Multiplexer optical coupling connector

Abstract

A catheter system 100 for treating a treatment site 106 within or adjacent to a blood vessel wall 108A or a heart valve includes a light source 124, a first light guide 122A, a second light guide 122A, and a guide bundle 152. The light source 124 generates light energy. The first light guide 122A receives light energy from the light source 124 and has a guide proximal end 122P. The second light guide 122A receives light energy from the light source 124 and has a guide proximal end 122P. The guide bundle 152 is in optical communication with the light source 124. The guide bundle 152 bundles the first light guide 122A and the second light guide 122A. The guide bundle 152 includes a first ferrule 778 that engages the guide proximal end 122P of the first light guide 122A and a second ferrule 778 that engages the guide proximal end 122P of the second light guide 122A. At least one of the ferrules 778 may be formed at least in part from a ceramic material or a metallic material.

Description

[Technical field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 236,633, entitled "CONNECTOR FOR MULTIPLEXER OPTICAL COUPLING," filed August 24, 2021, and U.S. Patent Application No. 17 / 882,586, entitled "CONNECTOR FOR MULTIPLEXER OPTICAL COUPLING," filed August 7, 2022. To the extent permitted, the contents of U.S. Provisional Patent Application No. 63 / 236,633 and U.S. Patent Application No. 17 / 882,586 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 thrombosis, stroke, etc. Severe vascular lesions can be difficult for physicians to treat and achieve patency in a clinical setting.

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

[0004] The present invention is directed to a catheter system for treating a treatment site within a blood vessel wall or a heart valve or adjacent to a blood vessel wall or a heart valve. In various embodiments, the catheter system includes a light source, a first light guide, a second light guide, and a guide bundle. The light source generates light energy. The first light guide receives light energy from the light source. The first light guide has a guide proximal end. The second light guide receives light energy from the light source. The second light guide has a guide proximal end. The guide bundle is in optical communication with the light source. The guide bundle bundles the first light guide and the second light guide. The guide bundle includes a first ferrule that engages the guide proximal end of the first light guide and a second ferrule that engages the guide proximal end of the second light guide.

[0005] In some embodiments, the guide bundle further includes (i) a first ferrule assembly including the first ferrule, and (ii) a second ferrule assembly including the second ferrule.

[0006] In certain embodiments, at least one of the first ferrule and the second ferrule is formed at least in part from a ceramic material.

[0007] In various embodiments, at least one of the first ferrule and the second ferrule is at least partially formed from a metallic material.

[0008] In some embodiments, the first ferrule assembly further includes a first spring that engages the first ferrule and the second ferrule assembly further includes a second spring that engages the second ferrule.

[0009] In certain embodiments, the catheter system further includes a receptacle assembly that receives the first ferrule and the second ferrule.

[0010] In various embodiments, the receptacle assembly is formed at least in part from a ceramic material.

[0011] In some embodiments, the receptacle assembly is formed at least partially from a metallic material.

[0012] In certain embodiments, the receptacle assembly includes at least one alignment guide configured to guide alignment of the receptacle assembly with the guide bundle.

[0013] In various embodiments, the alignment guide is a guide pin.

[0014] In some embodiments, the alignment guide is a guide tang of a tongue-and-groove system.

[0015] In certain embodiments, the alignment guide is a guide rail.

[0016] In various embodiments, the receptacle assembly includes a receptacle block coupled to a backing plate, the backing plate configured to engage the first ferrule and the second ferrule.

[0017] In some embodiments, each of the ferrules includes a proximal end face, and the backing plate is configured to engage each of the proximal end faces.

[0018] In certain embodiments, the backing plate includes (i) a first alignment hole configured to align the first guide beam with the first light guide and (ii) a second alignment hole configured to align the second guide beam with the second light guide.

[0019] In various embodiments, the receptacle assembly includes (i) a first receptacle bore configured to receive the first ferrule and (ii) a second receptacle bore configured to receive the second ferrule.

[0020] In some embodiments, the first receptacle hole and the second receptacle hole are each formed in a receptacle block, and the first receptacle hole and the second receptacle hole are aligned on the same linear axis as one another.

[0021] In a particular embodiment, the first receptacle hole and the second receptacle hole are each formed in the receptacle block as a V-groove.

[0022] In various embodiments, the receptacle assembly includes a retention assembly that retains (i) a first ferrule in the first receptacle bore and (ii) a second ferrule in the second receptacle bore.

[0023] In some embodiments, the retention assembly includes a clamp bar having a ball spring plunger configured to (i) contact at least a portion of the first ferrule such that the first ferrule is retained within the first receptacle bore and (ii) contact at least a portion of the second ferrule such that the second ferrule is retained within the second receptacle bore.

[0024] In certain embodiments, the clamp bar is configured to be rotatable about a clamp bar axis.

[0025] In various embodiments, the clamping bar includes a compliant material configured to spread a retention force across the ferrules such that each of the ferrules is retained within a corresponding receptacle hole.

[0026] The present invention is also directed to a method for treating a vascular lesion within or adjacent to a blood vessel wall using the catheter system of any of the embodiments described herein.

[0027] The present invention is further directed to a method for manufacturing a catheter system according to any of the embodiments described herein.

[0028] The present invention is also directed to a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve. In various embodiments, the catheter system includes a light source, a plurality of light guides, a guide bundle, and a receptacle assembly. The light source generates light energy. Each of the plurality of light guides individually receives light energy from the light source. Each of the plurality of light guides has a corresponding guide proximal end. The guide bundle is in optical communication with the light source. The guide bundle bundles the plurality of light guides. The guide bundle includes a plurality of ferrules each engaging one of the guide proximal ends of a corresponding light guide. The receptacle assembly receives the plurality of ferrules and aligns the plurality of ferrules into one of (i) a circular pattern and (ii) a hexagonal pattern.

[0029] In some embodiments, at least one of the light guides is an optical fiber.

[0030] In a particular embodiment, the light source is a laser.

[0031] This Summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the subject matter. Further details are found in the detailed description and the appended claims. Other aspects will become apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part of it, each of which should not be taken in a limiting sense. The scope of the present specification is defined by the appended claims and their legal equivalents.

[0032] The novel features of the present invention, as well as the invention itself, both as to its structure and its operation, can best be understood from the accompanying drawings in conjunction with the accompanying description, in which like reference numerals refer to like parts and in which: [Brief description of the drawings]

[0033] [Figure 1] FIG. 1 is a simplified cross-sectional view of one embodiment of a catheter system according to various embodiments herein, the catheter system including a multiplexer and a guide bundle having features of the present invention. [Diagram 2] FIG. 1 is a top view of a portion of an embodiment of a catheter system including an embodiment of a guide bundle. [Diagram 3] FIG. 1 is a front perspective view of a portion of an embodiment of a catheter system including an embodiment of a guide bundle. [Figure 4] A front perspective view of a portion of an embodiment of a catheter system including an embodiment of a receptacle assembly. [Diagram 5] A rear perspective view of a portion of an embodiment of a catheter system including an embodiment of a receptacle assembly. [Figure 6] FIG. 1 is a top view of a portion of an embodiment of a catheter system including an embodiment of a guide bundle and a receptacle assembly, the guide bundle being shown partially connected to the receptacle assembly. [Figure 7] FIG. 7 is a simplified cross-sectional view of a portion of one embodiment of a catheter system taken along line 7-7 of FIG. 6, the catheter system including one embodiment of a guide coupling housing and a receptacle assembly, the guide coupling housing shown partially connected to the receptacle assembly. [Figure 8] A front perspective view of a portion of an embodiment of a catheter system including an embodiment of a receptacle assembly. [Figure 9] A front view of a portion of an embodiment of a catheter system including an embodiment of a portion of a receptacle assembly. [Figure 10] FIG. 10 is a simplified cross-sectional view of a portion of an embodiment of a catheter system taken along line 10-10 of FIG. 9, the catheter system including an embodiment of a receptacle assembly. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0034] While embodiments of the invention are susceptible to various modifications and alternative forms, details thereof have been shown by way of example and in the drawings and are described in detail herein. It is understood, however, that the scope of the 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.

[0035] Treatment of vascular lesions (sometimes referred to herein as "treatment sites") can reduce major adverse events or deaths in affected subjects. As referred to 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 adverse events in the heart, major adverse events in the peripheral or central vasculature, major adverse events in the brain, major adverse events in muscle tissue, or major adverse events in any of the internal organs.

[0036] As used herein, the terms "intravascular lesion," "vascular lesion," and "treatment site" are used interchangeably unless otherwise noted. Intravascular lesion and / or vascular lesion may be referred to herein simply as "lesion." Also, as used herein, the terms "focused location" and "focused spot" are used interchangeably unless otherwise noted and may refer to any location where light energy is focused to a diameter smaller than the initial diameter of the light source.

[0037] Those skilled in the art will realize 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 themselves readily suggest themselves to such skilled artisans having the benefit of this disclosure. Reference will now be made in detail to embodiments of the invention as illustrated in the accompanying drawings.

[0038] For purposes of clarity, not all of the specific features of the embodiments described herein are shown and described. Of course, it will be recognized that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developer's particular goals, such as adhering to application-related and business-related constraints, and that these particular goals will vary from implementation to implementation and 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.

[0039] The catheter systems disclosed herein may include many different configurations. Referring now to Figure 1, a schematic cross-sectional view of a catheter system 100 according to various embodiments is shown. The catheter system 100 is adapted to deliver pressure waves to induce spallation at one or more treatment sites within or adjacent to a vessel wall of a blood vessel or on or adjacent to a heart valve within a patient's body. 1, the catheter system 100 may include a catheter 102, an energy guide bundle 122 including one or more energy guides 122A (some embodiments described herein include at least a first energy guide and a second energy guide), a source manifold 136, a fluid pump 138, a multiplexer 123, and one or more of a handle assembly 128, the multiplexer 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"). Alternatively, the catheter system 100 may include more or fewer components than those specifically shown and described with respect to FIG.

[0040] It is appreciated that in some embodiments, the illustrated and described energy guide bundle 122 may be a light guide bundle 122 that may include one or more light guides 122A. In certain embodiments, the energy source 124 may include a light source 124. For example, the energy guide 122A may be an optical fiber and / or the energy source 124 may include a laser. Alternatively, the energy guide bundle 122 may include a different type of energy guide 122A (e.g., an electrode or electrode pair) and / or may include a different type of energy source 124 (e.g., a high voltage energy source). It is appreciated that the energy guide 122A and / or the energy source 124 may include any suitable type of energy guide or energy source capable of generating and / or conducting energy.

[0041] In various examples, 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 a body 107 of a patient 109. The treatment site 106 may include one or more vascular lesions 106A, such as, for example, a calcified vascular lesion. Additionally or alternatively, the treatment site 106 may include a vascular lesion 106A, such as a fibrous vascular lesion. Further alternatively, in some embodiments, the catheter 102 may be used at a treatment site 106 within or adjacent to a heart valve in the body 107 of the patient 109.

[0042] 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 shaft 110 may also include a guidewire lumen 118 configured to travel over the guidewire 112. As utilized 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 to accommodate and track the guidewire 112 over 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.

[0043] The balloon 104 includes a balloon wall 130 that defines a balloon interior 146. The balloon 104 can be selectively inflated with a balloon fluid 132 to expand from a contracted state suitable for advancing the catheter 102 through the patient's vasculature to an inflated state (as shown in FIG. 1 ) suitable for securing the catheter 102 in place relative to the treatment site 106. Stated differently, 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. While FIG. 1 illustrates that the balloon wall 130 of the balloon 104 is shown spaced apart from the treatment site 106 of the blood vessel 108 when in the inflated state, it will be appreciated that this is done solely for ease of illustration. It will be appreciated that the balloon wall 130 of the balloon 104 will typically be substantially immediately adjacent and / or abutting the treatment site 106 when the balloon 104 is in the inflated state.

[0044] Balloons 104 suitable for use in the catheter system 100 include those that, when in a deflated state, can pass through the vasculature of a patient 109. In some embodiments, the balloon 104 is made from silicone. In other embodiments, the balloon 104 can be made from polydimethylsiloxane (PDMS), polyurethane, a polymer such as PEBAX™ material, nylon, or any other suitable material.

[0045] Balloon 104 can have any suitable diameter (when inflated). In various embodiments, balloon 104 can have a diameter (when inflated) ranging from less than 1 millimeter (mm) to 25 mm. In some embodiments, balloon 104 can have a diameter (when inflated) ranging from at least 1.5 mm to 14 mm. In some embodiments, balloon 104 can have a diameter (when inflated) ranging from at least 2 mm to 5 mm.

[0046] In some embodiments, the balloon 104 can have a length ranging from at least 3 mm to 300 mm. More particularly, in some embodiments, the balloon 104 can have a length ranging from at least 8 mm to 200 mm. It is recognized that a balloon 104 having a relatively long length can be positioned adjacent a larger treatment site 106 and thus can be used to impart pressure waves onto a larger vascular lesion 106A or multiple vascular lesions 106A and induce fragmentation at a precise location within the treatment site 106. It is further recognized that a longer balloon 104 can also be positioned adjacent multiple treatment sites 106 at any one given time.

[0047] The balloon 104 may be inflated to an inflation pressure of approximately 1 atmosphere (atm) to 70 atm. In some embodiments, the balloon 104 may be inflated to an inflation pressure of at least 20 atm to 60 atm. In other embodiments, the balloon 104 may be inflated to an inflation pressure of at least 6 atm to 20 atm. In yet other embodiments, the balloon 104 may be inflated to an inflation pressure of at least 3 atm to 20 atm. In yet other embodiments, the balloon 104 may be inflated to an inflation pressure of at least 2 atm to 10 atm.

[0048] The balloon 104 may have a variety of shapes, including, but not limited to, a conical, a square, a rectangular, a spherical, a conical / square, a conical / spherical, an expanded spherical, an elliptical, a tapered, a bone, a stepped diameter, an offset, or a conical offset. In some embodiments, the balloon 104 may include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or drug eluting stent may include one or more therapeutic agents, including anti-inflammatory agents, anti-tumor agents, anti-angiogenic agents, and the like.

[0049] The balloon fluid 132 may be a liquid or a gas. Some examples of balloon fluids 132 suitable for use may include, but are not limited to, one or more of water, saline, contrast, a gas such as fluorocarbon, perfluorocarbon, carbon dioxide, or any other suitable balloon fluid 132. In some embodiments, the balloon fluid 132 may be used as a base inflation fluid. In some embodiments, the balloon fluid 132 may include a mixture of saline and contrast in a volume ratio of approximately 50:50. In other embodiments, the balloon fluid 132 may include a mixture of saline and contrast in a volume ratio of approximately 25:75. In still other embodiments, the balloon fluid 132 may include a mixture of saline and contrast in a volume ratio of approximately 75:25. However, it is understood that any suitable ratio of saline and contrast may be used. The balloon fluid 132 may be adjusted based on composition, viscosity, etc., such that the speed of travel of the pressure wave is approximately appropriately manipulated. In certain embodiments, the balloon fluid 132 suitable for use herein is biocompatible. The volume of the balloon fluid 132 can be adjusted depending on the light source 124 selected and the type of balloon fluid 132 used.

[0050] In some embodiments, the imaging agent used in the imaging medium may include, but is not limited to, an iodine-based imaging agent, such as an ionic or non-ionic iodine-based imaging agent. Some non-limiting examples of ionic iodine-based imaging agents include diatrizoate, metrizoate, iothalamate, and ioxaglate. Some non-limiting examples of non-ionic iodine-based imaging agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based imaging agents may be used. Suitable non-iodine-containing imaging agents may include gadolinium(III)-based imaging agents. Suitable fluorocarbon and perfluorocarbon agents may include, but are not limited to, chemicals such as perfluorocarbon dodecafluoropentane (DDFP, C5F12).

[0051] The balloon fluid 132 may include those containing absorbers capable of selectively absorbing light in the ultraviolet (e.g., at least 10 nanometers (nm) to 400 nm), visible (e.g., at least 400 nm to 780 nm), or near infrared (e.g., at least 780 nm to 2.5 μm) regions of the electromagnetic spectrum. Suitable absorbers may include those having an absorption maximum along a spectrum of at least 10 nm to 2.5 μm. Alternatively, the balloon fluid 132 may include those containing absorbers capable of selectively absorbing light in the mid-infrared (e.g., at least 2.5 μm to 15 μm), or far-infrared (e.g., at least 15 μm to 1 mm) regions of the electromagnetic spectrum. In various embodiments, the absorbers may have an absorption maximum that matches the emission maximum of a laser used in the catheter system 100. As non-limiting examples, the various lasers described herein may include a neodymium:yttrium aluminum garnet (Nd:YAG-emission maximum=1064 nm) laser, a holmium:YAG (Ho:YAG-emission maximum=2.1 μm) laser, or an erbium:YAG (Er:YAG-emission maximum=2.94 μm) laser. In some embodiments, the absorber may be water soluble. In other embodiments, the absorber is not water soluble. In some embodiments, the absorber used in the balloon fluid 132 may be tailored to match the peak emission of the light source 124. Various light sources 124 having emission wavelengths of at least 10 nanometers to 1 millimeter are discussed elsewhere herein.

[0052] The catheter shaft 110 of the catheter 102 can be coupled to one or more light guides 122A of the light guide bundle 122 in optical communication with the light source 124. The light guides 122A can be disposed along the catheter shaft 110 and within the balloon 104. Each of the light guides 122A can have a guide distal end 122D at any suitable longitudinal position relative to the length of the balloon 104. In some embodiments, each light guide 122A can be an optical fiber and the light source 124 can be a laser. The light source 124 can be in optical communication with the light guide 122A at the proximal portion 114 of the catheter system 100. More specifically, the light source 124 can be in optical communication with the light guides 122A selectively, simultaneously, sequentially, and / or in any desired combination, order, and / or pattern, depending on the presence and operation of the multiplexer 128.

[0053] In some embodiments, the catheter shaft 110 can be coupled to multiple light guides 122A, such as a first light guide, a second light guide, a third light guide, etc., which can 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 light guides 122A can be spaced apart by approximately 180 degrees around the circumference of the guidewire lumen 118 and / or the catheter shaft 110, three light guides 122A can be spaced apart by approximately 120 degrees around the circumference of the guidewire lumen 118 and / or the catheter shaft 110, or four light guides 122A can be spaced apart by approximately 90 degrees around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Further alternatively, the multiple light guides 122A need not be evenly spaced from one another around the circumference of the guidewire lumen 118 and / or catheter shaft 110. More specifically, the light guides 122A can be either evenly or unevenly spaced around the guidewire lumen 118 and / or catheter shaft 110 to achieve a desired effect at a desired location.

[0054] The catheter system 100 and / or the light guide bundle 122 may include any number of light guides 122A in optical communication with the light source 124 at the proximal portion 114 and in optical communication with the balloon 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 light guide bundle 122 may include from one light guide 122A to five light guides 122A. In other embodiments, the catheter system 100 and / or the light guide bundle 122 may include from five light guides 122A to fifteen light guides 122A. In yet other embodiments, the catheter system 100 and / or the light guide bundle 122 may include from ten light guides 122A to thirty light guides 122A. Or, in still other embodiments, the catheter system 100 and / or the light guide bundle 122 may include more than thirty light guides 122A.

[0055] The light guide 122A may have any suitable design to generate plasma and / or pressure waves in the balloon fluid 132 within the balloon interior 146. In certain embodiments, the light guide 122A may include an optical fiber or a flexible light pipe. The light guide 122A may be thin and flexible, allowing for the transmission of optical signals with little loss of strength. The light guide 122A may include a core surrounded by a cladding. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of the light 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 light guide 122A may also include a protective coating, such as a polymer. It is recognized that the refractive index of the core is greater than the refractive index of the cladding.

[0056] Each light guide 122A can guide light energy along its length from a proximal guide end 122P to a distal guide end 122D having at least one optical window (not shown), positioned within the balloon interior 146.

[0057] The light guide 122A can take on many configurations around and / or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the light guide 122A can extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the light guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the light guide 122A can be disposed along the length of the outer diameter of the catheter shaft 110. In still other embodiments, the light guide 122A can be disposed within one or more light guide lumens within the catheter shaft 110.

[0058] The optical guides 122A may also be positioned at any suitable location around the circumference of the guidewire lumen 118 and / or catheter shaft 110, and the guide distal ends 122D of each of the optical guides 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 for the purpose of destroying the vascular lesion 106A at the treatment site 106.

[0059] In certain embodiments, the light guide 122A can include one or more opto-acoustic transducers 154, and each opto-acoustic transducer 154 can be in optical communication with the light guide 122A in which it is disposed. In some embodiments, the opto-acoustic transducers 154 can be in optical communication with the distal guide end 122D of the light guide 122A. Further, in such embodiments, the opto-acoustic transducers 154 can have a shape that corresponds to and / or matches the distal guide end 122D of the light guide 122A.

[0060] The photoacoustic transducer 154 is configured to convert light energy into sound waves at or near the distal guide end 122D of the light guide 122A. The direction of the sound waves can be adjusted by changing the angle of the distal guide end 122D of the light guide 122A.

[0061] In certain embodiments, the opto-acoustic transducer 154 disposed at the guide distal end 122D of the light guide 122A can have the same shape as the guide distal end 122D of the light guide 122A. For example, in certain non-exclusive embodiments, the opto-acoustic transducer 154 and / or the guide distal end 122D can have a conical shape, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a semicircular shape, an oval shape, etc. The light guide 122A can further include additional opto-acoustic transducers 154 disposed along one or more sides of the length of the light guide 122A.

[0062] In some embodiments, the light guide 122A can further include one or more diverting features or "diverters" (not shown in FIG. 1 ) within the light guide 122A that are configured to direct light out of the light guide 122A toward a side that may be located at or near the distal guide end 122D of the light guide 122A and toward the balloon wall 130. The diverting features can include any feature of the system that redirects light energy from the light guide 122A away from its axial flow path toward a side of the light guide 122A. Additionally, the light guides 122A can each include one or more optical windows disposed along a longitudinal or circumferential surface of each light guide 122A and in optical communication with the diverting features. Stated another way, the redirecting mechanism can be configured to direct optical energy of the light guide 122A towards a side surface at or near the guide distal end 122D, the side surface being in optical communication with the optical window. The optical window can include a portion of the light guide 122A that allows optical energy to exit the light guide 122A from within the light guide 122A, such as a portion of the light guide 122A that does not have cladding material on or around the light guide 122A.

[0063] Examples of redirecting mechanisms suitable for use include reflective elements, refractive elements, and fiber diffusers. Redirecting mechanisms suitable for focusing the optical energy away from the tip of the light guide 122A can include, but are not limited to, those with convex surfaces, gradient-index (GRIN) lenses, and mirror focus lenses. Upon contact with the redirecting mechanism, the optical energy is redirected within the light guide 122A to one or more of the plasma generator 133 and the opto-acoustic transducer 154, which is in optical communication with the side of the light guide 122A. As described, the opto-acoustic transducer 154 then converts the optical energy into acoustic waves that propagate away from the side of the light guide 122A.

[0064] The source manifold 136 may be positioned 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 one or more light guides 122A of the light 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 optionally include a fluid pump 138 configured to inflate the balloon 104 with balloon fluid 132.

[0065] As noted above, in the embodiment shown in FIG. 1, the multiplexer 123 includes one or more of the light source 124, the power source 125, the system controller 126, and the GUI 127. Alternatively, the multiplexer 123 may include more or fewer components than those specifically shown in FIG. 1. For example, in certain non-exclusive alternative embodiments, the multiplexer 123 may be designed without the GUI 127. Further alternatively, one or more of the light source 124, the power source 125, the system controller 126, and the GUI 127 may be provided in the catheter system 100 without a specific need for a multiplexer 123.

[0066] In some embodiments, the multiplexer 123 can include a two-channel splitter design. The light guide bundle 122 can include a manual positioning mechanism that is mounted on an optical breadboard and / or platen. This design allows linear position adjustment and tilting of the array by rotating about the light guide 122A axis (not shown in FIG. 1) of one of the channels. In other embodiments, the adjustment method can include at least two adjustment steps: 1) aligning the planar position of the source beam 124B in channel 1, and 2) adjusting the light guide bundle 122 to achieve the best alignment in channel 10.

[0067] As shown, the multiplexer 123 and components included therewith are operatively coupled to the catheter 102, the light guide bundle 122, and the remainder of the catheter system 100. For example, in some embodiments, as shown in FIG. 1, the multiplexer 123 can include a console connection aperture 148 (which may also be generically referred to as a "socket"), whereby the light guide bundle 122 is mechanically coupled to the multiplexer 123. In such embodiments, the light guide bundle 122 can include a guide coupling housing 150 that houses a portion of each of the light guides 122A, e.g., the guide proximal end 122P. The guide coupling housing 150 is configured to be selectively retained in the console connection aperture 148 to provide a mechanical coupling between the light guide bundle 122 and the multiplexer 123.

[0068] The light guide bundle 122 may also include a guide bundle 152 (or "shell") that groups each of the individual light guides 122A closer together, allowing the light guides 122A and / or the light guide bundle 122 to be in a more compact configuration as they extend with the catheter 102 into the blood vessel 108 during use of the catheter system 100. In some embodiments, the light guides 122A leading to the plasma generator 133 may be grouped together in a light guide bundle 122 that includes a linear block with an array of precision holes that form a multi-channel ferrule 778 (e.g., as shown in FIG. 7). In other embodiments, the light guide bundle 122 may include a mechanical connector array or block connector that groups the single ferrules 778 together in one of: (i) a linear array; (ii) a circular pattern; and (iii) a hexagonal pattern.

[0069] The light source 124 may be selectively and / or alternatively coupled in optical communication with each of the light guides 122A in the light guide bundle 122, i.e., to the guide proximal end 122P of each of the light guides 122A. In particular, the light source 124 may be configured to generate light energy in the form of a source beam 124A, e.g., a pulsed source beam, which may be selectively and / or alternatively directed and received as individual guide beams 124B to each of the light guides 122A in the light guide bundle 122. Alternatively, the catheter system 100 may include two or more light sources 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 may include a separate light source 124 for each of the light guides 122A in the light guide bundle 122. The light source 124 may be operated at low energy.

[0070] The light source 124 can have any suitable design. In certain embodiments, the light source 124 can be configured to provide sub-millisecond pulses of light energy from the light source 124, which are focused to a small spot for coupling the light source 124 to the proximal guide end 122P of the light guide 122A. Such pulses of light energy are then directed and / or guided along the light guide 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation (sometimes referred to herein as a "plasma flash") in the balloon fluid 132 within the balloon interior 146 of the balloon 104, for example, via a plasma generator 133, which may be located at the distal guide end 122D of the light guide 122A. In particular, light emitted at the distal guide end 122D of the light guide 122A energizes the plasma generator 133 to form plasma within the balloon fluid 132 within the balloon interior 146. The plasma formation causes rapid bubble formation imparting pressure waves to the treatment site 106. An exemplary plasma-induced bubble 134 is shown in FIG.

[0071] In various non-exclusive alternative embodiments, sub-millisecond pulses of light energy from light source 124 can be delivered to 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 light energy can be delivered to treatment site 106 at frequencies that can be greater than 5000 Hz or less than 1 Hz, or at any other suitable range of frequencies.

[0072] It will be appreciated that while light source 124 is typically utilized to provide pulses of light energy, light source 124 may still be described as providing a single source beam 124A, i.e., a single pulsed source beam.

[0073] Light sources 124 suitable for use can include various types of light sources, including lasers and lamps. For example, in certain non-exclusive examples, light source 124 can be an infrared laser that emits light energy in the form of pulses of infrared light. Alternatively, as noted above, light sources 124 as referred to herein can include any suitable type of energy source.

[0074] Suitable lasers can include short pulse lasers on the sub-millisecond time scale. In some embodiments, the light source 124 can include a laser on the nanosecond (ns) time scale. The laser can also include short pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (us) time scale. It is recognized that there are many combinations of laser wavelengths, pulse widths, and energy levels that can be employed to achieve a plasma within the balloon fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse widths can include those falling within a range including at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range can be used.

[0075] Exemplary nanosecond lasers can include those in the UV to IR spectrum, spanning wavelengths from approximately 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, the light 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 light source 124 can include those capable of generating light at wavelengths of at least 700 nm to 3000 nm. In still other embodiments, the light source 124 can include those capable of generating light at wavelengths of at least 100 nm to 10 micrometers (μm). The nanosecond laser can include those having 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 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.

[0076] 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 light source 124, the absorbing 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 approximately 2 MPa to 50 MPa, at least approximately 2 MPa to 30 MPa, or at least approximately 15 MPa to 25 MPa.

[0077] The pressure waves can be applied to the treatment site 106 from a distance extending radially from the light guide 122A within a range of at least about 0.1 millimeters (mm) to more than about 25 mm when the catheter 102 is positioned at the treatment site 106. In various non-exclusive alternative embodiments, the pressure waves can be applied to the treatment site 106 from a distance extending radially from the light guide 122A within a range of at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm when the catheter 102 is positioned at the treatment site 106. In other embodiments, the pressure waves can be applied to the treatment site 106 from another suitable distance different from the above ranges. In some embodiments, the pressure waves can be applied to the treatment site 106 from a distance of at least about 0.1 mm to 10 mm and in a range of at least about 2 MPa to 30 MPa. In some embodiments, the pressure waves can be applied to the treatment site 106 from a distance of at least about 0.1 mm to 10 mm and in a range of at least about 2 MPa to 25 MPa. Further alternatively, other suitable pressure ranges and distances may be used.

[0078] The power source 125 is electrically coupled to each of the light source 124, the system controller 126, the GUI 127, and the handle assembly 128 and is configured to provide the necessary power. The power source 125 may have any suitable design for such purposes.

[0079] The system controller 126 is electrically coupled to the power source 125 and receives power from the power source 125. Additionally, the system controller 126 is coupled to each of the light sources 124 and the GUI 127 and configured to control the operation of each. The system controller 126 may include one or more processors or circuitry to control the operation of at least the light sources 124 and the GUI 127. For example, the system controller 126 may control the light sources 124 to generate pulses of light energy as desired and / or at any desired firing rate.

[0080] 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 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 into the handle assembly 128.

[0081] 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 can be used by the user or operator to ensure that the catheter system 100 is effectively utilized to apply pressure to the treatment site 106 to induce fracturing. 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 alternatively, 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, different brightness, etc., which can serve as an alert to the user or operator. Additionally or alternatively, 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 desires of the user or operator.

[0082] 1, the handle assembly 128 may be positioned at or near the proximal portion 114 of the catheter system 100 and / or near the source manifold 136. 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 may be positioned in another suitable location.

[0083] The handle assembly 128 is manipulated and used by a user or operator to operate, 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 light source 124, the fluid pump 138, and the GUI 127. 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 certain such embodiments, the handle assembly 128 can include circuitry 156 that can form at least a portion of the system controller 126.

[0084] In one embodiment, circuitry 156 may include a printed circuit board having one or more integrated circuits or any other suitable circuitry. In alternative embodiments, circuitry 156 may be omitted or may be included within system controller 126, which in various embodiments may be located outside handle assembly 128, such as within multiplexer 123. It is understood that handle assembly 128 may include fewer or additional components than those specifically shown and described herein.

[0085] FIG. 2 is a top view of a portion of an embodiment of the catheter system 100 (shown in FIG. 1 ) including an embodiment of the guide bundle 252. As shown in the embodiment of FIG. 2 , the guide coupling housing 250 houses one or more ferrule assemblies 258 and one or more alignment guide receivers 260. Each ferrule assembly 258 can include a ferrule 778 (shown, for example, in FIG. 7 ), a portion of an individual light guide 222A including a guide proximal end 122P (shown, for example, in FIG. 1 ), and a spring 776 (shown, for example, in FIG. 7 ). The ferrule assembly 258 can hold the ferrule 778. In certain embodiments, the light guide 222A can be engaged by the ferrule assembly 258. In particular, the guide proximal end 122P can terminate within an individual ferrule 778 of the ferrule assembly 258. The ferrule assembly 258 can be configured to provide improved positioning and alignment guides that allow each ferrule 778 to be inserted into a receptacle hole 468 (e.g., shown in FIG. 4 ) in a receptacle assembly 462 (e.g., shown in FIG. 4 ) without damaging the ferrule 778.

[0086] The ferrule assembly 258 may vary depending on the design requirements of the catheter system 100, the light guide 222A, the guide proximal end 122P, and / or the guide bundle 252. It is understood that the ferrule assembly 258 may include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the ferrule assembly 258 may omit one or more of the systems, subsystems, and elements specifically shown and / or described herein. The ferrule assembly 258 may be positioned in any suitable location, including the locations shown in FIG. 2.

[0087] The ferrule assembly 258 can vary in shape. In some embodiments, the ferrule assembly 258 can be substantially plug-shaped, as shown in the embodiment depicted in Figure 2. In other embodiments, the ferrule assembly 258 can be substantially cylindrical, prismatic, cuboid, rectangular, and / or tubular.

[0088] The ferrule assembly 258 may be formed of any suitable material. In certain embodiments, the ferrule assembly 258 may be formed at least partially from metal, plastic, polymer, ceramic, composite, and / or organic materials. In other embodiments, the ferrule assembly 258 may be formed using mold injected plastic.

[0089] The alignment guide receiver 260 receives the alignment guide 470 (shown, for example, in FIG. 4 ). The alignment guide receiver 260 can be configured to improve the fit between the ferrule 778 and the receptacle hole 468 in the receptacle assembly 462.

[0090] The alignment guide receiver 260 may vary depending on the design requirements of the catheter system 100, the guide bundle 252, and / or the alignment guide 470. It is understood that the alignment guide receiver 260 may include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the alignment guide receiver 260 may omit one or more of the systems, subsystems, and elements specifically shown and / or described herein. The alignment guide receiver 260 may be positioned in any suitable location, including the locations shown in FIG. 2.

[0091] 2, alignment guide receiver 260 is a pin receiver. Non-limiting and non-exclusive examples of suitable alignment guide receivers include (i) a guide groove of a tongue and groove system, (ii) a guide slot of a tab-and-slot system, and (iii) a guide channel of a rail-and-channel system.

[0092] FIG. 3 is a front perspective view of a portion of an embodiment of the catheter system 100 (shown in FIG. 1 ) including an embodiment of the guide bundle 352. In particular, the shape and design of an embodiment of the guide coupling housing 350, the guide bundle 352, and the ferrule assembly 358 are shown in more detail in FIG. 3 . For example, as shown in FIG. 3 , the guide coupling housing 350 can have a substantially trapezoidal side profile and a substantially trapezoidal prism shape. The guide coupling housing 350 can extend outwardly from the guide bundle 352. The guide coupling housing 350 can include one or more apertures, and each of the ferrule assemblies 358 can extend through a corresponding aperture. As shown in the embodiment of FIG. 3 , the ferrule assembly 358 can be substantially cylindrical with a partially spherical end. The ferrule assembly 358 can include an opening or orifice to receive the guide beam 122B (shown in FIG. 1 ) from the multiplexer 128 (shown in FIG. 1 ).

[0093] 4 is a front perspective view of a portion of an embodiment of the catheter system 100 (shown in FIG. 1 ) including an embodiment of a receptacle assembly 462. As shown in the embodiment of FIG. 4 , the receptacle assembly 462 can include one or more of a receptacle block 464, a receptacle housing 466, a receptacle bore 468, and an alignment guide 470. The receptacle assembly 462 can be configured to mate with a guide bundle 252 (e.g., shown in FIG. 2 ) such that the guide beams 122B are aligned with each of the light guides 222A (e.g., shown in FIG. 2 ) within the guide bundle 252.

[0094] The receptacle assembly 462 may vary depending on the design requirements of the catheter system 100, the light guide 222A, the guide bundle 252, and / or the ferrule assembly 358 (e.g., as shown in FIG. 3). It is understood that the receptacle assembly 462 may include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the receptacle assembly 462 may omit one or more of the systems, subsystems, and elements specifically shown and / or described herein. The receptacle assembly 462 may be positioned in any suitable location, including the locations shown in FIG. 4.

[0095] Receptacle assembly 462 may be formed from any suitable material. In some embodiments, the components of receptacle assembly 462 may be formed at least partially from metal, plastic, ceramic, polymer, composite, and / or organic materials. In particular embodiments, the components of receptacle assembly 462 may be formed from hardened stainless steel configured to provide improved resilience and resistance to wear and tear.

[0096] The receptacle block 464 can be configured to receive the guide bundle 252. The receptacle block 464 can vary depending on the design requirements of the catheter system 100, the light guide 222A, the guide bundle 252, and / or the receptacle assembly 462. It is understood that the receptacle block 464 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the receptacle block 464 can omit one or more of the systems, subsystems, and elements specifically shown and / or described herein. The receptacle block 464 can be positioned in any suitable location, including the locations shown in FIG. 4.

[0097] The receptacle housing 466 can accommodate the receptacle block 464. In some embodiments, the receptacle housing 466 can be coupled to the receptacle block 464. The receptacle housing 466 can vary depending on the design requirements of the catheter system 100, the light guide 222A, the guide bundle 252, the receptacle assembly 462, and / or the receptacle block 464. It is understood that the receptacle housing 466 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the receptacle housing 466 can omit one or more of the systems, subsystems, and elements specifically shown and / or described herein. The receptacle housing 466 can be positioned in any suitable location, including the locations shown in FIG. 4.

[0098] The receptacle holes 468 may be precision drilled in the receptacle block 464. Alternatively, the receptacle holes 468 may be formed in the receptacle block 464 by any suitable method known in the art. As shown in the embodiment of FIG. 4, one or more receptacle holes 468 may be aligned in a linear array in the receptacle block 464. The receptacle holes 468 may vary depending on the design requirements of the catheter system 100, the light guide 222A, the guide bundle 252, the receptacle assembly 462, and / or the receptacle block 464. It is understood that the receptacle holes 468 may include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, receptacle aperture 468 may omit one or more of the systems, subsystems, and elements specifically shown and / or described herein.

[0099] 4. The receptacle assembly 462 can include any suitable number of receptacle holes 468, such as 1, 2, 3, 4, 5, 7, 8, 9, or 10 receptacle holes 468. In other embodiments, the receptacle assembly 462 can include more than 10 receptacle holes 468.

[0100] The alignment guide 470 can be coupled to the receptacle block 464. The alignment guide 470 can mate with the alignment guide receiver 260 (shown in FIG. 2) such that the guide bundle 252 and the receptacle assembly 464 are at least partially aligned and / or coupled (e.g., as shown in FIG. 6). The alignment guide 470 can vary depending on the design requirements of the catheter system 100, the light guide 222A, the guide bundle 252, the alignment guide receiver 260, the receptacle assembly 462, and / or the receptacle block 464. It is understood that the alignment guide 470 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the alignment guide 470 can omit one or more of the systems, subsystems, and elements specifically shown and / or described herein.

[0101] The alignment guides 470 may be positioned at any suitable location, including the locations shown in FIG. 4. The alignment guides 470 may be substantially dowel shaped. The receptacle assembly 462 may include any suitable number of alignment guides 470, such as one, two, three, four, five, seven, eight, nine, or ten alignment guides 470. In other embodiments, the receptacle assembly 462 may include more than ten alignment guides 470. The alignment guides 470 may be any alignment guides 470 known in the art. In the embodiment shown in FIG. 4, the alignment guides 470 are guide pins. Non-limiting and non-exclusive examples of suitable alignment guides include (i) a guide tongue in a tongue-and-groove system, (ii) a guide tab in a tab-and-slot system, and (iii) a guide rail in a rail-and-channel system.

[0102] Figure 5 is a rear perspective view of a portion of an embodiment of the catheter system 100 (shown in Figure 1) including an embodiment of a receptacle assembly 562. As shown in the embodiment shown in Figure 5, the receptacle assembly 562 can include a receptacle housing 566 and a backing plate 572 that includes one or more alignment holes 574.

[0103] The backing plate 572 can be configured to receive the proximal end face of the ferrule 766. The backing plate 572 can provide a precision reference surface for aligning the guide beams 122B from the multiplexer 128 with each of the corresponding light guides 122A (shown in FIG. 1 ). The alignment holes 574 can be precisely drilled in the backing plate 572. The alignment holes 574 can be formed in the backing plate 572 using any suitable method known in the art. The alignment holes 574 can be configured to couple the focused guide beams 122B with each of the corresponding light guides 122A.

[0104] The backing plate 572 and the alignment holes 574 may vary depending on the design requirements of the catheter system 100, the light guide 222A, the guide bundle 252, the alignment guide receiver 260, the receptacle assembly 462, and / or the receptacle block 464. It is understood that the backing plate 572 may include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the backing plate 572 may omit one or more of the systems, subsystems, and elements specifically shown and / or described herein. The backing plate 572 and the alignment holes 574 may be positioned in any suitable location, including the locations shown in FIG. 5. In certain embodiments, the alignment holes 574 may have a diameter smaller than the diameter of the ferrule 778. The alignment holes 574 may have a diameter large enough to accommodate the entire guide beam 128B without clipping.

[0105] 6 is a top view of a portion of an embodiment of the catheter system 100 (shown in FIG. 1 ) including an embodiment of a guide bundle 652 including a light guide 622A and a receptacle assembly 662, where the guide bundle 652 is shown partially connected to the receptacle assembly 662. In particular, in the embodiment shown in FIG. 6 , the guide coupling housing 650 is advanced such that the ferrule assembly 658 and alignment guide 670 are partially secured within the receptacle block 664.

[0106] 7 is a simplified cross-sectional view of a portion of one embodiment of the catheter system 100 (shown in FIG. 1 ) taken along line 7-7 of FIG. 6 , where the catheter system 100 includes one embodiment of a guide coupling housing 750 including a light guide 722A and a receptacle assembly 762, where the guide coupling housing 750 is shown partially connected to the receptacle assembly 762. In particular, in the embodiment shown in FIG. 7 , the guide coupling housing 750 is advanced such that the ferrule assembly 758 and the alignment guide 770 are partially secured within the receptacle block 764. In FIG. 7 , the ferrule assembly 758 (i) extends partially through the receptacle hole 768 and (ii) partially engages the backing plate 772 of the receptacle assembly 762 such that the alignment hole 774 is aligned with the ferrule assembly 758. As shown in the embodiment depicted in FIG. 7, the ferrule assembly 758 may further include a spring 776 , a ferrule 778 , and a ferrule collar 780 .

[0107] The spring 776 can engage the ferrule 778 and / or ferrule collar 780 in the ferrule assembly 758. The spring 776 can be configured to provide an insertion force when the ferrule assembly 758 is inserted into the receptacle hole 768. The spring 776 can vary depending on the design requirements of the catheter system 100, the light guide 222A, the guide coupling housing 750, the receptacle assembly 762, the receptacle hole 768, the ferrule 778, and / or the ferrule collar 780. It is understood that the spring 776 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the spring 776 can omit one or more of the systems, subsystems, and elements specifically shown and / or described herein. The spring 776 can be positioned in any suitable location, including the locations shown in FIG. 7. The spring 776 may be a spiral spring.

[0108] The ferrule 778 can engage the guide proximal end 122P (shown in FIG. 1 ) of the light guide 722A within the ferrule assembly 758. The ferrule 778 can secure, reinforce, and / or seal the guide proximal end 122P of the light guide 722A. The ferrule 778 can vary depending on the design requirements of the catheter system 100, the light guide 722A, the guide coupling housing 750, the receptacle assembly 762, the receptacle hole 768, the spring 776, and / or the ferrule collar 780. It is understood that the ferrule 778 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the ferrule 778 can omit one or more of the systems, subsystems, and elements specifically shown and / or described herein. The ferrule 778 can be positioned in any suitable location, including the locations shown in FIG. 7 .

[0109] The ferrule 778 can be formed from any suitable material. In certain embodiments, the ferrule 778 can be at least partially formed from a metal, a plastic, a ceramic, a polymer, a composite material, and / or an organic material. The ferrule 778 can have a proximal end face 778P. In some embodiments, the proximal end face 778P can engage the backing plate 772 when the ferrule 778 is at least partially inserted into the receptacle hole 768. As shown in FIG. 7, the alignment hole 774 can have a smaller diameter than the ferrule 778 such that the proximal end face 778P of the ferrule 778 is secured over the alignment hole 774.

[0110] The ferrule collar 780 can back the ferrule 778. The ferrule collar 780 can be secured within the spring 776. The ferrule 778 can vary depending on the design requirements of the catheter system 100, the light guide 222A, the guide coupling housing 750, the receptacle assembly 762, the receptacle hole 768, the spring 776, and / or the ferrule collar 780. It is understood that the ferrule 778 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the ferrule 778 can omit one or more of the systems, subsystems, and elements specifically shown and / or described herein. The ferrule 778 can be positioned in any suitable location, including the locations shown in FIG. 7.

[0111] Figure 8 is a front perspective view of a portion of an embodiment of the catheter system 100 (shown in Figure 1) including an embodiment of a receptacle assembly 862. Figure 8 illustrates an embodiment of a receptacle assembly 862 that differs slightly from other embodiments described herein. In the embodiment shown in Figure 8, a receptacle block 864 includes one or more receptacle holes 868 formed in a linear array as a V-groove rather than a single hole.

[0112] In some embodiments, the V-groove receptacle hole 868 shown in FIG. 8 can be formed by cutting into a hardened block of stainless steel. The V-groove can be cut into the receptacle hole 868 by an electric discharge machine. The V-groove provides at least two lines of contact while the ferrule 778 is held in the receptacle hole 868. In the embodiment shown in FIG. 8, the receptacle assembly 862 can include a retention assembly 881 including a clamp bar 882 having a clamp bar axis 882a, and a plunger 884. The retention assembly 881 retains the ferrule 778 in the receptacle hole 868. The retention assembly 881 can be configured to reduce and / or eliminate the insertion force required to retain the ferrule 778 in the receptacle hole 868.

[0113] The retention assembly 881 can vary depending on the design requirements of the catheter system 100, the receptacle assembly 862, and / or the ferrule 778. It is understood that the retention assembly 881 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the retention assembly 881 can omit one or more of the systems, subsystems, and elements specifically shown and / or described herein. The retention assembly 881 can be positioned in any suitable location, including the locations shown in FIG.

[0114] The clamp bar 882 clamps the ferrules 778 within the receptacle bores 868. The clamp bar 882 can move about a clamp bar axis 882a to apply and / or remove a retaining force on one or more ferrules 778 (see, e.g., FIG. 10 ). In certain embodiments, the clamp bar 882 can be raised and lowered to allow (i) movement of the ferrules 778 during insertion and (ii) retention of the ferrules 778 when the proximal end faces 778P are fixed against the backing plate 772 (shown in FIG. 7 ) and the clamp bar 882 is lowered to retain the ferrules 778.

[0115] The clamp bar 882 may vary depending on the design requirements of the catheter system 100, the receptacle assembly 862, the ferrule 778, the retaining assembly 881, and / or the plunger 884. It is understood that the clamp bar 882 may include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the clamp bar 882 may omit one or more of the systems, subsystems, and elements specifically shown and / or described herein. The clamp bar 882 may be positioned in any suitable location, including the locations shown in FIG.

[0116] The clamping bar 882 may include a malleable material and / or wave springs configured to spread a retention force across the ferrules 778 such that each of the ferrules 778 is retained within a corresponding receptacle hole 868. The clamping bar 882 may hold the ferrules 778 so that the ferrules 778 do not float within the receptacle hole 868. The clamping bar 882 may also be configured to provide an even or substantially even retention force to the ferrules 778, as is known in the art.

[0117] The plunger 884 engages (e.g., pushes) the ferrule 778 into the receptacle bore 868 such that the ferrule 778 is held in place. In some embodiments, the plunger 884 engages the top end of the ferrule 778 and secures the ferrule 778 in the V-groove of the receptacle bore 868. The plunger 884 may vary depending on the design requirements of the catheter system 100, the receptacle assembly 862, the ferrule 778, the retention assembly 881, and / or the clamp bar 882. It is understood that the plunger 884 may include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. Additionally or alternatively, the plunger 884 may omit one or more of the systems, subsystems, and elements specifically shown and / or described herein.

[0118] Plunger 884 may be positioned in any suitable location, including the locations shown in FIGURE 8. Plunger 884 may be substantially the same shape and / or function as a ball-spring plunger. Plunger 884 may be integral to clamp bar 882 (e.g., as shown in FIGURE 8).

[0119] Figure 9 is a front view of a portion of one embodiment of the catheter system 100 (shown in Figure 1) including one embodiment of a portion of a receptacle assembly 962. Figure 9 illustrates one embodiment of a receptacle assembly 962 that differs slightly from other embodiments described herein. In the embodiment shown in Figure 9, the interior of the receptacle block 964 is shown in greater detail, including the receptacle holes 968. Also shown in Figure 9 are alignment holes 974 and a retention assembly 981 that includes a clamp bar 982 and a plunger 984.

[0120] FIG. 10 is a simplified cross-sectional view of a portion of an embodiment of a catheter system 100 (shown in FIG. 1) taken along line 10-10 of FIG. 9, the catheter system 100 including an embodiment of a receptacle assembly 1062. FIG. 10 illustrates an embodiment of a receptacle assembly 1062 that differs slightly from other embodiments described herein. In the embodiment shown in FIG. 10, the receptacle block 1064 includes one or more receptacle holes 1068 formed in a linear array as a V-groove rather than a single hole. In the embodiment shown in FIG. 10, the receptacle assembly 1062 can include a retention assembly 1081 including a clamp bar 1082 and a plunger 1084. The retention assembly 1081 retains a ferrule 1078 in the receptacle hole 1068. The retention assembly 1081 can be configured to reduce and / or eliminate the insertion force required to retain the ferrule 1078 in the receptacle hole 1068. The clamp bar 1082 clamps the ferrule 1078 within the receptacle hole 1068 .

[0121] This technology provides a connector solution for multiple optical channels that improves optical coupling to individual light guides grouped into a multi-channel array. This technology can utilize individual low-cost ferrules to terminate the light guides. These ferrules are mounted in a ferrule assembly that is contained within a guide bundle. In some embodiments, the guide bundle aligns the ferrules in a linear array. The ferrules can float within the ferrule assembly with low positional tolerances. The connectorized ferrule assembly can be mated with a high-precision receptacle assembly that includes a receptacle plate and / or a receptacle block. Mechanical features of the receptacle assembly capture and align the individual ferrules. These features allow the floating ferrules to be aligned with tightly controlled tolerances in an improved alignment. This technology allows a single, stable energy source to be fed sequentially through a variable number of multiple channels.

[0122] Specific advantages offered by this technology include: 1) enabling the use of a single low-cost, high-precision ferrule in a disposable device for reliable connection, thereby reducing manufacturing costs; 2) reducing system performance dependency on the mechanical tolerances associated with the assembly of light guides into the ferrule block and their position within the multichannel array; 3) reducing performance dependency on the accuracy of the connection and alignment of the multichannel array to the multiplexer; and 4) reducing the need for high-cost, high-precision monolithic ferrule blocks.

[0123] In some embodiments, the light guide is an optical fiber, the energy source is a pulsed laser, and the emitter is a plasma generator. In its simplest form, the multiplexer is a precision linear mechanism that translates the coupling optical elements along a straight path. This approach requires a single degree of freedom. The connector block groups the individual optical fibers into a liner pattern with precise spacing.

[0124] In a particular embodiment, the linear translation mechanism is electronically controlled by the system to sequentially align the beam path with each of the individual fibers bundled in the ferrule. The translation mechanism carries the necessary beam directing and focusing optics to focus the laser energy on each fiber for optimal coupling. In this way, the low divergence of the laser beam during the short distance movement of the translation coupling mechanism has minimal impact on the coupling efficiency to the fiber. The system drives the mechanism to align the beam path with the selected optical fiber channel and then fires the laser in a pulsed or semi-continuous wave mode.

[0125] The system and method can be implemented for any linear, circular, patterned, or scanning multiplexer configuration. In some embodiments, the system can include a probe and multiple primary laser beams that can be combined and spot traced by beam paths that correlate with the parametric motion of the multiplexer mechanism.

[0126] It is recognized that the optical alignment systems and methods provided herein address a number of potential problems with the performance, reliability, and proper use of IVL catheters, particularly those that utilize an energy source to generate a localized plasma, thereby creating high-energy gas bubbles within a balloon. Specific problems solved by the systems and methods disclosed herein include:

[0127] 1) The technology disclosed herein reduces the assembly precision and mechanical tolerance stack-up and optical coupling dependency on proper alignment of light guides (such as optical fibers), ferrules, connectors, and receptacles, allowing lower cost, lower precision components to be used in disposable devices, improving cost of goods sold.

[0128] 2) The techniques disclosed herein reduce the dependency of the performance of a multiplexer on the accuracy of the positioning mechanisms within the multiplexer and the quality and accuracy associated with its optical and mechanical components, thereby improving the speed and performance of multiplexers and multi-channel ferrule systems.

[0129] 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.

[0130] It should also be noted that, as used herein and in the appended claims, the phrase "configured" describes a system, apparatus, or other structure that is constructed or arranged to perform a particular task or adopt a particular structure. The phrase "configured" may be used interchangeably with other similar phrases, such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, etc.

[0131] The headings used herein are provided for consistency with suggestions under 37 CFR 1.77 or to provide organizational guidance. These headings are not to be considered as limiting or characterizing the invention(s) set forth in any claim that may be issued 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" are to be considered as features of the invention(s) set forth in the claims to be issued.

[0132] 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. As such, aspects have been described with reference to various specific preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the present description.

[0133] Although several different embodiments of the catheter system have been shown 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 other embodiments so long as such combinations meet the intent of the invention.

[0134] While several exemplary aspects and embodiments of the catheter system have been described above, those skilled in the art will recognize certain modifications, permutations, additions and subcombinations thereof, and therefore, the following appended claims and the claims set forth below are intended to be construed to include all such modifications, permutations, additions and subcombinations as fall within their true spirit and scope, and are not intended to be limitations to the details of construction or design shown herein.

Claims

1. 1. A catheter system for treating a treatment site within a blood vessel wall or a heart valve, or adjacent to a blood vessel wall or a heart valve, comprising: a light source that generates light energy; a first light guide that receives the light energy from the light source, the first light guide having a guide proximal end; a second light guide that receives the light energy from the light source, the second light guide having a guide proximal end; a guide bundle in optical communication with the light source, the guide bundle bundling the first light guide and the second light guide and including a first ferrule engaging the guide proximal end of the first light guide and a second ferrule engaging the guide proximal end of the second light guide.

2. 2. The catheter system of claim 1, wherein the guide bundle further includes: (i) a first ferrule assembly including the first ferrule and a first spring that engages the first ferrule; and (ii) a second ferrule assembly including the second ferrule and a second spring that engages the second ferrule.

3. The catheter system of claim 1 or 2, wherein at least one of the first ferrule and the second ferrule is at least partially formed from a ceramic material.

4. The catheter system of claim 1 or 2, wherein at least one of the first ferrule and the second ferrule is at least partially formed from a metallic material.

5. The catheter system according to claim 1 or 2, further comprising a receptacle assembly that receives the first ferrule and the second ferrule.

6. The catheter system of claim 5 , wherein the receptacle assembly is formed at least in part from at least one of a ceramic material and a metallic material.

7. The catheter system of claim 5 , wherein the receptacle assembly includes at least one alignment guide configured to guide alignment of the receptacle assembly with the guide bundle.

8. The catheter system of claim 7 , wherein the at least one alignment guide comprises a guide pin.

9. The catheter system of claim 7 , wherein the at least one alignment guide comprises a guide tang of a tongue-and-groove system.

10. The catheter system of claim 7 , wherein the at least one alignment guide comprises a guide rail.

11. 6. The catheter system of claim 5, wherein the receptacle assembly includes a receptacle block and a backing plate coupled to the receptacle block, the backing plate configured to engage the first ferrule and the second ferrule.

12. The catheter system of claim 11 , wherein each of the ferrules includes a proximal end face, and the backing plate is configured to engage each of the proximal end faces.

13. 12. The catheter system of claim 11, wherein the backing plate includes: (i) a first alignment hole configured to align a first guide beam with the first light guide; and (ii) a second alignment hole configured to align a second guide beam with the second light guide.

14. 12. The catheter system of claim 11, wherein the receptacle assembly includes: (i) a first receptacle bore configured to receive the first ferrule; and (ii) a second receptacle bore configured to receive the second ferrule.

15. 15. The catheter system of claim 14, wherein the first receptacle hole and the second receptacle hole are each formed in the receptacle block, and the first receptacle hole and the second receptacle hole are aligned with each other on the same linear axis.

16. The catheter system of claim 14, wherein the first receptacle hole and the second receptacle hole are each formed as a V-groove in the receptacle block.

17. 15. The catheter system of claim 14, wherein the receptacle assembly includes a retention assembly configured to retain (i) the first ferrule in the first receptacle bore and (ii) the second ferrule in the second receptacle bore.

18. 18. The catheter system of claim 17, wherein the retention assembly comprises a clamp bar having a ball spring plunger configured to (i) contact at least a portion of the first ferrule to retain the first ferrule in the first receptacle bore, and (ii) contact at least a portion of the second ferrule to retain the second ferrule in the second receptacle bore.

19. 19. The catheter system of claim 18, wherein the clamp bar is configured to be rotatable about a clamp bar axis, and the clamp bar comprises a compliant material configured to spread a retention force across the ferrules such that each ferrule is retained within a corresponding receptacle hole.

20. The catheter system of claim 1 or 2, wherein the light source includes a laser and the light guide is an optical fiber.

21. 1. A catheter system for treating a treatment site within a blood vessel wall or a heart valve, or adjacent to a blood vessel wall or a heart valve, comprising: a light source that generates light energy; a plurality of light guides each individually receiving the light energy from the light source, each light guide having a corresponding proximal guide end; a guide bundle in optical communication with the light source, the guide bundle including a plurality of ferrules bundling the plurality of light guides and each ferrule engaging one of the guide proximal ends of a corresponding light guide; a receptacle assembly that receives the plurality of ferrules and aligns the plurality of ferrules into one of (i) a circular pattern, (ii) a linear pattern, and (iii) a hexagonal pattern.

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