Intravascular lithotripsy system with improved durability, efficiency and pressure output variability

Abstract

Various embodiments of systems, methods, and devices are provided for disrupting a calcification lesion in an anatomical conduit, where an exemplary system generates an arc between two spaced apart electrodes disposed within a fluid-filled balloon.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to Provisional Application No. 63 / 477,007, filed on December 23, 2022, entitled INTRAVASCULAR LITHOPLASTY AND / OR ANGIOPLASTY BALLOON SYSTEM WITH IMPROVED BALLOON MOUNT AND ELECTRODES, the entire contents of which are incorporated herein by reference as if reproduced in their entirety for all purposes.

[0003] Statement regarding federally funded research or development

[0004] none Background of the Invention Technical Field

[0006] This invention relates to systems, apparatus, and methods for breaking up calcified lesions in anatomical vessels. In one aspect, an electric arc is generated between two spaced-apart electrodes disposed within a fluid-filled member, thereby generating a pressure wave. In another aspect, the fluid-filled member can expand and contract to open occluded blood vessels, including but not limited to calcified occlusions. Background Technology

[0007] Various techniques and instruments have been developed for removing or repairing tissue in arteries and similar bodily pathways, including removing and / or removing calcified lesions that form within and / or within the walls of defined pathways. A common purpose of such techniques and instruments is to remove atherosclerotic plaques from a patient's arteries. Atherosclerosis is characterized by the accumulation of fatty deposits (atherosclerotic plaques) in the intima of a patient's blood vessels (i.e., under the endothelium). Typically, over time, the material that initially deposits as relatively soft, cholesterol-rich atherosclerotic material hardens within the vessel wall into calcified atherosclerotic plaques. These plaques restrict blood flow, causing the vessel to become less compliant than normal, and are therefore often referred to as stenotic lesions or stenosis, with the blocking material called stenotic material. If left untreated, such stenosis can lead to angina, high blood pressure, myocardial infarction, stroke, and other conditions.

[0008] Angioplasty, or balloon angioplasty, is an endovascular procedure that treats (typically) narrowed or blocked arteries or veins by widening them. A collapsed balloon is typically inserted through a pre-positioned catheter and along a guidewire into the narrowed occlusion, then inflated to a fixed pressure. The balloon forces the occlusion within the vessel and the surrounding muscular walls to expand until the occlusion yields due to the radial force applied by the inflating balloon, thereby opening the vessel to have an internal diameter similar to the native vessel in the occluded area and thus improving blood flow. Generally, known IVL devices include a voltage pulse generator operatively communicated with one or more pairs of electrodes mounted on a catheter and within an inflatable balloon.

[0009] The applicant has described the intravascular lithotripsy system, apparatus, and methods. See PCT / US2022 / 074607, filed August 5, 2022, entitled “INTRAVASCULAR LITHOTRIPSY BALLOON SYSTEMS, DEVICES AND METHODS,” the entire contents of which are hereby incorporated by reference.

[0010] like Figure 1 The illustration provides a schematic layout of various parts of an exemplary IVL system 12. The illustrative IVL system 12 includes a catheter assembly 114 and a fluid-filled member 16. The catheter assembly includes an elongated body of a catheter implemented as having a guidewire 15. The fluid-filled member is configured to contain conductive fluid, exemplified as an inflatable balloon, disposed near one end of the body and arranged to receive fluid for inflating to facilitate IVL treatment. A set of spaced-apart dischargeable electrodes 18 is shown disposed within the exemplary balloon 16, with at least some electrodes spaced apart from each other by gaps 17 to generate a spark or arc between the spaced-apart electrodes 18.

[0011] The IVL system embodiments described herein can be used in conjunction with electrodes within a fluid-filled member 16, which is configured to contain fluid, such as a conductive fluid. Embodiments of the fluid-filled member 16 may include, for example... Figure 1 The inflatable balloon shown can be compliant or non-compliant and is used to contain fluid such that spaced-apart electrodes 18 are immersed in the contained fluid. Furthermore, the fluid-filling member 16 may include at least partially rigid and / or non-flexible fillable members. In other embodiments, the fluid-filling member 16 may contain fluid, and wherein spaced-apart electrodes 18 are positioned or immersed in the contained fluid.

[0012] Alternatively, the IVL system control embodiments of this disclosure can be used in conjunction with electrodes that are not positioned or surrounded by the fluid-filled member or fillable member 16. In these embodiments, the IVL system may include spaced-apart electrodes 18 that may be continuously or periodically exposed to brine or other fluids, and during exposure, the IVL system may generate an electric arc between the spaced-apart electrodes 18.

[0013] Spacing-out electrodes 18 are arranged in communication with an electrical pulse generation system 20 (shown as a dashed conductor) to receive high-voltage electrical energy for generating a spark, thereby generating a pressure wave for IVL treatment. In an illustrative embodiment, one electrode may be grounded, and the other electrode may be supplied with a high voltage from the electrical pulse generation system 20, although in some embodiments, any voltage difference may be applied. The electrical pulse generation system 20 includes an IVL control system 22, which includes a processor 24 configured to execute instructions stored in a memory 26 and communication signals via circuitry 28 for performing IVL operations managed by the processor. The processor 24, memory 26, and circuitry 28 are arranged to communicate with each other (shown as dashed lines) to facilitate the disclosed operations.

[0014] 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 period of electron discharge, the desired energy control within such IVL devices and systems can be challenging. Moreover, adaptive control approaches can offer advantages in IVL effectiveness. Adjustable energy delivery can increase efficient electrical application, which can reduce patient risk. For example, it is exemplified to start with a predetermined initial 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 whose amplitude is confirmed to be within the acceptable voltage window. If, for example, the amplitude of the series of generated voltage pulses is below the predetermined upper voltage threshold, the target voltage can be increased by a predetermined amount, and another series of generated voltage pulses can be executed. Embodiments of IVL systems, devices, and methods within this disclosure include operations for adjusting the total electrical energy supplied to the set of electrodes for a given pulse. The applicant has described such control systems for intravascular lithotripsy systems, devices, and methods. See PCT / US2023 / 79209, filed November 9, 2023, entitled “CONTROL OF IVL SYSTEMS, DEVICES AND METHODS THEREOF”, the entire contents of which are hereby incorporated by reference.

[0015] Figure 2The image shows a portion of a known competitive IVL device in cross-section, viewed along a line cut through the IVL balloon (which in particular surrounds the catheter body).

[0016] Therefore, the expansion port of the prior art is in fluid communication with the filling cavity / passage. Figure 2 In competitive IVL devices, the filling cavity / access is formed between the inner surface of the catheter body and the outer surface of a sheath covering the lead conductor (terminating at an electrode positioned along the catheter and within the balloon). Thus, the lead conductor of the known device is not exposed to fluid within the filling cavity / access. The electrode, positioned within the balloon and electrically connected to the lead conductor, is not covered by the sheath and is therefore exposed to fluid within the balloon. Furthermore, known competitive devices include angioplasty balloons that adhere to the outer surface of the catheter body at both the proximal and distal ends, wherein the filling cavity / access extending into the balloon is formed within the catheter body and defined by the space between the sheath and the inner surface of the catheter body. Therefore, known competitive IVL balloons adhere to a structure, namely the outer surface of the catheter body, at both their proximal and distal ends.

[0017] also, Figure 2 Known competing IVL devices comprise a catheter body and a guidewire assembly (which defines a guidewire lumen), both extending through the balloon. Both structures continue distally beyond the distal end of the balloon to reach the distal tip. Therefore, the distal tip of known competing devices incorporates rigidity and deformability that can be improved to further enhance the device's ability to translate tortuous vascular systems and reduce the likelihood of damage to the vascular system during translation.

[0018] Furthermore, Figure 2 The sleeve shown has an added layer of material that adds thickness through the profile, increasing complexity and occupying a portion of the area of ​​the cavity / passage, thereby reducing the available volume of the cavity / passage during expansion and / or contraction cycles.

[0019] Figure 3 The diagram illustrates the situation when current leads are in an IVL system (such as...). Figure 1 The diagram illustrates the decrease in impedance of the current lead across the spark gap defined between the two spaced electrodes when an arc develops between them. This occurs after a voltage is applied to one of the spaced electrodes in the IVL system. This results in a rapid peak in the power dissipated in the arc, while both the voltage and current between the electrodes remain relatively high. The very rapid peak current and voltage drop indicate the presence or occurrence of an arc between the spaced electrodes. The peak power dissipated in the arc indicates a relatively short time interval during which all the useful work is done to heat the developing lead into an arc. Figure 3The graphic illustration is an example of one aspect of IVL surgery that generates pressure waves.

[0020] It would be advantageous to provide an IVL system and / or device that reduces the risk of trauma and the structural complexity of the lithotripsy system during the translation of the angioplasty balloon to the target anatomical location.

[0021] Moreover, it would be advantageous to provide an IVL system and / or device that includes a reduced through profile, a more flexible tip, and an anti-kink shaft.

[0022] Known IVL devices also include a spark gap between electrode pairs that, when a sufficiently high voltage is applied to the first electrode, facilitates the formation of a spark or arc that allows current to flow from the first electrode across the spark gap to the second electrode in the electrode pair. This process causes material loss or corrosion of each electrode in the electrode pair. Known spark gaps are generally axially arranged, i.e., the terminal faces of the conductors are spaced apart from each other and face each other in an axial spark gap configuration. In this case, the arc involves the terminal face or distal face of at least one electrode in the electrode pair. The continuous arcing across the spark gap during IVL procedures with these known devices causes corrosion of the material from each electrode involved in the arc. Each of these arcs causes a slight increase and / or decrease in the size of the spark gap, while the complete set of arcs causes a significant increase in the size of the spark gap, which can lead to unpredictability during arc generation. Alternatively, the first and second electrodes can be arranged concentrically, with the spark gap defined in the radial direction, wherein the first and second electrodes are not arranged along a common radial or circumferential plane. As will be demonstrated herein, this arrangement produces a pressure output with relatively high variability. Furthermore, it is known that IVL devices generate a resulting pressure output, or “shock wave” or “pressure wave,” which decreases in amplitude over a series of arcs as the IVL procedure is performed. Moreover, the high variability in pressure output produced by known IVL devices can lead to unpredictable or undesirable results and may cause instability of the balloon over time due to stress placed on the balloon material caused by the variability in pressure output. Further, it is known that IVL coronary devices are configured to generate a maximum total of 120 pulses per catheter at a frequency of 1 Hz. It is known that peripheral IVL devices are configured to generate a maximum total of 300 pulses per catheter at 1 Hz.

[0023] It would be advantageous to provide an IVL device or system that is designed to maintain the desired spark gap distance between spaced electrodes throughout the execution of the IVL procedure and to produce a tightly controlled output pressure with tighter data diffusion from high data points to low data points and a lower standard deviation compared to known IVL devices.

[0024] It would also be desirable to provide an IVL device or system that is more durable and efficient than known devices through structural and operational improvements, in some embodiments providing an IVL device or system capable of providing up to and more than 300 voltage pulses per catheter, and in other embodiments providing up to 500 voltage pulses per catheter at a frequency of 1 Hz to 5 Hz, with 2 Hz being a preferred frequency.

[0025] It would be advantageous to provide an IVL device or system with a catheter that includes key features, wherein the key features allow for improved pushability and kink resistance, particularly in the balloon region, and at least a reduced passage profile in that region.

[0026] Various embodiments of the present invention aim to achieve the advantages discussed above, etc. Attached Figure Description

[0027] These accompanying drawings are exemplary illustrations of certain embodiments and are therefore not intended to limit this disclosure.

[0028] Figure 1 A schematic diagram of an exemplary IVL device is shown.

[0029] Figure 2 The figure shows a cross-sectional view of a known IVL device.

[0030] Figure 3 The illustration shows a graphical representation of the typical timing of the applied voltage and current during the application of voltage and the generation of an electric arc between spaced electrodes.

[0031] Figure 4 An embodiment of this disclosure is illustrated.

[0032] Figure 5 An embodiment of this disclosure is illustrated.

[0033] Figure 6 The illustration shows a side sectional view of the distal portion of an exemplary embodiment of the present disclosure.

[0034] Figure 7A A side sectional view of an exemplary embodiment of the present disclosure is illustrated.

[0035] Figure 7B A side sectional view of an exemplary embodiment of the present disclosure is illustrated.

[0036] Figure 8 The illustration shows a side sectional view of a portion of the distal region of an exemplary embodiment of the present disclosure.

[0037] Figure 9 A partial cross-sectional view of a portion of an exemplary embodiment of the present disclosure is illustrated.

[0038] Figure 10 The diagram shows Figure 6 A partial side sectional view.

[0039] Figure 11 The diagram shows Figure 10 A side sectional view of an embodiment.

[0040] Figure 12A An embodiment of a portion of the system disclosed herein is illustrated.

[0041] Figure 12B An embodiment of a portion of the system disclosed herein is illustrated.

[0042] Figure 12C An embodiment of a portion of the system disclosed herein is illustrated.

[0043] Figure 12D An embodiment of a portion of the system disclosed herein is illustrated.

[0044] Figure 13A An embodiment of a portion of the system disclosed herein is illustrated.

[0045] Figure 13B An embodiment of a portion of the system disclosed herein is illustrated.

[0046] Figure 14A A side sectional view of an embodiment of the present disclosure is illustrated.

[0047] Figure 14B The diagram shows Figure 14A Part of the device illustrated in the figure.

[0048] Figure 15A An embodiment of this disclosure is illustrated.

[0049] Figure 15B An embodiment of this disclosure is illustrated.

[0050] Figure 15C An embodiment of this disclosure is illustrated.

[0051] Figure 15D An embodiment of this disclosure is illustrated.

[0052] Figure 15E A cross-sectional view of an embodiment of the present disclosure is illustrated.

[0053] Figure 16A An embodiment of this disclosure is illustrated.

[0054] Figure 16B An embodiment of this disclosure is illustrated.

[0055] Figure 16C An embodiment of this disclosure is illustrated.

[0056] Figure 16D An embodiment of this disclosure is illustrated.

[0057] Figure 17A An embodiment of this disclosure is illustrated.

[0058] Figure 17B An embodiment of this disclosure is illustrated.

[0059] Figure 17C An embodiment of this disclosure is illustrated.

[0060] Figure 17D An embodiment of this disclosure is illustrated.

[0061] Figure 18A An embodiment of this disclosure is illustrated.

[0062] Figure 18B An embodiment of this disclosure is illustrated.

[0063] Figure 19A An embodiment of this disclosure is illustrated.

[0064] Figure 19B An embodiment of this disclosure is illustrated.

[0065] Figure 20 A side view of an embodiment of the present disclosure is illustrated.

[0066] Figure 21 A schematic diagram of one embodiment of the present disclosure is shown.

[0067] Figure 22 A top sectional view of an embodiment of the present disclosure is illustrated.

[0068] Figure 23 A block diagram of one embodiment of the present disclosure is shown.

[0069] Figure 24 The diagram illustrates the pressure curves of a comparative test IVL device and a known IVL device.

[0070] Figure 25 The figure shows a force tracking curve comparing the tracking force of a tracking clamp used to test an IVL catheter and a known IVL catheter. Detailed Implementation

[0071] Figure 4An embodiment of the IVL system 100 of this disclosure is illustrated. A voltage pulse generator 110 is provided, operatively connected and in communication with a controller 112 configured to provide programmed operating instructions to the voltage pulse generator 110 and the fluid reservoir / fluid pump assembly 114. The controller 112 and the voltage pulse generator 110 are operatively electrically in communication with the aforementioned lead conductors and electrode pairs, wherein the lead conductors are arranged along the length of the conduit, and wherein the electrode pairs are disposed within the interior of an inflatable balloon positioned at or near the distal end of the conduit structure. The conduit balloon structure is schematically represented by element number 116. A hub 118 allows operative connection and communication with the controller 112, the fluid reservoir / pump 114, and the voltage pulse generator 110. Furthermore, a connector 120 is operatively connected and in communication with the controller 112 and provides operative electrical connection and communication with the lead conductors and electrode pairs. Controller 112 may include a processor for executing program instructions, such as initiating voltage pulses at a predetermined amplitude and frequency and in a predetermined pulse and amplitude pattern. The processor may be operatively communicateable and connectable to a memory and a display. In some embodiments, hub 118 may allow over-the-wire access through a lumen defined within a conduit. In a preferred embodiment, a rapid exchange (Rx) access is provided. Some embodiments of controller 112 may include an EPROM containing programming instructions, such as, but not limited to, initiating voltage pulses at a predetermined amplitude and frequency and in a predetermined pulse and amplitude pattern.

[0072] like Figure 22 and Figure 23 As discussed herein, some embodiments may include a handle that may include an EPROM containing programming instructions, such as, but not limited to, initiating voltage pulses at a predetermined amplitude and frequency and in a predetermined pulse and amplitude pattern. The EPROM may be operatively communicated and connected to a console including a processor for executing the program instructions, a memory operatively communicated with the processor and, in some embodiments, with the EPROM, and a display. In some embodiments, hub 118 may allow over-the-wire insertion through a lumen defined within a conduit.

[0073] Figure 5 A cross-sectional side view of an IVL system 100 is shown, the IVL system including a handle having a configuration for... Figure 4 The voltage pulse generator 110 and the connector 120 connected to the aforementioned console. The removable spindle M is shown as being inserted through a guidewire lumen defined along a portion of the catheter axis, extending proximally through a flexible distal tip and through the defined guidewire lumen of the catheter.

[0074] Figures 6 to 11 The diagram shows Figure 4 and Figure 5 An exemplary embodiment of the distal portion of the catheter and balloon element 116 of an IVL system 100.

[0075] Best seen at Figure 7A An inflatable balloon 200 is provided, which includes a cylindrical proximal segment 202, a cylindrical distal segment 206, and an inflatable segment 210, the inflatable segment including an unbonded segment 203 of the cylindrical distal segment 206, a tapered proximal segment 212, a tapered distal segment 214, and a generally cylindrical segment 216 disposed between the tapered proximal segment 212 and the tapered distal segment 214.

[0076] The proximal portion 207 of the cylindrical distal segment 206 of the balloon 200 surrounds the outer surface of the elongated member 220 and is bonded or sealed against the outer surface of the elongated member 220 in a waterproof manner, preferably as shown in Figure 6 The distal region of the cylindrical distal segment 206 extends (e.g., extruded) beyond the distal end of the elongated member 220 to form a trauma-resistant, flexible tip 218.

[0077] The proximal portion 204 of the cylindrical proximal segment 202 of the balloon surrounds the non-tapered outer surface 234 of the tapered outer member 230 (see...). Figure 8 The non-tapered outer surface 234 of the tapered outer member 230 is sealed or bonded in a waterproof manner, but not against any portion of the elongated member 220 that is received within the distal end of the tapered outer member 230 and extends distally from the distal end of the tapered outer member 230. The distal length of the unbonded portion 203 of the cylindrical proximal segment 202 of the balloon 200 surrounds the distal tapered segment 232 of the tapered outer member 230, but does not bond or seal against any portion of the tapered outer member 230. Therefore, the inflatable segment of the balloon 200 includes: the unbonded portion 203 of the cylindrical proximal segment 202, the proximal tapered segment 212, the distal tapered segment 214, and a generally cylindrical segment 216 disposed between the proximal tapered segment 212 and the distal tapered segment 214.

[0078] The tapered outer member 230 has an outer diameter larger than that of the elongated member 220 and is configured to receive the elongated member 220.

[0079] Furthermore, the length of the fluid delivery tube P is defined along the length of the device and is concentrically arranged between the outer surface of the elongated member 220 and the inner surface of the tapered outer member 230. The remaining portion of the fluid delivery tube P is defined proximally along the axial direction of the conduit. The fluid delivery tube P provides a dedicated path for fluid communication between the fluid reservoir / pump 114 and the inflatable section 210 of the balloon 200. The fluid delivery tube P terminates distally relative to the distal end of the tapered outer member 230, at which an opening O for fluid inflow and outflow from the balloon 200 is defined.

[0080] It is noteworthy that the distal end of the tapered outer member 230, and thus the opening O for fluid flow, extends distally beyond the distal end of the proximal cylindrical segment 202 of the balloon. Therefore, the proximal cylindrical segment 202 of the balloon surrounds at least a portion of the proximal non-tapered or cylindrical segment 234 of the tapered outer member 230 and seals or adheres to the outer surface of the non-tapered or cylindrical (proximal) segment 234 in a waterproof seal. However, the distal region of the tapered outer member 230 is not surrounded by the proximal cylindrical segment 202 of the balloon. Instead, the distal region of the tapered outer member 230 and its opening O extend into the proximal tapered segment 212 of the balloon 200.

[0081] Due to the aforementioned waterproof sealing mechanism and the location of the opening O of the inflatable portion 210 for fluid inflow and outflow from the balloon 200, the proximal cylindrical section 202 of the balloon 200 does not function in the movement of fluid into or out of the inflatable portion 210 of the balloon 200. Similarly, the inflatable portion 210 of the balloon 200 does not function in the expansion / contraction or deflation of fluid or in the movement of fluid into or out of the inflatable portion 210 of the balloon 200. The inflatable portion 210 only receives incoming fluid from the opening O at the distal end of the tapered outer member 230, or transfers outgoing fluid to the opening O.

[0082] Figure 8 The distal portion of the tapered outer member 230, including a tapered segment 232, is shown, the tapered segment 232 including a tapering angle α. In this embodiment, the tapered segment 232 includes the unbonded segment 203 of the balloon 200, wherein the proximal cylindrical segment 203 of the balloon 200 (see...) Figure 7AA portion of the tapered section 232 is adhered, bonded, or sealed against the outer surface of the tapered section 232. Proximal to the tapered section 232, the tapered outer member 230 includes a cylindrical section 234 of substantially constant diameter. This is indicated as an adhesive section and provides an outer surface that is surrounded by and sealed or bonded in a waterproof manner by the proximal portion 204 of the proximal cylindrical section 202 of the balloon 200. The fluid delivery tube P discussed above includes a final inner diameter shown in dashed lines, wherein the tube P terminates at an opening O at the distal end of the tapered outer member 230. As shown by the inner dashed lines, the inner diameter tapers distally within the tapered section 232. In other embodiments, the tube P may have a substantially constant diameter passing through both the cylindrical section 234 and the tapered section 232, wherein the wall thickness of the tube may be narrowed, or made to thinner in a distal direction at the tapered section 232, while maintaining a constant inner diameter passing through the cylindrical section 234 and the tapered section 232. In other embodiments, such as in Figure 8 In this embodiment, the profile of tube P may taper downwards at a taper angle α of the tapering segment 232. In some embodiments, the inner diameter of tube P may include a constant diameter.

[0083] like Figure 7A and Figure 7B As shown, and continue to refer to Figure 6 , Figure 8 , Figure 10 and Figure 11 The cylindrical proximal segment 202 of the balloon 200 includes a length L1 and an outer diameter OD1. Even though the length L1 of the cylindrical proximal segment 202 surrounds the tapered outer member 230, only the proximal portion 204 of the cylindrical proximal segment 202 is bonded or sealed against the outer surface of the elongated member in a waterproof configuration. The proximal portion 204, also referred to as the proximal waterproof seal or adhesive portion 204, has a length L2 less than L1. Finally, the cylindrical proximal segment 202 further includes an unbonded segment 203 at its distal end, which has a length L3 and surrounds the tapered outer member 230, but is not bonded or sealed to the elongated member, wherein the length L3 is less than L2 and L1, such that L2 plus L3 equals L1.

[0084] The balloon 200 further includes a cylindrical distal segment 206 having a total length of L4, including a distal tip 218. Excluding the distal tip 218, the proximal portion 207 of the cylindrical distal segment 206, which surrounds and seals or adheres to the outer surface of the elongated member 220 in a waterproof manner, includes a length of L5, shorter than L4. Thus, the distal tip 218 extends distally beyond the distal end of the elongated member 220 by a certain distance to provide a wound-resistant tip and facilitate translation through the vascular system.

[0085] As described above, the inflatable portion 210 of the balloon 200 includes an unbonded segment (length L3) 203, a tapered proximal segment 212, a tapered distal segment 214, and a generally cylindrical segment 216 disposed between the tapered proximal segment 212 and the tapered distal segment 214. Therefore, the length of the inflatable portion is L6, and for the total inflatable portion length L6, it includes the unbonded segment 203 of length L3 (proximal cylindrical segment), the proximal tapered segment 212 of length L7, the distal tapered segment 214 of length L8, and the generally cylindrical segment 216 of length L9.

[0086] The tapered outer member 230 can taper downwards to a minimum outer diameter OD2 at its distal end, which is smaller than the effective outer diameter OD1 of the proximal cylindrical segment 202 and the outer diameter of the non-tapered portion 234 of the tapered outer member 230. In this embodiment, the inner diameter of the cylindrical proximal segment 202 of the balloon can be approximately equal to the outer diameter of the tapered outer member at OD1, which is the non-tapered portion 234 of the tapered outer member, to which the proximal cylindrical segment is waterproofly bonded or sealed. Similarly, the inner diameter of the proximal portion 207 of the cylindrical distal segment 206 of the balloon can be approximately equal to the outer diameter of the elongated member 220 at OD3, to which the proximal portion 207 is waterproofly bonded or sealed.

[0087] exist Figure 6 and Figure 7A It can be seen that the outer diameter of the outer component to which the cylindrical proximal section of the balloon is sealed or bonded, i.e., OD1, can be larger than the outer diameter of the slender component with an outer diameter OD3.

[0088] As previously described, the elongated member 220 is received within the tapered outer member 230. Therefore, the balloon 200 is sealed against two different structures. Proximally, the balloon 200 is sealed against the non-tapered outer surface 234 of the outer member 230, while distally, the balloon 200 is sealed against the outer surface of the elongated member 220.

[0089] The distal tip 218 of the balloon is preferably flexible and includes a catheter defined therethrough, and this catheter is aligned with a catheter defined through an elongated member to allow guidewire access in particular.

[0090] In some embodiments, a larger proximal outer diameter OD1, compared to a smaller distal outer diameter OD3, can produce a taper angle μ for the tapered proximal segment of the balloon that is different from (e.g., smaller than) the taper angle of the tapered distal segment of the balloon. These taper angles are reference... Figure 7A The dashed lines in the figure are measured and are collinear with the non-tapered outer surface (tapered angle μ) of the outer member and the outer surface (tapered angle) of the elongated member. In some embodiments, the length L7 of the taper proximal segment may be shorter than the length L5 of the taper distal segment.

[0091] Due to these exemplary relative dimensions, such as Figure 7A and Figure 7B As shown, embodiments of the inflatable segment 210 of balloon 200 may not be longitudinally symmetrical. Specifically, the inflatable segment 210 may be longitudinally symmetrical, wherein the taper angle μ at the proximal taper segment 212 of balloon 200 is smaller than the taper angle at the distal taper segment 214, which facilitates access to tight lesions. In other embodiments, the taper angle μ and the taper angle at the distal taper segment 214 may be approximately the same. Furthermore, embodiments of the distal cylindrical segment 206 of balloon 200 include an outer diameter at OD3 smaller than the outer diameter of the proximal cylindrical segment 202, which also facilitates access to tight lesions. In other words, the passage profile distal to the generally cylindrical segment 216 of balloon 200 is smaller than the passage profile proximal to the generally cylindrical segment 216 of balloon 200.

[0092] like Figure 7B and Figure 14B As shown, the elongated member 220 to which the balloon 200 is sealed distally includes a polyamide core lined with polytetrafluoroethylene, commonly referred to as PTFE, on its inner surface. The outer surface of the polyamide core is lined with 72D... The electrode support components ES (proximal) and ES' (distal) may be stainless steel and coated with an insulating material, such as a polymer or polymer blend or other material, including but not limited to adhesives, polyamides or other high-temperature resistant flowable non-conductive materials.

[0093] Exemplary dimensions of the balloon 200 region may include the length of the distance from the distal end of the outer member 230 to the inflatable segment 210. An exemplary distance from the distal end of the outer member to the inflatable segment is 0.794 mm, but other extension distances are also within the scope of this disclosure.

[0094] The balloon can be made of nylon or similar materials. In some embodiments, the balloon material is uncoated, which allows energy from pressure waves to be transmitted through it more efficiently.

[0095] Furthermore, the presence of the tapered outer member 230 adds rigidity to the device, and the unbonded section 203 of the balloon 200 and the tapered section 232 of the tapered outer member 230 provide a smaller passage profile in the balloon-wrapped configuration. All of these serve to provide additional pushability and strength in the area of ​​the outer member, and further serve to prevent the wrapped balloon device from kinking during advancement through the patient's vascular system, both of which are highly advantageous.

[0096] like Figure 6 and Figures 9 to 11As shown, the proximal marking band BP and the distal marking band BD can be disposed within the inflatable section 210 of the balloon and around the elongated member 220 at or near the transition from the proximal tapering section 212 and the distal tapering section 214 to the generally cylindrical section 216, respectively. Furthermore, a first proximal electrode support member ES is positioned along the elongated member 220 within the inflatable section 210 at a location closer to the proximal side of the balloon 200. In some embodiments, a single electrode support member ES may be provided, as will be discussed further.

[0097] The second (distal) electrode support member ES' can be positioned along the elongated member 220 within the inflatable portion 210 at a location spaced apart from the first (proximal) electrode support member ES and closer to the distal side of the balloon 200. The two electrode support members ES and ES' are operatively connected and electrically connected by wire conductors W, which are operatively electrically connected to the pulse voltage generator 10, as will be discussed further.

[0098] Figure 9 A portion of the elongated member 220 and the outer member 230 is illustrated, with the balloon 200 removed. Here, the first electrode support member ES and the second electrode support member ES' are shown in more detail, with the conductors W connected in series. Each electrode support member ES, ES' includes a body B, which comprises a conductive material coated with an insulating material I and includes at least one slit, preferably two slits, as will be discussed further. A protrusion or arcuate region is defined on one of the two longitudinal sides of each slit, and the conductor has an insulating cover layer except that the distal end of the conductor has no insulating layer. As will be described further, a spark gap is formed between the exposed conductor of the conductor and the protrusion or arcuate region of the slit of the electrode support member ES, ES'.

[0099] Each electrode support member may include two rotating slits with spark gaps, which may be rotatably spaced 180 degrees apart, or may be rotated apart with different rotational intervals. For example... Figure 9 As shown, the spark gaps formed by electrode support members ES and ES' can also be rotatably spaced apart from each other. For example, if the spark gaps of electrode support members ES and ES' are spaced 180 degrees apart around the respective electrode support members ES and ES', the two electrode support members ES and ES' can be radially rotated to ensure that all spark gaps are rotatably spaced apart from each other, thereby providing circumferential coverage. In some embodiments, two or more cutouts and their corresponding spark gaps can be longitudinally aligned. Preferably, as Figure 6 and Figure 9As shown, electrode support members ES and ES' can rotate relative to each other, such that the corresponding cuts and spark gaps also rotate relative to each other about the elongated member 220. A preferred rotation interval may include a 90-degree rotation interval between spark gaps along the elongated member 220, although other rotation intervals are also within the scope of the invention.

[0100] Figure 10 and Figure 11 The illustration shows a proximal cross-sectional view of the balloon 200 and the catheter structure, where the first (proximal) electrode support member ES is shown with an associated wire conductor W. Furthermore, the wire conductors leading back to the positive and negative terminals of the voltage pulse generator occupy the fluid delivery tube.

[0101] Figure 10 The diagram also illustrates a first electrode support member ES on the nearest side, comprising a body B. Body B includes a conductive material and defines a cutout C1A having two opposing longitudinal sides LI, L2, and a proximal end PE and an opposing distal end DE. A protrusion or arcuate region 250 is formed or defined along one of the longitudinal sides LI. In addition to the protrusion or arcuate region 250 including exposed conductive material, the surface of the electrode support body ES is covered with an insulating material I.

[0102] As illustrated, the conductor 300 includes an insulating layer and has a bare conductor distal region 302 extending a distance from the distal end to the proximal end. The proximal region of the bare conductor region 302 is shown positioned within a cut, close to and laterally or radially spaced from the protrusion or arcuate region 250A. This configuration provides a pair of spaced-apart electrodes that define a spark gap between the lateral surface (preferably not the distal surface) of the bare conductor region 302 (including the first electrode in the illustrated spaced-apart electrode pair) and the protrusion or arcuate region 250 (including the second electrode in the spaced-apart electrode pair). In some embodiments, the surface of the distal surface of the conductor 300 may be used as the electrode in the above configuration.

[0103] This preferred embodiment includes a lateral surface of an exposed conductor located in a distal region of the conductor, serving as one of the electrodes in a spaced-out pair of electrodes. Figure 10 The illustrated embodiment includes the lateral surface of the exposed conductor region 302 of the conductor serving as the first electrode, meaning that current flows first to this electrode and then across the spark gap to the second electrode in the spaced-out electrode pair. As will be discussed, in some embodiments of the spaced-out electrodes, this current flow can be reversed, wherein the metal region (in Figure 10In one embodiment, the protrusion or arcuate region 250A includes a first electrode in a spaced-apart pair of electrodes. In this embodiment, the lateral surface of the conductor includes a second electrode in this pair of spaced-apart electrodes, and current flows to the first exemplary protrusion or arcuate region 250A and then across the spark gap to the second electrode, which includes the lateral surface of the exposed conductor region 302.

[0104] In a preferred embodiment, the surface areas of the first and second electrodes in a spaced-apart electrode pair are substantially equal. In other embodiments, the surface area of ​​the second electrode in the spaced-apart electrode pair may be larger than the surface area of ​​the first electrode. Alternatively, the surface area of ​​the first electrode in the spaced-apart electrode pair may be larger than the surface area of ​​the second electrode.

[0105] As will be discussed further, the preferred location for the exposed conductor region 302 is to position the distal end approximately half the distance between the proximal end of the protrusion or arcuate region 250A and the proximal end PE of the cutout C1A. This location is... Figure 10 , Figures 17A to 17C , Figures 18A-18B as well as Figures 19A-19B The diagram is shown via axis A. In this configuration, the portion of the conductor that directly covers the protrusion or arcuate region 250 remains insulated, wherein the lateral surface of the exposed conductor region 302 extends beyond (in this case, proximally) the boundary of the protrusion or arcuate region 250. The spaced-apart electrodes in the embodiments described herein are preferably positioned along a common radial or circumferential plane.

[0106] Although the protrusion or arcuate region (second electrode) 250A is illustrated as being positioned approximately midway along the longitudinal side L1 of the cut C1A, the protrusion or arcuate region 250A can also be positioned further proximally or distally. This alters the longitudinal position of the spaced-apart electrodes 250A, 302 and the longitudinal position of the spark gap defined between the spaced-apart electrodes 250A, 302, and effectively shifts the position and focus of the resulting pressure wave in the longitudinal direction to allow for more effective coverage and / or interaction between adjacent pressure waves.

[0107] Figure 11 The diagram shows Figure 10 The cross-section of the area shown in the figure.

[0108] Continue to refer to Figures 4 to 5 and Figures 6 to 11 We are now turning to Figures 12A to 12D The illustration depicts features of an embodiment of an exemplary IVL system. Figures 12A to 12D Move sequentially to the distal side along the exemplary system.

[0109] from Figure 12A At the beginning, just like Figure 4On the distal side of the hub 118, a thiocyanate tube 402 is provided, which serves as a conduit for fluid injection and removal and is in fluid communication with the fluid reservoir, pump 114, and the internal fluid communication of the inflatable portion 210 of the balloon 200. The thiocyanate tube 402 can be made of metal and can be stainless steel. Figure 12B The structure shown (its in) Figure 12A As shown in the combination of the structure on the far side, the exemplary length of the hysteresis tube 402 may be slightly longer than 1055 mm, but other lengths are also within the scope of this disclosure. Figure 12B The specified length is 1055mm; however, the 402 submersible extends a short distance further in the distal direction, along which it is composed of 72D... The material is overmolded to form the adhesive segment 403 to increase adhesive strength, etc. The sodium hypochlorite tube 402 is generally not coated on its outer or inner surface, but includes a polymer near the distal end, such as... Used to assist in bonding or adhesion, and includes an adhesive in the proximal region, also used to assist in bonding or adhesion.

[0110] Hypobo 402 Figure 12B The section is shown terminating at 404 on the distal side. In some embodiments, the substation 402 can extend distally from the hub by a distance of approximately 1080 mm. Figure 12B Extending distally from the adhesive section 403 by a certain distance (e.g., but not limited to, approximately 280 mm) to include a polyamide conduit PC for stress relief, the polyamide conduit having a 72D coating on its outer surface. It also includes the adhesive section 403.

[0111] Figure 12C The illustration shows a cross-section including the RX port 406, which provides access for a guidewire or other interventional tool. The RX port 406 leads to a guidewire catheter 408, which may include a 63D guidewire catheter. The pipe is made of high-density polyethylene (HDPE) such as Rezilok and has the capability to be lined with 63D. The inner surface of the guidewire conduit 408. The guidewire conduit 408 extends distally through the polyamide conduit PC and the elongated member 230, and exits the system at the distal end of the distal tip 218. The RX port 406 will... Figure 13A and Figure 13B Further discussion is needed.

[0112] like Figure 12C As shown, exactly on the far side of the RX port 406, there is an external component 230 including 63D. The proximal end is lined with HDPE, such as Rezilok. The outer member 230 continues distally for a certain length or distance to terminate at its distal end, positioned within the inflatable segment 216 of the balloon, as shown and described above. Figure 12D As illustrated, the elongated member 220 includes a proximal end 220P, which is connected to the aforementioned polyamide conduit PC, and includes an adhesive (e.g., laser reflow fusion) segment 409 to assist in adhesion. The elongated member 220 extends through the interior of the outer member 230 and the balloon 200 to a point just proximal to the distal tip 218.

[0113] Now go to Figure 13A and Figure 13B The figure illustrates RX port 406. As shown, a hyaluronic acid tube 410, which may comprise a polymer, is provided along the length of the polyamide tube proximal to RX port 406 for support. Further reference is given below. Figure 14A and Figure 14B Known devices typically use support wires instead of the hyaluronic acid tube 410, but the inventors have found that a polyamide tube with an outer polymer sheath (including an elongated member 220 that transitions into the hyaluronic acid tube 410) provides greater and necessary rigidity and support in this critical area.

[0114] Figure 14A The illustration shows a cross-sectional view of the tapered outer member 230, the balloon 200, the elongated member 220, and the first electrode support member ES and the second electrode support member ES'. The electrode support members are operatively electrically connected to the voltage pulse generator 110 discussed above. A bridging conductor WT is provided for operatively connecting ES and ES'. Unlike known IVL devices that use copper conductors throughout, the bridging conductor is preferably made of tantalum. Tantalum offers significantly improved durability compared to copper. During testing, copper conductors used as "bridging conductors" gradually deteriorate or corrode as the test voltage pulse and associated arcs and currents progress. Eventually, the copper bridging conductor becomes prone to displacement, thereby disrupting the series connection between the electrode support members ES and ES'. Thus, the tantalum bridging conductor is found to provide a key durability characteristic, one of the features of this disclosure, allowing a significantly greater number of arcs (up to 500 and more) than known devices.

[0115] Figure 14B yes Figure 14A A close-up of the cross-section of the middle electrode support member. The elongated member 220 may include three layers: a polyamide core layer (which helps resist heat generated by the electrode during operation), a Pebax outer layer, and a PTFE inner layer. Other polymers or polymer blends may also be used to construct the elongated member 220.

[0116] In some embodiments, an air gap or fluid gap 270 is provided between an electrode support member (e.g., ES and / or ES') and the outer surface of the elongated member 220, the electrode support members ES and / or ES' being adhered to or operatively attached to and at least partially surrounding the outer surface of the elongated member 220. The air gap or fluid gap 270 serves to help dissipate heat generated by the arc produced by the spark gap across the two spaced-apart electrodes 250, 302, thereby allowing fluid within the inflatable bladder 200 to flow through the air gap or fluid gap 270 and around and beneath a portion of the electrode support members ES and / or ES' to remove heat from the structure. This is another key durability element of this disclosure and contributes to generating a greater number and higher frequency of arcs compared to known devices through embodiments of this disclosure.

[0117] Furthermore, in addition to the exposed metal electrode elements (e.g., protrusions or arcuate regions 250), the electrode support members (e.g., ES, ES') are coated with an insulating material, and the wire conductors defining the exposed wire electrode elements are also coated with an insulating material. Therefore, in each case, the surface area of ​​the spaced-out electrodes is relatively tightly controlled. This contrasts with known IVL systems, which provide more exposed metal surface area for concentric metal electrodes than actually needed, and thus generate more undesirable gases as byproducts of arc generation. This is another key feature of this disclosure, contributing to durability and improved variability compared to known IVL systems.

[0118] In this embodiment, the unique aspect of the operative connection or adhesion between the electrode support members ES and / or ES' and the elongated member 220 is that, as discussed above, the electrode support members ES and / or ES' are coated or covered with an insulating material I. The insulating material I flows beneath a portion of the electrode support members ES and / or ES' to form a connection or adhesion between a portion of the lower surface of the electrode support members ES and / or ES' and the outer surface of the elongated member 220, while maintaining the desired air gap or fluid gap 270.

[0119] Now go to Figures 15A to 15E The illustration shows an embodiment of an electrode support member ES comprising two electrodes. The electrode support member ES can be used in the IVL system embodiments described above. The electrode support member ES includes a body B, which may be cylindrical and configured to at least partially surround the elongated member 220, as discussed above. In some embodiments, the electrode support member discussed herein may not be fully circumferential, as will be discussed further. Figures 15A to 15DThe embodiment includes two radially spaced cuts, namely a first cut C1A and a second cut C2B. Each cut C1A, C2B includes opposing longitudinal sides L1 and L2, and a proximal PE and a distal DE. The body B also includes a longitudinally arranged slot or channel 260 that extends along the body and is configured to receive a portion of an insulated conductor. The first cut C1A includes a slot or channel 262 extending longitudinally from the proximal PE of the first cut C1A in the proximal direction. The second cut C2B includes a slot or channel 264 extending longitudinally from the distal DE of the second cut C2B in the distal direction.

[0120] The electrode support member ES includes a body formed of a conductive material, which is covered with an insulating material I as described above. A region along one of the opposing longitudinal sides includes exposed conductive material, where the insulating material cover is removed. In the illustrated embodiment of the ES, exposed conductive material (e.g., metal) is disposed along longitudinal sides L2 at locations 250A and 250B, respectively, for the first cut C1A and the second cut C2B. Figures 15A to 15E In one embodiment, the exposed conductive material portion is designated as separate arcuate regions 250A and 250B, which extend radially into each cutout C1A and C2B, respectively. Each exemplary arcuate region 250A and 250B defines one electrode from a spaced-apart electrode pair.

[0121] Best seen at Figure 15C The electrode support member body B is provided with a longitudinal slot or channel 260 extending along its entire length, and the longitudinal slot or channel 260 is configured to receive the insulating portion of one or more wire conductors. Figure 15E The illustration shows a cross-sectional view through body B, illustrating that the longitudinal slot or channel 262 may include angled sides, with a smaller opening at the outermost portion of the slot or channel 262. This angled retaining structure can be used to retain wires in slots 260, 262, and / or 264.

[0122] Grooves or channels 260, 262, and 264 are provided to maintain the passage profile of the electrode support member, which is at most the outer diameter of the electrode support member body. Furthermore, grooves or channels 260, 262, and 264 also serve to hold the wire conductor and associated electrode area in proper position within the target electrode support member.

[0123] Figure 15DAn "unfolded" plan view of an exemplary electrode support member body B is provided. Electrodes with exposed conductive material define arcuate regions 250A, 250B that can be substantially centered along the longitudinal side L1 or L2 defining the arcuate regions 250A, 250B. Alternatively, as shown by dashed lines, one or both arcuate regions 250A, 250B with exposed conductive material can be offset from the center of the longitudinal side. Thus, arcuate regions 250A, 250B can be centered and / or offset from the center along the longitudinal side of the object. In one embodiment, one arcuate region (e.g., 250A) can be longitudinally offset from the position of another arcuate region (e.g., 250B). This allows tuning of the positions of the arcuate regions 250A and 250B defined by a single electrode support member body B (and consequently, spaced-apart electrodes and defined spark gap positions), and in some embodiments, allows the positions of the arcuate regions 250A and 250B to be radially and longitudinally offset from each other. This allows the body B of a single electrode support member with two radially spaced electrode pairs to generate pressure waves, which generate mechanical forces that are not only radially offset from each other but also longitudinally offset from each other.

[0124] The use of exemplary embodiment ES to form spaced-apart electrode pairs and defined spark gaps has been broadly described above and will be discussed further below.

[0125] Figures 15A to 15E An exemplary electrode support member ES may include a proximal electrode support member (such as in, for example...) Figure 6 The proximal electrode support member shown in the diagram is connected to the more distal, spaced-apart electrode support member ES', which will be discussed below. Figures 16A to 16D The following discussion will be held. Furthermore, when two or more electrode support members ES are electrically connected and operably connected to each other and electrically connected and operably connected to a more distal, spaced-apart electrode support assembly, one of the electrode support members ES may include the nearest electrode support member, and the remaining electrode support members ES may include intermediate electrode support members positioned between the near-side electrode support member and the far-side electrode support member.

[0126] Figures 16A to 16D An embodiment of the distal electrode support member ES' is illustrated. This embodiment may include an exemplary electrode support member ES' positioned further distally, such as... Figure 6As shown, this is when operatively combined with at least one more proximal spaced electrode support member (such as the ES described above). More fundamentally and alternatively, this embodiment can be used alone, thereby providing a single electrode support member ES' having two radially spaced electrode pairs when fully assembled. In an alternative embodiment, the single electrode support member ES' may include a single pair of spaced electrodes, wherein the spaced electrodes are operatively electrically connected to a first conductor, which is operatively electrically connected to a first electrode in the electrode pair and to the positive terminal or high-voltage side terminal of a voltage pulse generator. A second conductor may be operatively electrically connected to a second electrode in the electrode pair and to the ground terminal or low-voltage side terminal of the voltage pulse generator.

[0127] Figures 16A to 16D The embodiment also includes two radially spaced cuts, namely a first cut CIC and a second cut C2D. Each cut CIC and C2D defines two opposing longitudinal sides L1 and L2, a proximal PE and a distal DE, and grooves or channels 266, 268 extending in the proximal direction from the proximal PE of each of the first cut CIC and the second cut C2D. Figures 15A to 15E Similar to the embodiments, exemplary arcuate regions 250C and 250D of the exposed conductive material are defined along one of the longitudinal sides of the cutouts CIC and C2D, respectively. (Best seen in...) Figure 16D Regions 250C and 250D, containing exposed conductive material (e.g., metal), are each defined along the longitudinal side L2 of their respective cuts C1 and C2D. Each arcuate region 250C and 250D forms and defines one of a pair of spaced-apart electrodes. Figures 15A to 15E As in the embodiment, the location of one or both of the arcuate regions 250C and 250D (and the location of the spark gap defined when the wire conductor is added, and the location of the pressure wave generated by the spaced-apart electrodes thereafter) can be longitudinally offset from the center of the longitudinal side(s), in Figure 16D The image is shown in dashed lines. This embodiment may not include... Figures 15A to 15E The full-length longitudinal groove 260 in the embodiment.

[0128] Figures 17A to 17D An exemplary spaced-out electrode pair is illustrated. This can be provided as described above. Figures 15A to 16D Exemplary electrode support members of any of the embodiments discussed herein. We will describe as above in conjunction with Figures 14A to 14BThe electrode support member ES is the same as in the illustrated embodiment. A first cut C1A is shown, in which a portion of the insulated wire conductor 300A is positioned or received within a groove or channel 262 extending proximally away from the first cut C1A. The insulation layer of the distal region 302A of the wire conductor 300A is stripped, leaving the exposed distal region 302A of the exposed conductive wire. The lateral surface (opposite to the distal end face or surface) of the exposed distal region 302A of the wire conductor 300A, together with the exposed metal of the arcuate region 250A, forms a spaced-apart electrode pair, defining a spark gap between them.

[0129] The exposed conductive wire region 302A is preferably positioned beyond the arc-shaped region, as shown in the figure, such that the distal end of the exposed wire region is halfway between the arc-shaped region and the distal end of the cut C1A. This preferred dimension... Figure 17A The diagram is illustrated using x and y, where x = y. Alternatively, the exposed conductor region 302A at the distal end of the conductor can be positioned generally above the arcuate region to form an alternative embodiment of spaced-out electrode pairs.

[0130] Figure 17B and Figure 17C The illustration shows exemplary starting and ending positions of an electrode including an exposed conductor region 302A relative to spaced-apart electrodes including an exemplary arcuate region 250A. Figure 17B and Figure 17C The diagram also illustrates the approximate direction of current flow and arc across the spark gap defined by the spaced-out electrode pairs, where distance A represents the initial spark gap length and distance B represents the final spark gap length between the transverse surface of the exposed conductor (exemplary first electrode) and the exposed conductive material of the arc-shaped region (exemplary second electrode). The current flow and the resulting arc will be axially translated as the exposed conductor region 302A is translated.

[0131] As the electric arc is initiated and progresses between the spaced-out electrodes 302A and 250A, the electrode, including the exposed conductor region 302A, begins to corrode and translate, effectively moving axially (proximal in the illustrative embodiment) along the arc region 250A, and sequentially engaging different (proximal) regions of the arc region 250A during the arcing process. The insulation layer initially covering the conductor 300A burns away, thereby sequentially exposing more conductors, and as... Figure 17C In the example, there is an exemplary ending position where the spark gap is a distance B. It is now apparent that the spark gap changes its relative position, thus moving in the proximal direction along the longitudinal axis of the conductor 300A in this case. As the spark gap position changes, the effective direction of current flow and the resulting arc also change.

[0132] Figure 17D The diagram illustrates the combination Figures 15A to 15EA cross-sectional view of the exemplary electrode support member ES is provided to illustrate the relative positions and orientations of an exemplary first electrode including an exposed conductor region 302A and an exemplary second electrode including an arcuate region 250A, thereby defining a first spaced-apart electrode pair. Furthermore, the relative positions and orientations of a second spaced-apart electrode pair, circumferentially or radially spaced from the first spaced-apart electrode pair, are also shown. The second spaced-apart electrode pair includes an exemplary second electrode having an exposed conductor region 302B and an exemplary second electrode including an arcuate region 250B. Preferably, in all embodiments described herein, the electrodes formed by the lateral surfaces of the exemplary exposed conductive conductors 302A, 302B and the corresponding exemplary exposed metal regions (illustrated as arcuate regions 250A, 250B) are positioned substantially at the same location relative to the outer surface of the elongated member 220. In other words, the spaced-apart electrodes formed by 302A, 250A and 302B, 250B can each be positioned at a certain distance from the outer surface of the elongated member 220, wherein the distances of the spaced-apart electrodes 302A and 302B to the outer surface of the elongated member 220 are approximately equal to the distances of the spaced-apart electrodes 250A and 250B to the outer surface of the elongated member 220. This arrangement provides the air gap or fluid gap 270 discussed further above. Furthermore, referring to… Figures 15A to 15E At least a portion of the transverse surface of the exposed conductor segment of the first conductor can be positioned between and aligned with the first longitudinal side L1 and the second longitudinal side L2 of the cut, such that the transverse surface of the exposed conductor segment is spaced apart from and aligned with the exposed metal region. Alternatively, the spaced-apart electrodes formed by 302A and 250A can each be positioned along the outer surface of the elongated member 220.

[0133] In all embodiments, the spaced-out electrodes of this disclosure are positioned at approximately equal distances from the longitudinal axis of the shaft passing through the IVL device.

[0134] In some embodiments, the spark gaps represented by distances A and B can have equal lengths. This is important because it allows for the use of a predictable and predetermined voltage amplitude to be provided, which in turn produces a more controlled pressure output from the resulting pressure wave. Ultimately, the pressure output produced by a controlled, known spark gap length includes more consistent, less variable force compared to known IVL devices. This is understood to be crucial for producing less strain on the balloon, which in turn allows for the generation of a greater number of maximum voltage pulses, arcs, and resulting pressure waves with a single catheter or system than is currently possible. For example, known IVL coronary devices have a maximum of 120 voltage pulses. The disclosed embodiments have demonstrated the ability to effectively generate 300 voltage pulses per catheter in some embodiments and up to 500 pulses per catheter in others, where associated pressure waves are generated, all within a very tight distribution, and without a significant reduction in pressure output produced over 300 voltage pulses. In some embodiments, the spark gap can be controlled such that it is within a predetermined length range, with an exemplary minimum spark gap of 0.004.

[0135] Figure 18A and Figure 18B Similar to Figure 17A and Figure 17B In one embodiment, the arcuate electrode is replaced by a cutout C1A' comprising a raised flat region, which includes exposed metal and functions as an electrode. This arrangement further ensures that when an arc is generated on the lateral surface of the exposed conductor region 302A together with the raised flat region, the series of voltage pulses and arcs executed across the spark gap distance remain substantially the same. Thus, distances A and B are substantially equal, and each spark gap between distances A and B also has a length substantially the same as that between distances A and B.

[0136] Figure 19A and Figure 19B It is functionally similar to Figures 18A to 18B An alternative embodiment differs in that the raised, flat region electrode is replaced by the inner surface of a cutout C1A” in the electrode support member body B, where an insulating layer of a certain length or distance has been stripped away, exposing the conductive material in the area that functions as an electrode. This arrangement further ensures that when an arc is generated on the lateral surface of the exposed conductor region 302 together with the electrode including the exposed conductive material, the series of voltage pulses and arcs executed across the spark gap distance span remain approximately the same. Thus, distances A and B are approximately equal, and each spark gap between distances A and B also has a length approximately the same as that between distances A and B.

[0137] In some embodiments, as the exposed transverse surface of the conductor corrodes, the spark gap formation and associated distance can be tuned to the amplitude of the voltage pulses generated by a voltage pulse generator. In such embodiments, a series of initial voltage pulses of predetermined amplitude are tuned to ensure that an arc is generated between electrodes spaced apart by a known spark gap distance. In some embodiments, as the arcing process is performed, the spark gap distance can be varied at a known rate and within one or more series of voltage pulses and the associated arc. Thus, as the corrosion process progresses, an arc begins to be generated on the transverse surface of the exposed conductor, and the exposed conductor region (e.g., 302A) begins to translate and traverse the electrode (exposed metal) surface of the electrode support member. During this shortened traversal, the spark gap distance can be approximately the same within the pulse / arc cycle and / or can vary with the pulse / arc being performed. Changing the spark gap distance can be related to a known spark gap distance, which involves the relative position of the lateral surfaces of the exposed conductors of the conductor and the range of arc engagement locations along the exposed conductive material region of the electrode support member, including the electrode.

[0138] Thus, the controller can correlate the required or desired voltage pulse amplitude with a known spark gap distance or range for a series of initial voltage pulses and associated arcs, and further to the maximum number of voltage pulses and / or arcs allowed by the specific device. The known spark gap distance over time and the resulting arcs allow the controller to modify the voltage amplitude as the number of pulses progresses (and the spark gap distance changes) to ensure that (1) an arc occurs; and / or (2) the pressure output generated by the voltage pulses initiated by the controller at a predetermined amplitude is within a relatively tight and controllable window. In some embodiments, the controller can determine whether the energy storage element releases sufficient electrical energy to generate an arc.

[0139] The spaced spark gaps can be arranged and connected in a variety of ways.

[0140] The simplest arrangement might involve combining the above. Figures 16A to 16D The electrode support member ES' under discussion. Figure 20 As shown, the electrode support member ES' includes a first cutout C1C, wherein a first wire conductor 300A is received in a slot or channel 266, and wherein a first exposed wire 302A has a transverse surface serving as a first electrode and is positioned at a location spaced apart from an exemplary exposed metal arcuate region 250C serving as a second electrode in a first spaced-apart electrode pair.

[0141] Such as combination Figure 17DPreferably, in all embodiments described herein, the spaced-apart electrodes are positioned at substantially the same location relative to the outer surface of the elongated member 220. In other words, the spaced-apart electrodes can each be positioned at a certain distance from the outer surface of the elongated member 220, wherein the distance from the first spaced-apart electrode in the electrode pair to the outer surface of the elongated member 220 is substantially equal to the distance from the second spaced-apart electrode in the electrode pair to the outer surface of the elongated member 220. Furthermore, at least a portion of the transverse surface of the exposed conductor segment of the first conductor can be positioned between the first and second longitudinal sides of the cut, and aligned with the transverse surfaces of the first and second longitudinal sides of the cut and the exposed metal region. Alternatively, the two spaced-apart electrodes of the electrode pair can each be positioned along the outer surface of the elongated member 220.

[0142] The second cut C2D also includes an exposed metal arcuate region 250D, which serves as a third electrode. The second cut C2D also receives a second wire conductor 300B within a slot or channel 268, wherein the distal end of the second wire conductor 300B includes an exposed wire region 302B, the transverse surface of which serves as a fourth electrode.

[0143] In operation, when the voltage generator initiates a voltage pulse of sufficient amplitude, current flows through the first conductor 300A to the first electrode 302A and across a first spark gap from the first electrode 302A to the second electrode 250C within the first notch CIC, thereby generating an arc and a resulting pressure wave. The current continues to flow through the conductive body B of the electrode support member ES' until it reaches the third electrode at the exemplary arcuate region 250D of the second notch C2D. The current flows across a second spark gap from the third electrode to the fourth electrode, which includes the distal region of the second conductor 300B and its exposed conductor 302B, and then flows back along the second conductor 300B to the negative terminal of the voltage pulse generator. An arc and a resulting pressure wave are generated as the current flows across the second spark gap from the arcuate region 250D to the distal region of the exposed conductor 302B in the second notch C2D. The second conductor is operatively electrically connected to the negative terminal or grounding terminal of the voltage generator, and the first conductor is operatively electrically connected to the positive terminal or high-voltage side terminal of the voltage generator.

[0144] Figure 21 The diagram illustrates two electrode support components connected in series. (Continue to refer to...) Figures 15A to 15EThe first electrode support member located more proximally may include an electrode support member ES, as discussed, which includes two radially spaced cutouts C1A, C1B, each cutout C1A, C1B defining a pair of spaced-apart electrodes, wherein a spark gap is between the pair of spaced-apart electrodes, as described herein. The second (more distal) electrode support member may include ES' as described above, and like ES, ES' includes two radially spaced cutouts C2C, C2D, each cutout C2C, C2D defining a pair of spaced-apart electrodes, wherein a spark gap is between the pair of spaced-apart electrodes.

[0145] Continue to refer to Figures 15A to 16D , Figure 21 The current flow begins with a voltage pulse of sufficient amplitude generated by a voltage generator. The resulting current flows distally along the first conductor 300A to reach the first electrode 302A, which is the distal region of the exposed conductor. The lateral surface of the exposed conductor region 302A is spaced from the arcuate region 250A of the first cut C1A, which serves as the second electrode in the spaced-out electrode pair as described above. Figure 17D As described herein, preferably, the spaced-apart electrodes in all embodiments are positioned at substantially the same location relative to the outer surface of the elongated member 220. In other words, the spaced-apart electrodes may each be positioned at a certain distance from the outer surface of the elongated member 220, wherein the distance from the first spaced-apart electrode in the electrode pair to the outer surface of the elongated member 220 is substantially equal to the distance from the second spaced-apart electrode in the electrode pair to the outer surface of the elongated member 220. Furthermore, at least a portion of the transverse surface of the exposed conductor segment of the first conductor may be positioned between the first and second longitudinal sides of the cut and aligned with the exposed metal region. Alternatively, the two spaced-apart electrodes of the electrode pair may each be positioned along the outer surface of the elongated member 220.

[0146] The current flowing across the first spark gap will generate an electric arc and associated pressure waves.

[0147] Continue to refer to Figures 15A to 16D and Figure 21The current continues to flow through the conductive material of the body B of the electrical support member ES, located more proximally, until it reaches the third electrode, which includes a second arcuate region 250B within a second cut C2B radially spaced from the first cut C2A. A second conductor 300B, comprising tantalum, or a bridging conductor, has a proximal region and a distal region, both of which include exposed tantalum wire, with the remaining tantalum wire covered in an insulating layer. The proximal end of the exposed tantalum wire includes a lateral face at 302B, which functions as a fourth electrode in the system and is preferably spaced apart from the third electrode defined by the second arcuate region 250B.

[0148] As current flows from the third electrode to the fourth electrode within the second cut C2B, a second arc is formed across the spark gap, generating a pressure wave.

[0149] Next, current flows along the second conductor 300B, including a tantalum bridging wire, to the electrode support member ES', which is spaced and positioned further away. The distal exposed conductor 302C of the tantalum bridging wire includes a transverse facet that serves as the fifth electrode in this system and is positioned within the first cutout C1C of the electrode support member ES'. The transverse facet of the fifth electrode is spaced apart from a sixth electrode, which includes an exposed metal arcuate region 250C of the first cutout C1C of the electrode support member ES'. As current flows from the fifth electrode across the defined spark gap to the sixth electrode, an arc is generated, producing a pressure wave.

[0150] Current continues to flow from the sixth electrode through the conductive body B of the electrode support member ES' until it reaches the seventh electrode, which includes an exposed metal arcuate region 250D within the second cutout C2D of the electrode support member ES'. The eighth electrode includes a third conductor 300C with a distal region 302D of exposed wire, wherein the lateral surface of the exposed wire region 302D comprises the eighth electrode. The proximal end of the third conductor 300C is operatively electrically connected to the ground terminal, low-voltage terminal, or negative terminal of the voltage generator. As current flows from the seventh electrode to the eighth electrode within the second cutout C2D of the electrode support member ES', an arc is generated across the spark gap, and a pressure wave is produced. A portion of the third conductor 300C may be received within a slot or channel 260 of ES', wherein the proximal end of the third conductor 300C is positioned to be operatively electrically connected to the voltage generator as discussed above.

[0151] A similar configuration can be achieved using three or more electrode support members connected in series. For example, the proximal electrode support member ES can be connected in series to a second, more distal electrode support member ES via a tantalum bridging wire, and the second, more distal electrode support member ES can in turn be connected to the most distal electrode support member ES' via a second tantalum bridging wire. Current will flow through the first proximal electrode support member ES as described above, then through the second, more distal electrode support member ES in the same manner, and then through the distal electrode support member ES' as described above.

[0152] Two or more pairs of electrode support members connected in series can also be combined by using a controller and / or multiplexer, each pair of electrode support members functioning as described above, the controller and / or multiplexer selectively applying voltage to one pair of electrode support members and then selectively applying voltage to a second pair of electrode support members.

[0153] Furthermore, in each wiring configuration of the embodiments used for the electrode support members discussed above, the current flow within a given circuit can be reversed by changing the polarity of a series of voltage pulses. In other embodiments, the polarity can be reversed for each voltage pulse. Such a polarity change results in altering which side of the spaced-apart electrode pair acts as the anode and which side acts as the cathode. Functionally, this can offer advantages in expanding the number of arcs that can be generated between two spaced electrodes, especially if one of the spaced electrodes wears or corrodes faster than the other in the spaced-apart electrode pair.

[0154] Figure 22 The illustration shows a handle that can be operatively connected and linked to a console, which may include a processor and operatively connected memory (such as a combination of...). Figure 1 The aforementioned memory for executing instructions and the voltage pulse generator 110 are described above. In this embodiment, the handle includes or is in communication with an EPROM (erasable read-only programmable memory), which may be operatively connected to a processor and / or memory. The EPROM can provide treatment parameters that may be specific to a particular type of IVL device, such as a balloon with a specified length and / or a specified number of electrode support members and / or spark gaps. Furthermore, the processor and / or memory can store treatment parameters for comparison of treatment progress monitored by the processor with the stored treatment parameters. The processor can also generate a connection log, monitor the number of pulses (and the maximum allowed number of pulses), and generate a connection log. Figure 23 A general flow is provided for data involving the EPROM of an IVL system having this disclosure.

[0155] This document has described some key features of the exemplary IVL systems; we now turn to the functional results of these exemplary systems. Comparative stress output tests were performed on a known IVL system operating according to its instructions for use and a test system conforming to this disclosure.

[0156] The test methods and materials included a comparison of the tested IVL device with known IVL devices. Each IVL device comprised a catheter, a balloon, two radially spaced pairs of electrodes within the balloon, and a voltage pulse generator connected to the two pairs of electrodes. Test balloon sizes included 2.5 mm × 12 mm and 4.0 mm × 20 mm. Known balloon sizes included 2.5 mm × 12 mm, 4.0 mm × 20 mm, 2.5 mm × 40 mm, and 4.0 mm × 40 mm. Each IVL system under test included longitudinally spaced, but generally similar, spacing between adjacent electrode pairs. The test apparatus included a non-amplified ONDAHNR-0500 needle hydrophone (serial number 2149, calibration date May 3, 2023 and serial number 2160, calibration date May 5, 2023). This hydrophone had an effective diameter of 2.5 mm. The hydrophone was calibrated and traceable to Onda Corporation. The frequency response is flat from 0.5 MHz to 10 MHz within + / -6 dB, with a measurement uncertainty of 1.5 dB for the frequency range of 0.5 MHz to 1 MHz and a measurement uncertainty of 1 dB for the frequency range of 1 MHz to 10 MHz. The test setup was immersed in a water bath along with a known setup. The known system performed a total of 1,440 voltage pulses and measured the resulting pressure output; the test system performed a total of 13,320 voltage pulses using the test method and materials and measured the resulting pressure output.

[0157] For each device under test, the pressure output test method consists of the following steps:

[0158] 1. Place the IVL device balloon of the test subject in a water bath.

[0159] 2. Position the hydrophone approximately 2.89 mm distal to the test spark gap, with the hydrophone offset from the longitudinal axis of the conduit by approximately 5 mm.

[0160] 3. Generate a voltage pulse of predetermined amplitude.

[0161] 4. Move the conduit so that the spark gap of the hydrophone relative to the test electrode pair is positioned approximately 0.9375 mm proximally.

[0162] 5. Repeat steps 1 to 4 until the hydrophone is positioned more than 2.89 mm beyond the proximal side of the test spark gap.

[0163] 6. Repeat steps 1 to 5 by rotating the catheter axially at 45 degrees, 90 degrees, 135 degrees and 180 degrees.

[0164] Comparison Test and Feature Selection

[0165] Pressure output variability

[0166] Figure 24 Pressure output (initial peak pressure) data curves for a known IVL system and a test IVL system conforming to this disclosure are provided. Visually, it is immediately apparent that the pressure output of the known system varies considerably. In contrast, the pressure output data of the test system is relatively tightly controlled and exhibits relatively small variations compared to the known system. Table 1 provides a summary of the data:

[0167]

[0168] Table 1

[0169] Therefore, the coefficient of variation (“CV”), an indicator of intra-dataset variability, is 39.3% for the pressure output data of the known system and 23.8% for the pressure output data of the test system. Thus, it can be reasonably concluded that the pressure output data of the test system is more controlled and significantly less variable compared to the pressure output data of the known system. Therefore, using key features in the IVL system will allow a CV of less than 35% across a series of pressure output data. More preferably, the CV across a series of pressure output data will be less than 30%, and even more preferably, the CV across a series of pressure output data will be less than 25%. As stated above, compared to known IVL systems, the IVL system described herein provides a more durable (more pulses / arcs / pressure waves per catheter), more efficient (higher frequency pulses / arcs / pressure waves), and more controlled pressure output from the generated pressure waves.

[0170] Force required to traverse the vascular system

[0171] Force standard tracking tests were performed on the test system and a known system (Shockwave Medical C2 IVL catheter) using the ASTM F2394 tracking fixture, such as... Figure 25As shown. Each system under test comprises a total of two emitters, each consisting of spaced-apart electrodes. Each system under test is translated via a standard clamp illustrated, while tracking the force required to move the catheter under test from the start to the end of the clamp. Both the test system and the known system are dual-emitter designs (two spaced-apart electrode pairs, wherein the spaced-apart electrode pairs are longitudinally spaced from each other), and both systems have a balloon size of 3.0 mm × 20 mm. The ASTM F2394 tracking clamp is filled with water for lubrication. The test catheter and the known catheter are tracked along the lead wire through the model until the distal tip reaches the end of the model. Peak forces are values ​​recorded and observed in the graph, as shown. Figure 25 As shown. This comparative test measures the relative resistance through a tortuous vascular system.

[0172] As shown in the figure, the average peak force of the tested system is 368.425 grams, while the average peak force of the known system is 408.233 grams. This represents a 9.75% reduction in the force required by the tested system compared to the known system. The percentage difference between the two average peak forces is 10.8%.

[0173] Therefore, the average peak force of the test system using the ASTM F2394 tracking fixture is approximately 9.75% smaller than the average peak force of known systems.

[0174] Some embodiments of the test system may include an average peak force that is at least 9.5% smaller than the average peak force of known systems, achieved by tracking the clamp via ASTM F2394.

[0175] Some embodiments of the test system may include an average peak force that is at least 9% smaller than the average peak force of known systems, achieved by tracking the clamp via ASTM F2394.

[0176] Some embodiments of the test system may include an average peak force that is at least 8% smaller than the average peak force of known systems, achieved by tracking the clamp via ASTM F2394.

[0177] Some embodiments of the test system may include an average peak force that is at least 6% smaller than the average peak force of known systems, achieved by tracking the clamp via ASTM F2394.

[0178] Some embodiments of the test system may include an average peak force that is at least 5% smaller than the average peak force of known systems, achieved by tracking the clamp via ASTM F2394.

[0179] Therefore, the testing system traverses the fixture from the beginning to the end with a peak force of less than 405 grams.

[0180] Furthermore, the testing system traverses the fixture from the beginning to the end with a peak force of less than 400 grams.

[0181] The testing system also traverses the fixture from the beginning to the end with a peak force of less than 375 grams.

[0182] The testing system also traverses the fixture from the beginning to the end with a peak force of less than 370 grams.

[0183] Therefore, the peak thrust used to test the system can be in the range of approximately 400 grams to approximately 405 grams.

[0184] The peak thrust used to test the system can also be in the range of approximately 375 grams to approximately 405 grams.

[0185] The peak thrust measured for the test system can also be in the range of approximately 370 grams to approximately 405 grams.

[0186] In addition, Table 2 below provides a partial summary list of functional improvements and enhancements provided by embodiments of this disclosure relative to known systems, including a partial list of the disclosed features that cause the improvements and enhancements.

[0187]

[0188]

[0189]

[0190] The description of the invention and its applications set forth herein is illustrative and not intended to limit the scope of the invention. Features of the various embodiments may be combined with other embodiments contemplated by the invention. Variations and modifications to the embodiments disclosed herein are possible, and practical substitutions and equivalents of the various elements of the embodiments will be understood by those skilled in the art upon studying this patent document. These and other variations and modifications may be made to the embodiments disclosed herein without departing from the scope and spirit of the invention.

Claims

1. An intravascular lithotripsy (IVL) system, the IVL system comprising: a pulse generator 110 including a positive terminal, a negative terminal, and an interconnector; a cable having a proximal end and an interconnector at the proximal end configured to interconnect 120 with the interconnector of the pulse generator 110; an actuation handle positioned along the cable; an elongated member 220 having an outer surface; a fluid expandable balloon 200 positioned at or near a distal end of the elongated member 220, wherein one or more pairs of spaced apart electrodes are disposed within the fluid expandable balloon 200, wherein a first pair of spaced apart electrodes of the one or more pairs of spaced apart electrodes includes: a first electrode 302A including a first wire conductor 300A surrounded by an insulator and operably connected at a proximal end to the positive terminal of the pulse generator 110 and including a distal end, wherein the first wire conductor 300A includes a length of exposed wire segment 302A defining the first electrode 302A extending proximally from the distal end; a second electrode spaced apart from the first electrode and formed by a first electrode support member ES having a body B attached to and at least partially surrounding a length of the outer surface of the elongated member 220; and a slot 260 defined along a length of the body B, wherein the body of the first electrode support member ES includes a conductive material covered with an insulating material I and defines a first cutout CI A having an arcuate region defining the second electrode 250A positioned along a longitudinal side of the first cutout and extending toward an opposite longitudinal side of the first cutout, wherein a lateral surface of the arcuate region defining the second electrode 250A is stripped of the insulating material, and wherein the length of exposed wire segment defining the first electrode 302A extending from the distal end of the first wire conductor is positioned within the first cutout CI A such that a lateral surface of the length of exposed wire segment defining the first electrode 302A is positioned between and aligned with longitudinal sides LI, L2 of the first cutout CI A and is radially spaced apart from a lateral surface of the arcuate region of the first cutout CI A defining the first electrode 302A to define a spark gap between the lateral surface of the exposed wire defining the first electrode 302A and the lateral surface of the arcuate region defining the second electrode 250A.

2. The IVL system of claim 1, wherein, The first electrode is spaced a distance from an outer surface of the elongated member and the second electrode is spaced a distance from the outer surface of the elongated member, wherein the distance from the outer surface of the elongated member to each of the first electrode and the second electrode is approximately equal.

3. The IVL system of one or both of claims 1 and 2, wherein, At least a portion of a lateral surface of the exposed wire section of the first wire conductor is positioned between the first and second longitudinal sides of the cutout and aligned with the lateral surface of the arcuate region.

4. The IVL system of one or more of claims 1 to 3, wherein, The first cutout includes a first channel on a proximal end of the first cutout, the first channel extending away from the first cutout in a proximal direction, and wherein a portion of a distal end of the insulative portion of the first wire conductor is received within the first channel.

5. The IVL system of one or more of claims 1 to 4, wherein, A distal end of the first wire conductor is initially positioned at a location that is one-half of a distance between a distal side of the arcuate region and a distal end of the first cutout.

6. The IVL system of one or more of claims 1 to 5, wherein, An exposed wire section of the first wire conductor is initially positioned distal of the arcuate region.

7. The IVL system of one or more of claims 1 to 6, wherein, A portion of the exposed wire section of the first wire conductor is initially positioned alongside a portion of the arcuate region.

8. The IVL system of one or more of claims 1 to 7, wherein, A distal end of the first wire conductor is positioned at a location that is one-half of a distance between a center of the arcuate region and a distal end of the first cutout.

9. The IVL system of one or more of claims 1 to 8, further comprising a ground wire conductor in operable electrical communication with the second electrode and a negative terminal of the pulse generator.

10. The IVL system of one or more of claims 1 to 9, further comprising a second pair of spaced apart electrodes of the one or more pairs of spaced apart electrodes, the second pair of spaced apart electrodes comprising: a third electrode defined by the first electrode support, the third electrode comprising a second cutout spaced apart circumferentially from the first cutout, wherein the second cutout defines an arcuate region having a lateral surface stripped of the insulative material and the arcuate region is positioned along a longitudinal side of the second cutout and extends toward an opposing longitudinal side of the second cutout, wherein the third electrode is in operable electrical connection with the first pair of spaced apart electrodes of the one or more pairs of spaced apart electrodes; and a fourth electrode spaced apart from the third electrode and comprising a second wire conductor surrounded by an insulator, wherein the second wire conductor comprises an exposed wire section, wherein the exposed wire section is positioned between and aligned with the longitudinal sides of the second cutout and radially spaced apart from the lateral surface of the arcuate region of the second cutout to define a spark gap between a lateral surface of the exposed wire section of the second wire conductor and the arcuate region of the second cutout.

11. The IVL system of claim 10, wherein, The third electrode is positioned a distance from an outer surface of the elongated member, wherein the fourth electrode is positioned a distance from the outer surface of the elongated member, wherein the third electrode is positioned approximately equally distant from the outer surface of the elongated member as the fourth electrode.

12. The IVL system of one or both of claims 10-12, wherein, The second cut further includes a second channel on a proximal end of the second cut, and wherein a portion of a proximal end of an insulated portion of the second wire conductor is received within the second channel, and wherein the second channel extends proximally from the second cut.

13. The IVL system of one or both of claims 10-12, wherein, The first electrode, the second electrode, the third electrode, and the fourth electrode are approximately equally distanced from an outer surface of the elongate member.

14. The IVL system of one or more of claims 10 to 13, wherein, At least a portion of a lateral surface of the exposed wire segment of the first wire conductor is positioned between the first and second longitudinal sides of the cut and aligned with a lateral surface of the arcuate region.

15. The IVL system of one or more of claims 11 to 14, wherein, A distal end of the second wire conductor is positioned at a location that is at half the distance between a distal side of the arcuate region of the second cut and a distal end of the second cut.

16. The IVL system of one or more of claims 11 to 15, wherein, An exposed wire segment of the second wire conductor is positioned distal of the arcuate region of the second cut.

17. The IVL system of one or more of claims 11 to 16, wherein, A portion of the exposed wire segment of the second wire conductor is positioned alongside a portion of the arcuate region of the second cut.

18. The IVL system of one or more of claims 11 to 17, wherein, A proximal end of the first wire conductor is positioned at a location that is at half the distance between a center of the arcuate region and a distal end of the second cut.

19. The IVL system of one or more of claims 11 to 18, further comprising: A proximal end of the second wire conductor, the proximal end of the second wire conductor configured to be in operable electrical communication with a negative terminal of the pulse generator.

20. The IVL system of one or more of claims 11 to 19, wherein, The first electrode and the second electrode define a first spark gap, and wherein the third electrode and the fourth electrode define a second spark gap, wherein the first spark gap is circumferentially spaced apart from the second spark gap.

21. The IVL system of one or more of claims 11 to 20, wherein, The first spark gap and the second spark gap are electrically connected in a series configuration when electrical current flows across each of the first spark gap and the second spark gap.

22. An intravascular lithotripsy (IVL) system, the IVL system comprising: a pulse generator 110 including a positive terminal, a negative terminal, and an interconnector; a cable having a proximal end and having an interconnector 120 at the proximal end, the interconnector configured to interconnect with the interconnector of the pulse generator 110; an actuation handle positioned along the cable; an elongate member 220 having an outer surface; a fluid-inflatable balloon 200 positioned at or near a distal end of the elongate member 220, wherein one or more pairs of spaced-apart electrodes are disposed within the fluid-inflatable balloon, wherein a first pair of spaced-apart electrodes of the one or more pairs of spaced-apart electrodes includes: a first electrode 302A including a first wire conductor 300A surrounded by an insulator and operably connected at a proximal end to the positive terminal of the pulse generator 110 and including a distal end, wherein the first wire conductor 300A includes a length of exposed wire segment 302A of the first electrode 302A extending proximally from the distal end; and a second electrode 304A including a second wire conductor 300B surrounded by an insulator and operably connected at a proximal end to the negative terminal of the pulse generator 110 and including a distal end, wherein the second wire conductor 300B includes a length of exposed wire segment 304B of the second electrode 304A extending proximally from the distal end. a second electrode 250A spaced apart from the first electrode 302A and comprising a first electrode support member ES having a body B attached to and at least partially surrounding an outer surface of the elongated member 220; wherein the body B of the first electrode support member ES comprises a length, a slot 260 along the length of the body of the first electrode support member, and a conductive material covered with an insulating material I, and defines a first cutout CI A having an exposed metal region defining the second electrode 250A, the exposed metal region being located along a first longitudinal side of the first cutout, wherein a transverse surface defining the exposed metal region is stripped of the insulating material I, and wherein the exposed wire section defining the first electrode 302A extends from a distal end of the first wire conductor and is located within the first cutout CI A such that a transverse surface of the exposed wire section defining the first electrode 302A is located between and aligned with longitudinal sides LI, L2 of the first cutout CI A and is radially spaced apart from a transverse surface of the first cutout CI A defining the exposed metal region of the second electrode 250A to define a spark gap between the transverse surface of the exposed wire of the first electrode 302A and the transverse surface of the exposed metal region of the second electrode 250A.

23. The IVL system of claim 22, wherein, the exposed metal region comprises a flat surface.

24. The IVL system of claim 23, wherein, the flat surface extends from the first longitudinal side toward a second opposite longitudinal side of the first cutout.

25. The IVL system of one or more of claims 22 to 24, wherein, the distal end of the first wire conductor is initially located at a position that is half the distance between a distal side of the exposed metal region and a distal end of the first cutout.

26. The IVL system of claim 25, wherein, the exposed wire section of the first wire conductor is initially located distal to the exposed metal region.

27. The IVL system of claim 26, wherein, a portion of the exposed wire section of the first wire conductor is initially located alongside a portion of the exposed metal region.

28. The IVL system of one or more of claims 22 to 24, wherein, the distal end of the first wire conductor is located at a position that is half the distance between a center of the arcuate region and a distal end of the first cutout.

29. The IVL system of one or more of claims 22 to 28, further comprising a ground wire conductor in operable electrical communication with the second electrode and a negative terminal of the pulse generator.

30. The IVL system of one or more of claims 22 to 29, further comprising a second pair of spaced apart electrodes of the one or more pairs of spaced apart electrodes, the second pair of spaced apart electrodes comprising: a third electrode defined by the first electrode support, the third electrode including a second cutout circumferentially spaced from the first cutout, wherein the second cutout defines an exposed metal region having a lateral surface stripped of the insulating material and positioned along a first longitudinal side of the second cutout and extending toward a second, opposite longitudinal side of the second cutout, wherein the third electrode is operably electrically connected with a first one of the one or more pairs of spaced-apart electrodes; and a fourth electrode spaced from the third electrode including a second wire conductor surrounded by an insulator, wherein the second wire conductor includes an exposed wire section, wherein the exposed wire section is positioned between and aligned with the longitudinal sides of the second cutout and radially spaced from the lateral surface of the exposed metal region of the second cutout to define a spark gap between a lateral surface of the exposed wire section of the second wire conductor and the exposed metal region of the second cutout.

31. The IVL system of claim 30, wherein, The third electrode is positioned a distance from an outer surface of the elongated member, wherein the fourth electrode is positioned a distance from the outer surface of the elongated member, wherein the third electrode is positioned at a distance from the outer surface of the elongated member that is approximately equal to the distance that the fourth electrode is positioned from the outer surface of the elongated member.

32. The IVL system of claim 31, wherein, The second cutout further includes a second channel on a proximal end of the second cutout, and wherein a portion of a proximal end of the insulative portion of the second wire conductor is received within the second channel, and wherein the second channel extends proximally from the second cutout.

33. The IVL system of one of claims 30 to 32, wherein, The first electrode, the second electrode, the third electrode, and the fourth electrode are approximately equally distanced from an outer surface of the elongated member.

34. The IVL system of one or more of claims 30 to 33, wherein, A distal end of the second wire conductor is positioned at a location that is half the distance between a distal end of the second cutout and a distal side of the exposed metal region of the second cutout.

35. The IVL system of one or more of claims 30 to 34, wherein, The exposed wire section of the second wire conductor is positioned distal to the exposed metal region of the second cutout.

36. The IVL system of one or more of claims 30 to 35, wherein, A proximal end of the first wire conductor is positioned at a location that is half the distance between a center of the arcuate region and a distal end of the second cutout.

37. The IVL system of one or more of claims 30 to 36, further comprising: A proximal end of the second wire conductor is configured to be in operable electrical communication with a negative terminal of the pulse generator.

38. The IVL system of one or more of claims 30 to 37, wherein, The first electrode and the second electrode define a first spark gap, and wherein the third electrode and the fourth electrode define a second spark gap, wherein the first spark gap is circumferentially spaced from the second spark gap.

39. The IVL system of one or more of claims 30 to 38, wherein, The first spark gap and the second spark gap are electrically connected in a series configuration when electrical current flows across each of the first spark gap and the second spark gap.

40. An intravascular lithotripsy device comprising at least one pair of spaced-apart electrodes in operable electrical connection with a voltage pulse generator, the pair of spaced-apart electrodes comprising: a first electrode 302A comprising: a second electrode 302B comprising: a first wire conductor 300A comprising a proximal end and a distal end, wherein the first wire conductor 300A is surrounded by an insulator I and operably connected at the proximal end of the first wire conductor 300A to a positive terminal of the pulse generator 110, wherein the first wire conductor 300A comprises a bare wire section comprising a first electrode 302A having a lateral surface extending proximally from the distal end for a length, and a second electrode 250C spaced apart from the first electrode 302A to form a spark gap between the second electrode 250C and the first electrode 302A, and the second electrode 250C comprising: an electrode support member ES’ having a body B, wherein the body B of the first electrode support member comprises an electrically conductive material covered with an insulating material I and defines a first cutout C1C having a bare metal region positioned along a first longitudinal side L1 of the first cutout C1C, wherein the bare metal region comprises a lateral surface facing towards a second opposite longitudinal side L2 of the cutout C1C and a channel 266 leading away from the first cutout C1C in a proximal direction, wherein a portion of the first wire conductor 300A is received within the channel 262, and wherein the bare wire section of the first electrode 302A is positioned between and aligned with the longitudinal sides L1, L2 of the first cutout C1C and radially spaced apart from the lateral surface of the bare metal region defining the second electrode 302A to form a spark gap between the lateral surface of the first electrode 302A and the second electrode 250C of the first cutout C1C.

41. The spaced spark gap of claim 40 wherein, At least a portion of the lateral surface of the bare wire section of the first wire conductor is positioned between and aligned with the first and second longitudinal sides of the cutout and the bare metal region.

42. An electrode for an intravascular lithotripsy ("IVL") system, the electrode comprising: an electrode support member ES comprising a body B formed of an electrically conductive material and covered with an insulating material I, wherein the body B is operably attached to an elongated member 220 and configured to at least partially surround the elongated member 220, the electrode support member ES comprising: a first cutout C1A defined by the body B and comprising: a first bare metal region defining an electrode 250A positioned along a first longitudinal side L1 of the first cutout C1A and a channel 262 leading away from the first cutout C1C in a proximal direction, and a second bare metal region defining a second electrode 250B positioned along a second longitudinal side L2 of the first cutout C1A and a channel 264 leading away from the first cutout C1C in a proximal direction. a second cutout C2B defined by the body B, wherein the second cutout C2B is circumferentially spaced apart from the first cutout CI A, the second cutout C2B including a second exposed metal region defining an electrode 250B positioned along a first longitudinal side LI of the second cutout C2B and a channel 264 leading away from the second cutout C2B in a distal direction.

43. An electrode for an intravascular lithotripsy ("IVL") system, comprising: an electrode support member ES' including a body B formed of an electrically conductive material and covered with an insulating material I, wherein the body B is operably attached to an elongated member 220 and configured to at least partially enclose the elongated member 220, the electrode support member ES' including: a first cutout CI C defined by the body B and including: a first exposed metal region defining an electrode 250C positioned along a first longitudinal side LI of the first cutout CI C and a first channel 266 leading away from the first cutout CI C in a proximal direction, and a second cutout C2D defined by the body B, wherein the second cutout C2D is circumferentially spaced apart from the first cutout CI C, the second cutout C2D including a second exposed metal region defining an electrode 250C positioned along a first longitudinal side LI of the second cutout C2D and a channel 268 leading away from the second cutout C2B in a proximal direction.

44. An intravascular lithotripsy ("IVL") system having improved pressure output variability, the IVL system comprising: an elongated member; a fluid fillable balloon formed of a material having an outer surface and surrounding a distal region of the elongated member; at least two pairs of spaced apart electrodes positioned along the elongated member and positioned within the fluid fillable balloon, wherein the two pairs of spaced apart electrodes are longitudinally spaced apart from one another along the elongated member and each pair of spaced apart electrodes forms a spark gap; a voltage pulse generator in operable electrical connection with the at least one pair of spaced apart electrodes; and a controller configured to control the voltage pulse generator, wherein the IVL system is configured to generate a plurality of electrical arcs across the at least two pairs of spaced apart electrodes, each of the plurality of electrical arcs generated in response to a voltage pulse provided by the voltage pulse generator, wherein each of the plurality of generated electrical arcs generates a pressure wave that travels through the fluid fillable balloon, through the material forming the fluid fillable balloon and through a water bath in which the balloon is submerged, wherein a peak pressure of all of the generated pressure waves measured by an ONDA HNR-0500 needle hydrophone positioned at a predetermined position relative to a longitudinal axis of the spark gap and the elongated member includes a coefficient of variation ("CV") of less than 35%.

45. The IVL system of claim 44, wherein, the CV is less than 30%.

46. The IVL system of claim 44, wherein, the CV is less than 25%.

47. An intravascular lithotripsy ("IVL") system, comprising: an elongated member; a fluid-fillable balloon having dimensions of 3 mm x 20 mm and formed of a material and folded around a distal region of the elongated member; two pairs of spaced-apart electrodes positioned along the elongated member and positioned within the fluid-fillable balloon, wherein the two pairs of spaced-apart electrodes are longitudinally spaced apart from one another along the elongated member, wherein a peak push force measured from a starting end of an ASTM F2394 tracking clamp to a terminal end of the catheter when the catheter is subjected to a force standard tracking test using the ASTM F2394 tracking clamp filled with water is in a range of about 400 grams to about 405 grams.

48. The IVL system of claim 47, wherein, the peak push force measured is in a range of about 375 grams to about 405 grams.

49. The IVL system of claim 47, wherein, the peak push force measured is in a range of about 370 grams to about 405 grams.

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