Lithoplasty device with forward energy wavefront

Abstract

A catheter system 100 for treating a vascular lesion 106 within or adjacent to a vascular wall 108 includes an energy source 124, a plurality of energy guides 122A, and a system controller 126. The energy source 124 generates energy that is received by the energy guides 122A. The system controller 126 controls the energy source 124 so that energy is sequentially directed to each of the plurality of energy guides 122A in a forward wavefront. The system controller 126 controls the firing rate of the energy source 124 for each of the plurality of energy guides 122A. The system controller 126 can control the firing sequence of the plurality of energy guides 122A so that a forward wavefront is generated toward the vascular lesion 106 from near the balloon proximal end 104P and near the balloon distal end 104D. The system controller 126 can control the energy source 124 so that energy from the energy source 124 is alternatively directed to at least two of the plurality of energy guides 122A at different firing energy levels. The energy level can be based on the pulse width, wavelength, and / or amplitude of the energy pulse.

Description

[Technical field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 964,529, filed January 22, 2020, entitled "LITHOPLASTY DEVICE WITH ADVANCING ENERGY WAVEFRONT", to U.S. Non-Provisional Patent Application No. 17 / 146,867, filed January 12, 2021, entitled "LITHOPLASTY DEVICE WITH ADVANCING ENERGY WAVEFRONT", and to U.S. Non-Provisional Patent Application No. 17 / 149,160, filed January 14, 2021, entitled "LITHOPLASTY DEVICE WITH ADVANCING ENERGY WAVEFRONT". To the extent permitted, the contents of U.S. Provisional Application No. 62 / 964,529, and U.S. Non-Provisional Application Nos. 17 / 146,867 and 17 / 149,160 are incorporated by reference in their entirety into this application. [Background technology]

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

[0003] Vascular lesions may be treated using interventions such as medical therapy, balloon angioplasty, atherectomy, stenting, vascular graft bypass, to name a few, but such interventions are not always ideal or may require subsequent treatment to address the lesion. Summary of the Invention

[0004] The present invention relates to a method for treating a vascular lesion in or adjacent to a blood vessel wall. In various embodiments, the method includes generating energy with an energy source, receiving the energy with a plurality of energy guides, and controlling the energy source with a system controller of a catheter system such that energy from the energy source is sequentially directed to each of the plurality of energy guides in a first firing sequence.

[0005] In some embodiments, the controlling step can include the system controller controlling a firing rate of an energy source for each of the plurality of energy guides.

[0006] In certain embodiments, the controlling step can include the system controller controlling the energy source such that energy from the energy source is alternatively directed to each of the plurality of energy guides at a first rate of fire and a second rate of fire different from the first rate of fire.

[0007] In various embodiments, the receiving step can include the plurality of energy guides including a first energy guide and a second energy guide. The method can also include positioning a first guide distal end of the first energy guide at a first longitudinal location along the length of the balloon and positioning a second guide distal end of the second energy guide at a second longitudinal location along the length of the balloon such that the first longitudinal location is different from the second longitudinal location.

[0008] In some embodiments, the receiving step can include the plurality of energy guides including a first energy guide and a second energy guide. The method can also include positioning a first guide distal end of the first energy guide at a first longitudinal position along the length of the balloon and positioning a second guide distal end of the second energy guide at a second longitudinal position along the length of the balloon, such that the first longitudinal position is the same as the second longitudinal position.

[0009] In certain embodiments, the positioning step can include positioning at least a portion of the energy guide within a balloon coupled to the catheter shaft.

[0010] In various embodiments, the controlling step can include the system controller controlling a firing sequence for the multiple energy guides such that a forward-moving wavefront is generated from near the proximal end of the balloon and from near the distal end of the balloon toward the vascular lesion.

[0011] In some embodiments, the controlling step can include the system controller controlling the energy source such that energy from the energy source is alternatively directed to at least two of the plurality of energy guides at different firing rates from each other.

[0012] In certain embodiments, the controlling step can include the system controller controlling the energy source such that energy from the energy source is alternatively directed to at least two of the plurality of energy guides at different emission energy levels.

[0013] In various embodiments, the emitted energy level can depend at least in part on the pulse width of the energy pulse.

[0014] In some embodiments, the emitted energy level can depend at least in part on the wavelength of the energy pulse.

[0015] In certain embodiments, the emitted energy level can depend at least in part on the amplitude of the energy pulse.

[0016] In various embodiments, the controlling step can include the system controller controlling a firing sequence for the multiple energy guides such that a forward-moving wavefront is generated in a direction from one of the balloon proximal end and the balloon distal end toward the vascular lesion.

[0017] In some embodiments, the controlling step can include the system controller controlling the energy source such that energy from the energy source is alternatively directed to at least two of the plurality of energy guides at different firing rates from each other.

[0018] In various embodiments, the controlling step can include the system controller controlling the energy source such that energy from the energy source is alternatively directed to at least two of the plurality of energy guides at different emission energy levels.

[0019] In various embodiments, each of the plurality of energy guides can include an optical fiber.

[0020] In some embodiments, the energy source can be a laser source that generates laser energy.

[0021] In certain embodiments, the energy source may be an energy source that generates an electrical impulse.

[0022] The present invention also relates to a catheter system for treating vascular lesions in or adjacent to a vessel wall. In certain embodiments, the catheter system includes an energy source, a plurality of energy guides, and a system controller. The energy source generates energy. Each of the plurality of energy guides is configured to selectively receive energy from the energy source. The system controller controls the energy source such that energy from the energy source is sequentially directed to each of the plurality of energy guides in a first firing sequence.

[0023] In various embodiments, the system controller controls the energy source such that energy from the energy source is sequentially directed to each of the plurality of energy guides in a second firing sequence that is different from the first firing sequence.

[0024] In some embodiments, the system controller controls the firing rate of the energy source for each of the multiple energy guides.

[0025] In certain embodiments, the system controller controls the energy source such that energy from the energy source is alternatively directed to each of a plurality of energy guides at a first firing rate and a second firing rate different from the first firing rate.

[0026] In some embodiments, the system controller controls the energy source such that energy from the energy source is alternatively directed to each of a plurality of energy guides in a first firing sequence and a second firing sequence different from the first firing sequence.

[0027] In various embodiments, the plurality of energy guides includes a first energy guide and a second energy guide. The first energy guide can include a first guide distal end located at a first longitudinal position along the length of the balloon. The second energy guide can include a second guide distal end located at a second longitudinal position along the length of the balloon. The first longitudinal position can be different from the second longitudinal position. Alternatively, the first longitudinal position can be the same as the second longitudinal position.

[0028] In certain embodiments, the catheter system also includes a catheter shaft and a balloon coupled to the catheter shaft, hi some such embodiments, the plurality of energy guides are disposed along the catheter shaft and at least partially within the balloon.

[0029] In some embodiments, the balloon includes a proximal balloon end and a distal balloon end, and the system controller can control a firing sequence for the plurality of energy guides such that a forward wavefront is generated from near the proximal balloon end and from near the distal balloon end toward the vascular lesion.

[0030] In various embodiments, the system controller can control the energy source such that energy from the energy source is alternatively directed to at least two of the plurality of energy guides at different emission energy levels.

[0031] In certain embodiments, the emitted energy level can depend at least in part on a pulse width of at least one of the energy pulses.

[0032] In some embodiments, the emitted energy level can depend at least in part on the wavelength of at least one of the energy pulses.

[0033] In various embodiments, the emitted energy level can depend at least in part on the amplitude of at least one of the energy pulses.

[0034] In certain embodiments, the balloon includes a proximal balloon end and a distal balloon end, and the system controller can control a firing sequence for the plurality of energy guides to generate a forward moving wavefront that travels in a direction from one of the proximal balloon end and the distal balloon end toward the vascular lesion.

[0035] In some embodiments, the system controller controls the energy source such that energy from the energy source is alternatively directed to at least two of the plurality of energy guides at different firing rates from each other.

[0036] In various embodiments, the catheter system also includes a power source configured to provide power to the energy source.

[0037] In certain embodiments, each of the plurality of energy guides comprises an optical fiber.

[0038] In some embodiments, the energy source is a laser source that generates laser energy.

[0039] In various embodiments, the energy source is an energy source that generates an electrical impulse.

[0040] The present invention further relates to a method for treating a vascular lesion in or adjacent to a blood vessel wall, the method including the steps of generating energy with an energy source, selectively receiving energy from the energy source by a plurality of energy guides, and controlling the energy source by a system controller such that energy from the energy source is separately directed to each of the plurality of energy guides in any desired firing sequence.

[0041] This summary is a summary of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present 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 and understanding the following detailed description and viewing the drawings that form a part of the detailed description, each of which is not to be taken in a limiting sense. The scope of the present specification is defined by the appended claims and their legal equivalents.

[0042] The novel features of this invention, as well as the invention itself, both as to its structure and its operation, can best be understood from the accompanying drawings taken in conjunction with the accompanying description, in which like reference characters refer to like parts and in which: [Brief description of the drawings]

[0043] [Figure 1] FIG. 1 is a schematic cross-sectional view of one embodiment of a catheter system according to various embodiments herein, the catheter system including multiple energy guides and a multiplexer. [Figure 2A] FIG. 1 is a simplified schematic top view of a portion of one embodiment of a catheter system including one embodiment of a multiplexer. [Figure 2B] FIG. 2B is a simplified schematic perspective view of a portion of the catheter system and multiplexer shown in FIG. 2A. [Figure 3A] FIG. 1 is a simplified schematic top view of a portion of one embodiment of a catheter system including another embodiment of a multiplexer. [Figure 3B] FIG. 3B is a simplified schematic perspective view of a portion of the catheter system and multiplexer shown in FIG. 3A. [Figure 4] FIG. 13 is a simplified schematic top view of a portion of a catheter system and yet another embodiment of a multiplexer. [Diagram 5] FIG. 13 is a simplified schematic top view of a portion of a catheter system and yet another embodiment of a multiplexer. [Figure 6]FIG. 13 is a simplified schematic top view of a portion of a catheter system and another embodiment of a multiplexer. [Figure 7] FIG. 13 is a simplified schematic top view of a portion of a catheter system and yet another embodiment of a multiplexer. [Figure 8A] FIG. 13 is a simplified schematic side view of a portion of another embodiment of a catheter system. [Figure 8B] FIG. 8B is a simplified schematic cross-sectional view of a portion of the catheter system along line BB in FIG. [Figure 9] FIG. 1 is a simplified schematic cross-sectional view of another embodiment of a catheter system. [Figure 10] FIG. 13 is a simplified schematic cross-sectional view of yet another embodiment of a catheter system. [Figure 11] FIG. 13 is a simplified schematic cross-sectional view of yet another embodiment of a catheter system. [Figure 12] FIG. 1 is a simplified schematic cross-sectional view of another embodiment of a catheter system. [Figure 13] FIG. 13 is a simplified schematic cross-sectional view of yet another embodiment of a catheter system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0044] While embodiments of the present invention are susceptible to various modifications and alternative forms, details thereof have been shown by way of example and drawings and are described in detail herein. It is understood, however, that the scope of the present specification is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope of the specification.

[0045] Treatment of vascular lesions can reduce major adverse events or deaths in affected patients. As mentioned herein, major adverse events can occur anywhere in the body due to the presence of vascular lesions. Major adverse events can include, but are not limited to, major cardiac adverse events, major adverse events in the peripheral or central vascular system, major adverse events in the brain, major adverse events in muscle tissue, or major adverse events in any internal organ.

[0046] In a pressure wave generating medical device, it is often desirable to have several potential output channels for the treatment process. For safety and convenience, these output channels can consist of optical fibers. Because a high power laser source is often the largest and most expensive component in a system, it can be advantageous to utilize a single laser source that can be multiplexed to several different optical fibers for treatment purposes. This allows the use of all the laser power on each optical fiber. However, while the invention is often described herein as using a single laser source for the purpose of generating the desired pressure waves, it is understood that the invention is not limited to the use of laser generated pressure wave systems. For example, the invention can instead use any suitable type of device that utilizes a highly localized energy source to generate the desired pressure waves. In one non-exclusive alternative example, the energy source can generate electrical impulses that are directed through an energy guide to generate the desired pressure waves. It is understood that the invention can also utilize two or more laser sources and / or two or more other suitable pressure wave generating devices.

[0047] Thus, in various embodiments, the catheter system and associated methods disclosed herein are configured to provide a means to power multiple fiber optic channels in a pressure wave generating device designed to apply pressure to vascular lesions, such as calcified and / or fibrous vascular lesions, to induce fragmentation using a single energy source. As described in detail herein, in certain embodiments, the catheter system can be configured and controlled to selectively and / or separately power multiple fiber optic channels in any desired firing sequence, pattern, order, firing rate and / or firing duration, etc. Thus, the invention described in detail herein can include a single energy source that can be multiplexed into one or more of multiple energy guides in a disposable device. This allows a single stable energy source to be continuously directed through any or all of multiple energy guides in any desired firing sequence and at any firing rate and / or duration.

[0048] Each of the plurality of energy guides may be energized separately in any desired firing sequence, pattern, order, firing rate, firing duration, although it is understood that sets and / or subsets of the plurality of energy guides may also be energized at any given time. Each set or subset of the plurality of energy guides may include one or more of the plurality of energy guides. Thus, at any given time, power may be directed to one or more of the plurality of energy guides to alternatively create a first firing sequence, a second firing sequence, a third firing sequence, a fourth firing sequence, etc. Also, in various applications of the present invention, each firing sequence of the energy guides in such sets and subsets of the plurality of energy guides may be different from one or more of the other firing sequences of the energy guides.

[0049] As provided herein, the catheter system can utilize optical energy from an energy source, i.e., a laser source or other suitable energy source, to generate plasma in the balloon fluid at or near the guide distal end of each of a plurality of energy guides disposed within a balloon located at a treatment site. The plasma formation can initiate one or more pressure waves by initiating the rapid formation of one or more gas bubbles that can rapidly expand to a maximum size and then dissipate through a cavitation event that can launch a pressure wave upon collapse. Alternatively, the plasma formation can initiate one or more pressure waves of an explosive type that can spread to the treatment site to disrupt calcification. Stated differently, the rapid expansion of the gas bubbles induced by the plasma can generate one or more pressure waves in the balloon fluid held within the balloon, thereby imparting a pressure wave to the treatment site. As used herein, optical energy and / or electrical energy are collectively referred to simply as "energy." Stated differently, the term "energy" can include either optical energy or electrical energy.

[0050] As provided herein, the distal end of each of the multiple energy guides can be located at any suitable location relative to the length of the balloon to more effectively and precisely deliver pressure waves to destroy vascular lesions at the treatment site. Additionally, as previously described, the configurations of the present invention allow for firing individual energy guides, including one or more energy guides fired substantially simultaneously or sequentially, to obtain a firing sequence or pattern that may be more effective in destroying localized lesions. By firing separate plasma generator channels in a predetermined and / or specific firing sequence or pattern, a traveling energy wavefront can be created that can more effectively divide lesions at one location or extended lesions.

[0051] As used herein, the terms "endovascular lesion," "vascular lesion," and "treatment site" are used interchangeably unless otherwise noted and may include lesions located at or near a heart valve. Intravascular and / or vascular lesions may sometimes be referred to herein simply as "lesions."

[0052] Those skilled in the art will appreciate that the following detailed description of the invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the invention will readily suggest themselves to such skilled artisans having the benefit of this disclosure. Reference will now be made in detail to the implementation of the invention as illustrated in the accompanying drawings.

[0053] For clarity, not all of the typical features of the implementations described herein are shown and described. Of course, it will be understood that the development of any such actual implementation will require numerous implementation-specific decisions to be made in order to achieve the particular goals of the developer, such as compliance with application-related and business-related constraints, and that these particular goals will vary from implementation to implementation and from developer to developer. Moreover, it will be understood that such a development effort may be complex and time-consuming, but will nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure.

[0054] It is understood that the catheter system disclosed herein can include many different configurations. Referring now to FIG. 1, a schematic cross-sectional view of a catheter system 100 according to various embodiments of the present disclosure is shown. As described herein, the catheter system 100 is adapted to apply pressure to induce disruption of one or more vascular lesions in or adjacent to a vascular wall of a blood vessel or heart valve. In the embodiment shown in FIG. 1, the catheter system 100 can include one or more of a catheter 102, an energy guide bundle 122 including a plurality of energy guides 122A, a source manifold 136, a fluid pump 138, and a system console 123, which includes 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.

[0055] The catheter 102 is configured to navigate to a vascular lesion (also referred to herein as a "treatment site") 106 within or adjacent to a blood vessel 108. The treatment site 106 may include one or more vascular lesions, such as, for example, a calcified vascular lesion. Additionally or alternatively, the treatment site 106 may include a vascular lesion, such as a fibrotic vascular lesion.

[0056] The catheter 102 may include an inflatable balloon 104 (sometimes simply referred to herein as a "balloon"), a catheter shaft 110, and a guidewire 112. The balloon 104 may be coupled to the catheter shaft 110. The balloon 104 may include a balloon proximal end 104P and a balloon distal end 104D. The catheter shaft 110 may extend from a proximal portion 114 of the catheter system 100 to a distal portion 116 of the catheter system 100. The catheter shaft 110 may include a longitudinal axis 144. The catheter shaft 110 may also include a guidewire lumen 118 configured to travel over the guidewire 112. The catheter shaft 110 may further include an inflation lumen (not shown). In some embodiments, the catheter 102 can have a distal end opening 120 and can accommodate and track over the guidewire 112 as the catheter 102 is moved and positioned at or near the treatment site 106.

[0057] In various embodiments, the catheter shaft 110 of the catheter 102 can be coupled to a plurality of energy guides 122A of an energy guide bundle 122 that can be in optical and / or electrical communication with an energy source 124. The energy guides 122A can be disposed along the catheter shaft 110 and within the balloon 104. Additionally, each of the energy guides 122A can have a guide distal end (not shown in FIG. 1 ) that is at any suitable longitudinal position relative to the length 142 of the balloon 104 and / or relative to the length of the guidewire lumen 118. 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 in optical and / or electrical communication with the energy guides 122A at the proximal portion 114 of the catheter system 100. More specifically, as described in more detail herein, the energy source 124 can selectively and / or alternatively be in optical and / or electrical communication with each of the energy guides 122A due to the presence and operation of a multiplexer 128. Alternatively, each energy guide 122A can have another suitable design and / or the energy source 124 can be another suitable energy source.

[0058] In some embodiments, the catheter shaft 110 may be coupled to multiple energy guides, such as a first energy guide, a second energy guide, a third energy guide, etc., that may be positioned at any suitable location about the guidewire lumen 118 and / or the catheter shaft 110. For example, in certain non-exclusive embodiments, two energy guides 122A may be spaced apart about 180 degrees around the guidewire lumen 118 and / or the catheter shaft 110, three energy guides 122A may be spaced apart about 120 degrees around the guidewire lumen 118 and / or the catheter shaft 110, four energy guides 122A may be spaced apart about 90 degrees around the guidewire lumen 118 and / or the catheter shaft 110, and so forth. In one embodiment, the energy guides 122A may be spaced about 72 degrees apart around the guidewire lumen 118 and / or catheter shaft 110, five energy guides 122A may be spaced about 72 degrees apart around the guidewire lumen 118 and / or catheter shaft 110, six energy guides 122A may be spaced about 60 degrees apart around the guidewire lumen 118 and / or catheter shaft 110, or eight energy guides 122A may be spaced about 45 degrees apart around the guidewire lumen 118 and / or catheter shaft 110. Additionally or alternatively, the multiple energy guides 122A need not be uniformly spaced from one another around the guidewire lumen 118 and / or catheter shaft 110. More specifically, it is further understood that the energy guides 122A described herein may be uniformly or non-uniformly positioned around the guidewire lumen 118 and / or catheter shaft 110 to achieve a desired effect at a desired location.

[0059] The balloon 104 can include a balloon wall 130 that can be inflated with a balloon fluid 132 to expand from a collapsed configuration suitable for advancing the catheter 102 through the patient's vasculature to an expanded configuration suitable for securing the catheter 102 in place relative to the treatment site 106. Stated another way, when the balloon 104 is in the expanded configuration, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. In some embodiments, the energy source 124 of the catheter system 100 can be configured to induce plasma formation in the balloon fluid 132 within the balloon 104 by applying a sub-millisecond light pulse from the energy source 124 along the energy guide 122A to a location within the balloon 104. While not intending to be bound by any one particular theory, it is believed that the plasma formation causes rapid bubble formation, imparting a pressure wave to the treatment site 106, although other mechanisms for imparting the pressure wave are contemplated. An exemplary plasma-induced bubble is shown in FIG. 1 as bubble 134. The balloon fluid 132 may be a liquid or a gas.

[0060] Balloons 104 suitable for use with the catheter system 100 described in detail herein include those capable of passing through a patient's vasculature when in a collapsed configuration. In some embodiments, the balloons 104 herein are formed from silicone. In other embodiments, the balloons 104 herein are formed from polydimethylsiloxane (PDMS), polyurethane, polymers such as PEBAX™ material available from Arkema, King of Prussia, Pennsylvania, nylon, and the like. In some embodiments, the balloons 104 can include those having a diameter ranging from 1 millimeter (mm) to 25 mm. In some embodiments, the balloons 104 can include those having a diameter ranging from at least 1.5 mm to 12 mm. In some embodiments, the balloons 104 can include those having a diameter ranging from at least 1 mm to 5 mm.

[0061] Further, in some embodiments, the balloons 104 herein can include lengths 142 ranging from at least about 5 mm to 300 mm. More specifically, in some embodiments, the balloons 104 herein can include those having lengths 142 ranging from at least about 8 mm to 200 mm. It is understood that a longer balloon 104 can be positioned adjacent a relatively large treatment site 106 and thus can be used to apply pressure to and induce fragmentation of a larger vascular lesion or multiple vascular lesions at a particular location within the treatment site 106.

[0062] Additionally, the balloon 104 herein may be inflated to an inflation pressure of between about 1 atmosphere (atmosphere) and 70 atmospheres. In some embodiments, the balloon 104 herein may be inflated to an inflation pressure of at least about 20 atmospheres and 70 atmospheres. In other embodiments, the balloon 104 herein may be inflated to an inflation pressure of at least about 6 atmospheres and 20 atmospheres. In yet other embodiments, the balloon 104 herein may be inflated to an inflation pressure of at least about 3 atmospheres and 20 atmospheres. In yet other embodiments, the balloon 104 herein may be inflated to an inflation pressure of at least about 2 atmospheres and 10 atmospheres.

[0063] The balloon 104 herein can have a variety of shapes, including, but not limited to, a cone shape, a square shape, a rectangular shape, a sphere shape, a cone / square shape, a cone / sphere shape, an expanded sphere shape, an elliptical shape, a tapered shape, a bone shape, a step diameter shape, an offset shape, or a cone offset shape. In some embodiments, the balloon 104 herein can include a drug eluting coating structure or a drug eluting stent structure. The drug eluting coating or drug eluting stent can include one or more therapeutic agents, including anti-inflammatory agents, anti-tumor agents, anti-angiogenic agents, and the like.

[0064] Exemplary balloon fluids 132 suitable for use herein may include, but are not limited to, one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases such as carbon dioxide, and the like. In some embodiments, the described balloon fluids 132 may be used as a base inflation fluid. In some embodiments, the balloon fluid 132 includes a 50:50 volumetric ratio of saline to contrast medium. In other embodiments, the balloon fluid 132 includes a 25:75 volumetric ratio of saline to contrast medium. In yet other embodiments, the balloon fluid 132 includes a 75:25 volumetric ratio of saline to contrast medium. Additionally, balloon fluids 132 suitable for use herein may be adjusted based on composition, viscosity, and the like to manipulate the speed of travel of pressure waves in the fluid. In certain embodiments, balloon fluids 132 suitable for use herein are biocompatible. The amount of balloon fluid 132 may be adjusted depending on the selected energy source 124 and the type of balloon fluid 132 used.

[0065] In some embodiments, the contrast agents used in the contrast media herein may include, but are 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, iothalamic acid, and ioxaglate. Some non-limiting examples of non-ionic iodine-based contrast agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based contrast agents may be used. Suitable non-iodine-containing contrast agents may include gadolinium (III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon agents may include, but are not limited to, agents such as the perfluorocarbon dodecafluoropentane (DDFP, C5F12).

[0066] Additionally, the balloon fluid 132 herein can include those that include absorbers that can selectively absorb light in the ultraviolet region (e.g., at least 10 nanometers (nm) to 400 nm), the visible region (e.g., at least 400 nm to 780 nm), or the near infrared region of the electromagnetic spectrum (e.g., at least 780 nm to 2.5 μm). Suitable absorbers can include those that have an absorption maximum along a spectrum from at least 10 nm to 2.5 μm. Alternatively, the balloon fluid 132 can include those that include absorbers that can selectively absorb light in the mid-infrared region (e.g., at least 2.5 μm to 15 μm), or the far infrared region of the electromagnetic spectrum (e.g., at least 15 μm to 1 mm). In various embodiments, the absorbers can have an absorption maximum that coincides with the emission maximum of a laser used in the catheter system. As non-limiting examples, the various lasers described herein may include a neodymium:yttrium-aluminum-garnet (Nd:YAG-maximum emission=1064 nm) laser, a holmium:YAG (Ho:YAG-maximum emission=2.1 μm) laser, or an erbium:YAG (Er:YAG-maximum emission=2.94 μm). In some embodiments, the absorbers used herein may be water soluble. In other embodiments, the absorbers used herein are not water soluble. In some embodiments, the absorbers used in the balloon fluid 132 herein may be tailored to match the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths of at least 10 nanometers to 1 millimeter are discussed elsewhere herein.

[0067] It is understood that the catheter system 100 and / or energy guide bundle 122 disclosed herein can include any number of energy guides 122A in optical communication with the energy source 124 in the proximal portion 114 and the balloon fluid 132 in the balloon 104 in the distal portion 116. For example, in some embodiments, the catheter system 100 and / or energy guide bundle 122 can include from one energy guide 122A to five energy guides 122A. In other embodiments, the catheter system 100 and / or energy guide bundle 122 can include from five energy guides 122A to fifteen energy guides 122A. In still other embodiments, the catheter system 100 and / or energy guide bundle 122 can include from ten energy guides 122A to thirty energy guides 122A. Alternatively, in yet other embodiments, the catheter system 100 and / or the energy guide bundle 122 may include more than 30 energy guides 122A.

[0068] It will further be appreciated that the energy guides 122A may be positioned at any suitable location about the guidewire lumen 118 and / or the catheter shaft 110, and that the guide distal end of each of the energy guides 122A may be positioned at any suitable longitudinal location relative to the length 142 of the balloon 104 and / or relative to the length of the guidewire lumen 118. It will further be appreciated that at least a portion of one or more of the energy guides 122A may be positioned away from the guidewire lumen 118, e.g., the guide distal end of such energy guide 122A may be positioned laterally at any suitable location between the guidewire lumen 118 and the balloon wall 130 of the balloon 104.

[0069] Additionally, the energy guide 122A herein can take many forms around and / or relative to the catheter shaft 110 of the catheter 102 described herein. In some embodiments, the energy guide 122A can extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the energy guide 122A can be disposed along the length of the outer diameter of the catheter shaft 110. In still other embodiments, the energy guide 122A herein can be disposed within one or more energy guide lumens (not shown) within the catheter shaft 110.

[0070] In various embodiments, each of the energy guides 122A herein may include an optical fiber or a flexible light pipe. The energy guides 122A herein are thin and flexible and may transmit optical signals with little loss of strength. The energy guides 122A herein may include a core surrounded by a cladding around its periphery. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of the energy guide 122A may be formed from one or more materials, including, but not limited to, one or more types of glass, silica, or one or more polymers. The energy guide 122A may also include a protective coating, such as a polymer. It is understood that the refractive index of the core is greater than the refractive index of the cladding.

[0071] Each energy guide 122A can direct light along its length to a distal portion, i.e., a guide distal end, which can have one or more optical windows. The energy guides 122A can create a light path as part of an optical network that includes the energy source 124. Light paths in an optical network allow light to travel from one part of the network to another. Both optical fibers and flexible light pipes can provide light paths within the optical networks herein.

[0072] Additionally, the energy guide 122A herein can include one or more optoacoustic transducers (not shown), each of which can be in optical communication with the energy guide 122A within which it is disposed. In some embodiments, the optoacoustic transducers can be in optical communication with a distal guide end of the energy guide 122A. Additionally, in such embodiments, the optoacoustic transducers can have a shape that corresponds to and / or matches the distal guide end of the energy guide 122A.

[0073] The photoacoustic transducer is configured to convert light energy into acoustic waves at or near the distal guide end of energy guide 122A, and it is understood that the direction of the acoustic waves can be adjusted by changing the angle of the distal guide end of energy guide 122A.

[0074] It is further understood that any or all of the photoacoustic transducers that may be disposed at the guide distal end of the energy guide 122A herein can have the same shape as the guide distal end of the energy guide 122A. For example, in certain non-exclusive embodiments, the photoacoustic transducers and / or the guide distal end can have a conical shape, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a semicircular shape, an oval shape, etc. It is also understood that the energy guide 122A can further include additional photoacoustic transducers disposed along one or more sides of the length of the energy guide 122A.

[0075] The energy guides 122A described herein can further include one or more redirecting features (not shown) or "diverters" within the energy guide 122A configured to direct light, for example, toward the sides at or near the guide distal end of the energy guide 122A and out of the energy guide 122A toward the balloon wall 130. The redirecting features can include any feature of the systems herein that redirects light from the energy guide 122A away from its axial path toward the sides of the energy guide 122A. Additionally, the energy guides 122A can each include one or more optical windows (not shown) disposed along a longitudinal or axial surface of each energy guide 122A and in optical communication with the redirecting features. Stated another way, the redirecting features herein can be configured to direct light within the energy guide 122A toward the sides, for example, at or near the guide distal end where the sides are in optical communication with the optical windows. The optical window can include a portion of the energy guide 122A that allows light from within the energy guide 122A to exit the energy guide 122A, such as a portion of the energy guide 122A that lacks cladding on or around the energy guide 122A.

[0076] Examples of redirecting features suitable for use herein include reflective elements, refractive elements, and fiber diffusers. Additionally, redirecting features suitable for focusing light from the tip of the energy guide 122A herein may include, but are not limited to, those having convex surfaces, gradient index (GRIN) lenses, and mirror focusing lenses. Upon contact with the redirecting feature, the light is redirected within the energy guide 122A to an optoacoustic transducer that is in optical communication with the side of the energy guide 122A. As previously described, the optoacoustic transducer then converts the light energy into acoustic waves that extend away from the side of the energy guide 122A.

[0077] A source manifold 136 may be disposed at or near the proximal portion 114 of the catheter system 100. The source manifold 136 may include one or more proximal end openings that may receive the energy guides 122A of the energy guide bundle 122, the guidewire 112, and / or an inflation conduit 140 that is coupled in fluid communication with a fluid pump 138. The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with balloon fluid 132 as needed.

[0078] As provided herein, the system console 123 includes one or more of the energy source 124, the power source 125, the system controller 126, the GUI 127, and the multiplexer 128. Alternatively, the system console 123 may include more or fewer components than those specifically shown in FIG. 1. For example, in certain non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127. Additionally, or alternatively, one or more of the energy source 124, the power source 125, the system controller 126, the GUI 127, and the multiplexer 128 may be provided within the catheter system 100 without the specific need for the system console 123.

[0079] Further, as shown, the system console 123, and components included therein, are operatively coupled to the catheter 102, the energy guide bundle 122, and the remainder of the catheter system 100. For example, in some embodiments, as shown in FIG. 1, the system console 123 can include a console connection opening 148 (which may also be commonly referred to as a "socket") through which the energy guide bundle 122 is mechanically coupled to the system console 123. In such embodiments, the energy guide bundle 122 can include a guide connection housing 150 (which may also be commonly referred to as a "ferrule") that accommodates a portion of each of the energy guides 122A, such as the guide proximal end. The guide connection housing 150 is configured to be selectively retained within the console connection opening 148 to provide a desired mechanical coupling between the energy guide bundle 122 and the system console 123.

[0080] Additionally, 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 guides 122A and / or the energy guide bundle 122 can assume a more compact configuration as they extend with the catheter 102 into the blood vessel 108 during use of the catheter system 100.

[0081] As provided herein, the energy source 124 may be selectively and / or alternatively coupled in optical communication with each of the energy guides 122A in the energy guide bundle 122. In particular, the energy source 124 is configured to generate optical energy in the form of a source beam 124A, e.g., a pulsed source beam, that may be selectively and / or alternatively directed to and received by each of the energy guides 122A in the energy guide bundle 122. More specifically, as described in more detail herein below, the source beam 124A from the energy source 124 is directed through a multiplexer 128 such that individual guide beams 124B (or "multiplexed beams") may be selectively and / or alternatively directed to and received by each of the energy guides 122A in the energy guide bundle 122. In particular, each pulse of the energy source 124, i.e., each pulse of the source beam 124A, can be directed through a multiplexer 128 to generate a separate guide beam 124B that is selectively and / or alternatively directed to one of the energy guides 122A in the energy guide bundle 122.

[0082] The energy source 124 may have any suitable design. In certain embodiments, as previously described, the energy source 124 may be configured to provide sub-millisecond light pulses from the energy source 124 that are directed along the energy guide 122A to a location within the balloon 104 to induce plasma formation in the balloon fluid 132 within the balloon 104. The plasma formation causes rapid bubble formation and provides pressure waves at the treatment site 106. In such embodiments, the sub-millisecond light pulses from the energy source 124 may be delivered to the treatment site 106 at a frequency between about 1 Hertz (Hz) and 5000 Hz. In some embodiments, the sub-millisecond light pulses from the energy source 124 may be delivered to the treatment site 106 at a frequency between about 30 Hz and 1000 Hz. In other embodiments, the sub-millisecond light pulses from the energy source 124 may be delivered to the treatment site 106 at a frequency between about 10 Hz and 100 Hz. In still other embodiments, the sub-millisecond light pulses from the energy source 124 may be delivered to the treatment site 106 at a frequency between about 1 Hz and 30 Hz. Alternatively, sub-millisecond light pulses can be delivered to the treatment site 106 at frequencies that can exceed 5000 Hz.

[0083] It is understood that although energy source 124 is typically utilized to provide pulses of optical energy, energy source 124 may still be described as providing a single source beam 124A, i.e., a single pulsed source beam.

[0084] In various embodiments, the energy source 124 suitable for use herein can include various types of energy sources, including, but not limited to, lasers and lamps. Suitable lasers can include short pulse lasers on the sub-millisecond timescale. In some embodiments, the energy source 124 can include lasers on the nanosecond (ns) timescale. Lasers can also include short pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (μs) timescales. It is understood that there are many combinations of laser pulse wavelengths, pulse widths, and amplitudes that provide various energy levels that can be used to achieve plasma in the balloon fluid 132 of the catheter 102 described herein. In various embodiments, the pulse widths can include those that fall within a range of at least 10 ns to 200 ns, inclusive. In some embodiments, the pulse widths can include those that fall within a range of at least 20 ns to 100 ns, inclusive. In other embodiments, the pulse widths can include those that fall within a range of at least 1 ns to 500 ns, inclusive.

[0085] Further, typical nanosecond lasers can include lasers in the UV to IR spectrum, spanning pulse wavelengths of approximately 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, the energy source 124 suitable for use in the catheter system 100 herein can include those capable of generating light at pulse wavelengths of at least 750 nm to 2000 nm. In other embodiments, the energy source 124 can include those capable of generating light at pulse wavelengths of at least 700 nm to 3000 nm. In still other embodiments, the energy source 124 can include those capable of generating light at pulse wavelengths of at least 100 nm to 10 micrometers (μm). The nanosecond laser can include a laser with a repetition rate of up to 200 kHz. In some embodiments, the laser can include a Q-switched Thulium:Yttrium-Aluminum-Garnet (Tm:YAG) laser. In other embodiments, the laser can include neodymium:yttrium aluminum garnet (Nd:YAG), holmium:yttrium aluminum garnet (Ho:YAG), erbium:yttrium aluminum garnet (Er:YAG), excimer lasers, helium neon lasers, carbon dioxide lasers, and doped pulsed fiber lasers.

[0086] The catheter systems 100 disclosed herein can generate pressure waves 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 depends on the energy source 124, the absorber material, the bubble expansion, the propagation medium, the balloon material, and other factors. In some embodiments, the catheter systems 100 disclosed herein can generate pressure waves having a maximum pressure in the range of at least 2 MPa to 50 MPa. In other embodiments, the catheter systems 100 disclosed herein can generate pressure waves having a maximum pressure in the range of at least 2 MPa to 30 MPa. In still other embodiments, the catheter systems 100 disclosed herein can generate pressure waves having a maximum pressure in the range of at least 15 MPa to 25 MPa.

[0087] The pressure waves described herein may be applied to the treatment site 106 from a distance ranging from at least 0.1 millimeters (mm) to 25 mm radially from the energy guide 122A when the catheter 102 is positioned at the treatment site 106. In some embodiments, the pressure waves may be applied to the treatment site 106 from a distance ranging from at least 10 mm to 20 mm radially from the energy guide 122A when the catheter 102 is positioned at the treatment site 106. In other embodiments, the pressure waves may be applied to the treatment site 106 from a distance ranging from at least 1 mm to 10 mm radially from the energy guide 122A when the catheter 102 is positioned at the treatment site 106. In still other embodiments, the pressure waves may be applied to the treatment site 106 from a distance ranging from at least 1.5 mm to 4 mm radially from the energy guide 122A when the catheter 102 is positioned at the treatment site 106. In some embodiments, pressure waves may be applied to the treatment site 106 from a range of at least 2 MPa to 30 MPa separated by a distance of 0.1 mm to 10 mm. In some embodiments, pressure waves may be applied to the treatment site 106 from a range of at least 2 MPa to 25 MPa separated by a distance of 0.1 mm to 10 mm.

[0088] Power supply 125 is electrically coupled to and configured to provide the necessary power to one or more of energy source 124, system controller 126, and multiplexer 128. Power supply 125 may have any suitable design suitable for such purposes.

[0089] As mentioned above, the system controller 126 is electrically coupled to and receives power from the power source 125. Additionally, the system controller 126 is coupled to and configured to control the operation of each of the energy source 124, the GUI 127, and the multiplexer 128. The system controller 126 may include one or more processors or circuits for controlling the operation of at least 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 optical energy as desired, e.g., at a desired firing rate. Subsequently, the system controller 126 may then control the multiplexer 128 to selectively and / or alternatively direct the optical energy from the energy source 124, i.e., source beam 124A, to each of the energy guides 122A, i.e., in the form of individual guide beams 124B, in a desired manner.

[0090] More specifically, as provided herein, the system controller 126 can control the energy source 124 and / or the multiplexer 128 to direct the individual guide beams 124B to each of the energy guides 122A or to a set or subset of the energy guides 122A in a desired firing sequence, firing pattern, firing order, firing energy level (which may include any or all of pulse width, pulse amplitude, and / or pulse wavelength), and / or firing rate. For example, in a catheter system 100 including eight energy guides 122A, such as those shown in FIGS. 8A and 8B, arranged in a linear pattern with angular orientations spiraling around the guidewire lumen 118, the system controller 126 can control the sequencing of firing of optical energy from the energy source 124 to each of the energy guides 122A in any desired manner. As used herein, the term "firing rate" is intended to mean the number of pulses per given time period. Additionally, as used herein, the term "fired energy level" is intended to mean the intensity of the energy pulse, which may vary as a function of the pulse width and / or pulse amplitude of any or all of the pulses.

[0091] Specific, non-exclusive examples of alternative uses of the sequencing of firing of the eight energy guides 122A are described in more detail herein. As used herein, different "desired firing sequences" may be referred to equally as a first firing sequence, a second firing sequence, a third firing sequence, etc., for ease of discussion and understanding. Somewhat similarly, different firing patterns, firing sequences, firing energy levels+ and / or firing rates may be referred to equally as a first, second, third, etc., for ease of discussion and understanding, for example.

[0092] The system controller 126 may be further configured to control the operation of other components of the catheter system 100, such as positioning of the catheter 102 adjacent the treatment site 106, inflation of the balloon 104 with balloon fluid 132, etc. Additionally or alternatively, the catheter system 100 may include one or more additional controllers, which may be located in any manner suitable for the purpose of controlling various operations of the catheter system 100.

[0093] The GUI 127 is accessible by a user or operator of the catheter system 100. Additionally, the GUI 127 is electrically connected to the system controller 126. With such a design, the GUI 127 may be used by the user or operator to ensure that the catheter system 100 is used as needed to apply pressure to the vascular lesion at the treatment site 106 to induce fractures in the vascular lesion. Additionally, the GUI 127 may provide information to the user or operator that may be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 may provide static visual data and / or information to the user or operator. Additionally or alternatively, the GUI 127 may provide dynamic visual data and / or information to the user or operator, such as video data or any other data that changes over time during use of the catheter system 100. Additionally, in various embodiments, the GUI 127 may include one or more colors, different sizes, varying brightness, etc., that may serve as warnings to the user or operator. Additionally or alternatively, the GUI 127 may provide audio data or information to the user or operator. It is understood that the details of the GUI 127 may vary depending on the design requirements of the catheter system 100 or the particular needs, specifications, and / or desires of the user or operator.

[0094] As provided herein, where applicable, the multiplexer 128 can be configured to selectively and / or alternatively direct optical energy from the energy source 124 to each of the energy guides 122A in the energy guide bundle 122. More specifically, the multiplexer 128 is configured to receive optical energy from the energy source 124, e.g., a single source beam 124A from a single laser source, and selectively and / or alternatively direct such optical energy in the form of individual guide beams 124B to each of the energy guides 122A in the energy guide bundle 122. Thus, the multiplexer 128 enables the catheter system 100 to separately direct the single energy source 124 through the multiple energy guides 122A in any desired firing sequence or pattern such that the catheter system 100 can apply pressure to induce disruption of vascular lesions at the treatment site 106 within or adjacent to the vessel wall of the blood vessel 108 in a desired manner. Additionally, as shown, the catheter system 100 can include one or more optical elements 146 to direct optical energy from the energy source 124, such as source beam 124A, to the multiplexer 128.

[0095] As described herein, multiplexer 128 may have any suitable design suitable for selectively and / or alternatively directing optical energy from energy source 124 to each of energy guides 122A of energy guide bundle 122. Various non-exclusive alternative embodiments of multiplexer 128 are described in detail herein below in connection with Figures 2A-7.

[0096] 2A is a simplified schematic top view of a portion of an embodiment of a catheter system 200. More specifically, FIG. 2A illustrates one embodiment of 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. The multiplexer 228 receives optical energy in the form of a source beam 224A, e.g., a pulsed source beam, from the energy source 224. The multiplexer 228 can selectively and / or alternatively direct optical energy in the form of individual guide beams 224B to each of the energy guides 222A-222E in any desired firing sequence and / or pattern (whether predetermined or not) under the control of the system controller 226. The energy guides 222A-222E, energy source 224, and system controller 226 are substantially similar in design and function, as previously described. Accordingly, such components will not be described in detail with respect to the embodiment shown in Figure 2A. It will be further appreciated that certain components of the system console 123 illustrated and described above with respect to Figure 1, such as power supply 125 and GUI 127, are not shown in Figure 2A for simplicity and ease of illustration, but will generally be included in many embodiments.

[0097] As previously discussed, multiplexer 228 is configured to receive optical energy in the form of source beam 224A from energy source 224 and selectively and / or alternatively direct that optical energy in the form of individual guide beams 224B to each of energy guides 222A-222E in any desired firing sequence and / or pattern (whether predetermined or not). Thus, as shown in FIG. 2A, multiplexer 228 is operative in optical communication with and / or optically coupled to energy guide bundle 122, i.e., multiple energy guides 222A-222E.

[0098] Further, as shown, the guide proximal ends 222P of each of the plurality of energy guides 222A-222E are retained within the guide coupling housing 250, i.e., within guide coupling slots 254 formed into the guide coupling housing 250. In various embodiments, the guide coupling housing 250 is configured to be selectively coupled to the system console 123 (shown in FIG. 1 ) such that the guide coupling slots 254, and thus the energy guides 222A-222E, are maintained in a desired predetermined position relative to the multiplexer 228 during use of the catheter system 200. In some embodiments, the guide coupling slots 254 are provided in the form of a V-groove, such as a V-groove ferrule block commonly used in multi-channel fiber optic communication systems. Alternatively, the guide coupling slots 254 can have another suitable design.

[0099] The guide coupling housing 250 can have any suitable number of guide coupling slots 254, which can be positioned and / or oriented relative to one another in any suitable manner, for example, to better align the guide coupling slots 254, and thus the energy guides 222A-222E, with the multiplexer 228. In the embodiment shown in FIG. 2A, the guide coupling housing 250 includes seven guide coupling slots 254 spaced apart in a linear array with respect to one another, with precise spacing between adjacent guide coupling slots 254. Thus, in such an embodiment, the guide coupling housing 250 can hold the guide proximal ends 222P of up to seven energy guides (although only five energy guides 222A-222E are specifically shown in FIG. 2A). Alternatively, the guide coupling housing 250 can have a different number of guide coupling slots, i.e., more than seven or less than seven, and / or the guide coupling slots 254 can be arranged differently relative to one another.

[0100] The design of the multiplexer 228 can vary depending on the requirements of the catheter system 200, the relative positioning of the energy guides 222A-222E, and / or to suit the desires of a user or operator of the catheter system 200. In the embodiment shown in Figure 2A, the multiplexer 228 includes one or more of a multiplexer base 260, a multiplexer stage 262, a stage mover 264 (shown in phantom), a redirector 266, and a coupling optics 268. Alternatively, the multiplexer 228 can include more or fewer components than those specifically shown in Figure 2A.

[0101] During use of the catheter system 200, the multiplexer base 260 is fixed in position relative to the energy source 224 and the energy guides 222A-222E. Further, in this embodiment, the multiplexer stage 262 is movably supported on the multiplexer base 260. More specifically, a stage mover 264 is configured to move the multiplexer stage 262 relative to the multiplexer base 260. As shown in FIG. 2A , the redirector 266 and the coupling optical element 268 are mounted on and / or carried by the multiplexer stage 262. Thus, movement of the multiplexer stage 262 relative to the multiplexer base 260 results in corresponding movement of the redirector 266 and the coupling optical element 268 relative to the fixed multiplexer base 260. Furthermore, with the energy guides 222A-222E fixed in position relative to the multiplexer base 260, movement of the multiplexer stage 262 results in corresponding movement of the redirector 266 and the coupling optical element 268 relative to the energy guides 222A-222E.

[0102] In various embodiments, the multiplexer 228 is configured to precisely align the coupling optics 268 with each of the energy guides 222A-222E such that the source beam 224A generated by the energy source 224 can be precisely directed and focused by the multiplexer 228 as the guide beam 224B corresponding to each of the energy guides 222A-222E. In its simplest form, as shown in FIG. 2A, the multiplexer 228 translates the coupling optics 268 along a linear path using a precision mechanism, i.e., a stage mover 264. This approach requires a single degree of freedom. In certain embodiments, the linear translation mechanism, i.e., the stage mover 264, and / or the multiplexer stage 262 can have mechanical stops to precisely align the coupling optics 268 with the respective positions of the energy guides 222A-222E in any desired firing sequence and / or pattern (predetermined or not). Alternatively, the stage mover 264 can be electronically controlled to align the beam path of the guide beam 224B with each of the individual energy guides 222A-222E that are partially held within the guide coupling housing 250 in any desired firing sequence and / or pattern.

[0103] As previously mentioned, the multiplexer stage 262 is configured to support the necessary optical elements, such as redirector 266 and coupling optical elements 268, to focus the optical energy generated by the energy source 224 towards each of the energy guides 222A-222E for optimal coupling. With such a design, the small divergence of the guide beam 224A over the short travel distance of the translated multiplexer stage 262 has minimal impact on the coupling efficiency to the energy guides 222A-222E.

[0104] In operation, the stage mover 264 drives the multiplexer stage 262 to align the beam path of the guide beam 224B with the selected energy guide 222A-222E, and then the system controller 226 fires the energy source 224 in pulsed or semi-CW mode. The stage mover 264 then advances the multiplexer stage 262 to the next stop, i.e., the next desired energy guide 222A-222E, and the system controller 226 again fires the energy source 224. This process is repeated as desired such that optical energy in the form of the guide beam 224B is directed to each of the energy guides 222A-222E in a desired firing sequence and / or pattern. The stage mover 264 can move the multiplexer stage 262 so that it is aligned with any of the energy guides 222A-222E, after which the system controller 226 fires the energy source 224. In this manner, the multiplexer 228 can achieve a firing sequence through the energy guides 222A-222E in any desired firing pattern.

[0105] In this embodiment, stage mover 264 can have any suitable design suitable for moving multiplexer stage 262 linearly relative to multiplexer base 260. More particularly, stage mover 264 can be any suitable type of linear translation mechanism.

[0106] 2A, the catheter system 200 can further include an optical element 246, e.g., a reflective or redirecting element such as a mirror, that reflects the source beam 224A from the energy source 224 so that the source beam 224A is directed to the multiplexer 228. In one embodiment, as shown, the optical element 246 can be positioned along the beam path to redirect the source beam 224A by about 90 degrees so that the source beam 224A is directed to the multiplexer 228. Alternatively, the optical element 246 can redirect the source beam 224A by more than 90 degrees or less than 90 degrees. Alternatively, the catheter system 200 can be designed without the optical element 246 and the energy source 224 can directly direct the source beam 224A to the multiplexer 228.

[0107] Further, in this embodiment, the source beam 224A directed to the multiplexer 228 first encounters a redirector 266 configured to redirect the source beam 224A toward the combining optics 268. In some embodiments, the redirector 266 redirects the source beam 224A toward the combining optics 268 by approximately 90 degrees. Alternatively, the redirector 266 can redirect the source beam 224A toward the combining optics 268 by more than 90 degrees or less than 90 degrees. Thus, the redirector 266 mounted to the multiplexer stage 262 is configured to direct the source beam 224A through the combining optics 268 such that the individual guide beams 224B are focused into the individual energy guides 222A-222E within the guide combining housing 250.

[0108] The combining optics 268 may have any suitable design for the purpose of focusing the individual guide beams 224B into each of the energy guides 222A-222E. In one embodiment, the combining optics 268 includes two lenses that are specifically configured to focus the individual guide beams 224B as desired. Alternatively, the combining optics 268 may have another suitable design.

[0109] In certain non-exclusive alternative embodiments, steering the source beam 224A so that it is properly aimed and focused at each of the energy guides 222A-222E can be accomplished using an optomechanical scanner, an XY galvanometer, or other multi-axis beam steering device.

[0110] 2A shows the energy guides 222A-E fixed in place relative to the multiplexer base 260, it is understood that in some embodiments the energy guides 222A-E can be configured to move relative to the coupling optics 268 that are fixed in place. In such embodiments, the guide coupling housing 250 itself moves. In one non-exclusive example, the guide coupling housing 250 can be supported by a linear translation stage, and the system controller 226 can control the linear translation stage to move in steps such that the energy guides 222A-E are aligned with the coupling optics and guide beam 224B, respectively, in a desired firing sequence or pattern. It is further understood that while such embodiments can be effective, because the guide coupling housing 250 moves relative to the coupling optics 268 of the multiplexer 228 during use, additional protection and control is required to make it safe and reliable.

[0111] Figure 2B is a simplified schematic perspective view of the catheter system 200 and a portion of the multiplexer 228 shown in Figure 2A. In particular, Figure 2B shows another view of the multiplexer 228 including a guide coupling housing 250 with guide coupling slots 254 configured to hold a portion of each of the energy guides 222A-222E, an optical element 246 that initially redirects the source beam 224A from the energy source 224 (shown in Figure 2A) toward the multiplexer 228, and a multiplexer base 260, a multiplexer stage 262, a redirector 266, and a coupling optical element 268 that receives the source beam 224A and then focuses the individual guide beams 224B toward each of the energy guides 222A-222E in any desired firing sequence and / or pattern. It is understood that the stage mover 264 is not shown in Figure 2B for simplicity and ease of illustration.

[0112] 3A is a simplified schematic top view of a portion of an embodiment of a catheter system 300 including another embodiment of a multiplexer 328. More specifically, FIG. 3A illustrates a plurality of energy guides, e.g., 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 optical energy in the form of a source beam 324A from the energy source 324 and directs the optical energy in the form of individual guide beams 324B to each of the energy guides 322A-322C in any desired firing sequence and / or pattern, i.e., under the control of the system controller 326. The energy guides 322A-322C, the energy source 324, and the system controller 326 are substantially similar in design and function, as described in detail herein above. Accordingly, such components will not be described in detail in connection with the embodiment shown in Figure 3 A. Certain components of system console 123 illustrated and described above in connection with Figure 1, such as power supply 125 and GUI 127, are not shown in Figure 3 A for simplicity and ease of illustration, but are typically included in many embodiments.

[0113] Similar to the previous embodiment, multiplexer 328 is configured to receive optical energy in the form of source beam 324A, e.g., a single pulsed source beam, from energy source 324 and selectively and / or alternatively direct that optical energy in the form of individual guide beams 324B to each of energy guides 322A-322C in any desired firing sequence and / or pattern. Thus, as shown in FIG. 3A, multiplexer 328 is operative and / or optically coupled to energy guide bundle 322, i.e., in optical communication with multiple energy guides 322A-322C.

[0114] Further, as shown, the guide proximal ends 322P of each of the plurality of energy guides 322A-322C are retained within a guide coupling housing 350, i.e., within a guide coupling slot 354 formed in the guide coupling housing 350. In various embodiments, the guide coupling housing 350 is configured to be selectively coupled to the system console 123 (shown in FIG. 1 ) such that the guide coupling slots 354, and thus the energy guides 322A-322C, are maintained in a desired predetermined position relative to the multiplexer 328 during use of the catheter system 300.

[0115] 3B, which is a simplified schematic perspective view of a portion of the catheter system 300 and multiplexer 328 shown in FIG. 3A. As shown in FIG. 3B, the guide coupling housing 350 can be substantially cylindrical in shape. It will be appreciated that the guide coupling housing 350 can have any suitable number of guide coupling slots 354 that can be positioned and / or oriented relative to one another in any suitable manner, e.g., to best align the guide coupling slots 354 and thus the energy guides 322A-322C of the energy guide bundle 322 with the multiplexer 328. In the embodiment shown in FIG. 3B, the guide coupling housing 350 includes seven guide coupling slots 354 arranged in a circular and / or hexagonal packing pattern. Thus, in such an embodiment, the guide coupling housing 350 can hold the guide proximal ends of up to seven energy guides. Alternatively, the guide coupling housing 350 can have a different number of guide coupling slots, i.e., more than seven or less than seven guide coupling slots, and / or the guide coupling slots 354 can be arranged differently relative to one another, for example, in another suitable circular periodic pattern.

[0116] 3A, in this embodiment, multiplexer 328 includes one or more of a multiplexer stage 362, a stage mover 364, a redirector 366, and a combining optics 368. Alternatively, multiplexer 328 can include more or fewer components than those specifically shown in FIG.

[0117] 3A, the stage mover 364 is configured to rotationally move the multiplexer stage 362. More specifically, in this embodiment, the multiplexer stage 362 and / or the stage mover 364 require a single rotational degree of freedom. Further, as shown, the multiplexer stage 362 and the guide coupling housing 350 are aligned on a central axis 324X of the energy source 324. Thus, the multiplexer stage 362 is configured to be rotated by the stage mover 364 about the central axis 324X.

[0118] The redirector 366 and the coupling optics 368 are mounted on and / or carried by the multiplexer stage 362. During use of the catheter system 300, the source beam 324A is initially directed along a central axis 324X of the energy source 324 to the multiplexer 328, i.e., the multiplexer stage 362. The redirector 366 is then configured to laterally deflect the source beam 324A a predetermined distance, i.e., away from the central axis 324X of the energy source 324, such that the source beam 324A is directed in a direction generally parallel to and away from the central axis 324X. More specifically, the redirector 366 deflects the source beam 324A to coincide with a radius of the circular pattern of the energy guides 322A-322C within the guide coupling housing 350. When multiplexer stage 362 is rotated, source beam 324A directed through redirector 366 follows a circular path.

[0119] It will be appreciated that the redirector 366 can have any suitable design. For example, in certain non-exclusive alternative embodiments, the redirector 366 can be provided in the form of an anamorphic prism pair, a wedge prism pair, or a pair of closely spaced right angle mirrors or prisms. Alternatively, the redirector 366 can include another suitable form of optical element to achieve the desired lateral beam offset.

[0120] Additionally, as discussed above, coupling optics 368 is also mounted on and / or carried by multiplexer stage 362. As with the previous embodiment, coupling optics 368 is configured to focus individual guide beams 324B onto each of the energy guides 322A-322C within energy guide bundle 322, which is partially carried within guide coupling housing 350, for optimal coupling.

[0121] As previously described, the multiplexer 328 is configured to precisely align the coupling optics 368 with each of the energy guides 322A-322C such that the source beam 324A generated by the energy source 324 is precisely focused by the multiplexer 328 as a corresponding guide beam 324B into each of the energy guides 322A-322C. In certain embodiments, the stage mover 364 and / or the multiplexer stage 362 may have mechanical stops to allow the coupling optics 368 to be precisely aligned with the position of each of the energy guides 322A-322C in any desired firing sequence or pattern. Alternatively, the stage mover 364 may be electronically controlled using, for example, a stepper motor or a piezoelectrically actuated rotational stage to align the beam path of the guide beam 324B with each of the individual energy guides 322A-322C partially held within the guide coupling housing 350 in any desired firing sequence and / or pattern.

[0122] During use of the catheter system 300, the stage mover 364 drives the multiplexer stage 362 to couple the guide beam 324B with the selected energy guide 322A-322C, and the system controller 326 then fires the energy source 324 in pulsed or semi-CW mode. The stage mover 364 then angles the multiplexer stage 362 to the next stop, i.e., the next desired energy guide 322A-322C, and the system controller 326 again fires the energy source 324. This process is repeated as desired such that optical energy in the form of the guide beam 324B is directed to each of the energy guides 322A-322C in a desired firing sequence and / or pattern. The stage mover 364 can move the multiplexer stage 362 so that it is aligned with any of the energy guides 322A-322C, after which the system controller 326 knows to fire the energy source 324. In this manner, the multiplexer 328 can achieve a particular firing sequence through the energy guides 322A-322C, or can fire in any desired firing sequence or pattern relative to the energy guides 322A-322C.

[0123] In this embodiment, stage mover 364 can have any suitable design suitable for rotationally moving multiplexer stage 362 about central axis 324X. More particularly, stage mover 364 can be any suitable type of rotational mechanism.

[0124] Alternatively, although FIG. 3A shows the energy guides 322A-322C fixed in place relative to the multiplexer stage 362, in some embodiments the energy guides 322A-322C can be configured to move, e.g., rotate, relative to the coupling optics 368, which are fixed in place. In such embodiments, the guide coupling housing 350 itself moves, e.g., the guide coupling housing 350 can be rotated about a central axis 324X, and the system controller 326 can control the rotation stage to move the energy guides 322A-322C in incremental steps so that they are aligned with the coupling optics and guide beam 324B, respectively, in a desired firing sequence and / or pattern. In such embodiments, the guide coupling housing 350 is not rotated continuously, but rather is rotated a predetermined number of degrees and then counter-rotated to avoid winding up of the energy guides 322A-322C.

[0125] Returning again to Figure 3B, another view of the guide coupling housing 350 is shown. Figure 3B shows guide coupling slots 354 configured to hold a portion of each of the energy guides, and multiplexer 328 including multiplexer stage 362, redirector 366 and coupling optics 368 that receives source beam 324A and then focuses individual guide beams 324B towards each of the energy guides in any desired firing sequence and / or pattern. It will be appreciated that stage mover 364 is not shown in Figure 3B for simplicity and ease of illustration.

[0126] Figure 4 is a simplified schematic top view of a portion of the catheter system 400 and yet another embodiment of a multiplexer 428. More specifically, Figure 4 illustrates a plurality of energy guides, e.g., 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 optical energy in the form of a source beam 424A from the energy source 424 and directs the optical energy in the form of individual guide beams 424B to each of the energy guides 422A-422E in any desired firing sequence and / or pattern, i.e., under the control of the system controller 426. The energy guides 422A-422E, energy source 424, and system controller 426 are substantially similar in design and function as described in detail hereinabove, and therefore such components will not be described in detail with respect to the embodiment shown in Figure 4. Certain components of the system controller 123 illustrated and described above with respect to Figure 1, such as power supply 125 and GUI 127, are not shown in Figure 4 for simplicity and ease of illustration, but will generally be understood to be included in many embodiments.

[0127] As previously discussed, multiplexer 428 is configured to receive optical energy in the form of source beam 424A, e.g., a single pulsed source beam, from energy source 424 and selectively and / or alternatively direct that optical energy in the form of individual guide beams 424B to each of energy guides 422A-422E in any desired firing sequence and / or pattern. Thus, as shown in FIG. 4, multiplexer 428 is operative in optical communication with and / or optically coupled to energy guide bundle 422, i.e., multiple energy guides 422A-422E.

[0128] Further, as shown, the guide proximal ends 422P of each of the plurality of energy guides 422A-422E are retained within the guide coupling housing 450, i.e., within guide coupling slots 454 formed into the guide coupling housing 450. In various embodiments, the guide coupling housing 450 is configured to be selectively coupled to the system console 123 (shown in FIG. 1 ) such that the guide coupling slots 454, and thus the energy guides 422A-422E, are maintained in a desired predetermined position relative to the multiplexer 428 during use of the catheter system 400. It will be appreciated that the guide coupling housing 450 can have any suitable number of guide coupling slots 454. In the embodiment shown in FIG. 4 , five guide coupling slots 454 are visible in the guide coupling housing 450. Thus, in such an embodiment, the guide coupling housing 450 can retain the guide proximal ends 422P of up to five energy guides. Alternatively, the guide coupling housing 450 can have a different number of guide coupling slots 454, ie, more than five or less than five guide coupling slots 454.

[0129] 4, multiplexer 428 includes one or more of a multiplexer stage 462, a stage mover 464, one or more diffractive optical elements 470 (or "DOEs"), and a combining optical element 468. Alternatively, multiplexer 428 can include more or fewer components than are specifically shown in FIG.

[0130] As shown, diffractive optical element 470 is mounted on and / or carried by multiplexer stage 462. Further, stage mover 464 is configured to move, e.g., translationally, multiplexer stage 462 such that each of one or more diffractive optical elements 470 is selectively and / or alternatively positioned in the beam path of source beam 424A from energy source 424.

[0131] During use of the catheter system 400, each of the one or more diffractive optical elements 470 is configured to split the source beam 424A into one, two, three, or more individual guide beams 424B. It is understood that the diffractive optical element 470 can have any suitable design. For example, in certain non-exclusive embodiments, the diffractive optical element 470 can be created using an array of microprisms, microlenses, or other patterned diffractive elements.

[0132] Using this approach, it can be seen that there are many possible physical configurations, patterns, or setups for organizing the energy guides 422A-422E within the guide coupling housing 450. One such configuration for the energy guides 422A-422E within the guide coupling housing 450 would be a hexagonal close-packed configuration somewhat similar to that shown in Figures 3A and 3B. Alternatively, the energy guides 422A-422E within the guide coupling housing 450 could be arranged in a square, rectangular, triangular, pentagonal, linear, circular, or any other suitable geometric or non-geometric configuration.

[0133] 4, the guide coupling housing 450 can be aligned on the central axis 424X of the energy source 424, with a diffractive optical element 470 mounted on the multiplexer stage 462 being inserted along the beam path between the energy source 424 and the guide coupling housing 450. Additionally, as shown, a coupling optical element 468 is also positioned along the central axis 424X of the energy source 424, with the coupling optical element being disposed between the diffractive optical element 470 and the guide coupling housing 450.

[0134] In operation, a source beam 424A impinging on one of the diffractive optical elements 470 splits the source beam 424A into two or more deflected beams, i.e., two or more guide beams 424B. These guide beams 424B are then directed and focused by the combining optical element 468 into individual energy guides 422A-422E held within the guide combining housing 450. In one configuration, the diffractive optical element 470 splits the source beam 424A into as many energy guides as are present in the disposable device. In such a configuration, the power of each guide beam 424B is based on the number of guide beams 424B generated from a single source beam 424A minus scattering and absorption losses. Alternatively, the diffractive optical element 470 can be configured to split the source beam 424A such that the guide beams 424B are directed to any single energy guide or any selected number of energy guides. Thus, multiplexer stage 462 may be configured to hold multiple diffractive optical elements 470, for example with multiple diffractive optical elements pattern etched on a single plate, to give a user or operator the option to couple guide beam 424B into a desired number and pattern of energy guides. In such an embodiment, a desired firing sequence may be achieved by moving multiplexer stage 462, for example translationally, with stage mover 464 such that a desired diffractive optical element 470 is positioned in the beam path of source beam 424A between energy source 424 and coupling optical element 468.

[0135] As with the previous embodiment, the combining optics 468 may have any suitable design for the purpose of simultaneously focusing an individual guide beam 424B or multiple guide beams 424B onto desired energy guides 422A-422E.

[0136] 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, e.g., 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 optical energy in the form of a source beam 524A from the energy source 524 and directs the optical energy in the form of individual guide beams 524B to each of the energy guides 522A-522C in any desired firing sequence and / or pattern, i.e., 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 herein above. Accordingly, such components will not be described in detail in connection with the embodiment illustrated in FIG. 5. It will be further appreciated that certain components of the system console 123 illustrated and described above in connection with FIG. 1, such as power supply 125 and GUI 127, are not shown in FIG. 5 for simplicity and ease of illustration, but are generally included in many embodiments.

[0137] As previously discussed, multiplexer 528 is configured to receive optical energy in the form of source beam 524A, e.g., a single pulsed source beam, from energy source 524 and selectively and / or alternatively direct that optical energy in the form of individual guide beams 524B to each of energy guides 522A-522C in any desired firing sequence and / or pattern. Thus, as shown in FIG. 5, multiplexer 528 is operative in optical communication with and / or optically coupled to multiple energy guides 522A-522C.

[0138] However, as shown in FIG. 5, the multiplexer 528 has a different configuration than any of the previous embodiments. In some embodiments, it may be desirable to design the multiplexer 528 to receive a source beam 524A from a single energy source 524 and selectively and / or alternatively direct optical energy in the form of individual guide beams 524B to each of the energy guides 522A-522C in any desired firing sequence and / or pattern in a manner that is easily reconfigurable and does not include moving parts. For example, by using an acousto-optic deflector (AOD) as the multiplexer 528, the entire output of a single energy source 524, e.g., a single laser, can be directed to multiple individual energy guides 522A-522C. The guide beam 524B can be retargeted to different energy guides 522A-522C within microseconds by simply changing the drive frequency input to the multiplexer 528 (AOD); with a pulsed laser such as Nd:YAG, this switching occurs simply between pulses. In such an embodiment, the deflection angle (Θ) of multiplexer 528 may be defined as follows: Deflection angle (Θ) = Λf / v, where: Λ=light wavelength f = acoustic driving frequency v = speed of sound in the modulator

[0139] As shown in FIG. 5, the source beam 524A is directed from the energy source 524 to the multiplexer 528 and then redirected to each of the energy guides 522A-C due to the deflection angle generated as the desired guide beam 524B. More specifically, as shown, when the multiplexer 528 generates a first deflection angle for the source beam 524A, the first guide beam 524B1 is directed to the first energy guide 522A. When the multiplexer 528 generates a second deflection angle for the source beam 524A, the second guide beam 524B2 is directed to the second energy guide 522B. And when the multiplexer 528 generates a third deflection angle for the source beam 524A, the third guide beam 524B3 is directed to the third energy guide 522C. As shown, it can be seen that any desired deflection angle can include substantially no deflection angle at all, i.e., guide beam 524B can be directed to continue along the same axial beam path as source beam 524A.

[0140] In this embodiment, the multiplexer 528 (AOD) includes a transducer 572 and an absorber 574 that cooperate to generate a desired drive frequency and thus a desired deflection angle such that the source beam 524A is redirected as the desired guide beam 524B toward the desired energy guides 522A-522C. More specifically, the multiplexer 528 is configured to spatially control the source beam 524A. In operation of the multiplexer 528, the power driving the acoustic transducer 572 is kept on at a constant level while the acoustic frequency is varied to deflect the source beam 524A to different angular positions that define the guide beams 524B1-524B3. Thus, the multiplexer 528 utilizes the acoustic frequency dependent diffraction angles as described above.

[0141] 6 is a simplified schematic top view of a portion of the catheter system 600 and yet another embodiment of a multiplexer 628. More specifically, FIG. 6 illustrates a plurality of energy guides, e.g., 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 a multiplexer 628 that receives optical energy in the form of a source beam 624A, e.g., a single pulsed source beam, from the energy source 624 and selectively and / or alternatively directs the optical energy in the form of individual guide beams 624B to each of the energy guides 622A-622C in any desired firing sequence and / or pattern, i.e., under the control of the system controller 626. 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 herein above. Accordingly, such components will not be described in detail with respect to the embodiment shown in Figure 6. It will be further appreciated that certain components of system console 123 illustrated and described above with respect to Figure 1, such as power supply 125 and GUI 127, are not shown in Figure 6 for simplicity and ease of illustration, but are generally included in many embodiments.

[0142] It will be appreciated that the multiplexer 628 shown in Figure 6 is substantially similar to the multiplexer 528 illustrated and described in connection with Figure 5. For example, as shown in Figure 6, the multiplexer 628 again includes a converter 672 and an absorber 674 that cooperate to generate a desired drive frequency, which in turn can generate a desired deflection angle such that the source beam 624A is redirected as the desired guide beam 624B towards the desired energy guides 622A-622C. However, in this embodiment, the multiplexer 628 further includes an optical element 676 that can be used to convert the angular separation between the guide beams 624B into a linear offset.

[0143] In some embodiments, to improve the angular resolution and efficiency of the catheter system 600, the input laser 624 should be collimated with a diameter close to filling the aperture of the multiplexer 628 (AOD). The smaller the divergence of the input, the more discrete outputs can be generated. The angular resolution of such a device is very good, but the overall angular deflection is limited. To allow a sufficient number of energy guides 622A-622C of finite size to be accessed by a single energy source 624 and a single source beam 624A, there are several means to improve the separation of the different outputs. For example, as shown in FIG. 6, after the individual guide beams 624B are separated, an optical element 676, e.g., a lens, can be used to convert the angular separation between the guide beams 624B into a linear offset, e.g., to direct the guide beam 624B to the adjacent energy guides 622A-622C when the energy guides 622A-622C are held close to each other in the guide coupling housing 650. Additionally, folding mirrors may be used to allow an appropriate propagation distance to separate different beam paths of guide beam 624B within a limited volume.

[0144] Figure 7 is a simplified schematic top view of a portion of a catheter system 700 and yet another embodiment of a multiplexer 728. More specifically, Figure 7 illustrates a plurality of energy guides, e.g., 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 a multiplexer 728 that receives optical energy in the form of a source beam 724A, e.g., a single pulsed source beam, from the energy source 724 and directs the optical energy in the form of individual guide beams 724B to each of the energy guides 722A-722E in any desired firing sequence and / or pattern, i.e., under the control of the system controller 726. The energy guides 722A-722E, energy source 724, and system controller 726 are substantially similar in design and function as described in detail hereinabove, and therefore such components will not be described in detail with respect to the embodiment shown in Figure 7. It will be further appreciated that certain components of the system console 123 illustrated and described above with respect to Figure 1, such as power supply 125 and GUI 127, are not shown in Figure 7 for simplicity and ease of illustration, but will generally be included in many embodiments.

[0145] It will be appreciated that the manner in which the source beam 724A shown in FIG. 7 is multiplexed into multiple guide beams 724B is somewhat similar to the manner in which the source beam 524 is multiplexed into multiple guide beams 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) arranged in series with each other, i.e., a first acousto-optic deflector 728A and a second acousto-optic deflector 728B. With such a design, the multiplexer 728 may be able to access additional energy guides. It will be further appreciated that the multiplexer 728 may include more than three acousto-optic deflectors to provide access to even more energy guides, if necessary.

[0146] 7, the source beam 724A is initially directed to a first AOD 728A, which is utilized to deflect the source beam 724A to generate a first guide beam 724B1 that is directed to a first energy guide 722A, and a second guide beam 724B2 that is directed to a second energy guide 722B2. Additionally, the first AOD 728A also enables an undeflected beam to be transmitted via the first AOD 728A as a transmit beam 724C that is directed to a second AOD 728B. The second AOD 728B is then utilized to deflect the transmit beam 724C as required to generate a third guide beam 724B3 that is directed into the third energy guide 722C, a fourth guide beam 724B4 that is directed into the fourth energy guide 722D, and a fifth guide beam 724B5 that is directed into the fifth energy guide 722B5.

[0147] Further, each AOD 728A, 728B may be designed in a manner similar to that described in more detail above. For example, the first AOD 728A may include a first transducer 772A and a first absorber 774A that cooperate to generate a desired drive frequency and thus a desired deflection angle to redirect the source beam 724A as desired, and the second AOD 728B may include a second transducer 772B and a second absorber 774B that cooperate to generate a desired drive frequency and thus a desired deflection angle to redirect the transmit beam 724C as desired. Alternatively, the first AOD 728A and / or the second AOD 728B may have another suitable design.

[0148] 8A is a simplified schematic side view of a portion of another embodiment of a catheter system 800. More specifically, as shown in FIG. 8A, the catheter system 800 includes at least a balloon 804, a catheter shaft 810, a guidewire lumen 818, and a plurality of energy guides 822 spaced apart from one another around the circumference of the guidewire lumen 818. The balloon 804, the catheter shaft 810, the guidewire lumen 818, and the plurality of energy guides 822 are generally similar in design and operation to those described in detail herein above. Thus, the balloon 804, the catheter shaft 810, the guidewire lumen 818, and the plurality of energy guides 822 will not be described in detail again in connection with the embodiment shown in FIG. 8A.

[0149] Similar to the embodiments described in detail above, for example, the catheter system 800 including the energy source 124 (shown in FIG. 1) and / or the multiplexer 128 (shown in FIG. 1) may be configured and controlled, i.e., by the system controller 126 (shown in FIG. 1), to selectively and / or separately energize each of the plurality of energy guides 822 in any desired firing sequence, pattern, order, firing rate, and / or firing duration to apply pressure to the vascular lesion to induce disruption. Further, as discussed above, while each of the plurality of energy guides 822 may be separately energized in any desired firing sequence, pattern, order, firing rate, and / or firing duration, it will be appreciated that sets and / or subsets of the plurality of energy guides 822 may also be energized at any given time. Each set or subset of the plurality of energy guides 822 may include one or more of the plurality of energy guides 822. Thus, at any given time, power may be directed to one or more of the plurality of energy guides 822 to alternatively form a first firing sequence, a second firing sequence, a third firing sequence, a fourth firing sequence, etc. Additionally, although not required, one or more of the firing sequences of the energy guides 822 in such sets and subsets of the plurality of energy guides 822 may differ from any or all of the other firing sequences of the energy guides 822.

[0150] FIG 8B is a simplified schematic cross-sectional view of a portion of the catheter system 800 taken along line BB in FIG 8A. More specifically, FIG 8B again illustrates the balloon 804, the catheter shaft 810, the guidewire lumen 818, and a number of energy guides 822 that may be included in this embodiment of the catheter system 800. Additionally, as illustrated, FIG 8B illustrates that this particular, non-exclusive embodiment of the catheter system 800 includes eight energy guides, including a first energy guide 822A, a second energy guide 822B, a third energy guide 822C, a fourth energy guide 822D, a fifth energy guide 822E, a sixth energy guide 822F, a seventh energy guide 822G, and an eighth energy guide 822H. However, it will be understood that any suitable number of energy guides may be used. 8B, energy guides 822A-822H are evenly spaced about 45 degrees from one another around the circumference of guidewire lumen 818. However, it will be appreciated that energy guides 822A-822H need not be evenly spaced from one another, i.e., energy guides 822A-822H may be unequally spaced from one another around the circumference of guidewire lumen 818.

[0151] Further, as provided herein, each of the energy guides 822A-822H includes a guide distal end 880 (shown in FIG. 8A) that can be positioned at any suitable or desired longitudinal position relative to the length 842 of the balloon 804 and / or the length of the guidewire lumen 818 to more effectively and precisely deliver pressure waves for the purpose of destroying vascular lesions at the treatment site 106 (shown in FIG. 1). For example, and referring also to FIG. 8A , a first energy guide 822A can include a first guide distal end 880 disposed at a first longitudinal position relative to the length 842 of the balloon 804, a second energy guide 822B can include a second guide distal end 880 disposed at a second longitudinal position relative to the length 842 of the balloon 804, a third energy guide 822C can include a third guide distal end 880 disposed at a third longitudinal position relative to the length 842 of the balloon 804, and a fourth energy guide 822D can include a fourth guide distal end 880 disposed at a fourth longitudinal position relative to the length 842 of the balloon 804. the fifth energy guide 822E can include a fifth guide distal end 880 disposed at a fifth longitudinal position relative to the length 842 of the balloon 804, the sixth energy guide 822F can include a sixth guide distal end 880 disposed at a sixth longitudinal position relative to the length 842 of the balloon 804, the seventh energy guide 822G can include a seventh guide distal end 880 disposed at a seventh longitudinal position relative to the length 842 of the balloon 804, and the eighth energy guide 822H can include an eighth guide distal end 880 disposed at an eighth longitudinal position relative to the length 842 of the balloon 804.

[0152] In alternative embodiments, each of the longitudinal positions of the guide distal ends 880 relative to the length 842 of the balloon 804 can be different from one another, or two or more of the longitudinal positions of the guide distal ends 880 relative to the length 842 of the balloon 804 can be the same as one another. Additionally, as discussed above, while each of the energy guides 822A-H is shown to be disposed substantially directly adjacent to the guidewire lumen 818, it will be appreciated that a portion of the energy guides 822A-H, e.g., the guide distal end 880, can be spaced apart from the guidewire lumen 818. For example, the guide distal end 880 of any of the energy guides 822A-H can be disposed laterally at any suitable location between the guidewire lumen 818 and the balloon wall 830 of the balloon 804.

[0153] As discussed above, individual energy guides 822A-H and / or sets or subsets of energy guides 822A-H can be fired to achieve a desired firing sequence or pattern that may be more effective in destroying localized calcified lesions. More specifically, system controller 126 can control energy source 124 and / or multiplexer 128 to direct individual guide beams 124B (shown in FIG. 1 ) to each of energy guides 822A-H or sets or subsets of energy guides 822A-H in any desired firing sequence, pattern, order, firing rate, and / or firing duration to achieve a greater degree of destruction of calcified lesions. For example, with eight energy guides 822A-822H arranged in a linear pattern with a helical angular orientation around the guidewire lumen 818, the system controller 126 can control the sequence of emission of light energy from the energy source 124 to each of the energy guides 822A-822H in any desired predetermined or non-predetermined manner.

[0154] For example, in one non-exclusive embodiment, the system controller 126 can direct each individual guide beam 124B to a first energy guide 822A and an eighth energy guide 822H, respectively, in a first set of energy guides, then can direct each individual guide beam 124B to a second energy guide 822B and a seventh energy guide 822G, respectively, in a second set of energy guides, followed by directing each individual guide beam 124B to a third energy guide 822C and a sixth energy guide 822F, respectively, in a third set of energy guides, and finally can direct each individual guide beam 124B to a fourth energy guide 822D and a fifth energy guide 822E, respectively, in a fourth set of energy guides. This example firing sequence and / or firing pattern generates a propagating wavefront that converges from both ends of the balloon 804 toward a particular area, such as the treatment site 106 located between the guide distal ends 880 of the fourth energy guide 822D and the fifth energy guide 822E, thereby more effectively destroying lesions at that location.

[0155] As used herein, the term "advancing wavefront" is intended to mean a series of guide beams that are directed at one or more energy guides to generate an overall pattern of pressure wave-inducing optical energy generally moving toward the treatment site 106. Conversely, a "retreating wavefront" is actually somewhat the opposite of a forward-moving wavefront. In other words, a series of guide beams are directed at one or more energy guides to generate an overall pattern of pressure wave-inducing optical energy generally moving away from the treatment site 106. As will be appreciated by those skilled in the art, a rearward-moving wavefront operates in a manner substantially opposite to a forward-moving wavefront.

[0156] In another non-exclusive example, the system controller 126 can direct each guide beam 124B to a third energy guide 822C and a seventh energy guide 822G, respectively, in the first set of energy guides, then direct each guide beam 124B to a fourth energy guide 822D and a sixth energy guide 822F, respectively, in the second set of energy guides, and finally direct each guide beam 124B to a fifth energy guide 822E, respectively, in the third set of energy guides. This example firing sequence and / or firing pattern generates a forward moving wavefront that converges from both ends of the balloon 804 toward a particular region (such as the treatment site 106 in one example) located at a longitudinal location within the balloon 804 near the guide distal end 880 of the fifth energy guide 822E, i.e., the fifth longitudinal location.

[0157] In yet another non-exclusive example, the system controller 126 can control the energy source 124 and / or the multiplexer 128 to generate somewhat different forward wavefronts along substantially the entire length 842 of the balloon 804. In this example, the system controller 126 can control the energy source 124 and / or the multiplexer 128 to sequentially direct each guide beam 124B to the first energy guide 822A, the second energy guide 822B, and the third energy guide 822C in a first sequence. The system controller 126 can then control the energy source 124 and / or the multiplexer 128 to sequentially direct each guide beam 124B to the second energy guide 822B, the third energy guide 822C, and the fourth energy guide 822D in a second sequence. This type of sequence can continue in a similar manner until the final step when the system controller 126 controls the energy source 124 and / or the multiplexer 128 to sequentially direct the individual guide beams 124B to the sixth energy guide 822F, the seventh energy guide 822G, and the eighth energy guide 822H in the sixth sequence (e.g., to the third, fourth, and fifth energy guides in the third sequence, to the fourth, fifth, and sixth energy guides in the fourth sequence, to the fifth, sixth, and seventh energy guides in the fifth sequence, etc.).

[0158] In various embodiments, an advancing wavefront does not necessarily refer to a wavefront that advances toward the treatment site 106, but rather to a wavefront that advances toward the treatment site 106 and then continues (in any suitable direction) through the treatment site 106.

[0159] Additionally or alternatively, the system controller 126 may control the energy source 124 and / or the multiplexer 128 to generate a series of energy waves that travel along the length 842 of the balloon 804 to generate shear waves at the lesions in the treatment site 106. In such applications, individual guide beams 124B are directed to specific energy guides 822 in a specific sequence so that the pressure wave travels in the direction of activation. As new bubbles are generated in front of collapsing bubbles, it is possible to generate shear forces in the balloon wall 830. A non-perpendicular localized force acting on the leading edge of a spherical wavefront that strikes the balloon wall 830 at an angle generates a highly concentrated localized shear force. This may have a greater effect on cracking calcified lesions than simply hitting the wall through the length 842 of the balloon 804 with one radially directed pressure wave, which can expand across the entire cross section of the balloon 804 and create hoop stresses.

[0160] Further, in certain embodiments, it may be desirable to position the guide distal ends 880 of two or more energy guides 822A-822H at the same longitudinal position relative to the length 842 of the balloon 804, and the system controller 126 may control the energy source 124 and / or multiplexer 128 to fire each such energy guide 822A-822H substantially simultaneously to generate a pressure wave completely around the balloon 804 at such longitudinal position.

[0161] It is also understood that the foregoing example embodiments describing and / or illustrating particular firing sequences or patterns are provided as representative examples only and are not intended to be limiting in any manner. Indeed, it is further understood that an unlimited number of different such firing sequences and / or patterns can be achieved utilizing the disclosure provided herein. It is understood that the firing rate can be controlled to increase or decrease over time using any of the embodiments shown, described, and / or achievable using the disclosure herein. Furthermore, the firing rate can be controlled to increase or decrease depending on the particular energy guide to which the light energy is directed.

[0162] It is recognized that any desired firing sequence and / or pattern may be achieved with the designs provided herein. The type of firing sequence and / or pattern that may be achieved may be based at least in part on the number of energy guides, the axial and longitudinal location of each of the energy guides within the balloon, the energy level of each firing of the energy guides, the firing rate, etc. It is understood that by controlling these and any other suitable parameters, an advancing wavefront may be generated that results in gradual or sudden destruction of the calcification of the vascular lesion. These designs increase the likelihood of successful and / or satisfactory destruction of the calcification in the vascular lesion and / or heart valve.

[0163] Figure 9 is a simplified schematic cross-sectional view of another embodiment of a catheter system 900. The catheter system 900 shown in Figure 9 is similar to the catheter system 800 shown in Figures 8A and 8B, except that the catheter system 900 of Figure 9 includes a different number of energy guides. More specifically, Figure 9 shows that the catheter system 900 includes at least a balloon 904, a catheter shaft 910, a guidewire lumen 918, and a plurality of energy guides 922, namely, a first energy guide 922A, a second energy guide 922B, a third energy guide 922C, a fourth energy guide 922D, a fifth energy guide 922E, and a sixth energy guide 922F, the plurality of energy guides 922 being evenly spaced apart from each other by about 60 degrees around the circumference of the guidewire lumen 918. As with the previous embodiment, it will be appreciated that the energy guides 922A-922F need not be evenly spaced from one another around the circumference of the guidewire lumen 918.

[0164] Additionally, similar to the previous embodiment, each of the energy guides 922A-F can include a guide distal end (not shown in FIG. 9) that can be positioned at any desired longitudinal position relative to the length of the balloon 904 and / or relative to the length of the guidewire lumen 918. It will be further understood that the system controller 126 (shown in FIG. 1) can control the energy source 124 (shown in FIG. 1) and / or the multiplexer 128 (shown in FIG. 1) such that light energy is separately directed to each of the energy guides 922A-F in any desired firing sequence or pattern.

[0165] FIG 10 is a simplified schematic cross-sectional view of yet another embodiment of a catheter system 1000. The catheter system 1000 shown in FIG 10 is similar to the catheter systems illustrated and described herein above, except that the catheter system 1000 of FIG 10 includes a different number of energy guides. More specifically, FIG 10 shows that the catheter system 1000 includes at least a balloon 1004, a catheter shaft 1010, a guidewire lumen 1018, and a plurality of energy guides 1022, namely, a first energy guide 1022A, a second energy guide 1022B, a third energy guide 1022C, a fourth energy guide 1022D, and a fifth energy guide 1022E, the plurality of energy guides 1022 being evenly spaced apart from each other by approximately 72 degrees around the circumference of the guidewire lumen 1018. As with the previous embodiment, it will be appreciated that the energy guides 1022A-1022E need not be evenly spaced from one another around the circumference of the guidewire lumen 1018.

[0166] Additionally, similar to the previous embodiment, each of the energy guides 1022A-E can include a guide distal end (not shown in FIG. 10) that can be positioned at any desired longitudinal position relative to the length of the balloon 1004 and / or relative to the length of the guidewire lumen 1018. It will be further understood that the system controller 126 (shown in FIG. 1) can control the energy source 124 (shown in FIG. 1) and / or the multiplexer 128 (shown in FIG. 1) such that light energy is separately directed to each of the energy guides 1022A-E in any desired firing sequence or pattern.

[0167] FIG 11 is a simplified schematic cross-sectional view of yet another embodiment of a catheter system 1100. The catheter system 1100 shown in FIG 11 is similar to the catheter systems illustrated and described herein above, except that the catheter system 1100 of FIG 11 includes a different number of energy guides. More specifically, FIG 11 shows that the catheter system 1100 includes at least a balloon 1104, a catheter shaft 1110, a guidewire lumen 1118, and a plurality of energy guides 1122, namely, a first energy guide 1122A, a second energy guide 1122B, a third energy guide 1122C, and a fourth energy guide 1122D, the plurality of energy guides 1122 being evenly spaced apart about 90 degrees from one another around the circumference of the guidewire lumen 1118. As with the previous embodiment, it will be appreciated that the energy guides 1122A-1122D need not be evenly spaced from one another around the circumference of the guidewire lumen 1118.

[0168] Additionally, similar to the previous embodiment, each of the energy guides 1122A-1122D can include a guide distal end (not shown in FIG. 11) that can be positioned at any desired longitudinal position relative to the length of the balloon 1104 and / or relative to the length of the guidewire lumen 1118. It will be further understood that the system controller 126 (shown in FIG. 1) can control the energy source 124 (shown in FIG. 1) and / or the multiplexer 128 (shown in FIG. 1) such that light energy is separately directed to each of the energy guides 1122A-1122D in any desired firing sequence or pattern.

[0169] FIG. 12 is a simplified schematic cross-sectional view of yet another embodiment of a catheter system 1200. The catheter system 1200 shown in FIG. 12 is similar to the catheter systems illustrated and described herein above, except that the catheter system 1200 of FIG. 12 includes a different number of energy guides. More specifically, FIG. 12 illustrates that the catheter system 1200 includes at least a balloon 1204, a catheter shaft 1210, a guidewire lumen 1218, and a plurality of energy guides 1222, namely, a first energy guide 1222A, a second energy guide 1222B, and a third energy guide 1222C, the plurality of energy guides 1222 being evenly spaced apart from one another about 120 degrees around the circumference of the guidewire lumen 1218. As with the previous embodiment, it is understood that the energy guides 1222A-C need not be evenly spaced apart from one another around the circumference of the guidewire lumen 1218.

[0170] Additionally, similar to the previous embodiment, each of the energy guides 1222A-C can include a guide distal end (not shown in FIG. 12) that can be positioned at any desired longitudinal position relative to the length of the balloon 1204 and / or relative to the length of the guidewire lumen 1218. It will be further understood that the system controller 126 (shown in FIG. 1) can control the energy source 124 (shown in FIG. 1) and / or the multiplexer 128 (shown in FIG. 1) such that light energy is separately directed to each of the energy guides 1222A-C in any desired firing sequence or pattern.

[0171] FIG. 13 is a simplified schematic cross-sectional view of yet another embodiment of a catheter system 1300. The catheter system 1300 shown in FIG. 13 is similar to the catheter systems illustrated and described herein above, except that the catheter system 1300 of FIG. 13 includes a different number of energy guides. More specifically, FIG. 13 illustrates that the catheter system 1300 includes at least a balloon 1304, a catheter shaft 1310, a guidewire lumen 1318, and a plurality of energy guides 1322, namely a first energy guide 1322A and a second energy guide 1322B, which are evenly spaced apart from one another about 180 degrees around the guidewire lumen 1318. As with the previous embodiment, it is understood that the energy guides 1322A-B need not be evenly spaced apart from one another around the guidewire lumen 1318.

[0172] Additionally, similar to the previous embodiment, each of the energy guides 1322A-B can include a guide distal end (not shown in FIG. 13) that can be positioned at any desired longitudinal position relative to the length of the balloon 1304 and / or relative to the length of the guidewire lumen 1318. It will be further understood that the system controller 126 (shown in FIG. 1) can control the energy source 124 (shown in FIG. 1) and / or the multiplexer 128 (shown in FIG. 1) such that light energy is separately directed to each of the energy guides 1322A-B in any desired firing sequence or pattern.

[0173] As described in detail herein, in various embodiments, the present invention can be utilized to solve various problems present with more traditional catheter systems. For example, by allowing the catheter system to fire each energy guide separately, it is possible to achieve a sequence or firing sequence that may be much more effective at destroying localized lesions. Furthermore, firing the individual energy guides in a desired firing sequence or pattern can create a traveling energy wavefront that more effectively divides lesions in specific locations or dilated lesions. Additionally, the individual firing of separate energy guides can be utilized to create localized shear forces acting on the leading edge of a spherical wavefront that impinges at an angle (non-perpendicular) to the balloon wall, which may have a greater effect on cracking calcified lesions.

[0174] It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content and / or context clearly dictates otherwise. It should also be noted that the term "or" is generally used in its sense including "and / or" unless the content or context clearly dictates otherwise.

[0175] It should also be noted that, as used herein and in the appended claims, the phrase "configured" refers to a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The phrase "configured" can be used interchangeably with other similar phrases, such as arranged and configured, built and arranged, constructed, manufactured and arranged, etc.

[0176] The headings used herein are provided for consistency with suggestions under 37 CFR 1.77 or to provide organizational guidance. These headings should not be construed as limiting or characterizing the invention(s) described in any claim that may issue from this disclosure. As an example, a description of a technology in the "Background" is not an admission that the technology is prior art to any invention(s) in this disclosure. Neither the "Summary" nor the "Abstract" should be construed as a feature of the invention(s) described in the issued claims.

[0177] The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the detailed description provided herein. Rather, the embodiments are chosen and described so that those skilled in the art can appreciate and understand the principles and practices. Thus, aspects have been described with reference to various specific preferred embodiments and techniques. However, it should be understood that many variations and modifications can be made while remaining within the spirit and scope of the description.

[0178] Although several different embodiments of the catheter system have been illustrated and described herein, it will be understood that one or more features of any one embodiment may be combined with one or more features of one or more of the other embodiments, provided that such combination satisfies the intent of the invention.

[0179] While several exemplary aspects and embodiments of the catheter system have been discussed above, those skilled in the art will recognize certain modifications, permutations, additions, and subcombinations thereof. Accordingly, the following appended claims and the claims introduced below are intended to be construed to include all such modifications, permutations, additions, and subcombinations that are within the true spirit and scope thereof, and are not intended to be limited to the details of construction or design shown herein.

Claims

1. A catheter system for treating a treatment site within or adjacent to a vascular wall of a blood vessel, comprising: A catheter shaft; a balloon coupled to the catheter shaft, the balloon including a balloon first end, an opposing balloon second end, and a balloon wall configured to be positioned adjacent the treatment site; an energy source for generating energy; a plurality of energy guides, each configured to selectively receive the energy from the energy source, each of the plurality of energy guides disposed along the catheter shaft and at least partially within the balloon, each of the plurality of energy guides including a corresponding guide distal end, each of the guide distal ends positioned within the balloon at a different longitudinal position along a length of the balloon; a system controller that controls the energy source such that the energy from the energy source is sequentially directed to each of the plurality of energy guides, thereby generating a propagating wavefront that moves toward the treatment site in a direction from closer to the first balloon end toward the second balloon end; and A catheter system having:

2. The plurality of energy guides includes a first energy guide, a second energy guide, and a third energy guide, each disposed along the catheter shaft and at least partially within the balloon; (i) the first energy guide includes a first guide distal end positioned within the balloon at a first longitudinal position along the length of the balloon; (ii) the second energy guide includes a second guide distal end positioned within the balloon at a second longitudinal position along the length of the balloon, different from the first longitudinal position; (iii) the third energy guide includes a third guide distal end positioned within the balloon at a third longitudinal position along the length of the balloon, the third longitudinal position being different from the first longitudinal position and the second longitudinal position; the second longitudinal position is between the first longitudinal position and the third longitudinal position along the length of the balloon; 2. The catheter system of claim 1, wherein the system controller controls the energy source such that the energy from the energy source is sequentially directed to the first energy guide, then to the second energy guide, and then to the third energy guide, thereby generating the advancing wavefront that moves toward the treatment site in a direction from closer to the balloon first end toward the balloon second end.

3. The first end of the balloon is a proximal end of the balloon, and the second end of the balloon is a distal end of the balloon; 3. The catheter system of claim 2, wherein the system controller controls the energy source such that the energy from the energy source is directed sequentially to the first energy guide, then to the second energy guide, and then to the third energy guide, whereby the advancing wavefront moves toward the treatment site in a direction from closer to the balloon proximal end toward the balloon distal end.

4. The first end of the balloon is a distal end of the balloon, and the second end of the balloon is a proximal end of the balloon; 3. The catheter system of claim 2, wherein the system controller controls the energy source such that the energy from the energy source is directed sequentially to the first energy guide, then to the second energy guide, and then to the third energy guide, whereby the advancing wavefront moves toward the treatment site in a direction from closer to the balloon distal end toward the balloon proximal end.

5. The plurality of energy guides further includes a fourth energy guide disposed along the catheter shaft and at least partially within the balloon; the fourth energy guide includes a fourth guide distal end positioned within the balloon at a fourth longitudinal position along the length of the balloon, the fourth longitudinal position being different from the first longitudinal position, the second longitudinal position, and the third longitudinal position; 3. The catheter system of claim 2, wherein the third longitudinal position is between the second longitudinal position and the fourth longitudinal position along the length of the balloon.

6. The catheter system of claim 5, wherein the system controller controls the energy source so that the energy from the energy source is directed sequentially to the first energy guide, then to the second energy guide, then to the third energy guide, and then to the fourth energy guide, thereby generating the forward wavefront that moves toward the treatment site in a direction from the side closer to the balloon first end toward the balloon second end.

7. The plurality of energy guides further includes a fifth energy guide disposed along the catheter shaft and at least partially within the balloon; the fifth energy guide includes a fifth guide distal end positioned within the balloon at a fifth longitudinal position along the length of the balloon, the fifth longitudinal position being different from the first longitudinal position, the second longitudinal position, the third longitudinal position, and the fourth longitudinal position; 6. The catheter system of claim 5, wherein the fourth longitudinal position is between the third longitudinal position and the fifth longitudinal position along the length of the balloon.

8. The catheter system of claim 7, wherein the system controller controls the energy source so that the energy from the energy source is directed sequentially to the first energy guide, then to the second energy guide, then to the third energy guide, then to the fourth energy guide, and then to the fifth energy guide, thereby generating the forward wavefront that moves toward the treatment site in a direction from the side closer to the balloon first end toward the balloon second end.

9. The system controller controls the energy source such that the energy from the energy source is sequentially directed to the first energy guide, then to the second energy guide, and then to the third energy guide, thereby generating the advancing wavefront that moves toward the treatment site in a first direction from a side closer to the first end of the balloon toward the second end of the balloon; and 8. The catheter system of claim 7, wherein the system controller controls the energy source such that the energy from the energy source is sequentially directed to the fifth energy guide, then to the fourth energy guide, and then to the third energy guide, thereby generating a second forward moving wavefront that moves toward the treatment site in a second direction from a side closer to the balloon second end toward the balloon first end.

10. A catheter system as described in any one of claims 1 to 9, wherein the advancing wavefront is spherical and impacts the balloon wall at a predetermined angle, thereby generating a shear force in the balloon wall substantially adjacent the treatment site.

11. A catheter system described in any one of claims 1 to 10, wherein the system controller controls the firing rate of the energy source to each of the multiple energy guides.

12. The catheter system of claim 11, wherein the system controller controls the energy source so that the energy from the energy source is selectively directed to at least two of the plurality of energy guides at different firing rates.

13. A catheter system described in any one of claims 1 to 12, wherein the system controller controls the emission energy level of the energy from the energy source to each of the plurality of energy guides.

14. The catheter system of claim 13, wherein the system controller controls the energy source so that the energy from the energy source is selectively directed to at least two of the plurality of energy guides at different emission energy levels.

15. A catheter system as described in any one of claims 13 to 14, wherein the energy source generates pulses of energy that are selectively received by each of the plurality of energy guides, and the system controller controls the emission energy level of the energy from the energy source to each of the plurality of energy guides by varying the pulse width of the energy pulses.

16. A catheter system as described in any one of claims 13 to 15, wherein the energy source generates pulses of energy that are selectively received by each of the plurality of energy guides, and the system controller controls the emission energy level of the energy from the energy source to each of the plurality of energy guides by varying the amplitude of the energy pulses.

17. A catheter system described in any one of claims 1 to 16, wherein each of the multiple energy guides includes an optical fiber.

18. A catheter system described in any one of claims 1 to 17, wherein the energy source is a laser source that generates laser energy.

19. A catheter system described in any one of claims 1 to 17, wherein the energy source generates an electrical impulse.

20. A catheter system described in any one of claims 1 to 19, further comprising a power source configured to supply power to the energy source.

Images