Intravascular lithotripsy device with plasma generator comprising polymeric material

Abstract

The present invention relates to a catheter system (100) for treating a treatment site (106) within or adjacent to a vessel wall (108A) of a vessel (108), the catheter system (100) comprising 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 the energy from the energy source (124). The energy guide (122A) includes a guide distal end (122D). The energy received by the energy guide (122A) is emitted from the guide distal end (122D). The guidewire lumen (118) has an outer surface (218S). At least the guide distal 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) contains a plasma generator (133), the plasma generator (133) being located proximate to the guide distal end (122D) of the energy guide (122A). The plasma generator (133) may be located proximate to the treatment site (106). The plasma generator (133) is made of a polymer material.

Description

Cross-reference to related applications

[0001] This application relates to and claims priority to U.S. Provisional Patent Application No. 63 / 516,938, filed August 1, 2023, entitled "Intravascular Lithotripsy Device with Launcher Including Polymer Material," and U.S. Patent Application No. 18 / 741,023, filed June 12, 2024, entitled "Intravascular Lithotripsy Device with Plasma Generator Including Polymer Material." To the extent permitted, the entire contents of U.S. Provisional Patent Application No. 63 / 516,938 and U.S. Patent Application No. 18 / 741,023 are incorporated herein by reference. Background Technology

[0002] Vascular lesions within the human body can be associated with an increased risk of major adverse events, such as myocardial infarction, embolism, deep vein thrombosis, and stroke. In a clinical setting, severe vascular lesions are difficult for physicians to treat and to achieve patent vasodilation.

[0003] Vascular lesions can be treated with interventions such as medication, balloon angioplasty, plaque resection, stent placement, and vascular grafting. However, these interventions are not always ideal and may require follow-up treatment to resolve the lesion. Summary of the Invention

[0004] This invention relates to a catheter system for placement within a blood vessel having a vessel wall. The catheter system can be used by an operator to treat a treatment site within or adjacent to the vessel 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 the energy guide includes a distal end of the guide, from which the energy received by the energy guide is emitted. The guidewire lumen has an outer surface. At least the distal 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 end of the energy guide. The plasma generator may be located near the treatment site. The plasma generator is made of a polymer material.

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

[0006] In some embodiments, the plasma generator is made at least in part of one of plastic, polyimide, nylon, and polyether block amide.

[0007] In several embodiments, the plasma generator is positioned spaced apart from the distal end of the energy guide.

[0008] In various embodiments, energy received by the energy guide is emitted from the distal end of the guide and contacts the plasma generator, causing plasma to be generated in the vicinity of the plasma generator.

[0009] In some embodiments, plasma generation produces sound waves that are directed away from the plasma generator. In some embodiments, the sound waves apply pressure to the blood vessel wall near the treatment site.

[0010] In some embodiments, polymer fillers are added to the polymer material of the plasma generator.

[0011] In some embodiments, the polymer filler includes one or more of titanium dioxide, bismuth, barium sulfate, gold nanoparticles, silver nanoparticles, and tungsten particles.

[0012] In several embodiments, the catheter system further includes a catheter shaft and a balloon coupled to the catheter shaft. The balloon includes a balloon wall defining an interior. The balloon is configured to retain catheter fluid within its interior. A distal end of an energy guide and a plasma generator are located within the balloon.

[0013] In some embodiments, energy received by the energy guide is emitted from the distal end of the guide and contacts the plasma generator, thereby generating plasma in the duct fluid held inside the balloon.

[0014] In some embodiments, the distal end of the energy guide is inclined relative to the outer surface of the guidewire lumen, such that energy emitted from the distal end of the guide is directed toward the outer surface of the guidewire lumen within a recess. In some embodiments, a portion of the outer surface of the guidewire lumen includes a plasma generator.

[0015] In some embodiments, the distal end of the energy guide is angled relative to the outer surface of the guidewire lumen, the angle being between approximately 5 degrees and 45 degrees relative to a flat vertical configuration.

[0016] In some embodiments, the plasma generator extends outward away from the outer surface of the guidewire lumen and includes an inclined surface, such that energy emitted from the distal end of the energy guide is directed toward the inclined surface of the plasma generator and redirected to the treatment site.

[0017] In some embodiments, the inclined surface of the plasma generator is at an angle relative to the outer surface of the guidewire lumen, the angle being between approximately 5 degrees and 45 degrees relative to a flat vertical configuration.

[0018] In several embodiments, the conduit system further includes a system controller that includes a processor for controlling an energy source such that energy from the energy source is selectively directed to the energy guide.

[0019] In various embodiments, the energy source is a light source that generates light pulses.

[0020] In some embodiments, the light source is a laser.

[0021] In several embodiments, the energy guide includes an optical fiber.

[0022] The present invention also relates to a method for treating a treatment site within or adjacent to the wall of a blood vessel, the method comprising the steps of: generating energy using an energy source; receiving energy from the energy source using an energy guide, the energy guide including a distal end of the guide; emitting the energy received by the energy guide from the distal end of the guide; positioning at least the distal end of the energy guide adjacent to an outer surface of a guidewire lumen, a portion of the guidewire lumen including a plasma generator located near the distal end of the energy guide; and positioning the plasma generator near the treatment site; the plasma generator being made of a polymer material.

[0023] This invention provides an overview of some of the teachings of this application and is not intended to be exclusive or exhaustive of the subject matter. Further details are found in the detailed description and the appended claims. Other aspects will become apparent to those skilled in the art upon reading and understanding the following detailed description and observing the accompanying drawings, which form a part of it, and none of these drawings are to be construed as limiting. The scope of this document is defined by the appended claims and their legal equivalents. Attached Figure Description

[0024] The novel features of the invention, as well as the invention itself in terms of its structure and operation, will be best understood in conjunction with the accompanying drawings, in which similar reference numerals denote similar parts, and wherein:

[0025] Figure 1 According to a simplified schematic cross-sectional view of an embodiment of a catheter system, the catheter system includes a guidewire lumen and one or more energy guides positioned adjacent to the guidewire lumen, a portion of which contains a plasma generator;

[0026] Figure 2 A simplified schematic end view as part of an embodiment of a catheter system including a guidewire lumen and an energy guide positioned adjacent to the guidewire lumen;

[0027] Figure 3A for Figure 2 A simplified schematic side view of a portion of the guidewire lumen, a portion of the energy guide, and an embodiment of a plasma generator that may be contained within a portion of the guidewire lumen;

[0028] Figure 3B for Figure 3A A simplified schematic side view of the portion of the guidewire lumen, the plasma generator, and the portion of the energy guide shown. Figure 3A The initiation of the plasma plume was also shown;

[0029] Figure 3C for Figure 3A A simplified schematic side view of the portion of the guidewire lumen, the plasma generator, and the portion of the energy guide shown, which also illustrates the generation of the plasma plume and the resulting high-frequency acoustic waves.

[0030] Figure 3D for Figure 3A A simplified schematic side view of the portion of the guidewire lumen, the plasma generator, and the portion of the energy guide shown, which also illustrates cavitation bubble generation;

[0031] Figure 4A This is a simplified schematic side view of a portion of another embodiment of a guidewire lumen, a portion of another embodiment of an energy guide, and another embodiment of a plasma generator that may be contained within the guidewire lumen;

[0032] Figure 4B for Figure 4A A simplified schematic side view of the portion of the guidewire lumen, the plasma generator, and the portion of the energy guide shown, which also illustrates the initiation of the plasma plume; and

[0033] Figure 4C for Figure 4A The simplified schematic top view of the portion of the guidewire lumen, the plasma generator, and the portion of the energy guide also shows the generation of the plasma plume and the resulting high-frequency acoustic waves.

[0034] While embodiments of the invention may be subject to various modifications and alternatives, their specific details have been shown by way of example and drawings and are described in detail herein. However, it should be understood that the scope of this document is not limited to the specific embodiments described. Rather, it is intended to cover modifications, equivalents, and alternatives that fall within the spirit and scope of this document. Detailed Implementation

[0035] Treatment of vascular lesions at the treatment site within the patient's body can reduce major adverse events or death in affected subjects. As cited herein, a major adverse event is an event that can occur at any site in the body due to the presence of vascular lesions. Major adverse events may include, but are not limited to, major cardiac adverse events, major adverse events in the peripheral or central vascular system, major adverse events in the brain, major adverse events in muscle tissue, or major adverse events in any internal organ.

[0036] In various embodiments, the catheter systems and related methods disclosed herein may include a catheter configured to be advanced 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 some embodiments, the "treatment site" may be located at or near the wall of a patient's blood vessel. Additionally or alternatively, in other embodiments, the "treatment site" may be located at or near a patient's heart valve. Furthermore or alternatively, in other embodiments, the "treatment site" may be located at another suitable location within the patient's body.

[0037] As used herein, unless otherwise specified, the terms “treatment site,” “intrinsic lesion,” and “vascular lesion” are used interchangeably. Intravascular lesions and / or vascular lesions are sometimes referred to as “lesions” herein.

[0038] Those skilled in the art will recognize that the following specific embodiments of the invention are merely illustrative and not intended to be limiting in any way. Other embodiments of the invention will readily conceive of those skilled in the art who will understand the benefits of this disclosure. Reference will now be made in detail to embodiments of the invention as illustrated in the accompanying drawings.

[0039] For clarity, not all conventional features of the embodiments described herein are shown and described. It should be understood, of course, that in developing any such practical implementation, multiple implementation-specific decisions must be made to achieve the developer's specific objectives, such as compliance with application-related and business-related constraints; and these specific objectives will vary due to different implementations and different developers. Furthermore, it should be understood that such development work can be complex and time-consuming; however, it will still be a routine engineering task for those skilled in the art who understand the benefits of this disclosure.

[0040] The catheter systems disclosed herein may include a variety of different forms. See now. Figure 1 A simplified schematic cross-sectional view of a catheter system 100 is shown according to various embodiments. The catheter system 100 is adapted to apply high-frequency mechanical acoustic waves and / or pressure waves to rupture one or more vascular lesions within or near the vessel wall of a blood vessel in the patient's body, or at or near a treatment site on or near a heart valve. Figure 1In the illustrated embodiments, catheter system 100 may include (i) catheter 102, which includes one or more of an inflatable balloon 104 (sometimes referred to herein as a “balloon”), catheter shaft 110, guidewire 112, energy guide bundle 122, source manifold 136, fluid pump 138, stem assembly 129, and energy emission system 131 (also referred to herein as a “transmitter system”), energy guide bundle 122 including one or more energy guides 122A, and energy emission system 131 including one or more transmitter stations 180 and / or one or more transmitters 135; and (ii) system console 123, which includes an energy source 124 (such as a light source and / or laser source in some non-exclusive embodiments), power supply 125, system controller 126, graphical user interface 127 (“GUI”), and multiplexer 128. Alternatively, catheter system 100, catheter 102, and / or system console 123 may include, compared to Figure 1 Specifically, the more or fewer components shown and described. For example, in some non-exclusive alternative embodiments, the catheter system 100 and / or system console 123 may be designed without a GUI 127 and / or multiplexer 128.

[0041] The catheter 102 is configured to move to a treatment site 106 at any suitable location within the body 107 of the patient 109. In some embodiments, the treatment site 106 may be located within or adjacent to the wall 108A of a blood vessel 108 within the body 107 of the patient 109. Alternatively, in other embodiments, the catheter 102 may be used within or adjacent to a heart valve within the body 107 of the patient 109. The treatment site 106 may include one or more vascular lesions 106A, such as calcified vascular lesions. Furthermore or alternatively, the treatment site 106 may include vascular lesions 106A, such as fibrotic vascular lesions.

[0042] In some embodiments, balloon 104 may be coupled to catheter shaft 110. Balloon 104 may include a proximal balloon end 104P and a distal balloon end 104D. Catheter shaft 110 may extend from a proximal portion 114 of catheter system 100 to a distal portion 116 of catheter system 100. Catheter shaft 110 may include a longitudinal axis 144. Catheter 102 and / or catheter shaft 110 may also include a guidewire lumen 118 configured to move on guidewire 112. As used herein, guidewire lumen 118 defines a passage through which guidewire 112 extends. Catheter shaft 110 may also include an inflatable lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, catheter 102 may have a distal end opening 120; and when catheter 102 is moved and positioned at or near treatment site 106, guidewire 112 may be received and followed thereal. In some embodiments, the proximal end 104P of the balloon may be connected to the catheter shaft 110, and the distal end 104D of the balloon may be connected to the guidewire lumen 118.

[0043] Balloon 104 includes a balloon wall 130 defining a balloon interior 146. Balloon 104 can be selectively inflated using catheter fluid 132 to extend from a constricted state (suitable for advancing catheter 102 through the patient's vascular system) to an inflated state (e.g., Figure 1 As shown), this inflation state is suitable for anchoring the catheter 102 in a suitable position relative to the treatment site 106. In other words, when the balloon 104 is inflated, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106.

[0044] As described herein, each transmitter station 180 may include one or more transmitters 135, which are positioned in substantially the same longitudinal location within the balloon 104. Each transmitter 135 includes at least a distal end 122D of one of the energy guides 122A and a corresponding plasma generation structure 133 (also referred to herein as a "plasma generator"), which operates to generate plasma within the balloon 104. Because the transmitter system 131 may include one or more transmitter stations 180, it should be understood that the conduit system 100 and / or the transmitter system 131 may include any suitable number of transmitters 135, from only one transmitter 135 to more than 30 transmitters 135.

[0045] In summary, in various embodiments, each of the transmitters 135 of the catheter system 100 may be at least partially made of one or more polymeric materials. More specifically, the present invention relates to a polymeric transmitter 135 for an intravascular lithotripsy device, wherein the polymeric generator 135 generates acoustic waves through laser interaction. The invention includes an energy guide 122A, such as an optical fiber in some non-exclusive embodiments, which is attached to and / or positioned adjacent to the guidewire lumen 118. In several embodiments, a plasma generator 133 (which may be contained within a portion of the guidewire lumen 118 and spaced apart from the distal guide end 122D of the energy guide 122A) may be made of one or more polymeric materials.

[0046] In some embodiments, the guidewire lumen 118 and / or the plasma generator 133 are at least partially made of a polymeric material, such as polyether block amide (e.g., PEBAX™), polyimide, plastic, nylon, or other thermoplastics, and may also be configured to have thin walls to minimize cross-sectional dimensions. 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 polymeric or thermoplastic material of the guidewire lumen 118 and / or the plasma generator 133 to increase laser absorptivity and thus optimize the conversion efficiency between laser energy and acoustic output. In some embodiments, energy (such as laser energy) directed outward from the distal end 122D of the energy guide 122A contacts the polymeric material on the guidewire lumen 118 at a distance away from the distal end 122D of the energy guide 122A (in various embodiments, a portion of the guidewire lumen 118 includes the plasma generator 133). The photointeraction with the polymer material, substantially adjacent to the plasma generator 133, induces a plasma plume. The size of the plasma plume increases proportionally to the energy delivered through the emitter 135 and / or energy guide 122A. In various embodiments, the formation of the plasma plume generates high-frequency mechanosonic waves that are directed away from the plasma generator 133 and toward the vascular lesion 106A at the treatment site 106. Thus, plasma generation generates acoustic waves and / or pressure waves that apply pressure to the vicinity of the vascular lesion 106A at the treatment site 106. Cavitation bubbles can also be formed by these acoustic waves as they propagate away from the plasma generator 133 and toward the vascular lesion 106A at the treatment site 106.

[0047] Balloons 104 suitable for use in catheter systems 100 include those that can pass through the vascular system of a patient 109 in a constricted state. In some embodiments, balloons 104 are made of siloxane. In other embodiments, balloons 104 may be made of materials such as polydimethylsiloxane (PDMS), polyurethane, polymers such as polyether block amides (such as PEBAX™), nylon, or any other suitable material.

[0048] The balloon 104 may have any suitable diameter (in its inflated state). In various embodiments, the balloon 104 may have a diameter ranging from less than 1 mm to 25 mm (in its inflated state). In some embodiments, the balloon 104 may have a diameter ranging from at least 1.5 mm to 14 mm (in its inflated state). In some embodiments, the balloon 104 may have a diameter ranging from at least 2 mm to 5 mm (in its inflated state).

[0049] In some embodiments, balloon 104 may have a length 142 ranging from at least 3 mm to 300 mm. More specifically, in some embodiments, balloon 104 may have a length 142 ranging from at least 8 mm to 200 mm. It should be understood that a balloon 104 with a relatively long length can be positioned adjacent to a larger treatment site 106; and therefore, can 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 and cause it to rupture. It should also be understood that a longer balloon 104 may also be positioned adjacent to multiple treatment sites 106 at any given time.

[0050] The balloon 104 can be inflated to an inflation pressure between approximately 1 atmosphere (atm) and 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 other embodiments, the balloon 104 can be inflated to an inflation pressure of at least 3 atm to 20 atm. In other embodiments, the balloon 104 can be inflated to an inflation pressure of at least 2 atm to 10 atm.

[0051] The balloon 104 may have various shapes, including but not limited to conical, square, rectangular, spherical, conical / square, conical / spherical, extended spherical, elliptical, wedge-shaped, bone-shaped, 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, including anti-inflammatory agents, antitumor agents, anti-angiogenic agents, etc.

[0052] The catheter fluid 132 may be a liquid or a gas. Some examples of suitable catheter fluids 132 include, but are not limited to, water, saline, contrast agents, fluorocarbons, perfluorocarbons, gases (such as carbon dioxide), or any other suitable catheter fluid 132. In some embodiments, the catheter fluid 132 may be used as a base filling fluid. In some embodiments, the catheter fluid 132 may comprise a mixture of saline and contrast agent at a volume ratio of approximately 50:50. In other embodiments, the catheter fluid 132 may comprise a mixture of saline and contrast agent at a volume ratio of approximately 25:75. In some embodiments, the catheter fluid 132 may comprise a mixture of saline and contrast agent at a volume ratio of approximately 75:25. However, it should be understood that any suitable ratio of saline to contrast agent may be used. The catheter fluid 132 may be modulated based on composition, viscosity, etc., so that the travel rate of sound waves and / or pressure waves can be appropriately manipulated. In some embodiments, the suitable catheter fluid 132 is biocompatible. The volume of the conduit fluid 132 can be modulated by the selected energy source 124 and the type of conduit fluid 132 used.

[0053] In some embodiments, the contrast agent used as the contrast agent may include, but is not limited to, iodine-based contrast agents, such as ionic or non-ionic iodine-based contrast agents. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, methyldiatrizoate, iodophthalate, and iodixanol. Some non-limiting examples of non-ionic iodine-based contrast agents include iopamidol, iohexol, iodixanol, iopromide, iodixanol, and iofluoxetine. In other embodiments, non-iodine-based contrast agents may be used. Suitable iodine-free contrast agents may include gadolinium(III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon reagents may include, but are not limited to, perfluorocarbons such as dodecafluoropentane (DDFP, C5F). 12 ) reagents.

[0054] The catheter fluid 132 may include those containing an absorbent that selectively absorbs light in the ultraviolet region of the electromagnetic spectrum (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)). Suitable absorbents may include those having a maximum absorption value along the spectrum from at least 10 nm to 2.5 μm. Alternatively, the catheter fluid 132 may include those containing an absorbent that selectively absorbs light in the mid-infrared region of the electromagnetic spectrum (e.g., at least 2.5 μm to 15 μm) or the far-infrared region (e.g., at least 15 μm to 1 mm). In various embodiments, the absorbent may be those having a maximum absorption value that matches the maximum emission value of the laser used in the catheter system 100. By way of non-limiting example, various lasers available in the conduit system 100 may include neodymium:yttrium aluminum garnet (Nd:YAG—maximum emission = 1064 nm) lasers, holmium:yttrium aluminum garnet (Ho:YAG—maximum emission = 2.1 μm) lasers, or erbium:yttrium aluminum garnet (Er:YAG—maximum emission = 2.94 μm) lasers. In some embodiments, the absorbent may be water-soluble. In other embodiments, the absorbent is water-insoluble. In some embodiments, the absorbent used in the conduit fluid 132 may be modulated to match the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths of at least 10 nanometers to 1 millimeter are discussed separately herein.

[0055] The catheter shaft 110 of catheter 102 can be coupled to a plurality of energy guides 122A of energy guide bundle 122, which is optically in communication with energy source 124. Energy guides 122A can be disposed along catheter shaft 110 and within balloon 104. Each energy guide 122A may have a distal guide end 122D, which is positioned in any suitable longitudinal direction relative to the length 142 of balloon 104 and / or relative to the length of guidewire lumen 118.

[0056] 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 be optically connected to the energy guide 122A at the proximal portion 114 of the conduit system 100. More specifically, due to the presence and operation of the multiplexer 128, the energy source 124 may be selectively and / or alternatively optically connected to each of the energy guides 122A.

[0057] 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, etc.; the plurality of energy guides 122A may be positioned at any suitable location about and / or relative to the guidewire lumen 118 and / or the catheter shaft 110. For example, in some non-exclusive embodiments, two energy guides 122A may be spaced apart from each other by approximately 180 degrees about the circumference of the guidewire lumen 118 and / or the catheter shaft 110; three energy guides 122A may be spaced apart from each other by approximately 120 degrees about the circumference of the guidewire lumen 118 and / or the catheter shaft 110; four energy guides 122A may be spaced apart from each other by approximately 90 degrees about the circumference of the guidewire lumen 118 and / or the catheter shaft 110; five energy guides 122A may be spaced apart from each other by approximately 180 degrees about the circumference of the guidewire lumen 118 and / or the catheter shaft 110; and five energy guides 122A may be spaced apart from each other by approximately 180 degrees about the circumference of the guidewire lumen 118 and / or the catheter shaft 110. The guidewire lumen 118 and / or catheter shaft 110 are spaced apart from each other by approximately 72 degrees; six energy guides 122A may be spaced apart from each other by approximately 60 degrees around the circumference of the guidewire lumen 118 and / or catheter shaft 110; eight energy guides 122A may be spaced apart from each other by approximately 45 degrees around the circumference of the guidewire lumen 118 and / or catheter shaft 110; or ten energy guides 122A may be spaced apart from each other by approximately 36 degrees around the circumference of the guidewire lumen 118 and / or catheter shaft 110. Alternatively, the multiple energy guides 122A need not be uniformly spaced from each other around the circumference of the guidewire lumen 118 and / or catheter shaft 110. More particularly, it should be understood that 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.

[0058] In some embodiments, the guidewire lumen 118 may be generally annular and / or cylindrical in shape, and may have a slotted outer surface 218S. Figure 2 As shown), one or more of the grooves 260 ( Figure 2 (As shown) Extends in a generally longitudinal direction along the guidewire lumen 118. In such embodiments, each of the energy guides 122A may be positioned, received, and held within an individual recess 260 formed along and / or in the outer surface 218S of the guidewire lumen 118. Alternatively, the guidewire lumen 118 may not have a slotted outer surface 218S, and the position of the energy guide 122A relative to the guidewire lumen 118 may be maintained in another suitable manner.

[0059] The catheter system 100 and / or energy guide bundle 122 may include any number of energy guides 122A in optical communication with the energy source 124 at the proximal portion 114, and wherein catheter fluid 132 is located within 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 or desired longitudinal position within the balloon interior 146 relative to the length 142 of the balloon 104. Alternatively, in other embodiments, the catheter system 100 and / or energy guide bundle 122 may include more than 30 energy guides 122A.

[0060] The energy guide 122A may have any suitable design that can be used and adapted to allow the generation of plasma, acoustic waves, and / or pressure waves in the catheter fluid 132 within the balloon interior 146. Therefore, the general description of the energy guide 122A as a light guide is not intended to be limiting in any way, except as provided in the appended claims. More specifically, while the catheter system 100 is generally described with energy source 124 as a light source and one or more energy guides 122A as light guides, the catheter system 100 may alternatively include any suitable energy source 124 and energy guides 122A for generating a desired plasma in the catheter fluid 132 within the balloon interior 146. For example, in a 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 comprising spaced electrodes extending into the balloon interior 146. In such embodiments, each high-voltage pulse is applied to the electrode and forms an arc traversing the electrode, which in turn generates plasma and creates acoustic and / or pressure waves in the conduit fluid 132, which are used to deliver a rupture force to the vascular lesion 106A at the treatment site 106. Alternatively, the energy source 124 and / or energy guide 122A may have another suitable design and / or configuration, and may be electrical, acoustic, pneumatic, other mechanical, etc.

[0061] As shown, the catheter system 100 may include one or more transmitters 135 configured to generate plasma, acoustic waves, and / or pressure waves in the catheter fluid 132 within the balloon interior 146. Each transmitter 135 includes a distal end 122D of one of the energy guides 122A and a corresponding plasma generator 133, the distal end 122D of which is located within the balloon interior 146, and the corresponding plasma generator 133 located near but typically spaced from the distal end 122D of which is located.

[0062] Energy from energy source 124 is directed toward and received by energy guide 122A, guided through energy guide 122A, and then emitted from the distal end 122D of energy guide 122A. The energy emitted from the distal end 122D is directed toward and contacts the corresponding plasma generator 133 and powers it for generating plasma in the catheter fluid 132 within balloon interior 146. As described in more detail below, in several embodiments, plasma generator 133 may be incorporated into and / or form part of the structure of guidewire lumen 118. In other words, a portion of guidewire lumen 118 may contain plasma generator 133 located near the distal end 122D of energy guide 122A.

[0063] In some embodiments, another portion of the emitter 135 and / or the plasma generator 133 may be made at least partially of a polymer material. For example, in some embodiments, the plasma generator 133 and / or the guidewire lumen 118 may be made of a polymer material, such as polyether block amide (e.g., PEBAX™), nylon, plastic, polyimide, or other thermoplastics, and may be designed to have thin walls to minimize cross-sectional dimensions. 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 thus improve the conversion efficiency between laser energy and acoustic output.

[0064] During use of the conduit system 100, energy (such as optical or laser energy) directed outward from the distal end 122D of the energy guide 122A contacts the guidewire lumen 118 and / or plasma generator 133 at a distance away from the distal end 122D of the energy guide 122A. The interaction of this energy with the polymer material of the plasma emitter 133 and / or guidewire lumen 118 induces a plasma plume whose size increases proportionally to the energy delivered and / or emitted from the distal end 122D of the energy guide 122A. The formation of the plasma plume generates high-frequency mechanosonic waves that are directed away from the target site of the plasma generator 133. Cavitation bubbles can also be formed by the acoustic waves as they propagate through the conduit fluid 132.

[0065] In some embodiments, the energy guide 122A may include an optical fiber or a flexible optical tube. The energy guide 122A may be thin and flexible, allowing optical signals to be transmitted with extremely low intensity loss. The energy guide 122A may include a core surrounded by a cladding around its circumference. In some embodiments, the core may be cylindrical or partially cylindrical. The core and cladding of the energy guide 122A may be made of one or more materials, including but not limited to one or more types of glass, silica, or one or more polymers. The energy guide 122A may also include a protective coating, such as a polymer. It should be understood that the refractive index of the core will be greater than that of the cladding.

[0066] Each energy guide 122A can guide energy along its length from the proximal end 122P of the guide toward the distal end 122D of the guide, wherein the distal end 122D of the guide has at least one optical window (not shown) located within the balloon interior 146.

[0067] The energy guide 122A can be configured in various ways about and / or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the energy guide 122A can operate parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the energy guide 122A can be disposed along the length of the outer diameter of the catheter shaft 110. In other embodiments, the energy guide 122A can be disposed within one or more energy guide lumens within the catheter shaft 110.

[0068] The energy guide 122A can also be positioned at any suitable location around the circumference of the guidewire lumen 118 and / or the catheter shaft 110, and the distal end 122D of each of the energy guides 122A can be positioned at any suitable longitudinal location relative to the length 142 of the balloon 104 and / or relative to the length of the guidewire lumen 118 to more effectively and precisely apply acoustic and / or pressure waves to destroy the vascular lesion 106A at the treatment site 106.

[0069] In some embodiments, the energy guide 122A may include one or more photoacoustic transducers 153, wherein each photoacoustic transducer 153 may be optically communicated with the energy guide 122A therein. In some embodiments, the photoacoustic transducer 153 may be optically communicated with a guide distal end 122D of the energy guide 122A. In such embodiments, the photoacoustic transducer 153 may have a shape corresponding to and / or conforming to the guide distal end 122D of the energy guide 122A.

[0070] The photoacoustic transducer 153 is configured to convert light energy into sound waves at or near the distal end 122D of the energy guide 122A. The direction of the sound waves can be modulated by changing the angle of the distal end 122D of the energy guide 122A.

[0071] In some embodiments, the photoacoustic transducer 153 disposed at the distal end 122D of the energy guide 122A may have the same shape as the distal end 122D of the energy guide 122A. For example, in some non-exclusive embodiments, the photoacoustic transducer 153 and / or the distal end 122D of the guide may have a conical shape, a convex shape, a concave shape, a spherical shape, a square shape, a stepped shape, a semi-circular shape, an elliptical shape, etc. The energy guide 122A may also include an additional photoacoustic transducer 153 disposed along one or more side surfaces along the length of the energy guide 122A.

[0072] In some embodiments, the energy guide 122A may also include one or more steering structures or "steering gears" ( Figure 1 (Not shown), such as within the energy guide 122A and / or near the guide distal end 122D of the energy guide 122A; the one or more steering structures or "steering devices" are configured at an angle to direct energy from the energy guide 122A away from the guide distal end 122D of the energy guide 122A. For example, in some embodiments, the steering structure may direct energy from the energy guide 122A toward a side surface, which may be located at or near the guide distal end 122D of the energy guide 122A, before directing energy toward the balloon wall 130. Additionally or alternatively, the steering structure may direct energy from the energy guide 122A toward the outer surface 218S of the guidewire lumen 118 at an angle; as mentioned, the guidewire lumen 118 may include a plasma generator 133 and, in some embodiments, be made of one or more materials.

[0073] The steering structure may include any structure of the system that directs energy from the energy guide 122A away from its axial path, such as directing it toward a side surface of the energy guide 122A. Each energy guide 122A may include one or more optical windows disposed along a longitudinal or circumferential surface of each energy guide 122A and in optical communication with the steering structure. In other words, the steering structure may have any suitable structural configuration configured to direct energy in the energy guide 122A away from its axial path and / or toward a side surface at or near the distal end 122D of the guide, wherein the side surface is in optical communication with the optical window. The optical window may include a portion of the energy guide 122A that allows energy to exit from within the energy guide 122A, such as a portion of the energy guide 122A lacking cladding material on or near the energy guide 122A.

[0074] Examples of suitable deflection structures include reflective elements, refractive elements, and fiber diffusers. Deflection structures suitable for focusing energy away from the end of energy guide 122A may include, but are not limited to, those with convex surfaces, gradient refractive index (GRIN) lenses, and specular focusing lenses. Upon contact with the deflection structure, the first energy can be deflected within energy guide 122A to one or more of plasma generator 133 and photoacoustic transducer 154, plasma generator 133 being located near but typically spaced from the distal end 122D of energy guide 122A, and photoacoustic transducer 154 being optically connected to the side surface of energy guide 122A. In use, the plasma generator 133 receives energy emitted from the distal end 122D of the energy guide 122A to generate plasma in the duct fluid 132 within the balloon interior 146. This plasma then induces the formation of plasma bubbles, acoustic waves, and / or pressure waves, which can be directed away from the side surface of the energy guide 122A and toward the balloon wall 130. Alternatively, in use, the photoacoustic transducer 154 converts light energy into acoustic waves that extend away from the side surface of the energy guide 122A.

[0075] The source manifold 136 may be located at or near the proximal portion 114 of the catheter system 100. The source manifold 136 may include one or more proximal end openings, a guidewire 112, and / or an inflation line 140, the one or more proximal end openings receiving a plurality of energy guides 122A of the energy guide bundle 122, the inflation line 140 being fluidly connected to a fluid pump 138. The catheter system 100 may also include a fluid pump 138 configured to inflate a balloon 104 as needed using catheter fluid 132.

[0076] As mentioned above, in Figure 1In the illustrated embodiment, system console 123 includes one or more of a power source 124, a power supply 125, a system controller 126, a GUI 127, and a multiplexer 128. Alternatively, system console 123 may include components comparable to... Figure 1 The specific components may be more or fewer. For example, in some non-exclusive alternative embodiments, the system console 123 may be designed without a GUI 127 and / or a multiplexer 128. Alternatively, one or more of the power source 124, power supply 125, system controller 126, GUI 127, and multiplexer 128 may be located within the conduit system 100 without requiring a dedicated system console 123.

[0077] As shown, the system console 123 and the components included therewith are operatively coupled to the catheter 102, the energy guide bundle 122, and the remainder of the catheter system 100. For example, in some embodiments, such as Figure 1 As shown, the system console 123 may include a console connection port 148 (sometimes also commonly referred to as a "receptacle" or "console jack") through which the energy guide bundle 122 is mechanically coupled 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 typically include one or more sleeves and is sometimes also commonly referred to as a "connector housing") accommodating a portion of each of the energy guides 122A, such as the proximal end 122P of the guide. At least a portion of the guide coupling housing 150 is configured to engage and selectively remain within the console connection port 148 to provide mechanical coupling between the energy guide bundle 122 and the system console 123, and to facilitate optical coupling between the energy source 124 and the energy guides 122A of the energy guide bundle 122.

[0078] The energy guide bundle 122 may also include a guide bundle 152 (or “housing”) that brings each of the individual energy guides 122A closer together, such that the energy guides 122A and / or the energy guide bundle 122 can be in a more compact form as they extend into the blood vessel 108 together with the catheter 102 during use of the catheter system 100.

[0079] Energy source 124 may be selectively and / or alternatively optically connected to each of energy guides 122A, such as to a guide proximal end 122P of each of the energy guides 122A in energy guide bundle 122. Specifically, energy source 124 is configured to generate energy in the form of a source beam 124A, such as a pulsed source beam; this energy may be selectively and / or alternatively directed to and received by each of the energy guides 122A in energy guide bundle 122. More specifically, as shown, the source beam 124A of energy source 124 is directed through multiplexer 128 such that an independent guide beam 124B (or “multiplexed beam”) may be selectively and / or alternatively directed to and received by each of the energy guides 122A in energy guide bundle 122. Specifically, each pulse of energy source 124 and / or each pulse of source beam 124A can be directed through multiplexer 128 to generate an independent guide beam 124B, which selectively and / or alternatively directs to one of the energy guides 122A in the energy guide bundle 122. Thus, through the use and / or application of multiplexer 128, energy source 124 can be used to power any of transmitters 135, which may be included within conduit system 100. Alternatively, conduit system 100 may include more than one energy source 124. For example, in a non-exclusive alternative embodiment, conduit system 100 may include an independent energy source 124 for each of the energy guides 122A in energy guide bundle 122.

[0080] The energy source 124 may have any suitable design. In some embodiments, the energy source 124 may be configured to provide sub-millisecond energy pulses focused on a small spot to couple it into the proximal end 122P of the energy guide 122A. Such energy pulses are then guided and / or directed along the energy guide 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation in the conduit fluid 132 within the balloon interior 146 of the balloon 104, such as via a plasma generator 133, which may include and / or be incorporated into any suitable structure located at or near the distal end 122D of the energy guide 122A. In several embodiments, the plasma generator 133 may be positioned slightly spaced from the distal end 122D of the energy guide 122A. In some embodiments, the plasma generator 133 may be configured as part of the outer surface 218S of the guidewire lumen 118, the portion being made of one or more polymeric materials, for example, disposed within a groove 260 that may be formed in the outer surface 218S of the guidewire lumen 118. Alternatively, in other embodiments, the plasma generator 133 may be provided as a backstop-type structure having an inclined surface 433F, which may be integrally formed as part of the guidewire lumen 118 and positioned within a groove 260 that may be formed in the outer surface 218S of the guidewire lumen 118. As mentioned, the guidewire lumen 118 and / or the plasma generator 133 may be made of one or more polymeric materials, and the backstop-type plasma generator 133 may redirect energy emitted from the distal end 122D of the guide to the balloon wall 130 toward the balloon 104 and / or redirect it to the vessel wall 108A toward the vessel 108 at the treatment site 106.

[0081] Specifically, in several embodiments, the energy emitted from the distal end 122D of the energy guide 122A is directed toward and contacts 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, to generate plasma in the catheter fluid 132 within the balloon interior 146. Plasma generation ionizes and superheats the surrounding catheter fluid 132, thus causing rapid formation of inertial bubbles and applying acoustic and / or pressure waves to the treatment site 106. An exemplary plasma-induced bubble 134 is shown in… Figure 1 middle.

[0082] As used herein, the distal end 122D of the energy guide 122A and the corresponding plasma generator 133 can be collectively referred to as emitter 135. In some applications, one or more emitters 135 positioned at approximately the same longitudinal position relative to the length 142 of the balloon 104 within the interior 146 of the balloon can be referred to as "emitter stations," such as as... Figure 1 One or more transmitter stations 180 included in a portion of the transmitter system 131 shown.

[0083] In various non-exclusive alternative embodiments, sub-millisecond energy pulses from energy source 124 may be delivered to treatment site 106 at frequencies between approximately 1 Hz and 5000 Hz, between approximately 30 Hz and 1000 Hz, between approximately 10 Hz and 100 Hz, or between approximately 1 Hz and 30 Hz. Alternatively, sub-millisecond energy pulses may be delivered to treatment site 106 at frequencies greater than 5000 Hz or less than 1 Hz, or any other suitable frequency range.

[0084] It should be understood that although energy source 124 is typically used to provide energy pulses, energy source 124 can also be described as providing a single source beam 124A, such as a single pulse source beam.

[0085] Suitable energy sources 124 may include various types of light sources, including lasers and lamps. For example, in some non-exclusive embodiments, energy source 124 may be an infrared laser that emits energy in the form of infrared light pulses. Alternatively, as described above, energy source 124 may include any suitable type of energy source.

[0086] Suitable lasers may include sub-millisecond short-pulse lasers. In some embodiments, energy source 124 may include a nanosecond (ns) laser. Lasers may also include picosecond (ps), femtosecond (fs), and microsecond (μs) short-pulse lasers. It should be understood that various combinations of laser wavelengths, pulse widths, and energy levels exist that can be used to generate plasma in the conduit fluid 132 of conduit 102. In various non-exclusive alternative embodiments, pulse widths may include those falling within the range 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 may be used.

[0087] Exemplary nanosecond lasers may include those within the UV to IR spectrum, spanning wavelengths from about 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, an energy source 124 suitable for use in a conduit system 100 may include those capable of generating light at wavelengths from at least 750 nm to 2000 nm. In other embodiments, the energy source 124 may include those capable of generating light at wavelengths from at least 700 nm to 3000 nm. In other embodiments, the energy source 124 may include those capable of generating light at wavelengths from at least 100 nm to 10 micrometers (μm). Nanosecond lasers may include those having repetition frequencies up to 200 kHz.

[0088] 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 doped, pulsed, fiber lasers.

[0089] In other embodiments, energy source 124 may include multiple lasers connected in series. In other embodiments, energy source 124 may include one or more low-energy lasers fed into a high-energy amplifier, such as a master oscillator power amplifier (MOPA). In other embodiments, energy source 124 may include multiple lasers connected in parallel or in series to provide the required energy to generate plasma bubbles 134 in the conduit fluid 132.

[0090] The catheter system 100 can generate acoustic and / or pressure waves having a maximum pressure in the range of at least 1 MPa to 100 MPa. The maximum pressure generated by a particular catheter system 100 will depend on the energy source 124, the absorbent material, the bubble inflation, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter system 100 can generate acoustic 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.

[0091] When the catheter 102 is placed at the treatment site 106, acoustic and / or pressure waves may be applied to the treatment site 106 from the self-energy guide 122A over a distance ranging from at least about 0.1 mm to more than about 25 mm. In various non-exclusive alternative embodiments, when the catheter 102 is placed at the treatment site 106, acoustic and / or pressure waves may be applied to the treatment site 106 from the self-energy guide 122A over 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. In other embodiments, acoustic and / or pressure waves may be applied to the treatment site 106 from another suitable distance different from the foregoing ranges. In some embodiments, acoustic and / or pressure waves may be applied to the treatment site 106 over a distance ranging from at least about 0.1 mm to 10 mm at a pressure ranging from 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 and a pressure range of at least about 2 MPa to 25 MPa. Alternatively, other suitable pressure ranges and distances may be used.

[0092] Power supply 125 is electrically connected to and configured to provide the required power to each of energy source 124, system controller 126, GUI 127, multiplexer 128, and handle assembly 129. Power supply 125 may have any suitable design for such purposes.

[0093] System controller 126 is electrically connected to and receives power from power source 125. System controller 126 is connected to and configured to control the operation of each of energy source 124, GUI 127, and multiplexer 128. System controller 126 may include one or more processors or circuits for controlling the operation of at least energy source 124, GUI 127, and multiplexer 128. For example, system controller 126 may control energy source 124 to generate energy pulses as needed and / or at any desired trigger rate. Subsequently, system controller 126 may control multiplexer 128 such that energy from energy source 124 (as source beam 124A) may be selectively and / or alternatively directed in a desired manner to each of energy guides 122A, such as in the form of independently guided beam 124B.

[0094] System controller 126 may also be configured to control the operation of other components of catheter system 100, such as the positioning of catheter 102, the distal end 122D of energy guide 122A, and / or transmitter 135 adjacent to treatment site 106, inflation of balloon 104 with catheter fluid 132, etc. Alternatively or additionally, catheter system 100 may include one or more additional controllers that may be positioned in any suitable manner to control various operations of catheter system 100. For example, in some embodiments, an additional controller and / or a portion of system controller 126 may be located and / or incorporated within stem assembly 129.

[0095] 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. With this design, the GUI 127 can 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 and cause it to rupture. The GUI 127 can provide the user or operator with information available before, during, and after the use of the catheter system 100. In one embodiment, the GUI 127 can provide static visual data and / or information to the user or operator. Additionally or alternatively, the GUI 127 can provide dynamic visual data and / or information to the user or operator, such as video data and any other data that changes over time during the use of the catheter system 100. In various embodiments, the GUI 127 may include one or more colors, different sizes, different brightness, etc., which can function as an alarm for the user or operator. Additionally or alternatively, the GUI 127 can provide audio data or information to the user or operator. The details of GUI 127 may vary depending on the design requirements of the catheter system 100, or the specific needs, specifications and / or expectations of the user or operator.

[0096] Multiplexer 128 is configured to selectively and / or alternatively direct energy from energy source 124 to each of the energy guides 122A in energy guide bundle 122. More specifically, multiplexer 128 is configured to receive energy from energy source 124, such as in the form of a single source beam 124A from a single laser source; and to selectively and / or alternatively direct such energy in the form of an independent guide beam 124B to each of the energy guides 122A in energy guide bundle 122 as needed. Thus, multiplexer 128 allows a single energy source 124 to pass through multiple energy guides 122A respectively in any desired sequence or pattern, enabling catheter system 100 to apply pressure to and rupture vascular lesion 106A at treatment site 106, which is desiredly located within or adjacent to the vessel wall 108A of vessel 108. As shown, in some embodiments, the conduit system 100 may include one or more optical elements 147 for directing energy (such as source beam 124A) from energy source 124 to multiplexer 128.

[0097] The multiplexer 128 may have any suitable design for selectively and / or alternatively directing energy from the energy source 124 to each of the energy guides 122A of the energy guide bundle 122.

[0098] For example Figure 1 As shown, the stem assembly 129 may be located at or near the proximal portion 114 of the catheter system 100, and / or near the source manifold 136. In this embodiment, the stem assembly 129 is connected to the balloon 104 and positioned spaced apart from the balloon 104. Alternatively, the stem assembly 129 may be positioned at another suitable location.

[0099] The handle assembly 129 is attached to the catheter shaft 110 and is held and used by a user or operator to operate, position, and control the catheter 102. The design and specific features of the handle assembly 129 can be modified to suit the design requirements of the catheter system 100. Figure 1 In the illustrated embodiment, the handle assembly 129 is separate from, but electrically and / or fluidly connected to, one or more of the system controller 126, power source 124, fluid pump 138, and GUI 127.

[0100] 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 shown, in some such embodiments, the handle assembly 129 may include circuitry 155 electrically coupled between the conduit electronics and the system console 123 and forming at least a portion of the system controller 126. In one embodiment, the circuitry 155 may include a printed circuit board having one or more integrated circuits or any other suitable circuitry. In another embodiment, the circuitry 155 may be omitted or may be included within the system controller 126; the system controller 126 may be located outside the handle assembly 129 in various embodiments, such as within the system console 123. It should be understood that the handle assembly 129 may include fewer or additional components compared to those specifically shown and described herein.

[0101] The transmitter system 131 includes one or more transmitter stations 180, wherein each transmitter station 180 includes one or more transmitters 135. As described herein, each of the transmitters 135 includes a distal end 122D of one of the energy guides 122A and a corresponding plasma generator 133. As referenced herein, a “plasma generator” may include and / or be incorporated into any suitable type of structure located at or near the distal end 122D of the energy guide 122A. In some embodiments, the plasma generator 133 may be contained within and / or incorporated into a portion of the guidewire lumen 118. For example, the plasma generator 133 may be contained within and / or incorporated into a portion of the outer surface 218S of the guidewire lumen 118 and / or within a material, such as the polymeric material in several embodiments, which forms at least a portion of the outer surface 218S of the guidewire lumen 118. Alternatively, in some embodiments, the plasma generator 133 may be provided in the form of a backstop structure having an inclined surface 433F, which may be contained within and / or incorporated therein within the structure of the guidewire lumen 118 and redirect energy emitted from the distal end 122D of the guide to the balloon wall 130 toward the balloon 104 and / or the vessel wall 108A toward the vessel 108 at the treatment site 106.

[0102] Each of the transmitters 135 is configured to selectively receive energy from the energy source 124 (under the control of the system controller 126 and directed as by the multiplexer 128) and emit the energy from the distal end 122D of the guide towards the plasma generator 133. The energy emitted from the distal end 122D of the guide impinges on and excites the material of the plasma generator 133, such as the material on the outer surface 218S of the guidewire lumen 118 and / or the inclined surface 433F of the plasma generator 133, to generate plasma in the catheter fluid 132 within the balloon interior 146. Plasma generation ionizes and / or superheats the surrounding catheter fluid 132, and thus causes rapid formation of inertial bubbles, and applies acoustic and / or pressure waves to the treatment site 106.

[0103] The emitter 135 and / or plasma generator 133 may be made of any suitable material. For example, in some non-exclusive embodiments, as described above, the emitter 135 and / or plasma generator 133 may be made at least partially of one or more polymers, polymeric materials, and / or plastics, such as polyether block amides (such as PEBAX™), polyimide, nylon, or other suitable thermoplastics. In some embodiments, the emitter 135 and / or plasma generator 133 (such as the separate structures of the guidewire lumen 118 and / or plasma generator 133 in some embodiments) are configured to have thin walls to minimize cross-sectional dimensions. The emitter 135 and / or plasma generator 133 may also include polymer fillers, such as titanium dioxide, bismuth, barium sulfate, gold nanoparticles, silver nanoparticles, tungsten particles, or any other metallic material, which may also be added to the polymeric or thermoplastic material to increase laser absorption and thus better optimize the conversion efficiency between laser energy and acoustic output.

[0104] Alternatively, the emitter 135 and / or plasma generator 133 may be made of one or more metals and / or metal alloys having a high melting temperature, such as titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium, iridium, etc. Alternatively, the emitter 135 and / or plasma generator 133 may be made of at least one of magnesium oxide, beryllium oxide, tungsten carbide, titanium nitride, titanium carbonitride, and titanium carbide. Alternatively, the emitter 135 and / or plasma generator 133 may be made of at least one of diamond CVD and diamond. In other embodiments, the emitter 135 and / or plasma generator 133 may be made of transition metals, alloy metals, or ceramic materials. Alternatively, the emitter 135 and / or plasma generator 133 may be made of any other suitable material. It should also be understood that the emitter 135 and / or plasma generator 133 may be made of any suitable combination of any of the materials described above and any of the materials.

[0105] The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with catheter fluid 132 as needed.

[0106] As with all embodiments shown and described herein, various structures may be omitted from the accompanying drawings for clarity and ease of understanding. Additionally, the drawings may include certain structures that may be omitted without departing from the intent and scope of the invention.

[0107] Figure 2 This is a simplified schematic end view as part of an embodiment of a catheter system 200, which includes an embodiment of a guidewire lumen 218 and an energy guide 222A positioned adjacent to the guidewire lumen 218. More specifically, as shown in this embodiment, the guidewire lumen 218 includes a recess 260 (or channel) formed along and / or in the outer surface 218S of the guidewire lumen 218. The recess 260 is configured to extend in a generally longitudinal direction along at least a portion of the length of the guidewire lumen 218. As further shown, at least a portion of the energy guide 222A (such as at least the distal guide end 322D of the energy guide 222A) is... Figure 3A As shown, the energy guide 222A can be positioned, received, and held within the groove 260. Using this design, the energy guide 222A can be effectively held in a fixed position relative to the guidewire lumen 218. It should be understood that although only a single groove 260 is shown formed along and / or in the outer surface 218S of the guidewire lumen 218, the guidewire lumen 218 can be configured to include any suitable number of grooves 260, each configured to receive and hold an individual energy guide therein.

[0108] Alternatively, the guidewire lumen 218 may not have a slotted outer surface 218S, and the position of the energy guide 222A relative to the guidewire lumen 118 may be maintained in another suitable manner.

[0109] Figure 2 It also shows how the guidewire lumen 218 is generally annular and / or cylindrical in shape, and how it defines the lumen conduit 262, guidewire 112 ( Figure 1 (As shown) The guidewire lumen 218 extends through lumen 262. Alternatively, the guidewire lumen 218 may have another suitable shape.

[0110] Figure 3A for Figure 2The diagram shows a simplified schematic side view of an embodiment of a guidewire lumen 218, a portion of an energy guide 222A, and a plasma generator 333, which may be incorporated into the guidewire lumen 218. As shown in this embodiment, the distal guide end 322D of the energy guide 222A is angled relative to the outer surface 218S of the guidewire lumen 218; that is, the distal guide end 322D of the energy guide 222A is not perpendicular to the outer surface 218S of the guidewire lumen 218. With this design, energy emitted from the distal guide end 322D of the energy guide 222A will be naturally directed at a slightly downward angle toward the outer surface 218S of the guidewire lumen 218. More specifically, the energy emitted from the distal guide 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, which includes and / or is incorporated into the plasma generator 333. It should be understood that the angle between the distal end 322D of the guide and the outer surface 218S perpendicular to the guidewire lumen 218 can be any suitable angle, such as between approximately 5 degrees and 45 degrees in some non-exclusive embodiments.

[0111] In various embodiments, as described above, portions of the outer surface 218S of the guidewire lumen 218 (which includes and / or is incorporated into the plasma generator 333) and / or the entire guidewire lumen 218 may be made of any suitable polymeric material. For example, in some non-exclusive embodiments, portions of the outer surface 218S of the guidewire lumen 218 (which includes and / or is incorporated into the plasma generator 333) may be at least partially made of one or more polymers, polymeric materials, and / or plastics, such as polyether block amides (such as PEBAX™), polyimide, nylon, or other suitable thermoplastics. In some embodiments, the plasma generator 333 may also include polymeric 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 polymeric or thermoplastic material to increase laser absorption and thus better optimize the conversion efficiency between laser energy and acoustic output.

[0112] It should be understood that Figure 3A The outer surface 218S of the guide wire cavity 218 shown (which functions as a plasma generator 333) can be a groove 260 ( Figure 2 As shown, a groove 260 is formed along and / or in the outer surface 218S of the guidewire lumen 218, which is part of the outer surface 218S of the guidewire lumen 218. Alternatively, the outer surface 218S of the guidewire lumen 218, which functions as a plasma generator 333, may be another part of the outer surface 218S of the guidewire lumen 218.

[0113] It should also be understood that, in other embodiments, the distal end 322D of the energy guide 222A may be a square-cut and perpendicular to the outer surface 218S of the guidewire lumen 218, but may alternatively include any suitable type of diverting structure configured such that the energy emitted from the distal end 322D of the energy guide 222A is again directed at a slightly downward angle toward the portion of the outer surface 218S of the guidewire lumen 218 that includes and / or incorporates the plasma generator 333.

[0114] Figure 3B for Figure 3A The simplified schematic side view of the portion of the guidewire lumen 218, the plasma generator 333, and the portion of the energy guide 222A shown also illustrates the initiation of the plasma plume. More specifically, as shown, energy 364 (such as optical or laser energy in some embodiments) is emitted from the guide distal end 322D of the energy guide 222A and is guided at a slightly downward angle. The portion of the plasma generator 333 is included and / or incorporated into the outer surface 218S of the guidewire lumen 218. The portion of the plasma generator 333 included and / or incorporated into the outer surface 218S of the guidewire lumen 218 is shown spaced apart from the guide distal end 322D of the energy guide 222A.

[0115] When energy 364 emitted from the distal end 322D of the energy guide 222A contacts or otherwise impacts and excites the material of the plasma generator 333, a plasma plume 366 is formed 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 end 322D of the energy guide 222A and the polymer material incorporated within the plasma generator 333 induces the plasma plume 366, the size of which increases proportionally to the energy 364 delivered to the plasma generator 333.

[0116] Figure 3C for Figure 3A The portion of the guide wire lumen 218 shown, and the plasma generator 333 ( Figure 3B A simplified schematic side view of the portion of the energy guide 222A (shown more clearly) also illustrates the generation of the plasma plume and the resulting high-frequency acoustic waves. More specifically, Figure 3CIt is also shown that energy 364 (such as light energy or laser energy in some embodiments) is emitted from the distal end 322D of the energy guide 222A and is directed at a slightly downward angle toward the outer surface 218S of the guide wire lumen 218, which contains and / or incorporates the portion of the plasma generator 333.

[0117] When energy 364 emitted from the distal end 322D of the energy guide 222A contacts or otherwise impacts and excites the polymer material of the plasma generator 333, a plasma plume 366 is formed 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 proportionally to the energy 364 delivered to the plasma generator 333. Subsequently, as... Figure 3C As further shown, the formation of the plasma plume 366 generates a high-frequency mechanical acoustic wave 368, which is directed away from the plasma generator 333 and towards the treatment site 106. Figure 1 Vascular lesion 106A at the location shown) Figure 1 (As shown). Then, sound wave 368 applies pressure to the vascular lesion 106A near the treatment site 106 to cause the vascular lesion 106A at the treatment site 106 to rupture.

[0118] Figure 3D for Figure 3A A simplified schematic side view of the portion of the guidewire lumen 218, the plasma generator 333, and the portion of the energy guide 222A shown. Figure 3A Cavitation bubble formation is also shown. As illustrated, as sound wave 368 propagates through duct fluid 132 ( Figure 1 (as shown) and away from the plasma generator 333 and towards the treatment site 106 ( Figure 1 Vascular lesion 106A at the location shown) Figure 1 As shown), cavitation bubble 370 has been formed by sound wave 368 ( Figure 3C (As shown).

[0119] Figure 4A This is a simplified schematic side view of a portion of another embodiment of the guidewire lumen 418, another embodiment of the energy guide 422A, and another embodiment of the plasma generator 433, which may be incorporated into and / or integrally formed with the guidewire lumen 418. As shown, the distal end 422D of the energy guide 422A is cut straight so that the distal end 422D of the energy guide 422A is substantially perpendicular to the outer surface 418S of the guidewire lumen 418. Figure 4AIt is also shown that, in this embodiment, the plasma generator 433 is positioned spaced apart from the distal end 422D of the energy guide 422A and substantially adjacent to the remainder of the outer surface 418S of the guidewire lumen 418. More specifically, the plasma generator 433 protrudes and / or extends substantially outward away from the remainder of the outer surface 418S of the guidewire lumen 418 and can be positioned within the recess 260 ( Figure 2 As shown, a groove 260 is formed along and / or within the outer surface 418S of the guidewire lumen 418. Therefore, in several embodiments, the plasma generator 433 of this embodiment is again included within a portion of the guidewire lumen 418. Alternatively, in other embodiments, the plasma generator 433 may be a separate structure positioned substantially adjacent to and / or fixed to the guidewire lumen 418, such as being fixed within the groove 260, which is formed along and / or within the outer surface 418S of the guidewire lumen 418.

[0120] The design of plasma generator 433 can be modified. For example... Figure 4A As shown, in one embodiment, the plasma generator 433 may be provided in the form of a back-mounted structure with an inclined surface 433F, which is inclined (i.e., not parallel) to the flat-cut distal end 422D of the energy guide 422A. It should be understood that the angle of the inclined surface 433F of the plasma generator 433 relative to the distal end 422D of the energy guide 422A can be any suitable angle, such as between approximately 5 degrees and 45 degrees in some non-exclusive embodiments. Alternatively, the plasma generator 433 may have another suitable design, and / or the inclined surface 433F may be inclined to different degrees relative to the distal end 422D of the energy guide 422A.

[0121] In various embodiments, as described above, the plasma generator 433 or at least the inclined surface 433F of the plasma generator 433 may be made of any suitable polymer material. For example, in some non-exclusive embodiments, the plasma generator 433 and / or the inclined surface 433F may be at least partially made of one or more polymers, polymer materials, and / or plastics, such as polyether block amides (such as PEBAX™), polyimide, nylon, or other suitable thermoplastics. In some embodiments, the plasma generator 433 and / or the inclined surface 433F may also include 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 or thermoplastic material to increase laser absorption and thus better optimize the conversion efficiency between laser energy and acoustic output.

[0122] It should be understood that because the plasma generator 433 is physically incorporated into the physical structure of the guidewire lumen 418 in various embodiments, the guidewire lumen 418 as a whole can be made of any such polymer material.

[0123] Figure 4B for Figure 4A The simplified schematic side view of the portion of the guidewire lumen 418, the plasma generator 433, and the portion of the energy guide 422A shown also illustrates the initiation of the plasma plume. More specifically, as shown, energy 464 (such as optical or laser energy in some embodiments) is emitted from the guide distal end 422D of the energy guide 422A and guided to the inclined surface 433F of the plasma generator 433. The inclined surface 433F of the plasma generator 433 is again shown spaced apart from the guide distal end 422D of the energy guide 422A.

[0124] When energy 464 emitted from the distal end 422D of the energy guide 422A contacts or otherwise impacts and excites the material of the plasma generator 433, a plasma plume 466 is induced to form on the inclined surface 433F of the plasma generator 433, substantially adjacent to the material. In other words, the interaction between the energy 464 emitted from the distal end 422D of the energy guide 422A and the polymer material incorporated within the inclined surface 433F of the plasma generator 433 induces the plasma plume 466, the size of which increases proportionally to the energy 464 delivered to the inclined surface 433F of the plasma generator 433.

[0125] Figure 4C for Figure 4A A simplified schematic top view of the portion of the guidewire lumen 418, the plasma generator 433, and the energy guide 422A shown also illustrates the generation of the plasma plume and the resulting high-frequency acoustic waves. More specifically, Figure 4C Again, energy 464 (such as light energy or laser energy in some embodiments) is emitted from the distal end 422D of the energy guide 422A and directed to the inclined surface 433F of the plasma generator 433. Figure 4A (As shown more clearly).

[0126] When energy 464 emitted from the distal end 422D of the energy guide 422A contacts and excites the polymer material of the inclined surface 433F of the plasma generator 433, a plasma plume 466 is induced substantially adjacent to the inclined surface 433F of the plasma generator 433. The size of the plasma plume 466 then continues to increase proportionally to the energy 464 delivered to the plasma generator 433. Subsequently, as... Figure 4CAs further shown, the formation of the plasma plume 466 generates a high-frequency mechanical acoustic wave 468, which is directed away from the inclined surface 433F of the plasma generator 433 and directed toward the treatment site 106. Figure 1 Vascular lesion 106A at the location shown) Figure 1 (As shown). Then, sound wave 468 applies pressure to the vascular lesion 106A near the treatment site 106 to cause the vascular lesion 106A at the treatment site 106 to rupture.

[0127] Although Figure 4C Not specifically shown, but as in the previous embodiment, as sound wave 468 propagates through conduit fluid 132 ( Figure 1 (as shown) and the inclined surface 433F away from the plasma generator 433 and towards the treatment site 106 ( Figure 1 Vascular lesion 106A at the location shown) Figure 1 As shown in the figure, cavitation bubbles can also be formed by sound waves 468.

[0128] In summary, in various embodiments, the catheter systems and related methods disclosed herein are powered by an energy source guided by one or more energy guides and directed to a corresponding plasma generator, which may be contained within and / or physically or structurally incorporated into a guidewire lumen made of one or more polymeric materials to generate a plasma plume and associated high-frequency mechanoacoustic waves substantially adjacent to the plasma generator. More specifically, energy from the energy source is emitted from the distal end of the guide of the energy guide and directed as part of the emitter to the corresponding plasma generator. In some embodiments, the interaction of energy, optical energy, or laser energy with the polymeric material of the plasma generator induces a plasma plume whose size increases proportionally to the energy delivered from the energy guide to the plasma generator. The formation of the plasma plume subsequently generates high-frequency mechanoacoustic waves that are directed away from the plasma generator and toward one or more vascular lesions located within the vessel wall or adjacent to the treatment site within the patient. Therefore, sound waves apply pressure to the vascular lesions at the treatment site and cause the lesions to rupture.

[0129] In several embodiments, the distal end of the energy guide and the corresponding plasma generator (which together constitute the emitter) may be located in a catheter fluid held within the balloon, which is positioned adjacent to the treatment site. The distal end of the energy guide and the corresponding plasma generator may be located at any suitable position relative to the length of the balloon to more effectively and precisely apply acoustic and / or pressure waves to destroy vascular lesions at the treatment site.

[0130] Therefore, the catheter systems and related methods disclosed herein are configured to provide means for generating acoustic and / or pressure waves designed to apply pressure to vascular lesions and cause them to rupture, such as calcified vascular lesions and / or fibrotic vascular lesions. Importantly, in several embodiments, the transmitter and / or plasma generator (or the guidewire lumen as a whole) may be formed comprising one or more polymer materials.

[0131] It should be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content and / or context clearly indicate otherwise. It should also be noted that the term “or” is generally used in its meaning including “and / or” unless the content or context clearly specifies otherwise.

[0132] It should also be noted that, as used in this specification and the appended claims, the term "configuration" describes a system, device, or other structure constructed or configured to perform a particular task or employ a particular configuration. The phrase "configuration" may be used interchangeably with other similar phrases, such as arrangement and configuration, construction and arrangement, construction, manufacture and arrangement, etc.

[0133] Furthermore, the headings used herein are provided for conformity with the recommendations of 37 CFR.1.77, or otherwise to provide organizational clues. These headings should not be construed as limiting or characterizing any invention set forth in the claims that may be published by this disclosure. As an example, the technology described in the “Background Art” section does not acknowledge that it is prior art to any invention of this disclosure. Nor should the “Summary of the Invention” or “Abstract” be construed as characterizing the invention set forth in the published claims.

[0134] The embodiments described herein are not intended to be exhaustive, nor are they intended to limit the invention to the precise forms disclosed in the detailed descriptions provided below. Rather, the embodiments have been chosen and described so that others skilled in the art can understand and master the principles and practices. Therefore, various aspects have been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications can be made while remaining within the spirit and scope of this document.

[0135] It should be understood that although several different embodiments of the catheter system have been shown and described herein, one or more features of any one embodiment may be combined with one or more features of other embodiments, provided that such combinations satisfy the objectives of the invention.

[0136] While several exemplary aspects and embodiments of the catheter system have been discussed above, those skilled in the art will recognize certain modifications, arrangements, additions, and sub-combinations thereof. Therefore, it is contemplated that the appended claims and subsequently introduced claims be interpreted to include all such modifications, arrangements, additions, and sub-combinations within their true spirit and scope, and are not intended to limit the details of the constructions or designs shown herein.

Claims

1. A catheter system for treating a treatment site within or adjacent to the wall of a blood vessel, the catheter system comprising: Energy source, which generates energy; An energy guide configured to selectively receive energy from the energy source, the energy guide including a distal end from which the energy received by the energy guide is emitted; and A guidewire lumen having an outer surface, at least a distal end of the energy guide positioned adjacent to the outer surface of the guidewire lumen, a portion of the guidewire lumen including a plasma generator located near the distal end of the energy guide, the plasma generator being located near the treatment site, and the plasma generator being made of a polymer material.

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

3. The conduit system according to any one of claims 1 to 2, wherein the plasma generator is at least partially made of one of plastic, polyimide, nylon, and polyether block amide.

4. The conduit system according to any one of claims 1 to 3, wherein the plasma generator is positioned spaced apart from the distal end of the energy guide.

5. The conduit system according to any one of claims 1 to 4, wherein energy received by the energy guide is emitted from the distal end of the guide and contacts the plasma generator, such that plasma is generated adjacent to the plasma generator.

6. The conduit system of claim 5, wherein the plasma generation produces acoustic waves that are directed away from the plasma generator.

7. The catheter system of claim 6, wherein the acoustic waves apply pressure near the vessel wall at the treatment site.

8. The conduit system according to any one of claims 6 to 7, wherein the polymer filler is added to the polymer material of the plasma generator.

9. The conduit 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. The catheter system according to any one of claims 1 to 9, further comprising a catheter shaft and a balloon, the balloon being coupled to the catheter shaft, the balloon including a balloon wall defining an interior of the balloon, the balloon being configured to retain catheter fluid within the interior of the balloon; and wherein the distal end of the energy guide and the plasma generator are located within the interior of the balloon.

11. The catheter system of claim 10, wherein energy received by the energy guide is emitted from the distal end of the guide and contacts the plasma generator, such that plasma is generated in the catheter fluid held within the balloon.

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

13. The catheter system of claim 12, wherein the distal end of the energy guide forms an angle relative to the outer surface of the guidewire lumen, the angle being between approximately 5 degrees and 45 degrees relative to a flat vertical configuration.

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

15. The catheter system of claim 14, wherein the inclined surface of the plasma generator forms an angle with respect to the outer surface of the guidewire lumen, the angle being between approximately 5 degrees and 45 degrees relative to a flat vertical configuration.

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

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

18. The conduit system of claim 17, wherein the light source is a laser.

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

20. A method for treating a treatment site within or adjacent to the wall of a blood vessel, the method comprising the following steps: Energy is generated using an energy source; The energy is selectively received from the energy source using an energy guide, the energy guide including a distal end of the guide; Energy received by the energy guide is emitted from the distal end of the guide; At least the distal end of the energy guide is positioned adjacent to the outer surface of the guidewire lumen, a portion of which includes a plasma generator located near the distal end of the energy guide; and The plasma generator is positioned near the treatment site and is made of a polymer material.

21. The method of claim 20, wherein the step of positioning at least the distal end of the guide comprises: The outer surface of the guidewire lumen includes a groove, and at least the distal end of the energy guide is located within the groove formed along the outer surface of the guidewire lumen.

22. The method according to any one of claims 20 to 21, wherein the step of positioning the plasma generator comprises: The plasma generator is made at least in part of 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 positioning the plasma generator comprises: The plasma generator is positioned to be spaced apart from the distal end of the energy guide.

24. The method according to any one of claims 20 to 23, wherein the emission step comprises emitting energy received by the energy guide from a distal end of the guide, such that the energy contacts the plasma generator and causes plasma to be generated adjacent to the plasma generator.

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

26. The method of claim 25, wherein the emitting step comprises applying pressure to the blood vessel wall adjacent to the treatment site by the sound waves.

27. The method according to any one of claims 25 to 26, further comprising the step of adding polymer filler to the polymer material of the plasma generator.

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

29. The method of any one of claims 20 to 28, further comprising the step of coupling a balloon to a catheter shaft, the balloon comprising a balloon wall defining an interior of the balloon; and retaining catheter fluid within the interior of the balloon; and wherein the selective reception step comprises: The distal end of the energy guide and the plasma generator are positioned inside the balloon.

30. The method of claim 29, wherein the step of positioning at least the distal end of the guide comprises: The energy received by the energy guide is emitted from the distal end of the guide and contacts the plasma generator, thereby generating plasma in the duct fluid held inside the balloon.

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 comprises: The distal end of the energy guide is inclined relative 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. and The step of locating the plasma generator includes: incorporating the plasma generator into the outer surface of the guide wire lumen.

32. The method of claim 31, wherein the step of positioning at least the distal end of the guide comprises: The distal end of the energy guide forms an angle relative to the outer surface of the guidewire lumen, the angle being between approximately 5 degrees and 45 degrees relative to a flat vertical configuration.

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

34. The method of claim 33, wherein the step of positioning the plasma generator comprises: The inclined surface of the plasma generator forms an angle with respect to the outer surface of the guidewire lumen, the angle being between approximately 5 degrees and 45 degrees relative to a flat vertical configuration.

35. The method of any one of claims 20 to 34, further comprising the step of controlling the energy source with a system controller, the system controller including a processor, such that 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 generation step comprises: The energy source is a light source that generates light pulses.

37. The method of claim 36, wherein the generating step comprises: The light source is a laser.

38. The method according to any one of claims 20 to 37, wherein the selective receiving step comprises: The energy guide includes optical fibers.

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