CN116158800B - Coronary sinus pulse saccule control method and control device - Google Patents

Abstract

The present invention discloses a coronary sinus pulse balloon control method and control device, the control method comprising: receiving a set pressure difference value and a real-time blood pressure value; calculating the real-time pressure difference value according to the real-time blood pressure value, the real-time pressure difference value being the difference between the average pressure of the real-time blood pressure value and a preset reference pressure; adjusting the filling size of the balloon based on the real-time pressure difference value and the set pressure difference value, by adjusting the filling size of the balloon with the set pressure difference value as a parameter, the degree of occlusion of the coronary sinus by the balloon can be intuitively obtained, thereby achieving flexible control of the degree of vascular occlusion.

Description

A coronary sinus pulse balloon control method and control device

Technical Field

The present invention relates to the technical field of medical devices, and in particular to a coronary sinus pulse balloon control method and a control device.

Background technique

Coronary heart disease generally refers to coronary atherosclerotic heart disease. Most patients with coronary heart disease have varying degrees of coronary microcirculatory disorders (coronary microcirculatory disorders refer to microcirculatory changes when the microcirculatory system is affected by one or more adverse factors and becomes abnormal, mainly manifested as poor blood flow in microvessels, blood stasis, flow pattern changes, etc.). Clinically, acute myocardial infarction (AMI) often presents with severe and persistent pain behind the sternum, which cannot be completely relieved by rest and nitrate drugs, accompanied by increased serum myocardial enzyme activity and progressive electrocardiogram changes, which may be complicated by arrhythmia, shock or heart failure, and can often be life-threatening.

The coronary sinus pulse balloon is a new device for treating coronary heart disease. It is based on a catheter balloon structure platform. It periodically blocks (or semi-blocks) the coronary sinus with a balloon to intermittently block the blood flow in the coronary vein, thereby increasing the blood pressure in the coronary sinus vein, in order to dredge the occluded coronary microvessels and reshape the necrotic myocardium. At present, treatment with the coronary sinus pulse balloon has achieved certain clinical results. The existing coronary sinus pulse balloons are in the form of full blockage or semi-blockage. The impact of different degrees of blockage on the treatment effect requires more clinical data for quantitative analysis. However, whether it is a full blockage or semi-blockage form of the coronary sinus pulse balloon, the blockage changes are achieved through the shape of the balloon, and the degree of vascular blockage cannot be flexibly controlled.

Summary of the invention

In view of this, an embodiment of the present invention provides a coronary sinus pulse balloon control method and control device to solve the technical problem that the degree of blood vessel occlusion cannot be flexibly controlled in the prior art.

The technical solution proposed by the present invention is as follows:

A first aspect of an embodiment of the present invention provides a coronary sinus pulse balloon control method, comprising: receiving a set pressure difference value and a real-time blood pressure value; calculating a real-time pressure difference value based on the real-time blood pressure value, wherein the real-time pressure difference value is the difference between the average pressure of the real-time blood pressure value and a preset reference pressure; and adjusting the filling size of the balloon based on the real-time pressure difference value and the set pressure difference value.

Optionally, before receiving the set pressure difference value, the method includes: calculating and outputting an adjustment range of the set pressure difference value.

Optionally, the calculation and output of the adjustment range of the set pressure difference value includes: calculating the maximum average pressure when the balloon is completely blocked; subtracting the preset reference pressure from the maximum average pressure to obtain an upper adjustment limit, the adjustment range is greater than or equal to zero and less than or equal to the upper adjustment limit, and the preset reference pressure is the average pressure when the balloon is in a contracted state; outputting the adjustment range to a display screen for display.

Optionally, the coronary sinus pulse balloon control method further includes calculating the volume of gas entering the balloon, calculating the balloon volume according to the gas volume and an ideal gas state equation, and outputting the calculated volume.

Optionally, the calculating and outputting the balloon volume according to the gas volume and the ideal gas state equation includes: obtaining a first air pressure value of the gas before entering the balloon and a second air pressure value of the gas in the balloon; obtaining a first temperature value of the gas before entering the balloon and a second temperature value of the gas in the balloon; substituting the gas volume, the first air pressure value, the second air pressure value, the first temperature value, and the second temperature value into the ideal gas state equation to calculate the intermediate gas volume; subtracting the catheter volume from the intermediate gas volume to obtain the balloon volume and output it, wherein the catheter volume is the volume of the pipe for inflating the balloon.

A second aspect of an embodiment of the present invention provides a coronary sinus pulse balloon control device, comprising: an air circuit module, used to inflate and deflate the balloon; a blood pressure collection module, used to collect blood pressure values in the coronary sinus and send the blood pressure values to a control module; the control module is used to execute the coronary sinus pulse balloon control method as described in the first aspect of the embodiment of the present invention and any one of the first aspects.

Optionally, the coronary sinus pulse balloon control device further includes: an intra-balloon air pressure acquisition module, which is used to acquire a second air pressure value of the gas in the balloon and send the second air pressure value to the control module.

Optionally, the gas circuit module includes a cylinder, a first valve group, a first temperature acquisition module and a first gas circuit pressure acquisition module respectively connected to the control module; the cylinder is used to drive the gas into the balloon; the first valve group is used to control the opening and closing of the gas inlet and outlet channels; the first temperature acquisition module is used to obtain the first temperature value of the gas before entering the balloon; the first gas circuit pressure acquisition module is used to obtain the first air pressure value of the gas before entering the balloon.

Optionally, the control module is further used to calculate the volume of gas entering the balloon according to the cross-sectional area of the cylinder and the piston movement distance.

Optionally, the gas circuit module includes a vacuum pump, a second valve group, a second temperature acquisition module, a second gas circuit pressure acquisition module and a gas flow meter, which are respectively connected to the control module; the vacuum pump is used to drive the gas to leave the balloon to shrink the balloon; the second valve group is used to control the opening and closing of the gas inlet and outlet channels; the second temperature acquisition module is used to obtain a first temperature value of the gas before entering the balloon; the second gas circuit pressure acquisition module is used to obtain a first air pressure value of the gas before entering the balloon; the gas flow meter is used to obtain the volume of gas entering the balloon.

It can be seen from the above technical solutions that the embodiments of the present invention have the following advantages:

A coronary sinus pulse balloon control method and control device provided by an embodiment of the present invention receives a set pressure difference value and a real-time blood pressure value; calculates a real-time pressure difference value according to the real-time blood pressure value, wherein the real-time pressure difference value is the difference between the average pressure of the real-time blood pressure value and a preset reference pressure; adjusts the filling size of the balloon based on the real-time pressure difference value and the set pressure difference value, and by adjusting the filling size of the balloon with the set pressure difference value as a parameter, the degree of occlusion of the coronary sinus by the balloon can be intuitively obtained, thereby achieving flexible control of the degree of blood vessel occlusion.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to more clearly express the technical solutions of the embodiments of the present invention, the drawings required for describing the embodiments are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

FIG1 is a flow chart of a coronary sinus pulse balloon control method according to an embodiment of the present invention;

FIG2 is a closed-loop control flow chart of an embodiment of the present invention;

FIG3 is another closed-loop control flow chart in an embodiment of the present invention;

FIG4 is a block diagram of a coronary sinus pulse balloon control device according to an embodiment of the present invention;

FIG5 is a block diagram of another coronary sinus pulse balloon control device according to an embodiment of the present invention;

FIG6 is a schematic structural diagram of a gas path module according to an embodiment of the present invention;

FIG7 is a block diagram of another coronary sinus pulse balloon control device according to an embodiment of the present invention;

FIG. 8 is a schematic structural diagram of another gas path module in an embodiment of the present invention.

Detailed ways

In order to enable those skilled in the art to better understand the scheme of the present invention, the technical scheme in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

In the prior art, when a balloon is used to block the coronary sinus, the coronary venous blood flow will not be able to flow out through the coronary sinus in a short period of time. If the patient's heart function is weak, the complete blockage of the coronary sinus may not be tolerated by the patient and may cause adverse reactions. The advantage of the semi-blocking balloon is that, while ensuring a certain blood flow, the coronary sinus is blocked to a certain extent, which can avoid the complete blockage of blood flow caused by full blockage. However, the pressure difference in the coronary sinus before and after the semi-blocking balloon blockage is small, which may have an adverse effect on the improvement of coronary microcirculation. If the surgeon can flexibly choose the blocking effect, targeted coronary microcirculation improvement treatment can be carried out according to the strength of the patient's heart function and the thickness of the blood vessels. In principle, when the balloon is located in the coronary sinus, the degree of blood vessel blockage will increase synchronously during the gradual filling and expansion process, and the blood pressure in the coronary sinus will also increase accordingly; when the blood vessel is completely blocked, the blood pressure in the coronary sinus will remain in a relatively constant state; by monitoring the increase in blood pressure, the degree of balloon filling can be known accordingly. Based on this, an embodiment of the present invention proposes a coronary sinus pulse balloon control method.

A coronary sinus pulse balloon control method provided by an embodiment of the present invention, as shown in FIG1 , includes:

Step S100, receiving the set pressure difference value and the real-time blood pressure value. Specifically, in the unblocked state, the real-time blood pressure in the coronary sinus will increase and decrease accordingly with the contraction and relaxation of the heart. The corresponding blood pressure values are called systolic pressure and diastolic pressure. The real-time blood pressure value includes real-time systolic pressure and real-time diastolic pressure. The set pressure difference value is the difference between the set mean pressure and the preset reference pressure. The mean pressure is also called mean arterial pressure, which represents the average value of arterial blood pressure in a cardiac cycle. The relationship between the mean pressure and the systolic pressure and diastolic pressure is: mean pressure = [systolic pressure + (2 × diastolic pressure)] ÷ 3.

Step S200, calculate the real-time pressure difference value according to the real-time blood pressure value, and the real-time pressure difference value is the difference between the average pressure of the real-time blood pressure value and the preset reference pressure. The real-time blood pressure value is obtained by calculating the average pressure of the real-time blood pressure value according to the relationship between the average pressure and the systolic pressure and the diastolic pressure, and then subtracting the preset reference pressure from the average pressure of the real-time blood pressure value to obtain the real-time pressure difference value. The preset reference pressure is a set reference average pressure. Exemplarily, the preset reference pressure is to keep the balloon in a contracted state after placing the balloon into the coronary sinus, and continuously monitor the blood pressure in the coronary sinus for 10 seconds through the distal opening of the guidewire lumen of the balloon catheter, and obtain the mean value of the average pressure in the coronary sinus during this period.

Step S300, adjusting the filling size of the balloon based on the real-time differential pressure value and the set differential pressure value. Specifically, a closed-loop control strategy is adopted, when the real-time differential pressure value is less than the set differential pressure value, the balloon is inflated to increase the real-time differential pressure value, and when the real-time differential pressure value is greater than the set differential pressure value, the balloon is deflated to reduce the real-time differential pressure value, and finally the real-time differential pressure value is equal to the set differential pressure value.

A coronary sinus pulse balloon control method according to an embodiment of the present invention receives a set pressure difference value and a real-time blood pressure value; calculates a real-time pressure difference value according to the real-time blood pressure value, and the real-time pressure difference value is the difference between the average pressure of the real-time blood pressure value and the preset reference pressure; adjusts the filling size of the balloon based on the real-time pressure difference value and the set pressure difference value, and by adjusting the filling size of the balloon with the set pressure difference value as a parameter, the degree of occlusion of the coronary sinus by the balloon can be intuitively obtained, and a coronary sinus occlusion treatment with an adjustable average pressure difference value before and after occlusion can be achieved, and the operator can flexibly adjust the occlusion amount according to the actual clinical situation of the patient. For patients with stronger heart function, a larger occlusion degree can be selected to achieve more efficient microcirculation improvement treatment; for patients with weaker heart function, a smaller occlusion degree can be selected to achieve coronary sinus pulse balloon control with adjustable occlusion degree, which can solve the limitations and risks of semi-occlusion and full occlusion in the prior art for coronary microcirculation improvement treatment, and can achieve more reliable microcirculation improvement treatment.

In one embodiment, before receiving the set pressure difference value, it includes: calculating and outputting the adjustment range of the set pressure difference value. The adjustment range of the set pressure difference value can show the blocking degree of the set pressure difference value. For example, if the set pressure difference value is in the middle of the adjustment range, it means that the balloon is in a semi-blocked state, and if the set pressure difference value is close to the upper limit of the adjustment range, it means that the blocking degree is large. Specifically, according to the position of the set pressure difference value in the adjustment range, the set pressure difference value is converted into a corresponding blocking ratio. For example, when the set pressure difference value is the upper limit of the adjustment range, the corresponding blocking ratio is 100%, and when the set pressure difference value is the middle point of the adjustment range, the corresponding blocking ratio is 50%. By replacing the set pressure difference value with the corresponding blocking ratio, the blocking degree of the balloon can be adjusted more intuitively. The adjustable blocking degree can solve the problem so that the operator can flexibly select the blocking degree of the coronary sinus pulse balloon according to the patient's condition, improve the treatment efficiency, and ensure the patient's tolerance.

In one embodiment, calculating and outputting the adjustment range of the set pressure difference value includes: calculating the maximum average pressure when the balloon is completely blocked; subtracting the preset reference pressure from the maximum average pressure to obtain the upper limit of the adjustment, the adjustment range is greater than or equal to zero and less than or equal to the upper limit of the adjustment, and the preset reference pressure is the average pressure of the balloon in the contracted state; and outputting the adjustment range to the display screen for display. Specifically, taking the air intake power of the balloon as an example of a cylinder, in the preparation stage of the coronary sinus pulse treatment operation, firstly control the cylinder and the valve group to inflate the coronary sinus pulse balloon to fill it slowly, and during the filling process, synchronously monitor the blood pressure in the coronary sinus until the average pressure no longer continues to rise. At this time, the coronary sinus pulse balloon is in a completely blocked state, and the blood pressure in the coronary sinus is continuously monitored for 10 seconds, and the average of the blood pressure and the average pressure in the coronary sinus during this period is defined as the maximum average pressure. Subsequently, the cylinder and the valve group are controlled to extract the gas in the coronary sinus pulse balloon to contract it and restore the blood flow in the coronary sinus. Subtracting the preset reference pressure from the maximum average pressure, the upper limit of the adjustment and the adjustment range of the set pressure difference value are obtained. This adjustment range is displayed on the touch screen, and the operator is prompted to select an expected average pressure difference before and after occlusion within this adjustment range based on the patient's condition, that is, the set pressure difference. After the device receives the set pressure difference set by the operator, it uses the set pressure difference as the set value of the closed-loop control circuit. In the subsequent cyclic occlusion process, the closed-loop controls the filling size of the balloon according to this set value, thereby adjusting the degree of occlusion in the coronary sinus.

As shown in FIG2 , in the closed-loop control loop, the real-time blood pressure value in the coronary sinus is used as the controlled variable, and the average pressure of the real-time blood pressure value is calculated based on the real-time blood pressure value, and the average pressure of the real-time blood pressure value is subtracted from the preset reference pressure, and the result is transmitted to the control module as the feedback value. The control module subtracts the feedback value from the set value as the input of the discrete control algorithm, and controls the cylinder and the first valve group to act according to the calculation result of the control algorithm. After the cylinder and the first valve group perform corresponding actions, the coronary sinus pulse balloon will be filled or contracted, thereby affecting the controlled object - the degree of blockage in the coronary sinus, which is finally reflected in the real-time blood pressure value in the coronary sinus. Through the periodic discrete control of the closed-loop control loop, the real-time blood pressure value in the coronary sinus will reach a steady state according to the set pressure difference value. In another embodiment, the balloon's contraction power is a vacuum pump, and what drives the balloon to fill is the positive pressure of a gas cylinder containing a gas source after passing through a pressure reducing valve. The gas cylinder itself will have a relatively high positive pressure, and after passing through the pressure reducing valve, a relatively small positive pressure will be obtained. This positive pressure gas fills the balloon. In this embodiment, the closed-loop control process is shown in Figure 3, and the control process is the same as the control process of the cylinder, which will not be repeated here.

The embodiment of the present invention calculates and displays the adjustment range of the set pressure difference value, and the upper limit of the adjustment range is the maximum average pressure when the balloon is completely blocked. By comparing the interval of the set pressure difference value in the adjustment range, the blocking degree of the balloon corresponding to the set pressure difference value can be understood, and a clear adjustment range is given to the user so that the set pressure difference value will not exceed the adjustment range and cause the balloon to be over-filled.

In one embodiment, the coronary sinus pulse balloon control method further includes calculating the volume of gas entering the balloon, calculating the balloon volume according to the gas volume and the ideal gas state equation, and outputting it. Due to individual differences, the coronary sinus diameters of different patients also vary. The coronary sinus pulse balloon control method of the embodiment of the present invention can adjust the degree of occlusion through closed-loop control, and effectively avoid the difference in occlusion effect caused by individual differences in coronary sinus diameter. However, at the same time, the balloon volume will change due to individual differences and different closed-loop control setting values. Therefore, real-time and accurate measurement and display of the balloon volume can improve the surgeon's control over the surgical situation.

In one embodiment, the balloon volume is calculated and outputted according to the gas volume and the ideal gas state equation, including: obtaining the first air pressure value of the gas before entering the balloon and the second air pressure value of the gas in the balloon; obtaining the first temperature value of the gas before entering the balloon and the second temperature value of the gas in the balloon; substituting the gas volume, the first air pressure value, the second air pressure value, the first temperature value, and the second temperature value into the ideal gas state equation to calculate the intermediate gas volume; subtracting the catheter volume from the intermediate gas volume to obtain the balloon volume and output it, and the catheter volume is the volume of the pipeline for inflating the balloon. Taking the air intake power of the balloon as an example, the cylinder is a well-sealed piston cylinder, and the piston is driven by a stepper motor to move linearly, thereby generating positive and negative air pressure to drive the balloon; and the stepper motor is precisely controlled by the control module through the number of pulses. According to the number of stepper motor pulses, the number of subdivisions of the stepper motor driver, and the lead of the piston push rod, the movement displacement of the cylinder piston can be accurately calculated, thereby calculating the change in the cylinder volume, and then according to the real-time air pressure sensor and temperature sensor, the first air pressure value and the first temperature value of the gas in the air path before entering the balloon are obtained. At the same time, the air pressure acquisition module in the balloon is set to collect the second air pressure value of the gas in the balloon, and the second temperature value is taken as the human body temperature. =37°C. Of course, in other embodiments, the temperature can be collected by setting a corresponding temperature sensor, and then the ideal gas state equation can be used to perform the corresponding volume conversion to obtain the volume of the balloon at this time, thereby achieving accurate measurement of the coronary sinus pulse balloon volume.

Specifically, after the cylinder completes the action of pumping air from the air source, the number of pulses of the stepper motor is , stepper motor driver subdivision number (pulse/r) is a fixed value, the electric cylinder pitch (mm/r) is a constant value, and the piston movement distance is ,but , assuming that the cylinder diameter D is a constant value, and the gas volume in the cylinder during the exhaust phase is V1, then , the first pressure value is the pressure in the cylinder , which can be measured by a pressure gauge. The first temperature value is the gas temperature in the cylinder It can be measured by a gas temperature sensor. ,in is the amount of gas substance, is the molar gas constant.

After the cylinder has completed the action of pumping gas into the balloon, all the gas enters the balloon through the catheter from the cylinder and expands the balloon. It can be measured by the air pressure collection module in the balloon, and the gas temperature in the balloon can be measured by the human body temperature. =37℃, assuming that the total volume of gas in the balloon and catheter is . Thus we get ,in is the amount of gas substance, is the molar gas constant. According to the law of conservation of matter, = ,Available The length and cross-sectional area of the duct are constant in practical applications, so the volume of gas in the duct is is also a constant. Assume the volume of the balloon is .but , in summary, we can get .

The embodiment of the present invention can accurately measure the volume of the coronary sinus pulse balloon, can provide the operator and the patient with a clearer and more definite understanding of the surgical process, and is conducive to further evaluation and analysis of the treatment effect.

The embodiment of the present invention further provides a coronary sinus pulse balloon control device, as shown in FIG4 , the coronary sinus pulse balloon control device comprises:

The gas circuit module 201 is used to inflate and deflate the balloon.

The blood pressure acquisition module 203 is used to collect the blood pressure value in the coronary sinus and send the blood pressure value to the control module 202. The blood pressure acquisition module 203 adopts an invasive blood pressure detection method, based on the invasive blood pressure detection channel led out of the balloon guidewire cavity, and detects the blood pressure value of the blocked area in real time during the balloon filling state, contraction state and state switching process to calculate the invasive blood pressure average pressure.

The control module 202 is used to execute the coronary sinus pulse balloon control method as any of the above embodiments of the present invention. The execution process of the coronary sinus pulse balloon control method is as in the above embodiments, and will not be repeated here. In a specific embodiment, the control module 202 is set in the lower computer and connected to the upper computer, and the upper computer is connected to the display screen, and the display screen is specifically a touch display screen.

In the coronary sinus pulse balloon control device of the embodiment of the present invention, the control module 202 receives the set pressure difference value and the real-time blood pressure value; calculates the real-time pressure difference value according to the real-time blood pressure value, and the real-time pressure difference value is the difference between the average pressure of the real-time blood pressure value and the preset reference pressure; adjusts the filling size of the balloon based on the real-time pressure difference value and the set pressure difference value, and the degree of occlusion of the coronary sinus by the balloon can be intuitively obtained by adjusting the filling size of the balloon with the set pressure difference value as a parameter, so as to achieve a coronary sinus occlusion treatment with an adjustable average pressure difference value before and after occlusion, and the operator can flexibly adjust the occlusion amount according to the actual clinical situation of the patient. For patients with stronger heart function, a larger occlusion degree can be selected to achieve a more efficient microcirculation improvement treatment; for patients with weaker heart function, a smaller occlusion degree can be selected to achieve a more reliable microcirculation improvement treatment.

In one embodiment, the coronary sinus pulse balloon control device further includes: an air pressure collection module in the balloon, which is used to collect the second air pressure value of the gas in the balloon and send the second air pressure value to the control module 202. In the embodiment of the present invention, the second air pressure value of the gas in the balloon can be collected by the air pressure collection module in the balloon, so that the operator can understand the air pressure in the balloon.

In one embodiment, in the coronary sinus pulse balloon control device shown in FIG5 , the gas circuit module 201 includes a cylinder, a first valve group, a first temperature acquisition module, and a first gas circuit pressure acquisition module respectively connected to the control module 202; the cylinder is used to drive the gas into the balloon; the first valve group is used to control the opening and closing of the gas inlet and outlet channels; the first temperature acquisition module is used to obtain the first temperature value of the gas before entering the balloon; the first gas circuit pressure acquisition module is used to obtain the first pressure value of the gas before entering the balloon. The function of the gas circuit module 201 is to deliver gas to the balloon. The gas circuit module 201 includes multiple components,

In an exemplary embodiment, as shown in FIG. 6 , the gas circuit module 201 can be divided into a gas supply unit, a pulse action unit and a safety protection unit according to the gas intake.

The gas supply unit includes a gas source, a first pressure gauge, a pressure reducing valve, a second pressure gauge, and a first two-way solenoid valve connected in sequence. The pressure reducing valve includes a first-stage pressure reducing valve and a second-stage pressure reducing valve. The gas source supplies high-purity helium or carbon dioxide gas with a high pressure of 15MPa. The first pressure gauge monitors the gas usage and the pressure reducing valve performs pressure reduction. The pressure reducing valve includes a first-stage pressure reducing valve and a second-stage pressure reducing valve. The pressure of the high-pressure 15MPa gas can be reduced to 0.16MPa after passing through the first-stage pressure reducing valve, and can be reduced to 0.014MPa after passing through the second-stage pressure reducing valve. The two-stage pressure reducing valve reaches the system demand pressure of about 0.014MPa, and the output gas pressure is monitored by the second pressure gauge.

The pulse action unit is composed of a cylinder and a stepper motor. The stepper motor provides the power for linear motion, driving the shaft of the cylinder to reciprocate according to a certain pattern, thereby realizing the inflation and deflation functions of the pulse balloon.

The safety protection unit includes a one-way valve, a second two-way solenoid valve, a safety valve, a mechanical switch valve, a third pressure gauge and a third two-way solenoid valve. The one-way valve is connected to the second two-way solenoid valve. The exhaust gas function can be achieved by controlling the opening and closing of the second two-way solenoid valve. The safety valve can set an upper pressure threshold. If the pressure is overloaded, the pressure can be automatically released. The mechanical switch valve is connected to the third pressure gauge. The third pressure gauge can monitor the gas circuit pressure in real time. When the gas circuit pressure is overloaded and the safety valve fails, the user can open the mechanical switch valve to release the pressure to ensure the safety of the system and the safety of medical equipment during surgery.

In the embodiment of the present invention, the first temperature acquisition module and the first air path pressure acquisition module are installed between the third two-way solenoid valve and the third pressure gauge. The first valve group includes various valves in the air supply unit, the pulse action unit and the safety protection unit. The embodiment of the present invention realizes a safe, stable and reliable coronary sinus pulse balloon filling and contraction control system, and uses a cylinder as a power. In the initial cycle, after using the air source to perfuse the cylinder, the gas in the cylinder can be continuously used to control the filling and contraction of the balloon, which can greatly reduce the gas consumption and reduce the cost of use.

In one embodiment, the control module 202 is further used to calculate the volume of gas entering the balloon according to the cross-sectional area of the cylinder and the piston movement distance. Specifically, after the cylinder completes the action of pumping gas from the gas source, the number of stepper motor pulses is , stepper motor driver subdivision number (pulse/r) is a fixed value, the electric cylinder pitch (mm/r) is a constant value, and the piston movement distance is ,but , assuming that the cylinder diameter D is a constant value, and the gas volume in the cylinder during the exhaust phase is V1, then .

In one embodiment, as shown in FIG. 7 , the gas circuit module 201 includes a vacuum pump, a second valve group, a second temperature acquisition module, a second gas circuit pressure acquisition module and a gas flow meter, which are respectively connected to the control module 202; the vacuum pump is used to drive the gas to leave the balloon to shrink the balloon; the second valve group is used to control the opening and closing of the gas inlet and outlet channels; the second temperature acquisition module is used to obtain a first temperature value of the gas before entering the balloon; the second gas circuit pressure acquisition module is used to obtain a first air pressure value of the gas before entering the balloon; and the gas flow meter is used to obtain the volume of gas entering the balloon.

As shown in FIG8 , the gas circuit module 201 of the embodiment of the present invention is based on a gas flow meter and a vacuum pump as core units. Specifically, the second valve group is driven by the control module 202 to realize the filling and contraction control of the coronary sinus pulse balloon. The second valve group includes a pressure reducing valve, a two-position two-way solenoid valve, a two-position three-way solenoid valve and a safety valve. The pressure reducing valve is used to reduce the pressure of the gas cylinder storing the gas source. The gas source is the source of gas inside the balloon, which is a pure standard gas cylinder without solid particle impurities. The gas can be helium, nitrogen or carbon dioxide, and the absolute pressure inside the gas source needs to be higher than the standard atmospheric pressure. The two-position two-way solenoid valve is an inflation switch valve, the two-position three-way solenoid valve is a filling and contraction switching switch valve, and the safety valve is used to ensure that the pressure value inside the gas circuit does not exceed the maximum withstand pressure value. The gas flow meter collects the real-time flow of gas entering the coronary sinus pulse balloon and feeds it back to the control module 202, so as to perform discrete integral calculation to obtain the volume inside the coronary sinus pulse balloon. The second gas circuit pressure acquisition module collects the real-time pressure value of the relevant parts in the gas circuit to ensure function realization and safety alarm. The second temperature acquisition module uses a gas temperature sensor, which is connected in series between the two-position three-way solenoid valve and the coronary sinus pulse balloon to detect the temperature of the gas flowing into the coronary sinus pulse balloon. In this embodiment, the balloon is driven to fill with the positive pressure of the gas cylinder containing the gas source after passing through the pressure reducing valve. The gas cylinder itself will have a relatively high positive pressure. After passing through the pressure reducing valve, a relatively small positive pressure will be obtained. This positive pressure gas fills the balloon. The vacuum pump is connected to the two-position three-way solenoid valve to extract the gas inside the coronary sinus pulse balloon and discharge it to the gas outlet, thereby shrinking the balloon. The fourth pressure gauge is a mechanical pressure gauge, which indicates the current outlet pressure value of the gas cylinder and can also reflect the current remaining gas volume in the gas cylinder. The fifth pressure gauge is an electronic pressure gauge, which is used to monitor the pressure value after the pressure reducing valve. At the same time, the second gas circuit pressure acquisition module transmits the pressure value to the control module 202. The sixth pressure gauge is an electronic pressure gauge. When the two-position three-way solenoid valve is switched to the gas flow meter and the coronary sinus pulse balloon, it indicates the current gas pressure flowing into the balloon. At the same time, the second gas circuit pressure acquisition module transmits the pressure value to the control module 202.

The embodiment of the present invention realizes a safe, stable and reliable coronary sinus pulse balloon filling and contraction control system. By using a small-volume flow sensor and a vacuum pump, rapid control of balloon filling and contraction can be achieved, which can significantly reduce the size and weight of the equipment and increase the flexibility of the equipment application scenarios.

The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features thereof may be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims (7)

1. A coronary sinus pulse balloon control device, comprising:

the air path module is used for inflating and deflating the balloon;

the blood pressure acquisition module is used for acquiring the blood pressure value in the coronary sinus and sending the blood pressure value to the control module;

The control module is used for receiving the set pressure difference value and the real-time blood pressure value; calculating a real-time pressure difference value according to the real-time blood pressure value, wherein the real-time pressure difference value is the difference value between the average pressure of the real-time blood pressure value and a preset reference pressure; adjusting the filling size of the balloon based on the real-time differential pressure value and the set differential pressure value; calculating a volume of gas entering the balloon, calculating a balloon volume according to the gas volume and ideal gas state equation and outputting, wherein the calculating the balloon volume according to the gas volume and ideal gas state equation and outputting comprises: acquiring a first air pressure value of air before entering the balloon and a second air pressure value of air in the balloon; acquiring a first temperature value of gas before entering the balloon and a second temperature value of gas in the balloon; substituting the gas volume, the first gas pressure value, the second gas pressure value, the first temperature value and the second temperature value into an ideal gas state equation to calculate an intermediate gas volume; subtracting the volume of the catheter from the volume of the intermediate gas to obtain the volume of the balloon, and outputting the volume of the catheter, wherein the volume of the catheter is the volume of a pipeline for inflating the balloon.

2. The coronary sinus pulse balloon control device according to claim 1, further comprising:

And the air pressure acquisition module in the balloon is used for acquiring a second air pressure value of air in the balloon and sending the second air pressure value to the control module.

3. The coronary sinus pulse balloon control device according to claim 1, wherein the gas circuit module comprises a cylinder, a first valve group, a first temperature acquisition module and a first gas circuit pressure acquisition module respectively connected with the control module;

The air cylinder is used for driving air to enter the balloon;

the first valve group is used for controlling the opening and closing of the gas inlet and outlet channels;

The first temperature acquisition module is used for acquiring a first temperature value of the gas before entering the balloon;

The first air path pressure acquisition module is used for acquiring a first air pressure value of air before entering the balloon.

4. The coronary sinus pulse balloon control device according to claim 3, wherein the control module is further configured to calculate a volume of gas entering the balloon based on a cross-sectional area of the cylinder and a piston travel distance.

5. The coronary sinus pulse balloon control device according to claim 1, wherein the air circuit module comprises a vacuum pump, a second valve group, a second temperature acquisition module, a second air circuit pressure acquisition module and an air flow meter which are respectively connected with the control module;

the vacuum pump is used for driving gas to leave the balloon to enable the balloon to contract;

The second valve group is used for controlling the opening and closing of the gas inlet and outlet channels;

The second temperature acquisition module is used for acquiring a first temperature value of the gas before entering the balloon;

the second gas path pressure acquisition module is used for acquiring a first gas pressure value of gas before entering the balloon;

The gas flow meter is used to obtain the volume of gas entering the balloon.

6. The coronary sinus pulse balloon control device according to claim 1, wherein the control module is further configured to calculate and output an adjustment range of the set differential pressure value prior to receiving the set differential pressure value.

7. The coronary sinus pulse balloon control device according to claim 6, wherein said calculating and outputting the adjustment range of the set differential pressure value comprises:

calculating the maximum average pressure when the saccule is completely blocked;

Subtracting the preset reference pressure from the maximum average pressure to obtain an upper regulation limit, wherein the regulation range is greater than or equal to zero and less than or equal to the upper regulation limit, and the preset reference pressure is the average pressure of the balloon in a contracted state;

And outputting the adjusting range to a display screen for display.