Solution detection circuit, method, high voltage generator and blood vessel calcification treatment device

Abstract

The application provides a solution detection circuit, a method, a high-voltage generator and a blood vessel calcification treatment device. The solution detection circuit comprises a sampling module, a first processing module and a second processing module. The sampling module is arranged in a pulse discharge circuit and is used for sampling a current in the pulse discharge circuit to obtain a sampling voltage, and then comparing the sampling voltage with a threshold voltage to obtain a detection output level. The first processing module is used for controlling the conduction of the detection voltage to the pulse discharge circuit to charge a catheter balloon solution, and also controlling the disconnection of the detection voltage and obtaining the detection output level through the sampling module, and determining a discharge time length according to the time length when the detection output level is a valid level. The second processing module is used for judging whether the solution state is normal according to the comparison result of the discharge time length and a preset time length. The application charges and discharges the catheter balloon solution, samples and compares during discharging to obtain the discharge time length, judges whether the solution state is normal according to the discharge time length, and realizes safe and reliable treatment.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a solution detection circuit, method, high voltage generator, and vascular calcification treatment device. Background Technology

[0002] Vascular calcification is the process of calcium salt deposition within blood vessels. Over time, more and more calcified substances adhere to the vessel walls, causing the lumen of the vessel to become increasingly narrow, reducing the compliance and flexibility of the vessel, and making the vessel brittle and hard. This leads to a series of vascular diseases, such as atherosclerosis, hypertension, vascular damage, and aging. If not treated in time, it will seriously affect a person's physical and mental health.

[0003] Vascular calcification has always been a challenge in clinical treatment, especially deep calcified lesions, for which effective treatment methods are lacking, and the incidence of vascular calcification is increasing year by year. The incidence of peripheral artery calcification is also age-related. According to statistics, the global incidence of PAD (peripheral artery disease) is approximately 12%, increasing to 6.8% in people aged 60-69 and 9.2% in people over 70 years old. In my country, among the more than 5 million PAD patients, it is estimated that more than 50% present with peripheral vascular calcification, and nearly 150,000 peripheral artery interventional procedures were performed in 2020.

[0004] For vascular calcification lesions, commonly used clinical treatments include non-compliant balloons, cutting balloons, rotational atherectomy, and excimer laser therapy. However, these treatments are only suitable for mild to moderate calcification lesions and are difficult to treat deep calcification lesions. Shockwave lithotripsy, as an emerging technology, combines traditional electrohydraulic lithotripsy and balloon angioplasty. It can efficiently and safely pre-treat moderate to severe calcification lesions of the coronary or peripheral arteries. It can rupture calcified plaques without damaging the vascular intima and achieves good treatment results for calcified nodules, eccentric calcifications, and superficial and deep calcification lesions.

[0005] In existing vascular calcification treatment devices, when using shockwave energy systems for vascular calcification treatment, the conductive fluid inside the catheter balloon is prepared by the user using a specially formulated mixture of saline and contrast agent, which is then injected into the balloon using a syringe. Due to human error, there is an unavoidable risk of error. If the mixing ratio is incorrect or a different solution is mistakenly prepared and injected into the balloon, the liquid's impedance will be too high, affecting the shockwave intensity or even preventing the generation of a shockwave, thus impacting the procedure. Conversely, if the liquid's impedance is too low, a high shockwave intensity will be generated, causing rapid electrode damage, affecting the procedure, and potentially leading to balloon rupture and the leakage of the balloon's internal fluid into the body, posing a serious medical risk.

[0006] Similarly, during surgical treatment, as the electrodes discharge and wear down, the metal material of the electrodes exists in the discharge medium in an ionic state. As the dielectric impedance decreases, the intensity of the shock wave becomes too high, resulting in the consequences described above.

[0007] Therefore, a stable impedance medium inside the balloon is beneficial to the success rate of the surgery and reduces the surgical risk. Thus, it is also very necessary to detect the fluid inside the catheter balloon before and during shockwave therapy.

[0008] The preceding description is intended to provide general background information and does not necessarily constitute prior art. Summary of the Invention

[0009] To address the aforementioned technical problems, this application provides a solution detection circuit, method, high-voltage generator, and vascular calcification treatment device. The device charges and discharges the solution in a catheter balloon, samples and compares the discharge duration during discharge, and determines whether the solution is in a normal state based on the discharge duration, thus achieving safe and reliable treatment.

[0010] This invention provides a solution detection circuit, including a sampling module, a first processing module, and a second processing module; wherein,

[0011] The sampling module is set in the pulse discharge circuit to sample the current in the pulse discharge circuit to obtain a sampling voltage, and then compares the sampling voltage with a threshold voltage to obtain a detection output level.

[0012] The first processing module is connected to the sampling module and is used to control the conduction of the detection voltage to the pulse discharge circuit to charge the catheter balloon solution. It also controls the disconnection of the detection voltage and obtains the detection output level through the sampling module, and determines the discharge duration based on the duration during which the detection output level is an effective level.

[0013] The second processing module is connected to the first processing module and is used to determine whether the solution state is normal based on the comparison result of the discharge duration and the preset duration.

[0014] In one implementation, the sampling module includes a sampling resistor and a comparator; wherein,

[0015] The sampling resistor is connected between the catheter balloon solution and the negative electrode in the pulse discharge circuit;

[0016] The non-inverting input of the comparator receives the sampled voltage, the inverting input of the comparator receives the threshold voltage, and the output of the comparator (111) outputs the detection output level.

[0017] In one embodiment, the sampling module further includes a Zener diode, the first end of which is connected to the first end of the sampling resistor, and the second end of which is connected to the second end of the sampling resistor.

[0018] In one embodiment, the sampling module further includes an isolation amplifier; the first input terminal of the isolation amplifier is connected to the first terminal of the sampling resistor, the second input terminal of the isolation amplifier is connected to the second input terminal of the sampling resistor, and the output terminal of the isolation amplifier is connected to the non-inverting input terminal of the comparator.

[0019] In one embodiment, the isolation amplifier is an optical coupler or a magnetic coupler.

[0020] In one embodiment, the second processing module sends a voltage data signal to a digital-to-analog converter, and the digital-to-analog converter outputs the threshold voltage based on the voltage data signal.

[0021] In one implementation, when the second processing module sends a first control signal, the first processing module controls the conduction of the detection voltage to the pulse discharge circuit according to the first control signal; when the second processing module sends a second control signal, the first processing module controls the disconnection of the detection voltage and the pulse discharge circuit according to the second control signal.

[0022] Based on the same inventive concept, the present invention provides a solution detection method, which, as one embodiment, includes:

[0023] The detection voltage is switched on to the pulse discharge circuit to charge the catheter balloon solution;

[0024] Disconnect the detection voltage, sample the current in the pulse discharge circuit to obtain the sampling voltage, compare the sampling voltage with the threshold voltage to obtain the detection output level, and determine the discharge duration based on the duration for which the detection output level is valid.

[0025] Based on the comparison between the discharge duration and the preset duration, it is determined whether the solution state is normal.

[0026] Based on the same inventive concept, the present invention also provides a high-voltage generator. As one embodiment, the high-voltage generator includes a power supply module, a boost module, a discharge control module, and the solution detection circuit described in any of the above embodiments; wherein...

[0027] The power module is connected to the boost module, the first processing module and the second processing module, and is used to supply power to the boost module, the first processing module and the second processing module;

[0028] The first processing module is connected to the boost module and is used to control the boost module to generate a voltage of a preset amplitude;

[0029] The discharge control module is connected between the boost module and the catheter balloon solution, and is also connected to the second processing module. It is used to connect or disconnect the pulse discharge circuit between the boost module and the catheter balloon solution according to the control of the second processing module.

[0030] Based on the same inventive concept, the present invention also provides a vascular calcification treatment device, which, as one embodiment, includes the high voltage generator, connector, and consumable electrode described in any of the above embodiments.

[0031] The output terminal of the high-voltage generator is connected to the consumable electrode via the connector to form a pulse discharge circuit.

[0032] In summary, the solution detection circuit provided in this embodiment of the invention charges and discharges the solution in the catheter balloon, samples the current in the pulse discharge circuit during discharge to obtain a sampling voltage, obtains the detection output level by comparing the sampling voltage with a threshold voltage, obtains the discharge duration based on the validity of the detection output level, and then determines whether the solution is in a normal state by comparing the discharge duration with a preset duration. This avoids the situation where excessive dielectric impedance of the solution affects the intensity of the shock wave and results in an insignificant therapeutic effect, or excessive dielectric impedance of the solution causes electrode damage and leads to medical accidents, thus achieving safe and reliable shock wave therapy for vascular calcification.

[0033] The solution detection method, high-voltage generator, and vascular calcification treatment device provided by this invention belong to the same inventive concept as the discharge detection circuit provided by this invention, and therefore have the same beneficial effects.

[0034] To make the above and other objects, features and advantages of the present invention more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0035] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this application and, together with the description, serve to explain the principles of this application. To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, those skilled in the art can obtain other drawings based on these drawings without any creative effort.

[0036] Figure 1 This is a schematic diagram of the connection of a solution detection circuit according to an embodiment of the present invention.

[0037] Figure 2This is an equivalent circuit diagram of a catheter balloon solution according to an embodiment of the present invention.

[0038] Figure 3 This is a simplified equivalent circuit diagram of a catheter balloon solution according to an embodiment of the present invention.

[0039] Figure 4 This is a simplified equivalent circuit diagram of a catheter balloon solution according to another embodiment of the present invention.

[0040] Figure 5 This is a schematic diagram of the RC circuit discharge principle of a catheter balloon solution according to an embodiment of the present invention.

[0041] Figure 6 This is a discharge curve of a catheter balloon solution according to an embodiment of the present invention.

[0042] Figure 7 This is a structural block diagram of a vascular calcification treatment device according to an embodiment of the present invention.

[0043] Figure 8 This is a schematic diagram of the solution detection process of a vascular calcification treatment device according to an embodiment of the present invention.

[0044] Figure 9 This is a schematic diagram of the catheter balloon discharge principle of a vascular calcification treatment device according to an embodiment of the present invention.

[0045] The realization of the objectives, functional features, and advantages of this application will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. The accompanying drawings have illustrated specific embodiments of this application, which will be described in more detail below. These drawings and textual descriptions are not intended to limit the scope of the concept in any way, but rather to illustrate the concepts of this application to those skilled in the art through reference to specific embodiments. Detailed Implementation

[0046] To enable those skilled in the art to better understand the technical solutions of the present invention, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are merely some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort should fall within the protection scope of the present invention.

[0047] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects, but are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that includes a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0048] It should be understood that although the steps in the flowcharts of this application's embodiments are shown sequentially according to the arrows, these steps are not necessarily executed in the order indicated by the arrows. Unless explicitly stated herein, there is no strict order restriction on the execution of these steps, and they can be executed in other orders. Moreover, at least some of the steps in the figures may include multiple sub-steps or multiple stages. These sub-steps or stages are not necessarily completed at the same time, but can be executed at different times, and their execution order is not necessarily sequential, but can be performed alternately or in turn with other steps or at least a portion of the sub-steps or stages of other steps.

[0049] In the following description, the use of suffixes such as "module," "part," or "unit" to denote elements is solely for the purpose of illustrative purposes and has no specific meaning in itself. Therefore, "module," "part," or "unit" may be used interchangeably.

[0050] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

[0051] Figure 1 This is a schematic diagram of the connection of a solution detection circuit according to an embodiment of the present invention. Figure 1As shown, the solution detection circuit includes a sampling module 110, a first processing module 120, and a second processing module 130. The sampling module 110 is located in the pulse discharge circuit and is used to sample the current in the pulse discharge circuit to obtain a sampling voltage. The sampling voltage is then compared with a threshold voltage to obtain a detection output level. The first processing module 120 is connected to the sampling module 110 and is used to control the conduction of the detection voltage to the pulse discharge circuit to charge the catheter balloon solution. It also controls the disconnection of the detection voltage and obtains the detection output level through the sampling module 110, determining the discharge duration based on the duration the detection output level is valid. The second processing module 130 is connected to the first processing module 120 and is used to determine whether the solution state is normal based on the comparison result between the discharge duration and a preset duration.

[0052] Specifically, firstly, the first processing module 120 controls the conduction of the detection voltage to the pulse discharge circuit, so the detection voltage is the charging voltage. The catheter balloon solution is charged through the pulse discharge circuit, increasing the electrical energy in the solution and causing the voltage across the solution electrodes to rise, eventually stabilizing after a certain period. Then, the first processing module 120 disconnects the detection voltage and the pulse discharge circuit, and the catheter balloon solution begins to discharge. The first processing module 120 then acquires the discharge duration of the catheter balloon solution through the sampling module 110. At this time, the solution begins to release electrical energy, and the amount of energy released decreases over time, as does the current in the pulse discharge circuit. The sampling module 110 samples the current in the pulse discharge circuit, and the resulting sampling voltage also decreases. The sampling module 110 then compares the sampling voltage with a threshold voltage to obtain the detection output level. Initially, the sampling voltage is greater than the threshold voltage, and the output detection level is valid. However, as the sampling voltage decreases, when it falls below the threshold voltage, the output detection level from the sampling module 110 is no longer valid. The first processing module 120 obtains the discharge duration based on the duration during which the detection output level sent by the sampling module 110 is at a valid level. Finally, the second processing module 130 determines whether the solution state is normal based on the comparison between the discharge duration and the preset duration. For example, if the discharge duration is not greater than the first preset percentage of the preset duration and not less than the second preset percentage of the preset duration, the solution is in a normal state, meaning the dielectric impedance of the solution meets the requirements; otherwise, the solution is in an abnormal state, meaning the dielectric impedance of the solution does not meet the requirements.

[0053] It should be noted that a pulse discharge circuit refers to a discharge circuit that discharges using a pulsed method, such as a high-voltage pulse. For example... Figure 1In this circuit, the catheter balloon solution can be equivalent to a resistive-capacitive circuit, for example, an RC circuit with the solution resistance R1 and equivalent capacitance C1 connected in parallel. Then, HV+, the catheter balloon solution, and HV- constitute a pulse discharge loop. Even if a switching element is placed in the loop to control its conduction or disconnection, HV+, the catheter balloon solution, HV-, and the switching element still constitute a discharge loop. That is to say, disconnecting the discharge loop does not affect its function as a discharge loop. The above explanation is basic knowledge possessed by those skilled in the art and will not be elaborated upon here.

[0054] like Figure 1 As shown, in one embodiment, the pulse discharge circuit includes a second capacitor, which, together with the solution resistor Rx, forms an RC charge-discharge circuit. In one embodiment, the capacitor used for filtering and stabilizing the pulse discharge current in the pulse discharge circuit can be used as the second capacitor to reduce the number of capacitors.

[0055] like Figure 1 As shown, in one embodiment, the sampling module 110 includes a sampling resistor R2 and a comparator 111; wherein, the sampling resistor R2 is connected between the catheter balloon solution and the negative electrode of the pulse discharge circuit; the non-inverting input terminal of the comparator 111 receives the sampling voltage, the inverting input terminal of the comparator 111 receives the threshold voltage, and the output terminal of the comparator 111 outputs the detection output level. In one embodiment, the power supply terminal of the comparator receives the power supply voltage VCC.

[0056] Specifically, the sampling module 110 sets a sampling resistor R2 in the pulse discharge circuit. When the current in the pulse discharge circuit flows through the sampling resistor R2, a voltage will be generated across the sampling resistor R2. The sampling module 110 can obtain the corresponding sampling voltage based on the voltage across the sampling resistor R2, and then compare the sampling voltage with the threshold voltage through the comparator 111 to obtain the corresponding detection output level.

[0057] like Figure 1 As shown, in one embodiment, the sampling module 110 further includes a Zener diode D1, the first end of which is connected to the first end of the sampling resistor R2, and the second end of which is connected to the second end of the sampling resistor R2.

[0058] Specifically, Zener diode D1 can ensure that the voltage difference across the sampling resistor R2 is within a reasonable range, thus preventing damage to the sampling resistor R2 or the isolation amplifier 112 due to excessive voltage.

[0059] like Figure 1As shown, in one embodiment, the sampling module 110 further includes an isolation amplifier 112; the first input terminal of the isolation amplifier 112 is connected to the first terminal of the sampling resistor R2, the second input terminal of the isolation amplifier 112 is connected to the second input terminal of the sampling resistor R2, and the output terminal of the isolation amplifier 112 is connected to the non-inverting input terminal of the comparator 111. In one embodiment, the isolation amplifier 112 can be an optocoupler or a magnetic coupler, or other isolation devices, to isolate the high-voltage signal and convert it into a low-voltage signal, all of which fall within the scope of protection of this application.

[0060] Specifically, the isolation amplifier 112 can isolate the high-voltage discharge circuit from the low-voltage circuit, effectively preventing high-voltage signals from damaging the first processing module 120 and the second processing module 130, thus improving safety and reliability.

[0061] like Figure 1 As shown, in one embodiment, comparator 111 employs a high-speed comparator, thereby achieving a nanosecond-level processing speed and obtaining a more accurate detection value for the discharge duration.

[0062] like Figure 1 As shown, in one embodiment, the second processing module 130 sends a voltage data signal to the digital-to-analog converter 131, and the digital-to-analog converter 131 outputs a threshold voltage according to the voltage data signal.

[0063] Specifically, the second processing module 130 can send corresponding voltage data signals through a program. The digital-to-analog converter 131 outputs a threshold voltage based on the voltage data signal to adjust the magnitude of the threshold voltage. This allows it to adapt to the errors in the system parameters that are allowed during product manufacturing and testing, and provides high flexibility.

[0064] like Figure 1 As shown, in one embodiment, when the second processing module 130 sends the first control signal, the first processing module 120 controls the conduction of the detection voltage to the pulse discharge circuit according to the first control signal; when the second processing module 130 sends the second control signal, the first processing module 120 controls the disconnection of the detection voltage according to the second control signal.

[0065] Specifically, the second processing module 130 can control the first processing module 120 to perform, for example, switching the switch control module on or off, through different control signals, such as the first control signal and the second control signal, so as to turn on or off the detection voltage and realize the control of charging and discharging of the solution.

[0066] In one embodiment of the present invention, the first processing module 120 may be, but is not limited to, an FPGA, and the second processing module 130 may be, but is not limited to, an MCU.

[0067] Specifically, firstly, the first processing module 120 controls the conduction of the detection voltage to the pulse discharge circuit. The detection voltage then becomes the charging voltage, and the balloon solution is charged through the pulse discharge circuit. This increases the electrical energy in the solution, causing the voltage across the solution electrodes to rise and stabilize after a certain period. Preferably, the detection voltage is lower than the output voltage during treatment to avoid the solution inside the balloon from breaking down and generating a shock wave.

[0068] Then, the first processing module 120 disconnects the detection voltage and pulse discharge circuit, and the catheter balloon solution begins to discharge. The first processing module 120 begins to acquire the discharge duration of the catheter balloon solution through the sampling module 110. At this time, the solution begins to release electrical energy, and the amount of electrical energy released decreases over time, and the current in the pulse discharge circuit also decreases. The voltage across the sampling resistor R2 on the sampling module 110 also decreases, and the sampling voltage obtained by the isolation amplifier 112 through the isolation amplification of the voltage across the sampling resistor R2 also decreases. The comparator 111 compares this sampling voltage with the threshold voltage and outputs a corresponding detection output level. At the beginning of the discharge, the sampling voltage is greater than the threshold voltage, and the detection output level output by the comparator 111 is a valid level, such as a high level. However, as the sampling voltage decreases, when the sampling voltage is less than the threshold voltage, the detection output level output by the sampling module 110 will no longer be a valid level, for example, no longer a high level but a low level. The first processing module 120 obtains the discharge duration based on the duration for which the detection output level sent by the comparator 111 is a valid level.

[0069] Finally, the second processing module 130 determines whether the solution state is abnormal based on the discharge duration. For example, it determines whether the solution state is normal based on the comparison between the discharge duration and the preset duration. For example, if the discharge duration is not greater than the first preset percentage of the preset duration and not less than the second preset percentage of the preset duration, the solution is in a normal state, that is, the dielectric impedance of the solution meets the requirements; otherwise, the solution is in an abnormal state, that is, the dielectric impedance of the solution does not meet the requirements.

[0070] Figure 2 This is an equivalent circuit diagram of a catheter balloon solution according to an embodiment of the present invention. This embodiment provides a solution detection circuit, its basic structure and principle, and the resulting technical effects. Figure 1 The embodiments are the same. For the sake of brevity, any parts not mentioned in this embodiment can be found in the following examples. Figure 1 The corresponding content in the example. For example... Figure 2 As shown, in one embodiment, the equivalent circuit of the catheter balloon solution includes solution resistance Rx, first electrode lead resistance RL1, second electrode lead resistance RL2, first polarization impedance Z1, second polarization impedance Z2, and first double-layer capacitance C. DL1 Second double-layer capacitance C DL2The dielectric and electrode lead distributed capacitance Cp. The first terminal of the first electrode lead resistor RL1 and the first terminal of the second electrode lead resistor RL2 are used to receive external voltage. The second terminal of the first electrode lead resistor RL1 is connected to the first terminal of the first polarization impedance Z1. The second terminal of the first polarization impedance Z1 is connected to the first terminal of the solution resistor Rx. The second terminal of the second electrode lead resistor RL2 is connected to the first terminal of the second polarization impedance Z2. The second terminal of the second polarization impedance Z2 is connected to the second terminal of the solution resistor Rx. The first double-layer capacitance C... DL1 The first terminal is connected to the first terminal of the first polarization impedance Z1, and the first double-layer capacitance C DL1 The second terminal is connected to the second terminal of the first polarization impedance Z1. The second double-layer capacitance C DL2 The first terminal is connected to the first terminal of the second polarization impedance Z2, and the second double-layer capacitance C DL2 The second terminal is connected to the second terminal of the second polarization impedance Z2. The first terminal of the dielectric and electrode lead distributed capacitance Cp is connected to the second terminal of the first electrode lead resistor RL1, and the second terminal of the dielectric and electrode lead distributed capacitance Cp is connected to the first terminal of the second electrode lead resistor RL2.

[0071] Specifically, in this embodiment, the equivalent circuit of the catheter balloon solution generally uses pulse excitation to eliminate the polarization effect. The resistances RL1 of the first electrode wire, RL2 of the second electrode wire, and the dielectric capacitance are very small and can be ignored. Therefore, a reasonable and simplified equivalent circuit diagram can be obtained as follows: Figure 3 As shown. When measuring low-conductivity solutions or using high-frequency excitation, the first double-layer capacitance C... DL1 Second double-layer capacitance C DL2 The capacitive reactance is relatively small and can be ignored, resulting in a further equivalent circuit as follows: Figure 4 As shown, different solutions, or solutions mixed in different proportions, have different resistance values ​​(R) and capacitance values ​​(C). Therefore, the relationship between resistance value R and capacitance value C can be used to indirectly distinguish the types of liquids.

[0072] Figure 3 This is a simplified equivalent circuit diagram of a catheter balloon solution according to an embodiment of the present invention. This embodiment provides a solution detection circuit, its basic structure and principle, and the resulting technical effects. Figure 1 The embodiments are the same. For the sake of brevity, any parts not mentioned in this embodiment can be found in the following examples. Figure 1 The corresponding content in the example. For example... Figure 3As shown, in one embodiment, the equivalent circuit of the catheter balloon solution includes a solution resistance Rx, a double-layer capacitance Cx, and an electrode lead distributed capacitance Cp. The first terminal of the solution resistance Rx and the second terminal of the double-layer capacitance Cx are used to receive an external voltage, and the second terminal of the solution resistance Rx is connected to the first terminal of the double-layer capacitance Cx. The first terminal of the electrode lead distributed capacitance Cp is connected to the first terminal of the solution resistance Rx, and the second terminal of the electrode lead distributed capacitance Cp is connected to the second terminal of the double-layer capacitance Cx. Wherein, the double-layer capacitance Cx is the first double-layer capacitance C0. DL1 Second double-layer capacitance C DL2 The equivalent capacitance.

[0073] Figure 4 This is a simplified equivalent circuit diagram of a catheter balloon solution according to another embodiment of the present invention. This embodiment provides a solution detection circuit, its basic structure and principle, and the resulting technical effects. Figure 1 The embodiments are the same. For the sake of brevity, any parts not mentioned in this embodiment can be found in the following examples. Figure 1 The corresponding content in the example. For example... Figure 4 As shown, in one embodiment, the equivalent circuit of the catheter balloon solution includes a solution resistance Rx and an electrode lead distributed capacitance Cp. A first terminal and a second terminal of the solution resistance Rx are used to receive an external voltage. The first terminal of the electrode lead distributed capacitance Cp is connected to the first terminal of the solution resistance Rx, and the second terminal of the electrode lead distributed capacitance Cp is connected to the second terminal of the solution resistance Rx.

[0074] Figure 5 This is a schematic diagram of the RC circuit discharge principle of a catheter balloon solution according to an embodiment of the present invention. Figure 5 Corresponding to Figure 4 The simplified equivalent circuit diagram of the RC circuit for discharging a catheter balloon solution is shown. Figure 5 As shown, the solution resistance Rx corresponds to the resistance RL, and the electrode lead distributed capacitance Cp corresponds to the capacitance C. Therefore, the catheter balloon solution forms an RC circuit. It can be charged by turning on the switch S with a conduction voltage U, and discharged by turning off the switch S with a disconnection voltage U. It also has an RC time constant, which is the product of resistance and capacitance, i.e., t = RC. During charging, the time required for the capacitor's terminal voltage to reach 1 - 1 / e of its maximum value (approximately 0.63 times) is the time constant. During discharging, the time constant is the time required for the capacitor's terminal voltage to reach 1 / e of its maximum value (approximately 0.37 times). Therefore, during the charging and discharging process, the duration of the solution's charging and discharging is related to the solution's equivalent resistance and equivalent capacitance. The larger the equivalent resistance and equivalent capacitance, the longer the discharge time. Thus, by statistically analyzing the discharge time, the impedance characteristics of the solution can be indirectly reflected, thereby distinguishing different solutions.

[0075] Figure 6This is a discharge curve of a catheter balloon solution according to an embodiment of the present invention. Figure 6 Corresponding to Figure 5 The discharge curve of the RC circuit discharge principle diagram of the catheter balloon solution is shown in the figure. Figure 6 As shown, the voltage-time relationship under different impedances during RC circuit discharge corresponds to different discharge curves. When the initial discharge voltage is U but the impedance is different, the discharge curves differ. The higher the impedance, the longer it takes to drop to the specified threshold voltage. Therefore, the impedance relationship in the liquid can be analyzed by detecting the RC discharge time. In one embodiment, during detection, a certain voltage is first applied to the catheter balloon, the voltage in the solution increases, then the applied voltage is stopped, and the voltage is immediately detected. When the liquid voltage drops to the threshold voltage value, the voltage drop time is calculated. The magnitude of this time can indirectly reflect the impedance characteristics of the solution.

[0076] In summary, the solution detection circuit provided in this embodiment of the invention charges and discharges the solution in the catheter balloon, samples the current in the pulse discharge circuit during discharge to obtain a sampling voltage, obtains the detection output level by comparing the sampling voltage with a threshold voltage, obtains the discharge duration based on the validity of the detection output level, and then determines whether the solution is in a normal state by comparing the discharge duration with a preset duration. This avoids the situation where excessive dielectric impedance of the solution affects the intensity of the shock wave and results in an insignificant therapeutic effect, or excessive dielectric impedance of the solution causes electrode damage and leads to medical accidents, thus achieving safe and reliable shock wave therapy for vascular calcification.

[0077] Based on the same inventive concept, embodiments of the present invention also provide a solution detection method. This method includes:

[0078] The detection voltage is switched on to the pulse discharge circuit to charge the catheter balloon solution;

[0079] Disconnect the detection voltage, sample the current in the pulse discharge circuit to obtain the sampling voltage, compare the sampling voltage with the threshold voltage to obtain the detection output level, and determine the discharge duration based on the duration of the detection output level being effective.

[0080] Based on the comparison between the discharge duration and the preset duration, determine whether the solution state is normal.

[0081] It should be noted that for any parts of this method embodiment that are not described or explained in detail, please refer to the description of the foregoing embodiments, and will not be repeated here.

[0082] In summary, the solution detection method provided by this invention involves charging and discharging the solution in a catheter balloon, sampling the current in the pulse discharge circuit during discharge to obtain a sampling voltage, comparing the sampling voltage with a threshold voltage to obtain a detection output level, determining the discharge duration based on the validity of the detection output level, and comparing the discharge duration with a preset duration to determine whether the solution is in a normal state. This avoids the situation where excessive dielectric impedance of the solution affects the intensity of the shock wave and results in an insignificant therapeutic effect, or excessive dielectric impedance of the solution causes electrode damage and leads to medical accidents. This method achieves safe and reliable shock wave therapy for vascular calcification.

[0083] Based on the same inventive concept, embodiments of the present invention also provide a high-voltage generator. Please refer to... Figure 7 , Figure 7 This is a structural block diagram of a vascular calcification treatment device according to an embodiment of the present invention. Figure 7 As shown, the high-voltage generator includes a power supply module 200, a boost module 300, a discharge control module 400, and a solution detection circuit according to any of the aforementioned embodiments. The power supply module 200 is connected to the boost module 300, the first processing module 120, and the second processing module 130, and supplies power to these modules. The first processing module 120 is connected to the boost module 300 and controls the boost module 300 to generate a voltage of a preset amplitude. The discharge control module 400 is connected between the boost module 300 and the catheter balloon solution, and is also connected to the second processing module 130, and controls the pulse discharge circuit between the boost module 300 and the catheter balloon solution to be connected or disconnected according to the control of the second processing module 130.

[0084] Specifically, the high-voltage generator can first perform solution detection. The second processing module 130 controls the boost module 300 to generate a detection voltage of a preset amplitude. The sampling module 110 samples the voltage and compares it with a threshold voltage to obtain the detection output level. The first processing module 120 determines the discharge duration based on the level of the detection output level. The second processing module 130 determines whether the solution state is normal based on the comparison between the discharge duration and the preset duration. Optionally, after the second processing module 130 determines that the solution state is normal based on the comparison between the discharge duration and the preset duration, the high-voltage generator can perform vascular calcification shockwave therapy. The second processing module 130 controls the boost module 300 to generate a pulsed high voltage of a preset amplitude, and controls the switching element in the discharge control module 400 to conduct for a short time (e.g., a few microseconds) to perform pulsed discharge.

[0085] In one embodiment, when the second processing module 130 determines that the solution state is abnormal based on the comparison between the discharge duration and the preset duration, it prohibits discharge and promptly issues an alarm to inform the operator of the equipment's operating status. Specifically, the processing module can control the high-voltage-related switching elements to shut down, avoiding situations where excessive dielectric impedance of the solution affects the shock wave intensity and results in insignificant therapeutic effects, or where insufficient dielectric impedance of the solution damages the electrodes and leads to medical accidents. This ensures the safety and reliability of shock wave therapy for vascular calcification.

[0086] like Figure 7 As shown, in one embodiment, the high-voltage generator further includes a first step-down module 500 and a second step-down module 600, which are used to step down the voltage of the power supply module 200 and then supply power to the first processing module 120 and the second processing module 130, respectively.

[0087] like Figure 7 As shown, in one embodiment, the high-voltage generator further includes an analog-to-digital converter module 700, which is connected to the second processing module 130 and the boost module 300. The second processing module 130 can then sample the high-voltage output of the boost module 300 through the analog-to-digital converter module 700 to ensure the voltage value is within a reasonable range.

[0088] like Figure 7 As shown, in one embodiment, the high-voltage generator further includes a display screen 800, which is connected to the second processing module 130. The display screen 800 can display device status information, such as an LCD screen, and can also display solution detection results. Furthermore, it can provide an alarm when the solution is in an abnormal state.

[0089] In summary, the high-voltage generator provided in this embodiment of the invention charges and discharges the solution in the catheter balloon, and samples the current in the pulse discharge circuit during discharge to obtain a sampling voltage. The detection output level is obtained by comparing the sampling voltage with the threshold voltage, and the discharge duration is obtained based on the validity of the detection output level. Then, the solution is judged to be in a normal state by comparing the discharge duration with the preset duration. This avoids the situation where the dielectric impedance of the solution is too high, affecting the intensity of the shock wave and resulting in an insignificant therapeutic effect, or the dielectric impedance of the solution is too low, causing electrode damage and thus medical accidents. This achieves safe and reliable shock wave therapy for vascular calcification.

[0090] It should be noted that for any parts not described or explained in detail in this embodiment, please refer to the description in the foregoing embodiments, and will not be repeated here.

[0091] Based on the same inventive concept, this invention also provides a vascular calcification treatment device. The vascular calcification treatment device includes a high-voltage generator, a connector, and consumable electrodes as described in any of the foregoing embodiments. The output terminal of the high-voltage generator (i.e., the output terminal of the boost module 300) is connected to the consumable electrodes via the connector to form a high-voltage discharge circuit.

[0092] For details, please refer to Figure 8 , Figure 8 This is a schematic flowchart of the solution detection process in a vascular calcification treatment device according to an embodiment of the present invention. Figure 8 As shown, the specific workflow for discharge detection in vascular calcification treatment equipment includes the following steps:

[0093] Step S110: The second processing module 130 drives the digital-to-analog converter module to output a certain amplitude threshold voltage;

[0094] Step S111: Trigger the boost module 300 to generate a detection voltage;

[0095] Step S112: Control the discharge control module 400 to turn on and maintain it for a preset time;

[0096] Step S113: Disconnect the discharge control module 400 and start timing;

[0097] Step S114: Detect the level state of the detection output level sent by comparator 111, and count the high levels;

[0098] Step S115: Determine whether the detection output level is high.

[0099] If the output level is detected to be high, return to step S114;

[0100] When the output level is detected to be low, proceed to step S116: stop timing;

[0101] Step S117: Determine whether the discharge duration is significantly different from the preset duration;

[0102] When the difference between the discharge duration and the preset duration is small, proceed to step S118: determine that the solution state is normal;

[0103] When the discharge duration differs significantly from the preset duration, proceed to step S119: determine that the solution state is abnormal;

[0104] Step S120: Issue an error message and disable discharge.

[0105] Specifically, during discharge therapy, the second processing module 130, such as an MCU, drives the digital-to-analog converter to output a certain amplitude threshold voltage and controls the boost module 300 to generate a detection voltage of a preset amplitude. Then, the first processing module 120 controls the discharge control module 400 to be turned on and maintained for a preset time to charge the catheter balloon solution. The voltage across the solution electrode increases and stabilizes after a certain period. Then, the first processing module 120 controls the discharge control module 400 to be turned off and starts timing. At the same time as triggering the discharge control module 400 to be turned off, the sampling module 110 samples the current in the pulse discharge circuit to obtain a sampling voltage. The comparator 111 obtains the detection output level based on the comparison between the sampling voltage and the threshold voltage. The first processing module 120 detects the level state of the detection output level sent by the comparator 111 and counts the high levels. When the output level is detected to be low, the timer is turned off and stops counting. The second processor determines whether the discharge duration differs significantly from the preset duration. If the difference is significant, the solution state is considered abnormal, and abnormal prompts and operational restrictions can be issued to prohibit discharge, such as disabling the generation of high voltage and preventing the operator from triggering discharge treatment again. If the difference between the discharge duration and the preset duration is small, the solution state is normal. This avoids the situation where excessive dielectric impedance of the solution affects the intensity of the shock wave and results in an insignificant therapeutic effect, or excessive dielectric impedance of the solution damages the electrodes and causes medical accidents, thus achieving safe and reliable shock wave therapy for vascular calcification.

[0106] Figure 9 This is a schematic diagram illustrating the catheter balloon discharge principle of a vascular calcification treatment device according to an embodiment of the present invention. Figure 9As shown, in this embodiment, during shockwave therapy for vascular calcification, the initial voltage on the high-voltage capacitor of the boost module 300 is U0, the external circuit resistance and inductance are R0 and L0 respectively, and the solution gap resistance is RG. After the pulse trigger switch S is closed, a high-voltage pulse is applied to the solution gap G. The gap breaks down, forming a plasma channel and cavity, radiating a powerful shock wave into the weakly compressible liquid medium. When the liquid medium breaks down through the high-voltage pulse discharge, the liquid medium undergoes a transformation of three stages—liquid phase, gas phase, and plasma—in a very short time, forming a high-temperature, high-pressure plasma channel. Due to the high pressure inside the channel and the temperature steepness at the plasma boundary, a huge differential pressure is generated in the channel, causing the plasma channel to expand rapidly outward, thus achieving a rapid conversion of electrical energy into mechanical energy. Since the liquid is weakly compressible around the plasma channel, the mechanical energy mainly diffuses outward in the form of mechanical waves through the liquid medium, generating a high-energy-density shock wave. During the pre-breakdown phase, when voltage is applied across the gap in the solution, the voltage across the gap decays exponentially with the capacitor voltage. The gap does not break down immediately but after a certain period of time. This process is the jet formation stage between electrodes, during which leakage current flows across the gap. The discharge characteristics of the pre-breakdown process directly affect the energy efficiency and shock wave intensity of the main discharge process. During the main discharge phase, the voltage across the gap drops rapidly, and the discharge current rises rapidly. Generally, the circuit impedance is small, and the current decays in an RLC underdamped oscillatory manner. The plasma channel and cavity expand rapidly, and the electrostatic repulsion between ions can lead to the formation of microbubbles, providing electrons with a sufficiently long free path, resulting in electron avalanche, which in turn leads to breakdown and achieves the therapeutic effect.

[0107] It should be noted that for any parts of this method embodiment that are not described or explained in detail, please refer to the description of the foregoing embodiments, and will not be repeated here.

[0108] In summary, the vascular calcification treatment device provided by the present invention charges and discharges the catheter balloon solution, samples the current in the pulse discharge circuit during discharge to obtain the sampling voltage, obtains the detection output level by comparing the sampling voltage with the threshold voltage, obtains the discharge duration based on the validity of the detection output level, and then determines whether the solution is in a normal state by comparing the discharge duration with the preset duration. This avoids the situation where the dielectric impedance of the solution is too high, affecting the intensity of the shock wave and resulting in an insignificant treatment effect, or the dielectric impedance of the solution is too low, causing electrode damage and thus medical accidents. This achieves safe and reliable shock wave therapy for vascular calcification.

[0109] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the invention without departing from the scope of the invention shall still fall within the scope of the present invention.

Claims

1. A solution detection circuit, characterized by, It includes a sampling module (110), a first processing module (120), and a second processing module (130); wherein, The sampling module (110) is set in the pulse discharge circuit and is used to sample the current in the pulse discharge circuit to obtain a sampling voltage, and then compare the sampling voltage with the threshold voltage to obtain the detection output level. The first processing module (120) is connected to the sampling module (110) and is used to control the conduction of the detection voltage to the pulse discharge circuit to charge the catheter balloon solution. It also controls the disconnection of the detection voltage and obtains the detection output level through the sampling module (110), and determines the discharge duration based on the duration during which the detection output level is an effective level. The second processing module (130) is connected to the first processing module (120) and is used to determine whether the solution state is normal based on the comparison result of the discharge duration and the preset duration. The sampling module (110) includes a sampling resistor (R2), a comparator (111), and an isolation amplifier (112). The sampling resistor (R2) is connected between the catheter balloon solution and the negative electrode in the pulse discharge circuit. The non-inverting input of the comparator (111) receives the sampling voltage, the inverting input of the comparator (111) receives the threshold voltage, and the output of the comparator (111) outputs the detection output level. The first input of the isolation amplifier (112) is connected to the first terminal of the sampling resistor (R2), the second input of the isolation amplifier (112) is connected to the second input of the sampling resistor (R2), and the output of the isolation amplifier (112) is connected to the non-inverting input of the comparator (111).

2. The solution detection circuit according to claim 1, characterized in that, The sampling module (110) further includes a Zener diode (D1), the first end of which is connected to the first end of the sampling resistor (R2), and the second end of which is connected to the second end of the sampling resistor (R2).

3. The solution detection circuit according to claim 1, characterized in that, The isolation amplifier (112) is an optocoupler or a magnetic coupler.

4. The solution detection circuit according to claim 1, characterized in that, The second processing module (130) sends a voltage data signal to the digital-to-analog converter (131), and the digital-to-analog converter (131) outputs the threshold voltage according to the voltage data signal.

5. The solution detection circuit according to claim 1, characterized in that, When the second processing module (130) sends the first control signal, the first processing module (120) controls the conduction of the detection voltage to the pulse discharge circuit according to the first control signal; when the second processing module (130) sends the second control signal, the first processing module (120) controls the disconnection of the detection voltage and the pulse discharge circuit according to the second control signal.

6. A solution detection method, applied to the solution detection circuit as described in any one of claims 1 to 5, characterized in that, include: The detection voltage is switched on to the pulse discharge circuit to charge the catheter balloon solution; Disconnect the detection voltage, sample the current in the pulse discharge circuit to obtain the sampling voltage, compare the sampling voltage with the threshold voltage to obtain the detection output level, and determine the discharge duration based on the duration for which the detection output level is valid. Based on the comparison between the discharge duration and the preset duration, it is determined whether the solution state is normal.

7. A high-voltage generator, characterized in that, The system includes a power supply module (200), a boost module (300), a discharge control module (400), and a solution detection circuit as described in any one of claims 1 to 5; wherein the power supply module (200) is connected to the boost module (300), the first processing module (120), and the second processing module (130) and is used to supply power to the boost module (300), the first processing module (120), and the second processing module (130); The first processing module (120) is connected to the boost module (300) and is used to control the boost module (300) to generate a voltage of a preset amplitude; The discharge control module (400) is connected between the boost module (300) and the catheter balloon solution, and is also connected to the second processing module (130). It is used to connect or disconnect the pulse discharge circuit between the boost module (300) and the catheter balloon solution according to the control of the second processing module (130).

8. A device for treating vascular calcification, characterized in that, Includes the high-voltage generator, connector, and consumable electrode as described in claim 7; The output terminal of the high-voltage generator is connected to the connector and the consumable electrode to form a pulse discharge circuit.

Images