Active alignment system for laser photocoupling

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 on June 7, 2021, entitled "ACTIVE ALIGNMENT SYSTEM AND METHOD FOR LASER OPTICAL COUPLING", and U.S. Patent Application No. 17 / 831,056, filed on 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 hereby incorporated by reference in their entirety.

Background Art

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

[0003] Vascular lesions can be treated using, for example, interventions such as drug therapy, balloon angioplasty, atherectomy, stent placement, and vascular graft bypass. Such interventions are not always ideal or may require subsequent treatment to address the lesion.

Summary of the Invention

[0004] The present invention relates to a catheter system for treating a treatment site inside or adjacent to a blood vessel wall or heart valve. In various embodiments, the catheter system includes a light source, a first optical guide, a second optical guide, and an optical alignment system. The light source generates light energy. The first optical guide receives light energy from the light source and has a guide proximal end. The second optical guide receives light energy from the light source and has a guide proximal end. A multiplexer directs the light energy to the guide proximal ends of the first optical guide and the guide proximal end of the second optical guide. The optical alignment system determines the alignment of the light energy to at least one of the guide proximal ends. The optical alignment system adjusts the positioning of the light energy to at least one of the guide proximal ends, at least in part, based on the alignment of the light energy to at least one of the guide proximal ends.

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

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

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

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

[0009] In certain embodiments, the light source is a laser.

[0010] In various embodiments, the optical alignment system further includes an optical aligner configured to align light 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 comprising an imaging sensor, the imaging system configured to capture an image of the focal point of the light source and an image of at least one 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 guide proximal ends.

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

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

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

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

[0018] In certain embodiments, the catheter system further includes a light source movable element coupled to a multiplexer, the light source movable element being connected to the optical system movable element so that the optical system movable element can position the multiplexer along the light source movable element.

[0019] In various embodiments, the system controller is configured to align the light source with one of the following: (i) a third optical guide that receives light energy from the light source and has a guide proximal end, and (ii) a third optical 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 comprising a dichroic beam splitter that splits a 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 wavelength shorter than the light energy emitted by the light source.

[0023] In some embodiments, the dichroic beam splitter includes a dichroic coating that reflects a portion of the light energy emitted by the light source, adjusted so that 99% to 0.01% is 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 optical guides.

[0026] In some embodiments, the optical alignment system further includes an illuminator that illuminates at least one of the proximal ends of the guide 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 optical guides.

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

[0030] In certain embodiments, the optical compensator includes a plurality of optical steering wedges positioned in the path of the light source, and the plurality of optical steering wedges are configured to improve the 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 the vessel wall in a patient's body using any of the catheter systems of the embodiments described herein.

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

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

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

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

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

[0038] In certain embodiments, the light source is a laser.

[0039] In various embodiments, the optical alignment system further includes an optical aligner configured to align light energy with at least one of the guide proximal ends of an optical 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, which includes an imaging sensor, and the imaging system is configured to capture an image of the focal point of a 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 guide proximal ends of the optical guide.

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

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

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

[0046] In some embodiments, the method further includes the step of coupling a light source mover to a multiplexer, the light source mover being connected to the optical system mover so that the optical system mover can position the multiplexer along the light source mover.

[0047] In a particular embodiment, the system controller is configured to align the light source with one of the following: (i) a third optical guide that receives light energy from the light source and has a guide proximal end, and (ii) a third optical 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 includes an optical element that includes a dichroic beam splitter that splits the light source into at least two guide beams.

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

[0051] In various embodiments, the dichroic beam splitter includes a dichroic coating that reflects a portion of the light energy emitted by the light source, adjusted so that 99% to 0.01% is reflected.

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

[0053] In certain embodiments, the method further includes the step of directing the light energy reflected from at least one of the guide proximal ends of the optical 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 guide proximal ends of the optical guide to provide improved image quality and brightness.

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

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

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

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

[0059] In certain embodiments, the optical alignment system further includes a reflector and a reflector movable element for moving the reflector.

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

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

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

[0063] This summary is an overview of some of the teachings of this application and is not intended to be an exclusive or exhaustive treatment of the subject matter. Further details are found in the detailed description and the appended claims. Other aspects will be apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings which form part thereof, and each of these should not be construed as restrictive. The scope of this specification is defined by the appended claims and their legal equivalents.

[0064] The novel features of the present invention, and the invention itself, with respect to both its structure and its operation, will be best understood from the accompanying drawings in conjunction with the accompanying description. In the accompanying description, similar reference numerals refer to similar parts in most cases. [Brief explanation of the drawing]

[0065] [Figure 1] This is a schematic cross-sectional view of one embodiment of a catheter system according to various embodiments of this specification, the catheter system including a multiplexer having the features of the present invention. [Figure 2] This is a simplified schematic diagram of a part of an embodiment of a catheter system, including one embodiment of an optical alignment system, in which the optical alignment system is used in a first alignment configuration. [Figure 3]This is a simplified schematic diagram of a part of an embodiment of a catheter system, including one embodiment of an optical alignment system, in which the optical alignment system is used in a second alignment configuration. [Figure 4] This is a simplified schematic diagram of a part of an embodiment of a catheter system, including one embodiment of an optical alignment system, in which the optical alignment system is used in a third alignment configuration. [Figure 5A] This is a simplified diagram of the proximal guide end of the optical guide and a portion of the guide beam reflected from the proximal guide end of the optical guide, with the portion of the guide beam shown not being aligned. [Figure 5B] This is a simplified diagram of the proximal guide end of the optical guide and a portion of the guide beam reflected from the proximal guide end of the optical guide, with the portion of the guide beam shown in an aligned state. [Figure 6] This is a flowchart of one embodiment of a method for treating a treatment site inside or adjacent to a vascular wall or heart valve using a catheter system having the features and / or steps of the present invention. [Modes for carrying out the invention]

[0066] Embodiments of the present invention are susceptible to various modifications and substitutions, the details of which are shown in examples and drawings and described in detail herein. However, it should be understood that the scope of this specification is not limited to the specific embodiments described. Rather, the intent is to cover modifications, equivalents, and substitutions that fall within the spirit and scope of this specification.

[0067] Treatment of vascular lesions (sometimes referred to herein as “sites of treatment”) can reduce major adverse events or death in the affected patient. As used herein, major adverse events are any adverse events that may occur anywhere in the body as a result of 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 interchangeable unless otherwise specified. Intravascular lesions and / or vascular lesions may be simply referred to as “lesions” as used herein. Also, as used herein, the terms “focusing location” and “focusing spot” may be interchangeable unless otherwise specified, and can 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 understand that the following detailed description of the invention is illustrative and not intended to limit it in any way. Other embodiments of the invention will be readily apparent to such skilled in the art who are interested in this disclosure. Hereinafter, embodiments of the invention shown in the accompanying drawings will be used with reference in detail.

[0070] For clarity, not all of the everyday features of the embodiments described herein are shown or described. Naturally, in developing such actual embodiments, a number of decisions specific to the embodiment must be made to achieve the developer's particular objectives, such as compliance with application-related and business-related constraints, and it will be understood that these particular objectives will differ from embodiment to embodiment and from developer to developer. Furthermore, while such development efforts can be complex and time-consuming, it will nevertheless be understood as an everyday engineering task for those skilled in the art who are interested in this disclosure.

[0071] The catheter systems disclosed herein can take many different forms. Referring here to Figure 1, schematic cross-sectional views of catheter systems 100 according to various embodiments are shown. Catheter systems 100 are suitable for applying pressure waves to induce fragmentation at one or more treatment sites within or adjacent to the walls of blood vessels in a patient's body, or on or adjacent to heart valves. In the embodiment shown in Figure 1, catheter systems 100 can include a catheter 102, an optical guide bundle 122 including one or more optical guides 122A, a multiplexer 123 including one or more of a source manifold 136, a fluid pump 138, a light source 124, a power supply 125, a system controller 126, and a graphic user interface 127 ("GUI"), a handle assembly 128, and one or more of an optical analyzer assembly 142. Alternatively, catheter systems 100 can include more or fewer components than those specifically illustrated and described in relation to Figure 1.

[0072] Although the catheter system 100 is generally described herein as comprising an optical guide bundle 122 including one or more optical guides 122A and a light source 124, it will be understood that in some alternative embodiments the catheter system 100 may 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 travel inside or adjacent to the treatment site 106 of a blood vessel wall 108A of a blood vessel 108 within the patient's body 107. The treatment site 106 may include one or more vascular lesions 106A, such as calcified vascular lesions. Additionally or alternatively, the treatment site 106 may include vascular lesions 106A, such as fibrous vascular lesions. Further alternatively, in some embodiments, the catheter 102 can be used inside or adjacent to a treatment site 106 within the patient's body 107.

[0074] The catheter 102 may include an inflatable balloon 104 (sometimes simply referred to herein as the “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 proximal end 104P and a distal end 104D. The catheter shaft 110 may extend from the proximal portion 114 of the catheter system 100 to the 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 move along the guidewire 112. As used herein, the guidewire lumen 118 defines the conduit through which the guidewire 112 extends. The catheter shaft 110 may further include an inflatable lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, the catheter 102 may have a distal end opening 120 that can accommodate and pass over a guidewire 112 when the catheter 102 is moved and positioned at or near the treatment site 106. In some embodiments, the proximal end of the balloon 104P may be coupled to the catheter shaft 110, and the distal end of the balloon 104D may be coupled to the guidewire lumen 118.

[0075] The balloon 104 includes a balloon wall 130 that defines the interior 146 of the balloon. The balloon 104 can be selectively inflated with balloon fluid 132 to expand from a deflated state suitable for advancing the catheter 102 through the patient's vascular system to an inflated state (as shown in Figure 1) suitable for securing the catheter 102 in place relative to the treatment site 106. In other words, when the balloon 104 is inflated, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. Figure 1 shows the balloon wall 130 of the balloon 104 shown spaced apart from the treatment site 106 of the blood vessel 108 when inflated, but it is understood that this is done simply for the sake of illustration. It is recognized that the balloon wall 130 of the balloon 104 is typically substantially directly adjacent to and / or in contact with the treatment site 106 when the balloon 104 is inflated.

[0076] A balloon 104 suitable for use in a catheter system 100 includes one that can pass through the vascular system of a patient 109 when deflated. In some embodiments, the balloon 104 is made of silicone. In other embodiments, the balloon 104 can be made from a polymer such as polydimethylsiloxane (PDMS), polyurethane, PEBAX® material, nylon, or any other suitable material.

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

[0078] In some embodiments, the balloon 104 can have a length in the range of at least 3 mm to 300 mm. More specifically, in some embodiments, the balloon 104 can have a length in the range of at least 8 mm to 200 mm. It is understood that a balloon 104 having a relatively long length can be positioned adjacent to a larger treatment site 106 and thus can be used to induce fragmentation by applying a pressure wave to a larger vascular lesion 106A or multiple vascular lesions 106A at a precise location within the treatment site 106. Furthermore, it is understood that a longer balloon 104 can also be positioned adjacent to multiple treatment sites 106 at any given time.

[0079] The balloon 104 can be inflated to an inflation pressure of approximately 1 atmosphere (atm) to 70 atm. In some embodiments, the balloon 104 can be inflated to an inflation pressure of at least 20 atm to 60 atm. In other embodiments, the balloon 104 can be inflated to an inflation pressure of at least 6 atm to 20 atm. In yet another embodiment, the balloon 104 can be inflated to an inflation pressure of at least 3 atm to 20 atm. In yet another embodiment, the balloon 104 can 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 conical, square, rectangular, spherical, conical / square, conical / spherical, elongated spherical, elliptical, tapered, bony, stepped diameter, offset, or conical offset shapes. In some embodiments, the balloon 104 may include a drug-eluting coating or a drug-eluting stent structure. The drug-eluting coating or drug-eluting stent may contain one or more therapeutic agents, including anti-inflammatory agents, antineoplastic agents, and anti-angiogenic agents.

[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, water, saline, contrast media, gases such as fluorocarbons, perfluorocarbons, and carbon dioxide, or any other suitable balloon fluids 132. In some embodiments, the balloon fluid 132 can be used as a base inflation fluid. In some embodiments, the balloon fluid 132 may include a mixture of saline and contrast media in a volume ratio of approximately 50:50. In other embodiments, the balloon fluid 132 may include a mixture of saline and contrast media in a volume ratio of approximately 25:75. In yet another embodiment, the balloon fluid 132 may include a mixture of saline and contrast media in a volume ratio of approximately 75:25. However, it is understood that any suitable ratio of saline to contrast media can be used. The balloon fluid 132 can be adjusted based on composition, viscosity, etc., so that the velocity of the pressure wave is appropriately controlled. 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 selected light source 124 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, iodine-based contrast agents, such as ionic or nonionic iodine-based contrast agents. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, metrizoate, iotalamate, and ioxagrate. Some non-limiting examples of nonionic iodine-based contrast agents include iopamidol, iohexol, ioxiran, 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 fluorocarbons and perfluorocarbon agents may include, but is not limited to, agents such as perfluorocarbon dodecafluoropentane (DDFP, C5F12).

[0083] The balloon fluid 132 may include an absorbent capable of selectively absorbing light in the ultraviolet region (e.g., at least 10 nanometers (nm) to 400 nm), the visible region (e.g., at least 400 nm to 780 nm), or the near-infrared region (e.g., at least 780 nm to 2.5 μm) of the electromagnetic spectrum. A suitable absorbent may have an absorption maximum along the spectrum at least 10 nm to 2.5 μm. Alternatively, the balloon fluid 132 may include an absorbent capable of selectively absorbing light in the mid-infrared region (e.g., at least 2.5 μm to 15 μm) or the far-infrared region (e.g., at least 15 μm to 1 mm) of the electromagnetic spectrum. In various embodiments, the absorbent may have an absorption maximum that coincides with the emission maximum of the laser used in the catheter system 100. As non-limiting examples, the various lasers described herein may include neodymium:yttrium-aluminum-garnet (Nd:YAG - emission maximum = 1064 nm) lasers, holmium:YAG (Ho:YAG - emission maximum = 2.1 μm) lasers, or erbium:YAG (Er:YAG - emission maximum = 2.94 μm) lasers. In some embodiments, the absorbent may be water-soluble. In other embodiments, the absorbent is not water-soluble. In some embodiments, the absorbent used in the balloon fluid 132 may be adjusted 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 in this specification.

[0084] The catheter shaft 110 of the catheter 102 can be coupled to one or more optical guides 122A of an optical guide bundle 122 that optically communicates with a light source 124. The optical guides 122A can be positioned within the balloon 104 along the catheter shaft 110. Each optical guide 122A may have a distal guide end 122D at any suitable longitudinal position relative to the length of the balloon 104. In some embodiments, each optical guide 122A may be an optical fiber, and the light source 124 may be a laser. The light source 124 can optically communicate with the optical guides 122A in the proximal portion 114 of the catheter system 100. More specifically, the light source 124 can optically communicate with each of the optical guides 122A selectively, simultaneously, sequentially, and / or alternatively in any desired combination, order, and / or pattern due to the presence and operation of a multiplexer 128.

[0085] In some embodiments, the catheter shaft 110 can be coupled to multiple optical guides 122A, such as a first optical guide, a second optical guide, a third optical guide, etc., which can 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 optical guides 122A can be spaced about 180 degrees apart around the guidewire lumen 118 and / or the catheter shaft 110, three optical guides 122A can be spaced about 120 degrees apart around the guidewire lumen 118 and / or the catheter shaft 110, or four optical guides 122A can be spaced about 90 degrees apart around the guidewire lumen 118 and / or the catheter shaft 110. Alternatively, the multiple optical guides 122A do not need to be uniformly spaced apart from each other around the guidewire lumen 118 and / or the catheter shaft 110. More specifically, the optical guide 122A can be uniformly or non-uniformly positioned around the guidewire lumen 118 and / or catheter shaft 110 to achieve the desired effect at the desired location.

[0086] The catheter system 100 and / or optical guide bundle 122 may include any number of optical guides 122A that optically communicate with the light source 124 at the proximal portion 114 and with the balloon fluid 132 inside the balloon 146 of the balloon 104 at the distal portion 116. For example, in some embodiments, the catheter system 100 and / or optical guide bundle 122 may include from one optical guide 122A to five optical guides 122A. In other embodiments, the catheter system 100 and / or optical guide bundle 122 may include from five optical guides 122A to fifteen optical guides 122A. In yet another embodiment, the catheter system 100 and / or optical guide bundle 122 may include from ten optical guides 122A to thirty optical guides 122A. Alternatively, in yet another embodiment, the catheter system 100 and / or optical guide bundle 122 may include more than thirty optical guides 122A.

[0087] The optical guide 122A may have any suitable design for the purpose of generating plasma and / or pressure waves in the balloon fluid 132 inside the balloon 146. In certain embodiments, the optical guide 122A may include an optical fiber or a flexible optical pipe. The optical guide 122A may be thin and flexible and may allow the transmission of optical signals with little loss of intensity. The optical 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 optical 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 optical 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 that of the cladding.

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

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

[0090] The optical guide 122A can take many configurations around and / or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the optical guide 122A can extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the optical guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the optical guide 122A can be positioned along the length of the outer diameter of the catheter shaft 110. In yet another embodiment, the optical guide 122A can be positioned within one or more optical guide lumens within the catheter shaft 110.

[0091] The optical guide 122A can also be positioned at any suitable location around the guidewire lumen 118 and / or the catheter shaft 110, and each distal guide end 122D of the optical guide 122A can be positioned at any suitable longitudinal location relative to the length of the balloon 104 and / or the length of the guidewire lumen 118 to more effectively and accurately apply pressure waves for the purpose of destroying the vascular lesion 106A at the treatment site 106.

[0092] In certain embodiments, the optical guide 122A may include one or more photoacoustic transducers 154, each of which can communicate optically with the optical guide 122A located therein. In some embodiments, the photoacoustic transducers 154 can communicate optically with the guide distal end 122D of the optical guide 122A. Furthermore, in such embodiments, the photoacoustic transducers 154 may have a shape that corresponds to and / or conforms to the guide distal end 122D of the optical guide 122A.

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

[0094] In certain embodiments, a photoacoustic transducer 154 positioned at the guide distal end 122D of the optical guide 122A may have the same shape as the guide distal end 122D of the optical guide 122A. For example, in certain non-exclusive embodiments, the photoacoustic transducer 154 and / or the guide distal end 122D may have a conical, convex, concave, bulbous, square, stepped, semicircular, oval shape, and the like. The optical guide 122A may further include additional photoacoustic transducers 154 positioned along one or more sides of the length of the optical guide 122A.

[0095] In some embodiments, the optical guide 122A may further include one or more diverting mechanisms or "divertors" (not shown in Figure 1) within the optical guide 122A configured to direct light out of the optical guide 122A toward a side that may be located at or near the guide distal end 122D of the optical guide 122A, and toward the balloon wall 130. The diverting mechanism may include any mechanism of a system that redirects optical energy away from the optical guide 122A away from its axial path toward a side of the optical guide 122A. Furthermore, each optical guide 122A may include one or more optical windows arranged along the longitudinal or circumferential surface of each optical guide 122A and optically communicating with the diverting mechanism. In other words, the diverting mechanism may be configured to direct the optical energy within the optical guide 122A toward a side that may be located at or near the guide distal end 122D, which optically communicates with the optical window. The light window may include a portion of the optical guide 122A that allows light energy to exit the optical guide 122A from within the optical guide 122A, for example, a portion of the optical guide 122A that does not have cladding material on or around the optical guide 122A.

[0096] Examples of suitable redirection mechanisms include reflective elements, refractive elements, and fiber diffusers. Redirection mechanisms suitable for focusing light energy away from the tip of the optical guide 122A may include, but are not limited to, those having a convex surface, a distributed refractive index (GRIN) lens, and a mirror focus lens. Upon contact with the redirection mechanism, the light energy is redirected within the optical guide 122A to one or more of the plasma generator 133 and the photoacoustic transducer 154, which is in optical communication with the side of the optical guide 122A. As described above, the photoacoustic transducer 154 converts the light energy into acoustic waves that extend away from the side of the optical guide 122A.

[0097] The supply manifold 136 may be positioned in or near the proximal portion 114 of the catheter system 100. The supply manifold 136 may include one or more proximal end openings that can receive one or more optical guides 122A of the optical guide bundle 122, a guide wire 112, and / or an expansion conduit 140 which is fluidly connected to the fluid pump 138. The catheter system 100 may also include the fluid pump 138 configured to inflate the balloon 104 with balloon fluid 132, if necessary.

[0098] As described above, in the embodiment shown in Figure 1, the multiplexer 123 includes one or more of the light source 124, power supply 125, system controller 126, and GUI 127. Alternatively, the multiplexer 123 may include more or fewer components than those specifically shown in Figure 1. For example, in certain non-exclusive alternative embodiments, the multiplexer 123 can be designed without the GUI 127. Further alternatively, one or more of the light source 124, power supply 125, system controller 126, and GUI 127 can be provided within the catheter system 100 without specifically requiring the multiplexer 123.

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

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

[0101] As illustrated, the multiplexer 123 and its constituent components are operably coupled to the catheter 102, the optical guide bundle 122, and the rest of the catheter system 100. For example, in some embodiments, as shown in Figure 1, the multiplexer 123 may include a console connection opening 148 (sometimes commonly referred to as a “socket”) into which the optical guide bundle 122 is mechanically coupled. In such embodiments, the optical guide bundle 122 may include a guide coupling housing 150 (sometimes commonly referred to as a “ferrule”) that accommodates each portion of the optical guide 122A, for example, the proximal end 122P of the guide. The guide coupling housing 150 is configured to fit into and be selectively held within the console connection opening 148 to provide a mechanical coupling between the optical guide bundle 122 and the multiplexer 123.

[0102] The optical guide bundle 122 may also include a guide bundler 152 (or "shell") that brings each of the individual optical guides 122A closer together, thereby allowing the optical guides 122A and / or the optical guide bundle 122 to be in a more compact form when they extend into the blood vessel 108 together with the catheter 102 during use of the catheter system 100. In some embodiments, the optical guides 122A leading to the plasma generator 133 may be organized into an optical guide bundle 122 that includes a linear block having an array of precision holes forming a multi-channel ferrule. In other embodiments, the optical guide bundle 122 may include a mechanical connector array or block connector that organizes a single ferrule into a linear array.

[0103] The light source 124 can be optically connected to each of the optical guides 122A within the optical guide bundle 122, i.e., selectively and / or alternatively coupled to the proximal guide end 122P of each optical guide 122A. In particular, the light source 124 is configured to generate optical energy in the form of a light source beam 124A, such as a pulsed light source beam, which can be selectively and / or alternatively directed to and received by each of the optical guides 122A within the optical 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 optical guides 122A within the optical guide bundle 122. The light sources 124 can operate at low energy.

[0104] The light source 124 can have any suitable design. In a particular embodiment, the light source 124 can be configured to provide sub-millisecond pulses of light energy from the light source 124 that are focused onto a small spot to couple to the proximal guide end 122P of the optical guide 122A. Such pulses of light energy are then directed and / or guided along the optical guide 122A to a position 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 via a plasma generator 133, which can be positioned at the distal guide end 122D of the optical guide 122A. In particular, light emitted at the distal guide end 122D of the optical guide 122A excites the plasma generator 133 to form plasma within the balloon fluid 132 within the balloon interior 146. Plasma formation causes rapid bubble formation, imparting a pressure wave to the treatment site 106. An exemplary plasma-induced bubble 134 is shown in Figure 1.

[0105] When plasma is first formed in the balloon fluid 132 inside the balloon interior 146, it emits broad-spectrum electromagnetic radiation. This can be seen as a flash of broad-spectrum light detectable to 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 distal guide end 122D of the optical guide 122A, travel back to the proximal guide end 122P, where it can be separated, detected, and analyzed using the optical analyzer assembly 142. The intensity and timing of the visible light pulse relative to the plasma generation pulse provide an indicator that the plasma generator 133 was functioning, its energy output, and its functional state. If the optical guide 122A is damaged or broken, a visible light flash may occur at another location on the optical guide 122A. Such other visible light flashes can also be coupled to the optical guide 122A, transported back to the proximal guide end 122P. The intensity and timing of these other light pulses provide an indicator of damage or failure of the optical guide 122A or the plasma generator 133. In such a situation, the optical analyzer assembly 142 may include a safety shutdown system 283 (shown in Figure 2A) that can be selectively activated to shut down the operation of the catheter system 100.

[0106] The configuration of the plasma generator 133 and / or distal light receiver 122R further allows ambient light emanating from outside the catheter 102 to be coupled to the distal guide end 122D of the optical guide 122A. In one embodiment, the optical analyzer assembly 142 monitors the return ambient light energy traversing the optical guide 122A from the distal guide end 122D to the proximal guide end 122P. If ambient light energy is present and detected by the optical analyzer assembly 142 in such a situation, this is an indicator that the catheter 102 is located outside the patient's body 107, and the optical analyzer assembly 142 can be configured to lock out the light source 124 accordingly. In particular, in such a situation, 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, submillisecond pulses of light energy from the light source 124 may be delivered to the treatment site 106 at frequencies of approximately 1 Hz to 5000 Hz, approximately 30 Hz to 1000 Hz, approximately 10 Hz to 100 Hz, or approximately 1 Hz to 30 Hz. Alternatively, submillisecond 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 at any other suitable range of frequencies.

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

[0109] Suitable light sources 124 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 described above, light sources 124 referred to herein can include any suitable type of energy source.

[0110] A suitable laser may include a short-pulse laser on a sub-millisecond timescale. In some embodiments, the light source 124 may include a laser on a nanosecond (ns) timescale. The laser may also include short-pulse lasers on picosecond (ps), femtosecond (fs), and microsecond (us) timescales. It is understood that there are many combinations of laser wavelength, pulse width, and energy level that can be employed to realize the plasma in the balloon fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse width may include those in the range of 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 may 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, a light source 124 suitable for use in a catheter system 100 can include one capable of generating light with wavelengths of at least 750 nm to 2000 nm. In other embodiments, the light source 124 can include one capable of generating light with wavelengths of at least 700 nm to 3000 nm. In yet another embodiment, the light source 124 can include one 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 neodymium:yttrium-aluminum-garnet (Nd:YAG) lasers, holmium:yttrium-aluminum-garnet (Ho:YAG) lasers, erbium:yttrium-aluminum-garnet (Er:YAG) lasers, excimer lasers, helium-neon lasers, carbon dioxide lasers, and doped pulsed fiber lasers.

[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 wave may be applied to the treatment site 106 from a distance ranging from at least about 0.1 mm to more than about 25 mm, extending radially from the optical guide 122A, when the catheter 102 is placed on the treatment site 106. In various non-exclusive alternative embodiments, the pressure wave may be applied to the treatment site 106 from a distance ranging from at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm, extending radially from the optical guide 122A, when the catheter 102 is placed on the treatment site 106. In other embodiments, the pressure wave may be applied to the treatment site 106 from a different suitable distance different from the ranges described above. In some embodiments, the pressure wave may be applied to the treatment site 106 at a distance of at least about 0.1 mm to 10 mm within a range of at least about 2 MPa to 30 MPa. In some embodiments, a pressure wave may be applied to the treatment site 106 at a distance of at least about 0.1 mm to 10 mm in the range of at least about 2 MPa to 25 MPa. Alternatively, other suitable pressure ranges and distances may be used.

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

[0115] The system controller 126 is electrically coupled to the power supply 125 and receives power from the power supply 125. Furthermore, the system controller 126 is coupled to each of the light source 124, GUI 127, and 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, GUI 127, and optical analyzer assembly 142. For example, the system controller 126 can control the light source 124 to generate pulses of light energy as desired and / or at any desired firing rate. Furthermore, the system controller 126 can be controlled and / or operated 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 the catheter 102 adjacent to the treatment site 106 and inflating the balloon 104 with balloon fluid 132. Furthermore or alternatively, the catheter system 100 may include one or more additional controllers that can be positioned in any suitable manner for the purpose of controlling various operations of the catheter system 100. For example, in certain embodiments, additional controllers and / or a portion of the system controller 126 may be positioned and / or incorporated within the handle assembly 128.

[0117] The GUI 127 is accessible to the user or operator of the catheter system 100. Furthermore, the GUI 127 is electrically connected to the system controller 126. Such a design allows the GUI 127 to be used by the user or operator to ensure that the catheter system 100 is effectively utilized to apply pressure to the treatment site(s) 106 to induce fragmentation. The GUI 127 can provide the user or operator with information that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 can provide the user or operator with static visual data and / or information. Additionally or alternatively, the GUI 127 can provide the user or operator with dynamic visual data and / or information, such as video data or any other data that changes over time during use of the catheter system 100. In various embodiments, the GUI 127 may include one or more colors, different sizes, changing brightness, etc., which can function as warnings to the user or operator. Additionally or alternatively, the GUI 127 can provide the user or operator with audio data or information. The details of GUI127 may be modified according to the design requirements of the catheter system 100, or the specific needs, specifications, and / or requests of the user or operator.

[0118] As shown in Figure 1, the handle assembly 128 can be positioned at or near the proximal portion 114 of the catheter system 100 and / or near the supply manifold 136. In this embodiment, the handle assembly 128 is coupled to the balloon 104 and positioned at a distance from the balloon 104. Alternatively, the handle assembly 128 can be positioned at another suitable location.

[0119] The handle assembly 128 is handled and used by the user or operator to operate, position, and control the catheter 102. The design and specific features of the handle assembly 128 can be modified to conform to the design requirements of the catheter system 100. In the embodiment shown in Figure 1, the handle assembly 128 is isolated from, but electrically and / or fluidly communicating with, one or more of the system controller 126, light source 124, fluid pump 138, GUI 127, and optical analyzer assembly 142. In some embodiments, the handle assembly 128 may 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 may include a circuit 156 that can form at least a portion of the system controller 126. In some embodiments, the circuit 156 may receive electrical signals or data from the optical analyzer assembly 142. Furthermore or alternatively, the circuit 156 may transmit such electrical signals or otherwise provide data to the system controller 126.

[0120] In one embodiment, the circuit 156 may include one or more integrated circuits or a printed circuit board having any other suitable circuits. In alternative embodiments, the circuit 156 may be omitted or included within the system controller 126, and in various embodiments, the circuit 156 may be located outside the handle assembly 128, for example, within 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] Figure 2 is a simplified schematic diagram of a part of an embodiment of a catheter system 200, including an optical alignment system 257, in which the optical alignment system 257 is used in a first alignment configuration.

[0122] The design of the catheter system 200 is substantially the same as the embodiments shown and described herein. It is understood that various components of the catheter system 200, such as those shown in Figure 1, are not shown in Figure 2 for the sake of clarity and ease of explanation. 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 fixed onto a platen.

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

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

[0125] The light energy of each guide beam 224B is guided along the optical guide 222A from the proximal guide end 222P to the distal guide end 222D, exciting a plasma generator 233 positioned at or near the distal guide end 222D of the optical guide 222A and / or incorporated therein. The plasma generator 233 utilizes pulses of infrared energy to create a localized plasma in the balloon fluid 132 inside 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 shown in Figures 2, 3, and 4. The optical alignment system 257 aligns the light energy in the form of a light source beam 224A and / or individual guide beams 224B so that the light energy is coupled with one or more optical guides 222A.

[0127] The optical alignment system 257 can be modified according to the design requirements of the catheter system 200, the optical guide 222A, and / or the energy source 224. It is understood that the optical alignment system 257 may include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein. Additionally or alternatively, the optical alignment system 257 may 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 may include a multiplexer 223. The optical elements described herein may be contained within the multiplexer 223 (such as the multiplexer 128 described in relation to Figure 1). As shown in the embodiment in Figure 2, the multiplexer 223 may be movable about the multiplexer axis 223X. In some embodiments, the multiplexer 223 may be fixed to or attached to the multiplexer platen.

[0129] In some embodiments, the optical alignment system 257 may include one or more of the following: beam splitters 258, reflectors 260, coupling lenses 262, imaging lenses 263, filters 264, cameras 265, camera controllers 266, amplifiers 267, system controllers 268, signal processors 269, optical system movers 270, light source movers 271, illuminators 272, alignment controllers 273, detectors 274, and / or aligners 275.

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

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

[0132] In other embodiments, one or more beam splitters 258 can be positioned within 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 plane of the optical guide 222A or the proximal end 222P of the guide. This optical analysis can be used in diagnostic and fault detection methods.

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

[0134] The reflectors 260(or more) 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 reflectors 260(or more) may include mirrors. In certain embodiments, one or more of the reflectors 260 can bend 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 bend the light source beam 224A from the light source 224 at an angle greater than or less than 90 degrees. The reflectors 260(or more) can direct the light source beam 224A through the coupling lens 262 to one or more optical guides 222A. In one embodiment, one or more of the reflectors 260(or more) may be fixed. Alternatively, one or more of the reflectors 260(or more) may be movable by one or more optical movable elements 270, such as by one or more piezoelectric actuators in a non-exclusive embodiment.

[0135] The reflector 260 can be modified according to the design requirements of the catheter system 200, the optical guide 222A, and / or the optical alignment system 257. It is understood that the reflector 260 may include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein.

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

[0137] In some embodiments, the light source beam 224B and / or the imaging beam 224C can be collimated so that a separate set of optics can focus the light source beam 224B and / or the imaging beam 224C to form an image. In various embodiments, the light 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 critical to imaging performance. The various light beams disclosed herein can be separated by a distance convenient for positioning the optical elements on any given platen. The focal length of the optics controls the magnification of the optical guide 222A on the sensor (e.g., camera 265). The separation between the optics and the image sensor allows for the focusing of an image generated on a desired plane in an object, regardless of where the energy source is focused.

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

[0139] The imaging lens 263 can connect the imaging beam 224C to any suitable imaging system of the camera 265 or the optical alignment system 257. The imaging lens 263 can be modified according to the design requirements of the catheter system 200, the optical guide 222A, and / or the optical alignment system 257. It is understood that the imaging lens 263 may include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein.

[0140] The filter 264 can filter out light energy from the light source beam 224A, the guide beam 224B, and / or the imaging beam 224C. The filter 264 can be modified according to the design requirements of the catheter system 200, the optical guide 222A, the optical alignment system 257, and / or the camera 265. It is understood that the filter 264 may include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein.

[0141] The optical elements disclosed in various embodiments of this specification can be configured in any position or order. In some embodiments, such as the embodiment shown in Figure 2, it is possible to 1) combine the primary IR energy, and 2) image the end face of the ferrule (e.g., the proximal end 222P of the guide) and create an optical path for imaging a portion of the primary energy scattered or reflected by the end face of the ferrule or a conveniently collated target.

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

[0143] In various embodiments, the image of the focused spot is superimposed on the image of the guide proximal end 222P in the same image space. An additional filter 264 can be added to reduce the amount of IR signal arriving from the scattering source and to balance the intensity of the focused spot in the image with respect to the guide proximal end 222P and the optical guide 222A.

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

[0145] Camera 265 can be modified according to the design requirements of the catheter system 200 and / or the optical alignment system 257. It is understood that camera 265 may include additional systems, subsystems, components, and elements other than those specifically illustrated 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 as needed to adjust the brightness and contrast of the image. The camera controller 266 can be modified according to the design requirements of the catheter system 200, the optical guide 222A, the optical alignment system 257, the camera 265, and / or the signal processor 269. It is understood that the camera controller 266 may include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein.

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

[0148] The amplifier 267 can be modified according to the design requirements of the catheter system 200, the optical guide 222A, the optical alignment system 257, the camera 265, and / or the signal processor 269. It is understood that the amplifier 267 may include additional systems, subsystems, components, and elements other than those specifically illustrated 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 optical movable element 270.

[0150] The system controller 268 can be modified according to 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 may include additional systems, subsystems, components, and elements other than those specifically illustrated 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 received signal data. The signal processor 269 can segment the image to obtain the core / center position of the optical guide 222A and instruct the optical alignment system 257 to align the guide beam 224B to the focused spot position in the image space.

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

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

[0154] The optical movable element 270 moves and / or controls the movable components of the optical alignment system 257, such as the light source movable element 271. The optical movable element 270 can be modified according to the design requirements of the catheter system 200, the optical alignment system 257, and / or the light source movable element 271. It is understood that the optical movable element 270 may include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein.

[0155] The light source mover 271 can move the light energy, light source 224, and / or multiplexer 223 so that the light energy is properly aligned within at least one of the optical guides 222A. In some embodiments, a system controller 268 controls an 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 optical guides 222A. Using embodiments disclosed herein, an optical alignment system 257 can utilize the light source mover 271 to align the energy source 224 with any desired channel in the optical guide bundle 222, trigger the energy source 224, and move it to the next desired channel in the optical guide bundle 222.

[0156] The light source movable element 271 can be modified according to the design requirements of the catheter system 200, the optical guide 222A, the optical alignment system 257, and / or the optical system movable element 270. It is understood that the light source movable element 271 may include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein.

[0157] In some embodiments, the light source movable element 271 may include a linear translation stage. The multiplexer 223 may be configured to move across the linear transformation stage around the multiplexer axis 223X.

[0158] The illuminator 272 can illuminate the guide proximal end 222P so that the alignment of light energy with the guide proximal end 222P is easily detected and analyzed by the optical alignment system 257. The illuminator 272 may be modified according to the design requirements of the catheter system 200, the optical guide 222A, and / or the optical alignment system 257. It is understood that the illuminator 272 may include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein. In some embodiments, the illuminator 272 may 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 be modified according to the design requirements of the catheter system 200, the optical guide 222A, the optical alignment system 257, and / or the aligner 275. It is understood that the alignment controller 273 may include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein.

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

[0161] The detector 274 can be modified according to 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 may include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein.

[0162] The aligner 275 can align various components of the alignment system 257, such as the optical guide bundle 222 and the light source movable element 271. The aligner 275 can be modified according to the design requirements of the catheter system 200, the optical guide 222A, the optical alignment system 257, and / or the alignment controller 273. It is understood that the aligner 275 may include additional systems, subsystems, components, and elements other than those specifically illustrated and / or described herein.

[0163] In other embodiments, the aligner 275 may include a stepping motor and / or piezoelectric actuator for adjusting the height and tilt of the optical guide bundle 222. In one alignment process, the optical alignment system 257 aligns the light source movable element 271 near a first channel in the optical guide bundle 222 (corresponding to one optical guide 222A) and captures an image of the guide proximal end 222P and the corresponding optical guide 222A at the focused position of the guide beam 224B.

[0164] In certain embodiments, the magnification of the optical guide 222A in the image can be controlled so that the image is small relative to the size of the optical 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 focus position with the center / core of the optical guide 222A. The system controller 268 can align the light source beam 224B with the final optical guide 222A in the linear array of the optical guide bundle 222 and capture images of the guide proximal end 222P and the optical guide 222A along with the focus position. The position offset can be used to set the tilt of the optical guide bundle 222 by rotating it around the center of one of the optical guides 222A. This process can be continued iteratively to adjust the position and tilt parameters of the optical guides 222A as a whole. The process can continue back to the position of each optical 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 the optical alignment system 257 to the new guide bundle 222. Once the configuration described herein is complete, the optical alignment system 257 can operate over a time interval during which the alignment remains stable.

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

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

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

[0168] Figure 3 is a simplified schematic diagram of a part of an embodiment of the catheter system 300, including one embodiment of the optical alignment system 357, in which the optical alignment system 357 is used in a second alignment configuration.

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

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

[0171] In certain embodiments, as shown in Figure 3, the light 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 may be configured to focus, reflect, and / or filter the light source beam 324A as individual guide beams 324B onto the guide proximal end 322P of the optical guide 322A, thereby coupling the individual guide beams 324B to the optical guide 322A in the form of pulses of infrared energy. Once aligned with the optical guide 322A, the individual guide beams 324B travel toward the plasma generator 333. In some embodiments, each optical element may be configured to focus, reflect, and / or filter the imaging beam 324C toward the camera 365.

[0172] As shown in the embodiment of Figure 3, the catheter system 300 may include a multiplexer 323 having a multiplexer axis 323X, a camera controller 366, an amplifier 367, a system control unit 368, a signal processor 369, an optical movable element 370, a light source movable element 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 functions and / or components as those described in the embodiments disclosed herein.

[0173] In the second alignment configuration (shown in Figure 3), the detector 374 can receive light energy from the imaging beam 324C. The detector 374 can detect the light energy from the imaging beam 324C and convert the detected light energy into a signal. The detector 374 can transmit the signal to the amplifier 367 for amplification and then transmit it to the 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 movable element 371 at a predetermined position along the multiplexer axis 323X relative to a given optical channel and emit the light source 324. The optical alignment system 357 collects the reflected light as the imaging beam 324C and directs the imaging beam 324 to the detector 374. The detector 374 can be used in the second alignment configuration to analyze optical obstructions at the proximal and distal ends of the optical guide 322A and to monitor the plasma generated by the plasma generator 333. The optical alignment system 357 can acquire and analyze this data and decide whether to move the guide beam 324B to the next optical channel. If the optical alignment system 357 is nominal, the optical alignment system 357 aligns the guide beam 324B to the next channel, triggers the light source 324, and repeats the process across the entire array of optical guide bundles 322.

[0175] Figure 4 is a simplified schematic diagram of a part of an embodiment of the catheter system 400, including one embodiment of the optical alignment system 457, in which the optical alignment system 457 is used in a third alignment configuration.

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

[0177] As shown in Figure 4, the catheter system 400 also includes a light source 424 configured to generate light energy in the form of a light source beam 424A, for example, a pulsed light source beam, the light source beam 424A may be selectively and / or alternatively directed and received to each optical guide 422A (within the optical guide bundle 422) as individual guide beams 424B. Some or all of the optical elements may be configured to focus, reflect, and / or filter the light source beam 424A as individual guide beams 424B onto the guide proximal end 422P of the optical guide 422A, thereby coupling the individual guide beams 424B to the optical guide 422A in the form of pulses of infrared energy. Once aligned with the optical guide 422A, the individual guide beams 424B travel toward the plasma generator 433.

[0178] In certain embodiments, as shown in Figure 4, a light source beam 424A from a light 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 mounted mirrors. In some embodiments, a reflector 460 may include one or more adjustment fasteners (not shown) that allow for the positioning and / or adjustment of the reflector 460. In certain embodiments, it is understood that 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 movable elements 461.

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

[0180] Each reflector movable element 461 may include one or more suitable actuators, such as a stepping motor, a piezoelectric actuator, or any other suitable type of actuator. The reflector movable element 461 can move the corresponding reflector 460 in at least one, up to six degrees of freedom along and / or around the X, Y, and Z axes (not shown) of the reflector 460.

[0181] As shown in the embodiment of Figure 4, the catheter system 400 may include an optical movable element 470. The optical movable element 470 may have the same and / or substantially similar functions and / or components as those described in the embodiments disclosed herein. For example, the optical movable element 470 may include a stepping motor, a piezoelectric actuator, or any other suitable type of actuator.

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

[0183] Figures 5A and 5B illustrate a dual imaging approach to optical alignment. Figures 5A and 5B show portions of images captured by the camera 365 of the optical alignment system 357 (shown in Figure 3).

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

[0185] Figure 6 is a flowchart of one embodiment of a method for treating the inside of a vascular wall or heart valve or an adjacent treatment site using a catheter system having the features and / or steps of the present invention. It is understood that the methods disclosed herein may include more or fewer steps than those shown and described with respect to Figure 6. In other words, the methods according to the present invention may omit one or more steps shown in Figure 6, or add additional steps not shown and described in Figure 6, and still remain within the scope of the invention. Furthermore, the order of the steps may be changed from those shown and described with respect to Figure 6. The order of the steps shown in Figure 6 is not intended to limit the order of the steps in any way.

[0186] In the embodiment shown in Figure 6, in step 676, the system controller is configured to control the optical system's movable element.

[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 a light source, camera, aligner, amplifier, illuminator, detector, filter, beam splitter, camera controller, signal processor, multiplexer, and / or optical guide bundle.

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

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

[0190] In step 684, the multiplexer receives 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 optical guide reflects some of the light energy back to the detector.

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

[0194] In step 692, the optical alignment system aligns the light energy with the optical guide, and as a result, they are substantially coupled.

[0195] The active detection and alignment of the coupling of optical energy with an optical guide using the present invention is understood to offer several advantages in terms of performance, reliability, and proper use of IVL catheters, particularly those that utilize an energy source to create a localized plasma generating high-energy bubbles inside a balloon catheter. Specific advantages of the present invention include: 1) reducing the system performance's dependence on the mechanical tolerances of optical carriers and their positional tolerances within a multi-channel array by providing active compensation for the mechanical tolerances of connectors and ferrules; and 2) providing active compensation for energy beam pointing drift occurring in the light source itself due to thermal drift or other factors, or through changes or movements in the internal or coupled optical system. The active compensation ultimately reduces the performance dependence on the accuracy of connecting and aligning the multi-channel array to the multiplexer, improving the speed and performance of the multiplexer and multi-channel ferrule system.

[0196] In particular, in various embodiments, the present invention comprises a multiplexer as a precision linear mechanism for translating a coupling optical system along a linear path. This method may include a single degree of freedom. A ferrule can organize 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 is electronically controlled by an optical alignment system to sequentially align beam paths using each of the individual fibers organized within the ferrule. The translation mechanism carries beam-directing and focusing optical systems necessary to focus laser energy onto each fiber to improve optical coupling. By utilizing the systems and methods disclosed herein, the low divergence of the laser beam over short distances of the motion of the translated coupling mechanism has minimal impact on the coupling efficiency to the fibers. The optical alignment system can drive the mechanism to align the beam paths with selected optical fiber channels and then emit a laser in pulsed or semi-CW mode.

[0197] In other embodiments, the optical alignment system may incorporate a secondary optical system and 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 nearby target. The image of the energy spot is in the same image reference frame, allowing for direct calculation of the offset from the optical fiber core. This data can be calculated using image processing methods and algorithms to determine the offset and calculate compensation adjustments. The positioning mechanism can then adjust the positioning of the ferrule array to improve the 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-separated beam splitter can be inserted into the beam path between the coupling optical system and the energy source. The systems and methods disclosed herein can enable the coupling lens to function in dual-use mode, allowing energy to be coupled to both the optical guide and a portion of the imaging lens for imaging the optical guide.

[0199] The optical alignment systems and methods provided herein are understood to address several potential problems relating to the performance, reliability, and proper use of those that utilize an energy source to create a localized plasma generating high-energy bubbles inside IVL catheters and balloon catheters. Specific problems addressed by the systems and methods disclosed herein include: 1) Complex laser systems with movable components are affected by beam pointing errors. These pointing errors can be induced by vibration, 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 and generates an offset in the focused spot position. If these drifts are not compensated for, errors in the spot position relative to the optical fiber core lead to loss of coupling efficiency and fiber damage at high energies. The systems and methods disclosed herein provide active compensation for actual beam drift occurring at the coupling point. 2) The systems and methods disclosed herein provide compensation for the stacking of mechanical tolerances of assemblies, as well as true alignment of optical fibers, ferrules, connectors, and receptacles, thereby enabling the use of low-cost, low-precision components on SUDs and improving COGS. 3) The systems and methods disclosed herein reduce the dependence of multiplexer performance on the accuracy of static or fixed positioning mechanisms within a 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] Note that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” refer to multiple subjects unless otherwise clearly defined by the content and / or context. Note also that the term “or” is generally used to mean “and / or” unless otherwise clearly defined by the content or context.

[0201] As used herein and in the appended claims, the term “configured” also describes a system, apparatus, or other structure that is built or configured to perform a particular task or to adopt a particular configuration. The term “configured” can be used interchangeably with other similar terms such as “located and configured,” “built and located,” “constructed,” “manufactured and located.”

[0202] The headings used herein are provided for consistency with the proposals under 37 CFR 1.77, or otherwise to provide systematic cues. These headings should not be considered to limit or characterize any invention(s) described in any claims that may be issued from this disclosure. For example, the description of the technology in “Background Art” does not constitute an admission that the technology to any invention(s) in this disclosure is prior art. Neither “Summary” nor “Abstract” should be considered to characterize any invention(s) described in any claims that may be issued.

[0203] The embodiments described herein are not intended to be exhaustive or to limit the invention to the exact forms disclosed in the detailed description provided herein. Rather, the embodiments are selected and described so that those skilled in the art can recognize and understand the principles and practices. Accordingly, the embodiments are described with reference to various specific preferred embodiments and techniques. However, it should be understood that many modifications and alterations are possible while remaining within the spirit and scope of this specification.

[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 that such combination satisfies the intent of the present invention).

[0205] While several exemplary embodiments and designs of catheter systems have been described above, those skilled in the art will recognize specific modifications, substitutions, additions, and partial combinations thereof. Therefore, the appended claims and the claims introduced herein are intended to be construed as including all such modifications, substitutions, additions, and partial combinations as they are in their true spirit and scope, and are not intended to limit the details of the configurations or designs shown herein.

Claims

1. A catheter system for treating the inside of a blood vessel wall or heart valve or an adjacent treatment site, A light source that generates light energy, A first optical guide that receives the light energy from the light source and has a guide proximal end, A second optical guide, which receives the light energy from the light source and has a guide proximal end, A multiplexer that directs the aforementioned light energy to the proximal end of the first optical guide and the proximal end of the second optical guide, An optical alignment system for determining the alignment of the light energy with respect to at least one of the proximal ends of the guide, wherein the positioning of the light energy with respect to at least one of the proximal ends of the guide is adjusted at least partially based on the alignment of the light energy with respect to at least one of the proximal ends of the guide, and the optical alignment system includes an imaging system including an imaging sensor. Equipped with, The imaging system is configured to utilize an image reference frame that enables direct calculation of the distance offset of the proximal end of the guide from at least one of its centers, The imaging system is configured to determine the distance offset and to calculate the compensation adjustment of the alignment of the light energy with respect to at least one of the proximal ends of the guide, The optical alignment system further includes an aligner that adjusts the position of at least one of the guide proximal ends to adjust the alignment of the light energy with respect to at least one of the guide proximal ends based on the calculated compensation adjustments, in order to substantially couple the light source and the guide proximal end. Catheter system.

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

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

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

5. The catheter system according to claim 1, wherein the imaging system is configured to simultaneously acquire 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.

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

7. The catheter system according to claim 6, further comprising a light source movable element coupled to the multiplexer, wherein the light source movable element is connected to the optical system movable element such that the optical system movable element can adjust the position of the multiplexer along the light source movable element.

8. The catheter system according to claim 1, wherein the light source is a pulsed IR laser.

9. The catheter system according to 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.

10. The catheter system according to claim 9, wherein the dichroic beam splitter is configured to reflect light energy having a wavelength shorter than the light energy emitted by the light source.

11. A catheter system for treating the inside of a blood vessel wall or heart valve or an adjacent treatment site, A light source that generates light energy, A first optical guide that receives the light energy from the light source and has a guide proximal end, A second optical guide, which receives the light energy from the light source and has a guide proximal end, A multiplexer that directs the light energy to the proximal end of the first optical guide and the proximal end of the second optical guide, wherein the multiplexer includes a dichroic beam splitter. An optical alignment system for determining the alignment of the light energy with respect to at least one of the proximal ends of the guide, wherein the positioning of the light energy with respect to at least one of the proximal ends of the guide is adjusted at least partially based on the alignment of the light energy with respect to at least one of the proximal ends of the guide, and the optical alignment system includes an imaging system including an imaging sensor, wherein the imaging system is configured to capture an image of the focal point of the light source and an image of at least one of the proximal ends of the guide. Equipped with, A catheter system in which the dichroic beam splitter is configured to reflect a portion of the light energy emitted by the light source as an imaging beam, and the imaging beam is directed to a detector for analyzing the light energy reflected from at least one of the optical guides.

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

13. The catheter system according to claim 12, further comprising a system controller that controls the illuminator to adjust the brightness and contrast of the image.

14. The catheter system according to claim 1, wherein the optical alignment system further includes one of a stepping motor and a piezoelectric actuator configured to adjust the yaw, pitch, and roll of at least one of the optical guides.

15. The catheter system according to claim 1, further comprising an optical compensator configured to adjust the steering of the light energy relative to at least one of the proximal ends of the guide.

16. The catheter system according to claim 15, wherein the optical compensator includes a plurality of optical steering wedges positioned in the path of the light energy, and the plurality of optical steering wedges are configured to improve the coupling between the light energy and at least one of the proximal ends of the guide.

17. The catheter system according to claim 1, wherein the optical alignment system further includes a reflector and a reflector movable element for moving the reflector.

18. The catheter system according to claim 1, wherein the imaging system is configured to capture an image of the focal point of the light source and an image of at least one of the proximal ends of the guide.

Images