Routing assembly for an intravascular lithotripsy catheter system

Abstract

A catheter system 100 for treating a treatment site 106 within or adjacent to a vessel wall 108A of a vessel 108 within a body 107 of a patient 109 includes a first energy guide 222A, a second energy guide 222A, and a routing assembly 280. The routing assembly 280 defines a routing space 282 that holds a routing length 222L of each energy guide 222A. The routing assembly 280 includes an inner routing guide 287 disposed within the routing space 282. The routing length 222L of each energy guide 222A is disposed at least partially around the inner routing guide 287. The routing space 282 is configured such that the routing length 222L of at least one of the energy guides 222A is adjustable.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to and incorporates by reference in its entirety the contents of U.S. Provisional Patent Application No. 63 / 392,342, filed on July 26, 2022, entitled "ROUTING ASSEMBLY FOR USE IN INTRAVASCULAR LITHOTRIPSY CATHETER SYSTEM", U.S. Provisional Patent Application No. 63 / 395,853, filed on August 7, 2022, entitled "OPTOELECTRICAL CONNECTOR FOR INTRAVASCULAR LITHOTRIPSY DEVICE", and U.S. Patent Application No. 18 / 357,947, filed on July 24, 2023, entitled "ROUTING ASSEMBLY FOR INTRAVASCULAR LITHOTRIPSY CATHETER SYSTEM". To the extent permitted, the contents of U.S. Provisional Patent Application Nos. 63 / 392,342, 63 / 395,853, and U.S. Patent Application No. 18 / 357,947 are hereby incorporated by reference in their entirety into this specification.

Background Art

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

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

[0004] Intravascular lithotripsy is a method that has been used in recent years with some success to destroy vascular lesions within blood vessels in the body. Intravascular lithotripsy utilizes a combination of pressure waves and bubble dynamics generated within a fluid-filled balloon catheter within a blood vessel. In particular, during an intravascular lithotripsy treatment, a high-energy source is used to generate plasma within the fluid-filled balloon and ultimately pressure waves and rapid bubble expansion to destroy calcifications at a treatment site within a vascular system containing one or more vascular lesions. The plasma initiation within the balloon and the associated rapid bubble formation from the resulting local flow rate transmit mechanical energy through an incompressible fluid and impart a destructive force to intravascular calcium facing the balloon wall. The rapid change in fluid momentum when it collides with the balloon wall is known as hydraulic shock, or water hammer.

[0005] There is a continuing desire to enhance the optimization of vascular patency and treatment delivery parameters within an intravascular lithotripsy catheter system in a form that is relatively easy to control and can be consistently manufactured.

Summary of the Invention

Means for Solving the Problems

[0006] The present invention is directed to a catheter system for treating a treatment site within or adjacent to a blood vessel wall or heart valve within a patient's body. In various embodiments, the catheter system includes a first energy guide, a second energy guide, and a routing assembly. The routing assembly defines a routing space that holds the routing length of each energy guide. The routing assembly includes an inner routing guide disposed within the routing space. The routing length of each energy guide is disposed at least partially around the inner routing guide. The routing space is configured such that the routing length of at least one of the energy guides is adjustable.

[0007] In one embodiment, each energy guide includes an optical fiber.

[0008] In various embodiments, each energy guide includes a guide distal end and a guide proximal end.

[0009] In some embodiments, the guide proximal end is fixed relative to the routing assembly.

[0010] In one embodiment, the guide distal end is movable relative to the routing assembly.

[0011] In various embodiments, each energy guide is disposed at least substantially 90 degrees around the inner routing guide.

[0012] In some embodiments, the catheter system further includes an adapter assembly that houses the inner routing guide.

[0013] In one embodiment, the catheter system further includes an electrical cable disposed around the inner routing guide.

[0014] In various embodiments, each energy guide includes an optical guide that protects each energy guide.

[0015] In some embodiments, the catheter system further includes a handle assembly that can be used by a user to selectively position the energy guide near a treatment site, and the routing assembly is disposed outside the handle assembly.

[0016] In one embodiment, the catheter system further includes a connector assembly that brings each energy guide closer together and groups them so that the energy guides are in a more compact form, and the routing assembly is disposed within the connector assembly.

[0017] The present invention is also directed to a catheter system for treating a treatment site within or adjacent to a blood vessel wall or a heart valve within a patient's body. In various embodiments, the catheter system includes a first energy guide, a second energy guide, a handle assembly, and a routing assembly. The handle assembly is usable by a user to selectively position the energy guides near the treatment site. The routing assembly defines a routing space for holding the routing length of each energy guide. The routing assembly is disposed outside the handle assembly. The routing assembly includes an inner routing guide disposed within the routing space. The routing length of each energy guide is disposed at least partially around the inner routing guide. The routing space is configured such that the routing length of at least one of the energy guides is adjustable.

[0018] In some embodiments, the catheter system further includes a connector assembly that brings the respective energy guides closer together and groups them in a more compact form, and the routing assembly is disposed within the connector assembly.

[0019] In various embodiments, each energy guide includes an optical fiber.

[0020] In one embodiment, each energy guide includes a guide distal end and a guide proximal end.

[0021] In some embodiments, the guide proximal end is fixed relative to the routing assembly.

[0022] In various embodiments, the guide distal end is movable relative to the routing assembly.

[0023] In one embodiment, each energy guide is disposed at least approximately 90 degrees around the inner routing guide.

[0024] In some embodiments, the catheter system further includes an adapter assembly that houses the inner routing guide.

[0025] The present invention is also directed to a catheter system for treating a treatment site within or adjacent to a blood vessel wall or a heart valve within a patient's body. In various embodiments, the catheter system includes a first energy guide, a second energy guide, a handle assembly, a connector assembly, and a routing assembly. The handle assembly is usable by a user to selectively position the energy guides near the treatment site. The connector assembly brings the respective energy guides closer together and groups them such that the energy guides are in a more compact form. The routing assembly defines a routing space that holds the routing length of each energy guide. The routing assembly is disposed outside the handle assembly. The routing assembly includes an inner routing guide disposed within the routing space. The routing length of each energy guide is disposed at least partially around the inner routing guide. The routing space is configured such that the routing length of at least one of the energy guides is adjustable. Each energy guide is disposed at least approximately 90 degrees around the inner routing guide.

[0026] This summary is a sketch of some of the teachings of the present application and is not intended to be an exclusive or comprehensive treatment of the subject matter. Further details are found in the detailed description and the appended claims. Other aspects will be apparent to those of ordinary skill in the art upon reading the following detailed description and viewing the drawings that form a part thereof, and each of the drawings should not be taken in a limiting sense. The scope herein is defined by the appended claims and their legal equivalents.

[0027] The novel features of the invention and the invention itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, wherein like reference numerals refer to like parts, and in which:

Brief Description of the Drawings

[0028]

Figure 1

Figure 2A

Figure 2B

Figure 3

Figure 4A

Figure 4B

Figure 4C

Figure 5

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Embodiments of the present invention can permit various modifications and alternative forms, and details thereof are shown by way of example and in the drawings and are described in detail herein. However, the scope herein is understood not to be limited to the specific embodiments described. On the contrary, the invention covers modifications, equivalents, and alternatives that are included within the spirit and scope herein.

[0030] Treatment of a vascular lesion can reduce major adverse events or death in an affected subject. As used herein, when referred to, a major adverse event can occur anywhere in the body due to the presence of a vascular lesion. Major adverse events can include, but are not limited to, major cardiac adverse events, major adverse events in the peripheral or central vascular system, major adverse events in the brain, major adverse events in muscle tissue, or major adverse events in any of the internal organs.

[0031] As used herein, the terms “treatment site,” “intravascular lesion,” and “vascular lesion” are used interchangeably unless otherwise specified. Thereby, an intravascular lesion and / or a vascular lesion are sometimes simply referred to as “lesion” herein.

[0032] Those skilled in the art will understand that the following detailed description of the invention is by way of example only and is not intended to be limiting in any way. Other embodiments of the invention will readily suggest themselves to those skilled in the art having the benefit of this disclosure. Here, reference is made in detail to the embodiments of the invention shown in the accompanying drawings. The same or similar terminology and / or reference numerals are used throughout the drawings and the following detailed description to refer to the same or similar parts.

[0033] For clarity, not all of the conventional features of the embodiments described herein are shown and described. In the development of any such actual implementation, numerous specific decisions must be made in the embodiments to achieve the developer's particular purposes, such as compliance with application-related and business-related constraints, which will be recognized as different for each implementation and for each developer. Further, such development efforts can be complex and time-consuming, but nonetheless will be recognized as routine engineering matters for those of ordinary skill in the art having the benefit of this disclosure.

[0034] The catheter systems disclosed herein can include many different forms. Referring now to FIG. 1, a simplified schematic cross-sectional view of a catheter system 100 according to various embodiments is shown. The catheter system 100 is suitable for delivering a pressure wave to induce fragmentation at one or more vascular lesions within the vessel wall of a blood vessel within a patient's body, adjacent to the vessel wall, at a heart valve, or adjacent to a heart valve. In the embodiment shown in FIG. 1, the catheter system 100 can include one or more of a catheter 102, an energy guide bundle 122 including one or more energy guides 122A, a fluid pump 138, a system console 123 including one or more of an energy source 124, a power source 125, a system controller 126, and a graphic user interface 127 (the "GUI"), and a handle assembly 128 including an integrated source manifold 136. Alternatively, the catheter system 100 can include more or fewer components than specifically illustrated and described with respect to FIG. 1.

[0035] The catheter 102 is configured to move to a treatment site 106 within or adjacent to the vessel wall 108A of a blood vessel 108 within the body 107 of a patient 109. The treatment site 106 can include one or more vascular lesions 106A, such as, for example, a calcified vascular lesion. Additionally or alternatively, the treatment site 106 can include a vascular lesion 106A, such as a fibro-vascular lesion. Further alternatively, in some embodiments, the catheter 102 can be used at a treatment site 106 within or adjacent to a heart valve within the body 107 of the patient 109.

[0036] The catheter 102 can include an inflatable balloon 104 (sometimes simply referred to herein as a "balloon"), a catheter shaft 110, and a guide wire 112. The balloon 104 can be coupled to the catheter shaft 110. The balloon 104 can include a balloon proximal end 104P and a balloon distal end 104D. The catheter shaft 110 can 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 can include a longitudinal axis 144. The catheter 102 and / or the catheter shaft 110 can also include a guide wire lumen 118 configured to move over the guide wire 112. As used herein, the guide wire lumen 118 defines a conduit through which the guide wire 112 extends. The catheter shaft 110 can 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, and the catheter 102 can accommodate and follow the guide wire 112 when the catheter 102 is moved and positioned near or at 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 guide wire lumen 118.

[0037] Balloon 104 includes a balloon wall portion 130 that defines a balloon interior 146. Balloon 104 can be selectively inflated by a catheter fluid 132 so as to expand from a contracted state suitable for advancing catheter 102 through a patient's vasculature to an inflated state (shown in FIG. 1) suitable for fixing catheter 102 in a predetermined position relative to a treatment site 106. In other words, when balloon 104 is in the inflated state, the balloon wall portion 130 of balloon 104 is configured to be disposed substantially adjacent to treatment site 106. FIG. 1 shows the balloon wall portion 130 of balloon 104 shown spaced from treatment site 106 of blood vessel 108 when in the inflated state, but it should be recognized that this is done for ease of illustration. It should be recognized that the balloon wall portion 130 of balloon 104 generally is substantially directly adjacent to and / or adjacent to treatment site 106 when balloon 104 is in the inflated state.

[0038] Balloons 104 suitable for use in catheter system 100 include those that can be passed through a patient 109's vasculature when in the inflated state. In some embodiments, balloon 104 is formed from silicone. In other embodiments, balloon 104 can be formed from a polymer such as polydimethylsiloxane (PDMS), polyurethane, PEBAX™ material, a material such as nylon, or any other suitable material.

[0039] Balloon 104 can have any suitable diameter (in the inflated state). In various embodiments, balloon 104 can have a diameter (in the inflated state) in the range from less than 1 millimeter (mm) to 25 mm. In some embodiments, balloon 104 can have a diameter (in the inflated state) in the range from at least 1.5 mm to 14 mm. In some embodiments, balloon 104 can have a diameter (in the inflated state) in the range from at least 2 mm to 5 mm.

[0040] In some embodiments, balloon 104 can have a length ranging from at least 3 mm to 300 mm. More specifically, in some embodiments, balloon 104 can have a length ranging from at least 8 mm to 200 mm. It should be appreciated that a balloon 104 having a relatively long length can be positioned adjacent to a larger treatment site 106 and can thus be used to provide a pressure wave and induce disruption at a precise location within treatment site 106 to a larger vascular lesion 106A or a plurality of vascular lesions 106A. Further, it should be appreciated that a longer balloon 104 can also be positioned adjacent to multiple treatment sites 106 at any given time.

[0041] Balloon 104 can be inflated to an inflation pressure of about 1 atmosphere (atm) to 70 atm. In some embodiments, balloon 104 can be inflated to an inflation pressure of at least 20 atm to 60 atm. In other embodiments, balloon 104 can be inflated to an inflation pressure of at least 6 atm to 20 atm. In yet other embodiments, balloon 104 can be inflated to an inflation pressure of at least 3 atm to 20 atm. In yet other embodiments, balloon 104 can be inflated to an inflation pressure of at least 2 atm to 10 atm.

[0042] Balloon 104 can have various shapes including, but not limited to, conical, square, rectangular, spherical, conical / square, conical / spherical, elongated spherical, elliptical, tapered, bone-shaped, stepped diameter, offset, or conical offset shapes. In some embodiments, 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, but not limited to, anti-inflammatory agents, anti-tumor agents, angiogenesis inhibitors, and the like.

[0043] The catheter fluid 132 can be a liquid or a gas. Some examples of catheter fluids 132 suitable for use can include, but are not limited to, water, saline, contrast agents, fluorocarbons, perfluorocarbons, gases such as carbon dioxide, or one or more of any other suitable catheter fluids 132. In some embodiments, the catheter fluid 132 can be used as a base inflation fluid. In some embodiments, the catheter fluid 132 can include a mixture of saline to contrast agent at a volume ratio of about 50:50. In other embodiments, the catheter fluid 132 can include a mixture of saline to contrast agent at a volume ratio of about 25:75. In still other embodiments, the catheter fluid 132 can include a mixture of saline to contrast agent at a volume ratio of about 75:25. However, it should be understood that any suitable ratio of saline to contrast agent can be used. The catheter fluid 132 can be adjusted based on composition, viscosity, etc. such that the propagation speed of the pressure wave is appropriately manipulated. In one embodiment, the catheter fluid 132 suitable for use is biocompatible. The volume of the catheter fluid 132 can be adjusted by the selected energy source 124 and the type of catheter fluid 132 used.

[0044] In some embodiments, the contrast agent used in the contrast medium can include, but is not limited to, iodine contrast agents such as ionic or non-ionic iodine contrast agents. Some non-limiting examples of ionic iodine contrast agents include diatrizoic acid, metrizoic acid, iotalamic acid, and ioxaglic acid. Some non-limiting examples of non-ionic iodine contrast agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine contrast agents can be used. Suitable non-iodine-containing contrast agents can include gadolinium(III) contrast agents. Suitable fluorocarbons and perfluorocarbon agents can include, but are not limited to, agents such as perfluorocarbon dodecafluoropentane (DDFP, C5F12).

[0045] The catheter fluid 132 can include those containing an absorbent that can selectively absorb light in the ultraviolet region (e.g., at least 10 nanometers (nm) to 400 nm), visible region (e.g., at least 400 nm to 780 nm), or near-infrared region (e.g., at least 780 nm to 2.5 μm) of the electromagnetic spectrum. Suitable absorbents can include those having an absorption maximum along the spectrum of at least 10 nm to 2.5 μm. Alternatively, the catheter fluid 132 can include those containing an absorbent that can selectively absorb light in the mid-infrared region (e.g., at least 2.5 μm to 15 μm) or far-infrared region (at least 15 μm to 1 mm) of the electromagnetic spectrum. In various embodiments, the absorbent can be one having an absorption maximum that coincides with the emission maximum of the laser used in the catheter system 100. As non-limiting examples, various lasers that can be used in the catheter system 100 can 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 absorbent can be water-soluble. In other embodiments, the absorbent is water-insoluble. In some embodiments, the absorbent used in the catheter fluid 132 can be adjusted to coincide with the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths of at least 10 nanometers to 1 millimeter are described elsewhere herein.

[0046] The catheter shaft 110 of the catheter 102 can be coupled to one or more energy guides 122A of an energy guide bundle 122 that optically communicates with an energy source 124. The energy guides 122A can be disposed within the balloon 104 along the catheter shaft 110. In some embodiments, each energy guide 122A can be an optical fiber and the energy source 124 can be a laser. The energy source 124 can optically communicate with the energy guides 122A at the proximal portion 114 of the catheter system 100.

[0047] In some embodiments, the catheter shaft 110 can be coupled to a number of energy guides 122A, such as a first energy guide, a second energy guide, a third energy guide, etc., that can be disposed around and / or in any suitable position relative to the guidewire lumen 118 and / or the catheter shaft 110. For example, in one non-exclusive embodiment, two energy guides 122A can be spaced apart by approximately 180 degrees along the outer periphery of the guidewire lumen 118 and / or the catheter shaft 110; three energy guides 122A can be spaced apart by approximately 120 degrees along the outer periphery of the guidewire lumen 118 and / or the catheter shaft 110; four energy guides 122A can be spaced apart by approximately 90 degrees along the outer periphery of the guidewire lumen 118 and / or the catheter shaft 110; six energy guides 122A can be spaced apart by approximately 60 degrees along the outer periphery of the guidewire lumen 118 and / or the catheter shaft 110; eight energy guides 122A can be spaced apart by approximately 45 degrees along the outer periphery of the guidewire lumen 118 and / or the catheter shaft 110; ten energy guides 122A can be spaced apart by approximately 36 degrees along the outer periphery of the guidewire lumen 118 and / or the catheter shaft 110. Additionally or alternatively, the number of energy guides 122A need not be equally spaced from each other along the outer periphery of the guidewire lumen 118 and / or the catheter shaft 110. More specifically, it should be further recognized that the energy guides 122A can be disposed evenly or unevenly around the guidewire lumen 118 and / or the catheter shaft 110 to achieve a desired effect at a desired location.

[0048] The catheter system 100 and / or the energy guide bundle 122 can include any number of energy guides 122A that optically communicate with the energy source 124 at the proximal portion 114 and also with the catheter fluid 132 within the balloon interior 146 of the balloon 104 at the distal portion 116. For example, in some embodiments, the catheter system 100 and / or the energy guide bundle 122 can include from one energy guide 122A to more than 30 energy guides 122A. Alternatively, in other embodiments, the catheter system 100 and / or the energy guide bundle 122 can include more than 30 energy guides 122A.

[0049] The energy guide 122A can have any suitable design for generating plasma and / or pressure waves in the catheter fluid 132 within the balloon interior 146. Thus, a general description of the energy guide 122A as a light guide is not intended to be limiting in any way except as set forth in the claims appended hereto. More specifically, the catheter system 100 is often described with respect to an energy source 124 as a light source and one or more energy guides 122A as light guides, but the catheter system 100 can alternatively include any suitable energy source 124 and energy guide 122A for generating a desired plasma in the catheter fluid 132 within the balloon interior 146. For example, in one non-exclusive alternative embodiment, the energy source 124 can be configured to provide high voltage pulses, and each energy guide 122A can include an electrode pair including spaced-apart electrodes extending into the balloon interior 146. In such an embodiment, each high voltage pulse is applied to the electrodes, forming an electrical arc therebetween, which in turn generates a plasma and forms a pressure wave in the catheter fluid 132, and this pressure wave is utilized to provide a crushing force to the vascular lesion 106A at the treatment site 106. Further alternatively, the energy source 124 and / or the energy guide 122A can have another suitable design and / or configuration.

[0050] In one embodiment, the energy guide 122A can include an optical fiber or a flexible light pipe. The energy guide 122A can be thin and flexible and can transmit an optical signal with very little loss of intensity. The energy guide 122A can include a core surrounded by cladding along its outer perimeter. In some embodiments, the core can be a cylindrical core or a partially cylindrical core. The core and cladding of the energy guide 122A can be formed from one or more materials including, but not limited to, one or more types of glass, silica, or one or more polymers. The energy guide 122A can also include a protective coating such as a polymer. It should be appreciated that the refractive index of the core is greater than the refractive index of the cladding.

[0051] Each energy guide 122A can guide energy along its length from a guide proximal end 122P to a guide distal end 122D having at least one optical window (not shown) disposed within the balloon interior 146.

[0052] The energy guide 122A can be configured in many ways around and / or with respect to the catheter shaft 110 of the catheter 102. In some embodiments, the energy guide 122A can extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the energy guide 122A can be disposed along the length of the outer diameter of the catheter shaft 110. In still other embodiments, the energy guide 122A can be disposed within one or more energy guide lumens within the catheter shaft 110.

[0053] The energy guide 122A can also be disposed at any suitable position along the outer periphery of the guide wire lumen 118 and / or the catheter shaft 110, and the guide distal end 122D of each energy guide 122A can be disposed at any suitable longitudinal position with respect to the length of the balloon 104 and / or with respect to the length of the guide wire lumen 118 for more effectively and accurately providing a pressure wave for the purpose of destroying the vascular lesion 106A at the treatment site 106.

[0054] In certain embodiments, the energy guide 122A can include one or more photoacoustic transducers 154, and each photoacoustic transducer 154 can be in optical communication with the energy guide 122A in which the photoacoustic transducer 154 is disposed. In some embodiments, the photoacoustic transducer 154 can be in optical communication with the guide distal end 122D of the energy guide 122A. In such embodiments, the photoacoustic transducer 154 can have a shape corresponding to and / or matching the guide distal end 122D of the energy guide 122A.

[0055] The photoacoustic transducer 154 is configured to convert optical energy into sound waves at or near the guide distal end 122D of the energy guide 122A. The direction of the sound waves can be adjusted by changing the angle of the guide distal end 122D of the energy guide 122A.

[0056] In certain embodiments, the photoacoustic transducer 154 disposed at the guide distal end 122D of the energy guide 122A can have the same shape as the guide distal end 122D of the energy guide 122A. For example, in one non-exclusive embodiment, the photoacoustic transducer 154 and / or the guide distal end 122D can have a conical, convex, concave, bulbous, square, stepped, semi-circular, oval shape, etc. The energy guide 122A can further include additional photoacoustic transducers 154 disposed along one or more sides of the length of the energy guide 122A.

[0057] In some embodiments, the energy guide 122A can further include one or more diverting features or "diverters" (not shown in FIG. 1) configured to direct energy from the energy guide 122A toward a side surface that can be disposed at or near the guide distal end 122D of the energy guide 122A before the energy is directed toward the balloon wall portion 130. The diverting feature can include any feature of a system that diverts energy from the energy guide 122A away from its axial path and toward the side surface of the energy guide 122A. Each energy guide 122A can include one or more optical windows disposed along the longitudinal or circumferential surface of each energy guide 122A and in optical communication with the diverting feature. In other words, the diverting feature can be configured to direct energy in the energy guide 122A toward a side surface at or near the guide distal end 122D, and the side surface is in optical communication with the optical window. The optical window can include a portion of the energy guide 122A that allows energy to exit the energy guide 122A from within the energy guide 122A, such as a portion of the energy guide 122A that lacks cladding material on or around the energy guide 122A.

[0058] Examples of suitable diverting features include reflective elements, refractive elements, and fiber diffusers. Diverting features suitable for converging energy away from the tip of the energy guide 122A can include, but are not limited to, those having convex surfaces, gradient index (GRIN) lenses, and mirror focus lenses. When in contact with the diverting feature, the energy is diverted within the energy guide 122A to one or more of the plasma generator 133 and the photoacoustic transducer 154 that optically communicates with the side of the energy guide 122A. When used, the photoacoustic transducer 154 then converts the optical energy into sound waves that extend away from the side of the energy guide 122A.

[0059] As described above, in the embodiment shown in FIG. 1, the system console 123 includes one or more of an energy source 124, a power supply 125, a system controller 126, and a GUI 127. Alternatively, the system console 123 can include more or fewer components than specifically shown in FIG. 1. For example, in one non-exclusive alternative embodiment, the system console 123 can be designed without a GUI 127. Further alternatively, one or more of the energy source 124, the power supply 125, the system controller 126, and the GUI 127 can be provided at any suitable location within the catheter system 100 without the specific requirements of the system console 123.

[0060] As shown, system console 123 and the components included therewith are operably coupled to catheter 102, energy guide bundle 122, and the remainder of catheter system 100. For example, in some embodiments, as shown in FIG. 1, system console 123 can include a console connection aperture 148 (sometimes also commonly referred to as a “socket”), whereby energy guide bundle 122 is mechanically coupled to system console 123. In such embodiments, energy guide bundle 122 can include a guide coupling housing 150 (sometimes also commonly referred to as a “ferrule”) that houses portions of each energy guide 122A, such as guide proximal end 122P. Guide coupling housing 150 is configured to fit within and be selectively retained within console connection aperture 148 to provide a mechanical coupling between energy guide bundle 122 and system console 123.

[0061] Energy guide bundle 122 can also include a connector assembly 152 (or “shell”) that connects each individual energy guide 122A to system console 123.

[0062] Energy source 124 can be selectively and / or alternatively coupled to communicate with each energy guide 122A in energy guide bundle 122, such as at guide proximal end 122P of each energy guide 122A. In particular, energy source 124 is configured to generate energy in the form of a source beam 124A, such as a pulsed source beam, that can be selectively and / or alternatively directed and received by each energy guide 122A in energy guide bundle 122 as individual guide beams 124B. Alternatively, catheter system 100 can include more than one energy source 124. For example, in one non-exclusive alternative embodiment, catheter system 100 can include a separate energy source 124 for each energy guide 122A in energy guide bundle 122.

[0063] The energy source 124 can have any suitable design. In one embodiment, the energy source 124 can be configured to provide a sub-millisecond pulse of energy from the energy source 124 that is focused to a small spot for coupling to the guide proximal end 122P of the energy guide 122A. Such a pulse of energy is then directed and / or guided along the energy guide 122A to a location within the balloon interior 146 of the balloon 104, whereby plasma formation is induced in the catheter fluid 132 within the balloon interior 146 of the balloon 104 via, for example, a plasma generator 133 that can be disposed at or near the guide distal end 122D of the energy guide 122A. In particular, in such an embodiment, the energy emitted at the guide distal end 122D of the energy guide 122A is directed toward the plasma generator 133 to form plasma in the catheter fluid 132 within the balloon interior 146 and excite the plasma generator 133. Plasma formation results in rapid bubble formation and provides a pressure wave to the treatment site 106. Exemplary plasma-induced bubbles 134 are shown in FIG. 1.

[0064] In various non-exclusive alternative embodiments, the sub-millisecond pulse of energy from the energy source 124 can be delivered to the treatment site 106 at a frequency of about 1 Hertz (Hz) to 5000 Hz, about 30 Hz to 1000 Hz, about 10 Hz to 100 Hz, or about 1 Hz to 30 Hz. Alternatively, the sub-millisecond pulse of energy can be delivered to the treatment site 106 at a frequency greater than 5000 Hz or less than 1 Hz, or any other suitable range of frequencies.

[0065] Although the energy source 124 is generally utilized to provide a pulse of energy, it should be appreciated that the energy source 124 can be further described as providing one source beam 124A, i.e., one pulsed source beam.

[0066] An energy source 124 suitable for use can include various types of light sources including lasers and lamps. Alternatively, the energy source 124 can include any suitable type of energy source.

[0067] Suitable lasers can include short pulse lasers on the sub-millisecond time scale. In some embodiments, the energy source 124 can include a laser on the nanosecond (ns) time scale. Lasers can also include short pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (μs) time scales. It should be recognized that there are many combinations of laser wavelengths, pulse widths, and energy levels that can be used to obtain plasma in the catheter fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse width can include those included in a range including at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range can be used.

[0068] Exemplary nanosecond lasers can include those within the spectrum from UV to IR over a wavelength of about 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, the energy source 124 suitable for use in the catheter system 100 can include those capable of generating light at a wavelength of at least 750 nm to 2000 nm. In other embodiments, the energy source 124 can include those capable of generating light at a wavelength of at least 700 nm to 3000 nm. In still other embodiments, the energy source 124 can include those capable of generating light at a wavelength of at least 100 nm to 10 micrometers (μm). Nanosecond lasers can include those having a repetition rate of up to 200 kHz.

[0069] In some embodiments, the laser can include a Q-switched thulium:yttrium-aluminum-garnet (Tm:YAG) laser. In other embodiments, the laser can include a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser, a holmium:yttrium-aluminum-garnet (Ho:YAG) laser, an erbium:yttrium-aluminum-garnet (Er:YAG) laser, an excimer laser, a helium neon laser, a carbon dioxide laser, and a doped, pulsed, fiber laser.

[0070] In still other embodiments, the energy source 124 can include a plurality of lasers grouped in series. In still other embodiments, the energy source 124 can include one or more low-energy lasers supplied to a high-energy amplifier, such as a master oscillator power amplifier (MOPA). In still other embodiments, the energy source 124 can include a plurality of lasers that can be combined in parallel or in series to provide the energy required to generate plasma bubbles 134 in the catheter fluid 132.

[0071] The catheter system 100 can generate a pressure wave 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 energy source 124, the absorbent 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 a pressure wave 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.

[0072] The pressure wave can be provided to the treatment site 106 from a distance within a range of at least about 0.1 millimeter (mm) to more than about 25 mm that extends radially from the energy guide 122A when the catheter 102 is disposed at the treatment site 106. In various non-exclusive alternative embodiments, the pressure wave can be provided to the treatment site 106 from a distance within a range of at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm that extends radially from the energy guide 122A when the catheter 102 is disposed at the treatment site 106. In other embodiments, the pressure wave can be provided to the treatment site 106 from another suitable distance different from the foregoing ranges. In some embodiments, the pressure wave can be provided to the treatment site 106 within 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, the pressure wave can be provided to the treatment site 106 from a range of at least about 2 MPa to 25 MPa at a distance of at least about 0.1 mm to 10 mm. Additionally, alternatively, other suitable pressure ranges and distances can be used.

[0073] The power supply 125 is electrically coupled to each of the energy source 124, the system controller 126, the GUI 127, and the handle assembly 128 and is configured to provide the necessary power thereto. The power supply 125 can have any suitable design for such purposes.

[0074] The system controller 126 is electrically coupled to the power supply 125 and receives power from the power supply 125. The system controller 126 is coupled to each of the energy source 124 and the GUI 127 and is configured to control their operations. The system controller 126 can include one or more processors or circuits for controlling at least the operations of the energy source 124 and the GUI 127. For example, the system controller 126 can control the energy source 124 to generate energy pulses as needed and / or at any desired firing rate.

[0075] The system controller 126 can also be configured to control the operations of other components of the catheter system 100, such as the placement of the catheter 102 adjacent to the treatment site 106, the inflation of the balloon 104 with the catheter fluid 132, etc. Further, or in the alternative, the catheter system 100 can include one or more additional controllers that can be arranged in any suitable form for controlling the various operations of the catheter system 100. For example, in one embodiment, the additional controller and / or a portion of the system controller 126 can be arranged within and / or incorporated within the handle assembly 128.

[0076] The GUI 127 is accessible by a user or operator of the catheter system 100. The GUI 127 is electrically connected to the system console 126. With such a design, the GUI 127 can be used by the user or operator to ensure that the catheter system 100 is effectively utilized to apply pressure to the vascular lesion 106A at the treatment site 106 and induce fragmentation within the vascular lesion 106A. The GUI 127 can provide information that can be used by the user or operator before, during, and after the 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, such as video data or any other data that changes over time during the use of the catheter system 100, to the user or operator. In various embodiments, the GUI 127 can include one or more colors, different sizes, changing brightness, etc., that can act 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 can vary according to the design requirements of the catheter system 100, or the specific needs, specifications, and / or requirements of the user or operator.

[0077] As shown in FIG. 1, the handle assembly 128 can be disposed proximal to or near the proximal portion 114 of the catheter system 100. In this embodiment, the handle assembly 128 is coupled to the balloon 104 and is spaced from the balloon 104. Alternatively, the handle assembly 128 can be disposed at another suitable location.

[0078] The handle assembly 128 is attached to the catheter shaft 110 and is handled and used by a user or operator to manipulate, position, and control the catheter 102. The design and specific features of the handle assembly 128 can vary to conform to 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 communication and / or fluid communication with, one or more of the system controller 126, the energy source 124, the fluid pump 138, and the GUI 127.

[0079] 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 one such embodiment, the handle assembly 128 can include a circuit 156 that is electrically coupled between the catheter electronics and the system console 123 and can form at least a portion of the system controller 126. In one embodiment, the circuit 156 can include a printed circuit board having one or more integrated circuits or any other suitable circuitry. In an alternative embodiment, the circuit 156 can be omitted or can be included within the system controller 126, which can be disposed outside the handle assembly 128, such as within the system console 123 in various embodiments. It is understood that the handle assembly 128 can include fewer or additional components than those specifically shown and described herein.

[0080] Further, an energy-activating member 157, such as an energy-activating button, which can be coupled to a circuit 156 within a handle assembly 128 forming part of the system controller 126 (and which may in some cases be simply referred to herein as an "energy activator"), is included with the handle assembly 128. The energy activator 157 is configured to enable a user or operator to selectively activate the catheter system 100 as needed.

[0081] In various embodiments, as described above, the source manifold 136 can be integrated within and / or incorporated into the handle assembly 128 and can be disposed at or near the proximal portion 114 of the catheter system 100. As shown, the source manifold 136 can include an inflation conduit 140 fluidly coupled in communication with a fluid pump 138, a guide wire 112 and / or a guide wire lumen 118, one or more energy guides 122A of the energy guide bundle 122, and / or one or more openings capable of accommodating the catheter shaft 110. More specifically, the source manifold 136 can include one or more of a media inflation port 158, a guide wire lumen port 160, an energy guide port 162, and a catheter shaft port 164.

[0082] The catheter system 100 can also include a fluid pump 138 configured to inflate the balloon 104 with the catheter fluid 132 as needed.

[0083] Various embodiments of the source manifold 136 and the specific components included therein are illustrated and described in detail hereinafter in the following drawings.

[0084] As in all of the embodiments shown and described herein, various structures may be omitted from the drawings for clarity and ease of understanding. Further, the drawings may include structures that can be omitted without departing from the spirit and scope of the invention.

[0085] FIG. 2A is a simplified schematic diagram of a portion of an embodiment of a catheter system 200 including a handle assembly 228, a connector assembly 252, and an adapter assembly 285. In all embodiments, each of the handle assembly 228, the connector assembly 252, and the adapter assembly 285 is separated from and / or excluded from one another. In other words, in all embodiments, the elements of the handle assembly 228, the connector assembly 252, and / or the adapter assembly 285 are mutually exclusive of one another.

[0086] The design of the handle assembly 228 and the various components held therein can be varied to conform to the requirements of the catheter system 200. As shown in some embodiments, the handle assembly 228 can include an assembly housing 266 that includes and / or defines an energy activator 257 and one or more of an inflation lumen inlet 268, a guidewire inlet 270, and a handle distal outlet 276. Alternatively, the handle assembly 228 can include more or fewer components than specifically shown and described herein, excluding the components of the connector assembly 252, the routing assembly 280, and / or the adapter assembly 285.

[0087] In some embodiments, the assembly housing 266 can be formed from two housing members 266A (only one of which is shown in FIG. 2A) formed as a first housing side and a second housing side that are selectively coupled to form the complete assembly housing 266.

[0088] The inflation lumen inlet 268 is configured to couple an inflation lumen 240 into the assembly housing 266.

[0089] The guide wire inlet 270 is configured to couple the guide wire 212 into the assembly housing 266.

[0090] The energy guide inlet 272 is configured to couple an energy guide bundle 122 including one or more energy guides 222A (shown in FIG. 2B) into the assembly housing 266.

[0091] The electrical inlet 274 is configured to couple the electrical cable 280 (shown in FIG. 2B) into the assembly housing 266.

[0092] It should be appreciated that in some embodiments, the energy guide inlet 272 and the electrical inlet 274 can be formed together into a single inlet. For example, in one embodiment, the energy guide 222A and the electrical cable 281 (shown in FIG. 2B) can be sheathed within an optical / electrical cable 278 as the energy guide 222A and the electrical cable 281 enter the assembly housing 266 through the energy guide inlet 272 and the electrical inlet 274, respectively. Alternatively, the energy guide inlet 272 and the electrical inlet 274 can be formed independently of each other.

[0093] The handle distal outlet 276 provides an outlet from the assembly housing 266 for each of those components as the inflation conduit 240, catheter shaft 210, guide wire 112 (shown in FIG. 1), guide wire lumen 118 (shown in the drawings), and energy guide 122A (shown in FIG. 1) extend toward the balloon 104 (shown in FIG. 1).

[0094] The optical guide 283 can guide the energy guide 222A from the connector assembly 252 to the routing assembly 280. The connector assembly 252 is spaced apart from, remotely located from, and / or completely separate from the handle assembly 228 and the adapter assembly 285.

[0095] The electrical guide 284 can guide the electrical cable 281 from the electrical connector 286 to the routing assembly 280.

[0096] In some embodiments, the adapter assembly 285 can house components of the routing assembly 280. The adapter assembly 285 can interconnect the optical / electrical cable 278, the optical guide 283, and / or the electrical guide 284. The adapter assembly 285 can include a housing distal end 285D (shown in FIG. 2B) and a housing proximal end 285P (shown in FIG. 2B). In some embodiments, the adapter assembly 285 can include a y-adapter. The adapter assembly 285 is spaced apart from, remotely located from, and / or completely separate from the handle assembly 228 and the connector assembly 252.

[0097] The electrical connector 286 can connect the electrical cable 281 and / or the electrical guide 284 to the handle assembly 228 and / or the adapter assembly 285. The electrical connector 286 can also be connected to an external power source (such as the energy source 124 shown in FIG. 1).

[0098] FIG. 2B is a simplified schematic cross-sectional view of an embodiment of the adapter assembly 285 in FIG. 2A including the routing assembly 280. As shown in FIG. 2B, the adapter assembly 285 can include the optical / electrical cable 278, the electrical cable 281, and the routing assembly 280 including the inner routing guide 287, the optical guide 283, and / or the electrical guide 284. The routing assembly 280, the energy guide 222A, the optical / electrical cable 278, the optical guide 283, the electrical guide 284, and / or the adapter assembly 285 shown in FIG. 2B may be somewhat similar to the embodiments shown and described herein.

[0099] The routing assembly 280 can be configured to reduce mechanical strain in the energy guide 222A and / or the electrical cable 281. The routing assembly 280 can route the energy guide 222A and / or the electrical cable 281 in any suitable direction through the catheter system 200. The details of the routing assembly 280 can vary according to the design requirements of the catheter system 200 or the specific needs, specifications, and / or requirements of the user or operator. It should be appreciated that the routing assembly 280 can include additional or fewer elements than those shown in FIG. 2B. The routing assembly 280 can be disposed at any suitable location within the catheter system 100.

[0100] In all embodiments, the routing assembly 280 is spaced from and / or outside of the handle assembly 228. The optical / electrical cable 278 can be coupled between the routing assembly 280 and the handle assembly 228. The guide distal end 122D (shown in FIG. 1) and / or the guide proximal end 122P (shown in FIG. 1) can be secured to the routing assembly 280. In some embodiments, the guide distal end 122D is movable relative to the routing assembly 280.

[0101] The electrical cable 281 conducts power from the electrical connector 286 (shown in FIG. 2A) through the optical / electrical cable 278, the electrical guide 284, and the adapter assembly 285 to the handle assembly 228 (shown in FIG. 2A). The electrical cable 281 can connect the handle assembly 228 to any suitable power source, such as the energy source 124 shown in FIG. 1.

[0102] The routing assembly 280 can include a routing space 282. The routing space 282 defines a space for routing, positioning, and / or moving the energy guide 222A inside the routing assembly 280. The movement of the energy guide 222A through the catheter system 100 and / or the routing space 282 can create alternating periods of sag and tension in the energy guide 222A, which can cause axial and longitudinal movement of the guide and cable. Such movement can cause unwanted binding and / or twisting of the energy guide 222A of the catheter system 200 and can result in degradation of the energy guide 222A.

[0103] The routing space 282 holds the routing length 222L of each energy guide 222A. The routing length 222L includes the length of the energy guide 222A disposed within the routing space 282 during operation and use of the catheter system 200. The routing length 222L is a portion of the total length of the energy guide 222A. In the various embodiments shown in FIG. 2B, the routing length 222L is shown by a dashed line to indicate the routing length 222L inside the routing assembly 280. The routing space 282 can be configured such that the routing length 222L of at least one of the energy guides 222A is adjustable.

[0104] An inner routing guide 287 can be disposed in and / or within the routing space 282. The routing length 222L of each energy guide can be disposed around, about, and / or near the inner routing guide 287.

[0105] In one embodiment, the energy guide 222A can loop around the inner routing guide 287 by more than about 5 degrees and less than about 1080 degrees around the inner routing guide 287. The energy guide 222A can be centered around the inner routing guide at about 5 degrees, 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees, 85 degrees, 90 degrees, 95 degrees, 100 degrees, 105 degrees, 110 degrees, 115 degrees, 120 degrees, 125 degrees, 130 degrees, 135 degrees, 140 degrees, 145 degrees, 150 degrees, 155 degrees, 160 degrees, 165 degrees, 170 degrees, 175 degrees, 180 degrees, 185 degrees, 190 degrees, 195 degrees, 200 degrees, 205 degrees, 210 degrees, 215 degrees, 220 degrees, 225 degrees, 230 degrees, 235 degrees, 240 degrees, 245 degrees, 250 degrees, 255 degrees, 260 degrees, 265 degrees, 270 degrees, 275 degrees, 280 degrees, 285 degrees, 290 degrees, 295 degrees, 300 degrees, 305 degrees, 310 degrees, 315 degrees, 320 degrees, 325 degrees, 330 degrees, 335 degrees, 340 degrees, 345 degrees, 350 degrees, 355 degrees, 360 degrees, 365 degrees, 370 degrees, 375 degrees, 380 degrees, 385 degrees, 390 degrees, 395 degrees, 400 degrees, 405 degrees, 410 degrees, 415 degrees, 420 degrees, 425 degrees, 430 degrees, 435 degrees, 440 degrees, 445 degrees, 450 degrees, 455 degrees, 460 degrees, 465 degrees, 470 degrees, 475 degrees, 480 degrees, 485 degrees, 490 degrees, 495 degrees, 500 degrees, 505 degrees, 510 degrees, 515 degrees, 520 degrees, 525 degrees, 530 degrees, 535 degrees, 540 degrees, 545 degrees, 550 degrees, 555 degrees, 560 degrees, 565 degrees, 570 degrees, 575 degrees, 580 degrees, 585 degrees, 590 degrees, 595 degrees, 600 degrees, 605 degrees, 610 degrees, 615 degrees, 620 degrees, 625 degrees, 630 degrees, 635 degrees, 640 degrees, 645 degrees, 650 degrees, 655 degrees, 660 degrees, 665 degrees, 670 degrees, 675 degrees, 680 degrees, 685 degrees, 690 degrees, 695 degrees, 700 degrees, 705 degrees, 710 degrees, 715 degrees, 720 degrees, 725 degrees, 730 degrees, 735 degrees, 740 degrees, 745 degrees, 750 degrees, 755 degrees, 760 degrees, 765 degrees, 770 degrees, 775 degrees, 780 degrees, 785 degrees, 790 degrees, 795 degrees, 800 degrees, 805 degrees, 810 degrees, 815 degrees, 820 degrees, 825 degrees, 830 degrees, 835 degrees, 840 degrees, 845 degrees, 850 degrees, 855 degrees, 860 degrees, 865 degrees, 870 degrees, 875 degrees, 880 degrees, 885 degrees, 890 degrees,It can rotate by 895 degrees, 900 degrees, 905 degrees, 910 degrees, 915 degrees, 920 degrees, 925 degrees, 930 degrees, 935 degrees, 940 degrees, 945 degrees, 950 degrees, 955 degrees, 960 degrees, 965 degrees, 970 degrees, 975 degrees, 980 degrees, 985 degrees, 990 degrees, 995 degrees, 1000 degrees, 1005 degrees, 1010 degrees, 1015 degrees, 1020 degrees, 1025 degrees, 1030 degrees, 1035 degrees, 1040 degrees, 1045 degrees, 1050 degrees, 1055 degrees, 1060 degrees, 1065 degrees, 1070 degrees, 1075 degrees, or 1080 degrees. In various embodiments, the energy guide 222A can rotate less than about 5 degrees around the inner routing guide 287 and can rotate more than about 1080 degrees around the inner routing guide 287.,

[0106] The inner routing guide 282 can guide at least one of the movement and placement of the energy guide 222A within the routing assembly 280. The inner routing guide 287 can reduce mechanical strain in the energy guide 222A, various cables, guides, and / or other components within the routing assembly 280. As shown in FIG. 2B, the routing space 282 includes the routing length 222L of the energy guide 222A to reduce mechanical strain and / or mechanical forces that can affect the routing length 222L of the energy guide 222A.,

[0107] The adapter assembly 285 can cooperate with the routing space 282 so that a user can repair the energy guide 222A. For example, the adapter assembly 285 can be at least partially removable to expose the energy guide 222A and / or the routing space 282, whereby an operator can repair, service, and / or remove the energy guide 222A (or any other component of the routing assembly 280).

[0108] The inner routing guide 287 and / or the routing space 282 can (i) provide a storage area for the energy guide 222A and / or (ii) maintain the organization of the energy guide 222A. The details of the inner routing guide 287 can vary according to the design requirements of the catheter system 100, the handle assembly 228, the routing assembly 280, and / or the specific needs, specifications, and / or requirements of the user or operator.

[0109] The inner routing guide 287 can accommodate components such as the energy guide 222A. For example, as shown in FIG. 2B, the inner routing guide 287 can arrange the energy guide 222A in a substantially circular pattern. It should be recognized that the inner routing guide 287 can take the form of any suitable number of geometric structures of any suitable size. The inner routing guide 287 is shown as a circle in FIG. 2B for simplicity of understanding. The inner routing guide 287 can cooperate with the outer routing guide 288 to define a path that can accommodate a portion of the energy guide 222A, thereby allowing that portion to be disposed around, surrounding, and / or near the inner routing guide 287.

[0110] The outer routing guide 288 may be substantially similar to the inner routing guide 287 in shape and / or function. Although the outer routing guide 288 is shown as an arc in FIG. 2B, it should be recognized that the outer routing guide 288 can take the form of any suitable number of geometric structures of any suitable size.

[0111] The inner routing guide 287 and / or the outer routing guide 288 can be configured to allow movement of the guide distal end 122D relative to the routing assembly 280 due to a change in the routing length 222L stored in the routing space 282.

[0112] In one embodiment, the inner routing guide 287 and / or the outer routing guide 288 increase the likelihood that the routing length 222L remains in a loop-like orientation so that the tension or axial movement received by the energy guide 222A does not twist or bend the energy guide 222A at an undesirable angle. This reduces the potential for damage to the energy guide 222A.

[0113] In various embodiments, the inner routing guide 287 and / or the outer routing guide 288 can include a post or other structure having a width, thereby maintaining the spacing or diameter of the routing length 222L disposed within the routing space 282. The width of the inner routing guide 287 and / or the outer routing guide 288 may be greater than the bending or twisting radius of the energy guide 222A, which may depend on the particular material that makes up the energy guide 222A.

[0114] During use of the catheter system 100 of the present technology during a medical procedure, an energy guide 222A, such as an optical fiber, is routed within the routing space 282 around, about, and / or near the inner routing guide 287 through the optical guide 283 into the adapter assembly 285. Subsequently, the energy guide 222A is directed from the adapter assembly 285 toward the optical / electrical cable 278 in combination with the electrical cable 281 at the housing distal end 285D. Additionally, the electrical cable 281 can be directed (i) through the optical / electrical cable 278 via the adapter assembly 285, (ii) through the routing assembly 280, and / or (iii) from the adapter assembly 285 through the optical / electrical cable 278 toward the housing distal end 285D.

[0115] During a medical procedure, when the energy guide 222A is subject to axial movement and / or a change in tension, for example, due to the inflation of the balloon 104 (shown in FIG. 1) or a similar structure, the routing length 222L of the energy guide 222A can be looped within the routing space 282, i.e., an increase in the diameter of the looped portion occurs as shown in FIG. 2B, thereby reducing the likelihood of twisting and reducing any excessive force on the energy guide 222A that could cause misalignment in the arrangement. Alternatively, when the inner routing guide 287 is rotatably coupled to the housing, the routing length 222L of the energy guide 222A can be wound up by automatically or manually rotating the inner routing guide 287. If the adapter assembly 285 includes a substantially rounded shape, the diameter of the inflated loop portion of the energy guide 222A can expand up to the width of the housing without contacting the angled surface that could cause twisting or bending of the energy guide 222A. Additionally, separate inlet portions for the optical guide 283 and the electrical guide 284 allow for separate and independent routing of the energy guide 222A and the electrical cable 281, facilitating the connection and operation of the energy guide 222A and / or the electrical cable 281 and their connection points.

[0116] FIG. 3 is a perspective view of an embodiment of an optical guide 383 utilized by various embodiments of the energy guide 222A (shown in FIG. 2B), the routing assembly 280 (shown in FIG. 2B), and the adapter assembly 285 (e.g., shown in FIG. 2B).

[0117] The optical guide 383 can guide the energy guide 222A (shown in FIG. 2B) and / or protect it from damage. The optical guide 383 can include a flexible cable that reduces the accumulation of spring energy when the guide and / or cable is wound or bent. The details of the optical guide 383 can vary according to the design requirements of the catheter system 200, the handle assembly 228, the routing assembly 280, the adapter assembly 285, and / or the specific needs, specifications, and / or requirements of the user or operator.

[0118] The optical guide 383 can include a protector tube 383T. The protector tube 383T can be configured to allow free movement of the guide and / or cable within the optical guide 383. In some embodiments, the protector tube 383T can be helically cut (as shown in the various embodiments shown by FIG. 3). In various embodiments, the protector tube 383T can be formed at least in part from polytetrafluoroethylene and / or any suitable polymer. The optical guide 383 and / or the protector tube 383T can be at least partially formed from a light-absorbing material (with or without a filler) that at least partially prevents and / or absorbs unwanted light and / or energy from escaping from the optical guide 383 and / or the protector tube 383T in the event of damage to the energy guide 222A and / or the electrical cable 281.

[0119] FIG. 4A is a simplified schematic cross-sectional view of an embodiment of a connector assembly 452 that includes a routing assembly 480.

[0120] In some embodiments, the routing assembly 480 may include an outer routing guide 488 for guiding a routing length 222L (e.g., as shown in FIG. 2B), whereby the energy guide 422A is disposed between an inner routing guide 487 and the outer routing guide 488 in the routing space 482. The outer routing guide 488 can be offset from the inner routing guide 487 such that the energy guide 422A is disposed around, about, and / or near the inner routing guide 487. The inner routing guide 487 and / or the outer routing guide 488 cooperate to define the placement and / or routing of the individual energy guides 422A through the routing assembly 480.

[0121] The details of the outer routing guide 488 can vary depending on the catheter system 100 (shown in FIG. 1), the connector assembly 452, the design requirements of the routing assembly 480, and / or the specific needs, specifications, and / or requirements of the user or operator.

[0122] Between the inner routing guide 487 and the outer routing guide 488, the routing assembly 480 may include, for example, channels, grooves, recesses, apertures, or similar passages in the body of the routing assembly 480 between the inner routing guide 487 and the outer routing guide 488. As shown in the various embodiments illustrated by FIG. 4A, this space between the inner routing guide 487 and the outer routing guide 488 may define a number of paths for accommodating the routing length 222L of the energy guide 422A to assist in managing and routing the energy guide 422A through the length of the catheter system 100 to reduce the likelihood of entanglement, twisting, etc. of the energy guide 422A.

[0123] The inner routing guide 487 and / or the outer routing guide 488 can also include a guide retainer 489A. The guide retainer 489A can hold the energy guide 422A between the inner routing guide 487 and the outer routing guide 488, reducing the likelihood that the energy guide 422A will exit the routing space 482 during operation of the catheter system 100, including movement of the energy guide 422A. The design of the guide retainer 489A can vary according to the design requirements of the routing assembly 480, the inner routing guide 487, and / or the outer routing guide 488. Although the guide retainers 489A, 489B are shown as specific rectangles in FIG. 4A, it should be appreciated that any suitable geometric structure of any suitable size that can hold the individual energy guides 422A within the routing space 482 can be used.

[0124] FIG. 4B is a simplified schematic cross-sectional view of the routing assembly 480 in FIG. 4A. In some embodiments as shown in FIGS. 4A and 4B, a plurality of guide retainers 489A, 489B are spaced apart from each other along the path of the energy guide 422A within the routing space 482 (shown in FIG. 4A). For example, as shown in the embodiment illustrated by FIG. 4A, the energy guide 422A can be held by the guide retainers 489A, 489B in a substantially infinite loop and / or figure-eight orientation within the routing space 482 around the two inner routing guides 487A, 487B. This orientation limits the magnitude of mechanical strain imposed on the energy guide 422A as the energy guide 422A moves within the routing space 482. It should be appreciated that the inner routing guides 487A, 487B and / or the outer routing guide 488 can include any suitable number, size, structure, and / or distribution of the guide retainers 489A, 489B according to the design requirements of the routing assembly 480.

[0125] In the embodiments shown by FIGS. 4A and 4B, the inner routing guides 487A, 487B have various geometric shapes and sizes to receive an infinite loop-like and / or figure-eight orientation of the routing length 222L of the energy guide 222A (shown in FIG. 2B) in the routing space 482. For example, in the various embodiments shown by FIGS. 4A and 4B, one inner routing guide 487 is substantially O-shaped and the other inner routing guide 487 is substantially D-shaped.

[0126] The routing assembly 480 can also include an assembly opening 490A. In certain embodiments, the assembly opening 490A can be formed at various positions of the routing assembly 480. For example, in the embodiment shown in FIG. 4B, a plurality of assembly openings 480A, 490B are disposed immediately below the corresponding guide retainers 489A.

[0127] The placement of the assembly opening 490A enables the reception of an additional routing length 222L of the energy guide 422A and / or the reduction of stress / tension applied to the guide retainers 489A, 489B when the energy guide 422A is disposed between the guide retainers 489A, 489B. In other words, when the energy guide 422A is received by the outer routing guide 488 and held by the guide retainers 489A, 489B, the assembly openings 490A, 490B provide space for the movement of the energy guide 422A while maintaining the position of the energy guide 422A in the routing space 482.

[0128] For example, as shown in FIGS. 4A and 4B, the portion of routing length 222L disposed toward the center of routing assembly 480 may become congested due to the intersection and / or looping of energy guides 422A. Assembly opening 490A disposed in the central region of routing assembly 480 can have an increased area for receiving this congestion. Additionally, inner routing guides 487A, 487B can include a number of guide retainers 489C disposed directly on central assembly opening 490B.

[0129] FIG. 4C is a cross-sectional view of routing assembly 480 taken along line 4C-4C in FIG. 4B. As shown in FIG. 4C, routing assembly 480 can include cross-sectional spaces defined between inner routing guides 487A, 487B, between inner routing guide 487A and outer routing guide 488, and / or between inner routing guide 487B and outer routing guide 488. These cross-sectional spaces are shown as being substantially U-shaped in FIG. 4C, but it should be understood that any suitable number of cross-sectional spaces, shapes, and / or sizes can be used to define routing space 482 as shown in the various embodiments illustrated by FIGS. 4A-4C.

[0130] FIG. 5 is a simplified plan view of an embodiment of connector assembly 552. More specifically, FIG. 5 shows various internal components and features that can be included in various embodiments of connector assembly 552. As shown in FIG. 5, in one embodiment, connector assembly 552 can include a portion of one or more energy guides 522A (e.g., routing length 222L shown in FIG. 2B) and routing assembly 580 therein.

[0131] In various embodiments, the connector assembly 552 can be configured to provide slack when bringing the individual energy guides 522A closer together so that the energy guide 522A and / or the energy guide bundle 522 can be in a more compact state when extending into the blood vessel 108 (shown in FIG. 1) together with the catheter 102 (shown in FIG. 1) during use of the catheter system 100 (shown in FIG. 1). For ease of understanding, in some embodiments as shown in FIG. 5, the plurality of individual energy guides 522A are shown as one energy guide bundle 522 for ease of understanding. It should be appreciated that the individual energy guides 522 do not necessarily need to be bundled as shown in the various embodiments shown by FIG. 4A.

[0132] The design of the individual energy guides 522A can be changed. For example, as shown in FIG. 5, in one embodiment, each of the individual energy guides 522A and / or the energy guide bundle 522 can include a protector tube 583 (also shown in FIG. 3), and all the energy guides 522A are held within this protector tube 583 when the energy guide 522A extends within the catheter 102 towards the balloon 104 (shown in FIG. 1). The connector assembly 552 can also include a locking crimp 588 configured to tightly bundle the energy guides 522A in a controlled manner to form the energy guide bundle 522.

[0133] In some embodiments, the connector assembly 552 can be at least partially removable to expose the energy guide 522A and / or the routing space 582, whereby the operator can repair, service, and / or remove the energy guide 522A (or any other component of the connector assembly 552).

[0134] The inner routing guide 587C can arrange components such as the routing length 222L of the energy guide 522A (shown in FIG. 2B) within the routing space 582. For example, as shown in FIG. 5, the inner routing guide 587C can arrange the routing length 222L of the energy guide 522A in a substantially circular pattern. The inner routing guide 587C can take the form of any suitable geometric structure, and it should be recognized that the inner routing guide 587C is shown as a circle in FIG. 5 merely for ease of understanding. The inner routing guide 587C can define a path that can accommodate the routing length 222L of the energy guide 522A, whereby the routing length 222L can form a loop around the inner routing guide 587C. The inner routing guide 587C can be configured to enable the movement of the guide distal end 122D (shown in FIG. 1) with respect to the connector assembly 552.

[0135] In one embodiment, the inner routing guide 587C increases the likelihood that a portion of the energy guide 522A (e.g., the routing length 222L) remains in a looped orientation so that the tension or axial movement received by the energy guide 522A does not twist or bend the energy guide 522A at an undesirable angle. This reduces the potential for damage to the energy guide 522A.

[0136] The inner routing guide 587C can include a post or other structure having a width, thereby maintaining the spacing or diameter of the portion of the energy guide 522A disposed within the routing space 582. The width of the inner routing guide 587C may be greater than the bending or twisting radius of the energy guide 522A, which may depend on the specific material that makes up the energy guide 522A.

[0137] In some embodiments, the routing assembly 580 may include an outer routing guide 488 (e.g., shown in FIG. 4 with respect to routing assembly 480) that houses a portion of the energy guide 522A, thereby disposing the energy guide 522A within the routing space 582. The outer routing guide 488 may be offset from a portion of an inner routing guide 587C around which the energy guide 522A loops, thereby providing a spacing between the energy guides 522A within the connector assembly 552. The outer housing of the connector assembly 552 may also function as the outer routing guide 488, depending on the design requirements of the routing assembly 580.

[0138] As provided herein, in various embodiments, the catheter systems and related methods disclosed herein can include a catheter configured to advance to a vascular lesion, such as a calcified or fibro-vascular lesion, at a treatment site located within or adjacent to a blood vessel in a patient's body. The catheter can include a catheter shaft and an inflatable balloon coupled and / or secured to the catheter shaft. The balloon can include a balloon wall portion that defines an interior of the balloon. The balloon can be configured to receive catheter fluid therein to expand from a deflated state suitable for advancing the catheter through the patient's vasculature to an inflated state suitable for fixing the catheter in a predetermined position relative to the treatment site.

[0139] In one embodiment, a catheter system and related method utilize an energy source, such as a light source like a laser or another suitable energy source, to provide energy guided by one or more energy guides, such as an optical fiber, disposed along the catheter shaft and within the balloon of the balloon catheter to generate local plasma in the catheter fluid retained within the balloon of the balloon. The energy guide can be used in connection with a plasma generator disposed at or near the guide distal end of the energy guide within the balloon of the balloon disposed at the treatment site. Generation of local plasma can initiate a pressure wave and can initiate the rapid formation of one or more bubbles that can rapidly expand to a maximum size and then dissipate through a cavitation event that can release a pressure wave upon collapse. The rapid expansion of the plasma-induced bubbles (sometimes simply referred to as "plasma bubbles") can generate one or more pressure waves in the catheter fluid retained within the balloon of the balloon, thereby providing a pressure wave to a vascular lesion in or adjacent to the vessel wall at the treatment site within the patient's body and inducing disruption in the vascular lesion. In some embodiments, the energy source is configured to provide a submillisecond pulse of energy, such as optical energy, to initiate plasma formation in the catheter fluid within the balloon, resulting in rapid bubble formation and providing a pressure wave to the balloon wall at the treatment site. Thereby, the pressure wave can transmit mechanical energy through the non-compressible catheter fluid to the treatment site and provide a disruptive force to the intravascular lesion. Without wishing to be bound by any particular theory, it is believed that the rapid change in the momentum of the catheter fluid at the balloon wall in contact with the intravascular lesion is transmitted to the intravascular lesion and induces disruption of the lesion.

[0140] The catheter systems and related methods disclosed herein can further include a handle assembly that is attached to a catheter shaft and is handled and used by a user or operator to manipulate, position, and control the catheter. In various embodiments, the handle assembly has a source manifold incorporated and / or integrated therein. In such embodiments, the source manifold can include one or more of a manifold housing, a pressure sensor coupled and / or integrated with the manifold housing, and a media inflation port, a guidewire lumen port, an energy guide port, and a catheter shaft port formed in and / or coupled to the manifold housing. The pressure sensor is configured to sense the fluid pressure of the catheter fluid within the catheter system. For example, in one embodiment, the pressure sensor can be configured to sense the fluid pressure at any desired location inside the balloon or along the inflation conduit. The media inflation port is configured to couple an inflation conduit into and / or through the manifold housing such that catheter fluid can be directed into the balloon through the handle assembly as needed. The guidewire lumen port is configured to couple a guidewire lumen that defines a conduit through which a guidewire extends into, from, and / or through the manifold housing such that the guidewire lumen can extend from the handle assembly into and / or through the balloon. The energy guide port is configured to couple one or more energy guides into and / or through the manifold housing such that the energy guides can guide energy from an energy source through the handle assembly into the balloon.The catheter shaft port is configured to couple the catheter shaft to the manifold housing, whereby a user can effectively control the placement of the balloon - attached catheter shaft substantially adjacent to a vascular lesion at a treatment site through the operation of the handle assembly.

[0141] 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 context clearly dictates otherwise. Also, the term "or" is generally used in the sense of "and / or" unless the context clearly dictates otherwise.

[0142] Also, as used in this specification and the appended claims, the expression "configured to" represents a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The expression "configured to" can be used interchangeably with other similar expressions such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, etc.

[0143] The headings used in this specification are provided for consistency with the proposals of 37 CFR Rule 1.77 or, alternatively, to provide organizational cues. These headings should not be regarded as limiting or characterizing the inventions set forth in any claims arising from this disclosure. By way of example, the description of the technology in the "Background Art" is not an admission that such technology is prior art to any invention in this disclosure. Neither the "Summary" nor the "Abstract" should be considered as characterizing features of the inventions set forth in the issued patent claims.

[0144] The embodiments described in this specification are not intended to be comprehensive or to limit the invention to the exact forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that those skilled in the art can recognize and understand the principles and practices. Accordingly, aspects are described in connection with various specific preferred embodiments and techniques. However, it should be understood that many variations and modifications can be made within the spirit and scope of this specification.

[0145] Although many different embodiments of the catheter system are illustrated and described herein, it should be understood that one or more features of any one embodiment can be combined with one or more features of one or more of the other embodiments if such combination satisfies the intent of the invention.

[0146] Although many exemplary aspects and embodiments of the catheter system are described above, those skilled in the art will recognize certain modifications, variations, additions, and sub-combinations thereof. Accordingly, the following appended claims and the claims introduced hereinafter are intended to be construed to include all such modifications, variations, additions, and sub-combinations as being within their true spirit and scope, and no limitation with respect to the details of the construction or design shown herein is intended.

Claims

1. A catheter system for treating a treatment site within or adjacent to a blood vessel wall or heart valve in a patient's body, wherein the catheter system includes a first energy guide and a second energy guide, A catheter system comprising a routing assembly that defines a routing space for holding the routing lengths of each of the energy guides, the routing assembly including an inner routing guide positioned within the routing space, the routing lengths of each of the energy guides being at least partially positioned around the inner routing guide, and the routing space being configured such that the routing length of at least one of the energy guides is adjustable.

2. The catheter system according to claim 1, wherein each of the energy guides includes an optical fiber.

3. The catheter system according to claim 1 or 2, wherein each of the energy guides includes a distal guide end and a proximal guide end.

4. The catheter system according to claim 3, wherein the proximal end of the guide is fixed to the routing assembly.

5. The catheter system according to claim 3, wherein the distal end of the guide is movable relative to the routing assembly.

6. The catheter system according to claim 1 or 2, wherein each of the energy guides is positioned at least approximately 90 degrees around the inner routing guide.

7. The catheter system according to claim 1 or 2, further comprising an adapter assembly for housing the internal routing guide.

8. The catheter system according to claim 1 or 2, further comprising an electrical cable arranged around the internal routing guide.

9. The catheter system according to claim 1 or 2, wherein each of the energy guides includes an optical guide configured to protect each of the energy guides.

10. The catheter system according to claim 1 or 2, further comprising a handle assembly usable by a user for selectively positioning the energy guide near the treatment site, wherein the routing assembly is located away from the handle assembly.

11. The catheter system according to claim 1 or 2, further comprising a connector assembly that positions the energy guides close together, wherein the routing assembly is located within the connector assembly.

12. A catheter system for treating a treatment site within or adjacent to a blood vessel wall or heart valve in a patient's body, wherein the catheter system includes a first energy guide and a second energy guide, A handle assembly that can be used by the user to selectively position the energy guide near the treatment site, A catheter system comprising: a routing assembly defining a routing space for holding the routing lengths of each of the energy guides, wherein the routing assembly is located outside the handle assembly, and the routing assembly includes an inner routing guide located within the routing space, the routing lengths of each of the energy guides are at least partially located around the inner routing guide, and the routing space is configured such that the routing length of at least one of the energy guides is adjustable.

13. The catheter system according to claim 12, further comprising a connector assembly that positions the energy guides close together, wherein the routing assembly is located within the connector assembly.

14. The catheter system according to claim 12 or 13, wherein each of the energy guides includes an optical fiber.

15. The catheter system according to claim 12 or 13, wherein each of the energy guides includes a distal guide end and a proximal guide end.

16. The catheter system according to claim 15, wherein the proximal end of the guide is fixed to the routing assembly.

17. The catheter system according to claim 15, wherein the distal end of the guide is movable relative to the routing assembly.

18. The catheter system according to claim 12 or 13, wherein each of the energy guides is positioned at least approximately 90 degrees around the inner routing guide.

19. The catheter system according to claim 12 or 13, further comprising an adapter assembly for housing the internal routing guide.

20. A catheter system for treating a treatment site within or adjacent to a blood vessel wall or heart valve in a patient's body, wherein the catheter system includes a first energy guide and a second energy guide, A handle assembly that can be used by the user to selectively position the energy guide near the treatment site, A connector assembly that brings the energy guides closer together so that the energy guides can be made more compact, A catheter system comprising: a routing assembly defining a routing space for holding the routing length of each of the energy guides, wherein the routing assembly is located outside the handle assembly, the routing assembly includes an inner routing guide located within the routing space, the routing length of each of the energy guides is at least partially located around the inner routing guide, the routing space is configured such that the routing length of at least one of the energy guides is adjustable, and each of the energy guides is located at least approximately 90 degrees around the inner routing guide; and

Images