Multi-emitter assembly and excitation sequence for intravascular lithotripsy device

Abstract

A catheter system (100) includes an energy source (124), a catheter shaft (110), a balloon (104), a plurality of energy directors (122A), a plurality of emitters (135), and a system controller (126). An energy source (124) generates energy. The balloon (104) is coupled to the catheter shaft (110). The balloon (104) includes a balloon wall (130) that defines a balloon interior (146) that holds catheter fluid (132). The energy director (122A) selectively receives energy from the energy source (124). A transmitter (135) is positioned within the balloon interior (146). Each emitter (135) includes a director distal end (122D) of one of the energy directors (122A) and a corresponding plasma generator (133) spaced apart from the director distal end (122D). The energy received by each energy director (122A) is emitted from the director distal end (122D) and impinges on a corresponding plasma generator (133) such that a plasma is generated in the catheter fluid (132) within the balloon interior (146). The system controller (126) controls the energy source (124) such that energy from the energy source (124) is alternately directed to each energy director (122A) in a first excitation mode and a second excitation mode different from the first excitation mode.

Description

Related Applications

[0001] This application is related to and claims the benefit of priority of U.S. Provisional Patent Application Serial No. 63 / 389,321, filed on July 14, 2022, entitled “MULTIPLE EMITTER ASSEMBLY AND FIRING SEQUENCES FOR INTRAVASCULAR LITHOTRIPSY DEVICE” and U.S. Patent Application Serial No. 18 / 346,315, filed on June 30, 2023, entitled “MULTIPLE EMITTER ASSEMBLY AND FIRING SEQUENCES FOR INTRAVASCULAR LITHOTRIPSY DEVICE”. To the extent permissible, the contents of U.S. Application Serial No. 63 / 389,321 and U.S. Patent Application Serial No. 18 / 346,315 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. The catheter system can be used to treat a treatment site in or adjacent to the blood vessel wall. In various embodiments, the catheter system includes an energy source, a catheter shaft, a balloon, a plurality of energy guides, a plurality of transmitters, and a system controller. The energy source generates energy. The balloon is connected to the catheter shaft. The balloon includes a balloon wall defining the interior of the balloon. The balloon is configured to keep the catheter fluid inside the balloon. 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 guide distal end. A plurality of transmitters are positioned inside the balloon. Each transmitter includes a guide distal end of one of the plurality of energy guides and a corresponding plasma generator spaced apart from the guide distal end. The energy received by each of the plurality of energy guides is emitted from the guide distal end and strikes the corresponding plasma generator, so that plasma is generated in the catheter fluid held inside the balloon. The system controller includes a processor that controls the energy source so that energy from the energy source is alternately directed to each of the plurality of energy directors in a first excitation mode and a second excitation mode different from the first excitation mode.

[0005] In various embodiments, the generation of plasma results in bubble formation which generates pressure waves that exert pressure near the vessel wall.

[0006] In certain embodiments, each plasma generator includes an inclined surface that redirects energy emitted from the distal end of the introducer to generate plasma in the catheter fluid held inside the balloon.

[0007] In some embodiments, the inclined surface is formed of one or more of: titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium, and iridium.

[0008] In various embodiments, the catheter system further comprises a plurality of emitter stations positioned within the balloon interior, each emitter station being positioned within the balloon interior at a different longitudinal position 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.

[0009] In some embodiments, the multiple transmitter stations include a first transmitter station and a second transmitter station, wherein 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.

[0010] In various embodiments, the system controller controls the energy source such that energy from the energy source is directed to each of the plurality of emitters alternately in a first excitation mode and a second excitation mode.

[0011] In some embodiments, the first excitation mode includes a first excitation rate of the energy source and a first excitation sequence of each of the plurality of emitters; and the second excitation mode includes a second excitation rate of the energy source and a second excitation sequence of each of the plurality of emitters. In some embodiments, at least one of the following is true: (i) the first excitation rate of the energy source is different from the second excitation rate of the energy source, and (ii) the first excitation sequence of each of the plurality of emitters is different from the second excitation sequence of each of the plurality of emitters.

[0012] In some embodiments, a first firing rate of the energy source is different from a second firing rate of the energy source, and a first firing sequence of each of the plurality of emitters is different from a second firing sequence of each of the plurality of emitters.

[0013] In certain embodiments, the system controller controls at least one of: a firing rate of the energy source and a firing sequence of each of the plurality of emitters.

[0014] In some embodiments, the system controller controls each of: a firing rate of the energy source and a firing sequence of each of the plurality of emitters.

[0015] In various embodiments, the system controller controls the energy source so that energy from the energy source is directed to each of the plurality of emitters one at a time in any desired sequence.

[0016] In certain embodiments, the system controller controls the energy source such that energy from the energy source is directed to each of the plurality of emitters two at a time in any desired sequence.

[0017] In some embodiments, the system controller controls the energy source so that energy from the energy source is directed to each of the plurality of emitters three at a time in any desired sequence.

[0018] In certain 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 plurality of energy directors in the form of individually directed beams.

[0019] In some embodiments, the system controller controls the multiplexer so that energy from the energy source is directed as a separate guided beam into each of the plurality of energy directors in any desired firing sequence.

[0020] In some embodiments, the plurality of energy directors include at least a first energy director and a second energy director. In some embodiments, the system controller controls operation of the multiplexer such that the first guided beam is directed onto the first energy director and the second guided beam is directed onto the second energy director.

[0021] In various embodiments, the energy source is a light source that generates pulses of light energy.

[0022] In some embodiments, the light source is a laser source.

[0023] In certain embodiments, each of the plurality of energy directors comprises an optical fiber.

[0024] 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 with an energy source; connecting a balloon to a catheter shaft, the balloon comprising a balloon wall defining a balloon interior; maintaining a catheter fluid within the balloon interior; selectively receiving energy from the energy source using a plurality of energy directors, each of the plurality of energy directors comprising a director distal end; positioning a plurality of emitters within the balloon interior, each emitter comprising a director distal end of one of the plurality of energy directors and a corresponding plasma generator spaced from the director distal end; emitting energy received by each of the plurality of energy directors from the director distal end to impinge on the corresponding plasma generator, so that plasma is generated in the catheter fluid maintained within the balloon interior; and controlling the energy source using a system controller comprising a processor so that energy from the energy source is alternately directed to each of the plurality of energy directors in a first excitation mode and a second excitation mode different from the first excitation mode.

[0025] 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

[0026] 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 2Ais 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 plurality of transmitter stations; Fig. 9 is a simplified schematic perspective view of a portion of another embodiment of a catheter system including a plurality of transmitter stations; Figure 10A-10B is a simplified schematic diagram of an alternative excitation configuration that may be used in a transmitter station including two transmitters; Figure 11A-11C is a simplified schematic diagram of an alternative firing configuration that may be used in a transmitter station including three transmitters; and Figure 12A-12E is a simplified schematic diagram of an alternative excitation configuration that may be used in a transmitter station comprising four transmitters.

[0027] 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

[0028] 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.

[0029] 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. Thus, intravascular lesions and / or vascular lesions are sometimes referred to herein as "lesions."

[0030] 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.

[0031] 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.

[0032] 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 1In 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.

[0033] As an overview, in various embodiments, system controller 126 is configured to control energy source 124 and / or multiplexer 128 so that energy from energy source 124 is directed to each of energy directors 122A, or a collection or subset of energy directors 122A, in any desired firing sequence, firing mode, firing order, firing energy level, and / or firing rate to effectively treat vascular lesions 106A at treatment site 106. As described herein, each emitter station 180 may include one or more emitters 135 positioned at substantially the same longitudinal position within balloon 104. Each emitter 135 includes at least a director distal end 122D of one of energy directors 122A and a corresponding plasma generation structure 133 (also referred to herein as a "plasma generator") that cooperate to generate plasma within balloon 104. Plasma generation, in turn, results in bubble formation that generates pressure waves that exert pressure adjacent to vascular lesions 106A at treatment site 106. Thus, in order to effectively treat the vascular lesion 106A at the treatment site 106, the system controller 126 can control the energy source 124 and / or the multiplexer 128 so that energy from the energy source 124 is directed to any individual emitter 135 and / or any combination of emitters 135 at any one of the one or more emitter stations 180 in any desired excitation sequence, excitation mode, excitation order, excitation energy level and / or excitation rate.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] 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.

[0042] 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.

[0043] 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).

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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 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 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 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 around the circumference of the guidewire lumen 118 and / or the catheter shaft 110; and 110; six energy directors 122A may be spaced approximately 72 degrees around the circumference of the guidewire lumen 118 and / or catheter shaft 110; six energy directors 122A may be spaced approximately 60 degrees around the circumference of the guidewire lumen 118 and / or catheter shaft 110; eight energy directors 122A may be spaced approximately 45 degrees around the circumference of the guidewire lumen 118 and / or catheter shaft 110; or ten energy directors 122A may be spaced approximately 36 degrees around the circumference of the guidewire lumen 118 and / or catheter shaft 110. Still alternatively, the plurality of energy directors 122A need not be evenly spaced from one another around the circumference of the guidewire lumen 118 and / or 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 catheter shaft 110 to achieve a desired effect at a desired location.

[0048] 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.

[0049] 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.

[0050] Energy directors 122A may have any suitable design for generating 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 energy source 124 being a light source and one or more energy directors 122A being light directors, catheter system 100 may alternatively include any suitable energy source 124 and energy director 122A for generating 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.

[0051] 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.

[0052] Each energy director 122A can direct energy along its length from a director proximal end 122P to a director distal end 122D having at least one optical window (not shown) positioned within the balloon interior 146 .

[0053] 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.

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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.

[0058] 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.

[0059] 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 light energy into acoustic waves that extend from the side surfaces of energy director 122A.

[0060] 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.

[0061] 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.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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 .

[0066] 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.

[0067] In various embodiments, the catheter system 100 is configured to provide a means for providing power to a plurality of transmitter stations in a pressure wave generating device designed to apply pressure on and induce fracture in a vascular lesion 106A (such as a calcified vascular lesion and / or a fibrotic vascular lesion) at a treatment site 106. In many embodiments, the catheter system 100 can be configured and controlled to selectively and / or individually power a plurality of transmitter stations 180 and / or a plurality of transmitters 135 within any given transmitter station 180 in any desired pattern, order, sequence, and firing rate.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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 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.

[0076] 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.

[0077] 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.

[0078] 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 firing 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 energy director 122A in a desired manner (such as in the form of separate guide beams 124B).

[0079] 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 collection 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 emitters 135 contained within any emitter station 180 in any desired excitation sequence, excitation mode, excitation order, excitation energy level, and / or excitation rate. As used herein, the term "excitation rate" is intended to refer to the number of pulses per given time frame. Furthermore, as used herein, the term "excitation energy level" is intended to refer to the intensity of the energy pulses, which may vary according to the pulse width and / or pulse amplitude of any or all of the pulses. Certain non-exclusive examples of alternative applications of sequences for excitation of energy directors 122A and / or emitters 135 within a given emitter station 180 are described in detail below.

[0080] The system controller 126 may also be configured to control the operation of other components of the catheter system 100, such as the positioning of the catheter 102, the guide distal end 122D of the energy director 122A, and / or the emitter 135 adjacent to the treatment site 106, the inflation of the balloon 104 using 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.

[0081] GUI 127 is accessible by a user or operator of catheter system 100. GUI 127 is electrically connected to system controller 126. By such a design, a user or operator can use GUI 127 to ensure that catheter system 100 is effectively utilized to apply pressure to vascular lesions 106A at treatment site 106 and induce fractures in vascular lesions. GUI 127 can provide information to a 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 a 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 a 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 a user or operator. In addition, or alternatively, GUI 127 can provide audio data or information to a user or operator. The details of GUI 127 may vary depending on the design requirements of catheter system 100 or the specific needs, specifications, and / or desires of a 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 may integrate and / or include at least a portion of the system controller 126 within the handle assembly 129. For example, as shown, in some such embodiments, the handle assembly 129 may include a circuit 155 that is electrically coupled between the catheter electronics and the system console 123 and may form at least a portion of the system controller 126. In one embodiment, the circuit 155 may include a printed circuit board having one or more integrated circuits, or any other suitable circuit. In alternative embodiments, the circuit 155 may be omitted, or may be included within the system controller 126, which in various embodiments may 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 may include fewer or more components than 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 some embodiments, the plasma generator 133 may be provided in the form of a backstop structure having an inclined surface that redirects 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 and / or metal alloys having a relatively high melting temperature, such as titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium, iridium, etc. Alternatively, the plasma generator 133 may be formed of at least one of the following: magnesium oxide, beryllium oxide, tungsten carbide, titanium nitride, titanium carbonitride, and titanium carbide. Still alternatively, the plasma generator 133 may be formed of at least one of diamond CVD and diamond. In other embodiments, the plasma generator 133 may be formed of a transition metal, an alloy metal, or a ceramic material. Alternatively again, in some embodiments, the plasma generator 133 may be at least partially formed of a polymer, a polymer material, and / or a plastic (e.g., polyimide and nylon). Still alternatively, the plasma generator 133 may be formed of any other suitable material.

[0090] The following will combine Figure 8 and Fig. 9 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 2AThe 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 2AOnly 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 2AAs 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 2AAs 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 2AThe 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 2B Another 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 3AA 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 3A As 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 3BAs 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 3A In 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 enable sequential firing of energy directors 322A-322C, or firing 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 3A Energy 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 3BAnother 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 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 a separate guide beam 424B to each 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. Thus, 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 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.

[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 guided beam 524B to each 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. Thus, no further description will be given of the various embodiments of the present invention. Figure 5 The 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 5As 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 5 As 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 6 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.

[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 6As 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 7 A 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 7The 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 7 In 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 can be used to generate a ruptured (such as a calcified vascular lesion) requires a plurality of transmitter stations 180 distributed along its effective length on 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 multiple transmitter stations 180 (in Figure 1 ), 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] 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 835 (in Figure 8 842 ), which may be one transmitter 835 or a plurality of transmitters 835. Thus, each of the transmitters 835 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.

[0149] exist Figure 8 In the illustrated embodiment, each transmitter station 880A, 880B includes two transmitters 835, wherein each transmitter 835 is connected to a power source 124 (at Figure 1822A) to deliver energy to the transmitter 835. Thus, in many embodiments, the catheter system 800 relies on multiplexer 128 (in Figure 1 ), the multiplexer 128 combines the energy from the energy source 124 into a single source beam 124A (in Figure 1 ) into a plurality of guided beams 124B (in Figure 1 ), each guide beam 124B is directed into one of a plurality of energy directors 822A. Alternatively, each transmitter station 880A, 880B may include more than two transmitters 835 or only a single transmitter 835.

[0150] In various non-exclusive alternative embodiments, the catheter system 800 may have more than one transmitter 835 at each transmitter station 880, as well as more than one transmitter station 880. As indicated by the system controller 126 ( Figure 1 Various alternative multiplexing algorithms described using and functioning as shown in the Figure 3 can be designed to achieve unique results for lysing calcium. For example, some configurations and excitation sequences may be more effective at lysing eccentric or nodular calcium. Alternatively, other configurations and excitation sequences may be more effective at lysing circumferential calcium. Still alternatively, other configurations and excitation sequences may be better at lysing thick calcium. [Should we provide more specific examples of specific excitation sequences established by using the multiplexing algorithm?]

[0151] exist Figure 8 In another portion of FIG. 8 , an enlarged schematic side view of a single emitter 835 is provided. As shown, emitter 835 may include a guide distal end 822D of energy guide 822A and a corresponding plasma generator 833 spaced apart from but coupleable to guide distal end 822D of energy guide 822A. With this design, energy from energy source 124 is transmitted along energy guide 822A from guide proximal end 122P (at Figure 1 822A) is directed to guide distal end 822D, from which energy is directed toward plasma generator 833. Energy emitted from guide distal end 822D of energy guide 822A impinges upon and / or excites material of plasma generator 833 so that catheter fluid 132 ( Figure 1 ) to generate local plasma and / or generate desired pressure waves for destroying vascular lesions 106A ( Figure 1 ).

[0152] The plasma generator 833 can have any suitable design for redirecting energy emitted from the introducer distal end 822D to generate a local plasma and / or generate a desired pressure wave in the catheter fluid 132 within the balloon interior 846 of the balloon 804. For example, in some embodiments, Figure 8 As shown, the plasma generator 833 can be provided in the form of a backstop structure having an inclined surface 833F that redirects energy emitted from the introducer distal end 822D to generate local plasma and / or generate desired pressure waves in the catheter fluid 132 within the balloon interior 846 of the balloon 804. Therefore, the inclined surface 833F acts like a one-way mirror. In some embodiments, the inclined surface 833F of the plasma generator 833 can be at an angle of between approximately 5 degrees and 45 degrees relative to a flat vertical configuration. Alternatively, the inclined surface 833F of the plasma generator 833 can be at an angle of less than 5 degrees or greater than 45 degrees relative to a flat vertical configuration so as to direct energy in the form of plasma that has been generated in the catheter fluid 132 toward an adjacent treatment site 106 (such as Figure 1 830 is guided by the balloon wall 830 positioned as shown. Still alternatively, the plasma generator 833 may have another suitable design.

[0153] The plasma generator 833 and / or the inclined surface 833F can be formed of any suitable material. For example, in certain non-exclusive embodiments, the plasma generator 833 and / or the inclined surface 833F can be formed of one or more metals and / or metal alloys with relatively high melting temperatures, such as titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium, iridium, etc. Alternatively, the plasma generator 833 and / or the inclined surface 833F can be formed of at least one of the following: magnesium oxide, beryllium oxide, tungsten carbide, titanium nitride, titanium carbonitride and titanium carbide. Still alternatively, the plasma generator 833 and / or the inclined surface 833F can be formed of at least one of diamond CVD and diamond. In other embodiments, the plasma generator 833 and / or the inclined surface 833F can be formed of transition metals, alloy metals or ceramic materials. Alternatively, in some embodiments, the plasma generator 833 and / or the inclined surface 833F may be at least partially formed of a polymer, a polymer material, and / or a plastic (e.g., polyimide and nylon). Still alternatively, the plasma generator 833 and / or the inclined surface 833F may be formed of any other suitable material.

[0154] Fig. 9 is a simplified schematic perspective illustration of a portion of another embodiment of a catheter system 900 . Fig. 9 The embodiment of the catheter system 900 shown in FIG. 1 is substantially similar to Figure 8 An embodiment of a catheter system 800 is shown in FIG. Fig. 9 As shown, the catheter system 900 again includes a balloon 904 having a balloon wall 930 defining a balloon interior 946, and one or more transmitter stations 980, such as a first transmitter station 980A and a second transmitter station 980B in this particular embodiment (although it should be understood that the catheter system 900 may include any suitable number of transmitter stations 980), positioned within the balloon interior 946 of the balloon 904. Each of the transmitter stations 980A, 980B is again 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 position) relative to the length 942 of the balloon 904, and the second transmitter station 980B is positioned at a second longitudinal position 980L2 (or position) relative to the length 942 of the balloon 904 that is different from the first longitudinal position 980L1 (or position).

[0155] Still Fig. 9 In the illustrated embodiment, each transmitter station 980A, 980B again includes two transmitters 935, wherein each transmitter 935 is connected to an energy source 124 (at Figure 1 922A) to deliver energy to the transmitter 935. Thus, in many embodiments, the catheter system 900 again relies on the multiplexer 128 (in Figure 1 ), the multiplexer 128 combines the energy from the energy source 124 into a single source beam 124A (in Figure 1 ) into a plurality of guided beams 124B (in Figure 1 ), each guide beam 124B is directed into one of a plurality of energy directors 922A. Alternatively, each transmitter station 980A, 980B may include more than two transmitters 935 or only a single transmitter 935.

[0156] As described above, such as by the system controller 126 ( Figure 1 Various alternative multiplexing algorithms described using and functioning as shown in FIG. 4 can be designed to achieve unique results for lysing calcium. For example, some configurations and excitation sequences can more effectively lyse eccentric or nodular calcium. Alternatively, other configurations and excitation sequences can more effectively lyse circumferential calcium. Still alternatively, other configurations and excitation sequences can better lyse thick calcium.

[0157] exist Fig. 9In another portion of the drawings, an enlarged schematic perspective view of a single emitter 935 is provided. As shown, emitter 935 may include a guide distal end 922D of energy guide 922A and a corresponding plasma generator 933 spaced apart from but coupleable to guide distal end 922D of energy guide 922A. With this design, energy from energy source 124 is transmitted along energy guide 922A from guide proximal end 122P (at Figure 1 922A) is directed to guide distal end 922D, from which energy is directed toward plasma generator 933. Energy emitted from guide distal end 922D of energy guide 922A impinges upon and / or excites the material of plasma generator 933 so that catheter fluid 132 ( Figure 1 ) to generate local plasma and / or generate desired pressure waves for destroying vascular lesions 106A ( Figure 1 ).

[0158] The plasma generator 933 may again have any suitable design for redirecting energy emitted from the introducer distal end 922D to generate a localized plasma and / or to generate a desired pressure wave in the catheter fluid 132 within the balloon interior 946 of the balloon 904. For example, in some embodiments, Fig. 9 As shown, the plasma generator 933 can again be provided in the form of a backstop structure having an inclined surface 933F that redirects the energy emitted from the introducer distal end 922D to generate local plasma and / or generate a desired pressure wave in the catheter fluid 132 within the balloon interior 946 of the balloon 904. Thus, the inclined surface 933F acts like a one-way mirror. Alternatively, the plasma generator 933 can have another suitable design.

[0159] The plasma generator 933 and / or the inclined surface 933F can be formed of any suitable material. For example, in certain non-exclusive embodiments, the plasma generator 933 and / or the inclined surface 933F can be formed of one or more metals and / or metal alloys having a relatively high melting temperature, such as titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium, iridium, etc. Alternatively, the plasma generator 933 and / or the inclined surface 933F can be formed of at least one of the following: magnesium oxide, beryllium oxide, tungsten carbide, titanium nitride, titanium carbonitride, and titanium carbide. Still alternatively, the plasma generator 933 and / or the inclined surface 933F can be formed of at least one of diamond CVD and diamond. In other embodiments, the plasma generator 933 and / or the inclined surface 933F can be formed of a transition metal, an alloy metal, or a ceramic material. Alternatively, in some embodiments, the plasma generator 933 and / or the inclined surface 933F may be at least partially formed of a polymer, a polymer material, and / or a plastic (e.g., polyimide and nylon). Still alternatively, the plasma generator 933 and / or the inclined surface 933F may be formed of any other suitable material.

[0160] In the following about Figure 10A-10B , Figure 11A-11C and Figure 12A-12E Certain alternative examples of different potential firing sequences for catheter systems and / or transmitter stations having features of the present invention are shown and described.

[0161] Figure 10A-10B 1080 is a simplified schematic diagram of an alternative excitation configuration that may be used within an emitter station 1080 that includes two emitters 1035. As shown, in certain embodiments, the two emitters 1035 may be spaced approximately 180 degrees from one another around the guidewire lumen 1018, for example. Alternatively, the two emitters 1035 may be spaced from one another around the guidewire lumen 1018 in a different manner.

[0162] Specifically, Fig. 10A 1 is a simplified schematic diagram showing a transmitter station 1080 having two transmitters 1035 (such as a first transmitter 1035A and a second transmitter 1035B), wherein each of the two transmitters 1035A, 1035B is fired simultaneously. The simultaneous firing of the two transmitters 1035A, 1035B can then be repeated or varied as desired during the intravascular lithotripsy procedure. It should also be understood that the simultaneous firing of the two transmitters 1035A, 1035B can be performed at any desired and / or suitable firing rate and from the energy source 124 ( Figure 1 The energy (shown in ) is provided at any desired and / or suitable energy level.

[0163] Fig. 10B It is shown Fig. 10AA simplified schematic diagram of a transmitter station 1080 is shown in which each of the two transmitters 1035A, 1035B is individually activated, which can occur in any desired sequence. Fig. 10B In one embodiment of the transmitter station 1080 shown in FIG. 1 , the firing sequence may include first firing the first transmitter 1035A, then firing the second transmitter 1035B, and then repeating this firing sequence during the intravascular lithotripsy procedure. Alternatively, the first transmitter 1035A and the second transmitter 1035B may be fired separately in another suitable sequence during the intravascular lithotripsy procedure. It should also be understood that the sequential firing of the two transmitters 1035A, 1035B may be performed at any desired and / or suitable firing rate and from the energy source 124 ( Figure 1 The energy (shown in ) is provided at any desired and / or suitable energy level.

[0164] It should also be understood that the excitation of the two emitters 1035A, 1035B may be accomplished in any suitable combination of simultaneous and / or sequential excitation modes.

[0165] Figure 11A-11C 1 is a simplified schematic diagram of an alternative excitation configuration that may be used within an emitter station 1180 that includes three emitters 1135. As shown, in certain embodiments, the three emitters 1135 may be spaced approximately 120 degrees from one another around the guidewire lumen 1118, for example. Alternatively, the three emitters 1135 may be spaced from one another around the guidewire lumen 1118 in a different manner.

[0166] Specifically, Fig.11A 1 is a simplified schematic diagram showing a transmitter station 1180 having three transmitters 1135 (such as a first transmitter 1135A, a second transmitter 1135B, and a third transmitter 1135C), wherein each of the three transmitters 1135A-1135C is fired simultaneously. The simultaneous firing of the three transmitters 1135A-1135C can then be repeated or varied therefrom as desired during the intravascular lithotripsy procedure. It should also be understood that the simultaneous firing of the three transmitters 1135A-1135C can be performed at any desired and / or suitable firing rate and from the energy source 124 ( Figure 1 The energy (shown in ) is provided at any desired and / or suitable energy level.

[0167] Fig. 11B It is shown Fig.11A A simplified schematic diagram of a transmitter station 1180 is shown in which three transmitters 1135A-1135C are fired in pairs, which can occur in any desired sequence. Fig. 11BIn one implementation of the embodiment of the transmitter station 1180 shown, the firing sequence may fire the emitters 1135A-1135C in pairs in a circular pattern (such as clockwise). Thus, in such an implementation, the firing sequence may include simultaneously firing the first emitter 1135A and the second emitter 1135B, then simultaneously firing the second emitter 1135B and the third emitter 1135C, then simultaneously firing the third emitter 1135C and the first emitter 1135A, and then repeating such firing sequence during the intravascular lithotripsy procedure. Alternatively, the first emitter 1135A, the second emitter 1135B, and the third emitter 1135C may be fired in pairs in another suitable sequence during the intravascular lithotripsy procedure. It should also be understood that the sequential firing of two of the three emitters 1135A-1135C may be performed at any desired and / or suitable firing rate and from the energy source 124 ( Figure 1 The energy (shown in ) is provided at any desired and / or suitable energy level.

[0168] Fig. 11C It is shown Fig.11A A simplified schematic diagram of a transmitter station 1180 is shown in which each of the three transmitters 1135A-1135C is individually activated, which can occur in any desired sequence. Fig. 11C In one implementation of the embodiment of the transmitter station 1180 shown, the firing sequence may individually fire the emitters 1135A-1135C in a circular pattern (such as clockwise). Thus, in such an implementation, the firing sequence may include first firing the first emitter 1135A, then firing the second emitter 1135B, then firing the third emitter 1135C, and then repeating such firing sequence during the intravascular lithotripsy procedure. Alternatively, the first emitter 1135A, the second emitter 1135B, and the third emitter 1135C may be individually fired in another suitable sequence during the intravascular lithotripsy procedure. It should also be understood that the individual firing of each of the three emitters 1135A-1135C may be performed at any desired and / or suitable firing rate and from the energy source 124 ( Figure 1 The energy (shown in ) is provided at any desired and / or suitable energy level.

[0169] It should also be understood that the firing of the three emitters 1135A-1135C may be accomplished in any suitable combination of simultaneous, two at a time, and / or sequential firing modes.

[0170] Figure 12A-12E12 is a simplified schematic diagram of an alternative excitation configuration that may be used within an emitter station 1280 that includes four emitters 1235. As shown, in certain embodiments, the four emitters 1235 may be spaced apart from each other, such as approximately 90 degrees around the guidewire lumen 1218. Alternatively, the four emitters 1235 may be spaced apart from each other around the guidewire lumen 1218 in a different manner.

[0171] Specifically, Fig. 12A 1 is a simplified schematic diagram showing a transmitter station 1280 having four transmitters 1235 (such as a first transmitter 1235A, a second transmitter 1235B, a third transmitter 1235C, and a fourth transmitter 1235D), wherein each of the four transmitters 1235A-1235D is fired simultaneously. The simultaneous firing of the four transmitters 1235A-1235D can then be repeated or varied therefrom as desired during an intravascular lithotripsy procedure. It should also be understood that the simultaneous firing of the four transmitters 1235A-1235D can be performed at any desired and / or suitable firing rate and from the energy source 124 ( Figure 1 The energy (shown in ) is provided at any desired and / or suitable energy level.

[0172] Fig. 12B It is shown Fig. 12A A simplified schematic diagram of an emitter station 1280 is shown in which four emitters 1235A-1235D are fired in pairs, the pairs of emitters being fired approximately 180 degrees apart from each other around the guidewire lumen 1218, and can occur in any desired sequence. Fig. 12B In one implementation of the illustrated embodiment of the transmitter station 1280, the firing sequence may fire the emitters 1235A-1235D in pairs spaced approximately 180 degrees apart in a circular pattern (such as clockwise). Thus, in such an implementation, the firing sequence may include simultaneously firing the first emitter 1235A and the third emitter 1235C, then simultaneously firing the second emitter 1235B and the fourth emitter 1235D, and then repeating such firing sequence during the intravascular lithotripsy procedure. Alternatively, the first emitter 1235A, the second emitter 1235B, the third emitter 1235C, and the fourth emitter 1235D may be fired in pairs spaced approximately 180 degrees apart in another suitable sequence during the intravascular lithotripsy procedure. It should also be understood that the sequential firing of two of the four emitters 1235A-1235D (such as in pairs spaced approximately 180 degrees apart) may be performed at any desired and / or suitable firing rate and from the energy source 124 (at Figure 1 The energy (shown in ) is provided at any desired and / or suitable energy level.

[0173] Fig. 12C It is shown Fig. 12AA simplified schematic diagram of a transmitter station 1280 is shown in which four transmitters 1235A-1235D are activated in pairs, the pairs of transmitters being activated are spaced approximately 90 degrees apart from each other and can occur in any desired sequence. Fig. 12C In one implementation of the embodiment of the transmitter station 1280 shown, the firing sequence may fire the transmitters 1235A-1235D spaced approximately 90 degrees apart in pairs in a circular pattern, such as clockwise. Thus, in such an implementation, the firing sequence may include simultaneously firing the first transmitter 1235A and the second transmitter 1235B, then simultaneously firing the second transmitter 1235B and the third transmitter 1235C, then simultaneously firing the third transmitter 1135C and the fourth transmitter 1235D, then simultaneously firing the fourth transmitter 1235D and the first transmitter 1235A, and then repeating such firing sequence during the intravascular lithotripsy procedure. Alternatively, the first transmitter 1235A, the second transmitter 1235B, the third transmitter 1235C, and the fourth transmitter 1235D may be fired in pairs spaced approximately 90 degrees apart in another suitable sequence during the intravascular lithotripsy procedure. It should also be understood that the sequential firing of two of the four emitters 1235A-1235D (such as in pairs, spaced approximately 90 degrees apart) may be performed at any desired and / or suitable firing rate and from the energy source 124 (at Figure 1 The energy (shown in ) is provided at any desired and / or suitable energy level.

[0174] Fig.12D It is shown Fig. 12A A simplified schematic diagram of a transmitter station 1280 is shown in which each of the four transmitters 1235A-1235D is individually activated, which can occur in any desired sequence. Fig.12D In one implementation of the embodiment of the transmitter station 1280 shown, the firing sequence may individually fire the emitters 1235A-1235D in a circular pattern, such as clockwise. Thus, in such an implementation, the firing sequence may include first firing the first emitter 1235A, then firing the second emitter 1235B, then firing the third emitter 1235C, then firing the fourth emitter 1235D, and then repeating such firing sequence during the intravascular lithotripsy procedure. Alternatively, the first emitter 1235A, the second emitter 1235B, the third emitter 1235C, and the fourth emitter 1235D may be individually fired in another suitable sequence during the intravascular lithotripsy procedure. It should also be understood that the individual firing of each of the four emitters 1235A-1235D may be performed at any desired and / or suitable firing rate and from the energy source 124 ( Figure 1 The energy (shown in ) is provided at any desired and / or suitable energy level.

[0175] Fig.12E It is shown Fig. 12A A simplified schematic diagram of a transmitter station 1280 is shown in which four transmitters 1235A-1235D are excited in groups of three transmitters 1235, which can occur in any desired sequence. Fig.12E In one implementation of the embodiment of the transmitter station 1280 shown in , the firing sequence may fire the transmitters 1235A-1235D in groups of three transmitters 1235 in a circular pattern, such as clockwise. Thus, in such an implementation, the firing sequence may include simultaneously firing the first transmitter 1235A, the second transmitter 1235B, and the third transmitter 1235C, then simultaneously firing the second transmitter 1235B, the third transmitter 1235C, and the fourth transmitter 1235D, then simultaneously firing the third transmitter 1135C, the fourth transmitter 1235D, and the first transmitter 1235A, then simultaneously firing the fourth transmitter 1235D, the first transmitter 1235A, and the second transmitter 1235B, and then repeating such a firing sequence during the intravascular lithotripsy procedure. Alternatively, the first emitter 1235A, the second emitter 1235B, the third emitter 1235C, and the fourth emitter 1235D may be fired in groups of three emitters 1235 in another suitable sequence during an intravascular lithotripsy procedure. It should also be understood that the sequential firing of three of the four emitters 1235A-1235D may be performed at any desired and / or suitable firing rate and may be performed at any desired and / or suitable firing rate from the energy source 124 ( Figure 1 The energy (shown in ) is provided at any desired and / or suitable energy level.

[0176] It should also be understood that the excitation of the four emitters 1235A-1235D can be accomplished in any suitable combination of simultaneous, three at a time, two at a time, and / or sequential excitation modes.

[0177] 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 individually excite each transmitter station, and / or by individually exciting one or more emitters within each transmitter station, it is possible to implement an excitation sequence or pattern that can be more effective in breaking up localized lesions. Exciting each transmitter station and / or the emitters included in each transmitter station in a desired sequence pattern can more effectively break up a lesion or extended lesion at a specific location.

[0178] In summary, based on the various embodiments of the present invention shown and described in detail herein, the catheter system and related methods disclosed herein may include a catheter configured to be advanced to a vascular lesion, such as a calcified vascular lesion or a fibrotic vascular lesion, at a treatment site 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 the 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.

[0179] In medical devices that generate pressure waves, such as the catheter systems described herein, it is often desirable to have multiple potential output channels or transmitter stations or transmitters for use in a therapeutic procedure.

[0180] 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 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.

[0181] The 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.

[0182] Each energy director can be used in conjunction with a corresponding plasma generator positioned at or near the director distal end of the energy director within the balloon interior of the balloon at the treatment site for generating a localized plasma and / or for generating a desired pressure wave within the balloon interior for destroying vascular lesions. As described herein, the director distal ends of the energy directors and the corresponding plasma generators can be collectively referred to as "emitters." As further noted herein, in some applications, one or more emitters positioned at approximately the same longitudinal position within the balloon interior relative to the length of the balloon can be referred to as a "emitter station."

[0183] Thus, the catheter systems and related methods disclosed herein are configured to provide a means for providing power to a plurality of transmitter stations in a pressure wave generating device designed to apply pressure to and induce fractures in vascular lesions (such as calcified and / or fibrotic vascular lesions). Importantly, in many embodiments, the catheter system can be configured and controlled to selectively and / or individually power a plurality of transmitter stations and / or individual transmitters within any given transmitter station in any desired pattern, order, sequence, and firing rate.

[0184] Although each of the multiple energy directors or emitters can be individually powered in any desired mode, order, sequence, and excitation rate, sets and / or subsets of the multiple energy directors or emitters can also be powered at any given point in time. Each set or subset of the multiple energy directors or emitters can include one or more of the multiple energy directors or emitters. Thus, at any given point in time, power can be directed to one or more of the multiple energy directors or emitters to alternatively produce a first excitation mode, a second excitation mode, a third excitation mode, a fourth excitation mode, and the like. Furthermore, in various applications of the present invention, each excitation mode of an energy director or emitter in such sets and subsets of the multiple energy directors or emitters can be different from each other excitation mode of the energy director or emitter.

[0185] 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.

[0186] 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.

[0187] 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.

[0188] 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.

[0189] 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.

[0190] 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; catheter shaft; a balloon coupled to the catheter shaft, the balloon including a balloon wall defining a balloon interior, the balloon being configured to retain a catheter fluid within the balloon interior; 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 director distal end; a plurality of emitters positioned within the balloon interior, each emitter comprising the guide distal end of one of the plurality of energy directors and a corresponding plasma generator spaced from the guide distal end, energy received by each of the plurality of energy directors being emitted from the guide distal end and impinging on the corresponding plasma generator such that plasma is generated in the catheter fluid held within the balloon interior; and A system controller includes a processor that controls the energy source so that energy from the energy source is alternately directed to each of the plurality of energy directors in a first excitation mode and a second excitation mode different from the first excitation mode.

2. The catheter system according to claim 1, wherein: The generation of the plasma results in bubble formation which generates pressure waves which exert pressure near the vessel wall.

3. The catheter system of claim 1, wherein: Each plasma generator includes an inclined surface that redirects energy emitted from the introducer distal end to generate plasma in the catheter fluid retained within the balloon interior.

4. The catheter system of claim 3, wherein: The inclined surface is formed of one or more of titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium and iridium.

5. The catheter system according to any one of claims 1-4 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.

6. The catheter system of claim 5, 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.

7. The catheter system of claim 1, wherein: The system controller controls the energy source so that energy from the energy source is directed to each of the plurality of emitters alternately in the first excitation mode and the second excitation mode.

8. The catheter system of claim 7, wherein: The first excitation mode comprises a first excitation rate of the energy source and a first excitation sequence of each of the plurality of emitters; and wherein the second excitation mode comprises a second excitation rate of the energy source and a second excitation sequence of each of the plurality of emitters.

9. The catheter system of claim 8, wherein: At least one of the following is true: (i) the first firing rate of the energy source is different from the second firing rate of the energy source, and (ii) the first firing sequence of each of the plurality of emitters is different from the second firing sequence of each of the plurality of emitters.

10. The catheter system of claim 9, wherein: The first firing rate of the energy source is different from the second firing rate of the energy source; and wherein the first firing sequence of each of the plurality of emitters is different from the second firing sequence of each of the plurality of emitters.

11. The catheter system of claim 7, wherein: The system controller controls at least one of: a firing rate of the energy source and a firing sequence of each of the plurality of emitters.

12. The catheter system of claim 11, wherein: The system controller controls each of: a firing rate of the energy source and a firing sequence of each of the plurality of emitters.

13. The catheter system according to any one of claims 11-12, wherein: The system controller controls the energy source so that energy from the energy source is directed to each of the plurality of emitters one at a time in any desired sequence.

14. The catheter system according to any one of claims 11-12, wherein: The system controller controls the energy source so that energy from the energy source is directed to each of the plurality of transmitters two at a time in any desired sequence.

15. The catheter system according to any one of claims 11-12, wherein: The system controller controls the energy source so that energy from the energy source is directed to each of the plurality of transmitters three at a time in any desired sequence.

16. The catheter system of any one of claims 1-15, further comprising a multiplexer that receives energy from the energy source and directs the energy from the energy source to each of the plurality of energy directors in the form of a separate directed beam.

17. The catheter system of claim 16, wherein: The system controller controls the multiplexer so that energy from the energy source is directed as the individual guided beams into each of the plurality of energy directors in any desired firing sequence.

18. The catheter system of claim 16, 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.

19. The catheter system according to any one of claims 1 to 18, wherein: The energy source is a light source that generates pulses of light energy.

20. The catheter system of claim 19, wherein: The light source is a laser source.

21. The catheter system according to any one of claims 1 to 20, wherein: Each of the plurality of energy directors comprises an optical fiber.

22. 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; coupling a balloon to the catheter shaft, the balloon comprising a balloon wall defining a balloon interior; retaining a catheter fluid within the balloon interior; selectively receiving energy from the energy source using a plurality of energy directors, each of the plurality of energy directors comprising a director distal end; positioning a plurality of emitters within the balloon interior, each emitter comprising the director distal end of one of the plurality of energy directors and a corresponding plasma generator spaced apart from the director distal end; emitting energy received by each of the plurality of energy directors from the director distal end to impinge on the corresponding plasma generator such that plasma is generated in the catheter fluid held within the balloon interior; and The energy source is controlled using a system controller including a processor so that energy from the energy source is alternately directed to each of the plurality of energy directors in a first excitation mode and a second excitation mode different from the first excitation mode.

23. The method according to claim 22, wherein: The step of emitting includes: the generation of the plasma causes bubble formation, the bubble formation generates a pressure wave, and the pressure wave exerts pressure near the blood vessel wall.

24. The method according to claim 22, wherein: The step of positioning the plurality of emitters includes each plasma generator including an inclined surface; and wherein the step of emitting includes redirecting energy emitted from the distal end of the introducer using the inclined surface to generate plasma in the catheter fluid maintained within the balloon interior.

25. The method according to claim 24, wherein: The step of positioning the plurality of emitters includes forming the inclined surface from one or more of titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium, and iridium.

26. The method according to any one of claims 22-25 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.

27. The method according to claim 26, wherein: The step of positioning the plurality of transmitter stations includes positioning a first transmitter station comprising a first plurality of transmitters at a first longitudinal position within the balloon interior, and positioning a second transmitter station comprising a second plurality of transmitters at a second longitudinal position within the balloon interior different from the first longitudinal position.

28. The method of claim 22, wherein: The step of controlling includes controlling the energy source with the system controller so that energy from the energy source is directed to each of the plurality of emitters alternately in the first excitation mode and the second excitation mode.

29. The method according to claim 28, wherein: The controlling step includes: the first excitation mode includes a first excitation rate of the energy source and a first excitation sequence of each of the multiple emitters, and the second excitation mode includes a second excitation rate of the energy source and a second excitation sequence of each of the multiple emitters.

30. The method of claim 29, wherein: The step of controlling includes at least one of the following items: (i) the first excitation rate of the energy source is different from the second excitation rate of the energy source, and (ii) the first excitation sequence of each of the multiple emitters is different from the second excitation sequence of each of the multiple emitters.

31. The method according to claim 30, wherein: The controlling step includes: the first firing rate of the energy source is different from the second firing rate of the energy source, and the first firing sequence of each of the plurality of emitters is different from the second firing sequence of each of the plurality of emitters.

32. The method of claim 28, wherein: The step of controlling includes controlling, with the system controller, at least one of a firing rate of the energy source and a firing sequence of each of the plurality of emitters.

33. The method of claim 32, wherein: The step of controlling includes controlling, with the system controller, each of: a firing rate of the energy source and a firing sequence of each of the plurality of emitters.

34. The method according to any one of claims 32-33, wherein: The step of controlling includes controlling the energy source with the system controller such that energy from the energy source is directed to each of the plurality of emitters one at a time in any desired sequence.

35. The method according to any one of claims 32-33, wherein: The step of controlling includes controlling the energy source with the system controller such that energy from the energy source is directed to each of the plurality of emitters two at a time in any desired sequence.

36. The method according to any one of claims 32-33, wherein: The step of controlling includes controlling the energy source with the system controller such that energy from the energy source is directed to each of the plurality of emitters three at a time in any desired sequence.

37. The method according to any one of claims 22 to 36, further comprising the steps of: Energy is received from the energy source using a multiplexer; and energy is directed from the energy source to each of the plurality of energy directors in the form of a separate directed beam using the multiplexer.

38. The method according to claim 37, further comprising the steps of: The multiplexer is controlled with the system controller such that energy from the energy source is directed as the individual guided beams into each of the plurality of energy directors in any desired firing sequence.

39. The method of claim 37, wherein: The selectively receiving step includes: the multiple energy guides include at least a first energy guide and a second energy guide; and wherein the step of controlling the multiplexer includes: using the system controller to control the operation of the multiplexer so that the first guide beam is guided to the first energy guide and the second guide beam is guided to the second energy guide.

40. The method according to any one of claims 22 to 39, wherein: The generating step includes: the energy source is a light source that generates light energy pulses.

41. The method of claim 40, wherein: The generating step includes: the light source is a laser source.

42. The method according to any one of claims 22 to 41, wherein: The selectively receiving step includes each of the plurality of energy directors comprising an optical fiber.

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