WO2020259357A1

WO2020259357A1 - Coronary venous perfusion system and control method therefor

Info

Publication number: WO2020259357A1
Application number: PCT/CN2020/096474
Authority: WO
Inventors: 李金山; 郑帅; 李丽; 张文超; 王旭东; 崔建培
Original assignee: 北京康瑞迪医疗科技有限公司
Priority date: 2019-06-28
Filing date: 2020-06-17
Publication date: 2020-12-30
Also published as: CN110353753A

Abstract

A coronary venous perfusion system and a control method therefor. The system comprises an internal blood flow control device and an external control module. The internal blood flow control device comprises a blocking and filling unit. The blocking and filling unit, in a filling state, blocks blood in a coronary venous vessel from flowing back to the right atrium from cardiac muscle cells, and restores the blood flow in a contraction state. The external control module comprises a signal receiving unit and a control unit. The signal receiving unit is used to receive a body monitoring signal. The control unit controls filling and contraction operations of the blocking and filling unit on the basis of the body monitoring signal being fed back. The control unit controls, on the basis of the body signal for determining whether the cardiac muscle is ischemic, the filling and contraction operations of the blocking and filling unit. The blocking and filling unit, in the filling state, blocks coronary venous blood flow, such that the blood in the vein flows backwards into the venous microcirculation of the cardiac muscle to fully perfuse an ischemic myocardial region, thereby ensuring myocardial blood supply and avoiding myocardial injury caused by no-reflow.

Description

Cardiac coronary vein perfusion system and its control method

Technical field

The present invention relates to the field of medical equipment, in particular to a cardiac coronary vein perfusion system and a control method thereof.

Background technique

The coronary circulation is to provide the heart itself with the nutrients and oxygen it needs, and to transport away metabolic waste. It is a circulation in which blood flows directly from the coronary arteries at the base of the aorta to the capillary network inside the myocardium and finally flows from the veins back to the right atrium and right ventricle, and then enters the lungs for exchange and flows into the left atrium and left ventricle. In the coronary circulation, coronary artery stenosis or obstruction can cause myocardial ischemia, hypoxia or necrosis.

Acute myocardial infarction is myocardial necrosis caused by acute and persistent ischemia and hypoxia of coronary arteries. Clinically, there are often severe and long-lasting retrosternal pain, rest and nitrate drugs can not be completely relieved, accompanied by increased serum myocardial enzyme activity and progressive ECG changes, can be complicated by arrhythmia, shock or heart failure, often life-threatening. Coronary heart disease myocardial infarction is a common heart disease. About 1.5 million people in the United States suffer from myocardial infarction each year. China has at least 500,000 new cases every year, and at least 2 million are currently suffering.

At present, acute myocardial infarction mainly uses percutaneous coronary intervention to open and occlude the coronary arteries. However, in recent years, clinical results have shown that although the blood flow of the coronary arteries has been restored, the myocardium innervated by the occluded blood vessels has not truly achieved the tissue level. Blood perfusion means "no reflow phenomenon".

Summary of the invention

(1) Technical problems solved

In view of the shortcomings of the prior art, the present invention provides a cardiac coronary venous perfusion system and a control method thereof, which helps to solve the problem of no reflow after the coronary blood flow is restored in patients with acute myocardial infarction.

(2) Technical solution

In order to achieve the above objectives, the present invention is achieved through the following technical solutions:

In one aspect, a cardiac coronary venous perfusion system includes:

An internal blood flow control device, the internal blood flow control device includes a blocking and filling unit that blocks the flow of blood in the coronary venous vessels from the cardiomyocytes to the right atrium in the filled state, and restores the blood flow in the contracted state Cardiomyocytes flow to the right atrium;

An external control module, the external control module includes:

A signal receiving unit for receiving human body signals;

A control unit, which controls the filling and contraction of the blocking filling unit based on the human body signal.

Preferably, the human body signal includes an ECG monitoring signal, intravenous heart pressure, intraarterial pressure, venous oxygen saturation or/and pulse rate.

Preferably, when the signal receiving unit determines myocardial ischemia based on the human body signal, the control unit controls the blocking and filling unit to fill.

Preferably, the filling blocking unit includes:

A first catheter, a filling mechanism is connected to the proximal end of the first catheter;

The first balloon has an accommodating space inside the first balloon, the first balloon communicates with the distal end of the first catheter, and the filling mechanism makes the first The balloon is in an inflated state.

Preferably, the system further includes:

A vacuuming unit that vacuums the blocking and filling unit.

Preferably, the blood flow control device in the body further includes:

The perfusion pipe has an extracorporeal perfusion inlet and an intracorporeal perfusion outlet, the perfusion pipe is located in the first catheter, the extracorporeal perfusion inlet extends to the outside of the proximal port of the first catheter, and the intracorporeal perfusion The outlet extends to the outside of the distal end of the first catheter.

On the other hand, the present invention also provides a method for controlling cardiac coronary venous microperfusion, characterized in that the control method includes:

S1, receiving the human body signal, and transmitting the human body signal to the control unit;

S2, the control unit controls the filling and contraction of the filling blocking unit in the blood flow control device in the body based on the human body signal;

Wherein, the blocking filling unit blocks the flow of blood in coronary venous vessels from the cardiomyocytes to the right atrium in the filled state, and restores the blood flow from the cardiomyocytes to the right atrium in the contracted state.

(3) Beneficial effects

The invention provides a cardiac coronary vein perfusion system and a control method thereof. Compared with the prior art, it has the following beneficial effects:

The cardiac coronary venous perfusion system provided by the embodiment of the present invention controls the blocking of the filling and contraction of the filling unit through a control unit based on human body signals, and the blocking filling unit blocks the flow of blood in the coronary vein from the myocardium to the right atrium in the filling state, In the contracted state, the blood flow from the myocardium to the right atrium is restored; when the blocking filling unit is in the filling state, the coronary venous blood flow is blocked. As the normal myocardial cells flow out, the blood pressure in the blocked area increases, and under pressure The blood in this vein will flow back into the venous microcirculation of the myocardium, and the ischemic myocardial area will be fully perfused to ensure the blood supply of the myocardium and avoid no reflow.

Description of the drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained from these drawings without creative work.

Figure 1 is a schematic diagram of a cardiac coronary vein perfusion system according to an embodiment of the present invention;

2 is a schematic diagram of the structure of an internal blood flow control device according to an embodiment of the present invention;

3 is a schematic diagram of the first state of the blood flow control device in the body of the embodiment of the present invention;

Fig. 4 is a schematic diagram of a second state of the internal blood flow control device of the embodiment of the present invention.

Detailed ways

In order to make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention are described clearly and completely. Obviously, the described embodiments are part of the embodiments of the present invention, not all of them. example. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.

The embodiments of the present application provide a cardiac coronary venous perfusion system and a control method thereof, which solve the technical problem of no reflow phenomenon after the blood flow of the occluded epicardial blood vessel of the patient with acute myocardial infarction is restored. Realize the venous microcirculation that re-wet the blood in the veins into the myocardium, so that the ischemic myocardial area can be fully perfused by the veins, ensure the blood supply of the myocardium, and avoid no reflow.

The technical solutions in the embodiments of the present application are to solve the above technical problems, and the general idea is as follows:

Based on real-time monitoring of human body signals, the filling and contraction of the blocking filling unit is automatically controlled. Blocking the filling unit In the filling state, the coronary venous blood flow is blocked. Under pressure, the blood in the vein will infiltrate the venous microcirculation of the myocardium. The ischemic myocardial area is fully perfused to ensure the blood supply of the myocardium. Avoid no-reflow phenomenon.

In order to better understand the above technical solutions, the above technical solutions will be described in detail below in conjunction with the accompanying drawings of the specification and specific implementations.

On the one hand, as shown in FIG. 1, an embodiment of the present invention provides a cardiac coronary venous perfusion system. The system includes an internal blood flow control device and an external control module. The internal blood flow control device includes a filling blocking unit. The blocking and filling unit blocks the flow of blood in the coronary venous vessels from the myocardial cells to the right atrium in the filled state, and restores the blood flow in the contracted state; the external control module includes a signal receiving unit and a control unit, and the signal receiving unit is used After receiving the human body signal, the control unit controls the filling and contraction of the blocking filling unit based on the human body signal.

In the above-mentioned embodiment, in the specific implementation process, based on the human body signal, the filling and contraction of the blocking filling unit is automatically controlled through the feedback of the human body signal. Blocking the filling unit In the filling state, the coronary venous blood flow is blocked. Because the normal myocardial cell blood flows out, the blood pressure in the blocked area increases. Under pressure, the blood in the vein will flow back into the vein of the myocardium. Microcirculation, the ischemic myocardial area is fully perfused to ensure the blood supply of the myocardium and avoid no reflow phenomenon. In addition, the present embodiment supplies blood to the ischemic myocardium through a vein without being restricted by arterial obstruction, and can reduce the incidence of heart failure caused by myocardial ischemia.

In one embodiment, the human body signal includes an electrocardiographic monitoring signal, intravenous heart pressure, intraarterial pressure, venous oxygen saturation or/and pulse rate. Through real-time monitoring of human body signals, the filling and contraction of the filling unit is automatically controlled to block the filling and contraction of the filling unit, and the myocardial cells are supplied with high-frequency reverse coronary venous blood, which can be filled multiple times in one heartbeat cycle. Each time it is pulsed to ensure the myocardium Blood supply.

In one embodiment, when the ECG monitoring signal feeds back myocardial ischemia, the control unit controls the filling blocking unit to fill. This embodiment provides an embodiment for judging the human body signal. The ECG monitoring signal of the human body is monitored by the ECG monitoring system. The ECG monitoring signal detected by the ECG monitoring system can feed back whether the myocardial ischemia is ischemic; when the feedback is the myocardial ischemia When the signal unit receives the signal, the control unit controls the blocking filling unit to fill. When the blocking filling unit is in the filling state, the coronary blood flow is blocked. Under pressure, the blood in the vein will flow back into the vein micro Circulation, the ischemic myocardial area is fully perfused to ensure the blood supply of the myocardium and avoid no reflow phenomenon. It should be noted that other human body signals can also be used for judgment and control, such as the above-mentioned cardiac intravenous pressure, arterial intravascular pressure, venous oxygen saturation or pulse rate. Of course, multiple human signals can also be used for coordinated judgment.

In an embodiment, as shown in 2 to 4, the filling blocking unit includes a first catheter 2 and a first balloon 1, wherein the proximal connection portion of the first catheter 2 has an filling mechanism 4, and the first ball The inside of the balloon 1 has an accommodating space, the first balloon 1 communicates with the distal end of the first catheter 2, and the filling mechanism 4 makes the first balloon 1 in an inflated state through the first catheter 2.

In the actual implementation process of the above-mentioned embodiment, Fig. 3 shows the first balloon 1 in a contracted state, and Fig. 4 shows the first balloon 1 in a filled state. When the myocardium is in an ischemic state, the first balloon 1 is placed in the coronary vein of the heart by surgery, and the filling mechanism 4 fills the first balloon 1 through the first catheter 2. The accommodation space inside the first balloon 1 Is filled so that the first balloon 1 is in a filled state. The first balloon 1 in the inflated state blocks the vein, thereby blocking the end of the coronary vein close to the right atrium, so that the blood flow of the vein cannot return to the right Atrium, under pressure, the blood in this vein will infiltrate the venous microcirculation of the myocardium, and the ischemic myocardial area will be fully perfused to ensure the blood supply of the myocardium and avoid myocardial necrosis caused by no-reflow phenomenon.

In one embodiment, as shown in FIGS. 3 to 4, the system further includes a vacuuming mechanism 5, which vacuums the blocking device. In specific embodiments, the system needs to be vacuumed before it works.

In one embodiment, as shown in FIG. 2, the blocking filling unit further includes a perfusion pipe 3 having an in vitro perfusion inlet and an in vivo perfusion outlet, and the drug release pipe 3 is located in the first catheter 2 Inside, the drug outlet extends to the outside of the first catheter 2, and the drug inlet extends to the outside of the first balloon 1, and the drug is administered through the drug release tube 3 for drug-assisted therapy. The perfusion tube 3 can accurately administer the ischemic myocardium and activate the damaged myocardium. The perfusion tube 3 can also increase the oxygen content in the venous blood.

As shown in Figures 2 to 4, the filling mechanism 4 includes a cavity 401 and a piston 402. The cavity 401 has an accommodating space inside. The piston 402 is located in the accommodating space of the cavity 401 and is located along the center of the cavity 401. The accommodating space slides in the length direction. Specifically, when the piston 402 reciprocates in the cavity 401, the piston 402 pushes the gas or liquid in the cavity 401 to the first catheter 2 so that the first balloon 1 is filled. It should be noted that in order to promote the sealing of the piston 402, a sealing ring 4021 is provided on the side of the piston 402, and the sealing ring 4021 slides along the inner wall of the cavity 401.

In a specific implementation process, a motor 403 may also be provided, and the plug 402 is driven by the motor 403 to generate a reciprocating motion in the cavity 401 to inflate and contract the first balloon 1.

In addition, the embodiment of the present invention also provides a connection structure. A three-way valve 201 is provided at the proximal end of the first catheter 2, and the vacuuming mechanism 5 and the filling mechanism 4 are respectively connected through the three-way valve 201. It should be noted that in specific implementation, other connection methods can also be selected according to needs.

In the specific implementation process, a pressure monitoring unit 601 may also be included. The pressure monitoring unit 601 is used to monitor the blood pressure of the heart vein. The pressure monitored by the pressure monitoring unit 601 is transmitted to the human body through the pressure monitoring unit pipeline 6. The monitoring unit pipeline 6 can be set in the first catheter 2 to monitor the pressure of the venous blood in real time, and prevent excessive pressure difference between the blocked vein and the artery during the blocking process and damage the myocardium.

In another aspect, an embodiment of the present invention also provides a method for controlling microperfusion of the coronary veins of the heart, the control method including:

Wherein, the filling blocking unit blocks the return of blood in coronary venous vessels from the myocardial cells to the right atrium in the filled state, and restores the return of blood in the contracted state.

In one embodiment, the human body signal includes an electrocardiogram monitoring signal, cardiac intravenous blood vessel pressure, arterial intravascular pressure, venous oxygen saturation or/and pulse rate, and the signal is monitored by the human body signal to ensure the accuracy of venous blood supply.

In an embodiment, when the ECG monitoring signal feeds back myocardial ischemia, the control unit controls the filling of the blocking filling unit.

Specifically, as shown in Figure 1, the ECG monitoring signal of the human body is monitored by the ECG monitoring system, and the signal receiving unit is fed back. When the feedback signal is myocardial ischemia, the signal receiving unit transmits the signal of myocardial ischemia To the control unit, the control unit outputs a signal to vacuum the blocking and filling unit, and then starts the filling mechanism, so that the blocking and filling unit is in a filling state, and the blocking filling unit in the filling state blocks the vein, thereby realizing the resistance Cut off one end of the coronary vein close to the right atrium, so that the blood flow of the vein cannot return to the right atrium. Under pressure, the blood in this vein will regress into the venous microcirculation of the myocardium, and the ischemic myocardial area will be fully perfused to ensure The myocardium supplies blood to avoid myocardial necrosis caused by no-reflow phenomenon.

In the above implementation process, the pressure monitoring unit 601 is used to monitor the blood pressure of the heart vein, and the pressure monitored by the pressure monitoring unit 601 is transmitted to the outside of the human body through the pressure monitoring unit pipeline 6. The pressure monitoring unit pipeline 6 can be set in the first In the catheter 2, the pressure of the venous blood is monitored in real time to prevent the excessive pressure difference between the blocked vein and the artery during the blocking process, which may damage the myocardium.

At the same time, the drug can be administered through the drug release tube 3 for drug-assisted therapy.

It should be noted that this embodiment provides a judgment embodiment based on the ECG monitoring signal. In specific implementation, other human body signals can also be used for judgment and control, such as the above-mentioned cardiac intravenous pressure and arterial intravascular pressure. , Venous oxygen saturation or pulse rate, of course, multiple human body signals can also be used for collaborative judgment.

In summary, compared with the prior art, it has the following beneficial effects:

The cardiac coronary venous perfusion system provided by the embodiment of the present invention controls the blocking of the filling and contraction of the filling unit based on the human body signal, and the blocking filling unit blocks the blood flow in the coronary vein from the myocardium to the right atrium in the filled state, and the contracted state When the blocking filling unit is in the filling state, the coronary venous blood flow is blocked. Because the normal myocardial cell blood flows out, the blood pressure in the blocked area increases, and the blood in the vein will reverse under the pressure. Infiltrate the venous microcirculation of the myocardium, and the ischemic myocardial area is fully perfused to ensure the blood supply of the myocardium and avoid no reflow.

It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply one of these entities or operations. There is any such actual relationship or order between. Moreover, the terms "include", "include" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device that includes a series of elements includes not only those elements, but also includes Other elements of, or also include elements inherent to this process, method, article or equipment. If there are no more restrictions, the element defined by the sentence "including a..." does not exclude the existence of other same elements in the process, method, article, or equipment including the element.

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 recorded technical solutions are modified, or some of the technical features are equivalently replaced; these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

A cardiac coronary vein perfusion system, characterized in that the system includes:

An internal blood flow control device, the internal blood flow control device includes a blocking and filling unit that blocks the flow of blood in the coronary venous vessels from the cardiomyocytes to the right atrium in the filled state, and restores the blood flow in the contracted state Cardiomyocytes flow to the right atrium;

An external control module, the external control module includes:

A signal receiving unit for receiving human body signals;

A control unit, which controls the filling and contraction of the blocking filling unit based on the human body signal.
The coronary perfusion system of the heart according to claim 1, wherein the human body signal comprises an ECG monitoring signal, intravenous blood vessel pressure in the heart, intra-arterial blood vessel pressure, venous oxygen saturation or/and pulse rate.
3. The cardiac coronary venous perfusion system according to claim 2, wherein the control unit controls the filling of the blocking filling unit when the signal receiving unit judges myocardial ischemia based on the human body signal.
The coronary perfusion system of the heart according to claim 1, wherein the blocking and filling unit comprises:

A first catheter, a filling mechanism is connected to the proximal end of the first catheter;

The first balloon has an accommodating space inside the first balloon, the first balloon communicates with the distal end of the first catheter, and the filling mechanism makes the first The balloon is in an inflated state.
The coronary perfusion system of the heart according to claim 1, wherein the system further comprises:

A vacuuming unit that vacuums the blocking and filling unit.
3. The coronary perfusion system of the heart according to claim 1, wherein the blood flow control device further comprises:

The perfusion pipe has an extracorporeal perfusion inlet and an intracorporeal perfusion outlet, the perfusion pipe is located in the first catheter, the extracorporeal perfusion inlet extends to the outside of the proximal port of the first catheter, and the intracorporeal perfusion The outlet extends to the outside of the distal end of the first catheter.
A method for controlling cardiac coronary vein microperfusion, characterized in that the control method includes:

S1, receiving the human body signal, and transmitting the human body signal to the control unit;

S2, the control unit controls the filling and contraction of the filling blocking unit in the blood flow control device in the body based on the human body signal;

Wherein, the blocking filling unit blocks the flow of blood in coronary venous vessels from the cardiomyocytes to the right atrium in the filled state, and restores the blood flow from the cardiomyocytes to the right atrium in the contracted state.
8. The method for controlling cardiac coronary venous microperfusion according to claim 7, wherein the human body signal comprises an ECG monitoring signal, intravenous heart pressure, intraarterial pressure, venous oxygen saturation or/and pulse rate.
8. The method for controlling cardiac coronary venous microperfusion according to claim 7, wherein when the signal receiving unit judges myocardial ischemia based on the human body signal, the control unit controls the filling of the blocking filling unit.