Site emitter shock waveguide device with increased longevity and higher acoustic output

Abstract

An example shockwave guide tube system includes a tube body comprising a lumen, a transmitter wire configured to generate a shockwave, wherein one or more gaps are formed between two or more portions of the transmitter wire along a length of the tube body, each of the one or more gaps forming a site transmitter, a carrier wire configured to conduct electrical power to the transmitter wire, and one or more electrical joints configured to electrically couple and join the transmitter wire and the carrier wire.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Non-Provisional Application No. 18 / 586,299, filed February 23, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This disclosure relates generally to the field of medical devices and methods, and more specifically to shock wave catheter devices for treating calcified lesions in body cavities, such as calcifications and occlusions in the vascular system and kidney stones in the urinary system. Background Technology

[0003] Various catheters have been developed for treating calcified lesions, such as those in the vascular system associated with arterial disease. For example, treatment systems used in percutaneous coronary angioplasty or peripheral angioplasty use an angioplasty balloon to dilate the calcified lesion and restore normal blood flow to the vessel. In these types of procedures, a catheter carrying a balloon is advanced along a guidewire into the vascular system until the balloon is aligned with the calcified plaque. The balloon is then inflated (typically greater than 10 atm) to push the calcified plaque back into the vessel wall and dilate the occluded area of ​​the vascular system.

[0004] Recently, techniques and treatments for intravascular lithotripsy (IVL) have been developed, which is an interventional procedure used to improve calcified plaques in diseased arteries. The mechanism of plaque improvement is achieved through the use of a catheter with one or more acoustic shock wave generating sources located within a fluid that can generate acoustic shock waves to improve calcified plaques. IVL devices vary in design regarding the energy source used to generate the acoustic shock waves, with two exemplary energy sources being electrohydraulic generation and laser generation.

[0005] For electrohydraulic generation of acoustic shock waves, a conductive solution (e.g., saline) can be contained within a housing surrounding the electrodes, or flushed through a tube surrounding the electrodes. Improvement of calcified plaques is achieved by generating acoustic shock waves within the catheter through transelectrode discharge. This discharge produces one or more rapidly expanding vapor bubbles, thus generating acoustic shock waves. These shock waves propagate radially outward and improve calcified plaques within the blood vessel. For laser-generated acoustic shock waves, a laser pulse is transmitted into the fluid within the catheter and absorbed by the fluid. This absorption process rapidly heats the fluid and causes it to evaporate, generating rapidly expanding vapor bubbles and acoustic shock waves that propagate outward and improve calcified plaques. If a fluid exhibiting strong absorption at the laser wavelength used is selected, the intensity of the acoustic shock waves is higher. These examples of IVL devices are not intended to comprehensively list all potential energy sources for generating IVL shock waves.

[0006] IVL (intravascular coagulation) can be considered different from standard atherosclerotic plaque resection because it breaks up calcifications but does not release them from the tissue. Therefore, IVL generally does not require aspiration or embolization protection. Furthermore, due to the compliance of normal vessels and non-calcified plaques, the shock wave generated by IVL does not alter normal vascular tissue or non-calcified plaques. In addition, IVL does not carry the same risks of perforation, anatomical changes, or other damage to the vascular system as atherosclerotic resection or angioplasty using cutting or scribing balloons.

[0007] More specifically, catheters for delivering IVL treatment have been developed that include electrode pairs for electrohydraulically generating shock waves within an angioplasty balloon. Shock wave devices can be particularly effective for treating calcified plaque lesions because the acoustic pressure from the shock waves can rupture or destroy the lesion near the angioplasty balloon without damaging surrounding tissue. In these devices, the catheter is advanced over a guidewire through the patient's vascular system until it is positioned proximal to and / or aligned with the calcified plaque lesion in the body cavity. The balloon is then inflated with a conductive fluid (using a relatively low pressure of 2 atm to 4 atm) to inflate it to contact the lesion, but the inflation pressure is insufficient to substantially displace the lesion. Voltage pulses can then be applied across the electrodes in the electrode pair to generate an acoustic shock wave that propagates through the wall of the angioplasty balloon into the lesion. Once the acoustic shock wave ruptures the lesion, the balloon can be further inflated to increase the cross-sectional area of ​​the lumen and improve blood flow within the lumen. Alternative devices for delivering IVL treatment can be located within a closed volume (such as a cap, various compliant balloons, or other housings) other than angioplasty balloons.

[0008] Electrohydraulic shock wave transmitters (e.g., electrode pairs for generating shock waves) can have certain properties that can be improved. For example, the electrode pair may include cylinders comprising an outer electrode surrounding an inner electrode, with a sleeve positioned between the outer and inner electrodes. The cross-sectional profile of the electrodes may be larger than desired, thereby reducing the deliverability of the catheter during treatment. Furthermore, the cylinders may be rigid, also reducing deliverability. Additionally, portions of the conductor near or at the transmitter strip may degrade or corrode due to exposure to high-voltage pulses (e.g., greater than 3 kV) and / or the large number of pulses used to generate the shock wave. Degradation or corrosion can reduce catheter life and decrease its acoustic output. Flexible catheters with lower cross-sectional profiles, increased life, higher acoustic output, or a combination thereof may be required. Summary of the Invention

[0009] This document describes systems and methods for reducing cross-sectional profile, increasing flexibility, increasing lifespan, and / or increasing the acoustic output of a shock wave duct system. A duct may include: a duct body comprising one or more lumens; one or more conductive elements positioned along the duct body; and one or more shock wave emitters formed by exposed portions of at least one of the conductive elements separated by a spark gap. These shock wave emitters may be formed using spaces between segments of a first conductive element (e.g., an emitter wire), which may be at least partially located within the duct housing (e.g., a balloon). These shock wave emitters may be configured to generate a shock wave when a sufficiently high voltage is applied to the gap separating the segments of the emitter wire. The emitter wire may contain a highly durable material capable of withstanding high-voltage pulses and / or large pulses before deterioration or corrosion. In some examples, a second conductive element (referred to herein as a carrier wire) may be located in a channel within the conduit body (e.g., a conduit formed within the conduit body in which the wire is positioned / fixed) and may be configured to deliver current from a power source to these shock wave transmitters by conducting current to the transmitter wire. One or more electrical connectors may be configured to electrically connect and engage the transmitter wire and the carrier wire.

[0010] According to some aspects, an exemplary shock wave conduit system includes: a conduit body including a lumen; a transmitter wire configured to generate a shock wave, wherein one or more gaps are formed between two or more portions of the transmitter wire along the length of the conduit body, each of the one or more gaps forming a site transmitter; a carrier wire configured to conduct electricity to the transmitter wire; and one or more electrical connectors configured to electrically connect and engage the transmitter wire and the carrier wire.

[0011] Optionally, the system includes: a housing configured to be filled or inflated with fluid, wherein the transmitter wire is at least partially located within the housing. Optionally, the transmitter wire is positioned along the distal end of the shock waveguide system. Optionally, the transmitter wire comprises molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, or combinations thereof. Optionally, the diameter of the transmitter wire is between 0.002'' and 0.010''. Optionally, the transmitter wire is a flat wire or has a semi-circular profile. Optionally, the carrier wire is positioned along the proximal end of the shock waveguide system. Optionally, the carrier wire comprises copper. Optionally, the diameter of the carrier wire is larger than the diameter of the transmitter wire. Optionally, the one or more electrical connectors are located near the distal end of the conduit body and proximal to the transmitter wire. Optionally, the one or more electrical connectors are formed using spot welding, laser welding, crimping, wrapping stripped wires together, brazing, forging, conductive adhesive, ferrule pins, or combinations thereof. Optionally, the number of the one or more site transmitters is between 1 and 16 site transmitters, including 1 and 16.

[0012] Optionally, the system includes a wire wrap or marking tape located at the distal end of the shock wave duct system. Optionally, the one or more site emitters form an emitter region, wherein site emitters in the same emitter region are locatingly aligned along the length of the duct body. Optionally, the one or more site emitters include at least two site emitters angularly aligned along the circumference of the duct body. Optionally, the at least two site emitters angularly aligned along the circumference of the lumen are spaced 180 degrees apart around the circumference of the duct body.

[0013] Optionally, the system includes: a protective layer located between the conduit body and the transmitter lead. Optionally, the transmitter lead comprises a first material, and the carrier lead comprises a second material different from the first material. Optionally, relative to the second material, the first material has a high melting point, high resistivity, low conductivity, high stiffness, high density, or any combination thereof. Optionally, the diameter of the transmitter lead is between 0.08 mm and 0.23 mm. Optionally, the carrier lead is located proximal to the transmitter lead. Optionally, the system includes: a protective layer positioned to at least partially surround one or both of the transmitter lead and the carrier lead, and wherein the protective layer secures one or both of the transmitter lead and the carrier lead to the conduit body.

[0014] According to some aspects, a method for forming a shock wave duct system includes: laying a transmitter wire; securing the transmitter wire to a distal end of a duct body; cutting the transmitter wire at one or more locations of one or more electrical connectors; laying a carrier wire; securing the carrier wire to a proximal end of the duct body; and forming one or more electrical connectors for electrically connecting and joining the transmitter wire and the carrier wire. Optionally, forming the one or more electrical connectors includes: clamping the transmitter wire and the carrier wire; and fusing the transmitter wire and the carrier wire together using a laser. Optionally, forming the one or more electrical connectors includes: crimping a conductive cylinder or a ferrule pin comprising copper, brass, silver, tin, stainless steel, or a combination thereof. Optionally, forming the one or more electrical connectors includes: clamping the transmitter wire and the carrier wire; passing current through the transmitter wire, the carrier wire, or both to generate heat; and fusing the transmitter wire and the carrier wire together. Optionally, the transmitter wire comprises molybdenum, and the carrier wire comprises copper.

[0015] According to some aspects, a shock wave duct system includes: a duct comprising: a duct body including a lumen; a conductive element configured to generate a shock wave, wherein the conductive element includes one or more gaps along the length of the duct body, each of the one or more gaps forming a shock wave emitter, wherein the conductive element comprises molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, or combinations thereof; and a power source electrically connected to the conductive element.

[0016] According to some aspects, a method for emitting shock waves in a body cavity includes: positioning a distal portion of the catheter according to claim 1 adjacent to a lesion in a blood vessel; and emitting one or more shock waves from one or more site transmitters such that the one or more shock waves propagate toward and impact the lesion and apply a pressure between 25 atm and 75 atm.

[0017] According to some aspects, a shock wave duct system includes: a duct comprising: a duct body including a lumen; a transmitter wire configured to generate a shock wave, wherein the transmitter wire includes one or more gaps along the length of the lumen, each of the one or more gaps forming a shock wave transmitter; a carrier wire configured to conduct electricity to the transmitter wire; and one or more electrical connectors configured to electrically connect and engage the transmitter wire and the carrier wire; and a power source electrically connected to the carrier wire.

[0018] Optionally, the conduit further includes a housing configured to be filled or inflated with fluid, and the transmitter lead is located within the housing. Optionally, the transmitter lead is positioned along the distal end of the conduit body. Optionally, the transmitter lead comprises molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, or combinations thereof. Optionally, the diameter of the transmitter lead is greater than or equal to 0.08 mm and less than or equal to 0.23 mm. Optionally, the carrier lead is located proximal to the transmitter lead. Optionally, the carrier lead comprises copper. Optionally, the carrier lead has a lower resistivity than the transmitter lead. Optionally, the transmitter lead comprises a first metal, and the carrier lead comprises a second metal different from the first metal. Optionally, the one or more shock wave emitters comprise at least two shock wave emitters angled together along the circumference of the lumen. Attached Figure Description

[0019] The illustrative aspects of this disclosure are described in detail below with reference to the accompanying drawings. The embodiments and drawings disclosed herein are intended to be illustrative and exemplary, and not restrictive.

[0020] Figure 1A A side view of an exemplary angioplasty balloon catheter according to some implementation schemes is shown.

[0021] Figure 1B Examples of cylindrical inner and outer electrodes according to some embodiments are shown.

[0022] Figure 2 A side view of an exemplary conduit, including multiple site transmitters positioned within a housing, is shown according to some examples.

[0023] Figure 3 A side view of an exemplary portion of a catheter, according to some aspects, is shown, the catheter including a plurality of site emitters positioned along a catheter body including at least one lumen.

[0024] Figure 4A A cross-sectional view of an exemplary catheter including a catheter body according to some embodiments is shown.

[0025] Figure 4B A cross-sectional view of an exemplary catheter including a catheter body according to some embodiments is shown.

[0026] Figure 5 A side view of an exemplary conduit including wire windings is shown, according to some aspects.

[0027] Figure 6 A side view of an exemplary catheter, including a marking strip, is shown according to some aspects.

[0028] Figure 7A side view of an exemplary conduit including a six-site transmitter is shown, according to some aspects.

[0029] Figure 8 A side view of an exemplary conduit including staggered site emitters is shown according to some examples.

[0030] Figure 9 Examples of emitters arranged in a spiral or concentric configuration that rotate around the circumference of the conduit body are shown.

[0031] Figure 10 A cross-sectional view of an exemplary lumen of a catheter including a protective layer is shown according to some examples.

[0032] Figure 11A Examples of catheters with an outer layer are shown, which at least partially surrounds the wire and keeps the wire in contact with the catheter body.

[0033] Figure 11B Examples of catheters with an inner layer positioned between the wire and the catheter body are shown.

[0034] Figure 12 A portion of an exemplary conduit comprising multiple site transmitters is illustrated according to some examples.

[0035] Figure 13 A portion of an exemplary conduit comprising multiple site transmitters is illustrated according to some examples.

[0036] Figure 14 Exemplary IVL catheter systems according to one or more aspects of this disclosure are illustrated.

[0037] Figure 15 An exemplary computing system based on some examples is illustrated. Detailed Implementation

[0038] The following description is intended to enable those skilled in the art to make and use the various embodiments and aspects disclosed herein. Descriptions of specific devices, components, techniques, and applications are provided by way of example only. Various modifications to the examples described herein will be apparent to those skilled in the art, and the general principles described herein can be applied to other examples and applications without departing from the spirit and scope of its various embodiments and aspects. Therefore, its various embodiments and aspects are not intended to be limited to the examples described and illustrated herein, but are consistent with the scope of the claims.

[0039] Figure 1AA side view of an exemplary angioplasty balloon catheter is illustrated. The catheter 20 includes an elongated carrier, such as a hollow sheath 21, an inflatable balloon 26 formed around and sealed thereto within the sheath 21, and a guidewire member 28 to which the balloon 26 is sealed at a sealing portion 23. The guidewire member 28 may have a longitudinal lumen 29 through which a guidewire (not shown) can be received for guiding the catheter 20 to a desired location, such as within a vein or artery.

[0040] The sheath 21 and guidewire member 28 form a channel 27 through which fluid can enter the balloon 26 to inflate it. The balloon 26 can be filled with water, saline, a mixed saline solution, etc., allowing the balloon to be gently placed along the wall of an artery or vein, for example, in direct proximity to calcified lesions. The fluid may also contain an X-ray contrast agent to allow for fluoroscopic visualization of the catheter 20 during use. The channel 27 is in fluid communication with the electrode pair 25 and provides the conductive fluid required for shock wave generation. The electrode pair 25 may include electrodes 22 and 24 located within the fluid-filled balloon 26.

[0041] like Figure 1B As can be seen, electrodes 22 and 24 are arranged coaxially, with electrode 22 being the inner electrode and electrode 24 being the outer electrode, both in cylindrical form. Electrodes 22 and 24 can be formed of a metal (such as stainless steel) or another conductive material. In some aspects, the outer electrode 24 surrounds the conduit 20 within the volume of the balloon 26, and the inner electrode 22 is located inside the conduit 20. In some aspects, the inner electrode 22 can be coupled to a copper wire. Electrodes 22 and 24 can be spatially spaced (gap) to allow for the formation of a reproducible arc for a given applied voltage and current. Electrodes 22 and 24 can be spatially separated by an inner sleeve (e.g., an insulating sleeve).

[0042] As used herein, the term "electrode" refers to a conductive element (typically made of metal) that receives current and subsequently releases it to another conductive element. In the context of this disclosure, electrodes may be positioned relative to each other, such as in an arrangement of inner and outer electrodes or a proximal and distal electrode arrangement. Thus, as used herein, the term "electrode pair" refers to two electrodes positioned adjacent to each other and spaced apart, such that applying a sufficiently high voltage to the electrode pair will cause current to be transmitted across the gap between the two electrodes (also called a "spark gap") (e.g., from the inner electrode to the outer electrode and vice versa, optionally where electricity is transmitted through a conductive fluid or gas between them). In some contexts, one or more electrode pairs may also be referred to as an electrode assembly. In the context of this disclosure, the term "emitter" broadly refers to a region of the electrode assembly in which current is transmitted across the electrode pair, thereby generating a shock wave. The terms "emitter sheath" and "emitter strip" refer to continuous or discontinuous strips of conductive material that may form one or more electrodes of one or more electrode pairs, thereby forming the location of one or more emitters.

[0043] Examples of this disclosure include catheters that do not include at least one of the following: a transmitter band (as used herein, a site transmitter may refer to a transmitter without a transmitter band), an inner sleeve, or an insulating sleeve. Instead of using a gap between cylindrical electrodes of an electrode pair, the spark gap of the site transmitters described in this disclosure can use the space between segments of a conductive element, which may be referred to herein as a transmitter lead along the length of the catheter body. Using the space between segments of the transmitter lead inside the balloon (rather than the space between the inner and outer electrodes of the transmitter band) can also create a smoother surface, allowing the balloon to fully inflate and wrap more tightly around the catheter body. In some examples, the number of components for the site transmitter can be fewer (compared to a shockwave transmitter formed using a transmitter band). Therefore, the cross-sectional profile including the outer diameter of the site transmitter can be smaller. The smaller outer diameter of the site transmitter reduces the outer diameter of the catheter, making the catheter easier to handle and deliver during treatment. In some examples, the reduced number of components for the site transmitter can also make manufacturing easier and less costly. Additionally or alternatively, a smaller outer diameter can allow the balloon to fold and / or fold due to fewer launcher components, which can further reduce the outer diameter of the catheter.

[0044] Figure 2A side view of an exemplary catheter, including multiple site transmitters positioned within a housing, is illustrated according to some examples. Catheter 200 (part of a catheter system) includes an elongated carrier such as a catheter body 221, an inflatable balloon 226 formed around and sealed thereto around the catheter body 221, and a guidewire member to which the balloon 226 is sealed at a sealing portion 223. The guidewire member may have a longitudinal lumen through which a guidewire can be received for guiding the catheter 200 to a desired location, such as within a vein or artery.

[0045] The catheter body 221 forms a channel 227 through which fluid can enter the balloon 226 to inflate it. The balloon 226 can be filled with water, saline, a mixed saline solution, etc., allowing the balloon to be gently placed along the wall of an artery or vein, for example, in direct proximity to a calcified lesion. The fluid may also contain an X-ray contrast agent to allow for fluoroscopic visualization of the catheter 200 during use. The channel 227 is in fluid communication with one or more site emitters and provides the conductive fluid required for shock wave generation.

[0046] The conduit 20 in Figure 1 (as discussed above) includes a wire (not shown) located in the guidewire assembly 28. In some examples, additionally, the portion of the wire near or at the transmitter strip may deteriorate or corrode due to exposure to high-voltage pulses (e.g., greater than 3 kV) and / or a large number of pulses used to generate shock waves. Deterioration or corrosion can reduce the life of the conduit and decrease its acoustic output.

[0047] Examples of this disclosure may include conductors having slower degradation and / or lower erosion distribution. The conduit 200 includes a transmitter conductor 225, a carrier conductor 235, and one or more electrical connectors 233. The transmitter conductor 225 extends within a fluid-filled balloon 226, and the carrier conductor 235 extends at least partially within a channel 227 along the proximal end of the conduit 200. The carrier conductor 235 may be engaged with the transmitter conductor 225 using one or more electrical connectors 233 located proximal to the transmitter conductor between the transmitter conductor and the carrier conductor (e.g., engaging two conductors). A site transmitter may be formed by a gap in the transmitter conductor 225 (discussed in more detail below). The transmitter conductor 225 may include material configured for shock wave generation, and the carrier conductor 235 may include material configured for conducting electrical energy.

[0048] Figure 3A side view of an exemplary portion of a catheter according to some aspects is illustrated, the catheter including a plurality of site emitters positioned along a catheter body including at least one lumen. As shown, emitter lead 225 includes a plurality of site emitters 331. Site emitters 331 include at least two electrodes formed by exposed portions / segments of emitter lead 225 separated by gaps (referred to herein as “spark gaps”). As a non-limiting example, the spacing between adjacent site emitters 331 along the length of the lumen may be 2.0 mm, 3.0 mm, 4.5 mm, 5.0 mm, or 6.0 mm. Examples of this disclosure may include any number of site transmitters 331, such as at least one (1), two (2), three (3), four (4), five (5), six (6), seven (7), eight (8), nine (9), ten (10), eleven (11), twelve (12), thirteen (13), fourteen (14), fifteen (15), and / or sixteen (16). The number of transmitter regions and the spacing between site transmitters 331 can be customized and optimized for a given target catheter performance, such as increased acoustic output, power extraction, structural flexibility, specific or optional functionality for treatment, etc.

[0049] Compared to conduits using a transmitter band (e.g., conduit 20 in Figure 1), a conduit 200 with a site transmitter 331 can have greater flexibility at its distal end. The transmitter band and associated inner sleeve can include rigid cylinders that can increase the stiffness point at the distal end of the conduit 20. Replacing the rigid cylinders with gaps in the transmitter lead 225 can improve the flexibility of the conduit. The absence of material can cause an increase in bendability at the location of the gap (compared to the presence of material), thereby enhancing the flexibility of the site transmitter conduit 200.

[0050] Exemplary transmitter wire

[0051] In some aspects, the transmitter lead 225 may comprise a refractory material. Examples of refractory materials include, but are not limited to, molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, clad wires, or combinations thereof. Molybdenum or tungsten (used in the transmitter lead 225) may have greater durability than other materials such as copper. For example, molybdenum may have a higher melting temperature, allowing it to withstand longer treatment periods and deteriorate more slowly. The greater durability of the material allows the material of the transmitter lead 225 to last longer due to less corrosion when the site transmitter 331 is fired (allowing current to pass through it). Additionally, for example, when fired for a longer period, molybdenum or tungsten may cause a sustained output level from the site transmitter 331, thereby increasing the lifespan of the transmitter lead 225. In some embodiments, different combinations of transmitter leads 225 may also comprise copper, aluminum, gold, platinum, nickel, etc., to utilize or combine the electrical and resistive properties of these metals and the aforementioned refractory metals. These combinations or composites of metals may be structures having metals (with or without insulating material) plated on top of each other or alloys of these metals.

[0052] The use of molybdenum or other refractory materials can be considered counterintuitive because such refractory metals have low electrical conductivity (impeding the performance of generators providing voltage for shock wave generation), high stiffness / hardness (reducing the deliverability of conduit 200), and dissimilarity to other materials (making it difficult to form electrical connectors for electrically connecting these materials). The durability and / or flexibility of the conduit can be enhanced by configuring the conduit along a portion to include a carrier wire 235 comprising a first material (e.g., copper) having relatively high electrical conductivity and / or low stiffness. Additionally or alternatively, the conduit may include a transmitter wire 225 comprising a second material having greater durability than the first material. In some aspects, the transmitter wire 225 may be positioned along a second portion of the conduit distal to the first portion. In some examples, the second material may comprise a harder and less conductive material (e.g., molybdenum). Using a second material can advantageously produce a more durable electrode, while using a first, more conductive and / or more flexible material along the first portion of the conduit can reduce or minimize any impact that using a more durable material might have on the overall electrical conductivity and conduit stiffness. As described in detail throughout this disclosure, transmitter wire 225 and carrier wire 235 can be electrically connected and joined together using one or more electrical connectors.

[0053] The transmitter wire 225 may include a wire with a ratio of, for example, Figure 2The electrode pair 25 is a rounded or flattened conductor with a smaller cross-sectional profile. The smaller cross-sectional profile allows the catheter 200 to be used to access smaller vascular locations (e.g., coronary arteries). In some examples, the transmitter conductor 225 may have a certain amount of insulation. For example, when a small cross-sectional profile is required, the catheter 200 may include a small amount of insulation. When a high dielectric strength is required, the catheter 200 may include a large amount of insulation. Higher dielectric strength can produce better acoustic output (e.g., higher magnitude and longer lifespan).

[0054] The size of the transmitter lead 225 can be configured according to desired profile and / or lifespan. For example, a smaller diameter may result in a lower profile but may reduce lifespan. Exemplary lead sizes for the transmitter lead 225 include, but are not limited to, diameters of approximately 0.003'', 0.004'', 0.005'', 0.008'', 0.009'', etc. In some examples, the lead size for the transmitter lead 225 may be at least 0.003'', at least 0.0034'', at least 0.005'', at least 0.006'', at least 0.007'', at least 0.008'', at least 0.009'', and / or at least 0.010''. In some examples, the wire size for transmitter wire 225 can be up to 0.010'', up to 0.009'', up to 0.008'', up to 0.007'', up to 0.006'', up to 0.005'', up to 0.004'', up to 0.003'', up to 0.002'' and / or up to 0.001''.

[0055] Figure 4A and Figure 4B Cross-sectional views of exemplary catheters, including corresponding catheter bodies, are illustrated according to some embodiments. The catheter may include a lumen and a transmitter lead positioned within a channel of the elongated tube. In some examples, such as... Figure 4A As shown, the transmitter wire 225A can be a flat wire. A flat wire can enhance the flexibility of the wire (e.g., in at least one dimension), and thus strengthen the conduit body (e.g., Figure 3 The flexibility of the catheter body 339 and the distal end of the catheter 200. In such embodiments, a section of the flat guide wire can be arranged on the distal section of the catheter to bend in the same plane, thereby allowing the distal section of the catheter to bend or flex in that plane by up to or greater than 180°. The flat guide wire can also reduce the cross-sectional profile of the catheter 200.

[0056] In some examples, such as Figure 4BAs shown, the transmitter lead 225B may have a semi-circular profile with a convex side (e.g., the side of the transmitter lead 225B closest to the catheter body 339) and a flat side (e.g., the side of the transmitter lead 225B furthest from the catheter body 339). The catheter body 339 may include a plurality of recesses 441, and the transmitter lead 225B may be shaped such that the convex side is located within the recesses 441. This contrasts with a flat transmitter lead 225A having a flat side. Figure 4A Compared to (as shown in the diagram), configuring the transmitter wire 225B to have a convex side makes it easier to manufacture. In some aspects, the transmitter wire 225B can be configured with a flat side, thereby forming a smaller cross-sectional profile. In some examples, the transmitter wire with a flat side can be configured such that the flat side is flush with the outer surface of the conduit body 339.

[0057] Example carrier wire 235

[0058] return Figure 2 The conduit 200 may include a carrier wire 235 configured to be located within a channel 227 of the conduit 200. The carrier wire 235 may deliver current to the site transmitter 331 for generating a shock wave. The carrier wire 235 may include a low-resistance material suitable for transmitting power (voltage from the generator) to the distal end of the conduit 200 (to the transmitter wire). As a non-limiting example, the low-resistance material may be copper, silver, gold, stainless steel, etc.

[0059] When high current delivery is desired, the carrier lead 235 can be configured to have a large size (e.g., the lead size can be selected based on the current to be delivered). In some aspects, the carrier lead 235 can have a larger lead size (diameter) than the transmitter lead 225. The difference in lead size between the carrier lead 235 and the transmitter lead 225 can allow for high current delivery while also increasing the flexibility of the catheter 200 (due to the increased flexibility of the transmitter lead 225 within the balloon 226). In some examples, the transmitter lead 225 and the carrier lead 235 can have the same lead size.

[0060] Example electrical connector 233

[0061] In some cases, the transmitter lead 225 and the carrier lead 235 may comprise different materials. For example, the transmitter lead 225 may comprise a material that is harder and / or has a higher resistivity (lower conductivity) than the lead of the conduit 20 in FIG. 1. The material of the transmitter lead 225 may be more durable and less prone to corrosion, which can lead to fragmentation during shock wave generation and thus pinholes in the balloon 226. For example, the transmitter lead 225 may comprise a material such as molybdenum. Although the transmitter lead 225 may have an increased lifetime when formed of a more durable material such as molybdenum (compared to when formed of a material such as copper), the higher durability can result in an overall lower conductivity and higher stiffness. To ensure or increase the voltage or current delivered to the site transmitter 331 for shock wave generation, examples of this disclosure may comprise a carrier lead 235 comprising a material with relatively high conductivity. For example, the transmitter lead 225 may be molybdenum or tungsten, and the carrier lead 235 may be copper. The transmitter lead 225 and the carrier lead 235 can be electrically connected and joined by one or more electrical connectors 233. For example, the electrical connectors 233 can be located on the outside of the balloon 226. In some respects, the electrical connectors 233 can be smooth and seamless (or near-seamless) and / or located inside the balloon 226.

[0062] Carrier lead 235 (e.g., copper) may be used for most of the length of the lead in conduit 200 (e.g., greater than 50%), and transmitter lead 225 (e.g., molybdenum or tungsten) may be used at the distal end of conduit 200. This reduces the stiffness of the conduit, making conduit 200 more deliverable than in the exemplary embodiment where leads made of more durable materials such as molybdenum or tungsten (e.g., copper) are used along most of the length of the conduit. Figure 13 (As shown). This also reduces the overall resistance of the conduit, thereby reducing the strain on the source generator delivering voltage or current to the site transmitter compared to using materials such as molybdenum or tungsten along most of the conduit's length. In some examples, this can reduce the rate of transmitter corrosion due to the use of a stronger material for the transmitter wire 225, thus allowing the conduit 200 to have an increased lifespan; the conduit 200 can be used for a greater number of cycles. Additionally or alternatively, the size of the conduit 200 can be smaller due to its smaller cross-sectional profile and / or shorter lumen (because the spark gaps can be positioned closer together).

[0063] The differences between transmitter wire 225 and carrier wire 235 may make connecting the wires challenging. Transmitter wire 225 and carrier wire 235 can be electrically connected using electrical connector 233 and any method (including but not limited to spot welding, laser welding, crimping, wrapping stripped wires together, brazing, forging, using conductive adhesive, using ferrule pins, etc.).

[0064] In some aspects, the electrical connector 233 can be formed using laser welding, which allows for a smooth transition (minor change in profile height) between the transmitter lead 225 and the carrier lead 235. The laser welding process may include using a clamping mechanism to hold multiple parts (including the transmitter lead 225 and the carrier lead 235) and using heat from the laser to melt the parts together. Crimping may include crimping conductive cylinders or using ferrule pins comprising copper, brass, silver, tin, stainless steel, or combinations thereof. In some aspects, plating materials (e.g., nickel or chromium) may be used for rust prevention. When welding is used to form the electrical connector 233, as a non-limiting example, copper coatings, nickel plating, nickel-chromium (e.g., 50% nickel, 50% chromium) plating, nickel-copper plating (e.g., 5% nickel, 95% copper), etc., may be applied to the transmitter lead 225 (including portions such as the tip of the transmitter lead 225 or the entirety). When using conductive adhesives, example materials include, but are not limited to, silver, carbon graphite, gold, diamond, copper, aluminum, etc. A combination of techniques discussed above can be used, such as placing the solder under the press-fit structure via flux, or applying a conductive adhesive before forging or pressing.

[0065] The parameters of the method used to form the electrical connector 233 can be determined based on durability and / or lifespan. For example, the electrical connector 233 may not make complete electrical contact, or the crimp may weaken over time. In some aspects, the type of flux used for soldering and the flux cleaning method; the time and temperature used for resistance soldering; and the laser power, focal length, and time used for laser soldering can be adjusted based on target durability and / or lifespan.

[0066] Another example method is resistance welding, where a specific pressure, controlled by, for example, an air actuator, is used to clamp multiple flat material parts tightly together. The materials (emitter wire 225, carrier wire 325, or both) need to have a certain resistance to allow current to pass through to generate the heat required for resistance welding, and need to have low conductivity to ensure sufficient heat to melt the parts together. In some respects, the melting temperatures of the two material parts being welded may not be different. For example, molybdenum and copper have melting temperatures between approximately 2,000 and 4,700 degrees Celsius. In some examples, resistance welding can be performed in an oxygen-free environment. Inert gases such as argon, nitrogen, or carbon dioxide can be used to reduce the amount of oxygen in the environment, which will prevent or reduce oxidation of the parts during welding.

[0067] In some aspects, conduit 200 may include multiple electrical connectors 233. For example, a first electrical connector 233A ( Figure 3(As shown in the diagram) allows an electrical signal to travel from carrier wire 235 to transmitter wire 225 (proximal to distal end of conduit 200) to form a spark gap. Second electrical connector 223B ( Figure 3 (As shown in the figure) allows electrical signals to travel from transmitter lead 225 to carrier lead 235 (from the distal end to the proximal end of conduit 200). The first electrical connector 233A may be located at the same position as the second electrical connector 233B along the length of the conduit body 339 (as shown). In some respects, the first electrical connector 233A and the second electrical connector 223B may be staggered (located at different positions along the length of the conduit body) (not shown). Staggered connectors can reduce the risk of electrical short circuits.

[0068] Example formation of wires

[0069] To form the wires and electrical connectors, the transmitter wire 225 and the carrier wire 235 can be disposed on the conduit body 339. The conduit body 339 can be cylindrical and / or can have a groove 441 (e.g., Figure 4A and 4B (As shown). In some examples, the conduit body 339 may allow the transmitter wire 225 and the carrier wire 235 to slide inside it.

[0070] As part of forming conduit 200, transmitter wire 225 can be laid and secured to conduit body 339. The wire can be cut before or after laying, thereby placing wire gaps at or near the location of electrical connector 233. The wire can be cut in a manner that does not damage conduit body 339 during the manufacturing process. In some examples, forming conduit 200 also includes laying carrier wire 235, securing it to conduit body 339, and cutting the wire.

[0071] The wires (e.g., transmitter wire 225 or carrier wire 235) may be at least partially located in the groove 441 of the conduit body 339. Figure 4AWithin some recesses (including all recesses) of the catheter body 339. In some aspects, a topcoat material, for example, can be used to secure the wires to the catheter body 339. The topcoat material can be an adhesive that secures the transmitter wire 225 and / or carrier wire 235 to one or more surfaces of the catheter body 339. The topcoat material can be an adhesive or a plastic material. For example, after securing the transmitter wire 225 or carrier wire 235 to the catheter body 339, the wires are adhered to the catheter body 339. In some aspects, the catheter body 339 can be formed by adhering an outer layer to an inner layer using mechanical, thermal, and / or laser means. The wires (e.g., transmitter wire 225) can be placed on the inner layer. The outer layer can surround the wires and the inner layer, and the outer layer can then be attached to form an adhesive catheter body. The outer layer can be, for example, a topcoat material or a polyether block amide (PEBA) sleeve. The top coating material may include a thermoplastic (e.g., polyolefin) covering the transmitter lead 225 and the electrical connector 233 (to minimize short circuits on the exposed transmitter lead 225) and attaching at least a portion of the transmitter lead 225 or carrier lead 235 to the lumen 339. In some embodiments, one or more leads (e.g., transmitter lead 225) are secured to the inner lumen without the top coating material. For example, the leads may be attached or adhered to the inner lumen by mechanical, thermal, or laser means.

[0072] The top coating material and / or a portion of the transmitter wire 225 can be removed at the gap in the site transmitter 331. In some aspects, for the gap in the site transmitter 331, a portion of the transmitter wire 225 can be removed, for example, by cutting the material of the transmitter wire 225. In some aspects, the transmitter wire 225 can be partially cut at the gap to allow for the creation of a spark gap without damaging the lumen 339. In some aspects, the top coating material at the gap can be removed. In some examples, the gap in the transmitter wire 225 can also enhance the flexibility of the lumen 339.

[0073] Example configuration

[0074] Examples of this disclosure may include different configurations for the site transmitter conduit. In some examples, conduit 200 includes a wire wrapping. Figure 5A side view of an exemplary catheter including a wire wrapping is illustrated according to some aspects. The catheter body 339 includes a proximal end and a distal end. Near or at the distal end of the catheter body 339, a transmitter wire 225 is electrically connected to a carrier wire 235 via one or more electrical connectors 233. In some examples, the distal end of the catheter body 339 may be closer to the electrical connector 233 than the proximal end. It should be understood that the drawings used to illustrate the exemplary catheters herein may depict only a portion of the catheter and are not drawn to scale. Therefore, while the drawings may depict electrical connectors near the proximal end of a portion of the catheter, it should be understood that the catheter may extend far beyond the extent shown in the illustrative drawings. Electrical connectors may be positioned closer to the distal end of the catheter than they are to the proximal end. Near or at the distal end of the catheter body 339, the transmitter wire 225 may be routed via a wire wrapping 541 wound around the lumen 339. As shown, the catheter 200 may include four site transmitters 331, but examples of this disclosure may include any number (not limited to four). Adjacent transmitters 331 may be separated by a distance 330. As a non-limiting example, the distance 330 may be 6 mm. The distance between adjacent transmitters (e.g., 330) may be at least 2 mm, at least 3 mm, at least 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8 mm, at least 9 mm, at least 10 mm, at least 11 mm, at least 12 mm, at least 13 mm, at least 14 mm, at least 15 mm, at least 16 mm, at least 17 mm, at least 18 mm, at least 19 mm and / or at least 20 mm. The distance between adjacent transmitters (e.g., 330) can be up to 2 mm, up to 3 mm, up to 4 mm, up to 5 mm, up to 6 mm, up to 7 mm, up to 8 mm, up to 9 mm, up to 10 mm, up to 11 mm, up to 12 mm, up to 13 mm, up to 14 mm, up to 15 mm, up to 16 mm, up to 17 mm, up to 18 mm, up to 19 mm and / or up to 20 mm. The distance between adjacent transmitters (e.g., 330) can be between 2 mm and 20 mm.

[0075] In some examples, the catheter includes a marking band 643, such as Figure 6 As shown. The marking band 643 may be located at the distal end of the catheter 200. In some examples, the catheter includes an additional marking band (not shown) positioned proximal to the marking band 643. In some examples, the additional marking band may be positioned at or near the proximal end of the catheter. The marking band 643 may be used in place of the wire wrap 541 to electrically connect a first portion of the transmitter wire 225 to a second portion of the transmitter wire 225, such that current can flow from the supply side of the carrier wire 235 to the return side of the carrier wire 235.

[0076] Examples of this disclosure include any number of site transmitters, including but not limited to 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, etc. Figure 7 A side view of an exemplary catheter including six-site emitters is illustrated according to some aspects. For example, the six-site emitters 331 may form three emitter regions 333. Configuring the catheter to include a greater number of emitters may allow for more spark gaps, thereby increasing therapeutic effectiveness. Although the figures show an even number of site emitters 331 and spark gaps, examples of this disclosure may include an odd number of site emitters 331 and spark gaps (e.g., as shown in the figures). Figure 13 (As shown). In some examples, the number of site transmitters 331 can be determined based on the length of the balloon 226.

[0077] In some examples, site emitters in the same emitter region can be aligned in location (having the same position along the length of the duct body 339). For example, Figure 7 The six site transmitters 331 shown may include a first site transmitter 331A, a second site transmitter 331B, a third site transmitter 331C, and a fourth site transmitter 331D. In some examples, the first site transmitter 331A and the second site transmitter 331B may be part of transmitter region 333A and are located at the same position along the length of the catheter body 339. The third site transmitter 331C and the fourth site transmitter 331D may be part of transmitter region 333B and are located at the same position along the length of the catheter body 339.

[0078] In some respects, at least two site transmitters 331 in the plurality of transmitter regions can be angularly aligned (having the same angle around the circumference of the catheter body 339). For example, the first site transmitter 331A and the second site transmitter 331B of transmitter region 333A can be positioned around the catheter body 339 at 0 degrees and 180 degrees, respectively. The third site transmitter 331C and the fourth site transmitter 331C of transmitter region 33B can be positioned around the catheter body 339 at the same angle (e.g., 0 degrees) as the first site transmitter 331A and the same angle (e.g., 180 degrees) as the second site transmitter 331B.

[0079] Although the illustration shows a site emitter 331 at the top of the catheter body 339 that is positioned relative to the site emitter 331 at the bottom of the catheter body 339 due to having the same location (opposite to each other) along the length of the catheter body 339, examples of this disclosure may include emitters 331 that are not positioned correctly. For example, site emitters 331 may be staggered relative to each other along the length of the catheter body 339.

[0080] Figure 8 A side view of an exemplary catheter including staggered site emitters is illustrated. The catheter 200 may include a plurality of site emitters 331, including a first site emitter 331E, a second site emitter 331F, a third site emitter 331G, a fourth site emitter 331H, and a fifth site emitter 331I. The positions of the first site emitter 331A and the second site emitter 331B along the length of the catheter body 339 may be different (e.g., staggered).

[0081] In some cases, the catheter may fail due to a short circuit near the transmitter located at or near the distal end of the catheter. Spaced-out site transmitters 331 reduce the chance of short circuits, thereby increasing their lifespan. A staggered configuration allows the site transmitters 331 to be spaced apart with minimal or no increase in the required length of the site transmitters 331. For example, as shown, the first site transmitter 331E may be located at or near the distal end of the catheter body 339, and the fifth site transmitter 331I may be positioned relatively closer to the proximal end of the catheter body 339. For example, the distance 830 between the first site transmitter 331E (located at or near the distal end) and the fifth site transmitter 331I (located proximal to the site transmitter 331E) may be 7.5 mm. In some examples, the spacing between site transmitters 331 located at first positions around the circumference of the catheter body 339 may be the same as the spacing between site transmitters 331 located at second positions around the circumference of the catheter body 339. For example, the distance between the first point transmitter 331E and the third point transmitter 331G (positioned at 0 degrees) can be the same as the distance between the second point transmitter 331F and the fourth point transmitter 331H (positioned at 180 degrees).

[0082] In some examples, such as Figure 9As shown, the site emitters 331 can be arranged in a helical or spiral configuration, rotating around the circumference of the catheter body 339 along the length of the tube. At least some of the site emitters 331 can have different circumferential positions and / or angles along the length of the lumen 339. For example, the catheter 200 may include a plurality of site emitters 331, including a first site emitter 331J, a second site emitter 331K, a third site emitter 331L, a fourth site emitter 331M, and a fifth site emitter 331N. The first site emitter 331J and the second site emitter 331K (in the first emitter region) can be located at a first longitudinal position and positioned at a first set of angles (e.g., spaced 180 degrees apart from each other around the circumference of the catheter body 339 at the same longitudinal position). The site transmitters 331 (including the third site transmitter 331L) in the second transmitter region can be located at different second positions and positioned at a second set of (different) angles (e.g., spaced 180 degrees apart from each other around the circumference of the catheter body 339, but 90 degrees apart from transmitters 331K and 331J). The site transmitters in the third transmitter region (including the fourth site transmitter 331M and the fifth site transmitter 331N) can be located at a third position and positioned at a third set of angles (e.g., spaced 180 degrees apart from each other around the circumference of the catheter body 339, and 90 degrees apart from transmitter 331L). The third position can be different from the first and second positions. In some aspects, the third set of angles can be different from the second set of angles. In some aspects, the third set of angles (of site transmitters 331M and 331N) can have the same angles as the first set of angles (of site transmitters 331J and 331K), but site transmitters with the same angles can be formed on different sides of the transmitter guide 225. For example, the second-position transmitter 331K and the fourth-position transmitter 331M can be at 0 degrees, but the second-position transmitter 331K can be formed from the top side of the transmitter wire 225B, and the fourth-position transmitter 331M can be formed from the bottom side of the transmitter wire 225C. In this way, the spiral or coiled configuration can improve circumferential uniformity.

[0083] In some respects, the lifespan of a catheter can be extended by including a protective layer. Figure 10 A cross-sectional view of an exemplary lumen of a conduit including a protective layer is illustrated according to some examples. The conduit 200 may include a protective layer 1032 located between the transmitter lead 225 and the lumen 339. In some examples, the protective layer may be additionally or alternatively (e.g., Figure 11A (As shown) Located within the lumen axis of the catheter body 339 (second inner layer 1104) and / or surrounding the catheter body 339 (outer layer 1102 surrounding at least a portion of the guide wire and / or first inner layer 1105 positioned between the guide wire 1120 and the catheter body 339, as shown) Figure 11B(As shown). In some aspects, the protective layer 1032 can serve as an additional insulating layer to prevent or reduce pitting corrosion inside the lumen 339 due to the heat and pressure associated with shock wave generation. A non-limiting example type of protective layer is a polymer layer (e.g., a polyimide layer). In some examples, the protective layer can be made of an electrically insulating material. In some examples, the protective layer can be made of a material with low thermal conductivity. The protective layer 1032 can improve acoustic output and lifetime. As shown, the transmitter lead 225 can have a circular profile.

[0084] Figure 11A A conduit 1100 is also illustrated, having an outer layer 1102 that at least partially surrounds the conductor 1120 and maintains contact between the conductor 1120 and the conduit body 339. The outer layer 1102 may be made of an electrically insulating polymer (e.g., polyether block amide (PEBA) or nylon). In various embodiments, the outer protective layer 1102 does not surround the spark gap. In various embodiments, the outer protective layer 1102 surrounds the conductor and includes openings (e.g., orifices, slits, gaps) to expose the spark gap to a conductive fluid. In some examples, the inner protective layer 1106 may be formed of the same material as the outer protective layer.

[0085] As discussed throughout this disclosure, the disclosed examples can improve sound output. In some examples, the pressure at the treatment area (e.g., lesion) caused by the shock wave generated using the site transmitter described herein can be between 25 atm and 75 atm. In some examples, the pressure at the treatment area generated by the shock wave generated using the site transmitter is at least 20 atm, at least 25 atm, at least 30 atm, at least 35 atm, at least 40 atm, at least 45 atm, at least 50 atm, at least 55 atm, at least 60 atm, at least 65 atm, at least 70 atm, at least 75 atm, at least 80 atm, at least 85 atm, at least 90 atm, at least 95 atm, or at least 100 atm. In some examples, the pressure at the treatment area generated by the shock wave produced by the site transmitter does not exceed 100 atm, 95 atm, 85 atm, 75 atm, 65 atm, 60 atm, 55 atm, 50 atm, 45 atm, 40 atm, 35 atm, 30 atm, 25 atm, and / or 20 atm.

[0086] Figure 12 A portion of an exemplary conduit 1200 including multiple site transmitters is illustrated. The exemplary conduit 1200 may include any of the features described throughout this disclosure. Therefore, Figure 12The illustrated site transmitter 331 may include two exposed portions of transmitter wire 225, which are spaced apart from each other by corresponding spark gaps. Although Figure 3 The duct depicted includes four uniformly distributed site emitters, but duct 1200 includes five irregularly distributed site emitters 331. The positioning of the emitters around the circumference of the duct body 339 and longitudinally along the duct body 339 can affect the propagation mode of the emitted shock waves. For example, the positioning of the site emitters relative to each other may affect the location of maximum constructive interference of the shock waves emitted from the respective site emitters. An arrangement including an odd number of emitter regions can be used to deflect the acoustic output toward an off-center calcification.

[0087] Figure 13 An exemplary conduit comprising multiple site emitters is illustrated. As described throughout, in some examples, the site emitters may include two exposed portions of a first conductive element (e.g., emitter wire), which may be formed of a different, more rigid, more durable, and / or less conductive material (e.g., molybdenum) compared to a second conductive element (e.g., a carrier wire) formed of a material that is more conductive, less rigid, and less durable (e.g., copper). In such examples, the emitter wire and the carrier wire may be electrically connected to each other via one or more electrical connectors. However, in some examples, wiring extending along the length of the conduit from the power source to the site emitters (and forming exposed ends at each site emitter) may be formed of a material used for the emitter wires (e.g., a more durable, rigid, and less conductive material). For example, wiring along the length of the conduit body 339 may be formed entirely of molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, or combinations thereof.

[0088] Figure 14An exemplary IVL catheter system according to one or more aspects of this disclosure is illustrated. The catheter system includes a catheter 1400, a conductive lead, and a power source 1470, the conductive lead including an energy guide 1472 for routing energy to the catheter 1400. The catheter 1400 includes a catheter body 1410 having a guidewire lumen for guiding the catheter 1400 along a guidewire 1460 to a treatment site. The catheter 1400 also includes a housing 1420 surrounding at least a portion of the catheter body. The catheter 1400 includes shock wave generating regions 1401, 1402, 1403, 1404, and 1405 positioned along the catheter body 1400. In response to the delivery of energy from the power source 1470, one or more shock waves are generated from one or more of the shock wave generating regions 1401, 1402, 1403, 1404, and 1405. The conduit 1400 can be configured such that one or more shock wave generating regions in the shock wave generating region can generate shock waves independently of one or more shock wave generating regions in the remaining shock wave generating regions, and / or can be configured such that all shock wave generating regions generate shock waves simultaneously. Although Figure 14 Five shock wave generation zones are shown, but fewer shock wave generation zones may be included (e.g., one, two, three, or four shock wave generation zones) and / or additional shock wave generation zones may be included, for example, in shorter or longer catheters used to treat shorter or longer lesions.

[0089] Exemplary IVL catheter systems (such as) Figure 14 The illustrated IVL catheter system is used to treat lesions in body cavities. In various examples, the lesion may be a calcified area of ​​the vascular system, a thrombus or occlusion in the vascular system, an atherosclerotic plaque, or a lesion in another body cavity, such as a kidney stone in the ureter. In one or more embodiments, each of the shock wave generating regions 1401, 1402, 1403, 1404, and 1405 includes an electrode assembly comprising one or more pairs of electrodes. As described above, the term "electrode" refers to a conductive element (typically made of metal) that receives current and subsequently releases the current to another conductive element. In the context of this disclosure, electrodes are typically positioned relative to each other in an arrangement of two exposed conductive wire portions separated by a relatively small gap.

[0090] In one or more embodiments of this disclosure, Figure 14The power supply 1470 shown includes a high-voltage pulse generator. In one or more embodiments, the power supply 1470 supplies a high-voltage pulse of not less than 6 kV. In one or more embodiments, the power supply 1470 supplies a high-voltage pulse of not less than 10 kV. In one or more embodiments, the power supply 1470 supplies a high-voltage pulse between 3 kV and 30 kV. In one or more embodiments, the power supply 1470 supplies a high-voltage pulse between 6 kV and 10 kV. In one or more embodiments, the power supply 1470 is configured to supply a high-voltage pulse with adjustable intensity. In some examples, the power supply 1470 applies alternating current to the electrodes to cause a change in the polarity of the electrodes.

[0091] As explained above, applying relatively high voltage pulses (e.g., greater than or equal to 10 kV) may be beneficial for treating certain types of lesions (e.g., lesions associated with aortic stenosis) that require higher acoustic output for treatment. In some examples, high-voltage pulses are applied at voltages of at least 1 kV, at least 2 kV, at least 3 kV, at least 4 kV, at least 5 kV, at least 6 kV, at least 7 kV, at least 8 kV, at least 9 kV, at least 10 kV, at least 11 kV, at least 12 kV, at least 13 kV, at least 14 kV, at least 15 kV, at least 16 kV, at least 17 kV, at least 18 kV, at least 19 kV, at least 20 kV, and / or at least 30 kV. High voltage pulses may not exceed 30kV, 20kV, 19kV, 18kV, 17kV, 16kV, 15kV, 14kV, 13kV, 12kV, 11kV, 10kV, 9kV, 8kV, 7kV, 6kV, 5kV, 4kV, 3kV, 2kV, and / or 1kV.

[0092] The voltage pulse can be applied at a rate between 1 Hz and 50 Hz, including 1 Hz and 50 Hz. The shock wave energy generator 530 can be configured to deliver voltage pulses at rates of up to 100 Hz, up to 90 Hz, up to 80 Hz, up to 70 Hz, up to 60 Hz, up to 50 Hz, up to 40 Hz, up to 30 Hz, up to 20 Hz, and / or up to 10 Hz. The shock wave energy generator 530 can be configured to deliver voltage pulses at rates of at least 10 Hz, at least 20 Hz, at least 30 Hz, at least 40 Hz, at least 50 Hz, at least 60 Hz, at least 70 Hz, at least 80 Hz, at least 90 Hz, and / or at least 100 Hz.

[0093] In one or more implementations, Figure 14 The illustrated housing 120 is a balloon (e.g., an angioplasty balloon). The housing 120 can be in a collapsed or deflated configuration to provide a lower profile during delivery to the treatment site. During treatment, the housing 120 can be inflated with a liquid fluid (e.g., saline) to a pressure between two and four atmospheres (2 atm to 4 atm). Energy is then supplied to shock wave generation regions 101, 102, 103, 104, and 105 to generate one or more shock waves. The housing can then be deflated and reinflated to flush away any accumulated air bubbles before further treatment at the site. The housing 120 can optionally be further advanced to a different lesion (or a different segment of the same lesion) or withdrawn from the patient.

[0094] In some implementations, applying high-voltage pulses and / or applying a large number of pulses over time to the shock wave generation regions 101, 102, 103, 104, and 105 may lead to electrode degradation. Electrode degradation may result in less reliable shock wave generation and / or reduced acoustic output over time. Further electrode degradation may generate debris during shock wave generation that can puncture the housing surrounding the electrode (e.g., angioplasty balloon) and / or damage tissue within the body. Forming electrodes from relatively more abrasion-resistant materials can improve electrode durability, thereby increasing the lifespan of the shock wave generation catheter. However, such relatively more durable materials also present several challenges. For example, such materials can provide significantly lower conductivity (which can hinder generator performance) and can result in reduced catheter navigation due to the material's higher stiffness / hardness (e.g., in cases where wiring is used along a relatively significant portion of the catheter).

[0095] Therefore, this material may be a counterintuitive choice as the electrode material for the catheters described herein. However, the challenges posed by these relatively more durable materials can be overcome by using a first material with relatively low stiffness and relatively high conductivity to conduct electrical energy from a power source along the length of the catheter 100, and by using a relatively more durable second material with relatively high stiffness and low conductivity near the distal end of the catheter to conduct the power to one or more shock wave generating regions 101, 102, 103, 104, and 105. In some examples, at least one electrode of at least one shock wave emitter in at least one of the shock wave generating regions 101, 102, 103, 104, and 105 can be formed of a relatively more durable material, which can result in a longer lifespan and higher reliability (compared to emitters with electrodes formed of the first material) for the reasons described above.

[0096] Figure 15An exemplary computing system 1500 according to some examples of this disclosure is illustrated. System 1500 may be a client or a server. Figure 15 As shown, system 1500 can be any suitable type of processor-based system, such as a personal computer, workstation, server, handheld computing device (portable electronic device) such as a telephone or tablet, or a dedicated device. System 1500 may include, for example, one or more of an input device 1520, an output device 1530, one or more processors 1510, a storage device 1540, and a communication device 1560. Input device 1520 and output device 1530 can generally correspond to those devices described above and can be connected to or integrated with a computer.

[0097] Input device 1520 may be any suitable device that provides input, such as a touchscreen, keyboard or keypad, mouse, gesture recognition component of a virtual / augmented reality system, or voice recognition device. Output device 1530 may be or include any suitable device that provides output, such as a display, touchscreen, haptic device, virtual / augmented reality display, or speaker.

[0098] Storage device 1540 can be any suitable means of providing storage, such as electrical, magnetic, or optical memory including RAM, cache, hard disk drive, removable storage disk, or other non-transitory computer-readable media. Communication device 1560 can include any suitable means of transmitting and receiving signals over a network, such as a network interface chip or device. Components of computing system 1500 can be connected in any suitable manner, such as via a physical bus or wirelessly.

[0099] Processor 1510 may be any suitable processor or combination of processors, including any or any combination of a central processing unit (CPU), a graphics processing unit (GPU), a field-programmable gate array (FPGA), a programmable system-on-a-chip (PSOC), and an application-specific integrated circuit (ASIC). Software 1550, which may be stored in storage device 1540 and executed by one or more processors 1510, may include, for example, programming of functional or functional portions embodying the present disclosure (e.g., as embodied in the apparatus described above).

[0100] Software 1550 may also be stored and / or transmitted in any non-transitory computer-readable storage medium for use by or in conjunction with an instruction execution system, device, or apparatus (such as those described above), which may retrieve and execute instructions associated with the software. In the context of this disclosure, a computer-readable storage medium may be any medium, such as storage device 1540, which may contain or store programs for use by or in conjunction with an instruction execution system, device, or apparatus.

[0101] The software 1550 can also be propagated within any transmission medium for use by or in conjunction with an instruction execution system, device, or apparatus (such as those described above), from which the instruction execution system, device, or apparatus may retrieve and execute instructions associated with the software. In the context of this disclosure, the transmission medium can be any medium capable of communicating, propagating, or transmitting a program for use by or in conjunction with an instruction execution system, device, or apparatus. Transmission computer-readable media can include, but are not limited to, electronic, magnetic, optical, electromagnetic, or infrared wired or wireless propagation media.

[0102] System 1500 can be connected to a network, which can be any suitable type of interconnected communication system. The network can implement any suitable communication protocol and can be protected by any suitable security protocol. The network can include network links of any suitable arrangement that can implement the transmission and reception of network signals, such as wireless network connections, T1 or T3 lines, cable networks, DSL, or telephone lines.

[0103] System 1500 can implement any operating system suitable for operation on a network. Software 1550 can be written in any suitable programming language, such as C, C++, Java, or Python. In various implementations, application software embodying the functionality of this disclosure can be deployed in different configurations, such as client / server deployments, or deployed via a web browser as, for example, web-based applications or web services.

[0104] The elements and features of the exemplary electrode assemblies and conduits discussed above can be rearranged, recombined, and modified without departing from the invention. Furthermore, numerical indicators such as “first,” “second,” “third,” “fourth,” etc., are merely descriptive and do not indicate the relative order, position, or identity of the elements or features described by the indicators. For example, a “first” shock wave may be immediately followed by a “third” shock wave, and then a “second” shock wave. As another example, a “third” transmitter can be used to generate a “first” shock wave, and vice versa. Therefore, the numerical indicators of the various elements and features are not intended to limit this disclosure and can be modified and interchanged without departing from the invention.

[0105] As provided herein, it should be understood that any disclosure describing a range of values ​​for dimensions or measurements such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc. includes any numerical increments or gradients relative to the range stated for a given dimension or measurement.

[0106] It should be noted that elements and features of the exemplary catheters illustrated throughout this specification and drawings can be rearranged, recombined, and modified without departing from the invention. For example, while this specification and drawings describe and illustrate catheters with several exemplary balloon designs, this disclosure is intended to include catheters with various balloon configurations. The number, placement, and spacing of the electrode pairs of the shock wave generator can be modified without departing from the invention. Furthermore, the number, placement, and spacing of the balloons in the catheter can be modified without departing from the invention.

[0107] It should be understood that the foregoing is merely an explanation of the principles of the invention, and various modifications, alterations, and combinations can be made by those skilled in the art without departing from the scope and spirit of the invention. Any variation of the various catheters disclosed herein may include the features described by any other catheter or combination of catheters herein. Furthermore, any method may be used with any of the disclosed catheters. Therefore, the invention is not intended to be limited except for the appended claims.

Claims

1. A shock waveguide system, comprising: A catheter body, the catheter body including a lumen; A transmitter wire configured to generate a shock wave, wherein one or more gaps are formed between two or more portions of the transmitter wire along the length of the conduit body, each of the one or more gaps forming a site transmitter; A carrier wire configured to conduct power to the transmitter wire; and One or more electrical connectors configured to electrically connect and engage the transmitter wire and the carrier wire.

2. The shock waveguide system according to claim 1, further comprising: A housing configured to be filled or inflated with fluid, wherein the transmitter wires are at least partially located within the housing.

3. The shock waveguide system according to claim 1, wherein, The transmitter wire is positioned along the distal end of the shock wave duct system.

4. The shock waveguide system according to claim 1, wherein, The transmitter wire contains molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, or a combination thereof.

5. The shock waveguide system according to claim 1, wherein, The diameter of the transmitter wire is between 0.002'' and 0.010''.

6. The shock waveguide system according to claim 1, wherein, The transmitter wire is a flat wire or has a semi-circular outline.

7. The shock waveguide system according to claim 1, wherein, The carrier conductor is positioned along the proximal end of the shock wave duct system.

8. The shock waveguide system according to claim 1, wherein, The carrier wire contains copper.

9. The shock waveguide system according to claim 1, wherein, The diameter of the carrier wire is larger than the diameter of the transmitter wire.

10. The shock waveguide system according to claim 1, wherein, The one or more electrical connectors are located near the distal end of the conduit body and proximal to the transmitter lead.

11. The shock waveguide system according to claim 1, wherein, The one or more electrical connectors are formed using spot welding, laser welding, crimping, wrapping stripped wires together, brazing, forging, conductive adhesive, ferrule pins, or combinations thereof.

12. The shock waveguide system according to claim 1, wherein, The number of the one or more site transmitters is between 1 and 16 site transmitters, including 1 and 16.

13. The shock waveguide system according to claim 1, further comprising: A wire wrap or marking tape is located at the distal end of the shock wave duct system.

14. The shock waveguide system according to claim 1, wherein, The one or more site transmitters form a transmitter region, wherein site transmitters in the same transmitter region are positioned aligned along the length of the duct body.

15. The shock waveguide system according to claim 1, wherein, The one or more site emitters include at least two site emitters that are angled together along the circumference of the catheter body.

16. The shock waveguide system according to claim 1, wherein, The at least two site emitters, which are angularly aligned along the circumference of the lumen, are spaced 180 degrees apart around the circumference of the catheter body.

17. The shock waveguide system according to claim 1, further comprising: A protective layer is located between the conduit body and the transmitter wire.

18. The shock waveguide system according to claim 1, wherein, The transmitter wire comprises a first material, and the carrier wire comprises a second material different from the first material.

19. The shock waveguide system according to claim 1, wherein, The first material has a high melting point, high resistivity, low conductivity, high stiffness, high density, or any combination thereof, relative to the second material.

20. The shock waveguide system according to claim 1, wherein, The diameter of the transmitter wire is between 0.08 mm and 0.23 mm.

21. The shock waveguide system according to claim 1, wherein, The carrier wire is located near the transmitter wire.

22. The shock wave duct system of claim 1, comprising a protective layer positioned to at least partially surround one or both of the transmitter wire and the carrier wire, wherein the protective layer secures one or both of the transmitter wire and the carrier wire to the duct body.

23. A method for forming a shock waveguide system, the method comprising: Lay the transmitter wires; Secure the transmitter wire to the distal end of the conduit body; Cut the transmitter wire at one or more locations on one or more electrical connectors; Laying carrier wires; The carrier wire is fixed to the proximal end of the catheter body; as well as Form one or more electrical connectors for electrically connecting and joining the transmitter wires and the carrier wires.

24. The method according to claim 23, wherein, Forming the one or more electrical connectors includes: Clamping the transmitter wire and the carrier wire; and The transmitter wire and the carrier wire are fused together using a laser.

25. The method according to claim 23, wherein, Forming the one or more electrical connectors includes: Press-fit conductive cylinders or collar pins containing copper, brass, silver, tin, stainless steel or combinations thereof.

26. The method according to claim 23, wherein, Forming the one or more electrical connectors includes: Clamping the transmitter wire and the carrier wire; Passing current through the transmitter wire, the carrier wire, or both to generate heat; and The transmitter wire and the carrier wire are fused together.

27. The method according to claim 23, wherein, The transmitter wire contains molybdenum, and the carrier wire contains copper.

28. A shock waveguide system, comprising: The catheter includes: A catheter body, the catheter body including a lumen; A conductive element configured to generate a shock wave, wherein the conductive element includes one or more gaps along the length of the conduit body, each of the one or more gaps forming a shock wave emitter, wherein the conductive element comprises molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, or a combination thereof; and A power source, which is electrically connected to the conductive element.

29. A method for emitting a shock wave in a body cavity, the method comprising: The distal portion of the catheter according to claim 1 is positioned adjacent to the lesion in the blood vessel; as well as One or more shock waves are emitted from one or more sites, causing the one or more shock waves to propagate toward and impact the lesion and apply a pressure between 25 atm and 75 atm.

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