Intravascular lithotripsy catheter with rapid exchange port

Abstract

A method for manufacturing a catheter (102) including a rapid exchange port (157), the method comprising the steps of creating a port (258) in a catheter shaft (210), inserting a port tube (360) into the port (358), skiving the port tube (360) flush with the catheter shaft (310), inserting a guidewire lumen (718) into the port tube (760), coupling the guidewire lumen (718) to the port tube (760), and skiving the guidewire lumen (718) flush with the catheter shaft.

Description

[Technical Field]

[0001] The present invention is directed to a method of manufacturing a catheter that includes a rapid exchange port. [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, and stroke. Severe vascular lesions, such as severely calcified vascular lesions, can be difficult for physicians to treat and achieve patency in clinical practice.

[0003] Vascular lesions may be treated using interventions such as drug therapy, balloon angioplasty, atherectomy, stenting, and vascular graft bypass, to name a few. Such interventions are not always ideal, and subsequent treatment may be required to address the lesion.

[0004] Intravascular lithotripsy is a method recently used with some success to destroy vascular lesions within the body's blood vessels. Intravascular lithotripsy utilizes a combination of pressure waves and bubble dynamics generated within a fluid-filled balloon catheter. Specifically, during an intravascular lithotripsy procedure, a high-energy source is used to generate plasma, ultimately generating pressure waves and rapid bubble expansion within a fluid-filled balloon, cracking calcification within the vasculature at the treatment site, including one or more vascular lesions. The rapid bubble formation associated with plasma initiation and the resulting localized fluid velocity within the balloon transfer mechanical energy through the incompressible fluid, exerting a disruptive force on the calcium in the blood vessels against the balloon wall. The rapid change in fluid momentum upon impact with the balloon wall is often 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 enhance vascular patency and optimize therapy delivery parameters within intravascular lithotripsy catheter systems in a manner that is relatively easy to control and consistently manufacturable. [Means for solving the problem]

[0006] The present invention is directed to a method of manufacturing a catheter including a rapid exchange port. In various embodiments, the method includes drilling a port in a catheter shaft, inserting a port tube into the port, skiving the port tube flush with the catheter shaft, inserting a guidewire lumen into the port tube, coupling the guidewire lumen to the port tube, and skiving the guidewire lumen flush with the catheter shaft.

[0007] In some embodiments, the method further includes inserting a port mandrel into the port tube.

[0008] In certain embodiments, the method further comprises inserting a catheter manderel into the catheter shaft.

[0009] In various embodiments, the method further includes placing a heat shrink over a portion of the catheter shaft.

[0010] In some embodiments, the method further comprises applying heat to the heat shrink.

[0011] In certain embodiments, the method further includes removing the port mandrel from the port tube.

[0012] In various embodiments, the method further includes removing the catheter manderel from the catheter shaft.

[0013] In some embodiments, the method further comprises sealing a gap between the guidewire lumen and the port tube.

[0014] In certain embodiments, the method further includes inserting the energy guide into the catheter shaft such that the energy guide is generally parallel to the guidewire lumen.

[0015] In various embodiments, the energy guide is an optical fiber.

[0016] In some embodiments, the guidewire lumen is at least partially formed from a polymeric material.

[0017] In certain embodiments, the catheter shaft is at least partially formed from a polymeric material.

[0018] In various embodiments, the step of creating the port includes drilling a hole in the catheter shaft.

[0019] In some embodiments, the mandrel is at least partially formed from a flexible material.

[0020] In certain embodiments, the mandrel is at least partially curved.

[0021] In various embodiments, the catheter mandrel is generally U-shaped.

[0022] In some embodiments, the step of inserting the catheter manderel into the catheter shaft includes placing a port tube and a port manderel into the curved portion of the catheter manderel.

[0023] In certain embodiments, the heat shrink comprises heat shrink tubing.

[0024] In various embodiments, the step of scraping away the port tube is performed using a cutting tool.

[0025] In some embodiments, the step of skiving the guidewire lumen is performed using a cutting tool.

[0026] In certain embodiments, the step of sealing the gap is performed using an adhesive.

[0027] The present invention is also directed to a catheter including a rapid exchange port. In certain embodiments, the catheter includes an energy guide, a catheter shaft, a port tube, and a guidewire lumen. The catheter shaft is configured to receive the energy guide. The catheter shaft can have (i) a shaft wall and (ii) a port disposed in the shaft wall. The port tube can be disposed within the port. The port tube can have a tube end that is flush with the shaft wall. The guidewire lumen can be disposed within the port tube. The guidewire lumen can have a lumen end that is flush with the shaft wall and the tube end, forming a rapid exchange port.

[0028] In various embodiments, the catheter can further include an adhesive that bonds the guidewire lumen to the port tube.

[0029] In some embodiments, the adhesive at least partially surrounds the guidewire lumen.

[0030] This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will become apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which should not be construed in a limiting sense. The scope of the present specification is defined by the appended claims and their legal equivalents.

[0031] The novel features of this invention, as well as the invention itself, both as to its structure and its operation, will best be understood by reference to the accompanying drawings in conjunction with the accompanying description, in which like numerals refer to like parts, and in which: [Brief explanation of the drawings]

[0032] [Figure 1] FIG. 1 is a simplified schematic cross-sectional view of one embodiment of a catheter system according to various embodiments. [Figure 2] 1 is a simplified cross-section of a portion of one embodiment of a catheter at an initial step in the manufacture of a catheter having a rapid exchange port. [Figure 3] 10A-10C are simplified cross-sectional views of a portion of one embodiment of a catheter at subsequent steps in a method of manufacturing a catheter having a rapid exchange port. [Figure 4] 10A-10C are simplified cross-sectional views of a portion of one embodiment of a catheter at subsequent steps in a method for manufacturing a catheter having a rapid exchange port. [Figure 5] 5 is a cross-sectional view of an embodiment of a catheter mandrel taken along line 5-5 of FIG. 4. [Figure 6] 10A-10C are simplified cross-sectional views of a portion of one embodiment of a catheter at subsequent steps in a method for manufacturing a catheter having a rapid exchange port. [Figure 7] 10A-10C are simplified cross-sectional views of a portion of one embodiment of a catheter at subsequent steps in a method for manufacturing a catheter having a rapid exchange port. [Figure 8A]10A-10C are simplified cross-sectional views of a portion of one embodiment of a catheter at subsequent steps in a method for manufacturing a catheter having a rapid exchange port. [Figure 8B] 8B is a simplified cross-sectional view of a portion of one embodiment of a catheter with a rapid exchange port shown in FIG. 8A with a guidewire inserted into the rapid exchange port. [Figure 9] 1 is a flowchart outlining one embodiment of a method for manufacturing a catheter having a rapid exchange port. DETAILED DESCRIPTION OF THE INVENTION

[0033] While embodiments of the invention are susceptible to various modifications and alternative forms, details thereof have been shown by way of example and drawings and are herein described in detail. It is understood, however, that the scope of the specification is not limited to the particular embodiments described. On the contrary, the intent is to cover modifications, equivalents, and alternatives falling within the spirit and scope of the specification.

[0034] Treatment of vascular lesions can reduce serious adverse events or deaths in affected subjects.As referred to herein, major adverse events are events that can occur anywhere in the body due to the presence of vascular lesions.Major adverse events can include, but are not limited to, major cardiac adverse events, major adverse events in the peripheral or central vascular system, major adverse events in the brain, major adverse events in the muscular system, or major adverse events in any of the internal organs.

[0035] In various embodiments, the catheter systems and related methods disclosed herein can include a catheter configured to be advanced 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. As used herein, the terms "treatment site," "intravascular lesion," and "vascular lesion" are used interchangeably unless otherwise noted. Accordingly, an intravascular lesion and / or a vascular lesion may sometimes be referred to herein simply as a "lesion."

[0036] Those skilled in the art will understand that the following detailed description of the present invention is for purposes of illustration only and is not intended to be in any way limiting. Other embodiments of the present invention will readily suggest themselves to those skilled in the art 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 nomenclature and / or reference indicators will be used throughout the drawings and the following detailed description to refer to the same or similar parts.

[0037] For clarity, not all of the specific configurations of the implementations described herein are shown and described. It is understood that the development of any such actual implementation will require making numerous implementation-specific decisions to achieve the developer's specific goals, such as compliance with application- and business-related constraints, and that these specific goals will vary from implementation to implementation and developer to developer. It is further understood that such a development effort may be complex and time-consuming, but will nevertheless be a routine engineering undertaking for those of ordinary skill in the art having the benefit of this disclosure.

[0038] The catheter systems disclosed herein can include many different configurations. Referring now to FIG. 1 , a simplified schematic cross-sectional view of a catheter system 100 according to various embodiments is shown. The catheter system 100 is adapted to apply pressure waves to induce fracture of one or more vascular lesions within or adjacent to a blood vessel wall or adjacent to a heart valve within a patient. In the embodiment shown in FIG. 1 , the catheter system 100 includes a catheter 102, an energy guide bundle 122 including one or more energy guides 122A, a source manifold 136, a fluid pump 138, a system console 123 including one or more of an energy source 124, a power supply 125, a system controller 126, and a graphic user interface 127 (“GUI”), and a handle assembly 128. Alternatively, the catheter system 100 can include more or fewer components than those specifically shown and described in connection with FIG. 1 .

[0039] The catheter 102 is configured to navigate to a treatment site 106 within or adjacent to a vascular wall 108A of a blood vessel 108 within 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 embodiments, the catheter 102 may be used at a treatment site 106 within or adjacent to a heart valve within the body 107 of the patient 109.

[0040] The catheter 102 may include an inflatable balloon 104 (sometimes referred to herein simply as a "balloon"), a catheter shaft 110, and a guidewire 112. The balloon 104 may be coupled to the catheter shaft 110. The balloon 104 may include a balloon proximal end 104P and a balloon distal end 104D. The catheter shaft 110 may extend from a proximal portion 114 of the catheter system 100 to a distal portion 116 of the catheter system 100. The catheter shaft 110 may include a longitudinal axis 144. The catheter 102 and / or the catheter shaft 110 may also include a guidewire lumen 118 configured to travel 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 further include an inflation lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, the catheter 102 can have a distal end opening 120 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.

[0041] 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 securing the catheter 102 in place relative to the treatment site 106. Stated differently, when the balloon 104 is in the inflated state, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. While the balloon wall 130 of the balloon 104 is shown in FIG. 1 as 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 when the balloon 104 is in the inflated state, the balloon wall 130 of the balloon 104 is typically substantially directly adjacent and / or abutting the treatment site 106.

[0042] Balloons 104 suitable for use in 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 can be made from materials such as polydimethylsiloxane (PDMS), polyurethane, a polymer such as PEBAX™ material, nylon, or any other suitable material.

[0043] Balloon 104 can have any suitable diameter (in an inflated state). In various embodiments, balloon 104 can have a diameter (in an inflated state) ranging from less than 1 millimeter (mm) to a maximum of 25 mm. In some embodiments, balloon 104 can have a diameter (in an inflated state) ranging from at least 1.5 mm to a maximum of 14 mm. In some embodiments, balloon 104 can have a diameter (in an inflated state) ranging from at least 2 mm to a maximum of 5 mm.

[0044] In some embodiments, the balloon 104 can have a length ranging from at least 3 mm to 300 mm. More specifically, in some embodiments, the balloon 104 can have a length ranging from at least 8 mm to 200 mm. It is understood that a balloon 104 having a relatively long length can be positioned adjacent to a larger treatment site 106 and, therefore, can be used to apply pressure waves to induce fragmentation of a larger vascular lesion 106A or multiple vascular lesions 106A at precise locations within the treatment site 106. It is further understood that a longer balloon 104 can be positioned adjacent to multiple treatment sites 106 at any one time.

[0045] The balloon 104 can be inflated to an inflation pressure of approximately 1 atmosphere (atm) to 70 atm. In some embodiments, the balloon 104 can be inflated to an inflation pressure of at least 20 atm to 60 atm. In other embodiments, the balloon 104 can be inflated to an inflation pressure of at least 6 atm to 20 atm. In yet other embodiments, the balloon 104 can be inflated to an inflation pressure of at least 3 atm to 20 atm. In yet still other embodiments, the balloon 104 can be inflated to an inflation pressure of at least 2 atm to 10 atm.

[0046] The balloon 104 can have a variety of shapes, including, but not limited to, a conical, square, rectangular, spherical, conical / square, conical / spherical, elongated spherical, elliptical, tapered, bone, stepped 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-tumor agents, anti-angiogenic agents, etc.

[0047] The catheter fluid 132 can 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 a fluorocarbon, a perfluorocarbon, carbon dioxide, or any other suitable catheter fluid 132. In some embodiments, the catheter fluid 132 can be used as a base inflation fluid. In some embodiments, the catheter fluid 132 can include a mixture of saline and contrast medium in a volume ratio of approximately 50:50. In other embodiments, the catheter fluid 132 can include a mixture of saline and contrast medium in a volume ratio of approximately 25:75. In yet other embodiments, the catheter fluid 132 can include a mixture of saline and contrast medium in a volume ratio of approximately 75:25. However, it will be understood that any suitable ratio of saline to contrast medium can be used. The catheter fluid 132 can be adjusted based on its composition, viscosity, etc., to appropriately manipulate the propagation speed of the pressure wave. 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.

[0048] In some embodiments, the contrast agent used in the contrast medium may include, but is not limited to, an iodine-based contrast agent, such as an ionic or non-ionic iodine-based contrast agent. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, metrizoate, iothalamic acid (iothalamate), and ioxaglate. Some non-limiting examples of non-ionic iodine-based contrast agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based contrast agents may be used. Suitable non-iodine-containing contrast agents may include gadolinium(III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon agents may include, but are not limited to, agents such as the perfluorocarbon dodecafluoropentane (DDFP, C5F12).

[0049] 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 of 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 μm) regions of the electromagnetic spectrum. In various embodiments, the absorbers can have an absorption maximum that coincides with the emission maximum of the laser used in the catheter system 100. By way of non-limiting example, various lasers that can be used with the catheter system 100 may include a neodymium:yttrium-aluminum-garnet (Nd:YAG—emission maximum=1064 nm) laser, a holmium:YAG (Ho:YAG—emission maximum=2.1 nm) laser, or an erbium:YAG (Er:YAG—emission maximum=2.94 μm) laser. In some embodiments, the absorber may be water soluble. In other embodiments, the absorber is not water soluble. In some embodiments, the absorber used in the catheter fluid 132 may be tailored to match the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths from at least 10 nanometers to 1 millimeter are described elsewhere herein.

[0050] The catheter shaft 110 of the catheter 102 can be coupled to one or more energy guides 122A of the energy guide bundle 122 in optical communication with the energy source 124 via an optical-electrical connector assembly 151 (also referred to herein simply as an "optical-electrical connector"). Various embodiments of the optical-electrical connector 151 are described in more detail below.

[0051] The energy guide(s) 122A can be disposed along the catheter shaft 110 and within the balloon 104. In some embodiments, each energy guide 122A can be an optical fiber and the energy source 124 can be a laser. The energy source 124 can be in optical communication with the energy guides 122A at the proximal portion 114 of the catheter system 100.

[0052] In some embodiments, the catheter shaft 110 can be coupled to multiple energy guides 122A, such as, for example, a first energy guide, a second energy guide, a third energy guide, etc., which can 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 can be spaced approximately 180 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110, three energy guides 122A can be spaced approximately 120 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110, and four energy guides 122A can be spaced approximately 90 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110. Alternatively, the energy guides 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 will be further understood that the energy guides 122A can be evenly or unevenly spaced around the guidewire lumen 118 and / or catheter shaft 110 to achieve a desired effect at a desired location.

[0053] 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 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 from one energy guide 122A to more than 30 energy guides 122A. Alternatively, in other embodiments, the catheter system 100 and / or the energy guide bundle 122 can include more than 30 energy guides 122A.

[0054] The energy guide 122A can have any suitable design for generating plasma and / or pressure waves in the catheter fluid 132 within the balloon interior 146. Accordingly, the general description of the energy guide 122A as a light guide is not intended to be limiting in any way, except as set forth in the claims appended hereto. More specifically, 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 purposes 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 embodiments, each pulse of high voltage is applied to the electrodes, forming an electric arc between the electrodes, which in turn generates a plasma, creating pressure waves within the catheter fluid 132 that are utilized to impart a disruptive force to the vascular lesion 106A at the treatment site 106. Further alternatively, the energy source 124 and / or energy guide 122A can have another suitable design and / or configuration.

[0055] In certain embodiments, the energy guide 122A may include an optical fiber or a flexible light pipe. The energy guide 122A may be thin and flexible, allowing for the transmission of optical signals with little loss of strength. The energy guide 122A may include a core surrounded by a cladding. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of the energy guide 122A may be formed from one or more materials, including, but not limited to, one or more types of glass, silica, or one or more polymers. The 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.

[0056] Each energy guide 122A can direct energy along its length from a proximal guide end 122P to a distal guide end 122D having at least one optical window (not shown) disposed within the balloon interior 146.

[0057] The energy guide 122A can take on 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 positioned along the length of the outer diameter of the catheter shaft 110. In still other embodiments, the energy guide 122A can be positioned within one or more energy guide lumens within the catheter shaft 110.

[0058] The energy guides 122A may be positioned at any suitable location around 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 guidewire lumen 118 and / or the length of the catheter shaft 110 to more effectively and precisely deliver pressure waves for the purpose of destroying the vascular lesion 106A at the treatment site 106.

[0059] In certain embodiments, the energy guide 122A can include one or more optoacoustic transducers 154, each of which can be in optical communication with the energy guide 122A disposed therein. In some embodiments, the optoacoustic transducers 154 can be in optical communication with the distal guide end 122D of the energy guide 122A. In such embodiments, the optoacoustic transducers 154 can have a shape that corresponds to and / or mirrors the distal guide end 122D of the energy guide 122A.

[0060] 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, and the direction of the acoustic waves can be adjusted by changing the angle of the distal guide end 122D of the energy guide 122A.

[0061] In certain embodiments, the optoacoustic transducer 154 disposed at the distal guide end 122D of the energy guide 122A can have the same shape as the distal guide end 122D of the energy guide 122A. For example, in certain non-exclusive embodiments, the optoacoustic transducer 154 and / or the distal guide 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 further include additional optoacoustic transducers 154 disposed along one or more sides of the length of the energy guide 122A.

[0062] In some embodiments, the energy guide 122A can further include one or more redirecting mechanisms or “diverters” (not shown in FIG. 1 ), such as within and / or near the distal guide end, configured to direct energy from the energy guide 122A toward a side surface, which may be located at or near the distal guide end 122D of the energy guide 122A, before the energy is directed to the balloon wall 130. The redirecting mechanisms can include any mechanism in the system that redirects energy from the energy guide 122A away from its axial path toward a side surface 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 the respective energy guide 122A and in optical communication with the redirecting mechanisms. Stated another way, the redirecting mechanisms can be configured to direct energy within the energy guide 122A toward a side surface at or near the distal guide end 122D that is in optical communication with the optical windows. The optical window can include a portion of the energy guide 122A that allows energy to exit the energy guide 122A from within the energy guide 122A, for example, a portion of the energy guide 122A that lacks cladding material on or around the energy guide 122A.

[0063] Examples of redirecting mechanisms suitable for use include reflective elements, refractive elements, and fiber diffusers. Redirecting 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 redirecting mechanism, energy is redirected within the energy guide 122A to one or more of the plasma generator 133 and an optoacoustic transducer 154, which is in optical communication with the sides of the energy guide 122A. When used, the optoacoustic transducer 154 then converts the optical energy into acoustic waves, which propagate away from the sides of the energy guide 122A.

[0064] The source manifold 136 can be located at or near the proximal portion 114 of the catheter system 100. The source manifold 136 can include one or more proximal end openings that can receive the plurality of energy guides 122A of the energy guide bundle 122, the guidewire 112, and / or an inflation conduit 140 coupled in fluid communication with a fluid pump 138. Additionally or alternatively, in some embodiments, the source manifold 136 can be integrated and / or incorporated within the handle assembly 128.

[0065] The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 with the catheter fluid 132 as needed.

[0066] As mentioned above, in the embodiment shown in Figure 1, the system console 123 includes one or more of the energy source 124, the power supply 125, the system controller 126, and the GUI 127. Alternatively, the system console 123 may include more or fewer components than those specifically shown in Figure 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 supply 125, the system controller 126, and the GUI 127 may be provided in any suitable location within the catheter system 100 without the specific need for a system console 123.

[0067] As shown, the system console 123 and its included components 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 shown in FIG. 1 , the system console 123 can include a console connection opening 148 (sometimes commonly referred to as a “socket” or “console receptacle”) 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 an optical-electrical connector 151 having a guide coupling housing 150 (sometimes commonly referred to as a “connector housing”) that houses a portion of each of the energy guides 122A (e.g., the guide proximal end 122P). At least a portion of the guide coupling housing 150 is configured to fit and selectively retain within the console connection opening 148 to provide a mechanical coupling between the energy guide bundle 122 and the system console 123.

[0068] The energy guide bundle 122 and / or the optical-electrical connector 151 may also include a guide bundler 152 (or “shell”) that provides strain relief when bringing each of the individual energy guides 122A closer together so that the energy guides 122A and / or the energy guide bundle 122 can be in a more compact form when extended into the blood vessel 108 with the catheter 102 during use of the catheter system 100.

[0069] The energy source 124 can be selectively and / or alternatively coupled in optical communication with each of the energy guides 122A in the energy guide bundle 122 (e.g., 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 can be selectively and / or alternatively directed to each of the appropriately aligned energy guides 122A in the energy guide bundle 122 and received by each of the energy guides 122A as individual guide beams 124B. Alternatively, the catheter system 100 can include two or more energy sources 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 can include a separate energy source 124 for each of the energy guides 122A in the energy guide bundle 122.

[0070] The energy source 124 can have any suitable design. In certain embodiments, the energy source 124 can be configured to provide sub-millisecond pulses of energy focused to a small spot from the energy source 124 for coupling to the proximal guide end 122P of the energy guide 122A. Such pulses of energy are then directed and / or guided along the energy guide 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation within the catheter fluid 132 within the balloon interior 146 of the balloon 104, such as via a plasma generator 133, which can be located at or near the distal guide end 122D of the energy guide 122A. In particular, in such embodiments, energy emitted at the distal guide end 122D of the energy guide 122A is directed toward the plasma generator 133, energizing it to form plasma within the catheter fluid 132 within the balloon interior 146. The formation of the plasma causes rapid bubble formation, imparting pressure waves at the treatment site 106. An exemplary plasma-induced bubble 134 is shown in FIG.

[0071] In various non-exclusive alternative embodiments, sub-millisecond pulses of energy from energy source 124 may be delivered to treatment site 106 at frequencies 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 pulses of energy may be delivered to treatment site 106 at frequencies greater than 5000 Hz or less than 1 Hz, or any other suitable range of frequencies.

[0072] Although the energy source 124 is typically utilized to provide pulses of energy, it is understood that the energy source 124 can still be described as providing a single source beam 124A (e.g., a single pulsed source beam).

[0073] Suitable energy sources 124 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.

[0074] Suitable lasers may include short-pulse lasers on sub-millisecond timescales. In some embodiments, the energy source 124 may include a laser on a nanosecond (ns) timescale. Lasers may also include short-pulse lasers on picosecond (ps), femtosecond (fs), and microsecond (μs) timescales. It is understood that there are many combinations of laser wavelengths, pulse widths, and energy levels that can be used to generate plasma within the catheter fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse width may include pulse widths falling within a range including at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range may be used.

[0075] Exemplary nanosecond lasers can include those in the UV to IR spectrum, spanning wavelengths from approximately 10 nanometers (nm) to 1 millimeter (mm). In some embodiments, the energy source 124 suitable for use in the catheter system 100 can include an energy source capable of generating light with wavelengths of at least 750 nm to 2000 nm. In other embodiments, the energy source 124 can include an energy source capable of generating light with wavelengths of at least 700 nm to 3000 nm. In still other embodiments, the energy source 124 can include an energy source capable of generating light with wavelengths of at least 100 nm to 10 micrometers (μm). Nanosecond lasers can include lasers with repetition rates up to 200 kHz.

[0076] In some embodiments, the laser can include a Q-switched thulium:yttrium-aluminum-garnet (Tm:YAG) laser, hi other embodiments, the laser can include a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser, a holmium:yttrium-aluminum-garnet (Ho:YAG) laser, an erbium:yttrium-aluminum-garnet (Er:YAG) laser, an excimer laser, a helium-neon laser, a carbon dioxide laser, and a doped pulsed fiber laser.

[0077] 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 still other embodiments, the energy source 124 can include multiple lasers that can be combined in parallel or series to provide the energy necessary to generate the plasma bubbles 134 within the catheter fluid 132.

[0078] The catheter system 100 is capable of generating pressure waves having maximum pressures in the range of at least 1 megapascal (MPa) to 100 MPa. The maximum pressure generated by a particular catheter system 100 depends on the energy source 124, the absorber material, the bubble expansion, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter system 100 is capable of generating pressure waves having maximum pressures 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.

[0079] The pressure waves can be applied to the treatment site 106 from a distance ranging from at least about 0.1 millimeters (mm) to greater than about 25 mm, extending radially from the energy guide 122A when the catheter 102 is positioned at the treatment site 106. In various non-exclusive alternative embodiments, the pressure waves can be applied to the treatment site 106 from a distance ranging from at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm, extending radially from the energy guide 122A when the catheter 102 is positioned at the treatment site 106. In other embodiments, the pressure waves can be applied to the treatment site 106 from another suitable distance different from the aforementioned ranges. In some embodiments, the pressure waves can be applied to the treatment site 106 from a distance of at least about 0.1 mm to 10 mm and in a range of at least about 2 MPa to 30 MPa. In some embodiments, the pressure waves can be applied to the treatment site 106 from a distance of at least about 0.1 mm to 10 mm and in a range of at least about 2 MPa to 25 MPa. Further alternatively, other suitable pressure ranges and distances may be used.

[0080] Power supply 125 is electrically connected to and configured to provide the necessary power to each of energy source 124, system controller 126, GUI 127, and handle assembly 128. Power supply 125 may have any design suitable for such purposes.

[0081] System controller 126 is electrically coupled to and receives power from power source 125. System controller 126 is coupled to each of energy source 124 and GUI 127 and configured to control their operation. System controller 126 may include one or more processors or circuitry for the purpose of controlling the operation of at least energy source 124 and GUI 127. For example, system controller 126 may control energy source 124 to generate pulses of energy as desired and / or at any desired firing rate.

[0082] The system controller 126 may also be configured to control the operation of other components of the catheter system 100, such as, for example, 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 that may be arranged in any suitable manner to control 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 located and / or incorporated within the handle assembly 128.

[0083] 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. In 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 to induce fragmentation. The GUI 127 can provide the user or operator with information that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 can provide the user or operator with static visual data and / or information. Additionally or alternatively, the GUI 127 can provide the user or operator with dynamic visual data and / or information, such as video data or any other data that changes over time during use of the catheter system 100. In various embodiments, the GUI 127 can include one or more colors, different sizes, varying brightness, etc., that can serve as alerts to the user or operator. Additionally or alternatively, the GUI 127 can provide the user or operator with audio data or information. The details of the GUI 127 may vary depending on the design requirements of the catheter system 100 or the particular needs, specifications, and / or desires of a user or operator.

[0084] 1, the handle assembly 128 can be located at or near the proximal portion 114 of the catheter system 100 and / or near the source manifold 136. In this embodiment, the handle assembly 128 is coupled to the balloon 104 and is located separate from the balloon 104. Alternatively, the handle assembly 128 can be located in another suitable location.

[0085] The handle assembly 128 is attached to the catheter shaft 110 and is handled and used by a user or operator to manipulate, position, and control the catheter 102. The design and specific configuration of the handle assembly 128 can be varied to suit the design requirements of the catheter system 100. In the embodiment shown in FIG. 1 , the handle assembly 128 is separate from, but in electrical and / or fluid communication with, one or more of the system controller 126, the energy source 124, the fluid pump 138, and the GUI 127.

[0086] In some embodiments, the handle assembly 128 can integrate and / or include at least a portion of the system controller 126 within the handle assembly 128. For example, as shown, in certain such embodiments, the handle assembly 128 can include circuitry 156, which can 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 can include a printed circuit board having one or more integrated circuits, or any other suitable circuitry. In alternative embodiments, the circuitry 156 can be omitted or can be included within the system controller 126, and in various embodiments, the system controller 126 can be located external to the handle assembly 128, such as within the system console 123. It is understood that the handle assembly 128 can include fewer or additional components than those specifically illustrated and described herein.

[0087] The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 using the catheter fluid 132 as needed.

[0088] In various embodiments, the catheter 102 can include a rapid exchange port 157 located in a portion of the catheter shaft 110. The rapid exchange port 157 can be configured to accept the guidewire 112 (and other suitable components of the catheter system 100) distal to the handle assembly 128. In other embodiments, the rapid exchange port 157 can be located proximal to the handle assembly 128.

[0089] The design of the rapid exchange port 157 can vary depending on the design requirements of the catheter system 100 and the catheter 102. In certain embodiments, the rapid exchange port 157 can include one or more of: (i) a port 258 (e.g., as shown in FIG. 2 ), (ii) a port tube 360 ​​(e.g., as shown in FIG. 3 ), and / or (iii) a guidewire lumen 118.

[0090] As used herein, the term "rapid exchange" should be understood to have the same or similar meaning as other terms used in the catheter art, such as exchange by a single operator. In particular, a "rapid exchange catheter" includes a catheter designed to allow for the exchange of an indwelling catheter using a guidewire without the need for a guidewire extension or a guidewire substantially longer than the catheter itself. While much of the following description and some of the figures show balloon catheters, other catheter types may incorporate the improvements herein, including, for example, fluid infusion cannulas, cutting instruments, non-balloon, self-expanding stent delivery catheters, and / or atherectomy devices. Vascular and non-vascular (e.g., biliary or genitourinary) uses are contemplated.

[0091] As with all embodiments shown and described herein, various features may be omitted from the figures for clarity and ease of understanding. Additionally, the figures may include certain features that can be omitted without departing from the spirit and scope of the present invention.

[0092] 2 is a simplified cross-sectional view of a portion of one embodiment of a catheter 202 at an initial step in the manufacturing process of a catheter 202 having a rapid exchange port 257. For example, the catheter 202 can have a configuration of the present invention that can be included as part of the manufacturing process of a catheter 202 having a rapid exchange port 257 shown in FIG.

[0093] There are many variations in the design of the catheter 202. As shown, Figure 2 shows one embodiment of a catheter 202 that includes a catheter shaft 210 and a rapid exchange port 257. The rapid exchange port 257 shown in Figure 2 includes a port 258.

[0094] The port 258 can be configured to allow for rapid exchange of the guidewire lumen 118 (e.g., as shown in FIG. 1) near the distal portion 116 (shown in FIG. 1) of the catheter 202. The design of the port 258 can vary. The port 258 can be formed in the catheter shaft 210 using any suitable method in the art. In some embodiments, the port 258 is formed in the catheter shaft 210 by puncturing, boring, piercing, and / or penetrating the catheter shaft 210 with a suitable tool.

[0095] 3 is a simplified cross-sectional view of a portion of one embodiment of a catheter 302 at a subsequent step in a method of manufacturing a catheter 302 with a rapid exchange port 357. As shown in FIG. 3, in various embodiments, a port tube 360 ​​can be placed into the catheter shaft 310 through the port 358 to form the rapid exchange port 357. The embodiment of the catheter shaft 310 of the catheter 302 shown in FIG. 3 can be included as part of a method of manufacturing a catheter 302 with a rapid exchange port 357 shown in FIG.

[0096] The port tube 360 ​​can be configured to allow for rapid exchange of the guidewire lumen 118 (e.g., as shown in FIG. 1 ) near the distal portion 116 (as shown in FIG. 1 ) of the catheter 302. The design of the port tube 360 ​​can vary. The port tube 360 ​​can include any suitable tube or conduit capable of receiving the guidewire lumen 118.

[0097] 4 is a simplified cross-sectional view of a portion of one embodiment of a catheter 402 at a subsequent step in a method of manufacturing a catheter 402 having a rapid exchange port 457. As shown in FIG. 4, in various embodiments, a port tube 460 can be placed into the catheter shaft 410 through a port 458 to form the rapid exchange port 457. The embodiment of the catheter shaft 410 of the catheter 402 shown in FIG. 4 can be included as part of a method of manufacturing a catheter 402 having a rapid exchange port 457 shown in FIG. 9. The catheter 402 can include a port mandrel 462 and a catheter mandrel 464.

[0098] The port mandrel 462 can support the port tube 460 during the rapid exchange catheter manufacturing method shown in Figure 9. The port mandrel 462 can be placed within the port tube 460 so that the port tube 460 is positioned on top of the catheter shaft 410, as shown in Figure 4.

[0099] In certain embodiments, the port mandrel 462 can position the port tube 460 so that it contacts the upper shaft wall 410U of the catheter shaft 410. In other embodiments, the port mandrel 462 can position the port tube 460 so that the portion of the port tube 460 that is disposed within the catheter shaft 410 is generally parallel to the upper shaft wall 410U of the catheter shaft 410.

[0100] The port mandrel 462 can vary depending on the design requirements of the catheter 402 and the catheter shaft 410. The port mandrel 462 can be at least partially formed from a flexible material. The port mandrel 462 can be at least partially curved.

[0101] The catheter mandrel 464 can support the port tube 460 and port mandrel 462 during the manufacturing process of the catheter 402 having the rapid exchange port 457 shown in Figure 9. The catheter mandrel 464 can be positioned within the catheter shaft 410 such that the port tube 460 and port mandrel 462 are positioned in the curved portion of the catheter mandrel 464, as shown in Figure 4.

[0102] In some embodiments, the catheter mandrel 464 can position the port tube 460 and the port mandrel 462 so that the port tube 460 contacts the upper shaft wall 410U of the catheter shaft 410. In other embodiments, the catheter mandrel 464 can position the port tube 460 so that the portion of the port tube 460 that is disposed within the catheter shaft 410 is approximately parallel to the upper shaft wall 410U of the catheter shaft 410.

[0103] The catheter mandrel 464 can vary depending on the design requirements of the catheter 402, the catheter shaft 410, the port tube 460, and / or the port mandrel 462. The port mandrel 462 can be at least partially formed from a flexible material. The port mandrel 462 can be at least partially curved.

[0104] The heat shrink 465 can be disposed over a portion of the catheter shaft 410. Non-limiting, non-exclusive examples of suitable heat shrink 465 include heat shrink tubing, heat shrink wrap, and / or heat shrink sleeves. In certain embodiments, the heat shrink 465 can include a heat sink tube that is slid over the portion of the catheter shaft 410 including the port 458, the port tube 460, the port mandrel 462, and / or the catheter mandrel 464. Heat can be applied to the heat shrink 465 and the contents within the heat shrink 465. The heat shrink 465 and the separated contents therein can shrink when heat is applied.

[0105] Figure 5 is a cross-sectional view of one embodiment of a catheter mandrel 564 taken along line 5-5 in Figure 4. In the embodiment shown in Figure 5, the catheter mandrel 564 may be generally U-shaped and may include a mandrel curved surface 564C. As shown in Figure 4, the port tube 460 (shown in Figure 4) and the port mandrel 462 (shown in Figure 4) may be placed within the mandrel curved surface 564C of the catheter mandrel 564 during manufacturing of the catheter 402 (shown in Figure 4) and / or the catheter shaft 410 (shown in Figure 4). Alternatively, the mandrel 564 may have a different configuration and / or may include a mandrel curved surface 564C different from that shown in Figure 5. In one non-exclusive embodiment, the mandrel 564 may include a metal rod and / or a metal tube (e.g., SS Hypotube, etc.). Any suitable material may be used.

[0106] Figure 6 is a simplified cross-sectional view of one embodiment of a catheter shaft 610 of a catheter 602. As shown in Figure 6, the port 658 of the rapid exchange port 657 can include a port distal shoulder 658D and a port proximal shoulder 658P. The embodiment of the catheter shaft 610 of the catheter 602 shown in Figure 6 can be included as part of a method of manufacturing a catheter with a rapid exchange port shown in Figure 9.

[0107] A port distal shoulder 658D is formed distal to the port 658 where the distal portion of the port tube 660 meets the upper shaft wall 610U. The port distal shoulder 658D can be milled to be flush with both the upper shaft wall 610U and the port tube 660.

[0108] A port proximal shoulder 658P is formed on the proximal side of the port 658 where the proximal portion of the port tube 660 meets the upper shaft wall 610U. The port proximal shoulder 658P can be milled to be flush with both the upper shaft wall 610U and the port tube 660.

[0109] The port tube 660 can include a tube distal end 660D and a tube upper surface 660U. The tube distal end 660D can extend toward the distal portion 116 (e.g., as shown in FIG. 1). The tube upper surface 660U can be generally parallel to the catheter upper surface 610U. In some embodiments, the tube upper surface 660U can be fused to the upper shaft wall 610U to form a fused portion 661.

[0110] The fused portion 661 can include portions of both the catheter shaft 610 and the port tube 660 that are fused and / or reflowed together during the heating and / or reflow process described with respect to step 980 shown in Figure 9. As shown in Figure 6, the fused portion 660 can be formed directly between the port tube 660 and the catheter shaft 610. The fused portion 660 can fix the position of the port tube 660 relative to the catheter shaft 610.

[0111] Figure 7 is a simplified cross-sectional view of one embodiment of a catheter shaft 710 of a catheter 702. The embodiment of the catheter shaft 710 of a catheter 702 including a rapid-exchange port 757 shown in Figure 7 may be included as part of a method for manufacturing a catheter with a rapid-exchange port shown in Figure 9. In the embodiment shown in Figure 7, a guidewire lumen 718 can be disposed in the rapid-exchange port 757 through the port 758 between the port distal shoulder 758D and the port proximal shoulder 758P. The guidewire lumen 718 can extend through the port tube 760 distally from the tube distal end 760D toward the distal section 116 (e.g., as shown in Figure 1). The guidewire lumen 718 can be generally parallel to both the port tube 760 and the fused section 761.

[0112] The energy guide 722A can extend through the catheter shaft 710 toward the distal portion. The energy guide 722A can be adjacent to the guidewire lumen 718 and the port tube 760 within the catheter shaft 710.

[0113] Figure 8A is a simplified cross-sectional view of one embodiment of a catheter shaft 810 of a catheter 802 including a rapid exchange port 857. The embodiment of the catheter shaft 810 of a catheter 802 shown in Figure 8 can be included as part of a method for manufacturing a catheter with a rapid exchange port shown in Figure 9. As shown in Figure 8, an adhesive 866 can be applied to the interior of the port tube 860.

[0114] Adhesive 866 can bond the guidewire lumen 818 to the catheter shaft 810 and the port tube 860. As shown in FIG. 8 , the guidewire lumen 818 and adhesive 866 can be ground down to be flush with the catheter shaft 810. The adhesive 866 can seal gaps between (i) the tube distal end 860D, the port distal shoulder 858D, and the guidewire distal shoulder 818D, and (ii) the tube distal end 860D, the guidewire proximal shoulder 818P, and the port proximal shoulder 858P. The guidewire lumen 818 can be substantially adjacent to the energy guide 822A. In some embodiments, as shown in FIG. 8 , the top of the rapid-exchange port 857 can be formed such that a portion of the catheter shaft 810, the fused portion 861, a portion of the port tube 860, a portion of the adhesive 866, and a portion of the guidewire lumen 818 are bonded together in a layered manner.

[0115] Figure 8B is a simplified cross-sectional view of a portion of the embodiment of catheter 802 having rapid-exchange port 857 shown in Figure 8A, with guidewire 812 inserted into rapid-exchange port 857. As shown in Figure 8B, guidewire 812 can be inserted and removed from guidewire lumen 818 through rapid-exchange port 857.

[0116] 9 is a flowchart outlining one embodiment of a method for manufacturing a catheter having a rapid exchange port. The method may include one or more of the following steps provided herein. It is understood that the method may include additional steps other than those specifically shown and / or described herein. Additionally, or alternatively, the method may omit one or more of the steps specifically shown and / or described herein. Furthermore, it is understood that the steps may be completed in any order, and the order of the steps shown and / or described herein is for illustrative purposes only. It is also recognized that any of the steps shown and / or described herein may be combined and completed into a single step and / or a single step may be expanded into multiple steps.

[0117] Methods of manufacturing catheters that include rapid exchange ports can include manufacturing catheters that can be utilized in catheter system 100 (shown in FIG. 1) or other suitable systems and subsystems not explicitly shown and / or described herein.

[0118] At step 970, a port is drilled in the catheter shaft. In some embodiments, the port can be formed in the catheter shaft via any suitable port-forming method. Non-limiting and non-exclusive examples include boring, puncturing, piercing, perforating, gouging, and cutting. It is understood that in certain embodiments, the tool used to form the port in the catheter shaft should be configured to penetrate a catheter shaft of any suitable material, including a polymeric material.

[0119] In step 972, the port tube is inserted into the port. The port tube can be inserted so that a portion of the port tube extends into the catheter shaft and a portion of the port tube extends out of the catheter shaft.

[0120] In step 974, a catheter mandrel is inserted into the catheter shaft. The catheter mandrel may comprise a flexible material. The catheter mandrel may be inserted such that a portion of the catheter mandrel extends into the catheter shaft and a portion of the catheter mandrel extends out of the catheter shaft. The catheter mandrel may have a curved portion. The curved portion of the catheter mandrel may receive and / or accommodate the port tube and port mandrel. The catheter mandrel may position the port tube and port mandrel at any suitable location within the catheter shaft.

[0121] In step 976, a port mandrel is inserted into the port tube. The port mandrel can comprise a flexible material. The port mandrel can be inserted such that a portion of the port mandrel extends into (i) the catheter shaft and (ii) the port tube, and a portion of the port mandrel extends out of (i) the catheter shaft and (ii) the port tube.

[0122] In step 978, a heat shrink is placed over a portion of the catheter shaft. Non-limiting and non-exclusive examples of suitable heat shrinks include heat shrink tubing, heat shrink wrap, and / or heat shrink sleeves. In certain embodiments, the heat shrink can include a heat sink tube slid over a portion of the catheter shaft including the port, port tube, port mandrel, and catheter mandrel.

[0123] In step 980, heat is applied to the heat shrink and contents within the heat shrink. The port mandrel can prevent the port tube from collapsing during heating, and the catheter mandrel can prevent the catheter shaft from collapsing during heating. The port mandrel can maintain the position of the port tube during heating, and the catheter mandrel can maintain the position of the catheter shaft during heating. The heat reflows and bonds the catheter shaft and port tube together. In certain embodiments, the heating creates a fused joint where portions of the catheter shaft and port tube are fused together.

[0124] In step 982, the port mandrel is removed from the port tube.

[0125] In step 984, the catheter mandrel is removed from the catheter shaft.

[0126] In step 986, the port tube is skived flush with the catheter shaft. A portion of the port tube is skived away so that the size of the port is maintained and the port tube is contiguous with the catheter shaft. The port tube can be skived and / or cut using any suitable method. In some embodiments, the port tube is skived away using a cutting tool. Non-limiting and non-exclusive examples of cutting tools include a razor, a knife, and / or a rotary cutter.

[0127] In step 988, an energy guide is delivered to the catheter shaft. The energy guide can be positioned adjacent to the port tube and the guidewire lumen.

[0128] In step 990, a guidewire lumen is inserted into the port tube. The guidewire lumen can be inserted such that a portion of the guidewire lumen extends into (i) the catheter shaft and (ii) the port tube, and a portion of the guidewire lumen extends out of (i) the catheter shaft and (ii) the port tube. The guidewire lumen can be positioned to extend from the port toward a distal portion of the catheter shaft.

[0129] At step 992, a gap is sealed between the guidewire lumen and the port tube. The gap may be sealed with an adhesive. The adhesive may substantially surround the portion of the guidewire lumen that is disposed within the port tube. Non-limiting and non-exclusive examples of suitable adhesives include glues, wicking adhesives, and sealants.

[0130] In step 994, the guidewire lumen is skived flush with the catheter shaft. A portion of the guidewire lumen is skived so that the size of the port matches the opening of the guidewire lumen and the guidewire lumen is adjacent to the catheter shaft. The guidewire lumen can be skived and / or cut using any suitable method. In some embodiments, the guidewire lumen is skived using a cutting tool. Non-limiting and non-exclusive examples of cutting tools include a razor, a knife, and / or a rotary cutter. Adhesive disposed between the guidewire lumen and the port tube can also be skived flush with the catheter shaft, the port tube, and the guidewire lumen.

[0131] In one non-exclusive embodiment, a method of manufacturing a catheter having a rapid exchange port can include drilling a port in the catheter shaft, inserting a port tube into the port, skiving the port tube flush with the catheter shaft, inserting a guidewire lumen into the port tube, coupling (or securing) the guidewire lumen to the port tube, and skiving the guidewire lumen flush with the catheter shaft. It is understood that the foregoing example of an embodiment may include additional steps, such as those disclosed herein, or omit certain steps as desired.

[0132] The present technology is also directed to methods of treating treatment sites within or adjacent to a vessel wall, such methods utilizing the devices disclosed herein.

[0133] In summary, in accordance with various embodiments of the present invention as shown and described in detail herein, a catheter system and associated methods can include a catheter configured to be advanced to a vascular lesion, such as a calcified vascular lesion or a 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 and / or secured to the catheter shaft. The balloon can include a balloon wall defining an interior of the balloon. The balloon can be configured to receive catheter fluid therein and expand from a deflated state suitable for advancing the catheter through the patient's vasculature to an inflated state suitable for securing the catheter in place relative to the treatment site.

[0134] In certain embodiments, the catheter system and related methods utilize an energy source (e.g., a light source such as a laser source or another suitable energy source) that provides energy guided by one or more energy guides (e.g., optical guides such as optical fibers) positioned along the catheter shaft and within the balloon of the balloon to generate localized plasma within the catheter fluid held within the balloon of the balloon. The energy guides can be used in combination with a plasma generator positioned at or near the distal end of the energy guide within the balloon of the balloon located at the treatment site. The generation of localized plasma can initiate a pressure wave and the rapid formation of one or more bubbles that can rapidly expand to a maximum size and dissipate through a cavitation event that can release a pressure wave upon collapse. The rapid expansion of the plasma-induced bubbles (sometimes simply referred to as "plasma bubbles") generates one or more pressure waves within the catheter fluid held within the balloon of the balloon, thereby impinging on and inducing disruption of vascular lesions within or adjacent to the vessel wall within the patient's body at the treatment site. In some embodiments, the energy source can be configured to provide submillisecond pulses of energy (e.g., slight energy) to initiate plasma formation within the catheter fluid within the balloon, causing rapid bubble formation and imparting a pressure wave to the balloon wall at the treatment site. The pressure wave can then transfer mechanical energy through the incompressible catheter fluid to the treatment site, imparting a disruptive force to the intravascular lesion. While not wishing to be bound by 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 its disruption.

[0135] 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 used in its sense including "and / or" unless the context or content clearly dictates otherwise.

[0136] It should also be noted that, as used herein and in the appended claims, the phrase "configured" describes a system, apparatus, or other structure that is constructed or arranged to perform a particular task or adopt a particular configuration. The phrase "configured" can be used interchangeably with other similar phrases, such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, etc.

[0137] It will be appreciated that the figures shown and described are not necessarily drawn to scale, but are provided for ease of reference and understanding and for the relative positioning of structures.

[0138] The headings used herein are provided for consistency with recommendations under 37 CFR 1.77 or to provide organizational guidance. These headings are not to be construed as limiting or characterizing the invention(s) set forth in any claims that may issue from this disclosure. As an example, a description of technology in the "Background" section is not an admission that the technology is prior art to the invention(s) in this disclosure. The use of a "Summary" or "Abstract" is also not to be construed as a characterization of the invention(s) set forth in any issued claims.

[0139] 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 others skilled in the art can appreciate and understand the principles and practices. As such, aspects have been described with reference to various specific preferred embodiments and techniques. However, it should be understood that many variations and modifications can be made while remaining within the spirit and scope of the description.

[0140] Although several different embodiments of the catheter system are shown and described herein, it is understood that one or more features of any one embodiment may be combined with one or more features of one or more other embodiments, provided that such combinations meet the spirit of the invention.

[0141] While several exemplary aspects and embodiments of the catheter system have been discussed above, those skilled in the art will recognize certain modifications, permutations, additions, and subcombinations thereof. Accordingly, the following appended claims and any subsequent claims are intended to be interpreted to include all such modifications, permutations, additions, and subcombinations as fall within the true spirit and scope of the claims, and no limitations are intended to the details of construction or design shown herein.

Claims

1. 1. A method of manufacturing a catheter including a rapid exchange port, comprising: drilling a port in the catheter shaft; inserting a port tube into the port; grinding the port tube flush with the catheter shaft; inserting a guidewire lumen into the port tube; coupling the guidewire lumen to the port tube; skiving the guidewire lumen flush with the catheter shaft; A method comprising:

2. The method of claim 1 , further comprising inserting a port mandrel into the port tube.

3. The method of claim 2 , wherein the port mandrel is at least partially formed from a flexible material.

4. The method of claim 2 or 3, wherein the port mandrel is at least partially curved.

5. The method of any one of claims 2 to 4, further comprising removing the port mandrel from the port tube.

6. The method of any one of claims 1 to 5, further comprising inserting a catheter mandrel into the catheter shaft.

7. 7. The method of claim 6, wherein the step of inserting the catheter mandrel into the catheter shaft includes placing the port tube and the port mandrel in a curved portion of the catheter mandrel.

8. 8. The method of claim 6 or 7, further comprising removing the catheter manderel from the catheter shaft.

9. The method of any one of claims 6 to 8, wherein the catheter mandrel is generally U-shaped.

10. The method of any one of claims 1 to 9, further comprising placing a heat shrink over a portion of the catheter shaft.

11. The method of claim 10 , wherein the heat shrink comprises heat shrink tubing.

12. 12. The method of claim 10 or 11, further comprising the step of applying heat to the heat shrink.

13. The method of any one of claims 1 to 12, further comprising sealing a gap between the guidewire lumen and the port tube.

14. The method of claim 13 , wherein the step of sealing the gap is performed using an adhesive.

15. The method of any one of claims 1 to 14, further comprising inserting an energy guide into the catheter shaft such that the energy guide is generally parallel to the guidewire lumen.

16. The method of claim 15 , wherein the energy guide is an optical fiber.

17. The method of any one of claims 1 to 16, wherein at least one of the guidewire lumen and the catheter shaft is formed at least in part from a polymeric material.

18. The method of any one of claims 1 to 17, wherein the step of grinding away the port tube is performed using a cutting tool.

19. The method of any one of claims 1 to 18, wherein the step of skiving away the guidewire lumen is performed using a cutting tool.

20. 1. A catheter including a rapid exchange port, Energy Guide and a catheter shaft configured to receive the energy guide, the catheter shaft having (i) a shaft wall and (ii) a port disposed in the shaft wall; a port tube disposed within the port and having a tube end flush with the shaft wall; a guidewire lumen disposed within the port tube and having a lumen end flush with the shaft wall and the tube end, forming a rapid exchange port; an adhesive that bonds the guidewire lumen to the port tube; A catheter comprising:

Images