Patent Description:
Vascular lesions may be treated using interventions such as drug therapy, balloon angioplasty, atherectomy, stent placement, vascular graft bypass, to name a few. Such interventions may not always be ideal or may require subsequent treatment to address the lesion.

The present invention is directed toward a catheter system for treating a treatment site within or adjacent to a 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 the light energy from the light source. The first light guide has a guide proximal end. The second light guide receives the light energy from the light source. The second light guide has a guide proximal end. A 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.

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.

In certain embodiments, at least one of the first ferrule and the second ferrule are formed at least partially from a ceramic material.

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

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.

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

In various embodiments, the receptacle assembly is formed at least partially from a ceramic material.

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

In certain embodiments, the receptacle assembly includes at least one alignment guide that is configured to guide the alignment of the receptacle assembly and the guide bundle.

In various embodiments, the alignment guide is a guide pin.

In some embodiments, the alignment guide is a guide tongue of a tongue and groove system.

In certain embodiments, the alignment guide is a guide rail.

In various embodiments, the receptacle assembly includes a receptacle block that is coupled to a backing plate, the backing plate being configured to engage the first ferrule and the second ferrule.

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

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

In various embodiments, the receptacle assembly includes (i) a first receptacle hole that is configured to receive the first ferrule, and (ii) a second receptacle hole that is configured to receive the second ferrule.

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

In certain embodiments, the first receptacle hole and the second receptacle hole are each formed in the receptacle block as v-grooves.

In various embodiments, the receptacle assembly includes a retainer assembly that retains (i) the first ferrule in the first receptacle hole, and (ii) the second ferrule in the second receptacle hole.

In some embodiments, the retainer assembly includes a clamping bar having a ball spring plunger, the ball spring plunger being configured to contact (i) at least a portion of the first ferrule so that the first ferrule is retained in the first receptacle hole, and (ii) at least a portion of the second ferrule so that the second ferrule is retained in the second receptacle hole.

In certain embodiments, the clamping bar is configured to be rotatable about a clamping bar axis.

In various embodiments, the clamping bar includes a compliant material that is configured to spread a retaining force across the ferrules so that each of the ferrules is retained within a corresponding receptacle hole.

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

The present invention is further directed toward a method for manufacturing the catheter system of any of the embodiments described herein.

The present invention is also directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or a 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. The plurality of light guides each individually receives the 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 that each engages one of the guide proximal ends of a corresponding light guide. The receptacle assembly receives and aligns the plurality of ferrules into one of (i) a circular pattern, and (ii) a hexagonal pattern.

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

In certain embodiments, the light source is a laser.

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 present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not to be taken in a limiting sense.

The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which similar reference characters refer to similar parts, and in which:.

While embodiments of the present invention are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings, and are described in detail herein. It is understood, however, that the scope herein is not limited to the particular embodiments described.

Treatment of vascular lesions (also sometimes referred to herein as "treatment sites") can reduce major adverse events or death in affected subjects. As referred to herein, a major adverse event is one that can occur anywhere within the body due to the presence of a vascular lesion. Major adverse events can include but are not limited to, major adverse cardiac events, major adverse events in the peripheral or central vasculature, major adverse events in the brain, major adverse events in the musculature, or major adverse events in any of the internal organs.

As used herein, the terms "intravascular lesion", "vascular lesion" and "treatment site" are used interchangeably unless otherwise noted. The intravascular lesions and/or the vascular lesions are sometimes referred to herein simply as "lesions". Also, as used herein, the terms "focused location" and "focused spot" can be used interchangeably unless otherwise noted and can refer to any location where the light energy is focused to a small diameter than the initial diameter of the light source.

Those of ordinary skill in the art will realize that the following detailed description of the present invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the present invention will readily suggest themselves to such skilled persons having the benefit of this disclosure. Reference will now be made in detail to implementations of the present invention as illustrated in the accompanying drawings.

In the interest of clarity, not all of the routine features of the implementations described herein are shown and described. It will, of course, be appreciated that in the development of any such actual implementation, numerous implementation-specific decisions must be made in order to achieve the developer's specific goals, such as compliance with application-related and business-related constraints, and that these specific goals will vary from one implementation to another and from one developer to another. Moreover, it is appreciated that such a development effort might 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.

The catheter systems disclosed herein can include many different forms. Referring now to <FIG>, a schematic cross-sectional view is shown of a catheter system <NUM> in accordance with various embodiments. The catheter system <NUM> is suitable for imparting pressure waves to induce fractures in 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 body of a patient. In the embodiment illustrated in <FIG>, the catheter system <NUM> can include one or more of a catheter <NUM>, an energy guide bundle <NUM> including one or more energy guides 122A (some embodiments described here include at least a first energy guide and a second energy guide), a source manifold <NUM>, a fluid pump <NUM>, a multiplexer <NUM> including one or more of an energy source <NUM>, a power source <NUM>, a system controller <NUM>, and a graphic user interface <NUM> (a "GUI"), and a handle assembly <NUM>. Alternatively, the catheter system <NUM> can include more components or fewer components than those specifically illustrated and described in relation to <FIG>.

It is appreciated that in some embodiments the energy guide bundle <NUM> shown and described can be a light guide bundle <NUM>, which can include one or more light guides 122A. In certain embodiments, the energy source <NUM> can include a light source <NUM>. For example, the energy guides 122A can be optical fibers, and/or the energy source <NUM> can include a laser. Alternatively, the energy guide bundle <NUM> can include different types of energy guides 122A (such as electrodes or electrode pairs), and/or a different type of energy source <NUM> (such as a high voltage energy source, for example). It is understood that the energy guides 122A and/or the energy source <NUM> can include any suitable type of energy guides or energy sources that can generate and/or transmit energy.

In various embodiments, the catheter <NUM> is configured to move to a treatment site <NUM> within or adjacent to a vessel wall 108A of a blood vessel <NUM> within a body <NUM> of a patient <NUM>. The treatment site <NUM> can include one or more vascular lesions 106A such as calcified vascular lesions, for example. Additionally, or in the alternative, the treatment site <NUM> can include vascular lesions 106A such as fibrous vascular lesions. Still alternatively, in some implementations, the catheter <NUM> can be used at a treatment site <NUM> within or adjacent to a heart valve within the body <NUM> of the patient <NUM>.

The catheter <NUM> can include an inflatable balloon <NUM> (sometimes referred to herein simply as a "balloon"), a catheter shaft <NUM>, and a guidewire <NUM>. The balloon <NUM> can be coupled to the catheter shaft <NUM>. The balloon <NUM> can include a balloon proximal end 104P and a balloon distal end 104D. The catheter shaft <NUM> can extend from a proximal portion <NUM> of the catheter system <NUM> to a distal portion <NUM> of the catheter system <NUM>. The catheter shaft <NUM> can include a longitudinal axis <NUM>. The catheter shaft <NUM> can also include a guidewire lumen <NUM> which is configured to move over the guidewire <NUM>. As utilized herein, the guidewire lumen <NUM> defines a conduit through which the guide wire <NUM> extends. The catheter shaft <NUM> can further include an inflation lumen (not shown) and/or various other lumens for various other purposes. In some embodiments, the catheter <NUM> can have a distal end opening <NUM> and can accommodate and be tracked over the guidewire <NUM> as the catheter <NUM> is moved and positioned at or near the treatment site <NUM>. In some embodiments, the balloon proximal end 104P can be coupled to the catheter shaft <NUM>, and the balloon distal end 104D can be coupled to the guidewire lumen <NUM>.

The balloon <NUM> includes a balloon wall <NUM> that defines a balloon interior <NUM>. The balloon <NUM> can be selectively inflated with a balloon fluid <NUM> to expand from a deflated state suitable for advancing the catheter <NUM> through a patient's vasculature, to an inflated state (as shown in <FIG>) suitable for anchoring the catheter <NUM> in position relative to the treatment site <NUM>. Stated in another manner, when the balloon <NUM> is in the inflated state, the balloon wall <NUM> of the balloon <NUM> is configured to be positioned substantially adjacent to the treatment sites <NUM>. It is appreciated that although <FIG> illustrates the balloon wall <NUM> of the balloon <NUM> is shown spaced apart from the treatment site <NUM> of the blood vessel <NUM> when in the inflated state, this is done merely for ease of illustration. It is recognized that the balloon wall <NUM> of the balloon <NUM> will typically be substantially directly adjacent to and/or abutting the treatment site <NUM> when the balloon <NUM> is in the inflated state.

The balloon <NUM> suitable for use in the catheter system <NUM> includes those that can be passed through the vasculature of a patient <NUM> when in the deflated state. In some embodiments, the balloon <NUM> is made from silicone. In other embodiments, the balloon <NUM> can be made from polydimethylsiloxane (PDMS), polyurethane, polymers such as PEBAX™ material, nylon, or any other suitable material.

The balloon <NUM> can have any suitable diameter (in the inflated state). In various embodiments, the balloon <NUM> can have a diameter (in the inflated state) ranging from less than one millimeter (mm) up to <NUM>. In some embodiments, the balloon <NUM> can have a diameter (in the inflated state) ranging from at least <NUM> up to <NUM>. In some embodiments, the balloons104 can have a diameter (in the inflated state) ranging from at least two mm up to five mm.

In some embodiments, the balloon <NUM> can have a length ranging from at least three mm to <NUM>. More particularly, in some embodiments, the balloon <NUM> can have a length ranging from at least eight mm to <NUM>. It is appreciated that a balloon <NUM> having a relatively longer length can be positioned adjacent to larger treatment sites <NUM>, and, thus, may be used for imparting pressure waves onto and inducing fractures in larger vascular lesions 106A or multiple vascular lesions 106A at precise locations within the treatment site <NUM>. It is further appreciated that a longer balloon <NUM> can also be positioned adjacent to multiple treatment sites <NUM> at any one given time.

The balloon <NUM> can be inflated to inflation pressures of between approximately one atmosphere (atm) and <NUM> atm. In some embodiments, the balloon <NUM> can be inflated to inflation pressures of from at least <NUM> atm to <NUM> atm. In other embodiments, the balloon <NUM> can be inflated to inflation pressures of from at least six atm to <NUM> atm. In still other embodiments, the balloon <NUM> can be inflated to inflation pressures of from at least three atm to <NUM> atm. In yet other embodiments, the balloon <NUM> can be inflated to inflation pressures of from at least two atm to ten atm.

The balloon <NUM> can have various shapes, including, but not to be limited to, a conical shape, a square shape, a rectangular shape, a spherical shape, a conical/square shape, a conical/spherical shape, an extended spherical shape, an oval shape, a tapered shape, a bone shape, a stepped diameter shape, an offset shape, or a conical offset shape. In some embodiments, the balloon <NUM> 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-neoplastic agents, anti-angiogenic agents, and the like.

The balloon fluid <NUM> can be a liquid or a gas. Some examples of the balloon fluid <NUM> suitable for use can include, but are not limited to one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases, such as carbon dioxide, or any other suitable balloon fluid <NUM>. In some embodiments, the balloon fluid <NUM> can be used as a base inflation fluid. In some embodiments, the balloon fluid <NUM> can include a mixture of saline to contrast medium in a volume ratio of approximately <NUM>:<NUM>. In other embodiments, the balloon fluid <NUM> can include a mixture of saline to contrast medium in a volume ratio of approximately <NUM>:<NUM>. In still other embodiments, the balloon fluid <NUM> can include a mixture of saline to contrast medium in a volume ratio of approximately <NUM>:<NUM>. However, it is understood that any suitable ratio of saline to contrast medium can be used. The balloon fluid <NUM> can be tailored on the basis of composition, viscosity, and the like so that the rate of travel of the pressure waves are appropriately manipulated. In certain embodiments, the balloon fluid <NUM> suitable for use herein is biocompatible. A volume of balloon fluid <NUM> can be tailored by the chosen light source <NUM> and the type of balloon fluid <NUM> used.

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

The balloon fluids <NUM> can include those that include absorptive agents that can selectively absorb light in the ultraviolet region (e.g., at least ten nanometers (nm) to <NUM>), the visible region (e.g., at least <NUM> to <NUM>), or the near-infrared region (e.g., at least <NUM> to <NUM>) of the electromagnetic spectrum. Suitable absorptive agents can include those with absorption maxima along the spectrum from at least ten nm to <NUM>. Alternatively, the balloon fluid <NUM> can include absorptive agents that can selectively absorb light in the mid-infrared region (e.g., at least <NUM> to <NUM>), or the far-infrared region (e.g., at least <NUM> to one mm) of the electromagnetic spectrum. In various embodiments, the absorptive agent can be those that have an absorption maximum matched with the emission maximum of the laser used in the catheter system <NUM>. By way of non-limiting examples, various lasers described herein can include neodymium:yttrium-aluminum-garnet (Nd:YAG - emission maximum = <NUM>) lasers, holmium:YAG (Ho:YAG - emission maximum = <NUM>) lasers, or erbium:YAG (Er:YAG - emission maximum = <NUM>) lasers. In some embodiments, the absorptive agents can be water soluble. In other embodiments, the absorptive agents are not water soluble. In some embodiments, the absorptive agents used in the balloon fluids <NUM> can be tailored to match the peak emission of the light source <NUM>. Various light sources <NUM> having emission wavelengths of at least ten nanometers to one millimeter are discussed elsewhere herein.

The catheter shaft <NUM> of the catheter <NUM> can be coupled to the one or more light guides 122A of the light guide bundle <NUM> that are in optical communication with the light source <NUM>. The light guide(s) 122A can be disposed along the catheter shaft <NUM> and within the balloon <NUM>. Each of the light guides 122A can have a guide distal end 122D that is at any suitable longitudinal position relative to a length of the balloon <NUM>. In some embodiments, each light guide 122A can be an optical fiber, and the light source <NUM> can be a laser. The light source <NUM> can be in optical communication with the light guides 122A at the proximal portion <NUM> of the catheter system <NUM>. More particularly, the light source <NUM> can selectively, simultaneously, sequentially, and/or be in optical communication with each of the light guides 122A in any desired combination, order, and/or pattern due to the presence and operation of the multiplexer <NUM>.

In some embodiments, the catheter shaft <NUM> 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 disposed at any suitable positions about the guidewire lumen <NUM> and/or the catheter shaft <NUM>. For example, in certain non-exclusive embodiments, two light guides 122A can be spaced apart by approximately <NUM> degrees about the circumference of the guidewire lumen <NUM> and/or the catheter shaft <NUM>; three light guides 122A can be spaced apart by approximately <NUM> degrees about the circumference of the guidewire lumen <NUM> and/or the catheter shaft <NUM>, or four light guides 122A can be spaced apart by approximately <NUM> degrees about the circumference of the guidewire lumen <NUM> and/or the catheter shaft <NUM>. Still alternatively, multiple light guides 122A need not be uniformly spaced apart from one another about the circumference of the guidewire lumen <NUM> and/or the catheter shaft <NUM>. More particularly, the light guides 122A can be disposed either uniformly or non-uniformly about the guidewire lumen <NUM> and/or the catheter shaft <NUM> to achieve the desired effect in the desired locations.

The catheter system <NUM> and/or the light guide bundle <NUM> can include any number of light guides 122A in optical communication with the light source <NUM> at the proximal portion <NUM>, and with the balloon fluid <NUM> within the balloon interior <NUM> of the balloon <NUM> at the distal portion <NUM>. For example, in some embodiments, the catheter system <NUM> and/or the light guide bundle <NUM> can include from one light guide 122A to five light guides 122A. In other embodiments, the catheter system <NUM> and/or the light guide bundle <NUM> can include from five light guides 122A to fifteen light guides 122A. In yet other embodiments, the catheter system <NUM> and/or the light guide bundle <NUM> can include from ten light guides 122A to thirty light guides 122A. Alternatively, in still other embodiments, the catheter system <NUM> and/or the light guide bundle <NUM> can include greater than <NUM> light guides 122A.

The light guides 122A can have any suitable design for purposes of generating plasma and/or pressure waves in the balloon fluid <NUM> within the balloon interior <NUM>. In certain embodiments, the light guides 122A can include an optical fiber or flexible light pipe. The light guides 122A can be thin and flexible and can allow light signals to be sent with very little loss of strength. The light guides 122A can include a core surrounded by a cladding about its circumference. In some embodiments, the core can be a cylindrical core or a partially cylindrical core. The core and cladding of the light guides 122A can 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 guides 122A may also include a protective coating, such as a polymer. It is appreciated that the index of refraction of the core will be greater than the index of refraction of the cladding.

Each light guide 122A can guide light energy along its length from a guide proximal end 122P to the guide distal end 122D having at least one optical window (not shown) that is positioned within the balloon interior <NUM>.

The light guides 122A can assume many configurations about and/or relative to the catheter shaft <NUM> of the catheter <NUM>. In some embodiments, the light guides 122A can run parallel to the longitudinal axis <NUM> of the catheter shaft <NUM>. In some embodiments, the light guides 122A can be physically coupled to the catheter shaft <NUM>. In other embodiments, the light guides 122A can be disposed along a length of an outer diameter of the catheter shaft <NUM>. In yet other embodiments, the light guides 122A can be disposed within one or more light guide lumens within the catheter shaft <NUM>.

The light guides 122A can also be disposed at any suitable positions about the circumference of the guidewire lumen <NUM> and/or the catheter shaft <NUM>, and the guide distal end 122D of each of the light guides 122A can be disposed at any suitable longitudinal position relative to the length of the balloon <NUM> and/or relative to the length of the guidewire lumen <NUM> to more effectively and precisely impart pressure waves for purposes of disrupting the vascular lesions 106A at the treatment site <NUM>.

In certain embodiments, the light guides 122A can include one or more photoacoustic transducers <NUM>, where each photoacoustic transducer <NUM> can be in optical communication with the light guide 122A within which it is disposed. In some embodiments, the photoacoustic transducers <NUM> can be in optical communication with the guide distal end 122D of the light guide 122A. Additionally, in such embodiments, the photoacoustic transducers <NUM> can have a shape that corresponds with and/or conforms to the guide distal end 122D of the light guide 122A.

The photoacoustic transducer <NUM> is configured to convert light energy into an acoustic wave at or near the guide distal end 122D of the light guide 122A. The direction of the acoustic wave can be tailored by changing an angle of the guide distal end 122D of the light guide 122A.

In certain embodiments, the photoacoustic transducers <NUM> disposed at the guide distal end 122D of the light guide 122A can assume the same shape as the guide distal end 122D of the light guide 122A. For example, in certain non-exclusive embodiments, the photoacoustic transducer <NUM> 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 half-circle shape, an ovoid shape, and the like. The light guide 122A can further include additional photoacoustic transducers <NUM> disposed along one or more side surfaces of the length of the light guide 122A.

In some embodiments, the light guides 122A can further include one or more diverting features or "diverters" (not shown in <FIG>) within the light guide 122A that are configured to direct light to exit the light guide 122A toward a side surface which can be located at or near the guide distal end 122D of the light guide 122A, and toward the balloon wall <NUM>. A diverting feature can include any feature of the system that diverts light energy from the light guide 122A away from its axial path toward a side surface of the light guide 122A. Additionally, the light guides 122A can each include one or more light windows disposed along the longitudinal or circumferential surfaces of each light guide 122A and in optical communication with a diverting feature. Stated in another manner, the diverting features can be configured to direct light energy in the light guide 122A toward a side surface that is at or near the guide distal end 122D, where the side surface is in optical communication with a light window. The light windows can include a portion of the light guide 122A that allows light energy to exit the light guide 122A from within the light guide 122A, such as a portion of the light guide 122A lacking a cladding material on or about the light guide 122A.

Examples of the diverting features suitable for use include a reflecting element, a refracting element, and a fiber diffuser. The diverting features suitable for focusing light energy away from the tip of the light guides 122A can include but are not to be limited to, those having a convex surface, a gradient-index (GRIN) lens, and a mirror focus lens. Upon contact with the diverting feature, the light energy is diverted within the light guide 122A to one or more of a plasma generator <NUM> and the photoacoustic transducer <NUM> that is in optical communication with a side surface of the light guide 122A. As noted, the photoacoustic transducer <NUM> then converts light energy into an acoustic wave that extends away from the side surface of the light guide 122A.

The source manifold <NUM> can be positioned at or near the proximal portion <NUM> of the catheter system <NUM>. The source manifold <NUM> can include one or more proximal end openings that can receive the one or more light guides 122A of the light guide bundle <NUM>, the guidewire <NUM>, and/or an inflation conduit <NUM> that is coupled in fluid communication with the fluid pump <NUM>. The catheter system <NUM> can also include the fluid pump <NUM> that is configured to inflate the balloon <NUM> with the balloon fluid <NUM> as needed.

As noted above, in the embodiment illustrated in <FIG>, the multiplexer <NUM> includes one or more of the light source <NUM>, the power source <NUM>, the system controller <NUM>, and the GUI <NUM>. Alternatively, the multiplexer <NUM> can include more components or fewer components than those specifically illustrated in <FIG>. For example, in certain non-exclusive alternative embodiments, the multiplexer <NUM> can be designed without the GUI <NUM>. Still alternatively, one or more of the light source <NUM>, the power source <NUM>, the system controller <NUM>, and the GUI <NUM> can be provided within the catheter system <NUM> without the specific need for the multiplexer <NUM>.

In some embodiments, the multiplexer <NUM> can include a two-channel splitter design. The light guide bundle <NUM> can include a manual positioning mechanism that is mounted on an optical breadboard and/or platen. This design enables linear positional adjustment and array tilting by rotating about a channel one light guide 122A axis (not shown in <FIG>). The adjustment method, in other embodiments, can include at least two adjustment steps, <NUM>) aligning the planar positions of the source beam 124B at Channel <NUM>, and <NUM>) adjusting the light guide bundle <NUM> to achieve the best alignment at Channel <NUM>.

As shown, the multiplexer <NUM>, and the components included therewith, is operatively coupled to the catheter <NUM>, the light guide bundle <NUM>, and the remainder of the catheter system <NUM>. For example, in some embodiments, as illustrated in <FIG>, the multiplexer <NUM> can include a console connection aperture <NUM> (also sometimes referred to generally as a "socket") by which the light guide bundle <NUM> is mechanically coupled to the multiplexer <NUM>. In such embodiments, the light guide bundle <NUM> can include a guide coupling housing <NUM> that houses a portion, e.g., the guide proximal end 122P, of each of the light guides 122A. The guide coupling housing <NUM> is configured to fit and be selectively retained within the console connection aperture <NUM> to provide the mechanical coupling between the light guide bundle <NUM> and the multiplexer <NUM>.

The light guide bundle <NUM> can also include a guide bundle <NUM> (or "shell") that brings each of the individual light guides 122A closer together so that the light guides 122A and/or the light guide bundle <NUM> can be in a more compact form as it extends with the catheter <NUM> into the blood vessel <NUM> during use of the catheter system <NUM>. In some embodiments, the light guides 122A leading to the plasma generator <NUM> can be organized into a light guide bundle <NUM> including a linear block with an array of precision holes forming a multi-channel ferrule <NUM> (illustrated in <FIG>, for example). In other embodiments, the light guide bundle <NUM> could include a mechanical connector array or block connector that organizes singular ferrules <NUM> into one of (i) a linear array, (ii) a circular pattern, and (iii) a hexagonal pattern.

The light source <NUM> can be selectively and/or alternatively coupled in optical communication with each of the light guides 122A, i.e. to the guide proximal end 122P of each of the light guides 122A, in the light guide bundle <NUM>. In particular, the light source <NUM> is configured to generate light energy in the form of a source beam 124A, such as a pulsed source beam, that can be selectively and/or alternatively directed to and received by each of the light guides 122A in the light guide bundle <NUM> as an individual guide beam 124B. Alternatively, the catheter system <NUM> can include more than one light source <NUM>. For example, in one non-exclusive alternative embodiment, the catheter system <NUM> can include a separate light source <NUM> for each of the light guides 122A in the light guide bundle <NUM>. The light source <NUM> can be operated at low energies.

The light source <NUM> can have any suitable design. In certain embodiments, the light source <NUM> can be configured to provide sub-millisecond pulses of light energy from the light source <NUM> that are focused onto a small spot in order to couple it into the guide proximal end 122P of the light guide 122A. Such pulses of light energy are then directed and/or guided along the light guides 122A to a location within the balloon interior <NUM> of the balloon <NUM>, thereby inducing plasma formation (also sometimes referred to herein as a "plasma flash") in the balloon fluid <NUM> within the balloon interior <NUM> of the balloon <NUM>, such as via the plasma generator <NUM> that can be located at the guide distal end 122D of the light guide 122A. In particular, the light emitted at the guide distal end 122D of the light guide 122A energizes the plasma generator <NUM> to form the plasma within the balloon fluid <NUM> within the balloon interior <NUM>. The plasma formation causes rapid bubble formation and imparts pressure waves upon the treatment site <NUM>. An exemplary plasma-induced bubble <NUM> is illustrated in <FIG>.

In various non-exclusive alternative embodiments, the sub-millisecond pulses of light energy from the light source <NUM> can be delivered to the treatment site <NUM> at a frequency of between approximately one hertz (Hz) and <NUM>, between approximately <NUM> and <NUM>, between approximately ten Hz and <NUM>, or between approximately one Hz and <NUM>. Alternatively, the sub-millisecond pulses of light energy can be delivered to the treatment site <NUM> at a frequency that can be greater than <NUM> or less than one Hz, or any other suitable range of frequencies.

It is appreciated that although the light source <NUM> is typically utilized to provide pulses of light energy, the light source <NUM> can still be described as providing a single source beam 124A, i.e. a single pulsed source beam.

The light sources <NUM> suitable for use can include various types of light sources including lasers and lamps. For example, in certain non-exclusive embodiments, the light source <NUM> can be an infrared laser that emits light energy in the form of pulses of infrared light. Alternatively, as noted above, the light sources <NUM>, as referred to herein, can include any suitable type of energy source.

Suitable lasers can include short pulse lasers on the sub-millisecond timescale. In some embodiments, the light source <NUM> can include lasers on the nanosecond (ns) timescale. The lasers can also include short pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (us) timescales. It is appreciated that there are many combinations of laser wavelengths, pulse widths, and energy levels that can be employed to achieve plasma in the balloon fluid <NUM> of the catheter <NUM>. In various non-exclusive alternative embodiments, the pulse widths can include those falling within a range including from at least ten ns to <NUM> ns, at least <NUM> ns to <NUM> ns, or at least one ns to <NUM> ns. Alternatively, any other suitable pulse width range can be used.

Exemplary nanosecond lasers can include those within the UV to IR spectrum, spanning wavelengths of about ten nanometers (nm) to one millimeter (mm). In some embodiments, the light sources <NUM> suitable for use in the catheter system <NUM> can include those capable of producing light at wavelengths of from at least <NUM> to <NUM>. In other embodiments, the light sources <NUM> can include those capable of producing light at wavelengths of from at least <NUM> to <NUM>. In still other embodiments, the light sources <NUM> can include those capable of producing light at wavelengths of from at least <NUM> to ten micrometers (µm). Nanosecond lasers can include those having repetition rates of up to <NUM>. 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, holmium:yttrium-aluminum-garnet (Ho:YAG) laser, erbium:yttrium-aluminum-garnet (Er:YAG) laser, excimer laser, helium-neon laser, carbon dioxide laser, as well as doped, pulsed, fiber lasers.

The catheter system <NUM> can generate pressure waves having maximum pressures in the range of at least one megapascal (MPa) to <NUM> MPa. The maximum pressure generated by a particular catheter system <NUM> will depend on the light source <NUM>, the absorbing material, the bubble expansion, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter system <NUM> can generate pressure waves having maximum pressures in the range of at least approximately two MPa to <NUM> MPa, at least approximately two MPa to <NUM> MPa, or at least approximately <NUM> MPa to <NUM> MPa.

The pressure waves can be imparted upon the treatment site <NUM> from a distance within a range from at least approximately <NUM> millimeters (mm) to greater than approximately <NUM> extending radially from the light guides 122A when the catheter <NUM> is placed at the treatment site <NUM>. In various non-exclusive alternative embodiments, the pressure waves can be imparted upon the treatment site <NUM> from a distance within a range from at least approximately ten mm to <NUM>, at least approximately one mm to ten mm, at least approximately <NUM> to four mm, or at least approximately <NUM> to ten mm extending radially from the light guides 122A when the catheter <NUM> is placed at the treatment site <NUM>. In other embodiments, the pressure waves can be imparted upon the treatment site <NUM> from another suitable distance that is different than the foregoing ranges. In some embodiments, the pressure waves can be imparted upon the treatment site <NUM> within a range of at least approximately two MPa to <NUM> MPa at a distance from at least approximately <NUM> to ten mm. In some embodiments, the pressure waves can be imparted upon the treatment site <NUM> from a range of at least approximately two MPa to <NUM> MPa at a distance from at least approximately <NUM> to ten mm. Still alternatively, other suitable pressure ranges and distances can be used.

The power source <NUM> is electrically coupled to and is configured to provide the necessary power to each of the light source <NUM>, the system controller <NUM>, the GUI <NUM>, and the handle assembly <NUM>. The power source <NUM> can have any suitable design for such purposes.

The system controller <NUM> is electrically coupled to and receives power from the power source <NUM>. Additionally, the system controller <NUM> is coupled to and is configured to control the operation of each of the light source <NUM>, and the GUI <NUM>. The system controller <NUM> can include one or more processors or circuits for purposes of controlling the operation of at least the light source <NUM>, and the GUI <NUM>. For example, the system controller <NUM> can control the light source <NUM> for generating pulses of light energy as desired and/or at any desired firing rate.

The system controller <NUM> can further be configured to control the operation of other components of the catheter system <NUM> such as the positioning of the catheter <NUM> adjacent to the treatment site <NUM>, the inflation of the balloon <NUM> with the balloon fluid <NUM>, etc. Further, or in the alternative, the catheter system <NUM> can include one or more additional controllers that can be positioned in any suitable manner for purposes of controlling the various operations of the catheter system <NUM>. For example, in certain embodiments, an additional controller and/or a portion of the system controller <NUM> can be positioned and/or incorporated within the handle assembly <NUM>.

The GUI <NUM> is accessible by the user or operator of the catheter system <NUM>. Additionally, the GUI <NUM> is electrically connected to the system controller <NUM>. With such design, the GUI <NUM> can be used by the user or operator to ensure that the catheter system <NUM> is effectively utilized to impart pressure onto and induce fractures at the treatment site(s) <NUM>. The GUI <NUM> can provide the user or operator with information that can be used before, during, and after use of the catheter system <NUM>. In one embodiment, the GUI <NUM> can provide static visual data and/or information to the user or operator. In addition, or in the alternative, the GUI <NUM> can provide dynamic visual data and/or information to the user or operator, such as video data or any other data that changes over time during the use of the catheter system <NUM>. In various embodiments, the GUI <NUM> can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the user or operator. Additionally, or in the alternative, the GUI <NUM> can provide audio data or information to the user or operator. The specifics of the GUI <NUM> can vary depending upon the design requirements of the catheter system <NUM>, or the specific needs, specifications, and/or desires of the user or operator.

As shown in <FIG>, the handle assembly <NUM> can be positioned at or near the proximal portion <NUM> of the catheter system <NUM>, and/or near the source manifold <NUM>. In this embodiment, the handle assembly <NUM> is coupled to the balloon <NUM> and is positioned spaced apart from the balloon <NUM>. Alternatively, the handle assembly <NUM> can be positioned at another suitable location.

The handle assembly <NUM> is handled and used by the user or operator to operate, position, and control the catheter <NUM>. The design and specific features of the handle assembly <NUM> can vary to suit the design requirements of the catheter system <NUM>. In the embodiment illustrated in <FIG>, the handle assembly <NUM> is separate from, but in electrical and/or fluid communication with one or more of the system controller <NUM>, the light source <NUM>, the fluid pump <NUM>, and the GUI <NUM>. In some embodiments, the handle assembly <NUM> can integrate and/or include at least a portion of the system controller <NUM> within an interior of the handle assembly <NUM>. For example, as shown, in certain such embodiments, the handle assembly <NUM> can include circuitry <NUM> that can form at least a portion of the system controller <NUM>.

In one embodiment, the circuitry <NUM> can include a printed circuit board having one or more integrated circuits, or any other suitable circuitry. In an alternative embodiment, the circuitry <NUM> can be omitted or can be included within the system controller <NUM>, which in various embodiments can be positioned outside of the handle assembly <NUM>, e.g., within the multiplexer <NUM>. It is understood that the handle assembly <NUM> can include fewer or additional components than those specifically illustrated and described herein.

<FIG> is a top view of a portion of an embodiment of the catheter system <NUM> (illustrated in <FIG>) including an embodiment of a guide bundle <NUM>. As illustrated in the embodiment in <FIG>, the guide coupling housing <NUM> houses one or more ferrule assemblies <NUM> and one or more alignment guide receivers <NUM>. The ferrule assemblies <NUM> can each include a ferrule <NUM> (illustrated in <FIG>, for example), a portion of the individual light guide 222A, including the guide proximal end 122P (illustrated in <FIG>, for example), and a spring <NUM> (illustrated in <FIG>, for example). The ferrule assembly <NUM> can retain the ferrule <NUM>. In certain embodiments, the light guide 222A can be engaged by a ferrule assembly <NUM>. In particular, the guide proximal end 122P can be terminated into individual ferrules <NUM> of the ferrule assembly <NUM>. The ferrule assembly <NUM> can be configured to provide increased localization and improved alignment guides that enable each ferrule <NUM> to be inserted into receptacle holes <NUM> (illustrated in <FIG>, for example) within the receptacle assembly <NUM> (illustrated in <FIG>, for example) without damaging the ferrules <NUM>.

The ferrule assembly <NUM> can vary depending on the design requirements of the catheter system <NUM>, the light guide 222A, the guide proximal end 122P, and/or guide bundle <NUM>. It is understood that the ferrule assembly <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the ferrule assembly <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein. The ferrule assembly <NUM> can be positioned in any suitable location, including those shown in <FIG>.

The ferrule assembly <NUM> can vary in shape. In some embodiments, the ferrule assembly <NUM> can be substantially plug-shaped, as shown in the embodiment illustrated in <FIG>. In other embodiments, the ferrule assembly <NUM> can be substantially cylindrical-shaped, prism-shaped, cube-shaped, cuboid-shaped, and/or tube-shaped.

The ferrule assembly <NUM> can be formed with any suitable material. In certain embodiments, the ferrule assembly <NUM> can be at least partially formed from a metal, a plastic, a polymer, a ceramic, a composite, and/or an organic material. In other embodiments, the ferrule assembly <NUM> can be formed using mold-injected plastics.

The alignment guide receiver <NUM> receives an alignment guide <NUM> (illustrated in <FIG>, for example). The alignment guide receiver <NUM> can be configured to improve the mating of the ferrule <NUM> with the receptacle hole <NUM> within the receptacle assembly <NUM>.

The alignment guide receiver <NUM> can vary depending on the design requirements of the catheter system <NUM>, the guide bundle <NUM>, and/or the alignment guide <NUM>. It is understood that the alignment guide receiver <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the alignment guide receiver <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein. The alignment guide receiver <NUM> can be positioned in any suitable location, including those shown in <FIG>.

In the embodiment shown in <FIG>, the alignment guide receiver <NUM> is a pin receiver. Non-limiting, 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.

<FIG> is a perspective front view of a portion of an embodiment of the catheter system <NUM> (illustrated in <FIG>) including an embodiment of a guide bundle <NUM>. In particular, greater detail of the shape and design of the embodiments of the guide coupling housing <NUM>, the guide bundle <NUM>, and the ferrule assembly <NUM> are illustrated in <FIG>. For example, as shown in <FIG>, the guide coupling housing <NUM> can have a substantially trapezoidal side-profile and a substantially trapezoidal-prism shape. The guide coupling housing <NUM> can extend outwardly from the guide bundle <NUM>. The guide coupling housing <NUM> can include one or more apertures, each of the ferrule assemblies <NUM> can extend through corresponding apertures. As illustrated in the embodiment in <FIG>, the ferrule assemblies <NUM> can be substantially cylindrical with a partially spherical end portion. The ferrule assemblies <NUM> can include an opening or orifice in order to receive the guide beams 122B (illustrated in <FIG>) from the multiplexer <NUM> (Illustrated in <FIG>).

<FIG> is a perspective front view of a portion of an embodiment of the catheter system <NUM> (illustrated in <FIG>) including an embodiment of a receptacle assembly <NUM>. As illustrated in the embodiment in <FIG>, the receptacle assembly <NUM> can include one or more of a receptacle block <NUM>, a receptacle housing <NUM>, a receptacle hole <NUM>, and an alignment guide <NUM>. The receptacle assembly <NUM> can be configured to mate with the guide bundle <NUM> (illustrated in <FIG>, for example) so that the guide beams 122B are aligned with each of the light guides 222A (illustrated in <FIG>, for example) within the guide bundle <NUM>.

The receptacle assembly <NUM> can vary depending on the design requirements of the catheter system <NUM>, the light guides 222A, the guide bundle <NUM> and/or the ferrule assembly <NUM> (illustrated in <FIG>, for example). It is understood that the receptacle assembly <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the receptacle assembly <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein. The receptacle assembly <NUM> can be positioned in any suitable location, including those shown in <FIG>.

The receptacle assembly <NUM> can be formed from any suitable material. In some embodiments, the components of the receptacle assembly <NUM> can be formed at least partially from a metal, a plastic, a ceramic, a polymer, a composite, and/or an organic material. In certain embodiments, the components of the receptacle assembly <NUM> can be formed from a hardened stainless steel configured to have increased resilience and resistance to wear and tear.

The receptacle block <NUM> can be configured to receive the guide bundle <NUM>. The receptacle block <NUM> can vary depending on the design requirements of the catheter system <NUM>, the light guides 222A, the guide bundle <NUM>, and/or the receptacle assembly <NUM>. It is understood that the receptacle block <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the receptacle block <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein. The receptacle block <NUM> can be positioned in any suitable location, including those shown in <FIG>.

The receptacle housing <NUM> can house the receptacle block <NUM>. In some embodiments, the receptacle housing <NUM> can be coupled to the receptacle block <NUM>. The receptacle housing <NUM> can vary depending on the design requirements of the catheter system <NUM>, the light guides 222A, the guide bundle <NUM>, the receptacle assembly <NUM>, and/or the receptacle block <NUM>. It is understood that the receptacle housing <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the receptacle housing <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein. The receptacle housing <NUM> can be positioned in any suitable location, including those shown in <FIG>.

The receptacle hole <NUM> can be precision-bored into the receptacle block <NUM>. Alternatively, the receptacle hole <NUM> can be formed in the receptacle block <NUM> by any suitable method known in the art. As shown in the embodiment in <FIG>, one or more receptacle holes <NUM> can be aligned in a linear array in the receptacle block <NUM>. The receptacle hole <NUM> can vary depending on the design requirements of the catheter system <NUM>, the light guides 222A, the guide bundle <NUM>, the receptacle assembly <NUM>, and/or the receptacle block <NUM>. It is understood that the receptacle hole <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the receptacle hole <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein.

The receptacle hole <NUM> can be positioned in any suitable location, including those shown in <FIG>. The receptacle assembly <NUM> can include any suitable number of receptacle holes <NUM> such as <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> receptacle holes <NUM>. In other embodiments, the receptacle assembly <NUM> can include greater than <NUM> receptacle holes <NUM>.

The alignment guide <NUM> can be coupled to the receptacle block <NUM>. The alignment guide <NUM> can mate with the alignment guide receiver <NUM> (illustrated in <FIG>) so that the guide bundle <NUM> and the receptacle assembly <NUM> are at least partially aligned and/or coupled (for example, as illustrated in <FIG>). The alignment guide <NUM> can vary depending on the design requirements of the catheter system <NUM>, the light guides 222A, the guide bundle <NUM>, the alignment guide receiver <NUM>, the receptacle assembly <NUM>, and/or the receptacle block <NUM>. It is understood that the alignment guide <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the alignment guide <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein.

The alignment guide <NUM> can be positioned in any suitable location, including those shown in <FIG>. The alignment guide <NUM> can be substantially dowel-shaped. The receptacle assembly <NUM> can include any suitable number of alignment guides <NUM> such as <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> alignment guides <NUM>. In other embodiments, the receptacle assembly <NUM> can include greater than <NUM> alignment guides <NUM>. The alignment guide <NUM> can be any suitable alignment guide <NUM> known within the art. In the embodiment shown in <FIG>, the alignment guide <NUM> is a guide pin. Non-limiting, non-exclusive examples of suitable alignment guides include (i) a guide tongue of a tongue and groove system, (ii) a guide tab of a tab and slot system, and (iii) a guide rail of a rail and channel system.

<FIG> is a perspective rear view of a portion of an embodiment of the catheter system <NUM> (illustrated in <FIG>) including an embodiment of a receptacle assembly <NUM>. As illustrated in the embodiment displayed in <FIG>, the receptacle assembly <NUM> can include a receptacle housing <NUM> and a backing plate <NUM> including one or more alignment holes <NUM>.

The backing plate <NUM> can be configured to receive a proximal end face of the ferrules <NUM>. The backing plate <NUM> can provide a precision reference plane for aligning the guide beams 122B from the multiplexer <NUM> to each of the corresponding light guides 122A (illustrated in <FIG>). The alignment holes <NUM> can be precision-bored into the backing plate <NUM>. The alignment holes <NUM> can be formed into the backing plate <NUM> using any suitable method known in the art. The alignment holes <NUM> can be configured to couple the focused guide beams 122B with each of the corresponding light guides 122A.

The backing plate <NUM> and alignment holes <NUM> can vary depending on the design requirements of the catheter system <NUM>, the light guides 222A, the guide bundle <NUM>, the alignment guide receiver <NUM>, the receptacle assembly <NUM>, and/or the receptacle block <NUM>. It is understood that the backing plate <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the backing plate <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein. The backing plate <NUM> and alignment holes <NUM> can be positioned in any suitable location, including those shown in <FIG>. In certain embodiments, the alignment holes <NUM> can have a smaller diameter than the diameter of the ferrule <NUM>. The alignment holes <NUM> can have a sufficiently-sized diameter in order to accommodate the entire guide beam 128B without clipping.

<FIG> is a top view of a portion of an embodiment of the catheter system <NUM> (illustrated in <FIG>) including an embodiment of a guide bundle <NUM> including light guides 622A and a receptacle assembly <NUM>, the guide bundle <NUM> being shown in a partially connected state with respect to the receptacle assembly <NUM>. In particular, in the embodiment illustrated in <FIG>, the guide coupling housing <NUM> is advanced so that the ferrule assemblies <NUM> and the alignment guides <NUM> are partially seated within the receptacle block <NUM>.

<FIG> is a simplified cross-sectional view of a portion of an embodiment of the catheter system <NUM> (illustrated in <FIG>) taken on line <NUM>-<NUM> in <FIG>, the catheter system <NUM> including an embodiment of a guide coupling housing <NUM> including light guides 722A and a receptacle assembly <NUM>, the guide coupling housing <NUM> being shown in a partially connected state with respect to the receptacle assembly <NUM>. In particular, in the embodiment illustrated in <FIG>, the guide coupling housing <NUM> is advanced so that the ferrule assemblies <NUM> and the alignment guides <NUM> are partially seated within the receptacle block <NUM>. In <FIG>, the ferrule assembly <NUM> is (i) partially extended through the receptacle hole <NUM>, and (ii) partially engaged with the backing plate <NUM> of the receptacle assembly <NUM> so that the alignment hole <NUM> is aligned with the ferrule assembly <NUM>. As illustrated in the embodiment displayed in <FIG>, the ferrule assembly <NUM> can further include a spring <NUM>, a ferrule <NUM>, and a ferrule collar <NUM>.

The spring <NUM> can engage the ferrule <NUM> and/or the ferrule collar <NUM> within the ferrule assembly <NUM>. The spring <NUM> can be configured to provide an insertion force when the ferrule assembly <NUM> is inserted into the receptacle hole <NUM>. The spring <NUM> can vary depending on the design requirements of the catheter system <NUM>, the light guides 222A, the guide coupling housing <NUM>, the receptacle assembly <NUM>, the receptacle hole <NUM>, the ferrule <NUM>, and/or the ferrule collar <NUM>. It is understood that the spring <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the spring <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein. The spring <NUM> can be positioned in any suitable location, including those shown in <FIG>. The spring <NUM> can be a spiral spring.

The ferrule <NUM> can engage the guide proximal end 122P (illustrated in <FIG>) of the light guide 722A within the ferrule assembly <NUM>. The ferrule <NUM> can fasten, reinforce, and/or seal the guide proximal end 122P of the light guide 722A. The ferrule <NUM> can vary depending on the design requirements of the catheter system <NUM>, the light guides 722A, the guide coupling housing <NUM>, the receptacle assembly <NUM>, the receptacle hole <NUM>, the spring <NUM>, and/or the ferrule collar <NUM>. It is understood that the ferrule <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the ferrule <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein. The ferrule <NUM> can be positioned in any suitable location, including those shown in <FIG>.

The ferrule <NUM> can be formed from any suitable material. In certain embodiments, the ferrule <NUM> can be partially formed from a metal, a plastic, a ceramic, a polymer, a composite, and/or an organic material. The ferrule <NUM> can have a proximal end face 778P. In some embodiments, the proximal end face 778P can engage the backing plate <NUM> when the ferrule <NUM> is at least partially inserted in the receptacle hole <NUM>. As shown in <FIG>, the alignment hole <NUM> can have a smaller diameter than the ferrule <NUM> so that the proximal end face 778P of the ferrule <NUM> is seated on the alignment hole <NUM>.

The ferrule collar <NUM> can back the ferrule <NUM>. The ferrule collar <NUM> can be seated within the spring <NUM>. The ferrule <NUM> can vary depending on the design requirements of the catheter system <NUM>, the light guides 222A, the guide coupling housing <NUM>, the receptacle assembly <NUM>, the receptacle hole <NUM>, the spring <NUM>, and/or the ferrule collar <NUM>. It is understood that the ferrule <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the ferrule <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein. The ferrule <NUM> can be positioned in any suitable location, including those shown in <FIG>.

<FIG> is a perspective front view of a portion of an embodiment of the catheter system <NUM> (illustrated in <FIG>) including an embodiment of a receptacle assembly <NUM>. <FIG> illustrates one embodiment of the receptacle assembly <NUM> that is slightly different than the other embodiments described herein. In the embodiment illustrated in <FIG>, the receptacle block <NUM> includes one or more receptacle holes <NUM> that are formed in a linear array as v-grooves, rather than singular holes.

In some embodiments, the v-groove receptacle holes <NUM> shown in <FIG> can be formed by cutting into a hardened block of stainless steel. The v-grooves can be electrical discharge machine cut into the receptacle holes <NUM>. The v-grooves provide at least two contact lines while the ferrule <NUM> is retained within the receptacle hole <NUM>. In the embodiment illustrated in <FIG>, the receptacle assembly <NUM> can include a retainer assembly <NUM> including a clamping bar <NUM> having a clamping bar axis 882a, and a plunger <NUM>. The retaining assembly <NUM> retains the ferrule <NUM> within the receptacle hole <NUM>. The retaining assembly <NUM> can be configured to reduce and/or inhibit the insertion forces required to retain the ferrule <NUM> within the receptacle hole <NUM>.

The retaining assembly <NUM> can vary depending on the design requirements of the catheter system <NUM>, the receptacle assembly <NUM>, and/or the ferrule <NUM>. It is understood that the retaining assembly <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the retaining assembly <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein. The retaining assembly <NUM> can be positioned in any suitable location, including those shown in <FIG>.

The clamping bar <NUM> clamps the ferrule <NUM> into the receptacle hole <NUM>. The clamping bar <NUM> can be moved about the clamping bar axis 882a to apply and/or remove a retaining force onto one or more ferrule <NUM> (for example, see <FIG>). In certain embodiments, the clamping bar <NUM> can be raised and lowered thereby allowing (i) movement of the ferrule <NUM> upon insertion, and (ii) retention of the ferrule <NUM> once the proximal end face 778P is seated against the backing plate <NUM> (illustrated in <FIG>) and the clamping bar <NUM> is lowered to retain the ferrule <NUM>.

The clamping bar <NUM> can vary depending on the design requirements of the catheter system <NUM>, the receptacle assembly <NUM>, the ferrule <NUM>, the retaining assembly <NUM>, and/or the plunger <NUM>. It is understood that the clamping bar <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the clamping bar <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein. The clamping bar <NUM> can be positioned in any suitable location, including those shown in <FIG>.

The clamping bar <NUM> can include a compliant material and/or wave springs that are configured to spread a retaining force across the ferules <NUM> so that each of the ferrules <NUM> is retained within a corresponding receptacle hole <NUM>. The clamping bar <NUM> can retain the ferrule <NUM> so that the ferrule <NUM> is not free-floating within the receptacle hole <NUM>. The clamping bar <NUM> can also be configured to provide a uniform or substantially uniform retaining force to the ferrules <NUM>, as known in the art.

The plunger <NUM> engages (e.g., plunges) the ferrule <NUM> into the receptacle hole <NUM> so that the ferrule <NUM> is retained in place. In some embodiments, the plunger <NUM> engages the upper edges of the ferrule <NUM>, seating it into the v-groove of the receptacle hole <NUM>. The plunger <NUM> can vary depending on the design requirements of the catheter system <NUM>, the receptacle assembly <NUM>, the ferrule <NUM>, the retaining assembly <NUM>, and/or the clamping bar <NUM>. It is understood that the plunger <NUM> can include additional systems, subsystems, components, and elements than those specifically shown and/or described herein. Additionally, or alternatively, the plunger <NUM> can omit one or more of the systems, subsystems, and elements that are specifically shown and/or described herein.

The plunger <NUM> can be positioned in any suitable location, including those shown in <FIG>. The plunger <NUM> can be substantially similar in form and/or function as a ball-spring plunger. The plunger <NUM> can be integrated into the clamping bar <NUM> (for example, as illustrated in <FIG>).

<FIG> is a front elevation view of a portion of an embodiment of the catheter system <NUM> (illustrated in <FIG>) including an embodiment of a portion of a receptacle assembly <NUM>. <FIG> illustrates one embodiment of the receptacle assembly <NUM> that is slightly different than the other embodiments described herein. In the embodiment illustrated in <FIG>, greater detail is shown of the interior of the receptacle block <NUM> including a receptacle hole <NUM>. In <FIG>, the alignment hole <NUM> and the retaining assembly <NUM> including the clamping bar <NUM> and the plunger <NUM> are shown.

<FIG> is a simplified cross-sectional view of a portion of an embodiment of the catheter system <NUM> (illustrated in <FIG>) taken on line <NUM>-<NUM> in <FIG>, the catheter system <NUM> including an embodiment of a receptacle assembly <NUM>. <FIG> illustrates one embodiment of the receptacle assembly <NUM> that is slightly different than the other embodiments described herein. In the embodiment illustrated in <FIG>, the receptacle block <NUM> includes one or more receptacle holes <NUM> that are formed in a linear array as v-grooves, rather than singular holes. In the embodiment illustrated in <FIG>, the receptacle assembly <NUM> can include a retainer assembly <NUM> including a clamping bar <NUM>, and a plunger <NUM>. The retaining assembly <NUM> retains the ferrule <NUM> within the receptacle hole <NUM>. The retaining assembly <NUM> can be configured to reduce and/or inhibit the insertion forces required to retain the ferrule <NUM> within the receptacle hole <NUM>. The clamping bar <NUM> clamps the ferrule <NUM> into the receptacle hole <NUM>.

This technology provides a connector solution for multiple optical channels that improves optical coupling to an individual light guide organized in a multi-channel array. The technology can utilize individual, low-cost ferrules to terminate the light guides. These ferrules are carried in ferrule assembly included within the guide bundle. In some embodiments, the guide bundle aligns the ferrules into a linear array. The ferrules can float within the ferrule assembly with low location tolerances. The connectorized ferrule assembly can mate with a high-precision receptacle assembly including a receptacle plate and/or receptacle block. Mechanical features in the receptacle assembly capture and align the individual ferrules. These features can align the floating ferrules in an improved precision array with tightly controlled tolerances. This technology allows a single, stable energy source to be channeled sequentially through a plurality of channels with a variable number.

Specific advantages this technology provides include: <NUM>) enabling the use of low cost, high-precision, singular ferrules on a single-use device for an increased-reliability connection thereby reducing production costs, <NUM>) reducing the system performance dependence on the assembly of light guides into a ferrule block and the associated mechanical tolerances related to their location in a multi-channel array, <NUM>) reducing the performance dependence on accuracy of connecting and aligning the multi-channel array to the multiplexer, <NUM>) reducing the need for a high-cost, high-precision monolithic ferrule block.

In some embodiments the light guides are optical fibers, the energy source is a pulsed laser and the emitters are plasma generators. In its simplest form, the multiplexer is a precision linear mechanism that translates coupling optics along a linear path. This approach requires a single degree of freedom. A connector block organizes the individual optical fibers into a liner pattern with precise interval spacing.

In certain embodiments, the linear translation mechanism is electronically controlled by the system to line the beam path up sequentially with each individual fiber organized in the ferrule. The translating mechanism carries necessary beam directing optics and focusing optics to focus the laser energy onto each fiber for optimal coupling. That way, the low divergence of the laser beam over the short distance of motion of the translated coupling mechanism has a minimum impact on coupling efficiency to the fiber. The system drives the mechanism to align the beam path with a selected fiber optic channel and then fires the laser in pulsed or semi-continuous wave mode.

This system and method can be implemented for any multiplexer configuration either linear, circular, patterned, or scanned. In some embodiments, the system can include a probe and a plurality of primary laser beams that can be combined and spot traced by beam paths that are correlated to the parametric motion of the multiplexer mechanism.

It is appreciated that the systems and methods of optical alignment provided herein address multiple potential issues with the performance, reliability, and proper usage of an IVL catheter, in particular one that utilizes an energy source to create a localized plasma which in turn produces a high energy bubble inside a balloon. Specific problems solved by the systems and methods disclosed herein include:.

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 employed in its sense including "and/or" unless the content or context clearly dictates otherwise.

The headings used herein are provided for consistency with suggestions under <NUM> CFR <NUM> or otherwise to provide organizational cues. These headings shall not be viewed to limit or characterize the invention(s) set out in any claims that may issue from this disclosure. As an example, a description of a technology in the "Background" is not an admission that technology is prior art to any invention(s) in this disclosure. Neither is the "Summary" or "Abstract" to be considered as a characterization of the invention(s) set forth in issued claims.

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 others skilled in the art can appreciate and understand the principles and practices. As such, aspects have been described with reference to various specific and preferred embodiments and techniques.

It is understood that although a number of different embodiments of the catheter systems have been illustrated and described herein, one or more features of any one embodiment can be combined with one or more features of one or more of the other embodiments, provided that such combination satisfies the intent of the present invention.

Claim 1:
A catheter system for treating a treatment site within or adjacent to a vessel wall or a heart valve, the catheter system comprising:
a light source (<NUM>) configured to generate light energy;
a first light guide (122A) configured to receive the light energy from the light source, the first light guide having a guide proximal end;
a second light guide configured to receive the light energy from the light source, the second light guide having a guide proximal end; and
a guide bundle (<NUM>, <NUM>, <NUM>) that is in optical communication with the light source, the guide bundle bundling the first light guide and the second light guide, the guide bundle including a first ferrule (<NUM>) 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; and
a receptacle assembly (<NUM>) including (i) a first receptacle hole (<NUM>) that is configured to receive the first ferrule, and (ii) a second receptacle hole that is configured to receive the second ferrule;
wherein the receptacle assembly includes a retainer assembly (<NUM>) including a clamping bar (<NUM>) that is configured to apply a retaining force onto the first ferrule and the second ferrule so as to retain (i) the first ferrule in the first receptacle hole, and (ii) the second ferrule in the second receptacle hole.