Active alignment system for laser light coupling.

Abstract

A catheter system (100) for treating a treatment site (106) in 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 an optical alignment system (257). The light source (124) generates light energy (224A, 224B, 324A, 324B, 424B). The first light guide (122A) receives light energy (224A, 224B, 324A, 324B, 424B) from the light source (124). The first light guide (122A) has a guide proximal end (122P). The second light guide (122A) receives light energy (224A, 224B, 324A, 324B, 424B) from the light source (124). The second light guide (122A) has a guide proximal end (122P). The multiplexer (223) directs the light energy (224A, 224B, 324A, 324B, 424B) to the guide proximal end (122P) of the first light guide (122A) and to the guide proximal end (122P) of the second light guide (122A). The optical alignment system (257) determines the alignment of the light energy (224A, 224B, 324A, 324B, 424B) relative to at least one of the guide proximal ends (122P). The optical alignment system (257) adjusts the positioning of the optical energy (224A, 224B, 324A, 324B, 424B) relative to at least one of the guide proximal ends (122P) based at least in part on the alignment of the optical energy (224A, 224B, 324A, 324B, 424B) relative to at least one of the guide proximal ends (122P).

Description

[Technical field]

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 197,959, filed June 7, 2021, entitled "ACTIVE ALIGNMENT SYSTEM AND METHOD FOR LASER OPTICAL COUPLING," and U.S. Patent Application No. 17 / 831,056, filed June 2, 2022. To the extent permitted, the contents of U.S. Provisional Patent Application No. 63 / 197,959 and U.S. Patent Application No. 17 / 831,056 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 to treat and difficult for physicians to achieve patency in clinical practice.

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

[0004] The present invention relates 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 first light guide, a second light guide, and an optical alignment system. The light source generates light energy. The first light guide receives light energy from the light source, the first light guide having a guide proximal end. The second light guide receives light energy from the light source, the second light guide having a guide proximal end. A multiplexer directs light energy to the guide proximal end of the first light guide and to the guide proximal end of the second light guide. The optical alignment system determines an alignment of the light energy relative to at least one of the guide proximal ends. The optical alignment system adjusts the positioning of the light energy relative to at least one of the guide proximal ends based at least in part on the alignment of the light energy relative to at least one of the guide proximal ends.

[0005] In some embodiments, the optical alignment system is configured to improve optical coupling between the light energy and at least one of the light guides.

[0006] In certain embodiments, the optical alignment system further includes an image sensor that senses alignment of the light energy with at least one of the guide proximal ends, the image sensor configured to provide visualization of the alignment.

[0007] In various embodiments, the catheter system further includes a system controller configured to control the optical alignment system such that optical energy is substantially coupled into at least one of the guide proximal ends.

[0008] In some embodiments, at least one of the light guides is an optical fiber.

[0009] In a particular embodiment, the light source is a laser.

[0010] In various embodiments, the optical alignment system further includes an optical aligner configured to align the optical energy with at least one of the guide proximal ends.

[0011] In some embodiments, the optical aligner is controlled by a system controller.

[0012] In certain embodiments, the optical alignment system further includes an imaging system including an imaging sensor, the imaging system configured to capture an image of the focal point of the light source and at least one image of the proximal end of the guide.

[0013] In various embodiments, the imaging system is configured to simultaneously capture an image of the focal point of the light source and an image of the scattered energy beam scattered from at least one of the proximal ends of the guide.

[0014] In some embodiments, the imaging system is configured to utilize an image reference frame that allows direct calculation of a distance offset from the center of at least one of the guide proximal ends.

[0015] In certain embodiments, the imaging system is configured to determine the offset and calculate a compensating adjustment of the alignment of the optical energy to at least one of the proximal ends of the guide.

[0016] In various embodiments, the optical alignment system further includes an alignment positioner that positions the alignment of the light energy relative to at least one of the proximal ends of the guide based on the calculated compensation adjustment to substantially couple the light source with at least one of the proximal ends of the guide.

[0017] In some embodiments, the catheter system further includes a system controller configured to control the optical system mover to position the multiplexer and align the optical energy with at least one of the guide proximal ends.

[0018] In certain embodiments, the catheter system further includes a light source mover coupled to the multiplexer, the light source mover being connected to the optics mover such that the optics mover can position the multiplexer along the light source mover.

[0019] In various embodiments, the system controller is configured to align the light source with one of: (i) a third light guide that receives light energy from the light source and has a guide proximal end; and (ii) a third light guide that receives light energy from the light source and has a guide proximal end.

[0020] In some embodiments, the light source is a pulsed IR laser.

[0021] In certain embodiments, the multiplexer further includes an optical element that includes a dichroic beam splitter that splits the light source into at least two light beams.

[0022] In various embodiments, the dichroic beam splitter is configured to reflect reflected light energy having a shorter wavelength than the light energy emitted by the light source.

[0023] In some embodiments, the dichroic beamsplitter includes a dichroic coating tuned to reflect a portion of the light energy emitted by the light source, between 99% and 0.01% being reflected.

[0024] In certain embodiments, the dichroic beam splitter is configured to reflect a portion of the light energy emitted by the light source as an imaging beam.

[0025] In various embodiments, the imaging beam is directed to a detector for analyzing the light energy reflected from at least one of the light guides.

[0026] In some embodiments, the optical alignment system further includes an illuminator that illuminates at least one of the guide proximal ends to provide improved image quality and brightness.

[0027] In certain embodiments, the system controller controls the illuminator and adjusts the brightness and contrast of the image.

[0028] In various embodiments, the optical alignment system further includes one of a stepper motor and a piezoelectric actuator configured to adjust the yaw, pitch, and roll of at least one of the light guides.

[0029] In some embodiments, the optical alignment system further includes an optical compensator configured to adjust a positioning of the light source relative to at least one of the guide proximal ends.

[0030] In certain embodiments, the optical compensator includes a plurality of optical steering wedges positioned in a path of the light source, the plurality of optical steering wedges configured to improve coupling between the light source and at least one of the proximal ends of the guide.

[0031] The present invention also relates to a method for treating a vascular lesion within or adjacent to a blood vessel wall within a patient using a catheter system of any of the embodiments described herein.

[0032] The present invention further relates to a method for manufacturing a catheter system of any of the embodiments described herein.

[0033] The present invention also relates to a method for treating a treatment site within or adjacent a blood vessel wall or heart valve using a catheter system. In various embodiments, the method includes generating light energy using a light source, directing the light energy to at least one of a proximal guide end of a first light guide and a proximal guide end of a second light guide, determining an alignment of the light energy relative to the at least one proximal guide ends of the light guides using an optical alignment system, and adjusting the positioning of the light energy relative to the at least one proximal guide ends of the light guides using the optical alignment system based on the alignment of the light energy.

[0034] In some embodiments, the optical alignment system is configured to improve optical coupling between the light energy and at least one of the guide proximal ends of the light guide.

[0035] In certain embodiments, the optical alignment system further includes an image sensor that senses alignment between the light energy and at least one of the guide proximal ends of the light guide, the image sensor configured to provide visualization of the alignment.

[0036] In various embodiments, the method may further include configuring a system controller configured to control the optical alignment system such that light energy is substantially coupled into at least one of the guide proximal ends of the light guide.

[0037] In some embodiments, at least one of the light guides is an optical fiber.

[0038] In a particular embodiment, the light source is a laser.

[0039] In various embodiments, the optical alignment system further includes an optical aligner configured to align the light energy with at least one of the guide proximal ends of the light guide.

[0040] In some embodiments, the optical aligner is controlled by a system controller.

[0041] In certain embodiments, the optical alignment system further includes an imaging system including an imaging sensor, the imaging system configured to capture an image of the focal point of the light source.

[0042] In various embodiments, the imaging system is configured to simultaneously capture an image of the focal point of the light source and an image of the scattered energy beam scattered from at least one of the proximal guide ends of the light guide.

[0043] In some embodiments, the imaging system is configured to utilize an image reference frame that allows direct calculation of a distance offset from the center of at least one of the proximal guide ends of the light guide.

[0044] In certain embodiments, the imaging system is configured to determine the offset and calculate a compensating adjustment of the alignment of the light energy with at least one of the guide proximal ends of the light guide.

[0045] In various embodiments, the method further includes configuring a system controller configured to control an optical system mover that positions the multiplexer and aligns the light source with at least one of the guide proximal ends of the light guide.

[0046] In some embodiments, the method further includes coupling a light source mover to the multiplexer, the light source mover being connected to the optics mover such that the optics mover can position the multiplexer along the light source mover.

[0047] In certain embodiments, the system controller is configured to align the light source with one of: (i) a third light guide that receives light energy from the light source and has a guide proximal end; and (ii) a third light guide that receives light energy from the light source and has a guide proximal end.

[0048] In various embodiments, the light source is a pulsed IR laser.

[0049] In some embodiments, the multiplexer further comprises an optical element including a dichroic beam splitter that splits the light source into at least two guided beams.

[0050] In certain embodiments, the dichroic beam splitter is configured to reflect reflected light energy having a shorter wavelength than the light energy emitted by the light source.

[0051] In various embodiments, the dichroic beamsplitter includes a dichroic coating that is tuned to reflect a portion of the light energy emitted by the light source, between 99% and 0.01% being reflected.

[0052] In some embodiments, the dichroic beam splitter is configured to reflect a portion of the light energy emitted into at least one of the guide proximal ends of the light guide as an imaging beam.

[0053] In certain embodiments, the method further includes directing light energy reflected from at least one of the guide proximal ends of the light guide to a detector for analysis.

[0054] In various embodiments, the optical alignment system further includes an illuminator that illuminates at least one of the proximal guide ends of the light guide to provide improved image quality and brightness.

[0055] In some embodiments, the system controller controls the illuminators and adjusts the brightness and contrast of the images.

[0056] In certain embodiments, the optical alignment system further includes one of a stepper motor and a piezoelectric actuator configured to adjust the yaw, pitch, and roll of at least one of the light guides.

[0057] In various embodiments, the optical alignment system further includes an optical compensator configured to adjust the positioning of each guide beam with respect to at least one of the light guides.

[0058] In some embodiments, the optical compensator includes a plurality of optical steering wedges positioned in the path of the light source, the plurality of optical steering wedges configured to improve coupling between the light source and at least one of the guide proximal ends of the light guide.

[0059] In certain embodiments, the optical alignment system further includes a reflector and a reflector mover that moves the reflector.

[0060] The present invention also relates to a method for treating a treatment site within or adjacent to a blood vessel wall or a heart valve using a catheter system, in various embodiments, the method includes determining, with an optical alignment system, an alignment of optical energy relative to at least one of a proximal guide end of a first light guide and a proximal guide end of a second light guide, and adjusting, with the optical alignment system, a positioning of the optical energy relative to at least one of the proximal guide ends of the light guides based on the alignment of the optical energy.

[0061] The present invention relates to a catheter system for treating a treatment site within or adjacent a vessel wall or heart valve. In various embodiments, the catheter system includes a light source, a first light guide, a second light guide, and a light source mover. The light source generates light energy. The first light guide receives light energy from the light source, the first light guide having a guide proximal end. The second light guide receives light energy from the light source, the second light guide having a guide proximal end. An optical alignment system determines an alignment of the light energy relative to at least one of the guide proximal ends, and the optical alignment system adjusts the positioning of the light energy relative to at least one of the guide proximal ends based at least in part on the alignment of the light energy relative to at least one of the guide proximal ends.

[0062] The present invention also relates to a method for treating a treatment site within or adjacent to a blood vessel wall or heart valve using a catheter system. In various embodiments, the method includes generating light energy using a light source, receiving the light energy entering one of a first light guide and a second light guide, moving the light source using a light source mover such that the light energy is aligned within a guide proximal end of (i) the first light guide and (ii) the second light guide, and detecting alignment of the light energy with respect to the guide proximal end of at least one of the light guides using the light source mover.

[0063] 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 those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part hereof, 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.

[0064] The novel features of the present invention, as well as the invention itself, both as to its structure and its operation, will best be understood from the accompanying drawings taken in conjunction with the accompanying description, in which like reference characters refer to like parts throughout, and in which: [Brief description of the drawings]

[0065] [Figure 1] FIG. 1 is a schematic cross-sectional view of one embodiment of a catheter system according to various embodiments herein, the catheter system including a multiplexer having features of the present invention. [Diagram 2] FIG. 1 is a simplified schematic diagram of a portion of an embodiment of a catheter system including an embodiment of an optical alignment system utilized in a first alignment configuration. [Diagram 3]FIG. 1 is a simplified schematic diagram of a portion of an embodiment of a catheter system including an embodiment of an optical alignment system utilized in a second alignment configuration. [Figure 4] FIG. 1 is a simplified schematic diagram of a portion of an embodiment of a catheter system including an embodiment of an optical alignment system utilized in a third alignment configuration. [Figure 5A] 1 is a simplified diagram of a proximal guide end of a light guide and a portion of a guide beam reflected from the proximal guide end of the light guide, where the portion of the guide beam is shown misaligned. [Figure 5B] 1 is a simplified diagram of a proximal guide end of a light guide and a portion of a guide beam reflected from the proximal guide end of the light guide, the portion of the guide beam being shown in alignment. [Figure 6] 1 is a flow chart of one embodiment of a method for treating a treatment site within or adjacent to a blood vessel wall or heart valve using a catheter system having features and / or steps of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0066] While embodiments of the invention are susceptible to various modifications and alternatives, details thereof have been shown by way of example and drawings and are described in detail herein. It is understood, however, that the scope of the specification is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives that are within the spirit and scope of the specification.

[0067] 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 are adverse events that may occur anywhere in the body due to the presence of vascular lesions. Major adverse events may include, but are not limited to, major adverse cardiac events, major adverse events in the peripheral or central vascular system, major adverse events in the brain, major adverse events in the muscular system, or major adverse events in any of the internal organs.

[0068] 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" may be 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.

[0069] 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 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 which are illustrated in the accompanying drawings.

[0070] For clarity, not all of the routine features of the implementations described herein are shown and described. Of course, it will be understood that in the development of any such actual implementation, numerous implementation-specific decisions must be made to achieve the developer's particular goals, such as compliance with application-related and business-related constraints, and that these particular goals will vary from implementation to implementation and from developer to developer. Moreover, it will be understood that such a development effort may be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure.

[0071] The catheter system disclosed herein can include many different configurations. Referring now to FIG. 1, a schematic cross-sectional view of a catheter system 100 according to various embodiments is shown. The catheter system 100 is adapted to apply pressure waves to induce fracturing at one or more treatment sites within or adjacent to a blood vessel wall or on or adjacent to a heart valve within a patient. In the embodiment shown in FIG. 1, the catheter system 100 includes a catheter 102, a light guide bundle 122 including one or more light guides 122A, a source manifold 136, a fluid pump 138, a multiplexer 123 including one or more of a light source 124, a power source 125, a system controller 126, and a graphic user interface 127 ("GUI"), a handle assembly 128, and an optical analyzer assembly 142. Alternatively, the catheter system 100 can include more or fewer components than those specifically shown and described in connection with FIG. 1.

[0072] Although the catheter system 100 is generally described herein as including a light guide bundle 122 including one or more light guides 122A and a light source 124, it is understood that in some alternative embodiments, the catheter system 100 can include an energy guide bundle including different types of energy guides and / or different types of energy sources.

[0073] In various embodiments, the catheter 102 is configured to navigate to a treatment site 106 within or adjacent a vascular wall 108A of a blood vessel 108 in the 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 implementations, the catheter 102 may be used at a treatment site 106 within or adjacent a heart valve in the body 107 of the patient 109.

[0074] 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 pass 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.

[0075] 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 fixing the catheter 102 in a predetermined position relative to the treatment site 106. Stated differently, when the balloon 104 is in an 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 the balloon wall 130 of the balloon 104 shown spaced apart from the treatment site 106 of the blood vessel 108 when in the inflated state, it will be understood that this is done merely for ease of illustration. It will be appreciated that the balloon wall 130 of the balloon 104 will typically be substantially directly adjacent and / or abutting the treatment site 106 when the balloon 104 is in the inflated state.

[0076] 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 of 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.

[0077] The balloon 104 can have any suitable diameter (in an inflated state). In various embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from less than 1 millimeter (mm) to 25 mm. In some embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from at least 1.5 mm to 14 mm. In some embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from at least 2 mm to 5 mm.

[0078] In some embodiments, the balloon 104 can have a length ranging from at least 3 mm to 300 mm. More specifically, in some embodiments, the balloon 104 can have a length ranging from at least 8 mm to 200 mm. It is understood 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 to induce fragmentation at a larger vascular lesion 106A or multiple vascular lesions 106A at precise locations within the treatment site 106. It is further understood that a longer balloon 104 can also be positioned adjacent multiple treatment sites 106 at any given time.

[0079] 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.

[0080] The balloon 104 can have a variety of shapes, including, but not limited to, a conical shape, a square shape, a rectangular shape, a spherical shape, a conical / square shape, a conical / spherical shape, an elongated spherical shape, an elliptical shape, a tapered shape, a bone shape, a stepped diameter shape, an offset shape, or a conical offset shape. In some embodiments, the balloon 104 can include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or drug eluting stent can include one or more therapeutic agents, including anti-inflammatory agents, anti-neoplastic agents, anti-angiogenic agents, and the like.

[0081] 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 medium, 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 medium in a volume ratio of about 50:50. In other embodiments, the balloon fluid 132 may include a mixture of saline and contrast medium in a volume ratio of about 25:75. In yet other embodiments, the balloon fluid 132 may include a mixture of saline and contrast medium in a volume ratio of about 75:25. However, it is understood that any suitable ratio of saline to contrast medium 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 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.

[0082] In some embodiments, the contrast agent used in the contrast medium may include, but is not limited to, an iodine-based contrast agent, such as an ionic or non-ionic iodine-based contrast agent. 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 may be used. Suitable non-iodine-containing contrast agents may include gadolinium (III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon agents may include, but are not limited to, agents such as the perfluorocarbon dodecafluoropentane (DDFP, C5F12).

[0083] The balloon fluid 132 can 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 can include those having an absorption maximum along a spectrum of at least 10 nm to 2.5 μm. Alternatively, the balloon fluid 132 can include 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 can be those having an absorption maximum that coincides with the emission maximum of the laser used in the catheter system 100. As non-limiting examples, 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.

[0084] The catheter shaft 110 of the catheter 102 may 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 guide(s) 122A may be disposed within the balloon 104 along the catheter shaft 110. Each of the light guides 122A may 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 may be an optical fiber and the light source 124 may be a laser. The light source 124 may be in optical communication with the light guides 122A at the proximal portion 114 of the catheter system 100. More specifically, the light source 124 may be in optical communication selectively, simultaneously, sequentially, and / or alternatively with each of the light guides 122A in any desired combination, order, and / or pattern due to the presence and operation of the multiplexer 128.

[0085] In some embodiments, the catheter shaft 110 may be coupled to multiple light guides 122A, such as a first light guide, a second light guide, a third light guide, etc., that may be positioned at any suitable location around the guidewire lumen 118 and / or the catheter shaft 110. For example, in certain non-exclusive embodiments, two light guides 122A may be spaced approximately 180 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110, three light guides 122A may be spaced approximately 120 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110, or four light guides 122A may be spaced approximately 90 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Additionally alternatively, the multiple light guides 122A need not be uniformly spaced from one another around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. More specifically, the light guides 122A can be uniformly or non-uniformly positioned about the guidewire lumen 118 and / or catheter shaft 110 to achieve a desired effect at a desired location.

[0086] The catheter system 100 and / or 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 the balloon fluid 132 in the balloon interior 146 of the balloon 104 at the distal portion 116. For example, in some embodiments, the catheter system 100 and / or 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 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 light guide bundle 122 may include from ten light guides 122A to thirty light guides 122A. Alternatively, in still other embodiments, the catheter system 100 and / or light guide bundle 122 may include more than thirty light guides 122A.

[0087] The light guide 122A may have any suitable design for the purpose of generating 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 intensity. 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 understood that the refractive index of the core is greater than the refractive index of the cladding.

[0088] Each light guide 122A can direct light energy along its length from a proximal guide end 122P having at least one optical window (not shown) positioned within the balloon interior 146 toward a distal guide end 122D.

[0089] In various embodiments, the guide distal end 122D can further include and / or incorporate a distal light receiver 122R that allows light energy to be directed from the guide distal end 122D to the guide proximal end 122P into and back through the light guide 122A. Stated another way, light energy can generally travel in a first direction 121F along the light guide 122A from the guide proximal end 122P toward the guide distal end 122D of the light guide 122A. At least a portion of the light energy can also travel in a second direction 121S along the light guide 122A substantially opposite the first direction 121F, i.e., from the guide distal end 122D toward the guide proximal end 122P of the light guide 122A. Additionally, as described in more detail herein below, the light energy emitted from the guide proximal end 122P after passing back through the light guide 122A (in the second direction 121S) can be separated and then optically detected, interrogated, and / or analyzed using the optical analyzer assembly 142.

[0090] 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.

[0091] The optical guides 122A may also be positioned at any suitable location around 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 position relative to the length of the balloon 104 and / or relative to the length of the guidewire lumen 118 to more effectively and precisely apply pressure waves for the purpose of destroying vascular lesions 106A at the treatment site 106.

[0092] In certain embodiments, the light guide 122A can include one or more optoacoustic transducers 154, and each optoacoustic transducer 154 can be in optical communication with the light guide 122A in which it is disposed. In some embodiments, the optoacoustic transducers 154 can be in optical communication with the guide distal end 122D of the light guide 122A. Further, in such embodiments, the optoacoustic transducers 154 can have a shape that corresponds to and / or matches the guide distal end 122D of the light guide 122A.

[0093] The photoacoustic transducer 154 is configured to convert light energy into acoustic waves at or near the distal guide end 122D of the light guide 122A. The direction of the acoustic waves can be adjusted by changing the angle of the distal guide end 122D of the light guide 122A.

[0094] In certain embodiments, the optoacoustic 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 optoacoustic 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 optoacoustic transducers 154 disposed along one or more sides of the length of the light guide 122A.

[0095] In some embodiments, the light guide 122A can further include one or more redirecting mechanisms or "diverters" (not shown in FIG. 1) within the light guide 122A configured to direct light to exit the light guide 122A toward a side surface that may be located at or near the guide distal end 122D of the light guide 122A and toward the balloon wall 130. The redirecting mechanism can include any mechanism of the system that redirects 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 optical windows disposed along a longitudinal or circumferential surface of each light guide 122A and in optical communication with the redirecting mechanism. Stated another way, the redirecting mechanism can be configured to direct light energy within the light guide 122A toward a side surface that is at or near the guide distal end 122D, the side surface being in optical communication with the optical window. An optical window 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, for example, a portion of the light guide 122A that has no cladding material on or around it.

[0096] 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 optoacoustic transducer 154, which is in optical communication with the side of the light guide 122A. As described above, the optoacoustic transducer 154 converts the optical energy into acoustic waves that extend away from the side of the light guide 122A.

[0097] 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 include a fluid pump 138 configured to inflate the balloon 104 with balloon fluid 132 as needed.

[0098] As mentioned 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 the specific need for the multiplexer 123.

[0099] In some embodiments, the multiplexer 123 can include a two-channel splitter design. The guide bundle 122 can include a manual positioning mechanism attached to an optical breadboard and / or platen. This design allows linear position adjustment and array tilt by rotating about the axis of the light guide 122A of channel 1 (not shown in FIG. 1). In other embodiments, the adjustment method can have two adjustment steps: 1) align the planar position of the source beam 124B in channel 1, and 2) adjust the light guide bundle 122 to achieve the best alignment in channel 10.

[0100] 1, in certain embodiments, at least a portion of the optical analyzer assembly 142 may be positioned substantially within the multiplexer 123. Alternatively, the components of the optical analyzer assembly 142 may be positioned in a different manner than specifically shown in FIG.

[0101] As shown, the multiplexer 123 and the components included therein are operably 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 opening 148 (sometimes commonly referred to as a "socket") through which 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 (sometimes commonly referred to as a "ferrule") that accommodates a portion of each of the light guides 122A, e.g., the guide proximal end 122P. The guide coupling housing 150 is configured to fit and selectively retain within the console connection opening 148 to provide a mechanical coupling between the light guide bundle 122 and the multiplexer 123.

[0102] The light guide bundle 122 may also include a guide bundler 152 (or "shell") that brings each of the individual light guides 122A closer together, allowing the light guides 122A and / or the light guide bundle 122 to assume a more compact form when extended 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 organized into a light guide bundle 122 that includes a linear block with an array of precision holes that form a multi-channel ferrule. In other embodiments, the light guide bundle 122 may include a mechanical connector array or block connector that organizes single ferrules into a linear array.

[0103] 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 is configured to generate light energy in the form of a light source beam 124A, such as a pulsed light source beam, which may be selectively and / or alternatively directed to and received by each of the light guides 122A in the light guide bundle 122 as individual guide beams 124B. Alternatively, the catheter system 100 may include multiple 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 operate at low energy.

[0104] The light source 124 may have any suitable design. In certain embodiments, the light source 124 may be configured to provide sub-millisecond pulses of light energy from the light source 124 that are focused onto a small spot for coupling 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 (also referred to herein as a "plasma flash") in the balloon fluid 132 within the balloon interior 146 of the balloon 104, such as via a plasma generator 133 that 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 excites 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 a pressure wave to the treatment site 106. An exemplary plasma-induced bubble 134 is shown in FIG. 1.

[0105] When the plasma first forms in the balloon fluid 132 within the balloon interior 146, it emits broad spectrum electromagnetic radiation. This can be seen as a broad spectrum light flash detectable by the naked eye. A portion of the light emitted from the plasma bubble 134 can be coupled to the distal light receiver 122R at the guide distal end 122D of the light guide 122A and travel back to the guide proximal end 122P where it can be separated, detected, and analyzed through the use of the optical analyzer assembly 142. The intensity and timing of the visible light pulse relative to the plasma generating pulse provides an indication that the plasma generator 133 has functioned, its energy output, and its functional status. If the light guide 122A is damaged or broken, visible light flashes can occur at other locations in the light guide 122A. Such other visible light flashes can also be coupled to the light guide 122A and transported back to the guide proximal end 122P. The intensity and timing of these other light pulses provide an indication of damage or failure of the light guide 122A or the plasma generator 133. In such circumstances, the optical analyzer assembly 142 can include a safety shutdown system 283 (shown in FIG. 2A ) that can be selectively activated to shut down operation of the catheter system 100.

[0106] The configuration of the plasma generator 133 and / or the distal optical receiver 122R further allows for ambient light emanating from outside the catheter 102 to be coupled to the guide distal end 122D of the light guide 122A. In one embodiment, the optical analyzer assembly 142 monitors the return ambient light energy traversing the light guide 122A from the guide distal end 122D to the guide proximal end 122P. In such circumstances, if ambient light energy is present and detected by the optical analyzer assembly 142, this is an indication that the catheter 102 is located outside the body 107 of the patient 109, and the optical analyzer assembly 142 can be configured to lock out the light source 124 accordingly. Notably, in such circumstances, the safety shutdown system 283 of the optical analyzer assembly 142 can be selectively activated to shut down the operation of the catheter system 100.

[0107] In various non-exclusive alternative embodiments, sub-millisecond pulses of light energy from the light source 124 may be delivered to the treatment site 106 at frequencies between about 1 Hertz (Hz) and 5000 Hz, between about 30 Hz and 1000 Hz, between about 10 Hz and 100 Hz, or between about 1 Hz and 30 Hz. Alternatively, sub-millisecond pulses of light energy may be delivered to the treatment site 106 at frequencies that may be greater than 5000 Hz or less than 1 Hz, or any other suitable frequency range.

[0108] Although light source 124 is typically utilized to provide pulses of light energy, it is understood that light source 124 may be described as providing a single light source beam 124A, i.e., a single pulsed light source beam.

[0109] Light sources 124 suitable for use can include various types of light sources, including lasers and lamps. For example, in certain non-exclusive embodiments, light source 124 may be an infrared laser that emits light energy in the form of pulses of infrared light. Alternatively, as noted above, light sources 124 referred to herein can include any suitable type of energy source.

[0110] Suitable lasers include short pulse lasers on the sub-millisecond timescale. In some embodiments, the light source 124 can include lasers on the nanosecond (ns) timescale. Lasers can also include short pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (us) timescales. It is understood that there are many combinations of laser wavelengths, pulse widths, and energy levels that can be employed to achieve a plasma in the balloon fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse widths can include those in the ranges including at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range can be used.

[0111] 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, light source 124 suitable for use in catheter system 100 can include those capable of generating light with wavelengths of at least 750 nm to 2000 nm. In other embodiments, light source 124 can include those capable of generating light with wavelengths of at least 700 nm to 3000 nm. In still other embodiments, light source 124 can include those capable of generating light with wavelengths of at least 100 nm to 10 micrometers (μm). Nanosecond lasers can include those having repetition rates 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 may include a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser, a holmium:yttrium-aluminum-garnet (Ho:YAG) laser, an erbium:yttrium-aluminum-garnet (Er:YAG) laser, an excimer laser, a helium-neon laser, a carbon dioxide laser, and a doped pulsed fiber laser.

[0112] 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 about 2 MPa to 50 MPa, at least about 2 MPa to 30 MPa, or at least about 15 MPa to 25 MPa.

[0113] The pressure waves may be applied on the treatment site 106 from a distance ranging from at least about 0.1 millimeters (mm) to greater than about 25 mm extending radially from the light guide 122A when the catheter 102 is placed on the treatment site 106. In various non-exclusive alternative embodiments, the pressure waves may be applied on the treatment site 106 from a distance ranging from at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm extending radially from the light guide 122A when the catheter 102 is placed on the treatment site 106. In other embodiments, the pressure waves may be applied on the treatment site 106 from another suitable distance different from the aforementioned ranges. In some embodiments, the pressure waves may be applied on the treatment site 106 in a range of at least about 2 MPa to 30 MPa at a distance of at least about 0.1 mm to 10 mm. In some embodiments, pressure waves may be applied onto the treatment site 106 in the range of at least about 2 MPa to 25 MPa at a distance of at least about 0.1 mm to 10 mm. Further alternatively, other suitable pressure ranges and distances may be used.

[0114] The power supply 125 is electrically coupled to and configured to provide the necessary power to each of the light source 124, the system controller 126, the GUI 127, the handle assembly 128, and the optical analyzer assembly 142. The power supply 125 may have any suitable design for such purpose.

[0115] The system controller 126 is electrically coupled to the power source 125 and receives power therefrom. Additionally, the system controller 126 is coupled to each of the light source 124, the GUI 127, and the optical analyzer assembly 142 and configured to control their operation. The system controller 126 may include one or more processors or circuits for the purpose of controlling the operation of at least the light source 124, the GUI 127, and the optical analyzer assembly 142. For example, the system controller 126 may control the light source 124 to generate pulses of light energy as desired and / or at any desired firing rate. Additionally, the system controller 126 may control and / or operate in conjunction with the optical analyzer assembly 142 to effectively provide continuous real-time monitoring of the performance, reliability, safety, and proper use of the catheter system 100.

[0116] 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 for purposes of controlling 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 and / or incorporated within the handle assembly 128.

[0117] 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 on the treatment site(s) 106 to induce fracturing. The GUI 127 can provide information to the user or operator that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 can provide static visual data and / or information to the user or operator. Additionally or alternatively, the GUI 127 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 use of the catheter system 100. In various embodiments, the GUI 127 can include one or more colors, different sizes, changing brightness, etc., that can serve as an alert to the user or operator. Additionally or alternatively, the GUI 127 can 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 a user or operator.

[0118] 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 and positioned spaced apart from the balloon 104. Alternatively, the handle assembly 128 may be positioned in another suitable location.

[0119] The handle assembly 128 is handled 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, the GUI 127, and the optical analyzer assembly 142. 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 a circuit 156 that can form at least a portion of the system controller 126. In some embodiments, the circuit 156 can receive electrical signals or data from the optical analyzer assembly 142. Additionally or alternatively, the circuit 156 can transmit such electrical signals or otherwise provide data to the system controller 126.

[0120] In one embodiment, the circuitry 156 may include one or more integrated circuits, or a printed circuit board having any other suitable circuitry. In alternative embodiments, the circuitry 156 may be omitted or may be included within the system controller 126, and in various embodiments, the circuitry 156 may be positioned outside the handle assembly 128, for example, in the multiplexer 123. It is understood that the handle assembly 128 may include fewer or additional components than those specifically shown and described herein.

[0121] FIG. 2 is a simplified schematic diagram of a portion of an embodiment of a catheter system 200, including an embodiment of an optical alignment system 257, utilized in a first alignment configuration.

[0122] The design of the catheter system 200 is substantially similar to the embodiments shown and described herein. It is understood that various components of the catheter system 200, as shown in FIG. 1, are not shown in FIG. 2 for clarity and ease of illustration. However, it is understood that the catheter system 200 may include most, if not all, such components. Furthermore, in some embodiments, the components of the catheter system 200 may be mounted and / or secured on a platen.

[0123] 2, the catheter system 200 again includes a light source 224 configured to generate light energy in the form of a light source beam 224A, e.g., a pulsed light source beam, which may be selectively and / or alternatively directed to and received by each light guide 222A (within the light guide bundle 222) as individual guide beams 224B (shown in FIG. 2A). In one non-exclusive embodiment, the light source 224 is an infrared laser source and the light guide 222A is a small diameter multimode optical fiber.

[0124] In certain embodiments, as shown in FIG. 2, source beam 224A from light source 224 passes through at least one optical element, including but not limited to one or more beam splitters 258 (two beam splitters 258 are shown in FIG. 2), one or more reflectors 260 (one reflector 260 is shown in FIG. 2), one or more coupling lenses 262 (one coupling lens 262 is shown in FIG. 2), one or more imaging lenses 263 (one imaging lens 263 is shown in FIG. 2), and / or one or more filters 264 (two filters 264 are shown in FIG. 2). Each optical element can be configured to focus, reflect, and / or filter source beam 224A as an individual guide beam 224B onto guide proximal end 222P of light guide 222A, thereby coupling the individual guide beam 224B into light guide 222A in the form of pulses of infrared energy. Once aligned with the light guide 222A, each guide beam 224B travels towards the plasma generator 233. In some embodiments, each optical element can be configured to focus, reflect, and / or filter the imaging beam 224C towards the camera 265.

[0125] The optical energy of each guide beam 224B is guided along the light guide 222A from the proximal guide end 222P to the distal guide end 222D and excites a plasma generator 233 positioned and / or embedded at or near the distal guide end 222D of the light guide 222A. The plasma generator 233 utilizes pulses of infrared energy to create a localized plasma in the balloon fluid 132 within the balloon interior 146 of the balloon 104.

[0126] The optical alignment system 257 may include any and / or all of the components shown in the embodiments illustrated in Figures 2, 3, and 4. The optical alignment system 257 aligns optical energy in the form of the source beam 224A and / or the individual guide beams 224B such that the optical energy is coupled into one or more light guides 222A.

[0127] The optical alignment system 257 can vary depending on the design requirements of the catheter system 200, the light guide 222A, and / or the energy source 224. It is understood that the optical alignment system 257 can include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein. Additionally or alternatively, the optical alignment system 257 can omit one or more of the systems, subsystems, and elements specifically illustrated and / or described herein.

[0128] In various embodiments, the optical alignment system 257 can include a multiplexer 223. The optical elements described herein can be included in the multiplexer 223 (such as the multiplexer 128 described in connection with FIG. 1). As shown in the embodiment depicted in FIG. 2, the multiplexer 223 can be movable about a multiplexer axis 223X. In some embodiments, the multiplexer 223 can be fixed or attached to a multiplexer platen.

[0129] In some embodiments, the optical alignment system 257 may include one or more of beam splitter(s) 258, reflector(s) 260, coupling lens(es) 262, imaging lens(es) 263, filter(s) 264, camera 265, camera controller 266, amplifier 267, system controller 268, signal processor 269, optical system mover 270, light source mover 271, illuminator 272, alignment controller 273, detector 274, and / or aligner 275.

[0130] A beam splitter 258, such as a dichroic beam splitter in one embodiment, can be positioned in the optical path of the light source beam 224A between the light source 224 and the guide proximal end 222P of the light guide 222A. In certain embodiments, the beam splitter 258 is configured to pass light having wavelengths longer than those visible to other optical elements of the optical alignment system 257 such that the individual guide beams 224B are directed to the guide proximal end 222P of the light guide 222A. Such a threshold wavelength can be referred to as a cutoff wavelength. The beam splitter 258 can be further configured to reflect all light having a wavelength shorter than the cutoff wavelength. In some embodiments, the cutoff wavelength can be 950 nm. The dichroic beam splitter 258 may reflect a small percentage of the light energy depending on the ratio of the dichroic coatings on the beam splitter 258.

[0131] In some embodiments, other optical elements (e.g., coupling lens 262) can be positioned between one or more of the beam splitters 258 and the light guide 222A. The beam splitters 258 can be configured to focus the individual guide beams 224B onto the guide proximal end 222P of the light guide 222A, thereby coupling the individual guide beams 224B into the light guide 222A. One or more of the beam splitters 258 can be used in combination with other optical elements, such as an imaging lens 263 and a filter 264, to focus the imaging beam 224C onto a camera 265.

[0132] In other embodiments, one or more of the beam splitters 258 can be positioned in the path of the imaging beam 224C to allow a portion of the imaging beam 224C to be directed to the detector 274 for analysis of the light energy returning through the face of the light guide 222A or the proximal guide end 222P. This light analysis can be used for diagnostic and fault detection methods.

[0133] The beam splitter(s) 258 can vary depending on the design requirements of the catheter system 200, the light guide 222A, and / or the optical alignment system 257. It is understood that the beam splitter 258 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0134] The reflector(s) 260 can reflect the light energy emitted by the light source 224 to one or more optical elements of the optical alignment system 257. In one embodiment, the reflector(s) 260 can include a mirror. In a particular embodiment, one or more of the reflectors 260 can fold the light source beam 224A from the light source 224 at an angle of about 90 degrees. Alternatively, one or more of the reflectors 260 can fold the light source beam 224A from the light source 224 at an angle greater than or less than 90 degrees. The reflector(s) 260 can direct the light source beam 224A through a coupling lens 262 to one or more light guides 222A. In one embodiment, one or more of the reflectors 260 can be fixed. Alternatively, one or more of the reflectors 260 can be movable by one or more optics movers 270, such as manually or in one non-exclusive embodiment by one or more piezoelectric actuators.

[0135] The reflector 260 can vary depending on the design requirements of the catheter system 200, the light guide 222A, and / or the optical alignment system 257. It is understood that the reflector 260 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0136] The coupling lens 262 can couple the individual guide beams 224B to the guide proximal end 222P of one or more light guides 222A. The coupling lens 262 can focus and / or collimate the light source beams 224A to the individual guide beams 224B. The coupling lens 262 can be used to focus the guide beams 224B to form a spot that couples into at least one of the light guides 222A. The coupling lens 262 can also collimate the light source (e.g., light source 224) near a focusing position (see, e.g., light source beam 524B in FIG. 5B) that is set to be near the guide proximal end 222P of the light guide 222A. The light energy from the guide beam 224B is scattered from the focusing spot on the guide proximal end 222P.

[0137] In some embodiments, the source beam 224B and / or the imaging beam 224C may be collimated so that a separate set of optics can focus the source beam 224B and / or the imaging beam 224C to form an image. In various embodiments, the source beam 224B and / or the imaging beam 224C between the coupling lens 262 and the imaging lens 262 are collimated so that the separation between the optical elements is not important for imaging performance. The various light beams disclosed herein can be separated by a distance that is convenient for placing the optical elements on any given platen. The focal length of the optics controls the magnification of the light guide 222A on the sensor (such as the camera 265). The separation between the optics and the image sensor allows for focusing of the generated image at the desired plane at the object, independent of where the energy source is focused.

[0138] The coupling lens 262 can vary depending on the design requirements of the catheter system 200, the light guide 222A, and / or the optical alignment system 257. It is understood that the coupling lens 262 can include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein. Additionally or alternatively, the coupling lens 262 can omit one or more of the systems, subsystems, and elements specifically illustrated and / or described herein.

[0139] The imaging lens 263 can couple the imaging beam 224C to a camera 265 or any suitable imaging system of the optical alignment system 257. The imaging lens 263 can vary depending on the design requirements of the catheter system 200, the light guide 222A, and / or the optical alignment system 257. It is understood that the imaging lens 263 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0140] Filter 264 can filter optical energy from source beam 224A, guide beam 224B, and / or imaging beam 224C. Filter 264 can vary depending on the design requirements of catheter system 200, light guide 222A, optical alignment system 257, and / or camera 265. It is understood that filter 264 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0141] The optical elements disclosed in various embodiments herein can be configured in any position or order. In some embodiments, such as the embodiment shown in Figure 2, an optical path can be created to 1) couple primary IR energy and 2) image the ferrule end face (e.g., guide proximal end 222P) and image a portion of the primary energy scattered or reflected off the ferrule end face or a conveniently co-located target.

[0142] Camera 265 can capture an image of the light energy in the form of imaging beam 224C. In a first alignment configuration of optical alignment system 257 (shown in the embodiment shown in FIG. 2), the camera receives imaging beam 224C that is reflected and / or back-scattered from guide proximal end 222P. This scattered light is captured by coupling lens 262 and focused by imaging lens 263 to form an image of the focused spot.

[0143] In various embodiments, the image of the focused spot is overlaid on an image of the guide proximal end 222P in the same image space. Additional filters 264 can be added to reduce the amount of IR signal arriving from scattering sources and balance the intensity of the focused spot in the image relative to the guide proximal end 222P and the light guide 222A.

[0144] In certain embodiments, as multiplexer 223 scans laterally across proximal guide end 222P of one or more light guides 222A, camera 265 creates an image of proximal guide end 222P in the visible spectrum. This may rely on ambient visible light as an illumination source. Alternatively, a separate light source, such as illuminator 272, may illuminate proximal guide end 222P to improve image quality and brightness.

[0145] The camera 265 can vary depending on the design requirements of the catheter system 200 and / or the optical alignment system 257. It is understood that the camera 265 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0146] The camera controller 266 can control the camera 265. The camera controller 266 can also send signals to the signal processor 269. The camera controller 266 can control the illuminator 272 to adjust the brightness and contrast of the image as needed. The camera controller 266 can vary depending on the design requirements of the catheter system 200, the light guide 222A, the optical alignment system 257, the camera 265, and / or the signal processor 269. It is understood that the camera controller 266 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0147] Amplifier 267 may amplify various signals transmitted from components of optical alignment system 257. As shown in Figure 2, the signal from detector 274 may be directed to amplifier 267 where detection and intensity assessment of imaging beam 224C is determined. In particular, in certain embodiments, the signal from detector 274 is directed to amplifier 267 where the signal from detector 274 is amplified.

[0148] The amplifier 267 can vary depending on the design requirements of the catheter system 200, the light guide 222A, the optical alignment system 257, the camera 265, and / or the signal processor 269. It is understood that the amplifier 267 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0149] The system controller 268 can control any and / or all of the components of the catheter system 200, the multiplexer 223, and / or the optical alignment system 257. In some embodiments, the system controller 268 controls the emission of light energy from the light source 224. In other embodiments, the system controller 268 controls the optics mover 270.

[0150] The system controller 268 can vary depending on the design requirements of the catheter system 200, the multiplexer 223, and / or the optical alignment system 257. It is understood that the system controller 268 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0151] The signal processor 269 can process various signals sent from the components of the optical alignment system 257. The signal processor 269 can monitor and record image information and / or other data of the received signals. The signal processor 269 can segment the image to obtain the core / center position of the light guide 222A and can direct the optical alignment system 257 to align the guide beam 224B to a focused spot position in the image space.

[0152] In other embodiments, the signal processor 269 can use image scaling and separate calibrations to determine the exact displacement of the actual focal spot relative to the center / core position of the light guide 222A to improve coupling. These calibrations can account for all offsets and drifts in the physical positions of the guide beam 224B and the aligned light guide 222A due to mechanical tolerances and stacking. The system controller 268 can then use the data to adjust the position of the light guide bundle 222 using the aligner 275 so that the focal spot is perfectly aligned with the core / center of the aligned light guide 222A.

[0153] The signal processor 269 can vary depending on the design requirements of the catheter system 200, the light guide 222A, the optical alignment system 257, the camera 265, and / or the amplifier 267. It is understood that the signal processor 269 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0154] The optics mover 270 moves and / or controls moving components of the optical alignment system 257, such as the light source mover 271. The optics mover 270 can vary depending on the design requirements of the catheter system 200, the optical alignment system 257, and / or the light source mover 271. It is understood that the optics mover 270 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0155] The light source mover 271 can move the light energy, the light source 224, and / or the multiplexer 223 so that the light energy is properly aligned within at least one of the light guides 222A. In some embodiments, the system controller 268 controls the optics mover 270 connected to the light source mover, which positions the multiplexer 223 and aligns the beam axis (not shown) of the guide beam 224B within one or more of the light guides 222A. Using embodiments disclosed herein, the optical alignment system 257 can utilize the light source mover 271 to align the energy source 224 with any desired channel within the light guide bundle 222 and trigger and move the energy source 224 to the next desired channel within the light guide bundle 222.

[0156] The light source mover 271 can vary depending on the design requirements of the catheter system 200, the light guide 222A, the optical alignment system 257, and / or the optics mover 270. It is understood that the light source mover 271 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0157] In some embodiments, the light source mover 271 can include a linear translation stage. The multiplexer 223 can be configured to move across the linear translation stage about the multiplexer axis 223X.

[0158] The illuminator 272 can illuminate the guide proximal end 222P such that the alignment of the light energy with the guide proximal end 222P is more easily detected and analyzed by the optical alignment system 257. The illuminator 272 can vary depending on the design requirements of the catheter system 200, the light guide 222A, and / or the optical alignment system 257. It is understood that the illuminator 272 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein. In some embodiments, the illuminator 272 can include a visible light source, such as a visible LED.

[0159] The alignment controller 273 controls the alignment components of the optical alignment system 257, such as the aligner 275. The alignment controller 273 can vary depending on the design requirements of the catheter system 200, the light guide 222A, the optical alignment system 257, and / or the aligner 275. It is understood that the alignment controller 273 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0160] The detector 274 can receive optical energy from the imaging beam 224C when the optical alignment system 257 is in the second alignment configuration (shown in FIG. 3). The detector 274 can detect the optical energy from the imaging beam 224C and convert the detected optical energy into a signal. The detector 274 can transmit the signal to the amplifier 267 for amplification and transmission to the signal processor 269.

[0161] The detector 274 can vary depending on the design requirements of the catheter system 200, the optical alignment system 257, the amplifier 267, and / or the signal processor 269. It is understood that the detector 274 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0162] The aligner 275 can align various components of the alignment system 257, such as the light guide bundle 222 and the light source mover 271. The aligner 275 can vary depending on the design requirements of the catheter system 200, the light guide 222A, the optical alignment system 257, and / or the alignment controller 273. It is understood that the aligner 275 can include additional systems, subsystems, components, and elements other than those specifically shown and / or described herein.

[0163] In other embodiments, the aligner 275 can include stepper motors and / or piezoelectric actuators to adjust the height and tilt of the light guide bundle 222. In one alignment process, the optical alignment system 257 aligns the light source mover 271 near a first channel in the light guide bundle 222 (corresponding to one light guide 222A) and captures an image of the guide proximal end 222P and the corresponding light guide 222A at the focused position of the guide beam 224B.

[0164] In certain embodiments, the magnification of the light guide 222A in the image can be controlled such that the image is small relative to the size of the light guide bundle 222 in the image. The system controller 268 can calculate the offset and adjust the movement parameters in at least two directions to align the focal position with the center / core of the light guide 222A. The system controller 268 can align the light source beam 224B with the last light guide 222A in the linear array of light guide bundles 222 and capture an image of the guide proximal end 222P and the light guide 222A along with the focal position. The position offset can be used to set the tilt of the light guide bundle 222 by rotating it around the center of one of the light guides 222A. This process can continue iteratively to adjust the position and tilt parameters of the light guide 222A as a whole. The process can continue back to the position of each light guide 222A and adjust the linear position along the multiplexer axis 223X. This process can be performed as an initial alignment of the light source 224 and optical alignment system 257 to the new guide bundle 222. Once the configuration described herein is complete, the optical alignment system 257 can be operated for an interval during which the alignment remains stable.

[0165] In various embodiments, the optical alignment system 257 utilizes optical compensation devices (e.g., multiple reflectors 260, steering wedges) to adjust the focal position relative to the light guide bundle 222. Steering wedges (not shown) can be placed in the paths of the source beam 224A, the guide beam 224B, and / or the imaging beam 224C to account for deviations in linear directions in a plane. The optical alignment system 257 can adjust the position of the guide beam 224B to the pre-aligned light guide bundle 222.

[0166] In some embodiments, images of the focal position can also be acquired from other surfaces or targets other than the guide proximal end 222P and / or the light guide 222A. For example, a flat ceramic target can be located near the light guide 222A along the bundle axis of the guide bundle 222. The light source mover 222 can offset the multiplexer 223 by a set distance to track the position of the focal position on the new target. The signal processor 269 can subtract the offset when determining the position of the focal position relative to the image space of the light guide 222A.

[0167] In various embodiments, the first alignment configuration may be an initial setup and alignment configuration. In the first alignment configuration, the light guide bundle 222, including the individual light guides 222A, is coupled to the multiplexer 223. The system controller 268 may position the light source mover 271 at the position of the first light guide 222A. The camera controller 266 may engage the illuminator 272 and begin capturing images of the light guide 222A and the guide proximal end 222P. The system controller 268 may engage a pulse of the light source 224 at low energy and the camera 265 may capture a suitable image. The signal processor 269 may analyze this image and calculate offsets to align linear position parameters to improve coupling of the first optical channel (e.g., the first light guide 222A in the light guide bundle 222). The optical alignment system 257 may then repeat the process for each channel in the light guide bundle 222.

[0168] FIG. 3 is a simplified schematic diagram of a portion of an embodiment of a catheter system 300, including an embodiment of an optical alignment system 357, utilized in a second alignment configuration.

[0169] The design of the catheter system 300 is substantially similar to the embodiments shown and described herein. It is understood that various components of the catheter system 300 as shown in Figure 1 are not shown in Figure 3 for clarity and ease of illustration. However, it is understood that the catheter system 300 may include most, if not all, such components.

[0170] 3, the catheter system 300 again includes a light source 324 configured to generate light energy in the form of a light source beam 324A, e.g., a pulsed light source beam, which may be selectively and / or alternatively directed to and received by each light guide 322A (within the light guide bundle 322) as individual guide beams 324B. In one non-exclusive embodiment, the light source 324 is an infrared laser source and the light guide 322A is a small diameter multimode optical fiber.

[0171] In certain embodiments, as shown in FIG. 3, the source beam 324A from the light source 324 passes through at least one optical element, such as one or more beam splitters 358, one or more reflectors 360, one or more coupling lenses 362, one or more imaging lenses 363, and / or one or more filters 364. Some or all of the optical elements can be configured to focus, reflect, and / or filter the source beam 324A as individual guide beams 324B onto the guide proximal end 322P of the light guide 322A, thereby coupling the individual guide beams 324B into the light guide 322A in the form of pulses of infrared energy. When the individual guide beams 324B are aligned with the light guide 322A, they proceed toward the plasma generator 333. In some embodiments, each optical element can be configured to focus, reflect, and / or filter the imaging beam 324C toward the camera 365.

[0172] 3, catheter system 300 may include a multiplexer 323 having a multiplexer axis 323X, a camera controller 366, an amplifier 367, a system controller 368, a signal processor 369, an optics mover 370, a light source mover 371, an illuminator 372, an alignment controller 373, a detector 374, and / or an aligner 375. Each component may have the same and / or substantially similar functionality and / or components as described in the embodiments disclosed herein.

[0173] In a second alignment configuration (shown in FIG. 3), detector 374 can receive optical energy from imaging beam 324C. Detector 374 can detect optical energy from imaging beam 324C and convert the detected optical energy into a signal. Detector 374 can transmit the signal to amplifier 367 for amplification and transmission to signal processor 369.

[0174] In other embodiments, the second alignment configuration may be a high energy mode. In the second alignment configuration, the optical alignment system 357 has already completed the initial setup and alignment process described in the first alignment configuration. In the second alignment configuration, the optical alignment system 357 can position the light source mover 371 at a predetermined position along the multiplexer axis 323X for a given optical channel and launch the light source 324. The optical alignment system 357 collects the reflected light as an imaging beam 324C and directs the imaging beam 324 to a detector 374. The detector 374 can be used in the second alignment configuration to analyze optical impairments at the proximal and distal ends of the light guide 322A as well as monitor the plasma generated by the plasma generator 333. The optical alignment system 357 can capture and analyze this data to determine whether to move the guide beam 324B to the next optical channel. If optical alignment system 357 is nominal, then optical alignment system 357 aligns guide beam 324 B to the next channel, triggers light source 324 , and repeats the process across the entire array of light guide bundles 322 .

[0175] FIG. 4 is a simplified schematic diagram of a portion of an embodiment of a catheter system 400, including an embodiment of an optical alignment system 457, utilized in a third alignment configuration.

[0176] The design of the catheter system 400 is substantially similar to the embodiments shown and described herein. It is understood that various components of the catheter system 400, such as those shown in Figure 1, are not shown in Figure 4 for clarity and ease of illustration. However, it is understood that the catheter system 400 may include most, if not all, such components.

[0177] 4, the catheter system 400 again includes a light source 424 configured to generate light energy in the form of a light source beam 424A, e.g., a pulsed light source beam, which may be selectively and / or alternatively directed and received by each light guide 422A (within the light guide bundle 422) as an individual guide beam 424B. Some or all of the optical elements may be configured to focus, reflect, and / or filter the light source beam 424A as an individual guide beam 424B onto the guide proximal end 422P of the light guide 422A, thereby coupling the individual guide beam 424B into the light guide 422A in the form of pulses of infrared energy. When the individual guide beam 424B is aligned with the light guide 422A, it travels towards the plasma generator 433.

[0178] In certain embodiments, as shown in FIG. 4, the source beam 424A from the source 424 passes through, reflects from, or interacts with at least one optical element, such as one or more reflectors 460. Each reflector 460 may include one or more adjustable mirrors and / or attached mirrors. In some embodiments, the reflectors 460 may include one or more adjustment fasteners (not shown) that allow for positioning and / or adjustment of the reflectors 460. It is understood that in certain embodiments, one or more of the reflectors 460 may be fixed and immovable. In some embodiments, the optical alignment system 457 may further include one or more reflector movers 461.

[0179] Each reflector mover 461 can move one of the reflectors 460 to more precisely guide the light source beam 424A and / or the individual guide beams 424B within the proximal guide end 422P of the light guide 422A throughout the catheter system 400. The reflector movers 461 can be controlled by the alignment controller 473 and / or the system controller 463.

[0180] Each reflector mover 461 may include one or more suitable actuators, such as a stepper motor, a piezoelectric actuator, or any other suitable type of actuator, capable of moving the corresponding reflector 460 in at least one and up to six degrees of freedom along and / or about the X, Y, and Z axes (not shown) of the reflector 460.

[0181] 4, the catheter system 400 can include an optics mover 470. The optics mover 470 can have the same and / or substantially similar functionality and / or components as described in the embodiments disclosed herein. For example, the optics mover 470 can include a stepper motor, a piezoelectric actuator, or any other suitable type of actuator.

[0182] FIG. 5A is a simplified diagram of a guide proximal end 522P and a portion of a guide beam 524B reflected from a light guide 522A, where the portion of the guide beam 524B is shown in a misaligned state. As shown in the embodiment shown in FIG. 5A, a misaligned state is when a portion of the guide beam 524 is not substantially within the guide center 522C of the light guide 522A. FIG. 5A shows the focused position of the guide beam 324B (shown in FIG. 3) scattered from the guide proximal end 322P (shown in FIG. 3). By adjusting the position of the light guide bundle and / or the guide beam 324, the scattered light can be captured by the camera 365 (shown in FIG. 3).

[0183] 5A and 5B may illustrate a dual imaging approach to optical alignment. Figures 5A and 5B may illustrate a portion of an image captured by camera 365 of optical alignment system 357 (shown in Figure 3).

[0184] Figure 5B is a simplified diagram of guide proximal end 522P and a portion of guide beam 524B reflected from light guide 522A, with a portion of guide beam 524B shown aligned. In the embodiment shown in Figure 5B, a portion of guide beam 524B is shown aligned, with a portion of guide beam substantially within guide center 522C of light guide 522A. Figure 5B shows Fresnel reflection from fused silica surfaces in light guide 522A, rather than the scattering shown in Figure 5A.

[0185] 6 is a flow chart of one embodiment of a method for treating a treatment site in or adjacent to a blood vessel wall or heart valve using a catheter system having features and / or steps of the present invention. It is understood that a method according to the disclosure herein may include more or less steps than those shown and described with respect to FIG. 6. In other words, a method according to the present invention may omit one or more steps shown in FIG. 6 or add additional steps not shown and described in FIG. 6 and still fall within the scope of the present invention. Furthermore, the order of steps may be changed from that shown and described with respect to FIG. 6. The order of steps shown in FIG. 6 is not intended to limit the order of steps in any manner.

[0186] In the embodiment shown in FIG. 6, in step 676, the system controller is configured to control the optics mover.

[0187] In step 678, the system controller may be configured to control the optical alignment system and / or any components of the optical alignment system, such as light sources, cameras, aligners, amplifiers, illuminators, detectors, filters, beam splitters, camera controllers, signal processors, multiplexers, and / or light guide bundles.

[0188] In step 680, an optical mover is coupled to the multiplexer such that the optical mover can move the multiplexer. In some embodiments, the optical mover is a linear translation stage.

[0189] In step 682, a light source generates light energy.

[0190] In step 684, the multiplexer receives the light energy generated by the light source.

[0191] In step 686, the multiplexer directs the light energy into the light guide.

[0192] In step 688, the light guide reflects a portion of the light energy back to the detector.

[0193] In step 690, a detector or another component of the optical alignment system detects the alignment of the light energy with the light guide.

[0194] In step 692, the optical alignment system aligns the optical energy with the light guide so that they are substantially coupled.

[0195] It will be appreciated that the active detection and alignment of the coupling of optical energy with a light guide by the use of the present invention provides multiple advantages with respect to the performance, reliability, and proper use of IVL catheters, particularly those that utilize an energy source to create a localized plasma that generates high energy bubbles inside a balloon catheter. Specific advantages of the present invention include: 1) providing active compensation for mechanical tolerances of the connectors and ferrules, thereby reducing the dependency of system performance on the mechanical tolerances of the optical carriers and their position within the multichannel array, and 2) providing active compensation for drift in energy beam pointing that occurs in the light source itself due to thermal drift or other factors, or through changes or movements of the internal or coupling optics. Active compensation ultimately reduces the performance dependency on the accuracy of connecting and aligning the multichannel array to the multiplexer, improving the speed and performance of the multiplexer and multichannel ferrule system.

[0196] In particular, in various embodiments, the present invention comprises a multiplexer as a precision linear mechanism that translates the coupling optics along a linear path. This approach can include a single degree of freedom. The ferrule can organize the individual optical fibers into a linear pattern with precise spacing. An example of a ferrule that can be used by the system is a V-groove ferrule block used in multi-channel optical fiber communication systems. The linear translation mechanism can be electronically controlled by an optical alignment system to sequentially line up the beam path with each of the individual fibers organized in the ferrule. The translation mechanism carries the necessary beam directing and focusing optics to focus the laser energy on each fiber for improved optical coupling. By utilizing the systems and methods disclosed herein, the low divergence of the laser beam over the short distance of the translated coupling mechanism's motion has minimal impact on the coupling efficiency to the fiber. The optical alignment system can drive the mechanism to align the beam path with the selected optical fiber channel, and then fire the laser in a pulsed or semi-CW mode.

[0197] In other embodiments, the optical alignment system can incorporate secondary optics and an image sensor to directly image the ferrule block and optical fiber. This subsystem simultaneously images the focused spot of the energy beam scattered from the ferrule or a strategically located target nearby. The image of the energy spot is in the same image reference frame, allowing direct calculation of the offset from the core of the optical fiber. This data can be calculated using image processing methods and algorithms to determine the offset and calculate compensating adjustments. The positioning mechanism can then adjust the positioning of the ferrule array to improve coupling of the focused spot to the fiber core.

[0198] The systems and methods disclosed in the various embodiments provided herein can be implemented in any multiplexer configuration, including linear, circular, patterned, or scanning configurations, as long as a wavelength-separating beam splitter can be inserted in the beam path between the coupling optics and the energy source. The systems and methods disclosed herein can enable the coupling lens to function in a dual-use mode, allowing energy to be coupled into both the light guide and a portion of the imaging lens for imaging the light guide.

[0199] It will be appreciated that the optical alignment systems and methods provided herein address several potential problems with the performance, reliability, and proper use of IVL catheters, those utilizing an energy source to create a localized plasma that generates high energy bubbles inside balloon catheters. Specific problems solved by the systems and methods disclosed herein include: 1) Complex laser systems with moving components are subject to beam pointing errors. These pointing errors can be induced by vibrations, thermal drift of optical components and mirrors, and long-term mechanical changes in the mounting of the light source and optics. This drift in beam pointing can be angular or lateral, producing an offset in the focused spot position. Without compensation for these drifts, errors in the spot position relative to the optical fiber core lead to loss of coupling efficiency and damage to the fiber at high energies. The systems and methods disclosed herein provide active compensation of the actual beam drift that occurs at the coupling point. 2) The systems and methods disclosed herein provide compensation for assembly mechanical tolerance stack-up and true alignment of optical fibers, ferrules, connectors, and receptacles, thereby allowing the use of lower cost, lower precision components on the SUD and improving COGS. 3) The systems and methods disclosed herein reduce the dependency of multiplexer performance on the accuracy of the static or fixed positioning mechanisms within the multiplexer and the associated quality and precision of its optical and mechanical components, thereby improving the speed and performance of multiplexers and multi-channel ferrule systems.

[0200] 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.

[0201] 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 configured to perform a particular task or adopt a particular configuration. The phrase "configured" can be used interchangeably with other similar phrases such as arranged and configured, built and arranged, constructed, manufactured and arranged, etc.

[0202] The headings used herein are provided for consistency with suggestions under 37 CFR 1.77 or to otherwise provide an organizational cue. These headings should not be considered to limit or characterize the invention(s) recited in any claim that may issue from this disclosure. As an example, a description of a technology in the "Background" is not an admission that the technology is prior art to any invention(s) in this disclosure. Neither the "Summary" nor the "Abstract" should be considered a feature of the invention(s) recited in the issued claim.

[0203] The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the detailed description provided herein. Rather, the embodiments are chosen and described so that those skilled in the art can appreciate and understand the principles and practices. Thus, aspects have been described with reference to various specific preferred embodiments and techniques. However, it should be understood that many variations and modifications can be made while remaining within the spirit and scope of the description.

[0204] Although several different embodiments of the catheter system have been illustrated and described herein, it should be understood that one or more features of any one embodiment may be combined with one or more features of one or more of the other embodiments, provided such combinations meet the intent of the invention.

[0205] 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 thus, the following appended claims and claims introduced below are intended to be construed to include all such modifications, permutations, additions, and subcombinations as are within their true spirit and scope, and are not intended to be limited to the details of construction or design shown herein.

Claims

1. 1. A catheter system for treating a treatment site within 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 and has a guide proximal end; a second light guide receiving the light energy from the light source and having a guide proximal end; a multiplexer that directs the light energy to the proximal guide end of the first light guide and to the proximal guide end of the second light guide; an optical alignment system that determines an alignment of the optical energy with respect to at least one of the proximal guide ends, and adjusts a positioning of the optical energy with respect to the at least one of the proximal guide ends based at least in part on the alignment of the optical energy with respect to the at least one of the proximal guide ends, the optical alignment system including an imaging system including an imaging sensor, the imaging system configured to capture an image of a focal point of the light source and an image of the at least one of the proximal guide ends; A catheter system comprising:

2. The catheter system of claim 1 , wherein the optical alignment system is configured to improve optical coupling between the optical energy and at least one of the light guides.

3. The catheter system of claim 1 or 2, further comprising a system controller configured to control the optical alignment system such that the optical energy is substantially coupled to the at least one of the guide proximal ends.

4. The catheter system of claim 1 , wherein at least one of the light guides is an optical fiber and the light source is a laser.

5. The catheter system of claim 1 , wherein the imaging system is configured to simultaneously capture an image of the focal point of the light source and an image of a scattered energy beam scattered from the at least one of the guide proximal ends.

6. The catheter system of claim 5 , wherein the imaging system is configured to utilize an image reference frame that allows direct calculation of a distance offset of the at least one of the guide proximal ends from a center.

7. The catheter system of claim 6 , wherein the imaging system is configured to determine the distance offset and to calculate a compensating adjustment of the alignment of the optical energy relative to the at least one of the guide proximal ends.

8. 8. The catheter system of claim 7, wherein the optical alignment system further comprises an aligner that adjusts a position of at least one of the proximal guide ends to adjust the alignment of the light energy relative to the at least one of the proximal guide ends based on the calculated compensation adjustment to substantially couple the light source with the at least one of the proximal guide ends.

9. The catheter system of claim 1, further comprising a system controller configured to control an optical system mover and adjust the position of the multiplexer to align the optical energy with at least one of the proximal ends of the guide.

10. 15. The catheter system of claim 14, further comprising a light source mover coupled to the multiplexer, the light source mover being connected to the optics mover such that the actuator can adjust the position of the multiplexer along the light source mover.

11. The catheter system of claim 1 , wherein the light source is a pulsed IR laser.

12. The catheter system of claim 1 , wherein the multiplexer includes a dichroic beam splitter that splits the light energy from the light source into at least two light beams.

13. The catheter system of claim 12 , wherein the dichroic beam splitter is configured to reflect optical energy having a shorter wavelength than the optical energy emitted by the light source.

14. 14. The catheter system of claim 12 or 13, wherein the dichroic beam splitter is configured to reflect a portion of the optical energy emitted by the light source as an imaging beam, and the imaging beam is directed to a detector for analyzing the optical energy reflected from at least one of the light guides.

15. The catheter system of claim 1 , wherein the optical alignment system further comprises an illuminator that illuminates the at least one of the guide proximal ends to provide improved image quality and brightness.

16. The catheter system of claim 15, further comprising a system controller that controls the illuminator to adjust the brightness and contrast of the image.

17. The catheter system of claim 1 , wherein the optical alignment system further comprises one of a stepper motor and a piezoelectric actuator configured to adjust a yaw, pitch, and roll of at least one of the light guides.

18. The catheter system of claim 1 , wherein the optical alignment system further comprises an optical compensator configured to adjust the steering of the optical energy relative to the at least one of the guide proximal ends.

19. 20. The catheter system of claim 18, wherein the optical compensator comprises a plurality of optical steering wedges positioned in a path of the optical energy, the plurality of optical steering wedges configured to improve the coupling of the optical energy to the at least one of the guide proximal ends.

20. The catheter system of claim 1 , wherein the optical alignment system further comprises a reflector and a reflector mover that moves the reflector.

Images