Manifold-integrated handle assembly for intravascular lithotripsy device - Patents.com

Abstract

A catheter system 100 for treating a vascular lesion 106A within or adjacent to a vascular wall 108A of a blood vessel 108 within a body 107 of a patient 109 includes a catheter shaft 210, a handle assembly 228, and a source manifold 236. The handle assembly 228 is coupled to the catheter shaft 210. The handle assembly 228 includes an assembly housing 266. The handle assembly 228 is usable by a user to selectively position the catheter shaft 210 proximate the vascular lesion 106A. The source manifold 236 is coupled to the assembly housing 266. The source manifold 236 includes a manifold housing 282 having a catheter shaft port 264 configured to receive a portion of the catheter shaft 210 such that the catheter shaft 210 is coupled to the manifold housing 282.

Description

[Technical field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 309,867, filed February 14, 2022, and from U.S. Patent Application No. 18 / 106,801, filed February 7, 2023. To the extent permitted, the contents of U.S. Provisional Patent Application No. 63 / 309,867 and U.S. Patent Application No. 18 / 106,801 are incorporated herein by reference in their entireties. [Background technology]

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

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

[0004] Intravascular lithotripsy is a method that has been used in recent years with some success to break up vascular lesions in blood vessels in the body. Intravascular lithotripsy utilizes a combination of pressure waves and bubble dynamics that are intravascularly generated in a fluid-filled balloon catheter. In particular, during an intravascular lithotripsy treatment, a high energy source is used to generate plasma and ultimately pressure waves as well as rapid bubble expansion in a fluid-filled balloon to break up calcifications at a treatment site in the vasculature, including one or more vascular lesions. The associated rapid bubble formation from plasma initiation and the resulting localized fluid velocity in the balloon transfers mechanical energy through the incompressible fluid, providing a breakup force against the calcium in the blood vessel, which is opposed to the balloon wall. The rapid change in fluid momentum when hitting the balloon wall is known as hydraulic shock or water hammer. Summary of the Invention [Problem to be solved by the invention]

[0005] There is a continuing need to increase the optimization of vascular patency and therapy delivery parameters in intravascular lithotripsy catheter systems in a manner that is relatively controllable and can be consistently manufactured. [Means for solving the problem]

[0006] The present invention is directed to a catheter system for placement within a blood vessel having a vascular wall. The catheter system can be used by a user to treat a vascular lesion within or adjacent to a vascular wall within a patient. In various embodiments, the catheter system includes a catheter shaft, a handle assembly, and a source manifold. The handle assembly is coupled to the catheter shaft. The handle assembly includes an assembly housing. The handle assembly is usable by a user to selectively position the catheter shaft proximate the vascular lesion. The source manifold is coupled to the assembly housing. The source manifold includes a manifold housing having a catheter shaft port configured to receive a portion of the catheter shaft such that the catheter shaft is coupled to the manifold housing.

[0007] In some embodiments, the source manifold is positioned substantially within the assembly housing.

[0008] In certain embodiments, the catheter system further includes a pressure sensor coupled to the manifold housing and configured to sense a fluid pressure of a catheter fluid within the catheter system.

[0009] In some embodiments, the handle assembly further includes circuit wiring electrically coupled to the pressure sensor.

[0010] In one embodiment, the circuitry includes a printed circuit board.

[0011] In certain embodiments, the handle assembly further includes an energy activator coupled to the circuit wiring, the energy activator configured to allow a user to selectively activate the catheter system.

[0012] In some embodiments, the manifold housing includes a sensor bore and the pressure sensor is positioned in the sensor bore.

[0013] In many embodiments, the manifold housing includes a first housing member and a second housing member selectively attached to one another via a mounting assembly.

[0014] In some embodiments, the mounting assembly includes a first mounting member coupled to the first housing member and a second mounting member coupled to the second housing member, the first mounting member configured to engage the second mounting member when the first housing member is mounted to the second housing member.

[0015] In one embodiment, the first mounting member includes a mounting channel and the second mounting member includes a mounting projection.

[0016] In certain embodiments, the first mounting member and the second mounting member are attached to one another with an adhesive material.

[0017] In another embodiment, the first mounting member and the second mounting member are ultrasonically sealed to one another.

[0018] In some embodiments, the catheter system further includes a balloon coupled to the catheter shaft, the balloon including a balloon wall defining a balloon interior and configured to retain a catheter fluid within the balloon interior.

[0019] In certain embodiments, the balloon is selectively inflatable with catheter fluid to expand to an inflated state, and when the balloon is in the inflated state, the balloon wall is configured to be positioned substantially adjacent to the vascular lesion.

[0020] In some embodiments, the catheter system further includes a pressure sensor coupled to the manifold housing and configured to sense a fluid pressure of the catheter fluid within the balloon interior.

[0021] In many embodiments, the catheter system further includes an energy guide coupled to the source manifold, the energy guide including a guide distal end configured to be positioned within the balloon interior.

[0022] In some embodiments, the energy guide is configured to guide energy from the energy source through the energy guide and into the interior of the balloon.

[0023] In certain embodiments, an energy guide that guides energy from an energy source to the interior of the balloon creates plasma bubbles in the catheter fluid within the balloon interior.

[0024] In some embodiments, energy from the plasma bubbles is directed toward a portion of the balloon wall positioned substantially adjacent to the vascular lesion.

[0025] In various embodiments, the energy guide generates one or more pressure waves in the catheter fluid that impart a force to the vascular lesion.

[0026] In certain embodiments, the energy guide comprises an optical fiber.

[0027] In some embodiments, the energy source includes a laser.

[0028] In another embodiment, the energy source is a high voltage energy source that provides pulses of high voltage.

[0029] In one embodiment, the energy guide includes an electrode pair including spaced apart electrodes extending into the balloon interior, and high voltage pulses from an energy source are applied to the electrodes to form an electrical arc across the electrodes.

[0030] In certain embodiments, the manifold housing includes an energy guide port and the energy guide is coupled to the manifold housing via the energy guide port.

[0031] In some embodiments, the catheter system further includes a plurality of energy guides coupled to the source manifold, each including a guide distal end configured to be positioned within the balloon interior.

[0032] In many embodiments, the multiple energy guides are coupled into the energy guide port utilizing an optical sealing component, the optical sealing component including a sealing body and a multiple guide channels formed through the sealing body, and each of the multiple energy guides is configured to extend through one of the multiple guide channels.

[0033] In certain embodiments, the manifold housing further includes a guidewire lumen port, and the guidewire lumen is coupled to the manifold housing via the guidewire lumen port.

[0034] In some embodiments, the manifold housing further includes a media inflation port, and the inflation conduit is coupled to the manifold housing via the media inflation port.

[0035] In certain embodiments, the inflation conduit is configured to guide catheter fluid into the balloon interior.

[0036] In one embodiment, the manifold housing includes a first housing member and a second housing member selectively attached to one another, and each of the catheter shaft port, the energy guide port, the guidewire lumen port, and the media inflation port are formed in the second housing member.

[0037] The present invention is further directed to a method for treating a vascular lesion in or adjacent to a blood vessel within a patient's body, the method including the steps of coupling a handle assembly including an assembly housing to a catheter shaft, selectively positioning the catheter shaft proximate the vascular lesion through use of the handle assembly, and coupling a source manifold to the assembly housing, the source manifold including a manifold housing having a catheter shaft port configured to receive a portion of the catheter shaft such that the catheter shaft is coupled to the manifold housing.

[0038] 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 viewing the drawings that form a part of it, each of which should not be taken in a limiting sense. The scope of the present specification is defined by the appended claims and their legal equivalents.

[0039] The novel features of the present invention, as well as the invention itself, both as to its structure and its operation, can best be understood from the accompanying drawings in conjunction with the accompanying description, in which like reference characters refer to like parts and in which: [Brief description of the drawings]

[0040] [Figure 1] FIG. 1 is a simplified schematic cross-sectional view of one embodiment of a catheter system according to various embodiments, the catheter system including a handle assembly having distinctive features of the present invention, including a source manifold integrated into the handle assembly. [Diagram 2] FIG. 2 is a simplified cutaway view of one embodiment of the handle assembly of FIG. 1. [Diagram 3] FIG. 2 is a simplified perspective view of one embodiment of the source manifold of FIG. [Figure 4]FIG. 4 is a simplified cutaway perspective view of a portion of the source manifold of FIG. 3. [Diagram 5] FIG. 4 is a simplified schematic diagram of a multi-lumen optical sealing component coupling multiple energy guides within the source manifold of FIG. 3. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] While embodiments of the present invention are susceptible to various modifications and alternative forms, certain of which have been shown by way of example and drawings and are described in detail herein. It is to be understood, however, that the scope of the present invention is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives that are within the spirit and scope of the present invention.

[0042] Treatment of vascular lesions can reduce serious adverse events or death in affected subjects. With reference to this specification, serious adverse events are those that may occur anywhere in the body due to the presence of vascular lesions. Serious adverse events may include, but are not limited to, serious adverse events of the heart, serious adverse events in the peripheral or central vascular systems, serious adverse events of the brain, serious adverse events of the muscular system, or serious adverse events of any of the internal organs.

[0043] In various embodiments, the catheter systems and associated methods disclosed herein can include a catheter configured to advance to a vascular lesion, such as a calcified or fibrous vascular lesion, at a treatment site located within or adjacent to a blood vessel within a patient's body. The catheter can include a catheter shaft and an inflatable balloon coupled to and / or secured to the catheter shaft. The balloon can include a balloon wall defining a balloon interior. The balloon can be configured to contain a catheter fluid within the balloon interior to expand from a deflated state suitable for advancing the catheter through the patient's vasculature to an inflated state suitable for anchoring the catheter in place relative to the treatment site.

[0044] As used herein, the terms "treatment site," "intravascular lesion," and "vascular lesion" are used interchangeably unless otherwise indicated. Thus, an intravascular lesion and / or a vascular lesion may sometimes be referred to herein simply as a "lesion."

[0045] Those skilled in the art will recognize that the following detailed description of the present invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the present invention will readily suggest themselves to such skilled artisans having the benefit of this disclosure. Reference will now be made in detail to implementations of the present invention as illustrated in the accompanying drawings. The same or similar names and / or reference indices may be used throughout the drawings and the following detailed description to refer to the same or similar parts.

[0046] In the interest of clarity, not all of the typical features of the implementations described herein are shown and described. It is understood that in the development of any such actual implementation, many implementation-specific decisions will need to be made to achieve the specific goals of the developer, such as compliance with application-related and business-related constraints, and that such specific goals will vary from one implementation to another, and from one developer to another. It is further recognized that such a development effort may be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure.

[0047] The catheter system disclosed herein can include many different configurations. Referring now to FIG. 1, a simplified schematic cross-sectional view shows a catheter system 100 according to various embodiments. The catheter system 100 is adapted to induce a pressure wave to induce fragmentation in one or more vascular lesions in or adjacent to a vessel wall of a blood vessel or at or adjacent to a heart valve within a patient's body. In the embodiment illustrated 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 ("GUI"), and a handle assembly 128 including a source manifold 136 integrated into the handle assembly 128. Alternatively, the catheter system 100 can include more or fewer components than those specifically illustrated and described in connection with FIG. 1.

[0048] The catheter 102 is configured to travel to a treatment site 106 within or adjacent to a vascular wall 108A of a blood vessel 108 in the body 107 of a patient 109. The treatment site 106 may include one or more vascular lesions 106A, such as, for example, a calcified vascular lesion. Additionally or alternatively, the treatment site 106 may include a vascular lesion 106A, such as a fibrous vascular lesion. Further alternatively, in some implementations, the catheter 102 may be used at a treatment site 106 within or adjacent to a heart valve in the body 107 of a patient 109.

[0049] The catheter 102 may include an inflatable balloon 104 (sometimes simply referred to herein 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 travel over the guidewire 112. As utilized herein, the guidewire lumen 118 defines a conduit through which the guidewire 112 extends. The catheter shaft 110 may further include an inflation lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, the catheter 102 has a distal end opening 120 that can accommodate and track over the guidewire 112 as the catheter 102 is moved and positioned at or near the treatment site 106. In some embodiments, the balloon proximal end 104P can be coupled to the catheter shaft 110 and the balloon distal end 104D can be coupled to the guidewire lumen 118.

[0050] The balloon 104 includes a balloon wall 130 that defines a balloon interior 146. The balloon 104 can be selectively inflated with a catheter fluid 132 to expand from a deflated state suitable for advancing the catheter 102 through a patient's vasculature to an inflated state (as shown in FIG. 1 ) suitable for anchoring the catheter 102 in place relative to the treatment site 106. Stated differently, when the balloon 104 is in an inflated state, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. While FIG. 1 illustrates the balloon wall 130 of the balloon 104 shown spaced apart from the treatment site 106 of the blood vessel 108 when in the inflated state, it will be understood that this is done for ease of illustration. It will be appreciated that the balloon wall 130 of the balloon 104 will typically be substantially directly adjacent and / or directly abutting the treatment site 106 when the balloon 104 is in an inflated state.

[0051] Suitable balloons 104 for use within the catheter system 100 include those that, when in a deflated state, are capable of passing through the vasculature of a patient 109. In some embodiments, the balloon 104 is made from silicone. In other embodiments, the balloon 104 may be made from materials such as polydimethylsiloxane (PDMS), polyurethane, a polymer such as PEBAX® material, nylon, or any other suitable material.

[0052] The balloon 104 can have any suitable diameter (in an inflated state). In various embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from less than 1 millimeter (mm) to 25 mm. In some embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from at least 1.5 mm to 14 mm. In some embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from at least 2 mm to 5 mm.

[0053] In some embodiments, the balloon 104 can have a length ranging from at least 3 mm to 300 mm. More particularly, in some embodiments, the balloon 104 can have a length ranging from at least 8 mm to 200 mm. It is understood that a balloon 104 having a relatively longer length can be positioned adjacent a larger treatment site 106 and can be used to deliver pressure waves to a larger vascular lesion 106A or multiple vascular lesions 106A at precise locations within the treatment site 106 and induce fragmentation within such lesions. It is further understood that a longer balloon 104 can be positioned adjacent multiple treatment sites 106 at any given time.

[0054] The balloon 104 can be inflated to an inflation pressure of approximately between 1 atmosphere (atm) and 70 atm. In some embodiments, the balloon 104 can be inflated to an inflation pressure of at least 20 atm and 60 atm. In other embodiments, the balloon 104 can be inflated to an inflation pressure of at least 6 atm and 20 atm. In yet other embodiments, the balloon 104 can be inflated to an inflation pressure of at least 3 atm and 20 atm. In yet other embodiments, the balloon 104 can be inflated to an inflation pressure of at least 2 atm and 10 atm.

[0055] The balloon 104 can have a variety of shapes, including, but not limited to, conical, square, rectangular, spherical, conical / square, conical / spherical, elongated spherical, elliptical, tapered, bone, step diameter, offset, or conical offset. In some embodiments, the balloon 104 can include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or drug eluting stent can include one or more therapeutic agents, including anti-inflammatory agents, anti-neoplastic agents, anti-angiogenesis inhibitors, and the like.

[0056] 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, a gas such as fluorocarbon, perfluorocarbon, carbon dioxide, or any other suitable catheter fluid 132. In some embodiments, the catheter fluid 132 may be used as a base inflation fluid. In some embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium in an approximately 50:50 volume ratio. In other embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium in an approximately 25:75 volume ratio. In still other embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium in an approximately 75:25 volume ratio. However, it is understood that any suitable saline and contrast medium ratio may be used. The catheter fluid 132 may be adjusted based on composition, viscosity, etc., such that the speed of travel of the pressure wave is appropriately manipulated. In certain embodiments, the catheter fluid 132 suitable for use is biocompatible. The volume of catheter fluid 132 can be adjusted depending on the energy source 124 selected and the type of catheter fluid 132 used.

[0057] In some embodiments, the contrast agent used as the contrast medium may include, but is not limited to, an iodine-based contrast agent, such as an ionic or non-ionic iodine-based contrast agent. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoic acid, metrizoic acid, iothalamic acid salt, 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-based contrast agents may include gadolinium (III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon agents may include, but are not limited to, agents such as the perfluorocarbon dodecafluoropentane (DDFP, C5F12).

[0058] The catheter fluid 132 can include those containing absorbers capable of selectively absorbing light in the ultraviolet (e.g., at least 10 nanometers (nm) to 400 nm), visible (e.g., at least 400 nm to 780 nm), or near infrared (e.g., at least 780 nm to 2.5 μm) regions of the electromagnetic spectrum. Suitable absorbers can include those having an absorption maximum along a spectrum from at least 10 nm to 2.5 μm. Alternatively, the catheter fluid 132 can include those containing absorbers capable of selectively absorbing light in the mid-infrared (e.g., at least 2.5 μm to 15 μm) or far-infrared (e.g., at least 15 μm to 1 mm) regions. In various embodiments, the absorbers can have an absorption maximum that coincides with the emission maximum of a laser used in the catheter system 100. By way of non-limiting example, various lasers that can be used in the catheter system 100 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 may be water soluble. In other embodiments, the absorbent is water insoluble. In some embodiments, the absorbent used in the catheter fluid 132 can be tailored to match the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths of at least 10 nanometers to 1 millimeter are discussed elsewhere herein.

[0059] The catheter shaft 110 of the catheter 102 may be coupled to one or more energy guides 122A of the energy guide bundle 122 in optical communication with an energy source 124. The energy guides 122A may be disposed along the catheter shaft 110 and within the balloon 104. In some embodiments, each energy guide 122A may be an optical fiber and the energy source 124 may be a laser. The energy source 124 may be in optical communication with the energy guides 122A at the proximal portion 114 of the catheter system 100.

[0060] In some embodiments, the catheter shaft 110 may be coupled to multiple energy guides 122A, such as a first energy guide, a second energy guide, a third energy guide, etc., which may be positioned at any suitable location around and / or relative to the guidewire lumen 118 and / or catheter shaft 110. For example, in certain non-exclusive embodiments, two energy guides 122A may be spaced apart by approximately 180 degrees around the circumference of the guidewire lumen 118 and / or catheter shaft 110, three energy guides 122A may be spaced apart by approximately 120 degrees around the circumference of the guidewire lumen 118 and / or catheter shaft 110, four energy guides 122A may be spaced apart by approximately 90 degrees around the circumference of the guidewire lumen 118 and / or catheter shaft 110, and so forth. Alternatively, the multiple energy guides 122A need not be uniformly spaced from one another around the circumference of the guidewire lumen 118 and / or catheter shaft 110. More specifically, it will be further appreciated that the energy guides 122A can be uniformly or non-uniformly spaced around the guidewire lumen 118 and / or catheter shaft 110 to achieve a desired effect at a desired location.

[0061] The catheter system 100 and / or the energy guide bundle 122 can include any number of energy guides 122A in optical communication with the energy source 124 at the proximal portion 114 and in optical communication with the catheter fluid 132 in the balloon interior 146 of the balloon 104 at the distal portion 116. For example, in some embodiments, the catheter system 100 and / or the energy guide bundle 122 can include one energy guide 122A to more than thirty energy guides 122A. Alternatively, in other embodiments, the catheter system 100 and / or the energy guide bundle 122 can include more than thirty energy guides 122A.

[0062] The energy guide 122A can have any suitable design for the purpose of generating plasma and / or pressure waves in the catheter fluid 132 within the balloon interior 146. Thus, the general description of the energy guide 122A as a light guide is not intended to be limiting in any manner, except as described in the claims appended hereto. More specifically, while the catheter system 100 is often described with the energy source 124 as a light source and one or more energy guides 122A as light guides, the catheter system 100 can alternatively include any suitable energy source 124 and energy guides 122A for the purpose of generating the 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, pulses of high voltage are applied to the electrodes, forming an electric arc across the electrodes, which in turn generates a plasma in the catheter fluid 132, creating pressure waves that are utilized to provide a disruptive force against the vascular lesion 106A at the treatment site 106. Further alternatively, the energy source 124 and / or energy guide 122A may have another suitable design and / or configuration.

[0063] In certain embodiments, the energy guide 122A may include an optical fiber or a flexible light conductor. The energy guide 122A may be thin and flexible, allowing the optical signal to be transmitted with very little loss of intensity. The energy guide 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 the energy guide 122 may be formed from one or more materials, including, but not limited to, one or more types of glass, silica, or one or more polymers. The energy guide 122A may also include a protective coating, such as a polymer. It is understood that the refractive index of the core is greater than the refractive index of the cladding.

[0064] Each energy guide 122A can guide energy along its length from a proximal guide end 122P to a distal guide end 122D having at least one optical window (not shown) positioned within the balloon interior 146.

[0065] The energy guide 122A can assume many configurations around and / or relative 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.

[0066] The energy guides 122A may also be positioned at any suitable location around the circumference of the guidewire lumen 118 and / or catheter shaft 110, and the guide distal end 122D of each of the energy guides 122A may be positioned at any suitable longitudinal location relative to the length of the balloon 104 and / or relative to the length of the guidewire lumen 118 to more effectively and precisely deliver pressure waves at the treatment site 106 for the purpose of destroying the vascular lesion 106A.

[0067] In certain embodiments, the energy guide 122A can include one or more optoacoustic transducers 154, where each optoacoustic transducer 154 can be in optical communication with the energy guide 122A in which it is disposed. In some embodiments, the optoacoustic transducer 154 can be in optical communication with the guide distal end 122D of the energy guide 122A. In such embodiments, the optoacoustic transducer 154 can have a shape that corresponds to and / or matches the guide distal end 122D of the energy guide 122A.

[0068] The photoacoustic transducer 154 is configured to convert optical energy into acoustic waves at or near the distal guide end 122D of the energy guide 122A. The direction of the acoustic waves can be adjusted by changing the angle of the distal guide end 122D of the energy guide 122A.

[0069] 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 certain 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 spherical shape, a square shape, a stepped shape, a semicircular shape, an 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.

[0070] In some embodiments, the energy guide 122A can further include one or more redirection mechanisms or “diverters” (not shown in FIG. 1 ), such as within the energy guide 122A and / or near the guide distal end 122D of the energy guide 122A, configured to redirect energy from the energy guide 122A toward a side that may be located at or near the guide distal end 122D of the energy guide 122A before the energy is directed toward the balloon wall 130. The redirection mechanism can include any mechanism in the system that redirects energy from the energy guide 122A away from its axial path and toward a side of the energy guide 122A. The energy guides 122A can each include one or more optical windows disposed along a longitudinal or circumferential surface of each energy guide 122A and in optical communication with the redirection mechanism. Stated another way, the redirection mechanism can be configured to direct energy from the energy guide 122A towards a side at or near the guide distal end 122D, where that side 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 from within the energy guide 122A, such as a portion of the energy guide 122A that has no cladding material on or around it.

[0071] Examples of redirection mechanisms suitable for use include reflective elements, refractive elements, and fiber diffusers. Diversion mechanisms suitable for concentrating energy away from the tip of the energy guide 122A can include, but are not limited to, those with convex surfaces, gradient index (GRIN) lenses, and mirror focus lenses. Upon contact with the redirection mechanism, the energy is redirected within the energy guide 122A to one or more of the plasma generator 133 and the photoacoustic transducer 154, which are in optical communication with the sides of the energy guide 122A. When utilized, the photoacoustic transducer 154 then converts the optical energy into acoustic waves that extend away from the sides of the energy guide 122A.

[0072] As noted above, in the embodiment illustrated in FIG. 1, the system console 123 includes one or more of the energy source 124, the power source 125, the system controller 126, and the GUI 127. Alternatively, the system console 123 may include more or fewer components than those specifically illustrated in FIG. 1. For example, in certain non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127. Further alternatively, one or more of the energy source 124, the power source 125, the system controller 126, and the GUI 127 may be provided in any suitable location within the catheter system 100 without any special need for the system console 123.

[0073] As shown, the system console 123 and components included therewith are operably coupled to the catheter 102, the energy guide bundle 122, and the remainder of the catheter system 100. For example, in some embodiments, as illustrated in FIG. 1, the system console 123 can include a console connection hole 148 (sometimes also commonly referred to as a "socket") by which the energy guide bundle 122 is mechanically coupled to the system console 123. In such embodiments, the energy guide bundle 122 can include a guide coupling housing 150 (sometimes also commonly referred to as a "ferrule") that houses a portion of each of the energy guides 122A, such as the guide proximal end 122P. The guide coupling housing 150 is configured to fit into and be selectively retained within the console connection hole 148 to provide a mechanical coupling between the energy guide bundle 122 and the system console 123.

[0074] The energy guide bundle 122 may also include a guide bundler 152 (or “shell”) that allows each of the individual energy guides 122A to be closer together, thereby allowing the energy guides 122A and / or the energy guide bundle 122 to be in a more compact configuration as they extend into the blood vessel 108 with the catheter 102 during use of the catheter system 100.

[0075] The energy source 124 may be selectively and / or alternatively coupled within the energy guide bundle 122 in optical communication with each of the energy guides 122A, for example to the guide proximal end 122P of each of the energy guides 122A. In particular, the energy source 124 is configured to generate energy in the form of a source beam 124A, such as a pulsed source beam, that may be selectively and / or alternatively directed and received by each of the energy guides 122A within the energy guide bundle 122 as individual guide beams 124B. Alternatively, the catheter system 100 may include more than one energy source 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 may include a separate energy source 124 for each of the energy guides 122A within the energy guide bundle 122.

[0076] The energy source 124 can have any suitable design. In certain embodiments, the energy source 124 can be configured to provide a sub-millisecond pulse of energy from the energy source 124 that is focused onto a small spot to couple it into 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 specific location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation in the catheter fluid 132 within the balloon interior 146 of the balloon 104, for example, via a plasma generator 133 that can be located at or near the guide distal end 122D of the energy guide 122A. Specifically, in such embodiments, the energy released at the guide distal end 122D of the energy guide 122A is directed towards and actuates the plasma generator 133 to form plasma in the catheter fluid 132 within the balloon interior 146. The plasma formation causes rapid bubble formation resulting in pressure waves at the treatment site 106. An example of an exemplary plasma-induced bubble 134 is illustrated in FIG.

[0077] In various non-exclusive alternative embodiments, sub-millisecond pulses of energy from the energy source 124 can be delivered to the treatment site 106 at a frequency of between approximately 1 Hertz (Hz) and 5000 Hz, between approximately 30 Hz and 1000 Hz, between approximately 10 Hz and 100 Hz, or between approximately 1 Hz and 30 Hz. Alternatively, the sub-millisecond pulses of energy may be delivered to the treatment site 106 at a frequency that may be greater than 5000 Hz, or less than 1 Hz, or at any suitable range of frequencies.

[0078] It will 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, i.e., a single pulsed source beam.

[0079] Suitable energy sources 124 for use may include various types of light sources, including lasers and lamps, or may include any suitable type of energy source.

[0080] Suitable lasers 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 is understood that there are many combinations of laser wavelengths, pulse widths and energy levels that can be employed to achieve plasma in the catheter fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse widths can include those in the ranges including at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range may be used.

[0081] Exemplary nanosecond lasers can include those in the UV to IR spectrum, spanning wavelengths of approximately 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 wavelengths of at least 750 nm to 2000 nm. In other embodiments, the energy source 124 can include those capable of generating light at wavelengths of at least 700 nm to 3000 nm. In yet other embodiments, the energy source 124 can include those capable of generating light at wavelengths of at least 100 nm to 10 micrometers (μm). Nanosecond lasers can include those having repetition rates up to 200 kHz.

[0082] In some embodiments, the laser can include a Q-switched Thulium:Yttrium-Aluminum-Garnet (Tm:YAG) laser, while 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, as well as a doped laser, a pulsed laser, and a fiber laser.

[0083] In yet other embodiments, the energy source 124 can include multiple lasers grouped together in series. In yet other embodiments, the energy source 124 can include one or more low energy lasers fed into a high energy amplifier, such as a Master Oscillator Power Amplifier (MOPA). In yet other embodiments, the energy source 124 can include multiple lasers that can be combined in parallel or in series to provide the energy needed to form the plasma bubble 134 in the catheter fluid 132.

[0084] The catheter system 100 can generate pressure waves having a maximum pressure in the range of at least 1 megapascal (MPa) to 100 MPa. The maximum pressure generated by a particular catheter system 100 will depend on the energy source 124, the absorbent material, the expansion of the bubble, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter system 100 can generate pressure waves having a maximum pressure in the range of at least approximately 2 MPa to 50 MPa, at least approximately 2 MPa to 30 MPa, or at least approximately 15 MPa to 25 MPa.

[0085] The pressure waves can be delivered to the treatment site 106 from a distance extending radially from the energy guide 122A within a range of at least approximately 0.1 millimeters (mm) to more than approximately 25 mm when the catheter 102 is positioned at the treatment site 106. In various non-exclusive alternative embodiments, the pressure waves can be delivered to the treatment site 106 from a distance extending radially from the energy guide 122A within a range of at least approximately 10 mm to 20 mm, at least approximately 1 mm to 10 mm, at least approximately 1.5 mm to 4 mm, or at least approximately 0.1 mm to 10 mm when the catheter 102 is positioned at the treatment site 106. In other embodiments, the pressure waves can be delivered to the treatment site 106 from another suitable distance different from the above ranges. In some embodiments, the pressure waves can be delivered to the treatment site 106 at a distance of at least approximately 0.1 mm to 10 mm and within a range of at least approximately 2 MPa to 30 MPa. In some embodiments, pressure waves may be delivered to the treatment site 106 from within at least approximately 2 MPa to 25 MPa at a distance of at least approximately 0.1 mm to 10 mm. Further alternatively, other suitable pressure ranges and distances may be used.

[0086] The power supply 125 is electrically coupled to and configured to provide the 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 such purposes.

[0087] The system controller 126 is electrically coupled to 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 configured to control their operation. The system controller 126 may include one or more processors or circuitry for the purpose of 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 pulses of energy as desired and / or at any desired firing rate.

[0088] The system controller 126 may also be configured to control the operation of other components of the catheter system 100, such as positioning the catheter 102 adjacent the treatment site 106, inflation of the balloon 104 with 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 purposes of controlling various operations of the catheter system 100. For example, in certain embodiments, the additional controllers and / or portions of the system controller 126 may be positioned within and / or incorporated within the handle assembly 128.

[0089] The GUI 127 is accessible by a user or operator of the catheter system 100. The GUI 127 is electrically connected to the system controller 126. With such a design, the GUI 127 can be used by the user or operator to ensure that the catheter system 100 is effectively utilized to apply pressure to the vascular lesion 106A at the treatment site 106 and induce fragmentation therein. The GUI 127 can provide the user or operator with information that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 can provide the user or operator with static visual data and / or information. Additionally or alternatively, the GUI 127 may provide the user or operator with dynamic visual data and / or information, such as video data or any other data that changes over time during use of the catheter system 100. In various embodiments, the GUI 127 can include one or more colors, different sizes, varying brightness, etc., which may serve as a warning to the user or operator. Additionally or alternatively, the GUI 127 may provide acoustic data or information to a user or operator. The nature of the GUI 127 may vary depending on the design requirements of the catheter system 100 or the particular needs, specifications and / or desires of the user or operator.

[0090] 1, the handle assembly 128 may 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 positioned spaced apart from the balloon 104. Alternatively, the handle assembly 128 may be positioned in another suitable location.

[0091] The handle assembly 128 is attached to the catheter shaft 110 and is handled and used by a user or operator to actuate, position, and control the catheter 102. The design and specific features of the handle assembly 128 can be varied to suit the design requirements of the catheter system 100. In the embodiment illustrated in FIG 1, the handle assembly 128 is separate from, but in electrical and / or fluid communication with, one or more of the system controller 126, the energy source 124, the fluid pump 138, and the GUI 127.

[0092] In some embodiments, the handle assembly 128 may be integrated with and / or include at least a portion of the system controller 126 within the handle assembly 128. For example, as shown, in certain such embodiments, the handle assembly 128 may include circuitry 156, which may be electrically coupled between the catheter electronics and the system console 123 and form at least a portion of the system controller 126. In one embodiment, the circuitry 156 may include a printed circuit board having one or more integrated circuits, or any other suitable circuitry. In an alternative embodiment, the circuitry 156 may be omitted or may be included within the system controller 126, which in various embodiments may be positioned outside the handle assembly 128, such as within the system console 123. It is understood that the handle assembly 128 may include fewer or additional components than those specifically illustrated and described herein.

[0093] Additionally, included with the handle assembly 128 is an energy activation member 157 (sometimes referred to herein simply as an "energy activator"), such as an energy activation button, which may be coupled to circuit wiring 156 within the handle assembly 128 that forms part of the system controller 126. The energy activator 157 is configured to allow a user or operator to selectively activate the catheter system 100 as desired.

[0094] In various embodiments, as noted above, the source manifold 136 may be integrated into and / or incorporated into the handle assembly 128 and may be positioned at or near the proximal portion 114 of the catheter system 100. As shown, the source manifold 136 may include one or more openings capable of receiving an inflation conduit 140 coupled in fluid communication with a fluid pump 138, a guidewire 112 and / or a guidewire lumen 118, one or more energy guides 122A of the energy guide bundle 122 and / or the catheter shaft 110. More specifically, the source manifold 136 may include one or more of a media inflation port 158, a guidewire lumen port 160, an energy guide port 162, and a catheter shaft port 164.

[0095] The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with the catheter fluid 132 as needed.

[0096] Various embodiments of the source manifold 136, and the specific components included therewith, are illustrated and described in detail herein below in the figures that follow.

[0097] As with all embodiments illustrated and described herein, various features may be omitted from the drawings for clarity and ease of understanding. Additionally, the drawings may include certain features that can be omitted without departing from the spirit and scope of the invention.

[0098] 2 is a simplified cutaway view of one embodiment of a handle assembly 228. The handle assembly 228 and the various components carried therein may be modified to suit the requirements of the catheter system 100 (illustrated in FIG. 1). As illustrated in this embodiment, the handle assembly 228 may include an assembly housing 266 that includes and / or defines one or more of an inflation conduit inlet 268, a guidewire inlet 270, an energy guide inlet 272, an electrical inlet 274, a handle distal outlet 276, and a catheter shaft hub 278, circuit wiring 256 with an integrated energy activator 257, and a source manifold 236. Alternatively, the handle assembly 228 may include more or fewer components than those specifically illustrated and described herein.

[0099] In some embodiments, the assembly housing 266 can be formed from two housing members 266A (only one of which is shown in FIG. 2) formed as a first housing side and a second housing side that are selectively coupled together to form the complete assembly housing 266. FIG. 2 further illustrates that the housing member 266A can include a number of coupling members 266B configured to engage corresponding coupling members on the other housing member 266A. In one embodiment, the coupling members 266B can include a series of pins and corresponding holes configured to engage with one another when the housing members 266A are coupled together to form the complete assembly housing 266. Alternatively, the coupling members 266B can have another suitable design.

[0100] The inflation conduit inlet 268 is configured to couple the inflation conduit 240 within the assembly housing 266 .

[0101] Guidewire inlet 270 is configured to couple guidewire 212 within assembly housing 266 .

[0102] The energy guide inlet 272 is configured to couple the energy guide bundle 222, which includes one or more energy guides 222A, into the assembly housing 266.

[0103] The electrical inlet 274 is configured to couple an electrical cable 280 into the assembly housing 266 .

[0104] It is understood that in certain embodiments, as shown, the energy guide inlet 272 and the electrical inlet 274 may be formed together into a single inlet. For example, in one embodiment, the energy guide 222A and the electrical cable 280 may be encased within the optical / electrical cable 283 as the energy guide 222A and the electrical cable 280 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 may be formed independently of one another.

[0105] The handle distal exit 276 provides an exit from the assembly housing 266 for each of the inflation conduit 240, guidewire 212, guidewire lumen 218, energy guide bundle 222, and catheter shaft 210 as each of such components extends toward the balloon 104 (illustrated in FIG. 1).

[0106] The catheter shaft hub 278 is configured to support the catheter shaft 210 such that the catheter shaft 210 may be coupled into the handle distal outlet 276. In one embodiment, the catheter shaft hub 278 is glued to the catheter shaft 210. In certain embodiments, the handle assembly 228 may further include a locking mechanism 281 configured to secure the catheter shaft hub 278 in place when the housing members 266A are coupled together to form the complete assembly housing 266.

[0107] The source manifold 236 is configured to help guide the various components of the catheter 102 (illustrated in FIG. 1), such as the catheter shaft 210, the guidewire lumen 218, the guidewire 212, the energy guide 222A, and the inflation conduit 240, within the handle assembly 228 so that they can extend together to the balloon 104 (illustrated in FIG. 1).

[0108] The design of the source manifold 236 can vary. As illustrated in FIG. 2, the source manifold 236 can include a manifold housing 282 and a pressure sensor 284 coupled to the manifold housing 282. In certain embodiments, the pressure sensor 284 is configured to sense the fluid pressure of the catheter fluid 132 (illustrated in FIG. 1) at one or more locations within the catheter system 100 (illustrated in FIG. 1). For example, in certain embodiments, the pressure sensor 284 can be configured to sense the fluid pressure of the catheter fluid 132 in the balloon interior 146 (illustrated in FIG. 1) or at any desired location along the inflation conduit 240. Alternatively, the pressure sensor 284 can be configured to sense the fluid pressure of the catheter fluid 132 at one or more other locations within the catheter system 100. In some non-exclusive embodiments, the pressure sensor 284 can be configured to sense fluid pressure within the catheter fluid up to approximately 10 atm, 15 atm, 20 atm, 25 atm, 30 atm, 35 atm, 40 atm, 45 atm, 50 atm, 55 atm, 60 atm, 65 atm, 70 atm, 75 atm, 80 atm, 85 atm, 90 atm, 95 atm, or 100 atm in any suitable location.

[0109] As mentioned above, the source manifold 236 can include one or more of the media inflation port 258, the guidewire lumen port 260, the energy guide port 262, and the catheter shaft port 264, which can be coupled and / or integrated within the manifold housing 282. In some embodiments, the energy guide bundle 222 and / or the one or more energy guides 222A can be coupled within the energy guide port 262 through the use of a guide sealing component 585 (illustrated in FIG. 5 ). It is understood that the energy guide bundle 222 and / or the one or more energy guides 222A can be routed through the handle assembly 228 and / or the source manifold 236 in any suitable manner.

[0110] The circuitry 256 and integrated energy activator 257 are substantially similar to those illustrated and described herein above. More particularly, in some embodiments, the circuitry 256 may be provided in the form of a printed circuit board (PCB) that is mounted to a pressure sensor 284 in the source manifold 236, and the energy activator 257 is integrated into the circuitry 256 and in electrical communication with the system console 123 (illustrated in FIG. 1 ) through an electrical cable 280.

[0111] 3 is a simplified perspective view of one embodiment of a source manifold 336. The design of the source manifold 336 can be varied to suit the requirements of the catheter system 100 (illustrated in FIG. 1). In various embodiments, as shown, the source manifold 336 can include a manifold housing 382 having a first housing member 382A and a second housing member 382B. In certain embodiments, the manifold housing 382 can include a sensor hole 386, one or more sensor controller mounting holes 388 (two are shown in FIG. 3), at least one housing mounting hole 390, a media inflation port 358, a guidewire lumen port 360, an energy guide port 362, and a catheter shaft port 364. Alternatively, the source manifold 336 and / or the manifold housing 382 can include more or less components than those illustrated and described herein.

[0112] As shown, a first housing member 382A of the manifold housing 382 is selectively coupled to a second housing member 382B. The first housing member 382A and the second housing member 382B may be selectively coupled to one another in any suitable manner.

[0113] A sensor bore 386 is formed in manifold housing 382, ​​and in certain embodiments, in first housing member 382A, and is configured to receive and retain pressure sensor 284 (illustrated in FIG. 2). In some embodiments, sensor bore 386 is substantially circular in shape. Alternatively, sensor bore 386 may be another suitable shape and / or positioned in another suitable manner.

[0114] The sensor controller mounting holes 388 are available for coupling the circuit wiring 256 (illustrated in FIG. 2 ) to the source manifold 336 and / or the manifold housing 382. More specifically, in certain embodiments, a controller attachment (not shown), such as a screw or other suitable attachment, can extend through a portion of the circuit wiring 256 (or through another suitable device coupled to the circuit wiring 256) and be received in and retained within each of the sensor controller mounting holes 388 to couple the circuit wiring 256 to the source manifold 336 and / or the manifold housing 382. In some embodiments, the source manifold 336 and / or the manifold housing 382 can include two sensor controller mounting holes 388 positioned substantially adjacent the sensor holes 386. In certain embodiments, the sensor controller mounting holes 388 can be formed in the first housing member 382A of the manifold housing 382. Alternatively, the sensor controller mounting holes 388 can have a different design and / or be positioned in another suitable manner.

[0115] In one non-exclusive example, an O-ring can be installed with grease against the wall in the sensor hole 386, and a washer can be positioned between the circuit trace 256, such as a PCB, and the manifold housing 382 of the source manifold 336 adjacent to the sensor controller mounting hole 388.

[0116] At least one housing mounting hole 390 is available for mounting the source manifold 336 to the assembly housing 266 (illustrated in FIG. 2 ) of the handle assembly 228 (illustrated in FIG. 2 ). More specifically, in certain embodiments, a manifold mounting device (not shown), such as a screw or other suitable mounting device, can extend through the at least one housing mounting hole 390 and into an assembly hole (not shown) formed in the assembly housing 266 of the handle assembly 228 to mount the source manifold 336 and / or the manifold housing 382 to the assembly housing 266. With such a design, the source manifold 336 can be maintained in a desired position within the assembly housing 266 of the handle assembly 228.

[0117] In some embodiments, the housing mounting holes 390 may be formed in a mounting arm 390A that cantilevers away from the second housing member 382B of the manifold housing 382. Alternatively, the at least one housing mounting hole 390 may have a different design and / or be positioned in another suitable manner.

[0118] The design and general function of the media inflation port 358, the guidewire lumen port 360, the energy guide port 362, and the catheter shaft port 364 have been described in detail herein above. Accordingly, the media inflation port 358, the guidewire lumen port 360, the energy guide port 362, and the catheter shaft port 364 will not be described in detail again.

[0119] It should be noted, however, that in one embodiment, each of the media inflation port 358, guidewire lumen port 360, energy guide port 362, and catheter shaft port 364 are coupled to and / or formed in the second housing member 382B of the manifold housing 382. With this design, all lumens are maintained on a coaxial plane. Alternatively, one or more of the media inflation port 358, guidewire lumen port 360, energy guide port 362, and catheter shaft port 364 may be coupled to and / or formed in the first housing member 382A of the manifold housing 382.

[0120] Figure 4 is a simplified cutaway perspective view of a portion of the source manifold 336 illustrated in Figure 3. In particular, Figure 4 is a simplified cutaway perspective view showing a first housing member 382A of the manifold housing 382 mounted to a second housing member 382B.

[0121] It is understood that the attachment between the first housing member 382A and the second housing member 382B may be accomplished in any suitable manner. In certain embodiments, the attachment between the first housing member 382A and the second housing member 382B may be accomplished via a mounting assembly 492, which may include a first mounting member 492A coupled to and / or formed within the first housing member 382A and a second mounting member 492B coupled to and / or formed within the second housing member 382B. In various embodiments, the first mounting member 492A is configured to selectively engage the second mounting member 492B when the first housing member 382A is attached to the second housing member 382B. In one embodiment, as shown, the first mounting member 492A may include a mounting channel and the second mounting member 492B may include a mounting protrusion configured to fit within the mounting channel of the first mounting member 492A. In another embodiment, the second mounting member 492B can include a mounting channel, and the first mounting member 492A can include a mounting protrusion configured to fit within the mounting channel of the second mounting member 492B. Alternatively, the first mounting member 492A and / or the second mounting member 492B can have another suitable design.

[0122] In alternative embodiments, the attachment between the first mounting member 492A and the second mounting member 492B may be secured in another suitable manner. For example, in one embodiment, an adhesive may be used substantially adjacent to and / or between the first mounting member 492A and the second mounting member 492B, e.g., in the mounting channel. In another embodiment, the first mounting member 492A and the second mounting member 492B may be ultrasonically sealed to one another. In yet another embodiment, the first mounting member 492A and the second mounting member 492B may be held together through a friction fit. Alternatively, the first mounting member 492A and the second mounting member 492B may be secured together in another suitable manner.

[0123] 4 also illustrates that the first housing member 382A and the second housing member 382B of the manifold housing 382 define a media chamber 494 therebetween. In certain embodiments, it is desirable for the volume of the media chamber 494 to be minimized (in width and / or height) so that the volume of media within the media chamber 494 is minimized to allow easier inhalation of the balloon 104 (illustrated in FIG. 1) during inflation. For this reason, in some embodiments, the media inflation port 358 (illustrated in FIG. 3), the guidewire lumen port 360 (illustrated in FIG. 3), the energy guide port 362, and the catheter shaft port 364 are each coupled to and / or formed within the second housing member 382B of the manifold housing 382 to maintain all lumens in a coaxial plane.

[0124] As noted above, the energy guide port 362 is configured to couple one or more energy guides 222A (illustrated in FIG. 2) of the energy guide bundle 222 (illustrated in FIG. 2) within and / or through the manifold housing 382 such that the energy guide 222A can guide energy from the energy source 124 (illustrated in FIG. 1) through the handle assembly 228 (illustrated in FIG. 2) and into the balloon interior 146 (illustrated in FIG. 1) of the balloon 104 (illustrated in FIG. 1).

[0125] It is understood that sealing multiple energy guides 222A, such as optical fibers or other suitable energy guides, into a single bore, such as energy guide port 362, can be an extremely difficult task due to the small size of the energy guides. The number of energy guides 222A can also result in glue gaps occurring when the energy guides 222A of the energy guide bundle 222 are coupled into the energy guide port 362. One way to solve this problem is to organize the energy guides 222A into individual channels of a multi-lumen extrusion, as shown in FIG.

[0126] In particular, Figure 5 is a simplified schematic diagram of a multi-lumen optical sealing component 596 that can be used to couple multiple energy guides 222A (illustrated in Figure 2) into the source manifold 336 of Figure 3, such as via energy guide ports 362 (illustrated in Figure 3). In some embodiments, as shown, the optical sealing component 596 includes a sealing body 596A having multiple guide channels 598 formed therethrough.

[0127] In one embodiment, the sealing body 596A can be substantially circular and disk-shaped to match the substantially circular cross-section of the energy guide port 362 (illustrated in FIG. 3 ). Alternatively, the sealing body 596A and / or the energy guide port 362 can have another suitable shape.

[0128] The number of guide channels 598 formed in and / or through the hermetic body 596A can vary and can be configured to accommodate the number of energy guides 222A included in the energy guide bundle 222 (illustrated in FIG. 2). In one example, as shown in FIG. 5, the hermetic body 596A can include ten guide channels 598 to accommodate ten energy guides 222A. Alternatively, the hermetic body 596A can include more or less than ten guide channels 598.

[0129] In certain embodiments, once all of the energy guides 222A are seated within their respective guide channels 598, the energy guides 222A can be securely glued to the optical closure component 596 utilizing a capillary action adhesive. In one embodiment, the optical closure component 596 and / or the closure body 596A can be formed from a transparent material such that a UV glue can be used to facilitate curing. In one embodiment, the optical closure component 596 and / or the closure body 596A can also be glued as a subassembly prior to bonding within the energy guide ports 362 in the source manifold 336 (illustrated in FIG. 3 ).

[0130] In certain embodiments, the catheter system and associated methods utilize an energy source, e.g., a light source, e.g., a laser source or another suitable energy source, guided by one or more energy guides, e.g., optical fiber guides, disposed along the catheter shaft and within the balloon interior of the balloon to generate localized plasma in the catheter fluid held within the balloon interior of the balloon. The energy guides can be used in conjunction with a plasma generator positioned at or near the guide distal end of the energy guide within the balloon interior of the balloon disposed at the treatment site. The formation of the localized plasma can cause a pressure wave to 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 when collapsed. The rapid expansion of the plasma induced bubbles can generate one or more pressure waves in the catheter fluid held within the balloon interior of the balloon, which can result in pressure waves in a vascular lesion at a treatment site within or adjacent to a vascular wall within the patient's body, and can induce shattering in the vascular lesion. In some embodiments, the energy source can be configured to provide a sub-millisecond pulse of energy, e.g., light energy, to initiate plasma formation in the catheter fluid within the balloon, causing rapid bubble formation and imparting a pressure wave against the balloon wall at the treatment site. The pressure wave can then impart mechanical energy through the incompressible catheter fluid to the treatment site, imparting a spalling force to 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 relative to the balloon wall in contact with the intravascular lesion is imparted to the intravascular lesion, inducing spallation of the lesion.

[0131] The catheter systems and related methods disclosed herein further include a handle assembly that is attached to the catheter shaft and is handled and used by a user or operator to actuate, position, and control the catheter. In various embodiments, the handle assembly has a source manifold built into and / or integrated therein. In such embodiments, the source manifold can include a manifold housing, a pressure sensor coupled to and / or integrated into the manifold housing, and one or more of 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 certain embodiments, the pressure sensor can be configured to sense the fluid pressure within the balloon interior or at any desired location along the inflation conduit. The media inflation port can be configured to couple the inflation conduit into and / or through the manifold housing to direct the catheter fluid through the handle assembly and into the balloon interior as desired. The guidewire lumen port couples a guidewire lumen, defining 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 to and / or through the interior of 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 and into the interior of the balloon. The catheter shaft port couples the catheter shaft to the manifold housing, such that a user can more effectively control positioning of the catheter shaft with the balloon mounted substantially adjacent to a vascular lesion at a treatment site via manipulation of the handle assembly.

[0132] In some embodiments, the handle assembly may further include at least a portion of a system controller, for example in the form of a printed circuit board (PCB) mounted to the pressure sensor and an energy activation button.

[0133] The present technology is also directed to methods for treating treatment sites within or adjacent to a vessel wall utilizing the devices disclosed herein.

[0134] It should be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content and / or context clearly dictates otherwise. It should also be noted that the term "or" is generally utilized in its sense including "and / or" unless the content or context clearly dictates otherwise.

[0135] It should also be noted that, as used in this specification and the appended claims, the phrase "configured to" describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The phrase "configured to" can be used interchangeably with other similar phrases, such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, etc.

[0136] It will be appreciated that the drawings shown and described are not necessarily to scale, they are provided for ease of reference and understanding and for the relative positioning of structures.

[0137] The headings used herein are provided for consistency with suggestions under 37 CFR 1.77 or otherwise to provide organizational guidance. These headings should not be taken to limit or characterize the invention(s) set forth in any claims that may derive from this disclosure. As an illustration, a description of a technology in the "Background" is not an admission that the technology is prior art to any invention(s) in this disclosure. Neither the "Summary" nor the "Abstract" should be considered a characterization of the invention(s) set forth in the resulting claims.

[0138] The embodiments described herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that those skilled in the art can appreciate and understand the principles and practices. Thus, aspects have been described with reference to various specific preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope of the present description.

[0139] Although several different embodiments of the catheter system have been illustrated and described herein, it will be understood that one or more of the characteristic features of any one embodiment may be combined with one or more of the characteristic features of one or more of the other embodiments, provided that such combination meets the intent of the present invention.

[0140] While several exemplary aspects and embodiments of the catheter system have been discussed above, those skilled in the art will recognize certain modifications, variations, additions and subcombinations thereof. It is therefore intended that the following appended claims and any subsequent claims introduced therein be interpreted to include all such modifications, variations, additions and subcombinations, and are not intended to imply any limitations to the details of construction or design shown herein.

Claims

1. 1. A catheter system for use by a user in treating a vascular lesion in or adjacent to a blood vessel within a patient's body, comprising: A catheter shaft; a handle assembly coupled to the catheter shaft and including an assembly housing, the handle assembly usable by the user to selectively position the catheter shaft near the vascular lesion; a source manifold coupled to the assembly housing, the manifold housing having a catheter shaft port configured to receive a portion of the catheter shaft to couple the catheter shaft to the manifold housing.

2. The catheter system of claim 1 , wherein the source manifold is positioned substantially within the assembly housing.

3. The catheter system of claim 1 , further comprising a pressure sensor coupled to the manifold housing, the pressure sensor configured to sense a fluid pressure of a catheter fluid within the catheter system.

4. The catheter system of claim 3 , wherein the handle assembly further includes circuit wiring electrically coupled to the pressure sensor.

5. The catheter system of claim 1 , wherein the manifold housing includes a first housing member and a second housing member selectively attached to one another via a mounting assembly.

6. 6. The catheter system of claim 1, further comprising a balloon coupled to the catheter shaft, the balloon including a balloon wall defining a balloon interior and configured to retain a catheter fluid within the balloon interior.

7. 7. The catheter system of claim 6, further comprising a pressure sensor coupled to the manifold housing, the pressure sensor configured to sense a fluid pressure of the catheter fluid within the balloon interior.

8. 7. The catheter system of claim 6, further comprising an energy guide coupled to the source manifold, the energy guide including a guide distal end configured to be positioned within the balloon interior.

9. The catheter system of claim 8 , wherein the energy guide generates one or more pressure waves in the catheter fluid that impart a force to the vascular lesion.

10. The catheter system of claim 8 , wherein the energy guide comprises an optical fiber.

11. The catheter system of claim 8 , wherein the manifold housing includes an energy guide port, and the energy guide is coupled to the manifold housing via the energy guide port.

12. The catheter system of claim 8 , wherein the manifold housing further includes a guidewire lumen port, and a guidewire lumen is coupled to the manifold housing via the guidewire lumen port.

13. The catheter system of claim 8 , wherein the manifold housing further includes a media inflation port, and an inflation conduit is coupled to the manifold housing via the media inflation port.

14. The manifold housing includes: an energy guide port, the energy guide being coupled to the manifold housing through the energy guide port; a guidewire lumen port, wherein a guidewire lumen is coupled to the manifold housing through the guidewire lumen port; a media inflation port, an inflation conduit coupled to the manifold housing through the media inflation port; 9. The catheter system of claim 8, further comprising: a first housing member and a second housing member selectively attached to each other, wherein each of the catheter shaft port, the energy guide port, the guidewire lumen port, and the media inflation port is formed in the second housing member.

15. A method of assembling a catheter system, comprising: coupling a handle assembly including an assembly housing to a catheter shaft; and coupling a source manifold to the assembly housing, the source manifold including a manifold housing having a catheter shaft port configured to receive a portion of the catheter shaft to couple the catheter shaft to the manifold housing.

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