CN114259646A

CN114259646A - Blood circulation auxiliary device and control system

Info

Publication number: CN114259646A
Application number: CN202210028954.8A
Authority: CN
Inventors: 唐智荣; 曹殿嘉; 赵贤忠
Original assignee: Fengkaili Medical Instrument Shanghai Co ltd
Current assignee: Fengkaili Medical Instrument Shanghai Co ltd
Priority date: 2022-01-11
Filing date: 2022-01-11
Publication date: 2022-04-01
Also published as: WO2023134639A1

Abstract

The application discloses blood circulation auxiliary device and control system, wherein, blood circulation auxiliary device includes: a sheath for mounting within a blood vessel, the sheath having a proximal end and a distal end; a first balloon disposed within the sheath and within the vessel; the pump body is arranged at the distal end of the sheath tube and is provided with a blood flow channel, a blood inlet and a blood outlet which are communicated with the blood flow channel, and the pump body is used for pumping the blood in the ventricle into the blood vessel; a controller disposed at the proximal end of the sheath and configured to control operation of the pump body and to intermittently actuate inflation and deflation of the first balloon to cause the first balloon to at least partially occlude the blood vessel to cooperate with the pump body to generate pulsatile blood flow. The application provides a blood circulation auxiliary device and a control system, which can generate pulsating blood flow matched with the heart pulsation characteristic of a patient, and promote the recovery of the heart of the patient.

Description

Blood circulation auxiliary device and control system

Technical Field

The embodiment of the application belongs to the technical field of heart auxiliary circulation, and particularly relates to a blood circulation auxiliary device and a control system.

Background

Cardiovascular diseases are the general term for disorders of the heart and blood vessels, including coronary heart disease, cerebrovascular disease, rheumatic heart disease, congenital heart disease, etc. Coronary heart disease and apoplexy are usually acute diseases, and the main cause is blood vessel blockage, which prevents blood from flowing to cardiac muscle or brain, resulting in oxygen deficiency and necrosis of organ tissues. Vascular blockage can be caused by a variety of causes, the most common of which is the stenosis of the vessel caused by the accumulation of fat on the inner wall of the vessel.

The most common existing treatment for various cardiovascular diseases is a left heart auxiliary device, a blood pump assembly of the left heart auxiliary device can be introduced into a heart through a PCI operation, a blood pump of the blood pump assembly operates to pump blood from a left ventricle of the heart into an aorta, or pump blood from an inferior vena cava into a pulmonary artery, and the blood pump can be powered and driven by a motor positioned outside a patient body or a motor positioned inside the patient body. The left heart auxiliary device can provide more stable blood circulation support for patients in high-risk PCI operations, reduces the burden of the left ventricle while improving the perfusion of coronary artery and distal organs, is beneficial to the stabilization of physical signs of patients in the operations and postoperative rehabilitation, and promotes the recovery of the hearts of the patients.

In order to meet the requirements of minimally invasive and large flow, the blood pump of the existing left heart assist device needs to meet the requirements of miniaturization and high pump blood flow. The motor needs to provide a high rotating speed of up to fifty thousand revolutions per minute to drive the blood pump to pump blood, and in order to simulate pulsating blood flow delivery synchronous with the heart beating frequency, the blood pump needs to be repeatedly rotated and stopped by the frequent rotation and braking of the power motor, so that the blood pump generates pulsating blood flow delivery, which is technically difficult to realize. In addition, when the left heart assist device is in operation, due to the formation of a blood pumping channel between the left ventricle and the aorta, repeated rotation and stalling of the blood pump may bring about a risk of blood flowing back from the aorta to the left ventricle, which is not beneficial to the recovery of the heart function of the patient.

Some studies have found that because the existing left heart assist device provides continuous blood circulation support to the patient, rather than pulsatile or pulsatile blood circulation synchronized with the beating frequency of the heart, it increases the risk of gastrointestinal arteriovenous malformations and potential complications that cause deficiencies in the acquired von willebrand factor. Therefore, there is a need for a blood circulation assistance system that is capable of producing pulsatile blood flow to provide effective blood circulation support to the heart of a patient.

Disclosure of Invention

The present application is directed to solving at least one of the problems in the prior art. Therefore, the embodiment of the application provides a blood circulation auxiliary device and a control system, the structure is ingenious, pulsating blood flow can be generated during application, effective and reliable blood circulation support is provided for the heart of a patient, and adverse effects caused by continuous blood flow generated by a traditional ventricular auxiliary device are eliminated.

In a first aspect, the present application provides a blood circulation assistance device comprising:

a sheath for mounting within a blood vessel, the sheath having a proximal end and a distal end;

a first balloon disposed within the sheath and within the vessel;

the pump body is arranged at the distal end of the sheath tube and is provided with a blood flow channel, a blood inlet and a blood outlet which are communicated with the blood flow channel, and the pump body is used for pumping the blood in the ventricle into the blood vessel;

a controller disposed at the proximal end of the sheath and configured to control operation of the pump body and to intermittently actuate inflation and deflation of the first balloon to cause the first balloon to at least partially occlude the blood vessel to cooperate with the pump body to generate pulsatile blood flow.

The blood circulation assistance device according to the embodiment of the first aspect of the application has at least the following advantages:

the utility model provides a blood circulation auxiliary device is when using, the sheath pipe and locate the first sacculus of sheath pipe, the pump body can be synchronous intervene the patient internally through percutaneous operation for the sheath pipe and locate the first sacculus of sheath pipe intervene in the patient's blood vessel, the pump body is intervene in the human ventricle for above-mentioned blood vessel blood supply partially at least, and make the blood entry and the ventricle intercommunication of the pump body, blood export and blood vessel intercommunication, and then make the pump body realize sending the blood pump in the ventricle to the function in above-mentioned blood vessel. When the blood circulation auxiliary device of this application moves, the operation work of controller control pump body, the pump body flows into the blood vessel with the blood in the heart chamber along the blood entry, blood passageway and the blood export of the pump body in proper order to this blood pump with in the heart chamber is to vascular. In the process that blood flows into a blood vessel from a ventricle under the power action of the pump body, the controller intermittently drives the first balloon to inflate and deflate, so that the inflation and deflation of the first balloon are periodically performed, the first balloon is further periodically plugged and conducted with the blood vessel, the blood is periodically plugged and conducted in the flowing process of the blood vessel, pulsating blood flow matched with the heart in periodic relaxation and contraction characteristics is generated, adverse effects caused by continuous blood flow generated by a traditional ventricular assist device are eliminated, meanwhile, the blood perfusion volume of a coronary artery and a remote organ of a patient is improved, the load of the ventricle is relieved, the device is beneficial to stabilization of physical signs of the patient in operation and postoperative rehabilitation, and the cardiac recovery of the patient is promoted.

According to some embodiments of this application, first sacculus seal cover is located the outer wall of sheath pipe, first sacculus passes through the inflation and deflation pipeline and is connected with external pump, the controller is steerable pump's the frequency of inflating and deflating, so that the pump is right first sacculus is aerifyd intermittently and is deflated.

According to some embodiments of the application, still include to have elastic second sacculus, the second sacculus cover is established in part the pump body and the sheath pipe is close to on the position of the pump body, the cavity of second sacculus form with the blood circulation chamber of blood export intercommunication, the second sacculus is seted up at least one and is used for the intercommunication blood circulation chamber with the windowing of blood vessel.

According to some embodiments of the application, the pump body is an elastic structure body with a compression state and an expansion state, the pump body can be elastically accommodated in the protective sleeve and is abutted against the inner wall of the protective sleeve so as to maintain the compression state, and when the pump body is separated from the protective sleeve, the pump body expands outwards along the radial direction of the pump body so as to maintain the expansion state.

According to some embodiments of the application, the pump body includes the casing and locates rotatory impeller in the casing, the blood flow passageway, blood inlet and blood export all locate the casing, rotatory impeller is the elastic construction body that has expansion state and state of accomodating, when the pump body keeps the compression state, rotatory impeller elasticity is accomodate in the casing, when the pump body switches into the expansion state, rotatory impeller outwards expands along with the casing is synchronous to keep the expansion state.

According to some embodiments of the present application, the protective sheath is further configured to sheath the sheath, the first balloon, and the second balloon.

According to some embodiments of the application, the protective sheath is tubular with two open ends.

According to some embodiments of the application, the pump body is provided with a driving member arranged in or out of the body, an output end of the driving member is directly or indirectly connected with the pump body so as to drive the pump body to operate, and the controller is electrically connected with the driving member so as to control the driving speed of the driving member.

In a second aspect, the present application provides a control system comprising:

the blood circulation assistance device described above;

the signal electrode can be coupled to a part of the pump body extending into the ventricle to acquire an electrocardiogram signal of the ventricle;

the controller includes a first processor electrically connected with the signal electrode to receive the electrocardiogram signal and control an inflation frequency and a deflation frequency of the first balloon based on the electrocardiogram signal, and a second processor electrically connected with the pump body to control an operating rate of the pump body.

According to the control system of the embodiment of the second aspect of the application, at least the following advantages are achieved:

the control system of the present application includes the blood circulation support device described above, and therefore has the same technical effects as the blood circulation support device. In addition, the control system of this application, through coupling signal electrode on the position that the pump body stretches into the ventricle for can acquire the electrocardiogram signal of ventricle after the pump body intervenes patient's ventricle, first treater can be according to this electrocardiogram signal adjust the inflation frequency and the gassing frequency of first sacculus, so that first sacculus periodically blocks off and switches on the descending aorta to produce the pulsatility circulation blood flow with patient's heart or the synchronous of ventricle beat frequency, provide more effective and reliable blood circulation support for patient's heart, further promoted the recovery of patient's heart and other tissue organ functions.

According to some embodiments of the present application, a first pressure sensor is disposed within the first balloon, the first pressure sensor being configured to monitor a pressure within the first balloon, and the first processor is electrically connected to the first pressure sensor and configured to control an inflation amount of the first balloon based on a pressure signal from the first pressure sensor.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments of the present application will be briefly described below, and it is obvious that the drawings described below are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

FIG. 1 is a first schematic structural view of a blood circulation assistance device according to some embodiments of the present disclosure;

FIG. 2 is a schematic view of a portion of a blood circulation assistance device according to some embodiments of the present application;

FIG. 3 is a schematic diagram of a second embodiment of the blood circulation assistance device of the present application;

FIG. 4 is a schematic structural diagram of a second blood circulation assistance device according to some embodiments of the present application;

FIG. 5 is a first schematic view of the blood circulation assistance device of some embodiments of the present application in cooperation with a heart;

FIG. 6 is a second schematic illustration of the cooperation of the blood circulation assistance device of some embodiments of the present application with a heart;

FIG. 7 is a schematic view of a sheath and first balloon engagement configuration according to some embodiments of the present application;

FIG. 8 is a first block diagram illustrating the structure of a control system according to some embodiments of the present application;

FIG. 9 is a third schematic structural view of a blood circulation assistance device according to some embodiments of the present application;

FIG. 10 is a third schematic view of a blood circulation assistance device according to some embodiments of the present application in cooperation with a heart;

FIG. 11 is a fourth schematic view of a blood circulation assistance device according to some embodiments of the present application in cooperation with a heart;

FIG. 12 is a fifth schematic view of a blood circulation assistance device according to some embodiments of the present application in cooperation with a heart;

FIG. 13 is a fourth schematic structural view of a blood circulation assistance device according to some embodiments of the present application;

FIG. 14 is a fifth schematic structural view of a blood circulation assistance device according to some embodiments of the present application;

FIG. 15 is a sixth schematic illustration of the cooperation of a blood circulation assistance device according to some embodiments of the present application with a heart;

fig. 16 is a schematic structural diagram of a control system according to some embodiments of the present application.

In the drawings: a pump body 100; a blood inlet 110; a blood outlet 120; a housing 130; a signal electrode 200; a first balloon 300; a controller 400; a first processor 410; a second processor 420; a sheath 500; an air charging and discharging pipeline 510; an inflator 600; a second balloon 700; a blood flow lumen 710; a window 720; a protective sheath 800; the left ventricle 10; an aortic valve 20; the aorta 30; the descending aorta 40.

Detailed Description

Features and exemplary embodiments of various aspects of the present application will be described in detail below. In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present application. It will be apparent, however, to one skilled in the art that the embodiments of the present application may be practiced without some of these specific details. The following description of the embodiments is merely intended to provide a better understanding of the present application by illustrating examples thereof.

In the description of the present application, it should be understood that the orientation or positional relationship referred to in the description of the orientation, such as the upper, lower, front, rear, left, right, etc., is based on the orientation or positional relationship shown in the drawings, and is only for convenience of describing the embodiments of the present application and simplifying the description, but does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the embodiments of the present application.

In the description of the embodiments of the present application, the meaning of a plurality of means is one or more, the meaning of a plurality of means is two or more, and more than, less than, more than, etc. are understood as excluding the present number, and more than, less than, etc. are understood as including the present number. If the first and second are described for the purpose of distinguishing technical features, they are not to be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated or implicitly indicating the precedence of the technical features indicated.

In the description of the embodiments of the present application, unless otherwise explicitly limited, terms such as setting, installing, connecting and the like should be understood in a broad sense, and those skilled in the art can reasonably determine the specific meanings of the terms in the present application in combination with the specific contents of the technical solutions.

It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The embodiments will be described in detail below with reference to the accompanying drawings.

In addition, it should be noted that, in the description of the embodiments of the present application, "in vivo" means in a tissue organ of a patient and "in vitro" means outside the tissue organ of the patient, unless otherwise specifically defined.

It should be noted that in a normal human heart, during a beating cycle, when the heart contracts, the aortic valve located between the left ventricle and the aorta opens, and blood in the left ventricle flows into the aorta under systolic pressure, so that the aorta is transfused into the tissue and organs of the human body; at the same time, the pulmonary valve between the right ventricle and the pulmonary artery is opened, and the blood in the right ventricle flows into the pulmonary artery, so that the pulmonary artery transfuses blood into the pulmonary vein and branch organs of the human body. When the heart relaxes, the aortic valve closes, and blood in the aorta is prevented from flowing back to the left ventricle; at the same time, the pulmonary valve closes, preventing blood in the pulmonary artery from flowing back into the right ventricle. The aorta of the human body is sequentially divided into ascending aorta, aortic arch and descending aorta along the blood flowing direction, and the ascending aorta, the aortic arch and the descending aorta are sequentially communicated.

The main cause of cardiovascular diseases is that blood cannot flow to cardiac muscle or brain in time, resulting in hypoxia and necrosis of organ tissues. The blood circulation auxiliary device of this application can provide stable pulsive blood circulation support for patient's heart, improves patient's cardiovascular disease, promotes the recovery of patient's heart.

Referring to fig. 1, 2, 3 and 4, the present application discloses a blood circulation assistance device, comprising: sheath 500, first balloon 300, pump body 100, and controller 400.

The sheath 500 is used for being installed in a blood vessel, the sheath 500 has a proximal end and a distal end, and it should be noted that the "distal end" of the sheath 500 refers to a direction away from a doctor, and the "proximal end" of the sheath 500 refers to a direction close to the doctor. The first balloon 300 is disposed within the sheath 500 and within the vessel. A pump body 100 is provided at the distal end of the sheath 500, the pump body 100 having a blood flow channel and a blood inlet 110 and a blood outlet 120 in communication with the blood flow channel, the pump body 100 for pumping blood in the ventricle into the blood vessel, a controller 400 provided at the proximal end of the sheath 500, the controller 400 being configured to control operation of the pump body 100 and to intermittently actuate inflation and deflation of the first balloon 300 such that the first balloon 300 at least partially occludes the blood vessel to generate pulsatile blood flow in cooperation with the pump body 100.

In the present application, the sheath 500 is a flexible and bendable structure, and when the pump body 100, the sheath 500, and the first balloon 300 provided in the sheath 500 are introduced into a corresponding blood vessel or blood transfusion organ of a patient through a percutaneous operation, the sheath can be well adapted to the bent or spiral shape of the corresponding blood line without causing structural damage to the corresponding blood vessel or blood transfusion organ.

In the present application, the pump body 100 is preferably a miniature impeller pump, in which the blood in the heart chamber is delivered into the blood vessel by the continuous rotation of a rotating impeller. Of course, the pump body 100 may be another axial-flow centrifugal pump, which can have a function of transporting blood flow, and the specific structure is not limited. The start and stop of the pump body 100 and the operating speed can be controlled by the controller 400.

In the present application, the shape of the first balloon 300 is not limited, and it may be a cylinder, a sphere, or an ellipsoid. Preferably, the first balloon 300 is an ellipsoidal balloon that is inflatable, expandable, and deflatable to contract. The controller 400 may drive the inflation and deflation of the first balloon 300 through an electronic gas valve provided to the first balloon 300 or a pneumatic line provided on the sheath 500.

The blood circulation auxiliary device of this application is when using, sheath 500 and locate sheath 500 first sacculus 300, pump body 100 can be synchronous intervene the patient internal through percutaneous surgery for sheath 500 and locate sheath 500 first sacculus 300 intervene the patient's blood vessel, pump body 100 intervenes in the human body for the blood supply of above-mentioned blood vessel is ventricular, and make the blood entry 110 and the ventricle intercommunication of pump body 100, blood export 120 and blood vessel intercommunication, and then make pump body 100 realize sending the blood pump in the ventricle to the function in above-mentioned blood vessel.

When the blood circulation assisting device of the present application operates, the controller 400 controls the pump body 100 to operate, and the pump body 100 causes the blood in the heart chamber to flow into the blood vessel along the blood inlet 110, the blood passage and the blood outlet 120 of the pump body 100 in sequence, so as to pump the blood in the heart chamber into the blood vessel.

In the process that blood flows into a blood vessel from a ventricle under the power action of the pump body 100, the controller 400 intermittently drives the first balloon 300 to inflate and deflate, so that the inflation and deflation of the first balloon 300 are periodically performed, and further the first balloon 300 periodically blocks and conducts the blood vessel, so that the blood is periodically blocked and conducted in the flowing process of the blood vessel, and therefore pulsatile blood flow matched with the periodic diastolic and systolic characteristics of the heart is generated, adverse effects caused by continuous blood flow generated by a traditional ventricular assist device are eliminated, meanwhile, the blood perfusion amount of the coronary artery and the far-end organ of a patient is improved, the load of the ventricle is relieved, the device is beneficial to the physical sign stabilization and postoperative rehabilitation of the patient in operation, and the cardiac recovery of the patient is promoted.

Referring to fig. 5 and fig. 6, the blood circulation assistance device of the present application takes the left ventricle 10 and the aorta 30 communicating with the left ventricle 10 of the patient as an application scenario (i.e., in the present embodiment, the ventricle is specifically the left ventricle 10, and the blood vessel is specifically the aorta 30) to illustrate the specific application, operation principle and effect of the blood circulation assistance device.

When the blood circulation assisting device of the present application is applied specifically, the sheath 500, the first balloon 300 disposed on the sheath 500, and the pump body 100 are inserted into the body of the patient through percutaneous surgery, and the pump body 100 at least partially crosses the aortic valve 20 of the patient to extend into the left ventricle 10 of the patient, so that the blood inlet 110 of the pump body 100 is communicated with the left ventricle 10, the blood outlet 120 is directly or indirectly communicated with the aorta 30, the sheath 500 is disposed in the aorta 30 and extends toward the aorta 30, and the first balloon 300 disposed on the sheath 500 is located at the descending aorta 40.

Referring to fig. 5 and 6 again, when the whole blood circulation assistance device is operated, the controller 400 controls the pump body 100 to operate, and the pump body 100 pumps the blood in the heart chamber into the blood vessel along the blood inlet 110, the blood passage and the blood outlet 120 of the pump body 100 in sequence, so as to pump the blood in the heart chamber into the blood vessel.

In the process that blood flows into the aorta 30 from the left ventricle 10 under the power of the pump body 100, the controller 400 actuates the first balloon 300 to inflate and expand, when the outer wall of the first balloon 300 contacts with the inner wall of the descending aorta 40, the first balloon 300 is fully inflated, at this time, the first balloon 300 completely seals the descending aorta 40, blood is blocked at the upstream position of the descending aorta 40 by the first balloon 300, so that the blood flow of the ascending aorta and the aortic arch is increased, the blood flow of the ascending aorta delivered to the branch arteries of the ascending aorta of the left and right coronary arteries is correspondingly increased, the blood flow of the aortic arch delivered to the brachiocephalic trunk, the left common carotid artery and the branch arteries of the aortic arch of the left subclavian artery is correspondingly increased, and the blood flow of the head of a patient is correspondingly increased, thereby being beneficial to the relief and treatment of ischemic nervous system diseases.

It should be noted that the first balloon 300 may also be specifically disposed at a position downstream of a section of the descending aorta of the abdominal aorta of the patient located in the abdominal cavity, and similarly, after the first balloon 300 is fully inflated, blood is blocked upstream of the abdominal aorta by the first balloon 300, so that the upstream blood volume of the abdominal aorta is increased, and the blood flow volume of the branch artery of the abdominal aorta delivered to the hepatic artery and the abdominal aorta of the renal arteries is correspondingly increased, which is beneficial to the relief and treatment of ischemic liver and renal system diseases.

After the first balloon 300 seals the descending aorta 40 for a short time, the controller 400 drives the first balloon 300 to deflate and contract again, so that the outer wall of the first balloon 300 is gradually far away from the inner wall of the descending aorta 40, the blood in the descending aorta 40 is conducted, and the blood continues to flow along the descending aorta 40. This completes a cycle of inflation and deflation of the first balloon 300, resulting in a cycle of pulsatile blood flow.

Obviously, during the process that the blood flows into the aorta 30 from the left ventricle 10 under the power of the pump body 100, the controller 400 intermittently drives the first balloon 300 to inflate and deflate, so that the inflation and deflation of the first balloon 300 are performed periodically, and further the first balloon 300 periodically blocks and conducts the descending aorta 40, so that the blood is periodically blocked and conducted during the flowing process of the descending aorta 40, and therefore pulsatile blood flow matched with the periodic diastolic and systolic characteristics of the heart of the patient is generated, the adverse effect caused by the continuous blood flow generated by the traditional ventricular assist device is eliminated, meanwhile, the blood perfusion amount of the coronary artery and the distal organs of the patient is improved, the burden of the left ventricle 10 is relieved, and the device is beneficial to the stabilization of the physical signs of the patient during operation and the postoperative rehabilitation and the promotion of the heart recovery of the patient.

In addition, it should be noted that in the present embodiment, the controller 400 may be disposed outside the patient or coupled to the pump body 100 or the sheath 500 inside the patient. As an example, the controller 400 is programmed to receive a signal indicative of a change or fluctuation in hemodynamic status between the left ventricle 10 and the aorta 30 of the patient, and to adjust the operating rate of the pump body 100 and the inflation and deflation amounts of the first balloon 300 in real time in accordance with the signal to meet the demand for the amount of blood delivered by the aorta 30 to other tissues and organs, and to effect full or partial occlusion of the descending aorta 40 by the first balloon 300, thereby generating pulsatile blood flow in accordance with the pulsatile characteristics of the patient's heart.

Preferably, a pressure sensor, a rate sensor and a signal electrode are coupled to corresponding positions of the pump body 100, and are synchronously implanted after the pump body 100 is inserted into a corresponding portion of a patient, so that the pressure sensor can monitor and feed back a blood filling pressure and a blood pressure signal of the left ventricle 10 or the aorta 30 of the patient in real time, the rate sensor can monitor and feed back a blood flow rate signal between the left ventricle 10 and the aorta 30 in real time, and the signal electrode can monitor and feed back an electrocardiogram signal of the left ventricle 10 or the aorta 30 in real time, the controller 400 is electrically connected to the pressure sensor, the rate sensor and the signal electrode, respectively, the controller 400 is programmed to adjust the inflation and deflation amounts of the first balloon 300 and the operation rate of the pump body 100 in real time based on the blood filling pressure signal and/or the blood flow rate, meanwhile, the controller 400 is programmed to adjust the inflation frequency, the deflation frequency, and the interval period of inflation and deflation of the first balloon 300 in real time based on the electrocardiogram signal described above and according to the heart beat period or beat frequency fed back from the electrocardiogram signal, thereby intermittently driving the inflation and deflation of the first balloon 300, thereby generating pulsatile blood flow synchronized with the heart beat of the patient. Through the arrangement, the blood circulation auxiliary device provides efficient and reliable pulsating blood circulation support for the heart of the patient under the precise control of the controller 400.

Referring to fig. 1, 5, 6, 7 and 8, in some embodiments of the present application, the first balloon 300 is sealed and disposed on an outer wall of the sheath 500, the first balloon 300 is connected to an external inflator 600 through an inflation/deflation pipeline 510, and the controller 400 can control an inflation/deflation frequency of the inflator 600, so that the inflator 600 intermittently inflates and deflates the first balloon 300.

Specifically, referring to fig. 2, 3, 4, 5 and 6, in this embodiment, the pump body 100 is coupled to a signal electrode 200 electrically connected to the controller 400 at a position extending into the left ventricle 10 or located in the aorta 30, the signal electrode 200 can monitor and feed back an electrocardiogram signal of the left ventricle 10 or the aorta 30 in real time, and the controller 400 is programmed to control and adjust the inflation frequency, the deflation frequency and the interval period therebetween of the inflator 600 in real time based on the electrocardiogram signal and according to the heart beat period and beat frequency fed back by the electrocardiogram signal, so that the inflator 600 intermittently drives the first balloon 300 to inflate and deflate, thereby generating pulsatile blood flow synchronized with the heart beat of the patient.

In addition, in this embodiment, the first balloon 300 is in an ellipsoid shape, two ends of the first balloon 300 are hermetically connected to the outer wall of the sheath 500, so as to prevent gas leakage, the left and right sides of the first balloon 300 are symmetric with respect to the inner portion of the first balloon 300 cavity of the sheath 500, so that the first balloon 300 uniformly plugs or conducts the descending aorta 40, and smooth and stable blood flow is ensured, meanwhile, the sheath 500 further supports and bears the first balloon 300, so that the first balloon 300 is stably inflated, expanded and deflated, and the first balloon 300 is also prevented from moving or dislocating during inflation and deflation, thereby affecting the plugging or conducting effect on the descending aorta 40.

In addition, in this embodiment, in order to improve the accuracy of inflation and deflation of the first balloon 300, the sheath 500 may be provided with an electronic valve connected to the inflation and deflation pipeline 510, a wire channel for installing a wire may be opened in the sheath 500, and the electronic valve is electrically connected to the controller 400 through the wire passing through the wire channel, so that the controller 400 controls the opening and closing of the electronic valve, and the controller 400, the electronic valve and the inflator 600 cooperate to realize the accurate control of inflation and deflation of the first balloon 300. Meanwhile, in order to accurately control the inflation amount and deflation amount of the first balloon 300, a pressure sensor electrically connected to the controller 400 may be further disposed in the first balloon 300, the pressure sensor is configured to monitor the pressure in the first balloon 300 in real time, and the controller 400 may determine whether the inflation amount or deflation amount of the first balloon 300 meets the requirement based on the pressure signal, so as to control the occlusion degree of the descending aorta 40 by the first balloon 300.

Referring to fig. 9, in some embodiments of the present application, the blood circulation assistance device of the present application further includes a second balloon 700 having elasticity, the second balloon 700 is sleeved on a portion of the pump body 100 and a portion of the sheath 500 close to the pump body 100, a cavity of the second balloon 700 forms a blood circulation chamber 710 communicating with the blood outlet 120, and the second balloon 700 is opened with at least one opening 720 for communicating the blood circulation chamber 710 with a blood vessel.

It should be noted that the partial section of the pump body 100 and the partial section of the sheath 500 are inserted into the cavity of the second balloon 700 and are respectively connected to two ends of the second balloon 700 in a sealing manner, so as to provide support for the expansion and contraction of the second balloon 700 and prevent the second balloon 700 from moving along the pump body 100 or the sheath 500. The pump body 100, the sheath 500, the first balloon 300 and the second balloon 700 may be understood as one piece, i.e. the pump body 100, the sheath 500, the first balloon 300 and the second balloon 700 may be implanted in the respective blood vessel or blood transfusion organ in the patient's body simultaneously by percutaneous surgery. The second balloon 700 can be understood as an ellipsoid or a hose with an initial memory state, and the second balloon 700 is provided with a plurality of open windows 720 for communicating the blood circulation cavity 710 with the blood vessel along the circumferential direction uniformly and at intervals away from the outer wall of the pump body 100, so that the blood in the blood circulation cavity 710 can uniformly flow into the blood vessel.

Similarly, in the present embodiment, the blood circulation assistance device of the present application takes the left ventricle 10 of the patient and the aorta 30 communicating with the left ventricle 10 as an application scenario (i.e. in the present embodiment, the ventricle is the left ventricle, and the blood vessel is the aorta) as an example to illustrate the specific application, operation principle and the effect of the blood circulation assistance device of the present embodiment:

referring to fig. 9, 10 and 11, fig. 10 is a schematic view of the aortic valve 20 of the patient in an open state, and fig. 11 is a schematic view of the aortic valve 20 of the patient in a closed state.

When the blood circulation assisting device of the embodiment is specifically applied, the sheath 500, the first balloon 300 disposed on the sheath 500, and the pump body 100 are synchronously introduced into the body of the patient through a percutaneous operation, and the pump body 100 is enabled to fully cross over the aortic valve 20 of the patient and then extend into the left ventricle 10 of the patient, so that the blood inlet 110 of the pump body 100 is communicated with the left ventricle 10, and meanwhile, the second balloon 700 is enabled to cross over the aortic valve 20 of the patient and to be disposed between the left ventricle 10 and the aorta 30 of the patient, and three valve leaflets of the aortic valve 20 of the patient are respectively in contact with the outer wall of the second balloon 700. Meanwhile, the sheath 500 extends to the descending aorta 40 along the track of the aorta 30, and the first balloon 300 disposed on the sheath 500 is located in the descending aorta 40, thereby completing the implantation of the pump body 100, the second balloon 700, the sheath 500 and the first balloon 300. It is understood that in the present embodiment, the blood outlet 120 of the pump body 100 is indirectly communicated with the aorta 30 through the blood circulation chamber 710 of the second balloon 700 and the fenestration 720.

When the whole blood circulation assisting device is operated, the pump body 100 is operated, blood in the left ventricle 10 flows into the blood circulation chamber 710 of the second balloon 700 along the blood inlet 110, the blood flow passage and the blood outlet 120 of the pump body 100 in sequence under the action of the pump body 100, and the blood in the blood circulation chamber 710 flows into the aorta 30 through the fenestration 720.

When the heart or the left ventricle 10 contracts, the aortic valve 20 is in an open state, the second balloon 700 is in a fully expanded state under the impact of blood, and the blood in the left ventricle 10 is normally delivered into the aorta 30 under the action of the pump body 100;

when the heart or the left ventricle 10 is switched from the systolic state to the diastolic state, the aortic valve 20 is closed, that is, the three leaflets of the aortic valve 20 approach and coapt with each other, so that the three leaflets of the aortic valve 20 respectively press inward the contact points with the second balloon 700, the second balloon 700 is compressed along the connecting line of the contact points, so that the width of the blood circulation chamber 710 at the aortic valve 20 is reduced, and after the aortic valve 20 is completely closed, the width of the blood circulation chamber 710 at the aortic valve 20 is compressed to the minimum, at this time, the caliber of the blood circulation chamber 710 allowing the blood to flow into is compressed to the narrowest, so that the blood flow in the blood circulation chamber 710 and the blood flow from the blood circulation chamber 710 to the aorta 30 are reduced to the minimum;

when the heart or the left ventricle 10 contracts again, the aortic valve 20 opens again, the contact part of the second balloon 700 and the aortic valve 20 is no longer pressed or restrained by the aortic valve 20, the second balloon 700 expands and expands to return to the fully expanded state, the flow aperture of the blood circulation chamber 710 returns to the maximum, and the blood in the left ventricle 10 is pumped into the aorta 30 again at the initial flow rate.

The above process produces a periodic pulsatile blood flow output.

Obviously, the blood circulation chamber 710 formed by the cavity of the second balloon 700 can be pressed and restored synchronously with the closing and opening of the aortic valve 20, so that the flow rate of the blood pumped into the aorta 30 is reduced and increased synchronously with the closing and opening of the aortic valve 20, and the change frequency of the flow rate of the blood pumped into the aorta 30 by the blood of the left ventricle 10 is matched with the heart pulsation relaxation and contraction frequency of the patient, thereby generating pulsating blood flow synchronously with the heart pulsation relaxation and contraction of the patient.

This application second sacculus 700's ingenious design, cooperate the normal open and close state of patient's aortic valve 20, the electrocardiogram signal that does not need to cooperate corresponding signal electrode or pressure sensor to obtain, just can make whole blood circulation auxiliary device produce with the pulsive blood flow of patient's heart pulse diastole with shrink synchronization, the complication risk that brings has effectively eliminated the continuity blood flow that traditional ventricular auxiliary device produced, and simultaneously, aortic valve 20 has also been prevented to a certain extent under the closed state blood circulation chamber 710 or the blood in the aorta 30 from flowing back to left ventricle 10, the blood perfusion volume of patient's coronary artery and distal organ has also been improved, the burden of left ventricle has been lightened, be favorable to patient's sign stability and postoperative rehabilitation in the art, promote patient's heart to resume.

It should be noted that, in the above process, the first balloon 300 at the position of the descending aorta 40 may be always in a state of conducting the descending aorta 40, that is, the first balloon 300 is always kept in a flat uninflated state, so as to ensure that the whole aorta 30 is in a conducting state, and ensure the normal flow of blood in the aorta 30.

It should be noted that, when the heart or the left ventricle 10 is switched from the systolic state to the diastolic state, the blood flowing chamber 710 may not be compressed to the narrowest state by the closing of the heart valve, and blood still flows out to the aorta 30, at this time, the pressure in the descending aorta 40 may be increased by the inflation of the first balloon 300, so as to increase the pressure upstream of the aorta 30, and the blood flowing chamber 710 is completely closed by the pressing of the blood on the outer wall of the second balloon 700.

Of course, in the above process of the present embodiment, when the blood circulation chamber 710 of the second balloon 700 is compressed in the closed state of the aortic valve 20, the controller 400 may drive the first balloon 300 to inflate so that the first balloon 300 partially or completely seals off the descending aorta 40, and at this time, the blood pressure upstream of the descending aorta 40 is increased, which helps the blood in the aorta 30 to flow into the vein against the resistance of the arterioles and the branch vessels of the capillary aorta 30, and simultaneously discharges the metabolic products generated by the organs along the way;

when the second balloon 700 is returned to the fully expanded state in the open state of the aortic valve 20, the controller 400 further drives the first balloon 300 to deflate, so that the first balloon 300 conducts the descending aorta 40, again ensuring normal flow of blood in the aorta 30.

It will be appreciated that, referring again to fig. 12, in the above procedure, when the heart of the patient has a short pause, the descending aorta 40 is intermittently occluded and connected by the first balloon 300 by intermittently inflating and deflating the first balloon 300 by the controller 400. Moreover, the controller 400 controls the inflation frequency and the deflation frequency of the first balloon 300 to be programmable to be synchronous with the pre-operation heartbeat frequency of the patient, such as 60-100 times/min, so that the descending aorta 40 is blocked and conducted by the first balloon 300 within a short time, the diastole and the contraction of the heartbeat ventricles are ingeniously simulated until the heart of the patient beats again, and the function of supplying pulsating blood flow to the tissues and organs of the heart in time is achieved in the above way, so that the whole blood circulation device transiently proxies the heart, and meanwhile, corresponding treatment measures are adopted by a doctor to strive for enough time for the heart to rebound, thereby being beneficial to the functional recovery of the heart and the tissues and organs of the patient.

Referring to fig. 13, 14 and 15, in some embodiments of the present application, the pump body 100 further includes a protective sleeve 800, the pump body 100 is an elastic structural body having a compressed state and an expanded state, the pump body 100 can be elastically received in the protective sleeve 800 and abut against an inner wall of the protective sleeve 800 to maintain the compressed state, and when the pump body 100 is separated from the protective sleeve 800, the pump body 100 expands radially outward along itself to maintain the expanded state.

It can be understood that, before the pump body 100 is inserted into the patient, the protective sleeve 800 is elastically received by the pump body 100, and the outer wall of the pump body 100 abuts against the inner wall of the protective sleeve 800, so that the pump body 100 is kept in a compressed state. The protective cover 800 is a flexible and bendable structure, and the pump body 100 elastically housed therein can be synchronously introduced into a blood transfusion organ of a patient through a percutaneous operation. Specifically, after the pump body 100 partially or completely extends into the left ventricle 10, the operating physician can draw out the protective sheath 800 to separate the protective sheath 800 from the pump body 100, at this time, the pump body 100 is no longer constrained by the protective sheath 800 and expands radially outward under the elastic action of itself, and the expansion is completed, accordingly, the inner diameters of the blood inlet 110, the blood flow channel and the blood outlet 120 arranged in the pump body 100 are expanded and increased, and the delivery flow rate of the pump body 100 for pumping the blood in the left ventricle 10 to the aorta 30 is increased.

Obviously, through the design of the protection sleeve 800 and the pump body 100, which can be compressed and expanded, the area of the operation wound formed by the pump body 100 intervening in the corresponding blood vessel or blood transfusion organ of the patient can be effectively reduced, the blood pumping flow of the whole pump body 100 under the same area of the operation wound is increased, the tissue damage to the patient caused by the pump body 100 intervening in the body through the percutaneous operation is correspondingly reduced, and the adverse reaction of the postoperative bleeding is obviously improved.

Referring again to fig. 13, 14 and 15, in some embodiments of the present application, the pump body 100 includes a housing 130 and a rotary impeller disposed in the housing 130, the blood flow channel, the blood inlet 110 and the blood outlet 120 are all disposed in the housing 130, the rotary impeller is an elastic structure having an expanded state and a stored state, when the pump body 100 is in a compressed state, the rotary impeller is elastically stored in the housing 130, and when the pump body 100 is switched to an expanded state, the rotary impeller is synchronously expanded outwards along with the housing 130 to maintain the expanded state. In addition, the protective sheath 800 is further used for sheathing the sheath 500, the first balloon 300 and the second balloon 700. It should be noted that, in order to ensure a good compressed and expanded state of the entire pump body 10, the housing 130 is preferably an elastic housing.

It is understood that, before the whole blood circulation assisting device is inserted into the patient, the pump body 100, the sheath 500, the first balloon 300 and the second balloon 700 are all in the protective sheath 800, wherein the rotating impeller of the pump body 100 is elastically received in the housing 130, and the second balloon 700 is received in the protective sheath 800.

When the whole blood circulation assisting device needs to be inserted into a patient, the protective sleeve 800 can synchronously bring the pump body 100, the second balloon 700, the sheath 500 and the first balloon 300 therein into a corresponding blood vessel or blood transfusion organ along a predetermined insertion track through a percutaneous operation, and then an operator can extract the protective sleeve 800 out of the patient, so that the housing 130 and the rotary impeller arranged in the housing 130 are radially expanded outwards under the elastic action of the housing 130 and the rotary impeller, thereby increasing the inner diameter of the housing 130 and the outer diameter of the rotary impeller, and correspondingly, the inner diameters of the blood inlet 110, the blood flow channel and the blood outlet 120 arranged in the housing 130 are expanded and increased, so that the effect of pumping the blood in the left ventricle 10 into the aorta 30 by the pump body 100 is further improved on the premise of generating a small operation wound area for the patient. Meanwhile, on the basis of ensuring that the whole pump body 100 can generate enough pumping blood flow, the pump body 100 and the whole blood circulation auxiliary device are further miniaturized, and tissue damage caused by the intervention of the blood circulation auxiliary device in the body of a patient is further reduced.

Additionally, in some embodiments of the present application, protective sheath 800 is tubular with two open ends to facilitate withdrawal of protective sheath 800 from the patient.

In some embodiments of the present application, the pump further comprises a driving member disposed inside or outside the body, an output end of the driving member is directly or indirectly connected with the pump body 100 to drive the pump body 100 to operate, and the controller 400 is electrically connected with the driving member to control a driving rate of the driving member.

In particular, the driving member may be an electric motor or a motor. When the driving member is disposed in the patient, the driving member may be directly disposed in the pump body 100 and the output end of the driving member is directly connected to the rotating impeller of the pump body 100; when the driving member is disposed outside the body, the output end of the driving member is indirectly connected to the rotating impeller of the pump body 100 through a transmission twisted wire, and the transmission twisted wire can be disposed in the sheath tube 500. Likewise, the controller 400 is programmed to receive a signal indicative of a change or fluctuation in the hemodynamic status between the left ventricle 10 and the aorta 30 of the patient, and to drive the rotational speed of the rotating impeller of the pump body 100 via the drive member in real time in response to the signal, thereby achieving the effect of adjusting the pump blood flow of the pump body 100 in real time. Of course, in order to further provide the blood pumping flow rate of the pump body 100, the rotating impeller in the pump body 100 may have a plurality of rotating impellers distributed along the circumferential direction, and the rotating impeller is designed as a spiral blade, so as to increase the blood pumping effect.

In addition, referring to fig. 8 and 16, the present application also provides a control system comprising the blood circulation assistance device described above and a signal electrode 200. Wherein the signal electrode 200 can be coupled to a portion of the pump body 100 extending into the ventricle to obtain an electrocardiogram signal of the ventricle, the controller 400 includes a first processor 410 and a second processor 420, the first processor 410 is electrically connected with the signal electrode 200 to receive the electrocardiogram signal and control the inflation frequency and the deflation frequency of the first balloon 300 based on the electrocardiogram signal, and the second processor 420 is electrically connected with the pump body 100 to control the operation rate of the pump body 100.

Similarly, the control system of the present application takes the left ventricle 10 of the patient and the aorta 30 communicating with the left ventricle 10 as an example of an application scenario, that is, in the present embodiment, the ventricle is specifically the left ventricle 10, and the blood vessel is specifically the aorta 30, which illustrate the specific application, the operation principle, and the effect of the control system.

In this embodiment, the first processor 410 is programmed to adjust the inflation frequency, deflation frequency, and interval period of inflation and deflation of the first balloon 300 in real time based on the heart beat cycle or beat frequency fed back by the electrocardiogram signal acquired by the signal electrode 200 to intermittently drive the inflation and deflation of the first balloon 300 to generate pulsatile blood flow synchronized with the heart beat of the patient. It should be noted that the first processor 410 can be in signal connection with the signal electrode 200 via an electrocardiogram device outside the body.

Similarly, the second processor 420 can control the operation speed of the pump body 100 according to the pressure signal monitored by the pressure sensor implanted in the aorta 30 of the patient, and then adjust the pumping blood flow rate of the pump body 100 in real time according to the blood flow rate signal converted from the pressure signal. Through the arrangement, the blood circulation assisting device provides more effective and reliable blood circulation support for the heart of the patient under the precise control of the first processor 410 and the second processor 420, and further promotes the function recovery of the heart and other tissues and organs of the patient.

In addition, in some embodiments of the present application, a first pressure sensor is disposed in the first balloon 300, the first pressure sensor is configured to monitor the pressure in the first balloon 300, and the first processor 410 is electrically connected to the first pressure sensor and controls the inflation amount of the first balloon 300 based on a pressure signal of the first pressure sensor.

It should be understood that, in the present embodiment, the first pressure sensor can monitor the pressure in the first balloon 300 in real time, and the controller 400 determines whether the inflation amount or deflation amount of the first balloon 300 is satisfactory or not based on the pressure signal, so as to control the occlusion degree of the descending aorta 40 by the first balloon 300, so that the blood flow in the aorta 30 meets the blood supply requirement for the branch arteries and the tissue organs.

Obviously, the blood circulation auxiliary device and the control system can generate pulsating blood flow matched with the heart pulsation (diastole and contraction) characteristics of the patient, effectively eliminate the complication risk caused by continuous blood flow generated by the traditional ventricular auxiliary device, reduce the ventricular burden, facilitate the stabilization of physical signs of the patient in operation and the postoperative rehabilitation, and promote the heart recovery of the patient.

It should be noted that the blood circulation assisting device and the control system of the present application are not limited to be applied only to the section of the blood flow path of the left ventricle and the aorta communicating with the left ventricle, but also to be applied to the blood flow path of the right ventricle and the pulmonary artery communicating with the right ventricle, and the principle of the effect produced is consistent with the above description, and will not be repeated herein.

The above description is only a specific implementation of the embodiments of the present application, but the scope of the embodiments of the present application is not limited thereto, and any person skilled in the art can easily conceive various equivalent modifications or substitutions within the technical scope of the embodiments disclosed in the present application, and these modifications or substitutions should be covered by the scope of the embodiments of the present application. Therefore, the protection scope of the embodiments of the present application shall be subject to the protection scope of the claims.

Claims

1. A blood circulation assistance device comprising:

a first balloon disposed within the sheath and within the vessel;

2. The blood circulation assisting device as claimed in claim 1, wherein the first balloon sealing sleeve is arranged on the outer wall of the sheath tube, the first balloon is connected with an external inflator pump through an inflation and deflation pipeline, and the controller can control inflation and deflation frequency of the inflator pump, so that the inflator pump intermittently inflates and deflates the first balloon.

3. The blood circulation assisting device according to claim 1, further comprising a second balloon having elasticity, the second balloon being fitted over a portion of the pump body and a portion of the sheath tube near the pump body, a cavity of the second balloon forming a blood circulation chamber communicating with the blood outlet, the second balloon being provided with at least one opening for communicating the blood circulation chamber with the blood vessel.

4. A blood circulation assistance device according to claim 3 further comprising a protective sheath, the pump body being an elastic structure having a compressed state and an expanded state, the pump body being elastically receivable within the sheath and abutting against an inner wall of the sheath to maintain the compressed state, the pump body expanding radially outwardly of itself to maintain the expanded state when the pump body is detached from the sheath.

5. A blood circulation assistance device according to claim 4 wherein the pump body comprises a housing and a rotatable impeller disposed within the housing, the blood flow passageway, the blood inlet and the blood outlet being disposed in the housing, the rotatable impeller being a resilient structure having an expanded state and a stored state, the rotatable impeller being resiliently stored within the housing when the pump body is held in the compressed state, the rotatable impeller being synchronously expanded outwardly with the housing when the pump body is switched to the expanded state to hold the expanded state.

6. A blood circulation assistance device according to claim 4 wherein the protective sheath is also adapted to sheath the sheath, the first balloon and the second balloon.

7. A blood circulation assistance device according to claim 4 wherein the protective sleeve is tubular with two open ends.

8. A blood circulation assistance device according to any one of claims 1 to 7 further comprising an actuation member disposed internally or externally, the output of the actuation member being connected directly or indirectly to the pump body for actuating the pump body, the controller being electrically connected to the actuation member for controlling the rate of actuation of the actuation member.

9. A control system, comprising:

a blood circulation assistance device according to any one of claims 1 to 8;

10. The control system of claim 9, wherein a first pressure sensor is disposed within the first balloon, the first pressure sensor configured to monitor a pressure within the first balloon, the first processor being electrically connected to the first pressure sensor and configured to control an inflation amount of the first balloon based on a pressure signal from the first pressure sensor.