Control method for balloon inflation, medical balloon system, and storage medium

Abstract

The application provides a balloon inflation control method, a medical balloon system and a storage medium. The method is executed by a microprocessor, and the method comprises the following steps: the microprocessor controls a power system to inject inflation medium into a balloon at an initial inflation speed; whether the balloon is inflated to completion is determined according to a proximal end blood pressure value detected by a first sensor and / or a balloon internal pressure value detected by a second sensor, or an actual inflation volume of the balloon; when the inflation is completed and a first preset time elapses or the proximal end blood pressure value reaches a first preset value, the microprocessor controls the power system to release the balloon, so that the balloon internal pressure value detected by the second sensor reaches a second preset value; after the balloon internal pressure value remains the second preset value for a second preset time, the microprocessor acquires the proximal end blood pressure value detected by the first sensor after the second preset time; and the microprocessor controls the power system to adjust the inflation amount of the balloon according to the relationship between the proximal end blood pressure value and a standard value.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical first aid, in particular to a balloon inflation control method, a medical balloon system and a storage medium. BACKGROUND

[0002] Cardiac arrest refers to a sudden stop of heart beating caused by various reasons, which leads to termination of systemic blood circulation, and further causes ischemia and hypoxia of various organs and tissues and dysfunction. If the patient does not receive timely rescue, he will die rapidly. The traditional first aid method uses artificial or mechanical chest compression for cardiopulmonary resuscitation to assist in rebuilding the pumping function of the heart, but the resuscitation success rate is low. Therefore, the industry urgently needs to develop a new auxiliary technology that can improve the hemodynamics of cardiopulmonary resuscitation on the basis of external chest compression.

[0003] In recent years, research has shown that resuscitative aortic balloon occlusion (REBOA) can significantly improve the blood perfusion level of critical organs such as heart and brain by placing a balloon catheter in the aorta and completely inflating it during cardiopulmonary resuscitation, thereby improving the resuscitation success rate.

[0004] However, it has the following defects:

[0005] (1) With the prolongation of cardiopulmonary resuscitation time, complete aortic occlusion can cause ischemia of the distal end of the balloon for a long time, leading to necrosis of the lower limbs, i.e. severe ischemic injury of all organs and tissues below the occlusion site, which is difficult to achieve the optimal hemodynamic goal of individual physiological needs.

[0006] (2) The complete occlusion mode can cause rapid deflation of the balloon after successful resuscitation of the body, causing unstable blood flow in the cardiovascular system due to sudden changes in blood pressure, resulting in large fluctuations in the hemodynamics of the body, and even reappearing cardiac arrest.

[0007] The existing REBOA device is difficult to balance the optimization of hemodynamics, protection of distal organs and stability after cardiopulmonary resuscitation in pre-hospital and emergency scenarios, so the existing device for treating cardiac arrest has the problem of being difficult to accurately control the inflation and deflation of the balloon. SUMMARY

[0008] In view of the deficiencies of the prior art, the purpose of the present application is to provide a balloon inflation control method, a medical balloon system and a storage medium to solve the problem of being difficult to accurately control the inflation and deflation of the balloon in the prior art.

[0009] The above technical purpose of the present application is achieved by the following technical scheme:

[0010] In a first aspect, the embodiments of the present application provide a control method for balloon inflation, applied to a medical balloon system. The medical balloon system comprises a control host, a balloon catheter and a balloon. The balloon catheter is connected to the control host and the balloon. The balloon catheter comprises a medium cavity and a blood cavity which are independent of each other. The outlet of the medium cavity is located in the balloon, and the outlet of the blood cavity is located at the proximal end outside the balloon. The control host comprises a microprocessor, a first sensor connected to the blood cavity, a second sensor connected to the medium cavity, and a power system. The first sensor is used to detect the proximal blood pressure value in real time, and the second sensor is used to detect the balloon internal pressure value in real time. The microprocessor is connected to the first sensor, the second sensor and the power system. The method is executed by the microprocessor, and the method comprises the following steps: the microprocessor controls the power system to inject inflation medium into the balloon at an initial inflation speed; the microprocessor determines whether the balloon is inflated to completion according to the proximal blood pressure value detected by the first sensor and / or the balloon internal pressure value detected by the second sensor, or the actual inflation volume of the balloon; when the inflation is completed and after a first preset time elapses, or when the proximal blood pressure value reaches a first preset value, the microprocessor controls the power system to deflate the balloon, so that the balloon internal pressure value detected by the second sensor reaches a second preset value; after the balloon internal pressure value remains at the second preset value for a second preset time, the microprocessor acquires the proximal blood pressure value detected by the first sensor after the second preset time; and the microprocessor controls the power system to adjust the inflation amount of the balloon according to the relationship between the proximal blood pressure value and a standard value.

[0011] Further, the microprocessor controls the power system to adjust the inflation amount of the balloon according to the relationship between the proximal blood pressure value and the standard value, which comprises: if the proximal blood pressure value is higher than the standard value, the microprocessor controls the power system to continue deflating the balloon; and if the proximal blood pressure value is lower than the standard value, the microprocessor controls the power system to stop deflating the balloon, and controls the power system to inject inflation medium into the balloon, so that the balloon internal pressure value reaches a third preset value.

[0012] Further, if the proximal blood pressure value is higher than the standard value, the microprocessor controls the power system to continue deflating the balloon, which comprises: when the proximal blood pressure value is higher than the standard value, the deflation amount of each stage is determined according to the total inflation amount when the current inflation is completed, and the equal proportion of the preset deflation percentage of each stage; and the power system is controlled to deflate the inflation medium in stages according to the deflation amount and the preset deflation time. If the proximal blood pressure value is lower than the standard value, the microprocessor controls the power system to stop deflating the balloon, and controls the power system to inject inflation medium into the balloon, which comprises: when the proximal blood pressure value is lower than the standard value, the inflation amount of each stage is determined according to the total inflation amount when the current inflation is completed, and the equal proportion of the preset inflation percentage of each stage; and the power system is controlled to inject inflation medium into the balloon in stages according to the inflation amount and the preset inflation time.

[0013] Further, if the proximal end blood pressure value is higher than the standard value, the microprocessor controls the power system to continue deflating the balloon, including: when the proximal end blood pressure value is higher than the standard value, deflating the filling medium in stages according to the preset deflation speed and the preset deflation time of each stage; if the proximal end blood pressure value is lower than the standard value, the microprocessor controls the power system to stop deflating the balloon and controls the power system to inject the filling medium into the balloon, including: when the proximal end blood pressure value is lower than the standard value, injecting the filling medium into the balloon in stages according to the preset deflation speed and the preset filling time of each stage.

[0014] Further, the method further comprises: the microprocessor calculates the difference between the proximal end blood pressure value and the standard value to obtain a blood pressure deviation value; if the proximal end blood pressure value is higher than the standard value, the microprocessor controls the power system to continue deflating the balloon, including: when the proximal end blood pressure value is greater than or equal to the standard value, the microprocessor substitutes the blood pressure deviation value into the preset PID algorithm formula to determine a preset deflation amount, and controls the power system to continue deflating the balloon according to the preset deflation amount; if the proximal end blood pressure value is lower than the standard value, the microprocessor controls the power system to stop deflating the balloon and controls the power system to inject the filling medium into the balloon, including: when the proximal end blood pressure value is less than the standard value, the microprocessor substitutes the blood pressure deviation value into the preset PID algorithm formula to determine a preset filling amount, and controls the power system to inject the filling medium into the balloon according to the preset filling amount.

[0015] Further, the first sensor is also used to monitor the arterial pressure in real time and generate a waveform, and after the microprocessor controls the power system to adjust the filling amount of the balloon according to the relationship between the proximal end blood pressure value and the standard value, the method further comprises: after the balloon pressure value remains at a third preset value for a third preset time, the microprocessor obtains the waveform from the first sensor; the microprocessor determines whether the autonomous circulation is restored according to whether the spontaneous arterial pressure waveform is detected in the waveform and whether the proximal end blood pressure value reaches the standard value.

[0016] Further, the method further comprises: if the spontaneous arterial pressure waveform is detected and the proximal end blood pressure value reaches the standard value, it is determined that the autonomous circulation is restored; if the spontaneous arterial pressure waveform is not detected and / or the proximal end blood pressure value does not reach the standard value, it is determined that the autonomous circulation is not restored.

[0017] Further, the method further comprises: after it is determined that the autonomous circulation is restored, the microprocessor controls the power system to adjust the deflation amount of the balloon; after it is determined that the autonomous circulation is not restored, the microprocessor continues to control the power system to adjust the filling amount of the balloon according to the relationship between the proximal end blood pressure value and the standard value.

[0018] Further, the microprocessor determines whether the balloon is inflated completely according to the proximal end blood pressure value detected by the first sensor and the balloon inner pressure value detected by the second sensor, including: if the balloon inner pressure value is greater than the proximal end blood pressure value, and the change amount of the rising rate of the proximal end blood pressure value exceeds a preset threshold, then determining that the balloon is inflated completely; if the balloon inner pressure value is less than or equal to the proximal end blood pressure value, and / or the change amount of the rising rate of the proximal end blood pressure value does not exceed the preset threshold, then determining that the balloon is not inflated completely.

[0019] Further, the microprocessor determines whether the balloon is inflated completely according to the actual inflation volume of the balloon, including: judging the relationship between the actual inflation volume and a preset target inflation volume to determine whether the balloon is inflated completely; if the actual inflation volume reaches the target inflation volume, then determining that the balloon is inflated completely; if the actual inflation volume does not reach the target inflation volume, then determining that the balloon is not inflated completely.

[0020] In a second aspect, the embodiments of the present application further provide a medical balloon system, which applies the control method of balloon inflation provided in the above embodiments, and the medical balloon system comprises: a balloon; a balloon catheter, one end of which is connected to the balloon, the balloon catheter comprising a medium cavity and a blood cavity which are independent of each other, the outlet of the medium cavity being located in the balloon, and the outlet of the blood cavity being located at the proximal end outside the balloon; a control host, the other end of the balloon catheter being connected to the control host, the control host comprising: a power system, connected to the balloon; a microprocessor, connected to the power system, used for controlling the power system to work to drive the balloon to inflate or deflate; a first sensor, connected to the blood cavity and the microprocessor, used for detecting a proximal end blood pressure value; and a second sensor, connected to the medium cavity and the microprocessor, used for detecting a balloon inner pressure value.

[0021] Further, the inflation medium is physiological saline.

[0022] In a third aspect, the embodiments of the present application further provide a computer readable storage medium, which stores an executable program, and the executable program is used to implement the control method of balloon inflation provided in the above embodiments.

[0023] The beneficial effects of the embodiments of the present application are:

[0024] In an embodiment of the present application, the balloon is first inflated for a first preset time, then the pressure at the corresponding positions is detected by the first sensor and the second sensor respectively, and whether to inflate or deflate is determined according to the detection results, so that the inflation degree of the balloon is intelligently controlled throughout the process to realize the partial occlusion of the balloon, thereby improving the blood perfusion effect of the key organs and the heart and brain during the external chest compression by the medical balloon system provided with the external chest compression system. BRIEF DESCRIPTION OF DRAWINGS

[0025] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the embodiments of the present application will be briefly introduced.

[0026] Figure 1 A structural schematic diagram of a medical balloon system according to an embodiment of the present application;

[0027] Figure 2 A structural schematic diagram of a balloon catheter and a balloon of a medical balloon system according to an embodiment of the present application;

[0028] Figure 3 A structural schematic diagram of a power system of a medical balloon system according to an embodiment of the present application;

[0029] Figure 4 A main flowchart of a control method of balloon inflation according to an embodiment of the present application;

[0030] Figure 5 A flowchart of adjusting a balloon inflation amount of a control method of balloon inflation according to an embodiment of the present application;

[0031] Figure 6 A flowchart of autonomous circulation detection of a control method of balloon inflation according to an embodiment of the present application;

[0032] Figure 7 A flowchart of determining whether balloon inflation is completed of a control method of balloon inflation according to an embodiment of the present application;

[0033] Figure 8 A waveform diagram of displaying a balloon internal pressure value and a proximal end blood pressure value of a control method of balloon inflation according to an embodiment of the present application;

[0034] Figure 9 A flowchart of determining whether balloon inflation is completed of a control method of balloon inflation according to another embodiment of the present application;

[0035] Figure 10 A structural schematic diagram of a medical balloon system according to another embodiment of the present application;

[0036] Figure 11 A structural enlarged view of A in FIG. 1; Figure 10

[0037] A structural enlarged view of B in FIG. 1; Figure 12 Figure 10

[0038] Figure 13 A structural schematic diagram of a peristaltic pump of a medical balloon system according to an embodiment of the present application.

[0039] ​​Reference numerals: 1. Control host; 2. Balloon catheter; 21. Medium chamber; 22. Blood chamber; 3. Balloon; 4. First sensor; 5. Second sensor; 6. Power system; 61. Liquid storage bag; 62. Housing; 63. Peristaltic pump; 631. Pump pipe; 632. Rotor; 64. Three-way valve; 641. First valve port; 642. Second valve port; 643. Third valve port; 65. Power supply module; 66. First delivery pipe; 67. Second delivery pipe; 68. Signal connector. Detailed Implementation

[0040] In the description of this application, it should be noted that the terms "inner" and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product is in use. They are used only for the convenience of describing this application and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0041] The technical solutions in the embodiments of this application will now be described with reference to the accompanying drawings.

[0042] See Figures 1-4 The medical balloon system includes a control unit 1, a balloon catheter 2, and a balloon 3.

[0043] The balloon catheter 2 connects the control host 1 and the balloon 3. The balloon catheter 2 includes an independent medium chamber 21 and a blood chamber 22. The outlet of the medium chamber 21 is located inside the balloon 3, and the outlet of the blood chamber 22 is located at the proximal end outside the balloon 3.

[0044] The control host 1 includes a microprocessor, a first sensor 4 connected to the blood chamber 22, a second sensor 5 connected to the medium chamber 21, and a power system 6. The first sensor 4 is used to detect the proximal blood pressure value in real time, the second sensor 5 detects the intraballoon pressure value in real time, and the microprocessor is connected to the first sensor 4, the second sensor 5, and the power system 6.

[0045] The control host 1 is connected to a chest compression system that transmits signals to the microprocessor. The chest compression system is used to perform chest compressions. The medical balloon system works in conjunction with the chest compression system to control the inflation or deflation of the balloon 3.

[0046] This application provides a balloon inflation control method applied to the aforementioned medical balloon system. The balloon inflation control method is based on the aforementioned microprocessor system and includes steps S110~S150:

[0047] Step S110: The microprocessor controls the power system 6 to inject the filling medium into the balloon 3 at the initial filling rate.

[0048] In step S110 above, the initial inflation rate is the instantaneous flow rate of the inflation medium entering the balloon 3 at the beginning stage when performing operations such as balloon 3 expansion. It reflects the volume of the inflation medium entering per unit time initially. In one embodiment, the initial inflation rate shows a slow increasing trend, and the specific value is adjusted by the microprocessor according to the actual application.

[0049] Step S120: The microprocessor determines whether the balloon 3 has been fully inflated based on the proximal blood pressure value detected by the first sensor 4 and / or the intraballoon pressure value detected by the second sensor 5, or the actual inflation volume of the balloon 3.

[0050] In this context, "filling complete" generally refers to the balloon 3 reaching a volume sufficient to block the blood vessel, i.e., the outer wall of the balloon 3 and the inner wall of the blood vessel are in an interference fit.

[0051] In step S120 above, the first sensor 4 monitors the proximal blood pressure value and the second sensor 5 monitors the intraballoon pressure value in real time to ensure that feedback is received promptly when the balloon 3 is fully inflated, preventing balloon 3 rupture due to overinflation. This avoids the cumbersome nature of manual operation and improves the accuracy and automation of the occlusion control.

[0052] Step S130: When inflation is complete and after a first preset time has elapsed or when the proximal blood pressure value reaches a first preset value, the microprocessor controls the power system 6 to deflate the balloon 3 so that the balloon pressure value detected by the second sensor 5 reaches a second preset value.

[0053] In one embodiment, the first preset time is T1, where 4min≤T1≤6min.

[0054] In step S130 above, the balloon 3 is first kept fully inflated for a period of time, i.e., the first preset time, or the blood pressure value at the proximal end is detected to reach the first preset value, and then kept fully inflated for a period of time. During this period, the cardiopulmonary resuscitation operation of the external cardiac compression system can be performed simultaneously to ensure the patient's cardiac and cerebral perfusion and blood pressure recovery.

[0055] Step S140: After the intraballoon pressure value remains at the second preset value for a second preset time, the microprocessor acquires the proximal blood pressure value detected by the first sensor 4 after the second preset time.

[0056] In step S140 above, in order to determine whether it is necessary to continue inflating or deflating the balloon 3, the proximal blood pressure value needs to be measured.

[0057] In an embodiment, the second preset value can be 75% of the total filling amount, and the second preset time is T2, wherein 1 min≤T2≤3 min.

[0058] Step S150: The microprocessor controls the power system 6 to adjust the filling amount of the balloon 3 according to the relationship between the proximal end blood pressure value and the standard value.

[0059] In the step S150, adjusting the filling amount of the balloon 3 includes adjusting the deflation of the balloon 3 and adjusting the inflation of the balloon 3. Through real-time monitoring of each blood pressure value, the inflation and deflation of the balloon 3 are dynamically adjusted and accurately controlled to meet the actual blood flow required by the patient's body, improve the heart and brain perfusion effect, and the standard value is a target value set according to the current clinical evidence-based guidelines for traumatic shock, including mean arterial pressure target value, diastolic pressure target value and systolic pressure target value.

[0060] The mean arterial pressure target value refers to the ideal range or minimum threshold that the mean arterial pressure should reach in clinical practice in order to maintain the effective perfusion of the patient's tissues and organs, and is used to reflect the hemodynamic state of coronary artery and brain perfusion during cardiac arrest; The diastolic pressure target value represents the highest value of arterial blood pressure when the left ventricle pumps blood into the aorta during heart contraction, which is used to reflect the pumping capacity of the heart and the elasticity of the aorta; The systolic pressure target value represents the minimum pressure of the arterial elasticity to push the blood flow when the heart is diastolic.

[0061] In an embodiment, the chest compression system performs chest compression operation in real time to perform cardiopulmonary resuscitation at the same time when the inflation of the balloon 3 is completed, and signal transmission is performed in real time with the microprocessor.

[0062] In an embodiment, the first sensor 4 and the second sensor 5 can be voltage sensors or strain pressure sensors.

[0063] Referring to Figure 5 In an embodiment, the step S150 includes sub-steps S151-S152:

[0064] Sub-step S151: Determine whether the proximal end blood pressure value is higher than the standard value.

[0065] In an embodiment, the systolic pressure target value in the standard value is ≥60 mmHg, the diastolic pressure target value is ≥40 mmHg, and the mean arterial pressure target value is ≥45 mmHg. Determine whether the proximal end blood pressure value is higher than the value of the three.

[0066] Sub-step S152: If the proximal end blood pressure value is higher than the standard value, the microprocessor controls the power system 6 to continue to deflate the balloon 3.

[0067] Sub-step S153: If the proximal blood pressure value is lower than the standard value, the microprocessor controls the power system 6 to stop deflating the balloon 3, and controls the power system 6 to inject the inflation medium into the balloon 3 to make the pressure value in the balloon reach a third preset value.

[0068] In an embodiment, in the step S153, the third preset value is the pressure value in the balloon 3 after the injection of the inflation medium, when the proximal blood pressure value reaches the standard value.

[0069] In an embodiment, the sub-step S152 includes sub-step S1521 and sub-step S1522.

[0070] Sub-step S1521: When the proximal blood pressure value is higher than the standard value, the inflation amount of each stage is determined according to the total inflation amount when the inflation is completed and the equal proportion of the deflation percentage of the preset staged deflation.

[0071] It should be noted that the total inflation amount is different for different individuals, and thus the specific total inflation amount is determined by the system in actual application.

[0072] In the sub-step S1521, the deflation percentage can be between 5% and 40%, and in an embodiment, the deflation percentage can be 25% of the total inflation amount.

[0073] Sub-step S1522: The power system 6 is controlled to deflate the inflation medium in stages according to the deflation amount and the preset deflation time.

[0074] In an embodiment, the deflation time is the time from the start of deflating the balloon 3 to the pressure or volume in the balloon 3 dropping to the deflation completion standard, and the preset deflation time can be dynamically adjusted according to the actual situation, which is flexible.

[0075] In an embodiment, the sub-step S153 includes sub-step S1531 and sub-step S1532.

[0076] Sub-step S1531: When the proximal blood pressure value is lower than the standard value, the inflation amount of each stage is determined according to the total inflation amount when the inflation is completed and the equal proportion of the inflation percentage of the preset staged inflation.

[0077] In the sub-step S1531, the inflation percentage can be between 5% and 40%, and in an embodiment, the inflation percentage can be 25% of the total inflation amount.

[0078] Sub-step S1532: The power system 6 is controlled to inject the inflation medium into the balloon 3 in stages according to the inflation amount and the preset inflation time.

[0079] In an embodiment, the inflation time is the time from the start of the inflation medium injection to the balloon 3 reaching the preset volume. The preset inflation time can be dynamically adjusted according to actual conditions, which is flexible.

[0080] The embodiment of the application can smoothly restore blood flow by injecting the inflation medium into the balloon 3 according to the preset inflation amount and inflation time in stages, and avoid the influence on the heart recovery caused by the large fluctuation of the body hemodynamics due to the sudden recovery of blood flow.

[0081] In another embodiment, the above-mentioned sub-step S152 comprises, when the near-end blood pressure value is higher than the standard value, discharging the inflation medium in stages according to the preset discharging speed and the preset discharging time of each stage.

[0082] The preset discharging speed means discharging in a uniform speed manner, the preset discharging speed is S1, 3ml / min≤S1≤5ml / min, and the discharging time T3 of each stage is equal, and 1min≤T3≤2min.

[0083] In another embodiment, the above-mentioned sub-step S153 comprises, when the near-end blood pressure value is lower than the standard value, injecting the inflation medium into the balloon 3 in stages according to the preset inflation speed and the preset inflation time of each stage.

[0084] The preset inflation speed means inflating in a uniform speed manner, the preset inflation speed is S2, 3ml / min≤S2≤5ml / min, and the inflation time T4 of each stage is equal, and 1min≤T3≤2min.

[0085] The embodiment of the application can more smoothly restore blood flow by discharging the balloon 3 or injecting the inflation medium into the balloon 3 according to the preset percentage, and comparing the difference between the near-end blood pressure value and the standard value in the process, and avoid the adverse effects that may be caused by the sudden recovery of blood flow.

[0086] In other embodiments, the above-mentioned balloon inflation control method further comprises that the microprocessor calculates the difference between the near-end blood pressure value and the standard value to obtain a blood pressure deviation value.

[0087] In an embodiment, the near-end blood pressure value is , the standard value is , the blood pressure deviation value is , and the blood pressure deviation value is calculated by . .

[0088] The above-mentioned sub-step S152 comprises, when the near-end blood pressure value is greater than or equal to the standard value , the microprocessor calculates the blood pressure deviation value Substitute the preset PID algorithm formula, determine the preset discharge amount , and control the power system 6 to discharge the balloon 3 according to the preset discharge amount .

[0089] The above sub-step S153 includes that when the blood pressure value at the proximal end is less than the standard value , the microprocessor substitutes the blood pressure deviation value into the preset PID algorithm formula to determine the preset filling amount , and controls the power system 6 to fill the balloon 3 with the filling medium according to the preset filling amount .

[0090] In an embodiment, the preset PID algorithm formula is as follows:

[0091]

[0092] wherein V(t) is replaced by , respectively, to obtain the corresponding preset discharge amount and the preset filling amount .

[0093] is the blood pressure deviation value; is the proportional term, which is used to adjust the filling amount or the discharge amount in real time according to the current blood pressure deviation value , for example, when it is detected that the actual blood pressure deviates from the standard value and the blood pressure is low, i.e. < 0, and is a negative value, the proportional term immediately generates a filling amount adjustment value that is proportional to the deviation, i.e., the system increases the filling amount to increase the blood pressure, and the blood pressure deviation is adjusted in a linear relationship, i.e., the greater the deviation, the greater the adjustment value, which enables the system to quickly respond to sudden changes in the blood pressure and make timely adjustments. When the blood pressure is low, the filling amount is increased to increase the proximal blood pressure, and when the blood pressure is high, the discharge amount is increased to reduce the proximal blood pressure.

[0094] is the integral term, which is used to time-integrate the blood pressure deviation value, i.e., even if the deviation is very small, as long as it persists, the integral value will continuously accumulate and increase, which eliminates long-term errors. For example, when it is detected that the blood pressure rapidly decreases, if the blood pressure is still in a long-term low state after adjustment by the proportional term , the integral term will gradually accumulate the blood pressure deviation value, continuously increase the positive adjustment value, and as the integral term increases, the filling amount adjustment value output by the system also gradually increases, until the steady-state error is completely eliminated. The integral term ​The setting can prevent sustained hypotension caused by insufficient adjustment of the proportional term, and can gradually correct the filling amount through integral action, and can gradually correct the discharge amount through integral action when causing sustained hypertension.

[0095] The derivative term is used to predict the blood pressure change trend, and the filling amount or the discharge amount is adjusted in advance through the change of the blood pressure deviation value. The derivative term focuses on the change rate of the blood pressure deviation, i.e., the derivative of the blood pressure deviation value, rather than the deviation itself. For example, when the blood pressure rapidly decreases, the derivative of the blood pressure deviation value is negative, and the derivative term generates a positive adjustment amount, and the filling amount is increased in advance to slow down the decreasing trend, thereby inhibiting blood pressure overshoot or oscillation.

[0096] The embodiment of the present application automatically and dynamically adjusts the filling amount and the discharge amount of the balloon 3 through the PID algorithm, thereby improving the accuracy of controlling the filling and discharge of the balloon 3.

[0097] Referring to Figure 6 , in an embodiment, the first sensor 4 is further used to monitor the arterial pressure in real time and generate a waveform. After the step S150, the control method of the balloon filling further includes steps S160-S210:

[0098] Step S160: After the pressure value in the balloon maintains the third preset value for the third preset time, the microprocessor acquires the waveform from the first sensor 4.

[0099] The spontaneous arterial pressure waveform is the object for judging whether the cardiopulmonary resuscitation is successful, and the third preset time can be 3 min. The third preset value is maintained for the third preset time to ensure that the blood pressure is in a stable state.

[0100] Step S170: The microprocessor judges whether the spontaneous circulation is restored according to whether the spontaneous arterial pressure waveform is detected in the waveform and whether the near-end blood pressure value reaches the standard value.

[0101] The spontaneous circulation refers to the process of restoring spontaneous heartbeat and pulse after cardiac arrest through cardiopulmonary resuscitation, such as external chest compression by an external compression system.

[0102] It should be noted that the first sensor 4 acquires the arterial pressure in real time and forms the waveform during the operation of the system, and transmits the waveform to the microprocessor. The microprocessor judges whether the spontaneous arterial pressure waveform exists after the balloon 3 maintains the third preset value for the third preset time, i.e., the balloon 3 judges whether the spontaneous arterial pressure waveform exists after the balloon 3 occludes the aorta for a certain time.

[0103] Step S180: If the spontaneous arterial pressure waveform is detected and the near-end blood pressure value reaches the standard value, it is determined that the spontaneous circulation is restored.​

[0104] Step S190: If the spontaneous arterial pressure waveform is not detected, and / or the value of the blood pressure proximal to the heart does not reach the standard value, it is determined that spontaneous circulation is not restored.

[0105] Step S200: After determining that spontaneous circulation is restored, the microprocessor controls the power system 6 to adjust the amount of discharge of the balloon 3.

[0106] In an embodiment, in the above-mentioned step S200, after detecting the spontaneous arterial pressure waveform, i.e., determining spontaneous circulation, it can be indicated that cardiopulmonary resuscitation is successful, and the microprocessor can control the power system 6 to discharge the filling medium in the balloon 3 at a constant speed, and in this step, the dynamic feedback of the first sensor 4 and the second sensor 5 is maintained throughout, and after finally determining that the balloon 3 is discharged, the microprocessor can stop running.

[0107] The embodiment of the present application can improve the timing and degree of controlling the blockage and restoration of blood flow by starting to determine whether the balloon 3 can be discharged only when the spontaneous arterial pressure waveform is detected and the value of the blood pressure proximal to the heart reaches the standard value, thereby effectively overcoming the defect that it is difficult to accurately control the discharge in the prior art.

[0108] Step S210: After determining that spontaneous circulation is not restored, the microprocessor continues to control the power system 6 to adjust the amount of filling of the balloon 3 according to the relationship between the value of the blood pressure proximal to the heart and the standard value.

[0109] In the above-mentioned step S210, if spontaneous circulation is not restored, it is necessary to maintain the occlusion state of the balloon 3, and at the same time, it is necessary to always maintain the chest compression system to perform chest compression operation during this process.

[0110] In the embodiment of the present application, through the real-time monitoring function of the first sensor 4 and the second sensor 5, full monitoring during cardiopulmonary resuscitation is realized, when the spontaneous arterial pressure waveform is detected, it can be determined that cardiopulmonary resuscitation is successful, and after cardiopulmonary resuscitation is successful, through accurate control, based on the standard value which is the hemodynamic index currently clinically confirmed to ensure the basic demand of organ perfusion of the body, the degree of discharge of the balloon 3 is accurately controlled to maintain the target level, and the above-mentioned steps S610-S620 are repeated for stability monitoring, under the control method of the balloon filling, the balloon 3 is gradually discharged to be completely emptied, and the dynamic feedback of the first sensor 4 and the second sensor 5 is guaranteed throughout, and after the balloon 3 is discharged, the microprocessor can stop running.

[0111] Referring to Figures 7-8 In an embodiment, the microprocessor in the above-mentioned step S120 determines whether the balloon 3 is filled completely according to the value of the blood pressure proximal to the heart detected by the first sensor 4 and the value of the pressure in the balloon detected by the second sensor 5, including sub-step S121-sub-step S123:

[0112] Sub-step S121: judging whether the balloon inner pressure value is greater than the proximal end blood pressure value and whether the change amount of the rising rate of the proximal end blood pressure value exceeds the preset threshold.

[0113] Sub-step S122: if the balloon inner pressure value is greater than the proximal end blood pressure value and the change amount of the rising rate of the proximal end blood pressure value exceeds the preset threshold, it is determined that the balloon 3 is refilled completely.

[0114] Sub-step S123: if the balloon inner pressure value is less than or equal to the proximal end blood pressure value and / or the change amount of the rising rate of the proximal end blood pressure value does not exceed the preset threshold, it is determined that the balloon 3 is not refilled completely.

[0115] The embodiment of the present application can accurately and automatically determine the refilling degree of the balloon 3 by monitoring the balloon inner pressure value and the proximal end blood pressure value in real time and determining whether the balloon 3 is refilled completely according to the relationship therebetween, thereby improving the accuracy of subsequent control of the refilling and discharge of the balloon 3 compared with artificial detection and manual operation.

[0116] Referring to Figure 9 In another embodiment, the microprocessor in the above step S120 determines whether the balloon 3 is completed according to the actual refilling volume of the balloon, including sub-step S121'-sub-step S123':

[0117] Sub-step S121': judging whether the actual refilling volume reaches the preset target refilling volume.

[0118] The preset target refilling volume can be represented by the refilling amount of the refilling medium required when the volume of the balloon 3 reaches the maximum safety threshold. In actual application, the target refilling volume is different for different individuals, and the preset target refilling volume needs to be adjusted and set according to the actual situation.

[0119] In an embodiment, a flow meter is arranged in the power system 6, which is connected between the peristaltic pump 63 or other power pump of the power system and the passage of the balloon 3, detects the pulse signal in real time, and feeds back to the microprocessor. The microprocessor calculates the actual refilling volume according to the pulse signal.

[0120] Sub-step S122': if the actual refilling volume reaches the target refilling volume, it is determined that the balloon 3 is refilled completely.

[0121] Sub-step S122': if the actual refilling volume does not reach the target refilling volume, it is determined that the balloon 3 is not refilled completely.

[0122] The embodiment of the application determines the inflation degree of the balloon 3 by automatically judging the relationship between the actual inflation volume and the preset target inflation volume. Compared with the traditional way of manually judging the inflation degree of the balloon 3, the application realizes automatic judgment throughout the whole process, and can improve the accuracy of the judgment result.

[0123] The control method for balloon inflation provided by the embodiment of the application can improve the effect of blood perfusion of key organs and heart and brain during external chest compression by the external chest compression system, while ensuring blood perfusion of distal organs under partial occlusion of the balloon 3, and further improve the effect of first aid of the medical balloon system by intelligently controlling the deflation of the balloon 3 after successful cardiopulmonary resuscitation, that is, detecting a spontaneous arterial pressure waveform.

[0124] In combination with Figures 1-3 , referring to Figures 10-13 , the embodiment of the application also provides a medical balloon system applying the control method for balloon inflation provided by the above embodiment. The medical balloon system includes a balloon 3, a balloon catheter 2 and a control host 1.

[0125] One end of the balloon catheter 2 is connected to the balloon 3, and the other end of the balloon catheter 2 is connected to the control host 1. The balloon catheter 2 includes a medium cavity 21 and a blood cavity 22 which are independent of each other. The outlet of the medium cavity 21 is located in the balloon 3, and the outlet of the blood cavity 22 is located at the proximal end outside the balloon 3. The balloon 3 can be delivered into the aorta in the human body through the balloon catheter 2.

[0126] The control host 1 includes a power system 6, a microprocessor, a first sensor 4 and a second sensor 5.

[0127] The power system 6 is connected to the balloon 3 and is used for inflating or deflating the balloon 3.

[0128] The microprocessor is connected to the power system 6 and is used for controlling the power system 6 to work to drive the balloon 3 to inflate or deflate.

[0129] The first sensor 4 is connected to the blood cavity 22 and the microprocessor and is used for detecting the proximal end blood pressure value.

[0130] The second sensor 5 is connected to the medium cavity 21 and the microprocessor and is used for detecting the balloon internal pressure value.

[0131] The inflation medium is physiological saline.

[0132] The medical balloon system provided by the embodiment of the application simplifies the gas cylinder and gas path structure used by the traditional equipment by reasonable layout and setting the inflation medium as physiological saline, reduces the volume of the equipment and reduces the cost.

[0133] In an embodiment, the power system 6 comprises a liquid storage bag 61, a housing 62, a peristaltic pump 63 arranged in the housing 62, a three-way valve 64, and a power supply module 65.

[0134] The peristaltic pump 63 comprises a pump tube 631 and a rotor 632 abutting the pump tube 631, one end of the pump tube 631 is in communication with the liquid storage bag 61, and the other end of the pump tube 631 is connected to the three-way valve 64. The rotor 632 is rotated to extrude the filling medium in the pump tube 631.

[0135] The three-way valve 64 comprises a valve housing and a valve core arranged in the valve housing, the valve housing has a first valve port 641, a second valve port 642, and a third valve port 643, the first valve port 641 is connected to the blood cavity 22 of the balloon catheter 2 through a first delivery tube 66, the second valve port 642 is connected to the medium cavity 21 of the balloon catheter 2 through a second delivery tube 67, and the other end of the pump tube 631 is connected to the third valve port 643. The valve core is rotatably arranged in the valve housing, and the valve core is rotated to open or close the passageways of the first valve port 641 and the third valve port 643 and the passageways of the second valve port 642 and the third valve port 643, so as to realize the delivery of the filling medium.

[0136] In an embodiment, the medical balloon system further comprises an external chest compression system connected to the power system 6, which is used for external chest compression and cardiopulmonary resuscitation.

[0137] The power system 6 is further provided with a signal connector 68, which is connected to the peristaltic pump 63, the first sensor 4 and the second sensor 5, and the microprocessor, and the signal connector 68 is connected to the external chest compression system through an external connection line, and is used for communication with the external chest compression system.

[0138] In another embodiment, a wireless transmission module is arranged in the power system 6, which comprises a WIFI transmission module and a Bluetooth module, and the microprocessor is wirelessly connected to the external chest compression system through the wireless transmission module to transmit signals.

[0139] In an embodiment, the power supply module 65 is connected to the microprocessor to provide electric energy.

[0140] The medical balloon system provided by the embodiments of the present application simplifies the connection and storage structure, reduces the device size, and is convenient to carry by reasonably arranging the power system 6 and setting the filling medium as physiological saline.

[0141] The embodiments of the present application further provide a computer readable storage medium storing an executable program, and the executable program implements the balloon filling control method provided by the above embodiments.

[0142] In the description of the application, it also needs to be explained that, unless otherwise explicitly specified and limited, the terms "set", "connected" should be understood broadly, for example, can be fixedly connected, can also be detachably connected, or integrally connected, can be directly connected, can also be indirectly connected through an intermediate medium, can be the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in this application can be understood according to the specific circumstances.

[0143] It should be noted that the features in the embodiments of the present application can be combined with each other without conflict.

[0144] The above only describes the preferred embodiments of the present application and is not intended to limit the present application. For those skilled in the art, the present application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A medical balloon system, characterized in that, The medical balloon system includes a control unit, a balloon catheter, and a balloon. The balloon catheter connects the control unit and the balloon. The balloon catheter includes an independent media chamber and a blood chamber. The outlet of the media chamber is located inside the balloon, and the outlet of the blood chamber is located proximally outside the balloon. The control unit includes a microprocessor, a first sensor connected to the blood chamber, and a second sensor connected to the media chamber and a power system. The first sensor is used to detect proximal blood pressure in real time, and the second sensor is used to detect intra-balloon pressure in real time. The microprocessor connects the first sensor, the second sensor, and the power system. The microprocessor is used for: The power system is controlled to inject the inflation medium into the balloon at the initial inflation rate; Based on the proximal blood pressure value detected by the first sensor and / or the intraballoon pressure value detected by the second sensor, or the actual inflation volume of the balloon, it is determined whether the balloon is fully inflated. Full inflation generally means that the volume of the balloon has reached a level that can block the blood vessel, that is, the outer wall of the balloon and the inner wall of the blood vessel are in an interference fit. Once the inflation is complete, within the first preset time, combine with the external cardiac compression system to perform cardiopulmonary resuscitation operations to ensure cardiac and cerebral perfusion and blood pressure recovery in the patient; When inflation is complete and a first preset time has elapsed, or when the proximal blood pressure value reaches a first preset value, the power system is controlled to deflate the balloon so that the balloon pressure value detected by the second sensor reaches a second preset value. After the intraballoon pressure value remains at the second preset value for a second preset time, the proximal blood pressure value detected by the first sensor after the second preset time is obtained; Based on the relationship between the proximal blood pressure value and the standard value, the power system is controlled to adjust the inflation volume of the balloon; The step of controlling the power system to adjust the balloon inflation based on the relationship between the proximal blood pressure value and the standard value includes: If the proximal blood pressure value is higher than the standard value, the power system is controlled to continue deflating the balloon. If the proximal blood pressure value is lower than the standard value, the power system is controlled to stop deflating the balloon, and the power system is controlled to inject the inflation medium into the balloon so that the pressure value inside the balloon reaches the third preset value. The first sensor is also used to monitor arterial pressure in real time and generate waveforms. After the microprocessor controls the power system to adjust the inflation volume of the balloon based on the relationship between the proximal blood pressure value and the standard value, the microprocessor is further used to: After the intraballoon pressure value is maintained at a third preset value for a third preset time, the waveform is acquired from the first sensor; Whether spontaneous circulation has been restored is determined based on whether spontaneous arterial pressure waveforms are detected in the waveform and whether the proximal blood pressure value reaches the standard value.

2. The medical balloon system according to claim 1, characterized in that, If the proximal blood pressure value is higher than the standard value, controlling the power system to continue deflating the balloon includes: When the proximal blood pressure value is higher than the standard value, the release amount for each stage is determined based on the total filling amount when the filling is completed and the preset proportional release percentage for staged release. The power system is controlled to release the filling medium in stages according to the release amount and the preset release time; If the proximal blood pressure value is lower than the standard value, the system controls the power system to stop deflating the balloon and controls the power system to inject the filling medium into the balloon, including: When the proximal blood pressure value is lower than the standard value, the filling amount of each stage is determined based on the total filling amount when the filling is completed and the filling percentage of the preset staged filling. The power system is controlled to inject the inflation medium into the balloon in stages according to the inflation amount and the preset inflation time.

3. The medical balloon system according to claim 1, characterized in that, If the proximal blood pressure value is higher than the standard value, the power system is controlled to continue deflating the balloon, including: when the proximal blood pressure value is higher than the standard value, the inflation medium is deflated in stages according to the preset deflation rate and the preset deflation time of each stage; If the proximal blood pressure value is lower than the standard value, the power system is controlled to stop deflating the balloon, and the power system is controlled to inject the filling medium into the balloon, including: when the proximal blood pressure value is lower than the standard value, the filling medium is injected into the balloon in stages according to the preset deflating rate and the preset filling time of each stage.

4. The medical balloon system according to claim 1, characterized in that, The microprocessor is also used to: calculate the difference between the proximal blood pressure value and the standard value to obtain a blood pressure deviation value; If the proximal blood pressure value is higher than the standard value, the step of controlling the power system to continue deflating the balloon includes: when the proximal blood pressure value is greater than or equal to the standard value, substituting the blood pressure deviation value into a preset PID algorithm formula to determine a preset deflation amount, and controlling the power system to continue deflating the balloon according to the preset deflation amount; If the proximal blood pressure value is lower than the standard value, the system is controlled to stop deflating the balloon and to inject the filling medium into the balloon. This includes: when the proximal blood pressure value is lower than the standard value, substituting the blood pressure deviation value into a preset PID algorithm formula to determine a preset filling amount, and controlling the system to inject the filling medium into the balloon according to the preset filling amount.

5. The medical balloon system according to claim 1, characterized in that, The microprocessor is also used for: If the spontaneous arterial pressure waveform is detected and the proximal blood pressure value reaches the standard value, it is determined that spontaneous circulation has been restored. If the spontaneous arterial pressure waveform is not detected, and / or the proximal blood pressure value does not reach the standard value, it is determined that spontaneous circulation has not been restored.

6. The medical balloon system according to claim 5, characterized in that, The microprocessor is also used for: After determining that autonomous circulation has been restored, the power system is controlled to adjust the deflation rate of the balloon; After determining that spontaneous circulation has not been restored, the power system continues to adjust the inflation of the balloon based on the relationship between the proximal blood pressure value and the standard value.

7. The medical balloon system according to claim 1, characterized in that, The step of determining whether the balloon is fully inflated based on the proximal blood pressure value detected by the first sensor and the intraballoon pressure value detected by the second sensor includes: If the intraballoon pressure is greater than the proximal blood pressure, and the rate of increase of the proximal blood pressure exceeds a preset threshold, then the balloon is determined to be fully inflated. If the intraballoon pressure is less than or equal to the proximal blood pressure, and / or the rate of increase of the proximal blood pressure does not exceed a preset threshold, then the balloon is determined to be incompletely inflated.

8. The medical balloon system according to claim 1, characterized in that, The step of determining whether the balloon has been fully inflated based on its actual inflation volume includes: Determine the relationship between the actual inflation volume and the preset target inflation volume to determine whether the balloon has been fully inflated; If the actual inflation volume reaches the target inflation volume, the balloon is determined to be fully inflated. If the actual inflation volume does not reach the target inflation volume, the balloon is determined to be incompletely inflated.

9. The medical balloon system according to claim 1, characterized in that, The filling medium is physiological saline.

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