Shock wave cracking calcification device and control method

Abstract

The invention provides a shock wave cracking calcification device and a control method thereof. The shock wave cracking calcification device comprises a high-voltage pulse source, a shock wave balloon catheter, a detection module and a controller, wherein the high-voltage pulse source is used for generating excitation pulses acting on an electrode in the shock wave balloon catheter; the shock wave balloon catheter is used for generating shock waves; the detection module is used for detecting a first discharge current between the electrodes in the process that the shock wave balloon catheter generates shock waves; the controller is used for judging whether the excitation pulse acting on the electrode needs to be adjusted or not according to the first discharge current, and controlling the high-voltage pulse source to adjust the excitation pulse and act the adjusted excitation pulse on the electrode according to the electrochemical performance parameters related to the electrode in the shock wave generation process under the condition that the excitation pulse needs to be adjusted; the electrochemical performance parameters related to the electrode are in a first preset range in the process of generating the shock wave. According to the scheme, more stable shock waves meeting requirements can be generated.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a shock wave pyrolysis calcification device and a control method for the shock wave pyrolysis calcification device. Background Technology

[0002] For cardiovascular diseases with severe calcification in the blood vessels, medical professionals can make a diagnosis based on intravascular imaging and choose procedures such as rotational atherectomy or excimer laser ablation to reshape the calcified plaques and treat vascular stenosis. With advancements in medical technology, doctors can now also opt for intravascular lithotripsy, using an intravascular calcification-breaking device to break down the calcified plaques in the blood vessels.

[0003] During the use of an intravascular calcification lysis device, a high-voltage pulse source is controlled to output excitation pulses, which are used to excite the front-end catheter electrode to generate shock waves, thereby breaking down calcified plaques within the blood vessel. However, during the application of the excitation pulses to the catheter electrode, the electrode may be ablated, affecting its lifespan and also impacting the shock waves generated by the catheter.

[0004] In related technologies, the lifespan of the electrode is improved by using materials with higher hardness, greater thickness, or longer length to fabricate the catheter, thereby slowing down the ablation rate of the metal material used in its fabrication or providing more ablationable metal material. However, this method is not conducive to reducing the passage size of the balloon used to house the catheter electrode. Summary of the Invention

[0005] The present invention was proposed in view of the above-mentioned problems.

[0006] According to a first aspect of the present invention, a shock wave pyrolysis calcification device is also provided, comprising: a high-voltage pulse source, a shock wave balloon catheter, a detection module, and a controller; wherein the high-voltage pulse source is used to generate an excitation pulse acting on an electrode in the shock wave balloon catheter; the shock wave balloon catheter is used to generate a shock wave under the action of the excitation pulse; the detection module is used to detect a first discharge current between the electrodes during the generation of the shock wave by the shock wave balloon catheter; the controller is used to determine, based on the first discharge current, whether it is necessary to adjust the excitation pulse acting on the electrode, and if it is necessary to adjust the excitation pulse, control the high-voltage pulse source to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave and apply the adjusted excitation pulse to the electrode, so that the electrochemical performance parameters of the electrode are within a first preset range during the generation of the shock wave.

[0007] For example, the electrochemical performance parameters of the electrode include those determined based on the first discharge current.

[0008] For example, the electrochemical performance parameters determined based on the first discharge current include the first discharge current, the lower limit of the first preset range is the first preset current, and the controller controls the high-voltage pulse source to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, including performing the following operations: when the first discharge current is less than or equal to the first preset current and the pulse width of the excitation pulse does not reach the first pulse width threshold, the controller controls the high-voltage pulse source to increase the pulse width of the excitation pulse so that the first discharge current is greater than the first preset current.

[0009] For example, the controller controls the high-voltage pulse source to increase the pulse width of the excitation pulse, including performing the following operations: determining the amount of increase in the pulse width based on the difference between the peak value of the first discharge current and the second preset current, wherein the increase in the pulse width is proportional to the difference, and wherein the second preset current is the median value of the current value in the first preset range; controlling the high-voltage pulse source to increase the pulse width of the excitation pulse by the amount of increase in amplitude.

[0010] For example, the controller controls the high-voltage pulse source to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, and further includes performing the following operations: after the pulse width of the excitation pulse has reached the first pulse width threshold, if the first discharge current is less than or equal to the first preset current and the voltage amplitude of the excitation pulse has not reached the first voltage threshold, then the high-voltage pulse source is controlled to increase the voltage amplitude of the excitation pulse.

[0011] For example, the electrochemical performance parameters determined based on the first discharge current include the first discharge current, the lower limit of the first preset range is the first preset current, and the controller controls the high-voltage pulse source to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, including performing the following operations: when the first discharge current is less than or equal to the first preset current and the voltage amplitude of the excitation pulse does not reach the first voltage threshold, the controller controls the high-voltage pulse source to increase the voltage amplitude of the excitation pulse.

[0012] For example, the electrochemical performance parameters determined based on the first discharge current include the first discharge current, the upper limit of the first preset range is a third preset current, and the controller is further configured to shut down the high-voltage pulse source when the first discharge current is greater than or equal to the third preset current.

[0013] For example, the detection module is further configured to detect the voltage between the electrodes. The process of generating the shock wave includes a streamer propagation process and a morphology transformation process. The controller determines whether the excitation pulse applied to the electrodes needs to be adjusted based on the first discharge current, including performing the following operations: determining the first energy consumed by the electrodes during the streamer propagation process based on the first discharge current and the voltage between the electrodes during the streamer propagation process; determining the second energy consumed by the electrodes during the morphology transformation process based on the first discharge current and the voltage between the electrodes during the morphology transformation process; and determining whether the excitation pulse needs to be adjusted based on the first energy and the second energy.

[0014] For example, the controller determines the first energy according to the following formula:

[0015] W 流注 =∫0 tr U cath I cath dt

[0016] Among them, W 流注 U represents the first energy, tr represents the end time of the stream propagation process, and U represents the end time of the stream propagation process. cath I represents the voltage between the electrodes during the propagation of the stream. cath This represents the first discharge current during the propagation of the streamer.

[0017] For example, the electrochemical performance parameters determined based on the first discharge current include the second energy, the lower limit of the first preset range is the first preset energy threshold, and the controller controls the high-voltage pulse source to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, including performing the following operations: when the second energy is less than the first preset energy threshold, the peak value of the first discharge current in the morphological conversion process is greater than the fourth preset current, and the voltage amplitude of the excitation pulse does not reach the second voltage threshold, the high-voltage pulse source is controlled to increase the voltage amplitude of the excitation pulse according to the first energy and the second energy, so that the second energy is greater than or equal to the first preset energy threshold.

[0018] For example, the controller controls the high-voltage pulse source to increase the voltage amplitude of the excitation pulse based on the first energy and the second energy, including performing the following operations: determining the voltage increase amount of the excitation pulse based on the first energy, the second energy and the capacitance value of the excitation capacitor of the high-voltage pulse source; and controlling the high-voltage pulse source to increase the voltage amplitude of the excitation pulse by the voltage increase amount.

[0019] For example, the controller controls the high-voltage pulse source to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, and further includes performing the following operations: when the second energy is less than the first preset energy threshold, the peak value of the first discharge current of the morphological conversion process is greater than the fourth preset current, and the pulse width of the excitation pulse does not reach the second pulse width threshold, the controller controls the high-voltage pulse source to increase the pulse width of the excitation pulse according to the first energy and the second energy.

[0020] For example, the electrochemical performance parameters determined based on the first discharge current include the second energy, the lower limit of the first preset range is the first preset energy threshold, and the controller controls the high-voltage pulse source to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave. It also includes performing the following operations: when the second energy is less than the first preset energy threshold, the peak value of the first discharge current in the morphological conversion process is greater than the fourth preset current, and the pulse width of the excitation pulse does not reach the second pulse width threshold, the high-voltage pulse source is controlled to increase the pulse width of the excitation pulse according to the first energy and the second energy.

[0021] For example, the controller is further configured to: shut down the high-voltage pulse source when a preset condition is met, wherein the preset condition includes: the proportion of the total number of adjustment failures in the total number of adjustments of the excitation pulse is greater than a first proportion threshold and / or the number of consecutive adjustment failures is greater than the first number threshold, wherein the adjustment failure indicates that after one adjustment of the excitation pulse, the electrochemical performance parameters of the electrode are still less than the lower limit of the first preset range during the generation of the shock wave.

[0022] According to a second aspect of the present invention, a control method for a shock wave pyrolysis calcification device is provided, applied to a shock wave pyrolysis calcification device comprising a shock wave balloon catheter. The shock wave pyrolysis calcification method comprises: detecting a first discharge current between electrodes in the shock wave balloon catheter during the generation of a shock wave; determining, based on the first discharge current, whether it is necessary to adjust the excitation pulse applied to the electrodes; if it is necessary to adjust the excitation pulse, adjusting the excitation pulse according to the electrochemical performance parameters of the electrodes during the generation of the shock wave, and applying the adjusted excitation pulse to the electrodes so that the electrochemical performance parameters of the electrodes are within a first preset range during the generation of the shock wave.

[0023] In the aforementioned shock wave pyrolysis and calcification device, a detection module detects the first discharge current between the electrodes during the generation of the shock wave in the shock wave balloon catheter. A controller then determines, based on this first discharge current, whether the excitation pulse applied to the electrodes needs adjustment. If adjustment is required, the high-voltage pulse source is controlled to adjust the excitation pulse according to the electrode-related electrochemical performance parameters during shock wave generation. The adjusted excitation pulse is then applied to the electrodes, ensuring that the electrode-related electrochemical performance parameters remain within a preset range during shock wave generation. This allows the shock wave pyrolysis and calcification device to self-adjust based on the electrode ablation status, reducing the impact of electrode ablation on the shock wave generated by the shock wave balloon catheter, thereby generating a more stable shock wave that meets the required specifications.

[0024] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, and in order to make the above and other objects, features and advantages of the present invention more apparent and understandable, specific embodiments of the present invention are described below. Attached Figure Description

[0025] The above and other objects, features, and advantages of the present invention will become more apparent from the more detailed description of the embodiments of the invention in conjunction with the accompanying drawings. The drawings are provided to further illustrate the embodiments of the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention and do not constitute a limitation thereof. In the drawings, the same reference numerals generally represent the same parts or steps.

[0026] Figure 1 A schematic structural diagram of a shock wave pyrolysis calcification apparatus according to an embodiment of the present invention is shown;

[0027] Figure 2a A schematic diagram of the initiation process of a shockwave balloon catheter according to an embodiment of the present invention is shown;

[0028] Figure 2b A schematic diagram of the flow propagation process of a shock wave balloon catheter according to an embodiment of the present invention is shown;

[0029] Figure 2c A schematic diagram illustrating the morphological transformation process of a shockwave balloon catheter according to an embodiment of the present invention is shown;

[0030] Figure 3a A schematic structural diagram of a shock wave pyrolysis calcification apparatus according to another embodiment of the present invention is shown;

[0031] Figure 3b A schematic structural diagram of a shock wave pyrolysis calcification apparatus according to yet another embodiment of the present invention is shown;

[0032] Figure 4 A schematic diagram showing the variation curves of the voltage acting on the electrodes and the first discharge current between the electrodes during the generation of a shock wave according to an embodiment of the present invention;

[0033] Figure 5 A schematic diagram showing the relationship between the first discharge current variation curve and the excitation pulse width during the generation of a shock wave according to an embodiment of the present invention is shown.

[0034] Figure 6 A schematic diagram showing the relationship between the first discharge current variation curve and the voltage amplitude during the generation of a shock wave according to an embodiment of the present invention is provided.

[0035] Figure 7 A schematic flowchart of a control method for a shock wave pyrolysis calcification apparatus according to an embodiment of the present invention is shown;

[0036] Figure 8 A schematic diagram of a control method for a shock wave pyrolysis calcification apparatus according to yet another embodiment of the present invention is shown. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of the present invention more apparent, exemplary embodiments according to the present invention will be described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are merely a part of the embodiments of the present invention, and not all of the embodiments of the present invention. It should be understood that the present invention is not limited to the exemplary embodiments described herein. Based on the embodiments of the present invention described herein, all other embodiments obtained by those skilled in the art without inventive effort should fall within the protection scope of the present invention.

[0038] In the use of intravascular calcification devices, to excite the electrodes in the leading catheter to break down and discharge in a supersonic mode, thereby generating a shock wave, a high-amplitude excitation pulse from a high-voltage pulse source is typically controlled to achieve a high electric field strength between the electrodes, for example, above 1 MV / cm. Specifically, the excitation pulse drives the power of the catheter. Under the drive of the excitation pulse, the electrodes in the catheter generate spark breakdown, resulting in a hydroelectric effect and thus generating a pulsed shock wave. The electrode spacing in the catheter is typically 50 μm to 300 μm, while the high-voltage pulse source needs to output a voltage of over 10,000 volts to meet this requirement. However, in actual medical diagnosis and treatment, it is difficult for the high-voltage pulse source of the intravascular calcification device to output a voltage of over 10,000 volts. At lower voltages, the catheter electrodes may also ablate, and stable spark breakdown between the electrodes may not occur, thus failing to generate a stable shock wave that meets the requirements. To at least partially solve the above problems, a shock wave calcification device is proposed.

[0039] Figure 1 A schematic structural diagram of a shock wave pyrolysis calcification apparatus according to an embodiment of the present invention is shown. In this shock wave pyrolysis calcification apparatus, the ablation status of the electrodes is determined by the breakdown current between the electrodes, and the excitation pulse used to drive the electrodes is adjusted accordingly to compensate for the electric field attenuation caused by electrode ablation. Figure 1 As shown, the shock wave lysis calcification device may include a high-voltage pulse source 100, a shock wave balloon catheter 400, a detection module 300, and a controller 200. The detection module 300 may be connected between the high-voltage pulse source 100 and the electrodes in the shock wave balloon catheter 400, and the controller 200 may be connected between the detection module 300 and the high-voltage pulse source 100.

[0040] A high-voltage pulse source 100 is used to generate excitation pulses that act on the electrodes in the shockwave balloon catheter 400. The parameters of the generated excitation pulses, such as amplitude, pulse width, and frequency, can be adjusted by controlling the high-voltage pulse source 100. For example, the high-voltage pulse source 100 can output excitation pulses with a voltage amplitude of 1000V to 10000V to act on the shockwave balloon catheter 400.

[0041] The shockwave balloon catheter 400 is used to generate shock waves under the action of an excitation pulse. The shockwave balloon catheter 400 contains at least one pair of electrodes, and each pair of electrodes generates a shock wave under the action of an excitation pulse. An interelectrode fluid for generating a stream is present between each pair of electrodes. This interelectrode fluid has a certain degree of conductivity. When the excitation pulse is applied to each pair of electrodes, a certain current exists between the electrodes.

[0042] According to the above embodiments of the present invention, the voltage amplitude of the excitation pulse is in the kilovolt range. Under such an electric field strength, subsonic breakdown can be achieved first, followed by supersonic breakdown after pre-breakdown, to complete electrode discharge. In this mode, the electrode breakdown and the resulting shock wave will sequentially undergo three processes: the streamer initiation process, the streamer propagation process, and the morphology transformation process.

[0043] Figure 2a A schematic diagram of the initiation process of a shockwave balloon catheter 400 according to an embodiment of the present invention is shown. Each pair of electrodes in the shockwave balloon catheter 400 includes a positive electrode 410 and a negative electrode 420. When an excitation pulse is applied to one electrode of a pair (e.g., the positive electrode 410), a certain current exists between the electrodes due to the conductivity of the interelectrode liquid. The liquid near the positive electrode 410 vaporizes due to Joule heating, thereby heating the liquid near the positive electrode 410 to vaporization, generating microbubbles, such as... Figure 2a As shown.

[0044] Figure 2bA schematic diagram of the stream propagation process of a shockwave balloon catheter 400 according to an embodiment of the present invention is shown. Due to the significant difference in dielectric constants between the gas and liquid, a large electric field distortion will occur at the gas-liquid interface on the bubble surface, resulting in a localized increase in the electric field. When the excitation pulse continuously acts on the positive electrode 410, causing the local electric field intensity to exceed a certain value, ionization occurs on the bubble surface, thereby increasing conductivity. Under the influence of the electric field between the electrodes, the bubble develops towards the negative electrode 420, increasing its volume and converging on the side closer to the positive electrode 410 to form a bubble cluster, i.e., a stream. The stream gradually shortens its distance from the negative electrode 420 as the bubble cluster volume gradually increases, such as... Figure 2b As shown.

[0045] Figure 2c A schematic diagram illustrating the morphological transformation process of a shockwave balloon catheter 400 according to an embodiment of the present invention is shown. When the excitation pulse is continuously applied to the positive electrode 410 for a sufficiently long time, such as Figure 2c As shown, if the distance between the streamer and the negative electrode 420 is close enough, a supersonic arc discharge will form between the bubble at the front end of the streamer and the negative electrode 420. Due to the high temperature and pressure, the arc can instantly vaporize the surrounding liquid, and the bubble expands instantly, compressing the surrounding liquid and generating a shock wave.

[0046] The detection module 300 is used to detect the first discharge current between the electrodes during the generation of a shock wave by the shock wave balloon catheter 400. For example, the detection module 300 may include a sampling resistor 330 or a current transformer 340 to detect the first discharge current between the electrodes of the shock wave balloon catheter 400.

[0047] Figure 3a A schematic structural diagram of a shock wave pyrolysis calcification apparatus according to another embodiment of the present invention is shown. Figure 3a As shown, when the detection module 300 includes a sampling resistor 330, the sampling resistor 330 can be connected between the high-voltage pulse source 100 and the shock wave balloon catheter 400. The voltage across the sampling resistor 330 can be detected, and the voltage signal can be processed by the amplification module 320. The amplification module 320 then transmits the processed voltage signal to the analog-to-digital converter module 310 to convert it into a corresponding digital signal. Finally, the detection module 300 transmits the digital voltage signal to the controller 200, which can determine the first discharge current based on the received digital voltage signal and the resistance value of the sampling resistor 330.

[0048] Figure 3b A schematic structural diagram of a shock wave pyrolysis calcification apparatus according to yet another embodiment of the present invention is shown. Figure 3bAs shown, the current transformer 340 included in the detection module 300 can obtain a current signal corresponding to the first discharge current based on the mutual inductance principle. This current signal can then be transmitted to the amplification module 320 for processing. The amplification module 320 then transmits the processed current signal to the analog-to-digital converter 310 to convert it into a corresponding digital signal. Finally, the detection module 300 transmits the digital current signal to the controller 200, which can determine the first discharge current based on the received digital current signal and the inductance coil in the current transformer 340.

[0049] The controller 200 is used to determine whether the excitation pulse applied to the electrode needs to be adjusted based on the first discharge current. The controller 200 can receive digital signals from the detection module 300 to determine the first discharge current. The controller 200 can determine whether the first discharge current meets preset requirements, thereby determining whether the excitation pulse applied to the electrode needs to be adjusted. For example, when the first discharge current is not within a first preset range, it can be determined that the excitation pulse applied to the electrode needs to be adjusted. For example, electrochemical performance parameters related to the first discharge current can be determined based on the first discharge current; when the electrochemical performance parameters related to the first discharge current are not within the first preset range, it can also be determined that the excitation pulse applied to the electrode needs to be adjusted. Understandably, an electric arc is generated during the generation of a shock wave by the shock wave balloon catheter 400, causing electrode ablation. If the excitation pulse applied to the electrode after ablation is the same as the excitation pulse during the previous shock wave generation process, the first discharge current between the electrodes or the parameters related to the first discharge current will change, which may prevent the shock wave balloon catheter 400 from generating the required shock wave. At this point, the excitation pulse applied to the electrode needs to be adjusted to reduce the impact of electrode ablation on the generated shock wave.

[0050] The controller 200 is also used to control the high-voltage pulse source 100 to adjust the excitation pulse and apply the adjusted excitation pulse to the electrode according to the electrochemical performance parameters of the electrode during the generation of the shock wave when the excitation pulse needs to be adjusted, so that the electrochemical performance parameters of the electrode are within a first preset range during the generation of the shock wave.

[0051] For example, the electrochemical performance parameters of the electrode include those determined based on the first discharge current described above. These electrochemical performance parameters can be current, energy, discharge intensity, etc.

[0052] The electrochemical performance parameters of the electrode during the generation of the shock wave and the electrochemical performance parameters related to the first discharge current used to determine whether the excitation pulse acting on the electrode needs to be adjusted can be of the same type.

[0053] For example, when determining whether to adjust the excitation pulse applied to the electrode based directly on the first discharge current, the electrochemical performance parameter of the electrode can be the current value of the first discharge current. When determining the energy consumed to generate the first discharge current between the electrodes based on the first discharge current, and then determining whether to adjust the excitation pulse applied to the electrode based on this energy, the electrochemical performance parameter of the electrode can be the energy consumed by the electrode. The controller 200 can control the high-voltage pulse source 100 to adjust parameters such as the amplitude, pulse width, and frequency of the excitation pulse. The adjustment range of each type of parameter of the excitation pulse can be a preset range, or it can be determined according to the specific values ​​of the electrochemical performance parameters of the electrode during the generation of the shock wave. For example, when adjusting the amplitude of the excitation pulse, the corresponding adjustment range ΔU can be a fixed 200V. Alternatively, the corresponding adjustment range can be determined based on parameters such as the current between the electrodes and the energy consumed by the electrodes; for example, the smaller the current between the electrodes, the larger the adjustment range of the excitation pulse.

[0054] Different types of electrodes can have different first preset ranges for their electrochemical performance parameters. For example, when the electrochemical performance parameter of an electrode is the first discharge current, its corresponding first preset range can be a range of current values; when the electrochemical performance parameter of an electrode is the energy consumed by the electrode, its corresponding first preset range can be a range of energy values. The first preset range can be defined by a certain set value I. set The median value is used as the base value, and the difference ΔI is set before and after it. max The obtained range, that is, the first preset range, is [I set -△I max I set +△I max Furthermore, the lower limit of the first preset range is the first preset current, the middle value is the second preset current, and the upper limit is the third preset current.

[0055] Applying the adjusted excitation pulse to the electrode can reduce the impact of electrode ablation on the generated shock wave. By controlling the electrochemical performance parameters of the electrode within a first preset range, it can be ensured that the shock wave balloon catheter 400 can output a relatively stable shock wave that meets the requirements.

[0056] For example, adjusting the excitation pulse can be done by adjusting the pulse width or the voltage amplitude of the excitation pulse. Specifically, it can be done by increasing both the pulse width and the voltage amplitude of the excitation pulse. In practice, only the pulse width or only the voltage amplitude can be increased. Alternatively, both the pulse width and voltage amplitude can be increased simultaneously. They can also be increased sequentially, specifically by increasing the pulse width first, or by increasing the voltage amplitude first. In some cases, it can be done by first increasing the pulse width / voltage amplitude, then increasing the voltage amplitude / pulse width, and finally increasing the pulse width / voltage amplitude again. The specific adjustment process can be chosen according to actual needs and will not be elaborated further here.

[0057] In the aforementioned shock wave pyrolysis calcification device, the detection module 300 detects the first discharge current between the electrodes during the generation of the shock wave by the shock wave balloon catheter 400. The controller 200, based on the first discharge current, determines whether the excitation pulse applied to the electrodes needs adjustment. If adjustment is required, the high-voltage pulse source 100 adjusts the excitation pulse according to the electrochemical performance parameters of the electrodes during shock wave generation. The adjusted excitation pulse is then applied to the electrodes, ensuring that the electrochemical performance parameters of the electrodes remain within a first preset range during shock wave generation. This allows the shock wave pyrolysis calcification device to self-adjust based on the electrode ablation status, reducing the impact of electrode ablation on the shock wave generated by the shock wave balloon catheter 400, thereby generating a more stable shock wave that meets the required specifications.

[0058] For example, the electrochemical performance parameters determined based on the first discharge current include the first discharge current, the lower limit of the first preset range is the first preset current, and the controller 200 controls the high-voltage pulse source 100 to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, including performing the following operations: when the first discharge current is less than or equal to the first preset current and the pulse width of the excitation pulse does not reach the first pulse width threshold, the controller controls the high-voltage pulse source 100 to increase the pulse width of the excitation pulse so that the first discharge current is greater than the first preset current.

[0059] Figure 4 A schematic diagram illustrating the variation curves of the voltage acting on the electrodes and the first discharge current between the electrodes during the generation of a shock wave according to an embodiment of the present invention is shown. Figure 2bAs shown in the flow propagation process of the shockwave balloon catheter 400, when the excitation pulse continuously acts on the electrodes of the shockwave balloon catheter 400, because no electric arc has yet been generated between the electrodes, there is no strong energy release, and the voltage U at both ends of the electrodes does not change significantly at this time. However, during the initial flow process, a small current flows through both ends of the electrodes, causing the voltage across the electrodes to decrease by ΔU, which is maintained until the flow propagation stage, which occurs at time t. r End. Time t r The state transition process begins, and an electric arc is generated. During this process, a breakdown discharge occurs between the electrodes at a voltage (U-ΔU). At this point, the impedance between the electrodes becomes extremely low, and the energy from the excitation source is released instantaneously. Therefore, the voltage across the electrodes drops sharply, and the current rises sharply. The first discharge current I rises to a certain level and then decreases, and it decreases near time t during the state transition process. p The peak value is generated to produce a sufficiently high current, thereby vaporizing the surrounding liquid to generate a shock wave. Afterward, the energy of the electric arc will be gradually consumed due to the discharge, and the first discharge current between the electrodes will also weaken accordingly.

[0060] Figure 5 A schematic diagram showing the relationship between the first discharge current variation curve and the excitation pulse width during the generation of a shock wave according to an embodiment of the present invention is shown.

[0061] During the generation of the shock wave, the electric arc breaks down normally, and the excitation pulse width needs to be greater than the time t of the stream formation process. str and the time t of the stream propagation process sp The sum, i.e., T w >t str +t sp .like Figure 5 As shown, if the electrode ablation occurs, the maximum value of the first current required during the shape transition process will also increase in order to generate a sufficiently strong arc. During the shape transition process when the electrode has ablated, if the pulse width T of the excitation pulse... w1 Smaller than the actual required pulse width T w2 If the voltage applied to the electrode suddenly drops after the single pulse width ends, the maximum value that the first discharge current can reach will not be high enough to generate an arc of sufficient intensity, for example, less than or equal to the first preset current. This will affect the intensity of the final generated shock wave. Therefore, the pulse width of the excitation pulse can be increased to increase its total time applied to the electrode, thereby allowing the first discharge current to be greater than the first preset current to meet the requirements for generating a shock wave. Specifically, if the peak value of the first discharge current is greater than the first preset current, it can be considered that the first discharge current is greater than the first preset current. For example, the first preset current can be 85A.

[0062] In the aforementioned shock wave pyrolysis and calcification device, when the first discharge current is less than or equal to a first preset current and the pulse width of the excitation pulse does not reach a first pulse width threshold, the high-voltage pulse source 100 is controlled to increase the pulse width of the excitation pulse, so that the first discharge current is greater than the first preset current. By increasing the pulse width of the excitation pulse, the first discharge current can still meet the requirements for generating a shock wave even when the electrode is ablated, reducing the impact of electrode ablation on the generated shock wave, and also improving the service life of the conduit.

[0063] For example, the controller 200 controls the high-voltage pulse source 100 to increase the pulse width of the excitation pulse, including performing the following operations: determining the amount of increase in pulse width based on the difference between the peak value of the first discharge current and the second preset current, wherein the increase in pulse width is proportional to the difference, wherein the second preset current is the median value of the current value in the first preset range, and controlling the high-voltage pulse source 100 to increase the pulse width of the excitation pulse by the amount of increase.

[0064] The peak value of the first discharge current is the highest value that the first discharge current can reach under the current pulse width. This peak value affects the arc intensity used to generate the shock wave. Understandably, the larger the difference between the peak value of the first discharge current and the second preset current, the further the arc intensity generated between the electrodes is from the required intensity. In this case, it is necessary to increase the amplification force of the first amplification current. The first discharge current can be increased by increasing the pulse width, and the larger the discharge current pulse width, the larger the first discharge current will be. Therefore, the controller 200 can control the high-voltage pulse source 100 to increase the pulse width of the excitation pulse by a significant amount to increase the amplification force of the first discharge current.

[0065] For example, the increase in the amplitude ΔT of the increase in the pulse width of the excitation pulse can be determined according to the following formula 1:

[0066] △T=k*△I……Formula 1

[0067] Where ΔI represents the difference between the peak value of the first discharge current and the second preset current, and k is a preset parameter. For example, the second preset current can be 90A.

[0068] In pulse width T W The end time was not reached as Figure 5 The pulse width T is shown at the moment when the maximum current peak value can be released while the voltage amplitude remains constant. W It can control the release current by controlling any time between the start of current generation and the point where the peak current occurs, for example, T. W It can be equal to T w1 or T w2 .

[0069] When the pulse width T of the excitation pulse W For T w1 The pulse width T required to generate the shock wave is... w2 T can be determined according to Formula 1. w1 The corresponding increase in amplitude can then be used by the controller 200 to control the high-voltage pulse source 100 to increase the pulse width T of the excitation pulse. W By T w1 Increase to T w2 To meet the requirements for generating shock waves, where T w2 =T w1 +△T. For example... Figure 5 As shown, T w2 Greater than T w1 T w2 The peak value of the first discharge current is greater than the pulse width T. w1 The peak value of the first discharge current.

[0070] In the aforementioned shock wave pyrolysis calcification device, the controller 200 determines the increase in pulse width amplitude based on the difference between the peak value of the first discharge current and the second preset current, and controls the high-voltage pulse source 100 to increase the pulse width amplitude of the excitation pulse by this amount. This allows for more accurate adjustment of the excitation pulse width, thereby more accurately reducing the impact of electrode ablation on the generated shock wave and producing a more precise shock wave. Simultaneously, prioritizing pulse width adjustment while maintaining a constant voltage ensures that the voltage load on other components in the shock wave pyrolysis calcification device is not increased while still meeting the requirements for generating a shock wave, thus extending the device's service life to some extent.

[0071] For example, the controller 200 controls the high-voltage pulse source 100 to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, and further includes performing the following operations: after the pulse width of the excitation pulse has reached a first pulse width threshold, if the first discharge current is less than or equal to a first preset current and the voltage amplitude of the excitation pulse has not reached a first voltage threshold, then the high-voltage pulse source 100 is controlled to increase the voltage amplitude of the excitation pulse.

[0072] When the pulse width has reached the first pulse width threshold, it is no longer possible to increase the first discharge current by adjusting the pulse width. If the first discharge current is still too small, for example, less than or equal to the second preset current, the first discharge current can be further increased by increasing the voltage. For example, when the pulse width reaches the first pulse width threshold T... h (T hIf the voltage is set to 5µs, it indicates that the current discharge breakdown strength is still relatively small. The amplitude of the next pulse released by the high-voltage pulse source 100 can be controlled to be U + ΔU, thereby increasing the voltage amplitude of the excitation pulse. Here, ΔU is a preset voltage increase, for example, it can be fixed at 200V. For example, the first voltage threshold can be 3000V.

[0073] For example, the voltage increase ΔU can also be determined based on the difference between the peak value of the first discharge current and the second preset current, wherein the difference is proportional to ΔU.

[0074] In the aforementioned shock wave pyrolysis calcification device, if the first discharge current is insufficient to generate a shock wave after the pulse width of the excitation pulse has reached the first pulse width threshold, the controller 200 controls the high-voltage pulse source 100 to increase the voltage amplitude of the excitation pulse. By controlling the high-voltage pulse source 100 to increase the voltage amplitude of the excitation pulse through the controller 200, the impact of electrode ablation on the generated shock wave can be further reduced.

[0075] For example, the electrochemical performance parameters of the electrode include a first discharge current, the lower limit of the first preset range is a second preset current, and the controller 200 controls the high-voltage pulse source 100 to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, including performing the following operations: when the first discharge current is less than or equal to the second preset current and the voltage amplitude of the excitation pulse does not reach the voltage threshold, the controller controls the high-voltage pulse source 100 to increase the voltage amplitude of the excitation pulse.

[0076] Figure 6 A schematic diagram showing the relationship between the first discharge current variation curve and the voltage amplitude during the generation of a shock wave according to an embodiment of the present invention is provided.

[0077] The voltage amplitude of the excitation pulse affects the voltage between the electrodes, thus affecting the maximum value of the first discharge current. A higher voltage results in a shorter time for the first discharge current to reach the desired maximum value (e.g., a second preset current). Understandably, if the peak value of the first discharge current (when the voltage amplitude is U) is controlled to reach the desired maximum value (when the voltage amplitude is U + ΔU) before the end of the excitation pulse of a single pulse width by increasing the voltage amplitude, even if... Figure 6 The pulse width T shown w Even without changing the voltage, the requirement for generating a shock wave in the event of electrode ablation can still be met. Therefore, only the voltage amplitude of the excitation pulse needs to be increased, which reduces the corresponding computational load and simplifies the control process of related components in the shock wave pyrolysis and calcification device. The voltage increase can be a fixed value or determined based on the difference between the peak value of the first discharge current and the second preset current.

[0078] For example, when the first discharge current is less than or equal to the second preset current, the voltage amplitude of the excitation pulse does not reach the voltage threshold, and the pulse width of the excitation pulse does not reach the first pulse width threshold, the high-voltage pulse source 100 can be controlled to increase both the pulse width and the voltage amplitude of the excitation pulse. This allows for more accurate control of the arc intensity used to generate the shock wave, resulting in a more accurate shock wave. The voltage increase in amplitude and / or the pulse width increase can be fixed values, or they can be determined more accurately based on the difference between the peak value of the first discharge current and the second preset current.

[0079] For example, the electrochemical performance parameters of the electrode include a first discharge current, the upper limit of the first preset range is a third preset current, and the controller 200 is also used to turn off the high voltage pulse source 100 when the first discharge current is greater than or equal to the third preset current.

[0080] When the first discharge current is greater than or equal to the third preset current, it indicates that the discharge current is too high. If the excitation pulse voltage amplitude remains unchanged and continues to act on the shock wave balloon catheter 400, it will greatly increase the severity of electrode ablation. Therefore, the high-voltage pulse source 100 can be turned off at this time to reduce the increase in electrode ablation and thus extend the service life of the catheter. For example, the third preset current can be 95A.

[0081] For example, the detection module 300 is also used to detect the voltage between the electrodes. The process of generating the shock wave includes a streamer propagation process and a morphology transformation process. The controller 200 determines whether the excitation pulse acting on the electrodes needs to be adjusted based on the first discharge current, including performing the following operations:

[0082] The controller 200 determines the first energy consumed by the electrodes during the streamer propagation process based on the first discharge current and the voltage between the electrodes during the streamer propagation process. The controller 200 can detect the voltage U across the electrodes in real time. cath The first discharge current I between the electrodes cath The controller 200 integrates the voltage and the first discharge current during the streamer propagation process over time to obtain the first energy W consumed by the electrode during the streamer propagation process. 流注 .

[0083] For example, the controller 200 can determine the first energy W according to the following formula 3. 流注 :

[0084]

[0085] Where tr represents the end time t of the stream propagation process.r .

[0086] For example, with the presence of electrode ablation, t r As the timeframe is gradually delayed, the initial energy consumption will increase.

[0087] The controller 200 can also determine the second energy consumed by the electrodes during the form transition process based on the first discharge current and the voltage between the electrodes during the form transition process. The controller 200 can integrate the voltage and current during the form transition process over time to obtain the second energy W consumed by the electrodes during the form transition process. 电弧 .

[0088] For example, the second energy W can be determined according to the following formula 3. 电弧 :

[0089]

[0090] Where tr represents the end time of the stream propagation process (the start time of the morphological transformation process) t r tp represents the moment t is reached when the first discharge current reaches its peak value during the state transition process. p .

[0091] The controller 200 can also determine whether the excitation pulse needs to be adjusted based on the first energy and the second energy. The total energy consumed by the electrodes during the generation of the shock wave includes the first energy and the second energy.

[0092] For example, the acoustic pressure intensity P of the shock wave generated by the catheter and the second energy W consumed by the electrode can be determined according to the following formula 4. 电弧 Relationship:

[0093]

[0094] Where t0 represents the start time of the streamer initiation process, and tp represents the time when the first discharge current reaches its peak value during the morphological transition process. p η represents the energy conversion efficiency. As shown in Formula 4, the greater the second energy, the greater the sound pressure intensity P of the shock wave generated by the duct.

[0095] When ablation occurs, as shown in Formula 2, because the distance between the electrodes increases, t rAs the timing gradually shifts, the first energy requirement increases. When the total energy supplied to the electrodes by the excitation pulse remains constant, the total energy consumed by the electrodes also remains relatively unchanged. However, the second energy requirement decreases, making it impossible to generate a sufficiently strong arc during the morphological transition, and consequently, the conduit cannot generate a sufficiently strong shock wave. Therefore, the controller 200 can determine whether the total energy provided by the current excitation pulse is sufficient to meet the requirement based on the first and second energies. If the requirement for generating a shock wave is met, the excitation pulse is not adjusted. If the requirement for generating a shock wave is not met, the excitation pulse is adjusted.

[0096] For example, the total energy W consumed by the electrodes during the generation of the shock wave can be determined according to the following formula 5. C :

[0097]

[0098] Where C represents the capacitance value of the excitation capacitor used by the high-voltage pulse source 100 to output the excitation pulse, and U represents the voltage amplitude of the excitation pulse.

[0099] In the aforementioned shock wave pyrolysis calcification device, the controller 200 determines whether the excitation pulse needs adjustment based on the second energy consumed by the electrode during morphological transformation and the first energy consumed by the electrode during stream propagation. By determining the energy consumed by the electrode at different times, the impact of electrode ablation on the generated arc energy during shock wave generation can be accurately determined. This allows for precise adjustment of the excitation pulse, reducing the impact of electrode ablation on the generated shock wave and producing a more stable shock wave that meets the requirements.

[0100] For example, the electrochemical performance parameters determined based on the first discharge current include a first energy and a second energy, and the lower limit of the first preset range is a first preset energy threshold. The controller 200 controls the high-voltage pulse source 100 to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, including performing the following operations: when the second energy is less than the first preset energy threshold, the peak value of the first discharge current in the morphological transformation process is greater than the fourth preset current, and the voltage amplitude of the excitation pulse does not reach the second voltage threshold, the high-voltage pulse source 100 is controlled to increase the voltage amplitude of the excitation pulse according to the first energy and the second energy, so that the second energy is greater than or equal to the first preset energy threshold.

[0101] If the voltage amplitude of the excitation pulse is too small, the electrodes consume too much energy during stream propagation, leaving insufficient voltage to support electrode breakdown discharge, and the stream will disappear. If the voltage amplitude of the excitation pulse increases but is not high enough, the electrodes still consume a significant amount of energy during stream propagation, but because the remaining voltage is still sufficient to support breakdown discharge, a discharge arc can be generated at the negative electrode 420, although the breakdown strength is not high. If the voltage amplitude of the excitation pulse is high enough, the energy consumed by the electrodes during stream propagation is a small percentage of the total energy. When the stream propagates a certain distance, the voltage drop is small, thus providing sufficient energy to support breakdown discharge, resulting in a bright arc, a large breakdown strength, and a sufficiently strong shock wave.

[0102] When the second energy is less than the first preset energy threshold, it indicates that the electric arc generated by the current second energy is insufficient to generate a sufficiently strong shock wave. Therefore, the controller 200 can be used to control the high-voltage pulse source 100 to increase the voltage amplitude of the excitation pulse, thereby increasing the total energy W acting on the electrode. C This can indirectly increase the second energy, so that under the action of the adjusted excitation pulse, the second energy is greater than or equal to the first preset energy threshold. If the peak value of the first discharge current during the morphological transition process is greater than the fourth preset current, it indicates that the conduit is not damaged and that the first current can be normally generated between its electrodes. For example, the first preset energy threshold can be 0.3J, and the fourth preset current can be 50A.

[0103] For example, the voltage increase ΔU can also be determined based on the difference between the second energy and the second preset energy threshold. Here, ΔU is proportional to the difference.

[0104] For example, it can also be determined whether the first energy is greater than or equal to a second preset energy threshold to determine whether ablation exists on the conduit electrode. Specifically, when ablation is determined to exist on the conduit electrode, the higher the first energy, the more severe the ablation.

[0105] In the aforementioned shock wave pyrolysis calcification device, when the second energy is less than the first preset energy threshold, the peak value of the first discharge current during the morphological transformation process is greater than the fourth preset current, and the voltage amplitude of the excitation pulse has not reached the second voltage threshold, the controller 200 controls the high-voltage pulse source 100 to increase the voltage amplitude of the excitation pulse based on the first and second energies, so that the second energy is greater than or equal to the first preset energy threshold. By controlling the high-voltage pulse source 100 to increase the voltage amplitude of the excitation pulse using the controller 200, the second energy used to generate the arc can be indirectly increased, thereby supporting the generation of a sufficiently strong shock wave and reducing the impact of electrode ablation on the generated shock wave.

[0106] For example, the controller 200 controls the high-voltage pulse source 100 to increase the voltage amplitude of the excitation pulse according to the first energy and the second energy, including performing the following operations: determining the voltage increase amount of the excitation pulse according to the first energy, the second energy and the capacitance value of the excitation capacitor of the high-voltage pulse source 100, and controlling the high-voltage pulse source 100 to increase the voltage amplitude of the excitation pulse by the voltage increase amount.

[0107] The total energy consumed by the electrodes during the generation of the shock wave can be determined by summing the first and second energies. Then, based on the relationship between the total energy and the capacitance of the excitation capacitor, the required voltage amplitude of the excitation pulse can be determined. Finally, the voltage increase is determined based on the difference between the required voltage amplitude of the excitation pulse and the current voltage amplitude of the excitation pulse.

[0108] For example, the voltage increase ΔU can be determined according to the following formula 6:

[0109]

[0110] Where U represents the voltage amplitude of the excitation pulse before the increase.

[0111] From Formula 6, we know that when the first energy W 电弧 Second energy W 流注 The larger the value, the greater the increase in voltage.

[0112] For example, ΔU can be a fixed value, such as 200V, and the upper limit of the increased voltage amplitude (i.e., the second voltage threshold) can be 4000V.

[0113] In the aforementioned shock wave pyrolysis calcification device, the controller 200 determines the voltage increase of the excitation pulse based on the first energy, the second energy, and the capacitance value of the excitation capacitor of the high-voltage pulse source 100, and controls the high-voltage pulse source 100 to increase the voltage amplitude of the excitation pulse by the voltage increase. This allows for more accurate adjustment of the excitation pulse, precisely reducing the impact of electrode ablation on the generated shock wave and producing a more accurate shock wave.

[0114] For example, as the excitation voltage increases, the electric field strength across the electrode increases accordingly, and the electrode breakdown time t... r There will be some advance notice, such as Figure 6 As shown, the released current increases when the pulse width remains constant. When the voltage amplitude of the excitation pulse does not reach the second voltage threshold, the controller 200 can control the pulse width of the excitation pulse, thereby indirectly controlling the amplitude of the released current. To ensure that the energy of the arc is sufficiently high, it is necessary to detect the first discharge current I in real time. cath The size of the pulse width is determined by calculating the energy of the electric arc in real time. Specifically, the controller samples the voltage U across the electrode each time it begins to discharge after electrode breakdown.cath and current I cath Integrating and summing over time yields the energy W of the electric arc. 电弧 When W 电弧 If the pulse width is less than the set value, the pulse width is further extended. The implementation method for extending the pulse width can be referred to the previous or subsequent embodiments.

[0115] For example, the electrochemical performance parameters determined based on the first discharge current include a first energy and a second energy, and the lower limit of the first preset range is a first preset energy threshold. The controller 200 controls the high-voltage pulse source 100 to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave. It also includes performing the following operations: when the voltage amplitude of the excitation pulse has reached the second voltage threshold, the second energy is less than the first preset energy threshold, the peak value of the first discharge current in the morphological transformation process is greater than the fourth preset current, and the pulse width of the excitation pulse has not reached the second pulse width threshold, the high-voltage pulse source 100 is controlled to increase the pulse width of the excitation pulse according to the first energy and the second energy.

[0116] If the voltage amplitude of the excitation pulse has reached the second voltage threshold and the second energy is less than the first preset energy threshold, it indicates that the second energy is insufficient to generate an arc of sufficient intensity. In this case, the second energy cannot be increased by further increasing the voltage amplitude of the excitation pulse. From the above... Figure 5 It can be seen that the controller 200 can control the pulse width of the released signal, thereby indirectly controlling the amplitude of the first discharge current, and thus adjusting the total energy consumed by the electrode during the generation of the shock wave. To ensure that the second energy used to generate the arc is sufficiently high, the controller 200 can also acquire the first discharge current I in real time. cath The size of the high voltage pulse source 100 is increased by calculating the first energy in real time to adjust the pulse width of the excitation pulse, thereby increasing the total energy consumed by the electrodes during the generation of the shock wave, so as to indirectly increase the second energy, making the second energy sufficient to generate an electric arc of sufficient intensity.

[0117] For example, the total energy consumed by the electrodes during the generation of the shock wave can be determined based on the sum of the first and second energies. Then, based on this total energy, the increase in the amplitude of the excitation pulse width can be determined.

[0118] For example, the increase in amplitude ΔT can also be determined based on the difference between the second energy and the second preset energy threshold. Here, ΔT is proportional to this difference.

[0119] In the aforementioned shock wave pyrolysis and calcification device, when the voltage amplitude of the excitation pulse reaches the second voltage threshold, the second energy is less than the first preset energy threshold, the peak value of the first discharge current during the morphological transformation process is greater than the fourth preset current, and the pulse width of the excitation pulse has not reached the second pulse width threshold, the high-voltage pulse source 100 is controlled to increase the pulse width of the excitation pulse based on the first energy and the second energy. When the voltage amplitude of the excitation pulse has reached its maximum and the second energy is still too small, the controller 200 controls the high-voltage pulse source 100 to increase the pulse width of the excitation pulse, which can further increase the second energy used to generate the electric arc, thereby generating a sufficiently strong shock wave.

[0120] For example, the electrochemical performance parameters determined based on the first discharge current include a first energy and a second energy, the lower limit of the first preset range is a first preset energy threshold, the controller 200 controls the high-voltage pulse source 100 to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, and further includes performing the following operations: when the second energy is less than the first preset energy threshold, the peak value of the first discharge current in the morphological transformation process is greater than the fourth preset current, and the pulse width of the excitation pulse does not reach the second pulse width threshold, the high-voltage pulse source 100 is controlled to increase the pulse width of the excitation pulse according to the first energy and the second energy.

[0121] The controller 200 can be used to control the high-voltage pulse source 100 to increase only the pulse width of the excitation pulse, thereby indirectly increasing the second energy. The increase in the amplitude of the excitation pulse width can be a fixed value. Alternatively, the increase in the amplitude of the excitation pulse width can be determined based on the first and second energies; for example, the smaller the first energy, the larger the increase in amplitude. This reduces the computational load.

[0122] When the voltage amplitude of the excitation pulse does not reach the second amplitude, the voltage amplitude of the excitation pulse can be increased while the pulse width of the high-voltage pulse source 100 is controlled to increase. The increase in voltage amplitude and / or the increase in pulse width can be fixed values, or the increase in voltage amplitude and / or the increase in pulse width can be determined more accurately based on the difference between the second energy and the second preset energy threshold.

[0123] In the aforementioned shock wave pyrolysis calcification device, the controller 200 controls the high-voltage pulse source 100 to increase the pulse width of the excitation pulse based on the first energy and the second energy. This allows for adjustment of the energy allocated to the morphological transformation process, ensuring that the conduit electrode has sufficient energy to generate a sufficiently strong arc, thereby generating a shock wave that meets the requirements.

[0124] For example, the controller 200 is further configured to shut down the high-voltage pulse source 100 when preset conditions are met, wherein the preset conditions include: the proportion of the total number of adjustment failures in the total number of adjustment attempts of the excitation pulse is greater than a first proportion threshold and / or the number of consecutive adjustment failures is greater than a first number threshold. Adjustment failure indicates that after one adjustment of the excitation pulse, the electrochemical performance parameters of the electrode are still less than the lower limit of the first preset range during the generation of the shock wave.

[0125] The controller 200 can count the total number of excitation pulse adjustments, the total number of adjustment failures, and the number of consecutive adjustment failures. Specifically, when an excitation pulse needs to be adjusted once, but the voltage and pulse width of the excitation pulse cannot be adjusted further, it can be recorded as one adjustment failure.

[0126] If the number of consecutive adjustment failures exceeds the first threshold, it indicates that the shockwave balloon catheter 400 may be damaged and unable to generate a shockwave that meets the requirements. For example, if the second energy is lower than the first preset energy threshold multiple times (e.g., 5 times) consecutively, or if the first discharge current is lower than the first preset current and the peak value of the first preset current and the difference between the second preset current and the first preset current do not change significantly multiple times (e.g., 5 times), it can be determined that the shockwave balloon catheter 400 is damaged. If the proportion of total adjustment failures exceeds the first proportion threshold, it also indicates that the shockwave balloon catheter 400 may be damaged and unable to generate a shockwave that meets the requirements. For example, if the total number of adjustment failures is 8, the total number of adjustments is 15, and the first proportion threshold is 50%, it can be determined that the shockwave balloon catheter 400 is damaged.

[0127] For example, when the total number of adjustments exceeds the second threshold, it can also be directly determined that the shockwave balloon catheter 400 has been damaged.

[0128] In the aforementioned shock wave pyrolysis calcification device, the controller 200 determines to shut down the high-voltage pulse source 100 based on the total number of adjustments, the total number of adjustment failures, and the number of consecutive adjustment failures. This can eliminate damaged conduits and prevent the use of damaged conduits from affecting the user's normal operation.

[0129] Figure 7 A schematic flowchart illustrating a control method for a shock wave pyrolysis calcification apparatus according to an embodiment of the present invention is shown. Figure 7 As shown, the control method is applied to the above-mentioned shock wave lysis calcification device including the shock wave balloon catheter 400, including steps S110 to S130.

[0130] In step S110, during the generation of a shock wave by the shock wave balloon catheter 400, the first discharge current between the electrodes of the shock wave balloon catheter 400 is detected.

[0131] In step S120, it is determined whether the excitation pulse applied to the electrode needs to be adjusted based on the first discharge current.

[0132] In step S130, when it is necessary to adjust the excitation pulse, the excitation pulse is adjusted according to the electrochemical performance parameters of the electrode during the generation of the shock wave, and the adjusted excitation pulse is applied to the electrode so that the electrochemical performance parameters of the electrode are within a first preset range during the generation of the shock wave.

[0133] For example, the electrochemical performance parameters of the electrode include electrochemical performance parameters determined based on the first discharge current.

[0134] For example, the electrochemical performance parameters determined based on the first discharge current include the first discharge current, the lower limit of the first preset range is the first preset current, and the excitation pulse is adjusted according to the electrochemical performance parameters of the electrode during the generation of the shock wave, including: when the first discharge current is less than or equal to the first preset current and the pulse width of the excitation pulse does not reach the first pulse width threshold, increasing the pulse width of the excitation pulse so that the first discharge current is greater than the first preset current.

[0135] For example, increasing the pulse width of the excitation pulse includes: determining an increase in the amplitude of the pulse width based on the difference between the peak value of the first discharge current and the second preset current, wherein the increase in the pulse width is proportional to the difference, and wherein the second preset current is the median value of the current values ​​in the first preset range; and increasing the pulse width of the excitation pulse by the increase in amplitude.

[0136] For example, adjusting the excitation pulse based on the electrochemical performance parameters of the electrode during the generation of the shock wave further includes: after the pulse width of the excitation pulse has reached a first pulse width threshold, if the first discharge current is less than or equal to a first preset current and the voltage amplitude of the excitation pulse has not reached a first voltage threshold, then increasing the voltage amplitude of the excitation pulse.

[0137] For example, the electrochemical performance parameters determined based on the first discharge current include the first discharge current, the lower limit of the first preset range is the first preset current, and the excitation pulse is adjusted according to the electrochemical performance parameters of the electrode during the generation of the shock wave, including: increasing the voltage amplitude of the excitation pulse when the first discharge current is less than or equal to the first preset current and the voltage amplitude of the excitation pulse does not reach the first voltage threshold.

[0138] For example, the electrochemical performance parameters determined based on the first discharge current include the first discharge current, the upper limit of the first preset range is the third preset current, and the above method further includes: turning off the excitation pulse when the first discharge current is greater than or equal to the third preset current.

[0139] Exemplarily, the method further includes: detecting the voltage between the electrodes. The process of generating a shock wave includes a streamer propagation process and a morphology transition process. Determining whether the excitation pulse acting on the electrodes needs adjustment based on the first discharge current includes: determining the first energy consumed by the electrodes during streamer propagation based on the first discharge current during streamer propagation and the voltage between the electrodes during streamer propagation; determining the second energy consumed by the electrodes during morphology transition based on the first discharge current during morphology transition and the voltage between the electrodes during morphology transition; and determining whether the excitation pulse needs adjustment based on the first energy and the second energy.

[0140] For example, the controller determines the first energy according to the following formula:

[0141] W 流注 =∫0 tr U cath I cath dt

[0142] Among them, W 流注 U represents the first energy, tr represents the end time of the stream propagation process, and U represents the final energy. cath I represents the voltage between the electrodes during the stream propagation process. cath This represents the first discharge current during the propagation of the streamer.

[0143] For example, the electrochemical performance parameters determined based on the first discharge current include a first energy and a second energy, the lower limit of the first preset range is a first preset energy threshold, and the excitation pulse is adjusted according to the electrochemical performance parameters of the electrode during the generation of the shock wave, including:

[0144] When the second energy is less than the first preset energy threshold, the peak value of the first discharge current in the morphological transformation process is greater than the fourth preset current, and the voltage amplitude of the excitation pulse does not reach the second voltage threshold, the voltage amplitude of the excitation pulse is increased according to the first energy and the second energy so that the second energy is greater than or equal to the first preset energy threshold.

[0145] For example, increasing the voltage amplitude of the excitation pulse based on the first energy and the second energy includes performing the following operations: determining the voltage increase amount of the excitation pulse based on the first energy, the second energy and the capacitance value of the excitation capacitor of the high-voltage pulse source; and increasing the voltage amplitude of the excitation pulse by the voltage increase amount.

[0146] For example, adjusting the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave further includes: when the voltage amplitude of the excitation pulse has reached a second voltage threshold, the second energy is less than a first preset energy threshold, the peak value of the first discharge current in the morphological transformation process is greater than a fourth preset current, and the pulse width of the excitation pulse has not reached a second pulse width threshold, increasing the pulse width of the excitation pulse according to the first energy and the second energy.

[0147] For example, the electrochemical performance parameters determined based on the first discharge current include a first energy and a second energy, the lower limit of the first preset range is a first preset energy threshold, and the excitation pulse is adjusted according to the electrochemical performance parameters of the electrode during the generation of the shock wave. The adjustment further includes: when the second energy is less than the first preset energy threshold, the peak value of the first discharge current during the morphological transformation process is greater than the fourth preset current, and the pulse width of the excitation pulse does not reach the second pulse width threshold, the high-voltage pulse source is controlled to increase the pulse width of the excitation pulse according to the first energy and the second energy.

[0148] For example, the above method further includes: turning off the excitation pulse when a preset condition is met, wherein the preset condition includes: the proportion of the total number of adjustment failures in the total number of adjustments of the excitation pulse is greater than a first proportion threshold and / or the number of consecutive adjustment failures is greater than the first number threshold, and adjustment failure indicates that after performing an adjustment on the excitation pulse, the electrochemical performance parameters of the electrode are still less than the lower limit of the first preset range during the generation of the shock wave.

[0149] Figure 8 A schematic diagram of a control method for a shock wave pyrolysis calcification apparatus according to yet another embodiment of the present invention is shown.

[0150] like Figure 8 As shown, the controller 200 of the aforementioned shock wave pyrolysis calcification device can detect the first discharge current between the electrodes in real time and adjust the pulse width of the excitation pulse according to the first discharge current. If the pulse width does not reach the upper limit and the first discharge current still does not meet the requirement, it can be determined whether the electrode is damaged. If the electrode is not damaged, the controller 200 can control the high-voltage pulse source 100 to increase the voltage amplitude of the excitation pulse. After increasing the voltage amplitude, the first discharge current will increase. If the first discharge current still does not meet the requirement, the pulse width can be reset first, and the pulse width can be adjusted again to repeat the aforementioned process until the first discharge current meets the requirement or the electrode is determined to be damaged.

[0151] Those skilled in the art can understand the specific implementation and beneficial effects of the control method of the shock wave pyrolysis calcification device by reading the above detailed description of the shock wave pyrolysis calcification device, and will not be elaborated further here for the sake of brevity.

[0152] Although exemplary embodiments have been described herein with reference to the accompanying drawings, it should be understood that the above exemplary embodiments are merely illustrative and are not intended to limit the scope of the invention. Various changes and modifications can be made therein by those skilled in the art without departing from the scope and spirit of the invention. All such changes and modifications are intended to be included within the scope of the invention as claimed in the appended claims.

[0153] Those skilled in the art will recognize that the units and algorithm steps of the various examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementations should not be considered beyond the scope of this invention.

[0154] In the several embodiments provided in this application, it should be understood that the disclosed devices and methods can be implemented in other ways. For example, the device embodiments described above are merely illustrative. For instance, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another device, or some features may be ignored or not executed.

[0155] Numerous specific details are set forth in the specification provided herein. However, it will be understood that embodiments of the invention may be practiced without these specific details. In some instances, well-known methods, structures, and techniques have not been shown in detail so as not to obscure the understanding of this specification.

[0156] Similarly, it should be understood that, in order to streamline the invention and aid in understanding one or more of the various aspects of the invention, features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof in the description of exemplary embodiments of the invention. However, this approach should not be construed as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as reflected in the corresponding claims, its inventive point lies in solving the corresponding technical problem with fewer features than all of those in a single disclosed embodiment. Therefore, the claims following the detailed description are hereby expressly incorporated into that detailed description, wherein each claim itself is a separate embodiment of the invention.

[0157] Those skilled in the art will understand that, apart from the mutual exclusion of features, all features disclosed in this specification (including the accompanying claims, abstract, and drawings) and all processes or units of any method or apparatus so disclosed can be combined in any combination. Unless otherwise expressly stated, each feature disclosed in this specification (including the accompanying claims, abstract, and drawings) may be replaced by an alternative feature that serves the same, equivalent, or similar purpose.

[0158] Furthermore, those skilled in the art will understand that although some embodiments described herein include certain features but not others included in other embodiments, combinations of features from different embodiments are intended to be within the scope of the invention and form different embodiments. For example, in the claims, any of the claimed embodiments can be used in any combination.

[0159] The various component embodiments of the present invention can be implemented in hardware, or as software modules running on one or more processors, or a combination thereof. Those skilled in the art will understand that microprocessors or digital signal processors (DSPs) can be used in practice to implement some or all of the functions of some modules in the shock wave pyrolysis calcification apparatus according to embodiments of the present invention. The present invention can also be implemented as an apparatus program (e.g., a computer program and computer program product) for performing part or all of the methods described herein. Such programs implementing the present invention can be stored on a computer-readable medium or can be in the form of one or more signals. Such signals can be downloaded from an Internet website, provided on a carrier signal, or provided in any other form.

[0160] It should be noted that the above embodiments are illustrative of the invention and not restrictive, and that those skilled in the art can devise alternative embodiments without departing from the scope of the appended claims. In the claims, any reference signs placed between parentheses should not be construed as limiting the claims. The word "comprising" does not exclude the presence of elements or steps not listed in the claims. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. The invention can be implemented by means of hardware comprising several different elements and by means of a suitably programmed computer. In the unit claims enumerating several means, several of these means may be embodied by the same item of hardware. The use of the words first, second, and third, etc., does not indicate any order. These words can be interpreted as names.

[0161] The above description is merely a specific embodiment of the present invention or an explanation of that embodiment. The scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. The scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A shock wave pyrolysis calcification device, characterized in that, include: High-voltage pulse source, shock wave balloon catheter, detection module and controller; in The high-voltage pulse source is used to generate excitation pulses that act on the electrodes in the shock wave balloon catheter; The shock wave balloon catheter is used to generate a shock wave under the action of the excitation pulse; The detection module is used to detect the first discharge current between the electrodes during the generation of the shock wave by the shock wave balloon catheter. The controller is used to determine whether the excitation pulse applied to the electrode needs to be adjusted based on the first discharge current, and if the excitation pulse needs to be adjusted, the controller controls the high-voltage pulse source to adjust the excitation pulse based on the electrochemical performance parameters of the electrode during the generation of the shock wave, and applies the adjusted excitation pulse to the electrode so that the electrochemical performance parameters of the electrode are within a first preset range during the generation of the shock wave.

2. The apparatus according to claim 1, characterized in that, The electrochemical performance parameters of the electrode include those determined based on the first discharge current.

3. The apparatus according to claim 2, characterized in that, The electrochemical performance parameters determined based on the first discharge current include the first discharge current, and the lower limit of the first preset range is the first preset current. The controller adjusts the excitation pulse of the high-voltage pulse source based on the electrochemical performance parameters of the electrode during the generation of the shock wave, including performing the following operations: When the first discharge current is less than or equal to the first preset current and the pulse width of the excitation pulse does not reach the first pulse width threshold, the high-voltage pulse source is controlled to increase the pulse width of the excitation pulse so that the first discharge current is greater than the first preset current.

4. The apparatus according to claim 3, characterized in that, The controller controls the high-voltage pulse source to increase the pulse width of the excitation pulse, including performing the following operations: The increase in pulse width is determined based on the difference between the peak value of the first discharge current and the second preset current, wherein the increase in pulse width is proportional to the difference, and wherein the second preset current is the median value of the current values ​​in the first preset range. The high-voltage pulse source is controlled to increase the pulse width of the excitation pulse by the amount of amplitude increase.

5. The apparatus according to claim 3, characterized in that, The controller adjusts the excitation pulse of the high-voltage pulse source according to the electrochemical performance parameters of the electrode during the generation of the shock wave, and also includes performing the following operations: After the pulse width of the excitation pulse has reached the first pulse width threshold, if the first discharge current is less than or equal to the first preset current and the voltage amplitude of the excitation pulse has not reached the first voltage threshold, then the high voltage pulse source is controlled to increase the voltage amplitude of the excitation pulse.

6. The apparatus according to claim 2 or 3, characterized in that, The electrochemical performance parameters determined based on the first discharge current include the first discharge current, the lower limit of the first preset range is the first preset current, and the controller controls the high-voltage pulse source to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, including performing the following operations: When the first discharge current is less than or equal to the first preset current and the voltage amplitude of the excitation pulse does not reach the first voltage threshold, the high-voltage pulse source is controlled to increase the voltage amplitude of the excitation pulse.

7. The apparatus according to claim 2, characterized in that, The electrochemical performance parameters determined based on the first discharge current include the first discharge current, and the upper limit of the first preset range is a third preset current. The controller is also configured to shut down the high-voltage pulse source when the first discharge current is greater than or equal to the third preset current.

8. The apparatus according to claim 2, characterized in that, The detection module is also used to detect the voltage between the electrodes. The process of generating the shock wave includes a streamer propagation process and a morphology transformation process. The controller determines whether it is necessary to adjust the excitation pulse applied to the electrodes based on the first discharge current, including performing the following operations: The first energy consumed by the electrodes during the streamer propagation process is determined based on the first discharge current during the streamer propagation process and the voltage between the electrodes during the streamer propagation process. The second energy consumed by the electrodes during the morphological transition is determined based on the first discharge current during the morphological transition and the voltage between the electrodes during the morphological transition. Based on the first energy and the second energy, determine whether the excitation pulse needs to be adjusted.

9. The apparatus according to claim 8, characterized in that, The controller determines the first energy according to the following formula: Among them, W 流注 U represents the first energy, tr represents the end time of the stream propagation process, and U represents the end time of the stream propagation process. cath I represents the voltage between the electrodes during the propagation of the stream. cath This represents the first discharge current during the propagation of the streamer.

10. The apparatus according to claim 8, characterized in that, The electrochemical performance parameters determined based on the first discharge current include the first energy and the second energy, the lower limit of the first preset range is the first preset energy threshold, and the controller controls the high-voltage pulse source to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, including performing the following operations: When the second energy is less than the first preset energy threshold, the peak value of the first discharge current in the mode conversion process is greater than the fourth preset current, and the voltage amplitude of the excitation pulse does not reach the second voltage threshold, the high-voltage pulse source is controlled to increase the voltage amplitude of the excitation pulse according to the first energy and the second energy, so that the second energy is greater than or equal to the first preset energy threshold.

11. The apparatus according to claim 10, characterized in that, The controller, based on the first energy and the second energy, controls the high-voltage pulse source to increase the voltage amplitude of the excitation pulse, including performing the following operations: The voltage increase of the excitation pulse is determined based on the first energy, the second energy, and the capacitance value of the excitation capacitor of the high-voltage pulse source. The high-voltage pulse source is controlled to increase the voltage amplitude of the excitation pulse by the amount of voltage increase.

12. The apparatus according to claim 10, characterized in that, The controller adjusts the excitation pulse of the high-voltage pulse source according to the electrochemical performance parameters of the electrode during the generation of the shock wave, and also includes performing the following operations: When the voltage amplitude of the excitation pulse reaches the second voltage threshold, the second energy is less than the first preset energy threshold, the peak value of the first discharge current in the mode conversion process is greater than the fourth preset current, and the pulse width of the excitation pulse does not reach the second pulse width threshold, the high-voltage pulse source is controlled to increase the pulse width of the excitation pulse according to the first energy and the second energy.

13. The apparatus according to any one of claims 8 to 11, characterized in that, The electrochemical performance parameters determined based on the first discharge current include the first energy and the second energy, the lower limit of the first preset range is the first preset energy threshold, and the controller controls the high-voltage pulse source to adjust the excitation pulse according to the electrochemical performance parameters of the electrode during the generation of the shock wave, and further includes performing the following operations: When the second energy is less than the first preset energy threshold, the peak value of the first discharge current in the mode conversion process is greater than the fourth preset current, and the pulse width of the excitation pulse does not reach the second pulse width threshold, the high-voltage pulse source is controlled to increase the pulse width of the excitation pulse according to the first energy and the second energy.

14. The apparatus according to claim 1, characterized in that, The controller is also used for: When preset conditions are met, the high-voltage pulse source is shut off, wherein... The preset conditions include: the proportion of total adjustment failures in the total number of excitation pulse adjustments is greater than a first proportion threshold and / or the number of consecutive adjustment failures is greater than a first number threshold. The failure to adjust indicates that after one adjustment of the excitation pulse, the electrochemical performance parameters of the electrode are still less than the lower limit of the first preset range during the generation of the shock wave.

15. A control method for a shock wave pyrolysis calcification device, characterized in that, An application is made in a shock wave lysis calcification device, the shock wave lysis calcification device comprising a shock wave balloon catheter, and the shock wave lysis calcification method comprising: During the generation of a shock wave by the shock wave balloon catheter, the first discharge current between the electrodes in the shock wave balloon catheter is detected. Based on the first discharge current, determine whether it is necessary to adjust the excitation pulse applied to the electrode; When it is necessary to adjust the excitation pulse, the excitation pulse is adjusted according to the electrochemical performance parameters of the electrode during the generation of the shock wave, and the adjusted excitation pulse is applied to the electrode so that the electrochemical performance parameters of the electrode are within a first preset range during the generation of the shock wave.

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