Light emitter housing assembly for an intravascular lithotripsy device - Patent Application 20070233337

Abstract

A catheter system (100) for treating a treatment site (106) within or adjacent to a vessel wall (108A) of a blood vessel (108) in a body (107) of a patient (109) includes an energy source (124), a catheter fluid (132), and an emitter assembly (129). The energy source (124) generates energy. The emitter assembly (129) includes (i) at least a portion of an energy guide (122A) having a guide distal end (122D) selectively positioned near the treatment site (106), (ii) a plasma generator (133), and (iii) an emitter housing (260) secured to each of the energy guide (122A) and the plasma generator (133) to maintain a relative position between the guide distal end (122D) of the energy guide (122A) and the plasma generator (133). The energy guide (122A) is configured to receive energy from the energy source (124) and direct the energy towards the plasma generator (133) to generate plasma bubbles (134) within the catheter fluid (132). The plasma generator (133) directs energy from the plasma bubbles (134) towards the treatment site (106).

Description

[Technical field]

[0001] The present invention is directed to a catheter system for placement within a blood vessel having a blood vessel wall. [Background technology]

[0002] Vascular lesions within blood vessels in the body (also referred to herein as "treatment sites") may be associated with an increased risk of serious adverse events, such as, for example, myocardial infarction, embolism, deep vein thrombosis, stroke, etc. Severe vascular lesions, such as severe calcified vascular lesions, may be difficult for physicians to treat or achieve patency in clinical practice.

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

[0004] Intravascular lithotripsy is one method that has been recently used with some success to destroy vascular lesions within blood vessels in the body. Intravascular lithotripsy utilizes a combination of pressure waves and bubble dynamics that are generated within a fluid-filled balloon catheter in a blood vessel. In particular, during intravascular lithotripsy treatment, a high energy source is used to generate plasma, which ultimately generates pressure waves as well as rapid bubble expansion within a fluid-filled balloon to crack calcifications at the treatment site within the vasculature, including one or more vascular lesions. The rapid bubble formation that accompanies the initiation of plasma and the resulting localized fluid velocity within the balloon transfers mechanical energy through the incompressible fluid, exerting a destructive force on calcium within the blood vessels against the balloon wall. The rapid change in momentum of the fluid upon impact with the balloon wall is known as hydraulic shock or water hammer. Summary of the Invention [Problem to be solved by the invention]

[0005] It is desirable to more accurately and precisely direct and / or focus the energy generated within a fluid-filled balloon to apply pressure to a treatment site within or adjacent to a vessel wall to induce disruption.

[0006] There is a continuing desire to enhance vascular patency and optimize therapeutic delivery parameters within intravascular lithotripsy catheter systems in a consistently manufacturable manner. [Means for solving the problem]

[0007] 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 to treat a treatment site within or adjacent to a vascular wall or a heart valve within a patient's body. In various embodiments, the catheter system includes an energy source, a catheter fluid, and an emitter assembly. The energy source generates energy. The emitter assembly includes (i) at least a portion of an energy guide having a guide distal end selectively positioned near the treatment site, (ii) a plasma generator, and (iii) an emitter housing secured to each of the energy guide and the plasma generator to maintain a relative position between the guide distal end of the energy guide and the plasma generator. The energy guide is configured to receive energy from the energy source and direct the energy toward the plasma generator to generate plasma bubbles in the catheter fluid. The plasma generator directs energy from the plasma bubbles toward the treatment site.

[0008] In some embodiments, the emitter housing includes (i) a first housing section secured to the energy guide at or near the guide distal end, (ii) a second housing section secured to or integrally formed with the plasma generator, and (iii) a connector section coupled to the first housing section and the second housing section and extending between the first housing section and the second housing section.

[0009] In certain embodiments, the first housing section is generally cylindrical. In some such embodiments, the first housing section includes a small housing gap that extends completely along the length of the first housing section to allow for slight expansion or contraction of the first housing section due to changing environmental conditions.

[0010] In certain embodiments, the first housing section includes a guide opening, and at least a portion of the energy guide is secured within the guide opening.

[0011] In some embodiments, the catheter system further includes an adhesive material configured to secure the first housing section to the energy guide at or near the guide distal end.

[0012] In certain embodiments, the first housing section includes a first housing port through which an adhesive material can be supplied between the first housing section and the energy guide to secure the first housing section to the energy guide at or near the guide distal end.

[0013] In some embodiments, the second housing section is generally cylindrical.

[0014] In certain embodiments, the second housing section includes a small housing gap that extends completely along the length of the second housing section to allow for slight expansion or contraction of the second housing section due to changing environmental conditions.

[0015] In certain embodiments, the second housing section includes a generator opening, and at least a portion of the plasma generator is secured within the generator opening.

[0016] In some embodiments, the catheter system further includes an adhesive material configured to secure the second housing section to the plasma generator.

[0017] In certain embodiments, the second housing section includes a second housing port, and an adhesive material can be supplied between the second housing section and the plasma generator through the second housing port to secure the second housing section to the plasma generator.

[0018] In other embodiments, the second housing section is integrally formed with the plasma generator.

[0019] In certain embodiments, the connector section includes a section opening, and the plasma generator directs energy from the plasma bubbles through the section opening toward the treatment site.

[0020] In some embodiments, the connector section is partially cylindrical, with the section opening extending completely along the length of the connector section.

[0021] In some embodiments, the plasma generator has a proximal end that is angled to direct energy from the plasma bubbles through the section opening toward the treatment site.

[0022] In certain embodiments, the proximal end of the plasma generator is angled at about 5 degrees to 45 degrees relative to a flat vertical structure.

[0023] In some embodiments, the catheter system further includes a reinforcing cover disposed substantially surrounding the emitter housing.

[0024] In one embodiment, the stiffening cover comprises a polyimide tube.

[0025] In certain embodiments, the catheter system further includes a guidewire lumen including an outer surface having a groove, the emitter housing being disposed within the groove formed along the outer surface of the guidewire lumen.

[0026] In some embodiments, the catheter system further includes a first assembly fitting positioned adjacent to the first housing section and a second assembly fitting positioned adjacent to the second housing section for retaining the emitter housing within a groove formed along the outer surface of the guidewire lumen.

[0027] In some embodiments, the catheter system further includes a balloon including a balloon wall defining a balloon interior, the balloon configured to retain a catheter fluid within the balloon interior.

[0028] In various embodiments, the guide distal end, the plasma generator, and the emitter housing are disposed inside the balloon.

[0029] In certain such 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 treatment site.

[0030] In some embodiments, the plasma generator is configured to direct energy from the plasma bubbles toward a portion of the balloon wall located substantially adjacent to the treatment site.

[0031] In certain embodiments, the energy guide generates one or more pressure waves in the catheter fluid that impart a force to the treatment site.

[0032] In some embodiments, the energy guide comprises an optical fiber.

[0033] In various embodiments, the energy source includes a laser.

[0034] In certain embodiments, the catheter fluid includes one of a wetting agent and a surfactant.

[0035] The present invention is further directed to a method for treating a treatment site within or adjacent to a blood vessel or heart valve within a patient's body, the method comprising the steps of generating energy with an energy source; disposing an emitter assembly in a catheter fluid near the treatment site, the emitter assembly including: (i) at least a portion of an energy guide having a guide distal end selectively positioned near the treatment site; (ii) a plasma generator; and (iii) an emitter housing secured to each of the energy guide and plasma generator and maintaining a relative position between the guide distal end of the energy guide and the plasma generator; receiving energy from the energy source with the energy guide; generating plasma bubbles in the catheter fluid with energy from the energy guide directed toward the plasma generator; and directing energy from the plasma bubbles toward the treatment site using the plasma generator.

[0036] 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 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 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.

[0037] The novel configuration 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 description of the drawings]

[0038] [Figure 1]FIG. 1 is a simplified schematic cross-sectional view of one embodiment of a catheter system according to various embodiments, including an emitter assembly that includes at least a portion of an energy guide. [Diagram 2] FIG. 1 is a simplified schematic cross-sectional view of a portion of an embodiment of a catheter system including an embodiment of an emitter assembly. [Diagram 3] FIG. 3 is a simplified schematic perspective view of the emitter assembly shown in FIG. 2. [Figure 4] FIG. 3 is a simplified schematic exploded view of the emitter assembly shown in FIG. 2. [Diagram 5] FIG. 3 is a simplified schematic perspective view of the emitter assembly shown in FIG. 2 secured to a guidewire lumen of a catheter system. [Figure 6] FIG. 13 is a simplified schematic perspective view of another embodiment of an emitter assembly. [Figure 7] FIG. 7 is a simplified schematic end view of a portion of the emitter assembly shown in FIG. [Figure 8] FIG. 13 is a simplified schematic perspective view of yet another embodiment of an emitter assembly.

[0039] While embodiments of the present invention are susceptible to various modifications and alternative forms, details thereof have been shown by way of example and drawings and are described in detail herein. It is understood, however, that the scope of the present specification is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope of the specification. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0040] Treatment of vascular lesions can reduce serious adverse events or deaths in affected subjects.As referred to herein, major adverse events are events that may occur anywhere in the body due to the presence of vascular lesions.Major adverse events can include, but are not limited to, major adverse events in the heart, 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.

[0041] As used herein, the terms "treatment site," "intravascular lesion," and "vascular lesion" are used interchangeably unless otherwise noted. Thus, an intravascular lesion and / or a vascular lesion may also be referred to herein simply as a "lesion."

[0042] Those skilled in the art will appreciate that the following detailed description of the present invention is for illustrative purposes 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 indices will be used throughout the drawings and the following detailed description to refer to the same or similar parts.

[0043] For clarity, not all of the specific configurations of the implementations described herein are shown and described. It will be understood that the development of any such actual implementation will require numerous implementation-specific decisions to be made in order to achieve the specific goals of the developer, such as compliance with application-related and business-related constraints, and that these specific goals will vary from implementation to implementation and developer to developer. Moreover, it will be recognized 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.

[0044] The catheter system 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 spallation at one or more treatment sites within or adjacent to a blood vessel wall or adjacent to a heart valve within a patient's body. In the embodiment shown in FIG. 1, the catheter system 100 can include 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 source 125, a system controller 126, and a graphic user interface 127 ("GUI"), a handle assembly 128, and one or more of an emitter assembly 129. In various embodiments, the emitter assembly 129 includes and / or incorporates at least a portion of the energy guide 122A, and the emitter assembly 129 is configured to direct and / or focus energy toward one or more treatment sites 106A at a treatment site 106 within or adjacent a vascular wall 108A or heart valve of a blood vessel 108 in a body 107 of a patient 109. Alternatively, the catheter system 100 may include more or fewer components than those specifically illustrated and described in connection with FIG.

[0045] The catheter 102 is configured to navigate to a treatment site 106 within or adjacent a vascular wall 108A of a blood vessel 108 or a heart valve within a 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 a heart valve within the body 107 of a patient 109.

[0046] 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 to 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.

[0047] 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 contracted state suitable for advancing the catheter 102 through the patient's vasculature to an inflated state (as shown in FIG. 1 ) suitable for fixing the catheter 102 in 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 in FIG. 1 the balloon wall 130 of the balloon 104 is shown spaced apart from the treatment site 106 of the blood vessel 108 or heart valve 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.

[0048] Balloons 104 suitable for use in the catheter system 100 include those that are capable of passing through the vasculature of a patient 109 when in a deflated state. 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.

[0049] 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) up to 25 mm. In some embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from at least 1.5 mm up to 14 mm. In some embodiments, the balloon 104 can have a diameter (in an inflated state) ranging from at least 2 mm up to 5 mm.

[0050] In some embodiments, the balloon 104 can have a length ranging from at least 3 mm to 300 mm. More specifically, in some embodiments, the balloon 104 can have a length ranging from at least 8 mm to 200 mm. It is understood that a balloon 104 having a relatively long length can be positioned adjacent a larger treatment site 106 and thus can be used to apply pressure waves to induce disruption to 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 multiple treatment sites 106 at any one time.

[0051] 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 other embodiments, the balloon 104 can be inflated to an inflation pressure of at least 2 atm to 10 atm.

[0052] 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, stepped diameter, offset, or conical offset. In some embodiments, the balloon 104 can include a drug eluting coating or 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, and the like.

[0053] 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 a volume ratio of about 50:50. In other embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium in a volume ratio of about 25:75. In yet other embodiments, the catheter fluid 132 may include a mixture of saline and contrast medium in a volume ratio of about 75:25. However, it is understood that any suitable ratio of saline to contrast medium may be used. The catheter fluid 132 may be adjusted based on composition, viscosity, etc., such that the propagation speed 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.

[0054] In certain embodiments, the catheter fluid 132 may include a wetting agent or surface active agent (surfactant). These compounds can lower the tension between solids and liquids. These compounds can function as emulsifiers, dispersants, detergents, and water penetrants. The wetting agent or surfactant can reduce the surface tension of the liquid, allowing the liquid to completely wet and contact the optical components (e.g., the energy guide(s) 122A) and mechanical components (e.g., other parts of the emitter assembly(s) 129). This reduces or eliminates the accumulation of air bubbles and pockets or entrapment of gas within the emitter assembly 129. Non-limiting examples of chemicals that can be used as wetting agents include, but are not limited to, benzalkonium chloride, benzethonium chloride, cetylpyridinium chloride, poloxamer 188, poloxamer 407, polysorbate 20, polysorbate 40, and the like. Non-limiting examples of surfactants may include, but are not limited to, ionic and non-ionic detergents, and sodium stearate. Another suitable surfactant is 4-(5-dodecyl)benzenesulfonate. Other examples can include docusate (dioctyl sodium sulfosuccinate), alkyl ether phosphates, and perfluorooctane sulfonates (PFOS), to name a few.

[0055] By using a wetting agent or surfactant, direct contact of the liquid with the energy guide 122A allows for more efficient conversion of energy to plasma. With the use of a wetting agent or surfactant with the small sized optical and mechanical components used in the emitter assembly 129 and other parts of the catheter 102, greater (or complete) wetting is less difficult to achieve. By lowering the surface tension of the liquid, the difficulty of such small structures being effectively wetted and nearly or completely immersed by the liquid can be reduced. By reducing or eliminating the adhesion of air or other bubbles to the optical and mechanical structures and the energy guide 122A, the efficiency of the device can be greatly improved.

[0056] The specific percentage of wetting agent or surfactant can be varied to suit the design parameters of the catheter system 100 and / or emitter assembly 129 being used. In one embodiment, the percentage of wetting agent or surfactant can be less than about 50% by volume of the catheter fluid 132. In alternative, non-exclusive embodiments, the percentage of wetting agent or surfactant can be less than about 40%, 30%, 20%, 10%, 5%, 2%, 1%, 0.1%, or 0.01% by volume of the catheter fluid 132. Further alternatively, the percentage of wetting agent or surfactant can be outside of the aforementioned ranges.

[0057] In some embodiments, the contrast agents used in the contrast medium may include, but are not limited to, iodine-based contrast agents, such as ionic or non-ionic iodine-based contrast agents. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, metrizoate, iothalamate, and ioxaglate. Some non-limiting examples of non-ionic iodine-based contrast agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based contrast agents may be used. Suitable non-iodine-containing contrast agents may include gadolinium(III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon agents may include, but are not limited to, agents such as the perfluorocarbon dodecafluoropentane (DDFP, C5F12).

[0058] The catheter fluid 132 can include those containing absorbers that can selectively absorb light in the ultraviolet (e.g., at least 10 nanometers (nm) to 400 nm), visible (e.g., at least 400 nm to 780 nm), or near infrared (e.g., at least 780 nm to 2.5 μm) regions of the electromagnetic spectrum. Suitable absorbers can include those that have an absorption maximum along a spectrum of at least 10 nm to 2.5 μm. Alternatively, the catheter fluid 132 can include those containing absorbers that can selectively absorb light in the mid-infrared (e.g., at least 2.5 μm to 15 μm) or far-infrared (e.g., at least 15 μm to 1 mm) regions of the electromagnetic spectrum. In various embodiments, the absorbers can have an absorption maximum that coincides with the emission maximum of the laser used in the catheter system 100. As non-limiting examples, various lasers 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.

[0059] 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. The energy guide(s) 122A can be disposed within the balloon 104 along the catheter shaft 110. In some embodiments, each energy guide 122A can be an optical fiber and the energy source 124 can be a laser. The energy source 124 can 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 can be coupled to multiple energy guides 122A, e.g., 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 about 180 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110, three energy guides 122A can be spaced about 120 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110, or four energy guides 122A can be spaced about 90 degrees apart around the circumference of the guidewire lumen 118 and / or catheter shaft 110. Further alternatively, the multiple 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 is 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.

[0061] In certain embodiments, the guidewire lumen 118 can have a grooved outer surface, with the grooves extending generally longitudinally along the guidewire lumen 118. In such embodiments, each of the energy guide 122A and / or emitter assembly(es) 129 can be positioned, received, and retained within a respective groove formed along and / or in the outer surface of the guidewire lumen 118. Alternatively, the guidewire lumen 118 can be formed without a grooved outer surface, and the position of the energy guide 122A and / or emitter assembly(es) 129 relative to the guidewire lumen 118 can be maintained in another suitable manner.

[0062] 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 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.

[0063] The energy guide 122A may have any suitable design for purposes 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 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 may 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 may be configured to provide high voltage pulses, and each energy guide 122A may include an electrode pair including spaced apart electrodes extending into the balloon interior 146. In such an embodiment, each pulse of high voltage is applied to the electrodes, forming an electric arc between the electrodes which in turn generates a plasma and creates 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.

[0064] 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.

[0065] Each energy guide 122A can direct energy along its length from a proximal guide end 122P to a distal guide end 122D that has at least one optical window (not shown) disposed within the balloon interior 146.

[0066] The energy guide 122A can take 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 in the catheter shaft 110.

[0067] The energy guides 122A may be positioned at any suitable location about the guidewire lumen 118 and / or the 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 relative to 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.

[0068] 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 in which it is disposed. In some embodiments, the optoacoustic transducers 154 can be in optical communication with the guide distal end 122D of the energy guide 122A. In such embodiments, the optoacoustic transducers 154 can have a shape that corresponds to and / or follows the shape of the guide distal end 122D of the energy guide 122A.

[0069] 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.

[0070] In certain embodiments, the optoacoustic 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 optoacoustic transducer 154 and / or the guide distal end 122D can have a conical shape, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a semicircular shape, an oval shape, etc. The energy guide 122A can further include additional optoacoustic transducers 154 disposed along one or more sides of the length of the energy guide 122A.

[0071] In some embodiments, the energy guide 122A and / or emitter assembly 129 may further include one or more redirecting mechanisms or “diverters” (not shown in FIG. 1 ), such as within and / or near the guide distal end, configured to direct energy from the energy guide 122A toward a side surface, which may be located at or near the guide distal end 122D of the energy guide 122A, before the energy is directed to the balloon wall 130. The redirecting mechanism may include any mechanism of 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 may 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 mechanism. Stated another way, the redirecting mechanism may be configured to direct energy within the energy guide 122A toward a side surface at or near the guide distal end 122D that is in optical communication with the optical window. The optical window can include a portion of the energy guide 122A that allows energy to exit the energy guide 122A from within the energy guide 122A, for example, a portion of the energy guide 122A that is lacking cladding material on or around the energy guide 122A.

[0072] 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, the energy is redirected within the energy guide 122A to one or more of the plasma generator 133 and the photoacoustic transducer 154, which is in optical communication with the side of the energy guide 122A. When used, the photoacoustic transducer 154 then converts the optical energy into acoustic waves, which propagate away from the side of the energy guide 122A.

[0073] Additionally or alternatively, in certain embodiments, such redirection mechanisms that may be incorporated into the energy guide 122A may also be incorporated into the design of the emitter assembly 129 and / or plasma generator 133 for the purpose of directing and / or focusing acoustic and mechanical energy toward specific areas of the balloon wall 130 in contact with vascular lesions 106A at the treatment site 106 to apply pressure to such vascular lesions 106A and induce disruption within such vascular lesions 106A.

[0074] 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 one or more energy guides 122A of the energy guide bundles 122, the guidewire 112, and / or an inflation conduit 140 coupled in fluid communication with a fluid pump 138. The catheter system 100 can also include a fluid pump 138 configured to inflate the balloon 104 with the catheter fluid 132 as needed.

[0075] As mentioned above, in the embodiment shown 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 shown in FIG. 1. For example, in certain non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127. Further alternatively, one or more of the energy source 124, the power source 125, the system controller 126, and the GUI 127 may be provided within the catheter system 100 without the specific need for a system console 123.

[0076] 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 (which may also be generically 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 (which may also be generically referred to as a "ferrule") that houses a portion of each of the energy guides 122A (e.g., guide proximal end 122P). The guide coupling housing 150 is configured to fit and selectively retain within the console connection opening 148 to provide a mechanical coupling between the energy guide bundle 122 and the system console 123.

[0077] The energy guide bundle 122 may also include a guide bundler 152 (or “shell”) that brings 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 with the catheter 102 into a blood vessel 108 or heart valve during use of the catheter system 100.

[0078] 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 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.

[0079] The energy source 124 may have any suitable design. In certain embodiments, the energy source 124 may be configured to provide sub-millisecond pulses of energy from the energy source 124 that are focused to a small spot for coupling to the proximal guide end 122P of the energy guide 122A. Such pulses of energy are then guided and / or directed 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 that may 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 towards the plasma generator 133, energizing the plasma generator 133 to form plasma within the catheter fluid 132 within the balloon interior 146. The formation of plasma causes rapid bubble formation, imparting pressure waves to the treatment site 106. An exemplary plasma-induced bubble 134 is shown in FIG.

[0080] In various non-exclusive alternative embodiments, sub-millisecond pulses of energy from the energy source 124 may be delivered to the 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 the treatment site 106 at frequencies greater than 5000 Hz or less than 1 Hz, or any other suitable range of frequencies.

[0081] Although the energy source 124 is typically utilized to provide pulses of energy, it will be understood that the energy source 124 can still be described as providing a single source beam 124A, i.e., a single pulsed source beam.

[0082] Suitable energy sources 124 for use may include various types of light sources, including lasers and lamps. Alternatively, the energy source 124 may include any suitable type of energy source.

[0083] Suitable lasers may include short pulse lasers on sub-millisecond timescales. In some embodiments, the energy source 124 may include nanosecond (ns) timescale lasers. Lasers may also include picosecond (ps), femtosecond (fs), and microsecond (μs) timescale short pulse lasers. It is understood that there are many combinations of laser wavelengths, pulse widths, and energy levels that may 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 that fall 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.

[0084] Exemplary nanosecond lasers may 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 may 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 may 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 may include an energy source capable of generating light with wavelengths of at least 100 nm to 10 micrometers (μm). Nanosecond lasers may include lasers having repetition rates up to 200 kHz.

[0085] 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, and a doped pulsed fiber laser.

[0086] 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 yet 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 in the catheter fluid 132.

[0087] The catheter system 100 can generate 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 absorbent material, the expansion of the bubbles, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter system 100 can generate 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.

[0088] 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.

[0089] The power supply 125 is electrically connected 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 design suitable for such purposes.

[0090] 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 purposes 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.

[0091] 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 of 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 arranged 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 located and / or incorporated within the handle assembly 128.

[0092] 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 information to the user or operator that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 can provide static visual data and / or information to the user or operator. Additionally or alternatively, the GUI 127 can provide dynamic visual data and / or information to the user or operator, such as video data or any other data that changes over time during use of the catheter system 100. In various embodiments, the GUI 127 can include one or more colors, different sizes, varying brightness, etc., that may serve as an alert to the user or operator. Additionally or alternatively, the GUI 127 can provide audio data or information to the user or operator. The details of the GUI 127 may vary depending on the design requirements of the catheter system 100 or the particular needs, specifications, and / or desires of a user or operator.

[0093] 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 and spaced apart from the balloon 104. Alternatively, the handle assembly 128 can be located in another suitable location.

[0094] The handle assembly 128 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. 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 that can 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 may be omitted or may be included within the system controller 126, and in various embodiments, the system controller 126 may be located external to the handle assembly 128, such as in the system console 123. It is understood that the handle assembly 128 may include fewer or additional components than those specifically illustrated and described herein.

[0095] In various embodiments, the emitter assembly 129 is configured to maintain a desired positioning between the guide distal end 122D of the energy guide 122A and the plasma generator 133 to direct and / or focus energy generated within the catheter fluid 132 within the balloon interior, thereby applying pressure to induce disruption at the vascular wall 108A of the blood vessel 108 or the vascular lesion 106A of the treatment site 106 within or adjacent to a heart valve. More specifically, by effectively maintaining a desired positioning between the guide distal end 122D of the energy guide 122A and the plasma generator 133, certain design configurations that may be incorporated into the emitter assembly 129, the emitter assembly 129 is configured to focus and direct acoustic and / or mechanical energy toward specific regions of the balloon wall 130 in contact with the vascular lesion 106A of the treatment site 106, enhancing delivery of such energy to the treatment site 106. Thus, the emitter assembly 129 can effectively improve the efficacy of the catheter system 100.

[0096] It will be appreciated that in some embodiments, a separate emitter assembly 129 can be included in and / or incorporated into each individual energy guide 122A. Alternatively, in other embodiments, a single emitter assembly 129 can be configured to operate in conjunction with multiple energy guides 122A. Additionally alternatively, each energy guide 122A need not have an emitter assembly 129 incorporated therein or associated therewith.

[0097] The design of the emitter assembly 129 and / or the particular arrangement of the emitter assembly 129 can be varied to suit the requirements of the catheter system 100. In various embodiments, the emitter assembly 129 can utilize and / or incorporate at least a portion of the energy guide 122A, such as the portion of the energy guide 122A that includes the guide distal end 122D.

[0098] Various alternative embodiments of the emitter assembly 129 are illustrated in subsequent figures and described in detail below.

[0099] As with all embodiments illustrated and described herein, various structures may be omitted from the figures for clarity and ease of understanding. Additionally, the figures may include certain structures that can be omitted without departing from the spirit and scope of the present invention.

[0100] 2 is a simplified schematic cross-sectional view of a portion of an embodiment of a catheter system 200, including an embodiment of an emitter assembly 229. The design of the catheter system 200 can vary. In various embodiments, as shown in FIG. 2, the catheter system 200 can include a catheter 202 including a catheter shaft 210, a balloon 204 having a balloon wall 230 defining a balloon interior 246, a balloon proximal end 204P, and a balloon distal end 204D, a catheter fluid 232 held substantially within the balloon interior 246, and an emitter assembly 229 that can incorporate at least a portion of an energy guide 222A in certain embodiments. Alternatively, in other embodiments, the catheter system 200 can include more or fewer components than those specifically shown and described herein. For example, certain components shown in FIG. 1 , such as guidewire 112, guidewire lumen 118, source manifold 136, fluid pump 138, energy source 124, power supply 125, system controller 126, GUI 127, and handle assembly 128, are not specifically shown in FIG. 2 for clarity, but may be included in any embodiment of catheter system 200.

[0101] The design and function of the catheter shaft 210, balloon 204, and catheter fluid 232 are substantially similar to those shown and described herein above, and therefore a detailed description of such components will not be repeated.

[0102] The balloon 204 is again selectively movable between a deflated state suitable for advancing the catheter 202 through the patient's vasculature and an inflated state suitable for fixing the catheter 202 in place relative to the treatment site 106 (shown in FIG. 1). In some embodiments, the balloon proximal end 204P can be coupled to the catheter shaft 210 and the balloon distal end 204D can be coupled to the guidewire lumen 118 (shown in FIG. 1). The balloon 204 can again be inflated with catheter fluid 232, such as from a fluid pump 138 (shown in FIG. 1), directed to the balloon interior 246 of the balloon 204 via an inflation conduit 140 (shown in FIG. 1).

[0103] As with the previous embodiment, the energy guide 222A can include one or more optoacoustic transducers 154 (shown in FIG. 1 ), each of which can be in optical communication with the energy guide 222A in which it is disposed. In some embodiments, the optoacoustic transducers 154 can be in optical communication with the guide distal end 222D of the energy guide 222A. Alternatively, in other embodiments, the energy guide 222A can be designed without the optoacoustic transducer(s) 154.

[0104] In various embodiments, the emitter assembly 229 is configured to direct and / or focus energy generated in the catheter fluid 232 within the balloon interior 246 to apply pressure to induce disruption of the vascular lesion 106A (shown in FIG. 1 ) at the treatment site 106. More specifically, the emitter assembly 229 is configured to direct and focus acoustic and / or mechanical energy toward specific regions of the balloon wall 230 in contact with the vascular lesion 106A at the treatment site 106 to enhance delivery of such energy to the treatment site 106. As shown in this embodiment, at least a portion of the components of the emitter assembly 229 are disposed within the balloon interior 246.

[0105] 2, in certain embodiments, the emitter assembly 229 includes at least a portion of the energy guide 222A, a plasma generator 233, and an emitter housing 260 coupled and / or secured to the energy guide 222A and the plasma generator 233.

[0106] In some embodiments, as shown, the emitter housing 260 can include one or more of: (i) a first housing section 262 coupled and / or secured to the energy guide 222A at or near the guide distal end 222D of the energy guide 222A, (ii) a second housing section 264 coupled and / or secured to the plasma generator 233, and (iii) a connector section 266 coupled to, integrally formed with, and / or extending between the first housing section 262 and the second housing section 264. In such embodiments, the emitter housing 260 can be formed as a unitary structure including each of the first housing section 262, the second housing section 264, and the connector section 266, or the first housing section 262, the second housing section 264, and the connector section 266 of the emitter housing 260 can be formed as separate pieces that are secured to one another. Alternatively, emitter housing 260 may include more or fewer components than those specifically shown in FIG.

[0107] As shown, the first housing section 262 of the emitter housing 260 is configured to be secured to and substantially surround at least a portion of the energy guide 222A, such as at or near the guide distal end 222D of the energy guide 222A. In one such embodiment, the first housing section 262 of the emitter housing 260 is substantially annular and / or cylindrical in shape and includes a guide opening 362A (shown in FIG. 3 ) through which and / or into which the energy guide 222A can be positioned. Alternatively, the first housing section 262 can have another suitable shape. As used herein, the description of the first housing section 262 as substantially surrounding at least a portion of the energy guide 222A and / or being substantially annular and / or cylindrical in shape is intended to mean that the first housing section 262 surrounds at least about 90%-95% of such portion of the energy guide 222A, but may further include a small housing gap 368 (shown in FIG. 3 ) that extends completely along the length of the first housing section 262 and allows for slight expansion or contraction of the first housing section 262 due to changing environmental conditions in which the catheter system 200 is being used. The housing gap 368 allows for such potential expansion or contraction of the first housing section 262 without adversely affecting the structure of the guide distal end 222D of the energy guide 222A around which the first housing section 262 is disposed.

[0108] The first housing section 262 can be secured to a portion of the energy guide 222A, such as at or near the guide distal end 222D, in any suitable manner. For example, the first housing section 262 can be secured to the portion of the energy guide 222A using any suitable type of adhesive material. Alternatively, the first housing section 262 can be secured to the portion of the energy guide 222A in another suitable manner.

[0109] To some extent similarly, as shown, the second housing section 264 of the emitter housing 260 is configured to be secured to and substantially surround the plasma generator 233. In one such embodiment, the second housing section 264 of the emitter housing 260 is substantially annular and / or cylindrical in shape and includes a generator opening 364A (shown in FIG. 3 ) through which and / or into which the plasma generator 233 can be positioned. Alternatively, the second housing section 264 can have another suitable shape. As used herein, the description of the second housing section 264 as substantially surrounding the plasma generator 233 and / or being substantially annular and / or cylindrical in shape is intended to mean that the second housing section 264 surrounds at least about 90%-95% of the plasma generator 233, but may further include a small housing gap 370 (shown in FIG. 3 ), which extends completely along the length of the second housing section 264 and allows for slight expansion or contraction of the second housing section 264 due to changing environmental conditions in which the catheter system 200 is being used. The housing gap 370 allows for such potential expansion or contraction of the second housing section 264 without adversely affecting the structure of the plasma generator 233 around which the second housing section 264 is disposed.

[0110] The second housing section 264 may be secured to the plasma generator 233 in any suitable manner. For example, the second housing section 264 may be secured to the plasma generator 233 using any suitable type of adhesive material. Alternatively, the second housing section 264 may be secured to the plasma generator 233 in another suitable manner.

[0111] As described above, the connector section 266 of the emitter housing 260 is coupled to, integrally formed with, and / or extends between the first housing section 262 and the second housing section 264. In some embodiments, the connector section 266 can be partially annular and / or cylindrical in shape, extending completely along the length of the connector section 266 to help define the non-complete annular and / or cylindrical shape of the connector section 266, with a section opening 272 configured to direct and / or focus plasma energy formed within the catheter fluid 232 within the balloon interior 246 through the section opening 272 toward and / or to a vascular lesion 106A formed at the treatment site 106. The size and orientation of the section opening 272 can vary depending on the size and location of the vascular lesion 106A to be treated using the catheter system 200. In some non-exclusive alternative embodiments, the section opening 272 may be less than about 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75%, 80%, 85%, or 90% of what would otherwise form a complete annular and / or cylindrical shape of the connector section 266. Stated differently, the connector section 266 may be formed as at least about 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55%, 50%, 45%, 40%, 35%, 30%, 25%, 20%, 15%, or 10% of a complete annular and / or cylindrical body.

[0112] In various embodiments, the emitter housing 260 can be formed from an elongated tube (hypotube) and any suitable material. For example, in certain non-exclusive embodiments, the emitter housing 260 can be formed from a hypotube including one or more metals, such as, for example, titanium, stainless steel, tungsten, etc. Alternatively, the emitter housing 260 can be formed from a hypotube including a plastic, such as polyimide and nylon. Further alternatively, the emitter housing 260 may be injection molded and an overmolding process can be used to secure the energy guide 222A and / or the plasma generator 233 in place. Further alternatively, the emitter housing 260 can be formed in another suitable manner and / or from other suitable materials. For example, in certain alternative embodiments, the characterization of the emitter housing 260 can be performed by laser cutting, milling, or Swiss threading processes of the raw hypotube.

[0113] Such a design of the emitter housing 260 can effectively maintain a desired relative position between the guide distal end 222D of the energy guide 222A and the plasma generator 233. During use of the catheter system 200, energy can be transmitted through the energy guide 222A and directed through the guide distal end 222D toward the plasma generator 233, thereby generating plasma in the catheter fluid 232 within the balloon interior 246 of the balloon 202. The guide distal end 222D can have any suitable shape such that energy transmitted through the energy guide 222A can be effectively and precisely directed through the guide distal end 222D toward the plasma generator 233. In one embodiment, the guide distal end 222D can have a flat cleaved end through which energy is directed toward the plasma generator 233. Alternatively, the guide distal end 222D can be generally hemispherical, ball-shaped, conical, wedge-shaped, pyramidal, or another suitable shape.

[0114] 2, the plasma generator 233 (or target) may include a proximal end 233P that is angled or otherwise configured to more effectively direct and / or focus energy in the form of plasma generated in the catheter fluid 232 through a section opening 272 in the connector section 266 of the emitter housing 260 toward the balloon wall 230 disposed adjacent the vascular lesion 106A of the treatment site 106. It is understood that the proximal end 233P of the plasma generator 233 may be configured at any suitable angle to effectively direct and / or focus the plasma energy as desired. For example, in some such embodiments, the proximal end 233P of the plasma generator 233 may be angled at approximately 5 degrees to 45 degrees relative to a flat vertical configuration. Alternatively, the proximal end 233P of the plasma generator 233 can be angled less than 5 degrees or more than 45 degrees relative to a flat vertical configuration to direct energy in the form of plasma generated within the catheter fluid 232 toward the balloon wall 230 positioned adjacent to the treatment site 106.

[0115] The plasma generator 233 may be formed from any suitable material. For example, in certain non-exclusive embodiments, the plasma generator 233 may be formed from one or more metals, such as, for example, titanium, stainless steel, tungsten, etc. Alternatively, the plasma generator 233 may be formed from plastics, such as polyimide and nylon. Further alternatively, the plasma generator 233 may be formed from other suitable materials. It is understood that in different embodiments, the plasma generator 233 may be formed from the same material as the emitter housing 260 or may be formed from a different material than the emitter housing 260.

[0116] It will be appreciated that during use of the catheter system 200, the catheter fluid 232 utilized to inflate the balloon 204 can also enter the region of the connector section 266 of the emitter housing 260 through the section opening 272. Pulsed energy directed through the energy guide 222A toward the plasma generator 233 subsequently generates plasma-induced bubbles 134 (shown in FIG. 1 ) within the catheter fluid 232 within the general region of the connector section 266 of the emitter housing 260. As the bubbles 134 expand, they are directed and / or focused by the proximal end 233P of the plasma generator 233 through the section opening 272 of the connector section 266 toward the balloon wall 230 positioned adjacent the vascular lesion 106A of the treatment site 106.

[0117] Figure 3 is a simplified schematic perspective view of the emitter assembly 229 shown in Figure 2. More specifically, Figure 3 is a simplified schematic perspective view showing a portion of the energy guide 222A, the plasma generator 233, and the emitter housing 260 including a first housing section 262, a second housing section 264, and a connector section 266, which together form the emitter assembly 229.

[0118] As shown, the first housing section 262 can be substantially annular and / or cylindrical in shape and can include a small housing gap 368 that extends completely along the length of the first housing section 262 to allow for slight expansion or contraction of the first housing section 262 due to changing environmental conditions in which the catheter system 200 (shown in FIG. 2 ) is being used.

[0119] 3 also illustrates a first housing coupler 374 used to couple the first housing section 262 to a portion of the energy guide 222A, such as at or near the guide distal end 222D of the energy guide 222A. The design of the first housing coupler 374 can vary. For example, in one embodiment, the first housing coupler 374 can include an adhesive material disposed between an outer surface of the energy guide 222A and an inner surface of the first housing section 262 to effectively couple and / or secure the first housing section 262 to the energy guide 222A. Alternatively, the first housing coupler 374 can have another suitable design.

[0120] The type of adhesive material used with the first housing coupler 374 to secure the first housing section 262 to the energy guide 222A can vary. For example, in certain embodiments, an adhesive material with low hardness characteristics (e.g., a silicone-based adhesive) can be selected to attenuate / reduce shock wave forces on the energy guide 222A. Alternatively, other suitable adhesive materials may be selected.

[0121] In some embodiments, an extruded thermoplastic tube (e.g., made from materials such as Pebax®, nylon, polyurethane, etc.) can be used to add a soft protective layer 375 between the energy guide 222A and the first housing section 262 of the emitter housing 260. Such a protective layer 375 can also help to center the energy guide 222A in a slightly offset manner from the inner diameter of the emitter housing 260 to facilitate proper alignment with the plasma generator 233.

[0122] As shown, the second housing section 264 can be substantially annular and / or cylindrical in shape and can include a small housing gap 370 that extends completely along the length of the second housing section 264 to allow for slight expansion or contraction of the second housing section 264 due to changes in the environmental conditions in which the catheter system 200 is being used.

[0123] FIG. 3 also illustrates a second housing coupler 376 used to couple the second housing section 264 to the plasma generator 233. The design of the second housing coupler 376 can vary. For example, in one embodiment, the second housing coupler 376 can include an adhesive material disposed between an outer surface of the plasma generator 233 and an inner surface of the second housing section 264 to effectively couple and / or secure the second housing section 264 to the plasma generator 233. In such an embodiment, it is understood that any suitable type of adhesive material can be used for the second housing coupler 376. Alternatively, the second housing coupler 376 can have another suitable design and / or the second housing section 264 can be secured to the plasma generator 233 in another suitable manner. For example, a crimping process can mechanically crimp the plasma generator 233 into place within the second housing section 264. Alternatively still, the plasma generator 233 can be press-fitted into the second housing section 264. Further alternatively, the housing gap 368 may function as an expansion slot that may aid in an interference fit between the second housing section 264 and the plasma generator 233. The housing gap 368 or expansion slot may be made wide enough to remove wall thickness of the emitter housing 260 at the top end, thus minimizing the outer diameter of the emitter housing relative to the inner shaft.

[0124] As further shown in FIG. 3, a generally flat cleaved end of the guide distal end 222D faces across the connector section 266 of the emitter housing 260 to the angled proximal end 233P of the plasma generator 233.

[0125] Figure 4 is a simplified schematic exploded view of the emitter assembly 229 shown in Figure 2. More specifically, Figure 4 shows an exploded view of the emitter assembly 229 including at least a portion of the energy guide 222A, the plasma generator 233, and the emitter housing 260. Figure 4 also shows small housing gaps 368, 370 that can be formed in the first housing section 262 and the second housing section 264, respectively, of the emitter housing 260.

[0126] FIG. 4 also shows (i) a first housing port 478 formed in the first housing section 262 of the emitter housing 260, through which an adhesive material can be introduced to effectively secure the first housing section 262 to a portion of the energy guide 222A, such as at or near the guide distal end 222D of the energy guide 222A, and (ii) a second housing port 480 formed in the second housing section 264 of the emitter housing 260, through which an adhesive material can be introduced to effectively secure the second housing section 264 to the plasma generator 233.

[0127] FIG. 4 also more clearly illustrates the shape of one embodiment of the connector section 266, which includes a section opening 272 through which plasma energy can be directed toward the balloon wall 230 (shown in FIG. 2) positioned adjacent to the vascular lesion 106A (shown in FIG. 1) at the treatment site 106 (shown in FIG. 1).

[0128] FIG. 5 is a simplified schematic perspective view of the emitter assembly 229 shown in FIG. 2 secured to the guidewire lumen 518 of the catheter system 200 (shown in FIG. 2).

[0129] As shown in this embodiment, the guidewire lumen 518 may include one or more grooves 582 formed along and / or in an outer surface 518A of the guidewire lumen 518. The emitter assembly 229 may then be placed into one of the grooves 582 and held in place within the grooves 582 by one or more assembly fittings 584 (two are shown in FIG. 5 ). As shown, to effectively hold the emitter assembly 229 in place within the grooves 582 formed in the outer surface 518A of the guidewire lumen 518, a first assembly fitting 584 may be positioned substantially adjacent to the first housing section 262 of the emitter housing 260, and a second assembly fitting 584 may be positioned substantially adjacent to the second housing section 264 of the emitter housing 260.

[0130] The assembly fitting 584 can have any suitable design. In some embodiments, the assembly fitting 584 can be provided in the form of a heat shrink fitting, as shown in Figure 5. Alternatively, the assembly fitting 584 can have another suitable design.

[0131] It will be appreciated that the second emitter assembly 229 is also shown in FIG. 5 as being held in place within another of the grooves 582 formed in the outer surface 518A of the guidewire lumen 518.

[0132] 6 is a simplified schematic perspective view of another embodiment of an emitter assembly 629. As shown in FIG. 6, the emitter assembly 629 is somewhat similar in design, arrangement, and function to the previous embodiment. In this embodiment, the emitter assembly 629 again includes at least a portion of the energy guide 622A, a plasma generator 633, and an emitter housing 660. The emitter housing 660 also again includes (i) a first housing section 662 including a guide opening 662A configured to at least substantially surround a portion of the energy guide 622A, for example, at or near the guide distal end 622D of the energy guide 622A, (ii) a second housing section 664, and (iii) a connector section 666 again including a section opening 672 coupled to, integrally formed with, and / or extending between the first housing section 662 and the second housing section 664. In this embodiment, the emitter assembly 629 is again configured to effectively direct and / or focus energy generated within the catheter fluid 232 (shown in FIG. 2) held within the balloon 204 (shown in FIG. 2) to apply pressure onto the vascular lesion 106A (shown in FIG. 1) at the treatment site 106 (shown in FIG. 1) to induce fragmentation therein.

[0133] However, as shown in the embodiment depicted in FIG. 6, the plasma generator 633 is integrally formed with the second housing section 664 of the emitter housing 660, rather than being disposed and / or fixed substantially within the second housing section as in the previous embodiment.

[0134] In such a design, the emitter housing 660 can be manufactured by machining using a single piece rod instead of fabricating the rod from a hypotube, as is typically used for the embodiment of the emitter housing 260 shown in FIG. 2. The machining of the emitter housing 660 can be accomplished using any suitable machining process. For example, in certain non-exclusive implementations, the machining of the emitter housing 660 can be accomplished by electrical discharge machining, or micro-machining using milling or Swiss threading techniques.

[0135] It will be appreciated that this design may have several significant advantages over the hypotube design. First, this integrated design, in which the emitter housing 660 is formed from a single piece rod, allows for a guide opening 662A formed in the first housing section 662 and configured to receive and hold a portion of the energy guide 622A that is offset from the central axis 688 of the emitter housing 660 by an offset distance 786 (as shown in FIG. 7 ), thus allowing the connector section 666 to be thicker in dimension. Second, this integrated design maximizes the cross-sectional area of ​​the plasma generator 633 since the plasma generator 633 is made from the same material as the second housing section 664, whereas in a hypotube design, the plasma generator material and the hypotube material may be different, thus reducing the cross-sectional area of ​​the plasma generator due to the hypotube walls. It is desirable to maximize the cross-sectional area of ​​the plasma generator 633 to reduce the need for precise alignment of the guide distal end 622D of the energy guide 622A relative to the plasma generator 633. Third, as shown, the first housing section 662 and the second housing section 664 can each include a notch 690, 692 to interface with the shaft of the inner member and accommodate an assembly fitting 584 (shown in FIG. 5), such as a heat shrink fitting, and can be fabricated to reduce the cross-sectional profile of the balloon catheter assembly. Fourth, in some embodiments, a first housing port 678, such as an adhesive port to accommodate the addition of adhesive material between the first housing section 662 and the energy guide 622A, can be combined with the notch 690 in the first housing section 662, allowing the adhesive to penetrate inside and provide a consistent bond. Fifth, a radius 694 can be cut into the emitter housing 660 to reduce the number of sharp edges on the emitter housing 660 and limit potential damage to the balloon 204.Finally, compared to the hypotube design, there is no need to couple the plasma generator 633 to the emitter housing 660 since the plasma generator 633 is already integrated within the second housing section 664 of the emitter housing 660 .

[0136] FIG. 7 is a simplified schematic end view of a portion of the emitter assembly 629 shown in FIG. 6. In particular, FIG. 7 is a simplified end view looking directly at the first housing section 662 of the emitter housing 660, illustrating a guide opening 662A formed therein for receiving and retaining a portion of the energy guide 622A (shown in FIG. 6). As shown, the guide opening 662A is offset from a central axis 688 (shown as a small circle) of the emitter housing 660 by an offset distance 786, thus allowing the dimensions of the connector section 666 (shown in FIG. 6) to be thicker. In certain non-exclusive embodiments, the guide opening 662A can be offset from the central axis 688 of the emitter housing 660 by an offset distance 786 of approximately 0.010 inches to 0.020 inches. In one such embodiment, the guide opening 662A can be offset from the central axis 688 of the emitter housing 660 by an offset distance 786 of about 0.015 inches. Alternatively, the guide opening 662A can be offset from the central axis 688 of the emitter housing 660 by an offset distance 786 that is greater than 0.020 inches or less than 0.010 inches.

[0137] 8 is a simplified schematic perspective view of yet another embodiment of an emitter assembly 829. In this embodiment, the emitter assembly 829 is again configured to effectively direct and / or focus energy generated within the catheter fluid 232 (shown in FIG. 2) held within the balloon 204 (shown in FIG. 2) to apply pressure onto the vascular lesion 106A (shown in FIG. 1) at the treatment site 106 (shown in FIG. 1) to induce fragmentation therein.

[0138] 8, the emitter assembly 829 is somewhat similar in design, arrangement, and function to the embodiment shown in FIG. 6, and thus may achieve most, if not all, of the same advantages described above. For example, in this embodiment, the emitter assembly 829 again includes at least a portion of the energy guide 822A, a plasma generator 833, and an emitter housing 860. The emitter housing 860 also again includes (i) a first housing section 862 including a guide opening 862A configured to at least substantially surround a portion of the energy guide 822A, e.g., at or near the guide distal end 822D of the energy guide 822A, (ii) a second housing section 864 integrally formed with the plasma generator 833, and (iii) a connector section 866 again including a section opening 872 coupled to, integrally formed with, and / or extending between the first housing section 862 and the second housing section 864.

[0139] In such a design, the emitter housing 860 may again be manufactured by machining using a single piece rod instead of being made from a hypotube, as is typically used for the embodiment of the emitter housing 260 shown in FIG. 2. The machining of the emitter housing 860 may be accomplished using any suitable machining process. For example, in certain non-exclusive implementations, the machining of the emitter housing 860 may be accomplished by electrical discharge machining, or micromachining using milling or Swiss threading techniques.

[0140] 8, the emitter assembly 829 further includes a reinforcing cover 896 disposed about, over, and / or substantially surrounding the emitter housing 860. In some embodiments, the reinforcing cover 896 can be provided in the form of a polyimide tube, which can be cut to match the design of the emitter housing 860, as shown, and disposed about, over, and / or substantially surrounding the emitter housing 860 and glued in place, such as with a UV-curable adhesive. Alternatively, the reinforcing cover 896 can be formed from other materials and / or have another suitable design.

[0141] The reinforcing cover 896 serves to reinforce the structure of the solid emitter housing 860 and / or plasma generator 833 against repeated forces (such as acoustic pressures generated by the initiation of a plasma) applied during normal device function. Additionally, in the event that the solid emitter housing 860 and / or plasma generator 833 are damaged, the reinforcing cover 896 may be further configured to contain any debris or fragments that may be generated, thereby preventing them from becoming completely detached from the emitter housing 860.

[0142] As with the previous embodiment, the emitter housing 860 and / or the plasma generator 833 may be formed from any suitable material. For example, in some non-exclusive embodiments, the emitter housing 860 and / or the plasma generator 833 may be formed from one or more of a metal, such as, for example, titanium, stainless steel, tungsten, etc. Alternatively, the emitter housing 860 and / or the plasma generator 833 may be formed from other suitable materials.

[0143] Further, it is understood that in certain non-exclusive alternative embodiments, the reinforcing cover 896 may also be utilized with one or more of the other embodiments of the emitter assembly illustrated and described in detail herein.

[0144] In various embodiments, the catheter systems and associated 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 near a blood vessel or heart valve within a patient's body. The catheter includes a catheter shaft and an inflatable balloon coupled and / or secured to the catheter shaft. The balloon can include a balloon wall defining a balloon interior. The balloon can be configured to receive catheter fluid within the balloon interior and expand from a contracted state suitable for advancing the catheter through the patient's vasculature to an inflated state suitable for securing the catheter in a predetermined position relative to the treatment site. The technology is also directed to methods of treating a treatment site within or adjacent to a blood vessel wall, such methods utilizing the devices disclosed herein.

[0145] 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 used generally in its sense including "and / or" unless the context clearly dictates otherwise.

[0146] 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" may be used interchangeably with other similar phrases, such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, etc.

[0147] 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.

[0148] The headings used herein are provided for consistency with the suggestions under 37 CFR 1.77 or to provide organizational clues. These headings are not to be construed as limiting or characterizing the invention(s) set forth in any claim that may issue from this disclosure. As an example, a description of a technology in the "Background" is not an admission that the technology is prior art to the invention(s) in this disclosure. A "Summary" or "Abstract" is also not to be construed as a characterization of the invention(s) set forth in any issued claim.

[0149] 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. Thus, aspects have been described with reference to various specific preferred embodiments and techniques. However, it should be understood that many variations and modifications can be made while remaining within the spirit and scope of the specification.

[0150] Although several different embodiments of the catheter system are shown and described herein, it will be 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 combination meets the spirit of the invention.

[0151] 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, and thus, the following appended claims and any subsequent claims thereafter are intended to be construed to include all such modifications, permutations, additions, and subcombinations as are within the true spirit and scope of the claims, and are not intended to impose any limitations on the details of construction or design shown herein.

Claims

1. 1. A catheter system for treating a treatment site within or adjacent to a blood vessel or heart valve in a patient's body, comprising: an energy source for generating energy; A catheter fluid; Emitter Assembly and The emitter assembly comprises: (i) at least a portion of an energy guide having a guide distal end selectively positioned proximate the treatment site; (ii) a plasma generator; and (iii) an emitter housing fixed to each of the energy guide and the plasma generator, the emitter housing maintaining a relative position between the distal end of the energy guide and the plasma generator; Including, the energy guide is configured to receive energy from the energy source and direct the energy toward the plasma generator to generate plasma bubbles in the catheter fluid; The plasma generator is configured to direct energy from the plasma bubbles toward the treatment site.

2. The emitter housing includes: (i) a first housing section secured to the energy guide at or near the guide distal end; (ii) a second housing section secured to or integrally formed with the plasma generator; and (iii) a connector section coupled to the first housing section and the second housing section and extending between the first housing section and the second housing section; The catheter system of claim 1 ,

3. The catheter system of claim 2 , wherein the first housing section is generally cylindrical.

4. 4. The catheter system of claim 3, wherein the first housing section includes a housing gap extending substantially along a length of the first housing section, the first housing section configured to expand and contract due to changing environmental conditions.

5. The catheter system of any one of claims 2 to 4, wherein the first housing section includes a guide opening, and at least a portion of the energy guide is secured within the guide opening.

6. The catheter system of any one of claims 2 to 5, further comprising an adhesive material securing the first housing section to the energy guide at or near the guide distal end.

7. 7. The catheter system of claim 6, wherein the first housing section includes a first housing port located between the first housing section and the energy guide, the first housing port configured to receive the adhesive material such that the adhesive material secures the first housing section to the energy guide at or near the guide distal end.

8. The catheter system of any one of claims 2 to 7, wherein the second housing section is generally cylindrical.

9. 3. The catheter system of claim 2, wherein the second housing section includes a housing gap extending substantially along a length of the second housing section, the second housing section configured to expand and contract due to changing environmental conditions.

10. The catheter system of any one of claims 2 to 9, wherein the second housing section includes a generator opening, and at least a portion of the plasma generator is fixed within the generator opening.

11. The catheter system of claim 6 or 7, wherein the adhesive material secures the second housing section to the plasma generator.

12. 12. The catheter system of claim 11, wherein the second housing section includes a second housing port located between the second housing section and the energy guide, the second housing port configured to receive the adhesive material such that the adhesive material secures the second housing section to the energy guide at or near the guide distal end.

13. The catheter system according to any one of claims 2 to 12, wherein the second housing section is integrally formed with the plasma generator.

14. 14. The catheter system of claim 2, wherein the connector section includes a section opening, and the plasma generator is configured to direct the energy from the plasma bubble through the section opening toward the treatment site.

15. The catheter system of claim 14 , wherein the connector section is partially cylindrical and the section opening extends substantially along a length of the connector section.

16. 16. The catheter system of claim 14 or 15, wherein the plasma generator has an angled proximal end such that the plasma generator is configured to direct the energy from the plasma bubble through the section opening toward the treatment site.

17. 17. The catheter system of claim 16, wherein the proximal end of the plasma generator is angled at about 5 degrees to 45 degrees relative to a flat vertical structure.

18. The catheter system according to any one of claims 1 to 17, further comprising a reinforcing cover disposed substantially surrounding the emitter housing.

19. The catheter system of claim 18 , wherein the reinforcing cover comprises a polyimide tube.

20. The catheter system of any one of claims 1 to 19, further comprising a guidewire lumen including an outer surface having a groove, the emitter housing being disposed within the groove.

21. 21. The catheter system of claim 20, further comprising a first assembly fitting disposed adjacent to the first housing section and a second assembly fitting disposed adjacent to the second housing section, the first assembly fitting and the second assembly fitting configured to retain the emitter housing within the groove formed along the outer surface of the guidewire lumen.

22. 22. The catheter system of claim 1, further comprising a balloon including a balloon wall defining a balloon interior, the balloon configured to retain the catheter fluid within the balloon interior, and the guide distal end, the plasma generator, and the emitter housing are disposed within the balloon interior.

23. 23. The catheter system of claim 22, wherein the balloon is selectively inflatable with the catheter fluid to expand to an inflated state, and wherein the balloon wall is configured to be positioned substantially adjacent to the treatment site when the balloon is in the inflated state.

24. 24. The catheter system of claim 23, wherein the plasma generator is configured to direct the energy from the plasma bubbles toward a portion of the balloon wall located substantially adjacent the treatment site.

25. The catheter system of claim 1 , wherein the energy guide generates one or more pressure waves in the catheter fluid that impart a force to the treatment site.

26. The catheter system of claim 1 , wherein the energy guide comprises an optical fiber.

27. The catheter system of claim 1 , wherein the energy source comprises a laser.

28. The catheter system of claim 1 , wherein the catheter fluid includes one of a wetting agent and a surfactant.

29. A method of treating a treatment site within or adjacent to a blood vessel or heart valve in a patient's body utilizing a catheter system according to any one of claims 1 to 28.

30. 1. A method for treating a treatment site within or adjacent to a blood vessel or heart valve in a patient's body, comprising: generating energy using an energy source; placing an emitter assembly within the catheter fluid adjacent the treatment site, the emitter assembly comprising: (i) at least a portion of an energy guide having a guide distal end selectively positioned proximate the treatment site; (ii) a plasma generator; and (iii) an emitter housing fixed to each of the energy guide and the plasma generator, the emitter housing maintaining a relative position between the distal end of the energy guide and the plasma generator; and receiving energy from the energy source using the energy guide; generating plasma bubbles in the catheter fluid with the energy from the energy guide directed toward the plasma generator; directing energy from the plasma bubbles toward the treatment site using the plasma generator; A method comprising:

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