Shock wave balloon inflating and deflating device with flow control function

Abstract

The invention provides a shock wave balloon inflation and deflation device with flow control. The shock wave balloon inflation and deflation device comprises a body; the gas path subsystem comprises a high-pressure gas source, a piezoelectric proportional valve, a turbine flowmeter and a pressure relief electromagnetic valve; the electric control subsystem comprises an FPGA processor and a touch screen human-computer interface. An MEMS pressure sensor is integrated at the far end of the multi-cavity balloon catheter; the piezoelectric proportional valve and the turbine flowmeter form a closed-loop control loop of internal pressure-gas flow of the balloon; the FPGA processor processes pressure and flow signals in real time and dynamically adjusts the opening degree of the piezoelectric proportional valve, the double-closed-loop control system enables the fluctuation of the internal pressure of the balloon to be smaller than or equal to 0.3 atm (traditional equipment + / -2 atm), the pressure compensation delay in the shock wave emission stage is smaller than 8 ms, the energy transmission efficiency is effectively improved, the damage rate of the blood vessel wall is reduced, the elastic modulus self-learning algorithm enables the pressure curve matching degree to be improved, and the pressure compensation delay in the shock wave emission stage is smaller than 8 ms. The bivariate PID module shortens the balloon filling time to 3.2 s (9.5 s in a traditional method), the accuracy rate of the recommended pressure value of the calcification grading module is increased, and 50 ms-level emergency response is achieved through the double-path pressure relief design.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of shock wave balloon, and particularly relates to a shock wave balloon inflation and deflation device with flow control. BACKGROUND

[0002] Calcific aortic valve disease (CAVD) is a common valvular heart disease, and its disease spectrum covers a series of diseases from aortic valve sclerosis to calcific aortic valve stenosis (AS). Aortic valve sclerosis is often a pre-stage of aortic valve stenosis. About 9% of aortic valve sclerosis will progress to stenosis within 5 years. Cardiovascular health research shows that about 1%-2% of aortic valve sclerosis develops into stenosis every year. Among them, 75% of patients will undergo valve replacement surgery due to heart failure or die within 2-5 years. The rigidity of the valve leaflet of calcific aortic valve stenosis gradually increases in the clinical pathogenesis. The late lesion is similar to bone formation, and calcification is a prominent feature. At present, transcatheter aortic valve implantation (TAVI) is the main means for treating calcific aortic valve stenosis, while drug treatment is still in the research and discussion stage. The shock wave balloon releases pulse shock waves through low-pressure balloon expansion (4-6 atm) to selectively fragment the calcified plaque under the intima and media of the blood vessel, avoids damage to elastic tissue, and realizes targeted fragmentation of the calcified plaque by using the characteristics of "soft when encountering soft and rigid when encountering rigid". Single treatment triggers 30-40 pulse cycles, each cycle contains 80 microsecond-level impacts, the shock wave frequency is 1 Hz, the penetration depth covers shallow and deep calcification, and the shock wave balloon inflation and deflation device is a precision medical equipment specially used for cardiovascular intervention treatment. The inflation and deflation process of the balloon is accurately controlled to release pulse shock waves to fragment the calcified plaque of the blood vessel.

[0003] However, the existing shock wave balloon inflation and deflation device has the problems that, in the use process, the pressure fluctuation in the balloon of the traditional equipment is as high as ±2 atm (the target value fluctuation needs to be ≤0.3 atm), which leads to a decrease in the shock wave energy transmission efficiency to below 80%, insufficient calcification fragmentation, a delay of inflation response of >9.5 seconds, and an increase in the risk of flow-limited dissection due to the inability to match the real-time change of the blood vessel elasticity. SUMMARY

[0004] The present application provides a shock wave balloon inflation and deflation device with flow control to solve the problems of the existing shock wave balloon inflation and deflation device in the background art, i.e., in the use process, the pressure fluctuation in the balloon of the traditional equipment is as high as ±2 atm (the target value fluctuation needs to be ≤0.3 atm), which leads to a decrease in the shock wave energy transmission efficiency to below 80%, insufficient calcification fragmentation, a delay of inflation response of >9.5 seconds, and an increase in the risk of flow-limited dissection due to the inability to match the real-time change of the blood vessel elasticity.

[0005] To achieve the above-mentioned purpose, the present application provides a shock wave balloon inflation and deflation device with flow control, which comprises:

[0006] a body;

[0007] The gas path subsystem includes a high-pressure gas source, a piezoelectric proportional valve, a turbine flowmeter, and a pressure relief solenoid valve;

[0008] The electric control subsystem includes an FPGA processor and a touch screen human-machine interface;

[0009] A multi-lumen balloon catheter with a MEMS pressure sensor integrated at the distal end;

[0010] The piezoelectric proportional valve and the turbine flowmeter form a closed-loop control circuit for the pressure and gas flow in the balloon;

[0011] The FPGA processor processes the pressure and flow signals in real time and dynamically adjusts the opening of the piezoelectric proportional valve.

[0012] Preferably, the response time of the piezoelectric proportional valve is ≤10ms, achieving millisecond-level pressure compensation during the shock wave emission stage.

[0013] Preferably, the turbine flowmeter has a measurement accuracy of ±1.5% FS and a sampling frequency of ≥200Hz, capable of detecting a micro-leakage flow of 0.05ml / s.

[0014] Preferably, the FPGA processor is configured with a blood vessel elasticity modulus self-learning algorithm to dynamically correct the control parameters based on angiographic images.

[0015] Preferably, the algorithm includes a pressure-flow dual-variable PID adjustment module that prioritizes flow control during the filling stage and switches to pressure closed-loop control during the maintenance stage.

[0016] Preferably, the MEMS pressure sensor signal line of the multi-lumen balloon catheter uses double-layer shielding wiring with a signal-to-noise ratio of ≥60dB.

[0017] Preferably, the pressure relief solenoid valve is connected in parallel with a backup mechanical valve, and the balloon can be emptied within 50ms in the event of system failure.

[0018] Preferably, the working pressure of the gas path subsystem is 0atm-20atm, and the flow regulation resolution is 0.05ml / s.

[0019] Preferably, the touch screen human-machine interface has a built-in calcification grading module that automatically matches the preset pressure curve.

[0020] Compared with the prior art, the present application has the following advantages:

[0021] Breakthrough in pressure control accuracy: The dual-closed-loop control system makes the pressure fluctuation in the balloon ≤0.3atm (±2atm for traditional devices), the pressure compensation delay during the shock wave emission stage is <8ms, the energy transfer efficiency is effectively improved, and the blood vessel wall damage rate is reduced.

[0022] Intelligent algorithm optimization effect: the self-learning algorithm of elastic modulus improves the matching degree of the pressure curve, the dual-variable PID module shortens the balloon inflation time to 3.2s (traditional method 9.5s), and the accuracy of the recommended pressure value of the calcification grading module is increased;

[0023] Dual-path pressure relief design realizes 50ms-level emergency response; MEMS sensor anti-interference capability is improved: error <1.2% in 3T MRI environment; double-layer shielding wiring reduces signal noise, modular layout shortens maintenance time, and human-machine engineering interface reduces operation error rate. BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 It is a schematic view of the overall structure of the application.

[0025] In the figure: 1, main body; 2, gas path subsystem; 201, high-pressure gas source; 202, piezoelectric proportional valve; 203, turbine flowmeter; 204, pressure relief solenoid valve; 3, electric control subsystem; 301, FPGA processor; 302, touch screen human-machine interface; 4, multi-cavity balloon catheter; 5, MEMS pressure sensor. DETAILED DESCRIPTION

[0026] The technical solutions in the embodiments of the application will be described clearly and completely below with reference to the drawings in the embodiments of the application. Obviously, the described embodiments are only part of the embodiments of the application, rather than all the embodiments. Based on the embodiments in the application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the application.

[0027] Please refer to Figure 1 , the application provides a shock wave balloon inflation and deflation device with flow control, comprising:

[0028] main body 1;

[0029] The gas path subsystem 2 includes a high-pressure gas source 201, a piezoelectric proportional valve 202, a turbine flowmeter 203, and a pressure relief solenoid valve 204;

[0030] The electric control subsystem 3 includes an FPGA processor 301 and a touch screen human-machine interface 302;

[0031] The multi-cavity balloon catheter 4 has a MEMS pressure sensor 5 integrated at its distal end;

[0032] The piezoelectric proportional valve 202 and the turbine flowmeter 203 constitute a closed-loop control circuit for the pressure inside the balloon and the gas flow;

[0033] The FPGA processor 301 processes the pressure and flow signals in real time and dynamically adjusts the opening degree of the piezoelectric proportional valve 202.

[0034] Further, the piezoelectric proportional valve 202 response time ≤10 ms, achieving millisecond pressure compensation in the shock wave emission stage, through the setting of the piezoelectric proportional valve 202, as the core execution element of the gas path subsystem 2, through the electric signal accurate control of the valve core displacement, realizing the continuous proportional regulation of the gas flow and pressure, the input electric signal and the output flow / pressure show linear relationship, the response time ≤10 ms (millisecond level), in the shock wave emission stage to realize the dynamic compensation of pressure fluctuation ≤5%, and the turbine flowmeter 203 constitutes a "pressure-flow" double variable closed loop control circuit: receiving the instruction signal of the FPGA processor 301, dynamically adjusting the valve opening, correcting the output through real-time feedback flow data, eliminating the influence of system hysteresis.

[0035] Further, the turbine flowmeter 203 measurement accuracy ±1.5%FS, sampling frequency ≥200Hz, can detect 0.05ml / s of micro-leakage flow, through the setting of the turbine flowmeter 203, real-time flow accurate measurement: through the turbine blade rotation to convert fluid kinetic energy into electric pulse signal (frequency proportional to flow), realize 0.05ml / s-300ml / s range of dynamic monitoring; accuracy control: ±1.5%FS (full scale) accuracy guarantee balloon inflation process error ≤0.08ml / s; micro-leakage detection: can identify ≥0.05ml / s of small gas leakage; with piezoelectric proportional valve constitutes a dynamic adjustment circuit: sampling frequency ≥200Hz, realize 5ms level data refresh, output RS485 digital signal direct connection FPGA processor 301, drive voltage proportional valve 202 opening adjustment; abnormal flow early warning: when the flow mutation >20% is detected, the FPGA protection mechanism is triggered, and the balloon rupture risk is cross-verified combined with the pressure sensor data.

[0036] Further, the FPGA processor 301 is configured with a blood vessel elastic modulus self-learning algorithm, which dynamically corrects the control parameters according to the angiographic image, and through the setting of the FPGA processor, multiple signals are processed in parallel through programmable logic units, achieving nanosecond-level response (delay <2us), synchronously controlling the piezoelectric proportional valve 202, turbine flowmeter 203 and other subsystems, ensuring the accurate alignment of the gas path action timing, integrating the PID algorithm to dynamically adjust the inflation and deflation process (sampling frequency ≥200Hz), and millisecond-level compensation is made for the flow / pressure fluctuation (fluctuation suppression to ±5%).

[0037] Further, the algorithm contains a pressure-flow double variable PID adjustment module, which prioritizes flow control during inflation and switches to pressure closed loop during maintenance, through the setting of the pressure-flow double variable PID adjustment module, simultaneously adjusting the pressure and flow in a closed loop, solving the coupling interference problem in single variable control:

[0038] Pressure PID: Proportional and integral to suppress sudden pressure fluctuation, and derivative to predict overshoot trend (response time ≤10ms);

[0039] Flow PID: Integral to eliminate steady-state flow error (accuracy ±1.5% FS), ensuring linear growth during inflation.

[0040] When the pressure mutation is >20%, the flow PID automatically limits the flow to prevent the balloon from overpressure rupture;

[0041] When the flow anomaly is detected, the pressure PID triggers the pressure relief protection (response delay <50ms).

[0042] Further, the MEMS pressure sensor 5 signal line of the multi-lumen balloon catheter 4 adopts double-layer shielding wiring, and the signal-to-noise ratio is ≥60dB.

[0043] Further, the pressure relief solenoid valve 204 is connected in parallel with the standby mechanical valve, and the balloon can be emptied within 50ms when the system fails. Through the setting of the pressure relief solenoid valve 204, the pressure relief solenoid valve 202 undertakes the key safety control and pressure regulation functions in medical equipment (such as shock wave balloon system). When the system pressure exceeds the preset safety threshold (such as the balloon burst critical value), the solenoid coil is energized / de-energized to trigger the valve to open, and the high-pressure gas is released instantly to avoid equipment damage or medical risks. The electromagnetic drive realizes ≤5ms level fast pressure relief, which is more than 10 times faster than the mechanical valve. The pressure sensor feeds back in real time, and the FPGA controls the pressure relief action error ≤±0.5%. A double insurance mechanism is formed with the mechanical safety valve. The pressure relief solenoid valve 204 serves as the active protection layer, supporting dynamic threshold adjustment (such as setting the range of 3-8bar according to the balloon material). The mechanical valve serves as the ultimate protection layer and physically starts pressure relief when the circuit fails.

[0044] Further, the gas path subsystem 2 works at a pressure of 0atm-20atm, and the flow regulation resolution reaches 0.05ml / s. Through the setting of the gas path subsystem 2, the gas path subsystem 2 undertakes the core power transmission and precise control function in the shock wave balloon inflation and deflation device. The high-pressure gas source 201 (helium / gas carbon dioxide) provides a 0-20atm adjustable pressure, provides an initial power source for balloon inflation, meets the treatment needs of different calcification levels, and covers the whole scene of vascular intervention treatment (pre-expansion pressure 8-12atm, shock wave treatment pressure 3-5atm) in the working pressure range. The piezoelectric proportional valve 202 (response time ≤10ms) adjusts the gas flow in real time, compensates for pressure attenuation at the moment of shock wave emission, maintains the pressure fluctuation in the balloon ≤5%, and realizes the intelligent switching of inflation period flow priority (0-5s) and treatment period pressure priority through the flow-pressure double closed loop of the double variable PID algorithm. The turbine flowmeter 203 (±1.5%FS accuracy, 200Hz sampling) detects 0.05ml / s level micro leakage, which is 30ms earlier than the pressure sensor to find abnormalities. The pressure relief solenoid valve 204 and the mechanical valve are designed in parallel, which can force the balloon to be emptied within 50ms in case of system failure, avoid excessive expansion of the blood vessel to cause damage, and shorten the pressure stabilization time from 3.2s to 0.8s through closed-loop control, thereby improving the single shock wave energy transmission efficiency by 35%. The double pressure relief channel design reduces the accident rate of balloon overexpansion to below 0.1%, and automatically adapts to different blood vessel diameters (2.0-5.0mm) through the blood vessel elastic modulus self-learning algorithm.

[0045] Further, the touch screen human-computer interface 302 is built-in with a calcification grading module, which automatically matches a preset pressure curve. The touch screen human-computer interface 302 undertakes the core interaction and intelligent decision-making hub function, displays key parameters such as balloon pressure (0-20atm range), gas flow (0.05ml / s resolution) and shock wave emission times in real time, provides a calcification grading operation module (light / medium / severe three levels), automatically matches a preset pressure curve (such as a 12atm high-pressure mode for severe calcification), is built-in with a angiography data analysis module, integrates a blood vessel elastic modulus self-learning algorithm (based on DICOM image), dynamically generates a pressure-flow double variable PID control strategy: inflation period flow control priority (target value ±0.25ml / s), and switches to pressure closed loop (fluctuation ≤5%) in the maintenance period. Safety monitoring and emergency response: over-threshold alarm mechanism (pressure fluctuation >30% triggers double valve pressure relief), micro leakage real-time early warning (turbine flowmeter detects 0.05ml / s leakage and pops up a warning window).

[0046] Example 1 (basic type)

[0047] Hardware configuration

[0048] Gas path subsystem: helium high-pressure gas source (15MPa) is adopted, and SMC PVQ31 piezoelectric proportional valve (response time 8ms) is equipped

[0049] Electric control subsystem: Xilinx Artix-7 FPGA processor, control cycle 200μs, touch screen integrated calcification grading UI module

[0050] Catheter: 5F double-lumen balloon, distal Bosch BMP384 MEMS sensor embedded (signal-to-noise ratio 62dB)

[0051] Operation flow

[0052] Filling phase: inflation at 3ml / s initial flow rate, switch to PID pressure closed-loop therapy phase when 10atm detected: dynamic compensation for pressure fluctuations during shockwave emission (±0.3atm)

[0053] Example 2 (emergency enhanced)

[0054] Safety reinforcement design

[0055] Dual pressure relief channels: SMC VDW21 solenoid valves (response 25ms) in parallel 650 mechanical valve

[0056] Emergency algorithm: trigger three-stage alarm and automatic emptying when pressure gradient > 2atm / s

[0057] Vessel adaptation technology

[0058] Elastic modulus self-learning: real-time calculation of vessel wall stiffness coefficient K based on OCT images, dynamic adjustment of PID parameters

[0059] Example 3 (pediatric special type)

[0060] Miniaturization improvement

[0061] Balloon catheter: 3F three-lumen structure, MEMS sensor wire diameter reduced to 0.08mm

[0062] Low pressure mode: working range 0-8atm, flow resolution improved to 0.02ml / s

[0063] Special algorithm

[0064] Children's vessel recognition model: input patient age, weight to automatically generate personalized pressure curve.

[0065] Although embodiments of the present application have been shown and described, it is to be understood that various modifications, substitutions, replacements and changes can be made to these embodiments without departing from the principles and spirit of the present application, and the scope of the present application is defined by the appended claims and their equivalents.

Claims

1. A shockwave balloon inflation / deflation device with flow control, characterized in that... include: Main body (1); The gas circuit subsystem (2) includes a high-pressure gas source (201), a piezoelectric proportional valve (202), a turbine flow meter (203), and a pressure relief solenoid valve (204); The electronic control subsystem (3) includes an FPGA processor (301) and a touch screen human-machine interface (302); A multi-lumen balloon catheter (4) with a MEMS pressure sensor (5) integrated at its distal end; The piezoelectric proportional valve (202) and the turbine flow meter (203) constitute a closed-loop control circuit for the pressure-gas flow inside the balloon; The FPGA processor (301) processes pressure and flow signals in real time and dynamically adjusts the opening of the piezoelectric proportional valve (202).

2. The shockwave balloon inflation / deflation device with flow control according to claim 1, characterized in that: The piezoelectric proportional valve (202) has a response time of ≤10ms, achieving millisecond-level pressure compensation during the shock wave emission phase.

3. The shockwave balloon inflation / deflation device with flow control according to claim 1, characterized in that: The turbine flow meter (203) has a measurement accuracy of ±1.5%FS, a sampling frequency of ≥200Hz, and can detect micro-leakage flow of 0.05ml / s.

4. The shockwave balloon inflation / deflation device with flow control according to claim 1, characterized in that: The FPGA processor (301) is equipped with a vascular elastic modulus self-learning algorithm to dynamically correct control parameters based on angiography images.

5. The shockwave balloon inflation / deflation device with flow control according to claim 4, characterized in that: The algorithm includes a pressure-flow dual-variable PID control module, which prioritizes flow control during the filling period and switches to pressure closed-loop control during the maintenance period.

6. The shockwave balloon inflation / deflation device with flow control according to claim 1, characterized in that: The MEMS pressure sensor (5) signal line of the multi-lumen balloon catheter (4) adopts double-layer shielding and has a signal-to-noise ratio ≥60dB.

7. The shockwave balloon inflation / deflation device with flow control according to claim 1, characterized in that: The pressure relief solenoid valve (204) is connected in parallel with the backup mechanical valve, and the balloon can be emptied within 50ms in case of system failure.

8. The shockwave balloon inflation / deflation device with flow control according to claim 1, characterized in that: The gas circuit subsystem (2) operates at a pressure of 0 atm-20 atm and has a flow rate adjustment resolution of 0.05 ml / s.

9. The shockwave balloon inflation / deflation device with flow control according to claim 1, characterized in that: The touch screen human-machine interface (302) has a built-in calcification grading module that automatically matches a preset pressure curve.

Images