Optical Connector Assembly for Intravascular Lithotripsy Device

Abstract

A catheter system 100 for placement within a blood vessel 108 having a blood vessel wall 108A for treating a treatment site 106 within or adjacent to the blood vessel wall 108A within a body 107 of a patient 109 includes a system console 123, one or more energy guides 122A, and an optional connector assembly 251. The system console 123 includes an energy source 124 and a console connection opening 148. The one or more energy guides 122A are configured to receive energy from the energy source 124. The optical connector assembly 251 includes a guide coupling housing 250 that holds at least a portion of each of the one or more energy guides 122A. The guide coupling housing 250 is configured to be mechanically connected to the system console 123, and at least a portion of the guide coupling housing 250 is configured to fit within and selectively retain within the console connection opening 148 such that one or more energy guides 122A can be adjustably and more precisely aligned within the guide coupling housing 250 and with respect to energy from the energy source 124 to receive energy from the energy source 124.

Description

[Technical field]

[0001] This application is related to and claims priority to U.S. Provisional Patent Application No. 63 / 326,844, entitled "OPTICAL CONNECTOR ASSEMBLY FOR INTRAVASCULAR LITHOTRIPSY DEVICE," filed April 2, 2022, and U.S. Patent Application No. 18 / 125,050, entitled "OPTICAL CONNECTOR ASSEMBLY FOR INTRAVASCULAR LITHOTRIPSY DEVICE," filed March 22, 2023. To the extent permitted, the contents of U.S. Provisional Patent Application No. 63 / 326,844 and U.S. Patent Application No. 18 / 125,050 are incorporated herein by reference in their entireties. [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 embolism, stroke, etc. Severe vascular lesions, such as severely calcified vascular lesions, can be difficult for physicians to treat and achieve patency in a clinical setting.

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

[0004] Intravascular lithotripsy is one method that has been used in recent years with some success to destroy vascular lesions within blood vessels in the body. Intravascular lithotripsy utilizes a combination of pressure waves and bubble dynamics that are generated intravascularly in a fluid-filled balloon catheter. Specifically, during an intravascular lithotripsy treatment, a high energy source is used to generate plasma, and ultimately pressure waves and rapid bubble expansion, within a fluid-filled balloon to destroy calcifications at a treatment site within the vasculature that contains one or more vascular lesions. The plasma initiation within the balloon and the associated rapid bubble formation from the resulting localized flow velocity transfers mechanical energy through the incompressible fluid, exerting a destructive force on intravascular calcium against the balloon wall. The rapid change in fluid momentum upon impact with the balloon wall is known as hydraulic shock, or water hammer.

[0005] There is a continuing desire to enhance vascular patency and optimization of therapy delivery parameters within intravascular lithotripsy catheter systems in a format that is relatively easy to control and can be consistently manufactured. Summary of the Invention

[0006] The present invention relates to a catheter system for placement within a blood vessel having a vessel wall. The catheter system can be used by a user to treat a treatment site within or adjacent to a vessel wall within a patient's body. In various embodiments, the catheter system includes a system console, one or more energy guides, and an optical connector assembly. The system console includes an energy source and a console connection opening. The one or more energy guides are configured to receive energy from the energy source. The optical connector assembly includes a guide coupling housing that holds at least a portion of each of the one or more energy guides. The guide coupling housing is configured to be mechanically connected to the system console, and at least a portion of the guide coupling housing is configured to fit and selectively hold within the console connection opening such that the one or more energy guides can be adjustably and more precisely aligned within the guide coupling housing and with respect to the energy from the energy source to receive energy from the energy source.

[0007] In certain embodiments, the optical connector assembly further includes a plurality of ferrules, each of the plurality of ferrules configured to hold a portion of one of the one or more energy guides.

[0008] In one embodiment, the optical connector assembly further includes a ferrule housing having a plurality of locating apertures, each configured to hold at least a portion of one of the plurality of spaced apart ferrules, each of the plurality of locating apertures being larger than a diameter of a ferrule held therein to allow the ferrule to move relative to the locating aperture.

[0009] In some embodiments, the optical connector assembly further includes a position compensator configured to provide a spring force to hold the ferrule in an aligned position relative to the console connection opening while still allowing the ferrule to move relative to the ferrule housing.

[0010] In one embodiment, the ferrule housing is adjustably positioned within the guide mating housing such that the ferrule housing is moveable relative to the guide mating housing.

[0011] In some embodiments, the optical connector assembly further includes a resilient plate configured to control movement of the ferrule housing within the guide mating housing.

[0012] In one embodiment, the guide mating housing includes a console-facing side and the plurality of ferrules are recessed from the console-facing side of the guide mating housing.

[0013] In certain embodiments, the guide mating housing defines a housing cavity within the guide mating housing, and each of the plurality of ferrules, the ferrule housing, the position compensator, and the elastomeric plate are retained within the housing cavity.

[0014] In one embodiment, the guide coupling housing is formed from a first housing member and a second housing member selectively connected to one another to form the guide coupling housing and to define a housing cavity within the guide coupling housing.

[0015] In some embodiments, the optical connector assembly further includes a sealing member that seals the connection between the guide mating housing and the console connection opening.

[0016] In one embodiment, the sealing member is in the form of a face gasket.

[0017] In one embodiment, the optical connector assembly further includes a contaminant inhibitor positionable around at least a portion of the guide coupling housing, the contaminant inhibitor configured to prevent dust and particles from contaminating respective faces of the one or more energy guides.

[0018] In one embodiment, the contaminant inhibitor is disposable.

[0019] In certain embodiments, the optical connector assembly further includes a locking mechanism configured to selectively lock the guide coupling housing in place when the guide coupling housing is retained within the console connection opening.

[0020] In one embodiment, the system console further includes an optical sensor and an actuator, the optical sensor configured to sense a position of the guide coupling housing relative to the console connection opening and further configured to activate the actuator that mechanically draws the guide coupling housing into a predetermined position within the console connection opening.

[0021] In certain embodiments, the optical connector assembly further includes a guide bundler configured to provide strain relief while bundling one or more energy guides to form an energy guide bundle.

[0022] In one embodiment, the guide bundler includes a shaft jacket within which all of the one or more energy guides are held as an energy guide bundle.

[0023] In one embodiment, the guide bundler further includes a locking crimp configured to tightly pack one or more energy guides to form an energy guide bundle.

[0024] In various embodiments, the catheter system further includes a balloon configured to be positioned substantially adjacent to the treatment site, the balloon including a balloon wall defining a balloon interior, the balloon configured to retain a catheter fluid within the balloon interior.

[0025] In some embodiments, the balloon is selectively inflatable with catheter fluid to expand to an inflated state, and when the balloon is in the inflated state, the balloon wall is configured to be positioned substantially adjacent to the treatment site.

[0026] In some embodiments, the one or more energy guides each include a guide distal end configured to be positioned within the balloon.

[0027] In certain embodiments, each of the one or more energy guides is configured to guide energy from an energy source, through the energy guide, and to an interior of the balloon.

[0028] In one embodiment, one or more energy guides that guide energy from an energy source to the interior of the balloon each generate plasma bubbles in the catheter fluid inside the balloon.

[0029] In some embodiments, energy from the plasma bubble is directed toward a portion of the balloon wall positioned substantially adjacent the treatment site.

[0030] In one embodiment, the one or more energy guides each generate one or more pressure waves in the catheter fluid that apply a force to the treatment site.

[0031] In many embodiments, at least one of the one or more energy guides includes an optical fiber.

[0032] In various embodiments, the energy source includes a laser.

[0033] In other embodiments, the energy source is a high voltage energy source that provides pulses of high voltage.

[0034] In some embodiments, at least one of the one or more energy guides includes an electrode pair including spaced apart electrodes extending into the balloon interior, and high voltage pulses from an energy source are applied to the electrodes to form an electric arc between the electrodes.

[0035] The present invention further relates to a method for treating a treatment site within or adjacent to a blood vessel in a patient's body, comprising the steps of providing a system console including an energy source and a console connection opening; receiving energy from the energy source by one or more energy guides; holding at least a portion of each of the one or more energy guides by a guide coupling housing of an optical connector assembly; and mechanically connecting the guide coupling housing to the system console, at least a portion of the guide coupling housing configured to fit and selectively be held within the console connection opening such that the one or more energy guides may be adjustably and more precisely aligned within the guide coupling housing and with respect to energy from the energy source for receiving energy from the energy source.

[0036] This Summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or comprehensive treatment of the present subject matter. Further details are found in the detailed description and the appended claims. Other aspects will become apparent to one skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part hereof, 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.

[0037] The novel features of the present invention, as well as the invention itself, both as to its structure and 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]

[0038] [Figure 1] FIG. 1 is a simplified schematic cross-sectional view of an embodiment of a catheter system according to various embodiments. [Diagram 2] FIG. 2 is a simplified perspective view of an embodiment of an optical connector assembly having features of the present invention that can be included as part of the catheter system of FIG. [Diagram 3] FIG. 3 is a simplified plan view of a portion of the optical connector assembly shown in FIG. [Figure 4] FIG. 3 is a simplified end view of the optical connector assembly shown in Figure 2. [Diagram 5] FIG. 3 is a simplified plan view of another portion of the optical connector assembly shown in FIG. 2. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] 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 invention covers modifications, equivalents, and alternatives falling within the spirit and scope of the present specification.

[0040] Treatment of vascular lesions can reduce major adverse events or death in affected subjects. As referred to herein, a major adverse event 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, and major adverse events in any of the internal organs.

[0041] As used herein, the terms "treatment site," "intravascular lesion," and "vascular lesion" may be used interchangeably unless otherwise noted. Thus, intravascular lesions and / or vascular lesions are sometimes referred to herein simply as "lesions."

[0042] Those skilled in the art will appreciate that the following detailed description of the present invention is illustrative only and is not intended to be limiting in any way. Other embodiments of the present invention will readily suggest themselves to those skilled in the art having the benefit of this disclosure. Reference will now be made in detail to the embodiments of the present invention that are illustrated in the accompanying drawings. The same or similar nomenclature and / or reference numerals are used throughout the drawings and the following detailed description to refer to the same or similar parts.

[0043] In the interest of clarity, not all of the routine features of the implementations described herein are shown and described. It will be recognized that in the development of any such actual implementation, numerous implementation-specific decisions must be made to achieve the developer's particular objectives, such as compliance with application-related and business-related constraints, and that these particular objectives will vary from implementation to implementation and from developer to developer. Moreover, it will be recognized that such a development effort may be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure.

[0044] The catheter system disclosed herein can include many different configurations. Referring now to FIG. 1, a simplified schematic cross-sectional view of a catheter system 100 according to various embodiments is shown. The catheter system 100 is adapted to apply pressure waves to induce fracturing in one or more vascular lesions in or adjacent to a vessel wall of a blood vessel or at or adjacent to a heart valve within a patient's body. 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 one or more energy guides 122A, a system console 123 including one or more of an energy source 124, a power source 125, a system controller 126, and a graphic user interface 127 ("GUI"), a handle assembly 128, and a fluid pump 138. Alternatively, the catheter system 100 can include more or fewer components than those specifically illustrated and described with respect to FIG. 1.

[0045] The catheter 102 is configured to navigate to a treatment site 106 within or adjacent to a vascular wall 108A of a blood vessel 108 in the body 107 of a patient 109. The treatment site 106 can include one or more vascular lesions 106A, such as, for example, a calcified vascular lesion. Additionally or alternatively, the treatment site 106 can include a vascular lesion 106A, such as a fibrous vascular lesion. Further alternatively, in some embodiments, the catheter 102 can be used at a treatment site 106 within or adjacent to a heart valve in the body 107 of the patient 109.

[0046] The catheter 102 may include an inflatable balloon 104 (sometimes referred to herein simply as a "balloon"), a catheter shaft 110, and a guidewire 112. The balloon 104 may be coupled to the catheter shaft 110. The balloon 104 may include a balloon proximal end 104P and a balloon distal end 104D. The catheter shaft 110 may extend from a proximal portion 114 of the catheter system 100 to a distal portion 116 of the catheter system 100. The catheter shaft 110 may include a longitudinal axis 144. The catheter 102 and / or the catheter shaft 110 may also include a guidewire lumen 118 configured to travel over the guidewire 112. As used herein, the guidewire lumen 118 defines a conduit through which the guidewire 112 extends. The catheter shaft 110 may further include an inflation lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, the catheter 102 can have a distal end opening 120 that can accommodate and follow the guidewire 112 as the catheter 102 is moved and positioned at or near the treatment site 106. In some embodiments, the balloon proximal end 104P can be coupled to the catheter shaft 110 and the balloon distal end 104D can be coupled to the guidewire lumen 118.

[0047] The balloon 104 includes a balloon wall 130 that defines a balloon interior 146. The balloon 104 can be selectively inflated with a catheter fluid 132 to expand from a contracted state suitable for advancing the catheter 102 through the patient's vasculature to an inflated state (shown in FIG. 1 ) suitable for fixing the catheter 102 in place relative to the treatment site 106. In other words, when the balloon 104 is in the inflated state, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. It should be appreciated that while FIG. 1 shows the balloon wall 130 of the balloon 104 spaced apart from the treatment site 106 of the blood vessel 108 when in the inflated state, this is done for ease of illustration. It should be appreciated that the balloon wall 130 of the balloon 104 will generally be substantially directly adjacent and / or adjacent to the treatment site 106 when the balloon 104 is in the inflated state.

[0048] Balloons 104 suitable for use in the catheter system 100 include those that, when in an inflated state, can be passed through the vascular system of a patient 109. In some embodiments, the balloon 104 is formed from silicone. In other embodiments, the balloon 104 can be formed from materials such as polydimethylsiloxane (PDMS), polyurethane, a polymer such as PEBAX™ material, nylon, or any other suitable material.

[0049] The balloon 104 can have any suitable diameter (when inflated). In various embodiments, the balloon 104 can have a diameter (when inflated) ranging from less than 1 millimeter (mm) up to 25 mm. In some embodiments, the balloon 104 can have a diameter (when inflated) ranging from at least 1.5 mm to a maximum of 14 mm. In some embodiments, the balloon 104 can have a diameter (when inflated) ranging from at least 2 mm to a maximum of 5 mm.

[0050] In some embodiments, the balloon 104 can have a length ranging from at least 3 mm to 300 mm. More specifically, in some embodiments, the balloon 104 can have a length ranging from at least 8 mm to 200 mm. It should be appreciated that a balloon 104 having a relatively longer length can be positioned adjacent a larger treatment site 106 and thus can be used to provide pressure waves to and induce fragmentation at a larger vascular lesion 106A or multiple vascular lesions 106A at precise locations within the treatment site 106. It should further be appreciated that a longer balloon 104 can also be positioned adjacent multiple treatment sites 106 at any one given time.

[0051] In some embodiments, the balloon 104 can include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or drug eluting stent can include one or more therapeutic agents, including anti-inflammatory agents, anti-tumor agents, angiogenesis inhibitors, and the like.

[0052] The catheter fluid 132 can be a fluid, such as a liquid or a gas. Some examples of catheter fluids 132 suitable for use can include, but are not limited to, one or more of water, saline, contrast agents, fluorocarbons, perfluorocarbons, gases such as carbon dioxide, or any other suitable catheter fluid 132.

[0053] The catheter shaft 110 of the catheter 102 can be coupled to one or more energy guides 122A of the energy guide bundle 122 in optical communication with an energy source 124. The energy guides 122A can be disposed along the catheter shaft 110 and within the balloon 104. 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 communication with the energy guides 122A at the proximal portion 114 of the catheter system 100.

[0054] In some embodiments, the catheter shaft 110 may be coupled to multiple energy guides 122A, such as a first energy guide, a second energy guide, a third energy guide, etc., that may be positioned at any suitable location around and / or relative to the guidewire lumen 118 and / or the catheter shaft 110. For example, in one non-exclusive embodiment, two energy guides 122A may be spaced about 180 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Three energy guides 122A may be spaced about 120 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Four energy guides 122A may be spaced about 90 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Six energy guides 122A may be spaced about 60 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110. Eight energy guides 122A may be spaced about 45 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110. Or, ten energy guides 122A may be spaced about 36 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110. Alternatively, multiple energy guides 122A need not be equally spaced apart from one another around the circumference of the guidewire lumen 118 and / or catheter shaft 110. More specifically, it should be further appreciated that the energy guides 122A may be evenly or unevenly spaced around the circumference of the guidewire lumen 118 and / or catheter shaft 110 to achieve a desired effect at a desired location.

[0055] The catheter system 100 and / or the energy guide bundle 122 can include any number of energy guides 122A in optical communication with the energy source 124 at the proximal portion 114 and with the catheter fluid 132 within the balloon interior 146 of the balloon 104 at the distal portion 116. For example, in some embodiments, the catheter system 100 and / or the energy guide bundle 122 can include from one energy guide 122A to more than thirty energy guides 122A. Alternatively, in other embodiments, the catheter system 100 and / or the energy guide bundle 122 can include more than thirty energy guides 122A.

[0056] The energy guide 122A can have any suitable design for generating plasma and / or pressure waves in the catheter fluid 132 within the balloon interior 146. Thus, the general description of the energy guide 122A as a light guide is not intended to be limiting in any manner, except as set forth in the claims appended hereto. More specifically, although the catheter system 100 is often described with respect to the energy source 124 as a light source and one or more energy guides 122A as light guides, the catheter system 100 can alternatively include any suitable energy source 124 and energy guides 122A for generating the desired plasma in the catheter fluid 132 within the balloon interior 146. For example, in one non-exclusive alternative embodiment, the energy source 124 can be configured to provide high voltage pulses, and each energy guide 122A can include an electrode pair including spaced apart electrodes extending into the balloon interior 146. In such an embodiment, pulses of high voltage are applied to the electrodes, forming an electric arc between the electrodes which in turn generates a plasma and creates pressure waves in the catheter fluid 132 which are utilized to provide a disruptive force to the vascular lesion 106A at the treatment site 106. Further alternatively, the energy source 124 and / or energy guide 122A can have another suitable design and / or configuration.

[0057] In some embodiments, the energy guide 122A may include an optical fiber or a flexible light pipe. The energy guide 122A may be thin and flexible and may transmit optical signals with very little loss of intensity. The energy guide 122A may include a core surrounded by a cladding around its circumference. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of 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 should be appreciated that the refractive index of the core is greater than the refractive index of the cladding.

[0058] Each energy guide 122A can guide energy along a length between a proximal guide end 122P and a distal guide end 122D positioned within the balloon interior 146.

[0059] The energy guide 122A can be in a number of configurations around and / or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the energy guide 122A can extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the energy guide 122A can be disposed along the length of the outer diameter of the catheter shaft 110. In still other embodiments, the energy guide 122A can be disposed within one or more energy guide lumens within the catheter shaft 110.

[0060] The energy guides 122A may also be positioned at any suitable location around the circumference of the guidewire lumen 118 and / or catheter shaft 110. The guide distal end 122D of each energy guide 122A may be positioned at any suitable longitudinal location relative to the length of the balloon 104 and / or relative to the length of the guidewire lumen 118 to more effectively and precisely deliver pressure waves to destroy the vascular lesion 106A at the treatment site 106.

[0061] In certain embodiments, the energy guide 122A can include one or more optoacoustic transducers 154, each of which can be in optical communication with the energy guide 122A in which the optoacoustic transducer 154 is disposed. In some embodiments, the optoacoustic transducers 154 can be in optical communication with the guide distal end 122D of the energy guide 122A. In such embodiments, the optoacoustic transducers 154 can have a shape that corresponds to and / or matches the guide distal end 122D of the energy guide 122A.

[0062] Photoacoustic transducer 154 is configured to convert light energy into acoustic waves at or near distal guide end 122D of energy guide 122A. The direction of the acoustic waves can be adjusted by changing the angle of distal guide end 122D of energy guide 122A.

[0063] In certain embodiments, the optoacoustic transducer 154 disposed at the guide distal end 122D of the energy guide 122A can have the same shape as the guide distal end 122D of the energy guide 122A. For example, in certain non-exclusive embodiments, the optoacoustic transducer 154 and / or the guide distal end 122D can have a conical, convex, concave, bulbous, square, stepped, semicircular, oval, etc. The energy guide 122A can further include additional optoacoustic transducers 154 disposed along one or more sides of the length of the energy guide 122A.

[0064] In some embodiments, the energy guide 122A can further include one or more deflecting features or “diverters” (not shown in FIG. 1 ), such as within and / or near the guide distal end 122D of the energy guide 122A, configured to direct energy from the energy guide 122A toward a side surface, which may be located at or near the guide distal end 122D of the energy guide 122A, before the energy is directed toward the balloon wall 130. The deflecting features can include any feature of a system that deflects energy from the energy guide 122A away from its axial path toward a side surface of the energy guide 122A. The energy guides 122A can each include one or more optical windows disposed along a longitudinal or circumferential surface of each energy guide 122A and in optical communication with the deflecting features. In other words, the deflecting feature can be configured to direct energy in the energy guide 122A towards a side at or near the guide distal end 122D, which is in optical communication with the optical window. The optical window can include a portion of the energy guide 122A that allows energy from within the energy guide 122A to exit the energy guide 122A, such as a portion of the energy guide 122A that lacks cladding material on or around the energy guide 122A.

[0065] Examples of deflecting features suitable for use include reflective elements, refractive elements, and fiber diffusers. Deflecting features suitable for focusing energy away from the tip of the energy guide 122A can include, but are not limited to, those having a convex surface, a gradient index (GRIN) lens, and a mirror image focusing lens. Upon contact with the deflecting feature, the energy is deflected within the energy guide 122A to one or more of the plasma generator 133 and an optoacoustic transducer 154 in optical communication with the side of the energy guide 122A. When used, the optoacoustic transducer 154 then converts the optical energy into acoustic waves that extend away from the side of the energy guide 122A.

[0066] As noted above, in the embodiment shown in FIG. 1, the system console 123 can include one or more of the energy source 124, the power source 125, the system controller 126, and the GUI 127. Alternatively, the system console 123 can include more or fewer components than those specifically shown in FIG. 1. For example, in one non-exclusive alternative embodiment, the system console 123 can be designed without the GUI 127. Further alternatively, one or more of the energy source 124, the power source 125, the system controller 126, and the GUI 127 can be provided in any suitable location within the catheter system 100, including outside of or away from the system console 123.

[0067] The system console 123 and components included therewith may be operatively coupled to the catheter 102, the energy guide bundle 122, and / or the remainder of the catheter system 100. For example, in some embodiments, as shown in FIG. 1, the system console 123 may include a console connection opening 148 (sometimes also referred to generically as a "socket" or "console receptacle") by which the energy guide bundle 122 is mechanically coupled to the system console 123. In such embodiments, the energy guide bundle 122 may include an optical connector assembly 151 having a guide coupling housing 150 (sometimes also referred to generically as a "connector housing") that houses a portion of each energy guide 122A, such as the guide proximal end 122P. At least a portion of the guide coupling housing 150 is configured to fit and selectively retain within the console connection opening 148 to provide a mechanical coupling between the energy guide bundle 122 and the system console 123.

[0068] As described in more detail herein, in various embodiments, the optical connector assembly 151 is configured to ensure proper alignment and coupling of the energy guide bundle 122 and / or each of the one or more energy guides 122A to the system console 123 such that energy from the energy source 124 is more precisely and accurately directed into the guide proximal end 122P of each of the one or more energy guides 122A before such energy is guided by the one or more energy guides 122A to the balloon interior 146. As described further herein below, the system console 123 may also be configured to include certain features or components, such as at least one optical sensor 167 usable in association with at least one actuator 169, that further enable precise alignment and coupling of the energy bundle 122 and / or each of the one or more energy guides 122A to the system console 123 and / or energy from the energy source 124 held therein.

[0069] The energy guide bundle 122 and / or the optical connector assembly 151 may also include a guide bundler 152 (or “shell”) that provides strain relief while bringing each of the individual energy guides 122A closer together so that the energy guides 122A and / or the energy guide bundle 122 can be in a more compact configuration when extended with the catheter 102 into the blood vessel 108 during use of the catheter system 100.

[0070] The energy source 124 can be selectively and / or alternatively coupled in optical communication with each energy guide 122A in the energy guide bundle 122, such as to the guide proximal end 122P of each energy guide 122A. In particular, the energy source 124 is configured to generate energy in the form of a source beam 124A, such as a pulsed source beam, that can be selectively and / or alternatively directed and received as individual guide beams 124B to each appropriately aligned energy guide 122A in the energy guide bundle 122. Alternatively, the catheter system 100 can include more than one energy source 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 can include a separate energy source 124 for each energy guide 122A in the energy guide bundle 122.

[0071] The energy source 124 may have any suitable design. In certain embodiments, the energy source 124 may be configured to provide a sub-millisecond pulse of energy from the energy source 124 that is focused to a small spot for coupling to the guide proximal end 122P of the energy guide 122A. Such pulse of energy is then directed and / or guided along the energy guide 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation in the catheter fluid 132 within the balloon interior 146 of the balloon 104, such as via a plasma generator 133 that may be located at or near the guide distal end 122D of the energy guide 122A. In particular, in such embodiments, the energy emitted at the guide distal end 122D of the energy guide 122A is directed towards and excites the plasma generator 133 to form plasma in the catheter fluid 132 within the balloon interior 146. The plasma formation results in rapid bubble formation and provides pressure waves to the treatment site 106. An exemplary plasma-induced bubble 134 is shown in FIG.

[0072] In various non-exclusive alternative embodiments, sub-millisecond pulses of energy from the energy source 124 can be delivered to the treatment site 106 at frequencies between about 1 Hertz (Hz) and 5000 Hz, between about 30 Hz and 1000 Hz, between about 10 Hz and 100 Hz, or between about 1 Hz and 30 Hz. Alternatively, sub-millisecond pulses of energy can be delivered to the treatment site 106 at frequencies that may be greater than 5000 Hz or less than 1 Hz, or any other suitable range of frequencies.

[0073] While energy source 124 is typically utilized to provide pulses of energy, it should be appreciated that energy source 124 may further be described as providing a single source beam 124A, i.e., a single pulsed source beam.

[0074] Suitable energy sources 124 for use may include various types of light sources, including lasers and lamps, or alternatively, may include any suitable type of energy source.

[0075] Suitable lasers include short pulse lasers in the sub-millisecond time scale. In some embodiments, the energy source 124 can include a laser in the nanosecond (ns) time scale. The laser can also include short pulse lasers in the picosecond (ps), femtosecond (fs), and microsecond (μs) time scales. It should be appreciated that there are many combinations of laser wavelengths, pulse widths, and energy levels that can be used to achieve a plasma in the catheter fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse widths can include those in the ranges including at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range can be used.

[0076] Exemplary nanosecond lasers can include those in the UV to IR spectrum spanning 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 can include those capable of generating light at wavelengths of at least 750 nm to 2000 nm. In other embodiments, the energy source 124 can include those capable of generating light at wavelengths of at least 700 nm to 3000 nm. In yet other embodiments, the energy source 124 can include those capable of generating light at wavelengths of at least 100 nm to 10 micrometers (μm). Nanosecond lasers can include those having a repetition rate of up to 200 kHz.

[0077] In some embodiments, the laser can include a Q-switched Thulium:Yttrium-Aluminum-Garnet (Tm:YAG) laser, in other embodiments, the laser can include a Neodymium:Yttrium-Aluminum-Garnet (Nd:YAG) laser, a Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser, an Erbium:Yttrium-Aluminum-Garnet (Er:YAG) laser, an excimer laser, a Helium-Neon laser, a Carbon Dioxide laser, and a doped, pulsed, fiber laser.

[0078] In some embodiments, the energy source 124 can include multiple lasers grouped in series. In yet other embodiments, the energy source 124 can include one or more low energy lasers fed into a high energy amplifier, such as a Master Oscillator Power Amplifier (MOPA). In yet other embodiments, the energy source 124 can include multiple lasers that can be combined in parallel or series to provide the energy needed to generate plasma bubbles 134 in the catheter fluid 132.

[0079] The catheter system 100 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 various non-exclusive alternative embodiments, the catheter system 100 can generate pressure waves having a maximum pressure in the range of at least about 2 MPa to 50 MPa, at least about 2 MPa to 30 MPa, or at least about 15 MPa to 25 MPa.

[0080] The pressure waves can be provided to the treatment site 106 from a distance ranging from at least about 0.1 millimeters (mm) to greater than about 25 mm, extending radially from the energy guide 122A when the catheter 102 is positioned at the treatment site 106. In various non-exclusive alternative embodiments, the pressure waves can be provided to the treatment site 106 from a distance ranging from at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm, extending radially from the energy guide 122A when the catheter 102 is positioned at the treatment site 106. In other embodiments, the pressure waves can be provided to the treatment site 106 from another suitable distance different from the aforementioned ranges. In some embodiments, the pressure waves can be provided to the treatment site 106 in a range of at least about 2 MPa to 30 MPa at a distance of at least about 0.1 mm to 10 mm. In some embodiments, pressure waves can be provided to the treatment site 106 from a range of at least about 2 MPa to 25 MPa over a distance of at least about 0.1 mm to 10 mm. Further alternatively, other suitable pressure ranges and distances can be used.

[0081] The power supply 125 is electrically coupled to and configured to provide the necessary power to each of the energy source 124, the system controller 126, the GUI 127, and the handle assembly 128. The power supply 125 may have any suitable design for such purposes.

[0082] The system controller 126 is electrically coupled to the power source 125 and receives power from the power source 125. The system controller 126 is coupled to each of the energy source 124 and the GUI 127 and is configured to control their operation. The system controller 126 may include one or more processors or circuits for controlling the operation of at least the energy source 124 and the GUI 127. For example, the system controller 126 may control the energy source 124 to generate pulses of energy as needed and / or at any desired firing rate.

[0083] The system controller 126 may also be configured to control the operation of other components of the catheter system 100, such as positioning the catheter 102 adjacent the treatment site 106, inflation of the balloon 104 with catheter fluid 132, etc. Additionally or alternatively, the catheter system 100 may include one or more additional controllers, which may be positioned in any suitable manner to control various operations of the catheter system 100. For example, in certain embodiments, the additional controllers and / or portions of the system controller 126 may be positioned within and / or incorporated within the handle assembly 128.

[0084] The GUI 127 is accessible by a user or operator of the catheter system 100. The GUI 127 is electrically connected to the system controller 126. With such a design, the GUI 127 can be used by the user or operator to ensure that the catheter system 100 is effectively utilized to apply pressure to and induce fractures into the vascular lesion 106A at the treatment site 106. The GUI 127 can provide the user or operator with information that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 can provide the user or operator with static visual data and / or information. Additionally or in the alternative, the GUI 127 can provide the user or operator with dynamic visual data and / or information, such as video data or any other data that changes over time during use of the catheter system 100. In various embodiments, the GUI 127 can include one or more colors, different sizes, varying brightness, etc., that can act as an alert to the user or operator. Additionally or in the alternative, the GUI 127 may provide audio data or information to the user or operator. 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 requirements of the user or operator.

[0085] 1, the handle assembly 128 can be positioned at or near the proximal portion 114 of the catheter system 100. In this embodiment, the handle assembly 128 is coupled to the balloon 104 and positioned spaced apart from the balloon 104. Alternatively, the handle assembly 128 can be positioned in another suitable location.

[0086] The handle assembly 128 is attached to the catheter shaft 110 and is handled and used by a user or operator to manipulate, position and control the catheter 102. The design and specific features of the handle assembly 128 can be varied to suit the design requirements of the catheter system 100. In the embodiment shown in FIG. 1, the handle assembly 128 is separate from, but in electrical and / or fluid communication with, one or more of the system controller 126, the energy source 124, the fluid pump 138, and the GUI 127.

[0087] In some embodiments, the handle assembly 128 can integrate and / or include at least a portion of the system controller 126 within the handle assembly 128. For example, as shown, in one such embodiment, the handle assembly 128 can include circuitry 156 that is electrically coupled between the catheter electronics and the system console 123 and can form at least a portion of the system controller 126. In one embodiment, the circuitry 156 can include a printed circuit board having one or more integrated circuits or any other suitable circuitry. In alternative embodiments, the circuitry 156 can be omitted or can be included within the system controller 126, which in various embodiments can be positioned outside of the handle assembly 128, such as within the system console 123. It is understood that the handle assembly 128 can include fewer or additional components than those specifically shown and described herein.

[0088] The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with catheter fluid 132 as needed.

[0089] As with all embodiments shown and described herein, for purposes of clarity and ease of understanding, various features may be omitted from the drawings. Additionally, the drawings may include features that can be omitted without departing from the spirit and scope of the invention.

[0090] FIG. 2 is a simplified perspective view of an embodiment of an optical connector assembly 251 having features of the present invention that may be included as part of the catheter system 100 of FIG.

[0091] The design of the optical connector assembly 251 can be varied. As shown, FIG. 2 illustrates various external components and features that may be included in various embodiments of the optical connector assembly 251. In particular, as shown, the optical connector assembly 251 can include one or more of a guide mating (or connector) housing 250, a guide bundler 252, a sealing member 260, a contaminant inhibitor 262, and a locking mechanism 264. Alternatively, the optical connector assembly 251 can include more or fewer external components than those specifically mentioned.

[0092] The purpose of the optical connector assembly 251 is to provide a means for connecting a ferrule 366 (e.g., as shown in FIG. 3) disposed therein, and thus an energy guide 122A positioned at least partially within the ferrule 366, into a console connection opening 148 (or "console receptacle" as shown in FIG. 1). Thus, by way of the optical connector assembly 251, and the ferrule 366 and energy guide 122A at least partially held therein and precisely connected and aligned within the console connection opening 148 of the system console 123 (shown in FIG. 1), energy from the energy source 124 (shown in FIG. 1) can be effectively and selectively coupled to each of the one or more energy guides 122A.

[0093] In various embodiments, the optical connector assembly 251 and / or the system console 123 (shown in FIG. 1) can include certain features or components to better ensure a more precisely aligned connection therebetween. For example, in some embodiments, the optical connector assembly 251 may include (i) a ferrule 366 that is permitted to float relative to and / or within the ferrule housing 370 (shown in FIG. 3 ) by a ferrule housing 370 having a positioning opening 476 (shown in FIG. 4 ) in which at least a portion of the ferrule 366 is retained, the positioning opening 476 being slightly larger than the diameter of the ferrule 366; (ii) the ferrule housing 370 that is permitted to float relative to the guide mating housing 250 by selectively moving the ferrule housing 370 (up and down and / or left and right) relative to the guide mating housing 250 as needed; (iii) a position compensator 374 (shown in FIG. 3 ) configured to provide a spring force to hold the ferrule 366 in an aligned position while still allowing play within the ferrule housing 370; and (iv) a resilient plate 372 configured to control the float of the ferrule housing 370 within the guide mating housing 250. In one embodiment, the system console 123 may include one or more optical sensors 167 (shown in FIG. 1 ) configured to sense the position of the optical connector assembly 251 and / or the guide coupling housing 250 relative to the system console 123 and / or the console connection opening 148, and to activate an actuator 169 (shown in FIG. 1 ) that mechanically draws the optical connector assembly 251 more precisely into a predetermined position within the console connection opening 148.

[0094] During use of the catheter system 100, it is also desirable to limit the amount of dust, fluid and / or other particles that may otherwise contaminate the guide surface at the proximal guide end 122P (shown in FIG. 1) of each of the one or more energy guides 122A.

[0095] The guide coupling housing 250 is configured to receive a portion of each energy guide 122A, such as the guide proximal end 122P, and to fit and selectively retain within the console connection opening 148 to provide a mechanical coupling between the energy guide bundle 122 (shown in FIG. 1 ) and the system console 123. The design of the guide coupling housing 250 can be varied to suit the requirements of the catheter system 100 and / or the optical connector assembly 251. In one embodiment, the guide coupling housing 250 can be formed from multiple housing members, such as a first housing member 250A and a second housing member 250B, that can be selectively coupled to operatively retain various internal components of the optical connector assembly 251 within a housing cavity 368 (shown in FIG. 3 ) defined therein. In one embodiment, first housing member 250A and second housing member 250B can each form one half (such as an upper half and a corresponding lower half in one non-exclusive embodiment) of guide mating housing 250, with each half being substantially identical to the other half. It should be appreciated that housing members 250A, 250B can be selectively mated in any suitable manner. Alternatively, guide mating housing 250 can have another suitable design.

[0096] It should be appreciated that the guide mating housing 250 and / or the individual housing members 250A, 250B may be formed from any suitable material that provides an effective housing for protecting the various components retained therein. Various internal components of the optical connector assembly 251 are shown and described herein below in connection with FIG.

[0097] The guide bundler 252 is configured to provide strain relief when approximating each of the individual energy guides 122A such that the energy guides 122A and / or the energy guide bundle 122 may be more compact when extended with the catheter 102 (shown in FIG. 1) into the blood vessel 108 (shown in FIG. 1) during use of the catheter system 100. Certain internal components that may be included within the guide bundler 252 to provide strain relief when approximating the energy guides 122A within the energy guide bundle 122 are shown and described herein below in connection with FIG.

[0098] The sealing member 260 is configured to seal the connection between the optical connector assembly 251 and the system console 123 when the guide coupling housing 250 is inserted and selectively retained within the console connection opening 148. With such a design, the sealing member 260, which in one non-exclusive embodiment may be provided in the form of a face gasket, may help to limit the amount of dust and other particles that may otherwise be introduced into the guide coupling housing 250 and / or the guide coupler 252. In some embodiments, the sealing member 260 may be formed from a resilient material that may effectively provide a sealed connection between the guide coupling housing 250 and the console connection opening 148. Alternatively, the sealing member 260 may be formed from another suitable material.

[0099] The contaminant inhibitor 262 is configured to limit the amount of dust, fluid, and / or other particles (sometimes also referred to herein individually or collectively as "contaminants") that may act as an impediment or otherwise contaminate the guide surface of each of the one or more energy guides 122A. More specifically, as shown, the contaminant inhibitor 262 may be configured to be positioned about a portion of the guide coupling housing 250 within which the ferrule 366, and thus the guide proximal end 122P of each energy guide 122A, is retained. The contaminant inhibitor 262 may have any suitable design configured to block the introduction of dust and other particles into the guide coupling housing 250 while still allowing energy from the energy source 124 to be coupled into the guide proximal end 122P of each of the one or more energy guides 122A.

[0100] In certain embodiments, the contaminant inhibitor 262 can be disposable such that when the contaminant inhibitor 262 becomes sufficiently contaminated with a contaminant, the contaminant inhibitor 262 can simply be discarded. In other embodiments, the contaminant inhibitor 262 can be reusable such that it can be selectively removed from the guide coupling housing 250, cleaned, and then selectively recoupled to the guide coupling housing 250 for additional uses.

[0101] The locking mechanism 264 is configured to selectively lock the optical connector assembly 251 in place when coupled to the console connection opening 148. More specifically, during use of the catheter system 100, when the optical connector assembly 251 is inserted into the console connection opening 148 of the system console 123, the optical sensor 167 registers the same and activates the actuator 169 which mechanically draws the optical connector assembly 251 into a predetermined position and locks it in place. The locking mechanism 264 provides an effective means for thus locking the optical connector assembly 251 in such a position that the optical connector assembly 251 is inserted into the console connection opening 148 such that the optical connector assembly 251 can be selectively retained in the console connection opening 148.

[0102] FIG. 3 is a simplified plan view of a portion of the optical connector assembly 251 (shown in FIG. 2). More specifically, FIG. 3 illustrates various internal components and features that may be included in various embodiments of the optical connector assembly 251. As shown in FIG. 3, in various embodiments, the optical connector assembly 251 may include one or more of a plurality of ferrules 366, a ferrule housing 370, one or more energy guides 322A, a resilient plate 372, at least one position compensator 374 (such as a silicone gasket in one non-exclusive embodiment), and at least a portion of the guide bundler 252 therein within the guide coupling housing 250. It should be appreciated that only one of the housing members 250A, 250B of the guide coupling housing 250 is visible in FIG. 3 so that the other mentioned components positioned within the housing cavity 368 defined within the guide coupling housing 250 can be clearly seen.

[0103] As used herein, a "ferrule" is a component in fiber optics used to protect and align the stripped end of energy guide 322A (or optical fiber). During use, energy guide 322A is inserted into the thin structure of ferrule 366 and may be provided with an adhesive (not shown) to prevent contamination and provide long-term mechanical strength. Ferrule 366 may be formed from any suitable material to provide the desired contamination protection and enhanced long-term mechanical strength for stripped proximal guide end 322P of energy guide 322A.

[0104] The optical connector assembly 251 can include any suitable number of ferrules 366 within the housing cavity 368 as defined by the guide coupling housing 250, depending on the number of energy guides 322A to be optically coupled to the energy source 124 (shown in FIG. 1). For example, in one non-exclusive embodiment, the optical connector assembly 251 can include ten ferrules 366, each configured to hold and protect a portion of one of the one or more energy guides 322A, such as the guide proximal end 322P, as shown in FIG. Alternatively, the optical connector assembly 251 can include more or less than ten ferrules 366.

[0105] The ferrule housing 370 is configured to provide a housing for the ferrules 366 such that the ferrules 366 can be collectively moved and positioned relative to the energy from the energy source 124 while maintaining the ferrules 366 spaced apart from one another at a desired distance, and such that the guide proximal ends 322P of the respective energy guides 322A can be properly aligned to properly receive the energy from the energy source 124. A face of the ferrules 366 is exposed on the side of the guide coupling housing 250 that faces the console connection opening 148 (shown in FIG. 1) of the system console 123 (shown in FIG. 1), i.e., the left side in FIG. 3. In one embodiment, the ferrules 366 are allowed to float significantly in the ferrule housing 370 to more precisely align the ferrules 366, and thus the guide proximal ends 322P of the energy guides 322A, with the console connection opening 148 of the system console 123.

[0106] FIG. 4 is a simplified end view of the optical connector assembly 251 shown in FIG. 2. More specifically, FIG. 4 illustrates face 466F of each ferrule 366 when the ferrules 366 are held in a desired generally spaced apart position within the ferrule housing 370. In some embodiments, as shown, the ferrules 366 are positioned within locating openings 476 formed within the ferrule housing 370. As shown, the locating openings 476 can be sized to have a tolerance that allows for a loose fit of the ferrules 366 within the locating openings 476. In other words, in some embodiments, the locating openings 476 are slightly larger than the diameter of the ferrules 366 to allow the ferrules 366 to move relative to the ferrule housing 370. With such a design, as discussed above, the ferrule 366 is allowed a large amount of float in the ferrule housing 370 to allow the ferrule 366, and thus the guide proximal end 322P (shown in FIG. 3) of the energy guide 322A (shown in FIG. 3), to be more precisely aligned with the console connection opening 148 (shown in FIG. 1) of the system console 123 (shown in FIG. 1).

[0107] When the optical connector assembly 251 is advanced into the console connection opening 148, the ferrule 366 finds a home in the console connection opening 148 due to a chamfered lead-in at the console connection opening 148. This allows for close tolerances in the console connection opening 148 for driving mating and close tolerances on the outer diameter of the ferrule.

[0108] In various embodiments, the ferrule housing 370 may also be selectively adjustable to a predetermined position within the guide coupling housing 250 to better facilitate a desired alignment between the energy guides 322A and the energy from the energy source 124 (not shown in FIG. 1). In other words, in addition to a loose fit between the ferrules 366 and the positioning openings 476 in the ferrule housing 370, the ferrule housing 370 is also allowed to float (up and down and / or side to side) within the assembled guide coupling housing 250. Such a design further enhances the ability to accurately and precisely position the guide proximal end 322P of each energy guide 322A relative to the energy from the energy source 124.

[0109] 3, a resilient plate 372, such as a spring plate in one embodiment, is configured to control the floating of the ferrule housing 370 within the guide mating housing 250. More specifically, since the ferrule housing 370 is permitted to float within the guide mating housing 250, it is desirable that the ferrule housing 370 not float loosely without the control of the guide mating housing 250. The resilient plate 372 provides a biasing force that allows the ferrule housing 370 to float within the guide mating housing 250 while allowing the ferrule housing 370 to be resiliently maintained in place within the guide mating housing 250 once the desired positioning has been precisely determined.

[0110] At least one position compensator 374, such as a silicone gasket in one non-exclusive embodiment, is configured to provide a spring force to hold the ferrule 366 in an aligned position while still allowing play within the ferrule housing 370. However, if the ferrule housing 370 needs to be adjusted to accommodate mating with the ferrule 366 for energy from the console connection opening 148 and / or the energy source 124, the ferrule housing 370 can be moved to accommodate such adjusted position. Without the at least one position compensator 374, the ferrule 366 may become stuck in the console connection opening 148 due to mating interference.

[0111] The optical connector assembly 251 can include any suitable number of position compensators 374. In one non-exclusive embodiment, the optical connector assembly 251 can include four position compensators 374. Alternatively, in other embodiments, the optical connector assembly 251 can include more than four or less than four position compensators 374.

[0112] As described above, the guide bundler 252 is configured to provide strain relief when bringing each of the individual energy guides 322A closer together so that the energy guides 322A and / or the energy guide bundle 322 can be in a more compact state when extended with the catheter 102 (shown in FIG. 1 ) into the blood vessel 108 (shown in FIG. 1 ) during use of the catheter system 100 (shown in FIG. 1 ). The design of the guide bundler 252 can vary. For example, as shown in FIG. 3 , in one embodiment, the guide bundler 252 can include a shaft jacket 378 within which all of the energy guides 322A are maintained as the energy guide bundle 322 extends with the catheter 102 toward the balloon 104 (shown in FIG. 1 ). The guide bundler 252 can further include a locking crimp 380 configured to tightly bundle the energy guides in a controlled manner to form the energy guide bundle 322.

[0113] As shown, FIG. 3 also illustrates the routing of the energy guides 322A as they extend through the guide coupling housing 250 of the optical connector assembly 251. More specifically, the guide proximal end 322P of each energy guide 322A is positioned in one of the ferrules 366 near the side of the guide coupling housing 250 that faces the console connection opening 148 (shown in FIG. 1) of the system console 123, and the energy guides 322A are positioned at a desired spacing relative to one another. The energy guides 322A then extend through the guide coupling housing 250 until they are brought closer together or bundled in the guide bundler 252. The energy guide bundle 322, with the energy guides 322A positioned within the shaft jacket 378, then extends with the catheter 102 toward the balloon 104.

[0114] Figure 5 is a simplified plan view of another portion of the optical connector assembly 251 shown in Figure 2. As shown in Figure 5, in some embodiments, the ferrule 366 is positioned in a format within the guide coupling housing 250 such that the ferrule 366 is recessed against the console-facing side 582 of the guide coupling housing 250. Because the ferrule 366 is recessed from the console-facing side 582 of the guide coupling housing 250, the optical connector assembly 251 is configured to help ensure that fingers or other objects do not contact a surface of the energy guide 322A (shown in Figure 3) at the guide proximal end 322P (shown in Figure 3) of the energy guide 322A, which could otherwise lead to undesirable contamination.

[0115] The ferrule 366 can be recessed to any desired distance from the console-facing side 582 of the guide coupling housing 250 depending on the particular design requirements of the optical connector assembly 251 and / or the catheter system 100 (shown in FIG. 1).

[0116] The technology also relates to methods for treating a treatment site within or adjacent to a blood vessel wall, such methods utilizing the devices disclosed herein. In various embodiments, the catheter systems and associated methods disclosed herein can include a catheter configured to be advanced to a vascular lesion, such as a calcified vascular lesion or a fibrous vascular lesion, at a treatment site located within or adjacent to a blood vessel within a patient's body. The catheter can include a catheter shaft and an inflatable balloon coupled and / or secured to the catheter shaft. The balloon can include a balloon wall defining a balloon interior. The balloon can be configured to receive catheter fluid within the balloon interior for expansion from a contracted state suitable for advancing the catheter through the patient's vasculature to an inflated state suitable for fixing the catheter in place relative to the treatment site.

[0117] 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.

[0118] Additionally, as used herein and in the appended claims, the term "configured to" refers to a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The term "configured to" may be used interchangeably with other similar terms, such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, etc.

[0119] It should be appreciated that the drawings shown and described are not necessarily drawn to scale, but are provided for ease of reference and understanding and for the relative positioning of structures.

[0120] The headings used herein are provided for consistency with the suggestions of 37 CFR Rule 1.77 or to otherwise provide organizational cues. These headings are not to be viewed as limiting or characterizing the invention(s) set forth in any claim that may arise from this disclosure. By way of illustration, 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 considered as a feature of the invention(s) set forth in the issued claims.

[0121] The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art can appreciate and understand the principles and practices. Thus, aspects have been described in conjunction with various specific preferred embodiments and techniques. However, it should be understood that many changes and modifications can be made while remaining within the spirit and scope of the present disclosure.

[0122] Although many different embodiments of the catheter system are illustrated and described herein, it should 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, if such combinations meet the intent of the invention.

[0123] While a number of exemplary aspects and embodiments of the catheter system have been described above, those skilled in the art will recognize certain modifications, variations, additions and subcombinations thereof, and it is therefore intended that the following appended claims and any claims thereafter be construed to include all such modifications, variations, additions and subcombinations as are within the true spirit and scope of the invention, and are not intended to be limitations to the details of construction or design shown herein.

Claims

1. 1. A catheter system for use by a user in treating a treatment site within or adjacent to a blood vessel within a patient's body, comprising: a system console including an energy source and a console connection opening, the energy source generating energy; one or more energy guides configured to receive energy from the energy source; an optical connector assembly including a guide coupling housing that holds at least a portion of each of the one or more energy guides, the guide coupling housing configured to be mechanically connected to the system console, and at least a portion of the guide coupling housing configured to fit within and selectively retain within the console connection opening such that the one or more energy guides can be adjustably aligned within the guide coupling housing to better receive the energy from the energy source.

2. 10. The catheter system of claim 1, wherein the optical connector assembly further includes a plurality of ferrules, each ferrule configured to hold a portion of one of the one or more energy guides.

3. 3. The catheter system of claim 2, wherein the optical connector assembly further includes a ferrule housing having a plurality of positioning openings, each of the positioning openings configured to hold at least a portion of one of the plurality of ferrules, and each of the plurality of positioning openings having a diameter larger than a diameter of the ferrule held in the positioning opening such that the ferrule is movable within the positioning opening.

4. 4. The catheter system of claim 3, wherein the optical connector assembly further includes a position compensator configured to provide a spring force to maintain the ferrule in an aligned position relative to the console connection opening while allowing the ferrule to move relative to the ferrule housing.

5. The catheter system of claim 3 , wherein the ferrule housing is adjustably positioned within the guide coupling housing such that the ferrule housing is movable within the guide coupling housing.

6. The catheter system of claim 3 , wherein the optical connector assembly further includes a resilient plate configured to control movement of the ferrule housing within the guide coupling housing.

7. The catheter system of claim 1 , wherein the optical connector assembly further includes a sealing member that seals the connection between the guide coupling housing and the console connection opening.

8. 10. The catheter system of claim 1, wherein the optical connector assembly further includes a contaminant inhibitor positionable about at least a portion of the guide coupling housing, the contaminant inhibitor configured to prevent contaminants from contaminating at least one surface of the energy guide.

9. 2. The catheter system of claim 1, wherein the optical connector assembly further includes a locking mechanism configured to lock the guide coupling housing in place when the guide coupling housing is retained within the console connection opening.

10. 2. The catheter system of claim 1, wherein the system console further includes an optical sensor and an actuator, the optical sensor configured to (i) sense the position of the guide coupling housing relative to the console connection opening, and (ii) activate the actuator that mechanically retracts the guide coupling housing into a predetermined position within the console connection opening.

11. 11. The catheter system of claim 1, further comprising a balloon configured to be positioned substantially adjacent the treatment site, the balloon including a balloon wall defining a balloon interior and configured to retain a catheter fluid within the balloon interior.

12. The catheter system of any one of claims 1 to 10, wherein at least one of the one or more energy guides comprises an optical fiber.

13. The catheter system of any one of claims 1 to 10, wherein the energy source includes a laser.

14. The catheter system according to any one of claims 1 to 10, wherein the energy source is a high-voltage energy source that provides high-voltage pulses.

15. A method of assembling a catheter system, comprising: providing a system console including an energy source and a console connection opening; retaining, by a guide coupling housing of the optical connector assembly, at least a portion of each of one or more energy guides configured to receive energy from the energy source; mechanically connecting the guide coupling housing to the system console, at least a portion of the guide coupling housing configured to fit within and selectively retain within the console connection opening such that the one or more energy guides may be adjustably and more precisely aligned within the guide coupling housing and with respect to the energy from the energy source for receiving the energy from the energy source; A method of assembling a catheter system, comprising:

Images