Intravascular lithotripsy system

Abstract

An intravascular lithotripsy system can include a sheath configured to receive a guidewire, at least three insulated wires, and an energy generator. Each of the at least three insulated wires can include at least two exposed portions spaced apart from one another along a length of the insulated wire. The at least three insulated wires can be helically wound around the sheath and independently electrically connected with the energy generator. The exposed portions of the at least three insulated wires can define a plurality of emitters spaced apart from one another along a length of the sheath and independently operable by the energy generator. The energy generator can initiate a spark via each of the plurality of emitters.

Description

[0001] Cross-reference to related applications Any and all applications that claim foreign or domestic priority as indicated in the application data sheet filed with this application are incorporated herein by reference in full and for all purposes, pursuant to 37 CFR 1.57. Technical Field

[0002] This disclosure generally relates to intravascular lithotripsy catheters. More specifically, this disclosure relates to various embodiments of intravascular lithotripsy catheters and associated systems that selectively control the firing of one or more emitters. Background Technology

[0003] Intravascular lithotripsy (IVL) catheters can be used to treat calcified lesions within the cardiovascular system. In cases where severe calcification poses a challenge to traditional treatments, IVL catheters can improve the effectiveness of percutaneous cardiovascular interventions. IVL catheters may include a balloon that, when inflated with saline solution, delivers mechanical pressure waves to break up and / or alter calcified lesions, thereby facilitating arterial dilation during balloon angioplasty and / or stent placement procedures. Summary of the Invention

[0004] The systems, methods, and apparatuses described herein each have several aspects, none of which is the sole determinant of their desired properties. Without limiting the scope of this disclosure, several non-limiting features will now be briefly discussed.

[0005] This article describes an improved IVL catheter implementation method and system that can safely deliver one or more sonic pressure waves (hereinafter referred to as "sonic waves") within the blood vessels of the cardiovascular system.

[0006] This document discloses an intravascular lithotripsy system configured to alter calcified plaques within the blood vessels of a subject. The system may include: a sheath comprising a lumen configured to receive a guidewire; at least three insulated wires; and an energy generator. Each of the at least three insulated wires may include at least two exposed portions spaced apart from each other along the length of the insulated wire. The at least three insulated wires are helically wound around the outer surface of the sheath and are independently electrically connected to the energy generator. The exposed portions of the at least three insulated wires define a plurality of transmitters spaced apart from each other along the length of the sheath and independently operable by the energy generator. The energy generator can generate a spark via each of the plurality of transmitters.

[0007] In some embodiments, the plurality of transmitters includes: a first transmitter defined by a first exposed portion of a first insulated wire and a first exposed portion of a second insulated wire among the at least three insulated wires; a second transmitter defined by a second exposed portion of the first insulated wire and a first exposed portion of a third insulated wire among the at least three insulated wires; and a third transmitter defined by a second exposed portion of the second insulated wire and a second exposed portion of the third insulated wire among the at least three insulated wires.

[0008] In some embodiments, each of the at least three insulated wires is configured to form at least one of the plurality of transmitters with each of the other three insulated wires.

[0009] In some implementations, the plurality of transmitters are formed by the at least three insulated wires without having any other insulated wires.

[0010] In some embodiments, the at least three insulated wires include at least four insulated wires, and the plurality of transmitters includes more transmitters than the at least four insulated wires.

[0011] In some implementations, the at least three insulated wires do not include a dedicated return wire.

[0012] In some embodiments, the energy generator is configured to independently drive the voltage on the at least three insulated wires such that each of the at least three insulated wires switches between operating as a live wire conducting current from the energy generator and operating as a return wire conducting current to the energy generator.

[0013] In some embodiments, the system includes a balloon surrounding at least a portion of the sheath and configured to expand with a conductive fluid configured to conduct sound waves originating from a spark.

[0014] In some embodiments, the system includes a carrier that encloses the at least three insulated wires and the sheath, the carrier including a carrier opening aligned with the exposed portions of the at least three insulated wires.

[0015] This document discloses an intravascular lithotripsy catheter for altering calcified plaques within a subject's blood vessels. The intravascular lithotripsy catheter may include a sheath, a first insulated wire, a second insulated wire, and a carrier. The sheath may include a lumen configured to receive a guidewire, wherein the longitudinal axis of the intravascular lithotripsy catheter extends through the lumen. The first insulated wire may be wound around and contact the outer surface of the sheath. The first insulated wire may include an electrically conductive member, an insulating member encapsulating the conductive member, and an insulating member opening forming an exposed portion of the conductive member. The second insulated wire may be wound around and contact the outer surface of the sheath. The second insulated wire may be arranged adjacent to the first insulated wire and may include a conductive member, an insulating member encapsulating the conductive member of the second insulated wire, and an insulating member opening forming an exposed portion of the conductive member of the second insulated wire. The exposed portion of the second insulated wire may be offset circumferentially from the exposed portion of the first insulated wire at an angle originating from the longitudinal axis. The exposed portion of the second insulated wire may be offset longitudinally from the exposed portion of the first insulated wire by a longitudinal distance extending parallel to the longitudinal axis of the intravascular lithotripsy catheter. The carrier may enclose the first and second insulated wires and the sheath. The carrier may include: a first carrier opening aligned with the exposed portion of the conductive member of the first insulated wire; and a second carrier opening spaced apart from the first carrier opening and aligned with the exposed portion of the conductive member of the second insulated wire. The intravascular lithotripsy catheter may be configured to be electrically connected to an energy generator operable to cause a spark to travel longitudinally and circumferentially around the intravascular lithotripsy catheter between the exposed portions of the first and second insulated wires.

[0016] In some embodiments, the carrier includes an inner surface configured to contact the first insulated wire and the second insulated wire, and an outer surface opposite the inner surface, wherein the intravascular lithotripsy catheter is configured such that the spark travels from the exposed portion of the first insulated wire, through the opening of the first carrier, over the outer surface of the carrier, through the opening of the second carrier, and to the exposed portion of the second insulated wire.

[0017] This document discloses an intravascular lithotripsy catheter for altering calcified plaques within a subject's blood vessels. The intravascular lithotripsy catheter may include: a sheath configured to receive a guidewire through a lumen of the sheath; a longitudinal axis extending through the lumen of the sheath; a first insulated wire; a second insulated wire; and a carrier. The first insulated wire may include: a conductive member; an insulating member enclosing the conductive member; and an opening in the insulating member forming an exposed portion of the conductive member. The second insulated wire may be arranged adjacent to the first insulated wire and may include: a conductive member; an insulating member enclosing the conductive member of the second insulated wire; and an opening in the insulating member forming an exposed portion of the conductive member of the second insulated wire. The first and second insulated wires may be wound around the sheath. The exposed portion of the second insulated wire may be arranged at a different longitudinal position relative to the longitudinal axis than the exposed portion of the first insulated wire. The exposed portion of the second insulated wire may be arranged at a different angular position relative to a plane defined perpendicular to the longitudinal axis than the exposed portion of the first insulated wire.

[0018] This document discloses an intravascular lithotripsy catheter for altering calcified plaques within a subject's blood vessels. The intravascular lithotripsy catheter may include: a sheath having a lumen configured to receive a guidewire; a longitudinal axis extending through the lumen of the sheath; a first insulated wire; a second insulated wire; and a carrier. The first insulated wire may include: a conductive member; an insulating member enclosing the conductive member; and an opening in the insulating member forming an exposed portion of the conductive member. The second insulated wire may be arranged adjacent to the first insulated wire and may include: a conductive member; an insulating member enclosing the conductive member of the second insulated wire; and an opening in the insulating member forming an exposed portion of the conductive member of the second insulated wire. The first and second insulated wires may be wound around the sheath. A transverse section passing through the intravascular lithotripsy catheter and perpendicular to the longitudinal axis passes through the exposed portion of the first insulated wire but not through the exposed portion of the second insulated wire. A longitudinal section passing through the intravascular lithotripsy catheter and parallel to the longitudinal axis passes through the exposed portion of the first insulated wire but not through the exposed portion of the second insulated wire.

[0019] This disclosure also discloses and contemplates various combinations of the features, embodiments, implementation methods and aspects described above and below.

[0020] Additional embodiments of this disclosure are described below with reference to the appended claims and / or clauses, which may be used as additional inventive content to this disclosure. Attached Figure Description

[0021] Various embodiments will be described below with reference to the accompanying drawings. These embodiments are shown and described by way of example only and are not intended to limit the scope of this disclosure. In the drawings, similar elements may have similar reference numerals.

[0022] Figure 1 An example implementation of a system that can be used to alter calcified lesions in a patient's blood vessels is shown.

[0023] Figure 2A This is an example block diagram of a cardiac synchronization system.

[0024] Figure 2B This is an example block diagram of a cardiac synchronization system with electrodes having individual wiring.

[0025] Figure 2C-2F An example graph showing the asymmetric energy that can be emitted by an IVL catheter is shown.

[0026] Figure 3A An example side view of a spirally wound electrode pair as part of an IVL catheter is shown.

[0027] Figure 3B-3E An example geometry of a groove that is part of an IVL catheter is shown.

[0028] Figure 4A An example cross-sectional view of an embedded electrode pair as part of an IVL catheter is shown.

[0029] Figure 4B-4E An example geometry of a notch that is part of an IVL catheter is shown.

[0030] Figure 5A An example perspective view of an IVL conduit with conductive wires spirally wound around a carrier is shown.

[0031] Figure 5B An example perspective view shows a conductive wire spirally wound around a carrier.

[0032] Figure 5C An example perspective view showing a spirally wound conductive wire.

[0033] Figure 5D An example embodiment of a ring electrode as part of a helically wound electrode pair is shown.

[0034] Figure 5E A cross-sectional view of the conductive wire and the ring electrode is shown.

[0035] Figure 5F An example embodiment of an IVL conduit with helically wound insulated wires having variable pitch is shown.

[0036] Figure 6 An example implementation of an IVL conduit with one or more valves is shown.

[0037] Figure 7 An example implementation of an IVL conduit with one or more valves is shown.

[0038] Figure 8A An example implementation of a CTO (chronic total occlusion) IVL catheter is shown.

[0039] Figure 8B An example implementation of the distal end of the CTOIVL catheter is shown.

[0040] Figure 9A An example perspective view of a double-balloon IVL catheter is shown.

[0041] Figure 9B An example cross-sectional view of a double-balloon IVL catheter is shown.

[0042] Figure 9C An example cross-sectional view of a double-balloon IVL catheter in a blood vessel is shown.

[0043] Figure 10 An example implementation of a balloon-free IVL catheter is shown.

[0044] Figure 11 An example implementation of a balloon-free IVL catheter is shown.

[0045] Figure 12A An example perspective view of an eccentric IVL catheter is shown.

[0046] Figure 12B An example implementation of an eccentric IVL catheter is shown.

[0047] Figure 12C An example cross-sectional view of an eccentric IVL catheter balloon is shown.

[0048] Figure 13A An example implementation of a double-occlusion balloon IVL catheter is shown.

[0049] Figure 13B An example implementation of a double-occlusion balloon IVL catheter in a blood vessel is shown.

[0050] Figures 14A-14B An example implementation of a system for indicating the effectiveness of sonic pressure waves on calcified lesions is described.

[0051] Figure 15 An example method for synchronizing energy emitted from an IVL conduit, according to an example implementation, is described.

[0052] Figures 16A-16C This is a side view of the various parts of an example IVL catheter.

[0053] Figure 17A This is a schematic diagram showing an insulated wire with electrodes forming an emitter in an IVL catheter.

[0054] Figure 17B This is a schematic diagram showing an insulated wire with electrodes forming an emitter in an IVL catheter.

[0055] Figure 17C This is a cross-sectional view of an example IVL conduit with insulated wires that form electrodes to generate an emitter.

[0056] Figure 18A This is a side view of a portion of an example IVL catheter.

[0057] Figure 18B This is a schematic diagram showing an insulated wire with electrodes forming an emitter in an IVL catheter.

[0058] Figure 19 This is a flowchart of an example process for manufacturing an IVL catheter or a portion thereof. Detailed Implementation

[0059] This disclosure will now be described with reference to the accompanying drawings, wherein similar reference numerals may refer to similar elements throughout. The following description is illustrative in nature and is not intended to limit the disclosure, its application, or its use. Furthermore, the apparatuses, systems, and / or methods disclosed herein may include several novel features, wherein no single feature is solely responsible for its desired properties, nor is any single feature essential for practicing the apparatuses, systems, and / or methods disclosed herein. Additionally, the structures, systems, and / or apparatuses described herein may be implemented as integrated components or as separate components.

[0060] Some aspects and / or implementations have been described in conjunction with the accompanying drawings. The scale of the drawings is not limiting, as dimensions and scales other than those shown are contemplated and within the scope of the disclosed invention. Distances, angles, etc., are illustrative only and need not have a precise relationship to the actual dimensions and layout of the illustrated apparatus. Components may be added, removed, and / or rearranged. Furthermore, any particular feature, aspect, method, property, characteristic, quality, attribute, element, or such disclosure herein, in conjunction with various embodiments, can be used in all other embodiments set forth herein. Additionally, any method described herein can be implemented using any apparatus suitable for performing the steps. The various steps within a method may be performed in different orders without altering the principles of this disclosure.

[0061] Several medical procedures have been developed to alter and / or treat calcified lesions in blood vessels. In the context of interventional cardiovascular procedures, these procedures aim to make calcified plaques more accessible for subsequent treatments, such as balloon angioplasty and stent placement. Some common methods for altering calcified lesions include rotational atherectomy, balloon procedures (e.g., cutting balloons, scoring balloons, high-pressure balloons, etc.), excimer laser plaque ablation, and / or intravascular lithotripsy (IVL).

[0062] Each method has certain advantages and / or disadvantages. For example, rotational atherectomy (e.g., via a rotational atherectomy device) involves using a high-speed rotating device to abrade and remove calcified plaques. The rotational atherectomy device may be equipped with a diamond-coated abrasive head that rotates at high speed to remove the calcifications. The rotational atherectomy process can provide one or more benefits, such as preparing the vessel wall for subsequent angioplasty.

[0063] However, the use of rotational atherectomy devices has several drawbacks, including the risk of dissection. Specifically, if used improperly, the high-speed rotation can potentially cause vascular dissection (e.g., tearing of the arterial wall), especially in the presence of severe calcified lesions. Furthermore, the rotational action of the device can generate plaque debris or particles. This debris may be released into the bloodstream, potentially causing further complications, including downstream occlusion. In some cases, rotational atherectomy may not completely alter calcified lesions, as some severely calcified lesions may be difficult to reconstruct. Additionally, the use of rotating blades may prolong the procedure, exposing both patients and physicians to prolonged safety risks associated with percutaneous surgery.

[0064] Another common approach involves using several types of balloons, such as cutting balloons, scoring balloons, and / or high-pressure balloons. Cutting balloons can alter calcified lesions by using small blades and / or microsurgical blades mounted on the surface of the balloon. When the balloon is inflated, these blades form inclusions within the calcified plaque, allowing for better dilation of the vessel during angioplasty. In some cases, high-pressure balloons may be used. High-pressure balloons have a rigid structure, allowing for greater force to be applied during inflation to alter calcified lesions. While balloons can be effective in some situations, high-pressure balloons can still carry the risk of vessel dissection or rupture if over-applied. Scoring balloons can present challenges in achieving uniform scoring, potentially leaving some areas untreated. Furthermore, these balloons may generate plaque debris. Additionally, the balloon may be structurally rigid, limiting the physician's ability to maneuver the balloon across the artery and reducing its accessibility and versatility depending on the location of the calcified lesion.

[0065] Excimer laser plaque ablation is a routine technique that uses laser energy to vaporize and ablate calcified plaques. Laser energy is delivered via an optical fiber within a catheter, breaking down the calcifications into smaller particles. Common problems associated with laser use can include arterial perforation, where the ablation effect of the laser may weaken the arterial wall, increasing the risk of perforation. As mentioned above, lasers may generate plaque debris and / or microparticles. Furthermore, lasers may be ineffective at ablating extremely dense calcifications. Additionally, lasers may have limited penetration depth when attempting to alter deep and / or large-area calcifications. Moreover, the cost of using lasers and / or the necessary equipment associated with their use can be expensive compared to other methods.

[0066] IVL catheters are introduced into the coronary artery via, for example, a guide catheter (guidewire), using sonic waves to disrupt and alter calcified plaques. An IVL catheter may include a balloon positioned within or adjacent to the calcified plaque. The balloon can be inflated (typically with a conductive solution, such as saline), such that the fluid within the balloon serves as a medium for the sonic waves generated by one or more transmitters within the IVL catheter. The transmitters may include electrodes (e.g., where an arc across a spark gap generates the sonic waves), a laser emitting energy that induces the sonic waves, and / or mechanical means such as sound pressure that induces the sonic waves. The sonic waves are transmitted from the electrode pair via saline to the outer surface of the balloon, where the energy is transferred to the vessel wall. The sonic waves can induce fractures within the calcified plaque, thereby disrupting the rigid structure of the calcification.

[0067] Unlike some of the example methods mentioned above for altering calcified lesions (such as rotational atherectomy, cutting balloons, scoring balloons, high-pressure balloons, and excimer laser plaque ablation), IVL catheters can break up the associated plaque while reducing the risk of severe trauma to the surrounding vessel wall because the energy source is generated within the balloon. Furthermore, IVL catheters can reduce the likelihood of particles in the bloodstream because the primary energy source is not directly applied to the vessel wall. Additionally, IVL catheters provide physicians with more precise control over the dissipated energy, thereby shortening the procedure time.

[0068] However, IVL catheters do have performance issues that must be optimized to improve surgical safety and effectiveness. For example, the transmitter configuration within the IVL catheter may not optimally direct energy (e.g., acoustic waves) to a specific location, resulting in poor and / or uncontrollable acoustic wave direction control, dispersed energy density, and prolonged procedure time for both the physician and patient. IVL catheters may emit energy radially, axially, longitudinally, and / or in all directions, thus dispersing energy to the target calcified lesion and / or non-target areas. Consequently, procedure time may increase because the physician may not be able to effectively target areas with, for example, asymmetrical calcifications (e.g., calcifications not circumferentially uniformly distributed around the vessel). Furthermore, in some cases, when the electrode pairs are not optimized to deliver energy to the designated target location, the physician may need to generate an excessive number of acoustic waves when attempting to break up the calcified plaque.

[0069] Ineffective treatment, as described above, can increase the likelihood of exceeding the lifespan of an IVL catheter, increase the heat generated by the IVL catheter in the blood vessel, and / or expose the patient to greater health risks associated with excessive arcing (e.g., sparks during electrode use). If the IVL catheter exceeds its lifespan during the procedure, it must be removed and replaced, thus prolonging the procedure and increasing safety and health risks to the patient. Furthermore, in certain situations, the lifespan of an IVL catheter can be limited when the electrode pair generates an arc in one direction. For example, when a monophase energy source is used as part of an IVL catheter, arcing across the electrode pair can cause burns and / or scarring on the surface of one electrode, thus shortening the usable lifespan of the IVL catheter. Moreover, monophase energy can cause muscle contractions, potentially leading to a heart attack.

[0070] Beyond the issues associated with controlling the directionality of acoustic waves, conventional IVL catheter designs may inefficiently control one or more characteristics of the acoustic waves. Depending on the size, shape, and location of the calcified plaque, physicians may require acoustic waves with different characteristics. Specifically, physicians may wish to vary the intensity, duration, and / or frequency of the acoustic waves to optimize IVL catheter performance during the procedure. Furthermore, conventional IVL catheters may lack the ability to alter the acoustic wave source within the IVL catheter. For example, a physician may seek to generate acoustic waves from one or more electrode pairs within the IVL catheter to break up a target cluster of calcified plaques while simultaneously seeking to prevent acoustic waves from being generated by other electrode pairs. Conventional IVL catheter designs are detrimental to the selectivity and control physicians desire because the electrode pairs and / or each electrode within the IVL catheter may not be individually wired to an energy source (e.g., not individually electrically connected, etc.), and the electrode pairs and / or electrodes may not be multiplexed at the associated energy source.

[0071] Conventional IVL catheter designs can be too rigid and / or too large (e.g., increased cross-sectional area) to reach and treat all desired calcified lesions. In some cases, an overly rigid IVL catheter may be unable to reach highly tortuous and / or heavily calcified vessels, small vessels presenting navigational challenges, areas associated with bifurcation lesions where a single vessel branches into two, proximal lesions located near the proximal origin of the coronary artery, and / or areas where the IVL catheter must traverse the occluded segment. For example, conventional IVL catheter manufacturing techniques can result in an overly rigid catheter when polyethylene terephthalate (PET) tubing is used with one or more segments of the carrier and / or sheath. In some examples, manufacturers place PET tubing between electrode pairs to protect associated wiring from damage; however, the use of PET tubing increases the rigidity of the IVL catheter, limiting its usability and the range of accessible locations. Furthermore, conventional methods of manufacturing IVL catheters may place electrode pairs outside and / or adjacent to the sheath, thereby increasing the cross-sectional area of ​​the IVL catheter and thus preventing insertion into, for example, the occluded segment.

[0072] A standard IVL catheter may limit the number of pulses a physician can deliver (e.g., the number of cycles) because the arcing that occurs during each pulse can slowly degrade and / or erode the surface of the electrodes in the electrode pair. For example, during a procedure using a standard IVL catheter, a physician may be limited to 300 pulses. This pulse limitation may result in “pulse rationing,” where a physician chooses to limit the number of pulses used for the first calcified lesion, regardless of their effectiveness for that lesion, in order to conserve pulses for subsequent calcified lesions. Physicians may perform pulse rationing to reduce the number of procedures the patient may have to undergo, to reduce costs associated with having to change the IVL catheter during the procedure, and / or as covered by the patient’s medical insurance. Whatever the reason, due to the limited number of cycles associated with a standard IVL catheter, a patient may not receive the most effective treatment.

[0073] In summary, the inefficiencies associated with conventional catheters can lead to ineffective treatment for patients due to low energy density, high energy emission, increased procedure time, and / or the extensive application of sound waves to alter plaques, much like a sledgehammer relies on the user's physical strength and control to alter concrete. In contrast, one or more IVL catheters disclosed herein can provide functionality, efficiency, long lifespan, and / or precision similar to a jackhammer by applying a targeted energy source to the plaque to rapidly alter it while reducing risks to the patient. The problems associated with conventionally manufactured IVL catheters and their associated systems can be overcome by combining one or more IVL catheter implementations and associated system designs that incorporate one or more features described herein. For example, IVL catheters can be fabricated to be sufficiently flexible and / or small to allow physicians to navigate them to a wide range of desired locations within the body. IVL catheters can maximize their effective lifespan while efficiently targeting and breaking down calcified lesions by individually wiring electrodes to an energy source, combining multiplexed energy generators to selectively energize electrode pairs, and / or by providing an energy source that allows physicians to configure one or more characteristics of the emitted energy (e.g., monophasic and / or biphasic pulses, varying the intensity, duration, and frequency of the emitted energy, etc.). Furthermore, IVL catheters can optimize operative time and / or surgical efficiency by controlling the directionality of the acoustic waves based on one or more electrode pair configurations described herein.

[0074] This disclosure includes example embodiments and methods for treating calcified lesions in blood vessels using IVL catheters and / or systems. Blood vessels may include arteries or veins. Blood vessels may include coronary vessels (e.g., vessels close to and / or supplying blood to the heart) or peripheral vessels (e.g., vessels far from the heart, such as vessels in the arm or leg). Treating calcified lesions, deposits, plaques, buildup, etc., may include altering the deposits. Altering deposits, etc., may refer to altering the physical structure of the deposits, such as causing the deposits to fragment, disintegrate, crack, break apart, dissolve, rupture, etc. IVL catheters can be used for percutaneous interventions, which are procedures performed to treat blockages or stenosis in blood vessels, such as coronary interventions or peripheral interventions. For example, a guidewire may be passed through a vascular access site (e.g., the femoral artery and / or radial artery) and navigated to the vascular treatment site via one or more markers under fluoroscopic guidance. The IVL catheter may be advanced over the guidewire to the site of the calcified lesion. Once in place, the IVL catheter can be activated to generate acoustic waves that break down calcium deposits, making them easier to manage for subsequent interventions. Example embodiments of the IVL catheter and / or one or more associated systems and / or subsystems are described below with reference to the accompanying drawings.

[0075] Figure 1An example implementation of a system 100 that can be used to alter lesions in a patient's blood vessels is shown. System 100 may include an IVL catheter 101 electrically connected to an energy generator 150. The IVL catheter 101 may include a proximal end 33 and a distal end 34. The IVL catheter 101 may be percutaneously inserted into a patient's artery by a physician. The IVL catheter 101 may be positioned in an artery where one or more calcified lesions are present. Once in place, the physician may generate one or more electric arcs originating from the energy generator 150 to alter the patient's calcified lesions.

[0076] IVL catheter 101 may include balloon 111. Balloon 111 may have a component comprising a high molecular weight polymer, such as polyethylene and / or polyamide and / or any other suitable component. Balloon 111 may be, for example, transparent and / or opaque. Balloon 111 may have a distal end 34 and a proximal end 33. Balloon 111 may include a central portion extending longitudinally along a carrier 112 from the proximal end 33 to the distal end 34. In some examples, balloon 111 may be radially symmetrical along a first axis A1. Balloon 111 may have a seal 114 at the distal end and / or a seal 113 at the proximal end. Seals 113 and / or 114 may be, for example, a UV adhesive. Seals 113 and / or 114 may prevent axial, longitudinal, and / or radial movement of balloon 111 along the carrier 112 and / or prevent loss of solution (e.g., conductive fluid) within balloon 111 during the procedure. In some embodiments, balloon 111 may be inflated (e.g., expanded) with a solution such as saline at the proximal end 33. Furthermore, balloon 111 may be deflated at the proximal end 33. In some embodiments, balloon 111 may deflate in less than three seconds. The inflation and / or deflation time of balloon 111 can vary depending on the number of power leads 124 and / or common leads 123 (e.g., including a common ground lead) used, for example, as part of IVL catheter 101. As described above, a conductive solution may be used to transmit one or more acoustic waves from electrode pair 120 to the outer wall of balloon 111. In some examples, the conductive solution may amplify one or more acoustic waves generated by electrode pair 120. For example, increasing and / or decreasing the conductivity of the conductive solution may concentrate and / or disperse one or more acoustic waves generated by electrode pair 120.

[0077] Balloon 111 can deliver medication (e.g., an agent) to the target area. The surface of balloon 111 may be coated with an agent. When the drug-coated balloon 111 is inflated, it can deliver the medication to the target area (e.g., vascular cells). In some cases, balloon 111 may be coated with a medication for treating edema, etc. Edema is a swelling that can be caused by the IVL catheter during the procedure. Swelling may reduce the effectiveness of treatment and / or reduce accessibility to certain calcified lesions located downstream of the vessel. In some examples, when balloon 111 is coated with an agent for treating edema, the likelihood of success during the procedure can be significantly increased.

[0078] The balloon 111 may include one or more shapes as described herein. In some examples, the balloon 111 is cylindrical, such as... Figure 1 As depicted in [the original text]. However, balloon 111 can be of another shape, such as a semi-compliant and / or non-compliant shape along the first axis A1 (e.g., balloon 111 can conform to the irregularity of the vessel and / or maintain a given shape upon inflation). The length 130 of balloon 111 can vary based on factors such as the number of electrode pairs 120, the electrode pair spacing 26, the spark gap 125, the location of one or more calcified lesions, etc. In some embodiments, the length 130 of balloon 111 can be about 60 mm, while in some embodiments, the length 130 of balloon 111 can be about 58 mm. In some embodiments, balloon 111 can have an outer diameter on the order of millimeters, however, this outer diameter can be larger or smaller. IVL catheter 101 may include one, two, three or more balloons 111. In some embodiments, IVL catheter 101 may not include balloon 111.

[0079] IVL catheter 101 may also include a carrier 112. The carrier 112 may be a flexible, elongated axis centered along a first axis A1. The carrier 112 may facilitate the advancement and positioning of the IVL catheter 101 within the blood vessel. The cross-sectional area of ​​the carrier 112 along a plane intersecting the first axis A1 and / or the second axis A2 may have, for example, a circular, square, rectangular, hexagonal, conical, and / or any other shape (e.g., an asymmetrical shape along the first axis A1 and / or the second axis A2). The carrier 112 may comprise a solid composite material. In some examples, the carrier 112 may be formed from a first layered composite material and a second composite material. In some examples, the carrier 112 may be formed from multiple layers. The carrier 112 may have a hollow channel (e.g., a lumen) extending longitudinally along the first axis A1. The hollow channel of the carrier 112 may support a guidewire 118. The guidewire 118 may allow the carrier 112 to be advanced along the guidewire 118, thereby assisting the physician in positioning the IVL catheter 101 within the blood vessel. In some embodiments, the carrier 112 may have an outer diameter of approximately 0.018 inches, although the size may vary depending on the intended use.

[0080] IVL catheter 101 may include electrode pairs 120. IVL catheter 101 (e.g., as part of system 100) may generate an electric arc discharge between two or more electrode pairs 120. The electric arc discharge subsequently generates acoustic waves, transferring energy to the outer wall of balloon 111 to alter calcified lesions. Electrode pairs 120 may be coupled to carrier 112 along a first axis A1. Figure 1 As shown, the electrode as part of electrode pair 120 may be a ring electrode; however, electrode pair 120 (and / or a single electrode in electrode pair 120) may be any type of electrode and / or combination of electrode types described and / or shown herein. The electrode as part of electrode pair 120 may be one or more of gold, platinum-iridium alloy, stainless steel, nickel-titanium alloy, etc. In some examples, electrode pair 120 is not adjacent to the hollow channel of carrier 112 (e.g., not adjacent to a lumen).

[0081] The transmitter spacing 126 (e.g., the spacing between two transmitters) can be, for example, about 10 mm. In another example embodiment, the transmitter spacing 126 can be greater than and / or less than 10 mm, depending on the desired intensity and / or concentration of the sound waves at a given location along the IVL conduit 101. Figure 1 Four electrode pairs 120 are depicted; however, in one embodiment, the IVL conduit 101 may have five electrode pairs 120. In some embodiments, starting from the distal end 34 and / or the proximal end 33, the transmitter spacing 126 may be 11.5 mm between the first and second electrode pairs, 10.5 mm between the second and third electrode pairs, 9.5 mm between the third and fourth electrode pairs, and / or 7.5 mm between the fourth and fifth electrode pairs. In some examples, one or more electrodes of the electrode pair 120 may have a width of approximately 1 mm, although the width of the electrodes may vary depending on the desired intensity and / or concentration of the acoustic waves.

[0082] Electrode pair 120 may have a spark gap 125. The spark gap 125 may be the space between two electrodes in electrode pair 120 (e.g., on a first side and a second side of a first axis A1 and / or a second axis A2), which facilitates the formation of a controlled arc (e.g., electrical discharge) when electrical energy is applied to one or more electrode pairs 120. In some embodiments, the spark gap 125 may be 1 mm. In some embodiments, the spark gap 125 may be 0.5, 1, 2, 3, 4, 5, and / or more mm. In some embodiments, the spark gap 125 may vary from one electrode pair 120 to another. Furthermore, the spark gap 125 may be greater than or less than 1 mm, depending on the desired intensity and / or concentration of the pressure acoustic wave at a given location in IVL conduit 101. Advantageously, the spark gap 125 may be designed to direct acoustic waves to calcified plaques as described below.

[0083] Electrode pair 120 may also include a common lead 123 and a power lead 124. Leads 123 and / or 124 may be electrically connected to one or more electrodes of electrode pair 120 and electrically connected to energy generator 150. Leads 123 and / or 124 may transfer electrical energy from energy generator 150 to electrode pair 120 to generate an arc across spark gap 125. In some embodiments, system 100 may include separate leads 123 and / or 124 for each electrode in electrode pair 120, thereby enabling energy generator 150 to individually control each electrode pair 120 (e.g., an Nx2 configuration, where “N” is the number of electrode pairs 120). However, wiring each electrode pair 120 individually may result in an increased overall diameter of IVL conduit 101, as there may be two leads fitted in IVL conduit 101 for each electrode pair 120. Advantageously, the Nx2 configuration can be used to selectively generate spark gap 125 between any two electrodes within IVL conduit 101. In some implementations, system 100 may have a common conductor 123 and a separate power conductor 124, such as Figure 1 As depicted in [the text]. For example, one electrode of each electrode pair 120 can be individually wired to the energy generator 150, and the second electrode of each electrode pair 120 can be electrically connected together using a common wire 123 (e.g., an N+1 configuration, where "N" is the number of electrode pairs 120). Advantageously, wiring the electrode pairs 120 in an N+1 configuration can reduce the number of wires 123 and / or 124 within the IVL conduit 101 compared to individually wired electrode pairs 120 as mentioned above. For example, as [the text continues with further details about wiring options]. Figure 1As depicted, as the IVL catheter 101 moves from its proximal end 33 to its distal end 34, the number of wires 123 and / or 124 decreases for a given number of electrode pairs 120. In addition to the reduction in the overall diameter of the IVL catheter 101, the N+1 wiring configuration also allows the energy generator 150 to individually control each electrode pair 120, as described below. Figure 2A-2B To further describe, because only one electrode is individually wired to the energy generator 150 via power supply wire 124. (As...) Figure 1 As shown, the common conductor 123 and / or power conductor 124 may be arranged outside the carrier 112. In some embodiments, conductors 123 and / or 124 may be arranged inside the carrier 112 (e.g., below the outer surface, embedded, etc.).

[0084] IVL catheter 101 may also include markers 116. Markers 116 can be used during the procedure to help the physician visualize and locate IVL catheter 101. Markers 116 can be radiopaque markers visible under fluoroscopy and / or X-ray imaging. Furthermore, markers 116 can be alignment markers used to accurately position IVL catheter 101 within specific anatomical landmarks relative to the target calcified lesion within the vessel. Markers 116 can be located at the distal end 34, proximal end 33, and / or any other portion of IVL catheter 101. Additionally, one or more markers 116 may be present, each located at a different location within the IVL catheter, to assist the physician in alignment and treatment, such as on carrier 112, balloon 111, and / or any other area.

[0085] IVL catheter 101 may include an indicator 117. The indicator 117 may be a one-way valve, a pressure sensor, a flow indicator, a temperature sensor, and / or other sensors used to determine changes in the state of IVL catheter 101. The indicator may be coupled to the inner surface, outer surface, and / or located within the inner surface of balloon 111. Alternatively and / or optionally, the indicator 117 may be located at other locations within system 100, for example, positioned along carrier 112, as part of proximal seal 114 and / or distal seal 113 and / or along proximal seal 114 and / or distal seal 113, as part of energy generator 150, coupled to the hollow channel defined by carrier 112, along the inflatable lumen (described as... Figures 14A-14B (part of) etc.

[0086] Indicator 117 can sense changes in the state (e.g., physical properties) of one or more components of IVL catheter 101, such as changes in pressure, flow rate, temperature, motion (e.g., vibration), volume, etc. In some examples, indicator 117 can detect pressure changes within balloon 111. Once the calcified lesion is successfully broken up, balloon 111 may experience pressure fluctuations. As an illustrative example, during successful treatment of the calcified lesion with IVL catheter 101, the volume of balloon 111 may expand, and thus experience a decrease in pressure within balloon 111. Once the volume of balloon 111 increases, indicator 117 can sense the pressure drop within balloon 111. Therefore, indicator 117 can indicate to the user that intravascular lithotripsy has successfully altered the calcified lesion. Additionally and / or optionally, indicator 117 can sense changes in the pressure and / or flow rate of the conductive fluid within balloon 111 due to balloon rupture.

[0087] System 100 may also include an energy generator 150. As mentioned above, energy generator 150 can provide electrical energy (e.g., current) to electrode pair 120. Additionally, energy generator 150 can generate one or more electrical modes by changing the frequency, pulse width, amplitude, pulse polarity, pulse shape, and / or phase of one or more pulses transmitted to electrode pair 120, thereby altering the intensity, duration, and / or directionality of one or more sound waves, and thus altering calcified lesions. In some embodiments, energy generator 150 can transmit electrical energy to electrode pair 120 at a minimum rate of approximately 5 Hz. In some embodiments, energy generator 150 can transmit electrical energy to electrode pair 120 at a minimum rate less than and / or greater than 5 Hz (e.g., 1, 2, 3.5, 10 Hz, etc.). See below for reference. Figure 2A-2B As further described, the energy generator 150 may selectively emit energy to one or more electrode pairs 120, for example, based on the use of a multiplexer, and / or may be used with additional devices to improve patient safety by synchronizing the patient’s heart rhythm with one or more sound waves generated by IVL.

[0088] Figure 2A-2B This is an example block diagram of cardiac synchronization systems 200A and / or 200B. (See example diagram.) Figure 2AAs shown, the cardiac synchronization system 200A can be used to improve the safety and effectiveness of intravascular lithotripsy. The cardiac synchronization system 200A may include an IVL catheter 201A, an energy generator 250, a rhythm unit 260, and a patient 270. The IVL catheter 201A may be electrically connected to the energy generator 250 via wires 223 and / or 224. The IVL catheter 201A may be configured to receive electrical energy from the energy generator 250 in response to a physician's request, thereby generating sound waves within the IVL catheter 201A. The energy generator 250 may also communicate with the rhythm unit 260. For example, the rhythm unit 260 may transmit data associated with the patient 270's heart rhythm (e.g., via wired and / or wireless means) to the energy generator 250.

[0089] As mentioned above, an electric arc can be generated in the IVL catheter 201A during endovascular lithotripsy. The acoustic waves generated by the arc are used to alter calcified lesions. In some procedures, the IVL catheter 201A can be positioned close to the patient's heart and / or other electrically sensitive organs. Advantageously, timing the electric arc in the IVL catheter 201A according to the patient's heart rhythm during endovascular lithotripsy can mitigate certain health risks.

[0090] IVL catheter 201A can be compared with reference Figure 1 The IVL catheter 101 described herein and / or any additional configurations mentioned herein are identical and / or similar. In some examples, the IVL catheter 201A may have electrode pairs 220 (e.g., electrode pairs 220_1, 220_2, 220_n), each electrode pair 120 may include at least two electrodes (e.g., E_1_1 and / or E_1_2 for electrode pair 220_1). Electrode pairs 220 may be as mentioned above and as... Figure 1-2A The electrode pair 220 is configured in an N+1 configuration as shown. In some embodiments, the electrode pair 220 may be electrically connected via wires 223 and / or 224 in other configurations (e.g., parallel, series, separate wiring, etc.). In some examples, the electrode pair 220 is electrically connected to the multiplexer 255 via wires 223 and / or 224. In some examples, the electrode pair 220 is electrically connected to another component, such as the arc generator 254.

[0091] IVL catheter 201A may include an indicator 217. The indicator 217 can be used with... Figure 1 The indicator 217 is the same as or similar to the indicator 117. The indicator 217 may include, for example, a one-way valve, a pressure sensor, a flow indicator, a temperature sensor, a motion sensor, and / or other sensors for determining changes in the status of the IVL catheter 201A. The indicator 217 may indicate to the user that intravascular lithotripsy has successfully altered calcified lesions, that balloon 111 has ruptured, etc.

[0092] The rhythm unit 260 can transmit information associated with the heart rhythm of the patient 270 (e.g., wirelessly and / or via wired means) to, for example, an energy generator 250. Furthermore, the rhythm unit 260 can transmit discrete signals to the energy generator 250 based on one or more trigger events associated with the heart rhythm of the patient 270. The rhythm unit 260 can be any device designed to monitor and / or determine one or more characteristics of the heart rhythm of the patient 270, including but not limited to: heart rate, P wave (electrical activity associated with the upper chambers of the heart), QRS complex (lower chambers of the heart), PR interval (the time between the onset of the P wave and the onset of the QRS complex), QT interval (the time between the onset of the QRS complex and the end of the T wave), T wave (ventricular repolarization), etc. In some examples, the rhythm unit 260 can be an AccuSync® 72 ECG trigger monitor. In some examples, the rhythm unit 260 can detect R wave signals and, in response to one or more trigger events associated with the R wave signals, send discrete signals to the energy generator 250.

[0093] The cardiac synchronization system 200A may include an energy generator 250. The energy generator 250 may include a controller 251, a memory 252, a communication unit 253, an arc generator 254, and / or a multiplexer 255. The energy generator 250 can transmit electrical energy to the electrode pairs 220 of the IVL catheter 201A.

[0094] Energy generator 250 may include controller 251, memory 252, and / or communication unit 253. Energy generator 250 may store information obtained by controller 251 in memory 252. Examples of information stored in memory 252 may include operational data, such as electrical patterns, a counter for determining the lifespan of IVL catheter 201A based on the emitted energy from energy generator 250, and / or information associated with cardiac synchronization (e.g., thresholds). In some examples, the counter may generate an alarm after determining that IVL catheter 201A has exceeded a threshold number of pulses (e.g., 100, 200, 300, and / or more pulses). Additionally, energy generator 250 includes communication unit 253. Communication unit 253 may, for example, transmit data to and / or receive data from rhythm unit 260. For example, communication unit 253 may receive data representing the heart rhythm of patient 270 and / or discrete signals from rhythm unit 260. Discrete inputs can, for example, represent the time range within which the energy generator 250 is able to transmit electrical energy to the IVL conduit 201A. Additionally and / or alternatively, discrete signals can disable the energy generator 250 from transmitting electrical energy to the IVL conduit 201A.

[0095] Controller 251 can determine one or more electrical characteristics of the electrical energy transmitted to electrode pair 120. For example, controller 251 can determine the frequency, amplitude, pulse width (e.g., duty cycle), pulse shape, pulse polarity, and / or phase of one or more electrical pulses generated by arc generator 254. Controller 251 can modify one or more electrical characteristics based on input, for example, from a user (e.g., a physician performing intravascular lithotripsy). Controller 251 can modify the electrical characteristics of the energy transmitted to IVL catheter 201A based on user input regarding one or more aspects of calcified lesions (such as the location, number, and / or density of calcified lesions). In some examples, controller 251 can determine the electrical pattern generated by arc generator 254. The electrical pattern can include pulse width, amplitude, frequency, pulse shape, pulse polarity, duration, etc. In some examples, the electrical pattern can be linear, random pulse train, square wave, triangular wave. The electrical pattern can also include selectively transmitting energy to one or more electrode pairs 220. For example, controller 251 may instruct multiplexer 255 to select one or more channels based on a desired electrical pattern, such as that described herein.

[0096] Additionally and / or alternatively, controller 251 may determine whether to emit single-phase pulses and / or two-phase electrical pulses. In some examples, controller 251 may instruct arc generator 254 to emit single-phase pulses, wherein the polarity of one electrode in electrode pair 220 is positive and / or the polarity of the other electrode in electrode pair 220 is negative. In a single-phase pulse, the current generating the arc flows in one direction, from the first electrode (e.g., E_1_1) to the second electrode (e.g., E_1_2). Therefore, a single-phase pulse can create solder joints on the surface of one electrode. Over time, these solder joints may reduce control over the acoustic waves and / or the directionality of the acoustic waves, increase component degradation, and / or cause premature electrode failure.

[0097] Advantageously, controller 251 can instruct arc generator 254 to generate biphase pulses. Biphase pulses deliver electrical energy in two phases (positive and / or negative). Therefore, the current (and / or arc) flowing through electrode pair 220 can alternate between positive and negative phases. Since solder joints are less likely to accumulate on a single electrode, biphase pulses can improve the reliability and / or lifespan of IVL conduit 201A. In some embodiments, controller 251 can instruct arc generator 254 to combine one or more modes based on user input. For example, controller 251 can instruct arc generator 254 to generate electrical modes having single-phase pulses, biphase pulses, frequency, pulse width, amplitude, phase, pulse shape, etc., to improve the reliability and / or lifespan of IVL conduit 201A.

[0098] In some examples, controller 251 may instruct arc generator 254 to generate asymmetric pulses (e.g., biphasic pulses in which positive and / or negative pulses are asymmetrical to each other). Asymmetric pulses may include varying rise and / or fall times (e.g., slope), varying energy levels, etc., for both positive and / or negative pulses. Advantageously, asymmetric pulses can improve the durability of electrode pair 120 and thus increase the service life of IVL conduit 101 because erosion and / or pitting caused by arc discharge can be more uniformly distributed, and / or heat can be effectively dissipated compared to symmetric pulse modes.

[0099] An asymmetric pulse may be characterized by having different energy levels in the positive and / or negative portions of a biphase pulse. As an illustrative example, a positive pulse may include a larger voltage difference (e.g., ΔV) and / or a longer pulse width compared to a negative pulse. As another example, a negative pulse may have a smaller ΔV over a longer duration than a positive pulse. In some examples, an asymmetric pulse may have multiple ΔVs and / or different rise and / or fall times for both positive and / or negative pulses. As an illustrative example, a positive pulse may be characterized by a first ΔV lasting for a first duration with a first slope and a second ΔV lasting for a second duration with a second slope, while a negative pulse may be characterized by a third ΔV lasting for a third duration with a third slope and a fourth ΔV lasting for a fourth duration with a fourth slope.

[0100] Additionally and / or alternatively, controller 251 may determine and / or adjust the energy levels of the positive and / or negative pulses of the asymmetric pulses based on an estimate of the heat generated by arc generator 254. For example, controller 251 may generate a first pulse and / or a group of pulses with a pulse width of approximately 10 µs and adjust the pulse width accordingly based on calculated heat generation and / or heat dissipation associated with electrode pair 220 (e.g., as an exemplary example, but not limited to, based on spark gaps 125, 325, 425, 525, etc.). Controller 251 may calculate heat dissipation based, among other factors, on the body area being treated, the number and / or frequency of pulses, the type of arc generator 254, the type, location, number, composition, and / or other attributes associated with electrode pair 220.

[0101] In some examples, controller 251 may instruct arc generator 254 to emit energy, thereby generating an electric field at and / or near electrode pair 220. In some examples, controller 251 may instruct the first and second electrodes to emit energy to generate an electric field based on one or more electrical properties related to the efficacy of enhancing drug access to the arterial wall via reversible electroporation. The electric field can be controlled such that acoustic pressure waves are not generated by the spark gap. In some examples, an electric field can be applied to endothelial cells during the procedure. The electric field can enhance the effect of, for example, the effects described herein. Figure 1 The efficacy of the drug-coated balloon 111.

[0102] In some embodiments, controller 251 may instruct arc generator 254 to emit electrical energy to electrode pair 220 at and / or near the resonant frequency of the intra-arterial plaque to effectively promote plaque alteration. Like any object in the physical world, a plaque has a resonant frequency. When a plaque is subjected to an external force at its resonant frequency (e.g., acoustic waves from an IVL catheter such as 101, 201A, 201B, etc.), the plaque exhibits maximum vibration amplitude by absorbing and / or storing energy, resulting in significant oscillations that inevitably alter the plaque. In some examples, the resonant frequency is determined by the inherent properties of the plaque (e.g., mass, stiffness, etc.). In some examples, controller 251 may instruct arc generator 254 to emit electrical energy at the plaque's resonant frequency (e.g., approximately 54 Hz). In some examples, controller 251 may instruct arc generator 254 to emit electrical energy with a resonant frequency range of approximately 10 Hz to 55 Hz. In some examples, controller 251 may instruct arc generator 254 to emit electrical energy at the resonant frequency of the patch, wherein the frequency is greater than 5 Hz. However, controller 251 may instruct arc generator 254 to emit electrical energy at a resonant frequency greater than and / or less than 5 Hz (e.g., 1, 2, 6.5, 10.1, etc.). In some examples, controller 251 may instruct the arc generator to emit electrical energy having one or more electrical modes, which include the resonant frequency, pulse width, amplitude, pulse polarity, pulse shape, and / or phase described herein.

[0103] Additionally and / or optionally, controller 251 may instruct arc generator 254 to emit electrical energy, which may include one or more and / or combinations of the features and / or electrical characteristics described herein. As an illustrative example, controller 251 may instruct arc generator 254 to emit biphasic and / or asymmetrical pulse shapes, wherein positive pulses are associated with a first energy level and negative pulses are associated with a second energy level.

[0104] In some examples, controller 251 may receive input from rhythm unit 260. Based on the input received from rhythm unit 260, controller 251 may determine one or more cycles to enable and / or disable electrical power to IVL catheter 201A. Controller 251 may analyze one or more characteristics of the heart rhythm, including: heart rate, P wave (electrical activity associated with the upper ventricle), QRS complex (lower ventricle of the heart), PR interval (time between the onset of the P wave and the onset of the QRS complex), QT interval (time between the onset of the QRS complex and the end of the T wave), T wave (ventricular repolarization), etc. In some examples, when IVL catheter 201A is located close to the heart (e.g., coronary artery, coronary vein, etc.), controller 251 may determine, based on the heart rhythm received from rhythm unit 260, that arc generator 254 should be disabled. In some examples, controller 251 may ignore requests from users (e.g., physicians) to generate one or more arcs in IVL catheter 201A based on the patient 270's heart rhythm.

[0105] In some examples, controller 251 may determine, based on the received heart rhythm, whether to deliver electrical energy to electrode pairs 220 located distally and / or proximally at the IVL catheter 201A, while blocking the delivery of electrical energy to other electrode pairs 220. For example, controller 251 may instruct multiplexer 255 to deliver electrical energy to electrode pair 220_1, while also instructing multiplexer to block the delivery of electrical energy to electrode pair 220_2. In some examples, controller 251 may instruct multiplexer 255 to select one or more channels to increase the concentration of sound waves at a specific location within the blood vessel.

[0106] In some examples, controller 251 may indicate the status of the IVL catheter (e.g., whether the procedure was successful) based on indicator 217. For example, controller 251 may receive input from indicator 217, which may measure the status (e.g., physical properties) of IVL catheter 201A, such as pressure, flow rate, temperature, motion (e.g., vibration), volume changes, etc. In some examples, controller 251 may be based on balloon (e.g., Figure 1 The change in volume of the balloon 111 is used to determine if the pressure within the IVL catheter 201A has changed. In some examples, the controller 251 can be based on, as in reference... Figures 14A-14B The detected pressure fluctuations indicate that the IVL procedure successfully altered the calcified lesions.

[0107] The energy generator 250 may further include an arc generator 254. The arc generator 254 can generate one or more electrical pulses based on instructions, for example, from a controller 251. The arc generator 254 can generate arc patterns with one or more characteristics, such as single-phase pulses, two-phase pulses, frequency, pulse width, symmetrical and / or asymmetrical pulse shape, amplitude, phase, etc. The arc generator 254 can transmit one or more arc patterns to, for example, a multiplexer 255. Additionally and / or alternatively, the arc generator 254 can be directly wired to one or more electrode pairs 220 and / or directly transmit one or more arc patterns to the electrode pairs 220. Furthermore, the arc generator 254 can generate one or more arc patterns simultaneously. For example, the arc generator 254 can transmit a first arc mode and / or a second arc mode to the multiplexer 255, so that the first set of electrode pairs 220_1 generates sound waves based on the first arc mode, and / or the second set of electrode pairs 220_2 generates sound waves based on the second arc mode.

[0108] The energy generator 250 may also include a multiplexer 255. The multiplexer 255 may include any number of channels (e.g., one, two, three, four, or more) corresponding to the number of electrode pairs 220 associated with the IVL catheter 201A. The multiplexer 255 may receive instructions from the controller 251 and / or, in response, select one or more electrode pairs 120 to generate an arc according to an arc pattern determined by the controller 251. The multiplexer 255 is configured to select one or more electrode pairs 220 based on, for example, a desired acoustic concentration at a target location within the blood vessel.

[0109] To ignite a spark, the energy generator 250, under the control of the controller 251, can drive the wires 223B and 224B with a voltage, for example, between 1000V and 5000V, 1000V and 4000V, 1000V and 3000V, 1000V and 2000V, 2000V and 4000V, 1500V and 3000V, 1500V and 2500V, or 2000V and 3000V, or any value in between. The voltage provided by the energy generator 250 can be the voltage difference between the two wires, or the absolute value of the voltage driven on a single wire. Depending on the implementation, the wires 223B and 224B can have an impedance of several thousand ohms, which can increase as the electrode surface area decreases. The energy generator 250 can drive wires 223B and 224B with this voltage for a duration between 1µs and 50µs, 1µs and 40µs, 1µs and 30µs, 1µs and 20µs, 1µs and 10µs, 1µs and 5µs, 5µs and 50µs, 10µs and 50µs, 20µs and 50µs, 30µs and 50µs, 40µs and 50µs, 1µs and 25µs, 25µs and 50µs, or any value within these ranges. The duration for which the energy generator 250 drives this voltage can be inversely proportional to the voltage, such that a higher voltage requires a shorter duration, and vice versa. For example, the energy generator 250 can drive the wires 223B and 224B at 1500V for 50µs to ignite a spark, or it can drive the wires 223B and 224B at 3000V for a period between 1µs and 10µs to ignite a spark. Under such conditions, driving the wires 223B and 224B can result in a current of several hundred milliamperes flowing from the energy generator 250 to the wires 223B and 224B.

[0110] The impedance between the electrodes in the transmitter (e.g., between 1 and 10 ohms) can be less than the impedance of the wires themselves, such that when a spark is formed between the electrode pairs, it can result in an increased current (e.g., 30 A to 40 A) being drawn from the energy generator 250 in an additional few microseconds (e.g., 4 µs to 10 µs) at the same voltage output.

[0111] In some examples, one or more components and / or functions of the cardiac synchronization system 200A may be combined. For example, the arc generator 254 and / or multiplexer 255 may include one or more components designed to generate an arc pattern and / or select electrode pairs 220 in response to one or more instructions received from controller 251. Additionally and / or alternatively, the energy generator 250 and / or rhythm unit 260 may be combined into one or more units that can determine one or more aspects of the patient 270's heart rhythm and / or determine whether to enable / disable electrical power transfer to one or more electrode pairs 220, and / or transfer electrical power to the electrode pairs 220.

[0112] Figure 2B This is an example implementation of a cardiac synchronization system 200B, which has an IVL catheter 201B with individually wired electrode pairs 220. One or more components of the cardiac synchronization system 200B may be the same as and / or similar to components of the cardiac synchronization system 200A. Figure 2B As depicted, the cardiac synchronization system 200B can be electrically connected to electrode pairs 220_1, 220_2, and / or 220_n of the IVL catheter 201B. In some embodiments, each electrode within an electrode pair (e.g., electrodes E_1_1 and / or E_1_2 of electrode pair 220_1) can be individually wired to, for example, a multiplexer 255 via wires 223B and / or 224B. Advantageously, the cardiac synchronization system 200B can individually wire each electrode (e.g., via wires 223B and / or 224B) to the multiplexer 255 to create a spark gap between any two electrodes. For example, in some embodiments, a spark gap may exist between electrodes E_1_1, 220_2, and / or 220_n. Between E_1 and / or E_1_2, while in some embodiments, a spark gap may exist between E_1_1 and / or E_2_1. Additionally and / or alternatively, a spark gap may exist between electrode pairs E_1_1 and / or E_2_1, while a second spark gap exists between E_1_2 and / or E_2_2. In some embodiments, the multiplexer 255 can selectively transmit single-phase and / or two-phase pulses between any combination of electrodes, causing the arc to travel across the spark gap in one or more directions.

[0113] Figure 2C-2FExample graphs 200C-200F are shown as examples of pulse patterns that can be generated by the energy generator 250. Example graphs 200C-200F are illustrative examples of pulse patterns and are not intended to limit the scope of this disclosure. In some examples, the controller 251 may instruct the energy generator 250 to emit one or more pulses having rise times and / or fall times similar to the pulse examples shown in graphs 200C-200F. Additionally and / or alternatively, the controller 251 may instruct the energy generator 250 to emit pulses with different energy levels, frequencies, intensities, durations, etc., than those depicted in graphs 200C-200F.

[0114] Figure 200C illustrates an example of a symmetrical pulse mode. As depicted in Figure 200C, a symmetrical pulse mode can generate substantially equal amounts of energy for positive and negative pulses via the same and / or similar waveforms (e.g., pulses, step functions, energy levels, etc.).

[0115] Example curves 200D-200F illustrate asymmetric pulse modes. As mentioned above, asymmetric pulse modes can include varying rise and / or fall times (e.g., slope), biphasic pulses including energy levels varying based on polarity, etc. Advantageously, asymmetric pulses can improve the durability of electrode pair 220 and thus increase the service life of IVL catheter 201A because erosion and / or pitting caused by arc discharge can be more uniformly distributed, and / or heat can be effectively dissipated compared to symmetric pulse modes.

[0116] Figure 200D illustrates an example of an asymmetric pulse that generates equal amounts of energy for both positive and negative pulses. For example, although a positive pulse may have a higher intensity (e.g., voltage) for a shorter duration compared to a negative pulse, the total energy emitted by the positive and negative pulses can be equal and / or substantially equal because the total area above and below 0 volts is approximately equal. Figures 200E and 200F illustrate examples of asymmetric pulses with different intensities, durations, and / or energy levels.

[0117] Although the graphs 200D-200F depict a positive pulse followed by a negative pulse, this is not intended to be limiting. For example, a negative pulse may be emitted from electrode pair 220, followed by a positive pulse. Additionally and / or alternatively, the pulses do not necessarily have to alternate. For example, one, two, three, and / or more negative and / or positive pulses may be emitted after the first pulse. As an illustrative example, an additional negative pulse may follow the first negative pulse, followed by a positive pulse. Advantageously, generating biphasic pulse patterns (e.g., with both positive and negative pulses) and / or asymmetric pulse patterns can reduce the likelihood of inducing muscle contraction. Therefore, the systems and devices described herein can perform endovascular lithotripsy near the heart without the risk of triggering a heart attack.

[0118] This article refers to Figures 3A-3E And / or 4A-4E describe one or more example transmitter embodiments as part of an IVL catheter. Example embodiments of the transmitter can be used as part of, for example, IVL catheters 101, 201A, 201B, and / or any other example embodiment of the IVL catheter described herein.

[0119] One or more components of an IVL catheter (e.g., transmitter, lead, balloon, carrier, etc.) can be configured to optimize acoustic waves for altering calcified lesions. Optimizing the intensity and / or directionality of the acoustic waves can also provide several benefits to both the physician and / or the patient. For example, an efficient IVL catheter generates less heat, thus reducing the vessel's exposure to higher temperatures. An efficient IVL catheter can reduce the number of pulses required to alter calcified lesions, thereby shortening the overall procedure time. Furthermore, an efficient IVL catheter can alter calcified lesions located at multiple sites within the vessel without requiring replacement, thus improving the efficiency of the procedure. The directionality and / or intensity of the acoustic waves can be optimized by, for example, positioning the electrodes distally, proximally, within the carrier, and / or outside the carrier. Furthermore, the shape and / or size of the electrodes, the configuration of the spark gap and / or the location of one or more electrode pairs, and / or the associated wiring can produce smaller, lighter, more flexible, and / or therefore more efficient IVL catheters as described herein.

[0120] Figure 3A This is an example side view of a helically wound electrode pair 320. The electrode pair 320 may be electrically similar to and / or identical to... Figure 1 Electrode pair 120. In some examples, IVL catheters (e.g., IVL catheters 101 and / or 201A, 201B, etc.) may have one or more electrode pairs 320 electrically connected to the energy generator 250 to generate an electric arc within the IVL catheter.

[0121] In some examples, carrier 312 can be with Figure 1The carrier 312 is the same as and / or similar to the carrier 112. For example, the carrier 312 may have a solid core and / or a hollow channel along the first axis A1. The carrier 312 may be configured with a hollow channel to support, for example, a guidewire passing through it (e.g., Figure 1 (guide wire 118). The carrier 312 may have an inner surface 312_1 and an outer surface 312_2. The carrier 312 may have a volume between the inner surface 312_1 and the outer surface 312_2 that can accommodate electrodes 321 and / or 322. The inner surface 312_1 of the carrier 312 may form a lumen, for example, along a first axis A1. The outer surface 312_2 may have one or more grooves 328. In some examples, the carrier 312 may have grooves 328 as shown in the cross-section of the electrode pair 320 (e.g., a cross-section along a plane intersecting the first axis A1). For example, the carrier 312 may have grooves 328 that begin at the proximal end 34 and / or end at the distal end 33. In some examples, the grooves 328 may form a helix around the carrier 312.

[0122] The groove 328 may have a first height h1 of about 0.02 to 0.1 mm. The first height h1 of the groove 328 may be measured from one or more wires 323 and / or 324 to the outer surface 312_2 of the carrier. In some examples, the first height h1 is greater than and / or less than 0.03 mm (e.g., 0.001, 0.01, 0.1, 0.2, 0.4, 1, etc.). The groove may have a second height h2 measured from one or more wires 323 and / or 324 to the inner surface 312_1. The second height h2 may be about 0.02 to 0.06 mm. In some examples, the second height h2 may be greater than and / or less than about 0.02 to 0.06 mm (e.g., 0.001, 0.01, 0.1, 0.2, 0.3, 1, 2, and / or greater). In some examples, the groove 328 may have a distance d1 of about 0.25 to 0.07 mm. In some examples, the distance d1 of the groove 328 can be greater than and / or less than 0.25 to 0.07 mm (e.g., 0.01, 0.1, 0.2, 0.3, 1, 2 and / or greater). The first height h1 and the second height h2 can determine, for example, the depth of the groove 328 and / or the proximity of the wires 323 and / or 324 to the inner and / or outer surfaces 312_2 of the carrier 312. In some examples, the groove 328 has a varying first height h1 and / or distance d1, depending on the number of conductive wires 323 and / or 324 included in the groove 328. In some examples, the groove 328 has a reduced first height h1 and / or distance d1 at the distal end of the carrier 312 compared to the proximal end. In some embodiments, the groove 328 can have, as shown in the image... Figures 3A-3E One or more geometric shapes are depicted in the text.

[0123] Advantageously, insulated conductive wires 323 and / or 324 may be positioned below the recess 328 of the carrier 312 and / or below the outer surface 312_2 of the carrier 312 (e.g., embedded, located below, etc.) to optimize the directionality and / or control of the acoustic waves generated by the electrode pair 320. Positioning the wires 323 and / or 324 below the recess and / or outer surface 312_2 can, in some cases, reduce the overall diameter of the IVL catheter measured along the first axis A1. Furthermore, the arc between the electrodes 321 and / or 322 of the electrode pair 320 can generate acoustic waves within the recess 328 of the carrier 312 (e.g., below the outer wall and / or spaced inward from the outer surface), thereby directing the acoustic waves outward toward the target lesion in the blood vessel. Additionally, the carrier 312 may have a spark gap 325. The spark gap 325 may be, for example, a notch exposing the electrodes 321 and / or 322. In some examples, the carrier 312 may include one spark gap 325 for each electrode pair 320. In some examples, the first spark gap 325 may be positioned at the distal end 34 of the second axis A2, while the second spark gap 325 may be positioned at the proximal end of the second axis A2. Furthermore, the carrier 312 may include a plurality of spark gaps 325 positioned longitudinally, helically, and / or radially along the first axis A1 and / or the second axis A2 of the carrier 312.

[0124] The electrode pair 320 may include insulated conductive wires 323 and / or 324 (hereinafter referred to as "wires" 323 and / or 324). Wires 323 and / or 324 may be coupled with, for example... Figure 2A-2B The energy generator 250 shown is electrically connected. Wires 323 and / or 324 can be 36 AWG wire (e.g., copper wire insulated with one or more insulating materials). In some examples, the wire gauge of wires 323 and / or 324 can be greater than and / or less than 36 AWG (e.g., 34, 35, 37, 38, 39, etc.). In some examples, wire 323 can be a first wire gauge, while wire 324 can be a second wire gauge. Although... Figure 3A One of wires 323 and / or 324 is depicted, but other embodiments may include multiple wires 323 and / or 324. For example, wires 323 and / or 324 may be configured in an N+1 configuration as described herein to selectively transfer electrical energy to one or more electrode pairs 320. In some configurations, electrode pairs 320 may be wired in another configuration, such as in parallel, series, or individually (e.g., as shown in the diagram). Figure 2B (System 200B), etc.

[0125] In some examples, electrode pair 320 may include a first electrode 321 and / or a second electrode 322. Electrodes 321 and / or 322 may be, for example, part of wires 323 and / or 324, including portions where the insulation has been removed to expose the conductor. In some examples, the conductor may be copper wire. In some examples, electrodes 321 and / or 322 may be electrodes soldered to the conductors of wires 323 and / or 324. A spark gap 325 may be present between electrodes 321 and / or 322. The spark gap 325 may be, for example, 1 mm. However, depending on the configuration, the spark gap 325 may be wider and / or narrower. For example, Figure 3A Electrodes 321 and / or 322 are depicted in similar positions along wires 323 and / or 324, respectively. Electrodes 321 and / or 322 may be positioned along wires 323 and / or 324 at proximal end 33 and / or distal end 34 to increase and / or decrease the spark gap 325 as needed. In some examples, electrode pairs 320 may include multiple sets of electrodes 321, 322 and / or spark gaps 325 along a groove 328 of the carrier 312. In some examples, the groove may have the following... Figures 3A-3E One or more geometric shapes are depicted in the text.

[0126] although Figure 3A Electrodes 321 and / or 322 are depicted as being adjacent to each other, but in some embodiments, electrodes 321 and / or 322 may be separate and / or located below the outer surface 312_2 of the carrier 312 (e.g., within the volume between the inner surface 312_1 and the outer surface 312_2). For example, electrode 322 may be located adjacent to the inner surface 312_1 of the carrier 312, while electrode 321 may be located adjacent to the outer surface 312_2 of the carrier 312. In some examples, electrodes 321 and / or 322 may be as described in reference to Figure 2B As described above, they are individually wired to allow for individual control of one or more electrodes, thereby selectively generating an electric arc between any two electrodes.

[0127] As described above, an IVL catheter with a large outer diameter measured along the second axis A2 may be unable to pass through one or more occluded segments in a blood vessel, thus limiting its use. To expand the applicability of the IVL catheter, one design option is to reduce the overall diameter of the IVL catheter. However, as the diameter of the IVL catheter decreases, the structural integrity of the IVL catheter may also decrease. In some examples, the outer diameter of the IVL catheter may be reduced to the point that the IVL catheter becomes too flexible for a physician to insert into the desired blood vessel. Advantageously, to overcome this problem, leads 323 and / or 324 may be wound in a spiral shape around the carrier 312 to increase the overall rigidity of the IVL catheter while reducing its overall diameter. Leads 323 and / or 324 may be wound around the carrier 312 along the first axis A1, beginning at the proximal end 33 and / or ending at the distal end 34. In some examples, insulated conductive wires 323 and / or 324 may be wound in a spiral shape around the carrier 312 and / or along the outer surface 312_2 of the carrier as described above.

[0128] Figures 3A-3E Examples of other geometries for the groove 328 of the electrode pair 320 are shown. In some examples, the groove 328 may have the same shape throughout the carrier 312. In some embodiments, the groove 328 may have a varied shape. In some embodiments, the carrier 312 may include one or more grooves 328, etc., by removing the volume between the outer surface 312_2 and the inner surface 312_1. For example, the groove 328 may be formed when the proximal sidewall of the carrier 312 has a first geometry and the distal sidewall of the carrier 312 has a second geometry. Figures 3A-3E These are some examples of other groove geometries, not intended to be limiting. They can be implemented. Figures 3A-3E Other shapes and / or combinations of one or more shapes not shown. Advantageously, grooves 328, 328a, 328b, 328c, 328d, etc. can be implemented by the system (e.g., 100, 200A, 200B, etc.) to effectively control the directionality and / or concentration of the emitted energy generated by one or more arcs between two electrodes (e.g., electrodes 321 and / or 322).

[0129] Figure 3BAn exemplary electrode pair 320a is shown, having a groove 328a as part of a carrier 312a. In some examples, the groove 328a may have a distance d1 along the outer surface 312a_2 that is less than the distance of the spark gap 325 and / or less than the distance of the groove 328a adjacent to the inner surface 312a_1. In some examples, the distance d1 may be less than and / or equal to the distance of the spark gap 325 along the outer surface 312a_2. In some examples, the carrier 312a may have the groove 328a formed by removing a portion of the outer surface 312a_2. Figure 3B As depicted, the carrier 312a can form a groove 328a, which has substantially angled sidewalls at the proximal end 33 and / or distal end 34 of the second axis A2.

[0130] Figure 3C An exemplary electrode pair 320b is shown, which has a groove 328b as part of a carrier 312b. The groove 328b may have generally convex sidewalls at its proximal end 33 and / or distal end 34 along the second axis A2. In some examples, the groove 328b may have a distance d1 along the outer surface 312b_2 of the carrier 312b, which is less than the distance of the spark gap 325 and / or less than the distance of the groove 328b adjacent to the inner surface 312b_2. In some examples, the distance d1 may be greater than and / or equal to the distance of the spark gap 325. In some examples, the carrier 312b may be as follows: Figure 3C As depicted, the groove 328b is formed by removing a portion of the outer surface 312b_2.

[0131] Figure 3D An exemplary electrode pair 320c is shown, which has a groove 328c as part of a carrier 312c. The groove 328c may have generally concave sidewalls at its proximal end 33 and / or distal end 34 along the second axis A2. In some examples, the distance d1 of the recessed channel 328c is less than the distance of the spark gap 325. In some examples, the distance d1 may be greater than and / or equal to the distance of the spark gap 325. In some examples, the carrier 312c may be as follows: Figure 3D As depicted, the groove 328c is formed by removing a portion of the outer surface 312c_2.

[0132] Figure 3EAn exemplary electrode pair 320d is shown, having a groove 328d as part of a carrier 312d. In some examples, the groove 328d may have a distance d1 along the outer surface 312d_2 that is greater than the distance of the spark gap 325 and / or greater than the distance of the groove 328d adjacent to the inner channel 312d_1. In some examples, the distance d1 may be substantially greater than and / or approximately equal to the distance of the spark gap 325 along the outer surface 312d_2. In some examples, the carrier 312d may be formed by removing a portion of the surface of the outer surface 312d_2 to create the groove 328d. Figure 3E As depicted, the carrier 312d can form a groove 328d, which has substantially angled sidewalls at the proximal end 33 and / or distal end 34 of the second axis A2.

[0133] As described herein, the system may include any combination of electrode pairs (e.g., 120, 220, 320, 320a-d, 420, 420a-d, etc.) and one or more combinations of grooves in the carrier to effectively direct energy to plaque in the artery. In some examples, the system may include one or more grooves. The grooves may include one or more electrode pairs. In some examples, the grooves may have one or more exemplary geometries as described herein, etc.

[0134] Figure 4A It is an exemplary cross-sectional view along a plane intersecting the first axis A1. Figure 4A An embedded electrode pair 420 is depicted. The electrode pair 420 is electrically compatible with... Figure 1 The electrode pairs 120 are similar and / or identical. In some examples, IVL catheters (e.g., IVL catheters 101, 201A, 201B, etc.) may have one or more electrode pairs 420 electrically connected to the energy generator 250 to generate an electric arc within the IVL catheter.

[0135] In some examples, carrier 412 can be with Figure 1 The carrier 412 is the same as and / or similar to the carrier 112. The carrier 412 may have a solid core and / or a hollow channel along the first axis A1. The carrier 412 may be configured with a hollow channel to support, for example, a guide wire passing through it (e.g., Figure 1(guidewire 118). The carrier 412 may have an inner surface 412_1 and an outer surface 412_2. The carrier 412 may have a volume between the inner surface 412_1 and the outer surface 412_2. The volume may accommodate electrodes 421 and / or 422. The inner surface 412_1 of the carrier 412 may, for example, form a lumen along a first axis A1. As depicted in the cross-section of the electrode pair 420, the outer surface 412_2 may have a notch 428. Advantageously, electrodes 421 and / or 422 may be located below (e.g., below, embedded therein, etc.) the outer surface 412_2 of the carrier 412. Electrodes 421 and / or 422 may be exposed via the notch 428 along the proximal side 33 and / or distal side 34 of a second axis A2. Electrodes 421 and / or 422 may be exposed to a conductive fluid, such as that of an IVL catheter. Furthermore, the carrier 412 may include a cavity 427. Cavity 427 may be, for example, an additional region defining a spark gap 425 as part of electrodes 421 and / or 422. In some examples, cavity 427 may be located on one, both, or not on either of electrodes 421 and / or 422. In some embodiments, cavity 427 may be included as part of carrier 412 (e.g., inner surface 412_1 and / or outer surface 412_2, etc.). In some examples, electrodes 421 and / or 422 may include at least one cavity 427. In some examples, the first electrode of electrode pair 420 (e.g., electrodes 421 and / or 422) may include at least one cavity 427, while the second electrode of electrode pair 420 (e.g., electrodes 421 and / or 422) may not include at least one cavity 427. Advantageously, cavity 427, together with notch 428 of carrier 412, may be configured to optimize the directionality and / or control of acoustic waves generated by electrode pair 420. For example, the electric arc between electrodes 421 and / or 422 of electrode pair 420 can generate sound waves within a notch 428 of carrier 412 (e.g., below and / or spaced inward from outer surface 412_2), thereby directing the sound waves outward to the target region of the blood vessel. Furthermore, carrier 412 may have a solid core, and / or carrier 412 may include a hollow channel defined by inner surface 412_1 (e.g., along the first axis A2), thereby forming a lumen through which (e.g., for support) Figure 1 (guidewire 118).

[0136] The electrode pair 420 also includes electrodes 421 and / or 422. Electrodes 421 and / or 422 may be embedded within the carrier 412. Additionally and / or alternatively, electrodes 421 and / or 422 may be positioned below the outer wall of the carrier 412 (e.g., from the outer surface inwards). During the manufacturing process of the carrier 412, the outer wall of the carrier 412 may be removed to produce a result such as Figure 4AThe notch 428 shown exposes electrodes 421 and / or 422 and / or forms a spark gap 425.

[0137] The notch 428 may have a first height h1 of about 0.04 to 0.3 mm at its proximal end 33 and / or distal end 34 along the second axis A2. The first height h1 may, for example, be measured from the outer surface 412_2 to the bottom portion of the notch 428. In some examples, the first height h1 of the notch 428 may be greater than and / or less than about 0.04 to 0.3 mm (e.g., 0.001, 0.01, 0.1, 0.2, 0.4, 1, etc.). The notch 428 may have a second height h2, which, for example, is measured along the second axis A2 from the top portion of the electrode pair 420 to the outer surface 412_2. Along the second axis A2, the second height h2 may be about 0.01 to 0.06 mm. In some examples, the height h2 of the notch 428 may be greater than and / or less than 0.01 to 0.06 mm (e.g., 0.001, 0.01, 0.1, 0.2, 0.4, 1, etc.). The notch 428 may have a third height h3, which, for example, is measured along the second axis A2 from the top portion of the electrode pair 420 to the inner surface 412_1. Along the second axis A2, the third height h3 may be about 0.01 mm. In some examples, the third height h3 of the notch 428 may be greater than and / or less than about 0.01 to 0.03 mm (e.g., 0.001, 0.01, 0.1, 0.2, 0.4, 1, etc.). The notch 428 may have a fourth height h4, which, for example, is measured from the top portion of the electrode pair 420 to the outer surface 412_2. Along the second axis A2, the fourth height h4 may be greater than and / or less than about 0.01 to 0.05 mm. In some examples, the fourth height h4 of the notch 428 may be greater than and / or less than about 0.01 to 0.05 mm (e.g., 0.001, 0.01, 0.1, 0.2, 0.4, 1, etc.). In some examples, the notch 428 may have a first distance d1, which is measured along the outer surface 412_2 of the carrier 412. In some examples, the first distance d1 may be measured along the second axis A2 from the proximal end 33 and / or the distal end 34. The first distance d1 may, for example, be about 0.05 to 0.1 mm. In some examples, the first distance d1 of the notch 428 may be greater than and / or less than about 0.05 to 0.1 mm (e.g., 0.01, 0.1, 0.2, 0.3, 1, 2 and / or greater). In some examples, the notch 428 may have a second distance d2, which is measured from the proximal side 33 and / or the distal side 34 of the notch 428 to the proximal end 33 and / or the distal end 34 of the electrodes 421 and / or 422. The second distance d2 may, for example, measure the amount by which the electrodes (e.g., electrodes 421 and / or 422) extend into the notch 428 along the first axis A1. In some examples, the second distance d2 can be measured along the second axis A2 from the proximal end 33 and / or the distal end 34. The second distance d2 can be, for example, about 0.01 to 0.03 mm.In some examples, the second distance d2 may be greater than and / or less than about 0.01 to 0.03 mm (e.g., 0.01, 0.1, 0.2, 0.3, 1, 2 and / or greater). In some examples, depending on the number of conductive wires 423 and / or 424 included and / or exposed to the notch 428 and / or the type of electrodes 421 and / or 422, one or more aspects of the notch 428 and / or electrode pair 420 may have varying heights h1, h2, h3, h4. And / or distances d1, d2. In some examples, the notch 428 has a reduced height h1, h2 and / or distance d1 at the distal end of the carrier 412 compared to the proximal end.

[0138] In some embodiments, along the second axis A2, the first electrode 421 may be positioned at the distal end 34 and / or the second electrode 422 may be positioned at the proximal end 33. In some embodiments, electrodes 421 and / or 422 may be positioned longitudinally, radially, axially, and / or at any other location along the first axis A1 and / or the second axis A2. In some embodiments, the spark gap 425 may be formed by positioning electrodes 421 and / or 422 longitudinally, radially, axially, and / or at any other location along the carrier 412, and / or by exposing one or more portions of the carrier 412 (e.g., removing at least a portion of the outer surface 412_2, etc.).

[0139] Furthermore, the composition of electrodes 421 and / or 422 can be one or more combinations of gold, platinum-iridium alloy, stainless steel, nickel-titanium alloy, etc. As shown, electrodes 421 and / or 422 can be electrically connected to conductive wires 423 and / or 424. In some examples, conductive wires 423 and / or 424 can be soldered to electrodes 421 and / or 422. Conductive wires 423 and / or 424 can be configured in an N+1 configuration as described herein to selectively transfer electrical energy to one or more electrode pairs 420. In some configurations, electrode pairs 420 can be wired in another configuration, such as in parallel, series, or individually (e.g., such as...). Figure 2B (System 200B), etc.

[0140] In some embodiments, the IVL catheter may include one or more electrode pairs 120, 320, 420, etc. Additionally and / or alternatively, the IVL catheter may include one or more portions with different carrier configurations (e.g., carriers 112, 312, and / or 412, etc.).

[0141] Figures 4A-4DExamples of additional geometry for the notch 428 of the electrode pair 420 are shown. In some examples, the notch 428 may have the same shape along the first axis A1 and / or the second axis A2. In some embodiments, the notch 428 may have a varied shape along the first axis A1 and / or the second axis A2. In some embodiments, the carrier 412 may include a plurality of notches 428, etc. For example, a notch 428 may be formed having a first geometry at the proximal end 33 and a second geometry at the distal end 34 along the second axis A2. Figures 4A-4E These are examples of other geometries of the notch 428, inner surface 412_1, and / or outer surface 412_2 of the carrier 412, and are not intended to be limiting. These can be implemented. Figures 4A-4E Other shapes and / or combinations of one or more shapes not shown. Advantageously, notches 428, 428a, 428b, 428c, 428d, etc. can be implemented by the system (e.g., 100, 200A, 200B, etc.) to effectively control the directionality and / or concentration of emitted energy generated due to one or more arcs between the two electrodes.

[0142] Figure 4B An exemplary electrode pair 420a is shown, having a notch 428a as part of a carrier 412a. In some examples, the notch 428a may have a distance d1 along the outer surface 412a_2, which is less than the distance of the spark gap 425 and / or less than the distance of the notch 428a adjacent to the inner surface 412a_1. In some examples, the distance d1 may be less than and / or equal to the distance of the spark gap 425 along the outer surface 412a_2. In some examples, the carrier 412a may have the notch 428a formed by removing a portion of the outer surface 412a_2. Figure 4B As depicted, the carrier 412a may form a notch 428a, which has substantially angled sidewalls at the proximal end 33 and / or distal end 34 of the second axis A2.

[0143] Figure 4C An exemplary electrode pair 420b is shown, which has a notch 428b as part of a carrier 412b. The notch 428b may have generally convex sidewalls along the second axis A2 at its proximal end 33 and / or distal end 34. In some examples, the notch 428b may have a distance d1 along the outer surface 412b_2 of the carrier 412b, which is less than the distance of the spark gap 425 and / or less than the distance of the notch 428b adjacent to the inner surface 412b_2. In some examples, the distance d1 may be greater than and / or equal to the distance of the spark gap 425. In some examples, the carrier 412b may be as follows: Figure 4C As depicted, notch 428b is formed by removing a portion of the outer surface 412b_2.

[0144] Figure 4D An exemplary electrode pair 420c is shown, which has a notch 428c as part of a carrier 412c. The notch 428c may have generally concave sidewalls along the second axis A2 at its proximal end 33 and / or distal end 34. In some examples, the notch 428c may have a distance d1 smaller than the distance of the spark gap 425. In some examples, the distance d1 may be greater than and / or equal to the distance of the spark gap 425. In some examples, the carrier 412c may be as follows: Figure 4D As depicted, the notch 428c is formed by removing a portion of the outer surface 412c_2.

[0145] Figure 4E An exemplary electrode pair 420d is shown, having a notch 428d as part of a carrier 412d. In some examples, the notch 428d may have a distance d1 along the outer surface 412d_2, which is greater than the distance of the spark gap 425 and / or greater than the distance of the notch 428d adjacent to the inner channel 412d_1. In some examples, the distance d1 may be significantly greater than and / or approximately equal to the distance of the spark gap 425 along the outer surface 412d_2. In some examples, the carrier 412d may have the notch 428d formed by removing a portion of the surface of the outer surface 412d_2. Figure 4E As depicted, the carrier 412d may form a notch 428d, which has substantially angled sidewalls at the proximal end 33 and / or distal end 34 of the second axis A2.

[0146] As described above, the system (e.g., 100, 200A, 200B, etc.) may include any combination of electrode pairs (e.g., 120, 220, 320, 320a-d, 420, 420a-d, etc.) with one or more combinations of grooves and / or notches in the carrier to effectively direct energy to plaque in the artery. As an illustrative example, the system may include a groove and / or one or more notches, each notch having one or more geometries as described herein.

[0147] Figure 5A-13B One or more exemplary embodiments of an IVL catheter that can be used to alter calcified lesions in blood vessels are illustrated. Each exemplary embodiment of the IVL catheter may include one or more features described herein to provide physicians with the ability to efficiently navigate through one or more blood vessels to target and / or alter various calcified lesion build-ups, such as symmetrical and / or asymmetrical calcified plaques.

[0148] Figures 5A-5F Figures 6 and / or 7 illustrate exemplary embodiments of IVL catheters having conductive wires spirally wound around a sheath and / or carrier. Due to their spirally wound conductive wires, compared to other IVL catheter types, Figures 5A-5F IVL catheters of grades 6 and / or 7 have a reduced total cross-sectional area and / or increased rigidity, which advantageously allows physicians to navigate the IVL catheter through one or more arteries to reach a greater number of locations, including plaque.

[0149] Figures 5A-5C An exemplary embodiment of an IVL conduit 501 having a conductive wire spirally wound around a carrier is shown. Figure 5A As depicted, the IVL catheter 501 may include a balloon 511. The balloon 511 can be coupled with... Figure 1 The balloon 511 is the same as and / or similar to the balloon 511. The balloon 511 may be sealed at distal end 34 514 and / or proximal end 33 513. The IVL catheter 501 may include a carrier 512. The carrier 512 may be respectively with... Figure 1 And / or the carriers 112 and / or 312 of Figure 3 are similar to and / or identical to those in Figure 3. Furthermore, the IVL catheter 501 may include an electrode pair 520. The electrode pair 520 may be used with… Figure 3A The electrode pair 320 is the same as and / or similar. The balloon 511 may span a length of the IVL catheter 501, which is between 20 mm and 200 mm, between 20 mm and 150 mm, between 20 mm and 120 mm, between 20 mm and 100 mm, between 20 mm and 60 mm, between 40 mm and 150 mm, between 40 mm and 120 mm, between 60 mm and 120 mm, between 80 mm and 120 mm, between 100 mm and 150 mm, or any length in between. The length of the balloon 511 may be defined by the proximal and distal ends of the portion having the largest diameter. The diameter of the balloon 511 when inflated (e.g., the portion having the largest diameter) may be any length between 2 mm and 10 mm, such as 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, or 10 mm.

[0150] like Figures 5B-5CAs shown, electrode pair 520 may have four insulated conductive wires, including wire 524 and / or wire 523. In some examples, IVL catheter 501 may have more and / or fewer wires 523 and / or 524, depending on the desired number of electrode pairs 520 in IVL catheter 501. Wires 523 and / or 524 may be helically wound around carrier 512 and / or along first axis A1. Advantageously, helically winding wires 523 and / or 524 around carrier 512 and / or along first axis A1 can improve structural integrity while reducing the overall diameter of IVL catheter 501. Furthermore, IVL catheter 501 may have increased flexibility at distal end 34 compared to proximal end 33, as the number of wires 523 and / or 524 can be reduced with each electrode pair 520. Thus, a flexible IVL catheter 501 can allow physicians to navigate through one or more vessels and / or across occluded segments to reach the desired calcified lesion.

[0151] Wires 523 and / or 524 can be used with, for example, Figure 2A-2B The energy generator 250 shown is electrically connected. Furthermore, wires 523 and / or 524 can be, for example, 36AWG wires (e.g., copper wires insulated with one or more insulating materials). In some examples, the gauge of wires 523 and / or 524 can be greater than and / or less than 36AWG as described herein. In some examples, wire 523 can be a first wire gauge, while wire 524 can be a second wire gauge.

[0152] like Figure 5C As further shown, the electrode pair 520 may include a first electrode 521 and / or a second electrode 522. Electrodes 521 and / or 522 may, for example, be part of wires 523 and / or 524, including portions where the insulation has been removed to expose the conductor. In some examples, the conductor may be copper wire. In some examples, electrodes 521 and / or 522 may be electrodes soldered to the conductors of wires 523 and / or 524. A spark gap 525 may be present between electrodes 521 and / or 522. The spark gap 525 may, for example, be 1 mm. However, depending on the configuration, the spark gap 525 may be wider and / or narrower. For example, Figure 6 Electrodes 521 and / or 522 are depicted wound around a carrier 512 such that a spark gap 525 exists along the carrier 512 in the axial and / or circumferential directions. In some examples, electrodes 521 and / or 522 may be positioned along wires 523 and / or 524 on the proximal side 33 and / or distal side 34 to increase and / or decrease the spark gap 525 as needed.

[0153] In some embodiments, the number of leads 523 and / or 524 can be reduced as the IVL catheter 501 moves longitudinally from the proximal end 33 of the carrier 512 to the distal end 34 of the carrier 512, based on the number of electrode pairs 520 associated with the IVL catheter 501 (e.g., the N+1 configuration mentioned above). In one embodiment, the IVL catheter 501 may include a common lead 524 and / or three power leads 523 at the proximal end of the IVL catheter 501. As the IVL catheter moves longitudinally toward the distal end 34 of the carrier 512, the number of leads 523 and / or 524 can be reduced to three (e.g., one common lead 524 and / or two power leads 523) because the first power lead 523 may terminate at an electrode pair 520. Therefore, the electrode pair 520 at the distal end 34 requires two leads to form the electrode pair 520; one common lead 524 and / or one power lead 523.

[0154] Figure 5D-5E An exemplary embodiment of annular electrodes 521a, 522a as part of electrode pair 520a is shown. Electrode pair 520a may include a combination of annular electrodes 521a, 522a and / or other types of electrodes (e.g., electrodes 321, 322, 421, 422, 521, 522, etc.). Advantageously, annular electrodes 521a, 522a used as part of IVL catheters 101, 201A, 201B, 501 (and / or another IVL catheter described herein) can improve the lifespan and usefulness of the IVL catheter during the procedure compared to conventional IVL catheters. For example, conventional IVL catheters as described above may limit the number of pulses (e.g., number of cycles) that a physician can fire because the arcing that occurs during each pulse may slowly degrade and / or erode the surface of the electrodes in the electrode pair. In some cases, during procedures using conventional IVL catheters, the physician may be limited to 300 pulses. Pulse restriction may result in “pulse dosing,” in which a physician chooses to limit the number of pulses used for the first calcified lesion, regardless of their effectiveness for that lesion, in order to conserve pulses for subsequent calcified lesions. Physicians may perform pulse dosing to reduce the number of procedures the patient may undergo, reduce costs associated with changing IVL catheters during procedures, and / or as covered by the patient’s medical insurance.

[0155] The annular electrodes 521a and 522a, individually or in combination with one or more of the features described herein, can achieve cycle times far exceeding 300 pulses, thereby improving the durability and reliability of IVL catheters and similarly improving patient and physician outcomes. For example, the annular electrodes 521a and 522a can have a larger surface area than other electrode types, which can disperse erosion and / or pitting events along a larger surface. Additionally, compared to other electrode types, the annular electrodes 521a and 522a can uniformly distribute the electric field, thereby achieving, for example... Figure 1 The balloon 111 is coated with a type of drug designed to penetrate the cell membrane at the treatment site to improve electroporation.

[0156] Ring electrodes 521a, 522a may be electrically connected to the exposed conductors of wires 523, 524 to form electrode pair 520a. One or more ring electrodes 521a, 522a may be used in conjunction with other types of electrodes and / or electrode pairs (e.g., 120, 220, 320, 420, etc.) described herein to generate a spark along spark gap 525.

[0157] The ring electrodes 521a and 522a may comprise any and / or a combination of gold, platinum, platinum-iridium alloy, stainless steel, nickel-titanium alloy, copper alloy, tungsten, etc. In some examples, the ring electrodes 521a and 522a may be approximately 45% nickel and / or approximately 50% copper.

[0158] Figure 5E A cross-section 500E of the conductor 523 is shown, which includes an annular electrode 521a surrounding the conductor 523. Figure 5E This description refers to the lead wire 523 and / or the ring electrode 521a of electrode pair 520a; however, the description herein is interchangeable and / or equally applicable to the lead wire 524 and / or the ring electrode 522a of electrode pair 520a. Figure 5E As shown, wire 523 may include conductor 523a and insulator 523b. Conductor 523a may be any suitable conductive material, such as copper, silver, gold, platinum, alloys, etc. Insulator 523b may include any suitable insulator for IVL catheters, etc.

[0159] The annular electrode 521a may include the inner surface of the exposed portion 523c of the wire 523 electrically connected to it. For example, the annular electrode 521a may completely and / or partially surround, enclose, or encircle the wire 523, etc., to form a loop and / or a partial loop around the wire 523 and / or around the exposed portion 523c of the wire 523. The annular electrode 521a may be brazed, crimped, welded, or bonded to the exposed portion 523c of the wire 523. The annular electrode 521a may have a minimum thickness T1, which is measured radially from the central axis A3 and / or along the radial axis A4 of the wires 523, 524. The minimum thickness of the annular electrode 521a may be approximately 0.001 inches to 0.002 inches; however, the annular electrode 521a may have any thickness (e.g., 0.0001, 0.001, 0.01, 0.1 inches, etc.). The annular electrode 521a may have a minimum length L1 measured longitudinally along the central axis A3. In some examples, the minimum length L1 is 1 mm; however, this minimum length can be greater than and / or less than 1 mm (e.g., 0.01 mm, 0.1 mm, 0.98 mm, 1.2 mm, 2.0 mm, etc.). Additionally, the inner diameter ID and / or outer diameter OD of the annular electrode 521a can be measured radially from the central axis A3. In some examples, the inner diameter ID and / or outer diameter OD of the annular electrode 521a can be greater than, less than, the inner diameter and / or outer diameter of the wire 523 (e.g., conductor 523a and insulator 523b) and / or a portion of conductor 523a and / or insulator 523b, and / or fall between them.

[0160] Figure 5F An example embodiment of a variable-pitch helical wound coil 500F with insulated wires is shown. The coil 500F can be wound around a carrier 112, 512, etc., as part of an IVL catheter 501. Optionally and / or alternatively, the conductive wires 523, 524 can have varying pitches as they are wound along the carrier 512. For example, the pitch of the helically wound wires 523, 524 can be tightly wound 542 near the electrode pair 520 and / or loosely wound 541 at another location along the carrier 512, allowing a physician to determine the location of the electrode pair 520 using fluoroscopy, X-rays, etc. In some examples, the coil 500F located at and / or near the electrode pair 520 can be tightly wound 542, such that the wires 523, 524 are wound as... Figure 5FAs depicted, they are in contact with and / or close to each other. In some examples, the helical coil 500F may be loosely wound 541 (e.g., longitudinally spaced) at another location along the carrier 512. Thus, the tightly wound wires 542 can be identified by the physician during the procedure (e.g., via fluoroscopy, etc.) to indicate the approximate location of the intravascular electrode pair 520, spark gap 525, and / or electrodes 521, 522. Additionally and / or alternatively, the tightly wound wires 523, 524 may provide structural support at and / or near the electrode pair 520. In some cases, the tightly wound wires 542 may increase rigidity and ultimately increase the effectiveness of the acoustic electrodes from the IVL catheter 501. Additionally and / or optionally, markings (e.g., Figure 1 The marker 116 may be positioned at and / or near the electrode pair 520 to indicate the position of the electrode pair 520 to the physician during the procedure.

[0161] Figure 6 and / or Figure 7 An example embodiment of IVL catheter 601 and / or 701 is shown, having a conductive wire spirally wound around a carrier and / or one or more valves. Advantageously, the IVL catheter 601 and / or 701 with valves can be used by a physician to continuously flush conductive fluid through the IVL catheter 601 and / or 701 to maintain a prescribed pressure within the IVL catheter and / or remove heat generated by one or more electric arcs produced within the IVL catheter. Thus, the IVL catheter 601 and / or 701 can allow the physician to perform surgery without interruption due to deflation and / or inflation of the catheter 601 and / or 701 caused by excessive heat buildup in the artery.

[0162] Figure 6 An IVL catheter 601 including a balloon 611 is shown. The balloon 611 can be used with... Figure 1 The balloon 611 is the same as and / or similar to the balloon 611. The balloon 611 may be sealed at distal end 34 614 and / or proximal end 33 613. The IVL catheter 601 may include a carrier 612. The carrier 612 may be respectively with... Figure 1 And / or the carriers 112 and / or 312 of Figure 3 are similar to and / or identical to those in Figure 3. Furthermore, the IVL catheter 601 may include an electrode pair 620. The electrode pair 620 may be used with… Figure 3A The electrode pair 320 is the same as and / or similar to the electrode pair 620. The electrode pair 620 may, for example, be as follows: Figure 6 Positioned along the surface of the carrier 612 and / or below and / or between the valves 617 as depicted in the description.

[0163] Additionally and / or alternatively, IVL conduit 601 may include valve 617. Valve 617 may serve as an inlet and / or outlet for the conductive fluid. In some embodiments, valve 617 may be as follows: Figure 6 The IVL catheter 601 is positioned longitudinally along the carrier 612 as depicted. The IVL catheter 601 can be flushed with conductive fluid via valve 617 to maintain a predetermined pressure within the balloon 611. In some embodiments, the IVL catheter 601 can be configured to flush the balloon 611 with conductive fluid via valve 617 to dissipate heat within the IVL catheter 601 caused by one or more arcs, for example, generated across a spark gap. Furthermore, the IVL catheter 601 equipped with valve 617 can remove particles generated during electrical stimulation by flushing conductive fluid through the IVL catheter 601.

[0164] Figure 7 An IVL catheter 701 including a balloon 711 is shown. The balloon 711 can be used with... Figure 1 The balloon 711 is the same as and / or similar to the balloon 711. The balloon 711 may be sealed 714 at the distal end 34 and / or 713 at the proximal end 33. The IVL catheter 701 may include a carrier 712. The carrier 712 may be respectively connected to... Figure 1 And / or the carriers 112 and / or 312 of Figure 3 are similar to and / or identical to those in Figure 3. Furthermore, the IVL catheter 701 may include an electrode pair 720. The electrode pair 720 may be used with… Figure 3A The electrode pair 720 is the same as and / or similar to the electrode pair 320. The electrode pair 720 may, for example, be positioned along and / or below the surface of the carrier 712. Furthermore, the electrode pair 720 may be as follows: Figure 7 As depicted in the text, it spirals towards the proximal end 33.

[0165] Additionally and / or alternatively, the IVL conduit 701 may include a valve 717. The valve 717 may serve as an inlet and / or outlet for the conductive fluid. In some embodiments, the valve 717 may be as follows: Figure 7 As depicted, it is located outside the carrier 712. The IVL conduit 701 can be flushed with conductive fluid via valve 717 to maintain a predetermined pressure within the balloon 711. In some embodiments, the IVL conduit 701 can be configured to flush the balloon 711 with conductive fluid via valve 717 to dissipate heat within the IVL conduit 701 caused by one or more arcs, for example, generated across a spark gap. Furthermore, the IVL conduit 701 equipped with valve 717 can remove particles generated during electrical stimulation by flushing conductive fluid through the IVL conduit 701.

[0166] Figures 8A-8BAn example embodiment of a chronic total occlusion (CTO IVL) catheter 801 is shown, which can be used to treat partially and / or completely occluded segments of a blood vessel by selectively delivering acoustic waves to one or more areas including calcified lesions. For example, and as... Figure 8A As shown, catheter 801 can treat the occluded segment using an extension 802 located at the distal end 34 of catheter 801. The extension 802 can effectively treat the occluded segment by selectively emitting acoustic waves at the distal end of catheter 801. The acoustic waves can break up the calcified lesion into smaller fragments, thereby opening the blood vessel. Ultimately, the blood vessel can be opened sufficiently to allow catheter 801 to pass through the occluded segment. Therefore, since a single catheter can be used to modify and / or pass through partially and / or completely occluded segments, catheter 801 can significantly reduce procedure time and / or increase the range of locations accessible to catheter 801.

[0167] like Figure 8B As shown, the extension 802 portion of catheter 801 may include a carrier 812. The carrier 812 may be similar to and / or identical to carrier 112. The carrier 812 may have a hollow and / or solid core. In some examples, the carrier 812 may terminate at a distal end 34 via a seal 814. The seal 814 may be configured to retain saline within balloon 811. The shape of balloon 811 may vary from proximal to distal end 34. For example, balloon 811a may taper from a distal end with a seal 814 having a first diameter d1 to a proximal end having a second diameter d2. In some examples, the first diameter d1 may be about 0.5 mm. In some examples, the first diameter d1 may be greater than and / or less than 0.5 mm (e.g., 0.01, 0.1, 1, 2, 3, etc.). In some examples, the second diameter d2 may be about 1 mm. In some examples, the second diameter d2 may be greater than and / or less than 1 mm (e.g., 0.01, 0.1, 1, 2, 3, etc.). The balloon 811b may have a continuous diameter from distal to proximal. In some examples, the diameter of the balloon 811b may be the same as and / or similar to the diameter d2 described above. The balloon 811c may taper from a distal end having a second diameter d2 to a proximal end having a third diameter d3. In some examples, the second diameter d2 may be about 1 mm. In some examples, the second diameter d2 may be greater than and / or less than 1 mm (e.g., 0.01, 0.1, 1, 2, 3, etc.).

[0168] In some examples, the third diameter d3 can be approximately 2 mm. In some examples, the third diameter d3 can be greater than and / or less than 2 mm (e.g., 0.01, 0.1, 1, 2, 3, 4, 5, etc.). The balloon 811d can have a continuous diameter from distal to proximal. In some examples, the diameter of the balloon 811d can be the same as and / or similar to the diameter d3 as described above. In some examples, balloons 811a, 811b, 811c, and / or 811d can be in fluid communication with each other (e.g., a single balloon 811) and / or are separate balloons 811a, 811b, 811c, and / or 811d.

[0169] Advantageously, during treatment, the seal 814 can contact partially and / or completely occluded segments to alter calcified lesions. The carrier 812 can also support one or more electrode pairs 820 located near the distal end 34 of the extension 802. Electrode pairs 820 can be identical and / or similar to any electrode pairs described herein, such as electrode pairs 120, 220, 320, 420, 520, 520a, etc. Electrode pairs 820 can be configured to emit acoustic waves axially toward the distal end 34 of the catheter 801, radially, and / or in other directions to cause the seal 814 and / or balloon 811 to break up plaques based on the spark gap 825. Additionally and / or alternatively, one or more electrode pairs 820 may be present as follows: Figure 8A As shown and / or as Figure 1 As shown in 2 and / or 5, it is distributed along the carrier 812 toward the proximal end 33.

[0170] In some examples, electrode pair 820 can be connected to, for example... Figure 1 Energy generators 150 and / or 250 are described in section -2 respectively. Advantageously, a catheter 801 electrically connected to energy generators 150 and / or 250 allows a physician to selectively generate an electric arc in electrode pair 820 at distal end 34, thereby generating acoustic waves that can target plaques at specific locations while avoiding the emission of acoustic waves at one or more other locations within the blood vessel.

[0171] Figures 9A-9C An example implementation of the dual-balloon IVL catheter 901 is shown. Figure 9A As shown, catheter 901 may include a first balloon 911_1. The first balloon 911_1 may be sealed to a first carrier 915 via a seal 914. The first carrier 915 may be, for example, as shown in reference 1, 2, 3, 4, 5, 6, 7, 8, 9, 9, 1 ... Figure 1 The solid core carrier described in carriers 112 and / or 312 in section 3. In some embodiments, the first carrier 915 may be a conduit (e.g., hollow core) for one or more conductive wires, a solid and / or a cavity supporting the exchange of conductive fluids. The conductive wires (e.g., wires) may be, for example, inside the first carrier 915 and / or on the surface of the first carrier 915, such as... Figures 9B-9C As depicted herein. A first carrier 915 may be used to support one or more electrode pairs 920. Each electrode pair 920 may have a spark gap 925. Electrode pairs 920 may be identical and / or similar to one or more configurations of electrode pairs 120, 220, 320, 420, etc., as described herein. The catheter 901 may also include a second balloon 911_2. The second balloon 911_2 may be adjacent to the first balloon 911_1. The second balloon 911_2 may include a second carrier 912 passing through it. The second carrier 912 may be similar to those described herein, respectively in... Figure 1 The carriers 112 and / or 312 in 3 are the same as and / or similar to those in 3. In some embodiments, balloons 911_1 and / or 911_2 are two separate balloons. In some embodiments, balloons 911_1 and / or 911_2 share a common wall between the two balloons (e.g., a balloon with two separate chambers). In some examples, the first balloon 911_1 and / or the second balloon 911_2 may be in fluid communication with each other. In some examples, the first balloon 911_1 and / or the second balloon 911_2 may not be in fluid communication with each other. Balloons 911_1 and / or 911_2 may be filled with saline and / or other fluids. In some examples, catheter 901 may include a marker 916. In some examples, a physician may use marker 916 under fluoroscopic guidance to ensure that the first balloon 911_1 is positioned facing the plaque. Advantageously, the implementation of the dual-balloon IVL catheter 901 can be utilized together with one or more features described herein to directionally control and / or amplify one or more acoustic waves generated by the electrode pair 920.

[0172] Figure 9B The cross-section 900B of the conduit 901 is depicted, while Figure 9C A cross-section of a blood vessel 900C through which a catheter 901 is inserted is depicted. (See image.) Figure 9B As shown in 9C, the first carrier 915 may include wires 923 and / or 924. Wires 923 and / or 924 may be connected to... Figure 1 , 2AThe leads 123, 124, 223, and / or 224 of 2B are identical and / or similar. Leads 923 and / or 924 are depicted inside the first carrier 915 and / or on the surface of the first carrier 915; however, leads 923 and / or 924 may be located in other locations. In some embodiments, all leads 923 and / or 924 are located within the first carrier 915, while in some embodiments, one or more leads 923 and / or 924 are located on the surface of the first carrier 915. The catheter 901 can be used by a physician to effectively alter asymmetric plaque 971 in the vessel wall 970. For example, the first balloon 911_1 may include one or more electrode pairs 920 configured to generate acoustic waves, while the second balloon 911_2 is configured to reflect the acoustic waves generated by the electrode pairs 920 back toward the plaque 971. The physician may position the catheter 901 such that the balloon 911_1 is closest to the asymmetric plaque 971. Once catheter 901 is in place, the acoustic waves generated by electrode pair 920 can be directionally targeted at asymmetric plaque 971. Because the second balloon 911_2 reflects the acoustic waves generated by electrode pair 920, plaque 971 receives initial energy from the acoustic waves and / or reflected energy from balloon 911_2. Therefore, the design of the dual-balloon IVL catheter 901 allows for effective treatment of calcified lesions by directionally controlling the acoustic waves emitted from electrode pair 920. Furthermore, the dual-balloon IVL catheter 901 reduces the risk of damage to areas of vessel wall 970, as the second balloon 911_2 acts as a barrier, blocking energy emitted from the other side of vessel wall 970.

[0173] Figure 10-11 Example embodiments of balloon-free IVL catheters 1001 and / or 1101 are shown respectively. Catheters 1001 and / or 1101 can effectively and / or efficiently open partially and / or completely occluded blood vessels by concentrating energy at the distal end of catheters 1001 and / or 1101, thereby restoring blood flow while reducing complications.

[0174] like Figure 10 As depicted herein, catheter 1001 may include a membrane 1011, a shaft 1015, and / or a distal membrane 1016. Catheter 1001 may also include a carrier 1012 having electrode pairs 1020 and / or a cavity 1050. Electrode pairs 1020 may be the same as and / or similar to electrode pairs 120, 220, 320, 420, etc., described herein. One or more electrode pairs 1020 may be located at the distal end 34 of catheter 1001 such that acoustic waves are concentrated at said distal end 34. The cavity 1050 between membrane 1011 and / or carrier 1012 may be filled with, for example, saline and / or other solutions such as contrast agents. In some examples, membrane 1011 may be flexible enough to navigate through one or more blood vessels, including through partially occluded lesions.

[0175] In some examples, the film 1011 may have a recessed portion. In some examples, the recessed portion of the film 1011 may have a width w1 of approximately 1 mm. In some examples, the width w1 may be greater than and / or less than 1 mm (e.g., 0.01, 0.1, 2, 5, 10, etc.). In some examples, the recessed portion of the film 1011 may have a height h1 of approximately 0.5 mm. In some examples, the height h1 of the film 1011 may be greater than and / or less than 0.5 mm (e.g., 0.001, 0.01, 0.1, 1, 1.5, 3, etc.).

[0176] In some embodiments, shaft 1015 and / or distal membrane 1016 can be used to modify calcified lesions that other types of catheters may find difficult to traverse. For example, electrode pair 1020 can focus acoustic waves at the distal end 34 of catheter 1001, where the acoustic waves travel through a saline solution in cavity 1050 to shaft 1015, and / or then to distal membrane 1016. Thus, shaft 1015 and / or distal membrane 1016 can utilize the energy from the acoustic waves as... Figure 10 The mechanical force "F" described herein is transmitted to alter the calcified lesion, allowing a larger-profile balloon to pass through it. In some examples, the membrane 1011 and / or the distal membrane 1016 may be made of a material less rigid than the shaft 1015 and / or the carrier 1012. In some examples, the membrane 1011 and / or the distal membrane 1016 may be made of a material as rigid as and / or more rigid than the shaft 1015 and / or the carrier 1012. In some examples, the shaft 1015 and / or the carrier 1012 may be the same component, while in other examples, the shaft 1015 is separate from the carrier 1012.

[0177] like Figure 11 As depicted herein, catheter 1101 may include a membrane 1111, a shaft 1115, and / or a distal membrane 1116. Catheter 1101 may also include a carrier 1112 having electrode pairs 1120 and / or a cavity 1150. Electrode pairs 1120 may be the same as and / or similar to electrode pairs 120, 220, 320, 420, etc., described herein. One or more electrode pairs 1120 may be located at the distal end 34 of catheter 1101, such that sound waves are concentrated at said distal end 34. The cavity 1150 located between membrane 1111 and carrier 1112 may be filled with, for example, saline and / or other solutions such as contrast agents. Membrane 1111 and / or carrier 1112 may be... Figure 10 The thin film 1011 and / or the carrier 1012 are similar to and / or identical.

[0178] Shaft 1115 can extend toward the distal end 34 of conduit 1101. (And) Figure 10Unlike shaft 1015, shaft 1115 can have a constant diameter and / or a varying diameter, thereby providing a cavity 1150 extending to the distal membrane 1116. Advantageously, extending the cavity 1150 to the distal end 34 of the catheter 1101 can, in some cases, provide support for... Figure 11 The optimized directional control of the mechanical force "F" used to alter the calcified lesion, as depicted in the diagram, allows a larger-profile balloon to pass through the calcified lesion. In some embodiments, extending the cavity 1150 to the distal end 34 of catheter 1101 can provide improved flexibility compared to, for example, catheter 1001. For example, catheter 1001 can provide energy primarily in the axial direction at the distal end 34, while catheter 1101 can provide concentrated energy in the axial and / or radial directions at the distal end 34. In some examples, the membrane 1111 and / or the distal membrane 1116 can be made of a material less rigid than the shaft 1115 and / or the carrier 1112. In some examples, the membrane 1111 and / or the distal membrane 1116 can be made of a material as rigid as and / or more rigid than the shaft 1115 and / or the carrier 1112. In some examples, the shaft 1115 and / or the carrier 1112 can be the same component, while in other examples, the shaft 1115 is separate from the carrier 1112.

[0179] In some examples, the film 1111 may have a recessed portion. In some examples, the recessed portion of the film 1111 may have a width w1 of approximately 1 mm. In some examples, the width w1 may be greater than and / or less than 1 mm (e.g., 0.01, 0.1, 2, 5, 10, etc.). In some examples, the recessed portion of the film 1111 may have a height h1 of approximately 0.5 mm. In some examples, the height h1 of the film 1111 may be greater than and / or less than 0.5 mm (e.g., 0.001, 0.01, 0.1, 1, 1.5, 3, etc.).

[0180] Figures 12A-12C An example embodiment of an eccentric IVL catheter 1201 is shown. Advantageously, the eccentric IVL catheter 1201 can be easily navigated to a location within the artery to effectively target symmetrical and / or asymmetrical plaques without interrupting blood flow through the artery. Figure 12A This is an example perspective view of an eccentric IVL catheter 1201, while Figure 12B This is an example side view 1201B of an eccentric IVL catheter 1201. (See example...) Figure 12A-12BAs shown, catheter 1201 may include balloon 1211 having a second carrier 1215 extending within balloon 1211. The second carrier 1215 may have a solid core and / or a hollow core. The second carrier 1215 may include one or more electrode pairs 1220. Electrode pairs 1220 may be the same as and / or similar to electrode pairs 120, 220, 320, 420, etc., described herein. The second carrier 1215 may include wires 1223 and / or 1224. Wires 1223 and / or 1224 may be connected to… Figure 1 , 2A The wires 123, 124, 223, and / or 224 of 2B are identical and / or similar. Wires 1223 and / or 1224 are depicted inside the second carrier 1215 and / or on the surface of the second carrier 1215; however, wires 1223 and / or 1224 may be located at other locations. In some embodiments, all wires 1223 and / or 1224 are located within the second carrier 1215, while in some embodiments, one or more wires 1223 and / or 1224 are located on the surface of the second carrier 1215. The conduit 1201 may also include a carrier 1212. The carrier 1212 may have a hollow core and / or a solid core. In some examples, see reference... Figure 1 According to the carrier 112, the carrier 1212 and / or the second carrier 1215 may have a lumen therethrough (e.g., for support). Figure 1 (e.g., guidewire 118). In some examples, such as reference... Figure 1 As indicated by the mark 116, the carrier 1212 and / or the second carrier 1215 may include the mark 1216.

[0181] like Figure 12C As depicted in cross-sectional view 1200C, the IVL catheter 1201 may have a carrier 1212 positioned outside and / or adjacent to the balloon 1211. In some examples, the carrier 1212 may be fixed to the outer surface of the balloon 1211 via an adhesive. In some examples, the carrier 1212 may be attached to the proximal 33 and / or distal 34 of the balloon 1211. Furthermore, the balloon 1211 may be molded as follows: Figure 12C The shape depicted herein and / or molded as needed to alter one or more lesions. In some examples, the balloon 1211 may be shaped via a heat-setting technique.

[0182] In some examples, catheter 1201 can be positioned such that balloon 1211 is adjacent to a plaque (e.g., an asymmetric plaque), while carrier 1212 is positioned on the opposite side of said plaque. Similar to reference... Figure 9AOne or more of the functions described in the dual-balloon IVL catheter 901 can position the catheter 1201 such that acoustic waves emitted from the electrode pair 1220 are transmitted to the asymmetric plaque, while energy emitted toward the carrier 1212 is reflected back to the asymmetric plaque.

[0183] Figures 13A-13B An example implementation of a dual-occlusion balloon IVL catheter 1301 is shown. The catheter 1301 can have a relatively small profile, allowing physicians to navigate it into smaller vessels to reach one or more calcified lesions that are inaccessible by other catheter designs. Figure 13A As depicted, catheter 1301 may include a carrier 1312, a distal balloon 1311_1, a proximal balloon 1311_2, an electrode pair 1320, and / or a marker 1316. Furthermore, balloon 1311_1 may include a distal seal 1314_1 and / or a proximal seal 1313_1, and / or balloon 1311_2 may include a distal seal 1314_2 and / or a proximal seal 1313_2. Marker 1316 may be associated with... Figure 1 The marking 116 described herein is the same as and / or similar to that described herein. Electrode pairs 1320 may be the same as and / or similar to electrode pairs 120, 220, 320, 420, etc., described herein. Furthermore, catheter 1301 may include multiple sets of electrode pairs 1320 described herein.

[0184] Balloons 1311_1 and / or 1311_2 can be used with, for example, reference Figure 1 The balloon 111 described is identical and / or similar; however, the electrode pair 1320 may not be located inside balloons 1311_1 and / or 1311_2. Instead, the electrode pair 1320 may be positioned on the carrier 1312 between balloons 1311_1 and / or 1311_2. In some examples, the electrode pair 1320 may be longitudinally spaced between balloons 1311_1 and / or 1311_2. Advantageously, positioning the electrode pair 1320 outside balloons 1311_1 and / or 1311_2 can reduce the overall profile of catheter 1301. Furthermore, during treatment, balloons 1311_1 and / or 1311_2 may be filled with saline, resulting in temporary occlusion of the vessel. Blood within the vessel may be trapped between balloons 1311_1 and / or 1311_2. When the electrode pair 1320 generates sound waves within the blood vessel, acoustic energy is transmitted from the region adjacent to the electrode pair 1320 to the trapped blood and / or to the calcified lesion. Therefore, the trapped blood acts as a channel for delivering energy to the calcified lesion, similar to and / or identical to, for example, as described herein. Figure 1 The saline solution inside the balloon 111.

[0185] Figure 13BA catheter 1301 in an example vessel 1300B is depicted. The example vessel 1300B may have a wall 1370. The example vessel 1300B may include plaque 1371 within the wall 1370 and / or blood 1372 between the walls 1370. The catheter 1301 may be positioned such that plaque 1371 is located between a distal balloon 1311_1 and / or a proximal balloon 1311_2. See reference... Figure 13A As described, balloons 1311_1 and / or 1311_2 can occlude the wall 1370 of vessel 1300B near plaque 1371, allowing blood 1372 to transmit energy to plaque 1371 via acoustic waves when the electrode pair 1320 generates acoustic waves. Advantageously, catheter 1301 can have a relatively small profile, enabling physicians to navigate catheter 1301 into smaller vessels to reach one or more calcified lesions that are inaccessible by other catheter designs.

[0186] Figures 14A-14B An indicator 117 is depicted for determining changes in the state of the IVL catheter 1401 during the procedure. Figure 14A The wall 1470 and patch 1471 prior to the emission of sound pressure waves from IVL conduit 1401 are depicted, while Figure 14B The image depicts the wall 1470 and altered patch 1472 after the emission of a sound pressure wave from the IVL conduit 1401. As described above, the indicator 117 may be a check valve, pressure sensor, flow indicator, temperature sensor, and / or other sensor. The indicator 117 may be coupled to one or more locations of the IVL conduit 1401, be part of it, be placed along the IVL conduit 1401, and / or be integrated into one or more locations of the IVL conduit 1401. Figures 14A-14B As depicted, indicator 117 can be connected to inflation lumen 1419. (See reference...) Figure 1 As described, the inflatable lumen 1419 can be used to fill the balloon of catheter 1401 with a solution. An indicator signal 117a can be connected (e.g., electrically, optically, pneumatically, hydraulically, etc.) between the indicator 117 and a controller (e.g., controller 251, etc.). Controller 251 can receive signal 117a from indicator 117 and determine changes in the state of IVL catheter 1401.

[0187] like Figure 14A As depicted, the first volume V1 of the IVL catheter 1401 can be small because the calcified plaque 1471 within the wall 1470 of the vessel can be rigid, thus limiting, reducing, and / or defining the maximum volume of the catheter 1401 (e.g., the shape of the balloon of the catheter 1401). Figure 14AExample embodiments are also included, such as a one-way valve used as indicator 117, although this is not intended to be limiting. Other embodiments of indicator 117 (e.g., flow meter, temperature sensor, motion sensor, etc.) may be replaced and / or utilized by IVL conduit 1401. Figures 14A-14B As shown in the example, indicator 117 includes a ball and an electromagnetic coil electrically connected to signal 117a. During the intravascular lithotripsy procedure, catheter 1401 is positioned near calcified plaque 1471 and pressurized with conductive fluid (e.g., pressurized to approximately 4 atmospheres) via inflatable lumen 1419. When catheter 1401 and inflatable lumen 1419 reach stable pressure, one or more components of indicator 117 can stabilize to a first state. Figure 14A As depicted in the example implementation, the stop can be located at a first position P1 within the check valve based on the pressure within the conduit 1401.

[0188] Figure 14B An example of a successful endovascular lithotripsy procedure is illustrated. During the effective procedure, acoustic pressure waves are emitted from catheter 1401, causing the calcified plaque 1472 within the vessel wall 1470 to break up, fracture, and / or alter. When plaque 1472 is successfully altered, the vessel wall 1470 and the resulting expansion of catheter 1401 (e.g., the balloon of catheter 1401) expand in volume. As a result, catheter 1401 increases from a first volume V1 to a second volume V2, resulting in a decrease in pressure within catheter 1401. Indicator 117 can be used to sense the pressure decrease within catheter 1401 and transmit signal 117a to a controller (e.g., controller 251) to determine that the procedure has successfully altered the calcified plaque 1471 at the location along the vessel. Specifically... Figure 14B In an example implementation, the stop moves from a first position P1 to a second position P2 based on pressure changes in the conduit 1401.

[0189] Despite Figures 14A-14B A one-way valve is shown, but indicator 117 may include any type of sensor for indicating changes in the state of IVL catheter 1401. For example, indicator 117 may include a pressure sensor, flow sensor, temperature sensor, motion sensor, etc. Additionally and / or alternatively, a controller (e.g., controller 251) may determine whether balloon 111 has ruptured based on input from indicator 117.

[0190] Figure 15 An example implementation (such as) is shown. Figure 2A-2BThe illustrated cardiac synchronization system 200A and / or 200B presents an example workflow 1500 for synchronizing energy emitted from an IVL catheter according to a determined heart rhythm. As an example, the controller 251 of the cardiac synchronization system 200A and / or 200B can be configured to perform the example workflow 1500 of the cardiac synchronization routine. In one example implementation, the example workflow 1500 can be performed after the IVL catheter 201A has been inserted into the patient. Although referenced... Figure 2A The cardiac synchronization system 200A describes an example workflow 1500, but the example workflow 1500 can utilize... Figure 2B The example workflow 1500 can be implemented using a cardiac synchronization system 200B, etc. Alternatively, the example workflow 1500 can be implemented using any type of IVL catheter as described herein (e.g., catheters 101, 201A / B, 501, 601, 701, 801, 901, 1001, 1101, 1201, 1301, etc.). Furthermore, the IVL catheters disclosed herein and / or used to perform workflow 1500 can be configured with one or more electrode configurations, such as electrode pairs 120, 220, 320, 420, 520, 520a, 620, 720, 820, 920, 1020, 1120, 1220, 1320, etc.

[0191] In some procedures, the IVL catheter 201A can be positioned adjacent to the heart and / or other electrically sensitive organs of the patient 270. Advantageously, timing the electric arc in the IVL catheter 201A according to the patient 270's heart rhythm can mitigate certain health risks. Example workflow 1500 begins at block 1502.

[0192] At block 1502, controller 251 can receive indications of the heart rhythm of patient 270. The heart rhythm can be, for example... Figure 2A-2BThe rhythm unit 260 determines the rhythm of the patient 270. The rhythm unit 260 can transmit (e.g., wirelessly and / or wired) information associated with the patient 270's heart rhythm to, for example, an energy generator 250. Furthermore, the rhythm unit 260 can transmit discrete signals based on one or more trigger events associated with the patient 270's heart rhythm to the energy generator 250. As mentioned above, the rhythm unit 260 can be any device designed to monitor and / or determine one or more characteristics of the patient 270's heart rhythm, including but not limited to: heart rate, P wave (electrical activity associated with the upper chambers of the heart), QRS complex (lower chambers of the heart), PR interval (the time between the start of the P wave and / or the start of the QRS complex), QT interval (the time between the start of the QRS complex and the end of the T wave), T wave (ventricular repolarization), etc. In some examples, the rhythm unit 260 can be an AccuSync® 72 ECG trigger monitor. In some examples, the rhythm unit 260 can detect the R-wave signal and / or, in response, send discrete signals based on one or more triggering events associated with the R-wave signal.

[0193] At block 1504, controller 251 can determine cardiac synchronization periods based on received instructions. Controller 251 can determine one or more periods for enabling and / or disabling electrical power to IVL catheter 201A. Controller 251 can analyze one or more characteristics of the heart rhythm received from rhythm unit 260 (e.g., heart rate, P wave, QRS complex, PR interval, QT interval, T wave, etc.). Furthermore, controller 251 can determine, based on the received heart rhythm, whether to transmit electrical power to electrode pairs 220 located distally and / or proximally at IVL catheter 201A while blocking the transmission of electrical power to other electrode pairs 220. For example, controller 251 can instruct multiplexer 255 to transmit electrical power to electrode pair 220_1, while further instructing the multiplexer to block the transmission of electrical power to electrode pair 220_2. In some examples, controller 251 can instruct multiplexer 255 to select one or more channels to increase the concentration of acoustic waves at a specific location within the vessel.

[0194] At block 1506, controller 251 can receive user input requesting the generation of sound waves. User input can be received from, for example, a physician requesting the generation of sound waves in an IVL catheter during an intravascular lithotripsy procedure. Additionally and / or alternatively, controller 251 can receive user input from another system.

[0195] At block 1508, controller 251 determines whether the user input was received during one or more cardiac synchronization periods. If controller 251 determines that the user input was received during a cardiac synchronization period, workflow 1500 can continue to block 1510, where controller 251 can cancel the request (e.g., not generate sound waves). If controller 251 determines that the user input was received outside of one of the cardiac synchronization periods, workflow 1500 can continue to block 1512.

[0196] At block 1510, controller 251 can cancel a request to generate sound waves. In some examples, if controller 251 determines, based on the heart rhythm received from rhythm unit 260, that energy generator 250, arc generator 254, and / or multiplexer 255 should be disabled, controller 251 can ignore a request from a user (e.g., a physician) to generate sound waves in IVL catheter 201A. Additionally and / or alternatively, controller 251 can determine, based on the patient's heart rhythm, whether to selectively deliver electrical energy to one or more electrode pairs 220 during cardiac synchronization periods (e.g., while blocking the delivery of electrical energy to electrode pair 220_2, deliver electrical energy to electrode pair 220_1 located at, for example, the distal and / or proximal end of IVL catheter 201A). In some examples, controller 251 can instruct multiplexer 255 to deliver electrical energy to electrode pair 220_1, while further instructing multiplexer to block the delivery of electrical energy to electrode pair 220_2. In some examples, controller 251 may instruct multiplexer 255 to select one or more channels to increase the concentration of sound waves at a specific location within the blood vessel. Example workflow 1500 may terminate after controller 251 cancels the request to generate sound waves. In some examples, example workflow 1500 may continue to block 1502, where controller 251 may receive another indication of heart rhythm.

[0197] At block 1512, controller 251 can emit acoustic waves via electrode pairs 220. As described herein, the acoustic waves can be selectively emitted from one or more electrode pairs 220 via energy generator 250, arc generator 254, and / or multiplexer 255. Furthermore, controller 251 can instruct arc generator 254 to generate acoustic waves based on an arc pattern having one or more characteristics as described herein (e.g., single-phase pulse, bi-phase pulse, frequency, pulse width, amplitude, phase, pulse shape, etc.). Once controller 251 generates acoustic waves according to the user input, workflow 1500 can continue to block 1502, where controller 251 can receive another indication of heart rhythm.

[0198] Figure 16AA portion of an example IVL catheter 1601 is shown, comprising a sheath 1618, a carrier 1612, and one or more insulated wires 1623. The IVL catheter 1601 may include a balloon having structural and / or operational features similar to any other example balloons shown and / or described herein. The sheath 1618 includes a lumen configured to receive a guidewire. The longitudinal axis 16LA1 of the IVL catheter 1602 passes through the center of the lumen of the sheath 1618. The IVL catheter 1601 can pass over the guidewire to navigate through the patient's vascular system, thereby being delivered to and retracted from a treatment site where the IVL catheter 1601 can deliver acoustic waves to treat calcified deposits. The outer surface 1613 of the carrier 1612 is exposed to a solution (e.g., physiological saline within the balloon) in which the carrier 1612 is located. The sheath 1618 and / or the carrier 1612 may be formed of a flexible material (e.g., plastic or polymer). Therefore, the IVL catheter 1601 can bend as it travels through a patient's blood vessel without causing the sheath 1618 and / or carrier 1612 to crack, break, crease, or otherwise permanently deform. The carrier 1612 may be formed of a different material than the sheath 1618 and / or may be manufactured at a different time than the sheath 1618. In some embodiments, the carrier 1612 may be placed on top of the sheath 1618 (and the insulating wire 1623) in liquid form and may be cured in situ on the sheath 1618, thereby adhering to the sheath 1618 and / or the insulating wire 1623. In some embodiments, the sheath 1618 and the carrier 1612 may be formed of a single, monolithic material. In some embodiments, the IVL catheter 1601 may not include the carrier, such that the insulating wire 1623 is exposed to a solution surrounding the wire insulation 1623 and / or the sheath 1618. In some embodiments, the insulating wire 1623 may be wound around the outer surface 1613 of the carrier 1612. The carrier 1612 can be formed of an electrically insulating material.

[0199] In this example, the IVL conduit 1601 has six insulated wires 1623 (e.g., wires 1623A-1623F). The insulated wires 1623 are wound around the sheath 1618 and extend along the length of the sheath 1618, such that the insulated wires are wound around the sheath 1618 at a certain pitch. The insulated wires 1623 may be helically wound around the sheath 1618. The shape of the cross-sectional profile of the helix formed by the wound wires 1623 may depend on the cross-sectional shape of the sheath 1618. For example, as shown here, since the cross-sectional shape of the sheath 1618 is circular, the insulated wires 1623 are helically wound into a circular helix. In some embodiments, depending on the cross-sectional shape of the sheath 1618, the insulated wires 1623 may be helically wound around the sheath 1618 in the form of a polygonal helix (e.g., an octagonal helix, a nonagonal helix, a decagonal helix, etc.). In this example, the insulated wires 1623 form a six-fold helix around the sheath 1618. Advantageously, compared to the case where the insulated wire 1623 extends longitudinally along the sheath 1618 parallel to it rather than being wound around it, the insulated wire 1623, when wound around the sheath 1618, can provide more structural support to the IVL catheter 1601, specifically to the sheath 1618. The structural support provided by the wound wire 1623 can prevent the IVL catheter 1601 (e.g., the sheath 1618) from cracking, wrinkling, etc., when it bends in the patient's blood vessels.

[0200] In this example, at least along the portion of the sheath 1618 shown, the insulated wire 1623 is wound around the sheath 1618 with a uniform pitch. In some embodiments, the insulated wire 1623 is wound around the sheath 1618 with a pitch that varies along the length of the sheath 1618, for example... Figure 5F As shown and / or described, this facilitates visualization of the IVL catheter using imaging techniques such as fluoroscopy.

[0201] In this example, at least along the portion of the sheath 1618 shown, each of the insulated wires 1623 is wound around the sheath 1618 with the same pitch as every other wire 1623. Therefore, each insulated wire 1623 has the same pitch (whether varying or uniform) along the length of the sheath 1618. In some embodiments, at least one insulated wire 1623 may have a different pitch than at least one other insulated wire 1623. In some embodiments, each insulated wire 1623 may be wound with a unique pitch.

[0202] In this example, insulated wires 1623 are positioned adjacent to each other. For example, insulated wire 1623B is located between insulated wires 1623A and 1623C, while insulated wire 1623D is located between insulated wires 1623C and 1623E, and so on. Each insulated wire 1623 is in contact with its adjacent wire. Adjacent wires may be in contact with each other along their entire length, or at least along the length of the sheath 1618 on which they extend. For example, insulated wire 1623A extends along insulated wire 1623B such that insulated wires 1623A and 1623B are in contact with each other along the entire length of the sheath 1618 on which they extend. In some embodiments, one or more insulated wires 1623 may not be in contact with another one or more insulated wires 1623. For example, insulated wire 1623B may be spaced apart from insulated wires 1623A and / or insulated wire 1623C. Advantageously, by positioning the insulated wires 1623 adjacent to and in contact with each other as shown herein, it is convenient to control the spark gap distance between the electrode pairs of the transmitter. For example, since the insulated wires 1623B-1623C are located between electrodes 1620C1 and 1620C2, and there is no gap between the insulated wires 1623A-1623D, electrode 1620C2 may not be able to approach electrode 1620C1. Similarly, the insulated wires 1623E-1623F can inhibit the movement of electrode 1620C2 away from electrode 1620C1. Therefore, the insulated wires 1623 can maintain a constant distance between electrodes 1620C1 and 1620C2 by inhibiting movement between them. Maintaining an appropriate distance between the electrodes facilitates the generation of a spark when it is desired, or the suppression of a spark when it is not desired.

[0203] In the illustrated portion of IVL conduit 1601, the insulating wires 1623 are parallel to each other, such that, at least in the illustrated portion, no insulating wire 1623 crosses each other. In some embodiments, one or more insulating wires 1623 may not be parallel to one or more other insulating wires 1623. For example, one or more insulating wires 1623 may cross each other (e.g., overlap).

[0204] IVL catheter 1601 includes electrodes 1620C1, 1620C2, 1620D1, and 1620D2. Electrodes 1620C1 and 1620C2 form emitter 1620C and may be referred to as an electrode pair. Electrodes 1620D1 and 1620D2 form emitter 1620D and may also be referred to as an electrode pair. Figure 16BAs shown and / or described in more detail herein, electrodes may include exposed portions of insulated wire conductive members (e.g., exposed portions of conductive elements). Therefore, references to electrodes may refer in whole or in part to at least the exposed portions of conductive members. In some cases, “electrode” and “exposed portion” may be used interchangeably. Electrodes 1620C1 and 1620D1 are positioned on insulated wire 1623A. Electrode 1620C2 is positioned on insulated wire 1623D. Electrode 1620D2 is positioned on insulated wire 1623E.

[0205] Transmitter 1620C is separated from transmitter 1620D by a distance of Zeg. Specifically, electrode 1620C2 is separated from electrode 1620D1 by a distance of Zeg. Zeg is a straight line parallel to the longitudinal axis 16LA1 of IVL catheter 1601.

[0206] In response to a voltage difference exceeding a threshold between electrodes 1620C1 and 1620C2, a spark can be generated at transmitter 1620C between electrodes 1620C1 and 1620C2. The threshold may correspond to the distance between electrodes 1620C1 and 1620C2. Similarly, in response to a voltage difference exceeding a threshold between electrodes 1620D1 and 1620D2, a spark can be generated at transmitter 1620D between electrodes 1620D1 and 1620D2. This threshold may be the same as the threshold at transmitter 1620C, at least because the distance between electrodes 1620D1 and 1620D2 is the same as the distance between electrodes 1620C1 and 1620C2. Sparks may not form between emitters 1620C and 1620D (e.g., between electrodes 1620C2 and 1620D1), at least because the distance (Zeg distance) between electrodes 1620C2 and 1620D1 may be too large for the voltage difference between the electrodes to overcome a threshold. Since the energy generator connected to IVL conduit 1601 can have a predefined energy output, the voltage difference can have a predefined maximum value.

[0207] IVL catheter 1601 can be compared to Figure 16AThe illustrated version is longer and includes more transmitters. For example, the insulated wire 1623 may span a length of IVL conduit 1601, which is between 20 mm and 250 mm, between 40 mm and 250 mm, between 60 mm and 250 mm, between 80 mm and 250 mm, between 100 mm and 250 mm, between 150 mm and 250 mm, between 200 mm and 250 mm, between 20 mm and 100 mm, between 40 mm and 100 mm, between 60 mm and 100 mm, between 80 mm and 150 mm, between 100 mm and 200 mm, between 150 mm and 200 mm, between 170 mm and 220 mm, between 180 mm and 210 mm, or a length between the aforementioned lengths.

[0208] Figure 16B This is an enlarged view of a portion of IVL conduit 1601. Insulated conductor 1623A includes an insulating member 1624A and a conductive member 1626A. The insulating member 1624A encloses and electrically insulates the conductive member 1626A. The conductive member 1626A extends along the length of the insulated conductor 1623A within the insulating member 1624A and is connected to an energy generator. The conductive member 1626A can conduct current and can maintain voltage relative to other objects, such as other insulated conductors. The conductive member 1626A can be formed of a metal or metal alloy (e.g., copper). The insulating member 1624A can be formed of plastic or polymer. Insulated conductor 1623C includes an insulating member 1624C and a conductive member 1626C, having similar structural and operational features as described with respect to insulated conductor 1623A. Each of the other insulated conductors 1623B and 1623D-1623F may also include insulating and conductive members having similar structural and operational features as described. The insulated conductor 1623 can be any gauge, for example, between 30 AWG and 40 AWG (including end values). In some embodiments, all insulated conductors 1623 can be of the same gauge. In some embodiments, one or more insulated conductors 1623 can have different gauges than the other insulated conductors.

[0209] The carrier 1612 may include one or more carrier openings 1607, such as carrier opening 1607A and carrier opening 1607C. Carrier opening 1607A extends from the outer surface 1613 of the carrier 1612 to the insulated wire 1623A. The insulating member 1624A has an insulating member opening 1625A that exposes a portion of the conductive member 1626A, which may be referred to as the exposed portion 1627A. The exposed portion 1627A is the conductive portion. The insulating member opening 1625A (and therefore the exposed portion 1627A) is positioned within the carrier opening 1607A. For example, the exposed portion 1627A is aligned with (centered within) the carrier opening 1607A. Thus, the carrier opening 1607A exposes the exposed portion 1627A of the conductive member 1626A. The exposed portion 1627C of the insulated wire 1623C is exposed through the insulating member opening 1625C and the carrier opening 1607C.

[0210] In some embodiments, the carrier opening 1607A can be formed simultaneously with the insulating member opening 1625A, which ensures that the exposed portion is aligned with and / or positioned within the carrier opening 1607A. For example, a laser can form the carrier opening 1607A, and the insulating member opening 1625A can be formed immediately thereafter.

[0211] In this example, carrier openings 1607A and 1607C are depicted as having variable widths. For example, carrier openings 1607A and 1607C taper in a conical shape from the outer surface 1613 to the insulated wires 1623A and 1623C, respectively. In some embodiments, carrier openings 1607A and 1607C may have a uniform width from the outer surface 1613 to the corresponding insulated wire 1623.

[0212] The carrier 1612 encapsulates the insulated wire 1623, positioning the insulated wire 1623 between the sheath 1618 and the outer surface 1613 of the carrier 1612. However, as discussed, the carrier opening 1607 is configured such that the carrier 1612 does not cover the exposed portions 1627A and 1627C belonging to the insulated wires 1623A and 1623C, respectively. Therefore, the carrier opening 1607 provides passage to the exposed portions 1627A and 1627C, allowing a solution surrounding the carrier 1612 (e.g., a saline solution within the balloon) to conduct to the exposed portions 1627A and 1627C.

[0213] Electrode 1620B1 is associated with (e.g., formed of) insulated wire 1623A. Electrode 1620B2 is associated with (e.g., formed of) insulated wire 1623C. Electrodes 1620B1 and 1620B2 are an electrode pair forming transmitter 1620B. Electrode 1620B1 may include (e.g., referring to) one or more of carrier opening 1607A, insulating member opening 1625A, and / or exposed portion 1627A. Electrode 1620B2 may include (e.g., referring to) one or more of carrier opening 1607C, insulating member opening 1625C, and / or exposed portion 1627C.

[0214] A spark (e.g., current) can travel between electrodes 1620B1 and 1620B2. For example, the spark can originate from exposed portion 1627A and can pass through insulating member opening 1625A, carrier opening 1607A, along and / or across the outer surface 1613 of carrier 1612, carrier opening 1607C, insulating member opening 1625C, and down to exposed portion 1627C. The above description of a spark traveling from electrode 1620B1 to electrode 1620B2 is provided; however, depending on whether the voltage of insulating wire 1623A is higher or lower than the voltage of insulating wire 1623C, the spark can travel in either direction between electrodes 1620B1 and 1620B2. IVL conduit 1601 can be configured such that the voltage of insulating wire 1623A can alternately be higher or lower than the voltage of insulating wire 1623C. When the voltage difference between exposed portions 1627A and 1627C exceeds a threshold, a spark can travel between exposed portions 1627A and 1627C.

[0215] Figure 16C A side view of the various portions of IVL catheter 1601 is shown. Electrodes 1620A1 and 1620A2 are shown at the leftmost portion of IVL catheter 1601 and are the electrode pair of the first emitter; electrodes 1620B1 and 1620B2 are shown at the middle-left portion and are the electrode pair of the second emitter; electrodes 1620C1 and 1620C2 are shown at the middle-right portion and are the electrode pair of the third emitter; and electrodes 1620D1 and 1620D2 are shown at the rightmost portion and are the electrode pair of the fourth emitter. These four portions of IVL catheter 1601 can be circumferentially displaced from each other by rotating about the longitudinal axis 16LA1 by an angle. Therefore, although electrodes 1620A1, 1620A2, 1620A3, and 1620A4 are shown here as if they are circumferentially aligned along IVL catheter 1601, they can also be misaligned and circumferentially offset from each other by an angle about the longitudinal axis 16LA1. Further details regarding the circumferentially biased electrodes and / or emitters will be found in [reference]. Figure 17C Show and / or describe.

[0216] As shown in the figure, the emitters of the electrode pair are longitudinally offset by a distance zeg along the length of the IVL conduit 1601. For example, electrode 1620A2 is separated from electrode 1620B1 by a distance zeg, electrode 1620B2 is separated from electrode 1620C1 by a distance zeg, and so on. In some embodiments, the individual zeg distances may be the same. In some embodiments, one or more zeg distances may be different from the other zeg distances.

[0217] Zspc represents the length of the insulated wire between electrodes on the same conductor. For example, Zspc can represent the length of the insulated wire 1623B between electrodes 1620A2 and 1620B1, and the length of the insulated wire 1623C between electrodes 1620B2 and 1620C1, and so on. In some embodiments, the individual Zspc distances can be the same. In some embodiments, one or more Zspc distances can be different from the other Zspc distances. The relationship between the Zeg distance between certain electrodes and the Zspc length between these electrodes can depend on the pitch used when the insulated wire 1623 is wound around the sheath 1618. For example, if the wire 1623 extends longitudinally along the IVL conduit 1601 without being wound, the Zeg distance and the Zspc length can be the same, while in the example shown, the Zspc length is greater than the corresponding Zeg distance because the wire 1623 is wound around the sheath 1618. Therefore, if the insulated wire 1623 is wound more tightly together with a smaller pitch, the Zeg can be reduced relative to the Zspc.

[0218] Electrode pairs 1620A1 and 1620A2 are separated from each other by a distance rsg, which can be referred to as the spark gap distance. Electrode pairs 1620B1 and 1620B2, as well as 1620C1 and 1620C2, and 1620D1 and 1620D2 are also separated by a spark gap distance rsg. In some embodiments, the individual rsg distances may be the same. In some embodiments, one or more rsg distances may be different from each other.

[0219] Since the voltage difference required to generate a spark increases with distance, a larger spark gap distance rsg can produce a spark with greater energy due to the higher voltage difference required for spark formation. Similarly, a smaller rsg can produce a spark with lower energy. A spark with greater energy can generate sound waves with greater energy, which can more easily remove calcified deposits, but also carries the risk of damaging healthy tissue (e.g., blood vessel walls). Therefore, establishing an appropriate rsg distance can help to effectively treat calcified lesions while minimizing health risks. The spark gap distance rsg can be between 0.2 mm and 1.5 mm, between 0.25 mm and 1.0 mm, between 0.25 mm and 0.75 mm, between 0.35 mm and 0.6 mm, between 0.4 mm and 0.6 mm, between 0.5 mm and 1.0 mm, between 0.75 mm and 1.0 mm, or any value in between. In some embodiments, the spark gap distance rsg can be about 0.4 mm, 0.5 mm, or about 0.6 mm.

[0220] The longitudinal distance (Zeg distance) between adjacent emitters is greater than the spark distance rsg, which allows sparks to form at desired locations while suppressing sparks from forming at undesired locations. For example, to generate a spark between electrodes 1620A1 and 1620A2, the energy generator can drive a voltage on insulated wires 1623A and 1623B to create a voltage difference between electrodes 1620A1 and 1620A2. However, this will also create a voltage difference between electrodes 1620A2 and 1620B1. But since electrodes 1620A1 and 1620A2 are closer to each other than electrodes 1620A2 and 1620B1 (e.g., rsg < Zeg), the voltage difference required to form a spark between electrodes 1620A1 and 1620A2 will be less than the voltage difference required to form a spark between electrodes 1620A2 and 1620B1. Therefore, by controlling the output of the energy generator to maintain the voltage difference within a threshold, sparks are allowed to form between electrodes 1620A1 and 1620A2, but not between electrodes 1620A2 and 1620B1. Furthermore, sparks will form between electrodes 1620A1 and 1620A2, thereby preventing sparks from forming between electrodes 1620A2 and 1620B1.

[0221] While a large zeg distance can suppress unwanted spark formation, it also increases the distance between emitters (reducing emitter density on IVL catheter 1601), which can decrease therapeutic efficacy. Therefore, the zeg size should be appropriately determined to suppress unwanted sparks without unduly sacrificing emitter density. Zeg can be between 1.0mm and 10.0mm, between 1.0mm and 8.0mm, between 1.0mm and 6.0mm, between 1.0mm and 4.0mm, between 1.0mm and 3.0mm, between 1.5mm and 2.5mm, between 2.0mm and 7.0mm, between 2.0mm and 6.0mm, between 3.0mm and 6.0mm, between 4.0mm and 6.0mm, between 5.0mm and 6.0mm, between 3.0mm and 8.0mm, between 4.0mm and 8.0mm, between 5.0mm and 8.0mm, between 6.0mm and 8.0mm, between 5.0mm and 10.0mm, or any value in between. In some cases, Zeg can be approximately 2.25mm, or approximately 3.5mm, or approximately 5.7mm, or similar values.

[0222] Zeg can be approximately 2 to 15 times, 2 to 12 times, 2 to 10 times, 2 to 8 times, 2 to 6 times, 2 to 5 times, 2 to 4 times, 2 to 3 times, 5 to 15 times, 6 to 15 times, 7 to 15 times, 8 to 15 times, 9 to 15 times, 10 to 15 times, or 12 to 15 times the rsg. For example, Zeg can be approximately 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, etc., of the rsg. As an example, if the rsg is 0.5 mm, then Zeg can be approximately 11.4 times the rsg, or approximately 5.7 mm. As another example, if the rsg is 0.5 mm, then Zeg can be approximately 4.5 times the rsg, or approximately 2.25 mm.

[0223] In some implementations, for example in Figures 16A-16CWhen the insulated wire 1623 shown is wound around the sheath 1618, the continuous electrodes are separated by one or more turns of the wound wire 1623. For example, electrode 1620A2 may be separated from electrode 1620B1 by 1 to 30 turns, 1 to 20 turns, 1 to 15 turns, 1 to 10 turns, 1 to 5 turns, 5 to 30 turns, 5 to 20 turns, 5 to 15 turns, 5 to 10 turns, 10 to 30 turns, 10 to 20 turns, 10 to 15 turns, 15 to 25 turns, or any number of turns therein. The distance between turns (e.g., the pitch of the wound wire 1623) can be between 0.5 mm and 5.0 mm, between 0.5 mm and 4.0 mm, between 0.5 mm and 3.0 mm, between 0.5 mm and 2.0 mm, between 0.5 mm and 1.5 mm, between 0.5 mm and 1.0 mm, between 0.75 mm and 1.5 mm, between 0.75 mm and 1.25 mm, between 0.75 mm and 1.0 mm, between 1.0 mm and 1.5 mm, between 1.0 mm and 1.25 mm, or any distance in between. As the pitch decreases, the wire 1623 provides more structural support to the sheath 1618; as the pitch increases, the wire 1623 provides greater flexibility to the sheath 1618. Therefore, an optimal pitch can be achieved as described herein, providing optimized structural support and flexibility for the IVL catheter 1601.

[0224] A transverse section passing through IVL catheter 1601 and perpendicular to the longitudinal axis 16LA1 can pass through any one of the electrodes but not the other electrode in the pair (e.g., it can pass through electrode 1620A1 but not electrode 1620A1). A longitudinal section passing through IVL catheter 1601 and parallel to (and through) the longitudinal axis 16LA1 can pass through any one of the electrodes but not the other electrode in the pair (e.g., it can pass through electrode 1620A1 but not electrode 1620A1). Therefore, the electrodes in a pair can be circumferentially and / or longitudinally offset from each other.

[0225] Figure 17A This is a schematic diagram showing example insulated wires 1723A-1723F arranged in a straight line and not wrapped. Figure 17AMay not be shown to scale. Insulated wire 1723 is configured to generate sparks at emitters n=0, 1, 2, and 3. Emitter n=0 is formed by electrodes 0 and 1 on wire 1723A and electrodes 0 and 2 on wire 1723B. Emitter n=1 is formed by electrodes 1 and 1 on wire 1723A and electrodes 1 and 2 on wire 1723C. Emitter n=2 is formed by electrodes 2 and 1 on wire 1723A and electrodes 2 and 2 on wire 1723D. Emitter n=3 is formed by electrodes 3 and 1 on wire 1723A and electrodes 3 and 2 on wire 1723E. The electrodes shown and / or described herein may represent openings in the insulating members of the insulated wire and / or exposed portions of the conductive members.

[0226] When the insulated wire 1723 is arranged in a straight line and not wound, as shown here, the electrode pairs in the transmitter form right-angled triangles. Furthermore, if the insulated wire 1723 is wound in an IVL conduit, the electrode pairs in the transmitter may still form the same right-angled triangles, or at least substantially similar right-angled triangles, ignoring potential minor variations that may arise from the winding. An example right-angled triangle formed by the transmitter on the wound wire is shown in... Figure 16C The information shown and / or described herein. Figure 17A In the diagram, each right-angled triangle of the emitter includes a hypotenuse indicated by the spark gap distance rsg, a longitudinal side (vertical relative to the page) indicated by (n+1)Δw, and a transverse side (horizontal relative to the page). The hypotenuse (e.g., rsg) of each triangle of each emitter can be of the same length. The lengths of the other sides of the triangles of different emitters may vary. Since the spark gap distance rsg is the same for each emitter, the energy difference required to form a spark at each emitter will also be the same or substantially similar.

[0227] The width (e.g., diameter) of wire 1723 is Δw. Furthermore, since adjacent wires are in contact with each other, the center-to-center spacing between adjacent wires in this example is also Δw. If adjacent wires were not in contact with each other, the center-to-center spacing could be greater than Δw. As shown here, arranging adjacent wires 1723 in contact with each other helps to maintain a constant center-to-center spacing between the wires, which in turn helps to maintain a constant spark gap distance rsg in the transmitter, since the spark gap distance rsg is a function of the center-to-center spacing between adjacent wires 1723. For example, since the wires 1723 are in contact with each other, the center-to-center spacing between any wires 1723 is already at a minimum and will not decrease. Furthermore, the center-to-center spacing between any wires 1723 is unlikely to increase because the wires 1723, in contact with each other and holding themselves in place, prevent themselves from moving away from each other.

[0228] The longitudinal distance (n+1)Δw between electrode pairs in the transmitter is determined by the center-to-center spacing Δw between adjacent wires 1723, which in this example is also the same as the width of wire 1723. For example, in transmitter n=0, electrodes 0, 2 are separated from electrodes 0, 1 by a longitudinal distance of (0+1)Δw; and in transmitter n=1, electrodes 1, 2 are separated from electrodes 1, 1 by a longitudinal distance of (1+1)Δw. Therefore, in this example, the longitudinal distance between electrodes in each transmitter pair is given in increments of Δw. The longitudinal distance (n+1)Δw is parallel to the longitudinal axis of the IVL catheter. The distance (n+1)Δw can represent the minimum possible longitudinal distance between electrodes, for example, in embodiments where wires 1723 are in contact with each other. In some cases, the longitudinal distance between electrodes in the transmitter can be greater than (n+1)Δw, which depends, for example, on the pitch used when the wires are wound around the sheath. For example, as Figure 16C As shown, the longitudinal distance between electrodes in any given transmitter can be greater than (n+1)Δw.

[0229] Zspc represents the distance between consecutive emitters. For example, Zspc is shown as the distance between electrodes 0, 2 and electrodes 1, 1. The Zspc distance between different emitters can be the same or different. If the insulated wire 1723 is wound in an IVL conduit, the Zspc distance can extend along a helical path, thereby forming a distance between consecutive emitters such as... Figure 16C The longitudinal distance Zeg shown and / or discussed is the linear distance. The Zeg distance is a function of Zspc and pitch. If wire 1723 is not wound, then Zspc can be equal to Zeg.

[0230] The distance Zspc can suppress the unintentional formation of sparks between undesirable electrodes. For example, to form a spark at emitter n=0, the energy generator can drive voltages on wires 1723A and 1723B to create an energy difference between electrodes 0,1 and 0,2. However, this also creates an energy difference between electrodes 1,2 and 0,2, where a spark may not be desired. By adjusting Zspc (and Zeg) to be greater than rsg, the energy difference required to form a spark between electrodes 0,2 and 1,1 can be greater than the energy difference required to form a spark between electrodes 0,1 and 0,2 (assuming all electrodes have the same surface area). Therefore, when Zspc (and Zeg) is greater than rsg, a spark can form between electrode pairs in the emitter, but not between non-electrode pairs in adjacent emitters.

[0231] Figure 17B This is a schematic diagram showing exemplary insulated wires 2023A-2023E wrapped around the sheath 2018 of the IVL catheter 2001. Figure 17BMay not be shown to scale. In this example, five insulated wires 2023A-2023E are shown, but any number of wires can be used. Insulated wires 2023A-2023E may have similar operational and / or structural features to any other insulated wire shown and / or described herein. Emitter n=0 is formed by electrodes 0, 1 on wire 2023A and electrodes 0, 2 on wire 2023B. Emitter n=1 is formed by electrodes 1, 1 on wire 2023A and electrodes 1, 2 on wire 2023C. Emitter n=2 is formed by electrodes 2, 1 on wire 2023A and electrodes 2, 2 on wire 2023D. Emitter n=3 is formed by electrodes 3, 1 on wire 2023A and electrodes 3, 2 on wire 2023E. The electrodes shown and / or described herein may represent openings in the insulation of the insulated wire and / or exposed portions of the conductive components.

[0232] Electrodes n, 1 and n, 2 form right-angled triangles, as shown in the figure, which are superimposed on IVL catheter 2001. These right-angled triangles include a hypotenuse rsg, a longitudinal side parallel to the longitudinal axis 20LA1 of IVL catheter 2001, and a transverse side perpendicular to the longitudinal axis 20LA1. The longitudinal side has a length Zn, and the transverse side has a length dYn. The width of conductor 2023 and / or the center-to-center spacing between adjacent conductors is determined by... As shown.

[0233] Insulated wires 2023 are wound around the sheath 2018 such that they form an angle with the edge of the sheath as shown in the figure. .angle The length of IVL catheter 2001 can be consistent.

[0234] For clarity, Figure 17B Other right-angled triangles formed by electrodes superimposed on the IVL catheter 2001 are also shown. These other right-angled triangles include angles... For each triangle shown, the angle can be different. These right triangles are arranged such that their hypotenuses are parallel to the hypotenuses of the triangles superimposed on the IVL catheter 2001, and such that the angles... Extend from the hypotenuse of rsg to the right-angled side of the triangle parallel to the insulated wire 2023. Therefore, when moving clockwise from the edge of sheath 2018 to the hypotenuse of rsg, the angle from the edge of sheath 2018 to the hypotenuse of rsg is... Angle and The sum of angles. Therefore, and The length can be calculated as follows: angle The calculation can be performed as follows: The lateral distance dYn can be a function of the spark gap distance rsg (which may be predetermined) and the longitudinal distance ΔZn (which may be determined by the wire width and the number of wires between electrodes in a pair). Therefore, as shown here, the lateral distance can decrease as the longitudinal distance ΔZn increases (in order to maintain a constant rsg). In some embodiments, the lateral distance dYn can be zero, and the longitudinal distance ΔZn can be equal to rsg. For example, another emitter can be formed by electrodes on wires 1723A and 1723F, where the spark gap distance rsg is a straight line parallel to the longitudinal axis 20LA1 between the electrodes, without forming a right-angled triangle. In some cases, if the longitudinal distance ΔZn between wire 2023A and another wire would be greater than the predetermined spark gap distance rsg, then wire 2023A may not form an emitter with that other wire. Therefore, in some cases, one or more wires 1723 may not form an emitter with one or more other wires 1723.

[0235] Figure 17C This is a cross-sectional view of a portion of an exemplary IVL catheter 1701, which includes: a sheath 1718 having a lumen 1719 configured to receive a guidewire passing through it; an insulated wire 1723 wound around the sheath 1718; and a carrier 1712 encapsulating the wire 1723 and the sheath 1718. Figure 17C May not be shown to scale. A longitudinal axis 17LA1 extends through the center of the lumen 1719 of the sheath 1718. The carrier 1712 has an outer surface 1713. The IVL conduit 1701 has multiple electrodes (e.g., (0, 1), (0, 2), (1, 1), (1, 2), (2, 1), (2, 2), (3, 1), (3, 2)). In this example, the electrode refers to the outer surface 1713 of the carrier 1712, where a carrier opening for spark passage can be located; however, this is not intended to be limiting, as "electrode" can also refer to, and be represented by, the exposed portion and / or insulating member opening of the conductor 1723, which can be located between the carrier 1712 and the conductor 1723. Whether discussing the electrode relative to the outer surface 1713 of the carrier 1712 or the electrode between the carrier 1712 and the conductor 1723, the angle between the electrodes remains constant.

[0236] Electrodes 0, 1 and 0, 2 form an emitter, which can correspond to Figure 17A (in some cases correspond to) Figure 17BIn the given diagram, the emitter n=0. Electrode pairs 1, 1 and 1, 2 form an emitter, which can correspond to... Figure 17A The emitter n=1. Electrode pairs 2, 1 and 2, 2 form an emitter, which can correspond to... Figure 17A The emitter n=2. Electrode pairs 3, 1 and 3, 2 form an emitter, which can correspond to Figure 17A The transmitter n=3. The angles θE0, θE1, θE2, θE3 between the electrodes in the electrode pair may depend on the lateral distance (e.g., dYn) between the electrodes in the electrode pair. Therefore, the relationship between the angles can be as follows: θE0 > θE1 > θE2 > θE3. In some embodiments, θE0 can be between approximately 25° and 45°, θE1 can be between approximately 20° and 40°, θE2 can be between approximately 15° and 35°, and θE3 can be between approximately 5° and 20°.

[0237] The angles θG1, θG2, and θG3 between the transmitters can depend on the distances between adjacent transmitters (e.g., Zspc), which can be all equal or substantially equal. Therefore, in some cases, the angles θG1, θG2, and θG3 can be all equal or substantially equal (assuming a constant pitch). One or more of θG1, θG2, and θG3 can be between 50° and 85°, between 50° and 75°, between 50° and 60°, between 60° and 75°, between 55° and 70°, between 55° and 65°, or between 65° and 75°.

[0238] The transmitters are spaced apart by angles θG1, θG2, and θG3, which can be referred to as transmitter circumferential offset. For example, the transmitter formed by electrode pairs 0, 1 and 1, 1 is circumferentially offset by angle θG1 from the transmitter formed by electrode pairs 1, 1 and 1, 2. A single lead (e.g., lead 1723A) can have multiple electrodes forming multiple transmitters, which are circumferentially offset from other transmitters. Because these transmitters are circumferentially offset from each other (e.g., angularly spaced), each transmitter can emit sound waves in multiple directions without having to rotate the IVL catheter 1701, thus allowing for more effective treatment. For example, calcium deposits may form unevenly at multiple locations on the surface of a patient's blood vessels. Separating the transmitters circumferentially and / or longitudinally can increase the likelihood of applying sound waves from the transmitters to the calcium deposits, regardless of where the calcium deposits may have formed on the vascular system. In some aspects, successive transmitters can be longitudinally separated by a distance but not radially separated by an angle, or vice versa. Therefore, as described, successive emitters can be located at different longitudinal positions on the IVL conduit without being affected by the radial spacing angle. Thus, in some cases, emitters (e.g., emitters that are consecutively spaced and have no other emitters between them) may not be circumferentially aligned and / or longitudinally aligned, or in some cases they may be circumferentially aligned and / or longitudinally aligned.

[0239] A pair of electrodes of a single transmitter can be circumferentially biased (e.g.) Figure 17C (as shown) and / or longitudinal offset (as shown) Figures 17A-17B (As shown in the diagram). For example, electrodes 0, 1 and 1, 1 of transmitter n=0 are in... Figure 17C The electrodes are shown as circumferentially biased because they are separated by angle θE0. Therefore, the IVL conduit 1701, along its longitudinal axis 17LA1, passes through a longitudinal section of the plane of the paper, intersecting one of electrodes 0, 1 and 1, 1, but may not intersect the other electrode. Electrodes 0, 1 and 1, 1 can be longitudinally biased (e.g., ...). Figure 16C and / or Figures 17A-17B The example electrodes shown and / or described in the paper can be longitudinally separated by a distance, for example, (n=1)w. Therefore, the transverse section of the IVL conduit 1701 parallel to the plane of the paper intersects one of electrodes 0, 1 and 1, 1, but may not intersect the other electrode. Thus, in some cases, a pair of electrodes in the transmitter may not be circumferentially aligned and / or may not be longitudinally aligned, or in some cases they may be circumferentially aligned and / or longitudinally aligned.

[0240] The carrier 1712 may be thicker than the conductor 1723, such that the outer surface 1713 of the carrier 1712 extends beyond the conductor 1723 from the sheath 1718, as shown in the figure. The thickness of the carrier 1712 can be measured from the outer surface 1713 to the surface of the sheath 1718 that contacts the conductor 1723. The thickness of the conductor 1723 may correspond to its diameter, which is determined by its AWG size. In some embodiments, the carrier 1712 may be 100% to 200%, 100% to 150%, 100% to 125%, 100% to 115%, 100% to 110%, 125% to 200%, 150% to 200%, 175% to 200%, 125% to 175%, 125% to 150%, or 200% to 250% thicker than the conductor 1723.

[0241] like Figure 17C As shown in the cross-section, the insulated wire 1723 extends away from the sheath 1718 by a distance not exceeding the thickness of the wire 1723 itself. This is likely because the wire 1723 is in continuous contact with the sheath 1718. For example, the wires 1723 may not overlap or stack on each other, which would otherwise cause the sheath 1718 to separate from at least a portion of the wires 1723. This can be the case throughout the entire IVL conduit 1701. The diameter of the outer surface 1713 of the carrier 1712 can be between 0.02 inches and 0.06 inches, between 0.03 inches and 0.05 inches, between 0.03 inches and 0.045 inches, between 0.03 inches and 0.04 inches, between 0.035 inches and 0.05 inches, between 0.04 inches and 0.05 inches, or any value in between. As discussed, various embodiments of the IVL conduit can have any number of insulated wires, for example, from 3 to 15, or any other number of wires shown and / or discussed herein. Therefore, an IVL catheter with, for example, 10 insulated wires can have a diameter (carrier diameter) between 0.03 inches and 0.05 inches. In some cases, the diameter of various IVL catheters can remain constant regardless of the number of wires in each catheter. For example, an IVL catheter with 6 insulated wires can have the same carrier diameter as an IVL catheter with 12 insulated wires (and both diameters can be between 0.03 inches and 0.05 inches).

[0242] The outer surface 1713 of the carrier 1712 may be circular. The outer surface 1713 of the carrier 1712 may be smooth, without any protrusions from the outer surface 1713. Therefore, the outer surface 1713 may be more flexible than if any object is attached to the outer surface 1713 or if any part of the outer surface 1713 protrudes from the circular cross-section.

[0243] The positions of the electrodes on the IVL conduit can be determined to form carrier openings for the electrodes. For example, a laser drilling system can be programmed to form the positions of these carrier openings. The positions of the electrodes can be represented in cylindrical coordinates (r, θ, z). For example, the positions of electrodes (n, 1) and (n, 2) in a pair can be shown by the following matrices: R GWL R is the distance of the electrode from the longitudinal axis 17LA1, and can be equal to the radius of the outer surface 1713 of the carrier 1712. GWL This can be constant for all electrodes, at least because the carrier 1712 can have an outer surface 1713 with a uniform radius. θ OR It is the angular position of the first electrode in a pair, measured from a reference point, which can be from the electrodes of the previous pair (e.g., Elec). n-1,2 ).exist Figure 17C In, θ OR It can be equal to θ Gn θ En It is the angle between the electrodes in a pair. For example, Figure 17C The electrodes (0, 1) and (0, 2) shown are separated by angle θ. E0 Separate. θ En This can vary depending on the transmitter. θ En The following equation can be used to determine, where, for example Figure 17B As described in the text, dYn : The longitudinal coordinates of the electrodes are shown in Z coordinates. For example, the longitudinal position of electrode (n, 1) is the longitudinal position of the electrode (Elec (n-1, 2)) in the previous transmitter plus the Zeg distance (which is a function of the Zspc distance). The longitudinal position of electrode (n, 2) is the longitudinal position of the first electrode (Elec (n, 1)) in the pair plus... Distance. In some cases, The distance can be approximated by (n+1)Δw, for example, by ensuring that (n+1)Δw is always less than 1. In some cases, such as Figure 17B As stated in the text, = .

[0244] Substituting the above equations, we obtain the following electrode coordinate matrix that controls the electrode position in the IVL catheter: These matrices can be programmed into a system to form carrier openings in an IVL catheter. For example, electrode coordinate matrices can be programmed into a laser system that can use a laser to form carrier openings and / or insulating member openings at precise locations (e.g., aligned with each other), which can be associated with and / or used as electrodes.

[0245] The longitudinal distance Zeg between consecutive transmitters can vary depending on the implementation method and can be calculated as follows: As shown in the formula above, Zeg can depend on the balloon length (l bln ), the gap at either end of the balloon (d) gap The formulas define the number of emitters (nEM) and the sum of the longitudinal distances between each emitter (ΔZn). The above formulas give the maximum possible distance for Zeg under given constraints (e.g., the number of emitters, the working length of the conduit). Implementing Zeg as large a distance as possible ensures that the emitters are spaced apart to the maximum extent possible, resulting in a uniform distribution between the two ends of the conduit. The minimum distance for Zeg can be a function of the spark gap distance rsg. For example, Zeg can never be less than 5*rsg, 4*rsg, 3*rsg, 2*rsg, 1.5*rsg, etc. Such constraints can suppress the unintentional formation of sparks between undesirable electrodes, because at the threshold (voltage, time) of the energy generator drive wire, sparks may not be able to cross a gap larger than rsg.

[0246] Figure 18A This is a side view of a portion of an example IVL catheter 1801, which includes a sheath 1818, a carrier 1812 having an outer surface 1813, and multiple insulated wires 1823. The IVL catheter 1801 may include structural and / or operational features similar to any other example IVL catheters shown and / or described herein.

[0247] In this example, IVL conduit 1801 has 10 wires. In some embodiments, IVL conduit 1801 may have 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 15 to 20 wires, etc. Insulated wire 1823 may be electrically connected to an energy generator and may conduct energy originating from said energy generator. Insulated wire 1823 may change voltage in response to changes in the energy it conducts. Insulated wire 1823 may each include a conductive member enclosed within an electrically insulating member.

[0248] Figure 18AThis portion of the IVL conduit 1801 shown may be a distal portion. For example, the insulated wire 1823 may terminate at this distal portion shown here, and a proximal portion at the other end of the IVL conduit 1801 may be connected to an energy generator. The carrier 1812 tapers at this portion of the IVL conduit 1801, causing a change in the diameter of the outer surface 1813. The sheath 1818 extends distally beyond the insulated wire 1823.

[0249] In this example, the insulated wire 1823 is helically wound around the sheath 1818 along the length of the IVL catheter 1801. The insulated wire 1823 can be wound with a uniform pitch or a variable pitch. The sheath 1818 can be formed of a flexible material capable of deforming in response to force. Advantageously, the helically wound insulated wire 1823 can provide support to the sheath 1818, for example, to prevent the guidewire from breaking when bent, and to prevent the sheath of the IVL catheter 1801 from collapsing when bent. Therefore, the structural support provided by the helically wound insulated wire 1823 can allow for a longer IVL catheter than could be achieved without such a helically wound insulated wire 1823.

[0250] Figure 18B This is a schematic diagram showing example insulated wires 1823A-1823J arranged in a straight line and not spirally wound. Figure 18B It may not be shown to scale. Insulated wires 1823A-1823J may correspond to Figure 18A The insulated wire 1823 of the IVL conduit 1801 shown and / or described is in its unwound state. Although in Figure 18B The diagram shows it as straight, but insulated wires 1823A-1823J can be as follows: Figure 18A It is spirally wound as shown and / or described.

[0251] Insulated wires 1823A-1823J are symbolically divided into columns, each column representing a transmitter with one electrode pair. In this example, insulated wires 1823A-1823J form 35 transmitters, each transmitter shown as a different column. Electrodes are shown as circles within each cell of the row and column, and these electrodes represent one or more of the exposed portion of the wire, openings in the insulation of the wire, and / or carrier openings aligned with the exposed portion. For example, transmitter 1E is formed by electrodes in insulated wire 1823A and electrodes in insulated wire 1823B. Electrodes in transmitter pairs are shown as vertically aligned; for simplicity, any horizontal displacement between such electrodes can be ignored (e.g., ...). Figure 17B (The dYn component shown and / or described in the diagram). However, although not explicitly shown in the diagram, such a dYn component may exist.

[0252] Each insulated wire 1823A-1823J can form multiple transmitters. For example, as shown in the figure, insulated wire 1823A can form five transmitters (1E-5E) with wires 1823B-1823F respectively, and each wire 1823B-1823F can also form another five transmitters. The number of transmitters that can be formed from a certain number (n) of wires can be given by the following formula: Using the above formula, the following table shows examples of the possible number of transmitters given a certain number of wires. The table below provides example implementations of IVL conduits with various numbers of wires and transmitters. As shown in the figure, in an implementation with 10 wires, there may be 45 transmitters. Figure 18B An example implementation has 10 wires and 35 transmitters. For example, insulated wire 1823A may not form a transmitter with wires 1823G-1823J, insulated wire 1823B may not form a transmitter with wires 1823H-1823J, and so on. Figure 18B The number of possible emitters in the embodiments (and other embodiments) can be constrained by the distance between the wires. For example, the minimum achievable distance between the imaginary electrodes on wires 1823A and 1823G can be greater than the predetermined spark gap distance determined for this embodiment. This may be due to the size of the wires. For example, if the insulated wire 1823 has a diameter of about 0.1 mm, the center-to-center spacing between wires 1823A and 1823G will be about 0.6 mm (assuming the wires are in contact with adjacent wires). If the spark gap distance is less than 0.6 mm (e.g., 0.5 mm), a spark cannot be formed between the insulated wire 1823A and any of the wires 1823G-1823J. Therefore, in some cases, the number of possible emitters for a given number of wires can be constrained below the theoretical maximum given a given spark gap distance and wire dimensions.

[0253] As shown in the formulas and / or tables above, the number of possible transmitters can correspond exponentially to the number of leads. Advantageously, forming multiple transmitters from each lead (instead of just a single transmitter) can reduce the number of leads and / or increase the number of transmitters on the IVL catheter. Reducing the number of leads can reduce the size of the IVL catheter, thereby allowing for more precise endovascular treatment. Increasing the number of transmitters can allow the IVL catheter to generate more acoustic energy (e.g., acoustic energy per unit catheter length). Furthermore, multiple transmitters from each lead can increase the transmitter density per unit catheter length. Therefore, the systems and devices described herein can achieve long IVL catheters (e.g., longer than 60 mm, 80 mm, 100 mm, 150 mm, 200 mm, etc.) without sacrificing the transmitter density on the catheter and / or eliminating the need for significantly more leads.

[0254] In some embodiments, the IVL catheter may have insulated wires with multiple electrodes configured to form emitters with another insulated wire also having multiple electrodes. In some embodiments, the IVL catheter may have multiple insulated wires, each with multiple electrodes, such as at least three electrodes, so that each wire can form multiple emitters. In some embodiments, the number of electrodes on each insulated wire in the IVL catheter may be equal to the number of wires minus one. For example, in an IVL catheter with six wires, each of those six wires may have five electrodes. In some embodiments, each wire in the IVL catheter may have fewer electrodes than the number of wires. In some embodiments, each wire may have the same number of electrodes as each of the other wires.

[0255] As shown in the table above, this paper envisions various IVL catheter configurations, where the IVL catheter can form emitters with at least twice the number of leads, at least three times the number of leads, at least four times the number of leads, etc. This paper also envisions various IVL catheter configurations with electrodes having at least twice the number of leads, at least three times the number of leads, at least four times the number of leads, at least five times the number of leads, etc. The number of electrodes can be twice the number of emitters.

[0256] In some embodiments, the IVL catheter may have at least five leads configured to form six to ten (including end values) emitters. In some embodiments, the IVL catheter may have at least six leads configured to form at least ten emitters, such as ten to fifteen (including end values). In some embodiments, the IVL catheter may have at least seven leads configured to form at least ten emitters, such as ten to twenty-one (including end values). In some embodiments, the IVL catheter may have at least eight leads configured to form at least fifteen emitters, such as fifteen to twenty-eight (including end values). In some embodiments, the IVL catheter may have at least nine leads configured to form at least twenty-five emitters, such as twenty-five to thirty-six (including end values). In some implementations, the IVL catheter may have at least 10 wires configured to form at least 30 emitters, for example, 30 to 45 emitters (including end values).

[0257] Insulated wires 1823A-1823J are electrically connected to energy generator 1850. Each insulated wire 1823A-1823J can be connected to energy generator 1850 independently of each other, allowing energy generator 1850 to drive voltage on any one of the wires 1823A-1823J without driving voltage on any other wire. Insulated wires 1823A-1823J can be directly electrically connected to energy generator 1850 without the use of any other wires, conductors, contacts, etc., between the respective insulated wire 1823 and energy generator 1850. Direct electrical connection can include mechanical connection, such as physical contact between insulated wire 1823 and energy generator 1850. For example, there may be no gap between energy generator 1850 and wires 1823A-1823J. Therefore, energy generator 1850 can be directly and / or independently connected to multiple insulated wires, each configured to form multiple emitters. Each insulated wire 1823A-1823J may be continuous along its entire length. For example, the insulated wire 1823A may not have any gaps or breaks along its length between the energy generator 1850 and one or more electrodes on the insulated wire 1823A.

[0258] Energy generator 1850 can be configured to drive a voltage on any of the insulated wires 1823A-1823J. Driving a voltage on a wire can include conducting current through the wire. Energy generator 1850 can drive the voltage on the wire high or low. For example, energy generator 1850 can be configured according to any example pulse pattern shown and / or described herein (e.g., Figure 2C-2F The example pulse mode in the diagram is used to drive the voltage on wires 1823A-1823J. Driving a voltage on a wire can induce a voltage difference between that wire and other wires, which can cause a spark to form. The energy generator 1850 can simultaneously drive voltages on two wires 1823A-1823J. For example, the energy generator 1850 can drive the voltage on one of the wires 1823A-1823J high while simultaneously driving the voltage on the other wire 1823A-1823J low. Driving voltages on two wires (e.g., driving them high and low) can cause a single spark to form between the wires. The voltage difference between the two wires driven high and low, respectively, can be greater than the voltage difference between other wires. For example, the energy generator 1850 can drive a voltage (high or low) on the insulated wire 1823A and simultaneously drive a voltage on the insulated wire 1823F (which has the opposite polarity to the insulated wire 1823A and may or may not be equal to the voltage on the insulated wire 1823A). Therefore, a voltage difference can be formed between the insulated wires 1823A and 1823F, which can be greater than the voltage difference between any other two wires. If the voltage difference between the insulated wires 1823A and 1823F exceeds a threshold sufficient to form a spark, a spark can be formed between the electrodes on the insulated wires 1823A and 1823F.

[0259] The voltage used by the energy generator 1850 to drive the wires 1823A-1823J can correspond to a spark gap distance, which can be the same for all emitters. For example, the energy generator 1850 can be programmed with certain limitations to constrain the voltage used to drive the wires within certain thresholds, thereby avoiding the initiation of sparks between unintentional electrodes (e.g., between a pair of electrodes that are not emitters). Thus, for example, driving insulated wires 1823A and 1823C can induce a voltage difference between the two wires; however, this voltage difference may only be sufficient to induce a spark at emitter 2E, but may not be sufficient to induce a spark between the electrodes on wire 1823C in emitter 2E and the electrodes on wire 1823A in emitter 3E (which are a non-emitter pair), at least because the distance between those electrodes is greater than the spark gap distance between the electrodes in emitter 2E.

[0260] Energy generator 1850 can drive voltage on any of the wires 1823A-1823J to selectively cause sparks to form at any of the emitters 1E-35E, but not at any of the other emitters. Therefore, energy generator 1850 can cause sparks to form one at a time. Energy generator 1850 can rapidly and continuously drive voltage on wire 1823 to cause sparks to form rapidly and continuously. For example, energy generator 1850 can cause sparks to form sequentially at intervals of several microseconds, milliseconds, or centiseconds.

[0261] When the energy generator 1850 drives one of the wires 1823 with a high voltage and the other with a low voltage to create a spark, current can travel from the generator 1850 to the distal side along the energized wire and can return to the proximal side of the energy generator 1850 via the return wire. For example, if the energy generator 1850 drives wires 1823A and 1823B to high and low respectively, current can travel from the energy generator 1850 to the transmitter 1E via wire 1823A, which acts as the energized wire. Current can continue to flow from wire 1823A to wire 1823B in the form of a spark, thereby bridging the gap between the electrodes in the transmitter 1E. Current can travel from the transmitter 1E to the energy generator 1850 via wire 1823B, which acts as the return wire. Therefore, any one of the wires 1823A-1823J can serve as a live wire conducting current from the energy generator 1850, or as a return wire conducting energy to the energy generator 1850. Furthermore, the insulated wire 1823 can alternate between serving as a live wire and a return wire depending on which wire the energy generator 1850 is driving with voltage. In some embodiments, the return wire and the grounding wire can be used interchangeably.

[0262] although Figure 18B While not shown to scale, the horizontal distribution of the electrodes can be representative. For example, on insulated wire 1823C, the electrodes in transmitter 11E may be closer to the electrodes in transmitter 12E than the electrodes in transmitter 6E. Therefore, the electrodes on insulated wire 1823C are non-uniformly distributed along wire 1823C. This can be the case for one or more insulated wires 1823. On wire 1823A, the electrodes may be uniformly distributed along wire 1823A such that the distance between each electrode on wire 1823A is the same. In some embodiments, wires 1823A-1823J may all have the same length.

[0263] Conductors 1823A-1823J may be defined by a distal end and a proximal end, the distal end being identified by the transmitter furthest from the energy generator 1850 (e.g., transmitter 1E), and the proximal end being identified by the transmitter closest to the energy generator 1850 (e.g., transmitter 35E). For one or more conductors 1823A-1823J, the distance between the nearest transmitter and the proximal end of the conductor is between 25% and 50%, or at least 50%, of the distance between the proximal and distal ends of the conductor 1823. This can be seen at least in conductors 1823A-1823C, where transmitters 5E, 10E, and 15E are each located at more than half the distance from the proximal end on the right to the distal end on the left. For one or more of the wires 1823A-1823J, the distance between the farthest transmitter of the wire and the far end of the wire is between 25% and 50%, or at least 50%, of the distance between the proximal and distal ends of the wire 1823. This can be seen at least in wires 1823I-1823J, where transmitters 20E and 25E are located at more than half the distance from the far end on the left to the proximal end on the right. In some embodiments, one or more wires 1823 may not have any electrodes for at least half their length. For example, for at least half the length of insulated wire 1823A, there are no electrodes between transmitter 5E and the proximal end shown on the right towards the energy generator 1850.

[0264] The distance between the proximal end defined by transmitter 35E and the distal end defined by transmitter 1E can be between 40mm and 250mm, between 40mm and 220mm, between 40mm and 150mm, between 40mm and 100mm, between 40mm and 80mm, between 60mm and 220mm, between 80mm and 220mm, between 100mm and 220mm, between 100mm and 200mm, between 100mm and 180mm, between 100mm and 150mm, between 150mm and 200mm, or any length in between. These example distances also apply if the wires 1823A-1823J are wound around the sheath in the IVL catheter. Thus, for example, the IVL catheter can have 35 transmitters spanning 200mm. Or in other words, a transmitter is spaced approximately every 5.7mm along the longitudinal distance of the IVL catheter.

[0265] exist Figure 18B In the diagram, the bottom three rows below each row of conductor 1823 show the angular and longitudinal distances between the electrodes and / or emitters of the insulated conductor 1823, provided as a non-limiting example. θ En The angle between the electrodes in a pair is shown. θ GnThe angle between consecutive transmitters is shown. In this example, for each transmitter, θ... En + θ Gn It equals 120°. In some implementations, θ En With θ Gn The sum can vary between one or more transmitters. In some implementations, θ Gn This can be the same for each transmitter. Zeg shows the longitudinal distance between consecutive transmitters. In this example, the longitudinal distance between the individual transmitters is 5.7 mm. The bottom three lines showing the angular and longitudinal intervals can be provided as instructions when forming the electrodes and / or transmitters, and can be interpreted from top to bottom and left to right. For example, at transmitter 1E, an electrode can be formed on wire 1823A, and then the IVL conduit can be rotated 60° (θ). E1 (Angle). In some respects, at this stage of the process, the IVL catheter can be longitudinally translated as... Figures 17A-17B The distance of Zn shown and / or described. Then another electrode in emitter 1E can be formed on wire 1823B. After both electrodes of emitter 1E are formed, the IVL conduit can be rotated 60° (θ). G1 (Angle) and longitudinally translate 5.7 mm to transmitter 2E, where an electrode can be formed on wire 1823A. This process can continue until all electrodes are formed for all transmitters 1E-35E.

[0266] Figure 19 This is a flowchart of the process for manufacturing an IVL catheter or a portion thereof. At box 1901, a sheath may be provided having a lumen through which a guidewire can be received. At box 1903, one or more insulated wires may be wound around the sheath. The insulated wires may be helically wound with a uniform pitch or a varying pitch. At box 1905, the one or more insulated wires may optionally be encapsulated within a carrier that encapsulates both the wires and the sheath.

[0267] At frame 1907, a first electrode for the nth emitter can be formed. Forming the electrode may include forming an opening in the insulating member of an insulating wire to expose a portion of the conductive member of the insulating wire. In embodiments with a carrier, forming the electrode may include forming a carrier opening. The carrier opening may be aligned with the opening in the insulating member and / or the exposed portion of the insulating wire. A laser may form the electrode (e.g., the carrier opening, the insulating member opening, and / or the exposed portion). For example, the electrode may be formed using a laser etching process that removes portions of the carrier and / or the insulating member using light energy from a laser. In some embodiments, the carrier opening may be formed simultaneously with the opening in the insulating member and / or the exposed portion (e.g., immediately before and / or during the same process). For example, a laser may form the carrier opening, and then the insulating member opening may be formed immediately afterward, for example, without changing the energy or position of the laser. Using the same laser beam to form the carrier opening and the insulating member opening ensures that the carrier opening and the insulating member opening are aligned. This ensures that the exposed portion is exposed through the carrier opening, and also ensures that each exposed portion of each electrode has the same amount of surface area exposed through each carrier opening. This ensures the consistent energy difference required to form a spark gap at each emitter.

[0268] At frame 1909, the sheath, together with the one or more insulated wires wound thereon, can be rotated and / or translated. In some embodiments, such as when using a laser to form electrodes, the sheath can remain stationary while the laser travels relative to the sheath and / or the wires. Rotation can include any of the examples θ shown and / or discussed herein. En Angle. Translation can include any example (n+1)w distance shown and / or discussed herein.

[0269] At box 1911, the nth second electrode can be formed, which can be similar to the formation of the first electrode.

[0270] At box 1913, the sheath, together with the one or more insulated wires wound thereon, may be rotated and / or translated, whether it is physically moved or the electrode forming apparatus or system is moved relative to it. Rotation may include any of the examples θ shown and / or discussed herein. EG Angle. Translation can include any example Zeg distance shown and / or discussed herein.

[0271] The process can continue iteratively through any of blocks 1907-1913 until all electrodes and / or emitters have been formed. In some embodiments, blocks 1907-1913 can be performed before the wire is wound around the sheath at block 1903 and / or before the carrier encapsulates the insulated wire at block 1905. Thus, in some aspects, the carrier opening can be formed after the exposed portion has been formed.

[0272] I. Additional considerations All U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications, and non-patent publications mentioned in and / or listed in the application data sheets herein are incorporated herein by reference in their entirety. Such documents may be incorporated by reference for the purpose of describing and disclosing, for example, materials and methods described in the aforementioned publications that can be used in conjunction with this disclosure. The publications discussed above and throughout this document are provided only for their publication prior to the filing date of this application. Nothing herein should be construed as an admission that the inventor has no right to determine the date prior to any cited publication based on a prior invention.

[0273] Although certain implementations and examples have been described herein, those skilled in the art will understand that many aspects of the systems and apparatus shown and described herein can be combined and / or modified in different ways to form further implementations or acceptable examples. All such modifications and variations are intended to be included within the scope of this disclosure herein. A wide variety of designs and methods are possible. No feature, structure, or step disclosed herein is necessary or indispensable. The various features and processes described herein can be used independently of each other or can be combined in various ways. For example, elements may be added, removed, or rearranged compared to the disclosed example implementations. All possible combinations and sub-combinations are intended to fall within the scope of this disclosure.

[0274] Any methods and processes described herein are not limited to any particular order, and the associated boxes or states may be executed in other suitable orders. For example, the described boxes or states may be executed in a different order than specifically disclosed, or multiple boxes or states may be combined in a single box or state, or certain method or process boxes may be omitted, or certain boxes or states may be executed in the reverse order of those shown and / or described. The example boxes or states may be executed serially, in parallel, or in some other manner. Boxes or states may be added to or removed from the disclosed example embodiments.

[0275] The methods disclosed herein may include certain actions taken by practitioners; however, they may also include any explicit or implicit instructions from any third party regarding these actions.

[0276] The methods and tasks described herein can be performed and fully automated by a computer system. In some cases, the computer system may include multiple different computers or computing devices (e.g., physical servers, workstations, storage arrays, cloud computing resources, etc.) that communicate and interoperate via a network to perform the described functions. Each such computing device typically includes a processor (or multiple processors) that executes program instructions or modules stored in memory or other non-transitory computer-readable storage media or devices (e.g., solid-state storage devices, disk drives, etc.). The various functions disclosed herein may be embodied in such program instructions and / or implemented in the computer system's dedicated circuitry (e.g., ASICs or FPGAs). In cases where the computer system includes multiple computing devices, these devices may, but do not necessarily, be located in the same location. The results of the disclosed methods and tasks can be persistently stored by transforming physical storage devices (such as solid-state storage chips and / or disks) into different states. The computer system may be a cloud-based computing system whose processing resources are shared by multiple different entities or other users. The system and modules can also be transmitted as generated data signals (e.g., as part of a carrier or other analog or digital propagation signal) over various computer-readable transmission media, including wireless-based media and wired / cable-based media, and can take various forms (e.g., as part of a single or multiplexed analog signal, or as multiple discrete digital packets or frames).

[0277] Based on this disclosure, many other variations besides those described herein will be apparent. For example, depending on the implementation, certain actions, events, or functions of any algorithm described herein may be performed in a different order, may be added, combined, or omitted entirely (e.g., not all described actions or events are necessary for the practice of the algorithm). Furthermore, in some implementations, actions or events may be performed concurrently, such as through multithreading, interrupt handling, or through multiple processors or processor cores, or on other parallel architectures, rather than sequentially. Additionally, different tasks or processes may be performed by different machines and / or computing systems capable of working together.

[0278] The various illustrative logic blocks, modules, routines, and algorithmic steps that can be described in conjunction with the disclosure herein can be implemented as electronic hardware (e.g., ASIC or FPGA devices), computer software running on computer hardware, or a combination of both. The various illustrative components, blocks, and steps can be described generally according to their functionality. Whether such functionality is implemented as dedicated hardware or as software running on general-purpose hardware depends on the specific application and the design constraints imposed on the system as a whole. For each specific application, the described functionality may be implemented in different ways, but such implementation decisions should not be construed as departing from the scope of this disclosure.

[0279] Furthermore, the various exemplary logic blocks and modules described in conjunction with the embodiments disclosed herein can be implemented or executed by a machine, such as a general-purpose processor, a digital signal processor (“DSP”), an application-specific integrated circuit (“ASIC”), a field-programmable gate array (“FPGA”) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general-purpose processor can be a microprocessor, a controller, a microcontroller or state machine, a combination thereof, or the like. A processor can include circuitry configured to process computer-executable instructions. A processor can include an FPGA or other programmable device that performs logic operations without processing computer-executable instructions. A processor can also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors combined with a DSP core, or any other such configuration. While this document primarily describes digital technologies, a processor can also include components that are primarily analog. For example, some or all of the signal processing algorithms described herein can be implemented in analog circuitry or mixed analog-digital circuitry. Computing environments can include any type of computer system, including but not limited to microprocessor-based computer systems, mainframe computers, digital signal processors, portable computing devices, device controllers, or computing engines within appliances, to name just a few.

[0280] Elements of any method, process, routine, or algorithm described in connection with the disclosure herein may be embodied directly in hardware, in a software module executed by a processor, or in a combination of both. The software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, removable disk, CD-ROM, or any other form of non-transitory computer-readable storage medium. An exemplary storage medium may be coupled to a processor such that the processor can read information from and write information to the storage medium. Alternatively, the storage medium may be an integral part of the processor. The storage medium may be volatile or non-volatile. The processor and storage medium may reside in an ASIC. The ASIC may reside in a user terminal. Alternatively, the processor and storage medium may reside as discrete components in the user terminal.

[0281] The conditional language used herein, particularly terms such as “can,” “may,” “perhaps,” “can,” “for example,” etc., unless otherwise specifically stated or understood in the context in which they are used, is generally intended to express that certain features, elements, and / or steps are optional. Therefore, such conditional language is not generally intended to imply that features, elements, and / or steps are required in any way, or to imply that one or more embodiments necessarily include logic for determining whether such features, elements, and / or steps are included or whether they are always performed, with or without further input or prompting. The terms “comprising,” “including,” “having,” etc., are synonymous and used inclusively in an open-ended manner, and do not exclude additional elements, features, actions, operations, etc. Furthermore, the term “or” is used in its inclusive meaning (rather than its exclusive meaning), and thus, when used, for example, to connect a series of elements, the term “or” means one, some, or all of the elements in that list. Additionally, the term “each” as used herein, in addition to having its usual meaning, may also refer to any subset of the set of elements to which the term “each” is applied.

[0282] Unless otherwise specified, connective language such as the phrase “at least one of X, Y, and Z” should generally be understood in other ways, in the context in which it is used, to express that an item, term, etc., may be X, Y, or Z. Therefore, such connective language is not generally intended to imply that some embodiments require the presence of at least one X, at least one Y, and at least one Z.

[0283] The degree language used herein, such as the terms “approximately,” “about,” “generally,” and “substantially,” refers to a value, quantity, or characteristic that is close to the stated value, quantity, or characteristic and still performs the desired function or achieves the desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” can refer to a quantity that is less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated quantity. As another example, in some embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, quantity, or characteristic that deviates from exact parallelism by less than or equal to 10, 5, 3, or 1 degree. As another example, in some embodiments, the terms “generally perpendicular” and “substantially perpendicular” refer to a value, quantity, or characteristic that deviates from exact perpendicularity by less than or equal to 10, 5, 3, or 1 degree.

[0284] As used herein, "real-time" or "near-real-time" can refer to events that occur at the same time, occur within the same time period, or overlap in time (e.g., receiving, processing, transmitting, displaying, etc.). "Real-time" can also refer to events that occur at different or non-overlapping times, the differences between which are imperceptible and / or insignificant to humans, such as delays caused by electrical conduction or transmission. Regardless of whether real-time events occur at exactly the same time, humans can perceive them as occurring simultaneously. As a non-limiting example, "real-time" can refer to events occurring within time ranges on the order of milliseconds, seconds, tens of seconds, or minutes. For example, "real-time" can refer to events occurring within time ranges of less than 1 minute, less than 30 seconds, less than 10 seconds, less than 1 second, less than 0.05 seconds, less than 0.01 seconds, less than 0.005 seconds, less than 0.001 seconds, etc.

[0285] Unless otherwise expressly stated, articles such as “a” or “an” should generally be interpreted as including one or more of the described items. Therefore, phrases such as “device configured to…” are intended to include one or more of the described devices. Such one or more described devices may also be configured collectively to perform the stated description. For example, “processors configured to perform descriptions A, B, and C” could include a first processor configured to perform description A working in conjunction with a second processor configured to perform descriptions B and C.

[0286] As used herein, the terms “system,” “instrument,” “apparatus,” and “device” generally encompass hardware components (e.g., mechanical and electronic) as well as software components (e.g., dedicated computer programs for operational control) associated in some implementations.

[0287] It should be emphasized that many variations and modifications can be made to the embodiments described herein, and the elements of the embodiments should be understood as belonging to other acceptable examples. All such modifications and variations are intended to be included within the scope of this disclosure. Any section headings used herein are provided solely for readability and are not intended to limit the scope of the embodiments disclosed in a particular section to the features or elements disclosed in that section. The foregoing description details certain embodiments. However, it should be understood that the systems and methods described can be implemented in many ways, no matter how detailed the foregoing may appear in words. As also stated herein, it should be noted that the use of specific terms in describing certain features or aspects of the systems and methods should not be construed as implying that this document is redefining the term to be limited to any specific characteristic of the system and method that includes the features or aspects of the term associated with it.

[0288] Those skilled in the art will understand that information, messages, and signals can be represented using any of a variety of different techniques and skills. For example, data, instructions, commands, information, signals, bits, symbols, and chips that may be referenced throughout the above description can be represented by voltage, current, electromagnetic waves, magnetic fields or magnetic particles, light fields or optical particles, or any combination thereof.

[0289] While the above detailed description has shown, described, and pointed out novel features, it is understood that various omissions, substitutions, and changes can be made to the form and details of the illustrated devices or algorithms without departing from the spirit of this disclosure. As will be appreciated, certain portions of the description herein may be embodied in a form that does not provide all the features and benefits set forth herein, as some features may be used or practiced separately from other features. The scope of certain embodiments disclosed herein is indicated by the appended claims rather than by the foregoing description. All changes falling within the meaning and equivalent scope of the claims should be covered within their scope.

[0290] II. Example Terms Examples of embodiments of this disclosure may be described in light of the following example clauses. Features described in the following example embodiments may be combined with additional features disclosed herein. Furthermore, additional inventive combinations of features are disclosed herein, which are not specifically described in the following example embodiments and do not include the same features as those in the following detailed embodiments. For brevity, the following example embodiments do not identify every inventive aspect of this disclosure. The following example embodiments are not intended to identify key or essential features of any subject matter described herein. Any of the following example clauses, or any feature of the example clauses, may be combined with any one or more other example clauses, or features of the example clauses, or other features of this disclosure.

[0291] Clause 1. An intravascular lithotripsy system configured to alter calcified plaques within a subject's blood vessels, the system comprising: a sheath including a lumen configured to receive a guidewire; a first insulated wire coupled to the sheath and including a conductive member, an insulating member enclosing the conductive member, a first insulating member opening forming a first exposed portion of the first insulated wire, and a second insulating member opening forming a second exposed portion of the first insulated wire; and a second insulated wire coupled to the sheath and including a conductive member, an insulating member enclosing the conductive member of the second insulated wire, a first insulating member opening forming a first exposed portion of the second insulated wire, and a second insulating member opening forming a second exposed portion of the second insulated wire. The wire has a second insulating member opening at its second exposed portion; a third insulated wire, the third insulated wire being coupled to the sheath and including a conductive member, an insulating member enclosing the conductive member of the third insulated wire, a first insulating member opening forming the first exposed portion of the third insulated wire, and a second insulating member opening forming the second exposed portion of the third insulated wire, wherein the first insulated wire is spirally wound around the sheath, wherein the second insulated wire is spirally wound around the sheath adjacent to the first insulated wire, and wherein the third insulated wire is spirally wound around the sheath adjacent to the second insulated wire; and an energy generator configured to: at the first exposed portion of the first insulated wire... A first spark is generated between the exposed portion of the first insulated wire and the first exposed portion of the second insulated wire; a second spark is generated between the second exposed portion of the first insulated wire and the first exposed portion of the third insulated wire; and a third spark is generated between the second exposed portion of the second insulated wire and the second exposed portion of the third insulated wire, wherein the first insulated wire is directly electrically connected to the energy generator independently of the second insulated wire and the third insulated wire, and is configured to allow current to conduct across the first exposed portion of the first insulated wire between the energy generator and the second exposed portion of the first insulated wire when the second spark is formed but the first spark is not formed. The second insulated wire is directly electrically connected to the energy generator independently of the first insulated wire and the third insulated wire, and is configured to conduct current between the energy generator and the second exposed portion of the second insulated wire, across the first exposed portion of the second insulated wire, when the third spark is formed but the first spark is not formed. The third insulated wire is directly electrically connected to the energy generator independently of the second insulated wire and the third insulated wire, and is configured to conduct current between the energy generator and the second exposed portion of the third insulated wire, across the first exposed portion of the third insulated wire, when the third spark is formed but the second spark is not formed.

[0292] Clause 2. The intravascular lithotripsy system according to Clause 1, wherein the energy generator is configured to conduct current to the first insulated wire, the second insulated wire, or the third insulated wire without the need for a dedicated return lead.

[0293] Clause 3. The intravascular lithotripsy system according to any one of Clauses 1-2, wherein the energy generator is configured to independently drive voltages on the first insulated wire, the second insulated wire, and the third insulated wire to switch between operating as at least as live wires conducting current from the energy generator and as return wires conducting current to the energy generator.

[0294] Clause 4. The intravascular lithotripsy system according to any one of Clauses 1-3, wherein the energy generator is configured to drive a voltage on the first insulated wire and the second insulated wire, but not on the third insulated wire, to ignite the first spark without igniting the second spark and the third spark.

[0295] Clause 5. An intravascular lithotripsy system according to any one of Clauses 1-4, wherein a first distance between the first exposed portion of the first insulated wire and the first exposed portion of the second insulated wire is less than a second distance between the second exposed portion of the first insulated wire and the first exposed portion of the second insulated wire, wherein the energy generator is configured to induce a voltage difference within a threshold between the first insulated wire and the second insulated wire, the threshold being sufficient to induce the first spark at the first distance but insufficient to induce a fourth spark at the second distance.

[0296] Clause 6. The intravascular lithotripsy system according to any one of Clauses 1-5, wherein the first distance between the first exposed portion of the first insulated wire and the first exposed portion of the second insulated wire and the second distance between the second exposed portion of the second insulated wire and the second exposed portion of the third insulated wire are the same, thereby allowing the first spark and the third spark to be formed in response to the same voltage difference induced by the energy generator.

[0297] Clause 7. The intravascular lithotripsy system according to any one of Clauses 1-6, wherein the first exposed portion of the first insulated wire surrounds the outer surface of the sheath and is circumferentially offset relative to the second exposed portion of the first insulated wire.

[0298] Clause 8. The intravascular lithotripsy system according to any one of Clauses 1-7, wherein the first insulated wire, the second insulated wire, and the third insulated wire are of the same length.

[0299] Clause 9. The intravascular lithotripsy system according to any one of Clauses 1-8, wherein the second insulated wire extends along and contacts the first insulated wire and the third insulated wire.

[0300] Clause 10. The intravascular lithotripsy system according to any one of Clauses 1-9, wherein the distance between the second exposed portion of the first insulated wire and the proximal end of the first insulated wire is at least half the distance between the first exposed portion of the first insulated wire and the proximal end of the first insulated wire.

[0301] Clause 11. The intravascular lithotripsy system according to any one of Clauses 1-10, wherein the first insulated lead includes a proximal insulating member opening that forms a proximal exposed portion of the first insulated lead, wherein the distance between the first exposed portion of the first insulated lead and the proximal exposed portion is less than the distance between the proximal exposed portion and the proximal end of the first insulated lead.

[0302] Clause 12. The intravascular lithotripsy system according to any one of Clauses 1-11 further comprises: a fourth insulated lead wire coupled to the sheath and including a conductive member, an insulating member encapsulating the conductive member of the fourth insulated lead wire, and at least three insulating member openings forming at least three exposed portions of the fourth insulated lead wire; and wherein the first insulated lead wire includes a third insulating member opening forming a third exposed portion of the first insulated lead wire; wherein the energy generator is directly electrically connected to the fourth insulated lead wire and configured to: generate a fourth spark between the third exposed portion of the first insulated lead wire and the at least three exposed portions of the fourth insulated lead wire.

[0303] Clause 13. The intravascular lithotripsy system according to Clause 12, wherein the first, second, third and fourth exposed portions of the first insulated conductor are uniformly spaced apart.

[0304] Clause 14. The intravascular lithotripsy system according to any one of Clauses 12-13, wherein the second insulated lead includes a third insulating member opening forming a third exposed portion of the second insulated lead, wherein the energy generator is configured to ignite a sixth spark between the third exposed portion of the second insulated lead and the at least three exposed portions of the fourth insulated lead.

[0305] Clause 15. The intravascular lithotripsy system according to Clause 14, wherein the first, second, third and fourth exposed portions of the second insulated conductor are non-uniformly spaced.

[0306] Clause 16. The intravascular lithotripsy system according to any one of Clauses 1-15 further includes a balloon surrounding at least a portion of the sheath and configured to expand with a conductive fluid configured to conduct acoustic waves originating from the spark, wherein at least when the balloon expands, the exposed portions of the first insulated wire and the second insulated wire are exposed to the conductive fluid, wherein neither portion of the balloon contacts the exposed portions of the first insulated wire and the second insulated wire.

[0307] Clause 17. The intravascular lithotripsy system as described in Clause 16, wherein the balloon is coated with a drug.

[0308] Clause 18. An intravascular lithotripsy system according to any one of Clauses 1-17, wherein: the first insulated wire is wound around the sheath at a first pitch; and the second insulated wire is wound around the sheath at a second pitch substantially equal to the first pitch.

[0309] Clause 19. The intravascular lithotripsy system according to any one of Clauses 1-18, wherein the first insulated wire is wound around the sheath with a uniform pitch along the sheath.

[0310] Clause 20. The intravascular lithotripsy system according to any one of Clauses 1-19, wherein the first insulated wire is wound around the sheath with a variable pitch along the sheath.

[0311] Clause 21. The intravascular lithotripsy system according to any one of Clauses 1-20, wherein the first insulated wire and the second insulated wire are detachably electrically connected to the energy generator.

[0312] Clause 22. The intravascular lithotripsy system according to any one of Clauses 1-21 further includes a carrier encapsulating the first insulated wire, the second insulated wire, and the sheath, the carrier comprising: a first carrier opening aligned with the exposed portion of the conductive member of the first insulated wire; and a second carrier opening spaced apart from the first carrier opening and aligned with the exposed portion of the conductive member of the second insulated wire.

[0313] Clause 23. The intravascular lithotripsy system according to Clause 22, wherein the first carrier opening and the second carrier opening are configured such that the exposed portion of the conductive member is not covered by the carrier.

[0314] Clause 24. The intravascular lithotripsy system according to any one of Clauses 1-23, wherein each of the first, second, and third insulated wires is capable of generating a spark with each of the other insulated wires.

[0315] Clause 25. An intravascular lithotripsy system configured to alter calcified plaques within a subject's blood vessels, the system comprising: a sheath including a lumen configured to receive a guidewire; at least three insulated wires, each of the at least three insulated wires including at least two exposed portions spaced apart from each other along the length of the insulated wire, wherein the at least three insulated wires are helically wound around an outer surface of the sheath and are independently electrically connected to an energy generator, the exposed portions of the at least three insulated wires defining a plurality of transmitters spaced apart from each other along the length of the sheath and independently operable by the energy generator; and the energy generator configured to generate a spark via each of the plurality of transmitters.

[0316] Clause 26. The intravascular lithotripsy system according to Clause 25, wherein the plurality of transmitters comprises: a first transmitter defined by a first exposed portion of a first insulated wire and a first exposed portion of a second insulated wire of the at least three insulated wires; a second transmitter defined by a second exposed portion of the first insulated wire and a first exposed portion of a third insulated wire of the at least three insulated wires; and a third transmitter defined by a second exposed portion of the second insulated wire and a second exposed portion of the third insulated wire of the at least three insulated wires.

[0317] Clause 27. The intravascular lithotripsy system according to Clause 25, wherein each of the at least three insulated wires is configured to form at least one of the plurality of transmitters with each of the other three insulated wires.

[0318] Clause 28. The intravascular lithotripsy system according to Clause 25, wherein the plurality of transmitters are formed by the at least three insulated wires without having any other insulated wires.

[0319] Clause 29. The intravascular lithotripsy system according to Clause 25, wherein the at least three insulated leads comprise at least four insulated leads, and wherein the plurality of transmitters comprises more transmitters than the at least four insulated leads.

[0320] Clause 30. The intravascular lithotripsy system as described in Clause 25, wherein the at least three insulated leads do not include a dedicated return lead.

[0321] Clause 31. An IVL catheter for altering calcified plaques within a blood vessel of a subject, said IVL catheter comprising: A sheath including a lumen configured to receive a guidewire, wherein a longitudinal axis of the IVL catheter extends through the lumen; a first insulated wire wound around and in contact with the outer surface of the sheath, the first insulated wire including a conductive member, an insulating member enclosing the conductive member, and an insulating member opening forming an exposed portion of the conductive member; a second insulated wire wound around and in contact with the outer surface of the sheath, the second insulated wire arranged adjacent to the first insulated wire and including a conductive member, an insulating member enclosing the conductive member of the second insulated wire, and an insulating member opening forming an exposed portion of the conductive member of the second insulated wire; wherein the exposed portion of the second insulated wire is circumferentially offset relative to the exposed portion of the first insulated wire from the... An angle relative to the longitudinal axis of the first insulated wire; wherein the exposed portion of the second insulated wire is longitudinally offset relative to the exposed portion of the first insulated wire by a longitudinal distance extending parallel to the longitudinal axis along the IVL conduit; and a carrier enclosing the first insulated wire, the second insulated wire, and the sheath, the carrier comprising: a first carrier opening aligned with the exposed portion of the conductive member of the first insulated wire; and a second carrier opening spaced apart from the first carrier opening and aligned with the exposed portion of the conductive member of the second insulated wire; wherein the IVL conduit is configured to be electrically connected to an energy generator operable to cause a spark to travel longitudinally along the IVL conduit and circumferentially around the IVL conduit between the exposed portions of the first and second insulated wires.

[0322] Clause 32. The IVL conduit according to Clause 31, wherein the carrier includes an inner surface configured to contact the first insulated conductor and the second insulated conductor and an outer surface opposite the inner surface, wherein the IVL conduit is configured such that the spark travels from the exposed portion of the first insulated conductor, through the first carrier opening, over the outer surface of the carrier, through the second carrier opening, and to the exposed portion of the second insulated conductor.

[0323] Clause 33. The IVL catheter according to any one of Clauses 31-32, wherein the carrier has a fixed volume.

[0324] Clause 34. An IVL catheter according to any one of Clauses 31-33, wherein the carrier comprises a material different from at least one of the conductive member of the insulated wire or the sheath.

[0325] Clause 35. An IVL catheter according to any one of Clauses 31-34, wherein the first carrier opening and the second carrier opening are configured such that the exposed portion of the conductive member is not covered by the carrier.

[0326] Clause 36. The IVL catheter according to any one of Clauses 31-35 further includes a balloon configured to contain conductive fluid around at least a portion of the sheath, wherein the carrier inhibits the balloon from contacting the exposed portions of the conductive members of the first and second insulated wires, wherein the exposed portions of the conductive members of the first and second insulated wires are exposed to the conductive fluid.

[0327] Clause 37. The IVL catheter according to Clause 36, wherein the carrier is configured to separate the balloon from the exposed portions of the conductive members of the first and second insulated wires.

[0328] Clause 38. The IVL catheter as described in Clause 36, wherein the balloon is coated with a drug.

[0329] Clause 39. An IVL catheter according to any one of Clauses 31-38, wherein: the first insulating wire is wound around the outer surface of the sheath at a first pitch; and the second insulating wire is wound around the outer surface of the sheath at a second pitch substantially equal to the first pitch.

[0330] Clause 40. An IVL catheter according to any one of Clauses 31-39, wherein the first insulated wire is wound around the outer surface of the sheath at a uniform pitch along the sheath.

[0331] Clause 41. An IVL catheter according to any one of Clauses 31-40, wherein the first insulated wire is wound around the outer surface of the sheath at a variable pitch along the sheath.

[0332] Clause 42. The IVL catheter according to any one of Clauses 31-41 further includes an energy generator configured to: generate an energy difference between (i) the exposed portion of the conductive member of the first insulated conductor and (ii) the exposed portion of the conductive member of the second insulated conductor to generate the spark between the exposed portions of the conductive members of the first insulated conductor and the second insulated conductor.

[0333] Clause 43. The IVL conduit according to Clause 42, wherein the first insulated wire and the second insulated wire are detachably electrically connected to the energy generator.

[0334] Clause 44. An IVL catheter for altering calcified plaques within a blood vessel of a subject, the IVL catheter comprising: a sheath including a lumen configured to receive a guidewire; a first insulated wire including a conductive member, an insulating member enclosing the conductive member, and an insulating member opening forming an exposed portion of the conductive member; a second insulated wire disposed adjacent to the first insulated wire and including a conductive member, an insulating member enclosing the conductive member of the second insulated wire, and an insulating member opening forming an exposed portion of the conductive member of the second insulated wire; and a longitudinal axis extending through the sheath; wherein the first insulated wire and the second insulated wire are wound around the sheath such that: the exposed portion of the second insulated wire is disposed at a different longitudinal position relative to the longitudinal axis than the exposed portion of the first insulated wire; and the exposed portion of the second insulated wire is disposed at an angular position relative to a plane defined perpendicularly to the longitudinal axis than the exposed portion of the first insulated wire.

[0335] Clause 45. The IVL conduit according to Clause 44, wherein the first insulated conductor and the second insulated conductor are configured to be electrically connected to an energy generator operable to cause a spark to travel: longitudinally along the IVL conduit from the exposed portion of the first insulated conductor to the exposed portion of the second insulated conductor; and circumferentially around the IVL conduit from the exposed portion of the first insulated conductor to the exposed portion of the second insulated conductor.

[0336] Clause 46. An IVL catheter according to any one of Clauses 44-45, wherein: the first insulating wire is wound around the sheath at a first pitch; and the second insulating wire is wound around the sheath at a second pitch substantially equal to the first pitch.

[0337] Clause 47. An IVL catheter for altering calcified plaques within a blood vessel of a subject, the IVL catheter comprising: a sheath including a lumen configured to receive a guidewire; a first insulated wire including a conductive member, an insulating member enclosing the conductive member, and an insulating member opening forming an exposed portion of the conductive member; a second insulated wire including a conductive member, an insulating member enclosing the conductive member, and an insulating member opening forming an exposed portion of the conductive member of the second insulated wire; and a longitudinal axis extending through the sheath; wherein the first and second insulated wires are wound around the sheath such that: a transverse section through the IVL catheter and perpendicular to the longitudinal axis passes through the exposed portion of the first insulated wire but not through the exposed portion of the second insulated wire; and a longitudinal section through the IVL catheter and parallel to the longitudinal axis passes through the exposed portion of the first insulated wire but not through the exposed portion of the second insulated wire.

[0338] Clause 48. The IVL conduit according to Clause 47, wherein the first insulated conductor and the second insulated conductor are configured to be electrically connected to an energy generator operable to cause a spark to travel: longitudinally along the IVL conduit from the exposed portion of the first insulated conductor to the exposed portion of the second insulated conductor; and circumferentially around the IVL conduit from the exposed portion of the first insulated conductor to the exposed portion of the second insulated conductor.

[0339] Clause 49. An IVL catheter according to any one of Clauses 47-48, wherein: the first insulating wire is wound around the sheath at a first pitch; and the second insulating wire is wound around the sheath at a second pitch substantially equal to the first pitch.

[0340] Clause 50. An intravascular lithotripsy system configured to alter calcified plaques within a blood vessel of a subject, the system comprising: a sheath including a lumen configured to receive a guidewire; a first insulated wire helically wound around and in contact with an outer surface of the sheath, the first insulated wire including a conductive member, an insulating member encapsulating the conductive member, and an opening in the insulating member forming an exposed portion of the first insulated wire; and a second insulated wire helically wound around and in contact with the outer surface of the sheath, the second insulated wire being arranged adjacent to and in contact with the first insulated wire. The contact includes a conductive member, an insulating member encapsulating the conductive member, and an opening in the insulating member forming an exposed portion of the second insulated wire, wherein the second insulated wire is helically wound parallel to the first insulated wire; and an energy generator electrically connected to the first and second insulated wires and configured to: (i) generate a voltage difference between the exposed portions of the first and second insulated wires and (ii) generate a voltage difference exceeding a threshold to generate a spark between the exposed portions of the first and second insulated wires.

[0341] Clause 51. The system according to Clause 50, wherein: the energy difference is a first energy difference; the insulating member opening of the first insulated wire is a first insulating member opening of the first insulated wire, and the exposed portion of the first insulated wire is a first exposed portion of the first insulated wire; the first insulated wire further includes a second insulating member opening forming a second exposed portion of the first insulated wire; the system further includes a third insulated wire spirally wound around and in contact with the outer surface of the sheath, the third insulated wire being arranged adjacent to one of the first insulated wire or the second insulated wire, and including a conductive member, an insulating member encapsulating the conductive member of the third insulated wire, and an insulating member opening forming an exposed portion of the conductive member of the third insulated wire; and the energy generator is electrically connected to the third insulated wire and is further configured to: induce a second voltage difference between (i) the second exposed portion of the first insulated wire and (ii) the exposed portion of the third insulated wire; and cause the second energy difference to exceed the energy threshold to induce a spark between the second exposed portion of the first insulated wire and the exposed portion of the third insulated wire.

[0342] Clause 52. The system according to Clause 51, wherein the first voltage difference has the same energy as the second voltage difference.

[0343] Clause 53. The system according to any one of Clauses 51-52, wherein each of the first insulated wire, the second insulated wire, and the third insulated wire is independently electrically connected to the energy generator.

[0344] Clause 54. The system according to any one of Clauses 51-53, wherein the sheath includes a length; and the first exposed portion and the second exposed portion of the first insulated wire, and the exposed portions of the second insulated wire and the third insulated wire, are arranged such that: a spark induced between the first exposed portion of the first insulated wire and the exposed portion of the second insulated wire is induced at a first position along the length direction of the sheath; a spark induced between the second exposed portion of the first insulated wire and the exposed portion of the third insulated wire is induced at a second position along the length direction of the sheath; and the second position is spaced apart from the first position.

[0345] Clause 55. The system according to any one of Clauses 51-54, wherein the system is configured to induce the first energy difference between (i) the first exposed portion of the first insulated conductor and (ii) the exposed portion of the second insulated conductor, without inducing the second energy difference between (i) the second exposed portion of the first insulated conductor and (ii) the exposed portion of the third insulated conductor.

[0346] Clause 56. A system according to any one of Clauses 51-55, wherein: the insulating member opening of the second insulated conductor is a first insulating member opening of the second insulated conductor, and the exposed portion of the second insulated conductor is a first exposed portion of the second insulated conductor; the second insulated conductor further includes a second insulating member opening forming a second exposed portion of the second insulated conductor; the insulating member opening of the third insulated conductor is a first insulating member opening of the third insulated conductor, and the exposed portion of the third insulated conductor is a first exposed portion of the third insulated conductor; the third insulated conductor further includes a second insulating member opening forming a second exposed portion of the third insulated conductor; the energy generator is further configured to: induce the third voltage difference between (i) the second exposed portion of the second insulated conductor and (ii) the second exposed portion of the third insulated conductor; and cause the third energy difference to exceed the energy threshold to induce a spark between the second exposed portion of the second insulated conductor and the second exposed portion of the third insulated conductor.

[0347] Clause 57. The system according to any one of Clauses 50-56 further includes a balloon surrounding at least a portion of the sheath and configured to expand with a conductive fluid configured to conduct acoustic waves originating from the spark, wherein the exposed portions of the first insulated wire and the second insulated wire are exposed to the conductive fluid at least during balloon expansion, wherein no portion of the balloon contacts the exposed portions of the first insulated wire and the second insulated wire.

[0348] Clause 58. The system according to any one of Clauses 50-57, wherein: the first insulated wire is wound around the outer surface of the sheath at a first pitch; and the second insulated wire is wound around the outer surface of the sheath at a second pitch substantially equal to the first pitch.

[0349] Clause 59. The system according to any one of Clauses 50-58, wherein the first insulated wire is wound around the outer surface of the sheath at a uniform pitch along the sheath.

[0350] Clause 60. The system according to any one of Clauses 50-59, wherein the first insulated wire is wound around the outer surface of the sheath at a variable pitch along the sheath.

[0351] Clause 61. The system according to any one of Clauses 50-60, wherein the first insulated wire and the second insulated wire are detachably electrically connected to the energy generator.

[0352] Clause 62. The system according to any one of Clauses 50-61 further includes a carrier encapsulating the first insulated wire, the second insulated wire, and the sheath, the carrier comprising: a first carrier opening aligned with the exposed portion of the conductive member of the first insulated wire; and a second carrier opening spaced apart from the first carrier opening and aligned with the exposed portion of the conductive member of the second insulated wire.

[0353] Clause 63. The system according to Clause 62, wherein the first carrier opening and the second carrier opening are configured such that the exposed portion of the conductive member is not covered by the carrier.

[0354] Clause 64. An intravascular lithotripsy system configured to alter calcified plaques within a blood vessel of a subject, the system comprising: a sheath including a lumen configured to receive a guidewire; a first insulated wire wound around and in contact with an outer surface of the sheath, the first insulated wire including a conductive member, an insulating member enclosing the conductive member, and an insulating member opening forming an exposed portion of the first insulated wire; a second insulated wire wound around and in contact with the outer surface of the sheath, the second insulated wire disposed adjacent to the first insulated wire and including a conductive member, an insulating member enclosing the conductive member, and an insulating member opening forming an exposed portion of the second insulated wire; and an energy generator electrically connected to the first and second insulated wires and configured to generate a spark between the exposed portions of the first and second insulated wires.

[0355] Clause 65. The system according to Clause 64 further includes a balloon surrounding at least a portion of the sheath and configured to expand with a conductive fluid configured to conduct acoustic waves originating from the spark.

[0356] Clause 66. The system according to Clause 65, wherein the balloon is configured to transition between an inflated state and a non-inflated state, and wherein, at least when the balloon is in the inflated state, the exposed portions of the first insulated wire and the second insulated wire are exposed to the conductive fluid.

[0357] Clause 67. The system according to any one of Clauses 65-66, wherein the balloon is configured to transition between an inflated state and a non-inflated state, and wherein the exposed portions of the first insulated wire and the second insulated wire are exposed to the conductive fluid when the balloon is in the inflated state and when the balloon is in the non-inflated state.

[0358] Clause 68. The system according to any one of Clauses 65-67, wherein the system is configured such that no part of the balloon comes into contact with the exposed portions of the first insulated wire and the second insulated wire.

[0359] Clause 69. The system according to any one of Clauses 65-68, wherein the balloon is configured to transition between an inflated state and a non-inflated state, and wherein the system is configured such that: when the balloon is in the inflated state, no part of the balloon comes into contact with the exposed portions of the first insulating wire and the second insulating wire; and when the balloon is in the non-inflated state, no part of the balloon comes into contact with the exposed portions of the first insulating wire and the second insulating wire.

[0360] Clause 70. The system according to any one of Clauses 64-69, wherein: the first insulated wire is wound around the outer surface of the sheath at a first pitch; and the second insulated wire is wound around the outer surface of the sheath at a second pitch substantially equal to the first pitch.

[0361] Clause 71. The system according to any one of Clauses 64-70, wherein the first insulated wire is wound around the outer surface of the sheath at a uniform pitch along the sheath.

[0362] Clause 72. The system according to any one of Clauses 64-71, wherein the first insulated wire is wound around the outer surface of the sheath at a variable pitch along the sheath.

[0363] Clause 73. The system according to any one of Clauses 64-72, wherein the first insulated wire and the second insulated wire are independently electrically connected to the energy generator.

[0364] Clause 74. The system according to any one of Clauses 64-73, wherein the first insulated wire and the second insulated wire are detachably electrically connected to the energy generator.

[0365] Clause 75. The system according to any one of Clauses 64-74 further includes a carrier encapsulating the first insulated wire, the second insulated wire, and the sheath, the carrier comprising: a first carrier opening aligned with the exposed portion of the conductive member of the first insulated wire; and a second carrier opening spaced apart from the first carrier opening and aligned with the exposed portion of the conductive member of the second insulated wire.

[0366] Clause 76. The system according to Clause 75, wherein the first carrier opening and the second carrier opening are configured such that the exposed portion of the conductive member is not covered by the carrier.

[0367] Clause 77. The system according to any one of Clauses 64-76, wherein: the sheath includes a sheath length; the first insulated wire includes a first length; the second insulated wire includes a second length; and both the first length and the second length are greater than the sheath length.

[0368] Clause 78. A method of manufacturing an IVL catheter, comprising: providing a sheath including a lumen configured to receive a guidewire; helically winding a first insulated wire around the sheath, the first insulated wire including a conductive member and an insulating member encapsulating the conductive member; helically winding a second insulated wire around the sheath, the second insulated wire including a conductive member and an insulating member encapsulating the conductive member of the second insulated wire; and forming an opening in the insulating member in the first insulated wire to form an exposed portion of the first insulated wire; and forming an opening in the insulating member in the second insulated wire to form an exposed portion of the second insulated wire to allow the formation of a spark between the exposed portions of the first insulated wire and the second insulated wire.

[0369] Clause 79. The method according to Clause 78 further includes forming the openings in the insulating members of the first and second insulated wires using a laser.

[0370] Clause 80. The method according to any one of Clauses 78-79 further includes spirally winding the second insulated wire adjacent to the first insulated wire.

[0371] Clause 81. The method according to any one of Clauses 78-80 further comprises: spirally winding the first insulated wire around the sheath with a first pitch; and spirally winding the second insulated wire around the sheath with a second pitch, wherein the first pitch is the same as the second pitch.

[0372] Clause 82. The method according to any one of Clauses 78-81 further comprises spirally winding the first insulated wire around the sheath with a uniform pitch.

[0373] Clause 83. The method according to any one of Clauses 78-82 further includes spirally winding the first insulated wire around the sheath with a variable pitch.

[0374] Clause 84. The method according to any one of Clauses 78-83 further comprises spirally winding the first insulated wire around the sheath before forming the opening of the insulating member in the first insulated wire.

[0375] Clause 85. The method according to any one of Clauses 78-84 further comprises forming an opening in the insulating member in the first insulating wire before spirally winding the first insulating wire around the sheath.

[0376] Clause 86. The method according to any one of Clauses 78-85 further includes providing a carrier for encapsulating the first insulated conductor, the second insulated conductor, and the sheath.

[0377] Clause 87. The method according to Clause 86 further comprises: forming a first carrier opening aligned with the exposed portion of the conductive member of the first insulated wire; and forming a second carrier opening spaced apart from the first carrier opening and aligned with the exposed portion of the conductive member of the second insulated wire.

[0378] Clause 88. The method according to Clause 87 further comprises: forming the first carrier opening when forming the exposed portion of the conductive member of the first insulated wire; and forming the second carrier opening when forming the exposed portion of the conductive member of the second insulated wire.

[0379] Clause 89. The method according to any one of Clauses 87-88 further includes forming the first carrier opening and the second carrier opening with a laser.

Claims

1. An intravascular lithotripsy system configured to alter calcified plaques within a subject's blood vessels, the system comprising: A sheath, the sheath including a lumen configured to receive a guidewire; A first insulated wire, the first insulated wire being connected to the sheath and including a conductive member, an insulating member enclosing the conductive member, a first insulating member opening forming a first exposed portion of the first insulated wire, and a second insulating member opening forming a second exposed portion of the first insulated wire; A second insulated wire, the second insulated wire being connected to the sheath and including a conductive member, an insulating member enclosing the conductive member of the second insulated wire, a first insulating member opening forming a first exposed portion of the second insulated wire, and a second insulating member opening forming a second exposed portion of the second insulated wire; A third insulated conductor, connected to the sheath and including a conductive member, an insulating member enclosing the conductive member, a first insulating member opening forming a first exposed portion of the third insulated conductor, and a second insulating member opening forming a second exposed portion of the third insulated conductor. The first insulated wire is spirally wound around the sheath. The second insulated wire is spirally wound around the sheath adjacent to the first insulated wire. The third insulated wire is spirally wound around the sheath, adjacent to the second insulated wire; and An energy generator, the energy generator being configured to: A first spark is generated between the first exposed portion of the first insulated wire and the first exposed portion of the second insulated wire; A second spark is generated between the second exposed portion of the first insulated wire and the first exposed portion of the third insulated wire; as well as A third spark is generated between the second exposed portion of the second insulated wire and the second exposed portion of the third insulated wire. The first insulated wire is directly electrically connected to the energy generator independently of the second and third insulated wires, and is configured to allow current to conduct between the energy generator and the second exposed portion of the first insulated wire, across the first exposed portion of the first insulated wire, when the second spark is formed but the first spark is not formed. The second insulated wire is directly electrically connected to the energy generator independently of the first and third insulated wires, and is configured to allow current to conduct between the energy generator and the second exposed portion of the second insulated wire across the first exposed portion of the second insulated wire when the third spark is formed but the first spark is not formed. The third insulated wire is directly electrically connected to the energy generator independently of the second insulated wire and the second insulated wire, and is configured to conduct current between the energy generator and the second exposed portion of the third insulated wire across the first exposed portion of the third insulated wire when the third spark is formed but the second spark is not formed.

2. The intravascular lithotripsy system of claim 1, wherein the energy generator is configured to conduct current to the first insulated wire, the second insulated wire, or the third insulated wire without the need for a dedicated return wire.

3. The intravascular lithotripsy system according to any one of claims 1-2, wherein the energy generator is configured to independently drive voltages on the first insulated wire, the second insulated wire, and the third insulated wire, such that the first insulated wire, the second insulated wire, and the third insulated wire switch between operating as at least as a live wire conducting current from the energy generator and as a return wire conducting current to the energy generator.

4. The intravascular lithotripsy system according to any one of claims 1-3, wherein the energy generator is configured to drive a voltage on the first insulated wire and the second insulated wire, but not on the third insulated wire, to ignite the first spark without igniting the second spark and the third spark.

5. The intravascular lithotripsy system according to any one of claims 1-4, wherein a first distance between the first exposed portion of the first insulated wire and the first exposed portion of the second insulated wire is less than a second distance between the second exposed portion of the first insulated wire and the first exposed portion of the second insulated wire, wherein the energy generator is configured to induce a voltage difference within a threshold between the first insulated wire and the second insulated wire, the threshold being sufficient to induce the first spark at the first distance but insufficient to induce a fourth spark at the second distance.

6. The intravascular lithotripsy system according to any one of claims 1-5, wherein the first distance between the first exposed portion of the first insulated wire and the first exposed portion of the second insulated wire and the second distance between the second exposed portion of the second insulated wire and the second exposed portion of the third insulated wire are the same, thereby allowing the first spark and the third spark to be formed in response to the same voltage difference induced by the energy generator.

7. The intravascular lithotripsy system according to any one of claims 1-6, wherein the second insulated wire extends along the first insulated wire and the third insulated wire and contacts the first insulated wire and the third insulated wire.

8. The intravascular lithotripsy system according to any one of claims 1-7, further comprising: A fourth insulated conductor, the fourth insulated conductor being coupled to the sheath and including a conductive member, an insulating member enclosing the conductive member of the fourth insulated conductor, and at least three insulating member openings forming at least three exposed portions of the fourth insulated conductor; and The first insulated conductor includes a third insulating member opening forming a third exposed portion of the first insulated conductor; The energy generator is directly electrically connected to the fourth insulated wire and is configured as follows: A fourth spark is generated between the third exposed portion of the first insulated wire and the at least three exposed portions of the fourth insulated wire.

9. The intravascular lithotripsy system according to any one of claims 1-8, further comprising a balloon surrounding at least a portion of the sheath and configured to expand with a conductive fluid configured to conduct acoustic waves originating from the spark, wherein at least when the balloon expands, the exposed portions of the first insulated wire and the exposed portions of the second insulated wire are exposed to the conductive fluid, wherein neither portion of the balloon comes into contact with the exposed portions of the first insulated wire and the exposed portions of the second insulated wire.

10. The intravascular lithotripsy system of claim 9, wherein the balloon is coated with a drug.

11. The intravascular lithotripsy system according to any one of claims 1-10, wherein: The first insulated wire is wound around the sheath at a first pitch; and The second insulated wire is wound around the sheath at a second pitch that is substantially equal to the first pitch.

12. The intravascular lithotripsy system of claim 11, wherein the first pitch is uniform along the sheath.

13. The intravascular lithotripsy system according to any one of claims 1-11, further comprising a carrier encapsulating the first insulated wire, the second insulated wire, and the sheath, the carrier comprising: A first carrier opening is aligned with the exposed portion of the conductive member of the first insulated wire; as well as The second carrier opening is spaced apart from the first carrier opening and aligned with the exposed portion of the conductive member of the second insulated wire.

14. The intravascular lithotripsy system according to any one of claims 1-13, wherein each of the first insulated wire, the second insulated wire, and the third insulated wire is capable of generating a spark with each of the other insulated wires.

15. An intravascular lithotripsy system configured to alter calcified plaques within a subject's blood vessels, the system comprising: A sheath, the sheath including a lumen configured to receive a guidewire; At least three insulated wires, each of which includes at least two exposed portions spaced apart from each other along the length of the insulated wire, wherein the at least three insulated wires are spirally wound around the sheath and are independently electrically connected to the energy generator, and the exposed portions of the at least three insulated wires define a plurality of transmitters spaced apart from each other along the length of the sheath and independently operable by the energy generator; as well as The energy generator is configured to generate a spark via each of the plurality of emitters.

16. The intravascular lithotripsy system of claim 15, wherein the plurality of transmitters comprises: A first transmitter is defined by a first exposed portion of a first insulated wire and a first exposed portion of a second insulated wire of the at least three insulated wires. The second transmitter is defined by a second exposed portion of the first insulated wire and a first exposed portion of the third insulated wire among the at least three insulated wires; as well as The third transmitter is defined by the second exposed portion of the second insulated wire and the second exposed portion of the third insulated wire among the at least three insulated wires.

17. The intravascular lithotripsy system according to any one of claims 15-16, wherein each of the at least three insulated wires is configured to form at least one of the plurality of transmitters with each of the other three insulated wires.

18. The intravascular lithotripsy system according to any one of claims 15-17, wherein the plurality of transmitters are formed by the at least three insulated wires without having any other insulated wires.

19. The intravascular lithotripsy system according to any one of claims 15-18, wherein the at least three insulated wires comprise at least four insulated wires, and wherein the plurality of transmitters comprises more transmitters than the at least four insulated wires.

20. The intravascular lithotripsy system according to any one of claims 15-19, wherein the at least three insulated wires do not include a dedicated return wire.

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