Wiring assembly for endovascular 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 wiring assembly (280). The routing assembly (280) defines a routing space (282) holding a routing length (222L) of each of the energy guides (222A), the routing assembly (280) including an internal routing guide (287) positioned within the routing space (282), the routing length (222L) of each of the energy guides (222A) each being at least partially positioned around the internal routing guide (287), the routing space (282) is configured such that a routing length (222L) of at least one of the energy guides (222A) is adjustable.

Description

Related Applications

[0001] This application is related to and claims priority to U.S. Provisional Patent Application Serial No. 63 / 392,342, filed on July 26, 2022, entitled “ROUTING ASSEMBLY FOR USE ININTRAVASCULAR LITHOTRIPSY CATHETER SYSTEM,” U.S. Provisional Patent Application Serial No. 63 / 395,853, filed on August 7, 2022, entitled “OPTOELECTRICAL CONNECTOR FOR INTRAVASCULAR LITHOTRIPSY DEVICE,” and U.S. Non-Provisional Patent Application Serial 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 Serial Nos. 63 / 392,342 and 63 / 395,853 and U.S. Non-Provisional Patent Application Serial No. 18 / 357,947 are incorporated herein by reference in their entirety. background

[0002] Vascular lesions within the body's vessels may be associated with an increased risk of major adverse events, such as myocardial infarction, embolism, deep vein thrombosis, stroke, etc. For physicians in clinical settings, severe vascular lesions, such as heavily calcified vascular lesions, may be challenging to treat and achieve patency.

[0003] Vascular lesions can be treated using interventions such as medical therapy, balloon angioplasty, atherectomy, stenting, and vascular bypass surgery. These interventions may not always be ideal or may require subsequent treatment to resolve the lesion.

[0004] Intravascular lithotripsy is a method recently used to destroy vascular lesions within a blood vessel in the body with some success. Intravascular lithotripsy utilizes a combination of pressure waves and bubble dynamics generated within a fluid-filled balloon catheter. In particular, during intravascular lithotripsy treatment, a high energy source is used to generate plasma and ultimately pressure waves and rapid bubble expansion within a fluid-filled balloon to break up calcification at the treatment site including one or more vascular lesions within the vascular system. The associated rapid bubble formation triggered by the plasma and the resulting local fluid velocity within the balloon transfer mechanical energy through the incompressible fluid to exert a breaking force on the intravascular calcium relative to the balloon wall. The rapid change in fluid momentum when impacting the balloon wall is referred to as hydraulic shock or water hammer.

[0005] It remains desirable to enhance vessel patency and optimize therapy delivery parameters in intravascular lithotripsy catheter systems in a relatively easily controlled and consistently manufacturable manner. SUMMARY OF THE INVENTION

[0006] The present invention relates to a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve in a patient. In various embodiments, the catheter system includes a first energy director, a second energy director, and a wiring assembly. The wiring assembly defines a wiring space that holds a wiring length for each of the energy directors. The wiring assembly includes an internal wiring guide positioned within the wiring space. The wiring length of each of the energy directors is positioned to at least partially surround the internal wiring guide. The wiring space is configured so that the wiring length of at least one of the energy directors is adjustable.

[0007] In certain embodiments, each of the energy directors comprises an optical fiber.

[0008] In various embodiments, each of the energy directors includes a director distal end and a director proximal end.

[0009] In some embodiments, the proximal end of the introducer is fixed relative to the wiring assembly.

[0010] In certain embodiments, the guide distal end is movable relative to the wiring assembly.

[0011] In various embodiments, each energy director is positioned at least approximately 90 degrees around the inner wiring guide.

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

[0013] In certain embodiments, the catheter system further includes a cable positioned about the internal wiring guide.

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

[0015] In some embodiments, the catheter system further includes a handle assembly usable by a user to selectively position the energy director proximate the treatment site, the wiring assembly being positioned externally of the handle assembly.

[0016] In certain embodiments, the catheter system further includes a connector assembly that brings each of the energy directors closer together so that the energy directors are in a more compact form, the wiring assembly being positioned within the connector assembly.

[0017] The present invention also relates to a catheter system for treating a treatment site within or adjacent to a blood vessel wall or heart valve in a patient. In various embodiments, the catheter system includes a first energy director and a second energy director, a handle assembly, and a wiring assembly. The handle assembly can be used by a user to selectively position the energy director near the treatment site. The wiring assembly defines a wiring space that maintains the wiring length of each of the energy directors. The wiring assembly is located outside the handle assembly. The wiring assembly includes an internal wiring guide positioned within the wiring space. The wiring length of each of the energy directors is positioned to at least partially surround the internal wiring guide. The wiring space is configured so that the wiring length of at least one of the energy directors is adjustable.

[0018] In some embodiments, the catheter system further includes a connector assembly that brings each of the energy directors closer together so that the energy directors are in a more compact form, the wiring assembly being positioned within the connector assembly.

[0019] In various embodiments, each of the energy directors comprises an optical fiber.

[0020] In certain embodiments, each of the energy directors includes a director distal end and a director proximal end.

[0021] In some embodiments, the proximal end of the introducer is fixed relative to the wiring assembly.

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

[0023] In certain embodiments, each of the energy directors is positioned at least approximately 90 degrees around the internal wiring guide.

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

[0025] The present invention also relates to a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve in a patient. In various embodiments, the catheter system includes a first energy director and a second energy director, a handle assembly, a connector assembly, and a wiring assembly. The handle assembly can be used by a user to selectively position the energy director near the treatment site. The connector assembly brings each of the energy directors closer together so that the energy directors are in a more compact form. The wiring assembly defines a wiring space that maintains the wiring length of each of the energy directors. The wiring assembly is located outside the handle assembly. The wiring assembly includes an internal wiring guide positioned within the wiring space. The wiring length of each of the energy directors is positioned to at least partially surround the internal wiring guide. The wiring space is configured so that the wiring length of at least one of the energy directors is adjustable. Each of the energy directors is positioned to surround the internal wiring guide by at least approximately 90 degrees.

[0026] 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 subject matter. Further details are found in the detailed description and the appended claims. Other aspects will become apparent to those skilled in the art upon reading and understanding the following detailed description and upon viewing the accompanying drawings, which form a part thereof, each of which should not be construed as limiting. The scope of this article is defined by the appended claims and their legal equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The novel features of the invention, as well as the invention itself, both as to its structure and its operation, will be best understood from the accompanying description, when considered in conjunction with the accompanying drawings, in which like reference characters represent like parts, and in which: Figure 1 is a schematic cross-sectional view of an embodiment of a catheter system including a handle assembly having features of the present invention according to various embodiments; Figure 2A is a simplified schematic diagram of a portion of an embodiment of a catheter system, including a handle assembly and an adapter assembly; Figure 2B yes Figure 2A A simplified schematic cross-sectional view of an embodiment of an adapter assembly in, including a wiring assembly; Figure 3 is a perspective view of an embodiment of an optical guide for use in a catheter system; and Figure 4A is a simplified schematic cross-sectional view of an embodiment of a connector assembly including a wiring assembly; Figure 4B yes Figure 4A A simplified schematic cross-sectional view of a wiring assembly in; Figure 4Cis along Figure 4B A cross-sectional view of the wiring assembly taken along line 4C-4C in FIG. Figure 5 is a simplified top view of an embodiment of a connector assembly.

[0028] Although embodiments of the present invention allow for various modifications and alternative forms, their specific details have been illustrated by way of example and drawings and are described in detail herein. However, it is to be understood that the scope of this article is not limited to the specific embodiments described. On the contrary, the purpose is to cover modifications, equivalents, and alternatives that fall within the spirit and scope of this article. Detailed Description

[0029] Treatment of vasculopathy can reduce major adverse events or death in affected subjects. As described herein, a major adverse event is a major adverse event that may occur anywhere in the body due to the presence of a vasculopathy. Major adverse events can include, but are not limited to, major adverse cardiac events, major adverse events of the peripheral vasculature or central vasculature, major adverse events of the brain, major adverse events of the muscular system, or major adverse events of any internal organ.

[0030] As used herein, the terms "treatment site", "intravascular lesion" and "vascular lesion" are used interchangeably unless otherwise indicated. Therefore, intravascular lesions and / or vascular lesions are sometimes simply referred to as "lesions" herein.

[0031] Those of ordinary skill in the art will appreciate that the following detailed description of the present invention is illustrative only and is not intended to be limiting in any way. Other embodiments of the present invention will readily occur to such technicians who benefit from this disclosure. Reference will now be made in detail to the embodiments of the present invention shown in the accompanying drawings. In the accompanying drawings and the following detailed description, the same or similar names and / or reference numerals will be used to refer to the same or similar parts.

[0032] For the sake of clarity, not all conventional features of the embodiments described herein are shown and described. It is to be understood that in the development of any such actual embodiment, many decisions unique to the embodiment must be made to achieve the developer's specific goals, such as compliance with application-related and business-related constraints, and these specific goals will vary from one embodiment to another and from one developer to another. In addition, it should be recognized that such development efforts may be complex and time-consuming, however, for those of ordinary skill in the art who benefit from this disclosure, this is nothing more than a routine engineering task.

[0033] The catheter systems disclosed herein may include many different forms. Figure 1, shows a simplified schematic cross-sectional view of a catheter system 100 according to various embodiments. The catheter system 100 is suitable for applying pressure waves to induce a fracture in one or more vascular lesions in a patient's body, the one or more vascular lesions being in or adjacent to a vessel wall of a blood vessel, or on or adjacent to a heart valve. Figure 1 In the illustrated embodiment, catheter system 100 may include one or more of catheter 102, energy directing beam 122 including one or more energy directors 122A, system console 123 including one or more of energy source 124, power source 125, system controller 126, and graphical user interface 127 ("GUI"), and handle assembly 128 including source manifold 136 integrated therein. Alternatively, compared to incorporating Figure 1 Catheter system 100 may include more or fewer components than those specifically shown and described.

[0034] The catheter 102 is configured to be moved to a treatment site 106 within a body 107 of a patient 109 within or adjacent to a vessel wall 108A of a blood vessel 108. The treatment site 106 may include one or more vascular lesions 106A, such as, for example, calcified vascular lesions. Additionally, or alternatively, the treatment site 106 may include a vascular lesion 106A such as a fibrotic vascular lesion. Still alternatively, in some embodiments, the catheter 102 may be used at a treatment site 106 within a body 107 of a patient 109 within or adjacent to a heart valve.

[0035] The catheter 102 may include an expandable 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 102 and / or the catheter shaft 110 may also include a guidewire lumen 118 configured to move over the guidewire 112. As used herein, the guidewire lumen 118 defines a conduit through which the guidewire 112 extends. The catheter shaft 110 may also include an expansion lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, the catheter 102 can have a distal opening 120, and the catheter 102 can receive and be tracked by the guidewire 112 when 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.

[0036] The balloon 104 includes a balloon wall 130 defining a balloon interior 146. The balloon 104 can be selectively inflated using a catheter fluid 132 to expand from a deflated state to an expanded state (eg, Figure 1 ), the contracted state is suitable for advancing the catheter 102 through the patient's vasculature, and the expanded state is suitable for anchoring the catheter 102 in a suitable position relative to the treatment site 106. In another way of expression, when the balloon 104 is in the expanded state, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. It is to be understood that although Figure 1 The balloon wall 130 of the balloon 104 is shown as being spaced apart from the treatment site 106 of the blood vessel 108 when in the expanded state, but this is done for ease of illustration. It should be appreciated that the balloon wall 130 of the balloon 104 is generally substantially adjacent to and / or abuts the treatment site 106 when the balloon 104 is in the expanded state.

[0037] Balloons 104 suitable for use in the catheter system 100 include those balloons 104 that can pass through the vasculature of the patient 109 when in a deflated state. In some embodiments, the balloon 104 is made of silicone. In other embodiments, the balloon 104 can be made of materials such as polydimethylsiloxane (PDMS), polyurethane, polymers such as PEBAX, TM material), nylon or any other suitable material.

[0038] The balloon 104 can have any suitable diameter (in the inflated state). In various embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from less than 1 millimeter (mm) up to 25 mm. In some embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from at least 1.5 mm up to 14 mm. In some embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from at least 2 mm up to 5 mm.

[0039] 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 to be understood that a balloon 104 having a relatively long length can be positioned adjacent to a larger treatment site 106, and thus can be used to apply pressure waves and induce rupture to a larger vascular lesion 106A or multiple vascular lesions 106A at a precise location within the treatment site 106. It is also to be understood that a longer balloon 104 can also be positioned adjacent to multiple treatment sites 106 at any one given time.

[0040] The balloon 104 can be inflated to an inflation pressure between about one atmosphere (atm) and 70 atm. In some embodiments, the balloon 104 can be inflated to an inflation pressure of from at least 20 atm to 60 atm. In other embodiments, the balloon 104 can be inflated to an inflation pressure of from at least 6 atm to 20 atm. In still other embodiments, the balloon 104 can be inflated to an inflation pressure of from at least 3 atm to 20 atm. In still other embodiments, the balloon 104 can be inflated to an inflation pressure of from at least 2 atm to 10 atm.

[0041] The balloon 104 can have various 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 extended spherical shape, an elliptical shape, a conical 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 the drug eluting stent can include one or more therapeutic agents, including anti-inflammatory agents, anti-tumor agents, anti-angiogenic agents, etc.

[0042] The catheter fluid 132 may be a liquid or a gas. Some examples of catheter fluids 132 suitable for use may include, but are not limited to, one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases such as carbon dioxide, or any other suitable catheter fluid 132. In some embodiments, the catheter fluid 132 may be used as a base expansion fluid. In some embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium in a volume ratio of approximately 50:50. In other embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium in a volume ratio of approximately 25:75. In still other embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium in a volume ratio of approximately 75:25. However, it is to be understood that any suitable ratio of saline to contrast medium may be used. The catheter fluid 132 may be adjusted in terms of composition, viscosity, etc. so that the propagation rate of the pressure wave is appropriately manipulated. In certain embodiments, the catheter fluid 132 suitable for use is biocompatible. The volume of catheter fluid 132 may be adjusted by the energy source 124 selected and the type of catheter fluid 132 used.

[0043] In some embodiments, the contrast agent used in the contrast media may include, but is not limited to, an iodine-based contrast agent, such as an ionic iodine-based contrast agent or a 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 agents and perfluorocarbon agents may include, but are not limited to, agents such as perfluorocarbondodecafluoropentane (DDFP, C5F12).

[0044] The catheter fluid 132 may include those catheter fluids that contain absorbers that can selectively absorb light in the ultraviolet region (e.g., at least 10 nanometers (nm) to 400 nm), the visible region (e.g., at least 400 nm to 780 nm), or the near infrared region (e.g., at least 780 nm to 2.5 μm) of the electromagnetic spectrum. Suitable absorbers may include those absorbers that have an absorption maximum in the spectrum from at least 10 nm to 2.5 μm. Suitable absorbers may include those absorbers that have an absorption maximum in the spectrum from at least 10 nm to 2.5 μm. Alternatively, the catheter fluid 132 may include those fluids that contain absorbers that can selectively absorb light in the mid-infrared region (e.g., at least 2.5 μm to 15 μm) or the far-infrared region (e.g., at least 15 μm to 1 mm) of the electromagnetic spectrum. In various embodiments, the absorbers may be those absorbers that have an absorption maximum that matches 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 absorber can be water soluble. In other embodiments, the absorber is not water soluble. In some embodiments, the absorber used in the catheter fluid 132 can be adjusted to match the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths of at least 10 nanometers to one millimeter are discussed elsewhere herein.

[0045] The catheter shaft 110 of the catheter 102 can be coupled to one or more energy directors 122A of the energy directing bundle 122 in optical communication with an energy source 124. The energy directors 122A can be disposed along the catheter shaft 110 and within the balloon 104. In some embodiments, each energy director 122A can be an optical fiber and the energy source 124 can be a laser. The energy source 124 can be in optical communication with the energy directors 122A at the proximal portion 114 of the catheter system 100.

[0046] In some embodiments, the catheter shaft 110 can be connected to multiple energy directors 122A, such as a first energy director, a second energy director, a third energy director, etc., which can be disposed around the guidewire cavity 118 and / or the catheter shaft 110 and / or at any suitable position relative to the guidewire cavity 118 and / or the catheter shaft 110. For example, in certain non-exclusive embodiments, two energy directors 122A may be spaced approximately 180 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110; three energy directors 122A may be spaced approximately 120 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110; four energy directors 122A may be spaced approximately 90 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110; six energy directors 122A may be spaced approximately 60 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110; eight energy directors 122A may be spaced approximately 45 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110; or ten energy directors 122A may be spaced approximately 36 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110. Still alternatively, the plurality of energy directors 122A need not be evenly spaced from one another around the circumference of the guidewire lumen 118 and / or catheter shaft 110. More specifically, it is also understood that the energy directors 122A may be evenly or unevenly disposed around the guidewire lumen 118 and / or catheter shaft 110 to achieve a desired effect at a desired location.

[0047] The catheter system 100 and / or the energy directed beam 122 may include any number of energy directors 122A in optical communication with the energy source 124 at the proximal portion 114 and in optical communication 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 directed beam 122 may include from one energy director 122A to more than 30 energy directors 122A. Alternatively, in other embodiments, the catheter system 100 and / or the energy directed beam 122 may include more than 30 energy directors 122A.

[0048] Energy directors 122A may have any suitable design for generating plasma and / or pressure waves in catheter fluid 132 within balloon interior 146. Thus, the general description of energy directors 122A as light directors is not intended to be limiting in any way, except as set forth in the appended claims. More specifically, although catheter system 100 is generally described as energy source 124 being a light source and one or more energy directors 122A being light directors, catheter system 100 may alternatively include any suitable energy source 124 and energy director 122A for generating a desired plasma in catheter fluid 132 within balloon interior 146. For example, in one non-exclusive alternative embodiment, energy source 124 may be configured to provide high voltage pulses, and each energy director 122A may include an electrode pair including spaced apart electrodes extending into balloon interior 146. In such an embodiment, each high voltage pulse is applied to the electrodes and forms an arc across the electrodes, which in turn generates plasma and forms pressure waves in the catheter fluid 132, which are used to provide a disruptive force on the vascular lesion 106A at the treatment site 106. Still alternatively, the energy source 124 and / or the energy director 122A may have another suitable design and / or configuration.

[0049] In some embodiments, energy director 122A may include an optical fiber or a flexible light pipe. Energy director 122A may be thin and flexible and may allow optical signals to be sent with very little intensity loss. Energy director 122A may include a core surrounded by a cladding around its circumference. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of energy director 122A may be formed of one or more materials, including but not limited to one or more types of glass, silica, or one or more polymers. Energy director 122A may also include a protective coating, such as a polymer. It is understood that the refractive index of the core will be greater than the refractive index of the cladding.

[0050] Each energy director 122A can direct energy along its length from a director proximal end 122P to a director distal end 122D having at least one optical window (not shown) positioned within the balloon interior 146 .

[0051] Energy director 122A can take on many configurations around and / or relative to catheter shaft 110 of catheter 102. In some embodiments, energy director 122A can extend parallel to longitudinal axis 144 of catheter shaft 110. In some embodiments, energy director 122A can be physically coupled to catheter shaft 110. In other embodiments, energy director 122A can be disposed along the length of the outer diameter of catheter shaft 110. In still other embodiments, energy director 122A can be disposed within one or more energy director lumens within catheter shaft 110.

[0052] The energy guides 122A may also be disposed at any suitable position about the circumference of the guidewire lumen 118 and / or the catheter shaft 110, and the guide distal end 122D of each energy guide 122A may be disposed 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.

[0053] In some embodiments, energy director 122A may include one or more photoacoustic transducers 154, wherein each photoacoustic transducer 154 may be in optical communication with energy director 122A in which it is disposed. In some embodiments, photoacoustic transducer 154 may be in optical communication with director distal end 122D of energy director 122A. In such embodiments, photoacoustic transducer 154 may have a shape that corresponds to and / or conforms to director distal end 122D of energy director 122A.

[0054] Photoacoustic transducer 154 is configured to convert light energy into acoustic waves at or near distal director end 122D of energy director 122A. The direction of the acoustic waves can be adjusted by changing the angle of distal director end 122D of energy director 122A.

[0055] In some embodiments, the photoacoustic transducer 154 disposed at the guide distal end 122D of the energy guide 122A can take the same shape as the guide distal end 122D of the energy guide 122A. For example, in some non-exclusive embodiments, the photoacoustic 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 energy guide 122A can also include additional photoacoustic transducers 154 disposed along one or more side surfaces of the length of the energy guide 122A.

[0056] In some embodiments, energy director 122A may also include one or more steering features or “diverters” ( Figure 1 ), a steering feature or "diverter" is configured to direct energy from the energy director 122A toward a side surface located at or near the director distal end 122D of the energy director 122A before the energy is directed toward the balloon wall 130. The steering feature may include any feature of the system that redirects energy from the energy director 122A away from its axial path toward the side surface of the energy director 122A. Each energy director 122A may include one or more optical windows disposed along a longitudinal or circumferential surface of each energy director 122A and in optical communication with the steering feature. Stated another way, the steering feature may be configured to direct energy in the energy director 122A toward a side surface at or near the director distal end 122D, wherein the side surface is in optical communication with the optical window. An optical window may include a portion of energy director 122A that allows energy from within energy director 122A to exit energy director 122A, such as a portion of energy director 122A that lacks cladding material on or around energy director 122A.

[0057] Examples of steering features suitable for use include reflective elements, refractive elements, and fiber optic diffusers. Steering features suitable for focusing energy away from the tip of energy director 122A may include, but are not limited to, those with convex surfaces, gradient refractive index (GRIN) lenses, and mirror focusing lenses. Upon contact with the steering features, energy is redirected within energy director 122A to one or more of plasma generator 133 and photoacoustic transducer 154 in optical communication with a side surface of energy director 122A. When utilized, photoacoustic transducer 154 then converts the optical energy into acoustic waves that extend away from the side surface of energy director 122A.

[0058] As mentioned above, in Figure 1 In the illustrated embodiment, 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 may include more Figure 1 127. For example, in certain non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127. Still alternatively, one or more of the energy source 124, the power source 125, the system controller 126, and the GUI 127 may be disposed at any suitable location within the catheter system 100 without specifically requiring the system console 123.

[0059] As shown, system console 123 and the components it includes are operably coupled to catheter 102, energy directing beam 122, and the rest of catheter system 100. For example, in some embodiments, Figure 1 As shown, system console 123 may include console connection aperture 148 (sometimes also generally referred to as a "socket") through which energy directing beam 122 is mechanically coupled to system console 123. In such embodiments, energy directing beam 122 may include a director coupling housing 150 (sometimes also generally referred to as a "ferrule") that houses a portion of each energy director 122A, such as director proximal end 122P. Director coupling housing 150 is configured to fit and selectively retain within console connection aperture 148 to provide a mechanical coupling between energy directing beam 122 and system console 123.

[0060] Energy directing bundle 122 may also include a connector assembly 152 (or “shell”) that connects each individual energy director 122A to system console 123 .

[0061] Energy source 124 may be selectively and / or alternatively coupled in optical communication with each energy director 122A in energy directed beam 122, such as being optically coupled to a director proximal end 122P of each energy director 122A in energy directed beam 122. In particular, energy source 124 is configured to generate energy in the form of a source beam 124A, such as a pulsed source beam, which may be selectively and / or alternatively directed to each energy director 122A in energy directed beam 122 and received by each energy director 122A in energy directed beam 122 as a separate guided beam 124B. Alternatively, catheter system 100 may include more than one energy source 124. For example, in one non-exclusive alternative embodiment, catheter system 100 may include a separate energy source 124 for each energy director 122A in energy directed beam 122.

[0062] Energy source 124 may be of any suitable design. In certain embodiments, energy source 124 may be configured to provide sub-millisecond energy pulses from energy source 124 that are focused onto a small spot so as to couple the energy pulses into guide proximal end 122P of energy guide 122A. Such energy pulses are then directed along energy guide 122A to a location within balloon interior 146 of balloon 104, thereby inducing the formation of plasma in catheter fluid 132 within balloon interior 146 of balloon 104, such as by plasma generator 133, which may be located at or near guide distal end 122D of energy guide 122A. In particular, in such embodiments, energy emitted at guide distal end 122D of energy guide 122A is directed toward plasma generator 133 and energizes plasma generator 133 to form plasma in catheter fluid 132 within balloon interior 146. The formation of plasma results in rapid formation of bubbles and exerts pressure waves on treatment site 106. Exemplary plasma induced bubbles 134 in Figure 1 is shown in .

[0063] In various non-exclusive embodiments, sub-millisecond energy pulses from energy source 124 may be delivered to 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, sub-millisecond energy pulses may be delivered to treatment site 106 at a frequency that may be greater than 5000 Hz or less than 1 Hz, or any suitable frequency range.

[0064] It is to be understood that although the energy source 124 is typically utilized to provide pulses of energy, the energy source 124 may still be described as providing a single source beam 124A, ie, a single pulsed source beam.

[0065] Energy sources 124 suitable for use may include various types of light sources, including lasers and lamps. Alternatively, energy source 124 may include any suitable type of energy source.

[0066] Suitable lasers may include short pulse lasers on a sub-millisecond time scale. In some embodiments, the energy source 124 may include a laser on a nanosecond (ns) time scale. The laser may also include a short pulse laser on a picosecond (ps), femtosecond (fs), and microsecond (us) time scale. It is to be understood that many combinations of laser wavelength, pulse width, and energy level may be used to achieve plasma in the conduit fluid 132 of the conduit 102. In various non-exclusive alternative embodiments, the pulse width may include those pulse widths falling within a range including from at least 10 ns to 3000 ns, from at least 20 ns to 100 ns, or from at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range may be used.

[0067] Exemplary nanosecond lasers may include those within the UV to IR spectrum, spanning wavelengths from approximately 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, an energy source 124 suitable for use in the catheter system 100 may include a light source capable of generating light having a wavelength from at least 750 nm to 2000 nm. In other embodiments, the energy source 124 may include a light source capable of generating light having a wavelength from at least 700 nm to 3000 nm. In still other embodiments, the energy source 124 may include a light source capable of generating light having a wavelength from at least 100 nm to 10 micrometers (µm). Nanosecond lasers may include those having a repetition rate of up to 200 kHz.

[0068] In some embodiments, the laser may 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 laser, a pulsed laser, or a fiber laser.

[0069] In still other embodiments, the energy source 124 may include multiple lasers grouped together in series. In still other embodiments, the energy source 124 may include one or more low energy lasers fed into a high energy amplifier such as a master oscillator power amplifier (MOPA). In still other embodiments, the energy source 124 may include multiple lasers that may be combined in parallel or in series to provide the energy required to generate a plasma bubble 134 in the conduit fluid 132.

[0070] 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 will depend on the energy source 124, the absorbent material, the bubble expansion, the propagation medium, the balloon material, and other factors. In various non-exclusive 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.

[0071] When catheter 102 is placed at treatment site 106, pressure waves may be applied to treatment site 106 from a distance in the range of at least about 0.1 millimeter (mm) to greater than about 25 mm extending radially from energy director 122A. In various non-exclusive embodiments, when catheter 102 is placed at treatment site 106, pressure waves may be applied to treatment site 106 from a distance in the 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 extending radially from energy director 122A. In other embodiments, pressure waves may be applied to treatment site 106 from another suitable distance different from the foregoing ranges. In some embodiments, pressure waves in the range of from at least about 2 MPa to 30 MPa may be applied to treatment site 106 at a distance of from at least about 0.1 mm to 10 mm. In some embodiments, pressure waves within a range from at least about 2 MPa to 25 MPa may be applied to treatment site 106 at a distance from at least about 0.1 mm to 10 mm. Still alternatively, other suitable pressure ranges and distances may be used.

[0072] 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 necessary power to each of the energy source 124, the system controller 126, the GUI 127, and the handle assembly 128. The power supply 125 may have any suitable design for these purposes.

[0073] The system controller 126 is electrically coupled to the power source 125 and receives power from the power source 125. The system controller 126 is coupled to each of the energy source 124 and the GUI 127 and is configured to control the operation of each of the energy source 124 and the GUI 127. The system controller 126 may include one or more processors or circuits for controlling the operation of at least the energy source 124 and the GUI 127. For example, the system controller 126 may control the energy source 124 to generate energy pulses as desired, and / or generate energy pulses at any desired firing rate.

[0074] The system controller 126 may also be 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 using the catheter 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 controlling various operations of the catheter system 100. For example, in some embodiments, the additional controllers and / or a portion of the system controller 126 may be positioned and / or contained within the handle assembly 128.

[0075] GUI 127 is accessible by a user or operator of catheter system 100. GUI 127 is electrically connected to system controller 126. By such a design, a user or operator can use GUI 127 to ensure that catheter system 100 is effectively utilized to apply pressure to vascular lesions 106A at treatment site 106 and induce fractures in vascular lesions. GUI 127 can provide information to a user or operator that can be used before, during, and after using catheter system 100. In one embodiment, GUI 127 can provide static visual data and / or information to a user or operator. In addition, or alternatively, during the use of catheter system 100, GUI 127 can provide dynamic visual data and / or information to a user or operator, such as video data or any other data that changes over time. In various embodiments, GUI 127 can include one or more colors, different sizes, varying brightness, etc. that can be used as an alarm to a user or operator. In addition, or alternatively, GUI 127 can provide audio data or information to a user or operator. The details of GUI 127 may vary depending on the design requirements of catheter system 100 or the specific needs, specifications, and / or desires of a user or operator.

[0076] like Figure 1 As shown, the handle assembly 128 can be positioned at 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 positioned spaced apart from the balloon 104. Alternatively, the handle assembly 128 can be positioned at another suitable location.

[0077] The handle assembly 128 is attached to the catheter shaft 110 and 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. Figure 1 In the illustrated embodiment, the handle assembly 128 is separate from one or more of the system controller 126 , the energy source 124 , the fluid pump 138 , and the GUI 127 , but is in electrical and / or fluid communication therewith.

[0078] In some embodiments, the handle assembly 128 may integrate and / or include at least a portion of the system controller 126 within the handle assembly 128. For example, as shown, in some such embodiments, the handle assembly 128 may include a circuit 156 that is electrically coupled between the catheter electronics and the system console 123 and may form at least a portion of the system controller 126. In one embodiment, the circuit 156 may include a printed circuit board having one or more integrated circuits, or any other suitable circuit. In alternative embodiments, the circuit 156 may be omitted, or may be included within the system controller 126, which in various embodiments may be located external to the handle assembly 128, for example, within the system console 123. It is to be understood that the handle assembly 128 may include fewer or more components than specifically shown and described herein.

[0079] The handle assembly 128 also includes an energy activation member 157 (also sometimes referred to herein simply as an "energy activator"), such as an energy activation button, which can be coupled to a circuit 156 within the handle assembly 128, which forms part of the system controller 126. The energy activator 157 is configured to enable a user or operator to selectively activate the catheter system 100 as desired.

[0080] In various embodiments, as described above, the source manifold 136 can be integrated and / or incorporated into the handle assembly 128 and can be positioned at or near the proximal portion 114 of the catheter system 100. As shown, the source manifold 136 can include one or more openings that can receive an expansion conduit 140 coupled in fluid communication with the fluid pump 138, a guidewire 112 and / or a guidewire lumen 118, one or more energy directors 122A of an energy directing beam 122, and / or a catheter shaft 110. More specifically, the source manifold 136 can include one or more of a media expansion port 158, a guidewire lumen port 160, an energy director port 162, and a catheter shaft port 164.

[0081] The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with the catheter fluid 132 as needed.

[0082] Various embodiments of the source manifold 136 and specific components included therein are shown and described in detail in subsequent figures below.

[0083] As with all embodiments shown and described herein, various structures may be omitted from the drawings for clarity and ease of understanding. In addition, the drawings may include certain structures that may be omitted without departing from the intent and scope of the present invention.

[0084] Figure 2A 2 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 are separate and / or exclusive from each other. 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.

[0085] The design of the handle assembly 228 and the various components held therein can be varied to accommodate the requirements of the catheter system 100. As shown in some embodiments, the handle assembly 228 can include an energy activator 257, an assembly housing 266 that includes and / or defines one or more of an expansion tube inlet 268, a guidewire inlet 270, and a handle distal outlet 276. Alternatively, the handle assembly 228 can include more or fewer components than those specifically shown and described herein in addition to the components of the connector assembly 252, wiring assembly 280, and / or adapter assembly 285.

[0086] In some embodiments, the assembly housing 266 may be formed of two housing members 266A ( Figure 2A Only one of which is shown in the figure, the first shell side and the second shell side are selectively connected together to form a complete component housing 266.

[0087] The expansion duct inlet 268 is configured to couple the expansion duct 240 into the assembly housing 266 .

[0088] Guidewire inlet 270 is configured to couple guidewire 212 into assembly housing 266 .

[0089] Energy director inlet 272 is configured to include one or more energy directors 222A (at Figure 2B The energy directing beam 122 (shown in ) is connected to the component housing 266.

[0090] The electrical inlet 274 is configured to receive a cable 280 (eg, Figure 2B ) is connected to the component housing 266.

[0091] It should be understood that in some embodiments, energy director inlet 272 and electrical inlet 274 may be formed together as a single inlet. For example, in one embodiment, when energy director 222A and cable 281 enter assembly housing 266 through energy director inlet 272 and electrical inlet 274, respectively, energy director 222A and cable 281 (at Figure 2B274) may be encased within the optical / electrical cable 278. Alternatively, the energy director inlet 272 and the electrical inlet 274 may be formed independently of one another.

[0092] The distal outlet 276 of the handle is used to expand the catheter 240, the catheter shaft 210, the guide wire 112 (in Figure 1 ), guidewire lumen 118 (shown in the figure), energy director 122A (shown in Figure 1 ) each provide an outlet from the assembly housing 266, as these components are directed toward the balloon 104 (in Figure 1 ) extension.

[0093] Optical guide 283 can guide energy director 222A from connector assembly 252 to wiring assembly 280. Connector assembly 252 is spaced apart, remote from, and / or completely separate from handle assembly 228 and adapter assembly 285.

[0094] Electrical guides 284 may guide electrical cables 281 from electrical connectors 286 to wiring assembly 280 .

[0095] In some embodiments, the adapter assembly 285 can accommodate components of the wiring assembly 280. The adapter assembly 285 can interconnect the optical cable / cable 278, the optical guide 283, and / or the electrical guide 284. The adapter assembly 285 can include a housing distal end 285D (at Figure 2B ) and the housing proximal end 285P (shown in Figure 2B ). In some embodiments, the adapter assembly 285 can include a y-shaped adapter. The adapter assembly 285 is spaced apart, away from, and / or completely separated from the handle assembly 228 and the connector assembly 252.

[0096] The electrical connector 286 can connect the cable 281 and / or the electrical conductor 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 Figure 1 124).

[0097] Figure 2B yes Figure 2A A simplified schematic cross-sectional view of an embodiment of an adapter assembly 285 in FIG. 2 includes a wiring assembly 280. Figure 2B As shown, adapter assembly 285 may include optical / electrical cable 278 , electrical cable 281 , wiring assembly 280 including internal wiring guides 287 , optical guides 283 , and / or electrical guides 284 . Figure 2BThe wiring assembly 280, energy director 222A, optical cable / cable 278, optical guides 283, electrical guides 284, and / or adapter assembly 285 shown in can be somewhat similar to the embodiments shown and described herein.

[0098] Wiring assembly 280 may be configured to reduce mechanical strain on energy director 222A and / or cable 281. Wiring assembly 280 may route energy director 222A and / or cable 281 in any suitable direction throughout catheter system 200. The details of wiring assembly 280 may vary depending on the design requirements of catheter system 200 or the specific needs, specifications, and / or desires of a user or operator. It should be understood that wiring assembly 280 may include more than one embodiment. Figure 2B Wiring assembly 280 may be positioned in any suitable location within catheter system 100 .

[0099] In all embodiments, the wiring assembly 280 is spaced apart from and / or external to the handle assembly 228. The optical / electrical cable 278 can be coupled between the wiring assembly 280 and the handle assembly 228. Figure 1 ) and / or the introducer proximal end 122P (shown in Figure 1 ) can be fixed relative to the wiring assembly 280. In some embodiments, the guide distal end 122D can be moved relative to the wiring assembly 280.

[0100] Cable 281 carries power from electrical connector 286 (at Figure 2A ) is guided to the handle assembly 228 (shown in Figure 2A Cable 281 can connect handle assembly 228 to any suitable power source (such as Figure 1 energy source 124 as shown in FIG.

[0101] The wiring assembly 280 may include a wiring space 282. The wiring space 282 defines a space for the wiring, positioning and / or movement of the energy director 222A within the wiring assembly 280. The movement of the energy director 222A throughout the catheter system 100 and / or the wiring space 282 may result in alternating periods of relaxation and tension on the energy director 222A, which may result in axial and longitudinal movement of the director and the cable. Such movement may result in undesirable squeezing and / or twisting of the energy director 222A of the catheter system 200, and may result in degradation of the energy director 222A.

[0102] Wiring space 282 holds a wiring length 222L for each of energy directors 222A. Wiring length 222L includes the length of energy directors 222A positioned within wiring space 282 during operation and use of catheter system 200. Wiring length 222L is a portion of the total length of energy directors 222A. Figure 2B In the various embodiments shown, wiring length 222L is shown with a dashed line to illustrate wiring length 222L within wiring assembly 280. Wiring space 282 may be configured such that wiring length 222L of at least one of energy directors 222A is adjustable.

[0103] Internal routing guide 287 may be positioned in and / or within routing space 282. Routing length 222L of each of the energy directors may be positioned around, around and / or adjacent internal routing guide 287.

[0104] In some embodiments, energy director 222A may wrap around internal routing guide 287 greater than approximately 5 degrees and wrap around internal routing guide 287 less than approximately 1080 degrees. Energy directors 222A may wrap around the inner wiring director by approximately 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, 5 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, 4 70 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, 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, energy director 222A may wrap around internal wiring guide 287 less than about 5 degrees and wrap around internal wiring guide 287 greater than about 1080 degrees.

[0105] Internal wiring guides 282 may guide at least one of movement and positioning of energy director 222A within wiring assembly 280. Internal wiring guides 287 may reduce mechanical strain on energy director 222A, various cables, guides, and / or other components within wiring assembly 280. Figure 2B As shown, routing space 282 includes routing length 222L of energy director 222A to reduce mechanical strain and / or mechanical forces that may affect routing length 222L of energy director 222A.

[0106] Adapter assembly 285 may cooperate with wiring space 282 so that a user may maintain energy director 222A. For example, adapter assembly 285 may be at least partially removable to expose energy director 222A and / or wiring space 282 so that an operator may maintain, repair, and / or remove energy director 222A (or any other component of wiring assembly 280).

[0107] Internal wiring guides 287 and / or wiring spaces 282 may (i) provide storage areas for energy directors 222A and / or (ii) maintain organization of energy directors 222A. The details of internal wiring guides 287 may vary depending on the design requirements of catheter system 100, handle assembly 228, wiring assembly 280, and / or the specific needs, specifications, and / or desires of a user or operator.

[0108] Internal wiring guides 287 may position components such as energy director 222A. Figure 2B As shown, internal wiring guides 287 can position energy directors 222A in a slightly circular pattern. It should be understood that internal wiring guides 287 can take the form of any suitable number of geometric structures of any suitable size. Internal wiring guides 287 are merely provided for ease of understanding. Figure 2BInternal wiring guide 287 can cooperate with external wiring guide 288 to define a path capable of receiving a portion of energy director 222A so that the portion can be positioned around, around, and / or near internal wiring guide 287.

[0109] External wiring guide 288 may be substantially similar in form and / or function to internal wiring guide 287. Figure 2B Although shown as being arcuate in FIG. 2 , it will be appreciated that external wiring guides 288 may take the form of any suitable number of geometric structures of any suitable size.

[0110] Internal wiring guide 287 and / or external wiring guide 288 may be configured such that guide distal end 122D is movable relative to wiring assembly 280 due to changes in wiring length 222L stored in wiring space 282 .

[0111] In certain embodiments, inner wiring guide 287 and / or outer wiring guide 288 increase the likelihood that wiring length 222L remains in a circular orientation so that tension or axial movement experienced by energy director 222A does not cause energy director 22A to kink or otherwise bend at an undesirable angle. This reduces the likelihood of damaging energy director 222A.

[0112] In various embodiments, inner routing guides 287 and / or outer routing guides 288 may include posts or other structures having a width to maintain a spacing or diameter of routing lengths 222L positioned within routing spaces 282. The width of inner routing guides 287 and / or outer routing guides 288 may be greater than the bend or kink radius of energy director 222A, which may depend on the specific material from which energy director 222A is constructed.

[0113] During use of the catheter system 100 of the present technology during a medical procedure, an energy director 222A, such as an optical fiber, is positioned into the adapter assembly 285 through the optical guide 283, into the wiring space 282 around, around, and / or near the internal wiring guide 287. The energy director 222A is then directed out of the adapter assembly 285 at the housing distal end 285D toward the optical cable / electrical cable 278 combined with the cable 281. In addition, the cable 281 can be (i) directed through the optical cable / electrical cable 278 via the adapter assembly 285, (ii) directed through the wiring assembly 280, and / or (iii) directed out of the adapter assembly 285 and through the optical cable / electrical cable 278 to the housing distal end 285D.

[0114] During a medical procedure, if energy director 222A experiences, for example, Figure 1 In order to avoid axial movement and / or tension changes caused by the expansion of the energy director 222A, the wiring length 222L of the energy director 222A can be positioned in a ring within the wiring space 282, that is, as shown in Figure 2B As shown, an increase in the diameter of the ring portion will occur, thereby reducing the possibility of kinking, as well as reducing any excess forces on energy director 222A that may cause positioning deviation. Alternatively, if internal wiring guide 287 is rotatably coupled to the housing, the wiring length 222L of energy director 222A can be occupied by automatically or manually rotating internal wiring guide 287. If adapter assembly 285 includes a substantially circular shape, the diameter of the expanded ring portion of energy director 222A can be expanded to the width of the housing without contacting angled surfaces that may cause energy director 222A to kink or bend. In addition, separate entry portions of optical guide 283 and electrical guide 284 allow for separate and independent wiring of energy director 222A and cable 281, thereby allowing easy connection and manipulation of energy director 222A and / or cable 281 and their connection points.

[0115] Figure 3 is provided by energy director 222A (in Figure 2B ), wiring assembly 280 (in Figure 2B ) and adapter assembly 285 (e.g., as shown in Figure 2B 0048] A perspective view of an embodiment of an optical guide 383 used in various embodiments of the invention (shown in FIG. ).

[0116] Optical guide 383 can guide and / or protect energy director 222A (at Figure 2B The optical guide 383 may include a flexible cable that reduces spring energy accumulation when the guide and / or cable are coiled or bent. The details of the optical guide 383 may vary depending on the design requirements of the catheter system 200, handle assembly 228, wiring assembly 280, adapter assembly 285 and / or the specific needs, specifications and / or expectations of a user or operator.

[0117] The optical guide 383 may include a protective tube 383T. The protective tube 383T may be configured to allow the guide and / or the cable to move freely within the optical guide 383. In some embodiments, the protective tube 383T may be a spiral-cut (such as Figure 3383T can be at least partially formed of polytetrafluoroethylene and / or any suitable polymer. Optical guide light guide 383 and / or protective tube 383T can be at least partially formed of a light absorbing material (with or without fillers) that at least partially inhibits and / or absorbs unwanted light and / or energy escaping from optical guide 383 and / or protective tube 383T in the event of damage to energy director 222A and / or cable 281.

[0118] Figure 4A is a simplified schematic cross-sectional view of an embodiment of a connector assembly 452 including a wiring assembly 480 .

[0119] In some embodiments, routing assembly 480 may include external routing guides 488 for routing routing length 222L (eg, Figure 2B 480) to position energy directors 422A between inner routing guides 487 and outer routing guides 488 in routing space 482. Outer routing guides 488 may be displaced from inner routing guides 487 around, around, and / or near inner routing guides 487 around which energy directors 422A are positioned. Internal routing guides 487 and / or outer routing guides 488 cooperate to define the positioning and / or routing of respective energy directors 422A through routing assembly 480.

[0120] The details of the external wiring guide 488 can be determined according to the catheter system 100 (in Figure 1 ), connector assembly 452, wiring assembly 480 design requirements and / or the specific needs, specifications and / or expectations of a user or operator.

[0121] Between the inner wiring guide 487 and the outer wiring guide 488, the wiring assembly 480 may include, for example, a channel, groove, recess, hole, or the like in the body of the wiring assembly 480 between the inner wiring guide 487 and the outer wiring guide 488. Figure 4A As shown in the various illustrated embodiments, this space between the internal wiring guide 487 and the external wiring guide 488 can define multiple paths for receiving the wiring length 222L of the energy guide 422A to help manage and position the length of the energy guide 422A passing through the catheter system 100, thereby reducing the possibility of the energy guide 422A becoming tangled, kinked, etc.

[0122] Internal wiring guide 487 and / or external wiring guide 488 may also include guide retainer 489A. Guide retainer 489A may retain energy director 422A between internal wiring guide 487 and external wiring guide 488 and reduce the likelihood that energy director 422A will leave wiring space 482 during operation of catheter system 100 (including movement of energy director 422A). The design of guide retainer 489A may vary depending on the design requirements of wiring assembly 480, internal wiring guide 487, and / or external wiring guide 488. Although guide retainers 489A, 489B are preferably provided in a plurality of locations, guide retainers 489A, 489B may be provided in a plurality of locations. Figure 4A 482, it will be appreciated that any suitable geometry of any suitable size capable of retaining each energy director 422A within the wiring space 482 may be used.

[0123] Figure 4B yes Figure 4A A simplified schematic cross-sectional view of a wiring assembly 480 in FIG. Figure 4A-4B As shown, a plurality of guide retainers 489A, 489B are arranged in the wiring space 482 (in Figure 4A 422A are spaced apart from each other along the path of energy director 422A. Figure 4A As shown in the illustrated embodiment, energy director 422A can be held in routing space 482 around two inner directors 487A, 487B by director retainers 489A, 489B in some infinite annular and / or figure-eight orientation. This orientation limits the amount of mechanical strain applied to energy director 422A as it moves within routing space 482. It should be understood that inner routing guides 487A, 487B and / or outer routing guides 488 can include any suitable number, size, configuration, and / or distribution of director retainers 489A, 489B, depending on the design requirements of routing assembly 480.

[0124] exist Figure 4A-4B In the illustrated embodiment, the internal wiring guides 487A, 487B have different geometries and sizes to accommodate the wiring length 222L (eg, Figure 2B ) in an infinite annular and / or figure-of-eight orientation. For example, Figure 4A-4B In the various embodiments shown, one internal wiring guide 487 is slightly O-shaped, while another internal wiring guide 487 is slightly D-shaped.

[0125] The wiring assembly 480 may also include an assembly hole 490A. In some embodiments, the assembly hole 490A may be formed in various locations of the wiring assembly 480. For example, Figure 4BIn the illustrated embodiment, the plurality of assembly apertures 480A, 490B are positioned directly beneath corresponding guide retainers 489A.

[0126] The positioning of assembly aperture 490A allows for accommodation of additional wiring length 222L of energy director 422A and / or reduced stress / strain applied to guide retainers 489A, 489B when energy director 422A is positioned therebetween. In other words, assembly apertures 490A, 490B provide space for movement of energy director 422A while maintaining the position of energy director 422A in wiring space 482 when energy director 422A is received by external wiring guide 488 and retained by guide retainers 489A, 489B.

[0127] For example, Figure 4A and Figure 4B As shown, a portion of the wiring length 222L positioned toward the center of the wiring assembly 480 may become crowded due to the crossing and / or looping of the device 422A. The component hole 490A positioned in the central area of ​​the wiring assembly 480 can have an increased area to accommodate this crowding. In addition, the internal wiring guides 487A, 487B can include a plurality of guide retainers 489C positioned directly above the central component hole 490B.

[0128] Figure 4C is along Figure 4B A cross-sectional view of the wiring assembly 480 taken along line 4C-4C in FIG. Figure 4C As shown, the wiring assembly 480 may include cross-sectional spaces defined before the internal wiring guides 487A, 487B, between the internal wiring guide 487A and the external wiring guide 488, and / or between the internal wiring guide 487B and the external wiring guide 488. These cross-sectional spaces are Figure 4C shaped, but it should be understood that any suitable number of cross-sectional spaces, shapes and / or sizes may be used to define Figure 4A-4C Wiring space 482 is shown in the various embodiments shown.

[0129] Figure 5 is a simplified top view of an embodiment of a connector assembly 552. More specifically, Figure 5 Various internal components and features that may be included in various embodiments of connector assembly 552 are shown. Figure 5 As shown, in some embodiments, the connector assembly 552 may include a portion of one or more energy directors 522A (e.g., Figure 2B The wiring length 222L) and wiring assembly 580 shown in FIG.

[0130] In various embodiments, connector assembly 552 can be configured to provide strain relief as it brings each of the individual energy directors 522A closer together so that energy directors 522A and / or energy directing bundles 522 can be moved together as they are in catheter system 100 (at Figure 1 ) during use with the catheter 102 (in Figure 1 ) together with the blood vessel 108 (shown in Figure 1 For ease of understanding, in some embodiments, such as in Figure 5 As shown in FIG, for ease of understanding, multiple individual energy directors 522A are shown as an energy guiding bundle 522. It should be understood that the individual energy directors 522A do not necessarily need to be bundled, as shown in FIG. Figure 4A The various embodiments shown are shown.

[0131] The design of each energy director 522A can vary. Figure 5 As shown, in some embodiments, each of the individual energy directors 522A and / or energy directing beam 522 may include a protective tube 583 (also in Figure 3 ), when energy director 522A is directed with catheter 102 toward balloon 104 (at Figure 1 When the energy director 522A is extended (shown in FIG. 5 ), all energy directors 522A are retained within the protective tube 583. The connector assembly 552 may also include a locking crimp 588 configured to tightly gather the energy directors 522A together to form the energy directing bundle 522 in a controlled manner.

[0132] In some embodiments, connector assembly 552 may be at least partially removable to expose energy director 522A and / or wiring space 582 so that an operator can maintain, repair and / or remove energy director 522A (or any other component of connector assembly 552).

[0133] Internal wiring guide 587C can extend wiring length 222L (at Figure 2B ) are positioned in the wiring space 582. For example, Figure 5 As shown, internal wiring guide 587C can place wiring length 222L of energy director 522A in a slightly circular pattern. It should be understood that internal wiring guide 587C can take the form of any suitable geometric structure, and internal wiring guide 587C can be arranged in a circular pattern. Figure 5587C is shown as a circle, which is only for ease of understanding. Internal wiring guide 587C can define a path that can receive wiring length 222L of energy director 522A, so that wiring length 222L can form a ring around internal wiring guide 587C. Internal wiring guide 587C can be configured so that the distal end 122D (at Figure 1 ) is capable of moving relative to connector assembly 552.

[0134] In certain embodiments, internal wiring guide 587C increases the likelihood that a portion of energy director 522A (e.g., wiring length 222L) remains in a circular orientation so that tension or axial movement experienced by energy director 522A does not cause energy director 522A to kink or otherwise bend at an undesirable angle. This reduces the likelihood of damaging energy director 522A.

[0135] Internal routing guides 587C may include posts or other structures having a width to maintain the spacing or diameter of the portions of energy directors 522A that are located within routing spaces 582. The width of internal routing guides 587C may be greater than the bend or kink radius of energy directors 522A, which may depend on the specific materials from which energy directors 522A are constructed.

[0136] In some embodiments, wiring assembly 580 may also include external wiring guide 488 (e.g., as shown in FIG. 4 with respect to wiring assembly 480) for receiving a portion of energy director 522A to position energy director 522A within wiring space 582. External wiring guide 488 may be displaced from a portion of internal wiring guide 587C around which energy director 522A has been looped to provide spacing between energy directors 522A within connector assembly 552. Depending on the design requirements of wiring assembly 580, the outer housing of connector assembly 552 may also function as external wiring guide 488.

[0137] As provided herein, in various embodiments, the catheter systems and related methods disclosed herein may include a catheter configured to be advanced to a vascular lesion at a treatment site, the treatment site being located within or adjacent to a blood vessel in a patient's body, the vascular lesion being, for example, a calcified vascular lesion or a fibrotic vascular lesion. The catheter includes a catheter shaft and an expandable balloon coupled and / or fixed to the catheter shaft. The balloon may include a balloon wall defining an interior of the balloon. The balloon may be configured to receive a catheter fluid within the balloon interior to expand from a contracted state suitable for advancing the catheter through the patient's vascular system to an expanded state suitable for anchoring the catheter in an appropriate position relative to the treatment site.

[0138] In certain embodiments, catheter systems and related methods utilize an energy source, such as a light source (such as a laser or another suitable energy source) that provides energy directed by one or more energy directors (e.g., light directors such as optical fibers) disposed along the catheter shaft and disposed within the balloon interior of the balloon to generate a localized plasma in the catheter fluid retained within the balloon interior of the balloon. The energy directors may be used in conjunction with a plasma generator positioned at or near a director distal end of the energy director, the director distal end of the energy director being within the balloon interior of the balloon at a treatment site. The generation of a localized plasma may induce a pressure wave and may induce the rapid formation of one or more bubbles that may rapidly expand to a maximum size and then dissipate through a cavitation event that may emit a pressure wave upon collapse. The rapid expansion of the plasma-induced bubbles (sometimes also referred to simply as "plasma bubbles") may generate one or more pressure waves in the catheter fluid retained within the balloon interior of the balloon, thereby applying the pressure waves to and inducing a rupture in a vascular lesion at a treatment site within or adjacent to a vascular wall within the patient's body. In some embodiments, the energy source can be configured to provide sub-millisecond energy pulses, such as light energy, to induce plasma formation in the catheter fluid within the balloon, thereby causing rapid bubble formation and exerting pressure waves on the balloon wall at the treatment site. Thus, the pressure waves can transfer mechanical energy to the treatment site through the incompressible catheter fluid, thereby exerting a fracture force on the intravascular lesion. Without wishing to be bound by any particular theory, it is believed that the rapid change in momentum of the catheter fluid on the balloon wall in contact with the intravascular lesion is transferred to the intravascular lesion, inducing fracture of the lesion.

[0139] The catheter system and related methods disclosed herein may also include a handle assembly that is attached to the catheter shaft and is handled and used by a user or operator to operate, position and control the catheter. In various embodiments, the handle assembly has a source manifold that is incorporated into and / or integrated therein. In such embodiments, the source manifold may include one or more of the following: a manifold housing; a pressure sensor that is coupled to and / or integrated in the manifold housing; and a medium expansion port, a guidewire cavity port, an energy director 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 in the catheter system. For example, in certain embodiments, the pressure sensor may be configured to sense the fluid pressure inside the balloon or at any desired position along the expansion conduit. The medium expansion port is configured to couple the expansion conduit to the manifold housing and / or pass through the manifold housing so that the catheter fluid can be guided through the handle assembly and guided into the balloon interior as needed. The guidewire cavity port is configured to connect the guidewire cavity, which defines a conduit through which the guidewire extends into the manifold housing, extends from the manifold housing and / or extends through the manifold housing, so that the guidewire cavity can therefore extend from the handle assembly into the balloon interior and / or through the balloon interior. The energy director port is configured to connect one or more energy directors to the manifold housing and / or through the manifold housing, so that the energy director can direct energy from the energy source through the handle assembly and into the balloon interior. The catheter shaft port is configured to connect the catheter shaft to the manifold housing so that a user can effectively control the positioning of the catheter shaft substantially adjacent to the vascular lesion at the treatment site by manipulating the handle assembly, wherein the balloon is attached to the catheter shaft.

[0140] 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 dictate otherwise. It should also be noted that the term "or" is generally employed in its sense including "and / or" unless the content or context clearly dictates otherwise.

[0141] It should also be noted that, as used in this specification and the appended claims, the phrase "configured" describes a system, device, or other structure that is constructed or configured to perform a specific task or adopt a specific configuration. The phrase "configured" may be used interchangeably with other similar phrases, such as arrange and configure, construct and arrange, construct, manufacture, and arrange, etc.

[0142] The headings used herein are intended to be consistent with the recommendations under 37 CFR 1.77, or to otherwise provide organizational cues. These headings should not be considered to limit or characterize the invention(s) listed in any claims that may issue from this disclosure. As an example, a description of technology in the “Background” is not an admission that the technology is prior art to any invention in this disclosure. Nor should the “Summary” or “Abstract” be considered to characterize the invention(s) set forth in the issued claims.

[0143] The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the accompanying detailed description. Instead, the embodiments are selected and described to enable others skilled in the art to recognize and understand the principles and practices. Therefore, various aspects have been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of this article.

[0144] It is to be understood that although many different embodiments of the catheter system have been illustrated and described herein, one or more features of any one embodiment may be combined with one or more features of one or more other embodiments as long as such combination meets the intent of the present invention.

[0145] Although many exemplary aspects and embodiments of the catheter system have been discussed above, those skilled in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and the claims introduced below be interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope, and no limitations are intended to the details of construction or design shown herein.

Claims

1. A catheter system for treating a treatment site in or adjacent to a blood vessel wall or a heart valve in a patient, the catheter system comprising a first energy director and a second energy director, the catheter system comprising: A wiring assembly defining a wiring space that holds a wiring length for each of the energy directors, the wiring assembly including an internal wiring guide positioned within the wiring space, the wiring length for each of the energy directors at least partially positioned around the internal wiring guide, the wiring space being configured such that the wiring length of at least one of the energy directors is adjustable.

2. The catheter system according to claim 1, wherein: Each of the energy directors comprises an optical fiber.

3. The catheter system according to any one of claims 1 to 2, wherein: Each of the energy directors includes a director distal end and a director proximal end.

4. The catheter system of claim 3, wherein: The guide proximal end is fixed relative to the wiring assembly.

5. The catheter system according to any one of claims 3-4, wherein: The guide distal end is movable relative to the wiring assembly.

6. The catheter system according to any one of claims 1 to 5, wherein: Each energy director is positioned at least approximately 90 degrees around the internal wiring guide.

7. The catheter system of any one of claims 1-6, further comprising an adapter assembly that accommodates the internal wiring guide.

8. The catheter system of any one of claims 1-7, further comprising an electrical cable positioned around the internal wiring guide.

9. The catheter system according to any one of claims 1 to 8, wherein: Each energy director includes an optical director configured to protect each energy director.

10. The catheter system of any one of claims 1-9, further comprising a handle assembly usable by a user to selectively position the energy director proximate the treatment site, the wiring assembly being positioned distally from the handle assembly.

11. The catheter system of any one of claims 1-10, further comprising a connector assembly that positions the energy directors more closely together, the wiring assembly being positioned within the connector assembly.

12. A catheter system for treating a treatment site in or adjacent to a blood vessel wall or a heart valve in a patient, the catheter system comprising a first energy director and a second energy director, the catheter system comprising: a handle assembly usable by a user to selectively position the energy director proximate the treatment site; and A wiring assembly, the wiring assembly defining a wiring space, the wiring space maintaining a wiring length of each of the energy directors, the wiring assembly being positioned outside the handle assembly, the wiring assembly including an internal wiring guide positioned within the wiring space, the wiring length of each of the energy directors being at least partially positioned around the internal wiring guide, the wiring space being configured such that the wiring length of at least one of the energy directors is adjustable.

13. The catheter system of claim 12, further comprising a connector assembly that positions the energy directors more closely together, the wiring assembly being positioned within the connector assembly.

14. The catheter system according to any one of claims 12-13, wherein: Each of the energy directors comprises an optical fiber.

15. The catheter system according to any one of claims 12 to 14, wherein: Each of the energy directors includes a director distal end and a director proximal end.

16. The catheter system of claim 15, wherein: The guide proximal end is fixed relative to the wiring assembly.

17. The catheter system according to any one of claims 15-16, wherein: The guide distal end is movable relative to the wiring assembly.

18. The catheter system according to any one of claims 12 to 17, wherein: Each of the energy directors is positioned at least approximately 90 degrees around the internal wiring guide.

19. The catheter system of any one of claims 12-18, further comprising an adapter assembly that receives the internal wiring guide.

20. A catheter system for treating a treatment site in or adjacent to a blood vessel wall or a heart valve in a patient, the catheter system comprising a first energy director and a second energy director, the catheter system comprising: a handle assembly usable by a user to selectively position the energy director proximate the treatment site; a connector assembly that brings each of the energy directors closer together so that the energy directors are in a more compact form; and A wiring assembly, the wiring assembly defining a wiring space, the wiring space maintaining a wiring length of each of the energy directors, the wiring assembly being positioned outside of the handle assembly, the wiring assembly including an internal wiring guide positioned within the wiring space, the wiring length of each of the energy directors being positioned to at least partially surround the internal wiring guide, the wiring space being configured such that the wiring length of at least one of the energy directors is adjustable, each of the energy directors being positioned to surround the internal wiring guide by at least approximately 90 degrees.

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