Multiple radiator assemblies and firing sequences for an intravascular lithotripsy device

Abstract

The catheter system 100 includes an energy source 124, a catheter shaft 110, a balloon 104, a plurality of energy guides 122A, a plurality of radiators 135, and a system controller 126. The energy source 124 generates energy. The balloon 104 is coupled to the catheter shaft 110. The balloon 104 includes a balloon wall 130 that defines a balloon interior 146 that holds a catheter fluid 132. The energy guide 122A selectively receives energy from the energy source 124. The radiator 135 is positioned within the balloon interior 146. Each radiator 135 includes one guide tip 122D of the energy guides 122A and a corresponding plasma generator 133 spaced from the guide tip 122D. The energy received by each of the energy guides 122A is radiated from the guide tip 122D and impinges on the corresponding plasma generator 133, resulting in plasma being generated in the catheter fluid 132 within the balloon interior 146. The system controller 126 controls the energy source 124 such that the energy from the energy source 124 is directed alternately to each of the energy guides 122A in a first pattern of emission and a second pattern of emission different from the first pattern of emission.

Description

Technical Field

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 389,321, filed on July 14, 2022, entitled "MULTIPLE EMITTER ASSEMBLY AND FIRING SEQUENCES FOR INTRAVASCULAR LITHOTRIPSY DEVICE", and U.S. Patent Application No. 18 / 346,315, filed on June 30, 2023, entitled "MULTIPLE EMITTER ASSEMBLY AND FIRING SEQUENCES FOR INTRAVASCULAR LITHOTRIPSY DEVICE". To the extent permitted, the contents of U.S. Provisional Patent Application No. 63 / 389,321 and U.S. Patent Application No. 18 / 346,315 are hereby incorporated by reference in their entirety.

Background Art

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

[0003] Vascular lesions can be treated, among other things, using interventions such as drug therapy, balloon angioplasty, atherectomy, stent placement, vascular graft bypass surgery, etc. 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 to treat a treatment site within or adjacent to the vessel wall. In various embodiments, the catheter system includes an energy source, a catheter shaft, a balloon, a plurality of energy guides, a plurality of radiators, and a system controller. The energy source generates energy. The balloon is coupled to the catheter shaft. The balloon includes a balloon wall that defines an interior of the balloon. The balloon is configured to hold a catheter fluid within the interior of the balloon. The plurality of energy guides are each configured to selectively receive energy from the energy source. Each of the plurality of energy guides includes a guide tip. The plurality of radiators are positioned within the interior of the balloon. Each radiator includes a guide tip of one of the plurality of energy guides and a corresponding plasma generator spaced apart from the guide tip. The energy received by each of the plurality of energy guides is radiated from the guide tip and impinges on the corresponding plasma generator, whereby plasma is generated in the catheter fluid held within the interior of the balloon. The system controller includes a processor that controls the energy source such that energy from the energy source is directed in an alternating manner to each of the plurality of energy guides in a first pattern of emission and a second pattern of emission different from the first pattern of emission.

[0005] In various embodiments, plasma generation causes cavitation, generating a pressure wave that applies pressure in the vicinity of the vessel wall.

[0006] In certain embodiments, each plasma generator includes an inclined surface that redirects the energy radiated from the guide tip such that plasma is generated in the catheter fluid held within the interior of the balloon.

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

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

[0009] In a particular embodiment, the plurality of radiator stations includes a first radiator station including a first plurality of radiators each positioned at a first longitudinal position within the balloon, and a second radiator station including a second plurality of radiators each positioned at a second longitudinal position within the balloon different from the first longitudinal position.

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

[0011] In some embodiments, the first pattern of emission includes a first frequency of emission of the energy source and a first sequence of emission of each of the plurality of radiators, and the second pattern of emission includes a second frequency of emission of the energy source and a second sequence of emission of each of the plurality of radiators. In a particular embodiment, at least one of (i) the first frequency of emission of the energy source is different from the second frequency of emission of the energy source, and (ii) the first sequence of emission of each of the plurality of radiators is different from the second sequence of emission of each of the plurality of radiators.

[0012] In some embodiments, the first frequency of emission of the energy source is different from the second frequency of emission of the energy source, and the first sequence of emission of each of the plurality of radiators is different from the second sequence of emission of each of the plurality of radiators.

[0013] In certain embodiments, the system controller controls at least one of the frequency of emission of the energy source and the sequence of emissions of each of the plurality of emitters.

[0014] In some embodiments, the system controller controls each of the frequency of emission of the energy source and the sequence of emissions of each of the plurality of emitters.

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

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

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

[0018] In certain embodiments, the catheter system further includes a multiplexer that receives energy from an energy source and directs energy from the energy source in the form of individual guide light rays to each of a plurality of energy guides.

[0019] In some embodiments, the system controller controls the multiplexer such that energy from the energy source is directed as individual guide light rays to each of the plurality of energy guides in any desired sequence of emissions.

[0020] In certain embodiments, the plurality of energy guides includes at least a first energy guide and a second energy guide. In some embodiments, the system controller controls the operation of the multiplexer such that a first guide beam is directed to the first energy guide and a second guide beam is directed to the second energy guide.

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

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

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

[0024] The present invention further provides a method for treating a treatment site within or adjacent to a blood vessel wall, the method comprising generating energy with an energy source, connecting a balloon to a catheter shaft, the balloon including a balloon wall defining an interior of the balloon, retaining a catheter fluid within the balloon, selectively receiving energy from the energy source with a plurality of energy guides, each of the plurality of energy guides including a guide tip, positioning a plurality of radiators within the balloon, each radiator including a guide tip of one of the plurality of energy guides and a corresponding plasma generator spaced from the guide tip, radiating the energy received by each of the plurality of energy guides from the guide tip to cause plasma to be generated in the catheter fluid retained within the balloon by impinging the corresponding plasma generator, and controlling the energy source with a system controller including a processor such that energy from the energy source is alternately directed to each of the plurality of energy guides in a first pattern of emission and a second pattern of emission different from the first pattern of emission.

[0025] This summary outlines some of the teachings of this application and is not intended to be exclusive or exhaustive of the subject matter. Further details are found in the detailed description and the appended claims. Other aspects will be apparent to those skilled in the art upon reading the following detailed description and viewing the drawings that form a part thereof, each of which should not be taken in a limiting sense. The scope herein is defined by the appended claims and their legal equivalents.

[0026] The novel features of the invention, as well as the invention itself, will be best understood from the accompanying drawings, incorporated in and considered with the accompanying description in which like reference numerals refer to like parts, both as to the structure and its operation.

Brief Description of the Drawings

[0027]

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Best Mode for Carrying Out the Invention

[0028] Embodiments of the present invention are capable of various changes and alternative forms, specific examples of which are shown by examples and drawings and 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 included within the spirit and scope herein.

[0029] The 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 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.

[0030] 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, intravascular lesions and / or vascular lesions may be referred to herein as "lesions."

[0031] 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 skilled persons having the benefit of this disclosure. Here, embodiments of the invention illustrated in the accompanying drawings are described in detail.

[0032] For clarity, not all of the ordinary features of the embodiments described herein are shown and described. Of course, in the development of such actual embodiments, 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 appreciated that these specific goals may vary from one embodiment to another and from one developer to another. Further, while such development efforts can be complex and time-consuming, it is recognized that they are routine engineering efforts for those of ordinary skill in the art having the benefit of this disclosure.

[0033] The catheter systems disclosed herein can 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 within a patient's body, or above or adjacent to a heart valve. In the embodiment illustrated in FIG. 1, the catheter system 100 can include a catheter 102, an energy guide bundle 122 including one or more energy guides 122A, a supply manifold 136, a fluid pump 138, a system console 123 including one or more of an energy source 124, a power supply 125, a system controller 126, a graphic user interface 127 ( "GUI"), and a multiplexer 128, a handle assembly 129, and 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 can include more or fewer components than specifically illustrated and described in connection with FIG. 1.

[0034] In general, in various embodiments, system controller 126 configures energy source 124 and / or multiplexer 128 such that energy from energy source 124 is directed to each of energy guides 122A, or a set or subset of energy guides 122A, at any desired emission sequence, emission pattern, emission order, emission energy level, and / or emission frequency to effectively treat vascular lesion 106A at treatment site 106. As referred to herein, each radiator station 180 may include one or more radiators 135 positioned at substantially the same longitudinal position within balloon 104. Each radiator 135 includes at least one guide tip 122D of one of energy guides 122A and a corresponding plasma generation structure 133 (also referred to herein as a "plasma generator") that cooperates to generate a plasma within balloon 104. Plasma generation then causes cavitation, which generates a pressure wave that applies pressure in the vicinity of vascular lesion 106A at treatment site 106. Thus, for the purpose of effectively treating vascular lesion 106A at treatment site 106, system controller 126 may control energy source 124 and / or multiplexer 128 such that energy from energy source 124 is directed to any individual radiator 135 and / or any combination of radiators 135 in any of one or more radiator stations 180 at any desired emission sequence, emission pattern, emission order, emission energy level, and / or emission frequency.

[0035] Catheter 102 is configured to move to treatment site 106 within or adjacent to vessel wall 108A of blood vessel 108 within body 107 of patient 109. Treatment site 106 may include one or more vascular lesions 106A, such as, for example, a calcified vascular lesion. Additionally or alternatively, treatment site 106 may include a vascular lesion 106A, such as a fibrotic vascular lesion. Further alternatively, in some embodiments, catheter 102 may be used at treatment site 106 within or adjacent to a heart valve within body 107 of patient 109.

[0036] Catheter 102 may include an inflatable balloon 104 (which may be referred to herein as the "balloon"), a catheter shaft 110, and a guidewire 112. The balloon 104 may be connected 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 guidewire, which is configured to move over the guidewire 112. As used herein, the internal lumen 118 for the guidewire defines a conduit through which the guidewire 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 guidewire 112 when the catheter 102 is moved and positioned at or near the treatment site 106. In some embodiments, the balloon proximal end 104P may be connectable to the catheter shaft 110 and the balloon distal end 104D may be connectable to the internal lumen 118 for the guidewire.

[0037] 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 contracted 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.

[0038] Balloon 104 suitable for use in catheter system 100 includes those that can pass through a patient 109's vasculature when in the contracted state. In some embodiments, balloon 104 is made of silicone. In other embodiments, balloon 104 can be made of a polymer such as polydimethylsiloxane (PDMS), polyurethane, PEBAX™ material, nylon, or any other suitable material.

[0039] Balloon 104 can have any suitable diameter (in the inflated state). In various embodiments, balloon 104 can have a diameter (in the inflated state) ranging from less than 1 millimeter (mm) to 25 mm. In some embodiments, balloon 104 can have a diameter (in the inflated state) ranging from at least 1.5 mm to 14 mm. In some embodiments, balloon 104 can have a diameter (in the inflated state) ranging from at least 2 mm to 5 mm.

[0040] In some embodiments, balloon 104 can have a length 142 ranging from at least 3 mm to 300 mm. More specifically, in some embodiments, balloon 104 can have a length 142 ranging from at least 8 mm to 200 mm. It is recognized that balloons 104 having a relatively longer length can be positioned adjacent to larger treatment sites 106 and can thus be used to apply pressure waves at precise locations within treatment site 106 to a larger vascular lesion 106A or multiple vascular lesions 106A and induce fragmentation there. It is further recognized that longer balloons 104 can also be positioned adjacent to multiple treatment sites 106 in a timely manner.

[0041] 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 from at least 20 atm to 60 atm. In other embodiments, balloon 104 can be inflated to an inflation pressure from at least 6 atm to 20 atm. In yet other embodiments, balloon 104 can be inflated to an inflation pressure from at least 3 atm to 20 atm. In still other embodiments, balloon 104 can be inflated to an inflation pressure from at least 2 atm to 10 atm.

[0042] 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, balloon 104 can include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or drug eluting stent can include one or more therapeutic agents including, but not limited to, anti-inflammatory agents, anti-neoplastic agents, anti-angiogenic agents, and the like.

[0043] 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, contrast media, fluorocarbons, perfluorocarbons, gases such as carbon dioxide, or one or more of any other suitable catheter fluid 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 contrast media in an approximate volume ratio of 50:50. In other embodiments, the catheter fluid 132 can include a mixture of saline and contrast media in an approximate volume ratio of 25:75. In still other embodiments, the catheter fluid 132 can include a mixture of saline and contrast media in an approximate volume ratio of 75:25. However, it is understood that any suitable ratio of saline and contrast media can be used. The catheter fluid 132 can be adjusted based on composition, viscosity, etc. so 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 catheter fluid 132 can be adjusted according to the selected energy source 124 and the type of catheter fluid 132 used.

[0044] In some embodiments, the contrast agent used in the contrast media can 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, iothalamate, and ioxaglate. Some non-limiting examples of non-ionic iodine-based contrast agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based contrast agents can be used. Suitable non-iodine-containing contrast agents can include gadolinium(III)-based contrast agents. Suitable fluorocarbons and perfluorocarbon agents can include, but are not limited to, agents such as dodecafluoropentane (DDFP) of perfluorocarbon.

[0045] 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 is not 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.

[0046] The catheter shaft 110 of the catheter 102 can be connected 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 end portion 122D at any suitable longitudinal position 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. For example, in a particular embodiment, the first radiator station 180 can include one or more radiators 135, and the guide end portions 122D of each radiator 135 and the corresponding plasma generators 133 within the first radiator station 180 can be positioned at a first longitudinal position 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, 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 end portions 122D of each radiator 135 and the corresponding plasma generators 133 within the second radiator station 180 can be positioned at a second longitudinal position 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, even if they can be slightly spaced apart from each other. 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 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. 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 substantially the same longitudinal position 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.

[0047] 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 virtue of the presence and operation of the multiplexer 128.

[0048] 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 inner cavity 118 for the guide wire and / or the catheter shaft 110 at any suitable position. For example, in certain non-exclusive embodiments, two energy guides 122A can be spaced approximately 180 degrees around the inner cavity 118 for the guide wire and / or the catheter shaft 110, or three energy guides 122A can be spaced approximately 120 degrees around the inner cavity 118 for the guide wire and / or the catheter shaft 110, or four energy guides 122A can be spaced approximately 90 degrees around the inner cavity 118 for the guide wire and / or the catheter shaft 110, or five energy guides 122A can be spaced approximately 72 degrees around the inner cavity 118 for the guide wire and / or the catheter shaft 110, or six energy guides 122A can be spaced approximately 60 degrees around the inner cavity 118 for the guide wire and / or the catheter shaft 110, or eight energy guides 122A can be spaced approximately 45 degrees around the inner cavity 118 for the guide wire and / or the catheter shaft 110, or ten energy guides 122A can be spaced approximately 36 degrees around the inner cavity 118 for the guide wire and / or the catheter shaft 110. Additionally alternatively, the plurality of energy guides 122A need not be evenly spaced from each other around the inner cavity 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 inner cavity 118 for the guide wire and / or the catheter shaft 110 to achieve the desired effect at the desired location.

[0049] In certain embodiments, the inner lumen 118 for the guide wire can have a grooved outer surface, and the grooves extend 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 retained along and / or within individual 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 guides 122A relative to the inner lumen 118 for the guide wire can be maintained in another suitable manner.

[0050] The catheter system 100 and / or the energy guide bundle 122 can include any number of energy guides 122A that are optically communicative with an 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 guides 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.

[0051] The energy guide 122A can have any suitable design for the purpose of generating plasma and / or pressure waves in the catheter fluid 132 inside the balloon 146. Thus, a 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 generating a desired plasma in the catheter fluid 132 inside the balloon 146. For example, in one non-exclusive alternative embodiment, the energy source 124 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.

[0052] 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, and can allow an optical signal to be sent with little loss of intensity. The energy guide 122A can include a core surrounded by a cladding around it. 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.

[0053] Each energy guide 122A can have at least one optical window (not shown) positioned inside the balloon 146 and can guide energy along its length from the guide proximal end 122P to the guide distal end 122D.

[0054] The energy guide 122A can take on 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 connected 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.

[0055] 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 can be arranged at any suitable longitudinal position (within any suitable or desired radiator station 180) 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, in order to more effectively and accurately apply a pressure wave for the purpose of destroying the vascular lesion 106A at the treatment site 106.

[0056] 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 122D 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.

[0057] 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.

[0058] 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, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a semi-circular shape, an 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.

[0059] 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, within the energy guide 122A and / or in the vicinity of 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.

[0060] Examples of turning structures suitable for use include reflective elements, refractive elements, fiber diffusers, and the like. Turning 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 contacting the turning 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 tip 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 directed away from the side surface of the energy guide 122A and toward the balloon wall 130. Additionally or alternatively, when utilized, the photoacoustic transducer 153 then converts the optical energy into acoustic waves that spread away from the side surface of the energy guide 122A.

[0061] 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.

[0062] As described above, in the embodiment illustrated in FIG. 1, system console 123 includes one or more of energy source 124, power supply 125, system controller 126, GUI 127, and multiplexer 128. Alternatively, system console 123 may include more or fewer components than specifically illustrated in FIG. 1. For example, in certain non-exclusive alternative embodiments, system console 123 may be designed without GUI 127. Further alternatively, one or more of energy source 124, power supply 125, system controller 126, GUI 127, and multiplexer 128 may be provided within catheter system 100 without a particular need for system console 123.

[0063] As shown, system console 123 and the components included therewith are operably coupled to catheter 102, energy guide bundle 122, and the remainder of catheter system 100. For example, in some embodiments, as illustrated in FIG. 1, system console 123 can include a console interface 148 (which may sometimes be referred to generally as a “socket” or “console receptacle”), whereby energy guide bundle 122 is mechanically coupled to system console 123. In such embodiments, energy guide bundle 122 can include an optical connector assembly having a guide connection housing 150 (which may sometimes be referred to generally as a “connector housing”) that houses portions such as each guide proximal end 122P of energy guide 122A. At least a portion of guide connection housing 150 is configured to fit within and be selectively retained within console interface 148 to effect a mechanical connection between energy guide bundle 122 and system console 123.

[0064] 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.

[0065] 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 below herein, 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.

[0066] Energy source 124 can have any suitable design. In certain embodiments, energy source 124 can be configured to supply submillisecond 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, such as via plasma generator 133 that can 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 gives it energy 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 bubbles 134 induced by plasma are illustrated in FIG. 1.

[0067] As used herein, guide distal end 122D of energy guide 122A and corresponding plasma generator 133 can 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 can 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.

[0068] In various embodiments, the catheter system 100 is configured to provide means for powering a plurality of radiator stations in a pressure wave generator designed to apply pressure to a vascular lesion 106A, such as a calcified or fibrotic vascular lesion of a treatment site 106, to induce fragmentation. In many embodiments, the catheter system 100 can be configured and controlled to selectively and / or separately power a plurality of radiator stations 180 and / or a plurality of radiators 135 within any given radiator station 180 in any desired pattern, order, sequence, and frequency of firing.

[0069] In various non-exclusive alternative embodiments, sub-millisecond 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 sub-millisecond 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.

[0070] 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, such as a single pulsed source beam 124A.

[0071] Suitable energy sources 124 can include various types of light sources, including lasers and lamps. Alternatively, the energy source 124 can include any suitable type of energy source.

[0072] Suitable lasers can include short-pulse lasers on the sub-millisecond time scale. In some embodiments, the energy source 124 can include a laser 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 a plasma in the catheter fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse width 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.

[0073] 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, the energy source 124 suitable for use in the catheter system 100 can include those capable of generating light with wavelengths from at least 750 nm to 2000 nm. In other embodiments, the energy source 124 can include those capable of generating light with wavelengths from at least 700 nm to 3000 nm. In still other embodiments, the 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 having a repetition rate of up to 200 kHz.

[0074] In some embodiments, the laser may include a Q-switch 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.

[0075] In yet other embodiments, the energy source 124 may include a plurality of lasers grouped together in series. In still 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 yet still 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.

[0076] 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.

[0077] When the catheter 102 is placed at the treatment site 106, the pressure wave can be applied to the treatment site 106 from a distance within a range that extends radially from the energy guide 122A of at least approximately 0.1 millimeter (mm) to more than approximately 25 mm. In various non-exclusive alternative embodiments, the pressure wave can be applied to the treatment site 106 from a distance within a range that extends radially from the energy guide 122A 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 when the catheter 102 is placed at the treatment site 106. In other embodiments, the pressure wave can be applied to the treatment site 106 from another suitable distance that is 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.

[0078] 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.

[0079] The system controller 126 is electrically connected to and receives power from the power supply 125. 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 so 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 in a desired manner.

[0080] More specifically, the system controller 126 can control the energy source 124 and / or the multiplexer 128 such that each individual guide light ray 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 light ray 124B can be directed to any of the radiator stations 180 and / or to a radiator 135 incorporated within any of the radiator stations 180 at any desired emission sequence, emission pattern, emission order, emission energy level, and / or emission frequency. 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 the energy pulse, which can be varied according to any or all of the pulse widths and / or pulse amplitudes of the pulses. Certain non-exclusive examples of the application of sequencing alternation of the emission of the energy guides 122A and / or the radiator 135 within a given radiator station 180 are described in detail below herein.

[0081] The system controller 126 can 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, and the inflation of the balloon 104 with the catheter fluid 132. Further or alternatively, the catheter system 100 can include one or more additional controllers that can 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 can be positioned within and / or incorporated into the handle assembly 129.

[0082] The GUI 127 is accessible by a user or an 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 the 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. The GUI 127 can provide information to the user or the operator that can be used before, during, and after the use of the catheter system 100. In one embodiment, the GUI 127 can provide static visual data and / or information to the user or the 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 the 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 the operator. Additionally or alternatively, the GUI 127 can provide audio data or information to the user or the 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 the 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, as desired, to each of the energy guides 122A within the energy guide bundle 122, in the form of individual guide beams 124B. In this way, the multiplexer 128 enables a single energy source 124 to be separately delivered through a plurality of energy guides 122A in any desired sequence or pattern, such that the catheter system 100 can apply pressure to and induce fragmentation of 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. As shown, in certain embodiments, the catheter system 100 may 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 one or more of the system controller 126, the energy source 124, the fluid pump 138, and the GUI 127, but is in electrical and / or fluid communication with them.

[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 such embodiments, the handle assembly 129 can include a circuit 155 that is electrically coupled between the catheter electronics and the system console 123 and can form at least a portion of the system controller 126. In one embodiment, the circuit 155 can include a printed circuit board having one or more integrated circuits, or any other suitable circuit. In an alternative embodiment, the circuit 155 can be omitted or, in various embodiments, can be included within the system controller 126, positioned outside the handle assembly 129, such as within the system console 123. 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), and each emitter station 180 includes 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 certain embodiments, the plasma generator 133 can be provided in the form of a non-return structure having an inclined surface that redirects the energy radiated from the guide end portion 122D towards the balloon wall 130 of the balloon 104 and / or towards 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 to radiate energy from the guide end portion 122D towards the plasma generator 133. The energy radiated from the guide end portion 122D impinges on the material of the plasma generator 133, such as the material at the inclined surface of the plasma generator 133, and imparts energy thereto for the purpose of generating plasma in the catheter fluid 132 within the balloon interior 146. Plasma generation ionizes and / or overheats the surrounding catheter fluid 132, resulting in rapid inertial bubble formation and applying 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 and / or metal alloys having a relatively high melting temperature, such as titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium, iridium, etc. Alternatively, the plasma generator 133 can be formed from at least one of magnesium oxide, beryllium oxide, tungsten carbide, titanium nitride, titanium carbonitride, and titanium carbide. Further alternatively, the plasma generator 133 can be formed from at least one of diamond CVD and diamond. In other embodiments, the plasma generator 133 can be formed from transition metals, alloy metals, or ceramic materials. Further alternatively, in some embodiments, the plasma generator 133 can be at least partially formed from polymers, polymeric materials, and / or plastics such as polyimide and nylon. Further alternatively, the plasma generator 133 can be formed from any other suitable material.

[0091] Further details of various embodiments of the radiator system 131, the radiator station 180, and / or the individual radiators 135 are provided herein below in connection with FIGS. 8 and 9.

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

[0093] Similar to all 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 each of the energy guide bundles 222 and / or 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 the 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 the 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 than seven 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 in accordance with the requirements of the catheter system 200, the relative positioning of the energy guides 222A - 222E, and / or 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 a stationary 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 thereby 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 a stationary 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 is accurately directed and focused by the multiplexer 228 as corresponding guide light beams 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 position 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, which are 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 deflector 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 pulse or semi-CW mode. The stage mover 264 then advances the multiplexer stage 262 to the next stop position, i.e., 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 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 towards 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 by approximately 90 degrees so that the source beam 224A is directed towards the multiplexer 228. Alternatively, the optical element 247 may redirect the source beam 224A by more than 90 degrees 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 towards the multiplexer 228.

[0105] In this embodiment, the source beam 224A that is directed towards the multiplexer 228 first impinges on a beam deflector 266 that is configured to redirect the source beam 224A towards the coupling optics 268. In some embodiments, the beam deflector 266 redirects the source beam 224A by approximately 90 degrees towards the coupling optics 268. Alternatively, the beam deflector 266 may redirect the source beam 224A by more than 90 degrees or less than 90 degrees towards 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 optical-mechanical scanner, an X - Y galvanometer, or other multi-axis beam manipulation devices.

[0108] As a further alternative, FIG. 2A illustrates that the energy guides 222A - 222E are fixedly positioned with respect to the multiplexer base 260. However, in some embodiments, the energy guides 222A - 222E can be configured to move with respect to a connecting optics 268 that is fixedly positioned. In such embodiments, the guide connection housing 250 itself will 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 stepwise so that each is aligned with the connecting 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 with respect to the connecting 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 illustrated in FIG. 2A and of the multiplexer 228. In particular, FIG. 2B shows 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 simplicity and ease of illustration.

[0110] FIG. 3A is a simplified schematic top view of a portion of an embodiment of a catheter system 300 that includes 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 ray 324A from the energy source 324 and selectively and / or alternately directs the energy in the form of individual guide rays 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 detailed above herein. Accordingly, such components are not described in detail in relation to 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 relation to 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 in the form of a source ray 324A, such as a single pulsed source ray, from the energy source 324 and selectively and / or alternately direct the energy in the form of individual guide rays 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 relative 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, direction changer 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] Direction changer 366 and coupling optics 368 are mounted on and / or held by multiplexer stage 362. During use of catheter system 300, source ray 324A is first directed along central axis 324X of energy source 324 toward multiplexer 328 and / or multiplexer stage 362. Thereafter, direction changer 366 is configured to deflect source ray 324A laterally a fixed distance from central axis 324X of energy source 324 such that source ray 324A is directed in a direction substantially parallel to and spaced from central axis 324X. More specifically, direction changer 366 deflects source ray 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 ray 324A directed through direction changer 366 traces a circular path.

[0117] It is recognized that the beam deflector 366 can have any suitable design. For example, in certain non-exclusive alternative embodiments, 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 by the multiplexer stage 362. Similar to the previous embodiments, 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 certain embodiments, 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 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 a pulsed or semi - CW mode. The stage mover 364 then angularly advances the multiplexer stage 362 to the next stop position, i.e., 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 one 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 about 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 fixed in a stationary position relative to the multiplexer stage 362. However, it is recognized that in some embodiments, the energy guides 322A-322C may be configured to move and / or rotate relative to the coupling optics 368 that are fixed in a stationary position. 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 coupling optics 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 each portion of the energy guide, as well as a multiplexer stage 362, a beam deflector 366, and coupling optics 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 a catheter system 400 and yet another embodiment of a 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 beam 424A from the energy source 424 and selectively and / or alternately directs the energy in the form of individual guide beams 424B to each 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 relation to 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 relation to 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 beam 424A, such as a single pulsed source beam, and selectively and / or alternately direct the energy in the form of individual guide beams 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 proximal ends 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 proximal ends 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 optics 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 beam path of the source beam 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 combining 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 closely packed hexagonal pattern similar to that illustrated in FIGS. 3A and 3B. Alternatively, the energy guides 422A - 422E within the guide connection housing 450 can 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 splits the source ray 424A into two or more deflected 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 splits the source ray 424A into the same number of energy guides as are present in 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 split 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 couple 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 illustrates 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 a multiplexer 528 that receives energy in the form of a source beam 524A from the energy source 524 and selectively and / or alternately directs the energy in the form of individual guide beams 524B to each of the energy guides 522A-522C in any desired sequence and / or pattern under the control of the system controller 526. 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 connection with 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 connection with 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 beam 524A, such as a single pulsed source beam, and selectively and / or alternately direct the energy in the form of individual guide beams 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, the multiplexer 528 has a design different from any of the previous embodiments. In some embodiments, it is desirable to design the multiplexer 528 to receive the source beam 524A from a single energy source 524 and selectively and / or alternately direct the energy in the form of individual guide beams 524B to any one or all of the 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 the 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 re-targeted to different energy guides 522A-522C within a few microseconds by changing the drive frequency input to the multiplexer 528 (AOD), and this switching can be easily done between pulses when using a pulsed laser such as a Nd:YAG laser. In such embodiments, the deflection angle (Θ) of the 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 redirected as the desired guide ray 524B to each of the energy guides 522A - 522C at the created deflection angles. More specifically, as illustrated, when the multiplexer 528 creates a first deflection angle with respect to the source ray 524A, the first guide 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 guide 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 guide 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 guide 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 guide ray 524B toward the desired energy guides 522A - 522C and then creates the 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 defining the guide 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 described in detail 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 create a desired deflection angle such that the source light beam 624A is redirected as the desired guide light beam 624B toward 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 to a diameter that substantially fills the aperture of the multiplexer 628 (AOD). The smaller the input divergence, the more discrete outputs can be generated. Although the angular resolution of such an apparatus is very good, the deflection over the full angle is limited. To enable 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 change 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 from the energy source 724, in the form of a source light beam 724A such as a single pulsed source light beam, receives energy, and under the control of the system controller 726, selectively and / or in an alternating manner in any desired sequence and / or pattern to any one or all of the energy guides 722A-722E, in the form of individual guide light beams 724B, illustrates a multiplexer 728 that directs energy. 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 relation to 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 as being 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, positioned in series with each other. Such a design may enable the multiplexer 728 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 enables 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 deflects the transmitted ray 724C, if desired, 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 of the AODs 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 which can then create a desired deflection angle such that the source ray 724A is redirected 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 which can then create a desired deflection angle such that the transmitted ray 724C is redirected 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 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 (illustrated in FIG. 1), each radiator station 180 being positioned at a different longitudinal position with respect 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 with respect 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 with respect 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 with respect 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 with respect to the length 142 of the balloon 104. Stated otherwise, the guide tip 122D (illustrated in FIG. 1) of the energy guide 122A 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 with respect 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 that is 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 the 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] FIG. 8 is a simplified schematic side view of a portion of an example catheter system 800 having the features of the present invention. As illustrated, the 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 the catheter system 800 may include any suitable number of radiator stations 880). Each of the 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) 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 the radiator stations 880A, 880B may include any suitable number of radiators 835 (illustrated in the enlarged view of the first radiator station 880A in FIG. 8), which may be one radiator 835 or multiple radiators 835. Thus, it can be said that each radiator 835 of any given radiator station 880 is positioned at substantially the same longitudinal position (or location) with respect to the length 842 of the balloon 804.

[0149] In the embodiment shown in FIG. 8, each radiator station 880A, 880B includes two radiators 835, and each radiator 835 is utilized with an individual energy guide 822A that transfers energy from an energy source 124 (illustrated in FIG. 1) to the radiator 835. Thus, in many embodiments, the catheter system 800 is modified in accordance with a multiplexer 128 (illustrated in FIG. 1) that multiplexes energy from an energy source 124 in the form of a single supply ray 124A (illustrated in FIG. 1) into a plurality of guide rays 124B (illustrated in FIG. 1), each of which is directed to one of a plurality of energy guides 822A. Alternatively, each radiator station 880A, 880B may include more than two radiators 835, or only a single radiator 835.

[0150] In various non-exclusive alternative embodiments, the catheter system 800 may have a plurality of radiators 835 at each radiator station 880 and may further have a plurality of radiator stations 880. Various alternative multiplexing algorithms, as described through the use and functionality of the system controller 126 (illustrated in FIG. 1), may be designed to achieve a unique effect for crushing calcium. For example, some configurations and firing sequences may be more efficient in crushing eccentric or nodular calcium. Alternatively, other configurations and firing sequences may be more efficient when crushing peripheral calcium. Further alternatively, still other configurations and firing sequences may be superior in crushing thick calcium. [Should more specific examples of particular firing sequences established through the use of multiplexing algorithms be presented?]

[0151] In another portion of FIG. 8, a schematic side view of a single radiator 835 is provided. As illustrated, the radiator 835 can include a guide end portion 822D of the energy guide 822A and a corresponding plasma generator 833 that is spaced from but can be coupled to the guide end portion 822D of the energy guide 822A. With such a design, energy from the energy source 124 is guided along the energy guide 822A from the guide base end portion 122P (illustrated in FIG. 1) to the guide end portion 822D, from which the energy is directed towards the plasma generator 833. The energy radiated from the guide end portion 822D of the energy guide 822A collides with and / or energizes the material of the plasma generator 833 to generate a local plasma in the catheter fluid 132 (illustrated in FIG. 1) within the balloon interior 846 of the balloon 804 and / or to generate a desired pressure wave for the purpose of destroying the vascular lesion 106A (illustrated in FIG. 1).

[0152] The plasma generator 833 can have any suitable design for the purpose of redirecting the energy radiated from the guide tip 822D to generate local plasma in the catheter fluid 132 inside the balloon 846 of the balloon 804 and / or to generate a desired pressure wave. For example, in certain embodiments, as shown in FIG. 8, the plasma generator 833 can be provided in the form of a non-return type structure having an inclined surface 833F for redirecting the energy radiated from the guide tip 822D to generate local plasma in the catheter fluid 132 inside the balloon 846 of the balloon 804 and / or to generate a desired pressure wave. Thus, the inclined surface 833F acts like a one-way mirror. In some embodiments, the inclined surface 833F of the plasma generator 833 can be inclined between approximately 5 degrees and 45 degrees with respect to a flat and vertical configuration. Alternatively, the inclined surface 833F of the plasma generator 833 can be inclined less than 5 degrees or more than 45 degrees with respect to a flat and vertical configuration to direct the energy in the form of plasma generated in the catheter fluid 132 towards the balloon wall 830 positioned adjacent to the treatment site 106 (illustrated in FIG. 1). Further alternatively, the plasma generator 833 can have another suitable design.

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

[0154] FIG. 9 is a simplified schematic perspective view of a portion of another embodiment of a catheter system 900. The embodiment of the catheter system 900 shown in FIG. 9 is substantially similar to the embodiment of the catheter system 800 shown in FIG. 8. For example, as shown in FIG. 9, the catheter system 900 also has a balloon 904 having a balloon wall 930 that defines an interior 946 of the balloon, and one or more radiator stations 980 such as a first radiator station 980A and a second radiator station 980B located in the interior 946 of the balloon 904 in this particular embodiment (it is understood that the catheter system 900 may include any suitable number of radiator stations 980). Each of the radiator stations 980A, 980B is also positioned at a different longitudinal position with respect to the length 942 of the balloon 904. Stated differently, 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, and the second radiator station 980B is positioned at a second longitudinal position 980L2 (or location) different from the first longitudinal position 980L1 (or location) with respect to the length 942 of the balloon 904.

[0155] Also, as illustrated in the embodiment shown in FIG. 9, each of the radiator stations 980A, 980B also includes two radiators 935, and each radiator 935 is utilized with an individual energy guide 922A that transmits energy from an energy source 124 (illustrated in FIG. 1) to the radiator 935. Thus, in many embodiments, the catheter system 900 is modified in accordance with a multiplexer 128 (illustrated in FIG. 1) that multiplexes energy from an energy source 124 in the form of a single source ray 124A (illustrated in FIG. 1) into a plurality of guide rays 124B (illustrated in FIG. 1), each of which is directed to one of a plurality of energy guides 922A. Alternatively, each of the radiator stations 980A, 980B may include more than two radiators 935, or only a single radiator 935.

[0156] As described above, various alternative multiplexing algorithms, such as those described through the use and functionality of the system controller 126 (illustrated in FIG. 1), can be designed to achieve a unique effect for crushing calcium. For example, some configurations and firing sequences may be more efficient in crushing eccentric or nodular calcium. Alternatively, other configurations and firing sequences may be more efficient when crushing peripheral calcium. Further alternatively, still other configurations and firing sequences may be superior in crushing thick calcium.

[0157] In another portion of FIG. 9, a schematic perspective view of a single radiator 935 is provided. As illustrated, the radiator 935 can include a guide end portion 922D of the energy guide 922A and a corresponding plasma generator 933 that is spaced from, but can be coupled to, the guide end portion 922D of the energy guide 922A. With such a design, energy from the energy source 124 is guided along the energy guide 922A from the guide base end portion 122P (illustrated in FIG. 1) to the guide end portion 922D, from which the energy is directed towards the plasma generator 933. The energy radiated from the guide end portion 922D of the energy guide 922A collides with and / or energizes the material of the plasma generator 933 to generate a local plasma in the catheter fluid 132 (illustrated in FIG. 1) within the balloon interior 946 of the balloon 904 and / or to generate a desired pressure wave for the purpose of destroying the vascular lesion 106A (illustrated in FIG. 1).

[0158] The plasma generator 933 may also have any suitable design for the purpose of redirecting the energy radiated from the guide tip 922D to generate local plasma in the catheter fluid 132 inside the balloon 946 of the balloon 904 and / or to generate a desired pressure wave. For example, in certain embodiments, as shown in FIG. 9, the plasma generator 933 may also be provided in the form of a non-return structure having an inclined surface 933F for redirecting the energy radiated from the guide tip 922D to generate local plasma in the catheter fluid 132 inside the balloon 946 of the balloon 904 and / or to generate a desired pressure wave. Thus, the inclined surface 933F acts like a one-way mirror. Alternatively, the plasma generator 933 may have another suitable design.

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

[0160] Certain alternative examples with different possible firing sequences for a catheter system and / or a radiator station having the features of the present invention are illustrated and described below herein in connection with FIGS. 10A - 10B, FIGS. 11A - 11C, and FIGS. 12A - 12E.

[0161] FIGS. 10A - 10B are simplified schematic diagrams of alternative firing configurations that can be used within a radiator station 1080 that includes two radiators 1035. As illustrated, in certain embodiments, the two radiators 1035 can be spaced approximately 180 degrees apart from each other, such as around the internal cavity 1018 for the guide wire. Alternatively, the two radiators 1035 can be spaced apart from each other around the internal cavity 1018 in different ways.

[0162] In particular, FIG. 10A is a simplified schematic diagram showing a radiator station 1080 having two radiators 1035, such as a first radiator 1035A and a second radiator 1035B, and each of the two radiators 1035A, 1035B is fired simultaneously. The simultaneous firing of the two radiators 1035A, 1035B can be repeated or varied as desired during an intravascular lithotripsy procedure. It is further recognized that the simultaneous firing of the two radiators 1035A, 1035B can be performed using energy from an energy source 124 (illustrated in FIG. 1) supplied at any desired and / or appropriate firing frequency and at any desired and / or appropriate energy level.

[0163] Figure 10B is a simplified schematic view showing the radiator station 1080 of Figure 10A, and each of the two radiators 1035A, 1035B is individually emitted, which can be done in any desired sequential manner. In certain embodiments of the radiator station 1080 example shown in Figure 10B, the emission sequence can include first emitting the first radiator 1035A, then emitting the second radiator 1035B, and then repeating such an emission sequence during an intravascular lithotripsy procedure. Alternatively, the first radiator 1035A and the second radiator 1035B can be individually emitted in another suitable sequential manner during an intravascular lithotripsy procedure. The sequential emission of the two radiators 1035A, 1035B is further recognized to be performed using energy from an energy source 124 (illustrated in Figure 1) supplied at any desired and / or suitable emission frequency and at any desired and / or suitable energy level.

[0164] It is also recognized that the emissions of the two radiators 1035A, 1035B can be performed in any suitable combination of simultaneous and / or sequential emission patterns.

[0165] Figures 11A - 11C are simplified schematic views of alternative emission configurations that can be used within a radiator station 1180 that includes three radiators 1135. As illustrated, in certain embodiments, the three radiators 1135 can be spaced approximately 120 degrees apart from each other, such as around an internal cavity 1118 for a guide wire. Alternatively, the three radiators 1135 can be spaced apart from each other around the internal cavity 1118 for a guide wire in different ways.

[0166] In particular, FIG. 11A is a simplified schematic diagram showing a radiator station 1180 having three radiators 1135 such as a first radiator 1135A, a second radiator 1135B, and a third radiator 1135C, and each of the three radiators 1135A-1135C is fired simultaneously. The simultaneous firing of the three radiators 1135A-1135C is then repeated or varied as desired during the intravascular lithotripsy procedure. The simultaneous firing of the three radiators 1135A-1135C can be performed using energy from an energy source 124 (illustrated in FIG. 1) supplied at any desired and / or appropriate firing frequency and at any desired and / or appropriate energy level.

[0167] FIG. 11B is a simplified schematic diagram showing the radiator station 1180 of FIG. 11A, and the three radiators 1135A-1135C are fired in pairs, which can be done in any desired sequential manner. In some embodiments of the radiator station 1180 shown in FIG. 11B, the firing sequence can fire the radiators 1135A-1135C in pairs in a circular pattern such as clockwise. Thus, in such an embodiment, the firing sequence can include firing the first radiator 1135A and the second radiator 1135B simultaneously, then firing the second radiator 1135B and the third radiator 1135C simultaneously, then firing the third radiator 1135C and the first radiator 1135A simultaneously, and then repeating such a firing sequence during the intravascular lithotripsy procedure. Alternatively, the first radiator 1135A, the second radiator 1135B, and the third radiator 1135C can be fired in pairs in another suitable sequential manner during the intravascular lithotripsy procedure. It is further recognized that the sequential firing of two of the three radiators 1135A-1135C can be performed using energy from an energy source 124 (illustrated in FIG. 1) supplied at any desired and / or appropriate firing frequency and at any desired and / or appropriate energy level.

[0168] FIG. 11C is a simplified schematic view showing the radiator station 1180 of FIG. 11A, and each of the three radiators 1135A - 1135C is fired individually, which can be done in any desired sequential manner. In certain embodiments of the embodiment of the radiator station 1180 shown in FIG. 11C, the firing sequence can fire the radiators 1135A - 1135C individually in a circular pattern such as clockwise. Thus, in such an embodiment, the firing sequence can include first firing the first radiator 1135A, then firing the second radiator 1135B, then firing the third radiator 1135C, and then repeating such a firing sequence during an intravascular lithotripsy procedure. Alternatively, the first radiator 1135A, the second radiator 1135B, and the third radiator 1135C can be fired individually in another suitable sequential manner during an intravascular lithotripsy procedure. It is further recognized that each individual firing of the three radiators 1135A - 1135C can be performed using energy from an energy source 124 (illustrated in FIG. 1) supplied at any desired and / or appropriate firing frequency and at any desired and / or appropriate energy level.

[0169] It is also recognized that the firings of the three radiators 1135A - 1135C can be done simultaneously, in pairs, and / or in any suitable combination of continuous firing patterns.

[0170] FIGS. 12A - 12E are simplified schematic views of alternative firing configurations that can be used within a radiator station 1280 that includes four radiators 1235. As illustrated, in certain embodiments, the four radiators 1235 can be spaced approximately 90 degrees apart from each other, such as around the internal cavity 1218 for the guide wire. Alternatively, the four radiators 1235 can be spaced apart from each other around the internal cavity 1218 for the guide wire in different ways.

[0171] In particular, FIG. 12A is a simplified schematic view showing a radiator station 1280 having four radiators 1235, such as a first radiator 1235A, a second radiator 1235B, a third radiator 1235C, and a fourth radiator 1235D, and each of the four radiators 1235A-1235D is fired simultaneously. The simultaneous firing of the four radiators 1235A-1235D is then repeated or varied as desired during an intravascular lithotripsy procedure. The simultaneous firing of the four radiators 1235A-1235D can be performed using energy from an energy source 124 (illustrated in FIG. 1) supplied at any desired and / or appropriate firing frequency and at any desired and / or appropriate energy level.

[0172] FIG. 12B is a simplified schematic view showing the radiator station 1280 of FIG. 12A, and the four radiators 1235A-1235D are fired in pairs, being approximately 180 degrees apart from each other around an internal cavity 1218 for a guide wire, which can be done in any desired continuous manner. In certain embodiments of the radiator station 1280 shown in FIG. 12B, the firing sequence can fire the radiators 1235A-1235D in pairs, approximately 180 degrees apart, in a circular pattern such as clockwise. Thus, in such an embodiment, the firing sequence can include firing the first radiator 1235A and the third radiator 1235C simultaneously, then firing the second radiator 1235B and the fourth radiator 1235D simultaneously, and thereafter repeating such a firing sequence during an intravascular lithotripsy procedure. Alternatively, the first radiator 1235A, the second radiator 1235B, the third radiator 1235C, and the fourth radiator 1235D can be fired in pairs, approximately 180 degrees apart, in another suitable continuous manner during an intravascular lithotripsy procedure. It is further recognized that two consecutive firings (such as in pairs approximately 180 degrees apart) of the four radiators 1235A-1235D can be performed using energy from an energy source 124 (illustrated in FIG. 1) supplied at any desired and / or appropriate firing frequency and at any desired and / or appropriate energy level.

[0173] FIG. 12C is a simplified schematic diagram showing the radiator station 1280 of FIG. 12A. The four radiators 1235A-1235D are fired in pairs, approximately 90 degrees apart from each other, which can be done in any desired sequential manner. In an embodiment having an example of the radiator station 1280 shown in FIG. 12C, the firing sequence can fire the radiators 1235A-1235D in pairs, approximately 90 degrees apart, in a circular pattern such as clockwise. Thus, in such an embodiment, the firing sequence can include firing the first radiator 1235A and the second radiator 1235B simultaneously, then firing the second radiator 1235B and the third radiator 1235C simultaneously, then firing the third radiator 1135C and the fourth radiator 1235D simultaneously, then firing the fourth radiator 1235D and the first radiator 1235A simultaneously, and then repeating such a firing sequence during an intravascular lithotripsy procedure. Alternatively, the first radiator 1235A, the second radiator 1235B, the third radiator 1235C, and the fourth radiator 1235D can be fired in pairs, approximately 90 degrees apart, in another suitable sequential manner during an intravascular lithotripsy procedure. It is further recognized that two consecutive firings (such as in pairs approximately 90 degrees apart) of the four radiators 1235A-1235D can be performed using energy from an energy source 124 (illustrated in FIG. 1) supplied at any desired and / or suitable firing frequency and at any desired and / or suitable energy level.

[0174] FIG. 12D is a simplified schematic diagram showing the radiator station 1280 of FIG. 12A, and each of the four radiators 1235A-1235D is individually emitted, which can be done in any desired sequential manner. In certain embodiments of the radiator station 1280 shown in FIG. 12D, the emission sequence can individually emit the radiators 1235A-1235D in a circular pattern such as clockwise. Thus, in such an embodiment, the emission sequence can include first emitting the first radiator 1235A, then the second radiator 1235B, then the third radiator 1235C, then the fourth radiator 1235D, and then repeating such an emission sequence during the intravascular lithotripsy procedure. Alternatively, the first radiator 1235A, the second radiator 1235B, the third radiator 1235C, and the fourth radiator 1235D can be individually emitted in another suitable sequential manner during the intravascular lithotripsy procedure. It is further recognized that each individual emission of the four radiators 1235A-1235D can be performed using energy from an energy source 124 (illustrated in FIG. 1) supplied at any desired and / or appropriate emission frequency and at any desired and / or appropriate energy level.

[0175] FIG. 12E is a simplified schematic view showing the radiator station 1280 of FIG. 12A, where four radiators 1235A-1235D are emitted in groups of three radiators 1235, which can be done in any desired sequential manner. In an embodiment with an example of the radiator station 1280 shown in FIG. 12E, the emission sequence can emit radiators 1235A-1235D in groups of three radiators 1235 in a circular pattern such as clockwise. Thus, in such an embodiment, the emission sequence includes simultaneously emitting the first radiator 1235A, the second radiator 1235B, and the third radiator 1235C, then simultaneously emitting the second radiator 1235B, the third radiator 1235C, and the fourth radiator 1235D, then simultaneously emitting the third radiator 1135C, the fourth radiator 1235D, and the first radiator 1235A, then simultaneously emitting the fourth radiator 1235D, the first radiator 1235A, and the second radiator 1235B, and including repeating such an emission sequence during an intravascular lithotripsy procedure. Alternatively, the first radiator 1235A, the second radiator 1235B, the third radiator 1235C, and the fourth radiator 1235D can be emitted in groups of three radiators 1235 in another suitable sequential manner during an intravascular lithotripsy procedure. It is further recognized that the sequential emission of three out of the four radiators 1235A-1235D can be done using energy from an energy source 124 (illustrated in FIG. 1) supplied at any desired and / or appropriate emission frequency and at any desired and / or appropriate energy level.

[0176] It is also recognized that the emissions of the four radiators 1235A-1235D can be done simultaneously, in groups of three, in groups of two, and / or in any suitable combination of sequential emission patterns.

[0177] As described in detail herein, in various embodiments, the present invention can be utilized to solve various problems present in more traditional catheter systems. For example, by enabling the catheter system to fire each radiator station separately and / or by firing one or more radiators within each radiator station separately, it is possible to achieve a firing sequence or pattern that can be even more effective in destroying local lesions. By firing individual radiator stations and / or the radiators contained therein in a desired continuous pattern, a lesion or an enlarged lesion at a particular location can be more effectively disrupted.

[0178] In summary, based on the various embodiments of the present invention illustrated and described in detail herein, the catheter systems and related methods disclosed herein can include a catheter configured to advance to a vascular lesion, such as a calcified or fibrotic vascular lesion, at or near a treatment site located within 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 that defines an interior of the balloon. The balloon can be configured to receive a catheter fluid 132 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 securing the catheter in a fixed position relative to the treatment site.

[0179] In a pressure wave generating medical device, such as the catheter system described herein, it is often desirable to have several possible output channels, i.e., radiator stations or radiators, for a treatment process.

[0180] 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 the balloon interior along the catheter shaft to generate local plasmas in the catheter fluid retained within the balloon interior at or near each guide tip of the energy guides disposed within the balloon interior at a treatment site. Generation of the local plasmas can cause pressure waves, cause rapid expansion to a maximum size, and then disappear through cavitation phenomena that can emit pressure waves 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 pressure waves to the vasculopathy at or near the treatment site within the blood vessel wall in the patient's body and inducing disruption.

[0181] The guide tip of each of the plurality of energy guides can be positioned at any suitable location relative to the length of the balloon to more effectively and accurately apply pressure waves for the purpose of disrupting the vasculopathy at the treatment site.

[0182] Each energy guide can be used with a corresponding plasma generator positioned at or near the guide tip of the energy guide within the balloon interior of the balloon located at the treatment site to generate local plasmas and / or to generate a desired pressure wave within the balloon interior of the balloon for the purpose of disrupting the vasculopathy. As described herein, the guide tip of the energy guide and the corresponding plasma generator can be collectively referred to as a "radiator." As further described herein, in some applications, one or more radiators positioned at substantially the same longitudinal position within the balloon interior relative to the length of the balloon can be referred to as a "radiator station."

[0183] Accordingly, the catheter systems and related methods disclosed herein are configured to provide means for powering a plurality of radiator stations in a pressure wave generator that is designed to apply pressure to and induce fragmentation of vascular lesions such as calcified vascular lesions and / or fibrotic vascular lesions. Importantly, in many embodiments, the catheter system can be configured and controlled to selectively and / or separately power a plurality of radiator stations and / or individual radiators within any given radiator station in any desired pattern, order, sequence, and frequency of emission.

[0184] Each of the plurality of energy guides or radiators can be separately powered in any desired pattern, order, sequence, and frequency of emission, but sets and / or subsets of the plurality of energy guides or radiators can also be powered at any given time. Each set or subset of the plurality of energy guides or radiators can include one or more of the plurality of energy guides or radiators. Thus, at any given time, the energy output can be directed to one or more of the plurality of energy guides or radiators to alternatively create a first pattern of emission, a second pattern of emission, a third pattern of emission, a fourth pattern of emission, and so on. Further, in various applications of the present invention, each pattern of emission of the energy guides or radiators in such sets and subsets of the plurality of energy guides or radiators can be different from each of the other patterns of emission of the energy guides or radiators.

[0185] It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the 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.

[0186] Also, as used in this specification and the appended claims, the phrase "configured to" should be noted to describe a system, device, 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, configured, constructed, arranged, constructed, manufactured, arranged, etc.

[0187] The headings used in this document are provided for consistency with the recommendations of 37 CFR 1.77 or, alternatively, to provide an organized clue. These headings should not be considered to limit or characterize the invention described in any claim that may be issued from this disclosure. By way of example, the description of the technology in the "Background Art" does not admit that the technology is prior art to any invention of this disclosure. Neither the "Summary of the Invention" nor the "Abstract" should be considered to characterize the invention described in the issued claims.

[0188] The embodiments described in this specification are not intended to be exhaustive or to limit the invention to the exact forms disclosed in the detailed description provided herein. Rather, the embodiments are selected and described so that others skilled in the art can recognize and understand its principles and practice. Thus, aspects have been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications can be made within the spirit and scope of this specification.

[0189] 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.

[0190] Although some exemplary aspects and embodiments of the catheter system have been discussed above, those of ordinary skill in the art will recognize certain modifications, permutations, additions, and sub-combinations thereof. Accordingly, the following appended claims and the claims introduced hereinafter are intended to be construed to include all such modifications, permutations, additions, and sub-combinations that fall within their true spirit and scope, and no limitation with respect 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, Catheter shaft and, A balloon connected to the catheter shaft, comprising a balloon wall defining the inside of the balloon, and configured to hold catheter fluid inside the balloon, 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 distal end portion of the guide, A plurality of radiators positioned inside the balloon, each radiator comprising a distal end of one of the plurality of energy guides and a corresponding plasma generator separated from the distal end of the guide, wherein the energy received by each of the plurality of energy guides is radiated from the distal end of the guide, strikes the corresponding plasma generator, and as a result, plasma is generated in the catheter fluid held inside the balloon, A system controller including a processor that controls the energy source such that the energy from the energy source is directed alternately to each of the plurality of energy guides in a first firing pattern and a second firing pattern different from the first firing pattern. A catheter system equipped with [a specific feature].

2. The catheter system according to claim 1, wherein each plasma generator includes an inclined surface that redirects the energy radiated from the distal end of the guide so that the plasma is generated in the catheter fluid held inside the balloon.

3. The catheter system according to claim 2, wherein the inclined surface is formed from one or more of titanium, stainless steel, tungsten, tantalum, platinum, molybdenum, niobium, and iridium.

4. The system further comprises 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, compared to each of the other radiator stations. The catheter system according to claim 1, wherein the plurality of radiation stations include a first radiation station, each including a first plurality of radiation devices positioned at a first longitudinal position inside the balloon, and a second radiation station, each including a second plurality of radiation devices positioned at a second longitudinal position inside the balloon different from the first longitudinal position.

5. The catheter system according to claim 1, wherein the system controller controls the energy source such that the energy from the energy source is alternately directed to each of the plurality of radiators in the first pattern of emission and the second pattern of emission.

6. The first pattern of emission comprises a first frequency of emission from the energy source and a first sequence of emission from each of the plurality of radiators, and the second pattern of emission comprises a second frequency of emission from the energy source and a second sequence of emission from each of the plurality of radiators. The catheter system according to claim 5, wherein at least one of the following is: (i) the first frequency of firing from the energy source is different from the second frequency of firing from the energy source, and (ii) the first sequence of firing from each of the plurality of radiators is different from the second sequence of firing from each of the plurality of radiators.

7. The catheter system according to claim 6, wherein the first frequency of firing from the energy source is different from the second frequency of firing from the energy source, and the first sequence of firing from each of the plurality of radiators is different from the second sequence of firing from each of the plurality of radiators.

8. The catheter system according to claim 5, wherein the system controller controls at least one of the emission frequency of the energy source and the emission sequence of each of the plurality of radiators.

9. The catheter system according to claim 8, wherein the system controller controls the frequency of firing from the energy source and each of the sequences of firing from each of the plurality of radiators.

10. The catheter system according to claim 8 or 9, wherein the system controller controls the energy source such that the energy from the energy source is directed one by one to each of the plurality of radiators in any desired sequence.

11. The catheter system according to claim 8 or 9, wherein the system controller controls the energy source such that the energy from the energy source is directed two times to each of the plurality of radiators in any desired sequence.

12. The catheter system according to claim 8 or 9, wherein the system controller controls the energy source such that the energy from the energy source is directed three times to each of the plurality of radiators in any desired sequence.

13. The catheter system according to any one of claims 1 to 9, 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.

14. The catheter system according to claim 13, 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, the second guide ray is directed to the second energy guide, and the energy from the energy source is directed to each of the plurality of energy guides as the individual guide ray in any desired sequence of emission.

15. The catheter system according to any one of claims 1 to 9, wherein the energy supply source is a light source that generates pulses of light energy, and each of the plurality of energy guides includes an optical fiber.

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