Expandable instrument control system and method

Abstract

The invention discloses an expandable instrument control system and method. The system is applied to expansion control of a balloon and comprises a pressure detection module used for obtaining pressure information of the balloon in a first preset time period; the stage analysis module is used for dividing the working state of the balloon into a first stage and a second stage according to the pressure information; the first inflation control module is used for controlling the inflation amount of the balloon in the first stage according to the pressure information; the volume detection module is used for detecting the real-time volume of the balloon in the second stage according to the inflation volume; the second inflation control module is used for controlling the inflation amount of the second stage according to the real-time diameter corresponding to the real-time volume of the balloon and the specified diameter. According to the invention, an operator can conveniently avoid the first stage in which the volume of the balloon is difficult to accurately control, and the balloon can be more conveniently and accurately operated and controlled to be rapidly expanded to an available state.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a control system and method for an expandable device including a semi-compliant balloon. Background Art

[0002] When the medical device includes an expandable component such as a catheter balloon, the balloon can generally be divided into three types according to compliance: compliant, semi-compliant or non-compliant. Compliance can be defined as the increase in balloon diameter above the nominal balloon pressure. Generally, a non-compliant balloon has a smaller diameter increase than a semi-compliant balloon, and a semi-compliant balloon has a smaller diameter increase than a compliant balloon. The inflation of a semi-compliant balloon usually requires an operator to manually operate the gas injection device, and the volume adjustment mainly depends on the scale line or the manual thrust control piston. The operation is cumbersome and the adjustment accuracy is limited. Due to the lack of automation means and real-time detection mechanism, the balloon is prone to under-inflation or over-inflation, low operating efficiency, poor accuracy, and increased risk of medical accidents in complex surgical environments.

[0003] In existing technology, operators typically fine-tune the balloon size by inflating it fully and then gradually deflating it. This method is cumbersome and lacks real-time monitoring, making it difficult to achieve high-precision adjustments. This is especially true in complex vascular structures or dynamic blood flow environments, where the lack of real-time monitoring and feedback makes rapid response difficult and increases operational risks. Summary of the Invention

[0004] In order to overcome the problem that the existing technology cannot fully and accurately control the state of the semi-compliant balloon and cannot accurately control the expansion state of the semi-compliant balloon, the present invention proposes an expandable device control system and method to solve the above problems.

[0005] A first aspect of the present invention provides an expandable device control system, wherein the expandable device includes a balloon, and the system includes:

[0006] A pressure detection module, configured to obtain pressure information of the balloon during a first predetermined period of time;

[0007] A stage analysis module, used to divide the working state of the balloon into the first stage and the second stage according to pressure information;

[0008] a first inflation control module, configured to divide the working state of the balloon into a first stage and a second stage according to pressure information;

[0009] A volume detection module, used for detecting the real-time volume of the balloon in the second stage according to the inflation volume;

[0010] The second inflation control module is used to control the inflation volume in the second stage according to the real-time diameter corresponding to the real-time volume of the balloon and the specified diameter.

[0011] In a possible implementation of the first aspect, the stage analysis module includes:

[0012] a pressure comparison unit, configured to compare pressure information at multiple different moments within a first predetermined period;

[0013] The stage judgment unit is used to judge whether the balloon reaches the expected pressure threshold according to the comparison result of the pressure comparison unit. If so, the balloon enters the second stage; the expected pressure threshold is the set dividing point between the first stage and the second stage;

[0014] The pressure control unit is used to generate an inflation control signal and transmit the signal to the first inflation control module to stop the first stage of inflation when the pressure value of the balloon reaches a desired pressure threshold.

[0015] In a possible implementation of the first aspect, the pressure comparison unit further includes:

[0016] a collection subunit, configured to continuously collect pressure values ​​at a plurality of different moments according to a preset sampling frequency within a first predetermined period;

[0017] A traversal subunit, configured to sequentially compare pressure values ​​at adjacent moments based on a preset sampling frequency to obtain pressure change information of the balloon within a first predetermined time period;

[0018] The threshold acquisition subunit is used to acquire the expected pressure threshold of the balloon according to the pressure change information.

[0019] In a possible implementation of the first aspect, the volume detection module includes:

[0020] a diameter obtaining unit, configured to obtain a desired diameter of the balloon when it reaches the second stage;

[0021] The target detection unit is used to detect whether the balloon has expanded from the expected diameter to the specified diameter according to the inflation amount of the balloon in the second stage.

[0022] In a possible implementation of the first aspect, the second inflation control module includes:

[0023] a flow control signal generating unit, configured to generate a gas flow control signal according to a volume difference between the real-time diameter and the specified diameter;

[0024] an inflation regulating unit, for dynamically regulating the gas inflow rate according to the gas flow control signal to adjust the inflation volume in the second stage;

[0025] The volume adjustment unit is used to generate an inflation adjustment signal and transmit the signal to the inflation adjustment unit when the balloon reaches a specified diameter.

[0026] In a possible implementation of the first aspect, the system further includes:

[0027] A state monitoring module, configured to monitor real-time data of the pressure detection module and / or the volume detection module when the balloon is in an operating state;

[0028] A state stage analysis module is used to analyze real-time data based on a preset closed-loop feedback control algorithm and generate analysis results that can represent the state of the balloon;

[0029] The status response module is used to respond to the analysis results of the status stage analysis module.

[0030] In a possible implementation of the first aspect, the state stage analysis module includes:

[0031] A difference calculation unit, used to calculate the data difference between real-time data and preset target data;

[0032] The abnormality analysis unit is used to analyze the data difference based on a preset closed-loop feedback control algorithm to obtain an analysis result of whether the balloon is abnormal.

[0033] In a possible implementation of the first aspect, the status response module includes:

[0034] a warning unit, configured to generate a warning signal for warning when the analysis result of the status phase analysis module is abnormal, wherein the warning signal can be output in a perceptible form;

[0035] The warning signal includes: a visual signal, an auditory signal, a tactile signal, a mechanical signal, a data communication signal, or a multimodal signal formed by a combination of multiple of the above.

[0036] In a possible implementation of the first aspect, the state response module also includes: a pressure relief regulation module, which is used to control the first inflation module and / or the second inflation module to relieve the pressure of the balloon when the abnormality of the balloon is that the real-time volume of the balloon exceeds the preset maximum volume and / or the pressure value of the balloon exceeds the preset safety pressure.

[0037] A second aspect of the present invention provides a method for controlling an expandable device, which is implemented based on any possible implementation of the first aspect, and includes:

[0038] obtaining pressure information of the balloon during a first predetermined period of time;

[0039] The working state of the balloon is divided into the first stage and the second stage according to the pressure information;

[0040] controlling the inflation volume of the balloon in the first stage according to the pressure information;

[0041] Detecting the real-time volume of the balloon in the second stage according to the inflation volume;

[0042] The inflation volume in the second stage is controlled according to the real-time diameter corresponding to the real-time volume of the balloon and the specified diameter.

[0043] The present invention uses a pressure detection module and a volume detection module to work together to achieve real-time monitoring of the internal pressure and inflation volume of the balloon, and through an automatic feedback mechanism, dynamically adjust the balloon state to meet surgical requirements. The pressure detection module can sense pressure changes with high sensitivity, and the volume detection module provides accurate feedback through precise inflation volume calculation to ensure the safety and reliability of balloon adjustment. The present invention introduces a gas filling automatic control function, combined with the pressure and volume detection modules, to achieve fully automated control of the inflation process, avoid human operation errors, and improve the consistency of balloon inflation. It further reduces the errors that may be caused by human operation intervention, improves the convenience of operation and medical safety. The present invention adds a size fine-tuning function, combined with the pressure and volume detection modules, through an automatic feedback mechanism, accurately controls the balloon expansion state, and achieves rapid fine-tuning to adapt to a variety of vascular conditions and surgical requirements. Compared with traditional methods, the present invention significantly improves the adjustment efficiency, reduces the complexity of operation, and improves surgical safety and accuracy.

[0044] The present invention enables the control system to automatically complete the first, nonlinear, and difficult-to-operate stage of balloon inflation by detecting the positive and negative directions and amplitudes of pressure changes. The gas flow sensor then precisely controls the balloon's real-time volume during the second, more user-friendly, stable inflation stage. This invention conveniently avoids the first, difficult-to-precise balloon volume control stage, allowing for more convenient and precise balloon operation and rapid inflation to a usable state, achieving the desired therapeutic effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] In order to more clearly illustrate the technical solutions in the present invention or the prior art, a brief introduction is given below to the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0046] Figure 1 The N-type pressure curve of the balloon corresponding to different inflation amounts is shown;

[0047] Figure 2 A schematic diagram of a module of an expandable device control system is shown;

[0048] Figure 3 A schematic diagram of the analysis process of the stage analysis module of the expandable instrument control system is shown;

[0049] Figure 4 shows a detection process diagram of the volume detection module;

[0050] Figure 5 A schematic diagram of a module of another expandable device control system is shown;

[0051] Figure 6 A flow chart of an expandable device control method is shown. DETAILED DESCRIPTION

[0052] In the description of this specification, the reference terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the embodiment of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and features of different embodiments or examples without contradiction.

[0053] Those skilled in the art will understand that the terms used herein are for the purpose of describing various embodiments only and are not intended to limit the present invention. As used herein, unless the context clearly indicates otherwise, the singular forms "a", "an" and "the" are intended to include the plural forms as well. It will be further understood that when used in this specification, the terms "include" and / or "comprise" specify the presence of stated features, integers, steps, operations, elements and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements and / or components, and / or combinations thereof.

[0054] At present, the "Theoretical and Experimental Study on Nonlinear Characteristics of Rubber Balloons" has disclosed that the semi-compliant balloons with more complex pressure variation characteristics on the market have a typical "N-shaped pressure curve" during the filling and pressurization process. Figure 1 As shown, combined with the real-time monitoring of the pressure inside the balloon by the pressure detection module, the different stages of the balloon device can be accurately judged, including the first stage formed by the pre-inflation stage and the expansion stage, and the second stage corresponding to the stable expansion stage of the balloon. The difference in the pressure curve characteristics of the first stage and the second stage can provide medical staff with timely and effective feedback information, thereby achieving precise control of the balloon size.

[0055] Specifically, the peak point (P1) in the N-type pressure curve indicates the end of the pre-expansion phase, and the valley point (P2) indicates the end of the expansion phase. The pressure gradually increases until it reaches the safety limit (P3), which is the stable expansion phase. Based on the pressure variation characteristics of the balloon body, the balloon expansion process is divided into a nonlinear phase (pre-expansion phase and expansion phase) and a linear phase (stable expansion phase). The junction between the pre-expansion phase and the expansion phase is called the peak point (P1), and the junction between the expansion phase and the stable expansion phase is called the valley point (P2).

[0056] The expansion process consists of the first stage corresponding to the nonlinear stage and the second stage corresponding to the linear stage. The specific characteristics are as follows:

[0057] Pre-expansion stage: gas is injected, the gas injection volume increases slowly, the pressure also rises slowly, and the balloon volume does not change significantly;

[0058] Expansion stage: Gas continues to be injected, the gas injection volume continues to increase, and the pressure drops sharply, starting from the peak value of the "N-type pressure curve" and continuing to drop until it reaches the valley value of the "N-type pressure curve". At this time, the balloon volume increases rapidly;

[0059] Stable expansion stage: Gas continues to be injected, the injection volume continues to increase, the pressure rises steadily, and the balloon volume slowly increases.

[0060] The designated diameter / designated volume of the balloon included in the present invention can be individually designated according to the actual condition of the patient when the balloon enters the patient's body, or can be pre-set according to the results of a preliminary examination, without limitation.

[0061] See also Figure 2 Based on the fact that the inflation process of the balloon complies with the N-type pressure curve, the first embodiment of the present invention provides an expandable device control system 1. The expandable device can be a balloon, and the expandable device control system 1 includes:

[0062] The pressure detection module 11 is used to obtain pressure information of the balloon in a first predetermined period of time.

[0063] The stage analysis module 12 is configured to divide the working state of the balloon into a first stage and a second stage according to the pressure information.

[0064] The first inflation control module 13 is configured to control the inflation volume of the balloon in the first stage according to the pressure information.

[0065] The volume detection module 14 is configured to detect the real-time volume of the balloon in the second stage according to the inflation volume.

[0066] The second inflation control module 15 is configured to control the inflation volume in the second stage according to the real-time diameter corresponding to the real-time volume of the balloon and a designated diameter.

[0067] In this embodiment, in the first predetermined period, pressure information of the balloon detected in real time by using a preset sampling frequency of a pressure sensor is included. The pressure information of the balloon includes a pressure change trend in which the real-time pressure value Pt presents a first increasing and then decreasing manner over time t as the inflation amount of the first inflation control module 13 increases.

[0068] In the first period, as the balloon is continuously inflated, the pressure shows a positive pressure change, and the pressure value gradually rises and gradually approaches P1. After reaching close to P1 and continuing to inflate, the balloon enters a negative pressure change and gradually reaches P2. The first predetermined period of gradually inflating the balloon can include at least a certain moment when the real-time pressure value P(t) is less than the pressure values at its adjacent moments before and after: P(t) < P(t - 1) and P(t) < P(t + 1). Thus, the detection of the pressure information in the first predetermined period can reliably include the first stage P1 and the critical pressure value P2 between the first stage and the second stage.

[0069] In this embodiment, according to the real-time pressure change and the target pressure (such as the target pressure that the balloon needs to reach), the first inflation control module 13 can use the PID control algorithm to dynamically adjust the gas inflation rate in the first stage to ensure that the balloon can stably reach the second stage.

[0070] In this embodiment, the inflation controls of the first inflation control module 13 and the second inflation control module 15 can both drive a peristaltic pump to achieve control of the gas inflow rate and the gas inflow amount.

[0071] In this embodiment, the first inflation control module 13 and the second inflation control module 15 can be integrated into the same module, using the same set of physical hardware, and implementing the control logics of the two stages through their respective corresponding control logics, reducing the hardware complexity. Of course, they can also be designed as two independent modules to have a clear division of labor and improve the flexibility of modular design.

[0072] In this embodiment, the pressure comparison unit 121 can compare the pressure change information at multiple moments in the first stage, and perform analysis and complete stage judgment according to the pressure change situation.

[0073] Specifically, the stage analysis module 12 includes:

[0074] A pressure comparison unit 121 for comparing the pressure change values at multiple moments within the first predetermined period.

[0075] A stage judgment unit 122 for judging whether the balloon reaches the expected pressure threshold P2 according to the comparison result of the pressure comparison unit. If so, the balloon enters the second stage.

[0076] A pressure control unit 123, configured to generate an inflation control signal and transmit it to the first inflation control module 13 to stop the inflation of the balloon in the first stage when the real-time pressure value Pt of the balloon reaches the desired pressure threshold P2.

[0077] In this embodiment, the pressure comparison unit 121 further includes:

[0078] An acquisition subunit 121a, configured to continuously acquire a plurality of the pressure values according to a preset sampling frequency within the first predetermined period.

[0079] A traversal subunit 121b, configured to obtain the pressure change information of the balloon within the first predetermined period by sequentially comparing the pressure values corresponding to adjacent preset sampling frequencies.

[0080] A threshold acquisition subunit 121c, configured to obtain the desired pressure threshold of the balloon according to the pressure change information.

[0081] In this embodiment, please refer to Figure 3 , the acquisition subunit 121a is configured to acquire the pressure values of the balloon at each moment within the first predetermined period based on the preset sampling frequency of the pressure sensor, and store the pressure values of the balloon at each moment. The traversal subunit 121b is configured to perform the following steps at each moment within the first predetermined period:

[0082] S1: Obtain the pressure value of the balloon at the moment t - 1, denoted as the previous balloon pressure P(t - 1);

[0083] S2: Obtain the pressure value of the balloon at the moment t, denoted as the current balloon pressure P(t);

[0084] S3: Obtain the pressure value of the balloon at the moment t + 1, denoted as the current balloon pressure P(t + 1);

[0085] S4: Traverse the balloon pressures P at all moments corresponding to the preset sampling frequencies within the first predetermined period in the order of P(t - 1), P(t), P(t + 1), and finally complete the comparison and evaluation of the pressure trend to obtain the pressure change information including the pressure change value and the pressure change rate within the first predetermined period. The threshold acquisition subunit 121c obtains the pressure value at the moment P(t) when P(t) < P(t - 1) and P(t) < P(t + 而as the desired pressure threshold P2.

[0086] It should be noted that there seems to be an error in the original text where "请参与" in line 15 is likely incorrect. Also, in the translation of line 29, there is an unclear part "P(t) < P(t - 1) and P(t) < P(t + 而", which might be a typo in the original. The translation is done based on the best understanding of the text as presented.In this embodiment, the balloon pressure Pt at each moment corresponding to all preset sampling frequencies within the first predetermined time period is traversed, and by calculating the pressure value difference, before the balloon reaches the desired pressure threshold P2, the balloon is in the first stage. After the real-time pressure Pt in the balloon reaches the desired pressure threshold P2, the balloon enters the second stage. In the second stage, as the peristaltic pump fills the balloon with gas, the real-time volume of the balloon and the gas inflow rate of the balloon in the second stage show a linear or approximately linear relationship.

[0087] In this embodiment, real-time acquisition of intra-balloon pressure data can be achieved using a high-precision pressure sensor, ensuring the accuracy and resolution of the collected data. The preset acquisition frequency can be set based on actual needs. For example, a preset acquisition frequency of 100 Hz means that pressure data is collected every 10 ms. The real-time collected pressure values ​​P(t) are stored in an array or queue for subsequent analysis.

[0088] In this embodiment, to reduce the impact of noise on the determination of the desired pressure threshold P2, a sliding average method or Gaussian filtering can be used to smooth the data and eliminate high-frequency noise, thereby enhancing the reliability of the first-stage and second-stage divisions. Similarly, data can be repeatedly collected during the pressure value change process, and the reliability can be improved by averaging the multiple results.

[0089] In this embodiment, when the real-time pressure value Pt reaches the desired pressure threshold value P2, the pressure control unit 123 generates an inflation control signal to the first inflation control module 13 to stop inflating the balloon. This signal controls the peristaltic pump to stop inflation at the desired pressure threshold value, at which point the balloon is in a spherical state. The balloon is then prepared to enter the spherical expansion phase based on the desired diameter calculation and the setting of the designated diameter. Thereafter, the second inflation module 15 begins inflation based on spherical volume-related information, such as the desired and designated diameters, ensuring stable balloon expansion and entering the second phase. By detecting the real-time balloon diameter Dt, the balloon is controlled to reach the designated diameter D2.

[0090] In this embodiment, the volume detection module 14 includes:

[0091] The diameter obtaining unit 141 is configured to obtain an expected diameter of the balloon according to the inflation volume of the balloon within a first predetermined period corresponding to when the balloon reaches the second stage.

[0092] The target detection unit 142 is configured to detect whether the balloon has expanded from the desired diameter at the time of reaching the second stage to the designated diameter according to the inflation amount.

[0093] Specifically, see Figure 4The diameter acquisition unit 141 calculates the expected diameter D1 of the balloon device at the expected pressure threshold based on the inflation volume V1 of the balloon in the first period collected by the gas flow sensor, where π represents pi:

[0094]

[0095] The target detection unit 142 is used to detect the gas flow Q(t) of the balloon in the second stage in real time through the gas flow sensor during the continuous inflation of the balloon in the second stage, and converts the volume of gas filled in the balloon into the detection of the balloon expansion diameter to detect whether the balloon reaches the specified diameter D2 during the continuous inflation process in the second stage.

[0096] In this embodiment, after the balloon reaches the specified diameter D2, the volume detection module 14 will continue to monitor the real-time volume of the balloon to ensure that the balloon's volume is stably maintained at the specified volume. If a gas leak or other abnormality is detected that causes the volume to drop, the volume detection module 14 will also detect the corresponding abnormality information and issue an abnormality information alarm or abnormality adjustment signal. This enables the second inflation control module 15 to drive the peristaltic pump to perform the corresponding action to maintain the balloon at the specified diameter D2. Similarly, when it is detected that Vt>Vtarget and the error exceeds the allowable error threshold, the inflation control module 15 controls the balloon to deflate.

[0097] In this embodiment, the second inflation control module 15 includes:

[0098] The flow control signal generating unit 151 is configured to generate a gas flow control signal according to the volume difference between the real-time diameter and the specified diameter. The real-time diameter Dt of the balloon can be detected by the diameter acquiring unit 141 of the volume detecting module 14.

[0099] The inflation regulating unit 152 is configured to dynamically regulate the gas inflow rate according to the gas flow control signal to adjust the inflation volume in the second stage.

[0100] The volume control unit 153 is configured to generate an inflation adjustment signal and transmit the signal to the inflation adjustment unit 152 after the balloon reaches the specified diameter.

[0101] After reaching the specified diameter D2, the target control unit 153 generates an inflation adjustment signal for stopping inflation and transmits it to the inflation adjustment unit 152, driving the peristaltic pump to turn off to stop inflating the balloon, so that the balloon maintains the specified diameter D2, which is convenient for the operator to use.

[0102] In this embodiment, when the balloon is in the second stage, the volume detection module 14 cooperates with the second inflation control module to enable the balloon to reach the specified volume V2. Specifically, in the second stage, the gas flow rate Q(t) flowing into the balloon is recorded, and the time t of gas filling is recorded, which is used to accumulate and calculate the total amount of gas filled in the second stage Q 总 Taking into account the elastic properties of the balloon material and the distribution of gas inside the balloon, combined with the inflation volume measured by the flow sensor, the real-time volume Vt of the balloon in the second stage is dynamically estimated. The specific formula is: Vt=V1+ηQt, V1 is the expected volume of the balloon, Vt is the real-time volume of the balloon, and ηQ is the volume change coefficient determined according to the characteristics of the balloon material.

[0103] The process of stable balloon expansion in the second stage is regarded as the gradual expansion of the spherical volume. The real-time volume Vt is calculated as follows:

[0104]

[0105] Wherein, the specified volume V2 of the balloon when the diameter D2 is specified is:

[0106]

[0107] The volume difference ΔV between the real-time volume and the specified volume is V2-Vs. The flow control signal generating unit 151 receives the volume difference ΔV and compares ΔV with the allowable error ∈ when the balloon reaches the specified volume. At the same time, the real-time gas inflow rate F(t) collected by the gas flow sensor in real time and the gas filling amount Q(t) of the balloon in the second stage are considered to generate a gas flow control signal. The regulating unit 152 receives the gas flow control signal and dynamically adjusts the gas inflow rate F(t). The volume detection module 14 detects the real-time diameter Dt of the balloon in real time according to the gas inflow rate F(t) and the gas flow Q and can determine whether the balloon reaches the specified diameter D2.

[0108] Alternatively, the real-time volume change of the balloon can be directly acquired, and the real-time volume Vt can be calculated using the inflation volume obtained by the volume detection module 14. The difference between the real-time volume Vt and the designated volume V2 corresponding to the designated diameter D2 can be used as the basis for determining whether the designated volume V2 of the balloon has been reached. When |ΔV|≤∈, the designated volume V of the balloon has been reached, and the gas flow control signal is a stop gas flow signal. The regulating unit 152 receives the stop gas flow signal and controls the peristaltic pump to shut down, completing the second stage of balloon inflation and making the balloon ready for use by the operator.

[0109] The regulating unit 152 can adjust the dynamic inflation by manually controlling an electronic valve, a proportional valve, etc., thereby controlling the gas flow rate of the balloon in the second stage. For example, when the balloon automatically enters the second stage, the operator can manually control the gas flow rate of the driving pump to achieve more precise control of the balloon volume.

[0110] In this embodiment, when the balloon is in the first stage, the pressure detection module 11 can respond to the real-time pressure data monitored by the pressure sensor according to a preset closed-loop feedback control algorithm, so that the first inflation module 12 can dynamically adjust the pressure inside the balloon to ensure safe and stable operation of the system.

[0111] In this embodiment, when the balloon is in the second stage, the volume detection module 14 can respond to the real-time volume data of the real-time monitored gas flow sensor according to a preset closed-loop feedback control algorithm, thereby detecting whether the balloon has reached the specified volume V2 corresponding to the specified diameter D2, and can feed back the relevant difference information to the second inflation control module 15. The operator can control the second inflation control module 15 to dynamically adjust the peristaltic pump to control the gas flow rate filled into the balloon, ensuring the safe and stable operation of the system, so that the balloon expands to the specified diameter D2 and maintains it to achieve the desired therapeutic effect.

[0112] In this embodiment, since each person's vascular conditions are different, factors such as the diameter, shape, and elasticity of the blood vessels will vary. Therefore, when performing balloon expansion, it is necessary to select an appropriate balloon size based on the specific vascular characteristics. The differences in vascular structure of each patient result in different diameters, lengths, and inflation volumes of the required balloons. Therefore, the inflation volume of the balloon needs to be adjusted individually according to the patient's specific conditions to ensure that the balloon can accurately expand to the target position of the blood vessel without causing over-expansion or under-expansion, thereby avoiding damage to the blood vessel or poor treatment effect. Therefore, when the balloon is in the second stage, the operator can also manually adjust the inflation volume of the balloon based on the real-time volume data of the gas flow sensor monitored in real time by the volume detection module 14, which can ensure that the balloon expands stably under appropriate pressure, so that the balloon expands to the specified diameter D2 and maintains it to achieve the desired treatment effect.

[0113] Based on Example 1, please refer to Figure 5 The expandable device control system 1 of the present invention may further include:

[0114] The state monitoring module 16 is used to monitor the real-time data of the pressure detection module and / or the volume detection module when the balloon is in the operating state.

[0115] The state stage analysis module 17 is used to analyze the real-time data based on a preset closed-loop feedback control algorithm to generate an analysis result that can represent the state of the balloon.

[0116] The state response module 18 is used to respond to the analysis result of the state stage analysis module.

[0117] The balloon status includes the normal process of balloon inflation and deflation under normal conditions. Abnormal conditions include abnormal conditions that occur during balloon inflation or deflation, including but not limited to data deviation, exceeding the preset range, or equipment failure.

[0118] Among them, the state stage analysis module 17 includes:

[0119] The difference calculation unit 171 is used to calculate the data difference between the real-time data and the preset target data.

[0120] The abnormality analysis unit 172 is configured to analyze the data difference based on the preset closed-loop feedback control algorithm to obtain the analysis result of whether the balloon is abnormal.

[0121] In this embodiment, when the first inflation control module 12 and / or the second inflation control module 15 controls the peristaltic pump to inflate or deflate the balloon, the state monitoring module 16 can monitor real-time data on changes in balloon pressure and volume using the pressure and flow rates collected by the pressure sensor and gas flow sensor. The state stage analysis module 17 can calculate, in real time, the pressure and volume differences based on a preset sampling frequency using the difference calculation unit 171.

[0122] The abnormality analysis unit 172 can directly compare the pressure difference and / or volume difference with a preset pressure threshold and / or volume threshold based on a preset closed-loop feedback control algorithm. Alternatively, the abnormality analysis unit 172 can directly obtain the corresponding pressure change rate and volume change rate based on the pressure difference and volume difference, and compare and analyze them with a preset deviation rate. If the abnormality in ΔP or ΔV, or in at least one of the pressure change rate or volume change rate, persists for a certain period of time, or the pressure change trend or volume change trend of the balloon does not follow the predetermined trend, the analysis result of the balloon's operating status is abnormal.

[0123] The preset closed-loop feedback control algorithm specifically uses the collected real-time pressure difference (ΔP) and / or volume difference (ΔV) as feedback input signals. It is compared with the preset pressure threshold and / or volume preset threshold set in the system to generate a deviation signal. According to the real-time deviation value (such as ΔP, ΔV or its rate of change), the pressure or volume change trend is dynamically tracked, and abnormal conditions are detected through the preset feedback logic. For example, when it is detected that the deviation in ΔP or ΔV continues to exceed the threshold, or there is at least one abnormality in the pressure change rate (dP / dt) or volume change rate (dV / dt), and the abnormal state lasts for more than a certain time, the closed-loop system determines that the current control state deviates from the predetermined trend. At the same time, it can adapt to changes in the working state of the balloon by dynamically adjusting the threshold range to ensure the real-time and reliability of the detection.

[0124] In this embodiment, an abnormality can be understood as the detection of pressure changes and / or volume change trends that differ from the peak and valley values ​​observed during normal inflation. This includes, but is not limited to, abnormalities occurring during balloon inflation or deflation, including, but not limited to, data deviations, exceeding preset ranges, or device failures. For example, abnormalities caused by disconnected or blocked tubing, or balloon device leakage.

[0125] In this embodiment, the state response module 18 can utilize system errors and PID control algorithms to respond to the data of real-time monitoring pressure sensors and / or gas flow sensors during abnormality detection analysis, accurately identify abnormalities of the balloon during inflation or deflation operation, and generate response signals that can trigger safety mechanisms to ensure the reliability and safety of the system.

[0126] In this embodiment, the state response module 18 may further include a warning unit 181 for generating a warning signal to issue a warning when the analysis result of the state phase analysis module is abnormal. The warning signal is output via a perceptible signal.

[0127] The perceptible signals include multimodal signals formed by one or more combinations of visual, auditory, tactile, mechanical, and data communication signals. Specifically, the operator can receive warning signals by receiving one or more of the following: text, visual, audio, tactile, and mechanical signals. If the balloon status is abnormal, the system will trigger a warning signal from warning unit 181, prompting the operator to check. In the event of an abnormality, the system can also synchronously control the peristaltic pump to shut down, ensuring the safety of the equipment running on the control system.

[0128] On the basis of the first embodiment, the state response module 18 of the expandable instrument control system 1 of the present invention may further include: a pressure relief regulating module 181, which is used to control the first inflation module and / or the second inflation module to relieve the pressure of the balloon when the balloon exceeds the preset maximum volume and / or the pressure value of the balloon exceeds the preset safety pressure. When the pressure relief regulating module 181 detects that the current balloon diameter of the balloon instrument exceeds the preset maximum diameter threshold or the current pressure value inside the balloon exceeds the safety pressure threshold, it starts the pressure relief operation and adjusts the balloon pressure to the safety limit value. When the real-time pressure value or the real-time volume of the balloon does not drop significantly during the pressure relief process, it indicates that the system pressure relief module may be abnormal. And stop further inflation or pressure relief operations to prevent the balloon from over-expanding or other safety risks. Among them, the safety pressure threshold can be preset according to the material properties of the balloon and the surgical requirements (such as the patient area, the patient's condition), or dynamically adjusted by the system in combination with the real-time pressure change trend. Another embodiment of the present invention also provides an expandable instrument control method, which is implemented using the expandable instrument control system of any of the above embodiments, with reference to Figure 6 The expandable device control method for balloon expansion control includes the following steps:

[0129] Step 10: Obtaining pressure information of the balloon during the first predetermined period of time;

[0130] Step 20: Divide the working state of the balloon into the first stage and the second stage according to the pressure information;

[0131] Step 30: controlling the inflation volume of the balloon in the first stage according to the pressure information;

[0132] Step 40: Detecting the real-time volume of the balloon in the second stage according to the inflation amount;

[0133] Step 50: Control the inflation volume of the second stage according to the real-time diameter corresponding to the real-time volume of the balloon and the designated diameter.

[0134] The expandable device control method disclosed in the present invention is similar in principle to the expandable device control system of any of the aforementioned embodiments, and will not be described in detail.

[0135] Although the embodiments of the present invention have been shown and described above, it will be understood that the above embodiments are illustrative and are not to be construed as limitations on the present invention. A person skilled in the art may change, modify, replace and modify the above embodiments within the scope of the present invention.

Claims

1. An expandable device control system, characterized in that: The expandable device comprises a balloon, and the system comprises: A pressure detection module, configured to obtain pressure information of the balloon during a first predetermined period of time; a stage analysis module, configured to divide the working state of the balloon into a first stage and a second stage according to the pressure information; a first inflation control module, configured to control the inflation volume of the balloon in the first stage according to the pressure information; a volume detection module, configured to detect the real-time volume of the balloon in the second stage according to the inflation amount; The second inflation control module is used to control the inflation volume of the second stage according to the real-time diameter corresponding to the real-time volume of the balloon and the specified diameter.

2. The expandable device control system according to claim 1, wherein: The stage analysis module includes: a pressure comparison unit, configured to compare the pressure information at a plurality of different moments within the first predetermined period; a stage judgment unit, configured to judge whether the balloon reaches a desired pressure threshold according to the comparison result of the pressure comparison unit, and if so, the balloon enters the second stage; A pressure control unit is configured to generate an inflation control signal and transmit the signal to the first inflation control module to stop the first stage of inflation when the pressure value of the balloon reaches the desired pressure threshold.

3. The expandable device control system according to claim 2, wherein: The pressure comparison unit further includes: a collection subunit, configured to continuously collect pressure values ​​at a plurality of different moments according to a preset sampling frequency within the first predetermined period; a traversal subunit, configured to sequentially compare the pressure values ​​at adjacent moments based on the preset sampling frequency to obtain pressure change information of the balloon within the first predetermined time period; A threshold value acquisition subunit is used to acquire the expected pressure threshold value of the balloon according to the pressure change information.

4. The expandable device control system according to claim 1, wherein: The volume detection module includes: a diameter obtaining unit, configured to obtain an expected diameter of the balloon when the balloon reaches the second stage; A target detection unit is configured to detect whether the balloon has expanded from the desired diameter to a specified diameter based on the inflation amount of the balloon in the second stage.

5. The expandable device control system according to claim 4, wherein: The second inflation control module includes: a flow control signal generating unit, configured to generate a gas flow control signal according to a volume difference between the real-time diameter and the specified diameter; an inflation regulating unit, configured to dynamically regulate a gas inflow rate according to the gas flow control signal, so as to adjust an inflation volume in the second stage; The volume adjustment unit is used to generate an inflation adjustment signal and transmit the inflation adjustment signal to the inflation adjustment unit when the balloon reaches the specified diameter.

6. The expandable device control system according to claim 1, wherein: The system further comprises: a state monitoring module, configured to monitor real-time data of the pressure detection module and / or the volume detection module when the balloon is in an operating state; a state stage analysis module, configured to analyze the real-time data based on a preset closed-loop feedback control algorithm and generate an analysis result capable of representing the state of the balloon; A status response module is used to respond to the analysis result of the status stage analysis module.

7. The expandable device control system according to claim 6, wherein: The state stage analysis module includes: A difference calculation unit, configured to calculate the data difference between the real-time data and the preset target data; An abnormality analysis unit is used to analyze the data difference based on the preset closed-loop feedback control algorithm to obtain the analysis result of whether the balloon is abnormal.

8. The balloon control system according to claim 6, characterized in that: The status response module includes: a warning unit, configured to generate a warning signal for warning when the analysis result of the status phase analysis module is abnormal, wherein the warning signal is output in a perceptible form; The warning signal includes: a multimodal signal formed by one or more combinations of visual signals, auditory signals, tactile signals, mechanical signals, and data communication signals.

9. The expandable device control system according to claim 6, wherein: The status response module includes: The pressure relief regulating module is used to control the first inflation module and / or the second inflation module to relieve the pressure of the balloon when the abnormality of the balloon is that the real-time volume of the balloon exceeds the preset maximum volume and / or the pressure value of the balloon exceeds the preset safety pressure.

10. A method for controlling an expandable device, characterized in that: The method is implemented based on the expandable device control system according to any one of claims 1 to 9, and the method comprises: obtaining pressure information of the balloon during a first predetermined period of time; dividing the working state of the balloon into a first stage and a second stage according to the pressure information; controlling the inflation amount of the balloon in the first stage according to the pressure information; detecting a real-time volume of the balloon in the second stage according to the inflation amount; The inflation volume of the second stage is controlled according to the real-time diameter corresponding to the real-time volume of the balloon and the designated diameter.

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