CN116158800A - Coronary sinus pulse saccule control method and control device - Google Patents

Coronary sinus pulse saccule control method and control device Download PDF

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Publication number
CN116158800A
CN116158800A CN202310138524.6A CN202310138524A CN116158800A CN 116158800 A CN116158800 A CN 116158800A CN 202310138524 A CN202310138524 A CN 202310138524A CN 116158800 A CN116158800 A CN 116158800A
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China
Prior art keywords
balloon
pressure
gas
value
coronary sinus
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Inventor
戴辰晨
郭磊
余盛达
孙宏轩
范华东
刘湃
左廷涛
张昱昕
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Lepu Medical Technology Beijing Co Ltd
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Lepu Medical Technology Beijing Co Ltd
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Priority to CN202310138524.6A priority Critical patent/CN116158800A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10184Means for controlling or monitoring inflation or deflation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10184Means for controlling or monitoring inflation or deflation
    • A61M25/10185Valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00Measuring parameters of the user
    • A61M2230/04Heartbeat characteristics, e.g. ECG, blood pressure modulation

Abstract

The invention discloses a coronary sinus pulse saccule control method and a control device, wherein the control method comprises the following steps: receiving a set pressure difference value and a 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; and adjusting the filling size of the balloon based on the real-time pressure difference value and the set pressure difference value, and intuitively obtaining the plugging degree of the balloon to the coronary sinus by adjusting the filling size of the balloon by taking the set pressure difference value as a parameter, so as to realize flexible control of the vascular plugging degree.

Description

Coronary sinus pulse saccule control method and control device
Technical Field
The invention relates to the technical field of medical appliances, in particular to a coronary sinus pulse balloon control method and a coronary sinus pulse balloon control device.
Background
Coronary heart disease generally refers to coronary atherosclerotic heart disease, and most patients with coronary heart disease have coronary microcirculation disturbance (coronary microcirculation disturbance refers to microcirculation change when the microcirculation system is affected by one or more adverse factors and is mainly manifested by unsmooth blood circulation, blood stasis, flow state change and the like in the microvascular). Acute Myocardial Infarction (AMI) usually has severe and durable poststernal pain clinically, rest and nitrate medicines cannot be completely relieved, and the Acute Myocardial Infarction (AMI) is accompanied by increased serum myocardial enzyme activity and progressive electrocardiographic changes, can be complicated with arrhythmia, shock or heart failure, and can endanger life.
The coronary sinus pulse balloon is a novel instrument for treating coronary heart disease, and based on a catheter balloon structure platform, the coronary sinus is periodically plugged (or semi-plugged) by the balloon, so that the intermittent obstruction of coronary venous blood flow is realized, and the coronary sinus venous blood pressure is further increased, so that the purposes of dredging the occluded coronary microvascular and remodelling necrotic myocardium are achieved. At present, a certain clinical result is achieved by adopting coronary sinus pulse saccule treatment. The existing coronary sinus pulse balloon is in a full-plugging form or a half-plugging form, different plugging degrees have influence on the treatment effect, more clinical data are needed to be quantitatively analyzed, but the coronary sinus pulse balloon in the full-plugging form or the half-plugging form is in plugging change realized through the form of the balloon, and flexible control on the blood vessel plugging degree cannot be realized.
Disclosure of Invention
In view of the above, the embodiment of the invention provides a coronary sinus pulse balloon control method and a coronary sinus pulse balloon control device, which are used for solving the technical problem that the degree of vascular occlusion cannot be flexibly controlled in the prior art.
The technical scheme provided by the invention is as follows:
a first aspect of an embodiment of the present invention provides a coronary sinus pulse balloon control method, including: receiving a set pressure difference value and a 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; 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 differential pressure value, the method includes: and calculating and outputting the adjusting range of the set pressure difference value.
Optionally, the calculating and outputting the adjustment range of the set differential pressure value includes: 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.
Optionally, the coronary sinus pulse balloon control method further comprises the steps of calculating the volume of gas entering the balloon, calculating the volume of the balloon according to the volume of gas and an ideal gas state equation and outputting the calculated volume of the balloon.
Optionally, the calculating the balloon volume according to the gas volume and ideal gas state equation and outputting includes: 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.
A second aspect of an embodiment of the present invention provides a coronary sinus pulse balloon control device, including: 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 executing the coronary sinus pulse balloon control method according to the first aspect and any one of the first aspect of the embodiments of the invention.
Optionally, the coronary sinus pulse balloon control device further comprises: 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.
Optionally, the air circuit module comprises an air cylinder, a first valve group, a first temperature acquisition module and a first air circuit pressure acquisition module which are 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.
Optionally, the control module is further configured to calculate a volume of gas entering the balloon based on the cross-sectional area of the cylinder and the piston travel distance.
Optionally, the gas circuit module comprises a vacuum pump, a second valve group, a second temperature acquisition module, a second gas circuit pressure acquisition module and a gas flowmeter 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.
From the above technical solutions, the embodiment of the present invention has the following advantages:
the embodiment of the invention provides a coronary sinus pulse balloon control method and a coronary sinus pulse balloon control device, which are characterized in that a set pressure difference value and a real-time blood pressure value are received; 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; and adjusting the filling size of the balloon based on the real-time pressure difference value and the set pressure difference value, and intuitively obtaining the plugging degree of the balloon to the coronary sinus by adjusting the filling size of the balloon by taking the set pressure difference value as a parameter, so as to realize flexible control of the vascular plugging degree.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed for the description of the embodiments will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a flow chart of a method of coronary sinus pulse balloon control in accordance with an embodiment of the present invention;
FIG. 2 is a closed-loop control flow chart according to an embodiment of the present invention;
FIG. 3 is a flow chart of another closed loop control in an embodiment of the present invention;
FIG. 4 is a block diagram of a coronary sinus pulse balloon control device according to an embodiment of the present invention;
FIG. 5 is a block diagram of another coronary sinus pulse balloon control device according to an embodiment of the present invention;
FIG. 6 is a schematic diagram of an air path module according to an embodiment of the invention;
FIG. 7 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 air path module according to an embodiment of the invention.
Detailed Description
In order to make the present invention better understood by those skilled in the art, the following description will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
In the prior art, when the coronary sinus is plugged by adopting a balloon, coronary venous blood flow cannot flow out through the coronary sinus in a short time, if the heart function of a patient is weaker, the coronary sinus is completely plugged, and the patient cannot tolerate the operation type and generate adverse reaction. The semi-plugging balloon has the advantages that under the condition of ensuring certain blood flow, the coronary sinus is plugged to a certain extent, so that the blood flow full blockage caused by full plugging can be avoided, but the pressure difference in the coronary sinus before and after the semi-plugging balloon is smaller, and the improvement effect on the coronary microcirculation can be adversely affected. If the operator can flexibly select the plugging effect, the specific coronary microcirculation improvement treatment can be performed according to the intensity of the heart function and the thickness difference of blood vessels of the patient. In a specific principle, when the saccule is positioned in the coronary sinus, the degree of the vascular occlusion is synchronously increased in the gradual filling and expanding process, and the blood pressure in the coronary sinus is correspondingly increased; when the blood vessel is completely blocked, the blood pressure in the coronary sinus can be maintained in a relatively constant state; the balloon filling degree can be correspondingly known by monitoring the blood pressure rising condition. Based on the above, the embodiment of the invention provides a coronary sinus pulse balloon control method.
The coronary sinus pulse balloon control method provided by the embodiment of the invention, as shown in fig. 1, comprises the following steps:
step S100, receiving a set pressure difference value and a real-time blood pressure value. Specifically, in the non-occluded state, the real-time blood pressure in the coronary sinus will increase and decrease accordingly with the contraction and relaxation of the heart, and the corresponding blood pressure values are called systolic pressure and diastolic pressure, and the real-time blood pressure values include real-time systolic pressure and real-time diastolic pressure. The set pressure difference is the difference between the set average pressure and the preset reference pressure, the average pressure is also called average arterial pressure, and represents the average value of arterial blood pressure in a cardiac cycle, and the relationship between the average pressure and the systolic pressure as well as the diastolic pressure is as follows: average pressure= [ systolic pressure + (2 x diastolic pressure) ]/3.
And step 200, 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 the preset reference pressure. And obtaining a real-time blood pressure value, 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 subtracting a preset reference pressure from the average pressure of the real-time blood pressure value to obtain a real-time pressure difference value. The preset reference pressure is a set reference average pressure, and is illustratively the average pressure of the blood pressure in the coronary sinus in the period obtained by continuously monitoring the blood pressure in the coronary sinus for 10 seconds through the distal opening of the guide wire cavity of the balloon catheter and keeping the contracted state of the balloon after the balloon is placed in the coronary sinus.
And 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 smaller than the set differential pressure value, the balloon is inflated, the real-time differential pressure value is increased, when the real-time differential pressure value is larger than the set differential pressure value, the balloon is deflated, the real-time differential pressure value is reduced, and finally the real-time differential pressure value is the same as the set differential pressure value.
The coronary sinus pulse saccule control method of the embodiment of the invention is characterized by receiving a set pressure difference value and a 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; the filling size of the balloon is adjusted based on the real-time pressure difference value and the set pressure difference value, the blocking degree of the balloon to the coronary sinus can be intuitively obtained by adjusting the filling size of the balloon by taking the set pressure difference value as a parameter, the coronary sinus blocking treatment with an average pressure difference value adjustable before and after blocking is realized, and an operator can flexibly adjust the blocking amount according to the clinical actual condition of a patient. The patient with stronger heart function can select larger plugging degree to realize more efficient microcirculation improvement type treatment; the coronary sinus pulse balloon control device has the advantages that the coronary sinus pulse balloon control device can realize the coronary sinus pulse balloon control with adjustable plugging degree by selecting smaller plugging degree for the patient with weaker cardiac function, can solve the limitation and risk brought by semi-plugging type and full plugging type coronary microcirculation improvement type treatment in the prior art, and can realize more stable microcirculation improvement type treatment.
In one embodiment, prior to receiving the set differential pressure value, the method comprises: and calculating and outputting an adjusting range of the set pressure difference value. The adjustment range of the set differential pressure value can display the plugging degree of the set differential pressure value, for example, if the set differential pressure value is in the middle of the adjustment range, the balloon is in a semi-plugging state, and if the set differential pressure value is close to the upper limit of the adjustment range, the plugging degree is larger. Specifically, according to the position of the set differential pressure value in the adjusting range, the set differential pressure value is converted into a corresponding plugging proportion, for example, when the set differential pressure value is the upper limit of the adjusting range, the corresponding plugging proportion is 100%, and when the set differential pressure value is the middle point of the adjusting range, the corresponding plugging proportion is 50%, and the balloon plugging degree can be more intuitively adjusted by replacing the set differential pressure value with the corresponding plugging proportion. The adjustable shutoff degree can solve thereby to make the operator can select the shutoff degree of coronary sinus pulse sacculus in a flexible way according to patient's state, improves treatment effeciency, guarantees patient tolerance.
In one embodiment, calculating and outputting the adjustment range of the set differential pressure value includes: calculating the maximum average pressure when the saccule is completely blocked; subtracting a 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. Specifically, taking the air inlet power of the balloon as an example, in the preparation stage of coronary sinus pulse therapy operation, firstly controlling the air cylinder and the valve group to charge air into the coronary sinus pulse balloon so as to enable the coronary sinus pulse balloon to be slowly filled, and in the filling process, synchronously monitoring the blood pressure in the coronary sinus until the average pressure does not continuously rise, wherein the coronary sinus pulse balloon is in a complete blocking state, continuously monitoring the blood pressure in the coronary sinus for 10 seconds, and defining the average value of the average pressure in the coronary sinus of the blood pressure in the period as the maximum average pressure. And then, controlling the air cylinder and the valve group to pump out the gas in the coronary sinus pulse saccule, so that the coronary sinus pulse saccule contracts, and restoring the blood flow in the coronary sinus. Subtracting a preset reference pressure from the maximum average pressure to obtain an upper regulation limit and a regulation range of the set pressure difference value. The adjusting range is displayed on a touch display screen, and the operator is prompted to select an expected average pressure difference value before and after plugging in the adjusting range, namely a set pressure difference value, based on the state of the patient. After the equipment receives the set pressure difference value set by the operator, the set pressure difference value is used as a set value of a closed loop control circuit, and in the subsequent cyclic plugging process, the filling size of the balloon is controlled in a closed loop mode according to the set value, so that the plugging degree in the coronary sinus is achieved.
As shown in fig. 2, in the closed loop control circuit, a real-time blood pressure value in the coronary sinus is taken as a controlled variable, an average pressure of the real-time blood pressure value is calculated according to the real-time blood pressure value, the average pressure of the real-time blood pressure value is subtracted from a preset reference pressure, the obtained result is transmitted to the control module as a feedback value, the feedback value is subtracted from a set value by the control module as input of a discrete control algorithm, the cylinder and the first valve group are controlled to act according to the calculation result of the control algorithm, and after the cylinder and the first valve group act correspondingly, the coronary sinus pulse balloon is inflated or contracted to some extent, so that the blocking degree of a controlled object in the coronary sinus is affected, and finally the real-time blood pressure value in the coronary sinus is reflected. By the periodic discrete control of the closed-loop control circuit, the real-time blood pressure value in the coronary sinus can reach a steady state according to the set pressure difference value. In another embodiment, the contraction power of the balloon is a vacuum pump, the balloon is driven to be filled with positive pressure of a gas cylinder provided with a gas source after passing through a pressure reducing valve, the gas cylinder has a relatively high positive pressure, a relatively small positive pressure is obtained after passing through the pressure reducing valve, the balloon is filled with the positive pressure gas, in this embodiment, a closed loop control flow is shown in fig. 3, and the control flow is the same as that of the gas cylinder and is not repeated here.
According to the embodiment of the invention, the adjustment range of the set pressure difference value is calculated and displayed, the upper limit of the adjustment range is the maximum average pressure when the balloon is completely plugged, the plugging degree of the balloon corresponding to the set pressure difference value can be known by comparing the interval of the set pressure difference value in the adjustment range, and a clear adjustment range is provided for a user, so that the balloon is not excessively filled due to the fact that the set pressure difference value exceeds the adjustment range.
In one embodiment, the coronary sinus pulse balloon control method further comprises calculating a volume of gas entering the balloon, calculating the balloon volume according to the gas volume and the ideal gas state equation, and outputting. Because of the inter-individual differences, the coronary sinus diameters of different patients are also different, and the coronary sinus pulse balloon control method provided by the embodiment of the invention can realize closed-loop control and adjustment on the blocking degree, so that the difference of blocking effects caused by the individual differences of the coronary sinus diameters is well avoided. At the same time, however, balloon volume may vary due to the presence of individual differences, as well as differences in closed loop control settings. Therefore, the balloon volume can be accurately calculated and displayed in real time, so that the control degree of an operator on the operation condition can be improved.
In one embodiment, calculating and outputting balloon volume from the gas volume and ideal gas state equation includes: 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 air pressure value, the second air pressure value, the first temperature value and the second temperature value into an ideal gas state equation to calculate an intermediate gas volume; the volume of the balloon is obtained by subtracting the volume of the catheter from the volume of the intermediate gas, and the volume of the catheter is the volume of a pipeline for inflating the balloon. Taking the air inlet power of the balloon as an example, the air cylinder is a well-sealed piston cylinder, and the piston is driven by the stepping motor to perform linear motion, so that positive and negative air pressure is generated to drive the balloon; the stepping motor is precisely controlled by the control module through the pulse number. According to the pulse number of the stepping motor, the subdivision of the stepping motor driver and the lead of the piston push rod, the movement displacement of the cylinder piston can be accurately calculated, so that the change amount of the cylinder volume is calculated, and further, according to the real-time air pressure sensor and the temperature sensor, the first air pressure value and the first temperature value of the air before entering the balloon in the air path are obtained, and meanwhile, the air pressure acquisition module in the balloon is arranged to acquire the second air pressure value of the air in the balloon, and the second temperature value takes the human body temperature
Figure SMS_1
In other embodiments, the temperature sensor is set to collect the balloon, and then the ideal gas state equation is used to perform corresponding volume conversion to obtain the volume of the balloon, so as to realize accurate measurement and calculation of the coronary sinus pulse balloon volume.
Specifically, after the air cylinder completes the air pumping action from the air source, the pulse number of the stepping motor is
Figure SMS_4
Step motor driver fine fraction ++>
Figure SMS_7
(pulse/r) is a constant value, the pitch of the electric cylinder + ->
Figure SMS_9
(mm/r) is a constant value, and the piston movement distance is set to +.>
Figure SMS_3
Then->
Figure SMS_6
The cylinder diameter D is set as a constant value, and the volume of gas in the cylinder at the air extraction stage is set as V1>
Figure SMS_10
The first air pressure value is the air pressure in the cylinder +.>
Figure SMS_12
The first temperature value is the temperature of the gas in the cylinder, which can be measured by a pressure gauge>
Figure SMS_2
Can be measured by a gas temperature sensor. Thus get +.>
Figure SMS_5
Wherein->
Figure SMS_8
The amount of substance being a gas, +.>
Figure SMS_11
Is the molar gas constant.
After the cylinder completes the pumping of the gas into the balloon, all the gas is admitted into the balloon by the cylinder via the catheter and expands the balloon volume. Second air pressure value
Figure SMS_16
The temperature of the gas in the balloon can be measured by the air pressure acquisition module in the balloon, and the temperature of the gas in the balloon is taken as the body temperature of a person>
Figure SMS_19
Let the total volume of the balloon and the gas in the catheter be +.>
Figure SMS_22
. Thus get +.>
Figure SMS_14
Wherein->
Figure SMS_20
The amount of substance being a gas, +.>
Figure SMS_23
Is the molar gas constant. From substance conservation law, +.>
Figure SMS_25
=/>
Figure SMS_13
Can get->
Figure SMS_17
. The length and cross-sectional area of the conduit are fixed in practical application, so the volume of gas in the conduit is +.>
Figure SMS_21
Is also a constant value. Let the balloon volume +.>
Figure SMS_24
. Then
Figure SMS_15
To sum up, get->
Figure SMS_18
The embodiment of the invention can accurately measure and calculate the coronary sinus pulse saccule volume, can give a clearer and more definite understanding to the operation process to operators and patients, and is beneficial to further evaluation and analysis of the treatment effect.
The embodiment of the invention also provides a coronary sinus pulse balloon control device, as shown in fig. 4, comprising:
the air path module 201 is used for inflating and deflating the balloon.
The blood pressure acquisition module 203 is configured to acquire a 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 mode, and calculates the pressure equalizing pressure of the invasive blood pressure by detecting the slave blood pressure value of the blocked area in real time in the switching process of the balloon filling state, the contraction state and the state based on an invasive blood pressure detection channel led out by the balloon guide wire cavity.
A control module 202 for performing a coronary sinus pulse balloon control method according to any of the above embodiments of the invention. The coronary sinus pulse balloon control method is performed in the above embodiments, and will not be described herein. In a specific embodiment, the control module 202 is disposed in the lower computer and connected to the upper computer, and the upper computer is connected to a display screen, where the display screen specifically adopts a touch display screen.
According to the coronary sinus pulse balloon control device, the control module 202 receives a set pressure difference value and a 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; the filling size of the balloon is adjusted based on the real-time pressure difference value and the set pressure difference value, the blocking degree of the balloon to the coronary sinus can be intuitively obtained by adjusting the filling size of the balloon by taking the set pressure difference value as a parameter, the coronary sinus blocking treatment with an average pressure difference value adjustable before and after blocking is realized, and an operator can flexibly adjust the blocking amount according to the clinical actual condition of a patient. The patient with stronger heart function can select larger plugging degree to realize more efficient microcirculation improvement type treatment; and for the person with weaker heart function, a smaller plugging degree is selected, so that more stable microcirculation improvement type treatment is realized.
In one embodiment, the coronary sinus pulse balloon control device further comprises: the intra-balloon air pressure acquisition module 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 202. According to the embodiment of the invention, the second air pressure value of the air in the balloon can be acquired through the air pressure acquisition module in the balloon, so that an operator can know the air pressure in the balloon.
In one embodiment, as shown in fig. 5, in the coronary sinus pulse balloon control device, the air circuit module 201 includes an air cylinder, a first valve group, a first temperature acquisition module and a first air circuit pressure acquisition module, which are respectively connected with the control module 202; the cylinder is used for driving gas into 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. The gas circuit module 201 functions to deliver gas to the balloon, the gas circuit module 201 comprising a plurality of components,
in an exemplary embodiment, as shown in fig. 6, the gas path module 201 may be divided into a gas supply unit, a pulse action unit, and a safety protection unit according to a gas intake division.
The gas supply unit comprises a gas source, a first pressure gauge, a pressure reducing valve, a second pressure gauge and a first two-way electromagnetic valve which are sequentially connected, the pressure reducing valve comprises a first-stage pressure reducing valve and a second-stage pressure reducing valve, the gas source supplies high-purity helium gas or carbon dioxide gas with high pressure of 15MPa, the first pressure gauge monitors the usage amount of the gas and reduces the pressure of the gas, the pressure reducing valve comprises the first-stage pressure reducing valve and the second-stage pressure reducing valve, the pressure of the gas with high pressure of 15MPa can be reduced to 0.16MPa through the first-stage pressure reducing valve, and the pressure of the gas with high pressure of 15MPa can be reduced to 0.014MPa through the second-stage pressure reducing valve. The two-stage decompression reaches about 0.014MPa of the system demand pressure, and the second pressure gauge monitors the output gas pressure.
The pulse action unit consists of a cylinder and a stepping motor, the stepping motor provides power for linear motion and drives a shaft lever of the cylinder to reciprocate according to a certain rule, so that the inflation and deflation functions of the pulse saccule are realized.
The safety protection unit comprises a one-way valve, a second two-way electromagnetic valve, a safety valve, a mechanical switch valve, a third pressure gauge and a third two-way electromagnetic valve, wherein the one-way valve is connected with the second two-way electromagnetic valve, the exhaust gas discharge function can be realized by controlling the opening and closing of the second two-way electromagnetic valve, the safety valve can be provided with a pressure upper limit threshold value, if the pressure is overloaded, the mechanical switch valve can automatically release pressure, the third pressure gauge can be connected with the third pressure gauge, the air circuit pressure can be monitored in real time, when the air circuit pressure is overloaded, and the safety valve also fails, a user can open the mechanical switch valve to release pressure, so that the safety of the system and the safety of medical equipment in operation can be ensured.
According to the embodiment of the invention, the first temperature acquisition module and the first air path pressure acquisition module are arranged between the third two-way electromagnetic valve and the third pressure gauge, the first valve group comprises various valves in the air supply unit, the pulse action unit and the safety protection unit, the embodiment of the invention realizes a safe, stable and reliable coronary sinus pulse balloon filling and contracting control system, the air cylinder is adopted as power, and after the air cylinder is filled by the air source in the initial one cycle, the filling and contracting of the air in the air cylinder can be continuously used, so that the air consumption can be greatly reduced, and the use cost is reduced.
In one embodiment, the control module 202 is also used to calculate the volume of gas entering the balloon based on the cross-sectional area of the cylinder and the piston travel distance. Specifically, after the air cylinder completes the air pumping action from the air source, the pulse number of the stepping motor is
Figure SMS_26
Step motor driver fine fraction ++>
Figure SMS_27
(pulse/r) is a constant value, the pitch of the electric cylinder + ->
Figure SMS_28
(mm/r) is a constant value, and the piston movement distance is set to +.>
Figure SMS_29
Then
Figure SMS_30
The cylinder diameter D is set as a constant value, and the volume of gas in the cylinder at the air extraction stage is set as V1>
Figure SMS_31
In one embodiment, as shown in fig. 7, the air path module 201 includes a vacuum pump, a second valve group, a second temperature acquisition module, a second air path pressure acquisition module and an air flow meter, which are respectively connected with the control module 202; 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 that enters the balloon.
As shown in fig. 8, the gas circuit module 201 according to the embodiment of the present invention uses a gas flow meter and a vacuum pump as core units. Specifically, the second valve group is driven by the control module 202 to act, and realizes filling and shrinkage control on the coronary sinus pulse balloon, the second valve group comprises a pressure reducing valve, a two-position two-way electromagnetic valve, a two-position three-way electromagnetic valve and a safety valve, the pressure reducing valve is used for reducing pressure of a gas cylinder for storing a gas source, the gas source is a gas source inside the balloon and is a standard gas cylinder with purity and no solid particle impurity, the gas can be helium, nitrogen or carbon dioxide, the absolute pressure inside the gas source needs to be higher than standard atmospheric pressure, the two-position two-way electromagnetic valve is an inflation switch valve, the two-position three-way electromagnetic valve is a filling and shrinkage switch valve, and the safety valve is used for ensuring that the pressure value inside a gas path does not exceed the maximum pressure resistance value. The gas flowmeter collects the real-time flow of the gas entering the coronary sinus pulse saccule and feeds the flow back to the control module 202, so that discrete integral calculation is performed to obtain the inner volume of the coronary sinus pulse saccule, and the second gas circuit pressure collection module collects the real-time pressure value of the relevant part in the gas circuit and is used for ensuring function realization and safety alarm. The second temperature acquisition module adopts a gas temperature sensor which is connected in series between the two-position three-way electromagnetic valve and the coronary sinus pulse saccule and is used for detecting the temperature of the gas flowing into the coronary sinus pulse saccule. In this embodiment, the balloon is driven to be filled with the positive pressure of the gas cylinder provided with the gas source after passing through the pressure reducing valve, the gas cylinder has a relatively high positive pressure, and a relatively small positive pressure is obtained after passing through the pressure reducing valve, and the positive pressure gas fills the balloon. The vacuum pump is connected with the two three-way electromagnetic valves and is used for extracting the gas in the coronary sinus pulse saccule and discharging the gas to the gas outlet so as to shrink the saccule. The fourth pressure gauge is a mechanical pressure gauge, indicates the outlet pressure value of the current gas cylinder, can also reflect the residual gas quantity of the current gas cylinder, the fifth pressure gauge is an electronic pressure gauge and is used for monitoring the pressure value after the pressure reducing valve, the second gas circuit pressure acquisition module is used for transmitting the gas pressure value to the control module 202, the sixth pressure gauge is an electronic pressure gauge, and when the two-position three-way electromagnetic valve is switched to the gas flowmeter and the coronary sinus pulse balloon, the current gas pressure flowing into the balloon is indicated, and meanwhile, the second gas circuit pressure acquisition module is used for transmitting the gas pressure value to the control module 202.
The embodiment of the invention realizes a safe, stable and reliable coronary sinus pulse balloon filling and contracting control system, and can realize rapid control of balloon filling and contracting by using a small-volume flow sensor and a vacuum pump, thereby remarkably reducing the volume and the weight of equipment and increasing the application scene flexibility of the equipment.
The above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims (10)

1. A method of coronary sinus pulse balloon control, comprising:
receiving a set pressure difference value and a 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;
and adjusting the filling size of the balloon based on the real-time pressure difference value and the set pressure difference value.
2. The coronary sinus impulse balloon control method according to claim 1, comprising, prior to receiving the set differential pressure value: and calculating and outputting the adjusting range of the set pressure difference value.
3. The coronary sinus pulse balloon control method according to claim 2, wherein the calculating and outputting the adjustment range of the set differential pressure value includes:
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.
4. The coronary sinus pulse balloon control method according to claim 1, further comprising calculating a volume of gas entering the balloon, calculating a balloon volume from the gas volume and ideal gas state equation, and outputting.
5. The coronary sinus pulse balloon control method according to claim 4, wherein the calculating and outputting balloon volumes according to the gas volume and ideal gas state equation 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.
6. 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 configured to perform the coronary sinus pulse balloon control method of any one of claims 1-5.
7. The coronary sinus pulse balloon control device according to claim 6, 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.
8. The coronary sinus pulse balloon control device according to claim 6, 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.
9. The coronary sinus pulse balloon control device according to claim 8, 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.
10. The coronary sinus pulse balloon control device according to claim 6, 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.
CN202310138524.6A 2023-02-15 2023-02-15 Coronary sinus pulse saccule control method and control device Pending CN116158800A (en)

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US20110295302A1 (en) * 2010-05-25 2011-12-01 Miracor Medical Systems Gmbh Treating Heart Tissue
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CN104688209A (en) * 2013-12-04 2015-06-10 乐普(北京)医疗器械股份有限公司 Invasive blood pressure detecting and analyzing method and system
CN113769246A (en) * 2021-09-13 2021-12-10 王建 Coronary sinus pressure regulating system
CN113967316A (en) * 2021-11-22 2022-01-25 山东瑞安泰医疗技术有限公司 Implanted aorta counterpulsation device with pressure sensing automatic regulation and control function
CN114886495A (en) * 2022-01-11 2022-08-12 武汉拓扑转化医学研究中心有限公司 Pressure control intermittent coronary sinus plugging device
CN115120849A (en) * 2022-08-01 2022-09-30 首都医科大学附属北京安贞医院 Vein bridge vasodilator

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040172004A1 (en) * 2001-07-17 2004-09-02 Werner Mohl Method and device for the intermitten occlusion of the coronary sinus
CN1839765A (en) * 2005-02-24 2006-10-04 伊西康内外科公司 Device for non-invasive measurement of fluid pressure in an adjustable restriction device
US20110295302A1 (en) * 2010-05-25 2011-12-01 Miracor Medical Systems Gmbh Treating Heart Tissue
CN102512225A (en) * 2011-12-31 2012-06-27 重庆邮电大学 Device and method for intelligently controlling blood flow of femoral artery
CN104688209A (en) * 2013-12-04 2015-06-10 乐普(北京)医疗器械股份有限公司 Invasive blood pressure detecting and analyzing method and system
CN113769246A (en) * 2021-09-13 2021-12-10 王建 Coronary sinus pressure regulating system
CN113967316A (en) * 2021-11-22 2022-01-25 山东瑞安泰医疗技术有限公司 Implanted aorta counterpulsation device with pressure sensing automatic regulation and control function
CN114886495A (en) * 2022-01-11 2022-08-12 武汉拓扑转化医学研究中心有限公司 Pressure control intermittent coronary sinus plugging device
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