Balloon inflation and deflation control method and computer readable storage medium

Abstract

The invention provides a balloon inflation and deflation control method and a computer readable storage medium, the method is applied to a balloon inflation and deflation system, a balloon catheter of the balloon inflation and deflation system comprises a medium cavity and a blood cavity which are mutually independent, and a puncture sheath is provided with a lateral opening; the first sensor is connected with the medium cavity, the second sensor is connected with the lateral opening, and the third sensor is connected with the blood cavity; the method comprises the steps that a pumping mechanism is controlled to inject a filling medium into a balloon, and whether filling of the balloon is completed or not is determined according to a balloon internal pressure value detected by a first sensor and / or a balloon rear pressure value detected by a second sensor or a proximal end blood pressure value detected by a third sensor; determining the discharge amount of each stage according to the total filling amount when filling is completed and the preset discharge percentage of staged discharge; determining the discharge time of each stage according to a preset discharge speed and the discharge amount of each stage; and the pumping mechanism is controlled to discharge the filling medium in stages according to the preset discharge speed and the discharge time of each stage.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a balloon inflation and deflation control method and a computer-readable storage medium. Background Art

[0002] Trauma has always been the most common type of injury in public emergencies and daily accidents. Studies have shown that post-traumatic hemorrhage is the main cause of death in trauma patients in the early stage of treatment. Therefore, in order to prevent post-traumatic hemorrhage, traditional technologies mostly use tourniquet fixation, bandage dressing, and hemostatic material packing to prevent hemorrhage after a traumatic bleeding incident. However, these methods can only be used to control relatively minor bleeding in local limbs and the entire body surface, and are not suitable for controlling massive bleeding caused by injuries to non-compressive parts. Others use radiological intervention, damage control surgery, aortic clamps and other hemostatic methods. Although these methods are helpful in controlling massive bleeding in the above-mentioned parts, their implementation has certain limitations in the early stage of treatment.

[0003] Studies have shown that resuscitative aortic occlusion has the advantages of being portable, minimally invasive and effective. It can be used for early hemostatic treatment of massive bleeding caused by various reasons, and its hemostatic effect is significantly higher than traditional hemostatic methods. However, the equipment used in existing resuscitative aortic occlusion can only roughly control the volume of the balloon to achieve the purpose of blocking the blood vessels. However, since it is difficult to accurately control the degree of blocking of the blood vessels by the balloon in existing resuscitative aortic occlusion, there are cases where the blocking effect is poor or excessive blocking causes damage to the aorta. In addition, there is no precise control method for various factors during balloon deflation. There is a problem that the balloon is deflated too quickly, resulting in drastic fluctuations in hemodynamics, or deflated too slowly, prolonging the blocking time, leading to ischemia of organs and tissues in distal parts.

[0004] Therefore, the current equipment used in resuscitative aortic occlusion surgery has the problem of being unable to accurately achieve balloon inflation and automatic deflation. Summary of the Invention

[0005] In view of the shortcomings of the existing technology, the purpose of the present invention is to provide a balloon inflation and deflation control method and a computer-readable storage medium to solve the problem that the existing technology cannot accurately achieve balloon inflation and automatic deflation.

[0006] The above technical objectives of the present invention are achieved through the following technical solutions: In the first aspect, an embodiment of the present application provides a balloon inflation and deflation control method, which is applied to a balloon inflation and deflation system, wherein the balloon inflation and deflation system includes a control host, a balloon catheter, a balloon and a puncture sheath, the balloon catheter is connected to the control host and the balloon, the balloon catheter includes a medium cavity and a blood cavity which are independent of each other, the outlet of the medium cavity is located inside the balloon, and the outlet of the blood cavity is located at the proximal end outside the balloon; the inner diameter of the puncture sheath is larger than the outer diameter of the balloon catheter, the puncture sheath has a lateral opening, and the lateral opening is located at the distal end outside the balloon catheter; the control host includes a microprocessor, a first sensor connected to the medium cavity and a pumping mechanism, a second sensor connected to the lateral opening, and a third sensor connected to the blood cavity; the microprocessor is connected to the control host, and the balloon is deflated. The device is connected to a first sensor, a second sensor, a third sensor and a pumping mechanism; the method is executed by a microprocessor, and includes: controlling the pumping mechanism to inject a filling medium into the balloon, and determining whether the balloon is fully filled based on the balloon internal pressure value detected by the first sensor and / or the balloon back pressure value detected by the second sensor, or the proximal end blood pressure value detected by the third sensor; determining the discharge volume of each stage based on the total filling volume when the filling is completed and the preset discharge percentage of the staged discharge; determining the discharge time of each stage based on the preset discharge speed and the discharge volume of each stage; and controlling the pumping mechanism to discharge the filling medium in stages according to the preset discharge speed and the discharge time of each stage.

[0007] Furthermore, based on the balloon internal pressure value detected by the first sensor, it is determined whether the balloon is fully filled, including: when the rising rate of change of the balloon internal pressure value exceeds a preset threshold, it is determined that the balloon is fully filled; when the rising rate of change of the balloon internal pressure value does not exceed the preset threshold, it is determined that the balloon is not fully filled.

[0008] Furthermore, based on the balloon back pressure value detected by the second sensor, it is determined whether the balloon is fully filled, including: when the balloon back pressure value is equal to or close to zero, it is determined that the balloon is fully filled; when the balloon back pressure value is not equal to or not close to zero, it is determined that the balloon is not fully filled.

[0009] Furthermore, based on the proximal blood pressure value detected by the third sensor, it is determined whether the balloon is fully filled, including: when the rising rate of the proximal blood pressure value exceeds the preset blood pressure threshold, it is determined that the balloon is fully filled; when the rising rate of the proximal blood pressure value does not exceed the preset blood pressure threshold, it is determined that the balloon is not fully filled.

[0010] Furthermore, the preset discharge percentage of the staged discharge is an equal percentage or an unequal percentage; wherein the equal percentage means that the percentage of the discharge amount in each stage is equal; and the unequal percentage means that the percentage of the discharge amount in at least two stages is unequal.

[0011] Furthermore, each stage includes a discharge stage and a pause discharge stage; wherein the discharge stage is a stage in which the pumping mechanism drives the balloon to discharge; and the pause discharge stage is a stage in which the pumping mechanism does not drive the balloon to discharge but remains powered on or in standby mode.

[0012] Furthermore, the discharge time includes a first sub-time and a second sub-time, wherein the first sub-time is the discharge duration of the discharge phase; and the second sub-time is the pause duration of the pause discharge phase.

[0013] Furthermore, the control method also includes: when the balloon is fully filled, judging whether the balloon is faulty based on the detected pressure fluctuation; wherein the pressure includes the balloon front pressure value, the balloon rear pressure value and the proximal end blood pressure value.

[0014] Furthermore, the fluctuation condition is a continuous change in time, and the control method also includes: when the continuous change in time is a unidirectional continuous rise or fall, determining that the balloon is faulty; when the continuous change in time is a periodic change, determining that the balloon is not faulty.

[0015] Furthermore, the fluctuation situation is a recovery situation, and the control method also includes: when the internal pressure value of the balloon recovers to the initial set internal pressure value within the preset time, it is determined that the balloon is not faulty; when the internal pressure value of the balloon does not recover to the initial set internal pressure value within the preset time, it is determined that the balloon is faulty.

[0016] In a second aspect, an embodiment of the present application further provides a computer-readable storage medium, which stores an executable program, and the executable program can execute the balloon inflation control method provided in the above embodiment.

[0017] In a third aspect, an embodiment of the present application further provides a computer program product, including a computer program / instruction, which, when executed by a processor, implements the balloon inflation control method provided in the above embodiment.

[0018] The beneficial effects of the embodiments of the present invention are: First, the embodiment of the present invention sets a first sensor in the balloon inflation and deflation system to detect the internal pressure value of the balloon, sets a second sensor to detect the back pressure value of the balloon, and sets a third sensor to detect the proximal blood pressure value, so as to monitor the pressure changes at the distal end and inside the balloon in real time, and provides a basis for the subsequent precise control of balloon filling and deflation. At the same time, through the cooperation of structures such as the puncture sheath, it can ensure that when a double-lumen balloon catheter is used, the pressure of the above three routes can be detected in real time. On the premise of ensuring the accuracy of the detection results, the design of the balloon catheter is simplified and the circulation volume of the filling medium is increased.

[0019] Secondly, the embodiment of the present application determines the filling volume based on the total filling volume and the preset discharge percentage, and then determines the discharge time, controls the pumping mechanism to discharge the filling medium in the balloon in stages according to the preset discharge speed and discharge time, thereby realizing real-time monitoring of the pressure inside and outside the balloon and automatic and precise control of the discharge, thereby playing a role in precisely controlling the blood flow in the blood vessel in which the balloon is set. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following briefly introduces the drawings required for use in the embodiments of the present application.

[0021] Figure 1 This is a schematic structural diagram of a balloon inflation and deflation system according to an embodiment of the present application; Figure 2 This is a schematic structural diagram of a balloon inflation and deflation system according to another embodiment of the present application; Figure 3 This is a schematic structural diagram of a balloon and a balloon catheter of a balloon inflation and deflation system according to one embodiment of the present application; Figure 4 This is a schematic diagram of the main process of a balloon inflation and deflation control method according to an embodiment of the present application; Figure 5 This is a flow chart of determining whether the balloon is fully inflated in a balloon inflation and deflation control method according to an embodiment of the present application; Figure 6 A curve diagram showing changes in the balloon internal pressure and proximal blood pressure values ​​in a balloon inflation and deflation control method according to an embodiment of the present application; Figure 7 This is a flow chart of determining whether a balloon is fully inflated in a balloon inflation and deflation control method according to another embodiment of the present application; Figure 8 This is a flow chart of determining whether a balloon is faulty in a balloon inflation and deflation control method according to an embodiment of the present application; Figure 9 This is a flow chart of determining whether a balloon is faulty in a balloon inflation and deflation control method according to another embodiment of the present application.

[0022] Figure numerals: control host 1; first channel 11; second channel 12; third channel 13; balloon catheter 2; blood chamber 21; medium chamber 22; balloon 3; puncture sheath 4; side opening 41; three-way connector 5; first interface 51; second interface 52; third interface 53. DETAILED DESCRIPTION

[0023] In the description of this application, it should be noted that the terms "inner" and "outer" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, or the orientations or positional relationships in which the product of this application is typically placed when in use. These terms are intended solely to facilitate the description of this application and simplify the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this application. Furthermore, the terms "first" and "second" and the like are used solely for distinction and should not be construed as indicating or implying relative importance.

[0024] The technical solutions in the embodiments of the present application will be described below in conjunction with the drawings in the embodiments of the present application.

[0025] See also Figure 1-4 An embodiment of the present application provides a balloon inflation and deflation control method, which is applied to a balloon inflation and deflation system, wherein the balloon inflation and deflation system includes a control host 1, a balloon catheter 2, a balloon 3 and a puncture sheath 4.

[0026] The balloon catheter 2 connects the control host 1 and the balloon 3 . The balloon catheter 2 includes a blood cavity 21 and a medium cavity 22 that are independent of each other. The outlet of the blood cavity 21 is located at the proximal end outside the balloon 3 , and the outlet of the medium cavity 22 is located inside the balloon 3 .

[0027] In one embodiment, the balloon inflation and deflation system also includes a puncture sheath 4, the inner diameter of the puncture sheath 4 is larger than the inner diameter of the balloon catheter 2, and the puncture sheath 4 has a lateral opening 41, which is located at the distal end outside the balloon catheter 2. The setting of the lateral opening 41 of the puncture sheath 4 is conducive to detecting the balloon back pressure value and is conducive to subsequent judgment of the filling degree of the balloon 3.

[0028] The control host 1 includes a microprocessor, a first sensor connected to the medium chamber 22 and a pumping mechanism, a second sensor connected to the lateral opening 41, and a third sensor connected to the blood chamber 21. The first sensor is used to detect the balloon internal pressure value, the second sensor is used to detect the balloon back pressure value, and the third sensor is used to detect the proximal blood pressure value.

[0029] The microprocessor is connected to the first sensor, the second sensor, the third sensor and the pumping mechanism.

[0030] Among them, in another embodiment, the component for detecting the balloon back pressure value can be a component that can be extended to be detachable and can be connected to the blood vessel at the rear end of the balloon 3, as long as it can be connected to the detection balloon 3 back pressure passage and can allow the second sensor to detect the balloon back pressure value.

[0031] In one embodiment, the first sensor and the second sensor may be disposed inside the pumping mechanism or outside the pumping mechanism.

[0032] The above-mentioned balloon inflation and deflation control method is executed by a microprocessor and includes steps S110 to S140: Step S110: Control the pumping mechanism to inject filling medium into the balloon 3, and determine whether the balloon 3 is fully filled based on the balloon internal pressure value detected by the first sensor and / or the balloon back pressure value detected by the second sensor, or the proximal blood pressure value detected by the third sensor.

[0033] In the above step S110, the completion of filling of the balloon 3 generally means that the volume of the balloon 32 reaches a level that can block the blood vessel, that is, there is an interference fit between the outer wall of the balloon 3 and the inner wall of the blood vessel. By real-time monitoring of the balloon internal pressure value and the balloon back pressure value, it is determined whether the balloon 3 is fully filled, thereby improving the accuracy of detection.

[0034] Step S120: Determine the discharge volume of each stage according to the total filling volume when filling is completed and the discharge percentage of the preset staged discharge.

[0035] In the above step S120 , the discharge percentage is the percentage of the filling medium extracted from the balloon 3 by the microprocessor through the pumping mechanism in the total filling volume under specific circumstances.

[0036] In the embodiment of the present application, the balloon 3 is released in stages and a release percentage is set to improve the accuracy of the release of the balloon 3 .

[0037] Step S130: Determine the discharge time of each stage according to the preset discharge speed and the discharge amount of each stage.

[0038] In the above step S130, the discharge speed is the volume of the filling medium extracted from the balloon 3 per unit time, which reflects the speed of the retraction of the balloon 3. The preset discharge speed can be set according to actual conditions. The discharge time is the time from the start of discharging the balloon 3 to the time when the pressure or volume in the balloon 3 drops to the discharge completion standard.

[0039] Step S140: Control the pumping mechanism to discharge the filling medium in stages according to the preset discharge speed and the discharge time of each stage.

[0040] The application can realize the function of automatic release control of the balloon inflation and deflation system, can smoothly restore blood flow, and avoid the adverse effects caused by sudden recovery of blood flow in the blood vessel due to the uncertainty of release speed and release time. At the same time, through the cooperation of the puncture sheath 4 and other structures, the pressure of the three paths can be detected in real time in the case of using the double-lumen balloon catheter 2, the design of the balloon catheter is simplified under the premise of ensuring the accuracy of the detection results, and the flow of the inflation medium is improved.

[0041] In an embodiment, the balloon inflation and deflation system further comprises an arterial pressure sensor connected to the microprocessor, for detecting the arterial pressure in real time and transmitting the detected arterial pressure signal to the microprocessor, and the microprocessor judges whether the arterial pressure is stable according to the arterial pressure signal.

[0042] In the above step S140, when the microprocessor monitors that the arterial pressure is in a stable state, the pumping mechanism is controlled to continue the staged release of the inflation medium. When the microprocessor monitors that the arterial pressure is in a descending state or the arterial pressure waveform of the arterial pressure disappears, the pumping mechanism is controlled to re-inflate the balloon 3 until the inflation of the balloon 3 is completed, and the above steps S110-S140 are repeated when the inflation is completed to realize the whole-process automatic pressure dynamic feedback.

[0043] In an embodiment, as shown in Figure 5-6 The step S110 of determining whether the balloon 3 is inflated according to the balloon internal pressure value detected by the first sensor comprises sub-steps S111-S112: Step S111: judging whether the rising rate change speed of the balloon internal pressure value exceeds a preset threshold.

[0044] The preset threshold is a value determined according to the safety threshold of the rising speed of the balloon internal pressure value. Generally, the rising rate change speed exceeding the preset threshold means that the rising speed of the balloon internal pressure value suddenly becomes faster than the normal level.

[0045] Step S112: when the rising rate change speed of the balloon internal pressure value exceeds the preset threshold, it is determined that the balloon 3 is inflated.

[0046] Step S113: when the rising rate change speed of the balloon internal pressure value does not exceed the preset threshold, it is determined that the balloon 3 is not inflated.

[0047] In an embodiment, the balloon catheter 2 further comprises a blood cavity 21 independent of the medium cavity 22.

[0048] In the embodiment of the present application, the balloon catheter 2 is configured as a double-lumen catheter, which increases the flow rate of the filling medium in its internal passage. The filling and deflation of the balloon 3 can be achieved by simply controlling the flow rate of the filling medium in the two cavities, thereby improving the accuracy of control and reducing the problem of pressure detection errors caused by too many passages.

[0049] The embodiment of the present application integrates a third sensor, a second sensor and a first sensor in the balloon inflation and deflation system, thereby being able to monitor the changes in the proximal blood pressure value, the balloon back pressure value and the balloon internal pressure value in real time, thereby providing a basis for accurately controlling the pressure of the balloon 3, that is, controlling the degree of filling and deflation of the balloon 3, thereby avoiding the risk of severe ischemia of distal organs and limbs.

[0050] In one embodiment, if Figure 2 As shown, the control host 1 is provided with a first channel 11 communicating with the blood chamber 21, a second channel 12 communicating with the medium chamber 22, and a third channel 13 communicating with the lateral opening 41 of the puncture sheath 4. The balloon inflation and deflation system includes a three-way connector 5 for connecting the puncture sheath 4 and the pumping mechanism in the control host 1.

[0051] Specifically, the three-way connector 5 includes a first interface 51 , a second interface 52 and a third interface 53 . The first interface 51 is connected to the puncture sheath 4 , the second interface 52 is connected to the first channel 11 , and the third interface 53 is connected to the second channel 12 .

[0052] See also Figure 7 In another embodiment, the balloon inflation and deflation control method further includes step S110': Step S110 ′: determining whether the balloon 3 is fully inflated based on the proximal blood pressure value detected by the third sensor.

[0053] The above step S110' includes sub-steps S111' to S113': Sub-step S111 ′: determining whether the rate of increase of the proximal blood pressure value exceeds a preset blood pressure threshold.

[0054] In the above sub-step S111 ′, the preset blood pressure threshold is a pre-set blood pressure critical value in the blood vessel at the proximal end of the balloon, which is used to determine whether the proximal blood pressure value is within a normal range.

[0055] Sub-step S112 ′: When the rate of increase of the proximal end blood pressure value exceeds a preset blood pressure threshold, it is determined that the balloon 3 is fully filled.

[0056] Sub-step S113 ′: when the rate of increase of the proximal blood pressure value does not exceed the preset threshold, it is determined that the balloon 3 is not fully filled.

[0057] The embodiment of the present application monitors the rate of change of the rising rate of the proximal blood pressure value as a condition for judging whether the balloon 3 is filled, thereby improving the accuracy of real-time monitoring of the filling degree of the balloon 3, achieving the effect of system automated judgment, avoiding the uncertainty of traditional manual judgment and the risk of excessive blockage of the blood vessel by the balloon 3.

[0058] In other embodiments, the step S110 of determining whether the balloon 3 is fully filled according to the balloon back pressure value detected by the second sensor includes: When the balloon back pressure value is equal to or close to zero, it is determined that the balloon 3 is fully filled; when the balloon back pressure value is not equal to or close to zero, it is determined that the balloon 3 is not fully filled. Specifically: In one embodiment, before controlling the pumping mechanism to inject the filling medium into the balloon 3, the microprocessor automatically determines the filling degree of the balloon 3 based on the detected balloon internal pressure, balloon back pressure, and proximal blood pressure, and selects the filling degree of the balloon 3 based on the real-time fluctuations of the above values. Specifically: When the balloon 3 is connected to the pumping mechanism of the control host 1 through the balloon catheter 2 and all the components are assembled in place, the balloon 3 is in an unfilled state. The second sensor detects the back pressure value of the balloon and the third sensor detects the proximal end blood pressure value, and the front and rear pressure difference of the balloon 3 is calculated, wherein the proximal end blood pressure value is The balloon back pressure is , the pressure difference before and after is , calculated by Get the front and rear pressure difference of balloon 3 .

[0059] Obtaining the front and rear pressure difference of balloon 3 before inflation After that, the pumping mechanism is controlled to completely fill the balloon 3, and when the balloon 3 is completely filled, the balloon internal pressure value at this time is recorded.

[0060] The microprocessor fits the front and rear pressure difference according to the pressure change of the balloon internal pressure value during the balloon 3 filling period. A monotonic function relationship is established between the balloon internal pressure value and the filling volume, and the pumping mechanism is controlled to fill the balloon 3 with the filling medium according to the above monotonic function relationship, so that the filling of the balloon 3 can adapt to the different physiological conditions of different individuals and improve the effect of the balloon 3 in blocking blood vessels.

[0061] In an embodiment, the pumping mechanism comprises a peristaltic pump or other powered pump and a storage bag, the peristaltic pump or powered pump is connected to the storage bag and the balloon 3 through a pump pipe respectively, the puncture sheath 4 is arranged between the connecting passage of the balloon 3 and the powered pump, the storage bag is provided with a filling medium, the filling medium is physiological saline, and the filling medium is pumped into or extracted from the balloon 3 by the peristaltic pump or other powered pump and then pumped back into the storage bag.

[0062] The embodiment of the present application controls the flow direction of the filling medium by arranging the peristaltic pump or other powered pump, so as to accurately control the inflation and deflation of the balloon 3.

[0063] In an embodiment, the balloon inflation and deflation system is further provided with an external cardiac compression system in cooperation, which is signal connected with the control host 1 and is used for external cardiac compression operation.

[0064] It should be noted that during the inflation of the balloon 3 and the occlusion of the blood vessel, the external cardiac compression system can perform real-time external cardiac compression operation for cardiopulmonary resuscitation.

[0065] In an embodiment, the preset staged deflation percentage is an equal percentage or an unequal percentage.

[0066] The equal percentage means that the percentage of the deflation amount of each stage is equal.

[0067] The unequal percentage means that the percentage of the deflation amount of at least two stages is not equal.

[0068] In an embodiment, the preset staged number is greater than or equal to 3, and the preset staged deflation percentage is an equal percentage, if the deflation is divided into three stages, the equal percentage can be 33%, if the deflation is divided into four stages, the equal percentage can be 25%, and the specific value of the deflation percentage can be automatically adjusted according to actual needs.

[0069] In another embodiment, the preset staged number is greater than or equal to 3, and the preset staged deflation percentage is an unequal percentage, if the deflation is divided into three stages, the deflation percentage of each stage can be 40%, 35% and 25%, if the deflation is divided into four stages, the deflation percentage of each stage can be 40%, 30%, 25% and 10%, and the specific value of the deflation percentage can be flexibly adjusted according to different deflation stages.

[0070] In an embodiment, each stage comprises a deflation stage and a pause deflation stage, wherein the deflation stage is a stage in which the pumping mechanism drives the balloon 3 to deflate, and the pause deflation stage is a stage in which the pumping mechanism does not drive the balloon 3 to deflate but keeps powered or on standby.

[0071] In one embodiment, the discharge time includes a first sub-time and a second sub-time, wherein the first sub-time is the discharge duration of the discharge phase, and the second sub-time is the pause duration of the pause discharge phase.

[0072] The discharge time of each stage is equal, which is T, and T=2min. The first sub-time of each stage is set to T1, and T1<2min, then the second sub-time is T2=(2-T1)min.

[0073] The embodiment of the present application divides each stage into a release stage and a release pause stage, and sets respective first sub-times and second sub-times, thereby achieving phased release of the balloon 3, and performing periodic release and release pauses to ensure that the volume of the balloon 3 can be regularly reduced, providing a buffer time for blood flow recovery in the blood vessels, and avoiding adverse reactions in the body caused by sudden recovery of blood flow.

[0074] In one embodiment, the total discharge time of the total stage is ≥12 minutes.

[0075] In another embodiment, each stage is a discharge stage, each stage has only a discharge time, and the discharge time of each stage is equal to T, and T=2min, and the total discharge time of all stages can be ≥12min.

[0076] In the embodiment of the present application, each stage is set as a release stage, and the release time of each stage is equal, so as to realize system automation and slow release of the balloon 3 in stages.

[0077] In one embodiment, the first sensor is further configured to detect a spontaneous arterial pressure waveform. During each of the above-mentioned release phases, the first sensor monitors the spontaneous arterial pressure waveform in real time to determine whether cardiopulmonary resuscitation is successful.

[0078] When it is detected that there is no significant change in the spontaneous arterial pressure waveform, the balloon 3 is continuously deflated until the blood flow is fully restored.

[0079] When significant changes in the spontaneous arterial pressure waveform are detected, it can be subsequently determined whether the hemodynamics are stable.

[0080] Among them, the obvious changes in the spontaneous arterial pressure waveform are waveform changes caused by breathing itself without the need for human intervention.

[0081] See also Figure 8 In one embodiment, an alarm module (not shown in the figure) is provided in the control host 1, and the balloon inflation and deflation control method further includes: Step S200: When the balloon 3 is completely filled, determine whether the balloon 3 is faulty based on the fluctuation of the balloon internal pressure value.

[0082] In the above step S200, the fluctuation condition refers to the dynamic change characteristic of the balloon internal pressure value deviating from the stable reference value during the detection period.

[0083] In one embodiment, the fluctuation is a time-dependent change, and the balloon inflation and deflation control method further includes: Step S210: When the time duration changes continuously in a single direction, it is determined that the balloon 3 is faulty.

[0084] In the above step S210 , a unidirectional continuous increase or decrease indicates that the balloon internal pressure value continues to increase or decrease.

[0085] Step S220: When the time-dependent change is a periodic change, it is determined that the balloon 3 is not faulty.

[0086] In the above step S220, because under normal circumstances, the time duration change is a periodic change, and its periodic change is related to the heart rate and respiratory rate, when the change of the balloon internal pressure value is a periodic change, it is determined that the balloon 3 is not faulty.

[0087] Specifically, the microprocessor monitors the data changes of the balloon internal pressure value in real time through the first sensor. If the value of the balloon internal pressure value keeps changing when the balloon 3 is fully filled and in a stable state, it is determined that the balloon 3 may have a fault.

[0088] However, it should be noted that, because the failure of balloon 3 - rupture may be a tiny crack, causing the filling medium to slowly seep out, there will not be a large fluctuation in the balloon internal pressure value. At the same time, when balloon 3 is located in the blood vessel, the blood is continuously pumped by the heart, and the pressure fluctuations itself will affect the value of the balloon internal pressure value, but its influence makes the changes of balloon 3 still regular. Therefore, if the value of the balloon internal pressure value changes, but it is a unidirectional continuous rise or fall, it can be determined that balloon 3 has failed, and an alarm prompt will be issued through the alarm module.

[0089] See also Figure 9 In another embodiment, the changes in the balloon internal pressure value and the balloon back pressure value can be further monitored to comprehensively determine whether the balloon 3 is faulty.

[0090] In another embodiment, the fluctuation condition is a recovery condition, and the balloon inflation and deflation control method further includes: Step S210 ′: when the internal pressure value of the balloon returns to the initially set internal pressure value within the preset time, it is determined that the balloon 3 is not faulty.

[0091] In the above step S210', the initial set internal pressure value is the static internal pressure value in the balloon 3 used as a benchmark during the design or system startup phase, and is the target control pressure value of the system. The subsequent actual balloon internal pressure value is adjusted, monitored, or allowed to fluctuate within a certain range around the initial set internal pressure value.

[0092] Step S220 ′: when the internal pressure value of the balloon does not return to the initially set internal pressure value within the preset time, it is determined that the balloon 3 is faulty.

[0093] In other embodiments, the fluctuation condition is a change amplitude, and the balloon inflation and deflation control method further includes: When the change in the balloon pressure is small, for example, between 5 mmHg and 10 mmHg, and synchronized with the cardiac cycle, it is determined that the balloon 3 is not faulty. When the change in the balloon pressure is large, for example, a slow but continuous decrease of 11-12 mmHg per minute, it is determined that the balloon 3 is faulty.

[0094] The embodiment of the present application intelligently controls the filling degree of the balloon 3 during filling, the discharge speed and discharge time during discharge, etc., and also ensures that the blood pressure at the proximal end of the balloon 3 - the proximal end blood pressure value is maintained within the normal range throughout the whole process. At the same time, the blood pressure at the distal end of the balloon 3 - the balloon back pressure value is maintained at a normal range of blood perfusion level during the filling of the balloon 3, and gradually recovers to the normal range during the discharge period, and ensures that the balloon internal pressure value is within a safe range throughout the whole process, thereby achieving optimized hemostasis treatment after a traumatic bleeding event.

[0095] An embodiment of the present application further provides a computer-readable storage medium, which stores an executable program. The executable program can execute the balloon inflation control method provided in the above embodiment.

[0096] An embodiment of the present application further provides a computer program product, including a computer program / instruction, which, when executed by a processor, implements the balloon inflation control method provided in the above embodiment.

[0097] It should also be noted that, in the description of this application, unless otherwise expressly specified or limited, the terms "disposed" and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to direct connections, indirect connections through an intermediate medium, or internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0098] It should be noted that, unless there is any conflict, the features in the embodiments of this application can be combined with each other.

[0099] The above description is merely a preferred embodiment of the present application and is not intended to limit the present application. Various modifications and variations are possible for those skilled in the art. Any modifications, equivalent substitutions, or improvements made within the spirit and principles of the present application shall be included within the scope of protection of the present application.

Claims

1. A balloon inflation and deflation control method, characterized in that: Applicable to a balloon inflation and deflation system, the balloon inflation and deflation system includes a control host, a balloon catheter, a balloon, and a puncture sheath, the balloon catheter connecting the control host and the balloon, the balloon catheter including a mutually independent medium cavity and a blood cavity, the outlet of the medium cavity being located inside the balloon, and the outlet of the blood cavity being located at the proximal end outside the balloon; the inner diameter of the puncture sheath is larger than the outer diameter of the balloon catheter, the puncture sheath having a lateral opening, and the lateral opening being located at the distal end outside the balloon catheter; the control host includes a microprocessor, a first sensor connected to the medium cavity and a pumping mechanism, a second sensor connected to the lateral opening, and a third sensor connected to the blood cavity; The microprocessor is connected to the first sensor, the second sensor, the third sensor and the pumping mechanism; The method is executed by the microprocessor, and the method includes: controlling the pumping mechanism to inject a filling medium into the balloon, and determining whether the balloon is fully filled based on the balloon internal pressure value detected by the first sensor and / or the balloon back pressure value detected by the second sensor, or the proximal end blood pressure value detected by the third sensor; Determine the discharge volume in each stage based on the total filling volume when filling is completed and the discharge percentage of the preset staged discharge; Determine the discharge time for each stage according to the preset discharge speed and the discharge volume of each stage; The pumping mechanism is controlled to discharge the filling medium in stages according to a preset discharge speed and a discharge time for each stage.

2. The balloon inflation and deflation control method according to claim 1, characterized in that: The step of determining whether the balloon is fully filled according to the balloon internal pressure value detected by the first sensor includes: When the rate of increase of the balloon internal pressure value exceeds a preset threshold, it is determined that the balloon is fully filled; When the rising rate of the balloon internal pressure value does not exceed a preset threshold, it is determined that the balloon is not fully filled.

3. The balloon inflation and deflation control method according to claim 1, characterized in that: The step of determining whether the balloon is fully filled according to the balloon back pressure value detected by the second sensor includes: When the balloon back pressure value is equal to or close to zero, it is determined that the balloon is fully filled; When the balloon back pressure value is not equal to or close to zero, it is determined that the balloon is not fully filled.

4. The balloon inflation and deflation control method according to claim 1, characterized in that: The step of determining whether the balloon is fully filled based on the proximal blood pressure value detected by the third sensor includes: When the rate of increase of the proximal blood pressure value exceeds a preset blood pressure threshold, it is determined that the balloon is fully filled; When the rate of increase of the proximal blood pressure value does not exceed a preset blood pressure threshold, it is determined that the balloon is not fully inflated.

5. The balloon inflation and deflation control method according to claim 1, characterized in that: The preset staged release percentage is an equal percentage or an unequal percentage; Wherein, the said equal distribution percentage is equal to the percentage of the said discharge amount in each said stage; The uneven distribution percentage means that the percentages of the discharge amounts in at least two stages are not equal.

6. The balloon inflation and deflation control method according to claim 1, characterized in that: Each of the said stages includes a discharge stage and a discharge suspension stage; Wherein, the discharge stage is the stage in which the pumping mechanism drives the balloon to discharge; The suspended deflation stage is a stage in which the pumping mechanism does not drive the balloon to deflate but remains powered on or in standby mode.

7. The balloon inflation and deflation control method according to claim 6, characterized in that: The discharge time includes a first sub-time and a second sub-time, wherein the first sub-time is the discharge duration of the discharge phase; and the second sub-time is the pause duration of the pause discharge phase.

8. The balloon inflation and deflation control method according to claim 1, characterized in that: The control method further includes: When the balloon is fully inflated, determining whether the balloon is faulty based on the detected pressure fluctuations; The pressure includes the balloon front pressure value, the balloon back pressure value and the proximal end blood pressure value.

9. The balloon inflation and deflation control method according to claim 8, characterized in that: The fluctuation condition is a time-dependent change, and the control method further includes: When the time duration changes continuously in a single direction, it is determined that the balloon is faulty; When the time-dependent change is a periodic change, it is determined that the balloon is not faulty.

10. The balloon inflation and deflation control method according to claim 8, characterized in that: The fluctuation situation is a recovery situation, and the control method further includes: When the internal pressure value of the balloon returns to the initially set internal pressure value within a preset time, it is determined that the balloon is not faulty; When the balloon internal pressure value does not return to the initially set internal pressure value within a preset time, it is determined that the balloon is faulty.

11. A computer-readable storage medium, characterized in that The computer-readable storage medium stores an executable program, and the executable program executes the balloon inflation control method according to any one of claims 1 to 10.

12. A computer program product comprising a computer program / instructions, characterized in that When the computer program / instruction is executed by a processor, the balloon inflation control method according to any one of claims 1 to 10 is implemented.

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