Shock wave catheter system

Abstract

The utility model relates to a shock wave catheter system which comprises a catheter and a power source. A transmitter wire configured to generate a shock wave, where the transmitter wire includes one or more gaps in the transmitter wire along a length of the lumen, each of the one or more gaps forming a shock wave transmitter; a carrier line configured to conduct electricity to the transmitter line; and one or more electrical connectors configured to link and electrically couple the transmitter wire and the carrier wire; the power source is electrically coupled to the carrier line.

Description

Technical Field

[0001] The utility model generally relates to the field of medical equipment and medical methods, and more particularly, to a shock wave catheter device for treating calcified lesions in body lumens, such as calcified lesions and occlusions in vascular systems and kidney stones in urinary systems. Background Art

[0002] A variety of catheters have been developed for treating calcified lesions, such as calcified lesions associated with arterial disease in the vascular system. For example, treatment systems for percutaneous coronary angioplasty or peripheral angioplasty use angioplasty balloons to dilate calcified lesions and restore normal blood flow in the blood vessels. In these types of surgeries, a catheter carrying a balloon is introduced into the vascular system along a guide wire until the balloon is aligned with the calcified plaque. The balloon is then pressurized (usually to greater than 10 atmospheres) to inflate the balloon in the blood vessel to push the calcified plaque back into the vessel wall and dilate the occluded area of ​​the vascular system.

[0003] Recently, techniques and treatments for intravascular lithotripsy (IVL) have been developed, which is an interventional procedure to improve calcified plaque in diseased arteries. The mechanism of plaque improvement is through the use of a catheter having one or more acoustic shock wave generators located in a fluid that are capable of generating acoustic shock waves that improve calcified plaque. IVL devices vary in design with respect to the energy source used to generate the acoustic shock waves, with two exemplary energy sources being an electrohydraulic generator and a laser generator.

[0004] For electrohydraulic generators that generate acoustic shock waves, a conductive solution (such as saline) may be contained within a housing surrounding the electrodes, or may be flushed through / flowing through a tube surrounding the electrodes. Improvement of calcified plaque is achieved by generating acoustic shock waves within the catheter through electrode discharge. This discharge produces one or more rapidly expanding vapor bubbles, thereby generating acoustic shock waves. These shock waves propagate radially outward and improve calcified plaque within the blood vessel. For laser generation of acoustic shock waves, laser pulses are transmitted to and absorbed by the fluid within the catheter. This absorption process rapidly heats and evaporates the fluid, thereby generating rapidly expanding vapor bubbles and acoustic shock waves that propagate outward and improve calcified plaque. If a fluid is selected that exhibits strong absorption at the laser wavelength employed, the acoustic shock wave intensity will be higher. These examples of IVL devices are not intended to be a comprehensive list of potential energy sources for generating IVL shock waves.

[0005] The IVL procedure can be considered different from standard atherectomy because it ruptures the calcium but does not release the ruptured calcium from the tissue. Therefore, IVL does not, in general, require aspiration or embolic protection. In addition, due to the compliance of normal vessels and non-calcified plaque, the shock waves generated by IVL do not improve normal vascular tissue or non-calcified plaque. In addition, IVL does not carry the same degree of risk of perforation, dissection, or other vasculature damage as angioplasty atherectomy using a cutting or scoring balloon.

[0006] More specifically, a catheter for delivering IVL therapy has been developed, which includes an electrode pair for generating shock waves in an angioplasty balloon in an electrohydraulic manner. Shock wave devices may be particularly effective for treating calcified plaque lesions, because the acoustic pressure from the shock wave can rupture and destroy the lesion near the angioplasty balloon without harming surrounding tissue. In these devices, the catheter is advanced through the patient's vascular system on a guide wire until it is positioned near and / or aligned with the calcified plaque lesion in the body lumen. The balloon is then inflated with a conductive fluid (using a relatively low pressure of 2-4 atmospheres) so that the balloon expands to contact the lesion, but the expansion pressure does not substantially move the lesion. A voltage pulse can then be applied to the electrodes of the electrode pair to generate an acoustic shock wave that propagates through the wall of the angioplasty balloon and enters the lesion. Once the lesion is broken by the acoustic shock wave, the balloon can be further inflated to increase the cross-sectional area of ​​the lumen and improve blood flow through the lumen. Alternative devices for delivering IVL therapy may be within a closed volume other than an angioplasty balloon, such as a cap, balloon of various compliances, or other enclosures.

[0007] An electrohydraulic shock wave transmitter (e.g., an electrode pair for generating shock waves) may have certain properties that may be improved. For example, the electrode pair may include a cylinder containing an outer electrode surrounding an inner electrode, wherein a sleeve is located between the inner electrode and the outer electrode. The cross-sectional profile of the electrode may be larger than desired, thereby reducing the delivery capacity of the catheter during treatment. In addition, the cylinder may be rigid, which also reduces the delivery capacity. In addition, due to the high voltage pulse (e.g., greater than 3kV) and / or the large number of pulses used to form the shock waves, the wire portion near or at the transmitter band may degrade or corrode. Degradation or corrosion may shorten the life of the catheter and reduce its acoustic output. It may be desirable to have a flexible catheter with a lower cross-sectional profile, increased life, higher acoustic output, or a combination thereof. Utility Model Content

[0008] Described herein are systems and methods for reducing the cross-section of a shock wave catheter system, increasing its flexibility, extending its life, and / or increasing its acoustic output. A catheter may include a catheter body including one or more lumens, one or more conductive elements positioned along the catheter body, and one or more shock wave emitters formed by exposed portions of at least one of the one or more conductive elements, the exposed portions separated by spark gaps. The 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 a housing (e.g., a balloon) of the catheter. The shock wave emitters may be configured to generate shock waves when a sufficiently high voltage is applied across the gap separating the segments of the emitter wire. The emitter wire may include a highly durable material that can withstand high voltage pulses and / or a large number of pulses before degradation or corrosion. In some examples, a second conductive element (referred to herein as a carrier wire) can be located in a channel of the catheter body (e.g., a conduit formed in the catheter body of the catheter in which the wire is positioned / secured) and can be configured to deliver current from the power source to the shock wave transmitter by conducting the current to the transmitter wire. One or more electrical connectors can be configured to join and electrically couple the transmitter wire and the carrier wire.

[0009] According to some aspects, an exemplary shock wave catheter system includes: a catheter body including a lumen; a transmitter wire configured to generate shock waves, wherein one or more gaps are formed between two or more portions of the transmitter wire along the length of the catheter 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 join and electrically couple the transmitter wire and the carrier wire.

[0010] Optionally, the system includes: a housing configured to be filled with a fluid or expandable with a 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 wave catheter system. Optionally, the transmitter wire comprises molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, or a combination thereof. Optionally, the diameter of the transmitter wire is in the range of 0.002 inches to 0.010 inches. Optionally, the transmitter wire is a flat wire or has a semicircular profile / profile. Optionally, a carrier wire is positioned along the proximal end of the shock wave catheter system. Optionally, the carrier wire comprises copper. Optionally, the diameter of the carrier wire is greater than the diameter of the transmitter wire. Optionally, the one or more electrical connectors are located near the distal end of the catheter 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 around each other, soldering, swaging, conductive adhesives, ferrule pins, or a combination thereof. Optionally, the number of the one or more site transmitters includes between 1 and 16 site transmitters, inclusive.

[0011] Optionally, the system includes: a winding wire or marker band located at the distal end of the shock wave catheter system. Optionally, the one or more site transmitters form a transmitter zone, wherein the site transmitters of the same transmitter zone are positioned in alignment along the length of the catheter body. Optionally, the one or more site transmitters include at least two site transmitters aligned in angle along the circumference of the catheter body. Optionally, the at least two site transmitters aligned along the length of the catheter body are spaced 180 degrees around the circumference of the catheter body.

[0012] Optionally, the system includes: a protective layer located between the catheter body and the transmitter wire. Optionally, the transmitter wire comprises a first material and the carrier wire comprises a second material different from the first material. Optionally, the first material comprises a high melting point, a higher resistivity, a lower conductivity, a higher stiffness, a higher density, or any combination thereof relative to the second material. Optionally, the diameter of the transmitter wire is in the range of 0.08 mm to 0.23 mm. Optionally, the carrier wire is located proximal to the transmitter wire. Optionally, the system includes: a protective layer positioned to at least partially encapsulate 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 catheter body.

[0013] Connections and Electrical Couplings According to some aspects, a shock wave catheter system includes: a catheter comprising: a catheter body including a lumen; a conductive element configured to generate shock waves, wherein the conductive element includes one or more gaps along a length of the catheter body, each of the one or more gaps forming a shock wave transmitter, wherein the conductive element comprises molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, or a combination thereof; and a power source electrically coupled to the conductive element.

[0014] According to some aspects, a shock wave catheter system includes: a catheter, the catheter comprising: a catheter body including a lumen; a transmitter wire configured to generate shock waves, wherein the transmitter wire includes one or more gaps in the transmitter wire 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 join and electrically couple the transmitter wire and the carrier wire; and a power source electrically coupled to the carrier wire.

[0015] Optionally, the catheter further comprises a housing configured to be filled with a fluid or expandable with a fluid, the transmitter wire being located within the housing. Optionally, the transmitter wire is positioned along the distal end of the catheter body. Optionally, the transmitter wire comprises molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, or a combination thereof. Optionally, the diameter of the transmitter wire is greater than or equal to 0.08 mm and less than or equal to 0.23 mm. Optionally, the carrier wire is located proximal to the transmitter wire. Optionally, the carrier wire comprises copper. Optionally, the carrier wire has a lower resistivity than the transmitter wire. Optionally, the transmitter wire comprises a first metal and the carrier wire comprises a second metal different from the first metal. Optionally, the one or more shock wave transmitters comprise at least two shock wave transmitters aligned angularly along the circumference of the lumen.

[0016] According to some aspects, a method for forming a shock wave catheter system includes: laying a transmitter wire; fixing the transmitter wire to the distal end of the catheter body; cutting the transmitter wire at one or more locations for one or more electrical joints; laying a carrier wire; fixing the carrier wire to the proximal end of the catheter body; and forming one or more electrical joints for joining and electrically coupling the transmitter wire and the carrier wire. Optionally, forming the one or more electrical joints 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 joints includes: crimping a conductive cylinder or ferrule pin comprising copper, brass, silver, tin, stainless steel, or a combination thereof. Optionally, forming the one or more electrical joints includes: clamping the transmitter wire and the carrier wire; passing an electric current through the transmitter wire, the carrier wire, or both the transmitter wire and the carrier wire 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.

[0017] According to some aspects, a method for emitting shock waves within a body lumen includes: positioning the distal portion of a catheter as described above near a lesion in a blood vessel; and emitting one or more shock waves from the one or more site transmitters such that the one or more shock waves propagate toward and impact the lesion and apply a pressure of 25 atmospheres (atm) to 75 atm. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Illustrative aspects of the present invention are described in detail below with reference to the following drawings. The embodiments and drawings disclosed herein are intended to be considered illustrative and exemplary rather than restrictive.

[0019] Figure 1A Shown is a side view of an exemplary angioplasty balloon catheter in accordance with some embodiments.

[0020] Figure 1B Inner and outer electrodes are shown in the form of cylinders according to some embodiments.

[0021] Figure 2 A side view of an exemplary catheter including a plurality of site transmitters within a housing is shown according to some examples.

[0022] Figure 3 A side view of an exemplary portion of a catheter including a plurality of site transmitters positioned along a catheter body including at least one lumen is shown according to some aspects.

[0023] Figure 4A A cross-sectional view of an exemplary catheter including a catheter body according to some embodiments is shown.

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

[0025] Figure 5 A side view of an exemplary catheter including a coil is shown according to some aspects.

[0026] Figure 6 A side view of an exemplary catheter including a marker band according to some aspects is shown.

[0027] Figure 7 Shown is a side view of an exemplary catheter including six site transmitters according to some aspects.

[0028] Figure 8 A side view of an exemplary catheter including staggered multiple-site transmitters is shown according to some examples.

[0029] Fig. 9Multiple transmitters are shown arranged in a helical or spiral configuration that rotates around the circumference of the catheter body according to some examples.

[0030] Fig.10 A cross-sectional view of an exemplary lumen of a catheter including a protective layer is shown according to some examples.

[0031] Fig.11A A catheter having an outer layer that at least partially surrounds the wire and holds the wire in contact with the catheter body is shown according to some examples.

[0032] Fig. 11B A catheter according to some examples is shown having an inner layer between the wire and the catheter body.

[0033] Fig.12 A portion of an exemplary catheter including multiple site transmitters is shown according to some examples.

[0034] Fig.13 A portion of an exemplary catheter including multiple site transmitters is shown according to some examples.

[0035] Fig.14 An exemplary IVL catheter system according to one or more aspects of the present invention is shown.

[0036] Fig.15 An exemplary computing system according to some examples is shown. DETAILED DESCRIPTION

[0037] The following description is presented to enable one of ordinary skill in the art to make and use the various embodiments disclosed herein and their various aspects. Descriptions of specific devices, components, techniques, and applications are provided as examples only. Various modifications of the examples described herein will be apparent to one of ordinary skill in the art, and the general principles described herein may be applied to other examples and applications without departing from the spirit and scope of the various embodiments and their various aspects. Therefore, the various embodiments and their various aspects are not intended to be limited to the examples described and shown herein, but to conform to the scope consistent with the claims.

[0038] Figure 1A A side view of an exemplary angioplasty balloon catheter is shown. The catheter 20 includes an elongated carrier such as a hollow sheath 21, a dilation balloon 26 formed around the sheath 21 in a sealingly connected relationship to the sheath, and a guidewire member 28, the balloon 26 being sealingly connected to the guidewire member 28 at a seal 23. The guidewire member 28 may have a longitudinal lumen 29 through which a guidewire (not shown) may be received for guiding the catheter 20 to a desired location, such as within a vein or artery.

[0039] The sheath 21 and the guidewire member 28 form a channel 27 through which a fluid can enter the balloon 26 to expand the balloon 26. The balloon 26 can be filled with water, saline, mixed saline solutions, etc. to allow the balloon to be gently placed along the arterial or venous wall, for example, directly adjacent to a calcified lesion. The fluid can also contain an X-ray contrast agent to allow fluorescent observation 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 can include electrodes 22 and 24 located in the balloon 26 filled with fluid.

[0040] If you can Figure 1B As can be seen, electrodes 22 and 24 are coaxially arranged, wherein electrode 22 is an internal electrode and electrode 24 is an external electrode, both in the form of a cylinder. Electrodes 22 and 24 can be formed of a metal such as stainless steel or another conductive material. In some aspects, the external electrode 24 surrounds the catheter 20 within the volume of the balloon 26, and the internal electrode 22 is inside the catheter 20. In some aspects, the internal electrode 22 can be connected to a copper wire. Electrodes 22 and 24 can be separated in space by a certain distance (gap) to allow a reproducible arc to be formed for a given applied voltage and current. Electrodes 22 and 24 can be separated in space by an internal sleeve (e.g., an insulating sleeve).

[0041] The term "electrode" as used herein refers to a conductive element (usually made of metal) that receives an electric current and then releases the electric current to another conductive element. In the context of the present invention, the electrodes can be positioned relative to each other, for example, in the arrangement of an internal electrode and an external electrode, or in the arrangement of a proximal electrode and a distal electrode. Therefore, as used herein, the term "electrode pair" refers to two electrodes adjacent to each other and spaced apart, so that applying a sufficiently high voltage to the electrode pair will cause the current to be transmitted across the gap (also referred to as a "spark gap") between the two electrodes (e.g., from the internal electrode to the external electrode, or vice versa, optionally, the current passes through the conductive fluid or conductive gas therebetween). In some cases, one or more electrode pairs may also be referred to as an electrode assembly. In the context of the present invention, the term "transmitter" refers generally to such an area of ​​an electrode assembly, i.e., in this area, the current is transmitted across the electrode pair, thereby generating a shock wave. The terms "transmitter sheath" and "transmitter belt" refer to a continuous or discontinuous conductive material belt that can be formed as one or more electrodes in one or more electrode pairs, thereby forming the position of one or more transmitters.

[0042] Examples of the present invention 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 that does not include a transmitter band), an inner sleeve, or an insulating sleeve. Instead of using the gap between the cylindrical electrodes of the electrode pair, the spark gap of the site transmitter described in the present invention may use the space between the segments of the conductive element, which may be referred to herein as the transmitter wire along the length of the catheter body. Using the space between the segments of the transmitter wire inside the balloon (rather than the space between the inner electrode and the outer electrode of the transmitter band) can also produce a smoother surface, allowing the balloon to fully expand and wrap more tightly around the catheter body. In some examples, the number of parts of the site transmitter can be less (compared to a shock wave transmitter formed using a transmitter band). As a result, the outer diameter of the cross section, including 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 easier to deliver during treatment. In some examples, the reduction in the number of parts of the site transmitter can also lead to easier manufacturing and lower costs. Additionally or alternatively, due to fewer transmitter components, the smaller outer diameter may allow the balloon to be pleated and / or folded, which may further reduce the outer diameter of the catheter.

[0043] Figure 2 A side view of an exemplary catheter according to some examples is shown, the catheter including a plurality of site transmitters located within a housing. The catheter 200 (part of a catheter system) includes an elongated carrier such as a catheter body 221, an expansion balloon 226 formed around the catheter body 221 in a sealing relationship with the catheter body 221, and a guidewire member to which the balloon 226 is sealingly connected at a sealing portion 223. The guidewire member may have a longitudinal lumen through which a guidewire may be received for guiding the catheter 200 to a desired location within, for example, a vein or artery.

[0044] The catheter body 221 is formed with a channel 227 through which a fluid can enter the balloon 226 to inflate the balloon. The balloon 226 can be filled with water, saline, mixed saline solutions, etc. to allow the balloon to be gently placed along the wall of an artery or vein, for example, directly adjacent to a calcified lesion. The fluid can also contain an X-ray contrast agent to allow for fluorescent observation 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.

[0045] The catheter 20 of FIG. 1 (discussed above) includes a guidewire (not shown) positioned within the guidewire member 28. In some examples, portions of the wire near or at the emitter band may degrade or corrode due to exposure to high voltage pulses (e.g., greater than 3 kV) and / or a large number of pulses used to form the shock waves. Degradation or corrosion may shorten the life of the catheter and reduce its acoustic output.

[0046] Examples of the present invention may include wires having slower degradation and / or lower corrosion profiles / profiles. The catheter 200 includes a transmitter wire 225, a carrier wire 235, and one or more electrical connectors 233. The transmitter wire 225 extends within a balloon 226 filled with a fluid, and the carrier wire 235 extends at least partially within a channel 227 along the proximal end of the catheter 200. The carrier wire 235 can be connected to the transmitter wire 225 using one or more electrical connectors 233 near the distal end of the catheter 200, and the electrical connector 233 is located near the transmitter wire between the transmitter wire and the carrier wire (e.g., connecting the two wires). The site transmitter can be formed by a gap in the transmitter wire 225 (discussed in more detail below). The transmitter wire 225 may include a material configured to generate shock waves, and the carrier wire 235 may include a material configured to conduct electricity.

[0047] 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 transmitters positioned along a catheter body including at least one lumen. As shown, the transmitter line 225 includes a plurality of site transmitters 331. The site transmitter 331 includes at least two electrodes formed by exposed portions / sections of the transmitter line 225, the exposed portions / sections being separated by a gap, referred to herein as a "spark gap". As non-limiting examples, the spacing between adjacent site transmitters 331 along the length of the lumen can be 2.0 mm, 3.0 mm, 4.5 mm, 5.0 mm, or 6.0 mm. Examples of the present invention 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 emitter zones and spacing between site emitters 331 can be customized and optimized for a given target catheter performance (eg, increased acoustic output, power consumption, structural flexibility, specific or optional therapeutic functionality, etc.).

[0048] Compared to catheters using transmitter strips (e.g., catheter 20 in FIG. 1 ), catheter 200 with site transmitters 331 has greater flexibility at the distal end of catheter 200. The transmitter strip and associated inner sleeve may include a rigid cylinder that can add to the rigid point at the distal end of catheter 20. Replacing the rigid cylinder with a gap in transmitter wire 225 can increase the flexibility of the catheter. The removal of material can result in increased bendability at the location of the gap (compared to the case where the material is present), thereby enhancing the flexibility of site transmitter catheter 200.

[0049] Example Transmitter Line

[0050] In certain aspects, the transmitter wire 225 may include a refractory material. Exemplary refractory materials include, but are not limited to, molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, clad wire, or a combination thereof. Molybdenum or tungsten (for the transmitter wire 225) may have a higher durability than other materials (e.g., copper). For example, molybdenum may have a higher melting temperature, enabling it to survive treatment for a longer period of time and degrade more slowly. The higher durability material allows the material of the transmitter wire 225 to last longer due to less corrosion when firing (passing current through) the site transmitter 331. In addition, for example, molybdenum or tungsten may result in a sustained output level from the site transmitter 331 when firing for a longer period of time, thereby increasing the life of the transmitter wire 225. In some embodiments, different combinations of the transmitter wire 225 may also include copper, aluminum, gold, platinum, nickel, etc., in order to utilize or mix the electrical and resistive properties of these metals and the aforementioned refractory metals. The combination or composite of these metals may be a structure with metals plated on top of each other (with or without insulating / insulating materials) or may be an alloy of these metals.

[0051] The use of molybdenum or other refractory materials may be considered counter-intuitive because such refractory metals have lower electrical conductivity (hindering the performance of the generator that provides the voltage for shock wave generation), higher stiffness / hardness (reducing the delivery capacity of the catheter 200), and differences from other materials (difficult to form electrical joints for electrically connecting materials). The durability and / or flexibility of the catheter can be enhanced by configuring the catheter to include a carrier wire 235 that includes a first material (e.g., copper) having a relatively high electrical conductivity and / or relatively low stiffness along a portion of the catheter. Additionally or alternatively, the catheter can include a transmitter wire 225 that includes a second material having a higher durability than the first material. In some aspects, the transmitter wire 225 can be positioned along a second portion of the catheter that is distal to the first portion. In some examples, the second material can include a harder and less conductive material (e.g., molybdenum). The use of the second material can advantageously result in a more durable electrode, while the use of a more conductive and / or more flexible first material along the first portion of the catheter can reduce or minimize any impact on the overall conductivity and catheter stiffness that may result from the use of a more durable material. The transmitter wire 225 and the carrier wire 235 may be joined and electrically coupled together using one or more electrical connectors, as described in detail throughout the disclosure.

[0052] The emitter wire 225 may comprise a round or flat wire having a cross-section smaller than Figure 2The electrode pair 25 of FIG. 20 can be configured to have a smaller cross-section, such as a coronary artery. In some examples, the transmitter wire 225 can have a certain amount of insulating material. For example, when a small cross-section is required, the catheter 200 can include a small amount of insulation. When high dielectric strength is required, the catheter 200 can include a large amount of insulation. Higher dielectric strength can result in better acoustic wave output (e.g., higher amplitude and longer life).

[0053] The size of the transmitter wire 225 can be configured based on the target profile / profile and / or life. For example, a smaller diameter can result in a lower profile / profile, but may reduce life. Example wire sizes for the transmitter wire 225 include, but are not limited to, diameters of approximately 0.003 inches, 0.004 inches, 0.005 inches, 0.008 inches, 0.009 inches, etc. In some examples, the wire size of the transmitter wire 225 can be at least 0.003 inches, at least 0.0034 inches, at least 0.005 inches, at least 0.006 inches, at least 0.007 inches, at least 0.008 inches, at least 0.009 inches, and / or at least 0.010 inches. In some examples, the line size of transmitter line 225 can be at most 0.010 inches, at most 0.009 inches, at most 0.008 inches, at most 0.007 inches, at most 0.006 inches, at most 0.005 inches, at most 0.004 inches, at most 0.003 inches, at most 0.002 inches, and / or at most 0.001 inches.

[0054] Figure 4A and Figure 4B A cross-sectional view of an exemplary catheter including a corresponding catheter body according to some embodiments is shown. The tube may include a lumen and a transmitter wire located within the channel of the elongated tube. In some examples, such as Figure 4A As shown, the transmitter wire 225A can be a flat wire. The flat wire can enhance the flexibility / flexibility of the wire (e.g., in at least one dimension) and thus enhance the distal end and catheter body (e.g., Figure 3 In this embodiment, multiple segments of the flat wire can be arranged on the distal segment of the catheter to bend in the same plane, thereby allowing the distal segment of the catheter to bend or bend up to 180° or more in the plane. The flat wire can also reduce the cross-section of the catheter 200.

[0055] In some examples, such as Figure 4BAs shown, the emitter wire 225B can have a semicircular profile / cross-section with a convex side (e.g., the side of the emitter wire 225B closest to the catheter body 339) and a flat side (e.g., the side of the emitter wire 225B located away from the catheter body 339). The catheter body 339 can include a plurality of grooves 441, and the emitter wire 225B can be shaped such that the convex side is located within the grooves 441. Compared to a flat emitter wire 225A (e.g., having two flat sides), the emitter wire 225B can be shaped such that the convex side is located within the grooves 441. Figure 4A 339) may make it easier to manufacture. In some aspects, the transmitter line 225B may be configured to have flat sides, resulting in a smaller cross-section. In some examples, the transmitter line with flat sides may be configured so that the flat sides are flush with the outer surface of the catheter body 339.

[0056] Exemplary carrier wire 235

[0057] Back to Figure 2 , the catheter 200 may include a carrier wire 235 configured to be located within the channel 227 of the catheter 200. The carrier wire 235 may deliver current to the site transmitter 331 to generate shock waves. The carrier wire 235 may include a low-resistance material suitable for transmitting electricity (voltage from the generator / generator) to the distal end of the catheter 200 (to the transmitter wire). As non-limiting examples, the low-resistance material may be copper, silver, gold, stainless steel, etc.

[0058] When high current delivery is desired, the carrier wire 235 can be configured to have a large size (e.g., the wire size can be selected based on the current to be delivered). In some aspects, the carrier wire 235 can have a larger wire size (diameter) than the transmitter wire 225. The difference in wire size between the carrier wire 235 and the transmitter wire 225 can allow for high current delivery while also increasing the flexibility / flexibility of the catheter 200 (due to the increased flexibility / flexibility of the transmitter wire 225 within the balloon 226). In some examples, the transmitter wire 225 and the carrier wire 235 can have the same wire size.

[0059] Exemplary electrical connector 233 .

[0060] In some cases, the transmitter wire 225 and the carrier wire 235 may comprise different / dissimilar materials. For example, the transmitter wire 225 may comprise a material that is stiffer and / or has a higher resistivity (lower conductivity) (compared to the wire of the catheter 20 of FIG. 1 ). The material of the transmitter wire 225 may be more durable and less susceptible to corrosion, which may result in shrapnel formation during shock wave generation, thereby forming holes in the balloon 226. For example, the transmitter wire 225 may comprise a material such as molybdenum. Although the transmitter wire 225 may have a longer life when formed from a more durable material (relative to when formed from a material such as copper) (e.g., molybdenum), the higher durability may 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, an example of the present invention may include a carrier wire 235 that comprises a material having a relatively higher conductivity. For example, the transmitter wire 225 may be molybdenum or tungsten, and the carrier wire 235 may be copper. The transmitter wire 225 and the carrier wire 235 can be joined and electrically coupled via one or more electrical connectors 233. For example, the electrical connector 233 can be located on the exterior of the balloon 226. In some aspects, the electrical connector 233 can be smooth and seamless (or nearly seamless) and / or located inside the balloon 226.

[0061] The carrier wire 235 (e.g., copper) may be used for a majority of the length of the wire of the catheter 200 (e.g., greater than 50% of the length), and the transmitter wire 225 (e.g., molybdenum or tungsten) may be used at the distal end of the catheter 200. This reduces the stiffness of the catheter, making the catheter 200 more durable than an exemplary embodiment in which a wire formed of a more durable material such as molybdenum or tungsten is used along most of the length of the catheter (e.g., such as Fig.13 This can also reduce the overall resistance of the catheter relative to using materials such as molybdenum or tungsten along most of the length of the catheter, thereby reducing the amount of strain on the source generator that delivers the voltage or current to the site transmitter. In some embodiments, the catheter 200 can have an increased lifespan due to the use of stronger materials for the transmitter wire 225, which can reduce the rate at which the transmitter corrodes; the catheter 200 can be used for more cycles. Additionally or alternatively, the size of the catheter 200 can be smaller due to a smaller cross-section and / or a shorter lumen (because the spark gaps can be closer together).

[0062] The differences / dissimilarity between the transmitter wire 225 and the carrier wire 235 may make it challenging to connect the two wires. The transmitter wire 225 and the carrier wire 235 may be electrically coupled using the electrical connector 233 using any method including, but not limited to, spot welding, laser welding, crimping, wrapping stripped wires around each other, brazing, swaging, using a conductive adhesive, using ferrule pins, etc.

[0063] In some aspects, the electrical connector 233 can be formed using laser welding, which allows for a nice smooth transition (small profile / profile height change) between the emitter wire 225 and the carrier wire 235. The laser welding process may include using a clamping mechanism to hold multiple components (including the emitter wire 225 and the carrier wire 235) and using heat from the laser to fuse the components together. Crimping may include crimping a conductive cylinder or using a ferrule pin comprising copper, brass, silver, tin, stainless steel, etc., or a combination thereof. In some aspects, electroplating materials (e.g., nickel or chromium) can be used to prevent rust. In the case where brazing is used to form the electrical connector 233, as non-limiting examples, copper coatings, nickel plating, nickel-chromium (e.g., 50% nickel, 50% chromium) plating, nickel-copper plating (e.g., 5% nickel, 95% copper), etc. can be applied to the emitter wire 225 (including some portions, such as the tip of the emitter wire 225 or the entire emitter wire 225). When a conductive adhesive is used, example materials include, but are not limited to, silver, carbon graphite, gold, diamond, copper, aluminum, etc. A combination of the above techniques may be used, such as placing a solder under the crimp structure with flux, applying a conductive adhesive prior to swaging or crimping, etc.

[0064] The process parameters for forming the electrical joint 233 may be determined based on durability and / or longevity. For example, the electrical joint 233 may form an incomplete electrical contact, or the crimp may weaken over time. In certain aspects, the type of flux and flux cleaning method for brazing; the time and temperature for resistance welding; and the laser power, focus, and time for laser welding may be adjusted based on the target durability and / or longevity.

[0065] Another example method is resistance welding, in which a plurality of flat material parts are clamped tightly together using a specific pressure controlled by, for example, an air actuator. The material (emitter wire 225, carrier wire 325, or both the emitter wire 225 and the carrier wire 325) needs to have a certain resistance to allow current to pass through to generate heat for resistance welding, and needs to have a low conductivity to ensure that there is enough heat to fuse the parts together. In some aspects, the melting temperatures of the two welding material parts may be similar / identical. For example, the melting temperatures of molybdenum and copper are in the range of about 2000-4700 degrees. 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.

[0066] In some aspects, the catheter 200 may include a plurality of electrical connectors 233. For example, a first electrical connector 233A ( Figure 3 223B (shown in FIG. 224 ) allows an electrical signal to pass from carrier wire 235 to transmitter wire 225 (from the proximal end to the distal end of catheter 200) to form a spark gap. Figure 3The first electrical connector 233A can be located at the same position along the length of the catheter body 339 as the second electrical connector 233B (as shown). In some aspects, the first electrical connector 233A and the second electrical connector 223B can be staggered (located at different positions along the length of the catheter body) (not shown). The staggered arrangement of the connectors can reduce the risk of electrical short circuits.

[0067] Exemplary Line Formation

[0068] To form the wire and electrical connections, the transmitter wire 225 and the carrier wire 235 may be placed on the catheter body 339. The catheter body 339 may be cylindrical and / or may have a groove 441 (e.g., Figure 4A and 4B In some examples, the catheter body 339 may allow the transmitter wire 225 and the carrier wire 235 to slide therein.

[0069] As part of forming the catheter 200, the transmitter wire 225 can be laid and secured to the catheter body 339. The wire can be cut before or after laying, placing wire gaps at or near the location of the electrical connector 233. The wire can be cut in a manner that does not damage the catheter body 339 during manufacturing. In some examples, forming the catheter 200 also includes laying the carrier wire 235, securing to the catheter body 339, and cutting the carrier wire.

[0070] A wire (eg, transmitter wire 225 or carrier wire 235) may be at least partially located within some (including all) of the grooves 441 of the catheter body 339 ( Figure 4A). In some aspects, the wires may be secured to the catheter body 339 using, for example, a top coating material. The top coating material may be an adhesive that secures the transmitter wire 225 and / or the carrier wire 235 to one or more surfaces of the catheter body 339. The top coating material may be an adhesive or a plastic material. For example, after the transmitter wire 225 or the carrier wire 235 is secured to the catheter body 339, the wires are attached / adhered to the catheter body 339. In some aspects, the catheter body 339 may be formed by attaching / attaching / bonding an outer layer to an inner layer by mechanical, thermal, and / or laser means. The wire (e.g., the transmitter wire 225) may be laid on the inner layer. The outer layer may surround the wire and the inner layer, and then the outer layer may be attached to form a bonded / cohesive / combined catheter body. For example, the outer layer may be a top coating material or a polyether block amide (PEBA) sleeve. The top coating material may include a thermoplastic (e.g., a polyolefin) that covers the transmitter wire 225 and the electrical connector 233 (to minimize shorting through the exposed transmitter wire 225) and attaches at least a portion of the transmitter wire 225 or carrier wire 235 to the catheter body 339. In some embodiments, one or more wires (e.g., the transmitter wire 225) may not be secured to the internal lumen using a top coating material. For example, the wires may be attached or adhered / attached to the internal lumen by mechanical, thermal, or laser means.

[0071] A portion of the top coating material and / or the emitter wire 225 may be removed at the gap of the site emitter 331. In some aspects, for the gap of the site emitter 331, a portion of the emitter wire 225 may be removed by, for example, cutting the material of the emitter wire 225. In some aspects, the emitter wire 225 may be partially cut at the gap so that it can create a spark gap but does not damage the catheter body 339. In some aspects, the top coating material at the gap may be removed. In some examples, the flexibility / flexibility of the catheter body 339 may also be enhanced due to the gap in the emitter wire 225.

[0072] Example Configuration

[0073] Examples of the present invention may include different configurations of site transmitter catheters. In some examples, catheter 200 includes a coiled wire. Figure 5A side view of an exemplary catheter including a winding according to some aspects is shown. The catheter body 339 includes a proximal end and a distal end. Near or at the distal end of the catheter body 339, the transmitter line 225 is electrically connected to the carrier line 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 of the catheter body 339. It should be understood that the drawings used to illustrate the exemplary catheters herein may only depict a portion of the catheter and are not shown to scale. Therefore, although the drawings may depict the electrical connector near the proximal end of a portion of the catheter, it should be understood that the catheter may extend far beyond the range shown in the illustrative drawings. The electrical connector may be located at a position closer to the distal end of the catheter than the proximal end of the catheter. Near or at the distal end of the catheter body 339, the transmitter line 225 may be guided / wired by the winding 541 wrapped around the catheter body 339. As shown, catheter 200 may include four site transmitters 331, but examples of the present invention may include any number (not limited to four). Adjacent site transmitters 331 may be separated by a distance 330. As a non-limiting example, 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 emitters (e.g., 330) may be at most 2 mm, at most 3 mm, at most 4 mm, at most 5 mm, at most 6 mm, at most 7 mm, at most 8 mm, at most 9 mm, at most 10 mm, at most 11 mm, at most 12 mm, at most 13 mm, at most 14 mm, at most 15 mm, at most 16 mm, at most 17 mm, at most 18 mm, at most 19 mm, and / or at most 20 mm. The distance between adjacent emitters (e.g., 330) may be in the range of 2 mm to 20 mm.

[0074] In some examples, the catheter includes a marker band 643, such as Figure 6 As shown. The marker band 643 can be located at the distal end of the catheter 200. In some examples, the catheter includes an additional marker band (not shown) positioned proximal to the marker band 643. In some examples, the additional marker band can be positioned at or near the proximal end of the catheter. The marker band 643 can be used in place of the wire wrap 541 to electrically couple the first portion of the transmitter wire 225 to the second portion of the transmitter wire 225 so that current can flow from the supply side of the carrier wire 235 to the return side of the carrier wire 235.

[0075] Examples of the present invention 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. site transmitters. Figure 7 A side view of an exemplary catheter including six site emitters according to some aspects is shown. For example, the six site emitters 331 can form three emitter zones 333. Configuring the catheter to include a greater number of emitters can allow for more spark gaps, thereby increasing the effectiveness of the treatment. Although the figures show an even number of site emitters 331 and spark gaps, examples of the present invention may include an odd number of site emitters 331 and spark gaps (e.g., Fig.13 In some examples, the number of site transmitters 331 can be determined based on the length of balloon 226.

[0076] In some examples, multiple site transmitters in the same transmitter zone may be positionally aligned (have the same location along the length of the catheter body 339). Figure 7 The six position transmitters 331 shown may include a first position transmitter 331A, a second position transmitter 331B, a third position transmitter 331C, and a fourth position transmitter 331D. In some examples, the first position transmitter 331A and the second position transmitter 331B may be part of the transmitter area 333A and located at the same position along the length of the catheter body 339. The third position transmitter 331C and the fourth position transmitter 331D may be part of the transmitter area 333B and located at the same position along the length of the catheter body 339.

[0077] In certain aspects, at least two of the multiple transmitter zones' position transmitters 331 may be angularly aligned (have the same angle around the circumference of the catheter body 339). For example, the first position transmitter 331A and the second position transmitter 331B of the transmitter zone 333A may be located at 0 degrees and 180 degrees around the catheter body 339. The third position transmitter 331C and the fourth position transmitter 331D of the transmitter zone 333B may be positioned at the same angle around the catheter body 339 as the first position transmitter 331A (e.g., 0 degrees) and the second position transmitter 331B (e.g., 180 degrees).

[0078] Although the site transmitter 331 at the top of the catheter body 339 is shown as being aligned with the site transmitter 331 at the bottom of the catheter body 339 because they have the same position (relative to each other) along the length of the catheter body 339 (e.g., the same transmitter area 333), examples of the present invention may include multiple transmitters 331 that are positioned non-aligned. For example, the site transmitters 331 may be staggered relative to each other along the length of the catheter body 339.

[0079] Figure 8 A side view of an exemplary catheter including multiple position transmitters that are staggered is shown. The catheter 200 may include multiple position transmitters 331, including a first position transmitter 331E, a second position transmitter 331F, a third position transmitter 331G, a fourth position transmitter 331H, and a fifth position transmitter 331I. The position of the first position transmitter 331A and the position of the second position transmitter 331B along the length of the catheter body 339 may be different (e.g., staggered).

[0080] In some cases, the catheter may fail due to a short circuit of a transmitter located at or near the distal end of the catheter. Separating the site transmitters 331 reduces the chance of a short circuit and increases its life. The staggered configuration allows the site transmitters 331 to be spaced apart, and the length required for the site transmitters 331 is minimally increased or not increased. For example, as shown in the figure, 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 on the proximal side of the site transmitter 331E) may be 7.5mm. In some examples, the spacing between those site transmitters 331 located at the first position around the catheter body 339 may be the same as the spacing between those site transmitters 331 located at the second position around the catheter body 339. For example, the spacing between the first spot emitter 331E and the third spot emitter 331G (both located at 0 degrees) may be the same as the spacing between the second spot emitter 331F and the fourth spot emitter 331H (both located at 180 degrees).

[0081] In some examples, such as Fig. 9As shown, the plurality of position transmitters 331 may be arranged in a spiral or helical configuration, rotating around the circumference of the catheter body 339 along the length of the catheter. At least some of the position transmitters 331 may have different circumferential positions and / or angles along the length of the catheter body 339. For example, the catheter 200 may include a plurality of position transmitters 331, including a first position transmitter 331J, a second position transmitter 331K, a third position transmitter 331L, a fourth position transmitter 331M, and a fifth position transmitter 331N. The first position transmitter 331J and the second position transmitter 331K (of the first transmitter area) may be located at a first longitudinal position and a first set of angles (e.g., spaced 180 degrees apart from each other at the same longitudinal position around the circumference of the catheter body 339). The site transmitters 331 of the second transmitter area (including the third site transmitter 331L) may be located at different second positions and a second set of (different) angles (e.g., 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 of the third transmitter area (including the fourth site transmitter 331M and the fifth site transmitter 331N) may be located at a third position and a third set of angles (e.g., 180 degrees apart from each other around the circumference of the catheter body 339, and 90 degrees apart from transmitter 331L). The third position may be different from the first and second positions. In some aspects, the third set of angles may be different from the second set of angles. In some aspects, the third set of angles (of site transmitters 331M and 331N) may collectively have the same angle as the first set of angles (of site transmitters 331J and 331K), but the site transmitters having the same angles may be formed on different sides of the transmitter line 225. For example, second position emitter 331K and fourth position emitter 331M may be at 0 degrees, but second position emitter 331K may be formed from the top side of emitter line 225B, while fourth position emitter 331M may be formed from the bottom side of emitter line 225C. In this way, the spiral or helical configuration may improve circumferential uniformity.

[0082] In certain aspects, the life of the catheter can be extended by including a protective layer. Fig.10 2 shows a cross-sectional view of an exemplary lumen of a catheter including a protective layer according to some examples. The catheter 200 may include a protective layer 1032 located between the transmitter wire 225 and the catheter body 339. In some examples, the protective layer may additionally or alternatively (e.g., Fig.11A 1104) and / or an outer layer 1102 surrounding at least a portion of the first inner layer 1105 (surrounding the wire and / or between the wire 1120 and the catheter body 339, as shown) within the lumen axis of the catheter body 339 (second inner layer 1104) and / or surrounding the catheter body 339 (surrounding the wire and / or at least a portion of the first inner layer 1105 between the wire 1120 and the catheter body 339, as shown Fig. 11B339 ) is provided. In some aspects, the protective layer 1032 can be used as an additional thermal insulation layer to prevent or reduce pitting inside the catheter body 339 due to the heat and pressure associated with the 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 increase the acoustic wave output and extend the life. As shown, the transmitter line 225 can have a circular profile / section.

[0083] Fig.11A Also shown is a catheter 1100 having an outer layer 1102 that at least partially surrounds the wire 1120 and maintains the wire 1120 in contact with the catheter body 339. The outer layer 1102 can be made of an electrically insulating polymer (e.g., polyether block amide (PEBA) or nylon). In various different embodiments, the outer protective layer 1102 does not surround the spark gap. In various different embodiments, the outer protective layer 1102 surrounds the wire and includes an opening (e.g., a hole, a slit, a gap) to expose the spark gap to the conductive fluid. In some examples, the inner protective layer 1106 can be formed of the same material as the outer protective layer.

[0084] As described herein, the disclosed examples can increase the output of the acoustic wave. In some examples, the pressure at the treatment area (e.g., lesion) caused by the shock waves generated using the site transmitter described herein can be in the range of 25 atmospheres to 75 atmospheres. In some examples, the pressure at the treatment area caused by the shock waves generated using the site transmitter is at least 20 atmospheres, at least 25 atmospheres, at least 30 atmospheres, at least 35 atmospheres, at least 40 atmospheres, at least 45 atmospheres, at least 50 atmospheres, at least 55 atmospheres, at least 60 atmospheres, at least 65 atmospheres, at least 70 atmospheres, at least 75 atmospheres, at least 80 atmospheres, at least 85 atmospheres, at least 90 atmospheres, at least 95 atmospheres, at least 100 atmospheres. In some examples, the pressure at the treatment area resulting from the shock waves generated by the use site emitter is no more than 100 atmospheres, no more than 95 atmospheres, no more than 85 atmospheres, no more than 75 atmospheres, no more than 65 atmospheres, no more than 60 atmospheres, no more than 55 atmospheres, no more than 50 atmospheres, no more than 45 atmospheres, no more than 40 atmospheres, no more than 35 atmospheres, no more than 30 atmospheres, no more than 25 atmospheres and / or no more than 20 atmospheres.

[0085] Fig.12 A portion of an exemplary catheter 1200 including multiple site transmitters is shown. The exemplary catheter 1200 may include any of the features described throughout the disclosure. Thus, Fig.12 The site transmitter 331 shown in FIG. 1 may include two exposed portions of the transmitter wire 225 separated from each other by respective spark gaps. Figure 3 The catheter shown includes four evenly distributed site emitters, but the catheter 1200 includes five irregularly distributed site emitters 331. The positioning of the emitters around the circumference of the catheter body 339 and along the longitudinal direction of the catheter body 339 can affect the propagation pattern of the emitted shock waves. For example, the positioning of the site emitters relative to each other can affect the location where the constructive interference of the shock waves emitted from the various site emitters is maximum. An arrangement including an odd number of emitter areas can be used to bias the acoustic wave output toward eccentric calcifications.

[0086] Fig.13 A portion of an exemplary catheter including multiple site transmitters is shown. As described throughout, in some examples, the site transmitter may include two exposed portions of a first conductive element (e.g., a transmitter wire), which may be formed of a different, stiffer, more durable, and / or less conductive material (e.g., molybdenum) than a second conductive element (e.g., a carrier wire), which is formed of a more conductive, less stiff, and less durable material (e.g., copper). In such examples, the transmitter wire and the carrier wire may be electrically coupled to each other via one or more electrical connectors. However, in some examples, the wiring / wiring extending from the power source to the site transmitters along the length of the catheter (and forming an exposed end at each site transmitter) may be formed of the material used for the transmitter wire (e.g., a more durable, stiffer, and less conductive material). For example, the wiring along the length of the catheter body 339 may be formed entirely of molybdenum, tungsten, rhodium, rhenium, tantalum, niobium, or a combination thereof.

[0087] Fig.14 An exemplary IVL catheter system according to one or more aspects of the present invention is shown. The catheter system includes a catheter 1400, a conductive wire including an energy guide 1472 for directing energy to the catheter 1400, and a power source 1470. The catheter 1400 includes a catheter body 1410 having a guidewire lumen for guiding the catheter 1400 to a treatment site along a guidewire 1460. The catheter 1400 also includes a housing 1420 surrounding at least a portion of the catheter body. The catheter 1400 includes shock wave generation regions 1401, 1402, 1403, 1404, and 1405 positioned along the catheter body 1400. In response to energy delivery from the power source 1470, one or more shock waves are generated from one or more of the shock wave generation regions 1401, 1402, 1403, 1404, and 1405. Catheter 1400 may be configured such that one or more of the shock wave generating regions may generate shock waves independently of one or more of the remaining shock wave generating regions and / or may be configured such that all shock wave generating regions generate shock waves simultaneously. Fig.14 Five shock wave generating regions are shown, but fewer shock wave generating regions (e.g., one, two, three, or four shock wave generating regions) may be included and / or more additional shock wave generating regions may be included, for example in a shorter or longer catheter used to treat shorter or longer lesions.

[0088] Exemplary IVL catheter systems (eg Fig.14 The one shown in ) is used to treat lesions in a body lumen. In a variety of different examples, the lesion can be a calcified area of ​​the vascular system, a thrombus or occlusion in the vascular system, an atherosclerotic plaque, or a lesion in some other body lumen, such as a kidney stone in the ureter. In one or more embodiments, each of the one or more of the shock wave generating areas 1401, 1402, 1403, 1404 and 1405 includes an electrode assembly, which includes one or more electrode pairs. As described above, the term "electrode" refers to a conductive element (usually made of metal) that receives an electric current and then releases the electric current to another conductive element. In the context of the present utility model, the electrodes are typically positioned relative to each other, for example, in an arrangement of two exposed conductive wire portions separated by a relatively small gap.

[0089] In one or more embodiments of the present invention, Fig.14 The power supply 1470 shown includes a high-voltage pulse generator. In one or more embodiments, the power supply 1470 provides a high-voltage pulse of not less than six kilovolts (6kV). In one or more embodiments, the power supply 1470 provides a high-voltage pulse of not less than ten kilovolts (10kV). In one or more embodiments, the power supply 1470 provides a high-voltage pulse of three kilovolts (3kV) to thirty thousand volts (30kV). In one or more embodiments, the power supply 1470 provides a high-voltage pulse of six kilovolts (6kV) to ten thousand volts (10kV). In one or more embodiments, the power supply 1470 is configured to provide a high-voltage pulse with adjustable intensity. In some examples, the power supply 1470 applies an alternating current to the electrode to cause a change in the polarity of the electrode.

[0090] As described above, applying a relatively high voltage pulse (e.g., greater than or equal to 10 kV) may be beneficial for treating certain types of lesions (e.g., lesions associated with aortic valve stenosis) that require a higher acoustic wave output for treatment. In some examples, the high voltage pulse is applied at a voltage 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. The high voltage pulse may be no more than 30 kV, no more than 20 kV, no more than 19 kV, no more than 18 kV, no more than 17 kV, no more than 16 kV, no more than 15 kV, no more than 14 kV, no more than 13 kV, no more than 12 kV, no more than 11 kV, no more than 10 kV, no more than 9 kV, no more than 8 kV, no more than 7 kV, no more than 6 kV, no more than 5 kV, no more than 4 kV, no more than 3 kV, no more than 2 kV and / or no more than 1 kV.

[0091] The voltage pulses may be applied at a rate of 1 Hz to 50 Hz, inclusive. The shock wave energy generator 530 may be configured to deliver voltage pulses at a rate 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 may be configured to deliver voltage pulses at a rate 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.

[0092] In one or more embodiments, Fig.14 The housing 120 shown is a balloon (e.g., an angioplasty balloon). The housing 120 can be in a collapsed configuration or a retracted configuration to provide a lower profile / profile during delivery to the treatment site. During treatment, the housing 120 can be expanded to a pressure of two atmospheres to four atmospheres (2atm to 4atm) using a liquid fluid (e.g., saline). Energy is then provided to the shock wave generating regions 101, 102, 103, 104, and 105 to cause the generation of one or more shock waves. The housing can then be deflated and re-expanded to flush out any accumulated bubbles before further treatment of the site. Alternatively, the housing 120 can be further advanced to a different lesion (or a different section of the same lesion) or removed from the patient.

[0093] In some embodiments, applying high voltage pulses and / or applying a large number of pulses to the shock wave generating areas 101, 102, 103, 104, and 105 over time may cause electrode degradation. Over time, degradation of the electrodes may result in reduced reliability of shock wave generation and / or reduced acoustic wave output. Further degradation of the electrodes may result in shrapnel during shock wave generation, which may pierce the housing (e.g., angioplasty balloon) around the electrodes and / or damage tissue within the body. Forming the electrodes from relatively more wear-resistant materials may improve the durability of the electrodes, thereby extending the life of the shock wave generating catheter. However, such relatively more durable materials also present some challenges. For example, such materials may provide significantly lower conductivity (which may hinder the performance of the generator) and may result in reduced navigability of the catheter due to the higher stiffness / hardness of the material (e.g., if used for routing along a relatively large portion of the length of the catheter).

[0094] Thus, such a material may be a counter-intuitive choice of catheter electrode material described herein. However, by using a first material having a relatively low stiffness and a relatively high electrical conductivity to conduct electrical energy from a power source along the length of catheter 100, and using a relatively more durable second material having a relatively high stiffness and a relatively low electrical conductivity near the distal end of the catheter to conduct electricity to one or more shock wave generation regions 101, 102, 103, 104, and 105, the challenges presented by these relatively more durable materials can be overcome. In some examples, at least one electrode of at least one shock wave transmitter of shock wave generation regions 101, 102, 103, 104, and 105 can be formed from the relatively more durable material, which can result in a shock wave transmitter having a longer life and reliability (relative to a transmitter having electrodes formed from the first material) for the reasons described above.

[0095] Fig.15 1 shows an exemplary computing system 1500 according to some examples of the present invention. The system 1500 can be a client or a server. Fig.15 As shown, system 1500 can be any suitable type of processor-based system, such as a personal computer, a workstation, a server, a handheld computing device (portable electronic device) such as a phone or a 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 may generally correspond to the above-mentioned devices and may be connected or integrated with a computer.

[0096] Input device 1520 may be any suitable device for providing input, such as a touch screen, a keyboard or keypad, a mouse, a gesture recognition component of a virtual / augmented reality system, or a voice recognition device. Output device 1530 may be or include any suitable device for providing output, such as a display, a touch screen, a tactile device, a virtual / augmented reality display, or a speaker.

[0097] Storage device 1540 may be any suitable device that provides storage, such as electrical, magnetic, or optical storage, including random access memory (RAM), cache, hard drive, removable storage disk, or other non-transitory computer-readable medium. Communication device 1560 may include any suitable device capable of sending and receiving signals over a network, such as a network interface chip or device. The components of computing system 1500 may be connected in any suitable manner, such as via a physical bus or a wireless connection.

[0098] The processor 1510 may be any suitable processor or combination of processors, including any one 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). The software 1550 that may be stored in the storage device 1540 and executed by one or more processors 1510 may include, for example, a program that embodies the functions or part of the functions of the present invention (e.g., as embodied in the above-mentioned devices).

[0099] The 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 (e.g., those described above), which may retrieve instructions associated with the software from the instruction execution system, device, or apparatus / storage medium and execute the instructions. In the context of the present invention, a computer-readable storage medium may be any medium, such as storage device 1540, which may contain or store a program for use by or in conjunction with an instruction execution system, device, or apparatus.

[0100] The software 1550 may also be transmitted in any transmission medium for use by or in conjunction with an instruction execution system, device, or apparatus (such as those described above), which may obtain instructions associated with the software from the instruction execution system, device, or apparatus / transmission medium and execute the instructions. In the context of the present invention, a transmission medium may be any medium capable of conveying, propagating, or transmitting a program used by or in conjunction with an instruction execution system, device, or apparatus. Transmission computer-readable media may include, but are not limited to, electronic, magnetic, optical, electromagnetic, or infrared wired or wireless propagation media.

[0101] System 1500 may be connected to a network, which may be any suitable type of interconnected communication system. The network may implement any suitable communication protocol and may be protected by any suitable security protocol. The network may include any suitably arranged network link capable of transmitting and receiving network signals, such as a wireless network connection, a T1 or T3 line, a cable network, DSL, or a telephone line.

[0102] System 1500 may implement any operating system suitable for operating on a network. Software 1550 may be written in any suitable programming language, such as C, C++, Java, or Python. In various different embodiments, application software embodying the functionality of the present invention may be deployed in different configurations, such as in a client / server arrangement or as a web-based application or web service through a web browser.

[0103] The elements and features of the exemplary electrode assemblies and catheters described above may be rearranged, recombined, and modified without departing from the present invention. In addition, numerical indicators such as "first," "second," "third," "fourth," and the like 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, followed by a "second" shock wave. As another example, a "third" transmitter may be used to generate a "first" shock wave, or vice versa. Therefore, the numerical indicators of various elements and features are not intended to limit the present invention, and may be modified and interchanged without departing from the present invention.

[0104] As described herein, it should be understood that any disclosure of a numerical range describing a dimension or measurement (such as thickness, length, weight, time, frequency, temperature, voltage, current, angle, etc.) includes any numerical increment or gradient within the range provided relative to a given dimension or measurement.

[0105] It should be noted that the elements and features of the exemplary catheters shown in this specification and the accompanying drawings may be rearranged, recombined, and modified without departing from the present invention. For example, although the present specification and the accompanying drawings describe and illustrate catheters with several exemplary balloon designs, the present invention is intended to include catheters with a variety of different balloon configurations. The number, position, and spacing of the electrode pairs of the shock wave generator may be modified without departing from the present invention. In addition, the number, position, and spacing of the catheter balloons may be modified without departing from the present invention.

[0106] It should be understood that the above is only an illustration of the principles of the present invention, and that those skilled in the art may make various changes, modifications, and combinations without departing from the scope and spirit of the present invention. Any variation of the various catheters disclosed herein may include features described by any other catheter or combination of catheters herein. In addition, any method may be used with any catheter disclosed. Therefore, the present invention is not intended to be limited except by the appended claims.

Claims

1. A shock wave guide system, characterized in that: The shock wave guide system includes: A catheter, the catheter comprising: a catheter body including a lumen; an emitter line configured to generate shock waves, wherein the emitter line includes one or more gaps in the emitter line along the length of the lumen, each of the one or more gaps forming a shock wave emitter; a carrier line configured to conduct electricity to the transmitter line; and one or more electrical connectors configured to join and electrically couple the transmitter wire and the carrier wire; and A power source is electrically coupled to the carrier wire.

2. The shock wave guide system according to claim 1, characterized in that: The catheter also includes a housing configured to be filled with a fluid or expandable with a fluid, and the transmitter wire is located within the housing.

3. The shock wave guide system according to claim 1, characterized in that: The transmitter wire is located along the distal end of the catheter body.

4. The shock wave guide system according to claim 1, characterized in that: The transmitter wire is made of one of molybdenum, tungsten, rhodium, rhenium, tantalum and niobium.

5. The shock wave guide system according to claim 1, characterized in that: The diameter of the emitter line is greater than or equal to 0.08 mm and less than or equal to 0.23 mm.

6. The shock wave guide system according to claim 1, characterized in that: The carrier wire is located proximal to the transmitter wire.

7. The shock wave guide system according to claim 1, characterized in that: The carrier wire is made of copper.

8. The shock wave guide system according to claim 1, characterized in that: The carrier wire has a resistivity lower than the emitter wire.

9. The shock wave guide system according to claim 1, characterized in that: The one or more electrical contacts are located proximal to the transmitter wire near the distal end of the catheter body.

10. The shock wave guide system according to claim 1, characterized in that The transmitter line is made of a first metal, and the carrier line is made of a second metal different from the first metal.

11. The shock wave guide system according to claim 1, characterized in that: The one or more shock wave transmitters include at least two shock wave transmitters angularly aligned along a circumference of the lumen.

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