IVL system control, apparatus, and method

Abstract

Various embodiments of systems, methods, and devices are provided for the controlled operation of an endovascular spallation system for destroying calcified lesions within an anatomical conduit. More specifically, control mechanisms are disclosed for managing and / or providing and / or terminating the supply of electrical energy to generate an electrical arc between a pair of spaced electrodes immersed within a contained fluid.

Description

[Technical Field]

[0001] The present disclosure relates to devices, systems, and methods for destroying calcified lesions within anatomical conduits, and more particularly, to control of devices, systems, and methods for applying an electrical arc of spaced electrodes disposed or contained within a fluid-filled member to generate flow and pressure waves. [Background technology]

[0002] Various techniques and devices have been developed for use in the removal or repair of tissue within arteries and similar body passageways, including the removal and / or disruption of calcified lesions formed within the passageways and / or within the walls that define the passageways. A common purpose of such techniques and devices is to remove atherosclerotic plaque within a patient's arteries. Atherosclerosis is characterized by the buildup of fatty deposits (atheromas) in the intimal layer (i.e., beneath the endothelium) of a patient's blood vessels. Over time, what often begins as relatively soft, cholesterol-rich atheromatous material hardens into calcified atherosclerotic plaque, often within the vessel wall. Such atheromas restrict blood flow and make the vessel less pliable than normal, and are therefore often referred to as stenotic lesions or stenoses, and the obstructing material is referred to as stenotic material. Left untreated, such stenoses can lead to angina, hypertension, myocardial infarction, stroke, and the like.

[0003] Angioplasty, or balloon angioplasty, is an intravascular procedure that widens and treats narrowed or blocked arteries or veins, typically to treat atherosclerosis. Typically, a folded balloon is passed through a pre-placed catheter and over a guidewire into the narrowed blockage, then inflated to a fixed pressure. The balloon widens the blockage until the blockage within the vessel and surrounding muscle wall yields to the radial force exerted by the expanding balloon, widening the vessel to approximately the same luminal diameter as the native blood vessel in the area of ​​the blockage, thereby improving blood flow.

[0004] Angioplasty procedures are associated with several risks and complications, including, but not limited to, arterial rupture or other damage to vessel wall tissue due to overinflation of the balloon catheter, the use of an inappropriately large or stiff balloon, the presence of a calcified target vessel, and / or the formation of a hematoma or pseudoaneurysm at the access site. Generally, pressures generated by conventional balloon angioplasty systems range from 10 to 15 atmospheres, although pressures can be higher. As noted above, a major problem with known angioplasty systems and methods is that the occlusion collapses under high stress and strain rates over a relatively short period of time, often resulting in damage or dissection of the conduit, e.g., blood vessel, wall tissue. Summary of the Invention

[0005] Conventional systems may apply coarse system control. For example, shutting off power from a power source may be utilized as the primary means for regulating the amount of energy applied to a treatment site. Such an approach is taught by U.S. Pat. No. 8,728,091, in which current is monitored during application of voltage by a pulse generator. If the current exceeds a predetermined threshold magnitude, the voltage is terminated by the pulse generator. As described in further detail herein, improved approaches to power quality control can support more effective and more consistent treatment. For example, improved durability, higher frequency, and substantially equivalent pressure output over a greater number of voltage pulses than previously possible are achieved using embodiments of the present disclosure.

[0006] Various embodiments of the present disclosure may address, among other issues, problems such as those mentioned above.

[0007] The following drawings are illustrative illustrations of certain embodiments and are therefore not intended to limit the disclosure. [Brief explanation of the drawings]

[0008] [Figure 1] FIG. 1 is a schematic diagram of an intravascular lithotripsy (IVL) mechanism according to one or more embodiments of the present disclosure. [Figure 2] 2 is a control operation flow diagram applicable to the IVL mechanism of FIG. 1 in accordance with one or more embodiments of the present disclosure. [Figure 3A] FIG. 3 is a diagram of a portion of one or more circuit configurations of the IVL mechanism and control operation of FIGS. 1 and 2 in accordance with one or more embodiments of the present disclosure. [Figure 3B] FIG. 3 is a diagram of a portion of one or more circuit configurations of the IVL mechanism and control operation of FIGS. 1 and 2 in accordance with one or more embodiments of the present disclosure. [Figure 4A] 3A-3C are diagrams of additional portions of one or more circuit configurations of the IVL mechanism and control operation of FIGS. 1 and 2 in accordance with one or more embodiments of the present disclosure. [Figure 4B] 3A-3C are diagrams of additional portions of one or more circuit configurations of the IVL mechanism and control operation of FIGS. 1 and 2 in accordance with one or more embodiments of the present disclosure. [Figure 4C] 3A-3C are diagrams of additional portions of one or more circuit configurations of the IVL mechanism and control operation of FIGS. 1 and 2 in accordance with one or more embodiments of the present disclosure. [Figure 4D] 3A-3C are diagrams of additional portions of one or more circuit configurations of the IVL mechanism and control operation of FIGS. 1 and 2 in accordance with one or more embodiments of the present disclosure. [Figure 5] 1 is a flowchart for controlling the delivery of voltage to electrodes and the generation of shock waves in accordance with one or more embodiments of the present disclosure. [Figure 6] 2 is a flow of control operations applicable to the IVL mechanism of FIG. 1 in accordance with one or more embodiments of the present disclosure. [Figure 7] FIG. 1 is a schematic comparison of the voltage applied to a known IVL device and an embodiment of an IVL device according to the present disclosure. [Figure 8] FIG. 1 is a graphical comparison of the average peak pressure produced over 80 voltage pulses by a known IVL device and an embodiment of an IVL device according to the present disclosure. [Figure 9] FIG. 10 is a graphical comparison of the average peak pressure produced over 80 voltage pulses by a known IVL device and over a predetermined maximum number of voltage pulses by an embodiment of an IVL device according to the present disclosure. [Figure 10] FIG. 1 is an exemplary flowchart method according to the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0009] Conventional intravascular laser (IVL) devices, systems, and methods can apply high-energy electrical power to generate a spark (arc) between discharging electrodes. Under appropriate conditions, the spark generated by the immersed electrodes can generate a pressure wave in a medium that can be applied to treat (destroy) calcified lesions within a patient's vasculature. It can be appreciated that proper control of such high-energy systems can be critical to effective, including safe, treatment.

[0010] Intravascular lithotripsy systems, devices, and methods have been described by the present applicant, see International Publication No. WO 2022 / 074607, filed August 5, 2022, entitled "INTRAVASCULAR LITHOTRIPSY BALLOON SYSTEMS, DEVICES AND METHODS," the entire contents of which are incorporated herein by reference.

[0011] As shown in FIG. 1 , a schematic arrangement of several portions of an exemplary IVL system 12 is shown, illustrating the control elements of the present disclosure. The exemplary IVL system 12 includes a catheter assembly 14 having an elongate body embodied as a catheter with a guidewire 15 and a fluid-filled member 16 configured to contain an electrically conductive fluid therein, exemplified by an inflatable balloon, disposed near one end of the body and configured to expand to receive the fluid to facilitate IVL treatment. A set of discharge electrodes 18 is shown disposed within the exemplary balloon 16, with at least some of the electrodes spaced apart by gaps 17 to create a spark or electric arc between the spaced apart electrodes 18.

[0012] The IVL system control mechanisms described herein may be used in conjunction with electrodes contained within a fluid-filled member 16 configured to contain a fluid, e.g., a conductive fluid, therein. An embodiment of the fluid-filled member 16 may include an inflatable balloon, as shown in FIG. 1, which may be flexible or non-compliant and serves to contain the fluid such that the spaced apart electrodes 18 are immersed in the contained fluid. Additionally, the fluid-filled member 16 may be comprised at least in part of a rigid and / or non-compliant fillable member. In other embodiments, the fluid-filled member 16 may contain a fluid therein, with the spaced apart electrodes 18 positioned or immersed in the contained fluid.

[0013] Alternatively, the IVL system control mechanisms of the present disclosure may be used in conjunction with electrodes that are not located in or surrounded by a fluid-filled or fillable member 16. In those embodiments, the IVL system may include spaced apart electrodes 18 that may be continuously or periodically exposed to saline or other fluid, and during this exposure, the IVL system may generate an electric arc between the spaced apart electrodes 18.

[0014] The spaced apart electrodes 18 are disposed in communication with an electrical pulse-generating system 20 (as suggested by the dashed conductors) to receive high-voltage electrical energy for spark generation and to produce pressure waves for IVL treatment. In an exemplary embodiment, one electrode may be grounded and the other may be supplied with high voltage from the electrical pulse-generating system 20, although in some embodiments, any voltage difference may be applied. The electrical pulse-generating system 20 includes an IVL control system 22 comprising a processor 24 configured to execute instructions stored in a memory 26 and communicate signals via a circuit 28 for IVL operation under the direction of the processor. The processor 24, memory 26, and circuit 28 are disposed in communication with each other (as suggested by the dashed lines) to facilitate the disclosed operations.

[0015] Proper control of such high-energy systems may also be required to achieve sufficient energy at the discharge site. Given the high-energy environment and the microscale duration of electron discharge, achieving desirable energy control in such IVL devices and systems can be challenging. Furthermore, adaptive control methods may benefit the effectiveness of IVL. Adjustable energy delivery can increase efficient power application, potentially reducing risk to the patient. For example, starting from a predetermined starting voltage threshold, an attempt may be made to define a predetermined upper voltage threshold to form an acceptable voltage window. The acceptable voltage window may be coupled to a generated voltage pulse train with a magnitude that is confirmed to be within the acceptable voltage window. For example, if the magnitude of the generated voltage pulse train falls below the predetermined upper voltage threshold, the target voltage may be increased by a predetermined amount, and another series of generated voltage pulses is performed. Embodiments of the IVL systems, devices, and methods disclosed herein include operations for adjusting the total electrical energy delivered to the electrode set for a given pulse.

[0016] 2, a flow diagram for one embodiment of control 38 during operation of the IVL described with respect to boxes 40-60 is shown. Such control operation may be governed by electrical pulse generation system 20, illustratively by IVL control system 22. As described in further detail herein, control 38 applies incremental changes to power parameters during cycles of applied voltage while monitoring parameters related to spark generation. For example, incrementally increasing the duration of the voltage applied to the discharge electrode can increase the likelihood of generating an effective spark without using excessive energy.

[0017] Furthermore, if increasing the duration of the voltage applied to the discharge electrode does not produce a sufficient spark, then incremental increases in voltage can further increase the likelihood of generating an effective spark without excessive power. Furthermore, if incremental increases in voltage do not produce a sufficient spark, then the duration can be incrementally increased again before further increases in voltage are made. Thus, it can be appreciated that controlled incremental increases in duration and voltage can be implemented to achieve effective spark generation, and therefore pressure wave generation, at or near the lowest power requirements for effective spark generation. Increasing the likelihood of achieving a sufficient spark with lower power can increase efficiency, safety, and / or reduce the intensity of effective IVL treatment.

[0018] At box 40, an initial setting is applied. As an illustrative example, the default initial setting is applied as a discharge voltage of 2500 volts (V) for a duration of 0.5 microseconds. In some embodiments, the initial setting may be determined in any suitable manner, including, for example, using programmable defaults as application-based adjusted settings adjusted based on patient characteristics, environmental conditions, treatment modalities, and / or product cycle life (i.e., uptime), among other aspects. From box 40, control may proceed to box 42.

[0019] In box 42, electrical energy is applied to the electrodes to perform IVL treatment. In a first example proceeding from box 40 to box 42, electrical energy is applied at a default applied voltage of, for example, 2500 V for a duration of 0.5 microseconds. When applied in a clinical environment, pressure wave treatment can subsequently be performed while the IVL catheter is positioned within a patient's body lumen, specifically with the discharge electrode immersed in a fluid medium within a fluid-filled member such as an angioplasty balloon. However, as discussed below, in this condition, the energy initially supplied may in some cases be insufficient to generate a spark at the electrode or may generate insufficient sparks or insufficient pressure waves. From box 42, control may proceed to box 44.

[0020] At box 44, a determination of threshold aspects is made. In an exemplary embodiment, the determined value of the current applied at box 42 is compared to a threshold current value. In the illustrative example, the threshold current value is embodied as a predetermined fixed value, e.g., 20 amps, but in some embodiments may have any suitable value, e.g., 50 amps, 100 amps, 150 amps, 175 amps, and the threshold current value for a given cycle may be determined based on, among other factors, the number of previous cycles in a treatment session, the number of cycles in a treatment session that maintain the current setting (e.g., past box 46), a particular number of consecutive cycles (e.g., the number of consecutive cycles past box 46 or box 48 or box 52 or box 54 or box 58), patient characteristics, environmental conditions, treatment regimen, and / or product cycle life (i.e., uptime). Additionally, while the threshold current value may be set to a value, the actual current drawn during sufficient generation of an arc across the electrodes may be greater.

[0021] In response to determining in box 42 that the determined value of the applied current is greater than or equal to the threshold current value, control may proceed to box 46. Otherwise, in response to determining in box 42 that the determined value of the applied current is less than the threshold current value, control may proceed to box 48. For example, as discussed above, insufficient spark generation may result in little or no current flow across the electrodes (e.g., about 0 to about 5 amperes, which may correspond to energy dissipated into the medium without arcing), which will not achieve the threshold current value, thereby proceeding to box 48.

[0022] In an exemplary embodiment, the determined current value of the current applied in box 42 is embodied as the instantaneous current applied across the electrodes. In some embodiments, the determined current value may be embodied as an aggregate value, such as a time-averaged value of the current applied to the electrodes. Continuing with the exemplary embodiment applying a threshold current value of 20 amps, spark generation is deemed sufficient once 20 amps is achieved by the administered treatment.

[0023] It can be appreciated that the substantial generation of 20 amps provides a substantial current across the discharge electrode, meaning the generation of a significant spark. By comparison, when a spark cannot be generated, or when an insufficient spark is generated under the applied duration and applicable voltage, e.g., 2500 V, little or no current may flow across the discharge electrode; the applicable voltage may generally range from about 500 V to about 5000 V for IVL treatment, but may range from about 100 V to about 10,000 V for practical applications.

[0024] At box 46, a decision is made to maintain the currently selected settings. In the exemplary embodiment, the currently selected settings include the discharge voltage and applicable duration most recently applied at box 42. For the avoidance of doubt, if a default setting was most recently applied at box 42, resulting in a current of 20 amps, that default setting will be applied in the next treatment cycle. However, if the currently selected settings include updated settings, e.g., updated duration and / or voltage settings from a later portion of control 38, as described in more detail herein, maintaining the currently selected settings includes the most recently applied updated settings. Maintaining the currently selected settings proceeds back to box 42 to again apply electrical energy to the electrodes to perform IVL treatment.

[0025] In box 48, it is decided to increase the duration of the applied voltage to the discharge electrode. Continuing with the example where a current below 20 amps means insufficient spark generation, rather than immediately increasing the applied voltage, the duration of the applied voltage can be increased incrementally. On the scale of microseconds, increasing the duration of the applied voltage can increase the likelihood of sufficient spark generation using the same voltage previously applied. This can be achieved as a result of overcoming threshold system impedance and / or other factors that affect the ease of spark generation during a given cycle at a given voltage.

[0026] The duration of the applied voltage is increased by a predetermined time interval, illustratively embodied as a fixed value, e.g., 0.5 microseconds. In some embodiments, the predetermined interval corresponding to a given cycle may be determined based on factors such as the number of treatment cycles performed thus far during the treatment session (e.g., the number of cycle intervals that progressed through boxes 42, 44, and 46 before proceeding to box 48), patient characteristics, environmental conditions, treatment modality, and / or product cycle life (i.e., uptime), among other aspects. In some embodiments, the predetermined time interval corresponding to a given cycle may be varied by a predetermined rate of change, e.g., a percentage gain or loss per cycle. Control proceeds openly from box 48 to box 50.

[0027] In box 50, it is determined whether the maximum duration has been reached. In an exemplary embodiment, the maximum duration is a predetermined duration embodied as a fixed value, e.g., 6 microseconds. As an example, if the control sequence proceeds in a cycle from an initial setting in box 40 of 0.5 microseconds, through box 48, and ultimately reaches 6 microseconds, the maximum duration is reached as a threshold.

[0028] In some embodiments, the maximum duration for a given cycle may be determined based on, among other factors, the number of previous cycles in a treatment session, the number of cycles in a treatment session maintaining the current settings (e.g., past box 46), a particular number of consecutive cycles (e.g., the number of consecutive cycles past box 46 or box 48 or box 52 or box 54 or box 58), patient characteristics, environmental conditions, treatment regimen, and / or product cycle life (i.e., uptime). By inference, in box 50, the threshold current value has not been achieved in the current cycle, although in some embodiments, a positive determination and / or confirmation that the threshold current value has not been achieved may be made. In response to determining that the maximum duration has not been achieved, control proceeds to box 52. Otherwise, in response to determining that the maximum duration has been achieved, control proceeds to box 54.

[0029] In box 52, a decision is made to apply an updated duration. In an exemplary embodiment, the duration was updated in box 48 by increasing the currently selected duration by a predetermined duration interval, and the decision to apply the updated duration establishes and continues with the updated duration. In an exemplary embodiment, the applied voltage remains as currently selected. If continuing with the updated duration, proceed openly back to box 42 and again apply electrical energy to the discharge electrodes to administer treatment using the updated duration.

[0030] In box 54, the applied voltage is increased by a predetermined voltage interval. The currently selected setting of applied voltage is illustratively increased by the predetermined voltage interval. The currently selected duration is returned to a default value, illustratively 0.5 microseconds, and applied with the updated voltage, although in some embodiments the updated duration may have any suitable value under the newly updated voltage setting; for example, the updated duration may be determined based on the number of cycles of the treatment session in which the newly updated voltage occurred.

[0031] In an exemplary embodiment, the predetermined voltage interval is embodied as a fixed value of 250 V, and upon the first exemplary occurrence of window 54, the currently selected applied voltage is increased from a default value of 2500 V to 2750 V. In some embodiments, the predetermined voltage interval corresponding to a given cycle may be determined based on, among other aspects, the number of preceding cycles in a treatment session, the number of cycles in a treatment session that maintain the current setting (e.g., past window 46), a particular number of consecutive cycles (e.g., the number of consecutive cycles that go through window 46 or window 48 or window 52 or window 54 or window 58), patient characteristics, environmental conditions, treatment regimen, and / or product cycle life (i.e., operational time).

[0032] In box 56, it is determined whether the maximum voltage has been achieved. In an exemplary embodiment, the maximum voltage is a predetermined voltage embodied as a fixed value, e.g., 3500 V. As an example, if the control sequence proceeds in a cycle from an initial setting in box 40 of 2500 V, through box 54, and ultimately reaches 3500 V, the maximum voltage will be achieved as a threshold.

[0033] In some embodiments, the maximum voltage for a given cycle may be determined based on, among other factors, the number of previous cycles in a treatment session, the number of cycles in a treatment session maintaining the current setting (e.g., past box 46), a particular number of consecutive cycles (e.g., the number of consecutive cycles past box 46 or box 48 or box 52 or box 54 or box 58), patient characteristics, environmental conditions, treatment regimen, and / or product cycle life (i.e., uptime). By inference, in box 56, the threshold current value has not been achieved in the current cycle, although in some embodiments, a positive determination and / or confirmation that the threshold current value has not been achieved may be made. In response to determining that the maximum voltage has not been achieved, control proceeds to box 58. Otherwise, in response to determining that the maximum voltage has been achieved, control proceeds to box 60.

[0034] In box 58, a decision is made to apply an updated voltage. In the exemplary embodiment, the voltage was updated in box 54 by increasing the currently selected voltage by a predetermined voltage interval, and the decision to apply the updated voltage confirms and continues with the updated voltage. The duration is updated in box 45 back to a default value, illustratively 0.5 microseconds, and then applied with the updated applied voltage. If continuing with the updated voltage, proceed openly back to box 42 to again apply power to the electrodes and administer treatment using the updated voltage and updated duration.

[0035] At box 60, a determination of an error occurs. In response to the determination of an error, an error message is provided. Such an error message illustratively terminates the treatment session, but in some embodiments may take other safety and / or communication actions, such as displaying an error communication to the user.

[0036] In an exemplary embodiment, in response to the error determination, it may be determined by inference that the maximum voltage and maximum duration did not produce a spark, although in some embodiments, insufficient spark generation may be determined. In some embodiments, in response to the error determination, failed and / or insufficient spark generation under the maximum voltage and maximum duration may be determined by proactive determination and / or confirmation. After box 60, process control automatically terminates.

[0037] Although the description of control 38 provides an exemplary increase in duration, in some cases, for example, a voltage level may be decreased in a particular cycle of control 38. For example, the duration and / or voltage may be varied in accordance with control 38 in a given cycle to progressively decrease to achieve the appropriate conditions, e.g., to achieve the appropriate released energy, as described in more detail herein in connection with consideration of the voltage level of energy storage system 112, e.g., a capacitance system, before and after discharge.

[0038] 3 , several portions of an exemplary electrical pulse-generating system 20 are disclosed herein, including several portions of an IVL control system 22, which include various functions and / or circuits that may be implemented as part of circuit 28; however, in some embodiments, such systems 20, 22 may share components and / or have separate components, as appropriate; for example, circuit 28 is intended to be schematic and, as appropriate, may represent circuitry embodied solely by system 20. In the exemplary embodiment, IVL control system 22 includes an adjustable energy storage system 112, such as, by way of example, an exemplary capacitance system, for selectively adjusting the energy storage capacity or magnitude applied to supply electrical energy to the electrodes. Reference below will be made to energy storage system 112 as described in terms of, but certainly not limited to, the exemplary capacitance system.

[0039] The energy storage system 112 receives charging electrical energy from the power source of the electrical pulse generation system 20. The energy storage system 112 provides discharging electrical energy to the electrodes (e.g., illustratively via VCAP2 and ground), as described in more detail herein.

[0040] The adjustable energy storage system 112 illustratively includes several, e.g., one or more, energy storage units, illustrated as individual capacitors 114, forming an energy storage network. In an exemplary embodiment, each energy storage unit 114 may be sized to have the same energy storage capacity and may be arranged to connect in parallel with other energy storage units in the energy storage network, although in some embodiments, any size and / or arrangement of energy storage units may be provided to support variable energy storage for IVL therapy. A relay system 116 may be disposed in association with at least some of the energy storage elements 114 of the network. The relay system 116 comprises one or more relays for selectively connecting the energy storage elements 114 together to receive electrical charge and release electrical energy to the electrodes.

[0041] In the exemplary embodiment, the relay system 116 includes a coupling configuration in which all of the energy storage elements 114 in the network are connected for use in an IVL. When the energy storage elements 114 are connected for use in an IVL, they may be connected to other portions of the electrical pulse generation system 20 to exchange electrical energy under other control operations. For example, under typical charge control operations, the energy storage elements 114 connected for use in an IVL by the relay system 116 may receive charge from a power source, and / or under typical discharge control operations, the energy storage elements 114 connected for use in an IVL by the relay system 116 may provide discharge energy to the electrodes 18. Thus, it can be appreciated that the relay system 116 can selectively connect all of the energy storage elements 114 for use in an IVL treatment to provide maximum energy storage magnitude.

[0042] Additionally, the relay system 116 may include a decoupled configuration in which fewer than all of the energy storage elements 114 in the network are connected for use in an IVL, as suggested in FIG. 4. For ease of explanation, but not by way of limitation, some of the energy storage elements 114, illustratively two energy storage elements, are depicted as being disconnected from the other energy storage elements by disconnecting the relay system 116. Energy storage elements 114 that are disconnected for use in an IVL by the relay system 116 cannot receive charge from the power source and / or, under typical discharge control operation, cannot provide discharge energy to the electrodes 18. Energy storage elements that are disconnected for use in an IVL treatment may be discharged separately from the electrodes (e.g., for safe reduction of stored power), illustratively via diodes 118 arranged in parallel with the relay system 116.

[0043] It can be appreciated that the total amount of energy delivered to the electrodes can be controlled by adjusting the energy storage capacity available to deliver electrical energy to the electrodes.

[0044]

number

[0045] In an exemplary embodiment, IVL control system 22 is configured to govern the applied stored energy. IVL control system 22 illustratively determines the amount of stored energy to apply, and if it determines that a change in the magnitude of energy storage is desired, IVL control system 22 operates relay system 116 accordingly. For example, IVL control system 22 may determine that a lower magnitude of energy storage is desired and / or required for a certain voltage pulse and may communicate to relay system 116 to operate in a non-coupled configuration.

[0046] For one or more subsequent voltage pulses, IVL control system 22 may determine that a larger energy storage magnitude is desired and / or required for another voltage pulse and may communicate relay system 116 to operate in the coupled configuration. For one or more further subsequent voltage pulses, IVL control system 22 may determine that a lower energy storage magnitude is again desired and / or required and may return relay system 116 to the uncoupled configuration. Thus, IVL control system 22 may operate relay system 116 as needed to provide an adjustable energy storage magnitude for any given voltage pulse in the series of voltage pulses.

[0047] The applied energy storage may be adjusted as it progresses, for example, for any given pulse. In practice, adjustments to the energy storage capacity or size may be made in relation to the level of the applied voltage and / or to account for power, efficiency, and / or other aspects of the technology. Furthermore, over the life of the applied device and system, normal wear of components may change their electrical and / or physical properties, which may benefit from adjustments to the applied energy storage. For example, even small wear on electrodes may change the spacing (gap) between pairs of electrodes, which may change the conditions for the arc between the electrodes. Thus, an adjustable energy storage size can accommodate variations in the electrodes and / or parts of the discharge system under repeated use, whether during individual treatment sessions or otherwise.

[0048] Continuing to refer to FIG. 3 , embodiments of the present disclosure are directed to systems and methods for regulating the voltage provided to charge energy storage system 112 as a charging voltage. The charging voltage illustratively is provided as an input to energy storage system 112 as a store of energy that is released to generate controlled voltage pulses for variable charging. The charging voltage is illustratively controlled by charging control system 120 of IVL control system 22.

[0049] In an exemplary embodiment, charging control system 120 provides precise control of the charging voltage via a high frequency switched control signal from processor 24. The switched control signal ("HVIN_VSET") is illustratively embodied as a pulse width modulated (PWM) signal and amplified for control of the high voltage supply. High voltage DC / DC conversion system 122 receives switch control signal instructions in the range of approximately 0V to approximately 12V and provides a corresponding charging voltage in the range of approximately 0V to approximately 4000V, illustratively.

[0050] In the illustrated embodiment, charging control system 120 includes a step-down regulator system 124 for conditioning the low-voltage power. Step-down regulator system 124 is illustratively embodied as an integrated circuit (IC) that provides signal conditioning by low-pass filtering and buffering of the PWM signal. Step-down regulator system 124 receives the conditioned PWM signal along with feedback for providing regulated low-voltage power to conversion system 122 for applying high-voltage power.

[0051] Resistor 126 appropriately reduces the feedback voltage for IC operation, and an additional resistor 128 can provide a variable feedback voltage ranging from approximately 0 V to approximately 3.3 V to buck regulator system 124. As the duty cycle of the PWM signal increases from 0 percent to 100 percent, the filtered signal increases from 0 volts to 3.3 volts, which can increase the current provided to the feedback network and require lower voltages to achieve regulation, for example, resistors, inductors, and / or capacitors disposed between buck regulator system 124 and conversion system 122.

[0052] Continuing to refer to FIG. 3 , embodiments of the present disclosure are directed to systems and methods for controlling the effective time of a discharge voltage pulse supplied to an electrode. A switching signal (e.g., “GATE_PULSE”) is provided by processor 24 for high voltage switching via low voltage signaling. In an exemplary embodiment, the switching signal is applied to precisely operate discharge switch system 130. Discharge switch system 130 is illustratively embodied to implement driver 131 and semiconductor device 132 as a gate switch.

[0053] The gate switch 132 is illustratively embodied as an insulated gate bipolar transistor (IGBT) having an n-type gate control configuration. In an active state of the switching signal to the driver 131, the gate switch 132 is activated to a conducting state and transmits energy discharge from the energy storage system 112 to the electrodes. In an inactive state of the switching signal, the gate switch 132 is deactivated to a non-conducting state and prevents discharge of the energy storage system 112 to the electrodes.

[0054] In the exemplary embodiment, the gate switch 132 is arranged as an active-high device, but in some embodiments may be implemented as an active-low device. A gated, active-high IGBT can provide precise control of the discharge from the energy storage system 112, but may be implemented in any suitable manner, including with other suitable semiconductors (e.g., p-type, FET, etc.) and / or other control designs (e.g., current collector, emitter control, etc.).

[0055] In an exemplary embodiment, discharge switch system 130 includes an anti-parallel diode 134 arranged to reduce reverse voltage stress on gate switch 132. A disable signal ("HV_DISABLED") is provided to driver 131, which, under the direction of processor 24 and / or other safety systems, may inactive (low) to allow energy release to the electrodes and activate (high) to disable high voltage discharge. Snubber system 136 is illustratively embodied as a resistor-capacitor-diode (RCD) snubber network arranged to reduce voltage transients that may exceed the rated voltages of various high voltage components.

[0056] 4, the IVL control system 22 illustratively includes a power monitoring system 140. The power monitoring system 140 is configured to monitor various parameters of the IVL device and system power, including, by way of example, sensing the current and voltage delivered to the electrodes and the voltage of the adjustable energy storage system 112.

[0057] Power monitoring system 140 illustratively includes a current monitoring system 142. Current monitoring system 142 is embodied to sense the current delivered to the electrodes for a given voltage pulse. As described in further detail herein, the current delivered to the electrodes can be taken into account in determining the power characteristics of a subsequent voltage pulse.

[0058] In the exemplary embodiment shown in Figure 4, a current monitoring system 142 receives an indication of the voltage level applied with each voltage pulse to determine the current delivered to the electrodes. Returning momentarily to Figure 3, a shunt 138 is placed in the high voltage current path to establish a proportional voltage (e.g., "VCURR+", "VCURR-"). The proportional voltage is communicated to the current monitoring system 142 as shown in Figure 4.

[0059] A chip with amplifier 144 is arranged to scale the proportional voltage and provide the analog result to conditioning network 146, which may be embodied with a resistor-capacitor network for scaling and / or filtering. The conditioned signal is buffered by buffer amplifier 148, the output of which is provided to analog-to-digital conversion (ADC) system 150 for digital conversion.

[0060] ADC system 150 illustratively includes converter 152 and memory 154. In an exemplary embodiment, converter 152 provides a digital output from an analog input, and memory 154 is embodied as a first-in, first-out (FIFO) device for intermediate storage of the digital output. Memory 154 illustratively receives the same clock signal that drives converter 152, allowing for rapid sampling of several measurement points with low jitter. The memory output is provided to processor 24 for consideration in overall IVL therapy control.

[0061] The IVL control system 22 illustratively includes a current monitoring system that compares an output signal ("VCURR") generated by a chip including amplifier 144 with a threshold value. The threshold value is embodied as being generated by a variable duty cycle PWM signal ("ISNS_ISET") from the processor 24. The PWM signal may be low-pass filtered and / or buffered before being sent to the comparator. In response to the measured current exceeding the threshold value, the current monitoring system can assert an error signal (e.g., "ISNS OVER#") to avoid an overcurrent condition.

[0062] Power monitoring system 140 illustratively includes voltage monitoring system 170. Voltage monitoring system 170 is embodied to sense the voltage between a pair of electrodes. As described in further detail herein, the voltage between the electrodes for a given pulse may be considered in determining the power characteristics of subsequent voltage pulses.

[0063] In an exemplary embodiment, voltage monitoring system 170 includes a resistive network 172 arranged to attenuate the (switched) voltage of one of a pair of electrodes (e.g., "VCAP1"). The attenuated signal is provided to an operational amplifier network 174 for filtering and offsetting for output to digital conversion. The output from operational amplifier network 174 is provided to an ADC conversion system 176 for digitization, including storage in FIFO memory 178 for access by processor 24.

[0064] The power monitoring system 140 may illustratively include an energy storage capacity voltage monitoring system 180 configured to monitor the voltage within the adjustable energy storage system 112. Monitoring the voltage of the energy storage system 112 may enable a determination of the stored energy of the energy storage system 112. Furthermore, a comparison of the stored energy of the energy storage system 112 before and after discharge may provide an indication of the total energy delivered during a given discharge cycle. Considering such total energy data, increased confidence may be gained in determining whether sufficient sparks were generated for IVL treatment.

[0065] In the exemplary embodiment, voltage monitoring system 180 includes a voltage limiting system configured to monitor the net voltage of energy storage system 112 during charging. In the exemplary embodiment, voltage monitoring is described with reference to connected energy storage elements 114, more specifically, energy storage elements connected to provide controlled discharge energy for IVL therapy, and not with reference to energy storage elements, if any, that are disconnected via relay system 116.

[0066] A voltage monitoring system 180 receives an indication of the voltage of the energy storage system 112 during charging (“VCAP1”). System 180 includes an amplifier arrangement 182, illustratively comprising an amplifier 184 and a comparator 186. Comparator 186 is illustratively arranged to compare the voltage to a fixed voltage and trigger a signal (e.g., “VCAP1_OVER#”) accordingly if the voltage of the energy storage system 112 exceeds the fixed voltage. In the illustrative embodiment, the fixed voltage is embodied as a set value generated by a resistor-resistor-capacitor network 188 that is above normal operation but before damage occurs to various HV components.

[0067] The intermediate voltage of this circuit (e.g., "AN_VCAP1") can be used to monitor progress during a charging cycle of the energy storage system 112. The intermediate voltage illustratively represents a significantly attenuated version of the high voltage ("VCAP_1") supplied to the electrodes by the energy storage system. Such an attenuated signal can allow monitoring of the high voltage system while processing indications of low voltage in the high voltage system.

[0068] 5, and with continued reference to FIGS. 1 and 3, the IVL system 12 may consider the energy of the energy storage system 112 during operation. By monitoring the energy of the energy storage system 112 before and after a discharge event, an indication of spark generation (and / or sufficiency) may be determined, as described in further detail with respect to the exemplary embodiment with reference to operation 300 with respect to boxes 312-322.

[0069] At box 312, an evaluation of energy storage system 112 is performed. In an exemplary embodiment, this evaluation includes determining the voltage of the energy being stored by energy storage system 112. As described above, voltage monitoring system 180 may monitor the voltage of energy storage system 112 during charging, for example, via a voltage limiting system. In some embodiments, the evaluation may include determining any other suitable parameters to assist in energy monitoring of energy storage system 112.

[0070] In box 314, the energy of energy storage system 112 is determined. In an exemplary embodiment, the energy of energy storage system 112 is determined as follows:

[0071]

number

[0072] At box 316, IVL therapy can be attempted. In an exemplary embodiment, voltage pulses can be delivered to the electrodes. The voltage pulses can be applied according to the control mechanisms described herein, for example, based on determined durations in a control sequence.

[0073] At box 318, an evaluation of the energy storage system 112 occurs. The evaluation of the energy storage system 112 at box 218 is embodied to occur immediately after the attempted IVL treatment at box 216 to provide an indication of the energy state of the energy storage system 112 immediately after the (attempted) release to the electrodes. In an exemplary embodiment, the evaluation includes a determination of the voltage of the energy stored by the energy storage system 112, embodied as performed by voltage monitoring as described above, although in some embodiments, the evaluation of the energy storage system 112 at box 318 may differ in methodology and / or implementation from box 312.

[0074] In box 320, the energy of energy storage system 112 is determined. In an exemplary embodiment, the energy of energy storage system 112 is again determined in the same manner as in box 214.

[0075]

number

[0047] The determination is based on the measured voltage according to box 320, but is made after an attempt to deliver IVL therapy. In some embodiments, the determination of the energy of the energy storage system 112 in box 320 may differ in methodology and / or implementation from that in box 214. Accordingly, the processor 24 may calculate the current energy of the energy storage system 112, including immediately after (an attempted) release of energy to the electrodes.

[0076] A comparison of the energy determinations is made in box 322. The amount of energy determined in the energy storage system 112 in box 314 is illustratively subtracted from the amount of energy determined in the energy storage system 112 in box 320, and the result represents the amount of energy released from the energy storage system 112 in one attempt to perform IVL therapy.

[0077] The amount of energy released can be taken into consideration to determine whether a spark (or sufficient spark) has occurred so that IVL therapy occurs. In an exemplary embodiment, the threshold energy release represents a level of released energy that reliably indicates that sufficient spark has occurred for IVL. Thus, comparing the stored energy levels before and after the release in box 322 to determine whether the threshold energy release has been achieved can indicate a spark for IVL therapy.

[0078] In an exemplary embodiment, with reference to Figure 2, the threshold energy release is a fixed, predetermined value, such as 600 millijoules (e.g., 3700V, 90 nanofarads). However, in some embodiments, the threshold energy level for a given cycle may be determined based on, among other factors, the number of previous cycles in a treatment session, the number of cycles in a treatment session that maintain the current settings (e.g., past box 46 in Figure 2), a particular number of consecutive cycles (e.g., the number of consecutive cycles that go through box 46 or box 48 or box 52 or box 54 or box 58), patient characteristics, environmental conditions (e.g., location within the patient's body, such as on or above the lap), treatment modality, and / or product cycle life (i.e., operational time).

[0079] A comparison of the energy level of the energy storage system 112 indicating that a spark for IVL treatment has occurred can responsively cause a further treatment with the same duration, energy level, threshold characteristics, and / or thresholds adjusted for other parameters. A comparison of the energy level of the energy storage system 112 indicating that a spark for IVL treatment has not occurred can cause an adjustment of the duration and / or applied energy level, for example, as described with respect to control operation 38.

[0080] In some embodiments, a threshold current value can be applied along with a threshold energy release, and either threshold can individually indicate a spark for IVL therapy. In some embodiments, both thresholds may be required to be met to indicate a spark for IVL therapy.

[0081] Consideration of the energy state of the energy storage system 112 can provide desirable monitoring of IVL operation. For example, such monitoring can be less intrusive by reducing the need for direct measurements at the electrodes. Furthermore, in high-power applications, robust consideration of the energy state can promote reliability compared to merely direct measurements in unpredictable high-energy arc scenarios.

[0082] IVL control system 22 illustratively includes an external watchdog system configured to assist in safe operation. The watchdog system includes an integrated circuit configured to trigger an error upon a lack of timely switching of input signals to ensure proper high-voltage operation. In some embodiments, the watchdog system may be formed externally, including a processor, memory, and / or circuitry separate from or shared with IVL control system 22.

[0083] 3 , in an exemplary embodiment, IVL control system 22 includes an umbrella monitoring system 190 configured to assist in safe operation. Umbrella monitoring system 190 illustratively includes a flip-flop 192 and a logic gate 194 for considering monitoring signals. Logic gate 194 is positioned to receive from voltage monitoring system 180 monitoring signals embodied as an energy storage system overvoltage (“VCAP1_OVER#”), a high voltage warning (“HV_WD0#”) from a watchdog system, and, in some embodiments, an overcurrent (“ISNS_OVER#”) from a current monitoring system.

[0084] Logic gate 194 is embodied as an AND gate, flip-flop 192 is embodied as an asynchronous D flip-flop, and an activation signal from gate 194 that lasts longer than the minimum clock pulse width of flip-flop 192 causes the output to assert, disabling the high voltage output (e.g., "HV_DISABLED"), but an activation signal from gate 194 that is shorter than the minimum clock pulse width of flip-flop 192 does not raise the disable output from umbrella surveillance system 190.

[0085] Assertion of a signal to disable high voltage output ("HV_DISABLED") is illustratively provided to discharge switch system 130 to disable activation of the voltage pulse switch to the electrodes. In an exemplary embodiment, the disable output signal is provided to driver 131 to indirectly modify the on / off operation of gate switch 132. Such a disable output signal is illustratively provided to a low voltage source, e.g., buck regulator system 124, and a high voltage module, e.g., conversion system 122.

[0086] Thus, logic gate 194 receives the above-mentioned monitoring signals, including (1) an energy storage system overvoltage ("VCAP1_OVER#") from voltage monitoring system 180, (2) a high voltage warning ("HV_WD0#") from the watchdog system, and in some embodiments, (3) an overcurrent ("ISNS_OVER#") from the current monitoring system. These monitoring signals are also connected to a three-input AND logic gate [U12], which is upstream of a D flip-flop [U15] with asynchronous set and reset functionality, so that any signal asserting for longer than the minimum pulse width of flip-flop [U15] will cause its outputs [HV_DISABLED, HV_DISABLED#] to be asserted. These signals travel downstream to inhibit the operation of the gate driver [U11], the variable low voltage supply [U6], the high voltage module [U7], and slightly change the on-off behavior of the switching devices [Q10, Q11] via transistors [Q12, Q13]. This system allows any of the supervisory signals to disable the system's output if asserted for longer than an established duration.

[0087] In the present disclosure, the ability to disconnect from AC mains or battery DC can provide power and control versatility for IVL therapy. Unlike known IVL systems, certain embodiments of the present disclosure can avoid remaining idle until fully (or substantially) recharged for application in IVL therapy, for example, if the charge is insufficient by the time IVL therapy is desired. Therefore, such costly delays or interruptions in treatment can be avoided by embodiments of the present disclosure. The electrical pulse generation system 20 illustratively includes a battery storage system and is configured to selectively charge the energy storage system 112 solely with stored energy in the battery, with the battery storage system while connected to a mains power source, such as a wall outlet, or directly with DC power converted from the AC mains power source without the battery storage system. When connected to the AC mains power source, regulated DC power is sent directly to the high-voltage system. During operating conditions where the power demand for IVL operation is high, the charging current of the battery storage system can be reduced to allow for higher system current for IVL operation. When not connected to the AC mains power source, battery power can be sent directly to the energy storage system 112. In an exemplary embodiment, power management systems and devices, including, for example, inverters, regulators, power storage devices, and / or related aspects, may be configured by electrical pulse generation system 20 to provide applicable power to IVL control system 22.

[0088] Examples of suitable processors may include, among others, one or more microprocessors, integrated circuits, and systems-on-chips (SoCs). Examples of suitable memory may include, among others, one or more primary and / or non-primary memory (e.g., secondary, tertiary, etc.); permanent, semi-permanent, and / or temporary memory; and / or memory storage devices, including, but not limited to, hard drives (e.g., magnetic, solid-state), optical disks (e.g., CD-ROM, DVD-ROM), RAM (e.g., DRAM, SRAM, DRDRAM), ROM (e.g., PROM, EPROM, EEPROM, Flash EEPROM), volatile and / or non-volatile memory. Communications circuitry 58 includes components for facilitating processor operation; for example, suitable components may include transmitters, receivers, modulators, demodulators, filters, modems, analog-to-digital (AD or DA) converters, diodes, switches, operational amplifiers, and / or integrated circuits. In some embodiments, memory 26 may represent one or more memory devices operable for IVL therapy operations. For example, each memory (eg, 154, 178) may be included as part of, shared with, or separate from memory 26.

[0089] In this disclosure, discussion of sets of discharge electrodes has been in the context of pairs of electrodes, one of which may function as a cathode and the other as an anode in certain cases. However, the number of electrodes in a set may be more than one pair, and may include, for example, one or more cathodes in communication with one or more anodes. In addition, the devices, systems, and methods of this disclosure may include groups of two or more communicating electrodes, which may be electrically arranged in series, in parallel, or independently of each other.

[0090] The power control operations disclosed herein may be applied equally, simultaneously, and / or sequentially to individual sets or groups of electrodes in a given IVL treatment cycle. For example, a threshold current value may be applied to all deployed electrodes collectively or to individual groups or sets of electrodes. Decisions made regarding power control may be applied equally to associated electrodes in a given IVL treatment cycle or may be individualized to groups or sets of electrodes. In the present disclosure, support components such as power sources, sensors, and other mounting structures and / or functionality for performing IVL operations as disclosed herein are embodied as subportions of electrical pulse generation system 20 and / or IVL control system 22, e.g., as part of circuitry and / or instructions.

[0091] 6, an exemplary flow diagram of another embodiment of control 200 for the operation of an embodiment of an IVL system, specifically the number of voltage pulses generated and the magnitude of the pulses generated, is shown. It is understood that control 200 may be combined with aspects of the control system and method embodiments described above in connection with FIGS. 1-5.

[0092] The control operations of the control 200 may be governed by the electrical pulse generation system 20 and, illustratively, by the IVL control system 22 described above in connection with FIG. 1 . As further described herein, the control system 22 may control the number of voltage pulses generated in a series (or series) of voltage pulses. The tolerance voltage window comprises a predetermined starting voltage magnitude and a predetermined upper voltage magnitude. The IVL control system further comprises a predetermined voltage magnitude for progressively increasing the voltage magnitude after each series of voltage pulses if the magnitude of the executed voltage pulse is within the tolerance voltage window. Separate sets of predetermined control data may be provided within the control system 22 for IVL systems with balloons of distinguishable characteristics, such as, but not limited to, different size configurations, e.g., 2.5 mm, 3.0 mm, 3.5 mm, and / or 4.0 mm.

[0093] An exemplary embodiment of the IVL system may include a 2.5 mm or 3.0 mm balloon, in which case the control system 22 includes control data including an exemplary starting target voltage of 3000 V (a predetermined lower voltage threshold), an exemplary voltage pulse train comprising 10 pulses, and an exemplary incremental voltage increase of 25 V if the magnitude of the voltage pulse train is less than an exemplary upper voltage threshold of 3500 V. Those skilled in the art will recognize that the incremental voltage increase may be of any voltage magnitude, including, but not limited to, between 1 V and 250 V. An exemplary voltage increase may include 25 V, but may be greater or less than 25 V in certain embodiments. As those skilled in the art will recognize, the predetermined starting voltage may be less than 3000 V, and the predetermined upper voltage threshold may be greater than 3500 V. Thus, an exemplary starting voltage may include, but is not limited to, 2500 V, and an exemplary upper voltage threshold may include 4100 V. In other embodiments, an exemplary predetermined starting voltage may be greater than 3000V and an exemplary upper voltage threshold may be greater than 3250V.

[0094] Other exemplary embodiments may include a 3.5 mm or 4.0 mm balloon, in which case the control system 22 includes control data including an exemplary starting target voltage of 3250 V (a predetermined lower voltage threshold), a voltage pulse train including 10 pulses, and a gradual voltage increase of 25 V if the magnitude of the voltage pulse train is below an exemplary predetermined upper voltage threshold of 3700 V.

[0095] Continuing with reference to FIG. 1 and, in some embodiments, FIG. 2, FIG. 6 illustrates the initiation of the voltage pulse generation and control system 200, beginning at box 202, where a determination of a particular balloon characteristic of interest, e.g., the outer diameter (“OD”) of the balloon of the IVL system, is required. In a first embodiment, if the balloon outer diameter is, for example, 2.5 mm or 3.5 mm, the starting voltage is set to 3000 V at box 204, also referred to as the predetermined lower voltage threshold of the allowable voltage magnitude window. IVL treatment is initiated at box 206 by applying a series of voltage pulses (or impulses) from the electrical pulse generation system 20, each voltage pulse proceeding to the electrode 18 within the balloon 16. If the target voltage magnitude is not at the predetermined upper voltage threshold, e.g., 3500 V, at box 208, the target voltage is increased by an exemplary 25 V (from 3000 V to 3025 V), as at box 109, and another series of voltage pulses (10 pulses in this case) is performed at 3025 V, as at box 210. This process continues, cycling through boxes 208, 209, and 210, until the target voltage is 3500V. Once the target threshold voltage, i.e., a predetermined upper voltage threshold, is reached, and / or in some embodiments, a predetermined maximum or required number of voltage pulses (or shocks) has been generated, e.g., 300 pulses (or shocks), control system 22 determines whether the number of generated voltage pulses (or shocks) in the series of voltage pulses has reached the maximum or required number of pulses, e.g., 300 voltage pulses, as in box 212. If the maximum or required voltage pulse threshold, e.g., 300 voltage pulses, has not been reached, another series of voltage pulses (or shocks), e.g., 10 voltage pulses (or shocks), is applied, as in box 214. Once the maximum or required voltage pulse threshold, e.g., 300 voltage pulses, has been reached, no further voltage pulses (or shocks) are allowed, as in box 216.

[0096] The predetermined maximum number of voltage pulses in various embodiments of the present disclosure may be in the range of 10 to 300 voltage pulses. Exemplary embodiments described herein include a predetermined maximum number of voltage pulses equal to 300 pulses. In other embodiments, the maximum number of voltage pulses may be greater than 300 pulses.

[0097] In a second embodiment, continuing to refer to FIG. 1 , and in some embodiments, to FIG. 2 , if the outer diameter of the balloon is determined to be, for example, 3.5 mm or 4.0 mm in box 202, the electrical pulse generation system 20 begins treatment in box 118, with the starting voltage set to 3250 V, also referred to as the predetermined lower voltage threshold of the allowable voltage magnitude window. The IVL treatment is initiated in box 220 by applying a series of voltage pulses from the electrical pulse generation system 20, with each voltage pulse traveling to the electrodes 18 within the balloon 16. If the target voltage magnitude is not at the predetermined upper voltage threshold, for example, 3500 V, in box 222, the target voltage is increased by an exemplary 25 V (from 3250 V to 3275 V), as in box 223, and another series of voltage pulses (10 pulses in this case) is performed at 3275 V, as in box 224. This process continues, cycling between boxes 222, 223, and 224, until the target voltage is 3700 V. Once the target threshold voltage, or a predetermined upper voltage threshold, is reached, and / or in some embodiments, once a maximum or required number of pulses, e.g., 300 pulses (or shocks if applied to one or more pairs of spaced apart electrodes), have been generated, control system 22 determines whether the number of generated voltage pulses (or shocks) in the multiple series of voltage pulses has reached a maximum or required number of pulses, e.g., 300 voltage pulses, as in box 212. If the maximum or required voltage pulse threshold, e.g., 300 voltage pulses, has not been reached, another series of voltage pulses (or shocks), e.g., 10 voltage pulses (or shocks), as in box 214. Once the maximum or required voltage pulse threshold, e.g., 300 voltage pulses, has been reached, no further voltage pulses (or shocks) are allowed, as in box 216.

[0098] Alternatively, a physician administering an IVL treatment in accordance with the voltage pulse generation and control system 200 may determine that the treatment is complete at some point during the administration of the treatment. If the physician determines that the treatment is complete, the physician may terminate the process of the voltage pulse generation and control system 200 at any time.

[0099] In some embodiments, the voltage pulse generation and control system 200 may provide for varying the duration of the applied voltage within or across one or more of the multiple series of voltage pulses, according to the embodiment described above in connection with FIG. 2. For example, the duration may be increased or decreased by a predetermined duration interval, illustratively embodied as a fixed value, e.g., 0.5 microseconds. In some embodiments, the predetermined interval for a given cycle may be determined based on factors such as the number of treatment cycles performed thus far during a treatment session (e.g., the number of voltage pulse series performed by progressing through windows 206, 208, and 210, or 220, 222, and 224), patient characteristics, environmental conditions, treatment modality, and / or product cycle life (i.e., uptime), among other aspects. In some embodiments, the predetermined duration interval for a given cycle may be varied by a predetermined rate of change, e.g., a percentage gain or loss per cycle.

[0100] FIG. 7 shows a schematic comparison of a known IVL device (known) with balloons of 2.5 mm and 4.0 mm OD and an IVL device according to the present disclosure (test) with balloons of 2.5 mm and 4.0 mm OD.

[0101] The known device is capable of generating 80 voltage pulses or impulses. The test device generated 300 voltage pulses or impulses. During the comparative testing, the voltage peak magnitudes for each voltage pulse were obtained and plotted for each device tested. The known device provides a relatively flat or constant voltage for each voltage pulse or impulse number, starting at a lower voltage magnitude than the test device. The test device was operated and controlled in accordance with embodiments disclosed herein, for example, as shown in FIG. 3.

[0102] In contrast, the 2.5 mm and 4.0 mm test devices each start at a higher voltage magnitude than the known device. The 2.5 mm test device starts at a lower voltage than the 4.0 mm device. As shown, both the 2.5 mm and 4.0 mm test device voltages (lower data clusters) rise slowly over the generated voltage pulses, plateau at approximately 180 pulses, and remain substantially flat or constant thereafter. Referring again to FIG. 3, this pattern of rising voltage followed by a flattened or constant voltage region coincides with boxes 104-110 (2.5 mm) and boxes 118-124 (4.0 mm). In each case, the average voltage of the 4.0 mm test device is greater than that of the 2.5 mm test device.

[0103] Figure 8 compares the test IVL device with a known IVL device and shows a subset of the data from Figure 4, i.e., comparing the first 80 voltage pulses of each device. Here, the voltage pulse (or number of impulses) is compared to the average pressure generated during each voltage pulse. The known data (where the voltage in each voltage pulse is constant, as in Figure 3) exhibits a relatively significant decrease in pressure output as the voltage pulse progresses over time (dashed line). In contrast, the test data (solid line) obtained using the voltage and pulse generation algorithm of Figure 3 exhibits a pressure output line that decreases at a much smaller angle or slope. Thus, the pressure output of the test IVL device provides a more stable or consistent pressure output than the known IVL device. The known IVL device has a significant decrease in pressure output as the voltage pulse progresses. More specifically, the test IVL device produces a pressure output decrease of less than 0.25 MPa over the 80 pulses.

[0104] The tested pressure output was measured ex vivo using a pressure sensor (hydrophone) placed on the exterior of the catheter balloon within the acoustic field generated by the device pulse delivery. The tested device and hydrophone were immersed in degassed, deionized water maintained at approximately body temperature.

[0105] This concept is further illustrated in FIG. 9, where the average pressure produced by 80 pulses of known IVL devices (2.5 mm and 4.0 mm) at a constant voltage magnitude is compared to the average pressure produced by test IVL devices (2.5 mm and 4.0 mm) according to the voltage pulse and control method of FIG. 3.

[0106] As shown in Figure 9, both the known 2.5 mm and 4.0 mm devices produce pressure output slopes that drop significantly as the voltage pulses progress through 80 pulses. In contrast, the test 2.5 mm and 4.0 mm devices produce relatively flat, constant, or stable pressure output slopes as the voltage pulses progress through 300 pulses. Furthermore, the slope of the test pressure output slope appears to increase slightly as the voltage pulses progress, which may be beneficial for fracturing difficult calcified areas. Again, the known IVL device has a noticeable and significant pressure output decay over 80 pulses. The test IVL device has no pressure decay over 300 voltage pulses.

[0107] In summary, an IVL device operated and controlled according to the present disclosure provides voltage pulses with increasing voltage until an upper voltage magnitude threshold is reached. The voltage then progresses at the upper voltage magnitude threshold until 300 pulses have been performed or until the physician determines that treatment is complete. This leads to a constant and / or slightly increasing pressure output from each voltage pulse, as shown above. The magnitude of the pressure output and associated slope may be manipulated by varying the magnitude of each incremental increase in voltage. In some embodiments, the voltage magnitude may be increased incrementally, as in FIG. 3 . In other embodiments, the voltage magnitude may be increased incrementally for at least two consecutive voltage pulses and then held constant for one or more voltage pulses, after which the subsequent series of voltage pulses resumes the incremental increase in magnitude. In other embodiments, the voltage magnitude may be decreased for one or more series of voltage pulses. All combinations of increasing voltage, decreasing voltage, and / or no change in voltage over multiple series of voltage pulses to manipulate the resulting pressure output are within the scope of the present invention.

[0108] Additionally, with reference to the above disclosure, various embodiments of the present disclosure can provide substantially the same pressure output for all balloon sizes, which may be in the range of 2 mm to 4 mm outer diameter. In these embodiments, larger balloon sizes do not necessarily provide lower pressure output than relatively smaller balloon sizes.

[0109] The data in Figures 8 and 9, in conjunction with the pressure magnitude output control 200 of Figure 6, also demonstrate that an IVL device operated in accordance with the present disclosure is capable of stable operation and pressure output for at least 300 voltage pulses, in contrast to the significant pressure decay of known IVL devices after only 80 voltage pulses.

[0110] 8 and 9, in conjunction with the pressure magnitude output control 200 of FIG. 6, confirm that the IVL control system 22 shown in FIG. 1 is controllable such that the pressure output following an electrical arcing event between two spaced apart electrodes can be controlled within upper and lower pressure magnitude thresholds or pressure magnitude windows. Furthermore, using embodiments of the present disclosure, the pressure output can be controlled in a pattern of increasing pressure throughout treatment, decreasing pressure throughout treatment, constant pressure throughout treatment, and any combination thereof.

[0111] Examples of suitable processors may include, among others, one or more microprocessors, integrated circuits, and systems-on-chips (SoCs). Examples of suitable memory may include, among others, one or more primary and / or non-primary (e.g., secondary, tertiary, etc.) storage; permanent, semi-permanent, and / or temporary storage; and / or memory storage devices, including, but not limited to, hard drives (e.g., magnetic, solid-state), optical disks (e.g., CD-ROM, DVD-ROM), RAM (e.g., DRAM, SRAM, DRDRAM), ROM (e.g., PROM, EPROM, EEPROM, Flash EEPROM), volatile and / or non-volatile memory. Communications circuitry 58 includes components for facilitating processor operation; for example, suitable components may include transmitters, receivers, modulators, demodulators, filters, modems, analog-to-digital (AD or DA) converters, diodes, switches, operational amplifiers, and / or integrated circuits. In some embodiments, memory 26 may represent one or more memory devices operable for IVL therapy operations. For example, each memory (eg, 154, 178) may be included as part of, shared with, or separate from memory 26.

[0112] In this disclosure, discussion of sets of discharge electrodes has been in the context of pairs of electrodes, one of which may function as a cathode and the other as an anode in certain cases. However, the number of electrodes in a set may be more than one pair, and may include, for example, one or more cathodes in communication with one or more anodes. In addition, the devices, systems, and methods of this disclosure may include groups of two or more communicating electrodes, which may be electrically arranged in series, in parallel, or independently of each other.

[0113] FIG. 10 provides an exemplary flowchart illustrating an exemplary method 400 of one embodiment of the present invention. Thus, step 402 provides for determining the outer diameter, or OD, of the balloon of a subject IVL device. This may be done by manual input into the IVL control system described above. Alternatively, automatic detection and determination of the balloon's OD may be performed by connecting the catheter to the IVL control system. Step 404 provides for establishing an allowable voltage pulse window, which has predetermined lower and upper voltage magnitude thresholds, which may be stored in the IVL control system, as described above. Step 406 provides for executing a series of voltage pulses controlled and generated by the IVL control system at the predetermined lower voltage magnitude threshold; in the illustrative example, 10 pulses may be used. Step 408 provides for the IVL control system to direct the execution and generation of another series of voltage pulses if the IVL control system determines that the last executed series of voltage pulses did not perform at the predetermined upper voltage threshold target. In step 410, if the IVL control system determines that the last executed series of voltage pulses was executed at the predetermined upper voltage threshold target, the IVL control system attempts to determine whether an illustrative example of 300 voltage pulses has been executed during the current treatment. If step 412 determines that 300 voltage pulses have been executed, the IVL control system aborts treatment and does not allow further voltage pulse generation. On the other hand, if 300 voltage pulses have not been executed, the IVL control system directs the execution of another series of voltage pulses at the predetermined upper voltage threshold target magnitude.

[0114] In certain embodiments, the devices, systems, and methods described herein may include 1 pulse / second, 2 pulses / second, or 3 pulses / second. In some embodiments, the pulses / second produced by the described embodiments may be in the range of 1-5 pulses / second.

[0115] Exemplary Embodiments

[0116] The following non-limiting exemplary embodiments are supported by this disclosure:

[0117] Exemplary embodiment set 1:

[0118] 1. An intravascular lithotripsy system comprising: at least one set of electrodes disposed within an inflatable balloon for placement within a body lumen; 1. An electrical pulse generating system for providing electrical energy to at least one set of electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system comprising: an IVL control system, the IVL control system comprising: a processor for executing instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor; generating an initial series of voltage pulses to at least one set of electrodes; generating a voltage pulse having a target voltage magnitude set to a predetermined lower voltage magnitude threshold; determining whether a threshold parameter is achieved; In response to determining that the threshold parameter is not achieved, increasing the magnitude of the voltage by a predetermined amount; generating another series of voltage pulses at increased voltage magnitudes for application to at least one set of electrodes; The device is configured to:

[0119] 2. The intravascular disruption system of embodiment 1, wherein the IVL control system is configured to continue to determine whether a threshold parameter is achieved after each generated series of voltage pulses.

[0120] 3. The intravascular disruption system of embodiment 2, wherein the threshold parameter comprises a predetermined upper voltage magnitude threshold.

[0121] 4. The intravascular disruption system of embodiment 3, wherein the IVL control system is configured to determine whether the number of voltage pulses generated exceeds a predetermined maximum number of voltage pulses.

[0122] 5. The intravascular disruption system of embodiment 3, wherein the predetermined maximum number of voltage pulses is in the range of 10 to 300 voltage pulses.

[0123] 6. The intravascular disruption system of embodiment 4, wherein the IVL control system is configured to determine that a predetermined number of voltage pulses have not been generated, and if the predetermined number of voltage pulses have not been generated, the IVL control system is further configured to perform another series of voltage pulses at a predetermined upper voltage magnitude threshold.

[0124] 7. The intravascular disruption system of embodiment 4, wherein when the IVL control system determines that a predetermined number of voltage pulses have been generated, no further voltage pulses are performed.

[0125] 8. The intravascular disruption system of any one of embodiments 1-7, wherein the IVL control system is configured to define an allowable voltage magnitude window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold.

[0126] 9. The allowable voltage window varies for different outer diameter balloons in the intravascular disruption system.

[0127] 10. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is about 2500 V for a balloon having an outer diameter of 2.5 mm.

[0128] 11. The endovascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 2500 V for a balloon having an outer diameter of 3.0 mm.

[0129] 12. The endovascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 2500 V for a balloon having an outer diameter of 3.5 mm.

[0130] 13. The endovascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 2500 V for a balloon having an outer diameter of 4.0 mm.

[0131] 14. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is about 3000 V for a balloon having an outer diameter of 2.5 mm.

[0132] 15. The endovascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 3000 V for a balloon having an outer diameter of 3.0 mm.

[0133] 16. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 3000 V for a balloon having an outer diameter of 3.5 mm.

[0134] 17. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 3000 V for a balloon having an outer diameter of 4.0 mm.

[0135] 18. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is less than about 3000 V for a balloon having an outer diameter of 2.0 mm.

[0136] 19. The intravascular disruption system of embodiment 9, wherein the predetermined upper voltage magnitude threshold is less than about 3000 V for a balloon having an outer diameter of 2.5 mm.

[0137] 20. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is less than about 3000 V for a balloon having an outer diameter of 3.0 mm.

[0138] 21. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is less than about 3000 V for a balloon having an outer diameter of 3.5 mm.

[0139] 22. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is less than about 3000 V for a balloon having an outer diameter of 4.0 mm.

[0140] 23. The intravascular disruption system of embodiment 9, wherein the predetermined upper voltage magnitude threshold is greater than about 3000 V for a balloon having an outer diameter of 2.5 mm.

[0141] 24. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is greater than about 3000 V for a balloon having an outer diameter of 3.0 mm.

[0142] 25. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is greater than about 3000 V for a balloon having an outer diameter of 3.5 mm.

[0143] 26. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is greater than about 3000 V for a balloon having an outer diameter of 4.0 mm.

[0144] 27. The endovascular disruption system of any one of embodiments 9-26, wherein the predetermined upper voltage magnitude threshold is greater than about 3250 V for a balloon having an outer diameter of 2.5 mm.

[0145] 28. The endovascular disruption system of any one of embodiments 9-26, wherein the predetermined upper voltage magnitude threshold is greater than about 3250 V for a balloon having an outer diameter of 3.0 mm.

[0146] 29. The endovascular disruption system of any one of embodiments 9-26, wherein the predetermined upper voltage magnitude threshold is greater than about 3250 V for a balloon having an outer diameter of 3.5 mm.

[0147] 30. The endovascular disruption system of any one of embodiments 9-26, wherein the predetermined upper voltage magnitude threshold is greater than about 3250 V for a balloon having an outer diameter of 4.0 mm.

[0148] 31. An intravascular disruption system according to any one of embodiments 1 to 30, wherein the IVL control system is configured to determine whether the target voltage for a previously executed series of voltage pulses is not a predetermined upper voltage magnitude target, and if it is determined that the target voltage is not the predetermined upper voltage magnitude target, to increase the magnitude of the target voltage by a predetermined amount.

[0149] 32. The intravascular disruption system of embodiment 31, wherein the predetermined amount of increase in voltage magnitude is in the range of 1 to 250 V.

[0150] 33. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by 25 V if the target voltage for the previously executed series of voltage pulses is not the predetermined upper voltage magnitude target.

[0151] 34. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by more than 25 V if the target voltage for the previously executed series of voltage pulses is not a predetermined upper voltage magnitude target.

[0152] 35. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by less than 25 V if the target voltage for a previously executed voltage pulse is not at a predetermined upper voltage magnitude target.

[0153] 36. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by 25 V if the target voltage for a previously executed voltage pulse is not the predetermined upper voltage magnitude target.

[0154] 37. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by more than 25 V if the target voltage for a previously executed voltage pulse is not at a predetermined upper voltage magnitude target.

[0155] 38. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by less than 25 V if the target voltage for a previously executed voltage pulse is not at a predetermined upper voltage magnitude target.

[0156] 39. An intravascular disruption system according to any of embodiments 1 to 38, wherein the pressure output over a predetermined maximum number of voltage pulses does not decay or decrease by more than 0.25 MPa on average.

[0157] 40. The intravascular disruption system of any of embodiments 1-38, wherein the pressure output over the range of 10-300 voltage pulses does not decay or decrease by more than 0.25 MPa on average.

[0158] 41. The intravascular disruption system of any of embodiments 1-38, wherein the pressure output of the last voltage pulse of the predetermined maximum number of voltage pulses is greater than the pressure output of the first voltage pulse.

[0159] 42. The intravascular disruption system of any of embodiments 1-41, wherein the slope of the pressure output of the voltage pulse increases with time.

[0160] 43. The intravascular disruption system of any of embodiments 1-40, wherein the slope of the pressure output of the voltage pulse decreases over time.

[0161] 44. The intravascular disruption system of any of embodiments 1-40, wherein the slope of the pressure output of the voltage pulse exhibits a constant pressure magnitude output over the voltage pulse.

[0162] 45. The intravascular disruption system of any of embodiments 1-44, wherein multiple trains of voltage pulses are generated.

[0163] 46. ​​The intravascular disruption system of any of embodiments 1-45, wherein one or more of the series of voltage pulses comprises 10 voltage pulses.

[0164] 47. The intravascular disruption system of any of embodiments 1-45, wherein one or more of the series of voltage pulses comprises more than 10 voltage pulses.

[0165] 48. The intravascular disruption system of any of embodiments 1-45, wherein one or more of the series of voltage pulses comprises less than 10 voltage pulses.

[0166] 49. A method for generating and controlling voltage pulses, comprising: Providing an apparatus according to any one of embodiments 1 to 48; determining the outer diameter of a balloon of the device; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing a series of associated voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals a predetermined upper voltage magnitude threshold; determining that a predetermined number of voltage pulses have not been performed; continuing to perform one or more sequences of voltage pulses at the upper voltage magnitude threshold until it is determined that a predetermined number of voltage pulses have been performed; and Stopping the execution of the voltage pulse Includes.

[0167] 50. A method for generating and controlling voltage pulses, comprising: Providing an apparatus according to any one of embodiments 1 to 48; determining the outer diameter of a balloon of the device; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; determining that a predetermined number of voltage pulses have been performed; Stopping the execution of the voltage pulse Includes.

[0168] 51. A method of generating and controlling voltage pulses that produces a stable and substantially constant pressure output, comprising: Providing an apparatus according to any one of embodiments 1 to 48; determining the outer diameter of a balloon of the device; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; generating a pressure output having a stable and substantially constant magnitude for each voltage pulse; Includes.

[0169] 52. The method of embodiment 51, wherein the pressure output is generated over 10 to at least 300 voltage pulses.

[0170] 53. A method of generating and controlling voltage pulses that produces an increasing pressure output from the first voltage pulse to the last voltage pulse, comprising: Providing an apparatus according to any one of embodiments 1 to 48; determining the outer diameter of a balloon of the device; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; generating a pressure output with each voltage pulse having an increasing magnitude from the first voltage pulse to the last voltage pulse; Includes.

[0171] 54. The method of embodiment 53, wherein the pressure output is generated over 10 to at least 300 voltage pulses.

[0172] 55. The method of any one of embodiments 49-54, wherein the voltage pulses are generated at a frequency in the range of 1 to 5 pulses per second.

[0173] 56. The method of embodiment 55, wherein the voltage pulse frequency comprises 2 pulses per second.

[0174] 57. The method of embodiment 55, wherein the voltage pulse frequency comprises 3 pulses per second.

[0175] 58. The method of any one of embodiments 49-57, wherein the pressure output of a first balloon having an outer diameter is not less than the pressure output of a second balloon having an outer diameter smaller than the outer diameter of the first balloon.

[0176] Exemplary embodiment set 2:

[0177] 1. An intravascular disruption system having a controlled pressure output that is stable and constant over a series of voltage pulses, comprising: at least one pair of spaced apart electrodes for placement within a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid therein; An electrical pulse generation system for providing electrical energy to at least one set of spaced electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system, the IVL control system comprising: a processor configured to execute instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor; The IVL control system is generating an initial plurality of voltage pulses, including an initial series of voltage pulses, across at least one pair of spaced apart electrodes, wherein the magnitude of each voltage pulse in the initial series has a target voltage that is initially set to a predetermined lower voltage magnitude threshold, and wherein two or more of the generated plurality of voltage pulses generate pressure waves; generating one or more subsequent series of voltage pulses, each subsequent series including a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount; configured to: each pressure wave of the plurality of generated pressure waves having a pressure magnitude output; The IVL control system is configured to control the pressure magnitude output for multiple pressure waves such that the pressure magnitude output does not decay or decrease, on average, over the multiple pressure waves by more than a predetermined amount.

[0178] 2. An intravascular disruption system having a controlled pressure output that is stable and constant over a series of voltage pulses, at least one pair of spaced apart electrodes for placement within a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid therein; An electrical pulse generating system for providing electrical energy to at least one set of electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system including an IVL control system, the IVL control system comprising: a processor configured to execute instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor; The IVL control system is generating an initial plurality of voltage pulses, including an initial series of voltage pulses, across at least one pair of spaced apart electrodes, wherein the magnitude of each voltage pulse in the initial series has a target voltage that is initially set to a predetermined lower voltage magnitude threshold, and wherein two or more of the generated plurality of voltage pulses generate pressure waves; generating one or more subsequent series of voltage pulses, each subsequent series including a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount; configured to: each pressure wave of the plurality of generated pressure waves having a pressure magnitude output; The IVL control system is configured to control the target voltage so that the pressure magnitude output does not decay or decrease by more than a predetermined amount on average over multiple pressure waves.

[0179] 3. A method of generating and controlling voltage pulses in an intravascular disruption system that produces a controlled pressure output that is stable and substantially constant over a series of voltage pulses, comprising: providing an intravascular fragmentation system according to embodiment 2; determining an outer diameter of a balloon of an endovascular disruption system; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; generating a plurality of pressure waves, each pressure wave having a pressure output having a pressure magnitude that is controlled so that it does not decay or decrease, on average, over the plurality of pressure waves by more than a predetermined amount; Includes.

[0180] 4. An intravascular disruption system having a controlled magnitude of pressure output over a series of voltage pulses, comprising: at least one pair of spaced apart electrodes for placement within a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid therein; An electrical pulse generation system for providing electrical energy to at least one set of spaced electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system, the IVL control system comprising: a processor configured to execute instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor; The IVL control system is generating an initial plurality of voltage pulses, including an initial series of voltage pulses, across at least one pair of spaced apart electrodes, wherein the magnitude of each voltage pulse in the initial series has a target voltage that is initially set to a predetermined lower voltage magnitude threshold, and wherein two or more of the generated plurality of voltage pulses generate pressure waves; generating one or more subsequent series of voltage pulses, each subsequent series including a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount; configured to: each pressure wave of the plurality of generated pressure waves having a pressure magnitude output; The IVL control system is configured to control the pressure magnitude output within predetermined upper and lower threshold magnitudes over multiple pressure waves.

[0181] 5. An intravascular disruption system having a controlled magnitude of pressure output over a series of voltage pulses, comprising: at least one pair of spaced apart electrodes for placement within a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid therein; An electrical pulse generation system for providing electrical energy to at least one set of spaced electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system, the IVL control system comprising: a processor configured to execute instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor; The IVL control system is generating an initial plurality of voltage pulses, including an initial series of voltage pulses, across at least one pair of spaced apart electrodes, wherein the magnitude of each voltage pulse in the initial series has a target voltage that is initially set to a predetermined lower voltage magnitude threshold, and wherein two or more of the generated plurality of voltage pulses generate pressure waves; generating one or more subsequent series of voltage pulses, each subsequent series including a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount; configured to: each pressure wave of the plurality of generated pressure waves having a pressure magnitude output; The IVL control system is configured to control the target voltage within predetermined upper and lower thresholds, and further configured to control the resulting pressure wave output within predetermined upper and lower threshold magnitudes across multiple pressure waves.

[0182] 6. A method of controlling the magnitude of pressure output over a series of voltage pulses generated by an intravascular disruption system, comprising: Providing an intravascular disruption system according to embodiment 5, wherein the fluid-filled member comprises a balloon; determining an outer diameter of a balloon of an endovascular disruption system; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; generating a plurality of pressure waves, each pressure wave having a pressure output with a pressure magnitude that is controlled to not decay or decrease so that the pressure output across the plurality of pressure waves remains above a predetermined pressure magnitude; Includes.

[0183] 7. An intravascular disruption system having a controlled pressure output over multiple voltage pulses, comprising: at least one pair of spaced apart electrodes for placement within a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid therein; An electrical pulse generation system for providing electrical energy to at least one set of spaced electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system, the IVL control system comprising: a processor configured to execute instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor; The IVL control system is generating an initial plurality of voltage pulses across at least one set of electrodes, the magnitude of each voltage pulse in the initial series having a target voltage initially set to a predetermined lower voltage magnitude threshold, and two or more of the generated plurality of voltage pulses generating pressure waves; determining that a predetermined maximum number of voltage pulses has not been performed; if it is determined that a predetermined maximum number of voltage pulses has not been performed, sequentially increasing the target voltage by predetermined amounts and performing an associated series of voltage pulses until the target voltage is determined to meet a predetermined upper voltage threshold and / or a predetermined maximum number of voltage pulses has been performed, each pressure wave of the plurality of generated pressure waves comprising an output of a pressure magnitude; the IVL control system controls the pressure magnitude output within predetermined upper and lower pressure magnitude threshold magnitudes over multiple pressure waves; The execution of the voltage pulses is configured to terminate when it is determined that a predetermined maximum number of voltage pulses has been executed.

[0184] 8. A method of generating and controlling voltage pulses in an intravascular disruption system that produces a controlled pressure output that is stable and substantially constant over a series of voltage pulses, comprising: Providing an intravascular disruption system according to embodiment 1, wherein the fluid-filled member comprises a balloon; determining an outer diameter of a balloon of an endovascular disruption system; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; generating a plurality of pressure waves, each pressure wave comprising a pressure output having a pressure magnitude controlled within upper and lower pressure magnitude threshold magnitudes across the plurality of pressure waves; determining that a predetermined maximum number of voltage pulses has been performed; Terminating the execution of the voltage pulse Includes.

[0185] 9. An intravascular disruption system with a controlled increasing pressure output, comprising: at least one pair of spaced apart electrodes for placement within a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid therein; An electrical pulse generation system for providing electrical energy to at least one set of spaced electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system, the IVL control system comprising: a processor configured to execute instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor; The IVL control system is configured to generate an initial plurality of voltage pulses, including an initial series of voltage pulses, to at least one set of spaced apart electrodes; the magnitude of each voltage pulse in the initial series of voltage pulses has a target voltage that is initially set to a predetermined lower voltage magnitude threshold; Two or more of the generated voltage pulses generate pressure waves; generating one or more subsequent trains of voltage pulses, each subsequent train including a plurality of voltage pulses; the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount; each pressure wave of the plurality of generated pressure waves having a pressure magnitude output; The IVL control system is configured to control the pressure magnitude output for multiple pressure waves such that the pressure magnitude output increases over multiple pressure waves.

[0186] 10. An intravascular disruption system with a controlled increasing pressure output over a series of voltage pulses, comprising: at least one set of electrodes for placement within a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid therein; An electrical pulse generating system for providing electrical energy to at least one set of spaced electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system including an IVL control system, the IVL control system comprising: a processor for executing instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor. The IVL control system is generating an initial plurality of voltage pulses, including an initial series of voltage pulses, across at least one pair of spaced apart electrodes, wherein the magnitude of each voltage pulse in the initial series has a target voltage that is initially set to a predetermined lower voltage magnitude threshold, and wherein two or more of the generated plurality of voltage pulses generate pressure waves; generating one or more subsequent series of voltage pulses, each subsequent series including a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount; configured to: each pressure wave of the plurality of generated pressure waves having a pressure magnitude output; The IVL control system is configured to control the target voltage such that the pressure magnitude output is controlled to increase within a predetermined pressure magnitude window over multiple pressure waves.

[0187] 11. A method of generating and controlling voltage pulses that produce a controlled, increasing pressure output in an intravascular disruption system, comprising: Providing an intravascular disruption system according to embodiment 2, wherein the fluid-filled member comprises a balloon; determining an outer diameter of a balloon of an endovascular disruption system; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of two or more voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; generating a plurality of pressure waves, each pressure wave having a pressure output with a controlled increasing pressure magnitude over the plurality of pressure waves; Includes.

[0188] 12. An intravascular disruption system that generates a controlled, decreasing pressure output, comprising: at least one pair of spaced apart electrodes for placement within a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid therein; An electrical pulse generation system for providing electrical energy to at least one set of spaced electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system, the IVL control system comprising: a processor configured to execute instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor; The IVL control system is generating an initial plurality of voltage pulses, including an initial series of voltage pulses, across at least one pair of spaced apart electrodes, wherein the magnitude of each voltage pulse in the initial series has a target voltage that is initially set to a predetermined lower voltage magnitude threshold, and wherein two or more of the generated plurality of voltage pulses generate pressure waves; generating one or more subsequent series of voltage pulses, each subsequent series including a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount; configured to: each pressure wave of the plurality of generated pressure waves having a pressure magnitude output; The IVL control system is configured to control the pressure magnitude output for multiple pressure waves such that the pressure magnitude output decays or decreases within a predetermined pressure magnitude window across multiple pressure waves.

[0189] 13. An intravascular disruption system that generates a controlled, decreasing pressure output over a series of voltage pulses, comprising: at least one pair of spaced apart electrodes for placement within a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid therein; An electrical pulse generating system for providing electrical energy to at least one set of spaced electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system including an IVL control system, the IVL control system comprising: a processor for executing instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor. The IVL control system is generating an initial plurality of voltage pulses, including an initial series of voltage pulses, for at least one set of electrodes, wherein the magnitude of each voltage pulse in the initial series has a target voltage that is initially set to a predetermined lower voltage magnitude threshold, and wherein two or more of the generated plurality of voltage pulses generate pressure waves; generating one or more subsequent series of voltage pulses, each subsequent series including a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount; configured to: each pressure wave of the plurality of generated pressure waves having a pressure magnitude output; The IVL control system is configured to control the target voltage so that the pressure magnitude output decreases within a predetermined pressure magnitude window over multiple pressure waves.

[0190] 14. A method of generating and controlling voltage pulses that produce a controlled, decreasing pressure output in an intravascular disruption system, comprising: Providing an intravascular disruption system according to embodiment 2, wherein the fluid-filled member comprises a balloon; determining an outer diameter of a balloon of an endovascular disruption system; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of two or more voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; generating a plurality of pressure waves, each pressure wave comprising a pressure output having a pressure magnitude controlled to decrease within a predetermined pressure magnitude window over the plurality of pressure waves; Includes.

[0191] Exemplary embodiment set 3:

[0192] 1. An IVL system comprising: at least one pair of spaced apart electrodes for placement within a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid therein; An electrical pulse generating system for providing electrical energy to at least one set of spaced electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system including an IVL control system, the IVL control system comprising: a processor for executing instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor. The IVL control system is configured to generate an initial plurality of voltage pulses, including at least an initial series of voltage pulses, for at least one set of electrodes, the magnitude of each voltage pulse in the initial series having a target voltage initially set to a predetermined lower voltage magnitude threshold, and two or more of the generated plurality of voltage pulses generating pressure waves; The IVL control system is configured to control the pressure magnitude output over multiple pressure waves.

[0193] 2. The IVL system of embodiment 1, wherein the IVL control system is configured to control the pressure magnitude output so that it does not decay or decrease by more than a predetermined amount over multiple pressure waves.

[0194] 3. The IVL system of embodiment 2, wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds.

[0195] 4. The IVL system of embodiment 1, wherein the IVL control system is configured to control the pressure magnitude output to remain above a predetermined lower threshold over multiple pressure waves.

[0196] 5. The IVL system of embodiment 4, wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds.

[0197] 6. The IVL system of embodiment 1, wherein the IVL control system is configured to control the pressure magnitude output to remain within predetermined upper and lower thresholds across multiple pressure waves.

[0198] 7. The IVL system of embodiment 6, wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds.

[0199] 8. The IVL system of embodiment 1, wherein the IVL control system is configured to control the pressure magnitude output to remain a substantially constant magnitude across multiple pressure waves.

[0200] 9. The IVL system of embodiment 8, wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds.

[0201] 10. The IVL system of embodiment 1, wherein the IVL control system is configured to control the pressure magnitude output so that it does not increase by more than a predetermined amount over multiple pressure waves.

[0202] 11. The IVL system of embodiment 10, wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds.

[0203] 12. The IVL system of embodiment 1, wherein the IVL control system is further configured to terminate the execution of the voltage pulses when it is determined that a predetermined maximum number of voltage pulses has been executed.

[0204] Exemplary embodiment set 4:

[0205] 1. An intravascular disruption system comprising: at least one set of electrodes for placement within a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid therein; An electrical pulse generating system for providing electrical energy to at least one set of electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system including an IVL control system, the IVL control system comprising: a processor for executing instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor; The IVL control system is generating an initial series of voltage pulses to at least one set of electrodes, the magnitude of each voltage pulse in the initial series having a target voltage set to a predetermined lower voltage magnitude threshold; determining whether a threshold parameter is achieved; In response to determining that the threshold parameter is not achieved, increasing the magnitude of the voltage by a predetermined amount; generating another series of voltage pulses at increased voltage magnitudes for application to at least one set of electrodes; The device is configured to:

[0206] 2. The intravascular disruption system of embodiment 1, wherein the IVL control system is configured to continue to determine whether a threshold parameter is achieved after each generated series of voltage pulses.

[0207] 3. The intravascular disruption system of embodiment 2, wherein the threshold parameter comprises a predetermined upper voltage magnitude threshold.

[0208] 4. The intravascular disruption system of embodiment 3, wherein the IVL control system is configured to determine whether the number of voltage pulses generated exceeds a predetermined maximum number of voltage pulses.

[0209] 5. The intravascular disruption system of embodiment 3, wherein the predetermined maximum number of voltage pulses is in the range of 10 to 300 voltage pulses.

[0210] 6. The intravascular disruption system of embodiment 4, wherein the IVL control system is configured to determine that a predetermined number of voltage pulses have not been generated, and if the predetermined number of voltage pulses have not been generated, the IVL control system is further configured to perform another series of voltage pulses at a predetermined upper voltage magnitude threshold.

[0211] 7. The intravascular disruption system of embodiment 4, wherein when the IVL control system determines that a predetermined number of voltage pulses have been generated, no further voltage pulses are performed.

[0212] 8. The intravascular disruption system of any one of embodiments 1-7, wherein the IVL control system is configured to define an allowable voltage magnitude window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold.

[0213] 9. The endovascular disruption system of embodiment 8, wherein the allowable voltage magnitude window is different for balloons of different outer diameters.

[0214] 10. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is about 2500 V for a balloon having an outer diameter of 2.5 mm.

[0215] 11. The endovascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 2500 V for a balloon having an outer diameter of 3.0 mm.

[0216] 12. The endovascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 2500 V for a balloon having an outer diameter of 3.5 mm.

[0217] 13. The endovascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 2500 V for a balloon having an outer diameter of 4.0 mm.

[0218] 14. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is about 3000 V for a balloon having an outer diameter of 2.5 mm.

[0219] 15. The endovascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 3000 V for a balloon having an outer diameter of 3.0 mm.

[0220] 16. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 3000 V for a balloon having an outer diameter of 3.5 mm.

[0221] 17. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold comprises about 3000 V for a balloon having an outer diameter of 4.0 mm.

[0222] 18. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is less than about 3000 V for a balloon having an outer diameter of 2.0 mm.

[0223] 19. The intravascular disruption system of embodiment 9, wherein the predetermined upper voltage magnitude threshold is less than about 3000 V for a balloon having an outer diameter of 2.5 mm.

[0224] 20. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is less than about 3000 V for a balloon having an outer diameter of 3.0 mm.

[0225] 21. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is less than about 3000 V for a balloon having an outer diameter of 3.5 mm.

[0226] 22. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is less than about 3000 V for a balloon having an outer diameter of 4.0 mm.

[0227] 23. The intravascular disruption system of embodiment 9, wherein the predetermined upper voltage magnitude threshold is greater than about 3000 V for a balloon having an outer diameter of 2.5 mm.

[0228] 24. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is greater than about 3000 V for a balloon having an outer diameter of 3.0 mm.

[0229] 25. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is greater than about 3000 V for a balloon having an outer diameter of 3.5 mm.

[0230] 26. The intravascular disruption system of embodiment 9, wherein the predetermined lower voltage magnitude threshold is greater than about 3000 V for a balloon having an outer diameter of 4.0 mm.

[0231] 27. The endovascular disruption system of any one of embodiments 9-26, wherein the predetermined upper voltage magnitude threshold is greater than about 3250 V for a balloon having an outer diameter of 2.5 mm.

[0232] 28. The endovascular disruption system of any one of embodiments 9-26, wherein the predetermined upper voltage magnitude threshold is greater than about 3250 V for a balloon having an outer diameter of 3.0 mm.

[0233] 29. The endovascular disruption system of any one of embodiments 9-26, wherein the predetermined upper voltage magnitude threshold is greater than about 3250 V for a balloon having an outer diameter of 3.5 mm.

[0234] 30. The endovascular disruption system of any one of embodiments 9-26, wherein the predetermined upper voltage magnitude threshold is greater than about 3250 V for a balloon having an outer diameter of 4.0 mm.

[0235] 31. An intravascular disruption system according to any one of embodiments 1 to 30, wherein the IVL control system is configured to determine whether the target voltage for a previously executed series of voltage pulses is not a predetermined upper voltage magnitude target, and if it is determined that the target voltage is not the predetermined upper voltage magnitude target, to increase the magnitude of the target voltage by a predetermined amount.

[0236] 32. The intravascular disruption system of embodiment 31, wherein the predetermined amount of increase in voltage magnitude is in the range of 1 to 250 V.

[0237] 33. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by 25 V if the target voltage for the previously executed series of voltage pulses is not the predetermined upper voltage magnitude target.

[0238] 34. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by more than 25 V if the target voltage for the previously executed series of voltage pulses is not the predetermined upper voltage magnitude target.

[0239] 35. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by less than 25 V if the target voltage for a previously executed voltage pulse is not at a predetermined upper voltage magnitude target.

[0240] 36. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by 25 V if the target voltage for a previously executed voltage pulse is not the predetermined upper voltage magnitude target.

[0241] 37. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by more than 25 V if the target voltage for a previously executed voltage pulse is not at a predetermined upper voltage magnitude target.

[0242] 38. The intravascular disruption system of any one of embodiments 1-32, wherein the magnitude of the target voltage is increased by less than 25 V if the target voltage for a previously executed voltage pulse is not at a predetermined upper voltage magnitude target.

[0243] 39. An intravascular disruption system according to any of embodiments 1 to 38, wherein the pressure output over a predetermined maximum number of voltage pulses does not decay or decrease by more than 0.25 MPa on average.

[0244] 40. The intravascular disruption system of any of embodiments 1-38, wherein the pressure output over the range of 10-300 voltage pulses does not decay or decrease by more than 0.25 MPa on average.

[0245] 41. The intravascular disruption system of any of embodiments 1-38, wherein the pressure output of the last voltage pulse of the predetermined maximum number of voltage pulses is greater than the pressure output of the first voltage pulse.

[0246] 42. The intravascular disruption system of any of embodiments 1-41, wherein the slope of the pressure output of the voltage pulse increases with time.

[0247] 43. The intravascular disruption system of any of embodiments 1-40, wherein the slope of the pressure output of the voltage pulse decreases over time.

[0248] 44. The intravascular disruption system of any of embodiments 1-40, wherein the slope of the pressure output of the voltage pulse exhibits a constant pressure magnitude output over the voltage pulse.

[0249] 45. The intravascular disruption system of any of embodiments 1-44, wherein multiple trains of voltage pulses are generated.

[0250] 46. ​​The intravascular disruption system of any of embodiments 1-45, wherein one or more of the series of voltage pulses comprises 10 voltage pulses.

[0251] 47. The intravascular disruption system of any of embodiments 1-45, wherein one or more of the series of voltage pulses comprises more than 10 voltage pulses.

[0252] 48. The intravascular disruption system of any of embodiments 1-45, wherein one or more of the series of voltage pulses comprises less than 10 voltage pulses.

[0253] 49. A method for generating and controlling voltage pulses, comprising: Providing a device according to any one of embodiments 1 to 48, wherein the fluid-fillable member comprises a balloon; determining the outer diameter of a balloon of the device; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; determining that a predetermined number of voltage pulses have not been performed; continuing to perform one or more sequences of voltage pulses at the upper voltage magnitude threshold until it is determined that a predetermined number of voltage pulses have been performed; and Stopping the execution of the voltage pulse Includes.

[0254] 50. A method for generating and controlling voltage pulses, comprising: Providing a device according to any one of embodiments 1 to 48, wherein the fluid-fillable member comprises a balloon; determining the outer diameter of a balloon of the device; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; determining that a predetermined number of voltage pulses have been performed; Stopping the execution of the voltage pulse Includes.

[0255] 51. A method of generating and controlling voltage pulses that produces a stable and substantially constant pressure output, comprising: Providing a device according to any one of embodiments 1 to 48, wherein the fluid-fillable member comprises a balloon; determining the outer diameter of a balloon of the device; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; generating a pressure output having a stable and substantially constant magnitude for each voltage pulse; Includes.

[0256] 52. The method of embodiment 51, wherein the pressure output is generated over 10 to at least 300 voltage pulses.

[0257] 53. A method of generating and controlling voltage pulses that produces an increasing pressure output from the first voltage pulse to the last voltage pulse, comprising: Providing a device according to any one of embodiments 1 to 48, wherein the fluid-fillable member comprises a balloon; determining the outer diameter of a balloon of the device; establishing an allowable voltage pulse window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold; performing an initial series of voltage pulses at a predetermined lower voltage magnitude threshold; increasing the voltage magnitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage magnitude target; continuing to sequentially increase the voltage magnitude target and performing an associated series of voltage pulses at the sequentially increased voltage magnitude target until the voltage magnitude target equals the predetermined upper voltage magnitude threshold; generating a pressure output with each voltage pulse having an increasing magnitude from the first voltage pulse to the last voltage pulse; Includes.

[0258] 54. The method of embodiment 53, wherein the pressure output is generated over 10 to at least 300 voltage pulses.

[0259] 55. The method of any one of embodiments 49-54, wherein the voltage pulses are generated at a frequency in the range of 1 to 5 pulses per second.

[0260] 56. The method of embodiment 55, wherein the voltage pulse frequency comprises 2 pulses per second.

[0261] 57. The method of embodiment 55, wherein the voltage pulse frequency comprises 3 pulses per second.

[0262] 58. The method of any one of embodiments 49-57, wherein the pressure output of a first balloon having an outer diameter is not less than the pressure output of a second balloon having an outer diameter smaller than the outer diameter of the first balloon.

[0263] Exemplary embodiment set 5:

[0264] 1. An intravascular disruption system comprising: a catheter assembly comprising: an elongate member defining a lumen; and a fluid-fillable member located at a longitudinal region of the elongate member and configured to contain an electrically conductive fluid therein, the catheter assembly being configured to inflate the fluid-fillable member with the electrically conductive fluid to facilitate IVL treatment; at least one pair of spaced apart electrodes disposed within the inflatable balloon for immersion in the IVL fluid medium; Equipped with the IVL control system is configured to apply one or more voltage pulses to at least one spaced apart electrode under an initial control setting, determine whether a threshold parameter including a maximum number of voltage pulses resulting in an electric arc between at least one pair of spaced apart electrodes is achieved under the initial control setting, and increase at least one of the pulse duration and the voltage in response to determining that the threshold parameter is not achieved; The IVL control system is configured to apply increased at least one of pulse duration and voltage to at least one pair of spaced apart electrodes.

[0265] 2. An intravascular disruption system comprising: a catheter assembly comprising: an elongate member defining a lumen; and a fluid-fillable member located at a longitudinal region of the elongate member and configured to contain an electrically conductive fluid therein, the catheter assembly being configured to inflate the fluid-fillable member with the electrically conductive fluid to facilitate IVL treatment; at least one pair of spaced apart electrodes disposed within the inflatable balloon for immersion in the conductive fluid; an IVL control system comprising: a processor for executing instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor to provide IVL therapy to a patient; Equipped with the IVL control system is configured to generate and apply one or more voltage pulses to at least one spaced electrode under an initial control setting, determine whether a threshold parameter including a maximum number of voltage pulses resulting in an electric arc between at least one pair of spaced electrodes is achieved under the initial control setting, and increase at least one of the pulse duration and the voltage in response to determining that the threshold parameter is not achieved; the IVL control system is configured to apply increased at least one of pulse duration and voltage to at least one pair of spaced apart electrodes; the IVL control system continues to reapply an increased at least one of pulse duration and voltage to the at least one spaced apart electrode set after determining that the threshold parameter is not achieved; When a determination is made that the threshold parameter is achieved, generation of the voltage pulses is configured to terminate.

[0266] 3. A method of operating an endovascular lithotripsy (IVL) system, the IVL system comprising: a catheter assembly comprising an elongate member defining a lumen; and a fluid-fillable member configured to contain a conductive fluid and located at a distal region of the elongate member, the catheter assembly being configured to inflate the fluid-fillable member with the conductive fluid to facilitate IVL treatment; an IVL control system comprising: at least one set of spaced-apart electrodes disposed within an inflatable balloon for immersion in an IVL fluid medium; and a processor configured to execute instructions stored in a memory and a communication circuit configured to communicate signals based on operation of the processor to provide IVL treatment to a patient. The method comprises: generating and applying a voltage pulse under initial electrical settings including a voltage magnitude and a duration for applying the generated voltage to at least one pair of spaced apart electrodes; determining whether a predetermined maximum number of electric arcs generated between at least one pair of spaced apart electrodes is achieved under an initial electrical setting; increasing at least one of a pulse duration and a voltage of the electrical setting in response to determining that the threshold parameter is not achieved; terminating the generation of the voltage pulses in response to determining that the threshold parameter is achieved. Includes.

[0267] 4. An intravascular disruption system comprising: at least one pair of spaced apart electrodes disposed within a fluid-fillable member configured to contain a conductive fluid for placement within a body lumen; an electrical pulse generation system that provides a controlled level of electrical energy to at least one pair of spaced electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system that includes a processor configured to execute instructions stored in a memory and a communication circuit configured to communicate signals based on instructions from the processor, the IVL control system including a charge control system for controlling charging of the discharge system; The charge control system is configured to provide controlled variable power to the discharge system at different voltage levels over successive charge cycles.

[0268] 5. An intravascular disruption system comprising: at least one pair of spaced apart electrodes disposed within a fluid-fillable member configured to contain a conductive fluid for placement within a body lumen; An electrical pulse generation system configured to provide a controlled electrical energy level to at least one set of spaced electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system having a processor configured to execute instructions stored in a memory and a communication circuit configured to communicate signals based on instructions from the processor, the IVL control system including a charge control system for controlling charging of a discharge system; Equipped with The discharge system includes an energy storage system, and the charge control system is configured to provide controlled variable voltage power to the discharge system at different voltages over successive charge cycles after releasing energy from the energy storage system.

[0269] 6. An intravascular disruption system comprising: at least one pair of spaced apart electrodes disposed within a fluid-fillable member configured to contain a conductive fluid for placement within a body lumen; and an electrical pulse generation system that provides electrical energy to at least one set of spaced electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system that includes a processor configured to execute instructions stored in a memory and a communication circuit configured to communicate signals based on instructions from the processor, the IVL control system including: assessing a stored energy state of an energy storage system of the IVL system to determine stored energy; comparing the assessed stored energy state with a stored threshold; delivering voltage pulses to at least one pair of spaced apart electrodes of the IVL system; assessing a remaining energy state of an energy storage system of the IVL system to determine a remaining energy; comparing the assessed remaining energy state with a stored threshold; The device is configured to:

[0270] 7. A method of operating an intravascular disruption system, comprising: assessing a stored energy state of an energy storage system of an intravascular lithotripsy (IVL) system to determine stored energy; delivering a voltage pulse to at least one pair of electrodes of the IVL system; assessing a remaining energy state of an energy storage system of the IVL system to determine a remaining energy; comparing at least one of the evaluated energy states with a stored threshold to determine an energy of the voltage pulse; Includes.

[0271] 8. A method of operating an intravascular disruption system including at least one pair of spaced electrodes, comprising: assessing a stored energy state of an energy storage system of an intravascular lithotripsy (IVL) system to determine stored energy; delivering a voltage pulse to at least one of at least one set of spaced apart electrodes of the IVL system; assessing a remaining energy state of an energy storage system of the IVL system to determine a remaining energy; comparing at least one of the evaluated energy states with a stored threshold to determine an energy of the voltage pulse, wherein evaluating the energy states to determine the stored energy includes determining a voltage level of the energy storage system.

[0272] 9. An intravascular disruption system comprising: at least one pair of spaced apart electrodes disposed within a fluid-fillable member configured to contain a conductive fluid for placement within a body lumen; an electrical pulse generation system that provides electrical energy to at least one set of spaced electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system that includes a processor configured to execute instructions stored in a memory and a communication circuit configured to communicate signals based on commands from the processor; The electrical pulse generating system includes a power system including an AC main power supply and a DC storage system; the AC mains power source is configured to be connected to an AC power outlet to receive AC power from the infrastructure, and the DC storage system is configured to receive AC power from the AC mains power source and convert the AC power to DC power to charge a DC storage device of the DC storage system; The electrical pulse generating system is configured to selectively provide power from the AC mains power supply or the DC storage system for IVL operation.

[0273] 10. A method of powering an intravascular disruption system, comprising: Providing an intravascular fragmentation system according to embodiment 1; selecting to provide power from an AC mains supply; Powering the intravascular disruption system Includes.

[0274] 11. An intravascular disruption system comprising: at least one set of electrodes for placement in a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid; and an electrical pulse generation system that provides electrical energy to at least one set of spaced electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system that includes a processor configured to execute instructions stored in a memory and a communication circuit configured to communicate signals based on instructions from the processor, the IVL control system comprising: assessing a stored energy state of an energy storage system of the IVL system to determine stored energy; delivering a voltage pulse to at least one pair of electrodes of the IVL system; assessing a remaining energy state of an energy storage system of the IVL system to determine a remaining energy; Comparing the evaluated energy states to determine the energy of the voltage pulse; The device is configured to:

[0275] 12. A method of operating an intravascular disruption system, comprising: assessing a stored energy state of an energy storage system of an intravascular lithotripsy (IVL) system to determine stored energy; delivering voltage pulses to at least one pair of spaced apart electrodes of the IVL system; assessing a remaining energy state of an energy storage system of the IVL system to determine a remaining energy; Comparing the evaluated energy states to determine the energy of the voltage pulse; Includes.

[0276] 13. A method of operating an intravascular disruption system, comprising: assessing a stored energy state of an energy storage system of an intravascular lithotripsy (IVL) system to determine stored energy; delivering voltage pulses to at least one pair of spaced apart electrodes of the IVL system; assessing a remaining energy state of an energy storage system of the IVL system to determine a remaining energy; and comparing the assessed energy states to determine the energy of the voltage pulse, and assessing the energy states to determine the stored energy includes determining a voltage level of the energy storage system.

[0277] 14. An intravascular disruption system comprising: at least one pair of spaced apart electrodes disposed within a fluid-fillable member configured to contain a conductive fluid for placement within a body lumen; an electrical pulse generation system that provides electrical energy to at least one set of spaced electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generation system including an IVL control system that includes a processor configured to execute instructions stored in a memory and a communication circuit configured to communicate signals based on commands from the processor; The IVL control system includes an adjustable energy storage system configured to selectively adjust the electrical energy applied to at least one set of spaced apart electrodes for IVL treatment.

[0278] 15. A method of operating an intravascular lithotripsy (IVL) system, comprising: applying a voltage pulse to at least one pair of electrodes; determining to adjust the stored energy level of the IVL system; applying another voltage pulse to at least one pair of electrodes using a different energy level than the voltage pulse; Includes.

[0279] Set 6 of exemplary embodiments:

[0280] 1. An intravascular lithotripsy system comprising: at least one set of electrodes for placement in a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid; and an electrical pulse generating system that provides electrical energy to at least one set of electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system including an IVL control system that includes a processor that executes instructions stored in a memory and circuitry configured to communicate signals based on operation of the processor, the IVL control system comprising: applying initial electrical energy to at least one pair of electrodes; determining whether a threshold parameter is achieved; increasing the duration of the pulse of electrical energy applied to the at least one set of electrodes in response to determining that the threshold parameter is not achieved; The device is configured to:

[0281] 2. The system of embodiment 1, wherein the IVL control system is configured to reapply the initial electrical energy to the at least one set of electrodes in response to determining that the threshold parameter is achieved.

[0282] 3. The system of embodiment 2, wherein the threshold parameter is a value of current that achieves sufficient spark for IVL treatment.

[0283] 4. The system of embodiment 3, wherein the current value is about 20 amps.

[0284] 5. The system of embodiment 1, wherein the IVL control system is configured to cycle the application of electrical energy to at least one set of electrodes with increasing duration of pulses of electrical energy.

[0285] 6. The system of embodiment 5, wherein the IVL control system is configured to determine whether a threshold parameter is achieved under repeated application of electrical energy.

[0286] 7. The system of embodiment 6, wherein the IVL control system is configured to reapply electrical energy to at least one set of electrodes with an increased duration of the pulse of electrical energy in response to determining that a threshold parameter is achieved under the repeated application of electrical energy.

[0287] 8. The system of embodiment 5, wherein the threshold parameter remains the same under initial and repeated applications.

[0288] 9. The system of embodiment 5, wherein the IVL control system is configured to determine whether a maximum duration is achieved.

[0289] 10. The system of embodiment 9, wherein in response to determining that the maximum duration is achieved, the IVL control system is configured to increase the voltage of the applied electrical energy.

[0290] 11. The system of embodiment 10, wherein the IVL control system is configured to reapply electrical energy to at least one set of electrodes at an increased voltage.

[0291] 12. The system of embodiment 10, wherein reapplying electrical energy to at least one set of electrodes at an increased voltage includes adjusting a currently selected duration.

[0292] 13. The system of embodiment 12, wherein adjusting the currently selected duration includes decreasing the duration.

[0293] 14. The system of embodiment 13, wherein adjusting the currently selected duration includes resetting the currently selected duration equal to the duration under the initial electrical energy.

[0294] 15. The system of embodiment 10, wherein the IVL control system is configured to determine whether a maximum voltage is achieved, and in response to determining that the maximum voltage is not achieved, reapply electrical energy to the at least one set of electrodes at an increased voltage.

[0295] 16. The system of embodiment 9, wherein the maximum duration remains the same value upon reapplication.

[0296] 17. The system of embodiment 1, wherein applying electrical energy comprises delivering a voltage pulse having a voltage and duration.

[0297] 18. The system of embodiment 17, wherein the initial duration of the initial electrical energy delivered to the at least one electrode is a voltage pulse having a duration in the range of about 0.1 microseconds to about 2 microseconds.

[0298] 19. The system of embodiment 17, wherein the initial voltage of the initial electrical energy delivered to the at least one electrode is a voltage pulse having a voltage in the range of about 500 volts to about 4000 volts.

[0299] 20. A method of operating an intravascular disruption system, comprising: applying initial electrical energy to at least one pair of electrodes of an intravascular lithotripsy (IVL) system, the at least one pair of electrodes being immersed in a conductive fluid contained by a fluid-fillable member; determining whether a threshold parameter is achieved; increasing the duration of the pulse of electrical energy applied to the at least one set of electrodes in response to determining that the threshold parameter is not achieved; Includes.

[0300] 21. The method of embodiment 20, further comprising reapplying the initial electrical energy to the at least one set of electrodes in response to determining that the threshold parameter is achieved.

[0301] 22. The method of embodiment 21, wherein the threshold parameter is a value of current that achieves sufficient spark for IVL treatment.

[0302] 23. The method of embodiment 22, wherein the value of the current is about 20 amperes.

[0303] 24. The method of embodiment 20, further comprising repeating the application of electrical energy to at least one set of electrodes with increasing duration of pulses of electrical energy.

[0304] 25. The method of embodiment 24, further comprising determining whether a threshold parameter is achieved under repeated applications of electrical energy.

[0305] 26. The method of embodiment 25, further comprising, in response to determining that the threshold parameter is achieved under the repeated application of electrical energy, reapplying electrical energy to at least one set of electrodes with an increased duration of the pulse of electrical energy.

[0306] 27. The method of embodiment 25, wherein the threshold parameter remains the same under the initial and repeated applications.

[0307] 28. The method of embodiment 25, further comprising determining whether a maximum duration is achieved.

[0308] 29. The method of embodiment 28, further comprising increasing the voltage of the applied electrical energy in response to determining that the maximum duration is achieved.

[0309] 30. The method of embodiment 29, further comprising reapplying electrical energy to at least one set of electrodes at an increased voltage.

[0310] 31. The method of embodiment 30, wherein reapplying electrical energy to at least one set of electrodes at an increased voltage includes adjusting a currently selected duration.

[0311] 32. The method of embodiment 31, wherein adjusting the currently selected duration includes decreasing the duration.

[0312] 33. The method of embodiment 32, wherein adjusting the currently selected duration includes resetting the currently selected duration equal to the duration under the initial electrical energy.

[0313] 34. The method of embodiment 29, further comprising determining whether a maximum voltage is achieved, and, in response to determining that the maximum voltage is not achieved, reapplying electrical energy to the at least one set of electrodes at an increased voltage.

[0314] 35. The method of embodiment 20, wherein applying electrical energy comprises delivering a voltage pulse having a voltage and duration.

[0315] 36. The system of embodiment 35, wherein the initial duration of the initial electrical energy delivered to the at least one electrode is a voltage pulse having a duration in the range of about 0.1 microseconds to about 2 microseconds.

[0316] 37. The system of embodiment 35, wherein the initial voltage of the initial electrical energy delivered to the at least one electrode is a voltage pulse having a voltage in the range of about 500 volts to about 4000 volts.

[0317] 38. An intravascular fracturing system comprising: a catheter assembly comprising an elongate member defining a lumen and a fluid-fillable member configured to contain an electrically conductive fluid and located at or near a longitudinal end of the elongate member, the catheter assembly being configured to fill the fluid-fillable member with the electrically conductive fluid to facilitate IVL treatment; at least one pair of electrodes disposed within the fluid-fillable member so as to immerse the at least one pair of electrodes in the conductive fluid; an IVL therapy control system comprising: a processor for executing instructions stored in a memory; and circuitry configured to communicate signals based on operation of the processor to provide IVL therapy to a patient, the IVL therapy control system being configured to apply electrical energy having initial settings, determine whether threshold parameters are achieved under the electrical settings, and increase at least one of pulse duration and voltage in response to determining that the threshold parameters are not achieved; Equipped with.

[0318] 39. A method of operating an endovascular lithotripsy (IVL) system, the IVL system having a catheter assembly including an elongate member defining a lumen and a fluid-fillable member configured to contain a conductive fluid and located at or near a longitudinal end of the elongate member, the catheter assembly being configured to inflate the fluid-fillable member with the conductive fluid to facilitate IVL treatment; at least one set of electrodes disposed within an inflatable balloon for immersion in an IVL fluid medium; and an IVL treatment control system including a processor for executing instructions stored in a memory and a communication circuit configured to communicate signals based on operation of the processor to provide IVL treatment to a patient, the method comprising: applying electrical energy having electrical settings including an initial setting; determining whether threshold parameters are achieved under the applied electrical settings; increasing at least one of a pulse duration and a voltage of the electrical setting in response to determining that the threshold parameter is not achieved; Includes.

[0319] 40. An intravascular fracturing system comprising: at least one set of electrodes for placement in a body lumen disposed within a fluid-fillable member configured to contain a conductive fluid; An electrical pulse generating system for providing electrical energy to at least one set of electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system including an IVL control system having a processor for executing instructions stored in a memory and a communication circuit configured to communicate signals based on instructions from the processor, the IVL control system including an adjustable energy storage system for selectively adjusting stored energy applied to provide electrical energy to the at least one set of electrodes for IVL treatment; Equipped with.

[0320] 41. The system of embodiment 40, wherein the electrical pulse generating system includes a relay system for selectively connecting several energy storage elements of the energy storage system to be discharged to provide electrical energy to at least one set of electrodes.

[0321] 42. The system of embodiment 41, wherein in a combined configuration of the relay system, all of several energy storage elements are connected for discharge to provide electrical energy to at least one set of electrodes.

[0322] 43. The system of embodiment 42, wherein in the uncoupled configuration of the relay system, fewer than all of the energy storage elements of the number of energy storage elements are connected for discharge to provide electrical energy to at least one set of electrodes.

[0323] 44. The system of embodiment 43, wherein the electrical energy provided to at least one set of electrodes is greater in one of the above configurations of the relay system than under the other configuration of the relay system.

[0324] 45. The system of embodiment 43, wherein during one pulse of electrical energy to the electrode, the relay system is in either the coupled configuration or the uncoupled configuration, and during another pulse of electrical energy to the electrode, the relay system is in the uncoupled configuration.

[0325] 46. ​​A method of operating an intravascular lithotripsy (IVL) system, comprising: applying an initial voltage pulse to at least one pair of electrodes; determining to adjust the stored energy level of the IVL system; applying another voltage pulse to at least one pair of electrodes using a different magnitude or level of stored energy than the first voltage pulse; Includes.

[0326] 47. The method of embodiment 46, wherein applying the voltage pulse includes operating the adjustable energy storage system at a first stored energy level to apply the electrical energy.

[0327] 48. The method of embodiment 47, wherein applying another voltage pulse includes operating the adjustable energy storage system at a second stored energy level to apply electrical energy.

[0328] 49. The method of embodiment 48, wherein the second stored energy level is greater than the first stored energy level.

[0329] 50. The method of embodiment 48, wherein the second stored energy level is less than the first stored energy level.

[0330] 51. The method of embodiment 48, wherein applying a voltage pulse includes configuring a relay system to connect one or more stored energy elements of the adjustable energy storage system.

[0331] 52. The method of embodiment 51, wherein configuring the relay system to connect one or more stored energy elements of the adjustable energy storage system includes a maximum number of stored energy elements of the adjustable energy storage system.

[0332] 53. The method of embodiment 51, wherein configuring the relay system to connect one or more stored energy elements of the adjustable energy storage system includes fewer stored energy elements than a maximum number of stored energy elements of the adjustable energy storage system.

[0333] 54. The method of embodiment 48, wherein applying another voltage pulse includes configuring a relay system to connect additional stored energy elements of the adjustable energy storage system.

[0334] 55. The method of embodiment 54, wherein configuring the relay system to connect additional stored energy elements of the adjustable energy storage system includes a maximum number of stored energy elements of the adjustable energy storage system.

[0335] 56. The method of embodiment 54, wherein configuring the relay system to connect additional storage energy elements of the adjustable energy storage system includes storage energy elements that are less than the maximum number of storage energy elements of the adjustable energy storage system.

[0336] 57. The method of embodiment 47, wherein applying the voltage pulse includes configuring a relay system to connect some of the stored energy elements of the adjustable energy storage system.

[0337] 58. The method of embodiment 57, wherein configuring the relay system to connect some of the stored energy elements of the adjustable energy storage system includes a maximum number of stored energy elements of the adjustable energy storage system.

[0338] 59. The method of embodiment 58, wherein applying another voltage pulse includes operating the adjustable energy storage system at another stored energy magnitude to apply electrical energy.

[0339] 60. The method of embodiment 57, wherein configuring the relay system to connect some of the stored energy elements of the adjustable energy storage system includes fewer stored energy elements than a maximum number of stored energy elements of the adjustable energy storage system.

[0340] 61. The method of embodiment 60, wherein applying another voltage pulse includes operating the adjustable energy storage system at another stored energy magnitude to apply electrical energy.

[0341] 62. An intravascular fracturing system comprising: at least one pair of spaced apart electrodes disposed within a fluid-fillable member configured to contain a conductive fluid for placement within a body lumen; An electrical pulse generating system for providing electrical energy to at least one set of spaced electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system including an IVL control system having a processor for executing instructions stored in a memory and a communication circuit configured to communicate signals based on instructions from the processor, the IVL control system including a charge control system for controlling charging of a discharge system; Equipped with.

[0342] 63. The system of embodiment 62, wherein the charge control system includes a low-voltage power regulator arranged to receive low-voltage power and control the low-voltage power to output for conversion to high-voltage power.

[0343] 64. The system of embodiment 63, wherein the charging control system receives a modulated control signal that controls the output of low-voltage power for conversion to high-voltage power.

[0344] 65. The system of embodiment 63, wherein the charging control system is configured to apply a modulated control signal together with feedback of the output of the low-voltage power.

[0345] 66. The system of embodiment 63, wherein the modulated control signal is a high-frequency pulse-width modulated signal.

[0346] 67. The system of embodiment 61, wherein the charge control system includes a converter arranged to receive low-voltage power and convert the low-voltage power to high-voltage power for transmission to the discharge system.

[0347] 68. The system of embodiment 67, wherein the converter is a DC-DC converter.

[0348] 69. The system of embodiment 62, wherein the charge control system is configured to provide variable voltage power to the discharge system at different voltage levels over successive charge cycles.

[0349] 70. The system of embodiment 62, wherein the discharge system includes an energy storage system, and the charge control system is configured to provide variable voltage power to the discharge system at different voltages over successive charge cycles after release of the stored energy.

[0350] 71. An intravascular fracturing system comprising: at least one pair of spaced apart electrodes disposed within a fluid-fillable member configured to contain a conductive fluid for placement within a body lumen; An electrical pulse generating system for providing electrical energy to at least one set of spaced apart electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system including an IVL control system having a processor for executing instructions stored in a memory and a communication circuit configured to communicate signals based on instructions from the processor, the IVL control system including an electrical discharge system for selectively delivering a high voltage discharge to the at least one set of electrodes; Equipped with.

[0351] 72. The system of embodiment 71, wherein the electrical discharge system comprises a discharge switching system operable to modulate the delivery of high voltage power to at least one set of electrodes for IVL treatment.

[0352] 73. The system of embodiment 72, wherein the discharge switching system includes at least one gate-controlled switch operable by a processor signal to selectively enable delivery of high-voltage power to at least one set of electrodes for IVL treatment.

[0353] 74. The system of embodiment 73, wherein at least one gate-controlled switch is an insulated gate bipolar transistor.

[0354] 75. The system of embodiment 73, wherein at least one gate-controlled switch is selectively operable in a permissive state that enables delivery of high-voltage power to at least one set of electrodes for IVL treatment, and in a non-permissive state that prevents delivery of high-voltage power to at least one set of electrodes for IVL treatment.

[0355] 76. The system of embodiment 71, wherein the electrical discharge system comprises an energy storage system for charging high voltage energy for discharging to at least one set of electrodes.

[0356] 77. The system of embodiment 76, wherein the electrical discharge system comprises a discharge switching system operable to modulate the delivery of high voltage power from the energy storage system to at least one set of electrodes for IVL treatment.

[0357] 78. A method of operating an intravascular disruption system, comprising: assessing a stored energy state of an energy storage system of an intravascular lithotripsy (IVL) system to determine stored energy; delivering a voltage pulse to at least one pair of electrodes of the IVL system; assessing a remaining energy state of an energy storage system of the IVL system to determine a remaining energy; Comparing the evaluated energy states to determine the energy of the voltage pulse; Includes.

[0358] 79. The method of embodiment 78, wherein assessing the energy state to determine the stored energy includes determining a voltage level of the energy storage system.

[0359] 80. The method of embodiment 79, wherein assessing the energy state to determine the stored energy includes determining a level of energy stored in the energy storage system based on a voltage level of the energy storage system.

[0360] 81. The method of embodiment 78, wherein assessing the energy state to determine the remaining energy includes determining a voltage level of the energy storage system.

[0361] 82. The method of embodiment 81, wherein assessing the energy state to determine the remaining energy includes determining the level of energy remaining in the energy storage system based on a voltage level of the energy storage system.

[0362] 83. The method of embodiment 78, wherein comparing the assessed energy states includes determining a difference between the stored energy state and the remaining energy state of the energy storage system as released energy.

[0363] 84. The method of embodiment 83, wherein comparing the assessed energy state includes comparing the emitted energy to a threshold value.

[0364] 85. The method of embodiment 84, wherein determining that a sufficient spark has been generated in response to determining that the released energy is greater than or equal to a threshold value.

[0365] 86. The method of embodiment 84, wherein in response to determining that the released energy is less than a threshold, determining that an insufficient spark has been generated.

[0366] 87. The method of embodiment 78, further comprising determining parameters of a further voltage pulse based on the comparison of the energy states.

[0367] 88. The method of embodiment 87, wherein determining parameters of the further voltage pulse includes maintaining one or more parameters of the voltage pulse over the further voltage pulse in response to determining that the voltage pulse has generated a sufficient spark.

[0368] 89. The method of embodiment 88, further comprising delivering a further voltage pulse based on the one or more maintained parameters.

[0369] 90. The method of embodiment 89, wherein after delivering additional voltage pulses, the step of evaluating the remaining energy state of the energy storage system of the IVL system to determine the remaining energy is repeated.

[0370] 91. The method of embodiment 87, wherein determining parameters of the further voltage pulse includes, in response to determining that the voltage pulse produced an insufficient spark, altering one or more parameters of the voltage pulse over the further voltage spark.

[0371] 92. The method of embodiment 91, wherein altering one or more parameters includes altering a pulse duration for the additional voltage pulse.

[0372] 93. The method of embodiment 92, wherein varying the duration includes increasing the duration of the further voltage pulse to be greater than the duration of the voltage pulse.

[0373] 94. The method of embodiment 92, further comprising delivering a further voltage pulse based on the one or more modified parameters.

[0374] 95. The method of embodiment 94, wherein after delivering the additional voltage pulses, the step of evaluating the remaining energy state of the energy storage system of the IVL system to determine the remaining energy is repeated.

[0375] 96. The method of embodiment 78, wherein assessing the energy state to determine the stored energy includes assessing the energy state of the energy storage system after the previous voltage pulse is delivered.

[0376] 97. An intravascular lithotripsy system comprising: at least one pair of spaced apart electrodes disposed within a fluid-fillable member configured to contain a conductive fluid for placement within a body lumen; and an electrical pulse generating system that provides electrical energy to at least one pair of spaced electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system including an IVL control system having a processor for executing instructions stored in a memory and a communication circuit configured to communicate signals based on instructions from the processor, the IVL control system comprising: assessing a stored energy state of an energy storage system of the IVL system to determine stored energy; delivering a voltage pulse to at least one pair of electrodes of the IVL system; assessing a remaining energy state of an energy storage system of the IVL system to determine a remaining energy; Comparing the evaluated energy states to determine the energy of the voltage pulse; The device is configured to:

[0377] 98. The system of embodiment 97, wherein assessing the energy state to determine stored energy includes determining a voltage level of the energy storage system.

[0378] 99. The system of embodiment 98, wherein assessing the energy state to determine the stored energy includes determining a level of energy stored in the energy storage system based on a voltage level of the energy storage system.

[0379] 100. The system of embodiment 97, wherein assessing the energy state to determine the remaining energy includes determining a voltage level of the energy storage system.

[0380] 101. The system of embodiment 100, wherein assessing the energy state to determine the remaining energy includes determining the energy remaining in the energy storage system based on a voltage level of the energy storage system.

[0381] 102. The system of embodiment 97, wherein comparing the assessed energy states includes determining a difference between the stored energy state and the remaining energy state of the energy storage system as released energy.

[0382] 103. The system of embodiment 102, wherein comparing the assessed energy state includes comparing the emitted energy to a threshold value.

[0383] 104. The system of embodiment 103, wherein the system determines that a sufficient spark has been generated in response to determining that the released energy is greater than or equal to a threshold value.

[0384] 105. The system of embodiment 103, wherein in response to determining that the released energy is less than a threshold, the system determines that an insufficient spark has been generated.

[0385] 106. The system of embodiment 97, further comprising determining parameters of a further voltage pulse based on the comparison of the energy states.

[0386] 107. The system of embodiment 106, wherein determining parameters of the further voltage pulse includes maintaining one or more parameters of the further voltage pulse in response to determining that the voltage pulse has generated a sufficient spark.

[0387] 108. The system of embodiment 107, further comprising delivering a further voltage pulse based on the one or more maintained parameters.

[0388] 109. The system of embodiment 108, wherein after delivering the additional voltage pulses, the system repeats evaluating the remaining energy state of the energy storage system of the IVL system to determine the remaining energy.

[0389] 110. The method of embodiment 106, wherein determining parameters of the further voltage pulse includes, in response to determining that the voltage pulse produced an insufficient spark, altering one or more parameters of the voltage pulse over the further voltage spark.

[0390] 111. The method of embodiment 110, wherein varying one or more parameters includes varying a pulse duration for the additional voltage pulse.

[0391] 112. The method of embodiment 111, wherein varying the duration includes increasing the duration of the further voltage pulse to be greater than the duration of the voltage pulse.

[0392] 113. The method of embodiment 111, further comprising delivering a further voltage pulse based on the one or more modified parameters.

[0393] 114. The method of embodiment 113, wherein after delivering the additional voltage pulses, the step of evaluating the remaining energy state of the energy storage system of the IVL system to determine the remaining energy is repeated.

[0394] 115. An intravascular fracturing system comprising: at least one pair of spaced apart electrodes disposed within a fluid-fillable member configured to contain a conductive fluid for placement within a body lumen; an electric pulse generation system that provides electrical energy to at least one pair of spaced electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electric pulse generation system including an IVL control system having a processor for executing instructions stored in a memory and a communication circuit configured to communicate signals based on instructions from the processor; the electric pulse generation system includes a power system including an AC mains power supply and a DC storage system, the AC mains power supply configured to be connected to an AC power outlet to receive AC power from an infrastructure, the DC storage system configured to receive AC power from the AC mains power supply and convert the AC power to DC power to charge a DC storage device of the DC storage system; The electrical pulse generating system is configured to selectively provide power from the AC mains power supply or the DC storage system for IVL operation.

[0395] 116. The system of embodiment 115, wherein the IVL operation includes a high voltage pulse provided to at least one set of electrodes.

[0396] 117. The system of embodiment 115, wherein the DC storage device is a chemical battery.

[0397] 118. The system of embodiment 115, wherein the power system is configured to selectively provide power for IVL operation from stored power in a DC storage device, from a DC storage device while connected to receive charging power from an AC mains power source, or directly from an AC mains power source converted to DC power without a DC storage device.

[0398] The devices, systems, and methods described herein, and related applications, are illustrative and not intended to limit the scope of the invention. Features of various embodiments may be combined with other embodiments within the contemplation of the invention. Variations and modifications of the embodiments disclosed herein are possible, and practical substitutes and equivalents for the various elements of the embodiments will be apparent to those skilled in the art upon review of this patent document. These and other variations and modifications of the embodiments disclosed herein can be made without departing from the scope and spirit of the invention. [Explanation of symbols]

[0399] 12 IVL System 14 Catheter Assembly 15 Guidewire 16 components, balloons 17 Gap 18 electrodes 20 Electrical Pulse Generating System 22 IVL Control System 24 processors 26 memory 28 circuits 112 Energy Storage Systems 114 Capacitors, energy storage elements 116 Relay System 120 Charging Control System 122 Conversion System 124 Buck Regulator System 130 Discharge Switch System 131 Driver 132 Semiconductor devices, gate switches 134 Diode 138 Flow divider 140 Power Monitoring System 142 Current Monitoring System 144 Amplifier 146 Conditioning Network 148 Buffer Amplifier 150 ADC system 152 Converter 154 memory 170 Voltage Monitoring System 172 Resistor Network 174 Operational Amplifier Network 176 ADC conversion system 178 FIFO memory 180 Energy Storage Capacity Voltage Monitoring System 182 Amplifier Configuration 184 Amplifier 186 Comparator 188 Resistor-Resistor-Capacitor Networks 190 Umbrella Surveillance System 192 flip-flops 194 Logic Gates 200 Voltage Pulse Generation and Control System

Claims

1. An intravascular lysis ("IVL") system (12) with controllable pressure output, comprising: at least one pair of spaced apart electrodes (18) for placement within a body lumen disposed within a fluid-fillable member (16) configured to contain a conductive fluid therein; and a voltage pulse generating system configured to apply generated voltage pulses to the at least one set of spaced apart electrodes (18) to generate a plurality of pressure waves for intravascular spallation treatment, the voltage pulse generating system including a voltage pulse generator in operative communication with the at least one set of spaced apart electrodes (18) and in operative communication with an IVL control system (22), the IVL control system (22) comprising a processor (24) configured to execute instructions stored in a memory (26) and a circuit (28) configured to communicate signals based on operation of the processor (24), the voltage pulse generating system comprising: configured to generate a plurality of voltage pulses, including an initial series of voltage pulses configured to be applied to the at least one set of spaced apart electrodes (18); the magnitude of each voltage pulse of said initial series of voltage pulses having a target voltage magnitude that is initially set to a predetermined lower voltage magnitude threshold; two or more of said initial series of voltage pulses generate pressure waves; generating one or more subsequent series of voltage pulses, each subsequent series including a plurality of voltage pulses, wherein the magnitude of the target voltage is increased by a predetermined amount with each subsequent series of voltage pulses; each pressure wave of the generated pressure waves having a pressure magnitude output; The IVL system (12), wherein the IVL control system (22) is configured to control the pressure magnitude output of all of the generated pressure waves with the target voltage magnitude.

2. 10. The IVL system of claim 1, wherein the IVL control system is configured to control the pressure magnitude output such that the pressure magnitude output does not decay or decrease by more than a predetermined amount across all of the generated pressure waves.

3. 3. The IVL system of claim 2, wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds throughout the sequence of the generated voltage pulses.

4. 10. The IVL system of claim 1, wherein the IVL control system is configured to control the pressure magnitude output to remain above a predetermined lower threshold throughout the generated pressure wave.

5. 5. The IVL system of claim 4, wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds throughout the sequence of the generated voltage pulses.

6. 10. The IVL system of claim 1, wherein the IVL control system is configured to control the pressure magnitude output within predetermined upper and lower thresholds throughout the generated pressure waves.

7. The IVL system of claim 6 , wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds.

8. 10. The IVL system of claim 1, wherein the IVL control system is configured to control the pressure magnitude output to remain substantially constant throughout the generated pressure waves.

9. 10. The IVL system of claim 8, wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds throughout the sequence of the generated voltage pulses.

10. 10. The IVL system of claim 1, wherein the IVL control system is configured to control the pressure magnitude output so that the pressure magnitude output does not increase by more than a predetermined amount across all of the generated pressure waves.

11. 11. The IVL system of claim 10, wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds throughout the sequence of the generated voltage pulses.

12. 12. The IVL system of claim 1, wherein the IVL control system is further configured to determine a total number of voltage pulses generated and to terminate execution of voltage pulses if it is determined that a predetermined maximum number of voltage pulses has been generated.

13. 13. The IVL system of claim 12, wherein the predetermined maximum number of voltage pulses is in the range of 10 to 300 voltage pulses.

14. 14. The IVL system of claim 1, wherein the IVL control system is configured to define an allowable voltage magnitude window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold, and to control the magnitude of the voltage pulse to remain within the allowable voltage magnitude window.

15. 15. The IVL system of claim 14, wherein the predetermined lower voltage magnitude threshold is within a range of about 2500V to about 3250V.

16. 15. The IVL system of claim 14, wherein the allowable voltage magnitude window is different for balloons of different outer diameters.

17. 15. The IVL system of claim 14, wherein the predetermined lower voltage magnitude threshold is approximately 3000 V for a balloon having a nominal inflated outer diameter of 2.5 mm or 3.0 mm.

18. 15. The IVL system of claim 14, wherein the predetermined upper voltage magnitude threshold is approximately 3250 V for a balloon having a nominal inflated outer diameter of 3.5 mm or 4.0 mm.

19. 15. The IVL system of claim 14, wherein the IVL control system is configured to determine if the target voltage is not the predetermined upper voltage magnitude target for a previously executed series of voltage pulses, and to increase the magnitude of the target voltage by a predetermined amount if the target voltage is determined to be less than the predetermined upper voltage magnitude target.

20. 20. The IVL system of claim 19, wherein the predetermined amount of voltage magnitude increase is in the range of 1 to 250 volts.

21. 20. The IVL system of claim 19, wherein the IVL control system is configured to increase the magnitude of the target voltage by 25 V if the target voltage is not the predetermined upper voltage magnitude target for a previously executed series of voltage pulses.

22. An intravascular lysis ("IVL") system (12) with controllable pressure output, comprising: at least one pair of spaced apart electrodes (18) for placement within a body lumen disposed within a fluid-fillable member (16) configured to contain a conductive fluid therein; and a voltage pulse generating system configured to apply generated voltage pulses to the at least one set of spaced apart electrodes (18) to generate a plurality of pressure waves for intravascular spallation treatment, the voltage pulse generating system including a voltage pulse generator in operative communication with the at least one set of spaced apart electrodes (18) and in operative communication with an IVL control system (22), the IVL control system (22) comprising a processor (24) configured to execute instructions stored in a memory (26) and a circuit (28) configured to communicate signals based on operation of the processor, the voltage pulse generating system comprising: configured to generate a plurality of voltage pulses, including an initial series of voltage pulses configured to be applied to the at least one set of spaced apart electrodes (18); the magnitude of each voltage pulse of said initial series of voltage pulses comprises a target voltage that is initially set to a predetermined lower voltage magnitude threshold; two or more of said initial series of voltage pulses generate pressure waves; generating one or more subsequent series of voltage pulses, each subsequent series including a plurality of voltage pulses, wherein the target voltage is increased by a predetermined amount with each subsequent series of voltage pulses; each pressure wave of the generated pressure waves having a pressure magnitude output; The IVL control system (22) is configured to define an allowable voltage magnitude window comprising a predetermined lower voltage magnitude threshold and a predetermined upper voltage magnitude threshold, and to control the magnitude of the voltage pulse to remain within the allowable voltage magnitude window to control the pressure magnitude output within the upper and lower thresholds.

23. 23. The IVL system of claim 22, wherein the IVL control system is further configured to determine a total number of voltage pulses generated and to terminate execution of voltage pulses if it is determined that a predetermined maximum number of voltage pulses has been generated.

24. 24. The IVL system of claim 23, wherein the IVL control system is configured to determine whether the target voltage is not the predetermined upper voltage magnitude target for a previously executed series of voltage pulses, and to increase the magnitude of the target voltage by a predetermined amount if it is determined that the target voltage is not the predetermined upper voltage magnitude target.

25. 1. A method of administering intravascular lysis ("IVL") therapy, comprising: Providing an IVL system (12) according to claim 22; generating an initial train of voltage pulses at a predetermined voltage magnitude; applying an initial series of the generated voltage pulses to at least one pair of spaced apart electrodes (18); generating an initial series of pressure waves, each generated pressure wave having a pressure magnitude output controlled within upper and lower thresholds; determining that a maximum number of voltage pulses has not been generated; increasing the magnitude of the predetermined voltage by a predetermined amount; generating a second series of voltage pulses at the increased predetermined voltage magnitude; generating a second series of pressure waves, each generated pressure wave having a pressure magnitude output controlled within upper and lower thresholds; determining whether the increased predetermined voltage magnitude reaches a predetermined upper voltage magnitude threshold; terminating the IVL treatment if it is determined that the predetermined upper voltage magnitude threshold has been reached; A method comprising:

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