Optical analyzer assembly with safety shutdown system for intravascular lithotripsy device - Patents.com

Abstract

A catheter system (200) for treating a treatment site (106) within or adjacent to a blood vessel wall (108A) or a heart valve includes a light source (224), a balloon (104), a light guide (222A), and an optical analyzer assembly (242). The light source (224) generates a first light energy (224B). The balloon (104) is positionable substantially adjacent to the treatment site (106). The balloon (104) has a balloon wall (130) defining a balloon interior (146) that receives a balloon fluid (132). The light guide (222A) receives the first light energy (224B) and guides the first light energy (224B) in a first direction (121F) from a guide proximal end (222P) positioned within the balloon interior (146) toward a guide distal end (222D). The optical analyzer assembly (242) optically analyzes the second light energy (224C) from the light guide (222A) traveling in a second direction (121S) opposite the first direction. The optical analyzer assembly (242) includes a safety shutdown system (283) for inhibiting the first light energy (224B) from being received by the guide proximal end (222P) of the light guide (222A).

Description

[Technical field]

[0001] Related Applications This application is related to and claims priority to U.S. Provisional Patent Application No. 63 / 186,391, filed May 10, 2021, and U.S. Patent Application No. 17 / 736,894, filed May 4, 2022. To the extent permitted, the contents of U.S. Provisional Patent Application No. 63 / 186,391 and U.S. Patent Application No. 17 / 736,894 are incorporated herein by reference in their entireties. [Background technology]

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

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

[0004] The present invention relates to a catheter system for treating a treatment site within or adjacent a vessel wall or heart valve. In various embodiments, the catheter system includes a light source, a balloon, a light guide, and an optical analyzer assembly. The light source generates a first light energy. The balloon is positionable substantially adjacent to the treatment site. The balloon has a balloon wall defining a balloon interior that receives a balloon fluid. The light guide is configured to receive the first light energy at a guide proximal end and guide the first light energy in a first direction from the guide proximal end toward a guide distal end positioned within the balloon interior. The optical analyzer assembly is configured to optically analyze a second light energy from the light guide traveling in a second direction opposite the first direction. The optical analyzer assembly includes a safety shutdown system selectively actuated to prevent the first light energy from the light source from being received by the guide proximal end of the light guide.

[0005] In some embodiments, the catheter system further includes a pulse generator coupled to the light source, the pulse generator can be configured to trigger the light source to generate a light source beam that is directed toward the light guide.

[0006] In certain embodiments, the safety shutdown system includes a safety interlock that is selectively activated to prevent the pulse generator from triggering generation of the source beam with the light source.

[0007] In various embodiments, the safety shutdown system includes a shutter that is selectively actuated to prevent the light source beam from being directed toward the light guide.

[0008] In some embodiments, the first light energy induces the generation of plasma within the interior of the balloon.

[0009] In certain embodiments, the guide distal end includes a distal light receiver that receives second light energy from within the balloon interior, the second light energy traveling in a second direction through the light guide.

[0010] In some embodiments, the second light energy received by the distal light receiver is emitted from a plasma generated in the balloon fluid within the balloon interior.

[0011] In certain embodiments, the second light energy received by the distal light receiver is from ambient light near the guide distal end of the light guide.

[0012] In various embodiments, the second optical energy received by the distal optical receiver is optically analyzed by an optical analyzer assembly.

[0013] In some embodiments, the optical analyzer assembly is configured to optically determine whether plasma generation within the interior of the balloon has occurred within the interior of the balloon.

[0014] In certain embodiments, the optical analyzer assembly is configured to optically detect faults in the light guide between the proximal guide end and the distal guide end.

[0015] In some embodiments, the optical analyzer assembly is configured to optically detect potential damage to the light guide between the proximal guide end and the distal guide end.

[0016] In many embodiments, the optical analyzer assembly is configured to selectively activate a safety shutdown system upon optical detection by the optical analyzer assembly of any one of: (i) failure to generate plasma within the balloon interior; (ii) failure of the optical guide between the proximal guide end and the distal guide end; and (iii) potential damage to the optical guide between the proximal guide end and the distal guide end.

[0017] In some embodiments, the second light energy is guided back through the light guide in a second direction toward the guide proximal end. The optical analyzer assembly is configured to optically analyze the second light energy to determine if plasma generation has occurred within the balloon interior.

[0018] In certain embodiments, the optical analyzer assembly includes a beam splitter and a photodetector, the beam splitter configured to receive the second light energy and direct a portion of the second light energy to the photodetector.

[0019] In some embodiments, the optical analyzer assembly further includes an optical element positioned along the beam path between the beam splitter and the photodetector, the optical element configured to couple a portion of the second light energy to the photodetector.

[0020] In certain embodiments, the optical analyzer assembly may further include a second beam splitter positioned along the beam path between the beam splitter and the photodetector, the second beam splitter configured to receive the second optical energy and direct at least a portion of the second optical energy to the photodetector.

[0021] In some embodiments, the light detector generates a signal based at least in part on the visible light contained in the portion of the second light energy.

[0022] In certain embodiments, the signal from the photodetector is amplified with an amplifier to provide an amplified signal that is directed to control electronics to determine the intensity of the plasma generation within the balloon interior.

[0023] In some embodiments, the control electronics is configured to analyze the amplified signal to detect one or more of: (i) whether plasma generation has occurred within the balloon interior, (ii) potential failure of the light guide between the proximal guide end and the distal guide end, and (iii) potential damage to the light guide between the proximal guide end and the distal guide end.

[0024] In various embodiments, the optical analyzer is configured to optically analyze the second light energy to detect an operational condition of the catheter system.

[0025] In some embodiments, the optical analyzer is configured to optically analyze the second light energy to detect at least one of: (i) a normal operating condition; (ii) an intermittent air bubble generation condition; (iii) a distal guide end plasma initiation condition; (iv) a poor plasma generation condition; (v) a broken light guide condition; and (vi) a chewback condition.

[0026] In other embodiments, the optical analyzer is configured to optically analyze the second light energy to detect at least two of: (i) a normal operating condition; (ii) an intermittent air bubble condition; (iii) a distal guide end plasma initiation condition; (iv) a poor plasma ignition condition; (v) a broken light guide condition; and (vi) a chewback condition.

[0027] In yet another embodiment, the optical analyzer is configured to optically analyze the second light energy to detect at least three of: (i) a normal operating condition; (ii) an intermittent air bubble condition; (iii) a distal guide end plasma initiation condition; (iv) a poor plasma ignition condition; (v) a broken light guide condition; and (vi) a chewback condition.

[0028] In yet another embodiment, the optical analyzer is configured to optically analyze the second light energy to detect at least four of: (i) a normal operating condition; (ii) an intermittent bubble generation condition; (iii) a distal guide end plasma initiation condition; (iv) a poor plasma generation condition; (v) a broken light guide condition; and (vi) a chewback condition.

[0029] In yet another embodiment, the optical analyzer is configured to optically analyze the second light energy to detect at least five of: (i) a normal operating condition; (ii) an intermittent bubble generation condition; (iii) a distal guide end plasma initiation condition; (iv) a poor plasma generation condition; (v) a broken light guide condition; and (vi) a chewback condition.

[0030] In yet another embodiment, the optical analyzer is configured to optically analyze the second light energy to detect each of: (i) a normal operating condition; (ii) an intermittent bubble generation condition; (iii) a distal guide end plasma initiation condition; (iv) a poor plasma ignition condition; (v) a broken light guide condition; and (vi) a chewback condition.

[0031] In some embodiments, upon detecting one or more of a poor plasma generation condition, a broken light guide condition, and a chewback condition, the optical analyzer assembly can be further configured to stop operation of the catheter system.

[0032] In certain embodiments, a first pulse of light energy directed in a first direction through the light guide generates a plasma flash that can be captured by the optical analyzer assembly in the form of a flash signature that can include summary parameters such as at least one of pulse maximum, rise time, width, onset time relative to a baseline, and a measure of signal variability that can provide an indication of the operational status of the catheter system.

[0033] In some embodiments, if the pulse maximum of the flash signature is greater than a maximum pulse maximum threshold, the optical analyzer assembly can identify the operating condition as a guide distal end plasma start condition.

[0034] In certain embodiments, if the pulse maximum value of the flash signature is less than the minimum pulse maximum threshold, the optical analyzer assembly can identify the operating condition as one of an intermittent bubble generation condition, a poor plasma generation condition, and a broken light guide condition.

[0035] In some embodiments, the optical analyzer assembly is configured to require the number of pulses of first light energy in which the pulse maximum of the flash signature is less than a minimum pulse maximum threshold within a specified range of previous pulses to exceed a defined 0 pulse count in order to identify the operating condition as one of an intermittent gas bubble generation condition, a poor plasma generation condition, and a broken light guide condition.

[0036] In certain embodiments, the history of all pulses of a first optical energy directed in a first direction through a light guide is tracked to distinguish between an intermittent bubble generation condition, a poor plasma generation condition, and a broken light guide condition.

[0037] In some embodiments, the measure of signal variability of the flash signature includes the number of transitions identified in the flash signature.

[0038] In certain embodiments, if the number of transitions in the flash signature is greater than a transition threshold, the optical analyzer assembly can identify the operating condition as a Chewbuck condition.

[0039] In many embodiments, the guide distal end includes a distal light receiver that receives second light energy from within the balloon interior, the second light energy traveling in a second direction through the light guide.

[0040] In some embodiments, the second light energy received by the distal light receiver is from ambient light near the guide distal end of the light guide.

[0041] In certain embodiments, the optical analyzer assembly is configured to optically analyze the second light energy to determine if ambient light is collected near the guide distal end of the light guide.

[0042] In some embodiments, the optical analyzer assembly includes a beam splitter and an imaging device, the beam splitter configured to receive the second light energy and direct a portion of the second light energy to the imaging device.

[0043] In certain embodiments, the optical analyzer assembly further includes an optical element positioned along the beam path between the beam splitter and the imaging device, the optical element configured to couple a portion of the second light energy to the imaging device.

[0044] In some embodiments, the optical analyzer assembly further includes a second beam splitter positioned along the beam path between the beam splitter and the imaging device, the second beam splitter configured to receive the second optical energy and direct at least a portion of a portion of the second optical energy onto the imaging device.

[0045] In certain embodiments, the imager generates a signal based at least in part on any ambient light included in the portion of the second light energy.

[0046] In some embodiments, a signal from the imaging device is directed to the control electronics to determine if ambient light is collected near the guide distal end of the light guide.

[0047] In certain embodiments, a determination by the control electronics that ambient light is collected near the guide distal end of the light guide is an indication that the catheter system is being used in an improper manner, with the balloon not positioned substantially adjacent to the treatment site.

[0048] In various embodiments, the light source includes a laser.

[0049] In some embodiments, the light source includes an infrared laser that emits the first light energy in the form of pulses of infrared light.

[0050] In many embodiments, the light guide comprises an optical fiber.

[0051] The present invention is further directed to a method of treating a treatment site within or adjacent a blood vessel wall or heart valve, the method including the steps of generating a first light energy with a light source; positioning a balloon substantially adjacent the treatment site, the balloon having a balloon wall defining a balloon interior that receives a balloon fluid; receiving the first light energy at a guide proximal end of a light guide; guiding the first light energy in a first direction from the guide proximal end toward a guide distal end positioned within the balloon; and optically analyzing second light energy from the light guide traveling in a second direction opposite the first direction, wherein the optical analyzer assembly includes a safety shutdown system selectively activated to prevent the first light energy from the light source from being received by the guide proximal end of the light guide.

[0052] The present invention is also directed to a catheter system for treating a treatment site within or adjacent a blood vessel wall or heart valve, the catheter system comprising: a light source generating a first light energy; a balloon positionable substantially adjacent to the treatment site, the balloon having a balloon wall defining a balloon interior that receives a balloon fluid; a light guide configured to receive the first light energy at a guide proximal end and to guide the first light energy in a first direction from the guide proximal end toward a guide distal end positioned within the balloon; and an optical analyzer assembly configured to optically analyze second light energy from the light guide traveling in a second direction opposite the first direction, the optical analyzer configured to optically analyze the second light energy to detect an operational status of the catheter system.

[0053] The present invention is further directed to a method of treating a treatment site within or adjacent a blood vessel wall or heart valve, the method including generating a first light energy with a light source; positioning a balloon substantially adjacent the treatment site, the balloon having a balloon wall defining a balloon interior that receives a balloon fluid; receiving the first light energy at a guide proximal end of a light guide; guiding the first light energy in a first direction from the guide proximal end toward a guide distal end positioned within the balloon; and optically analyzing second light energy from the light guide traveling in a second direction opposite the first direction, wherein the optical analyzer is configured to optically analyze the second light energy to detect an operational status of the catheter system.

[0054] This Summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part hereof, each of which should not be taken in a limiting sense. The scope of the present specification is defined by the appended claims and their legal equivalents.

[0055] The novel features of the present invention, as well as the invention itself, both as to its structure and its operation, will best be understood from the accompanying drawings taken in conjunction with the accompanying description, in which like reference characters refer to like parts, and in which: [Brief description of the drawings]

[0056] [Figure 1] 1 is a schematic cross-sectional view of one embodiment of a catheter system including an optical analyzer assembly having features of the present invention, in accordance with various embodiments herein. [Figure 2A] 1 is a simplified schematic diagram of a portion of an embodiment of a catheter system including an embodiment of an optical analyzer assembly utilized in a first application. [Figure 2B] FIG. 2B is a simplified schematic diagram of a portion of a catheter system including the optical analyzer assembly of FIG. 2A utilized in a second application. [Figure 3A] 2 is a simplified schematic diagram of operating states that may be identified by the optical analyzer assembly during operation of the catheter system of FIG. 1. [Figure 3B] 2 is a simplified schematic diagram of operating states that may be identified by the optical analyzer assembly during operation of the catheter system of FIG. 1. [Figure 3C] 2 is a simplified schematic diagram of operating states that may be identified by the optical analyzer assembly during operation of the catheter system of FIG. 1. [Figure 3D] 2 is a simplified schematic diagram of operating states that may be identified by the optical analyzer assembly during operation of the catheter system of FIG. 1. [Figure 3E] 2 is a simplified schematic diagram of operating states that may be identified by the optical analyzer assembly during operation of the catheter system of FIG. 1. [Figure 3F] 2 is a simplified schematic diagram of operating states that may be identified by the optical analyzer assembly during operation of the catheter system of FIG. 1. [Figure 4A] FIG. 2 is a simplified graphical representation of a representative example of one flash signature that may be identified by the optical analyzer assembly during operation of the catheter system of FIG. [Figure 4B] FIG. 2 is a simplified graphical representation of a representative example of a second different flash signature that may be identified by the optical analyzer assembly during operation of the catheter system of FIG. [Diagram 5] FIG. 2 is a simplified graphical diagram of an example of a pulse maximum reading that may be identified by an optical analyzer assembly when a first pulse of light energy is sent through a light guide used in the catheter system of FIG. [Figure 6] FIG. 2 is a simplified graphical representation of an example of the number of transitions that may be identified by an optical analyzer assembly in a flash signal generated when a first pulse of light energy is sent through a light guide used in the catheter system of FIG. [Figure 7] FIG. 2 is a simplified graphical diagram of an example of how a no signal detection condition can be identified by an optical analyzer assembly when a first pulse of optical energy is sent through a light guide used in the catheter system of FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0057] While embodiments of the invention are susceptible to various modifications and alternative forms, details thereof have been shown by way of example and drawings and are described in detail herein. It is understood, however, that the scope of the specification is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives that are within the spirit and scope of the specification.

[0058] Treatment of vascular lesions (sometimes referred to herein as "treatment sites") can reduce major adverse events or deaths in affected subjects. As referred to herein, major adverse events are adverse events that may occur anywhere in the body due to the presence of vascular lesions. Major adverse events may include, but are not limited to, major adverse cardiac events, major adverse events in the peripheral or central vascular system, major adverse events in the brain, major adverse events in the muscular system, or major adverse events in any of the internal organs.

[0059] As used herein, the terms "intravascular lesion," "vascular lesion," and "treatment site" are used interchangeably unless otherwise noted. Intravascular lesions and / or vascular lesions may be referred to herein simply as "lesions."

[0060] Those skilled in the art will realize that the following detailed description of the invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the invention will readily suggest themselves to such skilled artisans having the benefit of this disclosure. Reference will now be made in detail to embodiments of the invention which are illustrated in the accompanying drawings.

[0061] For clarity, not all of the routine features of the implementations described herein are shown and described. Of course, it will be understood that in the development of any such actual implementation, numerous implementation-specific decisions must be made to achieve the developer's particular goals, such as adhering to application-related and business-related constraints, and that these particular goals will vary from implementation to implementation and from developer to developer. Moreover, it will be understood that such a development effort may be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure.

[0062] The catheter system disclosed herein can include many different configurations. Referring now to FIG. 1, a schematic cross-sectional view of a catheter system 100 according to various embodiments is shown. The catheter system 100 is adapted to apply pressure waves to induce fracturing at one or more treatment sites within or adjacent to a vessel wall or on or adjacent to a heart valve within a patient's body. In the embodiment shown in FIG. 1, the catheter system 100 includes a catheter 102, a light guide bundle 122 including one or more light guides 122A, a source manifold 136, a fluid pump 138, a system console 123 including one or more of a light source 124, a power supply 125, a system controller 126, and a graphic user interface 127 ("GUI"), a handle assembly 128, and an optical analyzer assembly 142. Alternatively, the catheter system 100 can include more or fewer components than those specifically shown and described in connection with FIG. 1.

[0063] Although the catheter system 100 has been generally described as including a light guide bundle 122 including one or more light guides 122A and a light source 124, it is understood that in some alternative embodiments, the catheter system 100 can include an energy guide bundle including different types of energy guides and / or different types of energy sources.

[0064] In various embodiments, the catheter 102 is configured to navigate to a treatment site 106 within or adjacent to a vascular wall 108A of a blood vessel 108 in the body 107 of a patient 109. The treatment site 106 may include one or more vascular lesions 106A, such as, for example, a calcified vascular lesion. Additionally or alternatively, the treatment site 106 may include a vascular lesion 106A, such as a fibrous vascular lesion. Further alternatively, in some implementations, the catheter 102 may be used at a treatment site 106 within or adjacent to a heart valve in the body 107 of the patient 109.

[0065] The catheter 102 may include an inflatable balloon 104 (sometimes referred to herein simply as a "balloon"), a catheter shaft 110, and a guidewire 112. The balloon 104 may be coupled to the catheter shaft 110. The balloon 104 may include a balloon proximal end 104P and a balloon distal end 104D. The catheter shaft 110 may extend from a proximal portion 114 of the catheter system 100 to a distal portion 116 of the catheter system 100. The catheter shaft 110 may include a longitudinal axis 144. The catheter shaft 110 may also include a guidewire lumen 118 configured to travel over the guidewire 112. As utilized herein, the guidewire lumen 118 defines a conduit through which the guidewire 112 extends. The catheter shaft 110 may further include an inflation lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, the catheter 102 can have a distal end opening 120 to accommodate and pass over the guidewire 112 as the catheter 102 is moved and positioned at or near the treatment site 106. In some embodiments, the balloon proximal end 104P can be coupled to the catheter shaft 110 and the balloon distal end 104D can be coupled to the guidewire lumen 118.

[0066] The balloon 104 includes a balloon wall 130 that defines a balloon interior 146. The balloon 104 can be selectively inflated with a balloon fluid 132 to expand from a contracted state suitable for advancing the catheter 102 through the patient's vasculature to an inflated state (as shown in FIG. 1 ) suitable for fixing the catheter 102 in a predetermined position relative to the treatment site 106. Stated differently, when the balloon 104 is in an inflated state, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. While FIG. 1 illustrates the balloon wall 130 of the balloon 104 shown spaced apart from the treatment site 106 of the blood vessel 108 when in the inflated state, it will be understood that this is done merely for ease of illustration. It will be appreciated that the balloon wall 130 of the balloon 104 will typically be substantially directly adjacent and / or abutting the treatment site 106 when the balloon 104 is in the inflated state.

[0067] Balloons 104 suitable for use in the catheter system 100 include those that, when in a deflated state, can pass through the vasculature of a patient 109. In some embodiments, the balloon 104 is made of silicone. In other embodiments, the balloon 104 can be made from polydimethylsiloxane (PDMS), polyurethane, a polymer such as PEBAX™ material, nylon, or any other suitable material.

[0068] The balloon 104 can have any suitable diameter (in an inflated state). In various embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from less than 1 millimeter (mm) to 25 mm. In some embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from at least 1.5 mm to 14 mm. In some embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from at least 2 mm to 5 mm.

[0069] In some embodiments, the balloon 104 can have a length ranging from at least 3 mm to 300 mm. More specifically, in some embodiments, the balloon 104 can have a length ranging from at least 8 mm to 200 mm. It is understood that a balloon 104 having a relatively long length can be positioned adjacent a larger treatment site 106 and thus can be used to impart pressure waves to induce fragmentation at a larger vascular lesion 106A or multiple vascular lesions 106A at precise locations within the treatment site 106. It is further understood that a longer balloon 104 can also be positioned adjacent multiple treatment sites 106 at any given time.

[0070] The balloon 104 may be inflated to an inflation pressure of approximately 1 atmosphere (atm) to 70 atm. In some embodiments, the balloon 104 may be inflated to an inflation pressure of at least 20 atm to 60 atm. In other embodiments, the balloon 104 may be inflated to an inflation pressure of at least 6 atm to 20 atm. In yet other embodiments, the balloon 104 may be inflated to an inflation pressure of at least 3 atm to 20 atm. In yet other embodiments, the balloon 104 may be inflated to an inflation pressure of at least 2 atm to 10 atm.

[0071] The balloon 104 can have a variety of shapes, including, but not limited to, a conical shape, a square shape, a rectangular shape, a spherical shape, a conical / square shape, a conical / spherical shape, an elongated spherical shape, an elliptical shape, a tapered shape, a bone shape, a stepped diameter shape, an offset shape, or a conical offset shape. In some embodiments, the balloon 104 can include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or drug eluting stent can include one or more therapeutic agents, including anti-inflammatory agents, anti-neoplastic agents, anti-angiogenic agents, and the like.

[0072] The balloon fluid 132 may be a liquid or a gas. Some examples of balloon fluids 132 suitable for use may include, but are not limited to, one or more of water, saline, contrast medium, a gas such as fluorocarbon, perfluorocarbon, carbon dioxide, or any other suitable balloon fluid 132. In some embodiments, the balloon fluid 132 may be used as a base inflation fluid. In some embodiments, the balloon fluid 132 may include a mixture of saline and contrast medium in a volume ratio of about 50:50. In other embodiments, the balloon fluid 132 may include a mixture of saline and contrast medium in a volume ratio of about 25:75. In yet other embodiments, the balloon fluid 132 may include a mixture of saline and contrast medium in a volume ratio of about 75:25. However, it is understood that any suitable ratio of saline to contrast medium may be used. The balloon fluid 132 may be adjusted based on composition, viscosity, etc., such that the speed of travel of the pressure wave is appropriately manipulated. In certain embodiments, the balloon fluid 132 suitable for use herein is biocompatible. The volume of the balloon fluid 132 can be adjusted depending on the light source 124 selected and the type of balloon fluid 132 used.

[0073] In some embodiments, the contrast agent used in the contrast medium may include, but is not limited to, an iodine-based contrast agent, such as an ionic or non-ionic iodine-based contrast agent. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, metrizoate, iothalamate, and ioxaglate. Some non-limiting examples of non-ionic iodine-based contrast agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based contrast agents may be used. Suitable non-iodine-containing contrast agents may include gadolinium (III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon agents may include, but are not limited to, agents such as the perfluorocarbon dodecafluoropentane (DDFP, C5F12).

[0074] The balloon fluid 132 can include those that include an absorber that can selectively absorb light in the ultraviolet (e.g., at least 10 nanometers (nm) to 400 nm), visible (e.g., at least 400 nm to 780 nm), or near infrared (e.g., at least 780 nm to 2.5 μm) regions of the electromagnetic spectrum. Suitable absorbers can include those that have an absorption maximum along a spectrum of at least 10 nm to 2.5 μm. Alternatively, the balloon fluid 132 can include an absorber that can selectively absorb light in the mid-infrared (e.g., at least 2.5 μm to 15 μm) or far-infrared (e.g., at least 15 μm to 1 mm) regions of the electromagnetic spectrum. In various embodiments, the absorber can have an absorption maximum that coincides with the emission maximum of the laser used in the catheter system 100. As non-limiting examples, various lasers described herein may include a neodymium:yttrium-aluminum-garnet (Nd:YAG-emission maximum=1064 nm) laser, a holmium:YAG (Ho:YAG-emission maximum=2.1 μm) laser, or an erbium:YAG (Er:YAG-emission maximum=2.94 μm) laser. In some embodiments, the absorber may be water soluble. In other embodiments, the absorber is not water soluble. In some embodiments, the absorber used in the balloon fluid 132 may be tailored to match the peak emission of the light source 124. Various light sources 124 having emission wavelengths of at least 10 nanometers to 1 millimeter are discussed elsewhere herein.

[0075] The catheter shaft 110 of the catheter 102 may be coupled to one or more light guides 122A of the light guide bundle 122 in optical communication with the light source 124. The light guide(s) 122A may be disposed within the balloon 104 along the catheter shaft 110. Each of the light guides 122A may have a guide distal end 122D at any suitable longitudinal position relative to the length of the balloon 104. In some embodiments, each light guide 122A may be an optical fiber and the light source 124 may be a laser. The light source 124 may be in optical communication with the light guides 122A at the proximal portion 114 of the catheter system 100. More specifically, the light source 124 may be in optical communication selectively, simultaneously, sequentially, and / or alternatively with each of the light guides 122A in any desired combination, sequence, and / or pattern.

[0076] In some embodiments, the catheter shaft 110 may be coupled to multiple light guides 122A, such as a first light guide, a second light guide, a third light guide, etc., that may be positioned at any suitable location around the guidewire lumen 118 and / or the catheter shaft 110. For example, in certain non-exclusive embodiments, two light guides 122A may be spaced approximately 180 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110, three light guides 122A may be spaced approximately 120 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110, or four light guides 122A may be spaced approximately 90 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Additionally alternatively, the multiple light guides 122A need not be uniformly spaced from one another around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. More specifically, the light guides 122A can be uniformly or non-uniformly positioned about the guidewire lumen 118 and / or catheter shaft 110 to achieve a desired effect at a desired location.

[0077] The catheter system 100 and / or light guide bundle 122 can include any number of light guides 122A in optical communication with the light source 124 at the proximal portion 114 and the balloon fluid 132 in the balloon interior 146 of the balloon 104 at the distal portion 116. For example, in some embodiments, the catheter system 100 and / or light guide bundle 122 can include from one light guide 122A to five light guides 122A. In other embodiments, the catheter system 100 and / or light guide bundle 122 can include from five light guides 122A to fifteen light guides 122A. In yet other embodiments, the catheter system 100 and / or light guide bundle 122 can include between ten light guides 122A and thirty light guides 122A. Alternatively, in still other embodiments, the catheter system 100 and / or light guide bundle 122 can include more than thirty light guides 122A.

[0078] The light guide 122A may have any suitable design for the purpose of generating plasma and / or pressure waves in the balloon fluid 132 within the balloon interior 146. In certain embodiments, the light guide 122A may include an optical fiber or a flexible light pipe. The light guide 122A may be thin and flexible, allowing for the transmission of optical signals with little loss of intensity. The light guide 122A may include a core surrounded by a cladding. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of the light guide 122A may be formed from one or more materials, including, but not limited to, one or more types of glass, silica, or one or more polymers. The light guide 122A may also include a protective coating, such as a polymer. It is understood that the refractive index of the core is greater than the refractive index of the cladding.

[0079] Each light guide 122A can direct a first light energy along its length from a guide proximal end 122P having at least one optical window (not shown) positioned within the balloon interior 146 toward a guide distal end 122D.

[0080] In various embodiments, the guide distal end 122D can further include and / or incorporate a distal light receiver 122R that allows the second light energy to be transmitted from the guide distal end 122D to the guide proximal end 122P into and back through the light guide 122A. Stated another way, the first light energy can travel in a first direction 121F along the light guide 122A, generally from the guide proximal end 122P toward the guide distal end 122D of the light guide 122A. In certain circumstances, the second light energy, which can include at least a portion of the first light energy, can travel in a second direction 121S along the light guide 122A substantially opposite to the first direction 121F, i.e., from the guide distal end 122D toward the guide proximal end 122P of the light guide 122A. Additionally, as described in more detail herein below, the second light energy emitted from the guide proximal end 122P after being returned through the light guide 122A (in the second direction 121S) can be separated and then optically detected, matched, and / or analyzed using the optical analyzer assembly 142 to determine the exact operating mode involving both non-fault and fault conditions of the light guide 122A.

[0081] The light guide 122A can take on many configurations around and / or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the light guide 122A can extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the light guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the light guide 122A can be disposed along the length of the outer diameter of the catheter shaft 110. In still other embodiments, the light guide 122A can be disposed within one or more light guide lumens within the catheter shaft 110.

[0082] The optical guides 122A may also be positioned at any suitable location around the guidewire lumen 118 and / or catheter shaft 110, and the guide distal ends 122D of each of the optical guides 122A may be positioned at any suitable longitudinal position relative to the length of the balloon 104 and / or relative to the length of the guidewire lumen 118 to more effectively and precisely apply pressure waves for the purpose of destroying vascular lesions 106A at the treatment site 106.

[0083] In certain embodiments, the light guide 122A can include one or more optoacoustic transducers 154, and each optoacoustic transducer 154 can be in optical communication with the light guide 122A disposed therein. In some embodiments, the optoacoustic transducers 154 can be in optical communication with the guide distal end 122D of the light guide 122A. The optoacoustic transducers 154 can have a shape that corresponds to and / or matches the guide distal end 122D of the light guide 122A.

[0084] The photoacoustic transducer 154 is configured to convert the first light energy into acoustic waves at or near the distal guide end 122D of the light guide 122A. The direction of the acoustic waves can be adjusted by changing the angle of the distal guide end 122D of the light guide 122A.

[0085] In certain embodiments, the optoacoustic transducer 154 disposed at the guide distal end 122D of the light guide 122A can have the same shape as the guide distal end 122D of the light guide 122A. For example, in certain non-exclusive embodiments, the optoacoustic transducer 154 and / or the guide distal end 122D can have a conical shape, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a semicircular shape, an oval shape, etc. The light guide 122A can further include additional optoacoustic transducers 154 disposed along one or more sides of the length of the light guide 122A.

[0086] In some embodiments, the light guide 122A can further include one or more redirecting mechanisms or "diverters" (not shown in FIG. 1) within the light guide 122A configured to direct light to exit the light guide 122A toward a side surface that may be located at or near the guide distal end 122D of the light guide 122A and toward the balloon wall 130. The redirecting mechanism can include any mechanism of the system that redirects the first light energy from the light guide 122A away from its axial path toward a side surface of the light guide 122A. The light guides 122A can each include one or more optical windows disposed along a longitudinal or circumferential surface of each light guide 122A and in optical communication with the redirecting mechanism. Stated another way, the redirecting mechanism can be configured to direct the first light energy within the light guide 122A toward a side surface that is at or near the guide distal end 122D, the side surface being in optical communication with the optical window. The optical window can include a portion of the light guide 122A that allows a first light energy to exit the light guide 122A from within the light guide 122A, for example, a portion of the light guide 122A that has no cladding material on or around the light guide 122A.

[0087] Examples of redirecting mechanisms suitable for use include reflective elements, refractive elements, and fiber diffusers. Redirecting mechanisms suitable for focusing the first light energy away from the tip of the light guide 122A can include, but are not limited to, those with convex surfaces, gradient index (GRIN) lenses, and mirror focus lenses. Upon contact with the redirecting mechanism, the first light energy is redirected within the light guide 122A to one or more of the plasma generator 133 and the optoacoustic transducer 154, which is in optical communication with the side of the light guide 122A. As described above, the optoacoustic transducer 154 converts the first light energy into acoustic waves that extend away from the side of the light guide 122A.

[0088] The source manifold 136 may be positioned at or near the proximal portion 114 of the catheter system 100. The source manifold 136 may include one or more proximal end openings that may receive one or more light guides 122A of the light guide bundle 122, the guidewire 112, and / or an inflation conduit 140 that is coupled in fluid communication with a fluid pump 138. The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with balloon fluid 132 as needed.

[0089] As mentioned above, in the embodiment shown in FIG. 1, the system console 123 includes one or more of the light source 124, the power source 125, the system controller 126, and the GUI 127. Alternatively, the system console 123 may include more or fewer components than those specifically shown in FIG. 1. For example, in certain non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127. Further alternatively, one or more of the light source 124, the power source 125, the system controller 126, and the GUI 127 may be provided within the catheter system 100 without the specific need for a system console 123.

[0090] 1, in certain embodiments, at least a portion of the optical analyzer assembly 142 may be located substantially within the system console 123. Alternatively, the components of the optical analyzer assembly 142 may be located in a manner different than that specifically shown in FIG.

[0091] As shown, the system console 123, and the components included therein, are operably coupled to the catheter 102, the light guide bundle 122, and the remainder of the catheter system 100. For example, in some embodiments, as shown in FIG. 1, the system console 123 can include a console connection opening 148 (sometimes commonly referred to as a "socket") through which the light guide bundle 122 is mechanically coupled to the system console 123. In such embodiments, the light guide bundle 122 can include a guide coupling housing 150 (sometimes commonly referred to as a "ferrule") that accommodates a portion of the light guides 122A, such as the respective guide proximal ends 122P. The guide coupling housing 150 is configured to fit and selectively retain within the console connection opening 148 to provide a mechanical coupling between the light guide bundle 122 and the system console 123.

[0092] The light guide bundle 122 may also include a guide bundler 152 (or "shell") that brings each of the individual light guides 122A closer together, thereby allowing the light guides 122A and / or the light guide bundle 122 to assume a more compact form when extended into the blood vessel 108 with the catheter 102 during use of the catheter system 100.

[0093] The light source 124 can be selectively and / or alternatively coupled in optical communication with each of the light guides 122A, such as the guide proximal end 122P of each of the light guides 122A in the light guide bundle 122. In particular, the light source 124 is configured to generate a first light 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 light guides 122A in the light guide bundle 122 as individual guide beams 124B. Alternatively, the catheter system 100 can include multiple light sources 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 can include a separate light source 124 for each of the light guides 122A in the light guide bundle 122.

[0094] The light source 124 may have any suitable design. In certain embodiments, the light source 124 may be configured to provide a sub-millisecond pulse of first light energy from the light source 124 that is focused onto a small spot for coupling to the proximal guide end 122P of the light guide 122A. Such pulse of first light energy is then directed and / or guided along the light guide 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation (also referred to herein as a "plasma flash") in the balloon fluid 132 within the balloon interior 146 of the balloon 104, such as via a plasma generator 133 that may be located at or near the distal guide end 122D of the light guide 122A. In particular, light emitted at the distal guide end 122D of the light guide 122A is directed to and excites the plasma generator 133 to form plasma within the balloon fluid 132 within the balloon interior 146. The plasma formation causes rapid bubble formation and imparts pressure waves to the treatment site 106. An exemplary plasma-induced bubble 134 is shown in FIG.

[0095] When the plasma first forms in the balloon fluid 132 within the balloon interior 146, it emits broad spectrum electromagnetic radiation. This can be seen as a broad spectrum light flash detectable by the naked eye. A portion of the light emitted from the plasma bubble 134, in the form of a second light energy, can be coupled to the distal light receiver 122R at the guide distal end 122D of the light guide 122A and travel back to the guide proximal end 122P where it can be separated, detected, and analyzed through the use of the optical analyzer assembly 142. The intensity and timing of the visible light pulse relative to the plasma generating pulse provides an indication that the plasma generator 133 has functioned, its energy output, and its functional or operational status. If the light guide 122A is damaged or broken, visible light flashes can occur at other locations in the light guide 122A. Such other visible light flashes can also be coupled to the light guide 122A and conveyed back to the guide proximal end 122P. The intensity and timing of these other light pulses provide an indication of damage or failure of the light guide 122A or the plasma generator 133. In such circumstances, the optical analyzer assembly 142 can include a safety shutdown system 283 (shown in FIG. 2A ) that can be selectively activated to shut down operation of the catheter system 100.

[0096] In various embodiments of the optical analyzer assembly 142, the optical analyzer assembly 142 can be configured to detect certain functional or operational conditions of the light guide 122A and / or the plasma generator 133, such as (i) a normal operating condition, (ii) an intermittent bubble generation condition, (iii) a guide distal end plasma initiation condition, (iv) a housing / target fault condition, (v) a light guide break (fiber) condition, such as due to a light guide break at the guide distal end, and (vi) a chewback condition, such as due to a light guide break along the light guide and at least some distance away from the guide distal end, as further shown in Figures 3A-3F. It is understood that some of the identified operational conditions, including the normal operating condition, the intermittent bubble generation condition, and the guide distal end plasma initiation condition, may require further monitoring of the condition of the light guide 122A and / or the plasma generator 133, but do not require immediate cessation of operation of the catheter system 100 or replacement of the light guide 122A and / or the plasma generator 133. However, it is further understood that other identified operational conditions, such as a housing / target failure condition, a light guide broken (fiber) condition, and a chewback condition, may, and often do, require the catheter system 100 to cease operation and replacement of the light guide 122A and / or the plasma generator 133.

[0097] The configuration of the plasma generator 133 and / or the distal optical receiver 122R further allows for ambient light emanating from outside the catheter 102 to be coupled to the guide distal end 122D of the light guide 122A. In one embodiment, the optical analyzer assembly 142 monitors the return ambient light energy traversing the light guide 122A from the guide distal end 122D to the guide proximal end 122P. In such circumstances, if ambient light energy is present and detected by the optical analyzer assembly 142, this is an indication that the catheter 102 is located outside the body 107 of the patient 109, and the optical analyzer assembly 142 can be configured to lock out the light source 124 accordingly. Notably, in such circumstances, the safety shutdown system 283 of the optical analyzer assembly 142 can be selectively activated to shut down the operation of the catheter system 100.

[0098] In various non-exclusive alternative embodiments, the sub-millisecond pulses of first light energy from the light source 124 may be delivered to the treatment site 106 at a frequency between about 1 Hertz (Hz) and 5000 Hz, between about 30 Hz and 1000 Hz, between about 10 Hz and 100 Hz, or between about 1 Hz and 30 Hz. Alternatively, the sub-millisecond pulses of first light energy may be delivered to the treatment site 106 at a frequency that may be greater than 5000 Hz or less than 1 Hz, or any other suitable frequency range.

[0099] Although light source 124 is typically utilized to provide a first pulse of light energy, it will be understood that light source 124 may be described as providing a single light source beam 124A, i.e., a single pulsed light source beam.

[0100] Light sources 124 suitable for use can include various types of light sources, including lasers and lamps. For example, in certain non-exclusive embodiments, the light source 124 can be an infrared laser that emits the first light energy in the form of pulses of infrared light. Alternatively, as noted above, the light sources 124 referred to herein can include any suitable type of energy source.

[0101] Suitable lasers include short pulse lasers on the sub-millisecond timescale. In some embodiments, the light source 124 can include lasers on the nanosecond (ns) timescale. Lasers can also include short pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (us) timescales. It is understood that there are many combinations of laser wavelengths, pulse widths, and energy levels that can be employed to achieve a plasma in the balloon fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse widths can include those in the ranges including at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range can be used.

[0102] Exemplary nanosecond lasers can include those in the UV to IR spectrum, spanning wavelengths from approximately 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, light source 124 suitable for use in catheter system 100 can include those capable of generating light with wavelengths of at least 750 nm to 2000 nm. In other embodiments, light source 124 can include those capable of generating light with wavelengths of at least 700 nm to 3000 nm. In still other embodiments, light source 124 can include those capable of generating light with wavelengths of at least 100 nm to 10 micrometers (μm). Nanosecond lasers can include those having repetition rates up to 200 kHz. In some embodiments, the laser can include a Q-switched Thulium:Yttrium-Aluminum-Garnet (Tm:YAG) laser. In other embodiments, the laser may include a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser, a holmium:yttrium-aluminum-garnet (Ho:YAG) laser, an erbium:yttrium-aluminum-garnet (Er:YAG) laser, an excimer laser, a helium-neon laser, a carbon dioxide laser, and a doped pulsed fiber laser.

[0103] 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.

[0104] The pressure waves may be applied on the treatment site 106 from a distance ranging from at least about 0.1 millimeters (mm) to greater than about 25 mm extending radially from the light guide 122A when the catheter 102 is positioned at the treatment site 106. In various non-exclusive alternative embodiments, the pressure waves may be applied on the treatment site 106 from a distance ranging from at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm extending radially from the light guide 122A when the catheter 102 is positioned at the treatment site 106. In other embodiments, the pressure waves may be applied on the treatment site 106 from another suitable distance different from the aforementioned ranges. In some embodiments, the pressure waves may be applied on the treatment site 106 in a range of at least about 2 MPa to 30 MPa at a distance of at least about 0.1 mm to 10 mm. In some embodiments, pressure waves may be applied onto the treatment site 106 in the range of at least about 2 MPa to 25 MPa at a distance of at least about 0.1 mm to 10 mm. Further alternatively, other suitable pressure ranges and distances may be used.

[0105] The power supply 125 is electrically coupled to and configured to provide the necessary power to each of the light source 124, the system controller 126, the GUI 127, the handle assembly 128, and the optical analyzer assembly 142. The power supply 125 may have any suitable design for such purposes.

[0106] The system controller 126 is electrically coupled to the power source 125 and receives power from the power source. The system controller 126 is coupled to each of the light source 124, the GUI 127, and the optical analyzer assembly 142 and configured to control their operation. The system controller 126 may include one or more processors or circuits for the purpose of controlling the operation of at least the light source 124, the GUI 127, and the optical analyzer assembly 142. For example, the system controller 126 may control the light source 124 to generate pulses of first light energy as desired and / or at any desired firing rate. The system controller 126 may control and / or operate in conjunction with the optical analyzer assembly 142 to effectively provide real-time continuous monitoring of the performance, reliability, safety, and proper use of the catheter system 100.

[0107] The system controller 126 may be further configured to control the operation of other components of the catheter system 100, such as positioning of the catheter 102 adjacent the treatment site 106, inflation of the balloon 104 with balloon fluid 132, etc. Additionally or alternatively, the catheter system 100 may include one or more additional controllers, which may be positioned in any suitable manner for purposes of controlling various operations of the catheter system 100. For example, in certain embodiments, the additional controllers and / or portions of the system controller 126 may be positioned and / or incorporated within the handle assembly 128.

[0108] The GUI 127 is accessible by a user or operator of the catheter system 100. The GUI 127 is electrically connected to the system controller 126. With such a design, the GUI 127 can be used by the user or operator to ensure that the catheter system 100 is effectively utilized to apply pressure on the treatment site(s) 106 to induce fracturing. The GUI 127 can provide information to the user or operator that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 can provide static visual data and / or information to the user or operator. Additionally or alternatively, the GUI 127 can provide dynamic visual data and / or information to the user or operator, such as video data or any other data that changes over time during use of the catheter system 100. In various embodiments, the GUI 127 can include one or more colors, different sizes, changing brightness, etc., that can serve as an alert to the user or operator. Additionally or alternatively, the GUI 127 can provide audio data or information to the user or operator. The details of the GUI 127 may vary depending on the design requirements of the catheter system 100 or the particular needs, specifications and / or desires of a user or operator.

[0109] 1, the handle assembly 128 can be positioned at or near the proximal portion 114 of the catheter system 100 and / or near the source manifold 136. In this embodiment, the handle assembly 128 is coupled to and positioned spaced apart from the balloon 104. Alternatively, the handle assembly 128 can be positioned in another suitable location.

[0110] The handle assembly 128 is handled and used by a user or operator to operate, position, and control the catheter 102. The design and specific features of the handle assembly 128 can be varied to suit the design requirements of the catheter system 100. In the embodiment shown in FIG. 1, the handle assembly 128 is separate from, but in electrical and / or fluid communication with, one or more of the system controller 126, the light source 124, the fluid pump 138, the GUI 127, and the optical analyzer assembly 142. In some embodiments, the handle assembly 128 can integrate and / or include at least a portion of the system controller 126 within the handle assembly 128. For example, as shown, in certain such embodiments, the handle assembly 128 can include a circuit 156 that can form at least a portion of the system controller 126. In some embodiments, the circuit 156 can receive electrical signals or data from the optical analyzer assembly 142. Additionally or alternatively, the circuit 156 can transmit such electrical signals or otherwise provide data to the system controller 126.

[0111] In one embodiment, the circuitry 156 may include a printed circuit board having one or more integrated circuits or any other suitable circuitry. In alternative embodiments, the circuitry 156 may be omitted or may be included within the system controller 126, and in various embodiments, the circuitry 156 may be located outside the handle assembly 128, such as in the system console 123. It is understood that the handle assembly 128 may include fewer or additional components than those specifically shown and described herein.

[0112] In summary, as provided in more detail herein, the optical analyzer assembly 142 is configured to effectively monitor the performance, reliability, safety and proper use of the catheter system 100. During use of the catheter system 100, when plasma is initially formed in the balloon fluid 132 within the balloon interior 146, as a result of a first pulse of light energy being directed into the balloon fluid 132 within the balloon interior 146, a plasma flash emits broad spectrum electromagnetic radiation. The plasma flash can be effectively captured in the form of a flash signature (or flash signal) which can include summary parameters such as pulse maximum, rise time, width, and start time relative to a baseline, as well as a measure of signal variability (described as transition times), all of which can provide an indication of the condition of the light guide 122A and / or the plasma generator 133.

[0113] At least a portion of the emitted first light energy may be reflected from or otherwise received by the distal light receiver 122R near the guide distal end 122D of the light guide 122A. Thus, such portion of the first light energy may return through the light guide 122A to the guide proximal end 122P as a second light energy traveling in the second direction 121S, where it may be separated, detected, and analyzed through the use of the optical analyzer assembly 142. The intensity and timing of the visible light pulse relative to the plasma generating pulse from the light source 124 provides an indication that the plasma generator 133 has functioned, its energy output, and its functional status. It is understood that if the light guide 122A is damaged or broken, visible light flashes may occur at other locations along the length of the light guide 122A. Such additional light flashes are also coupled into the light guide 122A and conveyed back to the guide proximal end 122P in the second direction 121S. The intensity and timing of these additional light pulses can indicate a damaged light guide 122A or plasma generator 133.

[0114] By evaluating and / or analyzing the intensity and timing of the visible light pulses relative to the plasma generating pulses from the light source 124, the optical analyzer assembly 142 can determine whether: (i) a normal operating condition in which a first optical energy is directed from the guide distal end 122D of the light guide 122A to the plasma generator 133, and thus a plasma is generated substantially immediately adjacent to the plasma generator 133 when the first optical energy strikes the target surface of the plasma generator 133; (ii) a gas bubble formed within the balloon fluid 132 is directed toward the guide distal end 122D of the light guide 122A; (iii) a guide distal end plasma initiation condition, where some debris may be present substantially adjacent to guide distal end 122D of light guide 122A, generating a plasma at such point substantially adjacent to guide distal end 122D of light guide 122A, but not substantially directly adjacent to plasma generator 133; (iv) a guide distal end plasma initiation condition, where some debris may be present substantially adjacent to guide distal end 122D of light guide 122A, generating a plasma at such point substantially adjacent to guide distal end 122D of light guide 122A, but not substantially directly adjacent to plasma generator 133; and / or plasma generator 133; (v) a light guide broken (fiber) condition, such as a broken light guide 122A at the guide distal end 122D, where little or no plasma is generated in the balloon fluid 132 within the balloon interior 146 and any minimum plasma that may be generated has a lower pulse maximum value because the first light energy is directed in multiple different directions away from the guide distal end 122D of the light guide 122A rather than simply directly toward the plasma generator 133; and (vi) a chewback condition, such as a broken light guide 122A along the length of the light guide 122A and at least some distance from the guide distal end 122D, where plasma generation may occur in the balloon fluid 132 within the balloon interior 146 substantially adjacent to where the break may exist along the length of the light guide 122A.It is understood that some of these identified operating conditions, including a normal operating condition, an intermittent air bubble generation condition, and a guide distal end plasma initiation condition, may require further monitoring of the condition of the light guide 122A and / or the plasma generator 133, but do not require immediate cessation of operation of the catheter system 100 or replacement of the light guide 122A and / or the plasma generator 133. However, it is further understood that other identified operating conditions, such as a housing / target failure condition, a light guide broken (fiber) condition, and a chewback condition, may, and often do, require cessation of operation of the catheter system 100 and replacement of the light guide 122A and / or the plasma generator 133.

[0115] It is understood that misuse or failure of the energy-driven plasma generator 133 or associated light guide 122A, such as when the light guide 122A and / or the catheter system 100 are used outside the body 107 of the patient 109 and / or when the light guide 122A breaks or is damaged during use of the catheter system 100, may result in harm to the patient or operator due to leaked energy. Potential damage includes tissue burns and retinal damage. As mentioned above, in some embodiments, the light source 124 is a laser that emits invisible infrared light, making visual detection by the operator impossible. Thus, if the optical analyzer assembly 142 indicates that such misuse or failure has occurred, the treatment and energy delivery, such as laser energy delivery, must be immediately stopped to mitigate the associated risks to the patient and operator. Stated differently, with the design of the optical analyzer assembly 142 described herein, the present invention provides an indicator or signal that can be used by the system controller 126 to detect misuse of the catheter system 100 and / or the above-mentioned misuse or failure within the catheter system 100, such as breakage, damage, or failure of the light guide 122A and / or the plasma generator 133, to lock out the light source 124. In certain embodiments, locking out the light source 124 can be accomplished through the use of a safety shutdown system 283, which in some such embodiments can include one or more of a safety interlock 284 (shown in FIG. 2A ) and a shutter 286 (shown in FIG. 2A ), which can be incorporated as part of the optical analyzer assembly 142. This provides the necessary safety interlock and mitigation against a potentially dangerous condition in which the light source 124 may leak from any part of the catheter system 100 or the light guide 122A due to misuse or failure. Additionally, the system controller 126 can be used to instruct the surgeon, such as via the GUI 127, to stop the procedure and remove the catheter 102 from the patient 109 being treated.A simple example of potential misuse is attempting to excite the catheter system 100 when it is outside the body 107 of the patient 109 and / or away from the intended treatment site 106. The emitted energy could be unintentionally seen by the operator and result in retinal damage.

[0116] It is further understood that the optical analyzer assembly 142 can have any suitable design for purposes of effectively monitoring the safety, performance, reliability, and proper use of the catheter system 100. Specific, non-exclusive examples of potential designs and applications of the optical analyzer assembly 142 are described in detail herein below.

[0117] Figure 2A is a simplified schematic diagram of a portion of an embodiment of a catheter system 200 including an embodiment of an optical analyzer assembly 242. As shown in Figure 2A, the optical analyzer assembly 242 is utilized in a first application. Figure 2B is a simplified schematic diagram of a portion of the catheter system 200 including the optical analyzer assembly 242 of Figure 2A. As shown in Figure 2B, the optical analyzer assembly 242 is utilized in a second application.

[0118] The design of the catheter system 200 is substantially similar to the embodiments described herein above. It is understood that various components of the catheter system 200, as shown in Figure 1, are not shown in Figures 2A and 2B for clarity and ease of illustration. However, it is understood that the catheter system 200 will likely include most, if not all, such components.

[0119] As shown in Figures 2A and 2B, the catheter system 200 again includes a light source 224 configured to generate a first light energy in the form of a light source beam 224A, such as a pulsed light source beam, which may be selectively and / or alternatively directed and received by each light guide 222A (only one light guide is shown in Figures 2A and 2B) as an individual guide beam 224B (shown in Figure 2A). In one non-exclusive embodiment, the light source 224 is an infrared laser source and the light guide 222A is a small diameter multimode optical fiber. In the embodiment shown in Figures 2A and 2B, a pulse generator 260 is coupled to the light source 224. The pulse generator 260 is configured to trigger the light source 224, thus emitting an energy pulse as the light source beam 224A.

[0120] In certain embodiments, as shown in FIG. 2A, the light source beam 224A from the light source 224 passes through a first optical element 262, such as a combining and / or focusing lens, configured to focus the light source beam 224A as an individual guide beam 224B onto the guide proximal end 222P of the light guide 222A, thereby coupling the individual guide beam 224B into the light guide 222A in the form of a pulse of infrared energy (first light energy). The individual guide beam 224B then travels along and / or through the light guide 222A as the first light energy, exciting a plasma generator 233 positioned and / or incorporated at or near the guide distal end 222D of the light guide 222A. The plasma generator 233 utilizes the pulse of infrared energy to generate a localized plasma 234 (such as in the form of a plasma bubble or plasma flash) in the balloon fluid 132 (shown in FIG. 1) within the balloon interior 146 (shown in FIG. 1) of the balloon 104 (shown in FIG. 1).

[0121] 2A , upon generating plasma 234 in the balloon fluid 132 within the balloon interior 146, in various embodiments, a pulse of broad-spectrum light energy emitted from the plasma flash 234 in the form of second light energy is coupled back to the distal guide end 222D of the light guide 222A via the distal light receiver 222R. Such pulse of broad-spectrum light energy (second light energy) then travels back along and / or through the light guide 222A, from where it is emitted from the proximal guide end 222P of the light guide 222A as second light energy 224C.

[0122] 2B, in some applications, ambient light 235 near the guide distal end 222D of the light guide 222A can be coupled into the guide distal end 222D of the light guide 222A via a distal light receiver 222R. Such ambient light energy (second light energy) then travels along and through the light guide 222A toward the guide proximal end 222P of the light guide 222A, from where it is emitted as second light energy 224C (which may also be referred to in this application as an "ambient energy beam").

[0123] As described in detail herein, the optical analyzer assembly 242 is configured to effectively monitor the performance, reliability, safety, and proper use of the catheter system 200 by optically analyzing the second light energy emitted from the guide proximal end 222P of the light guide 222A. In other words, the optical analyzer assembly 242 is configured to effectively monitor the performance, reliability, safety, and proper use of the catheter system 200 by optically analyzing the second light energy 224C generated as a result of the plasma flash 234 created by the plasma generator 233 in the balloon fluid 132 within the balloon interior 146 of the balloon 104, and / or the second light energy 224C in the form of an ambient energy beam 235 coupled to the guide distal end 222D of the light guide 222A via the distal light receiver 222R.

[0124] The design of the optical analyzer assembly 242 can be varied to suit the particular requirements of the catheter system 200. Specifically, in the embodiment shown in Figures 2A and 2B, the optical analyzer assembly 242 includes one or more of a first beam splitter 264, a first optical element 262, a second optical element 266, such as an imaging lens in one non-exclusive embodiment, a second beam splitter 268, a first filter 270, a photodetector 272, an amplifier 274, control electronics 276, which may include one or more processors or circuits, a second filter 278, an imaging device 280, such as a camera or other suitable imaging device, a device controller 282, and a safety shutdown system 283. As shown, the safety shutdown system 283 can include one or more of a safety interlock 284 and a shutter 286. Alternatively, in other embodiments, the optical analyzer assembly 242 and / or the safety shutdown system 283 may include more or fewer components than are specifically shown and described herein. Further alternatively, in still other embodiments, the various components of the optical analyzer assembly 242 may be positioned in a different manner than are specifically shown in Figures 2A and 2B.

[0125] As shown in the first application shown in FIG. 2A, in one embodiment, a first beam splitter 264, such as a dichroic beam splitter, is positioned in the optical path of the light source beam 224A between the light source 224 and the guide proximal end 222P of the light guide 222A. In a particular embodiment, the beam splitter 264 is configured to pass light having a wavelength longer than the wavelength visible to the photodetector 272 to provide individual guide beams 224B that are directed to the guide proximal end 222P of the light guide 222A. Such a threshold wavelength can be referred to as a cutoff wavelength. The beam splitter 264 is further configured to reflect all light having a wavelength shorter than the cutoff wavelength. As shown in this embodiment, the first optical element 262 is positioned between the first beam splitter 264 and the light guide 222A and configured to focus the individual guide beams 224B onto the guide proximal end 222P of the light guide 222A, thereby coupling the individual guide beams 224B to the light guide 222A.

[0126] The first light energy of each guide beam 224B is guided along the light guide 222A from the proximal guide end 222P to the distal guide end 222D and excites a plasma generator 233 positioned and / or incorporated at or near the distal guide end 222D of the light guide 222A. The plasma generator 233 utilizes a pulse of infrared energy to create a localized plasma 234 in the balloon fluid 132 within the balloon interior 146 of the balloon 104. The pulse of broad spectrum light energy emitted from the plasma flash 234 as a form of second light energy is then coupled back into the distal guide end 222D of the light guide 222A and travels back along and / or through the light guide 222A, from where it is emitted from the proximal guide end 222P of the light guide 222A as second light energy 224C.

[0127] 2A , the second light energy 224C emitted from the guide proximal end 222P of the light guide 222A is collimated by the first optical element 262 and then directed back toward the first beam splitter 264. At least a portion of the second light energy 224C is then redirected and / or reflected by the first beam splitter 264 toward the second beam splitter 268. The second optical element 266 is positioned in the optical path of the redirected portion of the second light energy 224C between the first beam splitter 264 and the second beam splitter 268. The optics of the second optical element 266 focuses the collimated second light energy 224C toward the second beam splitter 268. The second beam splitter 268 then redirects and / or reflects a portion of the collimated second optical energy 224C through a first filter 270, such as a bandpass filter in certain embodiments, onto the photodetector 272, thus forming an image of the proximal guide end 222P of the light guide 222A on the photodetector 272, thereby coupling the second optical energy 224C emitted from the proximal guide end 222P of the light guide 222A onto the photodetector 272. In certain embodiments, the photodetector 272 may be a photodiode or another suitable type of photodetector. With such a design, visible light emitted from the plasma flash 234 formed at the distal guide end 222D of the light guide 222A is collected by the photodetector 272.

[0128] In some embodiments, the photodetector 272 generates a signal based on visible light emitted from the plasma formed at the guide distal end 222D of the light guide 222A that is collected by the photodetector 272. As shown in FIG. 2A, the signal from the photodetector 272 is then directed to an amplifier 274 and control electronics 276 where a detection and intensity assessment of the plasma flash 234 is determined. Specifically, in certain embodiments, the signal from the photodetector 272 is directed to an amplifier 274 where the signal from the photodetector 272 is amplified. The amplified signal is then utilized within the control electronics 276 to determine the intensity of the plasma flash 234 generated within the balloon fluid 132 within the balloon interior 146.

[0129] In certain embodiments, the pulse from the amplified photodetector signal can be gated using a discriminator (not shown), such as a discriminator circuit triggered by a pulse from the pulse generator 260. This information can then be used in the control electronics 276 to determine when the plasma flash 234 occurred in the balloon fluid 132 within the balloon interior 146. More specifically, the control electronics 276 can compare the timing of the original energy pulse from the light source 224 triggered by the pulse generator 260 with the timing of the amplified photodetector signal gated using a discriminator to determine when the plasma flash 234 occurred in the balloon fluid 132 within the balloon interior 146.

[0130] In some embodiments, the control electronics 276 may be included as part of the system controller 126 (shown in FIG. 1 ). Alternatively, the control electronics 276 may be provided separately from the system controller 126 and in electrical communication with the system controller 126.

[0131] It is understood that there are numerous other configurations for the photodetector 272 required to detect and analyze the light pulses returning from the light guide 222A in the form of the second light energy 224C. For example, in another embodiment, the photodetector 272 can be a spectrometer that provides intensity and wavelength information regarding the second light energy 224C. In such an embodiment, this information can be used to generate a spectral (or flash) signature to further identify a particular condition or event within the light guide 222A and / or the plasma generator 233. More specifically, small amounts of material that make up the plasma generator 233 are vaporized during its normal operation. These generate distinct spectral lines. It is further understood that this approach can also be used to distinguish between a functioning plasma generator 233 and a broken or damaged light guide 222A. This can also be used to monitor external light entering the light guide 222A and / or the catheter system 200, such as an indoor light spectral signature.

[0132] Another application of the present invention would be to monitor the condition of the light guides 222A for the plasma generator 233. The light returned through the light guides 222A when they are first coupled to the catheter system 200 can be monitored to determine that all of the light guides 222A are intact.

[0133] 2A, a first application of the present invention involves the direct detection of a light pulse created by a plasma flash 234 in the balloon fluid 132 within the balloon interior 146. An optical analyzer assembly 242 can be utilized to indicate the intensity of the light pulse, its spectrum, and when the light pulse occurs relative to the input pulse from the light source 224. This can be interpreted as follows.

[0134] 1) The light pulse must occur after a time interval determined by the length of the light guide 222A and the duration of the input energy pulse from the light source 224. If the detected light pulse has the correct intensity and occurs within a particular time window, it is an indication that the plasma generator 233 has functioned correctly.

[0135] 2) If no light pulse is detected at all, this is an indication of a failure of the plasma generator 233, the light source 224 and / or the entire catheter system 200.

[0136] 3) If a smaller light pulse is detected that occurs too soon relative to the energy pulse from light source 224, this is an indication of a failure and / or damage to light guide 222A.

[0137] 4) If the light pulses are detected to have a different spectrum or lack a spectral line or signature, this can be used to indicate a fault in the catheter system 200.

[0138] In the event of any detected failure of the plasma generator 233, the light source 224, the light guide 222A, and / or the entire catheter system 200, the control electronics 276 can be configured to send a signal to a safety shutdown system 283 to shut down operation of the catheter system 200. More specifically, in this embodiment, the signal from the control electronics 276 to the safety shutdown system 283 can be used to activate a safety interlock 284, which blocks the signal from the pulse generator 260 to the light source 224, thus effectively ceasing the generation of light pulses from the light source 224. Additionally or alternatively, the signal from the control electronics 276 to the safety shutdown system 283 can be used to activate a shutter 286 that can be closed, thereby blocking any light pulses from the light source 224 that would otherwise be directed at and coupled to the light guide 222A. Such a safety shutdown system 283 can effectively limit potential injury to the patient 109 or operator.

[0139] 2B, a second application for the optical analyzer assembly 242 is shown and described. Specifically, in this second application, proper use of the catheter system 200 can be initially monitored prior to the generation of an energy pulse by the light source 224.

[0140] As shown, distal light receiver 222R can be configured to receive any ambient light 235 that may be present within the region of distal guide end 222D of light guide 222A. Specifically, any visible ambient light 235 present within the region of distal guide end 222D of light guide 222A can be coupled to distal guide end 222D of light guide 222A via distal light receiver 222R as second light energy 224C in the form of an ambient energy beam.

[0141] The second light energy 224C travels along and / or through the light guide 222A from the guide distal end 222D to the guide proximal end 222P, from where it is emitted from the guide proximal end 222P of the light guide 222A. As shown in FIG. 2B, the second light energy 224C emitted from the guide proximal end 222P of the light guide 222A is collimated by the first optical element 262 and then directed to the first beam splitter 264. At least a portion of the second light energy 224C is then redirected and / or reflected by the first beam splitter 264 towards the second beam splitter 268. The second optical element 266 is positioned in the optical path of the redirected portion of the second light energy 224C between the first beam splitter 264 and the second beam splitter 268. The optics of the second optical element 266 focus the collimated second optical energy 224C towards the second beam splitter 268. The second beam splitter 268 then transmits at least a portion of the collimated second optical energy 224C through a second filter 278, such as a short pass filter in certain embodiments, to the imaging device 280, thus forming an image of the guide proximal end 222P of the light guide 222A on the imaging device 280, thereby coupling the second optical energy 224C emitted from the guide proximal end 222P of the light guide 222A onto the imaging device 280. Thus, in a suitable arrangement, the first optical element 262 and the second optical element 266 can cooperate to create a high resolution image of the guide proximal end 222P of the light guide 222A on the imaging device 280. In certain embodiments, the imaging device 280 can be an area sensor, such as a CCD or CMOS camera, or another suitable type of imaging device. With such a design, visible ambient light 235 collected at the distal guide end 222D of the light guide 222A is collected by the imager 280.

[0142] In some embodiments, the imaging device 280, under the control of the device controller 282, generates a signal based on the visible ambient light 235 collected by the imaging device 280 at the guide distal end 222D of the light guide 222A. As shown in FIG. 2B, the signal from the imaging device 280 is then directed to the control electronics 276, where the detection of any potential ambient light 235 near the guide distal end 222D of the light guide 222A is determined. Specifically, in certain embodiments, the signal from the imaging device 280 is utilized within the control electronics 276 to determine whether ambient light 235 is present near the guide distal end 222D of the light guide 222A.

[0143] If the ambient light 235 is not detected by the optical analyzer assembly 242 as collected from an area near the guide distal end 222D of the light guide 222A, this is an indication that the catheter system 200 is not being utilized in an improper manner. However, if the optical analyzer assembly 242 detects a change in the light returning from the light guide 222A, thereby signaling the ambient light 235 originating from outside the catheter system 200, this is an indication that the catheter system 200 is being used in an unintended manner. In such a situation, the control electronics 276 may be configured to send a signal to the safety shutdown system 283 to shut down the operation of the catheter system 200. More specifically, in this embodiment, the signal from the control electronics 276 to the safety shutdown system 283 may be used to activate the safety interlock 284, which interrupts the signal from the pulse generator 260 to the light source 224, thus effectively stopping the generation of light pulses from the light source 224. Additionally or alternatively, a signal from the control electronics 276 to a safety shutdown system 283 can be used to activate a shutter 286 that can be closed to block any light pulses from the light source 224 that would otherwise be directed at and coupled to the light guide 222A. Such a safety shutdown system 283 can effectively limit potential injury to the patient 109 or operator.

[0144] As described in connection with Figures 2A and 2B, the optical analyzer assembly 242 utilizes a second beam splitter 268 and separate filters 270, 278 to couple the second light energy 224C to both the imager 280 (area sensor) and the photodetector 272 (single element photodetector such as a photodiode). However, it is understood that the above-described uses of the catheter system 200 and / or the optical analyzer assembly 242 may be implemented in any suitable manner and may be performed in a manner somewhat different than that described in detail herein. For example, in one non-exclusive alternative embodiment, the photodetector 272 of the optical analyzer assembly 242 may be used to monitor the ambient light 235 coupled into the guide distal end 222D of the light guide 222A, as well as to monitor the light pulses created by the plasma flash 234 in the balloon fluid 132 within the balloon interior 146. In such an alternative embodiment, the imager 280 is not used or may be omitted from the catheter system.

[0145] In summary, application of the optical analyzer assembly 242 as shown in Figures 2A and 2B, which is configured to monitor the nominal operation of the catheter system 200 as well as potential misuse of the catheter system 200, can include the following general steps. (1) The catheter system starts from standby mode. (2) The catheter system continuously monitors use via an optical analyzer assembly and / or imaging device (sometimes referred to as an image sensor subsystem) looking for evidence of ambient light transmitted from the guide distal end of the light guide (as evidence of potential improper use of the system). The optical analyzer assembly and / or imaging device monitors images of the light guide end face at high frame rates looking for non-zero states or predetermined changes in signal over time. (3) The pulse generator sends a trigger to the light source (an IR laser) to emit an energy pulse, which can be initiated, for example, by an operator pressing a start button. (4A) The image sensor subsystem detects no light returning from the light guide signaling acceptable use parameters. (4B) The image sensor subsystem detects changes in the light returning from the light guide signaling externally emanating ambient light, which is an indication that the catheter system is being used unintended and sends a signal to the control electronics. (5A) If step (4A) is satisfied, the control electronics enables use of the light source by overriding safety interlocks and / or opening shutters that would otherwise discontinue use of the light source beam. Then proceed to step (6). (5B) If step (4B) is satisfied, the control electronics locks out the light source by activating a safety interlock and / or closing a shutter to stop or interrupt the light source beam, after which the process is stopped and the catheter is repositioned if necessary, and / or returns to step (1). (6) A guided beam in the form of a first optical energy is focused into the guide proximal end of the light guide and a pulse of IR energy is coupled therein. (7) A pulse of IR energy in the form of a first light energy travels through the light guide and excites a plasma generator, which creates a localized plasma in the balloon fluid within the balloon interior of the balloon. (8) The pulse of broad-spectrum optical energy emitted from the plasma in the form of a second optical energy is coupled back into the distal end of the light guide via the distal optical receiver and passed back through the light guide to the proximal end. (9) The beam splitter and optical elements cooperate to form an image of the end face of the light guide onto the photodetector. (10) The signal from the photodetector is amplified and can be used to determine the intensity of the plasma event. (11) The pulses from the amplified photodetector are conditioned and this information is used to determine when a plasma event has occurred. (12) If no light pulse is detected at all, if a smaller light pulse is detected that occurs too soon relative to the energy pulse from the light source, or if a light pulse is detected to have a different spectrum or lack a spectral line or signature, this can be used to indicate a failure of the plasma generator, light source, light guide and / or the entire catheter system. (13) If (12) is satisfied, the control electronics will lock out the light source by activating a safety interlock and / or closing a shutter to stop or interrupt the light source beam. The process will then be stopped and will not proceed.

[0146] Thus, as discussed above, the optical analyzer assembly 242 of the present invention addresses several potential challenges related to the performance, reliability, safety, and proper use of IVL catheters, particularly those that utilize an energy source, such as a light source, for example a laser source, to generate a localized plasma that induces high energy bubbles in the balloon fluid 132 within the balloon interior 146 of the balloon 104. For example, as discussed above, challenges addressed by the present invention include, but are not limited to, 1) optical detection when the IVL catheter is in place at the treatment site, 2) optical detection of conditions under which the IVL catheter may be misused, 3) optical detection of successful firing of an energy source, such as a laser source, to generate a plasma within the balloon interior, 4) accurate determination of the energy output of the plasma generator, 5) optical detection of failure of the catheter system to generate a desired plasma within the balloon interior, and 6) optical detection of failure of the energy guide at any point along the length of the energy guide.

[0147] The remaining figures are provided to further illustrate and explain certain features and aspects of the present invention with respect to the operation and analysis of the optical analyzer assembly and the subsequent determination of operating conditions within the catheter system.

[0148] Figures 3A-3F are simplified schematic diagrams of operating states that may be identified by the optical analyzer assembly during operation of the catheter system of Figure 1. More specifically, Figure 3A is a simplified schematic diagram of a first operating state 388A that may be identified by the optical analyzer assembly during operation of the catheter system, Figure 3B is a simplified schematic diagram of a second operating state 388B that may be identified by the optical analyzer assembly during operation of the catheter system, Figure 3C is a simplified schematic diagram of a third operating state 388C that may be identified by the optical analyzer assembly during operation of the catheter system, Figure 3D is a simplified schematic diagram of a fourth operating state 388D that may be identified by the optical analyzer assembly during operation of the catheter system, Figure 3E is a simplified schematic diagram of a fifth operating state 388E that may be identified by the optical analyzer assembly during operation of the catheter system, and Figure 3F is a simplified schematic diagram of a sixth operating state 388F that may be identified by the optical analyzer assembly during operation of the catheter system.

[0149] 3A, a first operating state 388A is shown of the light guide 322A and plasma generator 333 in a normal operating state. In such normal operating state, when a first optical energy 324B is directed from a guide distal end 322D of the light guide 322A towards the plasma generator 333 and thus impinges on a target surface 333T of the plasma generator 333, a plasma 334 and subsequent acoustic waves (shown as a series of arc lines) are generated substantially immediately adjacent to the plasma generator 333.

[0150] In FIG. 3B, the light guide 322A and plasma generator 333 are shown in a second operating state 388B in which an intermittent bubble generation condition exists. In such second operating state 388B, bubbles 389 (one bubble 389 is shown in FIG. 3B) formed in the balloon fluid 132 (shown in FIG. 1) are found between the guide distal end 322D of the light guide 322A and the plasma generator 333, which optically affect the directing of the first light energy 324B to the target surface 333T of the plasma generator 333. Thus, little or no plasma (not shown in FIG. 3B) is generated, and the resulting flash signature may have a lower pulse maximum than desired to most effectively destroy the vascular lesion 106A (shown in FIG. 1) at the treatment site 106 (shown in FIG. 1). Under such conditions, the operator can shut down operation of the catheter system 100 (shown in FIG. 1) and address the fluid pump 138 (shown in FIG. 1) and / or the inflation conduit 140 (shown in FIG. 1) to suppress the creation of such intermittent bubbles 389 without having to replace the light guide 322A and / or the plasma generator 333.

[0151] In FIG. 3C, the light guide 322A and the plasma generator 333 are shown in a third operating state 388C in which a guide distal end plasma initiation condition exists. In such a third operating state 388C, there may be some debris substantially adjacent to the guide distal end 322D of the light guide 322A that will cause the plasma 334 and subsequent acoustic waves (shown as a series of arc lines) to occur at such a point substantially adjacent to the guide distal end 322D of the light guide 322A, rather than substantially directly adjacent to the plasma generator 333. The resulting flash signature may have a higher pulse maximum than under the baseline condition. This may also affect the ability of the catheter system 100 (shown in FIG. 1) to most effectively destroy the vascular lesion 106A (shown in FIG. 1) at the treatment site 106 (shown in FIG. 1). However, the third operating state 388C shuts down operation of the catheter system 100 so that such areas within the balloon 104 (shown in FIG. 1) can be cleaned by subsequent flushing without the need to replace the light guide 322A and / or the plasma generator 333.

[0152] In FIG. 3D, the light guide 322A is shown in a fourth operating state 388D in which a housing / target failure condition exists. In such fourth operating state 388D, the desired plasma flash cannot be generated in the balloon fluid 132 (shown in FIG. 1) within the balloon interior 146 (shown in FIG. 1) from the first light energy 324B directed by the light guide 322A. Under such conditions, the resulting flash signature has a lower pulse maximum. This provides evidence that there is a failure of the light guide 322A and / or the plasma generator 333 (e.g., shown in FIG. 3A) in the process of attempting to generate the desired plasma flash to effectively destroy the vascular lesion 106A (shown in FIG. 1) at the treatment site 106 (shown in FIG. 1). Thus, to correct or overcome this condition, the catheter system 100 (shown in FIG. 1) may be taken out of service and the light guide 322A and / or the plasma generator 333 may be removed and replaced, or the catheter system 100 may be discarded in its entirety. Note that plasma generator 333 is not shown in FIG. 3D to more clearly illustrate the failure to generate the desired plasma.

[0153] In FIG. 3E, the light guide 322A is shown in a fifth operating state 388E in which a broken light guide broken (fiber) condition exists. In such a fifth operating state 388E, little or no plasma (not shown in FIG. 3E) is generated in the balloon fluid 132 (shown in FIG. 1) in the balloon interior 146 (shown in FIG. 1), and any minimal plasma that does occur typically has a lower pulse maximum because the first light energy 324B is directed in multiple different directions away from the guide distal end 322D of the light guide 322A, rather than directly toward the plasma generator 333 (e.g., shown in FIG. 3A). It is understood that this failure mode can occur anywhere along the length of the catheter, not just within the balloon. When such a fifth operating state 388E is determined to exist, operation of the catheter system 100 (shown in FIG. 1) should be stopped.

[0154] In FIG. 3F, the light guide 322A and the plasma generator 333 are shown in a sixth operating state 388F in which a chewback condition exists, such as a broken light guide 322A at least some distance away from the guide distal end 322D along the length of the light guide 322A. In such a sixth operating state 388F, the generation of plasma 334 (shown as a series of arc lines) may occur in the balloon fluid 132 (shown in FIG. 1) within the balloon interior 146 (shown in FIG. 1) substantially adjacent to where the break may exist along the length of the light guide 322A. Under such conditions, the resulting flash signature is typically very sawtooth-like, increasing and decreasing in magnitude very rapidly over time. If such a sixth operating state 388F is determined to exist, the generated plasma 334 is much less likely to be directed in an appropriate manner to effectively destroy the vascular lesion 106A (shown in FIG. 1) at the treatment site 106 (shown in FIG. 1). Therefore, the operation of the catheter system 100 (shown in FIG. 1) should be stopped.

[0155] As provided herein, many of the analyses performed by the use of an optical analyzer assembly involve capturing an image of a flash signal (or flash signature) resulting from plasma generation in the balloon fluid within the balloon interior, and then analyzing the flash signal (or flash signature) as a means of determining the operating state of the catheter system. It is understood that the flash signal (or flash signature) can take any particular form, and there are infinite possibilities for all the details incorporated in the flash signal (or flash signature). Figures 4A and 4B provide simplified graphical illustrations of two potential examples of what a flash signal (or flash signature) may look like when captured via the use of an optical analyzer assembly.

[0156] 4A is a simplified graphical representation of a representative example of a first flash signature 490A that may be identified by the optical analyzer assembly 242 (e.g., shown in FIG. 2A) during operation of the catheter system 100 of FIG. 1 in terms of flash intensity (Y-axis) versus time (X-axis). More specifically, the first flash signature 490A is identified by the optical analyzer assembly 242 during the generation of a plasma flash 334 (shown in FIG. 3A) from a single pulse of first light energy 324B (shown in FIG. 3A) from the light source 124 (shown in FIG. 1) through the light guide 322A (shown in FIG. 3A). As shown, the first flash signature 490A has a single peak 491A and two transitions 492A. In analyzing the peaks of any given flash signature, the maximum or highest peak may be referred to as the "pulse maximum intensity" value or simply the "pulse maximum." In FIG. 4A, first flash signature 490A has only a single peak 491A, which is also referred to as the pulse maximum intensity value or "pulse maximum."

[0157] 4B is a simplified graphical representation of a representative example of a second flash signature 490B that may be identified by the optical analyzer assembly 242 (e.g., shown in FIG. 2A) during operation of the catheter system 100 of FIG. 1 in terms of flash intensity (Y-axis) versus time (X-axis). More specifically, the second flash signature 490B is identified by the optical analyzer assembly 242 during the generation of a plasma flash 334 (shown in FIG. 3A) from a single pulse of first light energy 324B (shown in FIG. 3A) from the light source 124 (shown in FIG. 1) through the light guide 322A (shown in FIG. 3A). As shown, the second flash signature 490B has three peaks 491B and six transitions 492B. Again, in analyzing the peaks of any given flash signature, the highest peak may be referred to as the "pulse maximum intensity" value or simply the "pulse maximum." In FIG. 4B, the second flash signature 490B has three peaks 491B, the first peak 491B being the largest or highest and therefore also referred to as the pulse maximum intensity value or "pulse maximum."

[0158] As referred to herein, a "transition" is generally defined as a change in the direction of the gradient of the flash signature as shown in a graph diagram. As shown in Figures 4A and 4B, both signals have a transition when the signal rises rapidly from the X-axis. Both signals also have another transition when the signal falls from the pulse maximum. Figure 4B has more transitions or variability in the signal from this point onwards. The exact number of transitions measured in each signal depends on the adjustment of various parameters. One parameter defines the magnitude of gradient change required to classify something as a transition, and the other parameter is a history parameter to avoid counting transitions on noise in the signature.

[0159] Figure 5 is a simplified graphical illustration 593 of an example of a pulse maximum intensity reading that may be identified by the optical analyzer assembly from a plasma flash generated when a pulse of first optical energy is sent through a light guide used in the catheter system of Figure 1. As shown, the pulse maximum intensity reading (in arbitrary units) from the plasma flash generated for each pulse of first optical energy being guided through the light guide is shown along the Y axis, and the pulse number of a particular light guide is shown along the X axis. Stated another way, the Y axis relates to the maximum value found in the flash signature (or flash signal) detected by the optical analyzer assembly for any given pulse of first optical energy sent through a given light guide.

[0160] FIG. 5 shows both a minimum pulse maximum intensity threshold 594 and a maximum pulse maximum intensity threshold 595 that may be used by the system controller to help define the operating conditions of the light guide and / or plasma generator.

[0161] A minimum pulse maximum intensity threshold 594 may be used by the system controller to determine whether the operating condition of the light guide is one of an intermittent air bubble condition, a housing / target failure condition, and / or a light guide broken (fiber) condition. In any of such operating conditions, the pulse maximum intensity has a low value that provides an indication that the plasma flash, if any, may not be sufficient to effectively destroy vascular lesions at the treatment site.

[0162] It is understood that a pulse maximum intensity value at or very close to zero is an indication of any of the conditions described in the previous paragraph where little or no plasma flash has occurred. Because of this ambiguity in potential failure modes, instead of responding to a single instance of a no signal condition, the history of all pulses on each fiber can be tracked to distinguish such conditions. As will be further explained below, the pulse maximum intensity value does not necessarily have to be zero to indicate such a failure condition, since it is always possible that at least some extraneous light may be captured by the distal optical receiver and transmitted back from the guide distal end towards the guide proximal end as a second optical energy.

[0163] In one non-exclusive embodiment, minimum pulse maximum intensity threshold 594 may be approximately 100 units, such that any recorded pulse maximum intensity value below 100 units may indicate such an undesirable operating condition of the light guide. Alternatively, in other embodiments, minimum pulse maximum intensity threshold 594 may be approximately 50 units, 75 units, 125 units, 150 units, 175 units, 200 units, or another suitable minimum pulse maximum intensity threshold.

[0164] As will be further described below in connection with FIG. 7, to avoid potential false positive readings of no signal conditions, it will be appreciated that for true positive identification of such no signal conditions, it may be desirable to require a certain number of pulses of the first light energy to have a pulse maximum intensity value below a pulse maximum intensity threshold without signal detection, such as 50 units in one non-exclusive embodiment, within a certain range or number of pulses of the first light energy.

[0165] The maximum pulse maximum intensity threshold 595 may be used by the system controller to determine whether the operating condition of the light guide is a guide distal end plasma initiation condition. Under such conditions, the pulse maximum intensity of the plasma flash when the second light energy is transmitted back through the light guide and optically analyzed by the optical analyzer assembly may be higher than under normal operating conditions because the plasma flash is often larger and occurs substantially immediately adjacent to the guide distal end of the light guide. Simply put, under such conditions, more of the second light energy is received by the distal light receiver and thus transmitted back through the light guide in a second direction because such light energy is generated and / or reflected substantially immediately adjacent to the guide distal end and thus the distal light receiver.

[0166] In one non-exclusive embodiment, maximum pulse maximum intensity threshold 595 may be approximately 1000 units, such that any recorded pulse maximum intensity value of 1000 units or greater may indicate such an undesirable operating condition of the light guide. Alternatively, in other embodiments, maximum pulse maximum intensity threshold 595 may be approximately 900 units, 925 units, 950 units, 975 units, 1025 units, 1050 units, 1075 units, 1100 units, 1125 units, 1150 units, or another suitable maximum pulse maximum intensity threshold.

[0167] FIG. 5 further illustrates exemplary pulse maximum intensity values, i.e., normal pulse maximum intensity range 596, of the plasma flash when the light guide is operating under normal operating conditions. In one non-exclusive embodiment, the normal operating condition may be determined if the normal pulse maximum intensity range 596 is between about 300 units and 800 units. Alternatively, the normal pulse maximum intensity range 596 for indication of a normal operating condition may vary from the ranges described above, so long as such normal pulse maximum intensity range 596 does not overlap or exceed a minimum pulse maximum intensity threshold 594 (i.e., below such minimum pulse maximum intensity threshold 594) or exceeds a maximum pulse maximum intensity threshold 595 (i.e., above such maximum pulse maximum intensity threshold 595). For example, in certain non-exclusive alternative embodiments, the normal pulse maximum intensity range 596 of the plasma flash may be between about 200 units and 900 units, such as between about 250 units and 850 units, between about 350 units and 900 units, between about 300 units and 850 units, or some other range of suitable pulse maximum intensity values.

[0168] FIG. 6 is a simplified graphical illustration 693 of an example number of transitions that may be identified by the optical analyzer assembly in a flash signal generated when a pulse of a first optical energy is sent through a light guide used in the catheter system of FIG. 1. As shown, the number of transitions identified in the flash signature (or flash signal) of the light guide for any given pulse of the first optical energy is shown along the Y-axis, and the pulse number of the particular light guide is shown along the X-axis. FIG. 6 provides an indication that the light guide may be suffering from chewback if the number of transitions in the plasma signature for any given pulse of the first optical energy exceeds a particular transition threshold 697. In one embodiment, as shown, the transition threshold 697 for identifying the light guide as suffering from chewback may be six transitions. Alternatively, in other embodiments, the transition threshold 697 for identifying the light guide as suffering from chewback may be four transitions, five transitions, seven transitions, eight transitions, nine transitions, ten transitions, or another suitable number of transitions.

[0169] It is understood that to avoid potential false positive readings for identifying the Chewback state, it may be desirable to require a certain number of pulses of the first light energy to have a number of transitions that are equal to or greater than the transition threshold 697 for a true positive identification of the Chewback state. For example, in one non-exclusive embodiment, it may be required to find at least three pulses of the first light energy with a number of transitions that are equal to or greater than the transition threshold to unambiguously identify the Chewback state. Alternatively, in other embodiments, it may be required to find only one, or at least two, four, five, six, or some other suitable number of pulses of the first light energy with a number of transitions that are equal to or greater than the transition threshold to unambiguously identify the Chewback state.

[0170] Figure 7 is a simplified graphical illustration 793 of one example of how a no signal detection condition may be identified by the optical analyzer assembly when a pulse of first light energy is sent through a light guide used in the catheter system of Figure 1. Similar to Figure 5, the pulse maximum intensity reading (in arbitrary units) from the plasma flash generated for each pulse of first light energy guided through the light guide is shown along the Y axis, and the pulse number of a particular light guide is shown along the X axis. Stated another way, the Y axis relates to the highest peak seen in the flash signature (or flash signal) detected by the optical analyzer assembly for any given pulse of first light energy sent through a given light guide.

[0171] As shown, Fig. 7 illustrates a zero threshold 798 (or no signal detection threshold) and a window zero count 799 (or no signal detection range). In order to effectively establish a no signal detection condition (and / or avoid inappropriately identifying such a condition), various embodiments may require finding a specific number of pulses (or zero pulse count) within the window zero count 799 (a given number or range of preceding pulses) that have a pulse maximum intensity value below the zero threshold 798. Stated another way, if the number of pulses within the window zero count 799 prior to the first pulse of light energy through a given light guide that has a pulse maximum intensity value below the zero threshold 798 meets or exceeds the zero pulse count, the system effectively identifies a no signal detection condition.

[0172] It is understood that the zero threshold 798, window zero count 799, and zero pulse count may all be varied in the process of attempting to unambiguously identify a no signal detection condition. For example, in one non-exclusive embodiment, the zero threshold 798 may be established when the pulse maximum intensity value of a given pulse of a first light energy through the light guide is less than or equal to 50 units. Alternatively, in other embodiments, the zero threshold 798 may be established where the pulse maximum intensity value is less than or equal to 10 units, 15 units, 20 units, 25 units, 30 units, 35 units, 40 units, 45 units, 55 units, 60 units, 65 units, 70 units, 75 units, or some other suitable number of units.

[0173] In one non-exclusive embodiment, the window zero count 799 can refer to a range of 20 pulses within which a defined zero pulse count of a first pulse of optical energy sent through a given light guide must have a reading below the zero threshold 798 to effectively identify a no signal detection condition. Alternatively, in other embodiments, the window zero count 799 can refer to a range of 15 pulses, 16 pulses, 17 pulses, 18 pulses, 19 pulses, 21 pulses, 22 pulses, 23 pulses, 24 pulses, 25 pulses, 26 pulses, 27 pulses, 28 pulses, 29 pulses, 30 pulses, 31 pulses, 32 pulses, 33 pulses, 34 pulses, 35 pulses, 36 pulses, 37 pulses, 38 pulses, 39 pulses, 40 pulses, or another suitable number of pulses within which a defined zero pulse count of a first pulse of optical energy sent through a given light guide must have a reading below the zero threshold 798 to effectively identify a no signal detection condition. As used herein, the window zero count 799 is specifically the number of previous pulses to look at for a given light guide when determining a no signal detection condition, rather than considering the entire history of the light guide.

[0174] In one non-exclusive embodiment, the defined zero pulse count is 11 pulses of first light energy being sent through a given light guide having a reading below the zero threshold 798 within the window zero count 799 range to effectively identify a no signal detected condition. Alternatively, the defined zero pulse count can be 5, 6, 7, 8, 9, 10, 12, 13, 14, 15, 16, 17, 18, 19, 20, or any other suitable number of pulses of first light energy being sent through a given light guide having a reading below the zero threshold 798 within the window zero count 799 range to effectively identify a no signal detected condition.

[0175] In one particular, non-exclusive embodiment, where the zero threshold is 50 units, the window zero count is 20 pulses and the defined zero pulse count is 11 pulses. Then, to effectively determine a no signal detection condition, one must find at least 11 pulses of the first light energy through a given light guide within the preceding 20 pulses that have a pulse maximum intensity value less than the zero threshold of 50 units.

[0176] It is understood that the present invention can be used to monitor the position and status of any device that uses an optical light source and light guide for energy transmission. One alternative example is nephrolithotomy using laser lithotripsy. Specifically, a beam splitter and optical system including the present invention can be incorporated into a lithotripsy laser system. This allows for continuous monitoring of light in the form of a second light energy returning from the guide distal end of the lithotripsy light guide. Once the light guide is inserted into the kidney through the nephroscope, the ambient lighting conditions are controlled by the nephroscope illumination. The characteristics and spectrum of the detected light can be used to determine whether the light guide is correctly positioned inside the kidney and whether it is safe to fire the light source. One means of achieving this is to use a signal source with specific wavelength characteristics in the scope illumination. For example, this includes a high intensity narrow band light source that is not present in the external ambient light. This can be detected using a band pass filter in front of the photodetector. The light source is locked out until its light signal is detected, preventing it from firing and emitting dangerous laser radiation outside the patient.

[0177] In summary, the catheter system and associated methods disclosed herein are configured to monitor the safety, performance, reliability and proper use of intravascular lithotripsy (IVL) catheters. In various embodiments, the catheter system of the present invention utilizes an energy source, e.g., a light source such as a laser source, or another suitable energy source that provides energy guided by an energy guide, such as a light guide, to create a localized plasma in the balloon fluid within the balloon interior of the inflatable balloon of the catheter. Thus, the energy guide may be referred to as or incorporate a "plasma generator" at or near the guide distal end of the energy guide that is positioned within the balloon interior. This localized plasma generates pressure waves that exert pressure on a treatment site within or adjacent a blood vessel or heart valve within the patient's body and induce fragmentation. As used herein, a treatment site may include a vascular lesion, such as a calcified vascular lesion or a fibrous vascular lesion, typically found in blood vessels and / or heart valves.

[0178] In particular, in various embodiments, the catheter system can include a catheter configured to be advanced to a treatment site in or adjacent to a blood vessel or heart valve in a patient's body. The catheter includes a catheter shaft and a balloon coupled and / or secured to the catheter shaft. The balloon can include a balloon wall defining a balloon interior and can be configured to receive balloon fluid within the balloon interior to expand from a deflated state suitable for advancing the catheter through the patient's vasculature to an inflated state suitable for securing the catheter in a predetermined position relative to the treatment site. The catheter system also includes one or more energy guides disposed within the balloon along the catheter shaft. Each energy guide can be configured to generate pressure waves within the balloon to destroy vascular lesions.

[0179] The catheter system utilizes energy from an energy source, such as a first light energy from a light source, to generate plasma, such as via a plasma generator, in a balloon fluid at or near a guide distal end of an energy guide disposed within a balloon located at a treatment site. The formation of the plasma can initiate one or more pressure waves and can initiate the rapid formation of one or more bubbles that can rapidly expand to a maximum size and then dissipate via a cavitation event that can emit a pressure wave upon collapse. The rapid expansion of the plasma-induced bubbles can generate one or more pressure waves in the balloon fluid held within the balloon, thereby imparting a pressure wave to the treatment site. In some embodiments, the energy source can be configured to provide sub-millisecond pulses of energy from the energy source to initiate the formation of plasma in the balloon fluid within the balloon, causing rapid bubble formation and imparting a pressure wave to the balloon wall at the treatment site. The pressure wave can thus transfer mechanical energy through the incompressible balloon fluid to the treatment site to impart a crushing force to the treatment site.

[0180] As described in detail herein, the catheter system of the present invention includes an optical analyzer assembly configured to provide real-time continuous monitoring of the energy emitted from the guide distal end of the energy guide to the balloon interior, and the optical analyzer assembly can be used to detect when a plasma event occurs and to monitor the nominal operation of the catheter system. The optical analyzer assembly is further configured to monitor the ambient energy received at the guide distal end of the energy guide and can be used as a monitor for proper use and positioning of the catheter system. For example, monitoring of the ambient energy from the distal end of the energy guide starting from the plasma generator can be used to detect the appearance and condition of the entire device as a monitor for nominally safe operation. Similarly, measuring the change in the intensity of the conducted energy over a time interval provides an indication of the location of the distal end and the plasma generator itself. When located inside the human body, the ambient energy conducted through the energy guide is minimal. This is expected to be zero and any baseline is minimally variable. Conversely, the energy conducted when the device is located outside the human body is not zero and is highly variable. This information can be used to determine the location of the distal end of the energy guide. This can be used to assess the state of the energy guide and determine if the device is functioning nominally.

[0181] The optical analyzer assembly can also be utilized to measure the intensity of the energy emitted from the energy guide to provide an accurate measurement of the energy output of a plasma generator incorporated as part of and / or used in combination with the energy guide. More specifically, the measurement of the energy output of the plasma generator can be used in conjunction with a known energy input from an energy source to determine the conversion efficiency. Such metrics can also be used to assess the status of the plasma generator and energy guide to determine whether the catheter system is operating normally as well as the number of operating cycles remaining.

[0182] In particular, in various embodiments, the invention includes a means for sampling the second light energy returned from the plasma generator and / or from inside the balloon through the energy guide. It is understood that the energy can travel in both opposite directions along the length of the energy guide. Thus, it is possible to detect energy originating at the guide proximal end of the energy guide, at the guide distal end of the energy guide, or at any other location along the length of the energy guide. Thus, such second light energy returned through the energy guide is separated and detected and / or analyzed via the optical analyzer assembly to effectively monitor the safety, performance, reliability and proper use of the catheter system.

[0183] It will be appreciated that the continuous monitoring of the energy emitted from the plasma generator and the measurement of the intensity of the emitted energy by use of the present invention addresses several potential challenges regarding the safety, performance, reliability, and proper use of IVL catheters, particularly the challenge of utilizing an energy source to create a localized plasma that generates high energy bubbles within the balloon catheter. The specific challenges addressed by the present invention include: 1) optical detection of when the IVL catheter is in place at the treatment site, 2) optical detection of conditions under which the IVL catheter may be misused, 3) optical detection of successful firing of an energy source, such as a laser source, to generate plasma within the balloon interior, 4) accurate determination of the energy output of the plasma generator, 5) optical detection of failure of the catheter system to generate the desired plasma within the balloon interior, and 6) optical detection of failure of the energy guide at any point along its length.

[0184] It is further understood that the optical analyzer assembly may be configured to automatically shut down operation of the catheter system if improper use or failure of the catheter system is detected and / or if a failure of the energy guide is detected at any point along the length of the energy guide. Thus, in various embodiments, the catheter system and / or the optical analyzer assembly may incorporate and / or include a safety shutdown system that may be selectively activated when it is necessary to automatically shut down operation of the catheter system. In some such embodiments, the safety shutdown system may include one or more of a safety interlock, a shutter, and / or other suitable safety shutdown mechanism that may be incorporated into the optical analyzer assembly. With such a design, the optical analyzer assembly is uniquely configured to prevent dangerous conditions for the patient and the operator of the catheter system.

[0185] It should be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content and / or context clearly dictates otherwise. It should also be noted that the term "or" is generally used in its sense including "and / or" unless the content or context clearly dictates otherwise.

[0186] It should also be noted that, as used in this specification and the appended claims, the term "configured" describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The term "configured" can be used interchangeably with other similar phrases such as arranged and configured, built and arranged, constructed, manufactured and arranged, etc.

[0187] The headings used herein are provided for consistency with suggestions under 37 CFR 1.77 or to otherwise provide an organizational cue. These headings should not be construed as limiting or characterizing the invention(s) recited in any claim that may issue from this disclosure. As an example, a description of a technology in the "Background" is not an admission that the technology is prior art to any invention(s) in this disclosure. Neither the "Summary" nor the "Abstract" should be construed as a feature of the invention(s) recited in the issued claims.

[0188] The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the detailed description provided herein. Rather, the embodiments are chosen and described so that those skilled in the art can appreciate and understand the principles and practices. Thus, aspects have been described with reference to various specific preferred embodiments and techniques. However, it should be understood that many variations and modifications can be made while remaining within the spirit and scope of the description.

[0189] Although several different embodiments of the catheter system have been illustrated and described herein, it should be understood that one or more features of any one embodiment may be combined with one or more features of one or more of the other embodiments, provided such combinations meet the intent of the invention.

[0190] While several exemplary aspects and embodiments of the catheter system have been described above, those skilled in the art will recognize certain modifications, permutations, additions and subcombinations thereof, and therefore, the following appended claims and claims introduced below are intended to be construed to include all such modifications, permutations, additions and subcombinations as are within their true spirit and scope, and are not intended to limit the details of construction or design shown herein.

Claims

1. 1. A catheter system for treating a treatment site within or adjacent to a blood vessel wall or a heart valve, comprising: A light source that generates a first light energy; a balloon positionable substantially adjacent the treatment site, the balloon having a balloon wall defining a balloon interior, the balloon interior receiving a balloon fluid; a light guide configured to receive first light energy at a guide proximal end and guide the first light energy in a first direction from the guide proximal end toward a guide distal end positioned within the balloon interior, the first light energy inducing generation of plasma within the balloon interior; an optical analyzer assembly configured to optically analyze second light energy from the light guide traveling in a second direction opposite to the first direction, the optical analyzer assembly including a safety shutdown system selectively activated to prevent the first light energy from the light source from being received by the guide proximal end of the light guide; A catheter system comprising:

2. 10. The catheter system of claim 1, further comprising a pulse generator coupled to the light source, the pulse generator configured to trigger the light source to generate a light source beam that is directed toward the light guide.

3. 3. The catheter system of claim 2, wherein the safety shutdown system includes a safety interlock selectively activated to prevent the pulse generator from triggering generation of the light source beam with the light source.

4. The catheter system of any one of claims 2 to 3, wherein the safety shutdown system includes a shutter that is selectively actuated to prevent the light source beam from being directed towards the light guide.

5. 2. The catheter system of claim 1, wherein the guide distal end includes a distal light receiver that receives the second light energy from within the balloon interior, the second light energy traveling through the light guide in the second direction.

6. 6. The catheter system of claim 5, wherein the second optical energy received by the distal optical receiver is emitted from a plasma generated in the balloon fluid within the balloon interior.

7. The catheter system of claim 5 , wherein the second light energy received by the distal light receiver is from ambient light near the guide distal end of the light guide.

8. The catheter system of any one of claims 5 to 7, wherein the second light energy received by the distal optical receiver is optically analyzed by the optical analyzer assembly.

9. 10. The catheter system of claim 8, wherein the optical analyzer assembly is configured to optically determine whether plasma generation has occurred within the balloon interior.

10. The catheter system of claim 8 , wherein the optical analyzer assembly is configured to optically detect faults in the light guide between the proximal guide end and the distal guide end.

11. The catheter system of claim 8 , wherein the optical analyzer assembly is configured to optically detect potential damage to the light guide between the proximal guide end and the distal guide end.

12. 10. The catheter system of claim 9, wherein the optical analyzer assembly is configured to selectively activate the safety shutdown system upon optical detection by the optical analyzer assembly of any one of: (i) failure to generate plasma within the balloon interior; (ii) failure of the light guide between the proximal guide end and the distal guide end; and (iii) potential damage to the light guide between the proximal guide end and the distal guide end.

13. 2. The catheter system of claim 1, wherein the second light energy is guided in the second direction back through the light guide toward the guide proximal end, and the optical analyzer assembly is configured to optically analyze the second light energy to determine whether plasma generation has occurred inside the balloon.

14. 14. The catheter system of claim 13, wherein the optical analyzer assembly includes a beam splitter and a photodetector, the beam splitter configured to receive the second optical energy and direct a portion of the second optical energy to the photodetector.

15. 15. The catheter system of claim 14, wherein the optical analyzer assembly further comprises an optical element positioned along a beam path between the beam splitter and the photodetector, the optical element configured to couple the portion of the second light energy to the photodetector.

16. 16. The catheter system of claim 15, wherein the optical analyzer assembly further includes a second beam splitter positioned along the beam path between the beam splitter and the optical detector, the second beam splitter configured to receive the second optical energy and direct at least a portion of the portion of the second optical energy to the optical detector.

17. The catheter system of any one of claims 14 to 16, wherein the optical detector generates a signal based at least in part on visible light contained in the portion of the second optical energy.

18. 18. The catheter system of claim 17, wherein the signal from the photodetector is amplified with an amplifier to provide an amplified signal that is directed to control electronics to determine an intensity of the plasma generation within the balloon interior.

19. 20. The catheter system of claim 18, wherein the control electronics is configured to analyze the amplified signal to detect one or more of: (i) whether plasma generation has occurred within the balloon interior, (ii) potential failure of the light guide between the proximal guide end and the distal guide end, and (iii) potential damage to the light guide between the proximal guide end and the distal guide end.

20. A catheter system for treating a treatment site within or adjacent to a vascular wall or a heart valve, comprising: A light source that generates a first light energy; a balloon positionable substantially adjacent the treatment site, the balloon having a balloon wall defining a balloon interior, the balloon interior receiving a balloon fluid; a light guide configured to receive first light energy at a guide proximal end and guide the first light energy in a first direction from the guide proximal end toward a guide distal end positioned within the balloon interior; an optical analyzer assembly configured to optically analyze second light energy from the light guide traveling in a second direction opposite to the first direction, the optical analyzer configured to optically analyze the second light energy to detect an operating condition of the catheter system, the optical analyzer configured to optically analyze the second light energy to detect at least one of: (i) a normal operating condition; (ii) an intermittent air bubble condition; (iii) a guide distal end plasma initiation condition; (iv) a plasma failure condition; (v) a light guide broken condition; and (vi) a chewback condition; A catheter system comprising:

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