Radiator Selection Based on a Radiopaque Radiator Station for an Intravascular Lithotripter

Abstract

A catheter system 100 for placement within a blood vessel 108 having a vessel wall 108A can be used to treat a treatment site 106 within or adjacent to the vessel wall 108A. The catheter system 100 includes an energy source 124, a plurality of energy guides 122A, and a plurality of emitters 135. The energy source 124 generates energy. Each of the energy guides 122A is configured to selectively receive energy from the energy source 124. Each of the energy guides 122A includes a corresponding guide tip 122D. The energy received by each of the energy guides 122A is emitted from the corresponding guide tip 122D. Each of the emitters 135 can be positioned in the vicinity of the treatment site 106. Each of the emitters 135 includes a corresponding guide tip 122D of one of the energy guides 122A. At least one of the emitters 135 includes a radiopaque material.

Description

Technical Field

[0001] Related Applications This application was filed on July 18, 2022, as U.S. Provisional Patent Application No. 63 / 390,102, entitled "EMITTER SELECTION BASED ON RADIOPAQUE EMITTER STATIONS FOR INTRAVASCULAR LITHOTRIPSY DEVICE", and on June 22, 2023, as U.S. Patent Application No. 18 / 339,901, entitled "EMITTER SELECTION BASED ON RADIOPAQUE EMITTER STATIONS FOR INTRAVASCULAR LITHOTRIPSY DEVICE", and claims the benefit of their priority. To the extent permitted, the contents of U.S. Provisional Patent Application No. 63 / 390,102 and U.S. Patent Application No. 18 / 339,901 are hereby incorporated by reference in their entirety into this specification.

Background Art

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

[0003] Vascular lesions can be treated using, among other things, interventions such as drug therapy, balloon angioplasty, atherectomy, stent placement, and vascular graft bypass. Such interventions are not always ideal and subsequent treatment may be required to address the lesion.

Summary of the Invention

[0004] The present invention is directed to a catheter system for placement within a blood vessel having a vessel wall. The catheter system can be used by an operator to treat a treatment site within or adjacent to the vessel wall. In various embodiments, the catheter system includes an energy source, a plurality of energy guides, and a plurality of emitters. The energy source generates energy. Each of the plurality of energy guides is configured to selectively receive energy from the energy source. Each of the plurality of energy guides includes a corresponding guide tip. The energy received by each of the plurality of energy guides is radiated from the corresponding guide tip. Each of the plurality of emitters is positionable in the vicinity of the treatment site. Each of the plurality of emitters includes a corresponding guide tip of one of the plurality of energy guides. At least one of the emitters includes a radiopaque material.

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

[0006] In some embodiments, the catheter system further includes a catheter shaft and a balloon coupled to the catheter shaft. The balloon includes a balloon wall defining an interior of the balloon. The balloon is configured to hold a catheter fluid within the interior of the balloon. The energy guides are arranged along the catheter shaft. The corresponding guide tip of each of the energy guides is positioned within the interior of the balloon such that each of the emitters is positioned within the interior of the balloon.

[0007] In certain embodiments, each emitter further includes a corresponding plasma generator positioned in the vicinity of a corresponding guide tip of one of the plurality of energy guides. The energy received by each of the plurality of energy guides is radiated from the corresponding guide tip and impinges on the corresponding plasma generator, resulting in plasma being generated in the catheter fluid held within the interior of the balloon.

[0008] In some embodiments, plasma generation causes bubble formation by generating a pressure wave that applies pressure in the vicinity of the vessel wall.

[0009] In certain embodiments, the catheter system further includes a plurality of radiator stations positioned within the balloon. Each radiator station can be positioned at a different longitudinal position within the balloon with respect to the length of the balloon from each of the other radiator stations. Each radiator station includes at least one of the plurality of radiators. At least one of the plurality of radiator stations includes a radiopaque material.

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

[0011] In some embodiments, the plurality of radiator stations includes a first radiator station that includes a first plurality of radiators each positioned at a first longitudinal position within the balloon, and a second radiator station that includes a second plurality of radiators each positioned at a second longitudinal position within the balloon that is different from the first longitudinal position.

[0012] In certain embodiments, the catheter system further includes a system controller that includes a processor that controls an energy source such that energy from the energy source is selectively directed to each of the radiators in any desired pattern of emission.

[0013] In some embodiments, the system controller is configured to either specifically select or specifically exclude a radiator that is actuated during use of the catheter system in an intravascular lithotripsy procedure, based at least in part on the proximity of the radiator to the treatment site.

[0014] In certain embodiments, the system controller is configured to selectively activate only the emitters positioned closest to the treatment site.

[0015] In other embodiments, the system controller is configured to selectively deactivate the emitters positioned most distally with respect to the treatment site.

[0016] In some embodiments, the catheter system further includes a graphical user interface including a plurality of emitter actuators that can be used to either specifically select or specifically exclude the emitters that are activated during use of the catheter system in an intravascular lithotripsy procedure.

[0017] In many embodiments, the catheter system further includes a multiplexer that receives energy from an energy source and directs the energy from the energy source in the form of individual guide light rays to each of the energy guides.

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

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

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

[0021] The present invention is a method for treating a treatment site within or in the vicinity of a blood vessel wall, the method comprising generating energy with an energy source, selectively receiving energy from the energy source with each of a plurality of energy guides, each of the plurality of energy guides including a corresponding guide tip, the energy received by each of the plurality of energy guides being radiated from the corresponding guide tip, and positioning a plurality of radiators in the vicinity of the treatment site, each radiator including a corresponding guide tip of one of the plurality of energy guides, at least one of the radiators including a radiopaque material.

[0022] This summary is a general description of some of the teachings of this application and is not intended to be an exclusive or comprehensive treatment of the subject matter. Further details are found in the detailed description and the appended claims. Other aspects will be apparent to those skilled in the art upon reading the following detailed description and viewing the drawings that form a part thereof, but each of them should not be taken in a limiting sense. The scope herein is defined by the appended claims and their legal equivalents.

[0023] The novel features of the invention, as well as the invention itself, will be best understood from the accompanying drawings, which are incorporated in and form a part of the specification, in which like reference numerals refer to like parts, both as to the structure and its operation.

Brief Description of the Drawings

[0024]

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[0025] Embodiments of the present invention are capable of various modifications and alternative forms, specific examples of which are shown by way of example and the drawings, and are described in detail herein. However, it is understood that the scope herein is not limited to the specific embodiments described. On the contrary, it is intended to cover modifications, equivalents, and alternatives falling within the spirit and scope herein.

[0026] Treatment of vascular lesions can reduce serious adverse events or death in the subject being treated. As referred to herein, a serious adverse event is an event that can occur anywhere in the body due to the presence of a vascular lesion. Serious adverse events can include, but are not limited to, serious cardiac adverse events, serious adverse events in peripheral or central vascular structures, serious adverse events in the brain, serious adverse events in the musculoskeletal system, or serious adverse events in any of the internal organs.

[0027] In various embodiments, the catheter systems and related methods disclosed herein can include a catheter configured to advance to a vascular lesion, such as a calcified vascular lesion or a fibrotic vascular lesion, at a treatment site located within or adjacent to a blood vessel in a patient's body. As used herein, the terms "treatment site," "intravascular lesion," and "vascular lesion" are used interchangeably unless otherwise specifically noted. Thus, an intravascular lesion and / or a vascular lesion may sometimes simply be referred to herein as a "lesion."

[0028] Those skilled in the art will recognize that the following detailed description of the invention is merely exemplary and is not intended to be in any way limiting. Other embodiments of the invention will be readily suggested to such persons having the benefit of this disclosure. Here, embodiments of the invention illustrated in the accompanying drawings will be described in detail.

[0029] For clarity, not all of the ordinary features of the embodiments described herein are shown and described. Of course, in the development of such an actual embodiment, numerous implementation-specific decisions must be made to achieve the developer's specific goals, such as adaptation to application-related and business-related constraints, and it will be recognized that these specific goals will vary from one embodiment to another and from one developer to another. Further, such development efforts can be complex and time-consuming, but nevertheless will be recognized as routine engineering efforts by persons having the benefit of this disclosure.

[0030] The catheter systems disclosed herein may include many different forms. Referring now to FIG. 1, a simplified schematic cross-sectional view of a catheter system 100 according to various embodiments is shown. The catheter system 100 is suitable for delivering a pressure wave to induce fragmentation at one or more vascular lesions within or adjacent to the vessel wall of a blood vessel in a patient's body, or within or adjacent to a heart valve. In the embodiment illustrated in FIG. 1, the catheter system 100 may include one or more of a catheter 102, an energy guide bundle 122 including one or more energy guides 122A, a supply manifold 136, a fluid pump 138, an energy source 124, a power supply 125, a system controller 126, a graphic user interface 127 ( "GUI: graphic user interface"), and a multiplexer 128, a system console 123, a handle assembly 129, and one or more of an energy radiation system 131 (also referred to herein as a "radiator system") including one or more radiator stations 180. Alternatively, the catheter system 100 may include more or fewer components than those specifically illustrated and described in connection with FIG. 1.

[0031] The catheter 102 is configured to move into the vessel wall 108A of or adjacent to a blood vessel 108 within the body 107 of the patient 109 to a treatment site 106. The treatment site 106 may include one or more vascular lesions 106A, such as, for example, a calcified vascular lesion. Additionally or alternatively, the treatment site 106 may include a vascular lesion 106A, such as a fibrotic vascular lesion. Further alternatively, in some embodiments, the catheter 102 may be used at a treatment site 106 within or adjacent to a heart valve within the body 107 of the patient 109.

[0032] The catheter 102 may include an inflatable balloon 104 (which may be referred to herein as the "balloon"), a catheter shaft 110, and a guide wire 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 the proximal portion 114 of the catheter system 100 to the distal portion 116 of the catheter system 100. The catheter shaft 110 may include a longitudinal axis 144. The catheter 102 and / or the catheter shaft 110 may also include an internal lumen 118 for the guide wire, which is configured to move over the guide wire 112. As used herein, the internal lumen 118 for the guide wire defines a conduit through which the guide wire 112 extends. The catheter shaft 110 may further include an inflation internal lumen (not shown) and / or various other internal lumens for various other purposes. In some embodiments, the catheter 102 may have a distal opening 120 and may accommodate and follow the guide wire 112 when the catheter 102 is moved and positioned at or near the treatment site 106. In some embodiments, the balloon proximal end 104P may be coupled to the catheter shaft 110 and the balloon distal end 104D may be coupled to the internal lumen 118 for the guide wire.

[0033] Balloon 104 includes a balloon wall 130 that defines a balloon interior 146. Balloon 104 can be selectively inflated with catheter fluid 132 to expand from a constricted state suitable for advancing catheter 102 through a patient's vasculature to an inflated state (shown in FIG. 1) suitable for securing catheter 102 in a fixed position relative to treatment site 106. Stated otherwise, when balloon 104 is in the inflated state, the balloon wall 130 of balloon 104 is configured to be positioned substantially adjacent to treatment site 106. FIG. 1 illustrates the balloon wall 130 of balloon 104 shown separated from treatment site 106 of blood vessel 108 when in the inflated state, it being recognized that this is for ease of illustration. The balloon wall 130 of balloon 104 is typically recognized to be substantially directly adjacent to and / or in contact with treatment site 106 when balloon 104 is in the inflated state.

[0034] As an overview, each of radiator system 131 and / or radiator station 180 of catheter system 100 can include one or more radiators 135 configured to generate plasma and / or pressure waves in catheter fluid 132 within balloon interior 146. Each of radiators 135 includes a corresponding guide tip 122D (which may also be simply referred to herein as a “guide tip”) of one of energy guides 122A positioned within balloon interior 146, and a corresponding plasma generation structure 133 (also referred to herein as a “plasma generator”) positioned in the vicinity of, but typically spaced from, guide tip 122D. Energy from energy source 124 is directed toward energy guide 122A, thereby received, conducted through energy guide 122A, and then radiated from guide tip 122D of energy guide 122A. The energy radiated from guide tip 122D is directed toward and collides with a corresponding plasma generator 133 for the purpose of generating plasma in catheter fluid 132 within balloon interior 146, thereby supplying energy thereto.

[0035] In various embodiments, the radiator station 180 and / or the individual radiators 135 can be formed of and / or include a radiopaque material that is readily visible when used with fluoroscopy during an intravascular lithotripsy procedure. The visibility of the radiator station 180 and / or the radiators 135 through the use of a radiopaque material allows a user or operator to more accurately position the radiator station 180 and / or the radiators 135 substantially adjacent to the vascular lesion 106A, as desired, and / or to selectively activate only the radiator station 180 and / or the radiators positioned closest to the vascular lesion 106A in order to more effectively destroy the vascular lesion 106A. By more accurately positioning the radiator station 180 and / or the radiators substantially adjacent to the vascular lesion 106A of the treatment site 106 and by selectively activating only certain radiator stations and / or radiators based on proximity to the vascular lesion 106A of the treatment site 106, the user or operator can more effectively and efficiently operate the catheter system 100. Accordingly, the user and operator can achieve savings in funds and resources.

[0036] Balloons 104 suitable for use in the catheter system 100 include those that can pass through the vascular structure 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 polymers such as polydimethylsiloxane (PDMS), polyurethane, PEBAX™ material, nylon, or any other suitable material.

[0037] Balloon 104 can have any suitable diameter (in the inflated state). In various embodiments, balloon 104 can have a diameter (in the inflated state) in the range from less than 1 millimeter (mm) to 25 mm. In some embodiments, balloon 104 can have a diameter (in the inflated state) in the range from at least 1.5 mm to 14 mm. In some embodiments, balloon 104 can have a diameter (in the inflated state) in the range from at least 2 mm to 5 mm.

[0038] In some embodiments, balloon 104 can have a length 142 in the range from at least 3 mm to 300 mm. More specifically, in some embodiments, balloon 104 can have a length 142 in the range from at least 8 mm to 200 mm. It is recognized that a balloon 104 having a relatively longer length can be positioned adjacent to a larger treatment site 106 and thus can be used to apply a pressure wave at an exact location within treatment site 106 to a larger vascular lesion 106A or a plurality of vascular lesions 106A to induce fragmentation there. It is further recognized that a longer balloon 104 can also be positioned adjacent to a plurality of treatment sites 106 in a timely manner.

[0039] Balloon 104 can be inflated to an inflation pressure between approximately 1 atmosphere (atm) and 70 atm. In some embodiments, balloon 104 can be inflated to an inflation pressure in the range from at least 20 atm to 60 atm. In other embodiments, balloon 104 can be inflated to an inflation pressure in the range from at least 6 atm to 20 atm. In still other embodiments, balloon 104 can be inflated to an inflation pressure in the range from at least 3 atm to 20 atm. In yet other embodiments, balloon 104 can be inflated to an inflation pressure in the range from at least 2 atm to 10 atm.

[0040] 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 cone / square shape, a cone / spherical shape, an elongated spherical shape, an elliptical shape, a tapered 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, for example, an anti-inflammatory agent, an anti-neoplastic agent, an anti-angiogenic agent, and the like.

[0041] The catheter fluid 132 can be a liquid or a gas. Some examples of catheter fluids 132 suitable for use include, but are not limited to, water, saline, a contrast medium, a fluorocarbon, a perfluorocarbon, a gas such as carbon dioxide, or one or more of any other suitable catheter fluids 132. In some embodiments, the catheter fluid 132 can be used as a base inflation fluid. In some embodiments, the catheter fluid 132 can include a mixture of saline and a contrast medium in an approximate volume ratio of 50:50. In other embodiments, the catheter fluid 132 can include a mixture of saline and a contrast medium in an approximate volume ratio of 25:75. In yet other embodiments, the catheter fluid 132 can include a mixture of saline and a contrast medium in an approximate volume ratio of 75:25. However, it is understood that any suitable ratio of saline and a contrast medium can be used. The catheter fluid 132 can be adjusted based on its composition, viscosity, etc., such that the propagation speed of the pressure wave is appropriately manipulated. In certain embodiments, the catheter fluid 132 suitable for use is biocompatible. The amount of the catheter fluid 132 can be adjusted depending on the selected energy source 124 and the type of catheter fluid 132 used.

[0042] In some embodiments, the contrast agent used in the contrast medium may include, but is not limited to, iodine-based contrast agents such as ionic or non-ionic iodine-based contrast agents. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, metrizoate, iotalamate, 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 fluorocarbons and perfluorocarbon agents may include, but are not limited to, agents such as dodecafluoropentane (DDFP) of perfluorocarbon.

[0043] The catheter fluid 132 may include those containing an absorbent that can selectively absorb light in the ultraviolet region (e.g., at least 10 nanometers (nm) to 400 nm), visible region (e.g., at least 400 nm to 780 nm), or near-infrared region (e.g., at least 780 nm to 2.5 μm) of the electromagnetic spectrum. Suitable absorbents may include those having an absorption maximum along the spectrum from at least 10 nm to 2.5 μm. Alternatively, the catheter fluid 132 may include those containing an absorbent that can selectively absorb light in the mid-infrared region (e.g., at least 2.5 μm to 15 μm) or far-infrared region (e.g., at least 15 μm to 1 mm) of the electromagnetic spectrum. In various embodiments, the absorbent may have an absorption maximum that coincides with 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 may include a neodymium:yttrium-aluminum-garnet (Nd:YAG - emission maximum = 1064 nm) laser, a holmium:YAG (Ho:YAG - emission maximum = 2.1 μm) laser, or an erbium:YAG (Er:YAG - emission maximum = 2.94 μm) laser. In some embodiments, the absorbent may be water-soluble. In other embodiments, the absorbent may not be water-soluble. In some embodiments, the absorbent used in the catheter fluid 132 may be adjusted to coincide with the peak emission of the energy source 124. Various energy sources 124 having a radiation wavelength from at least 10 nanometers to 1 millimeter are discussed elsewhere in this specification.

[0044] The catheter shaft 110 of the catheter 102 can be coupled to a plurality of energy guides 122A of an energy guide bundle 122 that is optically in communication with an energy source 124. The energy guides 122A can be arranged within the balloon 104 along the catheter shaft 110. Each of the energy guides 122A can have a guide tip 122D at any suitable longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the internal cavity 118 for the guide wire. For example, in certain embodiments, the first radiator station 180 can include one or more radiators 135, and the guide tips 122D of each radiator 135 within the first radiator station 180 and the corresponding plasma generators 133 can be positioned at a first longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the internal cavity 118 for the guide wire, even if they can be slightly spaced apart from each other. The second radiator station 180 can include one or more radiators 135, and the guide tips 122D of each radiator 135 within the second radiator station 180 and the corresponding plasma generators 133 can be positioned at a second longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the internal cavity 118 for the guide wire, even if they can be slightly spaced apart from each other, and the second longitudinal position is different from the first longitudinal position. It is recognized that the catheter system 100 can include any suitable or desired number of radiator stations 180, each positioned at a different longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the internal cavity 118 for the guide wire. Each radiator station 180 can include any suitable or desired number of radiators 135, and it is further recognized that each radiator 135 within a given radiator station 180 is necessarily at approximately the same longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the internal cavity 118 for the guide wire.

[0045] In some embodiments, each energy guide 122A can be an optical fiber and the energy source 124 can be a laser. The energy source 124 can be optically communicable with the energy guide 122A at the proximal portion 114 of the catheter system 100. More specifically, as detailed herein, the energy source 124 can be selectively and / or alternately optically communicable with each of the energy guides 122A by the presence and operation of the multiplexer 128.

[0046] In some embodiments, the catheter shaft 110 can be coupled to a plurality of energy guides 122A, such as a first energy guide, a second energy guide, a third energy guide, etc., which can be arranged around and / or relative to the internal lumen 118 for the guide wire and / or the catheter shaft 110 at any suitable location. For example, in certain non-exclusive embodiments, two energy guides 122A can be spaced approximately 180 degrees apart from each other around the internal lumen 118 for the guide wire and / or the catheter shaft 110, or three energy guides 122A can be spaced approximately 120 degrees apart from each other around the internal lumen 118 for the guide wire and / or the catheter shaft 110, or four energy guides 122A can be spaced approximately 90 degrees apart from each other around the internal lumen 118 for the guide wire and / or the catheter shaft 110, or five energy guides 122A can be spaced approximately 72 degrees apart from each other around the internal lumen 118 for the guide wire and / or the catheter shaft 110, or six energy guides 122A can be spaced approximately 60 degrees apart from each other around the internal lumen 118 for the guide wire and / or the catheter shaft 110, or eight energy guides 122A can be spaced approximately 45 degrees apart from each other around the internal lumen 118 for the guide wire and / or the catheter shaft 110, or ten energy guides 122A can be spaced approximately 36 degrees apart from each other around the internal lumen 118 for the guide wire and / or the catheter shaft 110. Further alternatively, the plurality of energy guides 122A need not be evenly spaced from each other around the internal lumen 118 for the guide wire and / or the catheter shaft 110. More specifically, it is further recognized that the energy guides 122A can be arranged uniformly or non-uniformly around the internal lumen 118 for the guide wire and / or the catheter shaft 110 to achieve a desired effect at a desired location.

[0047] In certain embodiments, the inner lumen 118 for the guide wire can have a grooved outer surface, and the groove extends generally longitudinally along the inner lumen 118 for the guide wire. In such embodiments, each of the energy guides 122A can be positioned, received, and held along and / or within the respective grooves formed along and / or in the outer surface of the inner lumen 118 for the guide wire. Alternatively, the inner lumen 118 for the guide wire can be formed without a grooved outer surface, and the position of the energy guide 122A relative to the inner lumen 118 for the guide wire can be maintained in another suitable manner.

[0048] The catheter system 100 and / or the energy guide bundle 122 can include any number of energy guides 122A that are optically in communication with the energy source 124 at the proximal portion 114 and 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 guide bundle 122 can include from one energy guide 122A to more than thirty energy guides 122A. Each guide tip 122D of the energy guide 122A can 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 radiator stations 180. Alternatively, in other embodiments, the catheter system 100 and / or the energy guide bundle 122 can include more than thirty energy guides 122A.

[0049] The energy guide 122A can have any suitable design that is useful and suitable for the purpose of enabling the generation of plasma and / or pressure waves in the catheter fluid 132 inside the balloon 146. Accordingly, a general description of the energy guide 122A as an optical waveguide is not intended to be limiting in any way except as set forth in the claims appended hereto. More specifically, the catheter system 100 is often described with an energy source 124 as a light source and one or more energy guides 122A as optical waveguides, but the catheter system 100 can alternatively include any suitable energy source 124 and energy guide 122A for the purpose of enabling the generation of a desired plasma in the catheter fluid 132 inside the balloon 146. For example, in one non-exclusive alternative embodiment, the energy source 124 can be configured to supply high voltage pulses, and each energy guide 122A can include an electrode pair including spaced electrodes extending into the balloon 146. In such an embodiment, each high voltage pulse is applied to the electrodes, forming an electrical arc across the electrodes, which then generates a plasma and forms a pressure wave that is utilized to impart a crushing force to the vascular lesion 106A at the treatment site 106 in the catheter fluid 132. Further alternatively, the energy source 124 and / or the energy guide 122A can have another suitable design and / or configuration.

[0050] In certain embodiments, the energy guide 122A can include an optical fiber or a flexible light pipe. The energy guide 122A can be thin and flexible, allowing optical signals to be transmitted with little loss of intensity. The energy guide 122A can include a core surrounded by a cladding. In some embodiments, the core can be a cylindrical core or a partially cylindrical core. The core and cladding of the energy guide 122A can be formed from one or more materials including, but not limited to, one or more glasses, silica, or one or more polymers. The energy guide 122A can also include a protective coating such as a polymer. It is recognized that the refractive index of the core is greater than the refractive index of the cladding.

[0051] Each energy guide 122A can conduct energy along its length from the guide proximal end 122P to the guide distal end 122D, and the guide distal end 122D has at least one optical window (not shown) positioned within the balloon interior 146.

[0052] The energy guide 122A can take many configurations around and / or with respect to the catheter shaft 110 of the catheter 102. In some embodiments, the energy guide 122A can extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the energy guide 122A can be arranged along the length of the outer diameter of the catheter shaft 110. In still other embodiments, the energy guide 122A can be arranged within one or more energy guide internal cavities within the catheter shaft 110.

[0053] The energy guide 122A can also be arranged at any suitable position around the internal cavity 118 for the guide wire and / or the catheter shaft 110, and each guide end portion 122D of the energy guide 122A is for the purpose of destroying the vascular lesion 106A at the treatment site 106, to apply pressure waves more effectively and accurately, with respect to the length 142 of the balloon 104 and / or with respect to the length of the internal cavity 118 for the guide wire, it can be arranged at any suitable longitudinal position (within any suitable or desired radiator station 180).

[0054] In certain embodiments, the energy guide 122A can include one or more photoacoustic transducers 153, in which case each photoacoustic transducer 153 can be optically in communication with the energy guide 122A in which it is arranged. In some embodiments, the photoacoustic transducer 153 can be optically in communication with the guide end portion �22D of the energy guide 122A. In such embodiments, the photoacoustic transducer 153 can have a shape corresponding to and / or conforming to the guide end portion 122D of the energy guide 122A.

[0055] The photoacoustic transducer 153 is configured to convert light energy into acoustic waves at or near the guide end portion 122D of the energy guide 122A. The direction of the acoustic wave can be adjusted by changing the angle of the guide end portion 122D of the energy guide 122A.

[0056] In certain embodiments, the photoacoustic transducer 153 arranged at the guide end portion 122D of the energy guide 122A can take the same shape as the guide end portion 122D of the energy guide 122A. For example, in certain non-exclusive embodiments, the photoacoustic transducer 153 and / or the guide end portion 122D can have a conical shape, convex shape, concave shape, bulbous shape, square shape, stepped shape, semi-circular shape, oval shape, etc. The energy guide 122A can further include additional photoacoustic transducers 153 arranged along one or more sides of the length of the energy guide 122A.

[0057] In some embodiments, the energy guide 122A may further include one or more turning structures or "turners" (not shown in FIG. 1) configured to direct energy from the energy guide 122A toward a side surface that may be located at or near the guide end portion 122D of the energy guide 122A before the energy is directed toward the balloon wall 130, such as within the energy guide 122A and / or near the guide end portion 122D of the energy guide 122A. The turning structure may include any structure of the system that turns energy from the axial path of the energy guide 122A toward the side surface of the energy guide 122A. The energy guide 122A may include one or more optical windows, each arranged along the longitudinal or circumferential surface of each energy guide 122A and in optical communication with the turning structure. Stated otherwise, the turning structure may have any suitable structural configuration configured to direct the energy in the energy guide 122A toward a side surface at or near the guide end portion 122D, in which case the side surface is in optical communication with the optical window. The optical window may include a portion of the energy guide 122A that allows energy to exit the energy guide 122A from within the energy guide 122A, such as a portion of the energy guide 122A that lacks cladding material on or around the energy guide 122A.

[0058] Examples of steering structures suitable for use include reflective elements, refractive elements, fiber diffusers, and the like. Steering structures suitable for focusing energy away from the tip of the energy guide 122A can include, but are not limited to, those having a convex surface, gradient-index (GRIN) lenses, and mirror focus lenses. When in contact with the steering structure, the energy is redirected within the energy guide 122A to one or more of the plasma generator 133 and the photoacoustic transducer 153 that are optically in contact with the side surface of the energy guide 122A. When utilized, the plasma generator 133 receives the energy radiated from the guide end portion 122D of the energy guide 122A and generates a plasma in the catheter fluid 132 within the balloon interior 146, which in turn can cause the generation of plasma bubbles and / or pressure waves that are directed away from the side surface of the energy guide 122A and towards the balloon wall 130. Additionally or alternatively, when utilized, the photoacoustic transducer 153 converts the optical energy into acoustic waves that spread away from the side surface of the energy guide 122A.

[0059] 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 inflation conduit 140 that is fluidly connected and in communication with a plurality of energy guides 122A of the energy guide bundle 122, the guide wire 112, and / or the fluid pump 138. The catheter system 100 can also optionally include a fluid pump 138 configured to inflate the balloon 104 with the catheter fluid 132.

[0060] As described above, in the embodiment illustrated in FIG. 1, 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 or fewer components than specifically illustrated in FIG. 1. For example, in certain non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127. Further alternatively, one or more of the energy source 124, the power supply 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.

[0061] As shown, the system console 123 and the components included therewith are operably coupled to the catheter 102, the energy guide bundle 122, and the remainder of the catheter system 100. For example, in some embodiments, as illustrated in FIG. 1, the system console 123 can include a console interface 148 (which may sometimes be generally referred to as a “socket” or “console receptacle”), whereby the energy guide bundle 122 is mechanically coupled to the system console 123. In such embodiments, the energy guide bundle 122 can include an optical connector assembly having a guide connection housing 150 (which may sometimes be generally referred to as a “connector housing”) that houses portions such as each guide proximal end 122P of the energy guide 122A. At least a portion of the guide connection housing 150 is configured to fit within and be selectively retained within the console interface 148 to effect a mechanical connection between the energy guide bundle 122 and the system console 123.

[0062] The energy guide bundle 122 may also include a guide bundler 152 (or "shell") that brings each of the individual energy guides 122A closer together so that the energy guide 122A and / or the energy guide bundle 122 can be in a smaller form when it extends with the catheter 102 into the blood vessel 108 during use of the catheter system 100.

[0063] The energy source 124 can be optically communicated with and selectively and / or alternatively coupled to each of the energy guides 122A within the energy guide bundle 122. In particular, the energy source 124 is configured to generate energy in the form of source light rays 124A, such as pulsed source light rays, that are selectively and / or alternatively directed to each of the energy guides 122A within the energy guide bundle 122 and thereby received. More specifically, as will be described in more detail hereinbelow, the source light rays 124A from the energy source 124 are directed through a multiplexer 128 such that individual guide light rays 124B (or "multiplexed light rays") are selectively and / or alternatively directed to each of the energy guides 122A within the energy guide bundle 122 and thereby received. In particular, each pulse of the energy source 124 and / or each pulse of the source light rays 124A can be directed through the multiplexer 128 to generate a separate guide light ray 124B that is selectively and / or alternatively directed to one of the energy guides 122A within the energy guide bundle 122. Thus, the energy source 124 can be utilized to provide energy to any of the radiators 135 at any of the radiator stations 180 that can be included within the catheter system 100 through the use and / or application of the multiplexer 128. Alternatively, the catheter system 100 can include a plurality of energy sources 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 can include a separate energy source 124 for each of the energy guides 122A within the energy guide bundle 122.

[0064] Energy source 124 can have any suitable design. In certain embodiments, energy source 124 is configured to supply sub-millisecond pulses of energy from energy source 124 that are focused to a small point for connection to guide proximal end 122P of energy guide 122A. Such pulses of energy are then directed and / or guided along energy guide 122A to a location within balloon interior 146 of balloon 104, thereby inducing plasma formation in catheter fluid 132 within balloon interior 146 of balloon 104, such as via plasma generator 133 that may be located at or near guide distal end 122D of energy guide 122A. In particular, the energy radiated at guide distal end 122D of energy guide 122A is directed toward plasma generator 133, collides with it, and imparts energy to it to form plasma in catheter fluid 132 within balloon interior 146. Plasma formation causes rapid bubble formation and applies a pressure wave to treatment site 106. Exemplary plasma-induced bubbles 134 are illustrated in FIG. 1.

[0065] As used herein, guide distal end 122D of energy guide 122A and corresponding plasma generator 133 may be collectively referred to as radiator 135. In some applications, one or more radiators 135 positioned at generally the same longitudinal position within balloon interior 146 relative to length 142 of balloon 104 may be referred to as a "radiator station," such as one or more radiator stations 180 included as part of radiator system 131 illustrated in FIG. 1.

[0066] In various embodiments, catheter system 100 is configured to provide means for powering a plurality of radiator stations 180 in a pressure wave generator designed to apply pressure to and induce fragmentation of vascular lesion 106A, such as a calcified vascular lesion and / or a fibrotic vascular lesion, at treatment site 106.

[0067] In many embodiments, one or more emitters 135 and / or emitter stations 180 can be formed from a particular material such that the plurality of emitters 135 and / or emitter stations 180 are more visible to a user or operator during use of the catheter system 100. For example, in many embodiments, one or more emitters 135 and / or emitter stations 180 can be formed from and / or include a radiopaque material that is readily visible when used with fluoroscopy during an intravascular lithotripsy procedure. Thus, the visibility of the emitter 135 and / or emitter station 180 enables a user or operator to more accurately position the emitter 135 and / or emitter station 180, as desired, substantially adjacent to the vascular lesion 106A, and / or to selectively activate only the emitter station 180 that is positioned closest to the vascular lesion 106A in order to more effectively ablate the vascular lesion 106A of the treatment site 106. Alternatively, the emitter 135 and / or emitter station 180 can be formed from other suitable materials that can be made more visible to a user or operator during an intravascular lithotripsy procedure.

[0068] In various non-exclusive alternative embodiments, the submillisecond pulses of energy from the energy source 124 can be delivered to the 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, the submillisecond pulses of energy can be delivered to the treatment site 106 at a frequency that can be greater than 5000 Hz or less than 1 Hz, or any other suitable range of frequencies.

[0069] The energy source 124 is typically utilized to supply pulses of energy, although it is recognized that the energy source 124 can still be described as supplying a single source beam 124A, such as a single pulsed source beam.

[0070] Suitable energy sources 124 can include various types of light sources, including lasers and lamps. Alternatively, energy source 124 can include any suitable type of energy source.

[0071] Suitable lasers can include short-pulse lasers on the sub-millisecond time scale. In some embodiments, energy source 124 can include lasers on the nanosecond (ns) time scale. Lasers can also include short-pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (μs) time scales. It is recognized that there are many combinations of laser wavelength, pulse width, and energy level that can be used to form plasma in the catheter fluid 132 of catheter 102. In various non-exclusive alternative embodiments, pulse widths can include those within a range including at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable range of pulse widths can be used.

[0072] Exemplary nanosecond lasers can include those within the UV to IR spectrum, with wavelengths ranging from about 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, energy sources 124 suitable for use in catheter system 100 can include those capable of generating light with wavelengths from at least 750 nm to 2000 nm. In other embodiments, energy source 124 can include those capable of generating light with wavelengths from at least 700 nm to 3000 nm. In still other embodiments, energy source 124 can include those capable of generating light with wavelengths from at least 100 nm to 10 micrometers (μm). Nanosecond lasers can include those with 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 pulsed fiber laser.

[0074] In still other embodiments, the energy source 124 may include a plurality of lasers grouped together in series. In yet other embodiments, the energy source 124 may include one or more low-energy lasers provided to a high-energy amplifier such as a master oscillator power amplifier (MOPA). In still yet other embodiments, the energy source 124 may include a plurality of lasers that can be combined in parallel or in series to supply the energy required to generate plasma bubbles 134 in the catheter fluid 132.

[0075] The catheter system 100 can generate a pressure wave having a maximum pressure in the range of at least 1 megapascal (MPa) to 100 MPa. The maximum pressure generated by a particular catheter system 100 varies depending on the energy source 124, the absorbent material, the expansion of the bubbles, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter system 100 can generate a pressure wave having a maximum pressure in the range of at least approximately 2 MPa to 50 MPa, at least approximately 2 MPa to 30 MPa, or at least approximately 15 MPa to 25 MPa.

[0076] A pressure wave can be applied to the treatment site 106 from a distance within a range of at least approximately 0.1 millimeter (mm) to more than approximately 25 mm radially extending from the energy guide 122A when the catheter 102 is positioned at the treatment site 106. In various non-exclusive alternative embodiments, the pressure wave can be applied to the treatment site 106 from a distance within a range of at least approximately 10 mm to 20 mm, at least approximately 1 mm to 10 mm, at least approximately 1.5 mm to 4 mm, or at least approximately 0.1 mm to 10 mm radially extending from the energy guide 122A when the catheter 102 is positioned at the treatment site 106. In other embodiments, the pressure wave can be applied to the treatment site 106 from another suitable distance different from the aforementioned ranges. In some embodiments, the pressure wave can be applied to the treatment site 106 at a distance of at least approximately 0.1 mm to 10 mm and within a range of at least approximately 2 MPa to 30 MPa. In some embodiments, the pressure wave can be applied to the treatment site 106 at a distance of at least approximately 0.1 mm to 10 mm and within a range of at least approximately 2 MPa to 25 MPa. Additionally alternatively, other suitable pressure ranges and distances can be used.

[0077] The power supply 125 is electrically connected 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 supply the necessary power thereto. The power supply 125 can have any design suitable for such purposes.

[0078] The system controller 126 is electrically connected to the power supply 125 and receives power therefrom. The system controller 126 is connected to each of the energy source 124, the GUI 127, and the multiplexer 128 and is configured to control their operations. The system controller 126 may include one or more processors or circuits for the purpose of controlling at least the operations of the energy source 124, the GUI 127, and the multiplexer 128. For example, the system controller 126 may control the energy source 124 to generate pulses of energy as desired and / or at any desired emission frequency. The system controller 126 may then control the multiplexer 128 such that the energy from the energy source 124 as the supply beam 124A can be selectively and / or alternately directed to each of the energy guides 122A in the form of individual guide beams 124B, for example, in any desired emission sequence and emission pattern.

[0079] More specifically, the system controller 126 can control the energy source 124 and / or the multiplexer 128 such that each individual guide beam 124B can be directed to each of the energy guides 122A, or a set or subset of the energy guides 122A, at any desired emission sequence, emission pattern, emission order, emission energy level (which can be affected by any or all of pulse width, pulse amplitude, and / or pulse wavelength), and / or emission frequency. In this way, the system controller 126 can control the energy source 124 and / or the multiplexer 128 such that each individual guide beam 124B can be directed to any one of the radiator stations 180 and / or any one of the radiators 135 incorporated within any one of the radiator stations 180 at any desired emission sequence, emission pattern, emission order, emission energy level, and / or emission frequency. For example, in a catheter system 100 including eight energy guides 122A that are oriented at a helical angle around the internal cavity 118 for the guide wire and arranged in a linear pattern, the system controller 126 can control the sequence of emission of energy from the energy source 124 to each of the energy guides 122A, or a set or subset thereof, in any desired manner. As used herein, the term "emission frequency" is intended to mean the number of pulses per given time frame. Further, as used herein, the term "emission energy level" is intended to mean the intensity of an energy pulse that can be varied according to the pulse width and / or pulse amplitude of any or all of the energy pulses. Certain non-exclusive examples of the application of interleaving the sequencing of emission of the energy guides 122A and / or the radiators 135 within a given radiator station 180 are described in detail below herein.

[0080] The system controller 126 may further be configured to control the operation of other components of the catheter system 100, such as the positioning of the catheter 102 in the vicinity of the treatment site 106, the guide tip 122D of the energy guide 122A, and / or the radiator 135 (or radiator station 180), the inflation of the balloon 104 with the catheter fluid 132, etc. Further or alternatively, the catheter system 100 may include one or more additional controllers that may be positioned in any suitable manner for the purpose of controlling the various operations of the catheter system 100. For example, in certain embodiments, the additional controller and / or portions of the system controller 126 may be positioned within and / or incorporated into the handle assembly 129.

[0081] The GUI 127 is accessible by a user or operator of the catheter system 100. The GUI 127 is electrically connected to the system controller 126. Using such a design, the GUI 127 can be used by the user or operator to ensure that the catheter system 100 is effectively utilized to apply pressure to the vascular lesion 106A at the treatment site 106 and induce fragmentation. More specifically, in certain embodiments, the GUI 127 enables the user or operator to select and / or exclude either the radiator station 180 and the individual radiators 135 to more effectively and efficiently generate plasma in the catheter fluid 132 within the balloon interior 146, and thus apply pressure to the vascular lesion 106A at the treatment site 106 and induce fragmentation.

[0082] The GUI 127 can be used before, during, and after the use of the catheter system 100 and can provide information to the user or operator. In certain embodiments, the GUI 127 can provide static visual data and / or information to the user or operator. Additionally or alternatively, the GUI 127 can provide dynamic visual data and / or information, such as video data or any other data that changes over time during the use of the catheter system 100, to the user or operator. In various embodiments, the GUI 127 can include one or more colors, different sizes, changing brightness, etc., that can act as warnings to the user or operator. Additionally or alternatively, the GUI 127 can provide audio data or information to the user or operator. The specifications of the GUI 127 can vary according to the design requirements of the catheter system 100, or the specific requirements, special circumstances, and / or desires of the user or operator.

[0083] The multiplexer 128 is configured to selectively and / or alternately direct energy from the energy source 124 to each of the energy guides 122A within the energy guide bundle 122. More specifically, the multiplexer 128 receives energy from the energy source 124, such as in the form of a single source beam 124A from a single laser source, and is configured to selectively and / or alternately direct such energy to each of the energy guides 122A within the energy guide bundle 122, in the form of individual guide beams 124B as desired. In this way, the multiplexer 128 enables a single energy source 124 to be separately sent through a plurality of energy guides 122A in any desired sequence or pattern, such that the catheter system 100 can apply pressure to the vascular lesion 106A at the treatment site 106 within or adjacent to the vessel wall 108A of the blood vessel 108 in a desired manner and induce fragmentation. As shown, in certain particular embodiments, the catheter system 100 can include one or more optical elements 147 for the purpose of directing energy, such as source beam 124A, from the energy source 124 to the multiplexer 128.

[0084] The multiplexer 128 can have any suitable design for the purpose of selectively and / or alternately directing energy from the energy source 124 to each of the energy guides 122A of the energy guide bundle 122. Various non-exclusive alternative embodiments of the multiplexer 128 are described in detail below herein in connection with FIGS. 2A-7.

[0085] As shown in FIG. 1, the handle assembly 129 can be positioned at or near the proximal end portion 114 of the catheter system 100. In this embodiment, the handle assembly 129 is connected to and positioned remotely from the balloon 104. Alternatively, the handle assembly 129 can be positioned at another suitable location.

[0086] The handle assembly 129 is attached to the catheter shaft 110 and is handled and used by a user or operator to manipulate, position, and control the catheter 102. The design and specific features of the handle assembly 129 can vary according to the design requirements of the catheter system 100. In the embodiment illustrated in FIG. 1, the handle assembly 129 is separated from, but in electrical and / or fluid communication with, one or more of the system controller 126, the energy source 124, the fluid pump 138, and the GUI 127.

[0087] In some embodiments, the handle assembly 129 can integrate and / or include at least a portion of the system controller 126 inside the handle assembly 129. For example, as shown, in certain embodiments, the handle assembly 129 can include a circuit 155 that is electrically coupled between the catheter electronics and the system console 123 and that can form at least a portion of the system controller 126. In some embodiments, the circuit 155 can include a printed circuit board having one or more integrated circuits, or any other suitable circuit. In alternative embodiments, the circuit 155 can be omitted or can be included within the system controller 126, such as within the system console 123, and located outside the handle assembly 129 in various embodiments. It is understood that the handle assembly 129 can include fewer or additional components than those specifically illustrated and described herein.

[0088] The emitter system 131 includes one or more emitter stations 180 (preferably a plurality of emitter stations 180), with each emitter station 180 including one or more emitters 135 (preferably a plurality of emitters 135). As described, each of the emitters 135 includes one of the guide end portions 122D of the energy guides 122A and a corresponding plasma generator 133. As referred to herein, a "plasma generator" can include and / or incorporate any suitable type of structure located at or near the guide end portion 122D of the energy guide 122A. In many embodiments, the plasma generator 133 can be positioned slightly spaced from the guide end portion 122D of the energy guide 122A. In certain embodiments, the plasma generator 133 can be provided in the form of an anti-reversal structure having an inclined surface that redirects the energy radiated from the guide end portion 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.

[0089] 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 when directed by the multiplexer 128, and radiate the energy from the guide tip 122D towards the plasma generator 133. The energy radiated from the guide tip 122D impinges on and energizes the material of the plasma generator 133, such as the material on the inclined surface of the plasma generator 133, for the purpose of generating plasma in the catheter fluid 132 within the balloon interior 146. Plasma generation ionizes and / or superheats the surrounding catheter fluid 132, which results in rapid inertial bubble formation and applies a pressure wave to the treatment site 106.

[0090] The plasma generator 133 can be formed from any suitable material. For example, in certain non - exclusive embodiments, the plasma generator 133 can be formed from one or more metals such as titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium, iridium, etc. Alternatively, the plasma generator 133 can be formed from plastics such as polyimide and nylon. Further alternatively, the plasma generator 133 can be formed from other suitable materials.

[0091] Further details of various embodiments of the emitter system 131, emitter station 180 and / or individual emitters 135 are provided hereinbelow in connection with FIGS. 8 - 10.

[0092] The catheter system 100 can also include a fluid pump 138 configured to inflate the balloon 104 with the catheter fluid 132 as needed.

[0093] Similar to all the embodiments illustrated and described herein, various structures may be omitted from the figures for clarity and ease of understanding. Further, the figures may include certain structures that may be omitted without departing from the intent and scope of the present invention.

[0094] FIG. 2A is a simplified schematic top view of a portion of an embodiment of a catheter system 200. More specifically, FIG. 2A shows a plurality of energy guides such as a first energy guide 222A, a second energy guide 222B, a third energy guide 222C, a fourth energy guide 222D, and a fifth energy guide 222E, an energy source 224, a system controller 226, and a multiplexer 228 that receives energy in the form of a source light beam 224A, such as a pulsed source light beam, from the energy source 224 and selectively and / or alternately directs the energy in the form of individual guide light beams 224B to any one or all of the energy guides 222A-222E in any desired sequence and / or pattern under the control of the system controller 226. The energy guides 222A-222E, the energy source 224, and the system controller 226 are substantially similar in design and function as described in detail above herein. Accordingly, such components are not described in detail in connection with the embodiment illustrated in FIG. 2A. Certain components of the system console 123, such as the power supply 125 and the GUI 127, which were illustrated and described above in connection with FIG. 1, are not illustrated in FIG. 2A for purposes of brevity and ease of illustration, but it is further recognized that they will typically be included in many embodiments.

[0095] As described above, the multiplexer 228 is configured to receive energy in the form of a source light beam 224A from the energy source 224 and selectively and / or alternately direct the energy in the form of individual guide light beams 224B to any one or all of the energy guides 222A-222E in any desired sequence and / or pattern. Thus, as shown in FIG. 2A, the multiplexer 228 is operably and / or optically coupled to optically communicate with the energy guide bundle 222 and / or each of the plurality of energy guides 222A-222E.

[0096] As illustrated, the guide base end portions 222P of each of the plurality of energy guides 222A - 222E are held within a guide connection housing 250, such as within a guide connection slot 254 formed in the guide connection housing 250. In various embodiments, the guide connection housing 250 is configured to be selectively coupled to a system console 123 (illustrated in FIG. 1) such that the guide connection slot 254 and thus the energy guides 222A - 222E are maintained in a desired fixed position relative to the multiplexer 228 and / or the system console 123 during use of the catheter system 200. In some embodiments, the guide connection slot 254 is provided in the form of a V - groove, such as in a V - groove ferrule block commonly used in multi - channel optical fiber communication systems. Alternatively, the guide connection slot 254 may have another suitable design.

[0097] The guide connection housing 250 can have any suitable number of guide connection slots 254, and it is recognized that they can be positioned and / or oriented relative to each other in any suitable manner to best align the guide connection slots 254 and thus the energy guides 222A - 222E with respect to the multiplexer 228. In the embodiment illustrated in FIG. 2A, the guide connection housing 250 includes seven guide connection slots 254 that are spaced apart from each other in a linear arrangement with an exact spacing between adjacent guide connection slots 254. Thus, in such an embodiment, the guide connection housing 250 is capable of holding the guide base end portions 222P of up to seven energy guides (although only five energy guides 222A - 222E are specifically shown in FIG. 2A). Alternatively, the guide connection housing 250 can have a different number of guide connection slots, more or less than seven, and / or the guide connection slots 254 can be arranged relative to each other in a different manner.

[0098] The design of the multiplexer 228 can be changed according to the requirements of the catheter system 200, the relative positioning of the energy guides 222A - 222E, and / or in accordance with the desires of the user or operator of the catheter system 200. In the embodiment illustrated in FIG. 2A, the multiplexer 228 includes one or more of a multiplexer base 260, a multiplexer stage 262, a stage mover 264 (illustrated by a dashed line), a beam deflector 266, and a coupling optics 268. Alternatively, the multiplexer 228 may include more or fewer components than specifically illustrated in FIG. 2A.

[0099] During use of the catheter system 200, the multiplexer base 260 is fixed in position relative to the energy source 224 and the energy guides 222A - 222E. In this embodiment, the multiplexer stage 262 is movably supported on the multiplexer base 260. More specifically, the stage mover 264 is configured to move the multiplexer stage 262 relative to the multiplexer base 260. As shown in FIG. 2A, the beam deflector 266 and the coupling optics 268 are mounted on and / or held by the multiplexer stage 262. Thus, movement of the multiplexer stage 262 relative to the multiplexer base 260 results in corresponding movement of the beam deflector 266 and the coupling optics 268 relative to the fixed multiplexer base 260. With the energy guides 222A - 222E fixed in position relative to the multiplexer base 260, movement of the multiplexer stage 262 results in corresponding movement of the beam deflector 266 and the coupling optics 268 relative to the energy guides 222A - 222E.

[0100] In various embodiments, multiplexer 228 is configured to accurately align the coupling optics 268 with each of the energy guides 222A - 222E such that the source light beam 224A generated by the energy source 224 can be accurately directed and focused by the multiplexer 228 as the corresponding guide light beam 224B to each of the energy guides 222A - 222E. In its simplest form, as shown in FIG. 2A, the multiplexer 228 uses a precision mechanism such as a stage mover 264 to translate the coupling optics 268 along a linear path. This approach requires one degree of freedom. In certain embodiments, the linear translation mechanism such as the stage mover 264 and / or the multiplexer stage 262 may be provided with mechanical stops such that the coupling optics 268 can be accurately aligned with the positions of each of the energy guides 222A - 222E in any desired sequence and / or pattern. Alternatively, the stage mover 264 can be electronically controlled to align the optical paths of the guide light beams 224B with each of the individual energy guides 222A - 222E partially held within the guide coupling housing 250 in any desired sequence and / or pattern.

[0101] As described above, the multiplexer stage 262 is configured to carry the necessary optics such as the beam deflectors 266 and the coupling optics 268 to direct and focus the energy generated by the energy source 224 to each of the energy guides 222A - 222E for optimal coupling. Such a design results in less divergence of the guide light beam 224A over the short travel distance of the translating multiplexer stage 262 and minimal impact on the coupling efficiency to the energy guides 222A - 222E.

[0102] During operation, the stage mover 264 drives the multiplexer stage 262 to align the optical paths of the selected energy guides 222A-222E and the guide beam 224B. Thereafter, the system controller 226 fires the energy source 224 in a pulsed or semi-CW mode. The stage mover 264 then advances the multiplexer stage 262 to the next stop position, i.e., to the next desired energy guide 222A-222E, and the system controller 226 fires the energy source 224 again. This process is repeated as desired such that the energy in the form of the guide beam 224B is directed to any or all of the energy guides 222A-222E in a desired sequence and / or pattern. It is recognized that the stage mover 264 can move the multiplexer stage 262 such that the multiplexer stage 262 is aligned with any one of the energy guides 222A-222E and thereafter the system controller 226 fires the energy source 224. In this way, the multiplexer 228 can achieve continuous firing through the energy guides 222A-222E or fire in any desired pattern with respect to the energy guides 222A-222E.

[0103] In this embodiment, the stage mover 264 can have any suitable design for the purpose of linearly moving the multiplexer stage 262 relative to the multiplexer base 260. More specifically, the stage mover 264 can be any suitable type of linear translation mechanism.

[0104] As shown in FIG. 2A, the catheter system 200 may further include an optical element 247, such as a mirror or a reflection or beam steering element, that reflects the source beam 224A from the energy source 224 so that the source beam 224A is directed toward the multiplexer 228. In certain embodiments, as shown, the optical element 247 may be positioned along the beam path to redirect the source beam 224A at approximately 90 degrees so that the source beam 224A is directed toward the multiplexer 228. Alternatively, the optical element 247 may redirect the source beam 224A at greater than or less than 90 degrees. Further alternatively, the catheter system 200 may be designed without the optical element 247, and the energy source 224 may be capable of directly directing the source beam 224A toward the multiplexer 228.

[0105] In this embodiment, the source beam 224A that is directed toward the multiplexer 228 first impinges on a beam deflector 266 that is configured to redirect the source beam 224A toward the coupling optics 268. In some embodiments, the beam deflector 266 redirects the source beam 224A at approximately 90 degrees toward the coupling optics 268. Alternatively, the beam deflector 266 may redirect the source beam 224A at greater than or less than 90 degrees toward the coupling optics 268. Thus, the beam deflector 266 mounted on the multiplexer stage 262 is configured to direct the source beam 224A through the coupling optics 268 such that the individual guide beams 224B are focused onto the individual energy guides 222A-222E in the guide coupling housing 250.

[0106] The coupling optics 268 may have any suitable design for the purpose of focusing the individual guide beams 224B onto each of the energy guides 222A-222E. In certain embodiments, the coupling optics 268 includes two lenses that are specifically configured to focus the individual guide beams 224B as desired. Alternatively, the coupling optics 268 may have another suitable design.

[0107] In certain non-exclusive alternative embodiments, manipulating the source beam 224A such that it is properly directed and focused onto each of the energy guides 222A - 222E can be accomplished using mirrors that are attached to an optomechanical scanner, an X - Y galvanometer, or other multi - axis beam manipulation devices.

[0108] Alternatively, FIG. 2A illustrates that the energy guides 222A - 222E are fixed in position relative to the multiplexer base 260. However, in some embodiments, the energy guides 222A - 222E can be configured to move relative to an alignment optics 268 that is fixed in position. In such embodiments, the guide connection housing 250 itself would move, such as being carried by a linear translation stage, and the system controller 226 can control the linear translation stage such that the energy guides 222A - 222E move step - by - step so that each is aligned with the alignment optics and the guide beam 224B in a desired pattern. Such embodiments can be effective, but it is further recognized that additional protection and control are required to make it safe and reliable since the guide connection housing 250 moves relative to the alignment optics 268 of the multiplexer 228 during use.

[0109] FIG. 2B is a simplified schematic perspective view of a portion of the catheter system 200 and the multiplexer 228 illustrated in FIG. 2A. In particular, FIG. 2B includes a guide connection housing 250 having guide connection slots 254 configured to hold portions of each of the energy guides 222A-222E, an optical element 247 that first redirects the source light ray 224A from the energy source 224 (illustrated in FIG. 2A) toward the multiplexer 228, and a multiplexer base 260, multiplexer stage 262, beam deflector 266, and coupling optics 268 that receive the source light ray 224A and then direct and focus individual guide light rays 224B in any desired sequence and / or pattern toward any one or all of the energy guides 222A-222E. It is recognized that the stage mover 264 is not illustrated in FIG. 2B for purposes of brevity and ease of illustration.

[0110] FIG. 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, FIG. 3A shows a plurality of energy guides such as a first energy guide 322A, a second energy guide 322B, and a third energy guide 322C, an energy source 324, a system controller 326, and a multiplexer 328 that receives energy in the form of a source beam 324A from the energy source 324 and selectively and / or alternately directs the energy in the form of individual guide beams 324B to each of the energy guides 322A-322C in any desired sequence and / or pattern under the control of the system controller 326. The energy guides 322A-322C, the energy source 324, and the system controller 326 are substantially similar in design and function as described in detail above herein. Accordingly, such components are not described in detail in connection with the embodiment illustrated in FIG. 3A. Certain components of the system console 123, such as the power supply 125 and the GUI 127, which were illustrated and described above in connection with FIG. 1, are not illustrated in FIG. 3A for purposes of brevity and ease of illustration, but it is further recognized that they will typically be included in many embodiments.

[0111] Similar to the previous embodiment, the multiplexer 328 is configured to receive energy from the energy source 324 in the form of a source beam 324A, such as a single pulsed source beam, and selectively and / or alternately direct the energy in the form of individual guide beams 324B to any one or all of the energy guides 322A-322C in any desired sequence and / or pattern. Thus, as shown in FIG. 3A, the multiplexer 328 is operably and / or optically coupled to communicate optically with the energy guide bundle 322 and / or the plurality of energy guides 322A-322C.

[0112] As illustrated, the guide base end portions 322P of each of the plurality of energy guides 322A-322C are held within the guide connection housing 350, such as within guide connection slots 354 formed in the guide connection housing 350. In various embodiments, the guide connection housing 350 is configured to be selectively coupled to the system console 123 (illustrated in FIG. 1) such that the guide connection slots 354 and thus the energy guides 322A-322C are maintained in a desired fixed position relative to the multiplexer 328 and / or the system console 123 during use of the catheter system 300.

[0113] Referring now to FIG. 3B, FIG. 3B is a simplified schematic perspective view of a portion of the catheter system 300 and multiplexer 328 illustrated in FIG. 3A. As shown in FIG. 3B, the guide connection housing 350 can be substantially cylindrical. The guide connection housing 350 can have any suitable number of guide connection slots 354, which can be positioned and / or oriented relative to each other in any suitable manner such that the guide connection slots 354 and thus the energy guides 322A-322C of the energy guide bundle 322 are optimally aligned with respect to the multiplexer 328. In the embodiment illustrated in FIG. 3B, the guide connection housing 350 includes seven guide connection slots 354 arranged in a circular and / or hexagonal packed pattern. Thus, in such an embodiment, the guide connection housing 350 can hold the guide base end portions of up to seven energy guides. Alternatively, the guide connection housing 350 can have a different number of guide connection slots, more than or less than seven, and / or the guide connection slots 354 can be arranged relative to each other in a different manner, such as in another suitable circulating cycle pattern.

[0114] Returning to FIG. 3A, in this embodiment, multiplexer 328 includes one or more of multiplexer stage 362, stage mover 364, beam deflector 366, and coupling optics 368. Alternatively, multiplexer 328 may include more or fewer components than specifically illustrated in FIG. 3A.

[0115] As shown in the embodiment illustrated in FIG. 3A, stage mover 364 is configured to rotationally move multiplexer stage 362. More specifically, in this embodiment, multiplexer stage 362 and / or stage mover 364 require one degree of rotational freedom. As shown, multiplexer stage 362 and guide coupling housing 350 are aligned on central axis 324X of energy source 324. Thus, multiplexer stage 362 is configured to be rotated by stage mover 364 about central axis 324X.

[0116] Beam deflector 366 and coupling optics 368 are mounted on and / or held by multiplexer stage 362. During use of catheter system 300, source beam 324A is first directed along central axis 324X of energy source 324 toward multiplexer 328 and / or multiplexer stage 362. Thereafter, beam deflector 366 is configured to deflect source beam 324A laterally a fixed distance from central axis 324X of energy source 324 such that source beam 324A is directed in a direction that is substantially parallel to and spaced from central axis 324X. More specifically, beam deflector 366 deflects source beam 324A to coincide with the radius of the circular pattern of energy guides 322A - 322C in guide coupling housing 350. When multiplexer stage 362 is rotated, source beam 324A directed through beam deflector 366 traces a circular path.

[0117] It is recognized that the beam deflector 366 can have any suitable design. For example, in one particular non - exclusive alternative embodiment, the beam deflector 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 beam deflector 366 can include any other suitable configuration of the optical system to achieve the desired lateral beam offset.

[0118] As described above, the coupling optical system 368 is also mounted on and / or held thereby by the multiplexer stage 362. Similar to the previous embodiment, the coupling optical system 368 is configured to focus the respective individual guide light rays 324B onto each of the energy guides 322A - 322C within the energy guide bundle 322, which is partially held within the guide coupling housing 350, for optimal coupling.

[0119] As described above, the multiplexer 328 is configured to accurately align the coupling optical system 368 with each of the energy guides 322A - 322C such that the source light ray 324A generated by the energy source 324 can be accurately directed and focused by the multiplexer 328 as the corresponding guide light ray 324B onto each of the energy guides 322A - 322C. In one particular embodiment, the stage mover 364 and / or the multiplexer stage 362 can be provided with mechanical stops such that the coupling optical system 368 can be accurately aligned with the positions of each of the energy guides 322A - 322C in any desired sequence and / or pattern. Alternatively, the stage mover 364 can be electronically controlled, such as by using a stepper motor or a piezoelectrically actuated rotating stage, to align the optical path of the guide light rays 324B with each of the individual energy guides 322A - 322C, which are partially held within the guide coupling housing 350, in any desired sequence and / or pattern.

[0120] During the use of the catheter system 300, the stage mover 364 drives the multiplexer stage 362 to connect the selected energy guides 322A - 322C with the guide beam 324B. Then, the system controller 326 fires the energy source 324 in pulse or semi - CW mode. The stage mover 364 then angularly advances the multiplexer stage 362 to the next stop position, i.e., to the next desired energy guide 322A - 322C, and the system controller 326 fires the energy source 324 again. This process is repeated as desired so that the energy in the form of the guide beam 324B is directed to any or all of the energy guides 322A - 322C in a desired sequence and / or pattern. It is recognized that the stage mover 364 can move the multiplexer stage 362 such that the multiplexer stage 362 is aligned with any of the energy guides 322A - 322C and then the system controller 326 fires the energy source 324. In this way, the multiplexer 328 can achieve continuous firing through the energy guides 322A - 322C or fire in any desired pattern with respect to the energy guides 322A - 322C.

[0121] In this embodiment, the stage mover 364 can have any suitable design for the purpose of rotationally moving the multiplexer stage 362 around the central axis 324X. More specifically, the stage mover 364 can be any suitable type of rotational mechanism.

[0122] Alternatively, FIG. 3A illustrates that the energy guides 322A-322C are fixedly positioned with respect to the multiplexer stage 362, although in some embodiments it is recognized that the energy guides 322A-322C may be configured to move and / or rotate with respect to an optical coupling system 368 that is fixedly positioned. In such embodiments, the guide coupling housing 350 itself may move, such as being rotated about the central axis 324X, and the system controller 326 may control the rotation stage such that the energy guides 322A-322C move stepwise so that each is aligned with the optical coupling system and the guide beam 324B in a desired sequence and / or pattern. In such embodiments, the guide coupling housing 350 is rotated by a certain angle rather than continuously, and then rotated in the reverse direction to avoid winding of the energy guides 322A-322C.

[0123] Returning again to FIG. 3B, FIG. 3B illustrates another view of the multiplexer 328 that includes a guide coupling housing 350 having guide coupling slots 354 configured to hold respective portions of the energy guides, as well as a multiplexer stage 362, a beam deflector 366, and an optical coupling system 368, which receives the source beam 324A and then directs and focuses the individual guide beams 324B in any desired sequence and / or pattern toward each of the energy guides. It is recognized that the stage mover 364 is not illustrated in FIG. 3B for purposes of simplicity and ease of illustration.

[0124] FIG. 4 is a simplified schematic top view of a portion of the catheter system 400 and yet another embodiment of the multiplexer 428. More specifically, FIG. 4 shows a plurality of energy guides such as a first energy guide 422A, a second energy guide 422B, a third energy guide 422C, a fourth energy guide 422D, and a fifth energy guide 422E, an energy source 424, a system controller 426, and a multiplexer 428 that receives energy in the form of a source ray 424A from the energy source 424 and selectively and / or alternately directs the energy in the form of individual guide rays 424B to any one or all of the energy guides 422A-422E in any desired sequence and / or pattern under the control of the system controller 426. The energy guides 422A-422E, the energy source 424, and the system controller 426 are substantially similar in design and function as described in detail above herein. Accordingly, such components are not described in detail in connection with the embodiment illustrated in FIG. 4. Certain components of the system console 123, such as the power supply 125 and the GUI 127, which were illustrated and described above in connection with FIG. 1, are not illustrated in FIG. 4 for purposes of brevity and ease of illustration, but it is further recognized that they will typically be included in many embodiments.

[0125] As described above, the multiplexer 428 is configured to receive energy from the energy source 424 in the form of a source ray 424A, such as a single pulsed source ray, and selectively and / or alternately direct the energy in the form of individual guide rays 424B to any one or all of the energy guides 422A-422E in any desired sequence and / or pattern. Thus, as shown in FIG. 4, the multiplexer 428 is operably and / or optically coupled to communicate optically with the energy guide bundle 422 and / or the plurality of energy guides 422A-422E.

[0126] As illustrated, the guide base end portions 422P of each of the plurality of energy guides 422A-422E are held within a guide connection housing 450, such as within a guide connection slot 454 formed in the guide connection housing 450. In various embodiments, the guide connection housing 450 is configured to be selectively coupled to a system console 123 (illustrated in FIG. 1) such that the guide connection slot 454 and thus the energy guides 422A-422E are maintained in a desired fixed position relative to the multiplexer 428 and / or the system console 123 during use of the catheter system 400. It is recognized that the guide connection housing 450 may have any suitable number of guide connection slots 454. In the embodiment illustrated in FIG. 4, five guide connection slots 454 are visible within the guide connection housing 450. Thus, in such an embodiment, the guide connection housing 450 is capable of holding the guide base end portions 422P of up to five energy guides. Alternatively, the guide connection housing 450 may have a different number of guide connection slots 454, more than five or less than five guide connection slots 454.

[0127] In the embodiment illustrated in FIG. 4, the multiplexer 428 includes one or more of a multiplexer stage 462, a stage mover 464, one or more diffractive optical elements 470 (or "DOE: diffractive optical element"), and a coupling optical system 468. Alternatively, the multiplexer 428 may include more or fewer components than specifically illustrated in FIG. 4.

[0128] As shown, the diffractive optical element 470 is mounted on and / or held thereby the multiplexer stage 462. The stage mover 464 is configured to move the multiplexer stage 462, such as by translating, so that each of the one or more diffractive optical elements 470 is selectively and / or alternately positioned in the light path of the source ray 424A from the energy source 424.

[0129] 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 individual guide beams 424B. It is recognized 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 fabricated using an array of micro-prisms, micro-lenses, or other patterned diffractive elements.

[0130] It is recognized that there are many possible patterns for grouping the energy guides 422A - 422E into the guide connection housing 450 using this approach. The simplest pattern for the energy guides 422A - 422E within the guide connection housing 450 would be a hexagonal closely packed pattern similar to that illustrated in FIGS. 3A and 3B. Alternatively, the energy guides 422A - 422E within the guide connection housing 450 can also be arranged in a square, linear, circular, or other suitable pattern.

[0131] As shown in FIG. 4, the guide connection housing 450 can be aligned on the central axis 424X of the energy source 424, and the diffractive optical element 470 mounted on the multiplexer stage 462 is inserted along the beam path between the energy source 424 and the guide connection housing 450. As illustrated, 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 connection housing 450.

[0132] During operation, the source ray 424A that impinges on one of the plurality of diffractive optical elements 470 divides the source ray 424A into two or more biased rays, i.e., two or more guide rays 424B. These guide rays 424B then descend to individual energy guides 422A - 422E held in the guide connection housing 450 and are directed and focused by the connection optics 468. In one configuration, the diffractive optical element 470 divides the source ray 424A into the same number of energy guides as are present within a single-use device. In such a configuration, the energy output of each guide ray 424B is based on the number of guide rays 424B generated from a single source ray 424A minus scattering and absorption losses. Alternatively, the diffractive optical element 470 can be configured to divide the source ray 424A such that the guide rays 424B are directed to any single energy guide or any selected plurality of energy guides. Thus, the multiplexer stage 462 can be configured to hold a plurality of diffractive optical elements 470, such as by using a plurality of diffractive optical element patterns etched on a single plate, to provide options for the user or operator to connect the guide rays 424B to the desired number and pattern of energy guides. In such an embodiment, the selection of the pattern can be achieved by moving the multiplexer stage 462 with a stage mover 464, such as by translating, so that the desired diffractive optical element 470 is positioned in the ray path of the source ray 424A between the energy source 424 and the connection optics 468.

[0133] Similar to the previous embodiments, the connection optics 468 can have any suitable design for the purpose of simultaneously focusing individual guide rays 424B or a plurality of guide rays 424B onto the desired energy guides 422A - 422E.

[0134] FIG. 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, FIG. 5 shows a plurality of energy guides such as a first energy guide 522A, a second energy guide 522B, and a third energy guide 522C, an energy source 524, a system controller 526, and from the energy source 524, receives energy in the form of a source ray 524A, and under the control of the system controller 526, selectively and / or alternately directs energy in the form of individual guide rays 524B to any one or all of the energy guides 522A-522C in any desired sequence and / or pattern. The energy guides 522A-522C, the energy source 524, and the system controller 526 are substantially similar in design and function as described in detail above herein. Accordingly, such components are not described in detail in relation to the embodiment illustrated in FIG. 5. Certain components of the system console 123, such as the power supply 125 and the GUI 127, which were illustrated and described above in relation to FIG. 1, are not illustrated in FIG. 5 for purposes of brevity and ease of illustration, but it is further recognized that they will typically be included in many embodiments.

[0135] As described above, the multiplexer 528 is configured to receive energy from the energy source 524 in the form of a source ray 524A, such as a single pulsed source ray, and selectively and / or alternately direct energy in the form of individual guide rays 524B to any one or all of the energy guides 522A-522C in any desired sequence and / or pattern. Thus, as shown in FIG. 5, the multiplexer 528 is operably and / or optically coupled to communicate optically with a plurality of energy guides 522A-522C.

[0136] However, as illustrated in FIG. 5, multiplexer 528 has a design different from 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 interchangeably direct the energy in the form of individual guide beams 524B to any one or all of energy guides 522A - 522C in a readily reconfigurable and non-moving part manner, in any desired sequence and / or pattern. For example, by using an acousto-optic deflector (AOD) as multiplexer 528, the entire output of a single energy source 524, such as a single laser, can be directed to a plurality of individual energy guides 522A - 522C. The guide beam 524B can be redirected to different energy guides 522A - 522C within a few microseconds by changing the drive frequency input to multiplexer 528 (AOD), and when using a pulsed laser such as Nd:YAG, this switching can be easily done between pulses. In such embodiments, the deflection angle (Θ) of multiplexer 528 can be defined as follows. Deflection angle (Θ) = Λf / v, where Λ = optical wavelength f = acoustic drive frequency v = speed of sound in the modulator

[0137] As shown in FIG. 5, the source ray 524A is directed from the energy source 524 toward the multiplexer 528 and then is redirected as the desired guided ray 524B to each of the energy guides 522A - 522C at a created deflection angle. More specifically, as illustrated, when the multiplexer 528 creates a first deflection angle with respect to the source ray 524A, the first guided ray 524B1 is directed to the first energy guide 522A, when the multiplexer 528 creates a second deflection angle with respect to the source ray 524A, the second guided ray 524B2 is directed to the second energy guide 522B, and when the multiplexer 528 creates a third deflection angle with respect to the source ray 524A, the third guided ray 524B3 is directed to the third energy guide 522C. As illustrated, it is recognized that as any desired deflection angle, it is possible to have virtually no deflection angle, and as a result, the guided ray 524B can be directed to be continuous along the same axial ray path as the source ray 524A.

[0138] In this embodiment, the multiplexer 528 (AOD) includes a transducer 572 and an absorber 574 that cooperate to generate a desired drive frequency such that the source ray 524A is redirected as the desired guided ray 524B toward the desired energy guides 522A - 522C and then creates a desired deflection angle. More specifically, the multiplexer 528 is configured to spatially control the source ray 524A. In the operation of the multiplexer 528, the power driving the acoustic transducer 572 is sustained at a constant level while the acoustic frequency is varied to deflect the source ray 524A to different angular positions that define the guided rays 524B1 - 524B3. Thus, the multiplexer 528 utilizes a diffraction angle that is dependent on the acoustic frequency, such as that described above.

[0139] FIG. 6 is a simplified schematic top view of a portion of a catheter system 600 and yet another embodiment of a multiplexer 628. More specifically, FIG. 6 shows a plurality of energy guides such as a first energy guide 622A, a second energy guide 622B, and a third energy guide 622C, an energy source 624, a system controller 626, and an energy source 624 that receives energy in the form of a source light beam 624A such as a single pulsed source light beam, and under the control of the system controller 626, selectively and / or alternately directs the energy in the form of individual guide light beams 624B to any desired one or all of the energy guides 622A-622C in any desired sequence and / or pattern. The energy guides 622A-622C, the energy source 624, and the system controller 626 are substantially similar in design and function as detailed above herein. Accordingly, such components are not described in detail in connection with the embodiment illustrated in FIG. 6. Certain components of the system console 123, such as the power supply 125 and the GUI 127, which were illustrated and described above in connection with FIG. 1, are not illustrated in FIG. 6 for purposes of brevity and ease of illustration, but it is further recognized that they will typically be included in many embodiments.

[0140] It is recognized that the multiplexer 628 illustrated in FIG. 6 is substantially similar to the multiplexer 528 illustrated and described in connection with FIG. 5. For example, as shown in FIG. 6, the multiplexer 628 also includes a transducer 672 and an absorber 674 that cooperate to generate a desired drive frequency that can then create a desired deflection angle such that the source light beam 624A is redirected as the desired guide light beam 624B towards the desired energy guides 622A-622C. However, in this embodiment, the multiplexer 628 further includes an optical element 676 that can be used to change the angular separation between the guide light 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 collimated with a diameter that substantially fills the aperture of the multiplexer 628 (AOD). The smaller the input divergence, the more discrete outputs can be generated. The angular resolution of such a device is very good, but the deflection over the full angle is limited. To allow a sufficient number of energy guides 622A - 622C of finite size to be accessed by a single energy source 624 and a single source ray 624A, there are several means for improving the separation of the different outputs. For example, as shown in FIG. 6, after the individual guide rays 624B are separated, an optical element 676 such as a lens can be used to convert the angular separation between the guide rays 624B into a linear offset, and can be used to direct the guide rays 624B to the closely spaced energy guides 622A - 622C, such as when the energy guides 622A - 622C are kept in close proximity to each other within the guide connection housing 650. Fold mirrors can be used to allow for a sufficient propagation distance to separate the different ray paths of the guide rays 624B within a limited volume.

[0142] FIG. 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, FIG. 7 shows a plurality of energy guides such as a first energy guide 722A, a second energy guide 722B, a third energy guide 722C, a fourth energy guide 722D, and a fifth energy guide 722E, an energy source 724, a system controller 726, and an energy source 724 that receives energy in the form of a source light beam 724A such as a single pulsed source light beam, and under the control of the system controller 726, selectively and / or in an alternating manner directs the energy in the form of individual guide light beams 724B to any one or all of the energy guides 722A-722E in any desired sequence and / or pattern, illustrating a multiplexer 728. The energy guides 722A-722E, the energy source 724, and the system controller 726 are substantially similar in design and function as detailed above herein. Accordingly, such components are not described in detail in connection with the embodiment illustrated in FIG. 7. Certain components of the system console 123, such as the power supply 125 and the GUI 127, which were illustrated and described above in connection with FIG. 1, are not illustrated in FIG. 7 for purposes of brevity and ease of illustration, but it is further recognized that they will typically be included in many embodiments.

[0143] The method for multiplexing the source ray 724A into the plurality of guide rays 724B illustrated in FIG. 7 is recognized to be somewhat similar to the method in which the source ray 524 is multiplexed into the plurality of guide rays 524B, as illustrated and described in connection with FIG. 5. However, in this embodiment, the 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, the multiplexer 728 may be able to access additional energy guides. It is further recognized that the multiplexer 728 may include more than two acousto-optic deflectors, if desired, so as to be able to access even more energy guides.

[0144] In the embodiment shown in FIG. 7, the source ray 724A is first directed towards the first AOD 728A. The first AOD 728A is utilized to deflect the source ray 724A to generate a first guide ray 724B1 directed towards the first energy guide 722A and a second guide ray 724B2 directed towards the second energy guide 722B2. The first AOD 728A also allows the non-biased ray to be transmitted through the first AOD 728A as a transmitted ray 724C directed towards the second AOD 728B. Thereafter, the second AOD 728B is utilized, if desired, to deflect the transmitted ray 724C to generate a third guide ray 724B3 directed towards the third energy guide 722C, a fourth guide ray 724B4 directed towards the fourth energy guide 722D, and a fifth guide ray 724B5 directed towards the fifth energy guide 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 that cooperate to generate a desired drive frequency that can then create a desired deflection angle such that the source ray 724A can be redirected again as desired, and the second AOD 728B can include a second transducer 772B and a second absorber 774B that cooperate to generate a desired drive frequency that can then create a desired deflection angle such that the transmitted ray 724C can be redirected again as desired. Alternatively, the first AOD 728A and / or the second AOD 728B can have another suitable design.

[0146] In various embodiments of the present invention, an optical pressure wave generator, such as a catheter system, designed to fragment a vascular lesion 106A (illustrated in FIG. 1), such as a calcified vascular lesion, requires a plurality of radiator stations 180 (illustrated in FIG. 1) distributed along and / or within the length 142 (illustrated in FIG. 1) of the balloon 104 (illustrated in FIG. 1). Stated otherwise, the catheter system 100 (illustrated in FIG. 1) can include a plurality of radiator stations 180, with each radiator station 180 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 can include (i) a first radiator station 180 positioned at a first longitudinal position relative to the length 142 of the balloon 104, (ii) a second radiator 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 radiator station 180 positioned at a third longitudinal position different from the first and second longitudinal positions relative to the length 142 of the balloon 104. Each radiator station 180 incorporated within a single-use device can include a single radiator 135 (illustrated in FIG. 1), or a plurality of radiators 135, and each of the radiators 135 at any given radiator station 180 is positioned at substantially the same longitudinal position relative to the length 142 of the balloon 104. Stated otherwise, the guide tip 122D (illustrated in FIG. 1) of the energy guide 122A (illustrated in FIG. 1) and the corresponding plasma generator 133 (illustrated in FIG. 1) that cooperate to form the individual radiators 135 within a particular radiator station 180 are positioned at substantially the same longitudinal position relative to the length 142 of the balloon 104 as the guide tip 122D and the corresponding plasma generator 133 of any additional radiators 135 within that same radiator station 180.

[0147] The catheter system 100 can be configured to selectively supply power to a plurality of radiator stations as part of a pressure wave generator designed to apply pressure to a vascular lesion 106A, such as a calcified vascular lesion and / or a fibrotic vascular lesion, to induce fragmentation. In many embodiments, the catheter system 100 can be configured and controlled to selectively and / or separately supply power to a plurality of radiator stations 180 in any desired pattern, order, sequence, and frequency of emission. Each radiator station 180 can also be configured to include any desired number of individual radiators 135, which can be a single radiator 135 or a plurality of radiators 135. In many embodiments, the catheter system 100 can be further configured and controlled to selectively and / or separately supply power to each of the individual radiators 135 within any given radiator station 180 in any desired pattern, order, sequence, and frequency of emission.

[0148] In many embodiments, it is desirable for the radiator station 180 to be visible to the user or operator during use of the catheter system 100 so that the user or operator can more accurately position the radiator 135 and / or the radiator station 180 relative to the vascular lesion 106A at the treatment site 106. The appropriate visibility of the radiator 135 and / or the radiator station 180 also enables the user or operator to selectively activate only the radiator station 180 that is positioned closest to the vascular lesion 106A in order to more effectively and efficiently disrupt the vascular lesion 106A at the treatment site 106.

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

[0150] FIG. 8 is a simplified schematic side view of a portion of an example catheter system 800 having features of the present invention. As illustrated, catheter system 800 includes a balloon 804 having a balloon wall 830 that defines an interior 846 of the balloon, and one or more radiator stations 880, such as a first radiator station 880A and a second radiator station 880B in this particular example, positioned within the interior 846 of the balloon 804 (it is understood that catheter system 800 may include any suitable number of radiator stations 880). Each of radiator stations 880A, 880B is positioned at a different longitudinal position with respect to the length 842 of the balloon 804. Stated otherwise, as illustrated, the first radiator station 880A is positioned at a first longitudinal position 880L1 (or location) with respect to the length 842 of the balloon 804, and the second radiator station 880B is positioned at a second longitudinal position 880L2 (or location) that is different from the first longitudinal position 880L1 (or location) with respect to the length 842 of the balloon 804. It is recognized that each of radiator stations 880A, 880B may include any suitable number of radiators 135 (illustrated in FIG. 1), which may be one radiator 135 or multiple radiators 135. Thus, it can be said that each of the radiators 135 of any given radiator station 880 is positioned at a generally the same longitudinal position (or location) with respect to the length 842 of the balloon 804.

[0151] During use of the catheter system 800, due to the visibility of the radiator station 880 and / or the radiator 135 enabled through the use of a radiopaque material or other suitable material for the radiator station 880 and / or the radiator 135, the user or operator can specifically select a particular radiator station 880 and / or radiator 135 that is used during an intravascular lithotripsy procedure and / or can specifically exclude a particular radiator station 880 and / or radiator 135 that is not used during an intravascular lithotripsy procedure. It is recognized that the specific selection or exclusion of the radiator station 880 and / or the radiator 135 can be based at least in part on proximity to the vascular lesion 106A (illustrated in FIG. 1) of the treatment site 106 (illustrated in FIG. 1). For example, in some possible applications, the user or operator can select only one of the radiator stations 880, such as only the first radiator station 880A or only the second radiator station 880B (and / or only one or more of the radiators 135 specifically included therein), for use during an intravascular lithotripsy procedure. Alternatively, in other possible applications, the user or operator can select both radiator stations 880A, 880B for use during an intravascular lithotripsy procedure.

[0152] FIG. 9 is a simplified schematic view of a portion of another embodiment of a catheter system 900. In particular, in this embodiment, the catheter system 900 includes a balloon 904 having a balloon wall 930 that defines an interior 946 of the balloon, and four radiator stations 980 such as a first radiator station 980A, a second radiator station 980B, a third radiator station 980C, and a fourth radiator station 980D that are positioned within the interior 946 of the balloon 904. Each of the radiator stations 980A, 980B, 980C, 980D is positioned at a different longitudinal position with respect to the length 942 of the balloon 904. Stated otherwise, as illustrated, the first radiator station 980A is positioned at a first longitudinal position 980L1 (or location) with respect to the length 942 of the balloon 904, the second radiator station 980B is positioned at a second longitudinal position 980L2 (or location) that is different from the first longitudinal position 980L1 (or location) with respect to the length 942 of the balloon 904, the third radiator station 980C is positioned at a third longitudinal position 980L3 (or location) that is different from the first longitudinal position 980L1 (or location) and the second longitudinal position 980L2 (or location) with respect to the length 942 of the balloon 904, and the fourth radiator station 980D is positioned at a fourth longitudinal position 980L4 (or location) that is different from the first longitudinal position 980L1 (or location), the second longitudinal position 980L2 (or location), and the third longitudinal position 980L3 (or location) with respect to the length 942 of the balloon 904. It is recognized that each of the radiator stations 980A, 980B, 980C, 980D can include any suitable number of radiators 135 (illustrated in FIG. 1), which can be one radiator 135 or multiple radiators 135. Thus, it can be said that each of the radiators 135 of any given radiator station 980 is positioned at substantially the same longitudinal position (or location) with respect to the length 942 of the balloon 904.

[0153] During use of the catheter system 900, due to the visibility of the radiator station 980 and / or the radiator 135 enabled through the use of a radiopaque material or other suitable material for the radiator station 980 and / or the radiator 135, the user or operator can specifically select a particular radiator station 980 and / or radiator 135 used during an intravascular lithotripsy procedure and / or can specifically exclude a particular radiator station 980 and / or radiator 135 not used during an intravascular lithotripsy procedure. It is recognized that the specific selection or exclusion of the radiator station 980 and / or the radiator 135 can be at least partially based on the proximity to the vascular lesion 106A (illustrated in FIG. 1) of the treatment site 106 (illustrated in FIG. 1). For example, in some possible applications, the user or operator can select only one of the radiator stations 980 (and / or one or more of the radiators 135 included therein), such as only the first radiator station 980A, only the second radiator station 980B, only the third radiator station 980C, or only the fourth radiator station 980D, etc., for use during an intravascular lithotripsy procedure. Alternatively, in other possible applications, the user or operator can select two radiator stations 980, such as (i) the first and second radiator stations 980A, 980B, (ii) the first and third radiator stations 980A, 980C, (iii) the first and fourth radiator stations 980A, 980D, (iv) the second and third radiator stations 980B, 980C, (v) the second and fourth radiator stations 980B, 980D, or (vi) the third and fourth radiator stations 980C, 980D, etc., for use during an intravascular lithotripsy procedure.Alternatively, in yet other possible applications, the user or operator can select three radiator stations 980, such as (i) the first, second, and third radiator stations 980A, 980B, 980C, (ii) the first, second, and fourth radiator stations 980A, 980B, 980D, (iii) the first, third, and fourth radiator stations 980A, 980C, 980D, or (iv) the second, third, and fourth radiator stations 980B, 980C, 980D, for use during an intravascular lithotripsy procedure. Additionally alternatively, in still other possible applications, the user or operator can select all four radiator stations 980A, 980B, 980C, 980D for use during an intravascular lithotripsy procedure.

[0154] FIG. 10 is a simplified schematic view of a further embodiment of a catheter system 1000. More specifically, in this embodiment, the catheter system 1000 includes a balloon 1004 having a balloon wall 1030 that defines an interior 1046 of the balloon, and five radiator stations 1080, such as a first radiator station 1080A, a second radiator station 1080B, a third radiator station 1080C, a fourth radiator station 1080D, and a fifth radiator station 1080E, that are positioned within the interior 1046 of the balloon 1004. Each of the radiator stations 1080A - 1080E is positioned at a different longitudinal position with respect to the length 1042 of the balloon 1004. Stated otherwise, as illustrated, the first radiator station 1080A is positioned at a first longitudinal position 1080L1 (or location) with respect to the length 1042 of the balloon 1004, the second radiator station 1080B is positioned at a second longitudinal position 1080L2 (or location) different from the first longitudinal position 1080L1 (or location) with respect to the length 1042 of the balloon 1004, the third radiator station 1080C is positioned at a third longitudinal position 1080L3 (or location) different from the first longitudinal position 1080L1 (or location) and the second longitudinal position 1080L2 (or location) with respect to the length 1042 of the balloon 1004, the fourth radiator station 1080D is positioned at a fourth longitudinal position 1080L4 (or location) different from the first longitudinal position 1080L1 (or location), the second longitudinal position 1080L2 (or location), and the third longitudinal position 1080L3 (or location) with respect to the length 1042 of the balloon 1004, and the fifth radiator station 1080E is positioned at a fifth longitudinal position 1080L5 (or location) different from the first longitudinal position 1080L1 (or location), the second longitudinal position 1080L2 (or location), the third longitudinal position 1080L3 (or location), and the fourth longitudinal position 1080L4 (or location) with respect to the length 1042 of the balloon 1004.It will be appreciated that each of the radiator stations 1080A-1080E can include any suitable number of radiators 135 (illustrated in FIG. 1), which can be one radiator 135 or multiple radiators 135. Thus, it can be said that each of the radiators 135 of any given radiator station 1080 is positioned at approximately the same longitudinal position (or location) with respect to the length 1042 of the balloon 1004.

[0155] During use of the catheter system 1000, through the use of a radiopaque material or other suitable material for the radiator station 1080 and / or the radiator 135, the visibility of the radiator station 1080 and / or the radiator 135 enables the user or operator to specifically select a particular radiator station 1080 and / or radiator 135 used during an intravascular lithotripsy procedure and / or to specifically exclude a particular radiator station 1080 and / or radiator 135 not used during an intravascular lithotripsy procedure. It is recognized that the specific selection or exclusion of the radiator station 1080 and / or the radiator 135 can be at least partially based on the proximity to the vascular lesion 106A (illustrated in FIG. 1) of the treatment site 106 (illustrated in FIG. 1). For example, in some possible applications, the user or operator can select only one of the radiator stations 1080 (and / or one or more of the radiators 13 included therein), such as only the first radiator station 1080A, only the second radiator station 1080B, only the third radiator station 1080C, only the fourth radiator station 1080D, or only the fifth radiator station 1080E, for use during an intravascular lithotripsy procedure. Alternatively, in other possible applications, the user or operator can select two radiator stations 1080 for use during an intravascular lithotripsy procedure, such as (i) the first and second radiator stations 1080A, 1080B, (ii) the first and third radiator stations 1080A, 1080C, (iii) the first and fourth radiator stations 1080A, 1080D, (iv) the first and fifth radiator stations 1080A, 1080E, (v) the second and third radiator stations 1080B, 1080C, (vi) the second and fourth radiator stations 1080B, 1080D, (vii) the second and fifth radiator stations 1080B, 1080E, (viii) the third and fourth radiator stations 1080C, 1080D, (ix) the third and fifth radiator stations 1080C, 1080E, or (x) the fourth and fifth radiator stations 1080D, 1080E.Alternatively, in yet other possible applications, the user or operator can select three radiator stations 1080, such as (i) the first, second, and third radiator stations 1080A, 1080B, 1080C, (ii) the first, second, and fourth radiator stations 1080A, 1080B, 1080D, (iii) the first, second, and fifth radiator stations 1080A, 1080B, 1080E, (iv) the first, third, and fourth radiator stations 1080A, 1080C, 1080D, (v) the first, third, and fifth radiator stations 1080A, 1080C, 1080E, (vi) the first, fourth, and fifth radiator stations 1080A, 1080D, 1080E, (vii) the second, third, and fourth radiator stations 1080B, 1080C, 1080D, (viii) the second, third, and fifth radiator stations 1080B, 1080C, 1080E, (ix) the second, fourth, and fifth radiator stations 1080B, 1080D, 1080E, or (x) the third, fourth, and fifth radiator stations 1080C, 1080D, 1080E, for use during an intravascular lithotripsy procedure. Alternatively, in still other possible applications, the user or operator can select four radiator stations 1080, such as (i) the first, second, third, and fourth radiator stations 1080A, 1080B, 1080C, 1080D, (ii) the first, second, third, and fifth radiator stations 1080A, 1080B, 1080C, 1080E, (iii) the first, second, fourth, and fifth radiator stations 1080A, 1080B, 1080D, 1080E, (iv) the first, third, fourth, and fifth radiator stations 1080A, 1080C, 1080D, 1080E, (v) the second, third, fourth, and fifth radiator stations 1080B, 1080C, 1080D, 1080E, for use during an intravascular lithotripsy procedure. Further alternatively, in yet still other possible applications, the user or operator can select all five radiator stations 1080A - 1080E for use during an intravascular lithotripsy procedure.

[0156] Figures 11A and 11B are fluoroscopic images of a portion of catheter system 1100 positioned substantially adjacent to vascular lesion 1106A. In particular, FIG. 11A is a fluoroscopic image 1182A of an example of a portion of catheter system 1100 positioned substantially adjacent to vascular lesion 1106A, the catheter system 1100 including a balloon 1104 having a balloon wall 1130 defining an interior 1146 of the balloon, and four radiator stations 1180 positioned within the interior 1146 of the balloon 1104, the balloon being in an inflated state, and FIG. 11B is a fluoroscopic image 1182B of catheter system 1100 illustrated in FIG. 11A positioned substantially adjacent to vascular lesion 1106A, the balloon 1104 being in a deflated state.

[0157] As shown in FIGS. 11A and 11B, the radiator stations 1180 of catheter system 1100 are readily visible when used with fluoroscopy during an intravascular lithotripsy procedure by virtue of the radiator stations 1180 being made of and / or including a radiopaque material.

[0158] Calcified lesions can take any of a variety of forms, ranging from short focal lesions to long lesions over 30 centimeters (cm) in length. Additionally, the cross-section of a calcified lesion can be eccentric, nodular, and circumferential. In any given lesion, the thickness of the calcium can range from a thin layer within the intimal region of the artery to a thick layer spanning the intimal and medial layers. In certain applications, a physician may not wish to deliver energy to a particular type of lesion morphology. For example, when the lesion is focal and only 10 millimeters (mm) in length and surrounded by healthy, non-calcified arteries, the physician may wish to target only the calcified arterial region.

[0159] Figure 12 is a fluoroscopic image 1282 of a portion of another embodiment of a catheter system 1200 positioned substantially adjacent to a vascular lesion 1206A of a treatment site 1206. In particular, FIG. 12 shows a catheter system 1200, which is an intravascular lithotripter device having four radiator stations 1280, such as a first radiator station 1280A, a second radiator station 1280B, a third radiator station 1280C, and a fourth radiator station 1280D, in a state where it is located inside a focal lesion, actually showing the focal lesion.

[0160] As described above, in various embodiments, a user or operator can specifically select and / or exclude a particular radiator station 1280, at least in part based on proximity to a vascular lesion 1206A of a treatment site 1206. In the embodiment illustrated in FIG. 12, the second radiator station 1280B and the third radiator station 1280C are installed substantially adjacent to the vascular lesion 1206A of the treatment site 1206. In this situation, the user or operator can choose to activate or select the second radiator station 1280B and the third radiator station 1280C so that energy is transmitted to the vascular lesion 1206A, and / or to stop or exclude the first radiator station 1280A and the fourth radiator station 1280D so that energy is not transmitted to healthy arteries.

[0161] FIG. 13 is a simplified diagram of an example of a graphical user interface 1327 that can be used as part of a catheter system. As shown in FIG. 13, the GUI 1327 includes four radiator actuators 1384, such as a first radiator actuator 1384A, a second radiator actuator 1384B, a third radiator actuator 1384C, and a fourth radiator actuator 1384D, corresponding to the radiator stations 1280A-1280D shown in FIG. 12. In particular, the first radiator actuator 1384A can be used to specifically activate (or select) or stop (exclude) the first radiator station 1280A (illustrated in FIG. 12), the second radiator actuator 1384B can be used to specifically activate (or select) or stop (exclude) the second radiator station 1280B (illustrated in FIG. 12), the third radiator actuator 1384C can be used to specifically activate (or select) or stop (exclude) the third radiator station 1280C (illustrated in FIG. 12), and the fourth radiator actuator 1384D can be used to specifically activate (or select) or stop (exclude) the fourth radiator station 1280D (illustrated in FIG. 12).

[0162] In connection with the embodiment illustrated in the image 1282 shown in FIG. 12, the GUI 1327 can include a touch screen display that can be utilized to specifically exclude or stop the first radiator station 1280A and the fourth radiator station 1280D through the corresponding radiator actuators 1384A, 1384D. Additionally or alternatively, the touch screen display of the GUI 1327 can be utilized to specifically select or activate the second radiator station 1280B and the third radiator station 1280C through the corresponding radiator actuators 1384B, 1384C. Thus, the user or operator can best target the vascular lesion 1206A of the treatment site 1206 while also best protecting the healthy non-calcified portions of the artery.

[0163] As described in detail herein, in various embodiments, the present invention can be utilized to solve various problems existing in more traditional catheter systems. For example, by enabling the catheter system to fire each radiator station and / or each radiator separately, it is possible to achieve a firing sequence or pattern that can be even more effective and efficient for destroying local lesions. By firing individual radiator stations and / or individual radiators in a desired continuous pattern, a lesion or an enlarged lesion at one specific location can be more effectively collapsed.

[0164] In summary, based on the various embodiments of the present invention illustrated and described in detail herein, a catheter system and related methods can include a catheter configured to advance to a vascular lesion, such as a calcified vascular lesion or a fibrotic vascular lesion, at or near a treatment site located within or adjacent to a blood vessel in a patient's body. The catheter includes a catheter shaft and an inflatable balloon coupled and / or locked to the catheter shaft. The balloon can include a balloon wall defining an interior of the balloon. The balloon can be configured to receive catheter fluid within the balloon to expand from a contracted state suitable for advancing the catheter through the patient's vasculature to an inflated state suitable for fixing the catheter in place relative to the treatment site.

[0165] In a pressure wave generating medical device, such as the catheter system described herein, it is often desirable to have several possible output channels, or radiator stations (or radiators), for a treatment process.

[0166] In certain embodiments, a catheter system and related methods utilize an energy source that supplies energy directed by one or more energy guides disposed within a balloon interior along a catheter shaft to generate local plasma in a catheter fluid retained within the balloon interior at or near each corresponding guide tip of the energy guides disposed within the balloon interior at a treatment site. Generation of the local plasma can cause a pressure wave, cause rapid expansion to a maximum size, and then dissipate through cavitation that can emit a pressure wave upon collapse, causing rapid formation of one or more bubbles. The rapid expansion of the plasma-induced bubbles generates one or more pressure waves within the catheter fluid retained within the balloon interior, thereby applying a pressure wave to a vasculopathy at or near a treatment site within a blood vessel wall in a patient's body and inducing disruption.

[0167] Each corresponding guide tip of the plurality of energy guides can be positioned at any suitable location with respect to the length of the balloon to more effectively and accurately apply a pressure wave for the purpose of disrupting a vasculopathy at the treatment site.

[0168] Each energy guide can be used with a corresponding plasma generator positioned at or near the corresponding guide tip of the energy guide within the balloon interior at a treatment site to generate local plasma and / or to generate a desired pressure wave within the balloon interior at the treatment site for the purpose of disrupting a vasculopathy. As used herein, the corresponding guide tip of the energy guide and the corresponding plasma generator can be collectively referred to as a "radiator." In some applications, one or more radiators positioned at generally the same longitudinal position within the balloon interior can be referred to as a "radiator station."

[0169] Accordingly, the catheter systems and related methods disclosed herein are configured to provide means for powering a plurality of radiator stations and / or a plurality of radiators in a pressure wave generator that is designed to apply pressure to a vascular lesion and induce fragmentation. In many embodiments, the catheter system can be configured and controlled to selectively and / or separately power the plurality of radiator stations in any desired pattern, sequence, order, and frequency of emission.

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

[0171] It should be noted that, as used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context and / or content clearly dictates otherwise. It should also be noted that the term "or" is generally used in the sense that it includes "and / or" unless the context and / or content clearly dictates otherwise.

[0172] Also, as used in this specification and the appended claims, the phrase "configured to" describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The phrase "configured to" can be used interchangeably with other similar phrases such as arranged, constructed, configured, arranged, constructed, manufactured, arranged, etc.

[0173] The headings used in this specification are provided for consistency with the recommendations of 37 CFR 1.77 or, alternatively, to provide a systematized cue. These headings should not be regarded as limiting or characterizing the invention claimed in any claim that may issue from this disclosure. By way of example, the description of the technology in the "Background Art" does not constitute an admission that the technology is prior art to any invention of this disclosure. Neither the "Summary of the Invention" nor the "Abstract" should be considered as characterizing the invention claimed in the issued claims.

[0174] The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the detailed description provided herein. Rather, the embodiments are selected and described so that others skilled in the art can appreciate and understand its principles and practice. As such, aspects have been described with reference to various specific and preferred embodiments and techniques. However, it is to be understood that many variations and modifications can be made within the spirit and scope of this specification.

[0175] Although several different embodiments of the catheter system have been illustrated and described herein, one or more features of any one embodiment can be combined with one or more features of one or more of the other embodiments, provided that such combination is suitable for the intent of the invention.

[0176] Although some exemplary aspects and embodiments of the catheter system have been discussed above, those skilled in the art will recognize certain variations, permutations, additions, and subcombinations thereof. Accordingly, the following appended claims and the claims introduced hereinafter are intended to be construed to include all such variations, permutations, additions, and subcombinations that are within their true spirit and scope, and no limitation to the details of the structures or designs shown herein is intended.

Claims

1. A catheter system for treating treatment sites within or near the wall of a blood vessel, An energy source that generates energy, A plurality of energy guides, each configured to selectively receive the energy from the energy source, wherein each of the plurality of energy guides includes a corresponding guide end, and the energy received by each of the plurality of energy guides is radiated from the corresponding guide end. A plurality of radiators, each capable of being positioned near the treatment site, wherein each radiator includes the corresponding guide end of one of the plurality of energy guides, and at least one of the radiators includes a radiopaque material. A catheter system equipped with [a specific feature / feature].

2. The catheter system according to claim 1, wherein the radiopaque material is visible when used by fluoroscopy during use of the catheter system in intravascular lithotripsy.

3. A catheter system according to claim 1 or 2, further comprising a catheter shaft and a balloon connected to the catheter shaft, wherein the balloon includes a balloon wall defining the interior of the balloon, the balloon is configured to hold catheter fluid inside the balloon, the energy guides are arranged along the catheter shaft, and the corresponding guide end of each of the energy guides is positioned inside the balloon such that each of the radiators is positioned inside the balloon.

4. The catheter system according to claim 3, further comprising a plurality of radiator stations located inside the balloon, each radiator station being positioned at a different longitudinal position inside the balloon relative to the length of the balloon from each of the other radiator stations, and each radiator station comprising at least one of the plurality of radiators.

5. The catheter system according to claim 4, wherein the plurality of radiator stations include a first radiator station, each including a first plurality of radiators positioned at a first longitudinal position inside the balloon, and a second radiator station, each including a second plurality of radiators positioned at a second longitudinal position inside the balloon different from the first longitudinal position.

6. The catheter system according to claim 1 or 2, further comprising a system controller including a processor that controls the energy source so that the energy from the energy source is selectively directed to each of the radiators in any desired pattern of emission.

7. The catheter system according to claim 6, wherein the system controller is configured to either specifically select or specifically exclude the radiators to be activated during use of the catheter system in an intravascular lithotripsy procedure, at least partially based on the proximity of the radiators to the treatment site.

8. The catheter system according to claim 7, wherein the system controller is configured to selectively operate only the radiator that is positioned closest to the treatment site.

9. The catheter system according to claim 7, wherein the system controller is configured to selectively stop the radiator that is positioned furthest distal to the treatment site.

10. The catheter system according to claim 7, further comprising a graphical user interface including a plurality of radiator activators that can be used to specifically select and specifically exclude the radiators to be activated during use of the catheter system in the intravascular lithotripsy procedure.

11. The catheter system according to claim 1 or 2, further comprising a multiplexer that receives the energy from the energy source and directs the energy from the energy source to each of the plurality of energy guides in the form of individual guide rays.

12. The catheter system according to claim 11, wherein the system controller controls the multiplexer such that the energy from the energy source is directed as individual guide rays to each of the energy guides in any desired sequence of emission.

13. The catheter system according to claim 11, wherein the plurality of energy guides include at least a first energy guide and a second energy guide, and the system controller controls the operation of the multiplexer such that the first guide ray is directed to the first energy guide and the second guide ray is directed to the second energy guide.

14. The catheter system according to claim 1 or 2, wherein the energy supply source is a light source that generates pulses of light energy.

15. The catheter system according to claim 1 or 2, wherein each of the plurality of energy guides includes an optical fiber.

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