1114. When the outer diameter of the second section 1114 increases, the inner diameter may also increase accordingly, which can slow down the blood flow rate and reduce energy loss.

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. The diameter (outer diameter) of the connecting frame 1112 in this embodiment is in the range of 2-10 mm.

As shown in FIG. 1 , when the ventricular assisting blood pumping device of this embodiment is in use, the main frame body 1111 is disposed in the left ventricle 1 , and the main frame body 1111 is used to protect the blades 210 . The connecting frame 1112 is connected between the aorta 2 and the main frame body 1111, so that the blood flow channel formed by the membrane 112 extends from the left ventricle 1 to the aorta 2, so that when the impeller mechanism 200 rotates, the blood of the left ventricle 1 flows from the main body 1111. The inlet 102 of the rack body 1111 enters the blood flow channel, and enters the aorta 2 along the blood flow channel under the driving action of the impeller mechanism 200 to assist the pumping of blood.

It can be understood that the ventricular assisted blood pumping device in this embodiment can pump blood in real time and is not affected by the aortic valve. The ventricular auxiliary blood pumping device in this embodiment can still pump blood in real time through the blood flow channel.

When blood flows into the aorta 2 , high-speed blood flow is likely to be formed due to large cross-sectional changes, and at the same time, large fluid energy loss is also likely to occur. In this embodiment, the outflow cross-section is increased by the connecting frame 1112 . That is, the connecting frame 1112 acts as a spreading mechanism, so that the blood flow channel of the blood flowing to the aorta 2 becomes larger, which increases the pipeline area when the blood flows out, and reduces the flow velocity, thereby reducing the pressure and energy loss. When the speed of the impeller mechanism 200 is too high, the rotation speed of the impeller mechanism 200 can be reduced, thereby reducing the possibility that the rotation speed of the impeller mechanism 200 is too large, resulting in a large shear force causing damage to the blood.

In order to improve the directionality during blood delivery, the blood outlet 101 includes a central hole 103, and the axis of the central hole 103 is consistent with the axis of the connecting frame 1112; or, the outlet 101 includes a plurality of through holes 104, and the axes of the plurality of through holes 104 Consistent with the axis of the connecting frame 1112 , the plurality of through holes 104 are arranged in a honeycomb shape. That is, for the structure of the outflow end of the coating film 112 , as shown in FIG. 7 , a central hole 103 may be provided, and the central hole 103 is a through hole structure. Alternatively, as shown in FIG. 8 , a plurality of through holes 104 may be provided, the plurality of through holes 104 form a honeycomb structure, and the normal direction of each through hole 104 is parallel to the axial direction of the coating film 112 .

It can be understood that, due to the rotation and agitation of the blood through the blades 210, there are many rotations and uneven flow rates, and the honeycomb-shaped design of the plurality of through holes 104 can rectify the fluid delivered to the aorta 2 to stabilize the flow. Therefore, a honeycomb-shaped plurality of through holes 104 is usually a preferred form.

Since the support cover 110 of the ventricular auxiliary blood pumping device in this embodiment is a hollow structure, the space formed by the support cover 110 is often large, and when the rotating shaft 220 is disposed in the support shaft, instability may occur. In order to solve this problem, in this embodiment, both ends of the main frame body 1111 are respectively provided with a first support sleeve 113 and a third support sleeve 115 , wherein the end of the main frame body 1111 close to the connection frame 1112 is the first support The sleeve 113, the connecting frame 1112 is connected to the first support sleeve 113, and the end of the connecting frame 1112 away from the main frame body is provided with a second support sleeve 114; The sleeve 113 , the connection frame 1112 and the second support sleeve 114 are inside, 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 .

As shown in FIG. 2 or FIG. 9 , 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 body 1111 , that is, the support cover 110 is in the first The positions of the first support sleeve 113 , the second support sleeve 114 and the third support sleeve 115 are retracted 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 are equivalent to bushings, so that the rotating shaft 220 can rotate relative to the support cover 110 and has good stability during rotation. In addition, when it needs to be explained, the structure of the coating film 112 is adapted to the hollow cover body 111. As shown in FIG. 2, the coating film 112 transitions smoothly at the position of the first support sleeve 113, and is spaced from the first support sleeve 113. In order to form a blood flow channel between the covering film 112 and the first support sleeve 113, the blood can smoothly flow from the main frame body 1111 to the connecting frame 1112 without blood flow resistance.

Further, the ventricular auxiliary blood pumping device in this embodiment further 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 blood flow channel. pressure within.

It can be understood that the pressure measuring mechanism can monitor the pressure at each point to evaluate the working state of the blood pump formed by the impeller mechanism 200 in cooperation with the blood flow channel. By monitoring the pressure of the left ventricle 1 corresponding to the inlet 102, the pressure of the blood at the inlet 102 can be known, and by monitoring the pressure in the aorta 2 corresponding to the outlet 101, the pressure when the blood is flowing out can be known. By monitoring the pressure within the blood flow channel, the pressure within the blood flow channel can be known. These pressure measurement positions can be selected and set according to needs. In this embodiment, a plurality of pressure measurement points are set in the blood flow channel. As shown in FIG. 2 , the first measurement point P1 is set on the first support sleeve 113 , and the first measurement point P1 is set at the end of the connecting frame 1112 close to the outlet 101 . There is a second measurement point P2 and a third measurement point P3 is provided at the outlet 101 . Through the first measurement point P1, it can be known that under the action of the impeller mechanism 200, the entry pressure of the blood entering the blood flow channel formed by the connection frame 1112 and the coating film 112 can be determined. Whether the driving pressure is appropriate. Through the second measurement point P2 and the third measurement point P3, the area A of the blood flow channel formed by the combination of the connecting frame 1112 and the covering film 112 (that is, the inner cross section of the blood flow channel formed by the connection frame 1112 matching the covering film 112) area, the inner cross-sectional area at a-a shown in Figure 2), can calculate the blood flow assisted by the device to pump, and then can evaluate the real-time flow of the blood pumping device. Among them, the calculation formula of the blood flow assisted by the ventricular auxiliary pumping device is:

Formula 1: The pressure difference ΔP is equal to the pressure value p2 of the second measurement point P2 minus the pressure value p3 of the third measurement point P3, that is, ΔP=p2-p3;

Formula 2: The pressure difference ΔP is equal to 4 times the square of the blood flow velocity V, that is, ΔP=4*V ² ;

Formula 3: The blood flow Q is equal to the blood flow velocity V multiplied by the area A, that is, Q=V*A.

Among them, the pressure value p2 of the second measurement point P2 and the pressure value p3 of the third measurement point P3 are obtained by measurement, so the blood flow velocity V can be calculated by combining formula 1 and formula 2; area A is the pre-measured or calculated Therefore, after obtaining the blood flow velocity V, formula 3 can be used to calculate the blood flow.

In this embodiment, the working flow of the ventricular auxiliary blood pumping device can be monitored in real time, so that the output flow of the device can be judged according to the degree of heart failure of the patient, and then the rotation speed of the blade 210 can be controlled by the control box to adjust to the ideal flow.

It should be noted that the pressure measuring mechanism includes a pressure sensor, the pressure measuring mechanism can be arranged in the body, and the pressure sensor is directly connected to the corresponding pressure measuring point at this time. The pressure measuring mechanism can also be arranged outside the body. At this time, the pressure measuring mechanism is communicated with the position to be pressure measured, that is, the corresponding pressure measuring point, through the conducting pipe.

Further, the ventricular auxiliary blood pumping device in this embodiment further includes a sheath tube 116, the sheath tube 116 is fixedly connected to the support cover 110, and the sheath tube 116 is provided with a corresponding functional hole, and the functional hole can be used for a conducting tube, a transmission member 310, wire 700, etc. pass through.

The sheath tube 116 can be configured as a sheath tube with an adjustable curvature, that is, in addition to the sheath tube 116 having flexibility to bend along with the bending of the blood vessel, the sheath tube 116 can also be manually adjusted in curvature. As shown in FIG. 2 , the sheath tube 116 is provided with a guide wire, and the artificial curvature adjustment of the sheath tube 116 can be realized by the pulling action of the guide wire. The curvature of the sheath tube 116 is adjustable, and the positions of the support cover 110 and the impeller mechanism 200 in the left ventricle 1 and the straightness of the rotating shaft 220 can be adjusted in a targeted manner.

The sheath 116 may also be connected to the catheter 600 to facilitate the connection of the intrabody assembly 100 to the extracorporeal component and to facilitate the placement of connectors between the intrabody component 100 and the extracorporeal component.

Further, the ventricular assisted blood pumping device in this embodiment further includes a drive assembly 300, the drive assembly 300 is connected to the rotating shaft 220, the drive assembly 300 is configured to be disposed in the support cover 110, or the drive assembly 300 is configured to be disposed outside the body, It is connected with the rotating shaft 220 through the transmission member 310 .

Specifically, the impeller mechanism 200 of the ventricular auxiliary blood pumping device in this embodiment may be one, the number of blades 210 of one impeller mechanism 200 may be one or more, and the plurality of blades 210 may be arranged in sequence along the circumferential direction of the rotating shaft 220, It can also be arranged in sequence along the axial direction of the rotating shaft 220 . The rotating shaft 220 of the impeller mechanism 200 is connected to the drive assembly 300 . The drive assembly 300 is usually a motor, and the motor can be a micro motor. At this time, the motor can be arranged in the support cover 110 at one end of the support cover 110 or at both ends of the support cover 110 Location. The drive assembly 300 can also be disposed outside the body, and the drive assembly 300 is connected to the rotating shaft 220 through a transmission member 310 formed by a drive wire, which is rotatably passed through the functional hole of the sheath tube 116 .

The impeller mechanisms 200 of the ventricular auxiliary blood pumping device in this embodiment may also include a plurality of impeller mechanisms 200 arranged in sequence. Driven by one drive assembly 300, the plurality of impeller mechanisms 200 rotate synchronously. In another way, the rotating shafts 220 of the plurality of impeller mechanisms 200 are configured to be relatively rotatably connected. At this time, the impeller mechanisms 200 can be driven separately. This embodiment provides a specific implementation for this form.

As shown in FIG. 12 or FIG. 13 , the number of the impeller mechanisms 200 is two, and the rotating shafts 220 of the two impeller mechanisms 200 are configured to be rotatably connected. Specifically, the two rotating shafts 220 are rotatably connected through a connecting shaft, so that the two impeller mechanisms 200 can rotate independently. The number of the driving assemblies 300 is two, the two driving assemblies 300 are respectively connected with the two rotating shafts 220 in a one-to-one correspondence, and the two driving assemblies 300 are respectively connected with two ends of the two rotating shafts 220 that are away from each other. Wherein, the end of the two rotating shafts 220 close to each other is provided with a slot 222, the blades 210 of the two impeller mechanisms 200 are respectively arranged at the end of the two slots 222 away from each other, and the two ends of the connecting shaft pass through the position of the slot 222 respectively. The two rotating shafts 220 are sleeved in the two rotating shafts 220 , the two rotating shafts 220 are respectively clearance-fitted with the connecting shafts, and the connecting shafts are provided with a limiting portion for restricting the axial movement of the two rotating shafts 220 .

The two impeller mechanisms 200 are arranged at intervals along the blood flow direction, and are located upstream of the blood flow direction (wherein, the arrows in FIG. 1 and FIG. 6 indicate the blood flow direction, and the upstream of the blood flow direction is also shown in FIG. The blade 210 on the lower side, the left side shown in FIG. 6 ) plays the role of blowing blood between the two impeller mechanisms 200 , and the blade 210 located downstream in the blood flow direction (the upper side shown in FIG. 1 , shown in FIG. 6 ) The right side of ) plays the role of sucking the blood between the two impeller mechanisms 200 .

As shown in FIG. 12 , the two driving assemblies 300 can be disposed in the body at the same time. At this time, the two driving assemblies 300 are disposed in the two ends of the support cover 110 in a one-to-one correspondence, and any one of the driving assemblies 300 is close to the driving assembly. The rotating shaft 220 of 300 is connected. As shown in FIG. 13 , the two drive assemblies 300 can also be placed outside the body at the same time. At this time, the two ends of the support cover 110 are respectively connected with the sheath tubes 116 , and the drive assemblies 300 , the drive wires and the sheath tubes 116 are arranged in a one-to-one correspondence. The wire passes through the functional hole of the sheath tube 116, and any one of the driving components 300 drives the corresponding rotating shaft 220 to rotate through the driving wire connected thereto.

It can be understood that the two impeller mechanisms 200 are driven independently, and both can form a pressure difference. The upstream impeller mechanism 200 (the left impeller mechanism 200 shown in FIG. 2 ) mainly blows fluid into the film 112 , while the downstream impeller mechanism 200 mainly blows fluid into the film 112 . The impeller mechanism 200 (the impeller mechanism 200 on the right shown in FIG. 2 ) is used to suck fluid into the interior, and the two impeller mechanisms 200 cooperate to realize large-flow delivery by using a small rotation speed. At the same time, it can be selected whether both blades 210 work according to needs, for example, the upstream impeller mechanism 200 is reserved to realize the function of blowing blood, and the downstream impeller mechanism 200 is reserved for the function of pumping blood, which increases the size of the ventricle. The blood pumping adjustment range of the auxiliary blood pumping device. In addition, after one impeller mechanism 200 fails, the other impeller mechanism 200 can still be used normally, which improves the reliability of the ventricular assisting blood pumping device; at the same time, the two driving assemblies 300 can intermittently alternately work independently to improve ventricular assisting The overall life of the blood pumping device. Further, the use of the rotation of two impeller mechanisms 200 to achieve pressurization of blood, compared with the high-speed rotation of one impeller mechanism 200, can avoid the large shear force caused by the high-speed rotating blades 210 and damage the cells in the blood. question. In addition, the two impeller mechanisms 200 are integrally connected by connecting shafts, so that the two connecting shafts have better support stability at the ends close to each other.

It should be noted that when there are multiple impeller mechanisms 200 , one or more blades 210 may also be provided on the same rotating shaft 220 , preferably two. The connecting shaft and the two rotating shafts 220 are coaxially arranged, so as to improve the running stability of the device when delivering blood. The two impeller mechanisms 200 can either rotate in the same direction or in different directions, and the controller 400 can realize the rotation control of the two impeller mechanisms 200 in the same direction or in different directions.

As shown in FIG. 1 , the ventricular auxiliary blood pumping device in this embodiment further includes a control box, which is respectively connected with the pressure measuring mechanism and the driving assembly 300 for driving the impeller mechanism 200 to rotate through the signal transmission unit. Wherein, the control box is usually set outside the body, and the signal transmission unit may be an independently set signal box 500 or a signal transmission module integrated in the control box.

The signal transmission unit collects the pressure of the corresponding measurement point through the pressure measuring mechanism, and feeds it back to the control box. The control box is provided with a corresponding controller 400 and a control knob, etc., to control and adjust the pressurization amount of the ventricular auxiliary pumping device and blood flow. Specifically, the controller 400 can automatically adjust the rotational speed of the driving assembly 300 according to the built-in program setting and the feedback of the signal transmission unit, or manually adjust the rotational speed of the driving assembly 300 according to the needs, referring to the feedback of the signal transmission unit, so as to achieve the adjustment The purpose of the boost volume.

In addition, it should be noted that when the drive assembly 300 is disposed outside the body, it can also be integrated in the control box, which facilitates the integrated setting of the outside part of the ventricular auxiliary blood pumping device and improves the inconvenience of carrying parts caused by scattered parts.

To sum up, the ventricular assisting blood pumping device in this embodiment is a transcatheter ventricular assisting device, which can be used to treat patients with heart failure, and can increase the control flow, reduce the pressure on the heart or the burden of pumping blood, and allow the myocardium to gradually increase. recovery, helps the heart to recover. The impeller mechanism 200 and the support cover 110 form a blood pump. The blood pump is a vane pump structure, and the vanes 210 are foldable vanes 210 . By adjusting the control box, the speed of the vane pump can be controlled, so as to realize the flow regulation of the blood pump; and the blood pump can realize the delivery of large flow at a lower speed. The signal box 500 is used to detect the real-time flow rate and rotation speed of the blood pump, and feed it back to the control box, and use the control box to adjust the rotation speed of the blood pump, so as to achieve the purpose of regulating the flow rate. There are three pressure measurement points on the device, which can be used to monitor the pressure changes inside and around the device, and at the same time, the flow of the device can be monitored according to the pressure values of the first measurement point P2 and the second measurement point P3. The instrument adopts the structure of double impellers driven by double motors. One impeller is used to blow fluid into the blood flow channel, and the other is used to suck fluid. At the same time, each impeller can work independently and can realize the function of pumping blood; The design improves the overall reliability of the system. At the same time, the motor can be designed in the body, or the motor can be set outside the body by means of driving wire transmission. The blood flow channel is composed of a support cover 110 and a covering film 112. Both ends of the covering film 112 are through-hole structures, and the outflow end can be a straight-through structure or a honeycomb circular hole structure. Can play a good rectification effect. The support cover 110 includes a main frame body 1111 and a connecting frame 1112. The main frame body 1111 is used to protect the impeller, and the connecting frame 1112 can increase the cross-sectional area of the blood outlet 101 and improve the delivery efficiency of the device. The instrument is also connected with an adjustable sheath tube 116, which realizes the function of bending and is convenient for passing through the position of the aortic arch during implantation.

Embodiment 2

As shown in FIGS. 14 to 16 , this embodiment provides a ventricular auxiliary blood pumping device. The ventricular auxiliary blood pumping device differs from the first embodiment only in that the support cover 110 includes a main frame body 1111 , and the main frame body 1111 The connecting frame 1112 is not connected, the middle of the main frame body 1111 is covered with a film 112 , and both ends of the film 112 are open to form the blood inlet 102 and the outlet 101 at the two ends of the main frame body 1111 , respectively.

The ventricular auxiliary blood pumping device in this embodiment can be implanted through the femoral artery or through the apex of the heart. The principle of the ventricular auxiliary blood pumping device in this embodiment is mainly to pump the blood at the bottom of the ventricle to the outflow tract position close to the aorta 2 when the heart contracts , thereby increasing the amount of excess blood at the location of the aortic valve. The specific principle is to judge the systolic or diastolic state of the heart by detecting the patient's ECG800 (ECG, also known as electrocardiogram equipment) signal, and the control box to determine what state the heart is in by receiving the ECG800 signal. When the heart is in a systolic state, the control box A pulse signal is sent out, and the motor rotates to realize the blood pumping function of the ventricular auxiliary blood pumping device. When the heart begins to relax, the motor is turned off immediately.

It should be noted that the arrows in Fig. 14 and Fig. 15 indicate the flow of blood, Fig. 14 shows the form of implantation through the femoral artery, and Fig. 15 shows the form of implantation through the apex.

The settings of other components of the ventricular assisted blood pumping device in this embodiment can be implemented with reference to the first embodiment. The ventricular auxiliary blood pumping device of this embodiment has the beneficial effects of the ventricular auxiliary blood pumping device of the first embodiment.

Embodiment 3

As shown in FIGS. 17 to 18 , the present embodiment provides an auxiliary ventricular blood pumping device, which is the same as the second embodiment, except that the support cover 110 is inserted through the aorta 2 and the left The junction of the ventricle 1, alternatively, can also be understood as within the aorta 2. That is, the support cover 110 passes through the aortic valve, one end of the main frame body 1111 exposed outside the membrane 112 is communicated with the left ventricle 1 to form the blood inlet 102, and the other end of the main frame body 1111 exposed outside the membrane 112 communicates with the main body 1111. The arteries 2 communicate and form an outlet 101 for blood.

In this embodiment, the ventricular auxiliary blood pumping device can be provided with two pressure measurement points. One pressure measurement point P4 is set at the end of the main frame body 1111 exposed outside the membrane 112 to communicate with the left ventricle 1 , and the other pressure measurement point P5 is set at the left ventricle 1 . The other end of the main frame body 1111 exposed outside the membrane 112 communicates with the end of the aorta 2 , and the pressure of the two is measured by the pressure measuring mechanism, and the state of the blood pump can be known. At the same time, according to the pressure values of the two measurement points, combined with the inner cross-sectional area of the main frame body 1111 (because the main frame body 1111 is set in the aorta 2 with interference, this cross-sectional area is also the cross-sectional area of the aorta 2 ). ) can calculate the blood flow of the ventricular auxiliary pumping device, so that the blood flow can be adjusted according to the degree of heart failure of the patient. For the specific calculation method of the blood flow of the ventricular auxiliary blood pumping device in this embodiment, reference may be made to the description in the first embodiment.

Similarly, the ventricular assisting blood pumping device in this embodiment can be implanted through the femoral artery, as shown in FIG. 17 ; that is, implanted through the apex of the heart, as shown in FIG. 18 .

The settings of other components of the ventricular assisted blood pumping device in this embodiment can be implemented with reference to Embodiment 1 or Embodiment 2. The ventricular auxiliary blood pumping device of this embodiment has the beneficial effects of the ventricular auxiliary blood pumping device of the first embodiment. In addition, the blood pump composed of the support cover 110 and the impeller mechanism 200 of the ventricular auxiliary blood pumping device in this embodiment can directly replace the aortic valve, which can not only treat heart failure, but also replace the left ventricle 1 to realize the blood pumping function. Since many heart failure patients may have calcification or regurgitation in the aorta 2, the ventricular assisted blood pumping device in this embodiment can be used to treat such patients, that is, the aortic valve is directly replaced with the in-vivo component 100 of the device, and the aortic valve 2 is replaced in the aorta 2. The position is fixed, and the suction function of the device is used to replace the function of the aortic valve, which can not only ensure the one-way flow of blood flow, but also treat heart failure.

Embodiment 4

As shown in FIG. 19 or FIG. 20 , this embodiment provides a ventricular auxiliary blood pumping device. The difference from the first embodiment is that the ventricular auxiliary blood pumping device in this embodiment is arranged in the aorta 2 , and the blood vessel wall of the aorta 2 is Combined with the main frame body 1111 to form a blood flow channel, it is not necessary to provide the membrane 112 .

Specifically, the ventricular assisted blood pumping device in this embodiment includes an in-vivo component 100, and the in-vivo component 100 includes a support cover 110 and an impeller mechanism 200; the support cover 110 includes a hollow cover body 111, and the impeller mechanism 200 is disposed in the hollow cover body 111, and the impeller mechanism 200 includes a rotating shaft 220 and a blade 210 connected with the rotating shaft 220; the in-body assembly 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 outwards, and the blades 210 are unfolded in the support cover 110 relative to the rotation shaft 220 for rotationally pumping blood to facilitate the delivery of blood from the left ventricle 1 to the aorta 2; the in-vivo assembly 100 is configured to be folded The state is implanted into the aorta 2 via the catheter, and is configured to be in the deployed state, and the support cap 110 is interference sleeved in the aorta 2 .

The in vivo assembly 100 of the ventricular assisted blood pumping device in this embodiment can be placed at the position of the aorta 2 , specifically the connection position between the aorta 2 and the outflow tract of the left ventricle 1 , and the device is fixed through the aorta 2 . The device may utilize a circular channel at the location of the blood vessels and outflow tract of the aorta 2 to create a pressure drop inside the channel to perfuse blood to the location of the aorta 2 .

The same ventricular assisted pumping device of this embodiment can be implanted through the femoral artery, as shown in FIG. 19 ; that is, implanted through the apex of the heart, as shown in FIG. 20 .

The settings of other components of the ventricular assisted blood pumping device in this embodiment can be implemented with reference to the first embodiment. The ventricular auxiliary blood pumping device of this embodiment has the beneficial effects of the ventricular auxiliary blood pumping device of the first embodiment.

Embodiment 5

This embodiment provides a ventricular assisted blood pumping system, including the ECG 800 and the ventricular assisted blood pumping device provided in any one of Embodiments 1 to 4.

The ECG800 is connected to the control box of the ventricular assisting blood pumping device. ECG800 can use existing conventional equipment. The ventricular assist pumping system is used to monitor the ECG of the patient's heart through the signal receiving module of ECG800, and receives the signal, and sends the received ECG signal to the control box, which converts it into a digital signal, and judges the contraction and contraction of the heart. In the diastolic state, the converted digital signal is then converted into a control command and sent to the drive assembly 300 , and the impeller mechanism 200 is driven to rotate by the drive assembly 300 , so as to assist the left ventricle 1 to pump blood to the aorta 2 .

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, but not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: The technical solutions described in the foregoing embodiments can still be modified, or some or all of the technical features thereof can be equivalently replaced; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the technical solutions of the embodiments of the present invention. scope.

Claims (17)

1. A ventricular assist blood pumping apparatus, comprising an intrabody assembly (100), the intrabody assembly (100) comprising a support housing (110) and an impeller mechanism (200);

the support cover (110) comprises a hollow cover body (111) and a coating film (112), the coating film (112) is coated on the hollow cover body (111), the impeller mechanism (200) is arranged in the hollow cover body (111), and the impeller mechanism (200) comprises a rotating shaft (220) and blades (210) connected with the rotating shaft (220);

the in-vivo assembly (100) has a folded state in which the support shroud (110) is folded inwardly over the impeller mechanism (200) and the blades (210) are folded over the rotational shaft (220), and an unfolded state; in the unfolding state, the supporting cover (110) is unfolded outwards to form a blood flow channel, and the blades (210) are unfolded in the supporting cover (110) relative to the rotating shaft (220) and used for rotationally pumping blood so as to promote the blood of the left ventricle (1) to be conveyed to the aorta (2);

the intracorporeal component (100) is configured to be catheterized into a junction of the aorta (2) and the left ventricle (1) or into the left ventricle (1) in a folded state, and configured to be disposed with the support cover (110) in a deployed state at the junction of the aorta (2) and the left ventricle (1) or into the left ventricle (1).

2. A ventricular assist blood pumping apparatus according to claim 1, wherein the hollow-out cover body (111) includes a main frame body (1111), the cross section of the main frame body (1111) is in an annular arrangement, the main frame body (1111) is in a grid-shaped hollow-out arrangement, two axial ends of the main frame body (1111) are respectively folded inwards along the directions departing from each other, and the blades (210) are correspondingly arranged in the main frame body (1111).

3. A ventricular assist pump blood device according to claim 2, characterized in that the main frame (1111) is covered with the coating (112) in the middle, and the two ends of the main frame (1111) form the inlet (102) and outlet (101) of blood, respectively.

4. A ventricular assist blood pumping apparatus according to claim 2, wherein the hollow cover (111) further comprises a connecting frame (1112), in the deployed state, the inner diameter of the connecting frame (1112) is smaller than the inner diameter of the hollow cover (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 cover (1111) close to the aorta (2), and the end of the connecting frame (1112) far away from the main cover (1111) is used for being arranged in the aorta (2);

the connecting frame (1112) is arranged in a hollow grid manner, the main frame body (1111) and the connecting frame (1112) are covered with the covering film (112), one end of the main frame body (1111), which is far away from the connecting frame (1112), is exposed to form an inlet (102) of blood, and the covering film (112), which is positioned at one end of the connecting frame (1112), which is far away from the main frame body (1111), forms an outlet (101) of blood; or, the connecting frame (1112) is arranged in a hollow tubular shape, the main frame body (1111) is covered with the coating (112), one end, far away from the connecting frame (1112), of the main frame body (1111) is exposed to form an inlet (102) of blood, and one end, far away from the connecting frame (1111), of the connecting frame (1112) is opened to form an outlet (101) of blood.

5. A ventricular assist blood pumping apparatus according to claim 4, characterized in that the connection frame (1112) comprises a first segment (1113) and a second segment (1114), the first segment (1113) being connected between the second segment (1114) and the main frame body (1111);

the first section (1113) has an outer diameter smaller than an outer diameter of the second section (1114), the first section (1113) being configured to correspond to an aortic valve.

6. A ventricular assist pump blood device according to claim 4 or 5, characterized in that the outlet (101) comprises a central hole (103), the axis of the central hole (103) coincides with the axis of the connection frame (1112); or the outlet (101) comprises a plurality of through holes (104), the axes of the through holes (104) are consistent with the axis of the connecting frame (1112), and the through holes (104) are arranged in a honeycomb shape.

7. A ventricular assist blood pumping apparatus according to any one of claims 2-5, characterized in that the main frame body (1111) is provided at its two ends with a first support sleeve (113) and a third support sleeve (115), respectively;

the rotating shaft (220) is arranged in the main frame body (1111), the first supporting sleeve (113) and the second supporting sleeve (114) in a penetrating mode, and the first supporting sleeve (113) and the third supporting sleeve (115) are used for supporting the rotating shaft (220).

8. A ventricular assist pump according to claim 4 or 5, characterized in that it further comprises a pressure measurement 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 path;

the pressure measuring mechanism is arranged in the body; or the pressure measuring mechanism is arranged outside the body and is communicated with the position needing pressure measurement through a conduction pipe.

9. A ventricular assist pump blood apparatus according to claim 1, characterized in that the number of the blades (210) is one or more, the blades (210) are fixedly connected with the rotating shaft (220), the material of the blades (210) is memory alloy, so that the blades (210) can be folded or unfolded;

and/or

Blade (210) with axis of rotation (220) are articulated to be connected, blade (210) with be provided with the piece that resets between axis of rotation (220), under the exogenic action, blade (210) can compress the piece that resets to make blade (210) are in folded state, the piece that resets makes blade (210) have relatively axis of rotation (220) the trend of expanding.

10. A ventricular assist pump device according to claim 1, characterized in that it further comprises a drive assembly (300), the drive assembly (300) being connected to the rotational shaft (220);

the drive assembly (300) is configured to be disposed within a support housing (110); alternatively, the driving assembly (300) is configured to be disposed outside the body and connected to the rotating shaft (220) through a transmission member (310).

11. A ventricular assist pump blood device according to claim 10, characterized in that the impeller mechanism (200) comprises a plurality of impeller mechanisms (200) arranged in sequence, and the rotating shafts (220) of the impeller mechanisms (200) are fixedly connected with each other or the rotating shafts (220) of the impeller mechanisms (200) are rotatably connected with each other.

12. A ventricular assist pump blood device according to claim 11, characterized in that the number of the impeller mechanisms (200) is two, and the rotating shafts (220) of the two impeller mechanisms (200) are configured to be rotatably connected with each other, so that the two impeller mechanisms (200) can rotate independently;

the number of the driving assemblies (300) is two, the two driving assemblies (300) are respectively connected with the two rotating shafts (220) in a one-to-one correspondence mode, and the two driving assemblies (300) are respectively connected with two ends, deviating from each other, of the two rotating shafts (220).

13. A ventricular assist pump blood device according to claim 1, characterized in that a sheath (116) is connected to one or both ends of the support shield (110), and the curvature of the sheath (116) is adjustable.

14. A ventricular assist blood pumping apparatus according to claim 8, further comprising a control box connected to the pressure measurement mechanism and the driving assembly (300) for driving the impeller mechanism (200) to rotate respectively through signal transmission units.

15. A ventricular assist blood pumping apparatus according to claim 1, wherein the hollow cover (111) is made of memory alloy, and the cover film (112) is a plastic film or a biological tissue film.

16. A ventricular assist pump device, characterized in that it comprises an intracorporeal component (100), the intracorporeal component (100) comprising a support housing (110) and an impeller mechanism (200);

the support cover (110) comprises a hollow cover body (111), the impeller mechanism (200) is arranged in the hollow cover body (111), and the impeller mechanism (200) comprises a rotating shaft (220) and blades (210) connected with the rotating shaft (220);

the in-vivo assembly (100) has a folded state in which the support shroud (110) is folded inwardly over the impeller mechanism (200) and the blades (210) are folded over the rotational shaft (220), and an unfolded state; in the unfolding state, the supporting cover (110) is unfolded outwards, and the blades (210) are unfolded in the supporting cover (110) relative to the rotating shaft (220) and used for rotationally pumping blood so as to promote the blood of the left ventricle (1) to be conveyed to the aorta (2);

the intracorporeal component (100) is configured to be transcatheter implanted into the aorta (2) in a collapsed state, and configured to be in an expanded state with the support cover (110) interference fit within the aorta (2).

17. A ventricular assist pumping system comprising an ECG (800) and a ventricular assist pumping apparatus according to any one of claims 1-16.

Images