Control of IVL system, apparatus and method thereof

Abstract

Various embodiments of systems, methods, and devices for controlled operation of an endolithotripsy system for fragmenting calcification lesions in anatomical catheters are provided. More specifically, control arrangements are disclosed relating to managing and / or providing and / or providing terminating electrical energy to generate an arc between a set of spaced apart electrodes submerged within a contained fluid.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to provisional application No. 63 / 424,573, filed on November 11, 2022, entitled DEVICES, SYSTEMS, AND METHODS OF INTRAVASCULAR LITHOTRIPSY, and provisional application No. 63 / 580,547, filed on September 5, 2023, entitled DEVICES, SYSTEMS AND METHODS OF INTRAVASCULAR LITHOTRIPSY, the entire contents of each of which are incorporated herein by reference.

[0003] STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0004] none Technical Field

[0005] The present disclosure relates to devices, systems, and methods for fragmenting calcified lesions in dissecting conduits. More particularly, the present disclosure relates to control of devices, systems, and methods for applying an electric arc to spaced electrodes disposed or contained within a fluid-filled member to generate flow and pressure waves. Background Art

[0006] Developed a variety of techniques and apparatus for use in removing or repairing arteries and similar body passages tissue, including removal and / or rupture of the passage and / or formation of calcified lesions in the wall of the passage. The common purpose of such techniques and apparatus is to remove the atherosclerotic plaque in the patient's artery. Atherosclerosis is characterized by the accumulation of fatty deposits (atheroma) in the intimal layer of the patient's blood vessels (i.e., under the endothelium). Usually over time, the material initially deposited as a relatively soft, cholesterol-rich atheromatous material hardens into a calcified atherosclerotic plaque, usually in the vessel wall. Such atheroma limits the flow of blood, causing the compliance of the blood vessel to be lower than normal, and is therefore commonly referred to as stenotic lesions or stenosis, and the obstructing material is referred to as stenotic material. If not treated, such stenosis may cause angina pectoris, hypertension, myocardial infarction, stroke, etc.

[0007] Angioplasty, or balloon angioplasty, is an intravascular procedure that treats narrowed or blocked arteries or veins (typically to treat atherosclerosis) by enlarging them. A deflated balloon is typically passed through a pre-positioned catheter and over a guidewire into the narrowed occlusion, then inflated to a fixed pressure. The balloon forces the occlusion to expand within the vessel and surrounding muscle wall until the occlusion yields due to the radial force exerted by the inflated balloon, thereby opening a vessel with a lumen diameter similar to that of the native vessel in the occluded area and thereby improving blood flow.

[0008] Angioplasty procedures are subject to several risks and complications, including, but not limited to: arterial rupture or other damage to vessel wall tissue due to over-inflation of the balloon catheter, use of an inappropriately large or stiff balloon, the presence of a calcified target vessel; and / or hematoma or pseudoaneurysm formation at the access site. Typically, the pressures generated by conventional balloon angioplasty systems are in the range of 10 to 15 atmospheres, but pressures can sometimes be higher. As described above, a major problem with known angioplasty systems and methods is that the occlusion yields under high stress and strain rates in a relatively short period of time, often resulting in damage or incision of the vessel (e.g., vessel) wall tissue.

[0009] Conventional systems may employ crude system controls. For example, stopping the supply of power from a power source may be employed as the primary means of regulating the amount of energy applied to the treatment site. US 8,728,091 teaches an approach in which the current is monitored during application of a voltage by a pulse generator. When the current exceeds a predetermined threshold amplitude, the voltage is shut off at the pulse generator. As discussed in further detail herein, improved approaches to control of power characteristics can aid in more effective and consistent treatment. For example, embodiments utilizing the present disclosure provide improved durability, higher frequency, and substantially equal pressure output over a greater number of voltage pulses than previously possible.

[0010] Various embodiments of the present disclosure may address these and other issues discussed above. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] These drawings are illustrative representations of certain embodiments and are therefore not intended to limit the present disclosure.

[0012] Figure 1 A diagrammatic intravascular lithotripsy (IVL) arrangement is shown in accordance with one or more embodiments of the present disclosure.

[0013] Figure 2 The present invention is shown to be applicable to one or more embodiments of the present invention. Figure 1 Flowchart of the control operations of the IVL arrangement.

[0014] FIG3 shows a diagram according to one or more embodiments of the present disclosure. Figure 1 and Figure 2 The IVL arrangement and control operations are part of one or more circuit arrangements.

[0015] FIG4 shows a diagram according to one or more embodiments of the present disclosure. Figure 1 and Figure 2 The IVL arrangement and control operations of one or more of the additional portions of the circuit arrangement.

[0016] Figure 5 A flow chart for controlling and delivering voltage to electrodes and generating shock waves according to one or more embodiments of the present disclosure is shown.

[0017] Figure 6 It shows that one or more embodiments of the present disclosure can be applied to Figure 1 Flowchart of the control operations of the IVL arrangement.

[0018] Figure 7 Shown is a graphical comparison of voltages applied to a known IVL device and an embodiment of an IVL device according to the present disclosure.

[0019] Figure 8 Shown 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.

[0020] Figure 9 A graphical comparison of the average peak pressure produced by a known IVL device over 80 voltage pulses and the average peak pressure produced by an embodiment of an IVL device according to the present disclosure over a predetermined maximum number of voltage pulses is shown.

[0021] Figure 10 An exemplary flow chart method according to the present disclosure is shown. DETAILED DESCRIPTION

[0022] Conventional intravascular lithotripsy (IVL) devices, systems, and methods can apply high-energy electricity to generate sparks (arcs) between discharge electrodes. Under appropriate conditions, the sparks generated by the submerged electrodes can generate pressure waves within the medium, which can be applied to treat (fragment) calcified lesions within the patient's vasculature. As can be appreciated, proper control of such high-energy systems can be crucial for effective treatment (including safe treatment).

[0023] Applicants have described intravascular lithotripsy systems, devices, and methods. See PCT / 2022 / 074607, filed on August 5, 2022, and entitled “INTRAVASCULAR LITHOTRIPSY BALLOON SYSTEMS. DEVICES AND METHODS,” the entire contents of which are incorporated herein by reference.

[0024] like Figure 1 , a diagrammatic layout of portions of an exemplary IVL system 12 is shown, indicating control elements within the present disclosure. The exemplary IVL system 12 includes a catheter assembly 14 comprising an elongated body, embodied as a catheter, having a guidewire 15, and a fluid-filled member 16 configured to contain a conductive fluid therein, exemplified by an inflatable balloon, disposed near one end of the body and arranged to receive the fluid for inflation to facilitate IVL treatment. A set of discharge electrodes 18 is shown disposed within the exemplary balloon 16, at least some of the discharge electrodes 18 being spaced apart from one another by gaps 17 to generate sparks or arcs between the spaced apart electrodes 18.

[0025] The IVL system control mechanisms described herein may be used in association with electrodes within a fluid-filled member 16 configured to contain a fluid, such as a conductive fluid, therein. Embodiments of the fluid-filled member 16 may include, for example, Figure 1 The inflatable balloon shown may be compliant or non-compliant and configured to contain a fluid such that the spaced electrodes 18 are immersed in the contained fluid. Furthermore, the fluid-filled member 16 may comprise an at least partially rigid and / or non-flexible fillable member. In other embodiments, the fluid-filled member 16 may contain a fluid therein, and wherein the spaced electrodes 18 are located or immersed in the contained fluid.

[0026] Alternatively, the IVL system control mechanisms of the present disclosure may be used in association with electrodes that are not positioned or surrounded by a fluid-filled or fluid-fillable member 16. In these embodiments, the IVL system may include spaced electrodes 18 that may be continuously or cyclically exposed to saline or other fluid, and during exposure, the IVL system may generate an arc between the spaced electrodes 18.

[0027] The spaced-apart electrodes 18 are arranged to communicate with an electrical pulse generating system 20 (as shown by the dashed conductors) to receive high voltage electrical energy for spark generation, thereby generating pressure waves for IVL treatment. In an exemplary embodiment, one electrode can be grounded and the other electrode is provided with a high voltage from the electrical pulse generating system 20, but in some embodiments, any voltage difference can be applied. The electrical pulse generating system 20 includes an IVL control system 22, which includes a processor 24 configured to execute instructions stored on a memory 26 and transmit signals via circuitry 28 for IVL operations managed by the processor. The processor 24, memory 26, and circuitry 28 are arranged to communicate with each other (as shown by the dashed lines) to facilitate the disclosed operations.

[0028] Proper control of such high energy systems may also require achieving sufficient energy at the discharge site. Given the high energy environment and microscale time periods for electron discharge, desired energy control within such IVL devices and systems may be challenging. In addition, adaptive control methods can provide advantages for IVL effectiveness. Adjustable energy delivery can increase effective power application, which can reduce patient risk. For example, it can be demonstrated to start with a predetermined starting voltage threshold and define a predetermined upper voltage threshold to form an acceptable voltage window. The acceptable voltage window can be coupled with a series of generated voltage pulses of an amplitude that is confirmed to be within the acceptable voltage window. If, for example, the amplitude of the series of generated voltage pulses is lower than the predetermined upper voltage threshold, the target voltage can be increased by a predetermined amount and another series of generated voltage pulses is performed. Embodiments of the IVL systems, devices, and methods within the present disclosure include operations for adjusting the total electrical energy provided to the group of electrodes for a given pulse.

[0029] Now refer to Figure 2 , a flow chart illustrating one embodiment of control 38 in the operation of an IVL as discussed with respect to blocks 40 through 60 is shown. Such control operations can be controlled by the electrical pulse generating system 20, and illustratively by the IVL control system 22. As discussed in further detail herein, control 38 applies incremental changes in electrical parameters during cycles of the applied voltage while monitoring parameters associated with 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 requiring excessive energy.

[0030] Furthermore, if increasing the duration of the voltage applied to the discharge electrode fails to produce a sufficient spark, incrementally increasing the voltage can further increase the likelihood of producing an effective spark without requiring excessive power. Furthermore, if the incrementally increased voltage fails to produce a sufficient spark, the duration can be incrementally increased again before further increasing the voltage. 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 minimum required power characteristics for effective spark generation. Increasing the likelihood of achieving an adequate spark at lower power can increase efficiency, safety, and / or reduce the intensity of effective IVL treatment.

[0031] At block 40, initial settings are applied. For the illustrative example, default initial settings are applied as a discharge voltage of 2500 volts (V) for a duration of 0.5 microseconds. In some embodiments, the initial settings can be determined by any suitable means, including by using programmable default values as usage-based adjustment settings, for example, based on patient characteristics, environmental conditions, surgical approach, and / or product cycle life (i.e., operational life). Control can proceed from block 40 to block 42.

[0032] In block 42, electrical energy is applied to the electrodes to perform IVL treatment. In a first example of proceeding from block 40 to block 42, electrical energy is applied at an initial setting, for example, an applied voltage of 2500V for a duration of 0.5 microseconds. When used in a clinical setting, with the IVL catheter positioned within a patient's body cavity and, specifically, with the discharge electrodes immersed within a fluid medium within a fluid-filled member such as an angioplasty balloon, pressure wave treatment can ensue. However, as described below, under current conditions, in some cases, the energy provided at the initial setting may be insufficient to generate a spark at the electrodes, or may generate an insufficient spark or insufficient pressure wave. Control may proceed from block 42 to block 44.

[0033] In block 44, a threshold determination is made. In the exemplary embodiment, the determined value of the current applied in block 42 is compared to a threshold current value. In the illustrative example, the threshold current value is implemented as a predetermined fixed value, such as 20 amperes (A), but in some embodiments, it can have any suitable value, such as 50 A, 100 A, 150 A, 175 A, etc. The threshold current value for a given cycle can be determined based on the number of previous cycles in the treatment session, the number of cycles in the treatment session that maintain the current setting (e.g., through block 46), the number of specific consecutive cycles (e.g., the number of consecutive cycles through blocks 46 or 48 or 52 or 54 or 58), patient characteristics, environmental conditions, surgical approach, and / or product cycle life (i.e., operational life), as well as other factors. In addition, although the threshold current value can be set to a value, the actual current passed during the generation of a sufficient arc on the electrode may be greater.

[0034] In response to determining that the determined value of the current applied in frame 42 is equal to or greater than the threshold current value, control may proceed to frame 46. Otherwise, in response to determining that the determined value of the current applied in frame 42 is less than the threshold current value, control may proceed to frame 48. For example, as described above, insufficient spark generation may result in little or no current flowing across the electrodes (e.g., about 0 to about 5 amps, which may represent energy dissipated into the dielectric in the absence of an arc), which will not reach the threshold current value and, therefore, will proceed to frame 48.

[0035] In the exemplary embodiment, the current value determined for the current applied in block 42 is implemented as the instantaneous current applied across the electrodes. In some embodiments, the current value determined can be implemented as an aggregate value, such as a time average of the current applied to the electrodes. Continuing from the exemplary embodiment of applying a threshold current value of 20 amps, spark generation is deemed sufficient when 20 amps is achieved by the treatment being performed.

[0036] As can be appreciated, the presence of a substantial 20 amps provides a substantial current across the discharge electrode, indicating the generation of a meaningful spark. By comparison, when a spark fails to generate or when insufficient spark is generated for the applied duration and at the applicable voltage, little or no current flows through the discharge electrode, which may be, for example, 2500 V. For IVL treatment, the applicable voltage may typically be in the range of about 500 V to about 5000 V, but for practical applications, it may conceivably be in the range of about 100 V to about 10,000 V.

[0037] At block 46, a determination is made to maintain the currently selected settings. In the exemplary embodiment, the currently selected settings include the discharge voltage and applicable duration as applied immediately prior at block 42. For the avoidance of doubt, if the initial settings were applied immediately prior at block 42, resulting in a current of 20 amps, then the initial settings will be applied during the next treatment cycle. However, if the currently selected settings include updated settings, such as updated duration and / or voltage settings from a later portion of control 38, as discussed in further detail herein, then maintaining the currently selected settings will include immediately applying the updated settings. Maintaining the currently selected settings directly results in a return to block 42 to once again apply electrical energy to the electrodes for IVL treatment.

[0038] In block 48, the duration of increasing the voltage applied to the discharge electrode is determined. Continuing with the example where a current less than 20 amps indicates insufficient spark generation, rather than immediately increasing the applied voltage, the duration of the applied voltage can be incrementally increased. On a microsecond scale, increasing the duration of the applied voltage can increase the likelihood of generating an adequate spark using the same previously applied voltage. This can be achieved by overcoming threshold system impedance and / or other factors that influence the ease of spark generation during a given cycle at a given voltage.

[0039] The duration of the applied voltage is increased by a predetermined duration time interval, which is illustratively implemented as a fixed value, such as 0.5 microseconds. In some embodiments, the predetermined duration time interval for a given cycle can be determined based on factors such as the number of treatment cycles that have previously occurred during the treatment session (e.g., the number of cycle intervals that have passed through blocks 42, 44, and 46 before proceeding to block 48), patient characteristics, environmental conditions, surgical approach, and / or product cycle life (i.e., operable period), among others. In some embodiments, the predetermined duration time interval for a given cycle can be varied by a predetermined rate of change, such as by a percentage gain or loss of cycles. Control proceeds directly from block 48 to block 50.

[0040] In block 50, a determination is made as to whether a maximum duration has been reached. In the exemplary embodiment, the maximum duration is a predetermined duration implemented as a fixed value (e.g., 6 microseconds). As an example, if the control sequence progresses through the loop from the initial setting of 0.5 microseconds at block 40 to block 48 until 6 microseconds are reached, the maximum duration will be implemented as a threshold.

[0041] In some embodiments, the maximum duration of a given cycle can be determined based on factors such as the number of previous cycles in the treatment session, the number of cycles in the treatment session during which the current setting was maintained (e.g., via block 46), the number of specific consecutive cycles (e.g., the number of consecutive cycles via blocks 46 or 48 or 52 or 54 or 58), patient characteristics, environmental conditions, surgical approach, and / or product cycle life (i.e., operable period). By inference, in block 50, the threshold current value has not been achieved in the current cycle, but in some embodiments, a positive determination and / or confirmation that the threshold current value has not been achieved can be performed. In response to determining that the maximum duration has not been reached, control passes to block 52. Otherwise, in response to determining that the maximum duration has been reached, control passes to block 54.

[0042] At block 52, a determination is made to apply the updated duration. In the exemplary embodiment, the duration is updated at block 48 by increasing the currently selected duration by a predetermined duration interval, and the determination to apply the updated duration confirms and continues with the updated duration. In the exemplary embodiment, the applied voltage remains at the currently selected duration. Continuing with the updated duration directly returns to block 42 to apply electrical energy to the discharge electrodes again for treatment using the updated duration.

[0043] At block 54, the applied voltage is increased by a predetermined voltage interval. The currently selected setting of the applied voltage is illustratively increased by the predetermined voltage interval. The currently selected duration is returned to the value at the initial setting, e.g., 0.5 microseconds, to be applied with the updated voltage. However, in some embodiments, the updated duration can have any suitable value at the newly updated voltage setting. For example, the updated duration can be determined based on the number of cycles in the treatment session when the newly updated voltage is applied.

[0044] In the exemplary embodiment, the predetermined voltage interval is implemented as a fixed value of 250 V, such that in the first exemplary occurrence of block 54, the currently selected applied voltage is increased from the value at the initial setting of 2500 V to 2750 V. In some embodiments, the predetermined voltage interval for a given cycle can be determined based on the number of previous cycles in the treatment session, the number of cycles in the treatment session during which the current setting is maintained (e.g., through block 46), the number of specific consecutive cycles (e.g., the number of consecutive cycles through blocks 46 or 48 or 52 or 54 or 58), patient characteristics, environmental conditions, surgical approach, and / or product cycle life (i.e., operable period).

[0045] In block 56 , a determination is made as to whether the maximum voltage has been reached. In the exemplary embodiment, the maximum voltage is a predetermined voltage implemented as a fixed value (e.g., 3500 V). As an example, if the control sequence cycles through the initial setting of 2500 V at block 40 through block 54 until 3500 V is reached, the maximum voltage will be implemented as the threshold.

[0046] In some embodiments, the maximum voltage for a given cycle can be determined based on factors such as the number of previous cycles in the treatment session, the number of cycles in the treatment session during which the current setting was maintained (e.g., through block 46), the number of specific consecutive cycles (e.g., the number of consecutive cycles through blocks 46 or 48 or 52 or 54 or 58), patient characteristics, environmental conditions, surgical approach, and / or product cycle life (i.e., operable life). By inference, in block 56, the threshold current value has not been achieved in the current cycle, but in some embodiments, a positive determination and / or confirmation that the threshold current value has not been achieved can be performed. In response to determining that the maximum voltage has not been reached, control passes to block 58. Otherwise, in response to determining that the maximum voltage has been reached, control passes to block 60.

[0047] At block 58, a determination is made to apply the updated voltage. In the exemplary embodiment, the voltage is updated at block 54 by increasing the currently selected voltage by a predetermined voltage interval, and the determination to apply the updated voltage confirms and continues the updated voltage. At block 45, the duration is updated to return to the value initially set, e.g., 0.5 microseconds, and the updated applied voltage is continued. Continuing with the updated voltage, the process returns directly to block 42 to apply power to the electrodes again for treatment using the updated voltage and duration.

[0048] In block 60, an error determination occurs. In response to an error determination, an error message is provided. Such an error message illustratively terminates the treatment session, but in some embodiments, other safety and / or communication actions may be taken, such as, for example, displaying an error communication to the user.

[0049] In the exemplary embodiment, by deduction, in response to an error determination, it may be determined that the maximum voltage and maximum duration did not produce a spark, but in some embodiments, it may be determined that insufficient spark production occurred. In some embodiments, in response to an error determination, a positive determination and / or confirmation may be made that the spark production failed and / or was insufficient at the maximum voltage and maximum duration. After block 60, process control automatically terminates.

[0050] In the discussion of control 38, exemplary increases in duration have been mentioned, but in some cases, the voltage level may be decreased, e.g., during certain cycles of control 38. For example, the duration and / or voltage may be varied in a given cycle according to control 38 to be incrementally decreased to achieve appropriate conditions, e.g., to achieve an appropriate discharge energy, as discussed in greater detail herein with respect to consideration of the voltage level of the energy storage system (e.g., capacitive system) 112 before and after discharge.

[0051] 3, portions of an exemplary electrical pulse generation system 20 (including portions of an IVL control system 22) disclosed herein include various features and / or circuits that can be implemented as part of a circuit 28, but in some embodiments, such systems 20, 22 share components and / or have isolated components where applicable, such that the circuit 28 is intended to be illustrative and may also represent circuitry implemented by the system 20 alone where applicable. In an exemplary embodiment, the IVL control system 22 includes an adjustable energy storage system (illustratively, an exemplary capacitive system) 112 for selectively adjusting the energy storage capacity or amplitude applied to provide electrical energy to the electrodes. We will hereinafter refer to the energy storage system 112, which is illustrated by an exemplary capacitive system, but is of course not limited thereto.

[0052] The energy storage system 112 receives charging power from the power source of the electrical pulse generation system 20. The energy storage system 112 provides discharge power to the electrodes (eg, illustratively via VCAP2 and ground), as discussed in further detail herein.

[0053] The adjustable energy storage system 112 illustratively includes a plurality (e.g., one or more) energy storage units (illustrated as individual capacitors 114), thereby defining an energy storage network. In an exemplary embodiment, each energy storage unit 114 can be sized to have the same energy storage capacity and can be arranged for connection in parallel with other energy storage units in the energy storage network, but in some embodiments, energy storage units of any suitable size and / or arrangement can be provided to support variable energy storage for IVL treatment. A relay system 116 can be arranged to connect to at least some of the energy storage elements 114 of the network. The relay system 116 includes one or more relays for selectively connecting the energy storage elements 114 together to receive charge and release electrical energy to the electrodes.

[0054] In the exemplary embodiment, the relay system 116 includes a coupled arrangement in which all energy storage elements 114 of the network are connected for use in IVL. When connected for use in IVL, the energy storage elements 114 can be connected to other portions of the electrical pulse generating system 20 to exchange electrical energy under other control operations. For example, under typical charge control operation, the energy storage elements 114 connected by the relay system 116 for use in IVL can receive charge from a power source, and / or under typical discharge control operation, the energy storage elements 114 connected by the relay system 116 for use in IVL can provide discharge energy to the electrodes 18. Thus, it will be appreciated that the relay system 116 can selectively connect all energy storage elements 114 for use in IVL treatment to provide maximum energy storage amplitude.

[0055] In addition, the relay system 116 includes a disengaged arrangement in which fewer than all of the energy storage elements 114 of the network are connected for use by the IVL, as shown in FIG4 . For ease of description and not limitation, a plurality of energy storage elements 114 (illustratively two energy storage elements) are disconnected from the other energy storage elements by disengaging the relay system 116. The energy storage elements 114 disconnected for use by the relay system 116 for use by the IVL cannot receive charge from the power source, and / or under typical discharge control operations, the energy storage elements 114 disconnected for use by the relay system 116 for use by the IVL cannot provide discharge energy to the electrode 18. The energy storage elements disconnected for use by the IVL can illustratively be discharged from the electrode via a diode 118 arranged in parallel with the relay system 116 (e.g., for safely reducing the stored power).

[0056] It will be appreciated that by adjusting the amount of energy storage available to supply electrical energy to the electrodes, the amount of energy supplied to the electrodes can be controlled. denoted by , where V represents voltage and C represents capacitance, such that the applied electrical energy is proportional to the amount of energy connected during use. Thus, by selectively engaging the relay system 116 to close the circuit and connect and disconnect the energy storage elements, the energy storage capacity of the IVL system can be adjusted to provide variable energy levels to the electrodes. While the illustrative embodiment includes relay controls for connecting and / or disconnecting a pair of energy storage elements, any suitable number of relays and / or energy storage elements can be employed to provide adjustable energy storage capacity for IVL therapy.

[0057] In the exemplary embodiment, the IVL control system 22 is configured to govern the amount of stored energy storage applied. The IVL control system 22 illustratively determines the amount of stored energy storage to be applied, and upon determining a change in the desired energy storage magnitude, the IVL control system 22 operates the relay system 116 accordingly. For example, the IVL control system 22 may determine that a voltage pulse desires and / or requires a lower energy storage magnitude and may communicate this to operate the relay system 116 in a disengaged configuration.

[0058] For one or more subsequent voltage pulses, the IVL control system 22 may determine that a greater energy storage magnitude is desired and / or required for another voltage pulse and may communicate to operate the relay system 116 in an engaged arrangement. For one or more additional subsequent voltage pulses, the IVL control system 22 may determine that a lower energy storage magnitude is again desired and / or required and may return the relay system 116 to a disengaged arrangement. Thus, the IVL control system 22 may operate the relay system 116 as needed to provide an adjustable energy storage magnitude for any given voltage pulse within a series of voltage pulses.

[0059] The applied energy storage can be adjusted on an ongoing basis, for example, for any given pulse. In practice, the energy storage capacity or amplitude can be adjusted in conjunction with the voltage level to be applied and / or taking into account power, efficiency and / or other aspects of the technology. In addition, over the life of the applied device and system, typical wear on components can change their electrical and / or physical properties, which can benefit from adjustments to the applied energy storage. For example, even small wear on the electrodes can change the spacing (gap) between a set of electrodes, which can change the arc conditions between the electrodes. Thus, the adjustable energy storage amplitude can accommodate changes in the electrodes and / or parts of the discharge system under repeated use, whether in a single treatment session or in other circumstances.

[0060] Continuing with reference to FIG3 , embodiments of the present disclosure relate to systems and methods for regulating a voltage provided to charge an energy storage system 112 to a charging voltage. The charging voltage is illustratively provided as an input to the energy storage system 112 to generate voltage pulses as energy accumulated for discharge, and is controlled for variable charging. The charging voltage is illustratively controlled by the charging control system 120 of the IVL control system 22.

[0061] In the exemplary embodiment, the charging control system 120 provides accurate control of the charging voltage via a high-frequency switching control signal from the processor 24. The switching control signal ("HVIN_VSET"), illustratively implemented as a pulse-width modulated (PWM) signal, is amplified for use in controlling the high-voltage supply. The high-voltage DC / DC converter system 122 receives an indication of the switching control signal in the range of approximately 0V to approximately 12V and provides a corresponding charging voltage, illustratively in the range of approximately 0V to approximately 4000V.

[0062] In the illustrated embodiment, the charging control system 120 includes a buck regulator system 124 for regulating low-voltage power. Buck regulator system 124 is illustratively implemented as an integrated circuit (IC) to provide signal conditioning with low-pass filtering and buffering of the PWM signal. Buck regulator system 124 receives the regulated PWM signal with feedback to provide controlled low-voltage power to converter system 122 for applying high-voltage power.

[0063] Resistor 126 may scale the feedback voltage appropriately for IC operation to provide a variable feedback voltage within a range of approximately 0 V to approximately 3.3 V to buck regulator system 124 at additional resistor 128. As the duty cycle of the PWM signal increases from zero to 100%, the filtered signal increases from zero volts to 3.3 volts, which may increase the current provided to the feedback network and may require less voltage to achieve regulation, e.g., across a resistor, inductor, and / or capacitor disposed between buck regulator system 124 and converter system 122.

[0064] Still referring to FIG3 , embodiments of the present disclosure relate to systems and methods for controlling the effective duration of discharge voltage pulses provided to electrodes. 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 activate the discharge switching system 130. The discharge switching system 130 is illustratively implemented by implementing a driver 131 and a semiconductor device 132 as gate switches.

[0065] The gate switch 132 is illustratively embodied as an insulated gate bipolar transistor (IGBT) with an n-type gate control arrangement. In the active state of the switching signal of the driver 131, the gate switch 132 is activated to its conductive state to transfer energy from the discharge of the energy storage system 112 to the electrode. In the inactive state of the switching signal, the gate switch 132 is deactivated to its non-conductive state, thereby preventing the energy storage system 112 from discharging to the electrode.

[0066] In the exemplary embodiment, the gate switch 132 is arranged as an active high device, although in some embodiments, it can be implemented as an active low device. The gate-controlled active high IGBT can provide precise control of the discharge from the energy storage system 112, but can be implemented in any suitable manner, including using other suitable semiconductors (e.g., p-type, FET, etc.) and / or other control designs (e.g., collector, emitter control, etc.).

[0067] In the exemplary embodiment, the discharge switch system 130 includes an anti-parallel diode 134 arranged to reduce reverse voltage stress on the gate switch 132. A disable signal ("HV_DISABLED") is provided to the driver 131, which allows energy to be discharged to the electrode on an inactive (low) signal and can be activated (high) to disable high voltage discharge under the guidance of the processor 24 and / or other safety systems. The snubber system 136 is illustratively implemented as a resistor-capacitor-diode (RCD) snubber network arranged to reduce voltage transients that may exceed the rated voltage of various high voltage components.

[0068] 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 power to the IVL device and system, illustratively including sensing the current and voltage delivered to the electrodes and the voltage of the adjustable energy storage system 112.

[0069] The power monitoring system 140 illustratively includes a current monitoring system 142. The current monitoring system 142 is implemented to sense the current delivered to the electrode for a given voltage pulse. As discussed in further detail herein, the current delivered to the electrode can be considered when determining the power characteristics of subsequent voltage pulses.

[0070] In the exemplary embodiment shown in FIG4 , the current monitoring system 142 receives an indication of the voltage level applied in each voltage pulse for use in determining the current delivered to the electrode. Returning briefly to FIG3 , the shunt resistor 138 is positioned within the high voltage current path to establish a proportional voltage (e.g., “VCURR+,” “VCURR-”). As shown in FIG4 , the proportional voltage is transmitted to the current monitoring system 142.

[0071] A chip including amplifier 144 is arranged to amplify the proportional voltage and provide the analog result to a conditioning network 146, which is implemented as a resistor-capacitor network for scaling and / or filtering. The conditioned signal is buffered by a buffer amplifier 148, the output of which is provided to an analog-to-digital conversion (ADC) system 150 for digital conversion.

[0072] ADC system 150 illustratively includes a converter 152 and a memory 154. In the exemplary embodiment, converter 152 provides a digital output from an analog input, and memory 154 is implemented 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 multiple measurement points with low jitter. The memory output is provided to processor 24 for consideration in overall IVL therapy control.

[0073] 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. The threshold is implemented as a variable duty cycle PWM signal ("ISNS_ISET") generated from the processor 24. The PWM signal can be low-pass filtered and / or buffered before being transmitted to the comparator. In response to the measured current exceeding the threshold, the current monitoring system can assert an error signal (e.g., "ISNS OVER#") to avoid an overcurrent condition.

[0074] The power monitoring system 140 illustratively includes a voltage monitoring system 170. The voltage monitoring system 170 is implemented to sense the voltage between the set of electrodes. As discussed in further detail herein, the voltage between the electrodes for a given pulse can be considered when determining power characteristics of subsequent voltage pulses.

[0075] In the exemplary embodiment, the voltage monitoring system 170 includes a resistor network 172 that is arranged to attenuate the (switched) voltage of one of the electrodes in a group (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 the operational amplifier network 174 is provided to an ADC conversion system 176 for digitization, including storage in a FIFO memory 178 for access by the processor 24.

[0076] 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 allow for determination of the stored energy capacity of the energy storage system 112. Furthermore, a comparison of the stored energy capacity of the energy storage system 112 before and after discharge may provide an indication of the total energy delivered during a given discharge cycle. Such total energy data may be considered to increase confidence in determining whether a sufficient spark has been generated for IVL treatment.

[0077] In the exemplary embodiment, the voltage monitoring system 180 includes a voltage limiting system configured to monitor the net voltage of the energy storage system 112 during charging. In the exemplary embodiment, voltage monitoring is discussed with respect to connected energy storage elements 114, more specifically, those energy storage elements connected to provide controlled discharge energy for IVL treatment, rather than energy storage elements disconnected via the relay system 116 (if present).

[0078] Voltage monitoring system 180 receives an indication of the voltage of energy storage system 112 ("VCAP1") during charging. System 180 illustratively includes an amplifier configuration 182, which includes an amplifier 184 and a comparator 186. Comparator 186 illustratively is arranged to compare the voltage to a fixed voltage and responsively trigger a signal (e.g., "VCAP1_OVER#") when the voltage of energy storage system 112 exceeds the fixed voltage. In the exemplary embodiment, the fixed voltage is implemented as a set point generated by a resistor-capacitor network 188 above normal operation but before damage to various HV components would occur.

[0079] The intermediate voltage of this circuit (e.g., "AN_VCAP1") can be used to monitor the progress of the charge cycle of the energy storage system 112. The intermediate voltage shown is an indication of a severe degradation of the high voltage provided by the energy storage system to the electrode ("VCAP_1"). Such a degradation signal can allow monitoring of the high voltage system while processing its lower voltage indication.

[0080] Now refer to Figure 5 , and continue to refer to Figure 1 3 , the IVL system 12 may consider the energy of the operating energy storage system 112. By monitoring the energy of the energy storage system 112 before and after a discharge event, an indication of the generation (and / or sufficiency) of a spark may be determined, as discussed in greater detail with respect to the illustrative embodiment with reference to operation 300 involving blocks 312 through 322.

[0081] In block 312, the energy storage system 112 is evaluated. In the exemplary embodiment, the evaluation includes determining the voltage of the energy stored by the energy storage system 112. As described above, the voltage monitoring system 180 may monitor the voltage of the 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 support energy monitoring of the energy storage system 112.

[0082] In block 314, the energy of the energy storage system 112 is determined. In the exemplary embodiment, based on The measured voltage of the electrodes 114 is used to determine the energy of the energy storage system 112. Thus, the processor 24 can calculate the current energy of the energy storage system 112, including the energy stored just before the energy is released to the electrodes.

[0083] In block 316, IVL treatment may be attempted. In an exemplary embodiment, voltage pulses may be delivered to the electrodes. The voltage pulses may be applied according to a control arrangement as described herein, for example, based on a determined duration in a control sequence.

[0084] In block 318, the energy storage system 112 is evaluated. The evaluation of the energy storage system 112 in block 218 is implemented to occur immediately after the IVL treatment is attempted in block 216 to provide an indication of the energy state of the energy storage system 112 immediately after the (attempted) discharge to the electrodes. In the exemplary embodiment, the evaluation includes determining the voltage of the energy stored by the energy storage system 112, which is implemented by voltage monitoring as described above, but in some embodiments, the evaluation of the energy storage system 112 in block 318 may differ in method and / or practice from that of block 312.

[0085] In block 320, the energy of the energy storage system 112 is determined. In the exemplary embodiment, the energy of the energy storage system 112 is again based on The energy storage system 112 may be determined based on the measured voltage of the electrode, as in block 214, but after attempting IVL treatment. In some embodiments, determining the energy storage system 112 energy in block 320 may differ in method and / or practice from that in block 214. Thus, the processor 24 may calculate the current energy of the energy storage system 112, including immediately after (attempting to) release energy to the electrodes.

[0086] In block 322, a comparison is made between the energy determinations. Illustratively, the amount of energy of the energy storage system 112 determined in block 320 is subtracted from the amount of energy within the energy storage system 112 determined in block 314, such that the result represents the amount of energy released from the energy storage system 112 in a single attempt to perform IVL treatment.

[0087] The amount of energy discharged can be considered to determine whether a spark (or sufficient spark) has occurred to allow IVL treatment to occur. In the exemplary embodiment, the threshold energy discharge represents a discharge energy level that confidently indicates that a spark sufficient for IVL has occurred. Therefore, in block 322, the stored energy levels before and after the discharge are compared to determine whether the threshold energy discharge has been achieved, which can indicate a spark for IVL treatment.

[0088] In the exemplary embodiment, and with reference to Figure 2, the threshold energy discharge is a fixed predetermined value, for example, 600 millijoules (e.g., 3700 V, 90 nanofarads). However, in some embodiments, the threshold energy level for a given cycle can be based on the number of previous cycles in the treatment session, the maintenance of the current setting during the treatment session (e.g., by Figure 2 The number of cycles of the procedure (e.g., box 46 of FIG. 48 ), the number of specific consecutive cycles (e.g., the number of consecutive cycles of box 46 or box 48 or box 52 or box 54 or box 58), patient characteristics, environmental conditions (e.g., location within the patient, such as above or below the knee), surgical method, and / or product cycle life (i.e., operable period).

[0089] Comparison of the energy level of the energy storage system 112 indicating that a spark for IVL treatment has occurred may responsively result in further treatment with the same duration, energy level, threshold characteristics, and / or thresholds adjusted for other parameters. Comparison of the energy level of the energy storage system 112 indicating that a spark for IVL treatment has not yet occurred may result in adjustments to the duration and / or energy level applied, e.g., as discussed with respect to control operation 38.

[0090] In some embodiments, a threshold current value may be applied in conjunction with a threshold energy discharge such that either threshold alone may indicate a spark for IVL therapy. In some embodiments, both thresholds may need to be met to indicate a spark for IVL therapy.

[0091] Considering 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, reliable consideration of the energy state can improve confidence in unpredictable, high-energy arcing scenarios over direct measurements alone.

[0092] The 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 in the absence of a timely switching input signal to ensure proper high-voltage operation. In some embodiments, the watchdog system can be implemented externally and include a processor, memory, and / or circuitry that is separate from or shared with the IVL control system 22.

[0093] Returning to FIG3 , in an exemplary embodiment, the IVL control system 22 includes an umbrella monitoring system 190 configured to assist in safety operations. The umbrella monitoring system 190 illustratively includes a flip flop 192 and a logic gate 194 for considering monitoring signals. The logic gate 194 is arranged to receive monitoring signals, which are implemented as energy storage system overvoltage (“VCAP1_OVER#”) from the voltage monitoring system 180, high voltage warning (“HV_WDO#”) from the watchdog system, and in some embodiments, may receive overcurrent (“ISNS_OVER#”) from the current monitoring system.

[0094] Logic gate 194 is implemented as an AND gate and flip-flop 192 is implemented as an asynchronous D flip-flop such that an activation signal from gate 194 that lasts longer than the minimum clock pulse width of flip-flop 192 causes the high voltage output (e.g., “HV_DISABLED”) to be disabled, but an activation signal from gate 194 that is shorter than the minimum clock pulse width of flip-flop 192 does not cause the output from umbrella monitoring system 190 to be disabled.

[0095] The assertion of a high voltage output disable ("HV_DISABLED") signal is illustratively provided to the discharge switch system 130 to disable the voltage pulse switch activation of the electrode. In the exemplary embodiment, the disable output signal is provided to the driver 131 and indirectly changes the on / off operation of the gate switch 132. Such a disable output signal is illustratively provided to the low voltage power supply (e.g., the buck regulator system 124) and the high voltage module (e.g., the converter system 122).

[0096] Thus, logic gate 194 receives the monitoring signals discussed above, including: (1) energy storage system overvoltage ("VCAP1_OVER#") from voltage monitoring system 180, (2) high voltage warning ("HV_WD0#") from the watchdog system, and in some embodiments, (3) overcurrent ("ISNS_OVER#") may be received from the current monitoring system. These monitoring signals are also connected to a three-input AND logic gate upstream of a D flip-flop with asynchronous set and reset capabilities, so that any signal that is valid for longer than the minimum pulse width of the flip-flop will cause its output to be valid. These signals propagate downstream and inhibit the operation of gate drivers, variable low voltage power supplies, high voltage modules, and slightly alter the turn-on and turn-off operation of switching devices through transistors. This system allows any of the monitoring signals to disable the system output if it is valid for longer than an established duration.

[0097] Within the present disclosure, the ability to operate on either AC grid power or battery DC power provides versatility in power and control for IVL treatment. Unlike known IVL systems, certain embodiments of the present disclosure can avoid idling until fully (or substantially) recharged in order to be used in IVL treatment, for example, if the battery is insufficiently charged when IVL treatment is needed. Thus, using embodiments of the present disclosure can avoid such costly delays or interruptions in surgery. The electrical pulse generating system 20 illustratively includes a battery energy storage system and is configured to selectively charge the energy storage system 112 solely from battery stored energy, either from a battery energy storage system connected to a grid power source (such as an outlet), or directly from DC power converted from AC grid power (without passing through the battery energy storage system). When plugged into AC grid power, conditioned DC power is delivered directly to the high-voltage system. In operating conditions where the current demand for IVL operation is high, the battery energy storage system charging current can be reduced to allow for higher IVL operating system current. When not plugged into AC grid power, battery power can be delivered directly to the energy storage system 112. In an exemplary embodiment, the electrical pulse generation system 20 may include power management systems and devices, including, for example, inverters, regulators, power storage devices, and / or related aspects, to provide suitable power to the IVL control system 22 .

[0098] Examples of suitable processors may include one or more microprocessors, integrated circuits, systems on a chip (SoCs), and the like. Examples of suitable memory may include one or more primary and / or non-primary storage (e.g., secondary, tertiary, etc. storage); permanent, semi-permanent, and / or temporary storage; and / or memory storage devices, including, but not limited to, hard disk 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, and the like. Communication circuitry 58 includes components for facilitating processor operations. For example, suitable components may include transmitters, receivers, modulators, demodulators, filters, modems, analog / 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 treatment operations. For example, each memory device (e.g., 154, 178) may be included as part of memory 26, shared with, or isolated from memory 26.

[0099] Throughout this disclosure, consideration of a set of discharge electrodes has been discussed in the context of a pair of electrodes, where, in a given example, one electrode can function as a cathode and the other electrode can function as an anode. However, the number of electrodes in a set can be greater than a pair, for example, including one or more cathodes in communication with one or more anodes. Furthermore, the devices, systems, and methods within this disclosure can include more than one set of communication electrodes, whether arranged in series, in parallel, or electrically independent of one another.

[0100] In a given IVL treatment cycle, the power control operations disclosed herein can be applied equally, simultaneously and / or sequentially to individual electrode groups or groups. For example, a threshold current value can be applied commonly to all deployed electrodes or a single electrode group or group. In a given IVL treatment cycle, determinations made regarding power control can be applied equally to related electrodes, or can be personalized for groups or groups of electrodes. Within the present disclosure, support components (such as power supplies, sensors, and other implementation structures and / or features) for performing IVL operations as disclosed herein are implemented as sub-portions of the electrical pulse generating system 20 and / or IVL control system 22, for example, as part of circuitry and / or instructions.

[0101] Now refer to Figure 6 , shows an exemplary flow chart of another embodiment of the control 200 in the operation of an embodiment of the IVL system, specifically showing the number of voltage pulses generated and the amplitude of the pulses generated. It should be understood that the controller 200 can be used in conjunction with the above-mentioned control 200. Figures 1 to 5 Aspects of the described control system and method embodiments are combined.

[0102] The control operation of the control 200 can be controlled by the electrical pulse generating system 20 and illustratively by the above combined Figure 1 The IVL control system 22 discussed herein can be controlled by the IVL control system 22. As further discussed herein, the control system 22 can control the number of voltage pulses generated in a series (or multiple series) of voltage pulses. The acceptable voltage window includes a predetermined starting voltage amplitude and a predetermined upper voltage amplitude. The IVL control system further includes a predetermined voltage amplitude for incrementally increasing the voltage amplitude after each sequence of voltage pulses if the amplitude of the voltage pulses performed is within the acceptable voltage window. Separate predetermined control data sets can be provided in the control system 22 for an IVL system that includes balloons having identifiable characteristics, such as, but not limited to, different sizes, for example, 2.5 mm, 3.0 mm, 3.5 mm, and / or 4.0 mm.

[0103] An exemplary embodiment of an IVL system may include a 2.5 mm or 3.0 mm balloon, wherein the control system 22 includes control data including an exemplary starting target voltage of 3000 V (a predetermined lower voltage threshold), the voltage pulse train including an exemplary 10 pulses, and an exemplary incremental voltage increase of 25 V if the voltage pulse train amplitude is less than an exemplary upper voltage threshold of 3500 V. As will be appreciated by those skilled in the art, the incremental voltage increase may include any voltage amplitude, including but not limited to within 1 V to 250 V. The exemplary voltage increase may include 25 V, but may be greater or less than 25 V in certain embodiments. As will be appreciated by those skilled in the art, the predetermined starting voltage may be less than 3000 V, and the predetermined upper voltage threshold may be greater than 3500 V. Thus, exemplary starting voltages may include but are not limited to 2500 V, and the exemplary upper voltage threshold may include 4100 V. In other embodiments, the exemplary predetermined starting voltage may be greater than 3000 V, and the exemplary upper voltage threshold may be greater than 3250 V.

[0104] Another exemplary embodiment may include a 3.5 mm or 4.0 mm balloon, wherein the control system 22 includes control data including an exemplary starting target voltage of 3250 V (a predetermined lower voltage threshold), the voltage pulse train includes 10 pulses, and the incremental voltage is increased by 25 V if the voltage pulse train amplitude is less than an exemplary predetermined upper voltage threshold of 3700 V.

[0105] Continue to refer Figure 1 And in some embodiments continue to refer to Figure 2 , Figure 6The activation of the voltage pulse generation and control system 200 is shown starting at block 202, which entails determining a particular balloon characteristic of interest, such as the outer diameter ("OD") of the balloon for the IVL system. In a first embodiment, if the balloon's OD is, for example, 2.5 mm or 3.5 mm, then in block 204, the starting voltage is set to 3000 V, also referred to as the predetermined lower voltage threshold of the acceptable voltage amplitude window. In block 206, IVL treatment is initiated by applying a series of voltage pulses (or shocks) from the electrical pulse generation system 20, wherein each voltage pulse propagates to the electrode 18 within the balloon 16. If, in block 208, the target voltage amplitude does not reach the predetermined upper voltage threshold (e.g., 3500 V), then, as in block 109, the target voltage is increased by an exemplary 25 V (from 3000 V to 3025 V), and another series of voltage pulses (in this case, 10 pulses), such as 3025 V in block 210, is performed. This process continues to loop between blocks 208, 209, and 210 until the target voltage is 3500V. When the target threshold voltage or a predetermined upper voltage threshold is reached, and / or in some embodiments, a predetermined maximum or desired number of voltage pulses (e.g., 300 pulses (or surges)) has been generated, the control system 22 determines whether the number of voltage pulses (or surges) generated in the plurality of series of voltage pulses has reached the maximum or desired number of pulses, e.g., 300 voltage pulses, as shown in block 212. If the maximum or desired (e.g., 300) voltage pulse threshold has not been reached, another series (e.g., 10) of voltage pulses (or surges) is applied, as shown in block 214. When the maximum or desired threshold, e.g., 300 voltage pulses, has been reached, no additional voltage pulses (or surges) are allowed, as shown in block 216.

[0106] The predetermined maximum number of voltage pulses in various embodiments of the present disclosure can be in the range of 10 to 300 voltage pulses. The exemplary embodiments discussed herein include a predetermined maximum number of voltage pulses equal to 300 pulses. In other embodiments, the maximum number of voltage pulses can be greater than 300 pulses.

[0107] In the second embodiment, continue to refer to Figure 1 And in some embodiments continue to refer to Figure 2If, in block 202, it is determined that the outer diameter of the balloon is, for example, 3.5 mm or 4.0 mm, the electrical pulse generating system 20 begins treatment at block 118, setting the starting voltage to 3250 V, also referred to as the predetermined lower voltage threshold of the acceptable voltage amplitude window. In block 220, IVL treatment is initiated by applying a series of voltage pulses from the electrical pulse generating system 20, wherein each voltage pulse propagates to the electrode 18 within the balloon 16. If, in block 222, the target voltage amplitude does not reach the predetermined upper voltage threshold (e.g., 3500 V), the target voltage is increased by, for example, 25 V (from 3250 V to 3275 V), as in block 223, and another series of voltage pulses (in this case, 10 pulses) is performed, such as 3275 V in block 224. This process continues to cycle through blocks 222, 223, and 224 until the target voltage is 3700 V. When the target threshold voltage or a predetermined upper voltage threshold is reached, and / or in some embodiments, a maximum or desired number of pulses (e.g., 300 pulses (or shocks, when applied to one or more pairs of spaced-apart electrodes)) has been generated, the control system 22 determines whether the number of voltage pulses (or shocks) generated in the plurality of series of voltage pulses has reached the maximum or desired number of pulses, e.g., 300 voltage pulses, as shown in block 212. If the maximum or desired (e.g., 300) voltage pulse threshold has not been reached, another series (e.g., 10) of voltage pulses (or shocks) is applied, as shown in block 214. When the maximum or desired threshold, e.g., 300 voltage pulses, has been reached, no additional voltage pulses (or shocks) are permitted, as shown in block 216.

[0108] Alternatively, a physician performing IVL treatment according to the voltage pulse generation and control system 200 may determine at some point during the treatment that the treatment is complete. If the treatment is determined to be complete, the physician may terminate the voltage pulse generation and control system 200 process at any point.

[0109] In some embodiments, the voltage pulse generation and control system 200 may include a system according to the above combined Figure 2The discussed embodiments modify the duration of the applied voltage within or across one or more series of voltage pulses in a plurality of series of voltage pulses. For example, the duration can be increased or decreased by a predetermined duration interval, which is illustratively implemented as a fixed value, such as 0.5 microseconds. In some embodiments, the predetermined interval for a given cycle can be determined based on factors such as the number of treatment cycles that have previously occurred during the treatment session (e.g., the number of series of voltage pulses that have been performed by performing blocks 206, 208, and 210 or blocks 220, 222, and 224), patient characteristics, environmental conditions, surgical approach, and / or product cycle life (i.e., operating life), among other factors. In some embodiments, the predetermined duration interval for a given cycle can be changed by a predetermined rate of change, for example, by a percentage gain or loss of the cycle.

[0110] Figure 7 A graphical comparison of a KNOWN IVL device (KNOWN) comprising 2.5 mm and 4.0 mm OD balloons and an IVL device according to the present disclosure (TEST) comprising 2.5 mm and 4.0 mm OD balloons is presented.

[0111] The KNOWN device allowed for the generation of 80 voltage pulses or shocks. The TEST device generated 300 voltage pulses or shocks. During the comparative test, for each voltage pulse, the peak voltage amplitude of each tested device was obtained and plotted. The KNOWN device provided a relatively flat or constant voltage for each voltage pulse or shock number and started with a lower voltage amplitude than the TEST device. The test device was operated and controlled according to the embodiments disclosed herein (e.g., as shown in FIG3 ).

[0112] In contrast, each of the TEST devices of 2.5mm and 4.0mm starts with a voltage amplitude higher than the KNOWN device. The TEST device of 2.5mm starts with a voltage lower than the device of 4.0mm. As shown in the figure, the TEST device voltage (lower data cluster) of 2.5mm and 4.0mm slowly rises on the voltage pulse produced, reaches steady at about 180 pulses, and thereafter keeps substantially flat or constant. Returning to reference figure 3, this increase voltage, followed by the pattern of flat or constant voltage region conforms to frame 104 to 110 (2.5mm) and frame 118 to 124 (4.0mm). In each case, the average voltage of the TEST device of 4.0mm is greater than the average voltage of the TEST device of 2.5mm.

[0113] Figure 8A comparison of the TEST IVL device and the KNOWN IVL device is shown, along with a subset of the data from FIG4 , i.e., a comparison of the first 80 voltage pulses for each device. Here, the voltage pulses (or number of impulses) are compared to the average pressure generated during each voltage pulse. The KNOWN data (having a constant voltage in each voltage pulse as in FIG3 ) presents (dashed line) a relatively severe decrease in pressure output as the voltage pulses progress over time. In contrast, the TEST data (solid line) obtained using the voltage and pulse generation algorithm of FIG3 presents a pressure output line that decreases at a much smaller angle or slope. Therefore, the pressure output of the TESTIVL device provides a more stable or constant pressure output than the KNOWN IVL device. The KNOWN IVL device has a significant pressure output decay as the voltage pulses progress. More specifically, the TESTIVL device provides a reduction in pressure output of less than 0.25 MPa over 80 pulses.

[0114] The pressure output of the test was measured in vitro using a pressure sensor (hydrophone) located externally on the catheter balloon within the acoustic field generated by the device's pulse delivery. The test device and hydrophone were immersed in degassed deionized water maintained at approximately body temperature.

[0115] This idea in Figure 9 This is further demonstrated in , where the average pressure generated by 80 pulses of the KNOWN IVL device (2.5 mm and 4.0 mm) with a constant voltage amplitude was compared to the average pressure generated by the TEST IVL device (2.5 mm and 4.0 mm) according to the voltage pulse and control method of Figure 3.

[0116] like Figure 9 As shown, both the KNOWN 2.5mm and 4.0mm devices provided a severely reduced pressure output slope line as the voltage pulses progressed to 80 pulses. In contrast, the TEST 2.5mm and 4.0mm devices provided a relatively flat, constant, or stable pressure output slope line as the voltage pulses progressed to 300 pulses. In addition, the slope of the TEST pressure output line appeared to increase slightly as the voltage pulses progressed, which may be beneficial in disrupting difficult-to-treat calcified areas. Similarly, the KNOWN IVL device had a clear and significant pressure output decay at 80 pulses. The TEST IVL device had no pressure decay at 300 voltage pulses.

[0117] In summary, an IVL device operated and controlled in accordance with the present disclosure provides increasing voltage to voltage pulses until an upper voltage amplitude threshold is reached. The voltage is then advanced at the upper voltage amplitude threshold until 300 pulses have been performed, or the treatment is physically determined to be complete. As shown above, this results in a constant and / or slightly increasing pressure output from each voltage pulse. The pressure output amplitude and associated slope can be manipulated by modifying the amplitude of each incremental increase in voltage. In some embodiments, the voltage amplitude can be incrementally increased as in FIG3 . In other embodiments, the voltage amplitude can be incrementally increased for at least two sequences of voltage pulses, then maintained constant for one or more voltage pulses, and then the subsequent sequence of voltage pulses can resume the incremental increase in amplitude. In other embodiments, the voltage amplitude can be reduced for one or more series of voltage pulses. All combinations of voltage increases, voltage decreases, 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.

[0118] Furthermore, with reference to the above disclosure, various embodiments of the present disclosure can provide substantially the same pressure output for all balloon sizes, wherein the balloon size can be in the range of 2 mm to 4 mm outer diameter. In these embodiments, a larger balloon size does not necessarily result in a lower pressure output than a relatively smaller balloon size.

[0119] Figure 8 and Figure 9 data, and combined Figure 6 The pressure amplitude output control 200 also demonstrates that the IVL device operated according to the present disclosure is also capable of stable operation and pressure output over at least 300 voltage pulses. This is in contrast to the significant pressure decay of the known IVL device over only 80 voltage pulses.

[0120] also, Figure 8 and Figure 9 data, combined with Figure 6 The pressure amplitude output control 200, confirmed Figure 1 The IVL control system 22 shown is controllable such that the pressure output following an arcing event between two spaced-apart electrodes can be controlled within upper and lower pressure amplitude thresholds or pressure magnitude windows. Further, embodiments of the present disclosure can be used to control the pressure output in a mode of increasing pressure throughout the procedure, decreasing pressure throughout the procedure, constant pressure throughout the procedure, and any combination thereof.

[0121] Examples of suitable processors may include one or more microprocessors, integrated circuits, systems on a chip (SoCs), and the like. Examples of suitable memory may include one or more primary and / or non-primary storage (e.g., secondary, tertiary, etc. storage); permanent, semi-permanent, and / or temporary storage; and / or memory storage devices, including, but not limited to, hard disk 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, and the like. Communication circuitry 58 includes components for facilitating processor operations. For example, suitable components may include transmitters, receivers, modulators, demodulators, filters, modems, analog / 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 treatment operations. For example, each memory device (e.g., 154, 178) may be included as part of memory 26, shared with, or isolated from memory 26.

[0122] Throughout this disclosure, consideration of a set of discharge electrodes has been discussed in the context of a pair of electrodes, where, in a given example, one electrode can function as a cathode and the other electrode can function as an anode. However, the number of electrodes in a set can be greater than a pair, for example, including one or more cathodes in communication with one or more anodes. Furthermore, the devices, systems, and methods within this disclosure can include more than one set of communication electrodes, whether arranged in series, in parallel, or electrically independent of one another.

[0123] Figure 10An exemplary flow chart illustrating an exemplary method 400 according to one embodiment of the present invention is provided. Thus, step 402 is used to determine the outer diameter (OD) of the balloon of the subject IVL device. This can be accomplished manually by accessing the IVL control system discussed above. Alternatively, connecting a catheter to the IVL control system can provide for automatic detection and determination of the balloon's OD. Step 404 is used to establish an acceptable voltage pulse window, as described above, including predetermined lower and upper voltage amplitude thresholds that can be stored in the IVL control system. Step 406 is used to execute a series of voltage pulses to be controlled and generated by the IVL control system, which in an illustrative and exemplary case may be 10 pulses, at the predetermined lower voltage amplitude threshold. Step 408 provides that if the IVL control system determines that the last series of voltage pulses executed was not executed at the predetermined upper voltage threshold target, the IVL control system may instruct the execution and generation of another series of voltage pulses. Step 410 provides that if the IVL control system determines that the last series of voltage pulses executed was executed at the predetermined upper voltage threshold target, the IVL control system attempts to determine whether an illustrative and exemplary 300 voltage pulses have been executed during the current treatment. If, according to step 412, it is determined that 300 voltage pulses have been performed, the IVL control system stops the procedure and does not allow further voltage pulses to be generated. On the other hand, if 300 voltage pulses have not been performed, the IVL control system instructs that another series of voltage pulses be performed at a predetermined upper voltage threshold target amplitude.

[0124] 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 generated by the embodiments may be in the range of 1 to 5 pulses / second.

[0125] Exemplary embodiments

[0126] The present disclosure supports the following non-limiting and exemplary embodiments.

[0127] Example embodiment set 1:

[0128] 1. An intravascular lithotripsy system comprising:

[0129] at least one set of electrodes, the at least one set of electrodes being configured to be disposed within a body cavity and disposed within the inflatable balloon;

[0130] An electric pulse generating system for providing electrical energy to at least one set of electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electric pulse generating system comprising an IVL control system, the IVL control system comprising a processor for executing instructions stored on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0131] generating an initial series of voltage pulses to at least one set of electrodes, wherein the amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage set at a predetermined lower voltage amplitude threshold,

[0132] Determine whether a threshold parameter has been reached, and

[0133] In response to determining that the threshold parameter has not been met, increasing the voltage amplitude by a predetermined amount, and

[0134] Another series of voltage pulses at increasing voltage amplitudes is generated for application to at least one set of electrodes.

[0135] 2. The intravascular lithotripsy system of embodiment 1, wherein the IVL control system is configured to continue determining whether the threshold parameter is reached after each generated series of voltage pulses.

[0136] 3. The intravascular lithotripsy system according to embodiment 2, wherein the threshold parameter includes a predetermined upper voltage amplitude threshold.

[0137] 4. The intravascular lithotripsy system of embodiment 3, wherein the IVL control system is configured to determine whether the number of generated voltage pulses does not exceed a predetermined maximum number of voltage pulses.

[0138] 5. The intravascular lithotripsy system of embodiment 3, wherein the predetermined maximum number of voltage pulses is in the range of 10 to 300 voltage pulses.

[0139] 6. An intravascular lithotripsy system according to embodiment 4, wherein if 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 amplitude threshold.

[0140] 7. The intravascular lithotripsy system of embodiment 4, wherein if the IVL control system determines that a predetermined number of voltage pulses have been generated, no additional voltage pulses are performed.

[0141] 8. The intravascular lithotripsy system of any one of embodiments 1 to 7, wherein the IVL control system is configured to define an acceptable voltage amplitude window, the acceptable voltage amplitude window comprising a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold.

[0142] 9. An intravascular lithotripsy system, wherein the acceptable voltage amplitude window is different for balloons of different outer diameters.

[0143] 10. The intravascular lithotripsy system according to embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 2500V for a balloon having an outer diameter of 2.5mm.

[0144] 11. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 2500V for a balloon having an outer diameter of 3.0 mm.

[0145] 12. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 2500V for a balloon having an outer diameter of 3.5mm.

[0146] 13. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 2500V for a balloon having an outer diameter of 4.0 mm.

[0147] 14. The intravascular lithotripsy system according to embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 3000V for a balloon having an outer diameter of 2.5mm.

[0148] 15. The intravascular lithotripsy system according to Example 9, wherein the predetermined lower voltage amplitude threshold is approximately 3000V for a balloon having an outer diameter of 3.0 mm.

[0149] 16. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 3000V for a balloon having an outer diameter of 3.5mm.

[0150] 17. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 3000V for a balloon having an outer diameter of 4.0 mm.

[0151] 18. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is less than about 3000V for a balloon having an outer diameter of 2.0 mm.

[0152] 19. The intravascular lithotripsy system of embodiment 9, wherein the predetermined upper voltage amplitude threshold is less than about 3000V for a balloon having an outer diameter of 2.5mm.

[0153] 20. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is less than about 3000V for a balloon having an outer diameter of 3.0 mm.

[0154] 21. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is less than about 3000V for a balloon having an outer diameter of 3.5mm.

[0155] 22. The intravascular lithotripsy system of Example 9, wherein the predetermined lower voltage amplitude threshold is less than about 3000V for a balloon having an outer diameter of 4.0 mm.

[0156] 23. The intravascular lithotripsy system of embodiment 9, wherein the predetermined upper voltage amplitude threshold is greater than about 3000V for a balloon having an outer diameter of 2.5mm.

[0157] 24. The intravascular lithotripsy system of Example 9, wherein the predetermined upper voltage amplitude threshold is greater than about 3000V for a balloon having an outer diameter of 3.0 mm.

[0158] 25. The intravascular lithotripsy system of embodiment 9, wherein the predetermined upper voltage amplitude threshold is greater than about 3000V for a balloon having an outer diameter of 3.5mm.

[0159] 26. The intravascular lithotripsy system of Example 9, wherein the predetermined upper voltage amplitude threshold is greater than about 3000V for a balloon having an outer diameter of 4.0 mm.

[0160] 27. The intravascular lithotripsy system of any one of embodiments 9 to 26, wherein the predetermined upper voltage amplitude threshold is greater than about 3250V for a balloon having an outer diameter of 2.5mm.

[0161] 28. The intravascular lithotripsy system of any one of embodiments 9 to 26, wherein the predetermined upper voltage amplitude threshold is greater than about 3250V for a balloon having an outer diameter of 3.0 mm.

[0162] 29. The intravascular lithotripsy system of any one of embodiments 9 to 26, wherein the predetermined upper voltage amplitude threshold is greater than about 3250V for a balloon having an outer diameter of 3.5 mm.

[0163] 30. The intravascular lithotripsy system of any one of embodiments 9 to 26, wherein the predetermined upper voltage amplitude threshold is greater than about 3250V for a balloon having an outer diameter of 4.0 mm.

[0164] 31. An intravascular lithotripsy system according to any one of embodiments 1 to 30, wherein the IVL control system is configured to determine whether the target voltage is not at a predetermined upper limit voltage amplitude target of a series of voltage pulses previously performed, and to increase the target voltage amplitude by a predetermined amount when it is determined that the target voltage is not at the predetermined upper limit voltage amplitude target.

[0165] 32. The intravascular lithotripsy system of embodiment 31, wherein the predetermined amount by which the voltage amplitude is increased is in the range of 1 to 250V.

[0166] 33. The intravascular lithotripsy system of any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by 25V when the target voltage is not at a predetermined upper voltage amplitude target of a previously performed series of voltage pulses.

[0167] 34. The intravascular lithotripsy system of any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by more than 25V when the target voltage is not at a predetermined upper voltage amplitude target of a previously performed series of voltage pulses.

[0168] 35. The intravascular lithotripsy system according to any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by less than 25V when the target voltage is not at the predetermined upper voltage amplitude target of 25V of a previously performed series of voltage pulses.

[0169] 36. The intravascular lithotripsy system of any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by 25V when the target voltage is not at a predetermined upper voltage amplitude target of a previously executed voltage pulse.

[0170] 37. The intravascular lithotripsy system of any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by more than 25V when the target voltage is not at a predetermined upper voltage amplitude target of a previously performed voltage pulse.

[0171] 38. The intravascular lithotripsy system of any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by less than 25V when the target voltage is not at the predetermined upper voltage amplitude target of 25V of a previously performed series of voltage pulses.

[0172] 39. The intravascular lithotripsy system of any one of embodiments 1 to 38, wherein the average decay or decrease in pressure output over a predetermined maximum number of voltage pulses does not exceed 0.25 MPa.

[0173] 40. The intravascular lithotripsy system of any one of embodiments 1 to 38, wherein the average decay or decrease in pressure output within the range of 10 to 300 voltage pulses does not exceed 0.25 MPa.

[0174] 41. The intravascular lithotripsy system of any one of embodiments 1 to 38, wherein the pressure output of a last voltage pulse of the predetermined maximum number of voltage pulses is greater than the pressure output of the first voltage pulse.

[0175] 42. The intravascular lithotripsy system according to any one of embodiments 1 to 41, wherein the slope of the pressure output of the voltage pulse increases with time.

[0176] 43. The intravascular lithotripsy system of any one of embodiments 1 to 40, wherein the slope of the pressure output of the voltage pulse decreases over time.

[0177] 44. The intravascular lithotripsy system of any one of embodiments 1 to 40, wherein the slope of the pressure output of the voltage pulse is indicative of a constant pressure amplitude output across the voltage pulse.

[0178] 45. The intravascular lithotripsy system according to any one of embodiments 1 to 44, wherein a plurality of trains of voltage pulses are generated.

[0179] 46. The intravascular lithotripsy system according to any one of embodiments 1 to 45, wherein the one or more voltage pulses in the series of voltage pulses comprises 10 voltage pulses.

[0180] 47. The intravascular lithotripsy system according to any one of embodiments 1 to 45, wherein one or more voltage pulses in the series of voltage pulses comprises more than 10 voltage pulses.

[0181] 48. The intravascular lithotripsy system according to any one of embodiments 1 to 45, wherein one or more voltage pulses in the series of voltage pulses comprises less than 10 voltage pulses.

[0182] 49. A method for generating and controlling voltage pulses, comprising:

[0183] providing a device according to any one of embodiments 1 to 48;

[0184] Determine the outer diameter of the device's balloon;

[0185] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0186] performing a first series of voltage pulses at a predetermined lower voltage amplitude threshold;

[0187] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0188] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold;

[0189] determining that a predetermined number of voltage pulses have not been performed; and

[0190] continuing to perform the one or more series of voltage pulses at the upper voltage amplitude threshold until a predetermined number of voltage pulses are determined to have been performed; and

[0191] Stops the execution of the voltage pulse.

[0192] 50. A method for generating and controlling voltage pulses, comprising:

[0193] providing a device according to any one of embodiments 1 to 48;

[0194] Determine the outer diameter of the device's balloon;

[0195] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0196] performing a first series of voltage pulses at a predetermined lower voltage amplitude threshold;

[0197] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0198] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold;

[0199] determining that a predetermined number of voltage pulses have been performed; and

[0200] Stops the execution of the voltage pulse.

[0201] 51. A method for generating and controlling a voltage pulse, the voltage pulse producing a stable and substantially constant pressure output, the method comprising:

[0202] providing a device according to any one of embodiments 1 to 48;

[0203] Determine the outer diameter of the device's balloon;

[0204] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0205] performing a first series of voltage pulses at a predetermined lower voltage amplitude threshold;

[0206] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0207] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold; and

[0208] A pressure output is generated for each voltage pulse, the pressure output comprising a stable and substantially constant amplitude.

[0209] 52. The method of embodiment 51, wherein the pressure output is generated by 10 to at least 300 voltage pulses.

[0210] 53. A method for generating and controlling voltage pulses, the voltage pulses producing a pressure output that increases from a first voltage pulse to a last voltage pulse, the method comprising: providing an apparatus according to any one of embodiments 1 to 48;

[0211] Determine the outer diameter of the device's balloon;

[0212] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0213] performing a first series of voltage pulses at a predetermined lower voltage amplitude threshold;

[0214] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0215] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold; and

[0216] A pressure output is generated for each voltage pulse, the pressure output comprising an increasing amplitude from the first voltage pulse to the last voltage pulse.

[0217] 54. The method of embodiment 53, wherein the pressure output is generated by 10 to at least 300 voltage pulses.

[0218] 55. The method of any one of embodiments 49 to 54, wherein the voltage pulses are generated at a frequency in the range of 1 to 5 pulses / second.

[0219] 56. The method of embodiment 55, wherein the voltage pulse frequency comprises 2 pulses / second.

[0220] 57. The method of embodiment 55, wherein the voltage pulse frequency comprises 3 pulses / second.

[0221] 58. The method of any one of embodiments 49 to 57, wherein the pressure output of a first balloon comprising an outer diameter is not less than the pressure output of a second balloon comprising an outer diameter that is less than the outer diameter of the first balloon.

[0222] Example embodiment set 2:

[0223] 1. An intravascular lithotripsy system having a controlled, stable and constant pressure output over a series of voltage pulses, comprising:

[0224] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while disposed within a fluid-fillable member configured to contain a conductive fluid therein;

[0225] An electrical pulse generating system for providing electrical energy to at least one set of spaced-apart electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system comprising an IVL control system, the IVL control system comprising a processor configured to execute instructions stored on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0226] generating an initial plurality of voltage pulses to at least one set of spaced-apart electrodes, the plurality of voltage pulses comprising an initial series of voltage pulses, wherein an amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage initially set at a predetermined lower voltage amplitude threshold, wherein one or more voltage pulses in the generated plurality of voltage pulses generates a pressure wave,

[0227] generating one or more subsequent series of voltage pulses, each subsequent series comprising a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount,

[0228] wherein each of the plurality of generated pressure waves comprises a pressure amplitude output, and

[0229] The IVL control system is configured to control the pressure amplitude output of the plurality of pressure waves so that the pressure amplitude output decays or decreases by no more than a predetermined amount on average over the plurality of pressure waves.

[0230] 2. An intravascular lithotripsy system having a controlled, stable and constant pressure output over a series of voltage pulses, comprising:

[0231] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while disposed within a fluid-fillable member configured to contain a conductive fluid therein;

[0232] 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 comprising an IVL control system, the IVL control system comprising a processor configured to execute instructions stored on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0233] generating an initial plurality of voltage pulses to at least one set of spaced-apart electrodes, the plurality of voltage pulses comprising an initial series of voltage pulses, wherein an amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage initially set at a predetermined lower voltage amplitude threshold, wherein one or more voltage pulses in the generated plurality of voltage pulses generates a pressure wave,

[0234] generating one or more subsequent series of voltage pulses, each subsequent series comprising a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount,

[0235] wherein each of the plurality of generated pressure waves comprises a pressure amplitude output, and

[0236] The IVL control system is configured to control the target voltage so that the pressure amplitude output does not decay or decrease by more than a predetermined amount on average over a plurality of pressure waves.

[0237] 3. A method for generating and controlling voltage pulses that produce a stable and substantially constant controlled pressure output over a series of voltage pulses in an intravascular lithotripsy system, the method comprising:

[0238] Providing an intravascular lithotripsy system according to Example 2;

[0239] Determine the outer diameter of the balloon of the intravascular lithotripsy system;

[0240] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0241] performing a first series of voltage pulses at a predetermined lower voltage amplitude threshold;

[0242] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0243] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold; and

[0244] A plurality of pressure waves are generated, each pressure wave comprising a pressure output, the pressure output comprising a pressure amplitude controlled not to decay or drop more than a predetermined amount averaged over the plurality of pressure waves.

[0245] 4. An intravascular lithotripsy system having a controlled pressure output amplitude over a series of voltage pulses, comprising:

[0246] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while disposed within a fluid-fillable member configured to contain a conductive fluid therein;

[0247] An electrical pulse generating system for providing electrical energy to at least one set of spaced-apart electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system comprising an IVL control system, the IVL control system comprising a processor configured to execute instructions stored on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0248] generating an initial plurality of voltage pulses to at least one set of spaced-apart electrodes, the plurality of voltage pulses comprising an initial series of voltage pulses, wherein an amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage initially set at a predetermined lower voltage amplitude threshold, wherein one or more voltage pulses in the generated plurality of voltage pulses generates a pressure wave,

[0249] generating one or more subsequent series of voltage pulses, each subsequent series comprising a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount,

[0250] wherein each of the plurality of generated pressure waves comprises a pressure amplitude output, and

[0251] The IVL control system is configured to control the pressure amplitude output to be within a predetermined upper threshold amplitude and a predetermined lower threshold amplitude over a plurality of pressure waves.

[0252] 5. An intravascular lithotripsy system having a controlled pressure output amplitude over a series of voltage pulses, comprising:

[0253] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while disposed within a fluid-fillable member configured to contain a conductive fluid therein;

[0254] An electrical pulse generating system for providing electrical energy to at least one set of spaced-apart electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system comprising an IVL control system, the IVL control system comprising a processor configured to execute instructions stored on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0255] generating an initial plurality of voltage pulses to at least one set of spaced-apart electrodes, the plurality of voltage pulses comprising an initial series of voltage pulses, wherein an amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage initially set at a predetermined lower voltage amplitude threshold, wherein one or more voltage pulses in the generated plurality of voltage pulses generates a pressure wave,

[0256] generating one or more subsequent series of voltage pulses, each subsequent series comprising a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount,

[0257] wherein each of the plurality of generated pressure waves comprises a pressure amplitude output, and

[0258] The IVL control system is configured to control the target voltage within predetermined upper and lower thresholds, and is further configured to control the resulting pressure wave output within predetermined upper and lower threshold amplitudes over the plurality of pressure waves.

[0259] 6. A method for controlling the pressure output amplitude over a series of voltage pulses generated by an intravascular lithotripsy system, comprising:

[0260] There is provided an intravascular lithotripsy system according to Example 5, wherein the fluid-filled member comprises a balloon;

[0261] Determine the outer diameter of the balloon of the intravascular lithotripsy system;

[0262] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0263] performing a first series of voltage pulses at a predetermined lower voltage amplitude threshold;

[0264] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0265] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold; and

[0266] A plurality of pressure waves are generated, each pressure wave comprising a pressure output, the pressure output comprising a pressure amplitude that is controlled not to decay or decrease such that the pressure output over the plurality of pressure waves remains above a predetermined pressure amplitude.

[0267] 7. An intravascular lithotripsy system having a controlled pressure output over a plurality of voltage pulses, comprising:

[0268] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while disposed within a fluid-fillable member configured to contain a conductive fluid therein;

[0269] An electrical pulse generating system for providing electrical energy to at least one set of spaced-apart electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system comprising an IVL control system, the IVL control system comprising a processor configured to execute instructions stored on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0270] generating an initial plurality of voltage pulses to at least one set of electrodes, wherein the amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage initially set at a predetermined lower voltage amplitude threshold, wherein at least one voltage pulse in the generated plurality of voltage pulses generates a pressure wave,

[0271] determining that a predetermined maximum number of voltage pulses has not been performed; and

[0272] when it is determined that a predetermined maximum number of voltage pulses has not been performed, sequentially increasing the target voltage by a predetermined amount and performing an associated series of voltage pulses until it is determined that the target voltage satisfies a predetermined upper voltage threshold and / or it is determined that a predetermined maximum number of voltage pulses has been performed, wherein each of the plurality of generated pressure waves comprises a pressure amplitude output,

[0273] wherein the IVL control system is configured to control the pressure amplitude output over a plurality of pressure waves to be within a predetermined upper pressure amplitude threshold amplitude and a predetermined lower pressure amplitude threshold amplitude, and

[0274] When it has been determined that a predetermined maximum number of voltage pulses has been executed, execution of the voltage pulses is terminated.

[0275] 8. A method for generating and controlling voltage pulses that produce a stable and substantially constant controlled pressure output over a series of voltage pulses in an intravascular lithotripsy system, the method comprising:

[0276] There is provided an intravascular lithotripsy system according to embodiment 1, wherein the fluid-filled member comprises a balloon;

[0277] Determine the outer diameter of the balloon of the intravascular lithotripsy system;

[0278] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0279] performing a first series of voltage pulses at a predetermined lower voltage amplitude threshold;

[0280] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0281] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold;

[0282] generating a plurality of pressure waves, each pressure wave comprising a pressure output, the pressure output comprising a pressure amplitude, the pressure amplitude being controlled over the plurality of pressure waves within an upper pressure amplitude threshold amplitude and a lower pressure amplitude threshold amplitude;

[0283] determining that a predetermined maximum number of voltage pulses has not been performed; and

[0284] Terminates the execution of the voltage pulse.

[0285] 9. An intravascular lithotripsy system comprising a controlled increase in pressure output, comprising:

[0286] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while disposed within a fluid-fillable member configured to contain a conductive fluid therein;

[0287] An electrical pulse generating system for providing electrical energy to at least one set of spaced-apart electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system comprising an IVL control system, the IVL control system comprising a processor configured to execute instructions stored on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0288] generating an initial plurality of voltage pulses to at least one set of spaced-apart electrodes, the initial plurality of voltage pulses comprising an initial series of voltage pulses,

[0289] wherein the amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage initially set at a predetermined lower voltage amplitude threshold,

[0290] Among them, at least one of the multiple voltage pulses generated generates a pressure wave,

[0291] generating one or more subsequent series of voltage pulses, each subsequent series comprising a plurality of voltage pulses,

[0292] wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount,

[0293] wherein each of the plurality of generated pressure waves comprises a pressure amplitude output, and

[0294] Wherein, the IVL control system is configured to control the pressure amplitude output of the plurality of pressure waves such that the pressure amplitude output increases over the plurality of pressure waves.

[0295] 10. An intravascular lithotripsy system comprising a controlled increasing pressure output over a series of voltage pulses, comprising:

[0296] at least one set of electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while being disposed within a fluid-fillable member configured to contain a conductive fluid therein;

[0297] An electrical pulse generating system for providing electrical energy to at least one set of spaced-apart electrodes to generate a plurality of pressure waves 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 on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0298] generating an initial plurality of voltage pulses to at least one set of spaced-apart electrodes, the plurality of voltage pulses comprising an initial series of voltage pulses, wherein an amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage initially set at a predetermined lower voltage amplitude threshold, wherein one or more voltage pulses in the generated plurality of voltage pulses generates a pressure wave,

[0299] generating one or more subsequent series of voltage pulses, each subsequent series comprising a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount,

[0300] wherein each of the plurality of generated pressure waves comprises a pressure amplitude output, and

[0301] Therein, the IVL control system is configured to control the target voltage so that the pressure magnitude output is controlled to increase within a predetermined pressure amplitude window over a plurality of pressure waves.

[0302] 11. A method for generating and controlling a voltage pulse that produces a controlled reduced pressure output in an intravascular lithotripsy system, the method comprising:

[0303] There is provided an intravascular lithotripsy system according to Example 2, wherein the fluid-filled member comprises a balloon;

[0304] Determine the outer diameter of the balloon of the intravascular lithotripsy system;

[0305] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0306] performing a first series of one or more voltage pulses at a predetermined lower voltage amplitude threshold;

[0307] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0308] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold; and

[0309] A plurality of pressure waves are generated, each pressure wave comprising a pressure output, the pressure output comprising a pressure amplitude, the pressure amplitude being controlled to increase over the plurality of pressure waves.

[0310] 12. An intravascular lithotripsy system for producing a controlled reduced pressure output, comprising:

[0311] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while disposed within a fluid-fillable member configured to contain a conductive fluid therein;

[0312] An electrical pulse generating system for providing electrical energy to at least one set of spaced-apart electrodes to generate a plurality of pressure waves for intravascular lithotripsy (IVL) treatment, the electrical pulse generating system comprising an IVL control system, the IVL control system comprising a processor configured to execute instructions stored on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0313] generating an initial plurality of voltage pulses to at least one set of spaced-apart electrodes, the plurality of voltage pulses comprising an initial series of voltage pulses, wherein an amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage initially set at a predetermined lower voltage amplitude threshold, wherein one or more voltage pulses in the generated plurality of voltage pulses generates a pressure wave,

[0314] generating one or more subsequent series of voltage pulses, each subsequent series comprising a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount,

[0315] wherein each of the plurality of generated pressure waves comprises a pressure amplitude output, and

[0316] The IVL control system is configured to control the pressure amplitude output of the plurality of pressure waves such that the pressure amplitude output decays or decreases within a predetermined pressure amplitude window over the plurality of pressure waves.

[0317] 13. An intravascular lithotripsy system for producing a controlled reduced pressure output over a series of voltage pulses, comprising:

[0318] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while disposed within a fluid-fillable member configured to contain a conductive fluid therein;

[0319] An electrical pulse generating system for providing electrical energy to at least one set of spaced-apart electrodes to generate a plurality of pressure waves 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 on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0320] generating an initial plurality of voltage pulses to at least one set of electrodes, the plurality of voltage pulses comprising an initial series of voltage pulses, wherein an amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage initially set at a predetermined lower voltage amplitude threshold, wherein one or more voltage pulses in the generated plurality of voltage pulses generates a pressure wave,

[0321] generating one or more subsequent series of voltage pulses, each subsequent series comprising a plurality of voltage pulses, wherein the target voltage of each subsequent series of voltage pulses is increased by a predetermined amount,

[0322] wherein each of the plurality of generated pressure waves comprises a pressure amplitude output, and

[0323] The IVL control system is configured to control the target voltage so that the pressure magnitude output decreases within a predetermined pressure amplitude window over a plurality of pressure waves.

[0324] 14. A method for generating and controlling a voltage pulse that produces a controlled reduced pressure output in an intravascular lithotripsy system, the method comprising:

[0325] There is provided an intravascular lithotripsy system according to Example 2, wherein the fluid-filled member comprises a balloon;

[0326] Determine the outer diameter of the balloon of the intravascular lithotripsy system;

[0327] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0328] performing a first series of one or more voltage pulses at a predetermined lower voltage amplitude threshold;

[0329] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0330] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold; and

[0331] A plurality of pressure waves are generated, each pressure wave comprising a pressure output, the pressure output comprising a pressure amplitude controlled to decrease within a predetermined pressure amplitude window over the plurality of pressure waves.

[0332] Example embodiment set 3:

[0333] 1. An IVL system comprising

[0334] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while disposed within a fluid-fillable member configured to contain a conductive fluid therein;

[0335] An electrical pulse generating system for providing electrical energy to at least one set of spaced-apart electrodes to generate a plurality of pressure waves 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 on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0336] generating an initial plurality of voltage pulses to at least one set of electrodes, the plurality of voltage pulses comprising at least an initial series of voltage pulses, wherein an amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage initially set at a predetermined lower voltage amplitude threshold, wherein at least one voltage pulse in the generated plurality of voltage pulses generates a pressure wave,

[0337] Among them, the IVL control system is configured to control the pressure amplitude output over multiple pressure waves.

[0338] 2. The IVL system of embodiment 1, wherein the IVL control system is configured to control the pressure amplitude output, the pressure amplitude output being controlled to not decay or decrease by more than a predetermined amount over the plurality of pressure waves.

[0339] 3. The IVL system according to embodiment 2, wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds.

[0340] 4. The IVL system of embodiment 1, wherein the IVL control system is configured to control the pressure amplitude output to remain above a predetermined lower threshold over a plurality of pressure waves.

[0341] 5. The IVL system according to embodiment 4, wherein the IVL control system is configured to control the target voltage to be within predetermined upper and lower thresholds.

[0342] 6. The IVL system of embodiment 1, wherein the IVL control system is configured to control the pressure amplitude output to remain within a predetermined upper threshold and a predetermined lower threshold over a plurality of pressure waves.

[0343] 7. The IVL system according to embodiment 6, wherein the IVL control system is configured to control the target voltage to be within predetermined upper and lower thresholds.

[0344] 8. The IVL system of embodiment 1, wherein the IVL control system is configured to control the pressure amplitude output to remain at a substantially constant amplitude over the plurality of pressure waves.

[0345] 9. The IVL system according to embodiment 8, wherein the IVL control system is configured to control the target voltage to be within predetermined upper and lower thresholds.

[0346] 10. The IVL system of embodiment 1, wherein the IVL control system is configured to control the pressure amplitude output, the pressure amplitude output being controlled not to increase by more than a predetermined amount over the plurality of pressure waves.

[0347] 11. The IVL system according to embodiment 10, wherein the IVL control system is configured to control the target voltage within predetermined upper and lower thresholds.

[0348] 12. The IVL system of embodiment 1, wherein the IVL control system is further configured to terminate execution of the voltage pulses when a predetermined maximum number of voltage pulses has been determined to be executed.

[0349] Example embodiment set 4:

[0350] 1. An intravascular lithotripsy system comprising:

[0351] at least one set of electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while being disposed within a fluid-fillable member configured to contain a conductive fluid therein;

[0352] An electric pulse generating system for providing electrical energy to at least one set of electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electric pulse generating system comprising an IVL control system, the IVL control system comprising a processor for executing instructions stored on a memory, and circuitry configured to transmit signals based on the operation of the processor, the IVL control system being configured to:

[0353] generating an initial series of voltage pulses to at least one set of electrodes, wherein the amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage set at a predetermined lower voltage amplitude threshold,

[0354] Determine whether a threshold parameter has been reached, and

[0355] In response to determining that the threshold parameter has not been met, increasing the voltage amplitude by a predetermined amount, and

[0356] Another series of voltage pulses is generated at increased voltage amplitudes for application to at least one set of electrodes.

[0357] 2. The intravascular lithotripsy system of embodiment 1, wherein the IVL control system is configured to continue determining whether the threshold parameter is reached after each generated series of voltage pulses.

[0358] 3. The intravascular lithotripsy system according to embodiment 2, wherein the threshold parameter includes a predetermined upper voltage amplitude threshold.

[0359] 4. The intravascular lithotripsy system of embodiment 3, wherein the IVL control system is configured to determine whether the number of generated voltage pulses does not exceed a predetermined maximum number of voltage pulses.

[0360] 5. The intravascular lithotripsy system of embodiment 3, wherein the predetermined maximum number of voltage pulses is in the range of 10 to 300 voltage pulses.

[0361] 6. An intravascular lithotripsy system according to embodiment 4, wherein if 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 amplitude threshold.

[0362] 7. The intravascular lithotripsy system of embodiment 4, wherein if the IVL control system determines that a predetermined number of voltage pulses have been generated, no additional voltage pulses are performed.

[0363] 8. The intravascular lithotripsy system of any one of embodiments 1 to 7, wherein the IVL control system is configured to define an acceptable voltage amplitude window comprising a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold.

[0364] 9. The intravascular lithotripsy system of embodiment 8, wherein the acceptable voltage amplitude window is different for balloons of different outer diameters.

[0365] 10. The intravascular lithotripsy system according to embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 2500V for a balloon having an outer diameter of 2.5mm.

[0366] 11. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 2500V for a balloon having an outer diameter of 3.0 mm.

[0367] 12. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 2500V for a balloon having an outer diameter of 3.5mm.

[0368] 13. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 2500V for a balloon having an outer diameter of 4.0 mm.

[0369] 14. The intravascular lithotripsy system according to embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 3000V for a balloon having an outer diameter of 2.5mm.

[0370] 15. The intravascular lithotripsy system according to Example 9, wherein the predetermined lower voltage amplitude threshold is approximately 3000V for a balloon having an outer diameter of 3.0 mm.

[0371] 16. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 3000V for a balloon having an outer diameter of 3.5mm.

[0372] 17. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is approximately 3000V for a balloon having an outer diameter of 4.0 mm.

[0373] 18. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is less than about 3000V for a balloon having an outer diameter of 2.0 mm.

[0374] 19. The intravascular lithotripsy system of embodiment 9, wherein the predetermined upper voltage amplitude threshold is less than about 3000V for a balloon having an outer diameter of 2.5mm.

[0375] 20. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is less than about 3000V for a balloon having an outer diameter of 3.0 mm.

[0376] 21. The intravascular lithotripsy system of embodiment 9, wherein the predetermined lower voltage amplitude threshold is less than about 3000V for a balloon having an outer diameter of 3.5mm.

[0377] 22. The intravascular lithotripsy system of Example 9, wherein the predetermined lower voltage amplitude threshold is less than about 3000V for a balloon having an outer diameter of 4.0 mm.

[0378] 23. The intravascular lithotripsy system of embodiment 9, wherein the predetermined upper voltage amplitude threshold is greater than about 3000V for a balloon having an outer diameter of 2.5mm.

[0379] 24. The intravascular lithotripsy system of Example 9, wherein the predetermined upper voltage amplitude threshold is greater than about 3000V for a balloon having an outer diameter of 3.0 mm.

[0380] 25. The intravascular lithotripsy system of embodiment 9, wherein the predetermined upper voltage amplitude threshold is greater than about 3000V for a balloon having an outer diameter of 3.5mm.

[0381] 26. The intravascular lithotripsy system of Example 9, wherein the predetermined upper voltage amplitude threshold is greater than about 3000V for a balloon having an outer diameter of 4.0 mm.

[0382] 27. The intravascular lithotripsy system of any one of embodiments 9 to 26, wherein the predetermined upper voltage amplitude threshold is greater than about 3250V for a balloon having an outer diameter of 2.5mm.

[0383] 28. The intravascular lithotripsy system of any one of embodiments 9 to 26, wherein the predetermined upper voltage amplitude threshold is greater than about 3250V for a balloon having an outer diameter of 3.0 mm.

[0384] 29. The intravascular lithotripsy system of any one of embodiments 9 to 26, wherein the predetermined upper voltage amplitude threshold is greater than about 3250V for a balloon having an outer diameter of 3.5 mm.

[0385] 30. The intravascular lithotripsy system of any one of embodiments 9 to 26, wherein the predetermined upper voltage amplitude threshold is greater than about 3250V for a balloon having an outer diameter of 4.0 mm.

[0386] 31. An intravascular lithotripsy system according to any one of embodiments 1 to 30, wherein the IVL control system is configured to determine whether the target voltage is not at a predetermined upper limit voltage amplitude target of a series of voltage pulses previously performed, and to increase the target voltage amplitude by a predetermined amount when it is determined that the target voltage is not at the predetermined upper limit voltage amplitude target.

[0387] 32. The intravascular lithotripsy system of embodiment 31, wherein the predetermined amount of voltage amplitude increase is in the range of 1 to 250V.

[0388] 33. The intravascular lithotripsy system of any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by 25V when the target voltage is not at a predetermined upper voltage amplitude target of a previously performed series of voltage pulses.

[0389] 34. The intravascular lithotripsy system of any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by more than 25V when the target voltage is not at a predetermined upper voltage amplitude target of a previously performed series of voltage pulses.

[0390] 35. The intravascular lithotripsy system according to any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by less than 25V when the target voltage is not at the predetermined upper voltage amplitude target of 25V of a previously performed series of voltage pulses.

[0391] 36. The intravascular lithotripsy system of any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by 25V when the target voltage is not at a predetermined upper voltage amplitude target of a previously executed voltage pulse.

[0392] 37. The intravascular lithotripsy system of any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by more than 25V when the target voltage is not at a predetermined upper voltage amplitude target of a previously performed voltage pulse.

[0393] 38. The intravascular lithotripsy system of any one of embodiments 1 to 32, wherein the target voltage amplitude is increased by less than 25V when the target voltage is not at the predetermined upper voltage amplitude target of 25V of a previously performed series of voltage pulses.

[0394] 39. The intravascular lithotripsy system of any one of embodiments 1 to 38, wherein the average decay or decrease in pressure output over a predetermined maximum number of voltage pulses does not exceed 0.25 MPa.

[0395] 40. The intravascular lithotripsy system of any one of embodiments 1 to 38, wherein the average decay or decrease in pressure output within the range of 10 to 300 voltage pulses does not exceed 0.25 MPa.

[0396] 41. The intravascular lithotripsy system of any one of embodiments 1 to 38, wherein the pressure output of a last voltage pulse of the predetermined maximum number of voltage pulses is greater than the pressure output of the first voltage pulse.

[0397] 42. The intravascular lithotripsy system according to any one of embodiments 1 to 41, wherein the slope of the pressure output of the voltage pulse increases with time.

[0398] 43. The intravascular lithotripsy system of any one of embodiments 1 to 40, wherein the slope of the pressure output of the voltage pulse decreases over time.

[0399] 44. The intravascular lithotripsy system of any one of embodiments 1 to 40, wherein the slope of the pressure output of the voltage pulse is indicative of a constant pressure amplitude output across the voltage pulse.

[0400] 45. The intravascular lithotripsy system according to any one of embodiments 1 to 44, wherein a plurality of trains of voltage pulses are generated.

[0401] 46. The intravascular lithotripsy system according to any one of embodiments 1 to 45, wherein the one or more voltage pulses in the series of voltage pulses comprises 10 voltage pulses.

[0402] 47. The intravascular lithotripsy system according to any one of embodiments 1 to 45, wherein one or more voltage pulses in the series of voltage pulses comprises more than 10 voltage pulses.

[0403] 48. The intravascular lithotripsy system according to any one of embodiments 1 to 45, wherein one or more voltage pulses in the series of voltage pulses comprises less than 10 voltage pulses.

[0404] 49. A method for generating and controlling voltage pulses, comprising:

[0405] Providing the device according to any one of embodiments 1 to 48, wherein the fluid-fillable member comprises a balloon;

[0406] Determine the outer diameter of the device's balloon;

[0407] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0408] performing a first series of voltage pulses at a predetermined lower voltage amplitude threshold;

[0409] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0410] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold;

[0411] determining that a predetermined number of voltage pulses have not been performed; and

[0412] continuing to perform the one or more series of voltage pulses at the upper voltage amplitude threshold until a predetermined number of voltage pulses are determined to have been performed; and

[0413] Stops the execution of the voltage pulse.

[0414] 50. A method for generating and controlling voltage pulses, comprising:

[0415] Providing the device according to any one of embodiments 1 to 48, wherein the fluid-fillable member comprises a balloon;

[0416] Determine the outer diameter of the device's balloon;

[0417] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0418] performing a first series of voltage pulses at a predetermined lower voltage amplitude threshold;

[0419] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0420] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold;

[0421] determining that a predetermined number of voltage pulses have not been performed; and

[0422] Stops the execution of the voltage pulse.

[0423] 51. A method for generating and controlling a voltage pulse, the voltage pulse producing a stable and substantially constant pressure output, the method comprising:

[0424] Providing the device according to any one of embodiments 1 to 48, wherein the fluid-fillable member comprises a balloon;

[0425] Determine the outer diameter of the device's balloon;

[0426] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0427] performing a first series of voltage pulses at a predetermined lower voltage amplitude threshold;

[0428] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0429] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold; and

[0430] A pressure output is generated for each voltage pulse, the pressure output comprising a stable and substantially constant amplitude.

[0431] 52. The method of embodiment 51, wherein the pressure output is generated by 10 to at least 300 voltage pulses.

[0432] 53. A method for generating and controlling voltage pulses, the voltage pulses producing a pressure output that increases from a first voltage pulse to said last voltage pulse, the method comprising: providing a device according to any one of embodiments 1 to 48, wherein the fluid-fillable member comprises a balloon;

[0433] Determine the outer diameter of the device's balloon;

[0434] Establishing an acceptable voltage pulse window, the acceptable voltage pulse window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold;

[0435] performing a first series of voltage pulses at a predetermined lower voltage amplitude threshold;

[0436] increasing the voltage amplitude target by a predetermined amount and performing another series of voltage pulses at the increased voltage amplitude target;

[0437] continuing to sequentially increase the voltage amplitude target and performing an associated series of voltage pulses at the sequentially increasing voltage amplitude targets until the voltage amplitude target equals a predetermined upper voltage amplitude threshold; and

[0438] A pressure output is generated for each voltage pulse, the pressure output comprising an increasing amplitude from the first voltage pulse to the last voltage pulse.

[0439] 54. The method of embodiment 53, wherein the pressure output is generated by 10 to at least 300 voltage pulses.

[0440] 55. The method of any one of embodiments 49 to 54, wherein the voltage pulses are generated at a frequency in the range of 1 to 5 pulses / second.

[0441] 56. The method of embodiment 55, wherein the voltage pulse frequency comprises 2 pulses / second.

[0442] 57. The method of embodiment 55, wherein the voltage pulse frequency comprises 3 pulses / second.

[0443] 58. The method of any one of embodiments 49 to 57, wherein the pressure output of a first balloon comprising an outer diameter is not less than the pressure output of a second balloon comprising an outer diameter that is less than the outer diameter of the first balloon.

[0444] Example embodiment set 5:

[0445] 1. An intravascular lithotripsy system comprising:

[0446] a catheter assembly comprising an elongated member defining a lumen and disposed concurrently within a fluid-fillable member configured to contain a conductive fluid therein, positioned along a longitudinal extent of the elongated member, the catheter assembly configured to be fluid-fillable and expandable with the conductive fluid to facilitate IVL treatment; and

[0447] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted to be disposed within the inflatable balloon for immersion within the IVL fluid medium;

[0448] wherein the IVL control system is configured to apply one or more voltage pulses to at least one of the spaced-apart electrodes under an initial control setting, determine whether a threshold parameter including a maximum number of voltage pulses that results in an arc between at least one set of the spaced-apart electrodes is achieved under the initial control setting, and increase at least one of a pulse duration and a voltage in response to determining that the threshold parameter is not achieved,

[0449] Therein, the IVL control system is configured to apply at least one of increased pulse duration and voltage to at least one set of spaced-apart electrodes.

[0450] 2. An intravascular lithotripsy system comprising:

[0451] A catheter assembly comprising an elongated member defining a lumen and disposed within a fluid-fillable member configured to contain a conductive fluid therein, the fluid-fillable member being positioned over a longitudinal extent of the elongated member, the catheter assembly configured to be fluid-fillable and expandable with the conductive fluid to facilitate IVL treatment; at least one set of spaced-apart electrodes for placement within the expandable balloon for immersion in the conductive fluid; and

[0452] an IVL control system comprising a processor for executing instructions stored on a memory, and circuitry configured to transmit signals to provide IVL treatment to a patient based on the operation of the processor,

[0453] wherein the IVL control system is configured to generate and 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 that results in an arc between at least one set of spaced-apart electrodes is achieved under the initial control setting, and increase at least one of a pulse duration and a voltage in response to determining that the threshold parameter is not achieved, wherein the IVL control system is configured to apply at least one of the increased pulse duration and voltage to the at least one set of spaced-apart electrodes, and wherein the IVL control system is configured to continue to reapply at least one of the increased pulse duration and voltage to the at least one set of spaced-apart electrodes after determining that the threshold parameter is not achieved, and

[0454] When it is determined that the threshold parameter is reached, generation of the voltage pulse is terminated.

[0455] 3. A method of operating an intravascular lithotripsy (IVL) system, the IVL system having a catheter assembly, at least one set of spaced-apart electrodes for placement within an inflatable balloon for immersion in the IVL fluid medium, and an IVL control system, the catheter assembly comprising an elongated member defining a lumen, and a fluid-fillable member configured to contain a conductive fluid and positioned at a distal region of the elongated member, the catheter assembly configured to inflate the fluid-fillable member with the conductive fluid to facilitate IVL treatment, the at least one set of spaced-apart electrodes for placement within the inflatable balloon for immersion in the IVL fluid medium, the IVL control system comprising a processor configured to execute instructions stored on a memory, and communication circuitry configured to communicate signals based on operation of the processor to provide IVL treatment to a patient, the method comprising:

[0456] generating a voltage pulse at an initial electrical setting and applying the generated voltage pulse to at least one set of spaced apart electrodes, the initial electrical setting including a voltage amplitude and a duration of application of the generated voltage;

[0457] determining whether a predetermined maximum number of arcs generated between at least one set of spaced-apart electrodes is achieved at the initial electrical setting;

[0458] In response to determining that the threshold parameter is not achieved, increasing at least one of a pulse duration and a voltage of the electrical setting; and

[0459] Responsive to determining that the threshold parameter is achieved, generation of the voltage pulse is terminated.

[0460] 4. An intravascular lithotripsy system comprising:

[0461] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while being disposed within a fluid-fillable member, the fluid-fillable member being configured to contain a conductive fluid;

[0462] An electrical pulse generating system for providing controlled levels of electrical energy to at least one set of spaced-apart 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 configured to execute instructions stored on a memory, and a communication circuit configured to transmit signals based on commands from the processor, the IVL control system comprising a charge control system for controlling a discharge system,

[0463] Therein, the charging control system is configured to provide controlled and variable power to the discharge system at different voltage levels during successive charging cycles.

[0464] 5. An intravascular lithotripsy system comprising:

[0465] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while being disposed within a fluid-fillable member, the fluid-fillable member being configured to contain a conductive fluid;

[0466] An electrical pulse generating system is configured to provide controlled electrical energy levels to at least one set of spaced-apart 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 configured to execute instructions stored on a memory, and communication circuitry configured to transmit signals based on commands from the processor, the IVL control system comprising a charge control system for controlling a discharge system,

[0467] 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 in successive charge cycles after releasing energy from the energy storage system.

[0468] 6. An intravascular lithotripsy system comprising:

[0469] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while being disposed within a fluid-fillable member, the fluid-fillable member being configured to contain a conductive fluid;

[0470] 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 comprising an IVL control system, the IVL control system comprising a processor configured to execute instructions stored on a memory, and communication circuitry configured to transmit signals based on commands from the processor, wherein the IVL control system is configured to:

[0471] evaluating a stored energy state of an energy storage system of the IVL system to determine stored energy;

[0472] comparing the assessed stored energy state to a stored threshold;

[0473] delivering voltage pulses to at least one set of spaced-apart electrodes of the IVL system;

[0474] evaluating the residual energy state of an energy storage system of the IVL system to determine the residual energy; and

[0475] The estimated remaining energy state is compared with a stored threshold value.

[0476] 7. A method of operating an intravascular lithotripsy system, the method comprising:

[0477] Evaluate the stored energy state of an intravascular lithotripsy (IVL) system to determine the stored energy state;

[0478] delivering voltage pulses to at least one set of electrodes of the IVL system;

[0479] evaluating a residual energy state of an energy storage system of the IVL system to determine the residual energy; and

[0480] At least one of the evaluated energy states is compared to a stored threshold value to determine the energy of the voltage pulse.

[0481] 8. A method of operating an intravascular lithotripsy system comprising at least one set of spaced-apart electrodes, the method comprising:

[0482] Evaluate the stored energy state of an intravascular lithotripsy (IVL) system to determine the stored energy state;

[0483] delivering a voltage pulse to at least one electrode of at least one set of spaced-apart electrodes of the IVL system;

[0484] evaluating the residual energy state of an energy storage system of the IVL system to determine the residual energy; and

[0485] At least one of the evaluated energy states is compared to a stored threshold value to determine an energy of the voltage pulse, wherein evaluating the energy state to determine the stored energy includes determining a voltage level of the energy storage system.

[0486] 9. An intravascular lithotripsy system comprising:

[0487] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while being disposed within a fluid-fillable member, the fluid-fillable member being configured to contain a conductive fluid;

[0488] 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 comprising an IVL control system, the IVL control system comprising a processor configured to execute instructions stored on a memory, and a communication circuit configured to transmit signals based on commands from the processor.

[0489] The electric pulse generating system includes a power system, which includes an AC power mains and a DC power storage system.

[0490] wherein the AC power mains is configured to connect to an AC power outlet to receive AC power from an infrastructure, and the DC power storage system is configured to receive AC power from the AC power source and convert the AC power into DC power for charging the DC power storage device of the DC power storage system, and

[0491] Therein, the electrical pulse generating system is configured to selectively provide power from an AC grid power source or a DC power storage system for IVL operation.

[0492] 10. A method for powering an intravascular lithotripsy system, comprising:

[0493] Providing an intravascular lithotripsy system according to embodiment 1;

[0494] Selecting to provide power from an AC mains power source; and

[0495] Provides power to the intravascular lithotripsy system.

[0496] 11. An intravascular lithotripsy system comprising:

[0497] at least one set of electrodes, the at least one set of electrodes being configured for placement within a body cavity and disposed within a fluid-fillable member configured to contain a conductive fluid;

[0498] 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 comprising an IVL control system, the IVL control system comprising a processor configured to execute instructions stored on a memory, and communication circuitry configured to transmit signals based on commands from the processor, wherein the IVL control system is configured to:

[0499] evaluating a stored energy state of an energy storage system of the IVL system to determine stored energy;

[0500] delivering voltage pulses to at least one set of electrodes of the IVL system;

[0501] evaluating a residual energy state of an energy storage system of the IVL system to determine the residual energy; and

[0502] The evaluated energy states are compared to determine the energy of the voltage pulse.

[0503] 12. A method of operating an intravascular lithotripsy system, the method comprising:

[0504] Evaluate the stored energy state of an intravascular lithotripsy (IVL) system to determine the stored energy state;

[0505] delivering voltage pulses to at least one set of spaced-apart electrodes of the IVL system;

[0506] evaluating the residual energy state of an energy storage system of the IVL system to determine the residual energy; and

[0507] The evaluated energy states are compared to determine the energy of the voltage pulse.

[0508] 13. A method of operating an intravascular lithotripsy system, the method comprising:

[0509] Evaluate the stored energy state of an intravascular lithotripsy (IVL) system to determine the stored energy state;

[0510] delivering voltage pulses to at least one set of spaced-apart electrodes of the IVL system;

[0511] evaluating the residual energy state of an energy storage system of the IVL system to determine the residual energy; and

[0512] The assessed energy states are compared to determine an energy of the voltage pulse, wherein assessing the energy state to determine the stored energy includes determining a voltage level of the energy storage system.

[0513] 14. An intravascular lithotripsy system comprising:

[0514] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while being disposed within a fluid-fillable member, the fluid-fillable member being configured to contain a conductive fluid;

[0515] 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 comprising an IVL control system, the IVL control system comprising a processor configured to execute instructions stored on a memory, and a communication circuit configured to transmit signals based on commands from the processor, wherein the IVL control system comprises an adjustable energy storage system, the adjustable energy storage system being configured to selectively adjust the electrical energy applied to at least one set of spaced-apart electrodes for IVL treatment.

[0516] 15. A method of operating an intravascular lithotripsy (IVL) system, the method comprising:

[0517] applying a voltage pulse to at least one set of electrodes;

[0518] Determine the stored energy level for adjusting the IVL system;

[0519] Another voltage pulse is applied to at least one set of electrodes using a different energy level than the voltage pulse.

[0520] Example embodiment set 6:

[0521] 1. An intravascular lithotripsy system comprising:

[0522] at least one set of electrodes, the at least one set of electrodes being configured for placement within a body cavity and disposed within a fluid-fillable member configured to contain a conductive fluid;

[0523] An electric pulse generating system for providing electric energy to at least one set of electrodes to generate sparks for intravascular lithotripsy (IVL) treatment, the electric pulse generating system comprising an IVL control system, the IVL control system comprising a processor for executing instructions stored on a memory, and circuitry configured to transmit signals based on operation of the processor, the IVL control system being configured to: apply initial electric energy to at least one set of electrodes;

[0524] Determine whether a threshold parameter has been reached, and

[0525] In response to determining that the threshold parameter has not been met, a duration of the electrical energy pulses applied to at least one set of electrodes is increased.

[0526] 2. The system of embodiment 1, wherein the IVL control system is configured to reapply initial electrical energy to the at least one set of electrodes in response to determining that the threshold parameter is reached.

[0527] 3. The system of embodiment 2, wherein the threshold parameter is a value of current for achieving sufficient spark for IVL treatment.

[0528] 4. The system of embodiment 3, wherein the value of the current is approximately 20 amperes.

[0529] 5. The system of embodiment 1, wherein the IVL control system is configured to repeatedly apply electrical energy to at least one set of electrodes with increasing duration of the pulses of electrical energy.

[0530] 6. The system of embodiment 5, wherein the IVL control system is configured to determine whether a threshold parameter is reached under repeated application of electrical energy.

[0531] 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 increasing duration of the electrical energy pulses in response to determining that the threshold parameter is reached with repeated application of the electrical energy.

[0532] 8. The system of embodiment 5, wherein the threshold parameter remains the same value between the initial application and the repeated application.

[0533] 9. The system of embodiment 5, wherein the IVL control system is configured to determine whether a maximum duration has been reached.

[0534] 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.

[0535] 11. The system of embodiment 10, wherein the IVL control system is configured to reapply electrical energy to the at least one set of electrodes at an increased voltage.

[0536] 12. The system of embodiment 10, wherein reapplying electrical energy to at least one set of electrodes at an increased voltage comprises adjusting a currently selected duration.

[0537] 13. The system of embodiment 12, wherein adjusting the duration of the current selection comprises decreasing the duration.

[0538] 14. The system of embodiment 13, wherein adjusting the currently selected duration comprises resetting the currently selected duration to be equal to the duration at the initial power.

[0539] 15. The system of embodiment 10, wherein the IVL control system is configured to determine whether a maximum voltage has been reached, and to reapply electrical energy to the at least one set of electrodes at an increased voltage in response to determining that the maximum voltage has not been reached.

[0540] 16. The system of embodiment 9, wherein the maximum duration remains the same value upon re-application.

[0541] 17. The system of embodiment 1, wherein the applying of electrical energy comprises delivering a voltage pulse having a voltage and a duration.

[0542] 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.

[0543] 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 range of about 500V to about 4000V.

[0544] 20. A method of operating an intravascular lithotripsy system, the method comprising:

[0545] applying initial electrical energy to at least one set of electrodes of an intravascular lithotripsy (IVL) system, wherein the at least one set of electrodes is immersed in a conductive fluid contained by a fluid-fillable member;

[0546] Determine whether a threshold parameter has been reached, and

[0547] In response to determining that the threshold parameter has not been met, a duration of the electrical energy pulses applied to at least one set of electrodes is increased.

[0548] 21. The method of embodiment 20, further comprising reapplying the initial electrical energy to at least one set of electrodes in response to determining that the threshold parameter is reached.

[0549] 22. The method of embodiment 21, wherein the threshold parameter is a value of current for achieving sufficient sparking for IVL treatment.

[0550] 23. The method of embodiment 22, wherein the value of the current is about 20 amperes.

[0551] 24. The method of embodiment 20, further comprising repeatedly applying electrical energy to at least one set of electrodes with increasing duration of the electrical energy pulses.

[0552] 25. The method of embodiment 24, further comprising determining whether a threshold parameter is reached with repeated application of electrical energy.

[0553] 26. The method of embodiment 25, further comprising reapplying electrical energy to at least one set of electrodes at an increased electrical energy pulse duration in response to determining that a threshold parameter is reached with repeated application of the electrical energy.

[0554] 27. The method of embodiment 25, wherein the threshold parameter remains the same value for the initial application and the repeated application.

[0555] 28. The method of embodiment 25, further comprising determining whether a maximum duration has been reached.

[0556] 29. The method of embodiment 28, further comprising increasing the voltage of the applied electrical energy in response to determining that the maximum duration has been reached.

[0557] 30. The method of embodiment 29, further comprising reapplying electrical energy to at least one set of electrodes at an increased voltage.

[0558] 31. The method of embodiment 30, wherein reapplying electrical energy to at least one set of electrodes at an increased voltage comprises adjusting a currently selected duration.

[0559] 32. The method of embodiment 31, wherein adjusting the duration of the current selection includes decreasing the duration.

[0560] 33. The method of embodiment 32, wherein adjusting the currently selected duration includes resetting the currently selected duration to be equal to the duration at the initial power.

[0561] 34. The method of embodiment 29, further comprising determining whether a maximum voltage has been reached, reapplying electrical energy to at least one set of electrodes at an increased voltage in response to determining that the maximum voltage has not been reached.

[0562] 35. The method of embodiment 20, wherein applying electrical energy comprises delivering a voltage pulse having a voltage and a duration.

[0563] 36. The method of embodiment 35, wherein the initial duration of the initial electrical energy delivered to at least one electrode is a voltage pulse having a duration in the range of about 0.1 microseconds to about 2 microseconds.

[0564] 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 range of about 500V to about 4000V.

[0565] 38. An intravascular lithotripsy system comprising:

[0566] a catheter assembly comprising an elongated member defining a lumen, and a fluid-fillable member configured to contain a conductive fluid and positioned at or near a longitudinal end of the elongated member, the catheter assembly being configured to fill the fluid-fillable member with the conductive fluid to facilitate IVL treatment;

[0567] at least one set of electrodes, the at least one set of electrodes being adapted to be disposed within the fluid-fillable member for immersing the at least one set of electrodes within the conductive fluid;

[0568] An IVL therapy control system includes a processor for executing instructions stored on a memory, and circuitry configured to transmit a signal to provide IVL therapy to a patient based on operation of the processor, the IVL therapy control system configured to apply electrical energy having an initial setting, determine whether a threshold parameter is achieved under the electrical setting, and increase at least one of a pulse duration and a voltage in response to determining that the threshold parameter is not achieved.

[0569] 39. A method of operating an intravascular lithotripsy (IVL) system, the IVL system having a catheter assembly, at least one set of electrodes, and an IVL control system, the catheter assembly including an elongated member defining a lumen, and a fluid-fillable member configured to contain a conductive fluid and positioned at or near a longitudinal end of the elongated member, the catheter assembly configured to inflate the fluid-fillable member with the conductive fluid to facilitate IVL treatment, the at least one set of electrodes being arranged within an inflatable balloon for immersion in an IVL fluid medium, the IVL treatment control system including a processor for executing instructions stored on a memory, and communication circuitry for communicating signals based on operation of the processor to provide IVL treatment to a patient, the method comprising:

[0570] applying electrical energy having electrical settings including an initial setting;

[0571] determining whether a threshold parameter is achieved under the applied electrical settings; and

[0572] At least one of a pulse duration and a voltage of the electrical setting is increased in response to determining that the threshold parameter is not met.

[0573] 40. An intravascular lithotripsy system comprising:

[0574] at least one set of electrodes, the at least one set of electrodes being configured for placement within a body cavity and disposed within a fluid-fillable member configured to contain a conductive fluid;

[0575] 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 on a memory, and a communication circuit configured to transmit signals based on commands from the processor, the IVL control system comprising an adjustable energy storage system, the adjustable energy storage system being used to selectively adjust the stored energy applied to provide electrical energy to at least one set of electrodes for IVL treatment.

[0576] 41. The system of embodiment 40, wherein the electrical pulse generating system comprises a relay system for selectively connecting a plurality of energy storage elements of the energy storage system for discharge to provide electrical energy to at least one set of electrodes.

[0577] 42. The system of embodiment 41, wherein, in the engaged arrangement of the relay system, all of the plurality of energy storage elements are connected to discharge to provide electrical energy to at least one set of electrodes.

[0578] 43. The system of embodiment 42, wherein, in the disengaged arrangement of the relay system, all of the plurality of energy storage elements are connected to discharge to provide electrical energy to at least one set of electrodes.

[0579] 44. The system of embodiment 43, wherein the electrical energy provided to at least one set of electrodes is greater in one arrangement of the relay system than in another arrangement of the relay system.

[0580] 45. The system of embodiment 43, wherein in one pulse of electrical energy to the electrode, the relay system is in an engaged arrangement or a disengaged arrangement, and in another pulse of electrical energy to the electrode, the relay system is in a disengaged arrangement.

[0581] 46. A method of operating an intravascular lithotripsy (IVL) system, the method comprising:

[0582] applying a first voltage pulse to at least one set of electrodes;

[0583] Determine the stored energy level for adjusting the IVL system;

[0584] Another voltage pulse is applied to at least one set of electrodes using a stored energy amplitude or level that is different from the first voltage pulse.

[0585] 47. The method of embodiment 46, wherein applying the voltage pulse comprises operating an adjustable energy storage system at a first stored energy level to apply the electrical energy.

[0586] 48. The method of embodiment 47, wherein applying the voltage pulse comprises operating the adjustable energy storage system at a second stored energy level to apply the electrical energy.

[0587] 49. The method of embodiment 48, wherein the second stored energy level is greater than the first stored energy level.

[0588] 50. The method of embodiment 48, wherein the second stored energy level is less than the first stored energy level.

[0589] 51. The method of embodiment 48, wherein applying the voltage pulse includes configuring a relay system to connect one or more energy storage capacity elements of the adjustable energy storage system.

[0590] 52. The method of embodiment 51, wherein arranging the relay system to connect one or more stored energy storage elements of the adjustable energy storage system comprises adjusting a maximum number of stored energy elements of the adjustable energy storage system.

[0591] 53. The method of embodiment 51, wherein arranging the relay system to connect one or more stored energy storage elements of the adjustable energy storage system comprises less than a maximum number of stored energy elements of the adjustable energy storage system.

[0592] 54. The method of embodiment 48, wherein applying another voltage pulse includes configuring a relay system to connect an additional energy storage capacity element of the adjustable energy storage system.

[0593] 55. The method of embodiment 54, wherein arranging the relay system to connect the additional energy storage capacity elements of the adjustable energy storage system includes adjusting a maximum number of stored energy storage elements of the adjustable energy storage system.

[0594] 56. The method of embodiment 54, wherein arranging the relay system to connect the additional energy storage capacity elements of the adjustable energy storage system comprises less than a maximum number of stored energy elements of the adjustable energy storage system.

[0595] 57. The method of embodiment 47, wherein applying the voltage pulse includes arranging a relay system to connect a plurality of energy storage capacity elements of the adjustable energy storage system.

[0596] 58. The method of embodiment 57, wherein arranging the relay system to connect a number of stored energy storage elements of the adjustable energy storage system comprises adjusting a maximum number of stored energy storage elements of the adjustable energy storage system.

[0597] 59. The method of embodiment 58, wherein applying the voltage pulse comprises operating an adjustable energy storage system at another stored energy amplitude to apply the electrical energy.

[0598] 60. The method of embodiment 57, wherein arranging the relay system to connect a plurality of stored energy storage elements of the adjustable energy storage system comprises less than a maximum number of stored energy elements of the adjustable energy storage system.

[0599] 61. The method of embodiment 60, wherein applying the voltage pulse comprises operating an adjustable energy storage system at another stored energy amplitude to apply the electrical energy.

[0600] 62. An intravascular lithotripsy system comprising:

[0601] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while being disposed within a fluid-fillable member, the fluid-fillable member being configured to contain a conductive fluid;

[0602] An electric 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 electric pulse generating system including an IVL control system, the IVL control system including a processor for executing instructions stored on a memory, and a communication circuit for transmitting signals based on commands from the processor, the IVL control system including a charging control system for controlling a discharge system.

[0603] 63. The system of embodiment 62, wherein the charging control system includes a low voltage power conditioner arranged to receive and control the low voltage power for output for conversion to high voltage power.

[0604] 64. The system of embodiment 63, wherein the charging control system receives a modulated control signal for controlling the output of the low voltage power for conversion to the high voltage power.

[0605] 65. The system of embodiment 63, wherein the charging control system is arranged to utilize feedback of the output of the low voltage power to apply the modulated control signal.

[0606] 66. The system of embodiment 63, wherein the modulated control signal is a high frequency pulse width modulated signal.

[0607] 67. The system of embodiment 61, wherein the charging control system includes a converter arranged to receive the low voltage power and convert the low voltage power to high voltage power for transmission to the discharging system.

[0608] 68. The system of embodiment 67, wherein the converter is a DC-DC converter.

[0609] 69. The system of embodiment 62, wherein the charging control system is configured to provide variable voltage power to the discharge system at different voltage levels for consecutive charging cycles.

[0610] 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 for successive charge cycles after the stored energy is discharged.

[0611] 71. An intravascular lithotripsy system comprising:

[0612] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while being disposed within a fluid-fillable member, the fluid-fillable member being configured to contain a conductive fluid;

[0613] An electric 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 electric pulse generating system comprising an IVL control system, the IVL control system comprising a processor for executing instructions stored on a memory, and a communication circuit for transmitting signals based on commands from the processor, the IVL control system comprising a discharge system for selectively delivering high-voltage discharges to at least one set of electrodes.

[0614] 72. The system of embodiment 71, wherein the discharge system comprises a discharge switching system operable to modulate delivery of high voltage power to at least one set of electrodes for IVL treatment.

[0615] 73. The system of embodiment 72, wherein the discharge switching system comprises at least one gate-controlled switch operable by a processor signal to selectively allow high voltage power to be delivered to at least one set of electrodes for IVL treatment.

[0616] 74. The system of embodiment 73, wherein at least one gate-controlled switch is an insulated gate bipolar transistor.

[0617] 75. The system of embodiment 73, wherein at least one gate-controlled switch is selectively operable in a permissive state and a non-permissive state, wherein the permissive state allows high voltage power to be delivered to at least one set of electrodes for IVL treatment, and the non-permissive state prevents high voltage power from being delivered to at least one set of electrodes for IVL treatment.

[0618] 76. The system of embodiment 71, wherein the discharge system comprises an energy storage system for charging high voltage energy for discharge to at least one set of electrodes.

[0619] 77. The system of embodiment 76, wherein the discharge system comprises a discharge switching system operable to modulate delivery of high voltage power from the energy storage system to at least one set of electrodes for IVL treatment.

[0620] 78. A method of operating an intravascular lithotripsy system, the method comprising:

[0621] Evaluate the stored energy state of an intravascular lithotripsy (IVL) system to determine the stored energy state;

[0622] delivering voltage pulses to at least one set of electrodes of the IVL system;

[0623] evaluating a residual energy state of an energy storage system of the IVL system to determine the residual energy; and

[0624] The evaluated energy states are compared to determine the energy of the voltage pulse.

[0625] 79. The method of embodiment 78, wherein evaluating the energy status to determine the stored energy includes determining a voltage level of the energy storage system.

[0626] 80. The method of embodiment 79, wherein evaluating the energy status to determine the stored energy comprises determining an energy level stored within the energy storage system based on a voltage level of the energy storage system.

[0627] 81. The method of embodiment 78, wherein evaluating the energy status to determine the stored energy includes determining a voltage level of the energy storage system.

[0628] 82. The method of embodiment 81, wherein evaluating the energy status to determine the stored energy comprises determining a level of energy retained within the energy storage system based on a voltage level of the energy storage system.

[0629] 83. The method of embodiment 78, wherein comparing the assessed energy states includes determining a difference between a stored energy state and a residual energy state of the energy storage system as a discharged energy.

[0630] 84. The method of embodiment 83, wherein comparing the assessed energy state comprises comparing the energy of the discharge to a threshold value.

[0631] 85. The method of embodiment 84, wherein determining that sufficient spark has been generated is responsive to determining that the discharge energy is equal to or greater than a threshold.

[0632] 86. The method of embodiment 84, wherein in response to determining that the discharge energy is less than a threshold, it is determined that insufficient spark was generated.

[0633] 87. The method of embodiment 78, further comprising determining parameters of the additional voltage pulse based on the comparison of the energy states.

[0634] 88. The method of embodiment 87, wherein determining parameters of the additional voltage pulse comprises maintaining one or more parameters of the voltage pulse for the additional voltage pulse in response to determining that the voltage pulse generated sufficient sparking.

[0635] 89. The method of embodiment 88, further comprising delivering additional voltage pulses based on the one or more maintained parameters.

[0636] 90. The method of embodiment 89, after delivering additional voltage pulses, repeatedly evaluating the residual energy state of the energy storage system of the IVL system to determine the residual energy.

[0637] 91. The method of embodiment 87, wherein determining parameters of the additional voltage pulse comprises changing one or more parameters of the voltage pulse for the additional voltage pulse in response to determining that the voltage pulse produced insufficient spark.

[0638] 92. The method of embodiment 91, wherein changing one or more parameters comprises changing a pulse duration of the additional voltage pulse.

[0639] 93. The method of embodiment 92, wherein changing the duration comprises increasing the duration of the additional voltage pulse to be greater than the duration of the voltage pulse.

[0640] 94. The method of embodiment 92, further comprising delivering additional voltage pulses based on one or more changed parameters.

[0641] 95. The method of embodiment 94, wherein after delivering additional voltage pulses, repeatedly evaluating the residual energy state of the energy storage system of the IVL system to determine the residual energy.

[0642] 96. The method of embodiment 78, wherein evaluating the energy state to determine the stored energy comprises evaluating the energy state of the energy storage system after the earlier voltage pulse has been delivered.

[0643] 97. An intravascular lithotripsy system comprising:

[0644] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while being disposed within a fluid-fillable member, the fluid-fillable member being configured to contain a conductive fluid;

[0645] 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 comprising an IVL control system, the IVL control system comprising a processor for executing instructions stored on a memory, and communication circuitry for transmitting signals based on commands from the processor, wherein the IVL control system is configured to:

[0646] evaluating a stored energy state of an energy storage system of the IVL system to determine stored energy;

[0647] delivering voltage pulses to at least one set of electrodes of the IVL system;

[0648] evaluating a residual energy state of an energy storage system of the IVL system to determine the residual energy; and

[0649] The evaluated energy states are compared to determine the energy of the voltage pulse.

[0650] 98. The system of embodiment 97, wherein evaluating the energy status to determine the stored energy comprises determining a voltage level of the energy storage system.

[0651] 99. The system of embodiment 98, wherein evaluating the energy status to determine the stored energy comprises determining a level of energy stored within the energy storage system based on a voltage level of the energy storage system.

[0652] 100. The system of embodiment 97, wherein evaluating the energy status to determine the remaining energy comprises determining a voltage level of the energy storage system.

[0653] 101. The method of embodiment 100, wherein evaluating the energy status to determine the remaining energy comprises determining a level of energy held within the energy storage system based on a voltage level of the energy storage system.

[0654] 102. The system of embodiment 97, wherein comparing the assessed energy states comprises determining a difference between a stored energy state and a remaining energy state of the energy storage system as a discharged energy.

[0655] 103. The system of embodiment 102, wherein comparing the assessed energy state comprises comparing the energy of the discharge to a threshold value.

[0656] 104. The system of embodiment 103, wherein in response to determining that the discharge energy is equal to or greater than the threshold, it is determined that sufficient spark has been generated.

[0657] 105. The system of embodiment 103, wherein in response to determining that the discharge energy is less than a threshold, it is determined that insufficient spark was generated.

[0658] 106. The system of embodiment 97, further comprising determining parameters of the additional voltage pulse based on the comparison of the energy states.

[0659] 107. The system according to embodiment 106, wherein determining parameters of the further voltage pulse comprises maintaining one or more parameters of the voltage pulse for the further voltage pulse in response to determining that the voltage pulse generated sufficient sparking.

[0660] 108. The system of embodiment 107, further comprising delivering additional voltage pulses based on the one or more maintained parameters.

[0661] 109. The system of embodiment 108, wherein after delivering the additional voltage pulses, repeatedly evaluating the remaining energy state of the energy storage system of the IVL system to determine the remaining energy.

[0662] 110. The method according to embodiment 106, wherein determining parameters of the further voltage pulse comprises changing one or more parameters of the voltage pulse for the further voltage pulse in response to determining that the voltage pulse produced insufficient spark.

[0663] 111. The method according to embodiment 110, wherein changing one or more parameters comprises changing a pulse duration of the further voltage pulse.

[0664] 112. The method according to embodiment 111, wherein changing the duration comprises increasing the duration of the further voltage pulse to be greater than the duration of the voltage pulse.

[0665] 113. The method of embodiment 111, further comprising delivering additional voltage pulses based on one or more changed parameters.

[0666] 114. The method of embodiment 113, wherein after delivering the additional voltage pulses, repeatedly evaluating the residual energy state of the energy storage system of the IVL system to determine the residual energy.

[0667] 115. An intravascular lithotripsy system comprising:

[0668] at least one set of spaced-apart electrodes, the at least one set of spaced-apart electrodes being adapted for placement within the body cavity while being disposed within a fluid-fillable member, the fluid-fillable member being configured to contain a conductive fluid;

[0669] 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 comprising an IVL control system, the IVL control system comprising a processor for executing instructions stored on a memory, and communication circuitry for transmitting signals based on commands from the processor, wherein the electrical pulse generating system comprises a power system, the power system comprising an AC power mains and a DC power storage system, wherein the AC power mains is configured to connect to an AC power outlet to receive AC power from an infrastructure, and the DC power storage system is configured to receive AC power from the AC power source and convert the AC power to DC power for charging a DC power storage device of the DC power storage system,

[0670] Therein, the electrical pulse generating system is configured to selectively provide power from an AC grid power source or a DC power storage system for IVL operation.

[0671] 116. The system of embodiment 115, wherein the IVL operation comprises providing high voltage pulses to at least one set of electrodes.

[0672] 117. The system of embodiment 115, wherein the DC power storage device comprises a chemical battery.

[0673] 118. A system according to embodiment 115, wherein the power system is configured to selectively provide power for IVL operation from stored power of a DC power storage device, from the DC power storage device when connected to receive charging power from an AC mains, or directly from AC grid power converted to DC power without a DC power storage device.

[0674] The description of the device, system and method and related applications as set forth herein is illustrative and is not intended to limit the scope of the present invention. The features of the various embodiments can be combined with other embodiments within the present invention's expectation. The variation and modification of the embodiments disclosed herein are possible, and those of ordinary skill in the art will understand the actual replacement and equivalents of the various elements of the embodiments when studying this patent document. These variations and modifications and other variations and modifications can be made to the embodiments disclosed herein without departing from the scope and spirit of the present invention.

Claims

1. An intravascular lithotripsy ("IVL") system (12) with controllable pressure output, the IVL system comprising: at least one set of spaced-apart electrodes (18) for placement within a body cavity while disposed within a fluid-fillable member (16) configured to contain a conductive fluid therein; A voltage pulse generating system configured to apply generated voltage pulses to the at least one set of spaced apart electrodes (18) and generate a plurality of pressure waves for intravascular lithotripsy treatment, the voltage pulse generating system comprising 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 on a memory (26) and a circuit (28) configured to transmit signals based on the operation of the processor (24), the voltage pulse generating system being configured to: generating a plurality of voltage pulses, the 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), wherein the amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage amplitude initially set at a predetermined lower voltage amplitude threshold, wherein one or more voltage pulses in the initial series of voltage pulses generate a pressure wave, and generating one or more subsequent series of voltage pulses, each subsequent series comprising a plurality of voltage pulses, wherein for each subsequent series of voltage pulses, the target voltage amplitude is increased by a predetermined amount, wherein each of the generated pressure waves comprises a pressure amplitude output, and Wherein, the IVL control system (22) is configured to control the pressure amplitude output of all of the generated pressure waves using the target voltage amplitude.

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

3. The IVL system according to claim 2, wherein: The IVL control system is configured to control a target voltage within a predetermined upper threshold and a predetermined lower threshold over all of the generated series of voltage pulses.

4. The IVL system according to claim 1, wherein: The IVL control system is configured to control the pressure amplitude output to be maintained above a predetermined lower threshold across all of the generated pressure waves.

5. The IVL system according to claim 4, wherein: The IVL control system is configured to control a target voltage within a predetermined upper threshold and a predetermined lower threshold over all of the generated series of voltage pulses.

6. The IVL system according to claim 1, wherein: The IVL control system is configured to control the pressure amplitude output to within a predetermined upper threshold and a predetermined lower threshold across all of the generated pressure waves.

7. The IVL system according to claim 6, wherein: The IVL control system is configured to control the target voltage within a predetermined upper threshold and a predetermined lower threshold.

8. The IVL system according to claim 1, wherein: The IVL control system is configured to control the pressure amplitude output to be maintained at a substantially constant amplitude across all of the generated pressure waves.

9. The IVL system according to claim 8, wherein: The IVL control system is configured to control a target voltage within a predetermined upper threshold and a predetermined lower threshold over all of the generated series of voltage pulses.

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

11. The IVL system according to claim 10, wherein: The IVL control system is configured to control a target voltage within a predetermined upper threshold and a predetermined lower threshold over all of the generated series of voltage pulses.

12. The IVL system according to one or more of claims 1 to 11, wherein: The IVL control system is further configured to determine a total number of voltage pulses to be generated, and to terminate execution of the voltage pulses when it is determined that a predetermined maximum number of voltage pulses is to be generated.

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

14. The IVL system according to one or more of claims 1 to 13, wherein: The IVL control system is configured to define an acceptable voltage amplitude window, the acceptable voltage amplitude window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold, and control the amplitude of the voltage pulse to remain within the acceptable voltage amplitude window.

15. The IVL system according to claim 14, wherein: The predetermined lower voltage amplitude threshold is in the range of about 2500V to about 3250V.

16. The IVL system of claim 14, wherein: The acceptable voltage amplitude window is different for balloons of different outer diameters.

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

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

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

20. The IVL system of claim 19, wherein: The predetermined amount by which the voltage amplitude is increased is in the range of 1V to 250V.

21. The IVL system of claim 19, wherein: The IVL control system is configured to increase the target voltage amplitude by 25V when the target voltage is not at the predetermined upper voltage amplitude target of a previously executed series of voltage pulses.

22. An intravascular lithotripsy ("IVL") system (12) with controllable pressure output, the IVL system comprising: at least one set of spaced-apart electrodes (18) for placement within a body cavity while disposed within a fluid-fillable member (16) configured to contain a conductive fluid therein; A voltage pulse generating system configured to apply generated voltage pulses to the at least one set of spaced apart electrodes (18) and generate a plurality of pressure waves for intravascular lithotripsy treatment, the voltage pulse generating system comprising 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 on a memory (26) and a circuit (28) configured to transmit signals based on the operation of the processor, the voltage pulse generating system being configured to: generating a plurality of voltage pulses, the 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), wherein the amplitude of each voltage pulse in the initial series of voltage pulses comprises a target voltage initially set at a predetermined lower voltage amplitude threshold, wherein one or more voltage pulses in the initial series of voltage pulses generate a pressure wave, and generating one or more subsequent series of voltage pulses, each subsequent series comprising a plurality of voltage pulses, wherein for each subsequent series of voltage pulses, the target voltage is increased by a predetermined amount, wherein each of the generated pressure waves comprises a pressure amplitude output, and The IVL control system (22) is configured to define an acceptable voltage amplitude window, the acceptable voltage amplitude window including a predetermined lower voltage amplitude threshold and a predetermined upper voltage amplitude threshold, and to control the amplitude of the voltage pulse to be maintained within the acceptable voltage amplitude window so as to control the pressure amplitude output within the upper and lower thresholds.

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

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

25. A method for performing an intravascular lithotripsy ("IVL") treatment, the method comprising: Providing an IVL system (12) according to claim 22; generating the initial series of voltage pulses at a predetermined voltage amplitude; applying the generated initial series of voltage pulses to the at least one set of spaced apart electrodes (18); generating a first series of pressure waves, wherein each generated pressure wave includes a pressure amplitude output controlled within an upper threshold and a lower threshold; determining that a maximum number of voltage pulses has not been generated; increasing the predetermined voltage amplitude by a predetermined amount; generating a second series of voltage pulses at increasing predetermined voltage amplitudes; generating a second series of pressure waves, wherein each generated pressure wave includes a pressure amplitude output controlled within an upper threshold and a lower threshold; determining whether the increased predetermined voltage amplitude has reached a predetermined upper voltage amplitude threshold; and If it is determined that the predetermined upper voltage amplitude threshold has been reached, the IVL treatment is terminated.

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