Intravascular lithotripsy device equipped with a plasma generator containing polymer materials

Abstract

A catheter system (100) for treating a treatment site (106) within or adjacent to the vessel wall (108A) of a blood vessel (108) includes an energy source (124), an energy guide (122A), and a guidewire lumen (118). The energy source (124) generates energy. The energy guide (122A) is configured to selectively receive energy from the energy source (124). The energy guide includes a distal guide end (122D). Energy received by the energy guide (122A) is released from the distal guide end (122D). The guidewire lumen (118) has an outer surface (218S). At least the distal guide end (122D) of the energy guide (122A) is positioned adjacent to the outer surface (218S) of the guidewire lumen (118). A portion of the guidewire lumen (118) includes a plasma generator (133) positioned near the distal end (122D) of the energy guide (122A). The plasma generator (133) can be positioned near the treatment site (106). The plasma generator (133) is formed from a polymer material.

Description

Technical Field

[0001] This application claims priority from and is related to U.S. Provisional Patent Application No. 63 / 516,938, filed on August 1, 2023, entitled "INTRAVASCULAR LITHOTRIPSY DEVICE WITH EMITTERS INCLUDING POLYMERIC MATERIAL", and U.S. Patent Application No. 18 / 741,023, filed on June 12, 2024, entitled "INTRAVASCULAR LITHOTRIPSY DEVICE WITH PLASMA GENERATOR INCLUDING POLYMERIC MATERIAL", the entire contents of which are incorporated herein by reference in their entirety as permitted.

Background Art

[0002] Vascular lesions within blood vessels in the body can be associated with an increased risk of serious adverse events such as myocardial infarction, embolism, deep vein thrombosis, and stroke. Severe vascular lesions can be difficult for clinicians in the clinical setting to treat and obtain patency.

[0003] [[ID=1S]] Vascular lesions can be treated, for example, using interventions such as drug therapy, balloon angioplasty, atherectomy, stent placement, vascular graft bypass, etc. Such interventions are not always ideal and may require subsequent treatment to address the lesion.

Summary of the Invention

[0004] The present invention relates to a catheter system for placement within a blood vessel having a vascular wall. The catheter system can be used by an operator to treat a treatment site within the vascular wall or a treatment site adjacent to the vascular wall. In various embodiments, the catheter system includes an energy source, an energy guide, and a guidewire lumen. The energy source generates energy. The energy guide is configured to selectively receive energy from the energy source and includes a distal guide end. The energy received by the energy guide is emitted from the distal guide end. The guidewire lumen has an outer surface. At least the distal guide end of the energy guide is positioned adjacent to the outer surface of the guidewire lumen. A portion of the guidewire lumen includes a plasma generator positioned near the distal guide end of the energy guide. The plasma generator can be positioned near the treatment site. The plasma generator is formed from a polymer material.

[0005] In some embodiments, the outer surface of the guidewire lumen includes a groove. In certain embodiments, at least the distal end of the energy guide is located within a groove formed along the outer surface of the guidewire lumen.

[0006] In certain embodiments, the plasma generator is at least partially formed from one of plastics, polyimides, nylons, and polyether block amides.

[0007] In many embodiments, the plasma generator is positioned away from the distal end of the energy guide. In various embodiments, the energy received by the energy guide is released from the distal end of the guide and comes into contact with the plasma generator, thereby generating plasma adjacent to the plasma generator.

[0008] In some embodiments, the generation of the plasma generates sound waves that travel away from the plasma generator. In certain embodiments, the sound waves apply pressure adjacent to the blood vessel wall at the treatment site.

[0009] In some embodiments, polymer fillers are added to the polymer material of the plasma generator. In certain embodiments, the polymer filler comprises one or more of titanium dioxide, bismuth, barium sulfate, gold nanoparticles, silver nanoparticles, and tungsten particles.

[0010] In many embodiments, the catheter system further includes a catheter shaft and a balloon coupled to the catheter shaft. The balloon includes a balloon wall defining the interior of the balloon. The balloon is configured to hold catheter fluid inside the balloon. The distal end of the energy guide and the plasma generator are located inside the balloon.

[0011] In some embodiments, the energy received by the energy guide is released from the distal end of the guide and comes into contact with the plasma generator, thereby generating plasma in the catheter fluid held inside the balloon.

[0012] In certain embodiments, the distal end of the energy guide is inclined with respect to the outer surface of the guidewire lumen such that the energy emitted from the distal end of the guide is directed toward the outer surface of the guidewire lumen in the groove. In some embodiments, a portion of the outer surface of the guidewire lumen includes the plasma generator.

[0013] In certain embodiments, the distal end of the energy guide is inclined with respect to the outer surface of the guidewire lumen at an angle of approximately 5 to 45 degrees relative to a flat, vertical orientation.

[0014] In some embodiments, the plasma generator extends outward from the outer surface of the guidewire lumen and includes an inclined surface, the inclined surface being configured such that energy emitted from the distal end of the energy guide is directed toward the treatment site by being emitted toward the inclined surface of the plasma generator.

[0015] In certain embodiments, the inclined surface of the plasma generator is inclined with respect to the outer surface of the guide wire lumen at an angle of approximately 5 to 45 degrees relative to the flat vertical arrangement.

[0016] In many embodiments, the catheter system further includes a system controller. The system controller includes a processor that controls the energy source so that the energy from the energy source is selectively directed to the energy guide.

[0017] In various embodiments, the energy source is a light source that generates pulses of light energy. In some embodiments, the light source is a laser.

[0018] In many embodiments, the energy guide includes an optical fiber. The present invention further relates to a method for treating a treatment site within the wall of a blood vessel or a treatment site adjacent to the wall of the blood vessel. The method includes the steps of: generating energy from an energy source; selectively receiving energy from the energy source by an energy guide including a distal guide end; releasing the energy received by the energy guide from the distal guide end; positioning at least the distal guide end of the energy guide adjacent to the outer surface of a guidewire lumen, wherein a portion of the guidewire lumen includes a plasma generator positioned near the distal guide end of the energy guide; and positioning the plasma generator, formed from a polymer material, near the treatment site.

[0019] This summary is a summary of some of the teachings of this application and is not intended to be an exclusive or exhaustive treatment of the subject matter. Further details are described in the detailed description and the appended claims. Several other embodiments will become apparent to those skilled in the art who read and understand the following detailed description and view the drawings forming part thereof, but each embodiment should not be construed as restrictive. The scope herein is defined by the appended claims and their equivalents.

[0020] The novel features of the present invention and its structure and operation can best be understood from the accompanying drawings, along with a detailed description. [Brief explanation of the drawing]

[0021] [Figure 1] Figure 1 is a simplified schematic cross-sectional view of one embodiment of a catheter system according to various embodiments, wherein the catheter system includes a guidewire lumen and one or more energy guides positioned adjacent to the guidewire lumen, and a portion of the guidewire lumen includes a plasma generator. [Figure 2]FIG. 2 is a simplified schematic end view of a portion of an embodiment of a catheter system, including an embodiment of a guide wire lumen and an energy guide disposed adjacent to the guide wire lumen. [Figure 3A] FIG. 3A is a simplified schematic side view of a portion of the guide wire lumen and a portion of the energy guide shown in FIG. 2, and an embodiment of a plasma generator that may be included in a portion of the guide wire lumen. [Figure 3B] FIG. 3B is a simplified schematic side view of a portion of the guide wire lumen, the plasma generator, and a portion of the energy guide shown in FIG. 3A, further showing the initiation of a plasma plume. [Figure 3C] FIG. 3C is a simplified schematic side view of a portion of the guide wire lumen, the plasma generator, and a portion of the energy guide shown in FIG. 3A, further showing the generation of a plasma plume and the resulting high-frequency acoustic waves. [Figure 3D] FIG. 3D is a simplified schematic side view of a portion of the guide wire lumen, the plasma generator, and a portion of the energy guide shown in FIG. 3A, further showing the generation of cavitation bubbles. [Figure 4A] FIG. 4A is a simplified schematic side view of a portion of a guide wire lumen of another embodiment, a portion of an energy guide of another embodiment, and another embodiment of a plasma generator that may be included within the guide wire lumen. [Figure 4B] FIG. 4B is a simplified schematic side view of a portion of the guide wire lumen, the plasma generator, and a portion of the energy guide shown in FIG. 4A, further showing the initiation of a plasma plume. [Figure 4C] FIG. 4C is a simplified schematic top view of a portion of the guide wire lumen, the plasma generator, and a portion of the energy guide shown in FIG. 4A, further showing the generation of a plasma plume and the resulting high-frequency acoustic waves.

DETAILED DESCRIPTION OF THE INVENTION

[0022] Embodiments of the present invention are capable of various changes and alternative forms, and specific details thereof are shown using examples and drawings and are described in detail herein. However, the scope of this specification is not limited to the specific embodiments described. Rather, it is intended to include modifications, equivalents, and alternative forms within the spirit and scope of the present disclosure.

[0023] Treatment of vascular lesions at a treatment site within a patient's body can reduce serious adverse events or death in affected subjects. As used herein, a serious adverse event refers to an event that can occur anywhere in the body due to the presence of a vascular lesion. Examples of serious adverse events include, but are not limited to, serious adverse events of the cardiovascular system, serious adverse events in the peripheral or central vascular system, serious adverse events in the brain, serious adverse events in muscle tissue, or serious adverse events in any internal organ.

[0024] In various embodiments, the catheter systems and related methods disclosed herein can include a catheter configured to be delivered to a vascular lesion, such as a calcified vascular lesion or a fibrotic vascular lesion, at a treatment site located within a patient's body. In certain examples, the "treatment site" can be located on or near the vessel wall of a patient's blood vessel. Additionally or alternatively, in other examples, the "treatment site" can be the patient's heart valve or near it. Additionally or alternatively, in still other examples, the "treatment site" can be another location within the patient's body.

[0025] As used herein, the terms "treatment site", "intravascular lesion", and "vascular lesion" are used interchangeably unless otherwise noted. Intravascular lesions and / or vascular lesions may also be referred to herein as "lesions".

[0026] Those skilled in the art will recognize that the following detailed description of the invention is merely illustrative and not intended to be limiting. Those skilled in the art who have an interest in this disclosure will readily recall other embodiments of the invention. Hereinafter, embodiments of the invention shown in the accompanying drawings will be used with reference in detail.

[0027] For clarity, not all routine features of the implementations described herein are illustrated and explained. Of course, in developing any such actual implementation, numerous implementation-specific decisions must be made to achieve the developer's specific objectives, including compliance with application-related and business-related constraints, and these specific objectives will differ from implementation to implementation and from developer to developer. Furthermore, while such development efforts can be complex and time-consuming, they will be understood by those skilled in the art who are interested in this disclosure as routine engineering work.

[0028] The catheter systems disclosed herein may include many different forms. Referring to Figure 1, simplified schematic cross-sectional views of catheter systems 100 according to various embodiments are shown. Catheter systems 100 are suitable for inducing fragmentation in one or more vascular lesions in the treatment site within or adjacent to the wall of blood vessels in a patient's body, or on or adjacent to a heart valve, by applying high-frequency mechanical sound waves and / or pressure waves. In the embodiment shown in Figure 1, the catheter system 100 may include (i) a catheter 102 comprising one or more of the following: an inflatable balloon 104 (which may also be referred to herein as the “balloon”), a catheter shaft 110, a guidewire 112, an energy bundle 122 including one or more energy guides 122A, a source manifold 136, a fluid pump 138, a handle assembly 129, and an energy emission system 131 (which may also be referred to herein as the “emitter system”) comprising one or more emitter stations 180 and / or one or more emitters 135; and (ii) a system console 123 comprising one or more of the following: an energy source 124 (which in certain non-exclusive embodiments may be such as a light source and / or a laser source), a power supply 125, a system controller 126, a graphic user interface 127 (“GUI”), and a multiplexer 128. Alternatively, the catheter system 100, catheter 102, and / or system console 123 may include more or fewer components than those specifically illustrated and described in relation to Figure 1. For example, in certain non-exclusive alternative embodiments, the catheter system 100 and / or system console 123 may be designed without the GUI 127 and / or multiplexer 128.

[0029] The catheter 102 is configured to travel to a treatment site 106 at any location within the patient's body 107. In some examples, the treatment site 106 may be within or adjacent to the vascular wall 108A of a blood vessel 108 within the patient's body 107. Alternatively, in other embodiments, the catheter 102 may be used at a treatment site 106 within or adjacent to a heart valve within the patient's body 107. The treatment site 106 may include one or more vascular lesions 106A, such as calcified vascular lesions. Additionally or alternatively, the treatment site 106 may include vascular lesions 106A, such as fibrous vascular lesions.

[0030] In certain embodiments, the balloon 104 may be coupled to the catheter shaft 110. The balloon 104 may include a proximal end 104P and a distal end 104D. The catheter shaft 110 may extend from the proximal portion 114 of the catheter system 100 to the distal portion 116 of the catheter system 100. The catheter shaft 110 may include a longitudinal axis 144. The catheter 102 and / or the catheter shaft 110 may also include a guidewire lumen 118 configured to move along the guidewire 112. The guidewire lumen 118 used in this disclosure defines the conduit through which the guidewire 112 extends. The catheter shaft 110 may further include an inflation lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, the catheter 102 may have a distal end opening 120. The catheter 102 can follow along the guidewire 112 while accommodating it as the catheter 102 is moved and positioned at or near the treatment site 106. In some embodiments, the proximal end of the balloon 104P may be coupled to the catheter shaft 110. The distal end of the balloon 104D may be coupled to the guidewire lumen 118.

[0031] The balloon 104 includes a balloon wall 130 that defines the interior 146 of the balloon. The balloon 104 can be selectively inflated using catheter fluid 132 to expand from a deflated state suitable for advancing the catheter 102 through the patient's vascular system to an inflated state (as shown in Figure 1) suitable for anchoring the catheter 102 in place relative to the treatment site 106. In other words, the balloon wall 130 of the balloon 104 is configured to be substantially adjacent to the treatment site 106 when the balloon 104 is in the inflated state.

[0032] Each emitter station 180 referred to herein may include one or more emitters 135 positioned at substantially the same longitudinal location within the balloon 104. Each emitter 135 includes at least one guide distal end 122D of a plurality of energy guides 122A and a corresponding plasma generating mechanism 133 (also referred to herein as a “plasma generator”) that cooperates to generate plasma within the balloon 104. Since the emitter system 131 may include one or more emitter stations 180, the catheter system 100 and / or emitter system 131 may include any suitable number of emitters 135, from one to more than 30.

[0033] In general, in various embodiments, each emitter 135 of the catheter system 100 may be formed from at least partially one or more polymer materials. More specifically, the present invention relates to a polymer emitter 135 for use in an intravascular lithotripsy device that generates sound waves by laser-optic interaction. In certain non-exclusive embodiments, the present invention includes an energy guide 122A, such as an optical fiber, which is attached to and / or positioned adjacent to the guidewire lumen 118. In many embodiments, a plasma generator 133 may be contained within a portion of the guidewire lumen 118 away from the guide distal end 122D of the energy guide 122A and may be formed from one or more polymer materials.

[0034] In some embodiments, the guidewire lumen 118 and / or plasma generator 133 are formed at least partially from a polymer material such as polyether block amide (e.g., PEBAX®), polyimide, plastic, nylon, or other thermoplastic material, and may further be configured to have thin walls to minimize the crossing profile. Polymer fillers such as titanium dioxide, bismuth, barium sulfate, gold nanoparticles, silver nanoparticles, tungsten particles, or any other metallic material may also be added to the polymer or thermoplastic material of the guidewire lumen 118 and / or plasma generator 133 to increase laser absorption and optimize the conversion efficiency of laser energy to sound wave output. In certain embodiments, energy such as laser energy emitted from the guide distal end 122D of the energy guide 122A comes into contact with the polymer material of the guidewire lumen 118 (which in various embodiments includes the plasma generator 133) located away from the guide distal end 122D of the energy guide 122A. The interaction of light with the polymer material initiates a plasma plume substantially adjacent to the plasma generator 133. The size of the plasma plume increases proportionally to the energy delivered through the emitter 135 and / or energy guide 122A. In various implementations, the generation of the plasma plume generates high-frequency mechanical sound waves directed toward the vascular lesion 106A of the treatment site 106 in a direction away from the plasma generator 133. Thus, the generation of plasma generates sound waves and / or pressure waves, thereby applying pressure adjacent to the vascular lesion 106A of the treatment site 106. In addition, as the sound waves propagate toward the vascular lesion 106A of the treatment site 106 in a direction away from the plasma generator 133, cavitation bubbles may be generated by the sound waves.

[0035] A balloon 104 suitable for use in a catheter system 100 includes one that can pass through the vascular system of a patient 109 when deflated. In some embodiments, the balloon 104 is made from silicone. In other embodiments, the balloon 104 may be made from a material such as polydimethylsiloxane (PDMS), polyurethane, a polymer such as polyether block amide (e.g., PEBAX®) material, nylon, or any other suitable material.

[0036] The balloon 104 may have any suitable diameter (inflated state). In various embodiments, the balloon 104 may have a diameter (inflated state) ranging from less than 1 millimeter (mm) to a maximum of 25 mm. In some embodiments, the balloon 104 may have a diameter (inflated state) ranging from at least 1.5 mm to a maximum of 14 mm. In certain embodiments, the balloon 104 may have a diameter (inflated state) ranging from at least 2 mm to a maximum of 5 mm.

[0037] In some embodiments, the balloon 104 may have a length 142 in the range of at least 3 mm to 300 mm. More specifically, in certain embodiments, the balloon 104 may have a length 142 in the range of at least 8 mm to 200 mm. A balloon 104 with a relatively longer length can be positioned adjacent to a larger treatment site 106, and can therefore be used to apply sound waves and / or pressure waves to a larger vascular lesion 106A or multiple vascular lesions 106A at a precise location within the treatment site 106 to induce fragmentation. Additionally, longer balloons 104 can be positioned adjacent to multiple treatment sites 106 at any given timing.

[0038] The balloon 104 can be inflated to an inflation pressure of approximately 1 atmosphere (atm) to 70 atm. In some embodiments, the balloon 104 can be inflated to an inflation pressure of at least 20 atm to 60 atm. In other embodiments, the balloon 104 can be inflated to an inflation pressure of at least 6 atm to 20 atm. In yet another embodiment, the balloon 104 can be inflated to an inflation pressure of at least 3 atm to 20 atm. In yet another embodiment, the balloon 104 can be inflated to an inflation pressure of at least 2 atm to 10 atm.

[0039] The balloon 104 may have a variety of shapes, including, but is not limited to, conical, square, rectangular, spherical, conical / square, conical / spherical, expanded spherical, oval, tapered, bony, stepped diameter, offset, or conical offset shapes. In some embodiments, the balloon 104 may include a drug-eluting coating or a drug-eluting stent structure. The drug-eluting coating or drug-eluting stent structure may include one or more therapeutic agents, such as anti-inflammatory agents, antitumor agents, or anti-angiogenic agents.

[0040] The catheter fluid 132 may be a liquid or a gas. Some examples of catheter fluids 132 suitable for use may include, but are not limited to, water, saline, contrast agents, gases such as carbon fluoride, perfluorocarbons, carbon dioxide, or one or more of any other suitable catheter fluids 132. In some embodiments, the catheter fluid 132 may be used as a base expansion fluid. In some embodiments, the catheter fluid 132 may include a mixture of saline to contrast agent in a volume ratio of about 50:50. In other embodiments, the catheter fluid 132 may include a mixture of saline to contrast agent in a volume ratio of about 25:75. In yet another embodiment, the catheter fluid 132 may include a mixture of saline to contrast agent in a volume ratio of about 75:25. However, any suitable ratio of saline to contrast agent may be used. The catheter fluid 132 may be adjusted based on composition, viscosity, etc., so that the propagation velocity of sound waves and / or pressure waves is appropriately manipulated. In certain embodiments, a catheter fluid 132 suitable for use is biocompatible. The volume of the catheter fluid 132 can be adjusted depending on the selected energy source 124 and the type of catheter fluid 132 used.

[0041] In some embodiments, the contrast agent used as the contrast medium may include, but is not limited to, iodine-based contrast agents such as ionic or nonionic iodine-based contrast agents. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, metrizoate, iotalamate, and ioxagrate. Some non-limiting examples of nonionic iodine-based contrast agents include iopamidol, iohexol, ioxiran, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based contrast agents may be used. Suitable non-iodine-containing contrast agents include gadolinium(III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon agents include the perfluorocarbon dodecafluoropentane (DDFP, C5F 12 Examples of such agents include, but are not limited to, those listed above.

[0042] The catheter fluid 132 may include an absorbent capable of selectively absorbing light in the ultraviolet region (e.g., at least 10 nanometers (nm) to 400 nm), the visible region (e.g., at least 400 nm to 780 nm), or the near-infrared region (e.g., at least 780 nm to 2.5 micrometers (μm)) of the electromagnetic spectrum. Suitable absorbents include those having an absorption maximum along the spectrum at least 10 nm to 2.5 μm. Alternatively, the catheter fluid 132 may include an absorbent capable of selectively absorbing light in the mid-infrared region (e.g., at least 2.5 μm to 15 μm) or the far-infrared region (e.g., at least 15 μm to 1 mm) of the electromagnetic spectrum. In various embodiments, the absorbent may have an absorption maximum that matches the emission maximum of the laser used in the catheter system 100. As a non-limiting example, various lasers usable in the catheter system 100 may include a neodymium:yttrium-aluminum-garnet (Nd:YAG, emission maximum = 1064 nm) laser, a holmium:YAG (Ho:YAG, emission maximum = 2.1 μm) laser, or an erbium:YAG (Er:YAG, emission maximum = 2.94 μm) laser. In some embodiments, the absorbent may be water-soluble. In other embodiments, the absorbent is not water-soluble. In some embodiments, the absorbent used in the catheter fluid 132 may be adjusted to match the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths from at least 10 nanometers to 1 millimeter are described elsewhere in this specification.

[0043] The catheter shaft 110 of catheter 102 may be coupled to a plurality of energy guides 122A of an energy guide bundle 122 that is in optical communication with an energy source 124. One or more energy guides 122A may be positioned within the balloon 104 along the catheter shaft 110. Each energy guide 122A may have a distal guide end 122D at any suitable longitudinal position relative to the length 142 of the balloon 104 and / or the length of the guidewire lumen 118.

[0044] In some embodiments, each energy guide 122A may be an optical fiber, and the energy source 124 may be a laser. The energy source 124 may communicate optically with the energy guides 122A in the proximal portion 114 of the catheter system 100. More specifically, the energy source 124 may communicate optically with each energy guide 122A selectively and / or alternately, by the presence and operation of a multiplexer 128.

[0045] In some embodiments, the catheter shaft 110 may be coupled to a plurality of energy guides 122A, such as a first energy guide, a second energy guide, a third energy guide, and so on. The plurality of energy guides 122A may be positioned around and / or at any suitable location relative to the guidewire lumen 118 and / or the catheter shaft 110. For example, in certain non-limiting embodiments, two energy guides 122A may be spaced about 180 degrees apart from each other around the outer circumference of the guidewire lumen 118 and / or the catheter shaft 110. Or, three energy guides 122A may be spaced about 120 degrees apart from each other around the outer circumference of the guidewire lumen 118 and / or the catheter shaft 110. Or, four energy guides 122A may be spaced about 90 degrees apart from each other around the outer circumference of the guidewire lumen 118 and / or the catheter shaft 110. Or, six energy guides 122A may be spaced about 60 degrees apart from each other around the outer circumference of the guidewire lumen 118 and / or the catheter shaft 110. Alternatively, eight energy guides 122A may be spaced approximately 45 degrees apart from each other around the outer circumference of the guidewire lumen 118 and / or catheter shaft 110. Alternatively, ten energy guides 122A may be spaced approximately 36 degrees apart from each other around the outer circumference of the guidewire lumen 118 and / or catheter shaft 110. Alternatively, the multiple energy guides 122A do not need to be uniformly spaced apart from each other around the outer circumference of the guidewire lumen 118 and / or catheter shaft 110. Specifically, the energy guides 122A may be uniformly or non-uniformly arranged around the guidewire lumen 118 and / or catheter shaft 110 to achieve the desired effect at the desired location.

[0046] In certain embodiments, the guidewire lumen 118 may be substantially annular and / or cylindrical in shape. The guidewire lumen 118 may have a grooved outer surface 218S (shown in Figure 2) with one or more grooves 260 (shown in Figure 2) extending substantially longitudinally along the guidewire lumen 118. In such embodiments, each energy guide 122A may be positioned, received, and held along the outer surface 218S of the guidewire lumen 118 and / or within the individual grooves 260 formed in the outer surface 218S. Alternatively, the guidewire lumen 118 may be formed without the grooved outer surface 218S, and the position of the energy guides 122A relative to the guidewire lumen 118 may be maintained by other suitable means.

[0047] The catheter system 100 and / or energy guide bundle 122 may include any number of energy guides 122A that are optically connected to the energy source 124 at the proximal portion 114 and to the catheter fluid 132 in the balloon interior 146 of the balloon 104 at the distal portion 116. For example, in some embodiments, the catheter system 100 and / or energy guide bundle 122 may include one to more than 30 energy guides 122A. The distal end 122D of each energy guide 122A may be located at any suitable position in the balloon interior 146 relative to the length 142 of the balloon 104 or at a desired longitudinal position. Alternatively, in other embodiments, the catheter system 100 and / or energy guide bundle 122 may include more than 30 energy guides 122A.

[0048] The energy guide 122A may have any suitable design that is useful and appropriate for enabling the generation of plasma, sound waves, and / or pressure waves in the catheter fluid 132 inside the balloon 146. Therefore, the general description of the energy guide 122A as an optical guide is not intended to be limited in any way except as described in the appended claims. Specifically, the catheter system 100 is often described with an energy source 124 as a light source and one or more energy guides 122A as optical guides, but alternatively, the catheter system 100 may include any suitable energy source 124 and energy guides 122A for generating a desired plasma in the catheter fluid 132 inside the balloon 146. For example, in one non-exclusive alternative embodiment, the energy source 124 may be configured to provide a high-voltage pulse, and each energy guide 122A may include an electrode pair containing spaced electrodes extending into the balloon 146. In this embodiment, each pulse of high voltage is applied to the electrodes to form an electric arc between the electrodes, which generates plasma, creating sound waves and / or pressure waves within the catheter fluid 132 that are used to fragment the vascular lesion 106A at the treatment site 106. Alternatively, the energy source 124 and / or energy guide 122A may have other suitable designs and / or configurations, such as electrical, acoustic, pneumatic, or other mechanical.

[0049] As illustrated, the catheter system 100 may include one or more emitters 135 configured to generate plasma, sound waves, and / or pressure waves in the catheter fluid 132 inside the balloon 146. Each emitter 135 includes a guide distal end 122D of one of a plurality of energy guides 122A located inside the balloon 146, and a corresponding plasma generator 133 located near the guide distal end 122D (typically spaced away from the guide distal end 122D).

[0050] Energy from the energy source 124 is directed toward the energy guide 122A, received by the energy guide 122A, and guided through the energy guide 122A, and is emitted from the guide distal end 122D of the energy guide 122A. The energy emitted from the guide distal end 122D is directed toward the corresponding plasma generator 133 for the purpose of generating plasma in the catheter fluid 132 inside the balloon 146, and imparts energy by contacting the plasma generator 133. In many embodiments, as will be described in more detail below herein, the plasma generator 133 may be incorporated into the structure of the guidewire lumen 118 and / or may form part of the guidewire lumen 118. In other words, part of the guidewire lumen 118 may include the plasma generator 133 located near the guide distal end 122D of the energy guide 122A.

[0051] In some embodiments, the plasma generator 133 and / or other parts of the emitter 135 may be formed at least partially from a polymer material. For example, in certain embodiments, the plasma generator 133 and / or guidewire lumen 118 may be made from a polymer material such as polyether block amide (e.g., PEBAX®), nylon, plastic, polyimide, or other thermoplastic material. The plasma generator 133 and / or guidewire lumen 118 may be designed to have thin walls to minimize the external shape that passes through. Also, polymer fillers such as titanium dioxide, bismuth, barium sulfate, gold nanoparticles, silver nanoparticles, tungsten particles, or any other metallic material may be added to the thermoplastic material to increase laser absorption and improve the conversion efficiency of laser energy to sound wave output.

[0052] When the catheter system 100 is in use, energy (such as light energy or laser energy) emitted outward from the distal guide end 122D of the energy guide 122A comes into contact with the structure of the guidewire lumen 118 and / or the plasma generator 133, which are located away from the distal guide end 122D of the energy guide 122A. The interaction of this energy with the polymer material of the plasma generator 133 and / or the guidewire lumen 118 initiates a plasma plume whose size increases in proportion to the energy delivered and / or emitted from the distal guide end 122D of the energy guide 122A. The generation of this plasma plume generates high-frequency mechanical sound waves directed away from the target site of the plasma generator 133. In addition, as the sound waves propagate through the catheter fluid 132, cavitation bubbles may be generated by the sound waves.

[0053] In certain embodiments, the energy guide 122A may include an optical fiber or a flexible optical pipe. The energy guide 122A may be thin and flexible and may enable the transmission of optical signals with little to no loss of intensity. The energy guide 122A may include a core surrounded by a cladding. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of the energy guide 122A may be formed from one or more materials, including one or more types of glass, silica, or one or more polymers. The energy guide 122A may also include a protective film, such as a polymer. The refractive index of the core is greater than that of the cladding.

[0054] Each energy guide 122A can guide energy along its length from the proximal guide end 122P to the distal guide end 122D. The distal guide end 122D has at least one optical window (not shown) located inside the balloon 146.

[0055] The energy guide 122A may be provided in various configurations around and / or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the energy guide 122A may extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guide 122A may be physically coupled to the catheter shaft 110. In other embodiments, the energy guide 122A may be positioned along the length of the outer diameter of the catheter shaft 110. In yet another embodiment, the energy guide 122A may be positioned within one or more energy guide lumens within the catheter shaft 110.

[0056] Furthermore, the energy guides 122A can be positioned at any suitable location around the outer circumference of the guidewire lumen 118 and / or the catheter shaft 110. The distal guide end 122D of each energy guide 122A can be positioned at any suitable longitudinal location relative to the length of the balloon 104 and / or the length of the guidewire lumen 118 in order to more effectively and accurately deliver sound waves and / or pressure waves for the purpose of fragmenting the vascular lesion 106A at the treatment site 106.

[0057] In certain embodiments, the energy guide 122A may include one or more photoacoustic transducers 153. Each photoacoustic transducer 153 may communicate optically with the energy guide 122A in which it is located. In some embodiments, the photoacoustic transducer 153 may communicate optically with the guide distal end 122D of the energy guide 122A. In such embodiments, the photoacoustic transducer 153 may have a shape that corresponds to and / or conforms to the guide distal end 122D of the energy guide 122A.

[0058] The photoacoustic transducer 153 is configured to convert light energy into sound waves at or near the distal guide end 122D of the energy guide 122A. The direction of the sound waves can be adjusted by changing the angle of the distal guide end 122D of the energy guide 122A.

[0059] In certain embodiments, a photoacoustic transducer 153 positioned at the distal guide end 122D of the energy guide 122A may have the same shape as the distal guide end 122D of the energy guide 122A. For example, in certain non-exclusive embodiments, the photoacoustic transducer 153 and / or the distal guide end 122D may have a conical, convex, concave, bulbous, square, stepped, semicircular, oval shape, and the like. The energy guide 122A may further include additional photoacoustic transducers 153 positioned along one or more sides in the longitudinal direction of the energy guide 122A.

[0060] In some embodiments, the energy guide 122A may further include, for example, one or more diverting structures or "diverters" (not shown in Figure 1) configured to deflect energy from the energy guide 122A at an angle to the guide distal end 122D of the energy guide 122A, for example, within the energy guide 122A and / or near the guide distal end 122D of the energy guide 122A. For example, in certain embodiments, the diverting structure may direct energy from the energy guide 122A toward a side that may be located near or in the guide distal end 122D of the energy guide 122A before the energy is directed toward the balloon wall 130. Additionally or alternatively, the diverting structure may direct energy from the energy guide 122A toward the outer surface 218S of the guidewire lumen 118 at an angle. The diverting structure may also include the plasma generator 133 described above and, in certain embodiments, may be formed from one or more polymer materials.

[0061] The deflection structure may include any structure of a system that deflects energy from the energy guide 122A away from its axial path, for example toward the side of the energy guide 122A. Each energy guide 122A may include one or more optical windows arranged along the longitudinal or circumferential surface of each energy guide 122A and optically communicating with the deflection structure. In other words, the deflection structure may have any suitable configuration configured to guide energy in the energy guide 122A away from its axial path and / or toward the side at the distal end 122D of the guide or a side near the distal end 122D of the guide, which is optically communicating with the optical window. The optical window may include a portion of the energy guide 122A that allows energy to escape from inside to outside the energy guide 122A, for example, a portion of the energy guide 122A that does not have cladding material on or around the energy guide 122A.

[0062] Examples of deflection structures suitable for use include reflectors, refractive elements, and fiber diffusers. Deflection structures suitable for focusing energy away from the tip of the energy guide 122A may include, but are not limited to, convex lenses, distributed refractive index (GRIN) lenses, and mirror focus lenses. When in contact with a deflection structure, the first energy can be deflected within the energy guide 122A to one or both of the plasma generator 133, which is located near the guide distal end 122D of the energy guide 122A (typically spaced away from the guide distal end 122D), and the photoacoustic transducer 154, which is optically communicating with the side of the energy guide 122A. When in use, the plasma generator 133 receives energy emitted from the guide distal end 122D of the energy guide 122A and generates plasma in the catheter fluid 132 inside the balloon 146. This can generate plasma bubbles, sound waves, and / or pressure waves that can be directed toward the balloon wall 130 in a direction away from the side of the energy guide 122A. Additionally or alternatively, the photoacoustic transducer 154, when in use, converts light energy into sound waves that spread away from the side of the energy guide 122A.

[0063] The source manifold 136 may be located in or near the proximal portion 114 of the catheter system 100. The source manifold 136 may include one or more proximal end openings capable of receiving a plurality of energy guides 122A of the energy guide bundle 122, guide wires 112, and / or an expansion conduit 140 which is fluidly connected to the fluid pump 138. The catheter system 100 may also include the fluid pump 138 configured to inflate the balloon 104 with catheter fluid 132 as needed.

[0064] As described above, in the embodiment shown in Figure 1, the system console 123 includes one or more of the energy source 124, power supply 125, system controller 126, GUI 127, and multiplexer 128. Alternatively, the system console 123 may include more or fewer components than those specifically shown in Figure 1. For example, in certain non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127 and / or multiplexer 128. Alternatively, one or more of the energy source 124, power supply 125, system controller 126, GUI 127, and multiplexer 128 may be provided within the catheter system 100 without specifically requiring the system console 123.

[0065] As illustrated, the system console 123 and its components are operably coupled to the catheter 102, the energy guide bundle 122, and the rest of the catheter system 100. For example, in some embodiments, as shown in Figure 1, the system console 123 may include a console connection opening 148 (which may also be generally referred to as a “socket” or “console receptacle”) that mechanically couples the energy guide bundle 122 to the system console 123. In such embodiments, the energy guide bundle 122 may include an optical connector assembly having a guide coupling housing 150 (which may generally include one or more ferrules and may also be generally referred to as a “connector housing”) that houses a portion of each energy guide 122A, such as the proximal end 122P of the guide. At least a portion of the guide coupling housing 150 is configured to provide a mechanical coupling between the energy guide bundle 122 and the system console 123, and to fit into and selectively hold therein within the console connection opening 148 to enable optical coupling between the energy source 124 and the energy guides 122A of the energy guide bundle 122.

[0066] Furthermore, the energy guide bundle 122 may include a guide bundler 152 (or "shell") that aggregates each energy guide 122A so that when the catheter system 100 is in use, the energy guides 122A and / or the energy guide bundle 122 extend into the blood vessel 108 together with the catheter 102, it takes on a compact form.

[0067] The energy source 124 may be selectively and / or alternately coupled to each energy guide 122A, such as the guide proximal end 122P of each energy guide 122A in the energy guide bundle 122, to optically communicate with each energy guide 122A. Specifically, the energy source 124 is configured to generate energy in the form of a source beam 124A, such as a pulsed source beam, which is selectively and / or alternately guided and received by each energy guide 122A in the energy guide bundle 122. More specifically, as shown in the figure, the source beam 124A from the energy source 124 is guided via a multiplexer 128 so that individual guide beams 124B (or “multiplexed beams”) are selectively and / or alternately guided and received by each energy guide 122A in the energy guide bundle 122. In particular, each pulse of the energy source 124 and / or each pulse of the source beam 124A are guided through the multiplexer 128, thereby generating individual guide beams 124B that are selectively and / or alternately guided to one of the multiple energy guides 122A in the energy guide bundle 122. Thus, by using and / or applying the multiplexer 128, the energy source 124 can be used to energize any of the multiple emitters 135 that may be included in the catheter system 100. Alternatively, the catheter system 100 may include two or more energy sources 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 may include a separate energy source 124 for each energy guide 122A in the energy guide bundle 122.

[0068] The energy source 124 may have any suitable design. In certain embodiments, the energy source 124 may be configured to provide sub-millisecond pulses of energy from the energy source 124 that are focused into a small spot to couple to the proximal guide end 122P of the energy guide 122A. Such pulses of energy are directed and / or guided along the energy guide 122A to a location inside the balloon 146 of the balloon 104, thereby inducing the formation of plasma within the catheter fluid 132 inside the balloon 146 of the balloon 104 via a plasma generator 133, etc., which may include and / or incorporate any suitable structure located in or near the distal guide end 122D of the energy guide 122A. In many embodiments, the plasma generator 133 may be positioned slightly away from the distal guide end 122D of the energy guide 122A. In certain embodiments, the plasma generator 133 may be provided as part of the outer surface 218S of the guidewire lumen 118, formed from one or more polymer materials, within a groove 260 that may be formed in the outer surface 218S of the guidewire lumen 118, for example. Alternatively, in other embodiments, the plasma generator 133 may be provided in the form of a backstop structure with an inclined surface 433F (shown in Figure 4A), which may be integrally formed as part of the guidewire lumen 118 and may be located within a groove 260 that may be formed in the outer surface 218S of the guidewire lumen 118. As described above, the guidewire lumen 118 and / or the plasma generator 133 may be formed from one or more polymer materials, and the backstop type plasma generator 133 may redirect the energy emitted from the distal end 122D of the guide towards the balloon wall 130 of the balloon 104 and / or towards the vascular wall 108A of the blood vessel 108 at the treatment site 106.

[0069] In particular, in many embodiments, the energy released at the distal guide end 122D of the energy guide 122A is directed toward and in contact with the material of the plasma generator 133, such as the material of the outer surface 218S of the guidewire lumen 118 and / or the material of the inclined surface 433F of the plasma generator 133, thereby imparting energy to generate plasma within the catheter fluid 132 inside the balloon 146. This plasma generation ionizes and overheats the surrounding catheter fluid 132, causing rapid inertial bubble formation, thereby imparting sound waves and / or pressure waves over the treatment site 106. An exemplary plasma-induced bubble 134 is shown in Figure 1.

[0070] As used herein, the guide distal end 122D of the energy guide 122A and the corresponding plasma generator 133 may be collectively referred to as the emitter 135. In some applications, one or more emitters 135 positioned at approximately the same longitudinal position in the interior 146 of the balloon 104 relative to the length 142 of the balloon may be referred to as an “emitter station,” such as one or more emitter stations 180 included as part of the emitter system 131 shown in Figure 1.

[0071] In various non-exclusive alternative embodiments, submillisecond pulses of energy from the energy source 124 may be delivered to the treatment site 106 at frequencies of approximately 1 Hz to 5000 Hz, approximately 30 Hz to 1000 Hz, approximately 10 Hz to 100 Hz, or approximately 1 Hz to 30 Hz. Alternatively, submillisecond pulses of energy may be delivered to the treatment site 106 at frequencies that may be above 5000 Hz or below 1 Hz, or at any other suitable range of frequencies.

[0072] While the energy source 124 is typically used to provide energy pulses, it can still be described as providing a single source beam 124A, such as a single pulsed source beam.

[0073] Suitable energy sources 124 may include various types of light sources, including lasers and lamps. For example, in certain non-exclusive embodiments, energy source 124 may be an infrared laser that emits energy in the form of pulses of infrared light. Alternatively, as described above, energy source 124 may include any suitable type of energy source.

[0074] A suitable laser may include a short-pulse laser on a sub-millisecond timescale. In some embodiments, the energy source 124 may include a laser on a nanosecond (ns) timescale. The laser may also include short-pulse lasers on picosecond (ps), femtosecond (fs), and microsecond (μS) timescales. Many combinations of laser wavelength, pulse width, and energy level can be used to achieve plasma in the catheter fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse width may include ranges of at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range may be used.

[0075] Exemplary nanosecond lasers may include those in the UV-IR spectrum, with wavelengths ranging from approximately 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, an energy source 124 suitable for use in a catheter system 100 may include one capable of generating light with wavelengths of at least 750 nm to 2000 nm. In other embodiments, the energy source 124 may include one capable of generating light with wavelengths of at least 700 nm to 3000 nm. In yet another embodiment, the energy source 124 may include one capable of generating light with wavelengths of at least 100 nm to 10 micrometers (μm). Nanosecond lasers may include those having repetition rates up to 200 kHz.

[0076] In some embodiments, the laser may include a Q-switched thulium:yttrium-aluminum-garnet (Tm:YAG) laser. In other embodiments, the laser may include a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser, a holmium:yttrium-aluminum-garnet (Ho:YAG) laser, an erbium:yttrium-aluminum-garnet (Er:YAG) laser, an excimer laser, a helium-neon laser, a carbon dioxide laser, and a doped pulsed fiber laser.

[0077] In yet another embodiment, the energy source 124 may include a plurality of lasers grouped in series. In yet another embodiment, the energy source 124 may include one or more low-energy lasers supplied to a high-energy amplifier, such as a main oscillator power amplifier (MOPA). In yet another embodiment, the energy source 124 may include a plurality of lasers combined in parallel or in series to supply the energy necessary to generate plasma bubbles 134 in the catheter fluid 132.

[0078] The catheter system 100 can generate sound waves and / or pressure waves having a maximum pressure in the range of at least 1 megapascal (MPa) to 100 MPa. The maximum pressure generated by a particular catheter system 100 depends on the energy source 124, the absorbing material, the bubble expansion, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter system 100 can generate sound waves and / or pressure waves having a maximum pressure in the range of at least about 2 MPa to 50 MPa, at least about 2 MPa to 30 MPa, or at least about 15 MPa to 25 MPa.

[0079] Sound waves and / or pressure waves may be applied to the treatment site 106 from a distance ranging from at least about 0.1 mm to more than about 25 mm, extending radially from the energy guide 122A, with the catheter 102 positioned at the treatment site 106. In various non-exclusive alternative embodiments, sound waves and / or pressure waves may be applied to the treatment site 106 from a distance ranging from at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm, extending radially from the energy guide 122A, with the catheter 102 positioned at the treatment site 106. In other embodiments, sound waves and / or pressure waves may be applied to the treatment site 106 from another suitable distance different from the ranges described above. In some embodiments, sound waves and / or pressure waves may be applied to the treatment site 106 at a distance of at least about 0.1 mm to 10 mm, within a range of at least about 2 MPa to 30 MPa. In some embodiments, sound waves and / or pressure waves may be applied to the treatment site 106 at a distance of at least about 0.1 mm to 10 mm from a pressure range of at least about 2 MPa to 25 MPa. Alternatively, other suitable pressure ranges and distances may be used.

[0080] The power supply 125 is configured to be electrically coupled to each of the energy source 124, system controller 126, GUI 127, multiplexer 128, and handle assembly 129 to supply them with the necessary power. The power supply 125 may have any suitable design for such purposes.

[0081] The system controller 126 is electrically coupled to the power supply 125 and receives power from the power supply 110. The system controller 126 is coupled to each of the energy source 124, GUI 127, and multiplexer 128 and is configured to control their operation. The system controller 126 may include one or more processors or circuits for controlling the operation of at least the energy source 124, GUI 127, and multiplexer 128. For example, the system controller 126 may control the energy source 124 to generate pulses of energy as desired and / or at any desired firing rate. The system controller 126 may then, by controlling the multiplexer 128, selectively and / or alternately direct the energy from the energy source 124 as a source beam 124A to each energy guide 122A in a desired manner, such as in the form of individual guide beams 124B.

[0082] The system controller 126 may further be configured to control the operation of other components of the catheter system 100, such as the positioning of the catheter 102, the positioning of the guide distal end 122D of the energy guide 122A, and / or the positioning of the emitter 135 adjacent to the treatment site 106, and the inflation of the balloon 104 with the catheter fluid 132. Additionally or alternatively, the catheter system 100 may include one or more additional controllers that can be arranged in any suitable manner for the purpose of controlling various operations of the catheter system 100. For example, in certain embodiments, additional controllers and / or parts of the system controller 126 may be located within and / or incorporated into the handle assembly 129.

[0083] The GUI 127 is accessible to the user or operator of the catheter system 100. The GUI 127 is electrically connected to the system controller 126. In such a design, the GUI 127 may be used by the user or operator to ensure that the catheter system 100 is effectively used to apply pressure to the vascular lesion 106A at the treatment site 106 to induce fragmentation within the vascular lesion 106A. The GUI 127 may provide the user or operator with information that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 may provide the user or operator with static visual data and / or information. Additionally or alternatively, the GUI 127 may provide the user or operator with dynamic visual data and / or information, such as video data or any other data that changes over time during use of the catheter system 100. In various embodiments, the GUI 127 may include one or more colors, different sizes, variable brightness, etc., which can act as alerts to the user or operator. Additionally or alternatively, GUI127 may provide voice data or information to the user or operator. The details of GUI127 may vary depending on the design requirements of the catheter system 100, or the specific needs, specifications, and / or requests of the user or operator.

[0084] The multiplexer 128 is configured to selectively and / or alternately direct energy from the energy source 124 to each energy guide 122A in the energy guide bundle 122. Specifically, the multiplexer 128 receives energy from the energy source 124, for example, in the form of a single source beam 124A from a single laser source, and is configured to selectively and / or alternately direct such energy to each energy guide 122A in the energy guide bundle 122, optionally in the form of individual guide beams 124B. Thus, the multiplexer 128 allows energy from a single energy source 124 to be individually directed through multiple energy guides 122A in any desired sequence or pattern, enabling the catheter system 100 to apply pressure to a treatment site 106 in the vessel wall 108A of a blood vessel 108 or to a vascular lesion 106A adjacent to the vessel wall 108A of the treatment site 106 in the desired manner, thereby inducing fragmentation within the vascular lesion 106A. As shown in the illustration, in certain embodiments, the catheter system 100 may include one or more optical elements 147 for directing energy, such as a source beam 124A, from the energy source 124 to the multiplexer 128.

[0085] The multiplexer 128 may have any suitable design for selectively and / or alternately directing energy from the energy source 124 to each energy guide 122A of the energy guide bundle 122.

[0086] As shown in Figure 1, the handle assembly 129 may be positioned in or near the proximal portion 114 of the catheter system 100 and / or near the source manifold 136. In this embodiment, the handle assembly 129 is coupled to the balloon 104 and positioned away from the balloon 104. Alternatively, the handle assembly 129 may be positioned in other suitable locations.

[0087] The handle assembly 129 is attached to the catheter shaft 110. The handle assembly 129 is handled and used by the user or operator to manipulate, position, and control the catheter 102. The design and specific mechanisms of the handle assembly 129 may be modified to conform to the design requirements of the catheter system 100. In the embodiment shown in Figure 1, the handle assembly 129 is separate from, but conductive and / or fluidically connected to, one or more of the system controller 126, energy source 124, fluid pump 138, and GUI 127.

[0088] In some embodiments, the handle assembly 129 may integrate and / or include at least a portion of the system controller 126 within the handle assembly 129. For example, as illustrated, in such particular embodiments, the handle assembly 129 may include a circuit 155 that is electrically coupled between the catheter electronics and the system console 123 and may form at least a portion of the system controller 126. In one embodiment, the circuit 155 may include a printed circuit board having one or more integrated circuits, or any other suitable circuit. In alternative embodiments, the circuit 155 may be omitted or included within the system controller 126. In various embodiments, the circuit 155 may be located outside the handle assembly 129, for example, in the system console 123. The handle assembly 129 may include fewer or additional components than those specifically illustrated and described in this disclosure.

[0089] The emitter system 131 includes one or more emitter stations 180, each emitter station 180 including one or more emitters 135. As described above, each emitter 135 includes the guide distal end 122D of one of the energy guides 122A and the corresponding plasma generator 133. The term “plasma generator” as used herein may include and / or incorporate any suitable type of structure located at or near the guide distal end 122D of the energy guide 122A. In some embodiments, the plasma generator 133 may be included in and / or incorporated into a portion of the guidewire lumen 118. For example, the plasma generator 133 may be included in and / or incorporated into a portion of the outer surface 218S of the guidewire lumen 118 and / or into a material (such as a polymer material in many embodiments) used to form at least a portion of the outer surface 218S of the guidewire lumen 118. Alternatively, in certain embodiments, the plasma generator 133 may be provided in the form of a backstop structure with an inclined surface 433F. This backstop structure may be contained within and / or incorporated into the structure of the guidewire lumen 118 and redirect the energy emitted from the distal end 122D of the guide toward the balloon wall 130 of the balloon 104 and / or toward the vessel wall 108A of the vessel 108 at the treatment site 106.

[0090] Each emitter 135 is configured to selectively receive energy from an energy source 124 directed by a multiplexer 128 under the control of a system controller 126, and to release that energy from the distal end 122D of the guide toward the plasma generator 133. The energy released from the distal end 122D of the guide imparts energy to the plasma generator 133 material, such as the material on the outer surface 218S of the guidewire lumen 118 and / or the material on the inclined surface 433F of the plasma generator 133, for the purpose of generating plasma within the catheter fluid 132 inside the balloon 146. This plasma generation ionizes and / or overheats the surrounding catheter fluid 132, causing rapid inertial bubble formation, thereby imparting sound waves and / or pressure waves over the treatment site 106.

[0091] The emitter 135 and / or plasma generator 133 may be formed from any suitable material. For example, in certain non-exclusive embodiments, as described above, the emitter 135 and / or plasma generator 133 may be formed at least partially from one or more polymers, polymer materials, and / or plastics, such as polyether block amide (e.g., PEBAX®), polyimide, nylon, or other suitable thermoplastic materials. In some embodiments, the emitter 135 and / or plasma generator 133, for example, the guidewire lumen 118 and / or a separate structure for the plasma generator 133 in a particular embodiment, is configured to have thin walls to minimize the shape that passes through. The emitter 135 and / or plasma generator 133 may also contain polymer fillers such as titanium dioxide, bismuth, barium sulfate, gold nanoparticles, silver nanoparticles, tungsten particles, or any other metallic material, which may be added to the polymer material or thermoplastic material to increase laser absorption and further optimize the conversion efficiency between laser energy and sound wave output.

[0092] Alternatively, the emitter 135 and / or plasma generator 133 may be formed from one or more metals and / or metal alloys having relatively high melting temperatures, such as titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium, and iridium. Alternatively, the emitter 135 and / or plasma generator 133 may be formed from at least one of magnesium oxide, beryllium oxide, tungsten carbide, titanium nitride, titanium carbonitride, and titanium carbide. Further alternatively, the emitter 135 and / or plasma generator 133 may be formed from at least one of diamond CVD and diamond. In other embodiments, the emitter 135 and / or plasma generator 133 may be formed from transition metals, alloying metals, or ceramic materials. Further alternatively, the emitter 135 and / or plasma generator 133 may be formed from any other suitable material. The emitter 135 and / or plasma generator 133 may be formed from any suitable combination of the above-mentioned materials.

[0093] The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with catheter fluid 132 as needed. As with all embodiments illustrated and described herein, various structures may be omitted from the drawings for clarity and to facilitate understanding. Furthermore, the drawings may include certain structures that can be omitted without departing from the intent and scope of the invention.

[0094] Figure 2 is a simplified schematic end view of a portion of an embodiment of a catheter system 200, which includes a guidewire lumen 218 and an energy guide 222A positioned adjacent to the guidewire lumen 218. Specifically, as shown in this embodiment, the guidewire lumen 218 includes a groove 260 (or channel) formed along and / or on the outer surface 218S of the guidewire lumen 218. The groove 260 is configured to extend substantially longitudinally along at least a portion of the length of the guidewire lumen 218. Furthermore, as shown, at least a portion of the energy guide 222A, such as at least the guide distal end 322D (shown in Figure 3A), can be positioned, received, and held within the groove 260. In such a design, the energy guide 222A can be effectively maintained in a fixed position relative to the guidewire lumen 218. Although it is shown that only a single groove 260 is formed along and / or within the outer surface 218S of the guidewire lumen 218, the guidewire lumen 218 may be configured to include any appropriate number of grooves 260, each configured to receive and hold a separate energy guide internally.

[0095] Alternatively, the guidewire lumen 218 may be formed without a grooved outer surface 218S. In this case, the position of the energy guide 222A relative to the guidewire lumen 118 may be maintained by other suitable means.

[0096] Figure 2 further illustrates how the guidewire lumen 218 is substantially annular and / or cylindrical in shape, and how it defines the lumen conduit 262 through which the guidewire 112 (shown in Figure 1) extends. Alternatively, the guidewire lumen 218 may have other suitable shapes.

[0097] Figure 3A is a simplified schematic side view of one embodiment of a portion of the guidewire lumen 218 and a portion of the energy guide 222A shown in Figure 2, as well as a plasma generator 333 that may be incorporated into the guidewire lumen 218. As shown in this embodiment, the guide distal end 322D of the energy guide 222A is inclined with respect to the outer surface 218S of the guidewire lumen 218. That is, the guide distal end 322D of the energy guide 222A is not perpendicular to the outer surface 218S of the guidewire lumen 218. In such a design, the energy emitted from the guide distal end 322D of the energy guide 222A can be naturally directed at a slightly downward angle toward the outer surface 218S of the guidewire lumen 218. Specifically, the energy emitted from the guide distal end 322D of the energy guide 222A is directed at a slightly downward angle toward a portion of the outer surface 218S of the guidewire lumen 218 that includes and / or incorporates the plasma generator 333. The angle of the guide distal end 322D with respect to the perpendicular to the outer surface 218S of the guide wire lumen 218 can be any suitable angle, such as about 5 to 45 degrees, in certain non-exclusive embodiments.

[0098] In various embodiments, as described above, a portion of the outer surface 218S of the guidewire lumen 218 including and / or incorporating the plasma generator 333, and / or the entire guidewire lumen 218, may be formed from any suitable polymer material. For example, in certain non-exclusive embodiments, a portion of the outer surface 218S of the guidewire lumen 218 including and / or incorporating the plasma generator 333 may be at least partially formed from one or more polymers, polymer materials, and / or plastics, such as polyether block amide (e.g., PEBAX®), polyimide, nylon, or other suitable thermoplastic materials. In some embodiments, the plasma generator 333 may include polymer fillers such as titanium dioxide, bismuth, barium sulfate, gold nanoparticles, silver nanoparticles, tungsten particles, or any other metallic material, which can be added to the polymer material or thermoplastic material to increase laser absorption and further optimize the conversion efficiency between laser energy and sound wave output.

[0099] Furthermore, the outer surface 218S of the guidewire lumen 218 shown in Figure 3A as functioning as the plasma generator 333 may be a portion of the outer surface 218S of the guidewire lumen 218 that is located along and / or in a groove 260 (shown in Figure 2) formed in the outer surface 218S of the guidewire lumen 218. Alternatively, the outer surface 218S of the guidewire lumen 218 functioning as the plasma generator 333 may be a different portion of the outer surface 218S of the guidewire lumen 218.

[0100] In other embodiments, the guide distal end 322D of the energy guide 222A may be cut at a right angle and perpendicular to the outer surface 218S of the guidewire lumen 218, or it may include any suitable type of deflection structure configured to redirect the energy emitted from the guide distal end 322D of the energy guide 222A at a slightly downward angle toward a portion of the outer surface 218S of the guidewire lumen 218 including and / or incorporating the plasma generator 333.

[0101] Figure 3B is a simplified schematic side view of a portion of the guidewire lumen 218, plasma generator 333, and energy guide 222A shown in Figure 3A, further illustrating the initiation of the plasma plume. Specifically, as illustrated, energy 364, such as optical energy or laser energy in a particular embodiment, is emitted from the guide distal end 322D of the energy guide 222A and directed at a slightly downward angle toward a portion of the outer surface 218S of the guidewire lumen 218, which includes and / or incorporates the plasma generator 333. It is shown that the portion of the outer surface 218S of the guidewire lumen 218, which includes and / or incorporates the plasma generator 333, is away from the guide distal end 322D of the energy guide 222A.

[0102] When the energy 364 emitted from the distal guide end 322D of the energy guide 222A comes into contact with or collides with the material of the plasma generator 333 and imparts energy, the formation of a plasma plume 366 begins substantially adjacent to the outer surface 218S of the plasma generator 333 and / or the guide wire lumen 218. In other words, the interaction between the energy 364 emitted from the distal guide end 322D of the energy guide 222A and the polymer material incorporated in the plasma generator 333 initiates the generation of a plasma plume 366, and the size of the plasma plume 366 increases in proportion to the energy 364 delivered to the plasma generator 333.

[0103] Figure 3C is a simplified schematic side view of a portion of the guidewire lumen 218 shown in Figure 3A, the plasma generator 333 (clearly shown in Figure 3B), and a portion of the energy guide 222A, further illustrating the generation of a plasma plume and the resulting high-frequency sound waves. Specifically, Figure 3C also shows that energy 364, such as optical energy or laser energy in a particular embodiment, is emitted from the guide distal end 322D of the energy guide 222A and directed at a slightly downward angle toward a portion of the outer surface 218S of the guidewire lumen 218 that surrounds and / or incorporates the plasma generator 333.

[0104] When energy 364 emitted from the distal guide end 322D of the energy guide 222A contacts or impacts the polymer material of the plasma generator 333 and imparts energy, the formation of a plasma plume 366 is initiated substantially adjacent to the outer surface 218S of the plasma generator 333 and / or the guidewire lumen 218. The size of the plasma plume 366 then continues to increase in proportion to the energy 364 delivered to the plasma generator 333. Subsequently, as further shown in Figure 3C, the generation of the plasma plume 366 generates a high-frequency mechanical sound wave 368 directed away from the plasma generator 333 towards the vascular lesion 106A (shown in Figure 1) at the treatment site 106 (shown in Figure 1). This sound wave 368 applies pressure adjacent to the vascular lesion 106A at the treatment site 106 in order to induce fragmentation at the vascular lesion 106A at the treatment site 106.

[0105] Figure 3D is a simplified schematic side view of a portion of the guidewire lumen 218, plasma generator 333, and energy guide 222A shown in Figure 3A, further illustrating the generation of cavitation bubbles. As shown, cavitation bubbles 370 are generated by the sound wave 368 (shown in Figure 3C) as the sound wave 368 propagates toward the vascular lesion 106A (shown in Figure 1) at the treatment site 106 (shown in Figure 1) in the direction away from the plasma generator 333 through the catheter fluid 132 (shown in Figure 1).

[0106] Figure 4A is a simplified schematic side view of a portion of a guidewire lumen 418 in another embodiment, a portion of an energy guide 422A in another embodiment, and a plasma generator 433 in another embodiment that may be incorporated into and / or formed integrally with the guidewire lumen 418. As shown, the guide distal end 422D of the energy guide 422A is cut at a right angle such that the guide distal end 422D of the energy guide 422A is substantially perpendicular to the outer surface 418S of the guidewire lumen 418. Figure 4A further shows that in this embodiment, the plasma generator 433 is positioned away from the guide distal end 422D of the energy guide 422A and is substantially adjacent to the rest of the outer surface 418S of the guidewire lumen 418. Specifically, the plasma generator 433 may be constructed and / or extend generally outward from the rest of the outer surface 418S of the guidewire lumen 418, and may be located within a groove 260 (shown in Figure 2) formed along and / or in the outer surface 418S of the guidewire lumen 418. Thus, as with many embodiments, the plasma generator 433 in this embodiment is also contained within a portion of the guidewire lumen 418. Alternatively, in other embodiments, the plasma generator 433 may be a separate structure located substantially adjacent to and / or fixed to the guidewire lumen 418, for example, within a groove 260 formed along and / or in the outer surface 418S of the guidewire lumen 418.

[0107] The design of the plasma generator 433 is modifiable. As shown in Figure 4A, in one embodiment, the plasma generator 433 may be provided in the form of a backstop-type structure having an inclined surface 433F that is angled (i.e., not parallel) with respect to the guide distal end 422D of the energy guide 422A, which is cut at a right angle. The angle of the inclined surface 433F of the plasma generator 433 with respect to the guide distal end 422D of the energy guide 422A may be any suitable angle, such as about 5 to 45 degrees, in certain non-exclusive embodiments. Alternatively, the plasma generator 433 may have other suitable designs, and / or the inclined surface 433F may be angled within a different range with respect to the guide distal end 422D of the energy guide 422A.

[0108] In various embodiments, the plasma generator 433, or at least the inclined surface 433F of the plasma generator 433, may be formed from any suitable polymer material, as described above. For example, in certain non-exclusive embodiments, the plasma generator 433 and / or the inclined surface 433F may be at least partially formed from one or more polymers, polymer materials, and / or plastics, such as polyether block amide (e.g., PEBAX®), polyimide, nylon, or other suitable thermoplastic materials. In some embodiments, the plasma generator 433 and / or the inclined surface 433F may also contain polymer fillers such as titanium dioxide, bismuth, barium sulfate, gold nanoparticles, silver nanoparticles, tungsten particles, or any other metallic material, which can be added to the polymer material or thermoplastic material to increase laser absorption and further optimize the conversion efficiency between laser energy and sound wave output.

[0109] In many embodiments, the plasma generator 433 is physically incorporated into the physical structure of the guidewire lumen 418, so the guidewire lumen 418 as a whole can be formed from any such polymer material.

[0110] Figure 4B is a simplified schematic side view of a portion of the guidewire lumen 418, the plasma generator 433, and a portion of the energy guide 422A shown in Figure 4A, further illustrating the initiation of the plasma plume. Specifically, as illustrated, energy 464, such as optical energy or laser energy in a particular embodiment, is emitted from the guide distal end 422D of the energy guide 422A and directed toward the inclined surface 433F of the plasma generator 433. The inclined surface 433F of the plasma generator 433 is shown to be away from the guide distal end 422D of the energy guide 422A.

[0111] When the energy 464 emitted from the distal guide end 422D of the energy guide 422A comes into contact with or collides with the material of the plasma generator 433 and imparts energy, the formation of a plasma plume 466 begins substantially adjacent to the inclined surface 433F of the plasma generator 433. In other words, the interaction between the energy 464 emitted from the distal guide end 422D of the energy guide 422A and the polymer material incorporated within the inclined surface 433F of the plasma generator 433 initiates the generation of a plasma plume 466, and as a result, the size of the plasma plume 466 increases in proportion to the energy 464 delivered to the inclined surface 433F of the plasma generator 433.

[0112] Figure 4C is a simplified schematic top view of a portion of the guidewire lumen 418, plasma generator 433, and energy guide 422A shown in Figure 4A, further illustrating the generation of a plasma plume and the resulting high-frequency sound waves. Specifically, Figure 4C also shows that energy 464, such as optical energy or laser energy in a particular embodiment, is emitted from the guide distal end 422D of the energy guide 422A and directed toward the inclined surface 433F of the plasma generator 433 (clearly shown in Figure 4A).

[0113] When energy 464 emitted from the distal guide end 422D of the energy guide 422A contacts the polymer material on the inclined surface 433F of the plasma generator 433 and imparts energy, the formation of a plasma plume 466 begins substantially adjacent to the inclined surface 433F of the plasma generator 433. The size of the plasma plume 466 then continues to increase in proportion to the energy 464 delivered to the plasma generator 433. Subsequently, as further shown in Figure 4C, the generation of the plasma plume 466 generates a high-frequency mechanical sound wave 468 that is redirected toward the vascular lesion 106A (shown in Figure 1) of the treatment site 106 (shown in Figure 1) in a direction away from the inclined surface 433F of the plasma generator 433. This sound wave 468 applies pressure adjacent to the vascular lesion 106A of the treatment site 106 in order to induce fragmentation at the vascular lesion 106A of the treatment site 106.

[0114] Although not specifically shown in Figure 4C, cavitation bubbles can similarly be generated by the sound wave 468 when it propagates through the catheter fluid 132 (shown in Figure 1) toward the vascular lesion 106A (shown in Figure 1) at the treatment site 106 (shown in Figure 1) in a direction away from the inclined surface 433F of the plasma generator 433, similar to the embodiment described above.

[0115] In summary, in various embodiments, the catheter systems and associated methods disclosed herein are configured such that energy is supplied from an energy source, which is guided by each of one or more energy guides and directed toward a corresponding plasma generator, the plasma generator being formed from one or more polymer materials and which may be contained within a guidewire lumen and / or physically or structurally incorporated to generate a plasma plume and associated high-frequency mechanical sound waves substantially adjacent to the plasma generator. Specifically, energy from the energy source is emitted from the distal end of the guide of the energy guide and directed toward the corresponding plasma generator as part of the emitter. In a particular embodiment, the interaction of energy, light energy, or laser energy with the polymer material of the plasma generator initiates the generation of a plasma plume, the size of which increases in proportion to the energy delivered from the energy guide to the plasma generator. The generation of this plasma plume generates high-frequency mechanical sound waves, which are directed toward one or more vascular lesions located in the treatment site within the vascular wall of the patient's body or adjacent to the vascular wall, away from the plasma generator. These sound waves apply pressure, inducing fragmentation within the vascular lesion at the treatment site.

[0116] In many embodiments, the guide distal end of an energy guide and the corresponding plasma generator, which integrally constitute the emitter, may be positioned within a catheter fluid held inside the balloon of a balloon positioned adjacent to the treatment site. The guide distal end of the energy guide and the corresponding plasma generator can be positioned at any suitable location relative to the length of the balloon, allowing for more effective and precise application of sound waves and / or pressure waves for the purpose of fragmenting vascular lesions at the treatment site.

[0117] Accordingly, the catheter systems and associated methods disclosed herein are configured to provide means for generating sound waves and / or pressure waves designed to apply pressure to vascular lesions, such as calcified vascular lesions and / or fibrous vascular lesions, and to induce fragmentation within the vascular lesions. Importantly, in many embodiments, the emitter and / or plasma generator (or the entire guidewire lumen) may be formed to comprise one or more polymer materials.

[0118] As used herein and in the claims, the singular forms “one” and “it” refer to multiple objects unless the content and / or context explicitly indicates otherwise. Similarly, the term “or” is used generally to mean “and / or” unless the content or context explicitly indicates otherwise.

[0119] As used herein and in the claims, the term “configured” describes a system, apparatus, or other structure that is built or configured to perform a particular task or to adopt a particular configuration. The term “configured” may be used interchangeably with other similar terms such as arranged and configured, built and arranged, constructed, manufactured and arranged.

[0120] The headings used in this disclosure are provided to give context to the entire document. These headings should not be considered to limit or characterize any inventions claimed that may arise from this disclosure. For example, the description of the technology in the background art does not constitute prior art to any invention in this disclosure. The summary or abstract of an invention should also not be considered to characterize one or more inventions described in the claims.

[0121] The embodiments described herein are not intended to be exhaustive, nor are they intended to limit the invention to the exact forms disclosed in the detailed description provided herein. Rather, the embodiments are selected and described so that others skilled in the art can recognize and understand the principles and practices thereof. Several aspects have been described above with reference to various specific preferred embodiments and techniques. However, many variations and modifications can be made within the spirit and scope of this specification.

[0122] While several different embodiments of the catheter system have been illustrated and described in this disclosure, one or more features of any one embodiment can be combined with one or more features of one or more other embodiments, provided that the intent of the present invention is satisfied.

[0123] While several exemplary embodiments and designs of catheter systems have been described above, those skilled in the art will recognize specific modifications, substitutions, additions, and partial combinations thereof. Therefore, the appended claims are intended to be construed to include all such modifications, substitutions, additions, and partial combinations within their spirit and scope, and are not intended to be limited to the details of the configuration or design shown herein.

Claims

1. A catheter system for treating a treatment site within the wall of a blood vessel or a treatment site adjacent to the wall of the blood vessel, Energy sources that generate energy, An energy guide configured to selectively receive energy from the energy source, the energy guide including a distal end, wherein the energy received by the energy guide is released from the distal end; A guidewire lumen having an outer surface, wherein at least the distal end of the energy guide is positioned adjacent to the outer surface of the guidewire lumen, and a portion of the guidewire lumen includes a plasma generator positioned near the distal end of the energy guide, wherein the plasma generator can be positioned near the treatment site and is formed of a polymer material, A catheter system equipped with the following features.

2. The catheter system according to claim 1, wherein the outer surface of the guidewire lumen includes a groove, and at least the distal end of the energy guide is positioned within the groove formed along the outer surface of the guidewire lumen.

3. The catheter system according to claim 1 or 2, wherein the plasma generator is at least partially formed from one of plastic, polyimide, nylon, and polyether block amide.

4. The catheter system according to any one of claims 1 to 3, wherein the plasma generator is located away from the distal end of the energy guide.

5. The catheter system according to any one of claims 1 to 4, wherein the energy received by the energy guide is released from the distal end of the guide and comes into contact with the plasma generator, thereby generating plasma adjacent to the plasma generator.

6. The catheter system according to claim 5, wherein the generation of the plasma generates sound waves that move away from the plasma generator.

7. The catheter system according to claim 6, wherein the sound waves apply pressure adjacent to the blood vessel wall at the treatment site.

8. The catheter system according to claim 6 or 7, wherein a polymer filler is added to the polymer material of the plasma generator.

9. The catheter system according to claim 8, wherein the polymer filler comprises one or more of titanium dioxide, bismuth, barium sulfate, gold nanoparticles, silver nanoparticles, and tungsten particles.

10. A catheter system according to any one of claims 1 to 9, further comprising a catheter shaft and a balloon coupled to the catheter shaft, wherein the balloon includes a balloon wall defining the interior of the balloon and is configured to hold catheter fluid inside the balloon, and the distal end of the energy guide and the plasma generator are located inside the balloon.

11. The catheter system according to claim 10, wherein the energy received by the energy guide is released from the distal end of the guide and comes into contact with the plasma generator, thereby generating plasma in the catheter fluid held inside the balloon.

12. The catheter system according to any one of claims 1 to 11, wherein the distal end of the energy guide is inclined with respect to the outer surface of the guidewire lumen such that energy emitted from the distal end of the guide is emitted toward the outer surface of the guidewire lumen, and the plasma generator is incorporated into the outer surface of the guidewire lumen.

13. The catheter system according to claim 12, wherein the distal end of the energy guide is inclined with respect to the outer surface of the guidewire lumen at an angle of approximately 5 to 45 degrees with respect to a flat, vertical orientation.

14. The catheter system according to any one of claims 1 to 11, wherein the plasma generator extends outward from the outer surface of the guidewire lumen and includes an inclined surface, the inclined surface is configured such that the energy emitted from the distal end of the energy guide is emitted toward the inclined surface of the plasma generator and redirected toward the treatment site.

15. The catheter system according to claim 14, wherein the inclined surface of the plasma generator is inclined with respect to the outer surface of the guidewire lumen at an angle of approximately 5 to 45 degrees with respect to a flat, vertical arrangement.

16. A catheter system according to any one of claims 1 to 15, further comprising a system controller including a processor that controls the energy source so that the energy from the energy source is selectively directed to the energy guide.

17. The catheter system according to any one of claims 1 to 16, wherein the energy source is a light source that generates pulses of light energy.

18. The catheter system according to claim 17, wherein the light source is a laser.

19. The catheter system according to any one of claims 1 to 18, wherein the energy guide includes an optical fiber.

20. A method for treating a treatment site within the wall of a blood vessel or a treatment site adjacent to the wall of the blood vessel, The steps of generating energy from an energy source, A step of selectively receiving energy from the energy source by an energy guide including the distal end of the guide, The steps include releasing the energy received by the energy guide from the distal end of the guide, A step of positioning at least the distal end of the energy guide adjacent to the outer surface of a guidewire lumen, wherein a portion of the guidewire lumen includes a plasma generator positioned near the distal end of the energy guide; The steps include: positioning the plasma generator, which is made of a polymer material, near the treatment site; A method for providing this.

21. The method according to claim 20, wherein the outer surface of the guidewire lumen includes a groove, and the step of positioning at least the distal end of the guide includes positioning at least the distal end of the energy guide in the groove formed along the outer surface of the guidewire lumen.

22. The method according to claim 20 or 21, wherein the step of arranging the plasma generator is comprising the step of the plasma generator being at least partially formed from one of plastic, polyimide, nylon, and polyether block amide.

23. The method according to any one of claims 20 to 22, wherein the step of arranging the plasma generator includes arranging the plasma generator away from the distal end of the energy guide.

24. The method according to any one of claims 20 to 23, wherein the emission step includes emitting the energy received by the energy guide from the distal end of the guide such that the energy comes into contact with the plasma generator and plasma is generated adjacent to the plasma generator.

25. The method according to claim 24, wherein the emission step includes generating sound waves directed away from the plasma generator by the generation of the plasma.

26. The method according to claim 25, wherein the discharge step includes applying pressure adjacent to the blood vessel wall at the treatment site by sound waves.

27. The method according to claim 25 or 26, further comprising the step of adding a polymer filler to the polymer material of the plasma generator.

28. The method according to claim 27, wherein the adding step includes adding the polymer filler comprising one or more of titanium dioxide, bismuth, barium sulfate, gold nanoparticles, silver nanoparticles, and tungsten particles.

29. The method according to any one of claims 20 to 28, further comprising the steps of connecting a balloon, including a balloon wall defining the interior of the balloon, to a catheter shaft, and retaining catheter fluid inside the balloon, wherein the selective receiving step includes positioning the distal end of the energy guide and the plasma generator inside the balloon.

30. The method according to claim 29, wherein the step of positioning at least the distal end of the guide includes generating plasma in the catheter fluid held inside the balloon by releasing energy received by the energy guide from the distal end of the guide and coming into contact with the plasma generator.

31. The method according to any one of claims 20 to 30, wherein the step of positioning at least the distal end of the guide includes inclining the distal end of the energy guide with respect to the outer surface of the guidewire lumen such that the energy emitted from the distal end of the guide is emitted toward the outer surface of the guidewire lumen, and the step of positioning the plasma generator includes incorporating the plasma generator into the outer surface of the guidewire lumen.

32. The method according to claim 31, wherein the step of positioning at least the distal end of the guide includes the distal end of the energy guide being inclined with respect to the outer surface of the guide wire lumen at an angle of about 5 to 45 degrees with respect to a flat vertical position.

33. The method according to any one of claims 20 to 30, wherein the plasma generator extends outward from the outer surface of the guidewire lumen and includes an inclined surface, and the step of positioning the plasma generator includes the energy emitted from the distal end of the energy guide being directed toward the treatment site by being emitted toward the inclined surface of the plasma generator.

34. The method according to claim 33, wherein the step of arranging the plasma generator includes the inclined surface of the plasma generator being inclined with respect to the outer surface of the guide wire lumen at an angle of about 5 to 45 degrees with respect to a flat vertical arrangement.

35. The method according to any one of claims 20 to 34, further comprising the step of controlling the energy source by a system controller including a processor so that the energy from the energy source is selectively directed to the energy guide.

36. The method according to any one of claims 20 to 35, wherein the generating step includes the energy source being a light source that generates pulses of light energy.

37. The method according to claim 36, wherein the generating step is the light source being a laser.

38. The method according to any one of claims 20 to 37, wherein the step of selectively receiving includes the energy guide including an optical fiber.

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