Emitter selection based on radiopaque emitter stations for intravascular lithotripsy devices

Abstract

A catheter system (100) for placement within a blood vessel (108) having a vessel wall (108A) may be used to treat a treatment site (106) within or adjacent to the vessel wall (108A). The catheter system (100) includes an energy source (124), a plurality of energy directors (122A), and a plurality of emitters (135). An energy source (124) generates energy. Each of the energy directors (122A) is configured to selectively receive energy from an energy source (124). Each energy director (122A) includes a corresponding director distal end (122D). The energy received by each energy director (122A) is emitted from a corresponding director distal end (122D). Each emitter (135) may be positioned proximate to a treatment site (106). Each of the transmitters (135) includes a corresponding director distal end (122D) of one of the energy directors (122A). At least one of the emitters (135) comprises a radiopaque material.

Description

Related Applications

[0001] This application is related to and claims the benefit of priority of U.S. Provisional Patent Application Serial No. 63 / 390,102, filed on July 18, 2022, entitled “EMITTER SELECTION BASED ON RADIOPAQUE EMITTER STATIONS FOR INTRAVASCULAR LITHOTRIPSY DEVICE” and U.S. Patent Application Serial No. 18 / 339,901, filed on June 22, 2023, entitled “EMITTER SELECTION BASED ON RADIOPAQUE EMITTER STATIONS FOR INTRAVASCULAR LITHOTRIPSY DEVICE”. To the extent permissible, the contents of U.S. Provisional Application Serial No. 63 / 390,102 and U.S. Patent Application Serial No. 18 / 339,901 are incorporated herein by reference in their entirety. background

[0002] Vascular lesions within the body's vessels may be associated with an increased risk of major adverse events, such as myocardial infarction, embolism, deep vein thrombosis, stroke, etc. Severe vascular lesions may be difficult for physicians to treat and achieve patency in a clinical setting.

[0003] Vascular lesions can be treated using interventions such as medical therapy, balloon angioplasty, atherectomy, stenting, vascular bypass grafting, etc. These interventions may not always be ideal or may require subsequent treatment to resolve the lesion. Overview

[0004] The present invention relates to a catheter system for placement in a blood vessel having a blood vessel wall. An operator can use the catheter system to treat a treatment site in or adjacent to the blood vessel wall. In various embodiments, the catheter system includes an energy source, a plurality of energy guides, and a plurality of transmitters. The energy source generates energy. Each of the plurality of energy guides is configured to selectively receive energy from the energy source. Each of the plurality of energy guides includes a corresponding guide distal end. The energy received by each of the plurality of energy guides is emitted from the corresponding guide distal end. Each of the plurality of transmitters can be positioned near the treatment site. Each of the plurality of transmitters includes a corresponding guide distal end of one of the plurality of energy guides. At least one transmitter includes a radiopaque material.

[0005] In many embodiments, the radiopaque material is visible when used with fluoroscopy during use of the catheter system for an intravascular lithotripsy procedure.

[0006] In some embodiments, the catheter system further comprises a catheter shaft and a balloon coupled to the catheter shaft. The balloon comprises a balloon wall defining a balloon interior. The balloon is configured to retain the catheter fluid within the balloon interior. Energy directors are provided along the catheter shaft. The corresponding director distal end of each energy director is positioned within the balloon interior so that each transmitter is positioned within the balloon interior.

[0007] In some embodiments, each emitter further comprises a corresponding plasma generator positioned near a corresponding director distal end of one of the plurality of energy directors. Energy received by each of the plurality of energy directors is emitted from the corresponding director distal end and impinges on the corresponding plasma generator, causing plasma to be generated in the catheter fluid held within the balloon interior.

[0008] In some embodiments, the generation of plasma results in bubble formation which generates pressure waves that exert pressure near the vessel wall.

[0009] In some embodiments, the catheter system further comprises a plurality of emitter stations positioned within the interior of the balloon. Each emitter station can be positioned at a different longitudinal position within the interior of the balloon relative to the length of the balloon than each of the other emitter stations. Each emitter station comprises at least one of the plurality of emitters. At least one of the plurality of emitter stations comprises a radiopaque material.

[0010] In many embodiments, each of the plurality of transmitter stations comprises a radiopaque material that is visible when used with fluoroscopy during use of the catheter system for an intravascular lithotripsy procedure.

[0011] In some embodiments, the plurality of transmitter stations include a first transmitter station including a first plurality of transmitters each positioned at a first longitudinal position within the interior of the balloon and a second transmitter station including a second plurality of transmitters each positioned at a second longitudinal position within the interior of the balloon different from the first longitudinal position.

[0012] In certain embodiments, the catheter system further includes a system controller including a processor that controls the energy source so that energy from the energy source is selectively directed to each of the emitters in any desired excitation pattern.

[0013] In some embodiments, the system controller is configured to one of: specifically select and specifically deselect transmitters to be activated during use of the catheter system for an intravascular lithotripsy procedure based at least in part on proximity of the transmitters to the treatment site.

[0014] In certain embodiments, the system controller is configured to selectively activate only those transmitters that are located closest to the treatment site.

[0015] In other embodiments, the system controller is configured to selectively deactivate those transmitters that are located least proximal to the treatment site.

[0016] In some embodiments, the catheter system further comprises a graphical user interface comprising a plurality of transmitter activators that can be used to one of: specifically select and specifically deselect transmitters to be activated during use of the catheter system for an intravascular lithotripsy procedure.

[0017] In many embodiments, the catheter system further includes a multiplexer that receives energy from the energy source and directs the energy from the energy source to each of the energy directors in the form of individually directed beams.

[0018] In many embodiments, the energy source is a light source that produces pulses of light energy.

[0019] In some embodiments, the light source is a laser.

[0020] In certain embodiments, each of the plurality of energy directors comprises an optical fiber.

[0021] The present invention also relates to a method for treating a treatment site within or adjacent to a blood vessel wall, the method comprising the following steps: generating energy using an energy source; selectively receiving energy from the energy source using each of a plurality of energy guides, each of the plurality of energy guides comprising a corresponding guide distal end, the energy received by each of the plurality of energy guides being emitted from the corresponding guide distal end; and positioning a plurality of emitters near the treatment site, each emitter comprising a corresponding guide distal end of one of the plurality of energy guides, at least one of the emitters comprising a radiopaque material.

[0022] This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment 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 upon viewing the accompanying drawings, which form a part thereof, each of which should not be construed as limiting. The scope of this article is defined by the appended claims and their legal equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The novel features of the invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying description, when considered in conjunction with the accompanying drawings, in which like reference characters represent like parts, and in which: Figure 1 is a simplified schematic cross-sectional view of an embodiment of a catheter system including a multiplexer and a plurality of energy directors according to various embodiments; Figure 2A is a simplified schematic top view of a portion of an embodiment of a catheter system including an embodiment of a multiplexer; Figure 2B yes Figure 2A A simplified schematic perspective view of a portion of a catheter system and a multiplexer is shown; Figure 3A is a simplified schematic top view of a portion of an embodiment of a catheter system including another embodiment of a multiplexer; Figure 3B yes Figure 3A A simplified schematic perspective view of a portion of a catheter system and a multiplexer is shown; Figure 4 is a simplified schematic top view of a portion of a catheter system and yet another embodiment of a multiplexer; Figure 5 is a simplified schematic top view of yet another embodiment of a portion of a catheter system and a multiplexer; Figure 6 is a simplified schematic top view of a portion of a catheter system and yet another embodiment of a multiplexer; Figure 7 is a simplified schematic top view of yet another embodiment of a portion of a catheter system and a multiplexer; Figure 8 is a simplified schematic side view of a portion of an embodiment of a catheter system having features of the present invention, the catheter system including a balloon having a balloon wall defining a balloon interior and two transmitter stations positioned within the balloon interior of the balloon; Fig. 9 is a simplified schematic diagram of a portion of another embodiment of a catheter system including four transmitter stations positioned within a balloon interior of a balloon; Fig.10 is a simplified schematic diagram of a portion of yet another embodiment of a catheter system including five transmitter stations positioned within a balloon interior of a balloon; Fig.11A is a fluoroscopic image of a portion of an embodiment of a catheter system positioned substantially adjacent to a vascular lesion, the catheter system comprising four transmitter stations positioned within a balloon interior of a balloon, the balloon being in an inflated state; Fig. 11B yes Fig.11A A fluoroscopic image of a catheter system positioned substantially adjacent to a vascular lesion is shown with the balloon in a deflated state; Fig.12 a fluoroscopic image of a portion of another embodiment of a catheter system positioned substantially adjacent to a vascular lesion; and Fig.13 is a simplified illustration of an embodiment of a graphical user interface that may be used as part of a catheter system.

[0024] Although embodiments of the present invention allow for various modifications and alternative forms, their specific details have been illustrated by way of example and drawings and are described in detail herein. However, it is to be understood that the scope of this article is not limited to the specific embodiments described. On the contrary, the purpose is to cover modifications, equivalents, and alternatives that fall within the spirit and scope of this article. describe

[0025] Treatment of vasculopathy can reduce major adverse events or death in affected subjects. As described herein, a major adverse event is a major adverse event that may occur anywhere in the body due to the presence of a vasculopathy. Major adverse events can include, but are not limited to, major adverse cardiac events, major adverse events of the peripheral vasculature or central vasculature, major adverse events of the brain, major adverse events of the muscular system, or major adverse events of any internal organ.

[0026] In various embodiments, the catheter systems and related methods disclosed herein may include a catheter configured to be advanced to a vascular lesion at a treatment site, the treatment site being located within or adjacent to a blood vessel in a patient's body, the vascular lesion being, for example, a calcified vascular lesion or a fibrotic vascular lesion. As used herein, unless otherwise indicated, the terms "treatment site," "intravascular lesion," and "vascular lesion" are used interchangeably. Therefore, intravascular lesions and / or vascular lesions are sometimes referred to herein simply as "lesions."

[0027] Those skilled in the art will appreciate that the following detailed description of the invention is illustrative only and is not intended to be limiting in any way. Other embodiments of the invention will readily occur to such technicians who benefit from this disclosure. Reference will now be made in detail to the embodiments of the invention shown in the accompanying drawings.

[0028] For the sake of clarity, not all conventional features of the embodiments described herein are shown and described. Of course, it is to be understood that in the development of any such actual embodiment, many decisions unique to the embodiment must be made to achieve the developer's specific goals, such as compliance with application-related and business-related constraints, and these specific goals will vary from one embodiment to another and from one developer to another. In addition, it is to be understood that such development efforts may be complex and time-consuming, however, for those of ordinary skill in the art who benefit from this disclosure, this is nothing more than a routine engineering task.

[0029] The catheter systems disclosed herein may include many different forms. Figure 1 , shows a simplified schematic cross-sectional view of a catheter system 100 according to various embodiments. The catheter system 100 is suitable for applying pressure waves to induce fractures in one or more vascular lesions in a patient's body, the one or more vascular lesions being in or adjacent to a vessel wall of a blood vessel, or on or adjacent to a heart valve. Figure 1 In the illustrated embodiment, catheter system 100 may include one or more of the following: catheter 102, energy director bundle 122 including one or more energy directors 122A, source manifold 136, fluid pump 138, system console 123 including one or more of energy source 124, power source 125, system controller 126, graphical user interface 127 ("GUI") and multiplexer 128, handle assembly 129, and energy transmitting system 131 (also referred to herein as "transmitter system") including one or more transmitter stations 180. Alternatively, compared to incorporating Figure 1 Catheter system 100 may include more or fewer components than those specifically shown and described.

[0030] The catheter 102 is configured to be moved to a treatment site 106 within a body 107 of a patient 109 within or adjacent to a vessel wall 108A of a blood vessel 108. The treatment site 106 may include one or more vascular lesions 106A, such as, for example, calcified vascular lesions. Additionally, or alternatively, the treatment site 106 may include a vascular lesion 106A such as a fibrotic vascular lesion. Still alternatively, in some embodiments, the catheter 102 may be used at a treatment site 106 within a body 107 of a patient 109 within or adjacent to a heart valve.

[0031] The catheter 102 may include an expandable balloon 104 (sometimes referred to herein as a "balloon"), a catheter shaft 110, and a guidewire 112. The balloon 104 may be coupled to the catheter shaft 110. The balloon 104 may include a balloon proximal end 104P and a balloon distal end 104D. The catheter shaft 110 may extend from a proximal portion 114 of the catheter system 100 to a distal portion 116 of the catheter system 100. The catheter shaft 110 may include a longitudinal axis 144. The catheter 102 and / or the catheter shaft 110 may also include a guidewire lumen 118 configured to move over the guidewire 112. As used herein, the guidewire lumen 118 defines a conduit through which the guidewire 112 extends. The catheter shaft 110 may also include an expansion lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, the catheter 102 can have a distal opening 120, and the catheter 102 can receive and be tracked by the guidewire 112 when the catheter 102 is moved and positioned at or near the treatment site 106. In some embodiments, the balloon proximal end 104P can be coupled to the catheter shaft 110, and the balloon distal end 104D can be coupled to the guidewire lumen 118.

[0032] The balloon 104 includes a balloon wall 130 defining a balloon interior 146. The balloon 104 can be selectively inflated using a catheter fluid 132 to expand from a deflated state to an expanded state (eg, Figure 1 ), the contracted state is suitable for advancing the catheter 102 through the patient's vasculature, and the expanded state is suitable for anchoring the catheter 102 in a suitable position relative to the treatment site 106. In another way of expression, when the balloon 104 is in the expanded state, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. It is to be understood that although Figure 1 The balloon wall 130 of the balloon 104 is shown as being spaced apart from the treatment site 106 of the blood vessel 108 when in the expanded state, but this is done for ease of illustration. It should be appreciated that the balloon wall 130 of the balloon 104 is generally substantially adjacent to and / or abuts the treatment site 106 when the balloon 104 is in the expanded state.

[0033] As an overview, each of the transmitter stations 180 of the transmitter system 131 and / or catheter system 100 may include one or more transmitters 135 configured to generate plasma and / or pressure waves in the catheter fluid 132 within the balloon interior 146. Each transmitter 135 includes a corresponding guide distal end 122D (sometimes also referred to herein simply as the "guide distal end") of one of the energy directors 122A located within the balloon interior 146 and a corresponding plasma generating structure 133 (also referred to herein as a "plasma generator"), the corresponding plasma generating structure 133 being positioned near the guide distal end 122D, but generally spaced apart from the guide distal end 122D. Energy from the energy source 124 is directed toward and received by the energy director 122A, directed through the energy director 122A, and then emitted from the guide distal end 122D of the energy director 122A. The energy emitted from the introducer distal end 122D is directed to and impinges upon and energizes the corresponding plasma generator 133 for generating plasma in the catheter fluid 132 within the balloon interior 146 .

[0034] In various embodiments, the transmitter stations 180 and / or individual emitters 135 may be formed of and / or may include a radiopaque material that is easily visible when used with fluoroscopy during an intravascular lithotripsy procedure. The visibility of the transmitter stations 180 and / or emitters 135 through the use of radiopaque materials enables a user or operator to more precisely position the transmitter stations 180 and / or emitters 135 substantially adjacent to the vascular lesion 106A as desired, and / or selectively activate only those transmitter stations 180 and / or emitters 135 that are positioned closest to the vascular lesion 106A, in order to more effectively destroy the vascular lesion 106A. By more precisely positioning the transmitter stations 180 and / or emitters 135 substantially adjacent to the vascular lesion 106A at the treatment site 106, and by activating only certain transmitter stations and / or emitters based on proximity to the vascular lesion 106A at the treatment site 106, the user or operator may operate the catheter system 100 more effectively and efficiently. As a result, users and operators can realize savings in money and resources.

[0035] Balloons 104 suitable for use in the catheter system 100 include those balloons 104 that can pass through the vasculature of the patient 109 when in a deflated state. In some embodiments, the balloon 104 is made of silicone. In other embodiments, the balloon 104 can be made of materials such as polydimethylsiloxane (PDMS), polyurethane, polymers such as PEBAX, TM material), nylon or any other suitable material.

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

[0037] In some embodiments, the balloon 104 can have a length 142 ranging from at least 3 mm to 300 mm. More specifically, in some embodiments, the balloon 104 can have a length 142 ranging from at least 8 mm to 200 mm. It is to be understood that a balloon 104 having a relatively long length can be positioned adjacent to a larger treatment site 106, and thus can be used to apply pressure waves and induce rupture to a larger vascular lesion 106A or multiple vascular lesions 106A at a precise location within the treatment site 106. It is also to be understood that a longer balloon 104 can also be positioned adjacent to multiple treatment sites 106 at any one given time.

[0038] The balloon 104 can be inflated to an inflation pressure between about one atmosphere (atm) and 70 atm. In some embodiments, the balloon 104 can be inflated to an inflation pressure of from at least 20 atm to 60 atm. In other embodiments, the balloon 104 can be inflated to an inflation pressure of from at least 6 atm to 20 atm. In still other embodiments, the balloon 104 can be inflated to an inflation pressure of from at least 3 atm to 20 atm. In still other embodiments, the balloon 104 can be inflated to an inflation pressure of from at least 2 atm to 10 atm.

[0039] The balloon 104 can have various shapes, including but not limited to a conical shape, a square shape, a rectangular shape, a spherical shape, a conical / square shape, a conical / spherical shape, an extended spherical shape, an elliptical shape, a conical shape, a bone shape, a stepped diameter shape, an offset shape, or a conical offset shape. In some embodiments, the balloon 104 can include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or the drug eluting stent can include one or more therapeutic agents, including anti-inflammatory agents, anti-tumor agents, anti-angiogenic agents, etc.

[0040] The catheter fluid 132 may be a liquid or a gas. Some examples of catheter fluids 132 suitable for use may include, but are not limited to, one or more of the following: water, saline, contrast medium, 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 expansion fluid. In some embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium in a volume ratio of approximately 50:50. In other embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium in a volume ratio of approximately 25:75. In still other embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium in a volume ratio of approximately 75:25. However, it is to be understood that any suitable ratio of saline to contrast medium may be used. The catheter fluid 132 may be adjusted in terms of composition, viscosity, etc. so that the propagation rate of the pressure wave is appropriately manipulated. In certain embodiments, the catheter fluid 132 suitable for use is biocompatible. The volume of catheter fluid 132 may be adjusted by the energy source 124 selected and the type of catheter fluid 132 used.

[0041] In some embodiments, the contrast agent used in the contrast media may include, but is not limited to, an iodine-based contrast agent, such as an ionic iodine-based contrast agent or a non-ionic iodine-based contrast agent. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, metrizoate, iothalamate, and ioxaglate. Some non-limiting examples of non-ionic iodine-based contrast agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based contrast agents may be used. Suitable non-iodine-containing contrast agents may include gadolinium (III)-based contrast agents. Suitable fluorocarbon agents and perfluorocarbon agents may include, but are not limited to, agents such as perfluorocarbondodecafluoropentane (DDFP, C5F12).

[0042] The catheter fluid 132 may include those catheter fluids that contain an absorbent that can selectively absorb light in the ultraviolet region (e.g., at least 10 nanometers (nm) to 400 nm), the visible region (e.g., at least 400 nm to 780 nm), or the near infrared region (e.g., at least 780 nm to 2.5 μm) of the electromagnetic spectrum. Suitable absorbents may include those absorbents that have an absorption maximum within the spectrum from at least 10 nm to 2.5 μm. Alternatively, the catheter fluid 132 may include those fluids that contain an absorbent that can selectively absorb light in the mid-infrared region (e.g., at least 2.5 μm to 15 μm) or the far-infrared region (e.g., at least 15 μm to 1 mm) of the electromagnetic spectrum. In various embodiments, the absorbent may be those absorbents that have an absorption maximum that matches the emission maximum of the laser used in the catheter system 100. As non-limiting examples, various lasers that can be used in the catheter system 100 can include a neodymium:yttrium aluminum garnet (Nd:YAG, emission maximum = 1064 nm) laser, a holmium:YAG (Ho:YAG, emission maximum = 2.1 µm) laser, or an erbium:YAG (Er:YAG, emission maximum = 2.94 µm) laser. In some embodiments, the absorber can be water soluble. In other embodiments, the absorber is not water soluble. In some embodiments, the absorber used in the catheter fluid 132 can be adjusted 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 elsewhere herein.

[0043] The catheter shaft 110 of the catheter 102 can be coupled to a plurality of energy directors 122A of an energy director bundle 122 in optical communication with an energy source 124. The energy directors 122A can be disposed along the catheter shaft 110 and positioned within the balloon 104. Each of the energy directors 122A can have a director distal end 122D at any suitable longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the guidewire lumen 118. For example, in some embodiments, the first transmitter station 180 may include one or more transmitters 135, wherein the guide distal end 122D and the corresponding plasma generator 133 of each transmitter 135 within the first transmitter station 180, even though they may be slightly spaced apart from each other, can be said to be positioned at a first longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the guidewire cavity 118; and the second transmitter station 180 may include one or more transmitters 135, wherein the guide distal end 122D and the corresponding plasma generator 133 of each transmitter 135 within the second transmitter station 180, even though they may be slightly spaced apart from each other, can be said to be positioned at a second longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the guidewire cavity 118, wherein the second longitudinal position is different from the first longitudinal position. It should be understood that the catheter system 100 can include any suitable or desired number of transmitter stations 180, each transmitter station 180 being positioned at a different longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the guidewire lumen 118. It should also be understood that each transmitter station 180 can include any suitable or desired number of transmitters 135, wherein each transmitter 135 within a given transmitter station 180 must be at approximately the same longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the guidewire lumen 118.

[0044] In some embodiments, each energy director 122A may be an optical fiber and energy source 124 may be a laser. Energy source 124 may be in optical communication with energy director 122A at proximal portion 114 of catheter system 100. More specifically, energy source 124 may be in selective and / or alternating optical communication with each energy director 122A due to the presence and operation of multiplexer 128, as described in detail herein.

[0045] In some embodiments, the catheter shaft 110 can be coupled to a plurality of energy directors 122A, such as a first energy director, a second energy director, a third energy director, etc., which can be disposed around and / or at any suitable location relative to the guidewire lumen 118 and / or the catheter shaft 110. For example, in certain non-exclusive embodiments, two energy directors 122A can be spaced approximately 180 degrees apart from each other around the circumference of the guidewire lumen 118 and / or the catheter shaft 110; three energy directors 122A can be spaced approximately 120 degrees apart from each other around the circumference of the guidewire lumen 118 and / or the catheter shaft 110; four energy directors 122A can be spaced approximately 90 degrees apart from each other around the circumference of the guidewire lumen 118 and / or the catheter shaft 110; five energy directors 122A can be spaced approximately 90 degrees apart from each other around the circumference of the guidewire lumen 118 and / or the catheter shaft 110; and five energy directors 122A can be spaced approximately 180 degrees apart from each other around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. The circumference of the guidewire lumen 118 and / or the catheter shaft 110 may be spaced approximately 72 degrees apart from one another; six energy directors 122A may be spaced approximately 60 degrees apart from one another around the circumference of the guidewire lumen 118 and / or the catheter shaft 110; eight energy directors 122A may be spaced approximately 45 degrees apart from one another around the circumference of the guidewire lumen 118 and / or the catheter shaft 110; or ten energy directors 122A may be spaced approximately 36 degrees apart from one another around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Still alternatively, the plurality of energy directors 122A need not be evenly spaced apart from one another around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. More specifically, it is also understood that the energy directors 122A may be evenly or unevenly disposed around the guidewire lumen 118 and / or the catheter shaft 110 to achieve a desired effect at a desired location.

[0046] In certain embodiments, the guidewire lumen 118 may have a grooved outer surface, wherein the grooves extend in a generally longitudinal direction along the guidewire lumen 118. In such embodiments, each of the energy directors 122A may be positioned, received, and retained within a separate groove formed along and / or into the outer surface of the guidewire lumen 118. Alternatively, the guidewire lumen 118 may be formed without a grooved outer surface, and the position of the energy directors 122A relative to the guidewire lumen 118 may be maintained in another suitable manner.

[0047] The catheter system 100 and / or the energy director bundle 122 may include any number of energy directors 122A in optical communication with the energy source 124 at the proximal portion 114 and in optical communication with the catheter fluid 132 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 the energy director bundle 122 may include from one energy director 122A to more than 30 energy directors 122A. The director distal end 122D of each energy director 122A may be at any suitable or desired longitudinal position within the balloon interior 146 relative to the length 142 of the balloon 104 so as to define any suitable or desired number of transmitter stations 180. Alternatively, in other embodiments, the catheter system 100 and / or the energy director bundle 122 may include more than 30 energy directors 122A.

[0048] Energy directors 122A may be of any suitable design that is useful and appropriate for enabling generation of plasma and / or pressure waves in catheter fluid 132 within balloon interior 146. Thus, the general description of energy directors 122A as light directors is not intended to be limiting in any way, except as set forth in the appended claims. More specifically, although catheter system 100 is generally described as having energy source 124 as a light source and one or more energy directors 122A as light directors, catheter system 100 may alternatively include any suitable energy source 124 and energy director 122A for enabling generation of a desired plasma in catheter fluid 132 within balloon interior 146. For example, in one non-exclusive alternative embodiment, energy source 124 may be configured to provide high voltage pulses, and each energy director 122A may include an electrode pair including spaced apart electrodes extending into balloon interior 146. In such an embodiment, each high voltage pulse is applied to the electrodes and forms an arc across the electrodes, which in turn generates plasma and forms pressure waves in the catheter fluid 132, which are used to provide a disruptive force on the vascular lesion 106A at the treatment site 106. Still alternatively, the energy source 124 and / or the energy director 122A may have another suitable design and / or configuration.

[0049] In some embodiments, energy director 122A may include an optical fiber or a flexible light pipe. Energy director 122A may be thin and flexible and may allow optical signals to be sent with very little intensity loss. Energy director 122A may include a core surrounded by a cladding around its circumference. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of energy director 122A may be formed of one or more materials, including but not limited to one or more types of glass, silica, or one or more polymers. Energy director 122A may also include a protective coating, such as a polymer. It is understood that the refractive index of the core will be greater than the refractive index of the cladding.

[0050] Each energy director 122A can direct energy along its length from a director proximal end 122P to a director distal end 122D, wherein the director distal end 122D has at least one optical window (not shown) positioned within the balloon interior 146 .

[0051] Energy director 122A can take on many configurations around and / or relative to catheter shaft 110 of catheter 102. In some embodiments, energy director 122A can extend parallel to longitudinal axis 144 of catheter shaft 110. In some embodiments, energy director 122A can be physically coupled to catheter shaft 110. In other embodiments, energy director 122A can be disposed along the length of the outer diameter of catheter shaft 110. In still other embodiments, energy director 122A can be disposed within one or more energy director lumens within catheter shaft 110.

[0052] The energy directors 122A may also be positioned at any suitable location around the circumference of the guidewire lumen 118 and / or the catheter shaft 110, and the director distal end 122D of each energy director 122A may be positioned at any suitable longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the guidewire lumen 118 (within any suitable or desired transmitter station 180) to more effectively and precisely apply pressure waves for destroying vascular lesions 106A at the treatment site 106.

[0053] In some embodiments, energy director 122A may include one or more photoacoustic transducers 153, wherein each photoacoustic transducer 153 may be in optical communication with energy director 122A in which photoacoustic transducer 153 is disposed. In some embodiments, photoacoustic transducer 153 may be in optical communication with director distal end 122D of energy director 122A. In such embodiments, photoacoustic transducer 153 may have a shape that corresponds to and / or conforms to director distal end 122D of energy director 122A.

[0054] Photoacoustic transducer 153 is configured to convert light energy into acoustic waves at or near distal end 122D of energy director 122A. The direction of the acoustic waves can be adjusted by changing the angle of distal end 122D of energy director 122A.

[0055] In some embodiments, the photoacoustic transducer 153 disposed at the guide distal end 122D of the energy guide 122A can take the same shape as the guide distal end 122D of the energy guide 122A. For example, in some non-exclusive embodiments, the photoacoustic transducer 153 and / or the guide distal end 122D can have a conical shape, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a semicircular shape, an oval shape, etc. The energy guide 122A can also include additional photoacoustic transducers 153 disposed along one or more side surfaces of the length of the energy guide 122A.

[0056] In some embodiments, energy director 122A may also include one or more steering structures or "diverters" (e.g., within energy director 122A and / or near distal director end 122D of energy director 122A). Figure 1 ), a steering structure or "diverter" is configured to direct energy from the energy director 122A toward a side surface that may be located at or near the director distal end 122D of the energy director 122A before directing the energy toward the balloon wall 130. The steering structure may include any structure of the system that diverts energy from the energy director 122A away from its axial path toward the side surface of the energy director 122A. The energy directors 122A may each include one or more optical windows disposed along a longitudinal or circumferential surface of each energy director 122A and in optical communication with the steering structure. Stated another way, the steering structure may have any suitable structural configuration that is configured to direct energy in the energy director 122A toward a side surface located at or near the director distal end 122D, wherein the side surface is in optical communication with the optical window. An optical window may include a portion of energy director 122A that allows energy from within energy director 122A to exit energy director 122A, such as a portion of energy director 122A that lacks cladding material on or around energy director 122A.

[0057] Examples of steering structures suitable for use include reflective elements, refractive elements, and fiber optic diffusers. Steering structures suitable for focusing energy away from the tip of energy director 122A may include, but are not limited to, those with convex surfaces, gradient refractive index (GRIN) lenses, and mirror focusing lenses. Upon contact with the steering structure, energy is redirected within energy director 122A to one or more of plasma generator 133 and photoacoustic transducer 153 in optical communication with the side surface of energy director 122A. When in use, plasma generator 133 receives energy emitted from the guide distal end 122D of energy director 122A to generate plasma in catheter fluid 132 within balloon interior 146, which in turn results in the generation of plasma bubbles and / or pressure waves that can be directed away from the side surface of energy director 122A and toward balloon wall 130. Additionally or alternatively, when in use, photoacoustic transducer 153 converts optical energy into acoustic waves that extend from the side surfaces of energy director 122A.

[0058] The source manifold 136 can be positioned at or near the proximal portion 114 of the catheter system 100. The source manifold 136 can include one or more proximal openings that can receive the plurality of energy directors 122A of the energy director bundle 122, the guidewire 112, and / or an inflation catheter 140 coupled in fluid communication with a fluid pump 138. The catheter system 100 can also include a fluid pump 138 configured to inflate the balloon 104 with the catheter fluid 132 as needed.

[0059] As mentioned above, in Figure 1 In the illustrated embodiment, the system console 123 includes one or more of an energy source 124, a power supply 125, a system controller 126, a GUI 127, and a multiplexer 128. Alternatively, the system console 123 may include more than one Figure 1 127. For example, in certain non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127. Still alternatively, one or more of the energy source 124, the power source 125, the system controller 126, the GUI 127, and the multiplexer 128 may be provided within the catheter system 100 without specifically requiring the system console 123.

[0060] As shown, the system console 123 and the components included therein are operably coupled to the catheter 102, the energy director bundle 122, and the remainder of the catheter system 100. For example, in some embodiments, Figure 1As shown, the system console 123 may include a console connection aperture 148 (sometimes also generally referred to as a "socket" or "console receptacle") through which the energy director bundle 122 is mechanically coupled to the system console 123. In such an embodiment, the energy director bundle 122 may include an optical connector assembly having a director coupling housing 150 (sometimes also generally referred to as a "connector housing") that houses a portion of each energy director 122A, such as the director proximal end 122P. At least a portion of the director coupling housing 150 is configured to fit and selectively remain within the console connection aperture 148 to provide a mechanical connection between the energy director bundle 122 and the system console 123.

[0061] Energy director bundle 122 may also include a director bundle 152 (or "shell") that holds each individual energy director 122A closer together so that energy directors 122A and / or energy director bundle 122 may be in a more compact form when they are extended into vessel 108 along with catheter 102 during use of catheter system 100.

[0062] Energy source 124 may be selectively and / or alternately coupled in optical communication with each energy director 122A in energy director bundle 122. Specifically, energy source 124 is configured to generate energy in the form of a source beam 124A (e.g., a pulsed source beam) that may be selectively and / or alternately directed to and received by each energy director 122A in energy director bundle 122. More specifically, as described in greater detail herein below, source beams 124A from energy source 124 are directed through multiplexer 128 such that individual guide beams 124B (or "multiplexed beams") may be selectively and / or alternately directed to and received by each energy director 122A in energy director 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 a separate guided beam 124B that is selectively and / or alternately directed to one energy director 122A in energy director beam 122. Thus, by using and / or applying multiplexer 128, energy source 124 can be used to excite any emitter 135 at any emitter station 180 that may be included within catheter system 100. Alternatively, catheter system 100 may include more than one energy source 124. For example, in one non-exclusive alternative embodiment, catheter system 100 may include a separate energy source 124 for each energy director 122A in energy director beam 122.

[0063] Energy source 124 may be of any suitable design. In certain embodiments, energy source 124 may be configured to provide sub-millisecond energy pulses from energy source 124 that are focused onto a small spot so as to couple the energy pulses into guide proximal end 122P of energy guide 122A. Such energy pulses are then directed and / or guided along energy guide 122A to a location within balloon interior 146 of balloon 104, thereby inducing the formation of plasma in catheter fluid 132 within balloon interior 146 of balloon 104, such as by plasma generator 133, which may be located at or near guide distal end 122D of energy guide 122A. Specifically, energy emitted at guide distal end 122D of energy guide 122A is directed toward plasma generator 133, impinges on plasma generator 133, and excites plasma generator 133 to form plasma in catheter fluid 132 within balloon interior 146. The formation of plasma causes bubbles to form rapidly and exerts pressure waves on the treatment site 106. The exemplary plasma-induced bubbles 134 are Figure 1 is shown in .

[0064] As used herein, the guide distal end 122D of the energy guide 122A and the corresponding plasma generator 133 may be collectively referred to as an emitter 135. In some applications, one or more emitters 135 positioned at approximately the same longitudinal position within the balloon interior 146 relative to the length 142 of the balloon 104 may be referred to as a "transmitter station", such as included as Figure 1 One or more transmitter stations 180 that are part of transmitter system 131 are shown in FIG.

[0065] In various embodiments, the catheter system 100 is configured to provide a means for providing power to a plurality of transmitter stations 180 in a pressure wave generating device designed to apply pressure on a vascular lesion 106A (such as a calcified vascular lesion and / or a fibrotic vascular lesion) at a treatment site 106 and induce a fracture in the vascular lesion 106A.

[0066] In many embodiments, one or more of the emitters 135 and / or the emitter stations 180 can be formed of certain materials so that the emitters 135 and / or the emitter stations 180 are more visible to a user or operator during use of the catheter system 100. For example, in many embodiments, one or more of the emitters 135 and / or the emitter stations 180 can be formed of and / or include a radiopaque material that is easily visible when used with fluoroscopy during an intravascular lithotripsy procedure. Thus, the visibility of the emitters 135 and / or the emitter stations 180 enables the user or operator to more precisely position the emitters 135 and / or the emitter stations 180 substantially adjacent to the vascular lesion 106A, as desired, and / or selectively activate only those emitter stations 180 that are positioned closest to the vascular lesion 106A, so as to more effectively destroy the vascular lesion 106A at the treatment site 106. Alternatively, transmitter 135 and / or transmitter station 180 may be formed from other suitable materials that are visible to a user or operator during an intravascular lithotripsy procedure.

[0067] In various non-exclusive embodiments, sub-millisecond energy pulses from energy source 124 may be delivered to treatment site 106 at a frequency between approximately 1 Hertz (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 a frequency that may be greater than 5000 Hz or less than 1 Hz, or any other suitable frequency range.

[0068] It is to be understood that while the energy source 124 is typically utilized to provide pulses of energy, the energy source 124 may still be described as providing a single source beam 124A, such as a single pulsed source beam.

[0069] Energy sources 124 suitable for use may include various types of light sources, including lasers and lamps. Alternatively, energy source 124 may include any suitable type of energy source.

[0070] Suitable lasers may include short pulse lasers on a sub-millisecond time scale. In some embodiments, the energy source 124 may include a laser on a nanosecond (ns) time scale. The laser may also include a short pulse laser on a picosecond (ps), femtosecond (fs), and microsecond (µs) time scale. It is to be understood that many combinations of laser wavelengths, pulse widths, and energy levels may be used to achieve plasma in the conduit fluid 132 of the conduit 102. In various non-exclusive alternative embodiments, the pulse width may include those pulse widths falling within a range including from at least 10 ns to 3000 ns, from at least 20 ns to 100 ns, or from at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range may be used.

[0071] Exemplary nanosecond lasers may include those within the UV to IR spectrum, spanning wavelengths from approximately 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, an energy source 124 suitable for use in the catheter system 100 may include a light source capable of generating light having a wavelength from at least 750 nm to 2000 nm. In other embodiments, the energy source 124 may include a light source capable of generating light having a wavelength from at least 700 nm to 3000 nm. In still other embodiments, the energy source 124 may include a light source capable of generating light having a wavelength from at least 100 nm to 10 micrometers (µm). Nanosecond lasers may include those having a repetition rate of up to 200 kHz.

[0072] In some embodiments, the laser may include a Q-switched thulium:yttrium aluminum garnet (Tm:YAG) laser. In other embodiments, the laser may include a neodymium:yttrium aluminum garnet (Nd:YAG) laser, a holmium:yttrium aluminum garnet (Ho:YAG) laser, an erbium:yttrium aluminum garnet (Er:YAG) laser, an excimer laser, a helium-neon laser, a carbon dioxide laser, and a doped laser, a pulsed laser, or a fiber laser.

[0073] In still other embodiments, the energy source 124 may include multiple lasers grouped together in series. In still other embodiments, the 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 still other embodiments, the energy source 124 may include multiple lasers that may be combined in parallel or in series to provide the energy required to generate a plasma bubble 134 in the conduit fluid 132.

[0074] The catheter system 100 can generate a pressure wave having a maximum pressure in a range of at least 1 megapascal (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 expansion, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter system 100 can generate a pressure wave having a maximum pressure in a 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.

[0075] When catheter 102 is placed at treatment site 106, pressure waves may be applied to treatment site 106 from a distance in the range of at least about 0.1 millimeter (mm) to greater than about 25 mm extending radially from energy director 122A. In various non-exclusive embodiments, when catheter 102 is placed at treatment site 106, pressure waves may be applied to treatment site 106 from a distance in the range of at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm extending radially from energy director 122A. In other embodiments, pressure waves may be applied to treatment site 106 from another suitable distance different from the foregoing ranges. In some embodiments, pressure waves in the range of from at least about 2 MPa to 30 MPa may be applied to treatment site 106 at a distance of from at least about 0.1 mm to 10 mm. In some embodiments, pressure waves within a range from at least about 2 MPa to 25 MPa may be applied to treatment site 106 at a distance from at least about 0.1 mm to 10 mm. Still alternatively, other suitable pressure ranges and distances may be used.

[0076] The power supply 125 is electrically coupled to each of the energy source 124, the system controller 126, the GUI 127, the multiplexer 128, and the handle assembly 129, and is configured to provide necessary power to each of the energy source 124, the system controller 126, the GUI 127, the multiplexer 128, and the handle assembly 129. The power supply 125 may have any suitable design for these purposes.

[0077] System controller 126 is electrically coupled to power source 125 and receives power from power source 125. System controller 126 is coupled to each of energy source 124, GUI 127, and multiplexer 128 and is 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 desired, and / or to generate energy pulses at any desired excitation rate. Subsequently, system controller 126 may then control multiplexer 128 so that energy from energy source 124 as source beam 124A may be selectively and / or alternately directed to each of energy directors 122A in any desired excitation sequence or excitation mode, such as in the form of separate guide beams 124B.

[0078] More specifically, system controller 126 may control energy source 124 and / or multiplexer 128 so that individual guide beams 124B may be directed to each energy director 122A or a set or subset of energy directors 122A in any desired excitation sequence, excitation mode, excitation order, excitation energy level (which may be affected by any or all of pulse width, pulse amplitude, and / or pulse wavelength), and / or excitation rate. Thus, system controller 126 may control energy source 124 and / or multiplexer 128 so that individual guide beams 124B may be directed to any emitter station 180 and / or any emitter 135 contained within any emitter station 180 in any desired excitation sequence, excitation mode, excitation order, excitation energy level, and / or excitation rate. For example, in a catheter system 100 that includes eight energy directors 122A arranged in a linear pattern having an angular orientation that spirals around a guidewire lumen 118, the system controller 126 can control the excitation sequence of energy from the energy source 124 to each of the energy directors 122A, or a set or subset thereof, in any desired manner. As used herein, the term "excitation rate" is intended to refer to the number of pulses per given time frame. Additionally, as used herein, the term "excitation energy level" is intended to refer to the intensity of the energy pulses, which may vary depending on the pulse width and / or pulse amplitude of any or all of the energy pulses. Certain non-exclusive examples of alternative applications of the sequence of excitation of the energy directors 122A and / or transmitters 135 within a given transmitter station 180 are described in detail below.

[0079] The system controller 126 may also be configured to control the operation of other components of the catheter system 100, such as the catheter 102, the guide distal end 122D of the energy guide 122A, and / or the positioning of the emitter 135 (or emitter station 180) adjacent to the treatment site 106, the inflation of the balloon 104 with the catheter fluid 132, etc. In addition, or alternatively, the catheter system 100 may include one or more additional controllers, which may be positioned in any suitable manner for controlling various operations of the catheter system 100. For example, in some embodiments, the additional controllers and / or a portion of the system controller 126 may be positioned and / or contained within the handle assembly 129.

[0080] The GUI 127 is accessible by a user or operator of the catheter system 100. The GUI 127 is electrically connected to the system controller 126. By such a design, the user or operator can use the GUI 127 to ensure that the catheter system 100 is effectively utilized to apply pressure to the vascular lesion 106A at the treatment site 106 and induce rupture in the vascular lesion. More specifically, in certain embodiments, the GUI 127 can enable the user or operator to select and / or deselect any of the emitter stations 180 and individual emitters 135 to more effectively and efficiently generate plasma in the catheter fluid 132 within the balloon interior 146 and thereby apply pressure to the vascular lesion 106A at the treatment site 106 and induce rupture in the vascular lesion 106A.

[0081] GUI 127 can provide information to the user or operator that can be used before, during and after using catheter system 100. In one embodiment, GUI 127 can provide static visual data and / or information to the user or operator. In addition, or alternatively, during the use of catheter system 100, GUI 127 can provide dynamic visual data and / or information to the user or operator, such as video data or any other data that changes over time. In various embodiments, GUI 127 can include one or more colors, different sizes, varying brightness, etc. that can be used as an alarm to the user or operator. In addition, or alternatively, GUI 127 can provide audio data or information to the user or operator. The details of GUI 127 can vary according to the design requirements of catheter system 100 or the specific needs, specifications and / or expectations of the user or operator.

[0082] Multiplexer 128 is configured to selectively and / or alternatively direct energy from energy source 124 to each energy director 122A in energy director beam 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 selectively and / or alternatively direct such energy in the form of a separate guide beam 124B to each energy director 122A in energy director beam 122, as desired. Thus, multiplexer 128 enables a single energy source 124 to be individually delivered through multiple energy directors 122A in any desired sequence or pattern, enabling catheter system 100 to apply pressure to a vascular lesion 106A at a treatment site 106 within or adjacent to a vascular wall 108A of a blood vessel 108 in a desired manner and induce disruption in the vascular lesion. As shown, in certain embodiments, the catheter system 100 may include one or more optical elements 147 for directing energy (such as source beam 124A) from the energy source 124 to the multiplexer 128 .

[0083] Multiplexer 128 may be of any suitable design for selectively and / or alternatively directing energy from energy source 124 to each energy director 122A of energy director bundle 122. Figure 2A-Figure 7 Various non-exclusive alternative embodiments of multiplexer 128 are described in detail.

[0084] like Figure 1 As shown, the handle assembly 129 can be positioned at or near the proximal portion 114 of the catheter system 100. In this embodiment, the handle assembly 129 is coupled to the balloon 104 and is positioned spaced apart from the balloon 104. Alternatively, the handle assembly 129 can be positioned at another suitable location.

[0085] The handle assembly 129 is attached to the catheter shaft 110 and is handled 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 varied to suit the design requirements of the catheter system 100. Figure 1 In the illustrated embodiment, the handle assembly 129 is separate from one or more of the system controller 126 , the energy source 124 , the fluid pump 138 , and the GUI 127 , but is in electrical and / or fluid communication therewith.

[0086] In some embodiments, the handle assembly 129 can integrate and / or include at least a portion of the system controller 126 within the handle assembly 129. For example, as shown, in some embodiments, the handle assembly 129 can include a circuit 155 that is electrically coupled between the catheter electronics and the system console 123 and can form at least a portion of the system controller 126. In one embodiment, the circuit 155 can include a printed circuit board having one or more integrated circuits, or any other suitable circuit. In alternative embodiments, the circuit 155 can be omitted, or can be included within the system controller 126, which in various embodiments can be located external to the handle assembly 129, for example, within the system console 123. It is to be understood that the handle assembly 129 can include fewer or more components than those specifically shown and described herein.

[0087] The emitter system 131 includes one or more emitter stations 180 (and preferably a plurality of emitter stations 180), wherein each emitter station 180 includes one or more emitters 135 (and preferably a plurality of emitters 135). As described above, each emitter 135 includes a guide distal end 122D of one of the energy directors 122A and a corresponding plasma generator 133. As described herein, a "plasma generator" may include and / or incorporate any suitable type of structure located at or near the guide distal end 122D of the energy director 122A. In many embodiments, the plasma generator 133 may be positioned slightly spaced from the guide distal end 122D of the energy director 122A. In certain embodiments, the plasma generator 133 may be provided in the form of a backstop structure having an inclined surface that redirects the energy emitted from the guide distal end 122D toward the balloon wall 130 of the balloon 104 and / or toward the vessel wall 108A of the blood vessel 108 at the treatment site 106.

[0088] Each of the emitters 135 is configured to selectively receive energy from the energy source 124 under the control of the system controller 126 and as directed by the multiplexer 128, and emit the energy from the introducer distal end 122D toward the plasma generator 133. To generate plasma in the catheter fluid 132 within the balloon interior 146, the energy emitted from the introducer distal end 122D impinges on and excites the material of the plasma generator 133 (such as the material on the inclined surface of the plasma generator 133). The generation of plasma ionizes and / or superheats the surrounding catheter fluid 132, thereby causing rapid inertial bubble formation and applying a pressure wave on the treatment site 106.

[0089] The plasma generator 133 may be formed of any suitable material. For example, in certain non-exclusive embodiments, the plasma generator 133 may be formed of one or more metals such as titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium, iridium, etc. Alternatively, the plasma generator 133 may be formed of plastics such as polyimide and nylon. Still alternatively, the plasma generator 133 may be formed of other suitable materials.

[0090] The following will combine Figure 8-Figure 10 Further details of various embodiments of transmitter system 131, transmitter station 180, and / or individual transmitters 135 are provided.

[0091] The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with the catheter fluid 132 as needed.

[0092] As with all embodiments shown and described herein, various structures may be omitted from the drawings for clarity and ease of understanding. In addition, the drawings may include certain structures that may be omitted without departing from the intent and scope of the present invention.

[0093] Figure 2A is a simplified schematic top view of a portion of an embodiment of a catheter system 200. More specifically, Figure 2A An embodiment of a plurality of energy directors (such as a first energy director 222A, a second energy director 222B, a third energy director 222C, a fourth energy director 222D, and a fifth energy director 222E), an energy source 224, a system controller 226, and a multiplexer 228 is shown, which multiplexer 228 receives energy in the form of a source beam 224A (such as a pulsed source beam) from the energy source 224 and, under the control of the system controller 226, selectively and / or alternatively directs energy in the form of a separate guide beam 224B to any one or all of the energy directors 222A-222E in any desired sequence and / or pattern. The energy directors 222A-222E, the energy source 224, and the system controller 226 are substantially similar in design and function to those described in detail above. Therefore, no specific description will be given herein. Figure 2A The illustrated embodiment describes these components in detail. It will also be appreciated that for the purpose of simplicity and ease of illustration, Figure 2A The above information is not shown in Figure 1 Certain components of the system console 123 are shown and described, such as the power supply 125 and the GUI 127, but these components will generally be included in many embodiments.

[0094] As described above, multiplexer 228 is configured to receive energy in the form of source beam 224A from energy source 224 and selectively and / or alternatively direct energy in the form of separate guide beam 224B to any or all of energy directors 222A-222E in any desired sequence and / or pattern. Figure 2A As shown, multiplexer 228 is operably and / or optically coupled in optical communication to energy director bundle 222 and / or each of the plurality of energy directors 222A-222E.

[0095] As shown, the director proximal end 222P of each of the plurality of energy directors 222A-222E is held within a director coupling housing 250, such as within a director coupling slot 254 formed into the director coupling housing 250. In various embodiments, the director coupling housing 250 is configured to selectively couple to the system console 123 (in Figure 1 ), so that during use of the catheter system 200, the guide coupling groove 254 and thus the energy directors 222A-222E remain in a desired fixed position relative to the multiplexer 228 and / or the system console 123. In some embodiments, the guide coupling groove 254 is provided in the form of a V-groove, such as a V-groove in a V-groove ferrule block commonly used in multi-channel fiber optic communication systems. Alternatively, the guide coupling groove 254 can have another suitable design.

[0096] It should be appreciated that director coupling housing 250 may have any suitable number of director coupling slots 254, which may be positioned and / or oriented relative to one another in any suitable manner to optimally align director coupling slots 254, and therefore energy directors 222A-222E, relative to multiplexer 228. Figure 2A In the illustrated embodiment, the director coupling housing 250 includes seven director coupling slots 254 that are spaced apart in a linear arrangement relative to one another with a precise spacing between adjacent director coupling slots 254. Thus, in such an embodiment, the director coupling housing 250 is capable of holding the director proximal ends 222P of up to seven energy directors (although in Figure 2A Only five energy directors 222A-222E are specifically shown in FIG. 2 ). Alternatively, director coupling housing 250 may have a different number of director coupling slots, ie, greater than seven or less than seven, and / or director coupling slots 254 may be arranged differently relative to each other.

[0097] The design of multiplexer 228 may be varied depending on the requirements of catheter system 200, the relative positioning of energy directors 222A-222E, and / or to meet the expectations of a user or operator of catheter system 200. Figure 2A In the illustrated embodiment, the multiplexer 228 includes one or more of a multiplexer base 260, a multiplexer stage 262, a stage mover 264 (shown in phantom), a redirector 266, and a coupling optical device 268. Alternatively, the multiplexer 228 may include a plurality of Figure 2A More or fewer components than those specifically shown.

[0098] During use of catheter system 200, multiplexer base 260 is fixed in position relative to energy source 224 and energy directors 222A-222E. In this embodiment, multiplexer stage 262 is movably supported on multiplexer base 260. More specifically, stage mover 264 is configured to move multiplexer stage 262 relative to multiplexer base 260. Figure 2A As shown, redirector 266 and coupling optics 268 are mounted on and / or held by multiplexer stage 262. Thus, movement of multiplexer stage 262 relative to multiplexer base 260 results in corresponding movement of redirector 266 and coupling optics 268 relative to the fixed multiplexer base 260. With energy directors 222A-222E fixed in position relative to multiplexer base 260, movement of multiplexer stage 262 results in corresponding movement of redirector 266 and coupling optics 268 relative to energy directors 222A-222E.

[0099] In various embodiments, multiplexer 228 is configured to precisely align coupling optics 268 with each energy director 222A-222E so that source beam 224A generated by energy source 224 can be precisely directed and focused by multiplexer 228 to each energy director 222A-222E as a corresponding guided beam 224B. In its simplest form, as Figure 2A As shown, multiplexer 228 uses a precision mechanism (such as stage mover 264) to translate coupling optics 268 along a linear path. This approach requires a single degree of freedom. In certain embodiments, the linear translation mechanism (such as stage mover 264) and / or multiplexer stage 262 can be equipped with mechanical stops so that coupling optics 268 can be precisely aligned with the position of each energy director 222A-222E in any desired sequence and / or pattern. Alternatively, stage mover 264 can be electronically controlled to align the beam path of guide beam 224B with each individual energy director 222A-222E held partially within director coupling housing 250 in any desired sequence and / or pattern.

[0100] As described above, multiplexer stage 262 is configured to carry the necessary optics, such as redirector 266 and coupling optics 268, to direct and focus the energy generated by energy source 224 onto each energy director 222A-222E for optimal coupling. By such a design, the low divergence of guide beam 224A over the short motion distance of the translated multiplexer stage 262 has minimal impact on the coupling efficiency to energy directors 222A-222E.

[0101] During operation, stage mover 264 drives multiplexer stage 262 to align the beam path of guide beam 224B with the selected energy director 222A-222E, and then system controller 226 activates energy source 224 in a pulsed or semi-CW mode. Stage mover 264 then steps multiplexer stage 262 to the next stop, i.e., to the next desired energy director 222A-222E, and system controller 226 again activates energy source 224. This process is repeated as desired so that energy in the form of guide beam 224B is directed to any one or all of energy directors 222A-222E in a desired sequence and / or pattern. It will be appreciated that stage mover 264 can move multiplexer stage 262 to align it with any one of energy directors 222A-222E, and then system controller 226 activates energy source 224. In this manner, multiplexer 228 may be enabled to fire sequentially through energy directors 222A-222E, or in any desired pattern with respect to energy directors 222A-222E.

[0102] In this embodiment, the stage mover 264 may be of any suitable design for moving the multiplexer stage 262 in a linear manner relative to the multiplexer base 260. More specifically, the stage mover 264 may be any suitable type of linear translation mechanism.

[0103] like Figure 2A As shown, the catheter system 200 can further include an optical element 247, such as a reflective or redirecting element (such as a mirror), which reflects the source beam 224A from the energy source 224 so that the source beam 224A is directed toward the multiplexer 228. In one embodiment, as shown, the optical element 247 can be positioned along the beam path to redirect the source beam 224A by approximately 90 degrees so that the source beam 224A is directed toward the multiplexer 228. Alternatively, the optical element 247 can redirect the source beam 224A by more than 90 degrees or less than 90 degrees. Still alternatively, the catheter system 200 can be designed without the optical element 247, and the energy source 224 can direct the source beam 224A directly toward the multiplexer 228.

[0104] In this embodiment, source beam 224A directed toward multiplexer 228 is initially incident upon redirector 266, which is configured to redirect source beam 224A toward coupling optics 268. In some embodiments, redirector 266 redirects source beam 224A toward coupling optics 268 by approximately 90 degrees. Alternatively, redirector 266 may redirect source beam 224A toward coupling optics 268 by more than 90 degrees or less than 90 degrees. Thus, redirector 266 mounted on multiplexer stage 262 is configured to direct source beam 224A through coupling optics 268 such that individual guide beams 224B are focused into individual energy directors 222A-222E in director coupling housing 250.

[0105] Coupling optics 268 may have any suitable design for focusing individual guide beams 224B onto each of energy directors 222A-222E. In one embodiment, coupling optics 268 includes two lenses that are specifically configured to focus individual guide beams 224B as desired. Alternatively, coupling optics 268 may have another suitable design.

[0106] In certain non-exclusive alternative embodiments, steering of source beam 224A may be accomplished using mirrors attached to an optomechanical scanner, XY galvanometer, or other multi-axis beam steering device so that it is properly directed and focused onto each energy director 222A-222E.

[0107] Still alternatively, although Figure 2A The energy directors 222A-222E are shown fixed in position relative to the multiplexer base 260, but in some embodiments, the energy directors 222A-222E may be configured to move relative to the coupling optics 268 that are fixed in position. In such an embodiment, the director coupling housing 250 itself will move, for example, the director coupling housing 250 may be carried by a linear translation stage, and the system controller 226 may control the linear translation stage to move in a stepwise manner so that the energy directors 222A-222E are each aligned with the coupling optics and the guide beam 224B in a desired pattern. Although such an embodiment may be effective, it will also be recognized that when the director coupling housing 250 moves relative to the coupling optics 268 of the multiplexer 228 during use, additional protection and control will be required to make it safe and reliable.

[0108] Figure 2B yes Figure 2A A simplified schematic perspective view of a portion of the catheter system 200 and the multiplexer 228 is shown. Specifically, Figure 2BAnother view of the following is shown: a director coupling housing 250 having a director coupling slot 254 configured to hold a portion of each of the energy directors 222A-222E; an optical element 247 that initially directs the source beam 224A from the energy source 224 (e.g., Figure 2A 224B; and multiplexer 228, which includes multiplexer base 260, multiplexer stage 262, redirector 266 and coupling optics 268, multiplexer 228 receives source beam 224A and then directs and focuses individual guide beams 224B toward any or all of energy directors 222A-222E in any desired sequence and / or pattern. It will be appreciated that for simplicity and ease of illustration, in Figure 2B The stage mover 264 is not shown.

[0109] Figure 3A is a simplified schematic top view of a portion of an embodiment of a catheter system 300 including another embodiment of a multiplexer 328. More specifically, Figure 3A A plurality of energy directors (e.g., first energy director 322A, second energy director 322B, and third energy director 322C), energy source 324, system controller 326, and multiplexer 328 are shown, which multiplexer 328 receives energy in the form of source beam 324A from energy source 324 under the control of system controller 326 and selectively and / or alternately directs energy in the form of separate guide beam 324B to each of energy directors 322A-322C in any desired sequence and / or pattern. Energy directors 322A-322C, energy sources 324, and system controller 326 are substantially similar in design and function to those described in detail above. Therefore, no further details will be given herein. Figure 3A The illustrated embodiment describes these components in detail. It will also be appreciated that for the purpose of simplicity and ease of illustration, Figure 3A The above information is not shown in Figure 1 Certain components of the system console 123 are shown and described, such as the power supply 125 and the GUI 127, but these components will generally be included in many embodiments.

[0110] As with the previous embodiments, multiplexer 328 is configured to receive energy in the form of source beam 324A (e.g., a single pulse source beam) from energy source 324 and selectively and / or alternately direct energy in the form of separate guide beam 324B to any or all of energy directors 322A-322C in any desired sequence and / or pattern. Figure 3AAs shown, multiplexer 328 is operably and / or optically coupled in optical communication to energy director bundle 322 and / or plurality of energy directors 322A-322C.

[0111] As shown, the director proximal end 322P of each of the plurality of energy directors 322A-322C is retained within a director coupling housing 350, such as within a director coupling slot 354 formed into the director coupling housing 350. In various embodiments, the director coupling housing 350 is configured to selectively couple to the system console 123 (in Figure 1 ), such that during use of the catheter system 300, the guide coupling slot 354 and therefore the energy directors 322A-322C remain in a desired fixed position relative to the multiplexer 328 and / or the system console 123.

[0112] Reference now Figure 3B , Figure 3B yes Figure 3A A simplified schematic perspective view of a portion of the catheter system 300 and multiplexer 328 is shown. Figure 3B As shown, the director coupling housing 350 can be substantially cylindrical. It will be appreciated that the director coupling housing 350 can have any suitable number of director coupling slots 354, which can be positioned and / or oriented relative to each other in any suitable manner, for example, to best align the director coupling slots 354 relative to the multiplexer 328 and therefore best align the energy directors 322A-322C in the energy director beam 322. Figure 3B In the illustrated embodiment, the director coupling housing 350 includes seven director coupling slots 354 arranged in a circular and / or hexagonal fill pattern. Thus, in such an embodiment, the director coupling housing 350 is capable of holding the director proximal ends of up to seven energy directors. Alternatively, the director coupling housing 350 can have a different number of director coupling slots, i.e., greater than seven or less than seven, and / or the director coupling slots 354 can be arranged in a different manner relative to each other (e.g., in another suitable circular periodic pattern).

[0113] Back to Figure 3A In this embodiment, the multiplexer 328 includes one or more of a multiplexer stage 362, a stage mover 364, a redirector 366, and a coupling optical device 368. Alternatively, the multiplexer 328 may include a multiplexer stage 362, a stage mover 364, a redirector 366, and a coupling optical device 368. Figure 3A More or fewer components than those specifically shown.

[0114] like Figure 3AIn the illustrated embodiment, the stage mover 364 is configured to move the multiplexer stage 362 in a rotational manner. More specifically, in this embodiment, the multiplexer stage 362 and / or the stage mover 364 require a single rotational degree of freedom. As shown, the multiplexer stage 362 and the director coupling housing 350 are aligned on the central axis 324X of the energy source 324. Therefore, the multiplexer stage 362 is configured to be rotated around the central axis 324X by the stage mover 364.

[0115] The redirector 366 and coupling optics 368 are mounted on and / or held by the multiplexer stage 362. During use of the catheter system 300, the source beam 324A is initially directed toward the multiplexer 328 and / or multiplexer stage 362 along the central axis 324X of the energy source 324. Subsequently, the redirector 366 is configured to laterally deflect the source beam 324A by a fixed distance from the central axis 324X of the energy source 324 so that the source beam 324A is directed in a direction that is substantially parallel to and spaced apart from the central axis 324X. More specifically, the redirector 366 deflects the source beam 324A to coincide with the radius of the circular pattern of energy directors 322A-322C in the director coupling housing 350. As the multiplexer stage 362 rotates, the source beam 324A directed through the redirector 366 describes a circular path.

[0116] It will be appreciated that the redirector 366 can have any suitable design. For example, in certain non-exclusive alternative embodiments, the redirector 366 can be provided in the form of an anamorphic prism pair, a pair of wedge prisms, or a pair of closely spaced right angle mirrors or prisms. Alternatively, the redirector 366 can include another suitable configuration of optics to achieve the desired lateral beam shift.

[0117] As depicted, coupling optics 368 are also mounted on and / or held by multiplexer stage 362. As with the previous embodiments, coupling optics 368 are configured to focus individual guide beams 324B onto each of energy directors 322A-322C in energy director beam 322, which is partially held within director coupling housing 350, for optimal coupling.

[0118] As described above, multiplexer 328 is configured to precisely align coupling optics 368 with each energy director 322A-322C so that source beam 324A generated by energy source 324 can be precisely directed and focused by multiplexer 328 to each energy director 322A-322C as a corresponding guide beam 324B. In certain embodiments, stage mover 364 and / or multiplexer stage 362 can be equipped with mechanical stops so that coupling optics 368 can be precisely aligned with the position of each energy director 322A-322C in any desired sequence and / or pattern. Alternatively, stage mover 364 can be electronically controlled, such as by using a stepper motor or piezoelectrically actuated rotation stage, to align the beam path of guide beam 324B with each individual energy director 322A-322C partially held within director coupling housing 350 in any desired sequence and / or pattern.

[0119] During use of catheter system 300, stage mover 364 drives multiplexer stage 362 to couple guide beam 324B with the selected energy director 322A-322C, and then system controller 326 activates energy source 324 in a pulsed mode or semi-CW mode. Stage mover 364 then angularly steps multiplexer stage 362 to the next stop, i.e., to the next desired energy director 322A-322C, and system controller 326 again activates energy source 324. This process is repeated as desired so that energy in the form of guide beam 324B is directed to any one or all of energy directors 322A-322C in a desired sequence and / or pattern. It will be appreciated that stage mover 364 can move multiplexer stage 362 to align it with any one of energy directors 322A-322C, and then system controller 326 activates energy source 324. In this manner, multiplexer 328 may be enabled to fire sequentially by energy directors 322A-322C, or in any desired pattern relative to energy directors 322A-322C.

[0120] In this embodiment, the stage mover 364 may be of any suitable design for moving the multiplexer stage 362 in a rotational manner about the central axis 324X. More specifically, the stage mover 364 may be any suitable type of rotation mechanism.

[0121] Alternatively, although Figure 3AEnergy directors 322A-322C are shown fixed in position relative to multiplexer stage 362, but in some embodiments, it will be appreciated that energy directors 322A-322C may be configured to move and / or rotate relative to coupling optics 368, which are fixed in position. In such embodiments, director coupling housing 350 itself would move, for example, director coupling housing 350 could rotate about central axis 324X, and system controller 326 could control the rotation stage to move in a stepwise manner so that energy directors 322A-322C are each aligned with coupling optics and guide beam 324B in a desired sequence and / or pattern. In such embodiments, director coupling housing 350 would not rotate continuously, but would rotate a fixed number of degrees and then reverse rotation to avoid entanglement of energy directors 322A-322C.

[0122] Return again Figure 3B , Figure 3B Another view of a director coupling housing 350 is shown, having a director coupling slot 354 configured to hold a portion of each energy director, and a multiplexer 328 including a multiplexer stage 362, a redirector 366, and coupling optics 368 that receive source beams 324A and then direct and focus individual guide beams 324B toward each energy director in any desired sequence and / or pattern. It will be appreciated that for purposes of simplicity and ease of illustration, the multiplexer 328 is shown in FIG. Figure 3B The stage mover 364 is not shown.

[0123] Figure 4 is a simplified schematic top view of a portion of the catheter system 400 and yet another embodiment of a multiplexer 428. More specifically, Figure 4 A plurality of energy directors (e.g., a first energy director 422A, a second energy director 422B, a third energy director 422C, a fourth energy director 422D, and a fifth energy director 422E), an energy source 424, a system controller 426, and a multiplexer 428 are shown, which, under the control of the system controller 426, receives energy in the form of source beam 424A from energy source 424 and selectively and / or alternately directs energy in the form of separate guide beams 424B to any one or all of energy directors 422A-422E in any desired sequence and / or pattern. Energy directors 422A-422E, energy sources 424, and system controller 426 are substantially similar in design and function to those described in detail above. Therefore, no further details will be given herein. Figure 4 The illustrated embodiment describes these components in detail. It will also be appreciated that for the purpose of simplicity and ease of illustration, Figure 4 The above information is not shown in Figure 1Certain components of the system console 123 are shown and described, such as the power supply 125 and the GUI 127, but these components will generally be included in many embodiments.

[0124] As described above, multiplexer 428 is configured to receive energy in the form of source beam 424A (e.g., a single pulse source beam) from energy source 424 and selectively and / or alternately direct energy in the form of separate guide beam 424B to any or all of energy directors 422A-422E in any desired sequence and / or pattern. Figure 4 As shown, multiplexer 428 is operably and / or optically coupled in optical communication to energy director bundle 422 and / or plurality of energy directors 422A-422E.

[0125] As shown, the director proximal end 422P of each of the plurality of energy directors 422A-422E is retained within a director coupling housing 450, such as within a director coupling slot 454 formed into the director coupling housing 450. In various embodiments, the director coupling housing 450 is configured to selectively couple to the system console 123 (in Figure 1 4 (shown in FIG. 4 ), so that during use of the catheter system 400, the guide coupling slots 454 and thus the energy directors 422A-422E remain in a desired fixed position relative to the multiplexer 428 and / or the system console 123. It will be appreciated that the guide coupling housing 450 can have any suitable number of guide coupling slots 454. Figure 4 In the illustrated embodiment, five guide coupling slots 454 are visible within the guide coupling housing 450. Thus, in such an embodiment, the guide coupling housing 450 is capable of holding the guide proximal ends 422P of up to five energy directors. Alternatively, the guide coupling housing 450 can have a different number of guide coupling slots 454, greater than five or less than five guide coupling slots 454.

[0126] exist Figure 4 In the illustrated embodiment, multiplexer 428 includes one or more of the following: a multiplexer stage 462, a stage mover 464, one or more diffractive optical elements 470 (or "DOE"), and a coupling optical element 468. Alternatively, multiplexer 428 may include a plurality of Figure 4 More components or fewer components than those specifically shown.

[0127] As shown, the diffractive optical element 470 is mounted on and / or held by the multiplexer stage 462. The stage mover 464 is configured to move the multiplexer stage 462, for example, translationally, so that each of the one or more diffractive optical elements 470 is selectively and / or alternately positioned in the beam path of the source beam 424A from the energy source 424.

[0128] During use of the catheter system 400, each of the one or more diffractive optical elements 470 is configured to separate the source beam 424A into one, two, three or more separate guided beams 424B. It will be appreciated that the diffractive optical element 470 can have any suitable design. For example, in certain non-exclusive embodiments, the diffractive optical element 470 can be created using an array of micro-prisms, micro-lenses, or other patterned diffractive elements.

[0129] It should be appreciated that there are many possible patterns for organizing energy directors 422A-422E in director coupling housing 450 using this approach. The simplest pattern of energy directors 422A-422E within director coupling housing 450 would be a close-packed pattern of hexagons, similar to Figure 3A and Figure 3B Alternatively, energy directors 422A-422E within director coupling housing 450 may also be arranged in a square, linear, circular, or other suitable pattern.

[0130] like Figure 4 As shown, the guide coupling housing 450 can be aligned on the central axis 424X of the energy source 424, with the diffractive optical element 470 mounted on the multiplexer stage 462 inserted along the beam path between the energy source 424 and the guide coupling housing 450. As shown, the coupling optics 468 are also positioned along the central axis 424X of the energy source 424, and the coupling optics are positioned between the diffractive optical element 470 and the guide coupling housing 450.

[0131] During operation, source beam 424A incident on one of the plurality of diffractive optical elements 470 splits source beam 424A into two or more deviated beams, i.e., two or more guided beams 424B. These guided beams 424B are in turn guided by coupling optics 468 and focused onto individual energy directors 422A-422E held in director coupling housing 450. In one configuration, diffractive optical element 470 splits source beam 424A into as many energy directors as there are within the disposable device. In this configuration, the power in each guided beam 424B is based on the number of guided beams 424B generated from a single source beam 424A minus scattering and absorption losses. Alternatively, diffractive optical element 470 can be configured to split source beam 424A so that guided beams 424B are directed into any single energy director or any selected plurality of energy directors. Thus, multiplexer stage 462 may be configured to hold a plurality of diffractive optical elements 470, e.g., where a variety of diffractive optical element patterns are etched on a single plate, to provide a user or operator with options for coupling guided beam 424B to a desired number and pattern of energy directors. In such an embodiment, pattern selection may be accomplished by moving multiplexer stage 462 (e.g., translationally) using stage mover 464 so that a desired diffractive optical element 470 is located in the beam path of source beam 424A between energy source 424 and coupling optics 468.

[0132] As with the previous embodiments, coupling optics 468 may have any suitable design for focusing a single guide beam 424B onto a desired energy director 422A-422E or focusing multiple guide beams 424B simultaneously onto a desired energy director 422A-422E.

[0133] Figure 5 5 is a simplified schematic top view of a portion of a catheter system 500 and yet another embodiment of a multiplexer 528. More specifically, Figure 5 A plurality of energy directors (e.g., first energy director 522A, second energy director 522B, and third energy director 522C), energy source 524, system controller 526, and multiplexer 528 are shown, which, under the control of system controller 526, receives energy in the form of source beam 524A from energy source 524 and selectively and / or alternately directs energy in the form of separate guide beam 524B to any one or all of energy directors 522A-522C in any desired sequence and / or pattern. Energy directors 522A-522C, energy sources 524, and system controller 526 are substantially similar in design and function to those described in detail above. Therefore, no further description will be given of the various embodiments. Figure 5The illustrated embodiment describes these components in detail. It will also be appreciated that for the purpose of simplicity and ease of illustration, Figure 5 The above information is not shown in Figure 1 Certain components of the system console 123 are shown and described, such as the power supply 125 and the GUI 127, but these components will generally be included in many embodiments.

[0134] As described above, multiplexer 528 is configured to receive energy in the form of source beam 524A (e.g., a single pulse source beam) from energy source 524 and selectively and / or alternately direct energy in the form of separate guide beam 524B to any or all of energy directors 522A-522C in any desired sequence and / or pattern. Figure 5 As shown, multiplexer 528 is operably and / or optically coupled in optical communication to a plurality of energy directors 522A-522C.

[0135] However, if Figure 5 As shown, multiplexer 528 has a different design than any of the previous embodiments. In some embodiments, it may be desirable to design multiplexer 528 to receive source beam 524A from a single energy source 524 and selectively and / or alternately direct energy in the form of separate guide beam 524B to any or all of energy directors 522A-522C in any desired sequence and / or pattern in a manner that is easily reconfigured and does not involve moving parts. For example, using an acousto-optic deflector (AOD) as multiplexer 528 can allow the entire output of a single energy source 524 (e.g., a single laser) to be directed to multiple individual energy directors 522A-522C. By changing the drive frequency input to multiplexer 528 (AOD), guide beam 524B can be re-targeted to different energy directors 522A-522C in microseconds, and with a pulsed laser such as Nd:YAG, such switching can easily occur between pulses. In such an embodiment, the deflection angle (θ) of the multiplexer 528 may be defined as follows:

[0136] Deflection angle (Θ) = Λf / v, where, Λ = wavelength of light f = acoustic drive frequency v = speed of sound in the modulator.

[0137] like Figure 5As shown, source beam 524A is directed from energy source 524 toward multiplexer 528, and is subsequently redirected to each of energy directors 522A-522C as a desired guided beam 524B due to the generated deflection angle. More specifically, as shown, when multiplexer 528 generates a first deflection angle for source beam 524A, first guided beam 524B1 is directed to first energy director 522A; when multiplexer 528 generates a second deflection angle for source beam 524A, second guided beam 524B2 is directed to second energy director 522B; and when multiplexer 528 generates a third deflection angle for source beam 524A, third guided beam 524B3 is directed to third energy director 522C. It will be appreciated that any desired deflection angle may include an angle of substantially no deflection at all, such that guide beam 524B may be directed to continue along the same axial beam path as source beam 524A, as shown.

[0138] In this embodiment, multiplexer 528 (AOD) includes transducer 572 and absorber 574, which cooperate to generate a desired drive frequency, which in turn can generate a desired deflection angle so that source beam 524A is redirected to desired energy directors 522A-522C as desired guide beam 524B. More specifically, multiplexer 528 is configured to spatially control source beam 524A. In operation of multiplexer 528, the power driving acoustic transducer 572 is maintained at a constant level while varying the acoustic frequency to deflect source beam 524A to different angular positions defining guide beams 524B1-524B3. Thus, multiplexer 528 utilizes acoustic frequency-dependent diffraction angles, as described above.

[0139] Figure 6 is a simplified schematic top view of a portion of the catheter system 600 and yet another embodiment of a multiplexer 628. More specifically, Figure 6 A plurality of energy directors (e.g., a first energy director 622A, a second energy director 622B, and a third energy director 622C), an energy source 624, a system controller 626, and a multiplexer 628 are shown, which, under the control of the system controller 626, receives energy in the form of a source beam 624A (e.g., a single pulse source beam) from the energy source 624 and selectively and / or alternately directs energy in the form of a separate guide beam 624B to any one or all of the energy directors 622A-622C in any desired sequence and / or pattern. The energy directors 622A-622C, the energy source 624, and the system controller 626 are substantially similar in design and function to those described in detail above. Therefore, no further description will be given of the multiplexer 628. Figure 6 The illustrated embodiment describes these components in detail. It will also be appreciated that for the purpose of simplicity and ease of illustration, Figure 6The above information is not shown in Figure 1 Certain components of the system console 123 are shown and described, such as the power supply 125 and the GUI 127, but these components will generally be included in many embodiments.

[0140] will realize that Figure 6 The multiplexer 628 shown is substantially similar to that described with respect to Figure 5 Multiplexer 528 shown and described. For example, as in Figure 6 As shown in , multiplexer 628 again includes transducer 672 and absorber 674, which cooperate to generate a desired drive frequency, which in turn can generate a desired deflection angle so that source beam 624A is redirected to the desired energy directors 622A-622C as a desired guide beam 624B. However, in this embodiment, multiplexer 628 also includes optical element 676, which can be used to convert the angular separation between guide beams 624B into a linear offset.

[0141] In some embodiments, to improve the angular resolution and efficiency of the catheter system 600, the input laser 624 should be calibrated to a diameter close to the aperture filling the multiplexer 628 (AOD). The smaller the divergence of the input, the greater the number of discrete outputs that can be generated. The angular resolution of such a device is quite good, but the total angular deflection is limited. In order to allow access to a sufficient number of energy directors 622A-622C of limited size by a single energy source 624 and a single source beam 624A, there are many ways to improve the separation of the different outputs. For example, Figure 6 As shown, after individual guide beams 624B are separated, optical element 676 (e.g., lens) can be used to convert the angular separation between guide beams 624B into linear offsets, and can be used to direct guide beams 624B into closely spaced energy directors 622A-622C (e.g., when energy directors 622A-622C are held in close proximity to each other within director coupling housing 650). Folding mirrors can be used to allow sufficient propagation distance to separate different beam paths of guide beams 624B within a limited volume.

[0142] Figure 7 7 is a simplified schematic top view of a portion of a catheter system 700 and yet another embodiment of a multiplexer 728. More specifically, Figure 7A plurality of energy directors (e.g., a first energy director 722A, a second energy director 722B, a third energy director 722C, a fourth energy director 722D, and a fifth energy director 722E), an energy source 724, a system controller 726, and a multiplexer 728 are shown, which, under the control of the system controller 726, receives energy in the form of a source beam 724A (e.g., a single pulse source beam) from the energy source 724 and selectively and / or alternately directs energy in the form of a separate guide beam 724B to any one or all of the energy directors 722A-722E in any desired sequence and / or pattern. The energy directors 722A-722E, the energy source 724, and the system controller 726 are substantially similar in design and function to those described in detail above. Therefore, no further details will be given herein. Figure 7 The illustrated embodiment describes these components in detail. It will also be appreciated that for the purpose of simplicity and ease of illustration, Figure 7 The above information is not shown in Figure 1 Certain components of the system console 123 are shown and described, such as the power supply 125 and the GUI 127, but these components will generally be included in many embodiments.

[0143] will realize that Figure 7 The manner shown for multiplexing source beam 724A into multiple guided beams 724B is somewhat similar to that described with respect to Figure 5 The manner in which source beam 524 is multiplexed into multiple guided beams 524B is shown and described. However, in this embodiment, multiplexer 728 includes a pair of acousto-optic deflectors (AODs), namely a first acousto-optic deflector 728A and a second acousto-optic deflector 728B, which are positioned in series with each other. With such a design, multiplexer 728 can access additional energy directors. It will also be appreciated that if desired, multiplexer 728 can include more than two acousto-optic deflectors to enable access to even more energy directors.

[0144] exist Figure 7In the illustrated embodiment, source beam 724A is initially directed toward first AOD 728A. First AOD 728A is used to deflect source beam 724A to generate first guided beam 724B1 directed toward first energy director 722A and second guided beam 724B2 directed toward second energy director 722B2. First AOD 728A also allows undeflected beams to be transmitted through first AOD 728A as transmitted beam 724C directed toward second AOD 728B. Subsequently, second AOD 728B is used to deflect transmitted beam 724C as needed to generate third guided beam 724B3 directed toward third energy director 722C, fourth guided beam 724B4 directed toward fourth energy director 722D, and fifth guided beam 724B5 directed toward fifth energy director 722B5.

[0145] Each AOD 728A, 728B can be designed in a manner similar to that described in more detail above. For example, the first AOD 728A can include a first transducer 772A and a first absorber 774A, which cooperate to generate a desired drive frequency, which in turn can generate a desired deflection angle, so that the source beam 724A is redirected as needed; and the second AOD 728B can include a second transducer 772B and a second absorber 774B, which cooperate to generate a desired drive frequency, which in turn can generate a desired deflection angle, so that the transmission beam 724C is redirected as needed. Alternatively, the first AOD 728A and / or the second AOD 728B can have another suitable design.

[0146] In various embodiments of the present invention, it is designed to make the vascular lesion 106A (such as Figure 1 An optical pressure wave generator (such as a catheter system) that is designed to detect a ruptured vascular lesion (such as a calcified vascular lesion) requires multiple transmitter stations 180 (in Figure 1 ), the transmitter stations 180 are distributed along the effective length of the balloon 104 (such as Figure 1 Length 142 (as shown) Figure 1 ) within and / or relative to balloon 104 (as shown Figure 1 Length 142 (as shown) Figure 1 Stated another way, the catheter system 100 (in Figure 1) may include a plurality of transmitter stations 180, wherein each transmitter station 180 is positioned at a different longitudinal position relative to the length 142 of the balloon 104. For example, in one non-exclusive embodiment, the catheter system may include (i) a first transmitter station 180 positioned at a first longitudinal position relative to the length 142 of the balloon 104, (ii) a second transmitter station 180 positioned at a second longitudinal position different from the first longitudinal position relative to the length 142 of the balloon 104, and (iii) a third transmitter station 180 positioned at a third longitudinal position different from the first longitudinal position and the second longitudinal position relative to the length 142 of the balloon 104. Each transmitter station 180 incorporated within the disposable device may include a single transmitter 135 (in Figure 1 180) or more emitters 135, wherein each emitter 135 at any given emitter station 180 is located at approximately the same longitudinal position relative to the length 142 of the balloon 104. Stated another way, the energy directors 122A (in Figure 1 The distal end 122D of the introducer (shown in Figure 1 ) and a corresponding plasma generator 133 (shown in Figure 1 ) is located at approximately the same longitudinal position relative to the length 142 of the balloon 104 as the guide distal end 122D and corresponding plasma generator 133 of any additional emitter 135 within the same emitter station 180.

[0147] The catheter system 100 can be configured to selectively provide power to a plurality of transmitter stations 180 as part of a pressure wave generating device, which is designed to apply pressure to a vascular lesion 106A (such as a calcified vascular lesion and / or a fibrotic vascular lesion) and induce a fracture in the vascular lesion 106A. In many embodiments, the catheter system 100 can be configured and controlled to selectively and / or individually provide power to the plurality of transmitter stations 180 in any desired mode, order, sequence, and firing rate. Each transmitter station 180 can also be configured to include any desired number of individual activators 135, which can be a single emitter 135 or more than one emitter 135. In many embodiments, the catheter system 100 can be further configured and controlled to selectively and / or individually provide power to each of the individual emitters 135 in any given transmitter station 180 in any desired mode, order, sequence, and firing rate.

[0148] In many embodiments, it is desirable for the transmitter stations 180 to be visible to a user or operator during use of the catheter system 100 so that the user or operator can more accurately position the transmitters 135 and / or transmitter stations 180 relative to the vascular lesion 106A at the treatment site 106. Proper visibility of the transmitters 135 and / or transmitter stations 180 also enables the user or operator to selectively activate only those transmitter stations 180 that are positioned closest to the vascular lesion 106A so as to more effectively and efficiently destroy the vascular lesion 106A at the treatment site 106.

[0149] In various embodiments, the transmitter 135 and / or transmitter station 180 of the catheter system 100 can be formed of and / or can include a radiopaque material that is easily visible when used with fluoroscopy during an intravascular lithotripsy procedure. Alternatively, the transmitter 135 and / or transmitter station 180 can be formed of other suitable materials that are visible to a user or operator during an intravascular lithotripsy procedure.

[0150] Figure 8 800 is a simplified schematic side view of a portion of an embodiment of a catheter system 800 having features of the present invention. As shown, the catheter system 800 includes a balloon 804 having a balloon wall 830 defining a balloon interior 846, and one or more transmitter stations 880 positioned within the balloon interior 846 of the balloon 804, such as a first transmitter station 880A and a second transmitter station 880B in this particular embodiment (although it should be understood that the catheter system 800 may include any suitable number of transmitter stations 880). Each of the transmitter stations 880A, 880B is positioned at a different longitudinal position relative to the length 842 of the balloon 804. Stated another way, as shown, the first transmitter station 880A is positioned at a first longitudinal position 880L1 (or position) relative to the length 842 of the balloon 804, and the second transmitter station 880B is positioned at a second longitudinal position 880L2 (or position) different from the first longitudinal position 880L1 (or position) relative to the length 842 of the balloon 804. It should be appreciated that each of the transmitter stations 880A, 880B may include any suitable number of transmitters 135 (in Figure 1 ), which can be one transmitter 135 or multiple transmitters 135. Thus, each transmitter 135 of any given transmitter station 880 can be said to be positioned at approximately the same longitudinal position (or location) relative to the length 842 of the balloon 804.

[0151] During use of the catheter system 800, due to the use of radiopaque or other suitable materials to make the transmitter stations 880 and / or emitters 135 visible, a user or operator can specifically select certain transmitter stations 880 and / or emitters 135 to be used during an intravascular lithotripsy procedure, and / or can specifically deselect certain transmitter stations 880 and / or emitters 135 not to be used during an intravascular lithotripsy procedure. It should be understood that the specific selection or deselection of transmitter stations 880 and / or emitters 135 can be based at least in part on the location of the treatment site 106 (e.g., Figure 1 106A (as shown) Figure 1 For example, in some potential applications, a user or operator may select only one of the transmitter stations 880 (and / or only one or more of the transmitters 135 specifically included therein) to use during an intravascular lithotripsy procedure, such as only the first transmitter station 880A or only the second transmitter station 880B. Alternatively, in other potential applications, a user or operator may select both transmitter stations 880A, 880B to use during an intravascular lithotripsy procedure.

[0152] Fig. 9is a simplified schematic diagram of a portion of another embodiment of a catheter system 900. Specifically, in this embodiment, the catheter system 900 includes a balloon 904 having a balloon wall 930 defining a balloon interior 946, and four transmitter stations 980, such as a first transmitter station 980A, a second transmitter station 980B, a third transmitter station 980C, and a fourth transmitter station 980D, positioned within the balloon interior 946 of the balloon 904. Each of the transmitter stations 980A, 980B, 980C, 980D is positioned at a different longitudinal position relative to the length 942 of the balloon 904. Stated another way, as shown, the first transmitter station 980A is positioned at a first longitudinal position 980L1 (or location) relative to the length 942 of the balloon 904; the second transmitter station 980B is positioned at a second longitudinal position 980L2 (or location) different from the first longitudinal position 980L1 (or location) relative to the length 942 of the balloon 904; the third transmitter station 980C is positioned at a third longitudinal position 980L3 (or location) different from the first longitudinal position 980L1 (or location) and the second longitudinal position 980L2 (or location) relative to the length 942 of the balloon 904; and the fourth transmitter station 980D is positioned at a fourth longitudinal position 980L4 (or location) different from the first longitudinal position 980L1 (or location), the second longitudinal position 980L2 (or location) and the third longitudinal position 980L3 (or location) relative to the length 942 of the balloon 904. It should be understood that each of transmitter stations 980A, 980B, 980C, 980D may include any suitable number of transmitters 135 (in Figure 1 ), which can be one transmitter 135 or multiple transmitters 135. Thus, each transmitter 135 of any given transmitter station 980 can be said to be positioned at approximately the same longitudinal position (or location) relative to the length 942 of the balloon 904.

[0153] During use of the catheter system 900, due to the use of radiopaque or other suitable materials to make the transmitter stations 980 and / or emitters 135 visible, a user or operator can specifically select certain transmitter stations 980 and / or emitters 135 to be used during an intravascular lithotripsy procedure, and / or can specifically deselect certain transmitter stations 980 and / or emitters 135 not to be used during an intravascular lithotripsy procedure. It should be understood that the specific selection or deselection of transmitter stations 980 and / or emitters 135 can be based at least in part on the location of the treatment site 106 (e.g., Figure 1 106A (as shown) Figure 1For example, in some potential applications, a user or operator may select only one of the transmitter stations 980 (and / or one or more of the transmitters 135 included therein) to use during an intravascular lithotripsy procedure, such as only the first transmitter station 980A, only the second transmitter station 980B, only the third transmitter station 980C, or only the fourth transmitter station 980D. Alternatively, in other potential applications, a user or operator may select two transmitter stations 980, such as (i) the first transmitter station 980A and the second transmitter station 980B, (ii) the first transmitter station 980A and the third transmitter station 980C, (iii) the first transmitter station 980A and the fourth transmitter station 980D, (iv) the second transmitter station 980B and the third transmitter station 980C, (v) the second transmitter station 980B and the fourth transmitter station 980D, or (vi) the third transmitter station 980C and the fourth transmitter station 980D, for use during an intravascular lithotripsy procedure. Still alternatively, in still other potential applications, a user or operator may select three transmitter stations 980, such as (i) a first transmitter station 980A, a second transmitter station 980B, and a third transmitter station 980C, (ii) a first transmitter station 980A, a second transmitter station 980B, and a fourth transmitter station 980D, (iii) a first transmitter station 980A, a third transmitter station 980C, and a fourth transmitter station 980D, or (iv) a second transmitter station 980B, a third transmitter station 980C, and a fourth transmitter station 980D, for use during an intravascular lithotripsy procedure. Still alternatively, in other potential applications, a user or operator may select all four transmitter stations 980A, 980B, 980C, 980D for use during an intravascular lithotripsy procedure.

[0154] Fig.101 is a simplified schematic diagram of a portion of yet another embodiment of a catheter system 1000. More specifically, in this embodiment, the catheter system 1000 includes a balloon 1004 having a balloon wall 1030 defining a balloon interior 1046, and five transmitter stations 1080, such as a first transmitter station 1080A, a second transmitter station 1080B, a third transmitter station 1080C, a fourth transmitter station 1080D, and a fifth transmitter station 1080E, positioned within the balloon interior 1046 of the balloon 1004. Each of the transmitter stations 1080A-1080E is positioned at a different longitudinal position relative to the length 1042 of the balloon 1004. Stated another way, as shown, the first transmitter station 1080A is positioned at a first longitudinal position 1080L1 (or location) relative to the length 1042 of the balloon 1004; the second transmitter station 1080B is positioned at a second longitudinal position 1080L2 (or location) different from the first longitudinal position 1080L1 (or location) relative to the length 1042 of the balloon 1004; the third transmitter station 1080C is positioned at a third longitudinal position 1080L3 (or location) different from the first longitudinal position 1080L1 (or location) and the second longitudinal position 1080L2 (or location) relative to the length 1042 of the balloon 1004; and the fourth transmitter station 1080A is positioned at a first longitudinal position 1080L1 (or location) relative to the length 1042 of the balloon 1004. 1080D is positioned at a fourth longitudinal position 1080L4 (or location) different from the first longitudinal position 1080L1 (or location), the second longitudinal position 1080L2 (or location), and the third longitudinal position 1080L3 (or location) relative to the length 1042 of the balloon 1004; and the fifth transmitter station 1080E is positioned at a fifth longitudinal position 1080L5 (or location) different from the first longitudinal position 1080L1 (or location), the second longitudinal position 1080L2 (or location), the third longitudinal position 1080L3 (or location), and the fourth longitudinal position 1080L4 (or location) relative to the length 1042 of the balloon 1004. It should be understood that each of the transmitter stations 1080A-1080E may include any suitable number of transmitters 135 (in Figure 1 ), which can be one transmitter 135 or multiple transmitters 135. Thus, each transmitter 135 of any given transmitter station 1080 can be said to be positioned at approximately the same longitudinal position (or location) relative to the length 1042 of the balloon 1004.

[0155] During use of the catheter system 1000, due to the use of radiopaque or other suitable materials to make the transmitter stations 1080 and / or emitters 135 visible, a user or operator can specifically select certain transmitter stations 1080 and / or emitters 135 to be used during an intravascular lithotripsy procedure, and / or can specifically deselect certain transmitter stations 1080 and / or emitters 135 not to be used during an intravascular lithotripsy procedure. It should be understood that the specific selection or deselection of the transmitter stations 1080 and / or emitters 135 can be based at least in part on the location of the treatment site 106 (e.g., Figure 1 106A (as shown) Figure 1For example, in some potential applications, a user or operator may select only one of the transmitter stations 1080 (and / or one or more of the transmitters 13 included therein) for use during an intravascular lithotripsy procedure, such as only the first transmitter station 1080A, only the second transmitter station 1080B, only the third transmitter station 1080C, only the fourth transmitter station 1080D, or only the fifth transmitter station 1080E. Alternatively, in other potential applications, a user or operator may select two transmitter stations 1080, such as (i) the first transmitter station 1080A and the second transmitter station 1080B, (ii) the first transmitter station 1080A and the third transmitter station 1080C, (iii) the first transmitter station 1080A and the fourth transmitter station 1080D, (iv) the first transmitter station 1080A and the fifth transmitter station 1080E, (v) the second transmitter station 1080B and the third transmitter station 1080C transmitter station 1080C, (vi) a second transmitter station 1080B and a fourth transmitter station 1080D, (vii) the second transmitter station 1080B and the fifth transmitter station 1080E, (viii) the third transmitter station 1080C and the fourth transmitter station 1080D, (ix) the third transmitter station 1080C and the fifth transmitter station 1080E, or (x) the fourth transmitter station 1080D and the fifth transmitter station 1080E for use during an intravascular lithotripsy procedure. Still alternatively, in other potential applications, a user or operator may select three transmitter stations 1080, such as (i) a first transmitter station 1080A, a second transmitter station 1080B, and a third transmitter station 1080C, (ii) a first transmitter station 1080A, a second transmitter station 1080B, and a fourth transmitter station 1080D, (iii) a first transmitter station 1080A, a second transmitter station 1080B, and a fifth transmitter station 1080E, (iv) a first transmitter station 1080A, a third transmitter station 1080C, and a fourth transmitter station 1080D, (v) a first transmitter station 1080A, a third transmitter station 1080C, and a fifth transmitter station 1080E. transmitter station 1080E, (vi) the first transmitter station 1080A, the fourth transmitter station 1080D and the fifth transmitter station 1080E, (vii) the second transmitter station 1080B, the third transmitter station 1080C and the fourth transmitter station 1080D, (viii) the second transmitter station 1080B, the third transmitter station 1080C and the fifth transmitter station 1080E, (ix) the second transmitter station 1080B, the fourth transmitter station 1080D and the fifth transmitter station 1080E, or (x) the third transmitter station 1080C, the fourth transmitter station 1080D and the fifth transmitter station 1080E for use during an intravascular lithotripsy procedure.Alternatively, in other potential applications, a user or operator may select four transmitter stations 1080, such as (i) a first transmitter station 1080A, a second transmitter station 1080B, a third transmitter station 1080C, and a fourth transmitter station 1080D, (ii) a first transmitter station 1080A, a second transmitter station 1080B, a third transmitter station 1080C, and a fifth transmitter station 1080E, (iii) a first transmitter station 1080 A, a second transmitter station 1080B, a fourth transmitter station 1080D, and a fifth transmitter station 1080E, (iv) a first transmitter station 1080A, a third transmitter station 1080C, a fourth transmitter station 1080D, and a fifth transmitter station 1080E, or (v) a second transmitter station 1080B, a third transmitter station 1080C, a fourth transmitter station 1080D, and a fifth transmitter station 1080E for use during an intravascular lithotripsy procedure. Still alternatively, in other potential applications, a user or operator may select all five transmitter stations 1080A-1080E for use during an intravascular lithotripsy procedure.

[0156] Fig.11A and Fig. 11B is a fluoroscopic image of a portion of the catheter system 1100 positioned substantially adjacent to the vascular lesion 1106A. Specifically, Fig.11A is a fluoroscopic image 1182A of a portion of an embodiment of a catheter system 1100 positioned substantially adjacent a vascular lesion 1106A, the catheter system 1100 including a balloon 1104 having a balloon wall 1130 defining a balloon interior 1146 and four transmitter stations 1180 positioned within the balloon interior 1146 of the balloon 1104, the balloon being in an inflated state; and Fig. 11B yes Fig.11A 1182B is a fluoroscopic image 1182 of the catheter system 1100 positioned substantially adjacent to the vascular lesion 1106A, with the balloon 1104 in a deflated state.

[0157] like Fig.11A and Fig. 11B As shown, because the transmitter station 1180 is made of and / or includes a radiopaque material, the transmitter station 1180 of the catheter system 1100 is easily visible when used with fluoroscopy during an intravascular lithotripsy procedure.

[0158] Calcified lesions can have various types of morphology, from short focal lesions to long lesions greater than 30 centimeters (cm) in length. In addition, the cross-section of calcified lesions can be eccentric, nodular, and circumferential. For any given lesion, the thickness of the calcium can range from a thin layer within the intimal portion of the artery to a thick layer spanning the intimal layer and the interlayer. In certain applications, the physician may not want to deliver energy to certain types of lesion morphologies. For example, if the lesion is focal and only 10 millimeters (mm) in length and is surrounded by healthy, non-calcified arteries, the physician may only want to target the calcified arterial area.

[0159] Fig.12 1282 is a fluoroscopic image of a portion of another embodiment of a catheter system 1200 positioned substantially adjacent to a vascular lesion 1206A at a treatment site 1206. Specifically, Fig.12 A focal lesion is shown along with a catheter system 1200 (intravascular lithotripsy device) having four transmitter stations 1280 located therein, such as a first transmitter station 1280A, a second transmitter station 1280B, a third transmitter station 1280C, and a fourth transmitter station 1280D.

[0160] As described above, in various embodiments, a user or operator may specifically select and / or deselect certain transmitter stations 1280 based at least in part on proximity to a vascular lesion 1206A at a treatment site 1206. Fig.12 In the illustrated embodiment, the second transmitter station 1280B and the third transmitter station 1280C have been placed substantially adjacent to the vascular lesion 1206A at the treatment site 1206. In this case, the user or operator may choose to turn on or select the second transmitter station 1280B and the third transmitter station 1280C so that energy is delivered to the vascular lesion 1206A, and / or turn off or deselect the first transmitter station 1280A and the fourth transmitter station 1280D so that energy is not delivered to the healthy artery.

[0161] Fig.13 13 is a simplified illustration of an embodiment of a graphical user interface 1327 that may be used as part of a catheter system. Fig.13 As shown in FIG. 1 , the GUI 1327 includes four emitter activators 1384, such as a first emitter activator 1384A, a second emitter activator 1384B, a third emitter activator 1384C, and a fourth emitter activator 1384D, which are connected to the transmitter activator 1384A. Fig.12 Specifically, the first transmitter activator 1384A can be used to specifically activate (or select) or deactivate (cancel select) the first transmitter station 1280A (in Fig.12); the second transmitter activator 1384B can be used to specifically activate (or select) or deactivate (cancel select) the second transmitter station 1280B (in Fig.12 The third transmitter activator 1384C can be used to specifically activate (or select) or deactivate (cancel select) the third transmitter station 1280C (in Fig.12 and the fourth transmitter activator 1384D can be used to specifically activate (or select) or deactivate (cancel select) the fourth transmitter station 1280D (in Fig.12 ).

[0162] Combination Fig.12 1282, the GUI 1327 may include a touch screen display that may be used to specifically deselect or turn off the first transmitter station 1280A and the fourth transmitter station 1280D via corresponding transmitter activators 1384A, 1384D. Additionally or alternatively, the touch screen display of the GUI 1327 may be used to specifically select or turn on the second transmitter station 1280B and the third transmitter station 1280C via corresponding transmitter activators 1384B, 1384C. Thus, the user or operator is able to optimally target the vascular lesion 1206A at the treatment site 1206 while also optimally protecting the healthy, non-calcified portion of the artery.

[0163] As described in detail herein, in various embodiments, the present invention can be used to solve various problems that exist in more traditional catheter systems. For example, by enabling the catheter system to excite each transmitter station and / or each transmitter separately, an excitation sequence or pattern that may be more effective and efficient for destroying localized lesions can be achieved. Exciting individual transmitter stations and / or individual transmitters in a desired sequence pattern can more effectively destroy lesions at a specific location or extended lesions.

[0164] In summary, based on the various embodiments of the present invention shown and described in detail herein, catheter systems and related methods 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 within a blood vessel or adjacent to a blood vessel in a patient's body. The catheter includes a catheter shaft and an expandable balloon connected and / or fixed to the catheter shaft. The balloon may include a balloon wall defining an interior of the balloon. The balloon may be configured to receive a catheter fluid within the balloon interior to expand from a contracted state suitable for advancing the catheter through the patient's vascular system to an expanded state suitable for anchoring the catheter in an appropriate position relative to the treatment site.

[0165] In medical devices that generate pressure waves, such as the catheter system described herein, it is often desirable to have multiple potential output channels or transmitter stations (or transmitters) for use in a therapeutic procedure.

[0166] In certain embodiments, catheter systems and related methods utilize an energy source, wherein the energy source provides energy directed by one or more energy directors disposed along a catheter shaft and within a balloon interior of a balloon to generate a localized plasma in a catheter fluid retained within the balloon interior of a balloon at or near a corresponding director distal end of each energy director within the balloon interior of the balloon located at a treatment site. The generation of the localized plasma may induce pressure waves and may induce rapid formation of one or more bubbles that may rapidly expand to a maximum size and then dissipate through a cavitation event that may emit pressure waves upon collapse. The rapid expansion of the plasma-induced bubbles may generate one or more pressure waves within the catheter fluid retained within the balloon interior of the balloon, thereby applying the pressure waves to and inducing rupture of vascular lesions at a treatment site within or adjacent to a vessel wall within a patient's body.

[0167] The corresponding director distal end of each of the plurality of energy directors may be positioned at any suitable location relative to the length of the balloon to more effectively and precisely apply pressure waves for destroying vascular lesions at the treatment site.

[0168] Each energy director can be used in conjunction with a corresponding plasma generator, which is positioned at or near the corresponding director distal end of the energy director and, in many embodiments, is spaced apart from the corresponding director distal end of the energy director, within the balloon interior of the balloon at the treatment site for generating a local plasma and / or for generating a desired pressure wave within the balloon interior for destroying vascular lesions. As used herein, the corresponding director distal ends of the energy directors and the corresponding plasma generators may be collectively referred to as "emitters". In some applications, one or more emitters positioned at approximately the same longitudinal position within the balloon interior of the balloon may be referred to as a "emitter station".

[0169] Thus, the catheter systems and related methods disclosed herein are configured to provide a means for providing power to multiple transmitter stations and / or multiple transmitters in a pressure wave generating device designed to apply pressure to a vascular lesion and induce a fracture in the vascular lesion. In many embodiments, the catheter system can be configured and controlled to selectively and / or individually power multiple transmitter stations in any desired mode, order, sequence, and firing rate.

[0170] Importantly, in various embodiments, the transmitter stations and / or emitters of the catheter system can be formed of and / or can include a radiopaque material that is readily visible when used with fluoroscopy during an intravascular lithotripsy procedure. Thus, visibility of the transmitter stations and / or emitters enables a user or operator to more precisely position the transmitter stations and / or emitters substantially adjacent to a vascular lesion, as desired, and / or selectively activate only those transmitter stations and / or emitters that are positioned closest to a vascular lesion, in order to more effectively and efficiently destroy the vascular lesion.

[0171] 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 dictate otherwise. It should also be noted that the term "or" is generally employed in its sense including "and / or" unless the content or context clearly dictates otherwise.

[0172] It should also be noted that, as used in this specification and the appended claims, the phrase "configured" describes a system, device, or other structure that is constructed or configured to perform a specific task or adopt a specific configuration. The phrase "configured" may be used interchangeably with other similar phrases, such as arrange and configure, construct and arrange, construct, manufacture, and arrange, etc.

[0173] The headings used herein are intended to be consistent with the recommendations under 37 CFR 1.77, or to otherwise provide organizational cues. These headings should not be considered to limit or characterize the invention(s) listed in any claims that may issue from this disclosure. As an example, a description of technology in the “Background” is not an admission that the technology is prior art to any invention in this disclosure. Nor should the “Summary” or “Abstract” be considered to characterize the invention(s) set forth in the issued claims.

[0174] The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the detailed description provided herein. On the contrary, the embodiments are selected and described to enable others skilled in the art to recognize and understand 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 changes and modifications may be made while remaining within the spirit and scope of this article.

[0175] It is to be understood that although many different embodiments of the catheter system have been illustrated and described herein, one or more features of any one embodiment may be combined with one or more features of one or more other embodiments as long as such combination meets the intent of the present invention.

[0176] Although many exemplary aspects and embodiments of the catheter system have been discussed above, those skilled in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and the claims introduced below be interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope, and no limitations are intended to the details of construction or design shown herein.

Claims

1. A catheter system for treating a treatment site in or adjacent to a blood vessel wall, the catheter system comprising: an energy source, the energy source generating energy; a plurality of energy directors, each of the plurality of energy directors being configured to selectively receive energy from the energy source, each of the plurality of energy directors comprising a corresponding director distal end from which energy received by each of the plurality of energy directors is emitted; and A plurality of emitters are each positionable proximate the treatment site, each emitter comprising the corresponding director distal end of one of the plurality of energy directors, at least one of the emitters comprising a radiopaque material.

2. The catheter system according to claim 1, wherein: The radiopaque material is visible when used with fluoroscopy during use of the catheter system for an intravascular lithotripsy procedure.

3. The catheter system of claim 1, wherein: Each of the plurality of emitters includes a radiopaque material that is visible when used with fluoroscopy during use of the catheter system in an intravascular lithotripsy procedure.

4. The catheter system according to any one of claims 1-3, further comprising a catheter shaft and a balloon coupled to the catheter shaft, the balloon comprising a balloon wall defining a balloon interior, the balloon being configured to retain a catheter fluid within the balloon interior; wherein, The energy directors are disposed along the catheter shaft; and wherein the corresponding director distal end of each of the energy directors is positioned within the balloon interior such that each of the transmitters is positioned within the balloon interior.

5. The catheter system of claim 4, wherein: Each emitter also includes a corresponding plasma generator positioned proximate a distal end of the corresponding energy director of one of the plurality of energy directors.

6. The catheter system of claim 5, wherein: Energy received by each of the plurality of energy directors is emitted from the corresponding director distal end and impinges on the corresponding plasma generator, causing plasma to be generated in the catheter fluid maintained within the balloon interior.

7. The catheter system of claim 6, wherein: The generation of the plasma results in bubble formation which generates pressure waves which exert pressure near the vessel wall.

8. The catheter system according to any one of claims 4-7 further includes a plurality of transmitter stations positioned within the interior of the balloon, each transmitter station being positioned at a different longitudinal position within the interior of the balloon relative to the length of the balloon than each of the other transmitter stations, and each transmitter station including at least one of the plurality of transmitters.

9. The catheter system of claim 8, wherein: At least one of the plurality of transmitter stations includes a radiopaque material.

10. The catheter system of claim 8, wherein: Each of the plurality of transmitter stations includes a radiopaque material that is visible when used with fluoroscopy during use of the catheter system in an intravascular lithotripsy procedure.

11. The catheter system according to any one of claims 8 to 10, wherein: The plurality of transmitter stations include a first transmitter station including a first plurality of transmitters each positioned at a first longitudinal position within the interior of the balloon and a second transmitter station including a second plurality of transmitters each positioned at a second longitudinal position within the interior of the balloon different from the first longitudinal position.

12. The catheter system of any one of claims 1-11, further comprising a system controller comprising a processor that controls the energy source so that energy from the energy source is selectively directed to each of the emitters in any desired excitation pattern.

13. The catheter system of claim 12, wherein: The system controller is configured to one of: specifically select and specifically deselect transmitters to be activated during use of the catheter system for an intravascular lithotripsy procedure based at least in part on proximity of the transmitters to the treatment site.

14. The catheter system of claim 13, wherein: The system controller is configured to selectively activate only those transmitters located closest to the treatment site.

15. The catheter system according to any one of claims 13-14, wherein: The system controller is configured to selectively deactivate those transmitters that are located least proximal to the treatment site.

16. The catheter system according to any one of claims 13-15 further includes a graphical user interface, which includes a plurality of transmitter activators, and the plurality of transmitter activators can be used for one of the following: specifically selecting and specifically deselecting transmitters to be activated during the use of the catheter system for the intravascular lithotripsy procedure.

17. The catheter system of any one of claims 1-16, further comprising a multiplexer that receives energy from the energy source and directs energy from the energy source to each of the plurality of energy directors in the form of a separate directed beam.

18. The catheter system of claim 17, wherein: The system controller controls the multiplexer so that energy from the energy source is directed as a separate guided beam into each of the energy directors in any desired firing sequence.

19. The catheter system of claim 17, wherein: The plurality of energy directors include at least a first energy director and a second energy director; and wherein the system controller controls operation of the multiplexer such that a first guided beam is directed onto the first energy director and a second guided beam is directed onto the second energy director.

20. The catheter system according to any one of claims 1 to 19, wherein: The energy source is a light source that generates pulses of light energy.

21. The catheter system of claim 20, wherein: The light source is a laser.

22. The catheter system of any one of claims 1-21, wherein: Each of the plurality of energy directors comprises an optical fiber.

23. A method for treating a treatment site in or adjacent to a blood vessel wall, the method comprising the steps of: Producing energy using energy sources; selectively receiving energy from the energy source with each of a plurality of energy directors, each of the plurality of energy directors comprising a corresponding director distal end, energy received by each of the plurality of energy directors being emitted from the corresponding director distal end; and A plurality of emitters are positioned proximate the treatment site, each emitter comprising the corresponding director distal end of one of the plurality of energy directors, at least one of the emitters comprising a radiopaque material.

24. The method according to claim 23, wherein: The step of positioning the plurality of emitters includes the step of wherein the radiopaque material is visible when used with fluoroscopy during use of the catheter system for an intravascular lithotripsy procedure.

25. The method according to claim 23, wherein: The step of positioning the plurality of emitters includes each of the plurality of emitters comprising a radiopaque material that is visible when used with fluoroscopy during use of the catheter system for an intravascular lithotripsy procedure.

26. The method according to any one of claims 23 to 25, further comprising the steps of: coupling a balloon to the catheter shaft, the balloon comprising a balloon wall defining a balloon interior; and maintaining catheter fluid within the balloon interior; and wherein the selectively receiving step includes setting the energy directors along the catheter axis and positioning the corresponding director distal end of each of the energy directors within the balloon interior so that each of the transmitters is positioned within the balloon interior.

27. The method according to claim 26, wherein: The step of positioning the plurality of emitters includes each emitter further comprising a corresponding plasma generator located proximate a corresponding director distal end of one of the plurality of energy directors.

28. The method according to claim 27, wherein: The selectively receiving step includes energy received by each of the plurality of energy directors being emitted from the corresponding director distal end and impinging on the corresponding plasma generator such that plasma is generated in the catheter fluid held within the balloon interior.

29. The method according to claim 28, wherein: The selectively receiving step further includes: the generation of the plasma causing bubble formation, the bubble formation generating a pressure wave, the pressure wave exerting pressure near the blood vessel wall.

30. The method according to any one of claims 26-29 further includes the step of positioning a plurality of transmitter stations within the interior of the balloon, each transmitter station being positioned at a different longitudinal position within the interior of the balloon relative to the length of the balloon than each of the other transmitter stations, each transmitter station comprising at least one of the plurality of transmitters.

31. The method according to claim 30, wherein: The step of positioning the plurality of transmitter stations includes at least one of the plurality of transmitter stations comprising a radiopaque material.

32. The method of claim 30, wherein: The step of positioning the plurality of transmitter stations includes each of the plurality of transmitter stations comprising a radiopaque material that is visible when used with fluoroscopy during use of the catheter system for an intravascular lithotripsy procedure.

33. The method according to any one of claims 30 to 32, wherein: The step of positioning the multiple transmitter stations includes: the multiple transmitter stations include a first transmitter station and a second transmitter station, the first transmitter station includes a first plurality of transmitters each positioned at a first longitudinal position within the interior of the balloon, and the second transmitter station includes a second plurality of transmitters each positioned at a second longitudinal position within the interior of the balloon different from the first longitudinal position.

34. The method according to any one of claims 23 to 33, further comprising the steps of: The energy source is controlled with a system controller including a processor so that energy from the energy source is selectively directed to each of the emitters in any desired excitation mode.

35. The method of claim 34, wherein: The step of controlling includes one of specifically selecting and specifically deselecting, using the system controller, a transmitter to be activated during an intravascular lithotripsy procedure based at least in part on a proximity of the transmitter to the treatment site.

36. The method of claim 35, wherein: The step of controlling includes selectively activating, using the system controller, only those transmitters that are located closest to the treatment site.

37. The method according to any one of claims 35-36, wherein: The step of controlling includes selectively deactivating, using the system controller, those transmitters that are located least proximate to the treatment site.

38. The method according to any one of claims 35 to 37, further comprising the steps of: A plurality of transmitter activators of the graphical user interface one of: specifically selecting and specifically deselecting transmitters to be activated during the intravascular lithotripsy procedure.

39. The method according to any one of claims 23 to 38, further comprising the steps of: Energy is received from the energy source using a multiplexer, and energy from the energy source is directed to each of the energy directors in the form of a separate directed beam using the multiplexer.

40. The method according to claim 39, further comprising the steps of: The multiplexer is controlled using the system controller so that energy from the energy source is directed as a separate guided beam into each of the energy directors in any desired firing sequence.

41. The method of claim 39, wherein: The step of selectively receiving includes: the multiple energy directors include at least a first energy director and a second energy director; and the method also includes the following steps: using the system controller to control the operation of the multiplexer so that the first guide beam is directed to the first energy director and the second guide beam is directed to the second energy director.

42. The method according to any one of claims 23 to 41, wherein: The generating step includes: the energy source is a light source that generates light energy pulses.

43. The method of claim 42, wherein: The generating step includes: the light source is a laser.

44. The method according to any one of claims 23 to 43, wherein: The step of selectively receiving includes each of the plurality of energy directors comprising an optical fiber.

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