CN116685282A - Optical emitter housing assembly for intravascular lithotripsy device - Google Patents

Abstract

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

Description

Optical emitter housing assembly for intravascular lithotripsy device

RELATED APPLICATIONS

The present application relates to U.S. provisional application Ser. No. 63/289,294, U.S. provisional application Ser. No. 63/335,131, U.S. provisional application Ser. No. OPTICAL EMITTER HOUSING ASSEMBLY FOR INTRAVASCULAR LITHOTRIPSY DEVICE, and U.S. patent application Ser. No. 17/970,363, filed on Ser. No. 2021, 12, 14, and U.S. provisional application Ser. No. 17/OPTICAL EMITTER HOUSING ASSEMBLY FOR INTRAVASCULAR LITHOTRIPSY DEVICE, filed on Ser. No. 2022, 10, 20. The contents of U.S. provisional applications Ser. Nos. 63/289,294 and 63/335,131 and U.S. patent application Ser. No. 17/970,363 are incorporated by reference herein in their entireties to the extent permitted.

Background

Vascular lesions (also referred to herein as "treatment sites") within blood vessels (vessels) in vivo may be associated with increased risk of serious adverse events such as myocardial infarction, embolism, deep vein thrombosis, stroke, and the like. Serious vascular lesions (such as severely calcified vascular lesions) can be difficult for a physician in a clinical setting to treat and achieve patency.

Vascular lesions may be treated using interventions such as drug therapy, balloon angioplasty, atherectomy, stenting, vascular graft bypass, and the like. These interventions may not always be ideal or may require subsequent treatment to address the lesion.

Endovascular lithotripsy is one method recently used to destroy endovascular vascular lesions in the body, with some success. Endovascular lithotripsy utilizes a combination of pressure waves and bubble dynamics generated within the blood vessel in a fluid-filled balloon catheter. In particular, during endovascular lithotripsy treatment, a high energy source is used to generate plasma and ultimately pressure waves and rapid bubble expansion within a fluid-filled balloon to disrupt calcification at a treatment site including one or more vascular lesions within the vasculature. The associated rapid bubble formation induced by the plasma and the resulting local fluid velocity within the balloon transfer mechanical energy through the incompressible fluid to exert a breaking force on the calcium within the vessel opposite the balloon wall. The rapid change in fluid momentum upon striking the balloon wall is known as a hydraulic impact or water hammer.

It is desirable to more accurately and precisely direct and/or concentrate the energy generated within the fluid-filled balloon in order to apply pressure to the treatment site within or adjacent the vessel wall and induce rupture at the treatment site.

It has been desired to enhance vascular patency and optimize treatment delivery parameters in intravascular lithotripsy catheter systems in a continuously manufacturable manner.

SUMMARY

The present invention relates to a catheter system for placement within a blood vessel having a blood vessel wall. The catheter system may be used to treat a treatment site within or adjacent to a vessel wall or heart valve within a patient's body. In various embodiments, a catheter system includes an energy source, a catheter fluid, and an emitter assembly. The energy source generates energy. The transmitter assembly includes: (i) at least a portion of the energy director having a director distal end that is selectively positioned adjacent to the treatment site, (ii) a plasma generator, and (iii) an emitter housing secured to each of the energy director and the plasma generator to maintain relative positioning between the director distal end of the energy director and the plasma generator. The energy director is configured to receive energy from the energy source and direct the energy toward the plasma generator to generate plasma bubbles in the conduit fluid. The plasma generator directs energy from the plasma bubbles toward the treatment site.

In some embodiments, the emitter housing comprises: (i) a first housing section secured to the energy director at or near the distal end of the director, (ii) a second housing section secured to or integrally formed with the plasma generator, and (iii) a connector section coupled to and extending between the first and second housing sections.

In certain embodiments, the first housing section is substantially cylindrical. In some such embodiments, the first housing section includes a small housing gap that extends entirely along the length of the first housing section and allows the first housing section to expand or contract slightly due to changes in environmental conditions.

In certain embodiments, the first housing section includes a pilot hole; and at least a portion of the energy director is secured within the director aperture.

In some embodiments, the catheter system further comprises an adhesive material configured to secure the first housing section to the energy director at or near the distal end of the director.

In certain embodiments, the first housing section includes a first housing port through which adhesive material may be provided between the first housing section and the energy director to secure the first housing section to the energy director at or near the distal end of the director.

In some embodiments, the second housing section is substantially cylindrical.

In certain embodiments, the second housing section includes a small housing gap that extends entirely along the length of the second housing section and allows the second housing section to expand or contract slightly due to changes in environmental conditions.

In certain embodiments, the second housing section includes a generator aperture; and at least a portion of the plasma generator is secured within the generator aperture.

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

In certain embodiments, the second housing section includes a second housing port through which an adhesive material may be provided between the second housing section and the plasma generator to secure the second housing section to the plasma generator.

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

In certain embodiments, the connector section includes a section opening (section opening); and the plasma generator directs energy from the plasma bubbles through the section opening and toward the treatment site.

In some embodiments, the connector section is partially cylindrical; and the section opening extends entirely along the length of the connector section.

In some embodiments, the plasma generator has a proximal end that is sloped such that energy from the plasma bubbles is directed through the segment opening and toward the treatment site.

In certain embodiments, the proximal end of the plasma generator is angled between about 5 degrees and 45 degrees relative to a flat vertical configuration.

In some embodiments, the catheter system further comprises a stiffening cover positioned to substantially surround the emitter housing.

In one embodiment, the reinforcement cover comprises a polyimide tube.

In certain embodiments, the catheter system further comprises a guidewire lumen comprising an outer surface having a groove; and the emitter housing is positioned within a groove formed along an outer surface of the guidewire lumen.

In some embodiments, the catheter system further comprises a first component attachment positioned adjacent the first housing section and a second component attachment positioned adjacent the second housing section to retain the emitter housing within a groove formed along an outer surface of the guidewire lumen.

In some embodiments, the catheter system further comprises a balloon comprising a balloon wall defining a balloon interior, the balloon configured to retain catheter fluid within the balloon interior.

In various embodiments, the distal end of the introducer, the plasma generator, and the emitter housing are positioned within the balloon interior.

In some such embodiments, the balloon is selectively expandable with a catheter fluid to expand to an expanded state, and the balloon wall is configured to be positioned substantially adjacent to the treatment site when the balloon is in the expanded state.

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

In certain embodiments, the energy director generates one or more pressure waves in the catheter fluid that exert a force on the treatment site.

In some embodiments, the energy director comprises an optical fiber.

In various embodiments, the energy source comprises a laser.

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

The invention also relates to a method for treating a treatment site within or adjacent to a blood vessel in a patient's body, the method comprising the steps of: generating energy using an energy source; positioning an emitter assembly within a catheter fluid in proximity to a treatment site, the emitter assembly comprising: (i) at least a portion of the energy director having a director distal end that is selectively positioned adjacent to the treatment site, (ii) a plasma generator, and (iii) an emitter housing secured to each of the energy director and the plasma generator to maintain relative positioning between the director distal end of the energy director and the plasma generator; receiving energy from an energy source with an energy director; generating plasma bubbles in the conduit fluid using energy directed toward the plasma generator from the energy director; and directing energy from the plasma bubbles toward the treatment site using the plasma generator.

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 accompanying drawings, which form a part thereof, and are not to be taken in a limiting sense. The scope of this document is defined by the appended claims and their legal equivalents.

Brief Description of Drawings

The novel features of this application, as well as the application itself, both as to its structure and its operation, will be best understood from the accompanying drawings, taken in conjunction with the accompanying description, in which like reference characters refer to like parts, and in which:

FIG. 1 is a simplified schematic cross-sectional view of an embodiment of a catheter system including an emitter assembly including at least a portion of an energy director, in accordance with various embodiments;

FIG. 2 is a simplified schematic cross-sectional view of a portion of an embodiment of a catheter system including an embodiment of an emitter assembly;

FIG. 3 is a simplified schematic perspective view of the emitter assembly shown in FIG. 2;

FIG. 4 is a simplified schematic exploded view of the emitter assembly shown in FIG. 2;

FIG. 5 is a simplified schematic perspective view of the emitter assembly shown in FIG. 2 secured to a guidewire lumen of a catheter system;

FIG. 6 is a simplified schematic perspective view of another embodiment of an emitter assembly;

FIG. 7 is a simplified schematic end view of a portion of the emitter assembly shown in FIG. 6; and

fig. 8 is a simplified schematic perspective view of yet another embodiment of an emitter assembly.

While embodiments of the invention are susceptible to various modifications and alternative forms, specific details thereof have been shown by way of example and the accompanying drawings and are herein described in detail. However, it is to be understood that the scope of this disclosure is not limited to the specific embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope of the invention.

Description of the invention

Treatment of vascular lesions may reduce significant adverse events or death in the affected subject. As described herein, a significant adverse event is a significant adverse event that may occur anywhere in the body due to the presence of a vascular lesion. Significant adverse events can include, but are not limited to: a major cardiac adverse event, a major adverse event of the surrounding vasculature or central vasculature, a major adverse event of the brain, a major adverse event of the muscular system, or a major adverse event of any internal organ.

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

Those of ordinary skill in the art will realize that the following detailed description of the present invention is illustrative only and is not intended to be in any way limiting. Other embodiments of the invention will readily suggest themselves to such skilled persons having the benefit of this disclosure. Reference will now be made in detail to embodiments of the present invention that are illustrated in the accompanying drawings. In the drawings and the detailed description that follows, the same or similar names and/or reference numerals will be used to refer to the same or similar parts.

In the interest of clarity, not all of the routine features of the implementations described herein are shown and described. It will be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with application-related and business-related constraints, and that these specific goals will vary from one implementation to another and from one developer to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking of engineering for those of ordinary skill in the art having the benefit of this disclosure.

The catheter systems disclosed herein may include many different forms. Referring now to fig. 1, a simplified schematic cross-sectional view of a catheter system 100 is shown, in accordance with various embodiments. The catheter system 100 is adapted to apply pressure waves to induce a fracture in one or more treatment sites within the patient's body, the one or more treatment sites being within or adjacent to the vessel wall of the vessel, or adjacent to the heart valve. In the embodiment shown in fig. 1, catheter system 100 may include one or more of catheter 102, energy-directing beam 122, source manifold 136, fluid pump 138, system console 123, handle assembly 128, and emitter assembly 129, energy-directing beam 122 including one or more energy directors 122A, system console 123 including one or more of energy source 124, power source 125, system controller 126, and graphical user interface 127 ("GUI"). In various embodiments, the emitter assembly 129 includes and/or comprises at least a portion of the energy director 122A, and the emitter assembly 129 is configured to direct and/or concentrate energy toward one or more treatment sites 106A within the patient 109 body 107 at the treatment site 106 of the vessel wall 108A of the vessel 108 or the heart valve or adjacent the vessel wall 108A of the vessel 108 or the heart valve. Alternatively, catheter system 100 may include more or fewer components than those specifically shown and described in connection with FIG. 1.

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

The catheter 102 may include an expandable balloon 104 (sometimes referred to herein simply as a "balloon"), a catheter shaft 110, and a guidewire 112. Balloon 104 may be coupled to catheter shaft 110. 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. Catheter 102 and/or catheter shaft 110 may also include a guidewire lumen 118, guidewire lumen 118 configured to move over guidewire 112. As used herein, the guidewire lumen 118 defines a conduit through which the guidewire 112 extends. The catheter shaft 110 may also include an expansion lumen (not shown) and/or various other lumens for various other purposes. In some embodiments, the catheter 102 may have a distal opening 120, and as the catheter 102 is moved and positioned at or near the treatment site 106, the catheter 102 may receive the guidewire 112 and track through the guidewire 112. In some embodiments, the balloon proximal end 104P may be coupled to the catheter shaft 110 and the balloon distal end 104D may be coupled to the guidewire lumen 118.

Balloon 104 includes a balloon wall 130 defining a balloon interior 146. Balloon 104 may be selectively inflated with catheter fluid 132 to expand from a collapsed state (as shown in fig. 1) adapted to advance catheter 102 through the vasculature of the patient to an expanded state adapted to anchor catheter 102 in position relative to treatment site 106. Stated another way, when the balloon 104 is in the expanded state, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. It is to be understood that while fig. 1 shows the balloon wall 130 of the balloon 104 as being spaced apart from the blood vessel 108 or treatment site 106 of the heart valve when in the expanded state, this is done for ease of illustration. It should be appreciated that when the balloon 104 is in the expanded state, the balloon wall 130 of the balloon 104 is generally substantially immediately adjacent and/or abutting the treatment site 106.

Balloons 104 suitable for use in the catheter system 100 include those balloons 104 that, when in a contracted state, may traverse the vasculature of the patient 109. In some embodiments, balloon 104 is made of silicone. In other embodiments, balloon 104 may be made of materials such as: polydimethylsiloxane (PDMS), polyurethane, polymer (such as PEBAX ^TM Material), nylon, or any other suitable material.

Balloon 104 may have any suitable diameter (in the expanded state). In various embodiments, balloon 104 may have a diameter ranging from less than 1 millimeter (mm) up to 25mm (in the expanded state). In some embodiments, balloon 104 may have a diameter (in the expanded state) ranging from at least 1.5mm up to 14 mm. In some embodiments, balloon 104 may have a diameter (in the expanded state) ranging from at least 2mm up to 5 mm.

In some embodiments, balloon 104 may have a length ranging from at least 3mm to 300 mm. More specifically, in some embodiments, balloon 104 may have a length ranging from at least 8mm to 200 mm. It is to be appreciated that a balloon 104 having a relatively longer length may be positioned adjacent to a larger treatment site 106 and, thus, may be used to apply pressure waves to a larger vascular lesion 106A or multiple vascular lesions 106A and induce a fracture at a precise location within the treatment site 106. It is also understood that longer balloons 104 may also be positioned adjacent multiple treatment sites 106 at any given time.

Balloon 104 may be inflated to an inflation pressure of between about 1 atmosphere (atm) and 70 atmospheres. In some embodiments, balloon 104 may be inflated to an inflation pressure of from at least 20atm to 60 atm. In other embodiments, the balloon 104 may be inflated to an inflation pressure of from at least 6atm to 20 atm. In still other embodiments, the balloon 104 may be inflated to an inflation pressure of from at least 3atm to 20 atm. In still other embodiments, the balloon 104 may be inflated to an inflation pressure of from at least 2atm to 10 atm.

The balloon 104 may have various shapes including, but not limited to, a conical shape, a square shape, a rectangular shape, a spherical shape, a conical/square shape, a conical/spherical shape, an expanded spherical shape, an elliptical shape, a conical shape, a bone shape, a stepped diameter shape (stepped diameter shape), an offset shape, or a conical offset shape. In some embodiments, balloon 104 may include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or drug eluting stent may include one or more therapeutic agents including anti-inflammatory agents, anti-tumor agents, anti-angiogenic agents, and the like.

The conduit fluid 132 may be a liquid or a gas. Some examples of suitable catheter fluids 132 for use may include, but are not limited to, water, saline, contrast media, fluorocarbon, perfluorocarbon, gases such as carbon dioxide, or any other suitable catheter fluid 132. In some embodiments, the catheter fluid 132 may be used as a base expansion fluid. In some embodiments, catheter fluid 132 may comprise a mixture of saline and contrast medium in a volume ratio of about 50:50. In other embodiments, catheter fluid 132 may comprise a mixture of saline and contrast medium in a volume ratio of about 25:75. In still other embodiments, catheter fluid 132 may comprise 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 according to composition, viscosity, etc., such that the propagation rate of the pressure wave is properly manipulated. In certain embodiments, catheter fluid 132 suitable for use is biocompatible. The volume of the catheter fluid 132 may be adjusted by the selected energy source 124 and the type of catheter fluid 132 used.

In certain embodiments, the catheter fluid 132 may include a wetting agent or surfactant (surfactant). These compounds can reduce the tension between solid and liquid materials. These compounds can be used as emulsifiers, dispersants, detergents and water penetrants. The wetting agent or surfactant reduces the surface tension of the liquid and allows the liquid to fully wet and contact the optical components (e.g., energy director 122A) and mechanical components (e.g., other portions of emitter assembly 129). This reduces or eliminates the accumulation of bubbles and air pockets or gaseous inclusions within the emitter assembly 129. Non-exclusive examples of chemicals that may be used as wetting agents include, but are not limited to, benzalkonium chloride (Benzalkonium Chloride), benzalkonium chloride (Benzethonium Chloride), cetylpyridinium chloride (Cetylpyridinium Chloride), poloxamer (Poloxamer) 188, poloxamer (Poloxamer) 407, polysorbate (Polysorbate) 20, polysorbate (Polysorbate) 40, and the like. Non-exclusive examples of surfactants may include, but are not limited to, ionic and nonionic detergents and sodium stearate. Another suitable surfactant is 4- (5-dodecyl) benzenesulfonate. Other examples may include docusate (dioctyl sulfosuccinate), alkyl ether phosphates and perfluorooctane sulfonate (PFOS), to name a few.

Direct liquid contact with the energy director 122A allows for more efficient conversion of energy to plasma through the use of wetting agents or surfactants. In the case of small sizes of optical and mechanical components used in the emitter assembly 129 and other portions of the catheter 102, it is less difficult to achieve greater (or complete) wetting with wetting agents or surfactants. Reducing the surface tension of the liquid may reduce the difficulty of such small structures being effectively wetted by the liquid and thus being nearly or completely submerged. By reducing or eliminating air or other bubbles adhering to the optical and mechanical structures and the energy director 122A, the efficiency of the device may be significantly improved.

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

In some embodiments, the contrast agent used in the contrast medium (contrast medium) may include, but is not limited to, an iodine-based contrast agent, such as an ionic iodine-based contrast agent or a nonionic iodine-based contrast agent. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate (diatrizoate), methyl diatrizoate (metazoate), iothalamate (iothamate), and ioxadate (ioxadate). Some non-limiting examples of non-ionic iodinated contrast agents include iopamidol (iopamidol), iohexol (iohexol), ioxilan (ioxilan), iopromide (iopromide), iodixanol (iodixanol), and ioversol (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 (gadolinium (III) -based contrast agent). Suitable fluorocarbon agents and perfluorocarbon agents may include, but are not limited to, formulations such as perfluorocarbon dodecafluoropentane (perfluorocarbon dodecafluoropentane (DDFP, C5F 12)).

Catheter fluids 132 may include those that include an absorber that may selectively absorb light in the ultraviolet region (e.g., at least 10 nanometers (nm) to 400 nm), visible region (e.g., at least 400nm to 780 nm), or near infrared region (e.g., at least 780nm to 2.5 μm) of the electromagnetic spectrum. Suitable absorbers may include those having a maximum absorption in the spectrum from at least 10nm to 2.5 μm. Alternatively, catheter fluid 132 may include those fluids that include an absorber that may selectively absorb light in the mid-infrared region (e.g., at least 2.5 μm to 15 μm) or the far-infrared region (e.g., at least 15 μm to 1 mm) of the electromagnetic spectrum. In various embodiments, the absorbers may be those having an absorption maximum that matches the emission maximum of the laser used in catheter system 100. As non-limiting examples, various lasers that may be used in catheter system 100 may include neodymium: yttrium aluminum garnet (Nd: YAG, emission maximum=1064 nm) lasers, holmium: YAG (Ho: YAG, emission maximum=2.1 μm) lasers, or erbium: YAG (Er: YAG, emission maximum=2.94 μm) lasers. In some embodiments, the absorbent may be water soluble. In other embodiments, the absorbent is not water soluble. In some embodiments, the absorber used in the catheter fluid 132 may be tuned to match the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths of at least 10 nanometers to one millimeter are discussed elsewhere herein.

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

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

In some embodiments, the guidewire lumen 118 can have an outer surface with grooves, wherein the grooves extend in a generally longitudinal direction along the guidewire lumen 118. In such embodiments, each of the energy director 122A and/or the emitter assembly 129 can be positioned, received, and retained within a separate groove formed along the outer surface of the guidewire lumen 118 and/or in the outer surface of the guidewire lumen 118. Alternatively, the guidewire lumen 118 may be formed as a non-grooved outer surface, and the positioning of the energy director 122A and/or the emitter assembly 129 relative to the guidewire lumen 118 may be maintained in another suitable manner.

Catheter system 100 and/or energy guiding beam 122 may include any number of energy directors 122A, energy directors 122A in optical communication with energy source 124 at proximal portion 114 and in optical communication with catheter fluid 132 within balloon interior 146 of balloon 104 at distal portion 116. For example, in some embodiments, catheter system 100 and/or energy-directing beam 122 may include one energy director 122A to more than 30 energy directors 122A. Alternatively, in other embodiments, catheter system 100 and/or energy guiding beam 122 may include more than 30 energy directors 122A.

The energy director 122A may have any suitable design for generating a plasma and/or pressure waves in the catheter fluid 132 within the balloon interior 146. Accordingly, the general description of the energy director 122A as a light director is not intended to be limiting in any way, except as set forth in the appended claims. More specifically, although catheter system 100 is generally described as energy source 124 being a light source and one or more energy directors 122A being light directors, catheter system 100 may alternatively include any suitable energy source 124 and energy directors 122A for generating a desired plasma in catheter fluid 132 within 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 director 122A may include an electrode pair including spaced apart electrodes extending into the balloon interior 146. In such embodiments, each high voltage pulse is applied to and forms an arc between the electrodes, which in turn generates a plasma and creates a pressure wave in the catheter fluid 132 that is used to provide a breaking force on the vascular lesion 106A at the treatment site 106. Still alternatively, the energy source 124 and/or the energy director 122A may have another suitable design and/or configuration.

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

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

The energy director 122A may take on a number of configurations about the catheter shaft 110 of the catheter 102 and/or relative to the catheter shaft 110. In some embodiments, the energy director 122A may extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy director 122A may be physically coupled to the catheter shaft 110. In other embodiments, the energy director 122A may be disposed along the length of the outer diameter of the catheter shaft 110. In still other embodiments, the energy director 122A may be disposed within one or more energy director cavities within the catheter shaft 110.

The energy directors 122A may also be disposed at any suitable location about the circumference of the guidewire lumen 118 and/or catheter shaft 110, and the introducer distal end 122D of each energy director 122A may be disposed at any suitable longitudinal location relative to the length of the balloon 104 and/or relative to the length of the guidewire lumen 118 for more efficient and accurate application of pressure waves for the purpose of disrupting the vascular lesion 106A at the treatment site 106.

In certain embodiments, the energy director 122A may include one or more photoacoustic transducers 154, wherein each photoacoustic transducer 154 may be in optical communication with the energy director 122A (the photoacoustic transducer 154 is disposed in the energy director 122A). In some embodiments, photoacoustic transducer 154 may be in optical communication with the introducer distal end 122D of energy introducer 122A. In such embodiments, photoacoustic transducer 154 may have a shape that corresponds and/or conforms to the guide distal end 122D of energy guide 122A.

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

In some embodiments, photoacoustic transducer 154 disposed at the distal end 122D of energy director 122A may take the same shape as the distal end 122D of energy director 122A. For example, in certain non-exclusive embodiments, photoacoustic transducer 154 and/or introducer distal end 122D may have a conical shape, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a semi-circular shape, an oval shape, and the like. The energy director 122A may also include additional photoacoustic transducers 154 disposed along one or more side surfaces of the length of the energy director 122A.

In some embodiments, energy director 122A and/or emitter assembly 129 may further include one or more steering features or "steerers" (not shown in fig. 1) such as within energy director 122A and/or near the director distal end 122D of energy director 122A, configured to direct energy from energy director 122A toward a side surface located at or near the director distal end 122D of energy director 122A before the energy is directed toward balloon wall 130. The steering feature may include any feature of the system that steers energy from the energy director 122A away from its axial path toward a side surface of the energy director 122A. Each energy director 122A may include one or more optical windows disposed along a longitudinal or circumferential surface of each energy director 122A and in optical communication with a turning feature. Stated another way, the turning feature may be configured to direct energy in the energy director 122A toward a side surface at or near the director distal end 122D, where the side surface is in optical communication with the optical window. The optical window may include a portion of energy director 122A that allows energy to exit energy director 122A from within energy director 122A, such as a portion of energy director 122A that lacks cladding material on or around energy director 122A.

Examples of suitable turning features for use include reflective elements, refractive elements, and fiber diffusers. Steering features suitable for focusing energy away from the end (tip) of the energy director 122A may include, but are not limited to, those having convex surfaces, gradient index (GRIN) lenses, and mirror focusing lenses. Upon contact with the turning features, the energy is turned within the energy director 122A to one or more of the plasma generator 133 and the photoacoustic transducer 154 in optical communication with the side surface of the energy director 122A. When utilized, photoacoustic transducer 154 then converts the light energy into an acoustic wave that spreads away from the side surfaces of energy director 122A.

Additionally, or alternatively, in certain embodiments, these steering features, which may be incorporated into the energy director 122A, may also be incorporated into the design of the emitter assembly 129 and/or the plasma generator 133 for directing and/or focusing acoustic and mechanical energy toward specific areas of the balloon wall 130 that are in contact with the vascular lesion 106A at the treatment site 106 to exert pressure on such vascular lesion 106A and induce fracture.

The source manifold 136 may be positioned at or near the proximal portion 114 of the catheter system 100. The source manifold 136 may include one or more proximal openings that may receive one or more energy directors 122A of the energy directing beam 122, the guidewire 112, and/or an expansion conduit 140 coupled in fluid communication with the fluid pump 138. Catheter system 100 may also include a fluid pump 138, fluid pump 138 configured to expand balloon 104 with catheter fluid 132 as desired.

As described above, in the embodiment shown in FIG. 1, the system console 123 includes one or more of an energy source 124, a power source 125, a system controller 126, and a GUI 127. Alternatively, the system console 123 may include more or fewer components than those specifically shown in fig. 1. For example, in some non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127. Still alternatively, one or more of the energy source 124, the power source 125, the system controller 126, and the GUI 127 may be disposed within the catheter system 100 without specifically requiring the system console 123.

As shown, the system console 123 and its included components are operably coupled to the catheter 102, the energy guiding beam 122, and the remainder of the catheter system 100. For example, in some embodiments, as shown in fig. 1, system console 123 may include a console connection aperture 148 (also sometimes referred to generally as a "socket") through which energy guiding beam 122 is mechanically coupled to system console 123. In such embodiments, the energy guiding beam 122 may include a guide coupling housing 150 (also sometimes referred to generally as a "ferrule") that houses a portion of each energy guide 122A, e.g., the guide proximal end 122P. The director coupling housing 150 is configured to mate and selectively remain within the console connection aperture 148 to provide a mechanical coupling between the energy directing beam 122 and the system console 123.

The energy guiding beam 122 may also include a guiding beam device 152 (or "shell portion"), the guiding beam device 152 bringing each of the individual energy guiding beams 122A closer together so that the energy guiding beam 122A and/or the energy guiding beam 122 may be in a more compact form when the energy guiding beam 122A and/or the energy guiding beam 122 extend into the blood vessel 108 or heart valve with the catheter 102 during use of the catheter system 100.

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

The energy source 124 may be of any suitable design. In some embodiments, the energy source 124 may be configured to provide sub-millisecond energy pulses from the energy source 124 that are focused onto a small spot to couple the energy pulses into the guide proximal end 122P of the energy guide 122A. Such energy pulses are then directed along the energy director 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing the formation of a plasma in the catheter fluid 132 within the balloon interior 146 of the balloon 104, such as by a plasma generator 133 that may be located at or near the director distal end 122D of the energy director 122A. In particular, in such embodiments, energy emitted at the introducer distal end 122D of the energy introducer 122A is directed toward and energizes the plasma generator 133 to form a plasma in the catheter fluid 132 within the balloon interior 146. The formation of the plasma causes rapid bubble formation and the application of pressure waves at the treatment site 106. An exemplary plasma-induced bubble 134 is shown in fig. 1.

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

It is to be appreciated that while the energy source 124 is typically utilized to provide energy pulses, the energy source 124 may nevertheless be described as providing a single source beam 124A, i.e., a single pulsed source beam.

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

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

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

In some embodiments, the laser may comprise a tuned Q thulium to yttrium aluminum garnet (Tm: YAG) laser. In other embodiments, the lasers may include neodymium: yttrium aluminum garnet (Nd: YAG) lasers, holmium: yttrium aluminum garnet (Ho: YAG) lasers, erbium: yttrium aluminum garnet (Er: YAG) lasers, excimer lasers, helium neon lasers, carbon dioxide lasers, and doped lasers, pulsed lasers, fiber lasers.

In still other embodiments, the energy source 124 may include multiple lasers grouped together in series. In still other embodiments, the energy source 124 may include one or more low energy lasers fed into a high energy amplifier such as a Master Oscillator Power Amplifier (MOPA). In still other embodiments, the energy source 124 may include a plurality of lasers, which may be combined in parallel or in series, to provide the energy required to generate the plasma bubbles 134 in the catheter fluid 132.

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

When the catheter 102 is placed at the treatment site 106, pressure waves may be applied to the treatment site 106 from a distance in the range of at least about 0.1 millimeters (mm) to greater than about 25 mm extending radially from the energy director 122A. In various non-exclusive embodiments, when the catheter 102 is placed at the treatment site 106, pressure waves may be applied to the treatment site 106 from a distance in the range of at least about 10mm to 20mm, at least about 1mm to 10mm, at least about 1.5mm to 4mm, or at least about 0.1mm to 10mm extending radially from the energy director 122A. In other embodiments, the pressure wave may be applied to the treatment site 106 from another suitable distance than the foregoing ranges. In some embodiments, pressure waves in the range of from at least about 2MPa to 30MPa may be applied to the treatment site 106 at a distance of from at least about 0.1mm to 10 mm. In some embodiments, pressure waves in the range from at least about 2MPa to 25MPa may be applied to the treatment site 106 at a distance from at least about 0.1mm to 10 mm. Still alternatively, other suitable pressure ranges and distances may be used.

The power supply 125 is electrically coupled to each of the energy source 124, the system controller 126, the GUI 127, and the handle assembly 128, and is configured to provide the necessary power to each of the energy source 124, the system controller 126, the GUI 127, and the handle assembly 128. The power supply 125 may be of any suitable design for these purposes.

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

The system controller 126 may also be configured to control the operation of other components of the catheter system 100, such as positioning of the catheter 102 adjacent the treatment site 106, inflation of the balloon 104 with the catheter fluid 132, and the like. Additionally, or alternatively, the catheter system 100 may include one or more additional controllers, which may be positioned in any suitable manner for controlling various operations of the catheter system 100. For example, in certain embodiments, additional controllers and/or portions of the system controller 126 may be located and/or contained within the handle assembly 128.

GUI 127 may be accessible to a user or operator of catheter system 100. The GUI 127 is electrically connected to the system controller 126. With such a design, a user or operator may use the GUI 127 to ensure that the catheter system 100 is effectively utilized to apply pressure into the vascular lesion 106A at the treatment site 106 and induce a break in the vascular lesion. GUI 127 may provide information to a user or operator that may be used before, during, and after use of catheter system 100. In one embodiment, GUI 127 may provide static visual data and/or information to a user or operator. Additionally, or alternatively, during use of catheter system 100, GUI 127 may provide dynamic visual data and/or information, such as video data or any other data that varies over time, to a user or operator. In various embodiments, GUI 127 may include one or more colors, different sizes, varying brightness, etc., that may be used as an alert to a user or operator. Additionally, or alternatively, the GUI 127 may provide audio data or information to a user or operator. The details of GUI 127 may vary depending on the design requirements of catheter system 100 or the particular needs, specifications, and/or desires of the user or operator.

As shown in fig. 1, the handle assembly 128 may be positioned at or near the proximal portion 114 of the catheter system 100, and/or near the source manifold 136. In this embodiment, handle assembly 128 is coupled to balloon 104 and is positioned spaced apart from balloon 104. Alternatively, the handle assembly 128 may be positioned in another suitable location.

The handle assembly 128 is manipulated and used by a user or operator to operate, position and control the catheter 102. The design and specific features of the handle assembly 128 may 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 may be integrated within the handle assembly 128 and/or include at least a portion of the system controller 126. For example, as shown, in some such embodiments, the handle assembly 128 may include a circuit 156, and the circuit 156 may form at least a portion of the system controller 126. In one embodiment, the circuitry 156 may comprise 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, for example, within the system console 123. It is to be understood that handle assembly 128 may include fewer or more components than are specifically shown and described herein.

In various embodiments, the emitter assembly 129 is configured to maintain a desired positioning between the introducer distal end 122D of the energy introducer 122A and the plasma generator 133 and to direct and/or concentrate energy generated in the catheter fluid 132 within the balloon interior 146 so as to apply pressure to the vascular lesion 106A and induce a break in the vascular lesion 106A at the treatment site 106 within the vascular wall 108A of the blood vessel 108 or the heart valve or adjacent the vascular wall 108A of the blood vessel 108 or the heart valve. More specifically, by effectively maintaining a desired positioning between the introducer distal end 122D of the energy introducer 122A and the plasma generator 133, and utilizing specific design features that may be incorporated into the emitter assembly 129, the emitter assembly 129 is configured to concentrate and direct acoustic and/or mechanical energy toward a specific region of the balloon wall 130 that is in contact with the vascular lesion 106A at the treatment site 106 to enhance delivery of such energy to the treatment site 106. Thus, the emitter assembly 129 can effectively enhance the efficacy of the catheter system 100.

It is to be appreciated that in some embodiments, separate emitter assemblies 129 may be included with each separate energy director 122A and/or incorporated into each separate energy director 122A. Alternatively, in other embodiments, a single emitter assembly 129 may be configured to operate in conjunction with more than one energy director 122A. Still alternatively, each energy director 122A need not have an emitter assembly 129 incorporated therein or associated therewith.

The design of the emitter assembly 129 and/or the particular positioning of the emitter assembly 129 may be varied to accommodate the requirements of the catheter system 100. In various embodiments, emitter assembly 129 may utilize and/or contain at least a portion of energy director 122A, such as a portion of director distal end 122D including energy director 122A.

Various alternative embodiments of the emitter assembly 129 are shown and described in detail in subsequent figures below.

As with all of the embodiments shown and described herein, various structures may be omitted from the figures for clarity and ease of understanding. Further, the drawings may include certain structures that may be omitted without departing from the intent and scope of the invention.

Fig. 2 is a simplified schematic cross-sectional view of a portion of an embodiment of a catheter system 200, which includes an embodiment of a transmitter assembly 229. The design of catheter system 200 may vary. In various embodiments, as shown in fig. 2, a catheter system 200 may include: a catheter 202, the catheter 202 comprising a catheter shaft 210; balloon 204, balloon 204 having a balloon wall 230 defining a balloon interior 246, a balloon proximal end 204P, and a balloon distal end 204D; and catheter fluid 232 substantially retained within balloon interior 246; and an emitter assembly 229, in some embodiments, the emitter assembly 229 may comprise at least a portion of the energy director 222A. Alternatively, in other embodiments, catheter system 200 may include more or fewer components than are 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 source 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.

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. Accordingly, detailed descriptions of these components will not be repeated.

The balloon 204 is also selectively movable between a contracted state adapted to advance the catheter 202 through the patient's vasculature and an expanded state adapted to anchor the catheter 202 in position relative to the treatment site 106 (shown in fig. 1). In some embodiments, the balloon proximal end 204P may be coupled to the catheter shaft 210 and the balloon distal end 204D may be coupled to the guidewire lumen 118 (shown in fig. 1). Balloon 204 may also be inflated with catheter fluid 232, such as with catheter fluid 232 from fluid pump 138 (shown in fig. 1), which catheter fluid 232 is directed into balloon interior 246 of balloon 204 via inflation conduit 140 (shown in fig. 1).

Similar to the previous embodiments, the energy director 222A may include one or more photoacoustic transducers 154 (shown in fig. 1), wherein each photoacoustic transducer 154 may be in optical communication with the energy director 222A in which that photoacoustic transducer 154 is disposed. In some embodiments, photoacoustic transducer 154 may be in optical communication with a distal end 222D of energy director 222A. Alternatively, in other embodiments, the energy director 222A may be designed without one or more photoacoustic transducers 154.

In various embodiments, the emitter assembly 229 is configured to direct and/or concentrate energy generated in the catheter fluid 232 within the balloon interior 246 onto the vascular lesion 106A (shown in fig. 1) at the treatment site 106 and induce a break in the vascular lesion 106A. More specifically, the emitter assembly 229 is configured to direct and concentrate acoustic and/or mechanical energy toward a particular region of the balloon wall 230 that is 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 some of the components of the emitter assembly 229 are positioned within the balloon interior 246.

The design of the emitter assembly 229 may be varied. As shown in fig. 2, in certain embodiments, the emitter assembly 229 includes at least a portion of the energy director 222A, a plasma generator 233, and an emitter housing 260 coupled to and/or secured to the energy director 222A and the plasma generator 233.

In some embodiments, as shown, the emitter housing 260 may include one or more of the following: (i) a first housing section 262 coupled and/or secured to the energy director 222A, such as at or near the director distal end 222D of the energy director 222A, (ii) a second housing section 264 coupled and/or secured to the plasma generator 233, and (iii) a connector section 266 coupled to the first and second housing sections 262, 264, integrally formed with the first and second housing sections 262, 264 and/or extending between the first and second housing sections 262, 264. In such an embodiment, the emitter housing 260 may 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 may be formed as separate components that are secured to one another. Alternatively, the emitter housing 260 may include more or fewer components than those specifically shown in fig. 2.

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 director 222A, such as at least a portion at or near the director distal end 222D of the energy director 222A. In one such embodiment, the first housing section 262 of the emitter housing 260 is substantially annular and/or cylindrical and includes a guide aperture 362A (shown in fig. 3), through which the energy guide 222A may pass and/or be positioned in the guide aperture 362A. Alternatively, the first housing section 262 may have another suitable shape. As used herein, describing the first housing section 262 as substantially surrounding at least a portion of the energy director 222A and/or substantially annular and/or cylindrical is intended to mean that the first housing section 262 surrounds at least about 90% to 95% of the portion of the energy director 222A, but may also include a small housing gap 368 (shown in fig. 3) that extends entirely along the length of the first housing section 262, and that the small housing gap 368 allows the first housing section 262 to expand or contract slightly due to changes in environmental conditions in which the catheter system 200 is 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 about which the first housing section 262 is positioned.

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

Somewhat similarly, as shown, the second housing section 264 of the emitter housing 260 is configured to be secured to the plasma generator 233 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 and includes a generator aperture 364A (shown in fig. 3) through which the plasma generator 233 may pass and/or be positioned in the generator aperture 364A. Alternatively, the second housing section 264 may have another suitable shape. As used herein, describing the second housing section 264 as substantially surrounding the plasma generator 233 and/or substantially annular and/or cylindrical is intended to mean that the second housing section 264 surrounds at least about 90% to 95% of the plasma generator 233, but may also include a small housing gap 370 (shown in fig. 3), which small housing gap 370 extends entirely along the length of the second housing section 264 and allows the second housing section 264 to expand or contract slightly due to changes in the environmental conditions in which the conduit system 200 is 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 about which the second housing section 264 is positioned.

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 with any suitable type of adhesive material. Alternatively, the second housing section 264 may be secured to the plasma generator 233 in another suitable manner.

As described above, the connector section 266 of the transmitter housing 260 is coupled to the first and second housing sections 262, 264, integrally formed with the first and second housing sections 262, 264, and/or extends between the first and second housing sections 262, 264. In some embodiments, the connector section 266 may be partially annular and/or cylindrical, with a section opening 272, the section opening 272 extending entirely along the length of the connector section 266 to help define an incomplete annular and/or cylindrical shape of the connector section 266, and the section opening 272 configured such that plasma energy formed in the catheter fluid 232 within the balloon interior 246 is directed and/or concentrated through the section opening 272 and toward the vascular lesion 106A formed at the treatment site 106. The size and orientation of the segment opening 272 may be varied depending on the size and location of the vascular lesion 106A being treated with the catheter system 200. In some non-exclusive alternative embodiments, the segment 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 the complete annular and/or cylindrical shape that would otherwise be formed for the connector segment 266. Stated another way, 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.

In various embodiments, the emitter housing 260 may be formed of a long and narrow tube (hypotube) and any suitable material. For example, in certain non-exclusive embodiments, the emitter housing 260 may be formed from a hypotube that includes one or more metals (such as titanium, stainless steel, tungsten, etc.). Alternatively, the emitter housing 260 may be formed of hypotubes comprising plastics such as polyimide and nylon. Still alternatively, the emitter housing 260 may be injection molded and an over-molding process (over molding processing) may be used to secure the energy director 222A and/or the plasma generator 233 in place. Still alternatively, the emitter housing 260 may be formed in another suitable manner and/or from other suitable materials. For example, in certain alternative embodiments, features on the emitter housing 260 may be accomplished by laser cutting, milling, or swiss threading the original hypotube.

With this design of the emitter housing 260, a desired relative positioning between the pilot distal end 222D of the energy pilot 222A and the plasma generator 233 can be effectively maintained. During use of catheter system 200, energy may be transmitted through energy director 222A and may be directed through director distal end 222D and toward plasma generator 233 such that a plasma may be generated in catheter fluid 232 within balloon interior 246 of balloon 202. The pilot distal end 222D may have any suitable shape such that energy transmitted through the energy pilot 222A may be efficiently and accurately directed through the pilot distal end 222D and toward the plasma generator 233. In one embodiment, the introducer distal end 222D may have a flat, split end through which energy is directed toward the plasma generator 233. Alternatively, the guide distal end 222D may be generally hemispherical, spherical, conical, wedge-shaped, pyramidal, or may be another suitable shape.

In some embodiments, as shown in fig. 2, the plasma generator 233 (or target) may include a proximal end 233P that is beveled or otherwise configured to more effectively direct and/or concentrate energy in the form of plasma that has been generated in the catheter fluid 232 through a section opening 272 in a connector section 266 of the emitter housing 260 and toward a balloon wall 230 positioned adjacent to the vascular lesion 106A at the treatment site 106. It is to be appreciated that the proximal end 233P of the plasma generator 233 can be configured at any suitable angle to efficiently direct and/or concentrate plasma energy as desired. For example, in some such embodiments, the proximal end 233P of the plasma generator 233 may be angled between about 5 degrees and 45 degrees relative to a flat vertical configuration. Alternatively, the proximal end 233P of the plasma generator 233 may be angled less than 5 degrees or greater than 45 degrees relative to a flat vertical configuration in order to direct energy in the form of plasma that has been generated in the catheter fluid 232 toward the balloon wall 230 positioned adjacent the treatment site 106.

The plasma generator 233 may be formed of any suitable material. For example, in certain non-exclusive embodiments, the plasma generator 233 may be formed from one or more metals (e.g., titanium, stainless steel, tungsten, etc.). Alternatively, the plasma generator 233 may be formed of plastic such as polyimide and nylon. Still alternatively, the plasma generator 233 may be formed of other suitable materials. It is to be understood that in different embodiments, the plasma generator 233 may be formed of the same material as the emitter housing 260 or a different material than the emitter housing 260.

It is to be understood that during use of the catheter system 200, the catheter fluid 232 used to expand the balloon 204 is also allowed to enter the region of the connector section 266 of the transmitter housing 260 through the section opening 272. Subsequently, the pulsed energy directed through the energy director 222A and toward the plasma generator 233 creates plasma-induced bubbles 134 (shown in fig. 1) in the conduit fluid 232 in the general area of the connector section 266 of the emitter housing 260. As the bubble 134 expands, it is directed and/or focused by the proximal end 233P of the plasma generator 233 through the section opening 272 of the connector section 266 and toward the balloon wall 230 positioned adjacent the vascular lesion 106A at the treatment site 106.

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

As shown, the first housing section 262 may be substantially annular and/or cylindrical and may include a small housing gap 368 that extends entirely along the length of the first housing section 262 and allows the first housing section 262 to expand or contract slightly due to changes in the environmental conditions in which the catheter system 200 (shown in fig. 2) is used.

Fig. 3 also shows a first housing coupler 374, the first housing coupler 374 being used to couple the first housing section 262 to a portion of the energy director 222A, such as a portion at or near the director distal end 222D of the energy director 222A. The design of the first housing coupler 374 may be varied. For example, in one embodiment, the first housing coupler 374 may include an adhesive material positioned between an outer surface of the energy director 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 director 222A. Alternatively, the first housing coupler 374 may have another suitable design.

The type of adhesive material used with the first housing coupler 374 to secure the first housing section 262 to the energy director 222A may be varied. For example, in certain embodiments, an adhesive material (e.g., silicone-based adhesive) having low hardness properties may be selected to dampen/mitigate the impact wave force on the energy director 222A. Alternatively, other suitable adhesive materials may be selected.

In some embodiments (e.g.) Nylon, polyurethane, etc.) extruded thermoplastic tubing may be used to add a soft protective layer 375 between the energy director 222A and the first housing section 262 of the emitter housing 260. Such a protective layer 375 may also help center the energy director 222A in a manner slightly offset from the inner diameter of the emitter housing 260 to facilitate proper alignment with the plasma generator 233.

As shown, the second housing section 264 may be substantially annular and/or cylindrical and may include a small housing gap 370 that extends entirely along the length of the second housing section 264 and allows the second housing section 264 to expand or contract slightly due to changes in the environmental conditions in which the catheter system 200 is used.

Fig. 3 also shows a second housing coupler 376 for coupling the second housing section 264 to the plasma generator 233. The design of the second housing coupler 376 may be varied. For example, in one embodiment, the second housing coupler 376 may include an adhesive material positioned 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. It is to be understood that in such embodiments, any suitable type of adhesive material may be used for the second housing coupler 376. Alternatively, the second housing coupler 376 may be of another suitable design and/or the second housing section 264 may be secured to the plasma generator 233 in another suitable manner. For example, the crimping process may mechanically crimp the plasma generator 233 in place within the second housing section 264. Still alternatively, the plasma generator 233 may also be press fit into the second housing section 264. Still alternatively, the housing gap 368 may serve as an expansion slot that may facilitate an interference fit (interference fit) between the second housing section 264 and the plasma generator 233. The housing gap 368 or expansion slot can be made wide enough to minimize the outer diameter of the emitter housing to the inner shaft, as it removes the wall thickness of the emitter housing 260 at the tip.

As further shown in fig. 3, the generally flat split end of the guide distal end 222D faces the angled proximal end 233P of the plasma generator 233 across the connector section 266 of the emitter housing 260.

Fig. 4 is a simplified schematic exploded view of the emitter assembly 229 shown in fig. 2. More specifically, fig. 4 shows an exploded view of the emitter assembly 229, the emitter assembly 229 including at least a portion of the energy director 222A, the plasma generator 233, and the emitter housing 260. Fig. 4 also shows small housing gaps 368, 370 that may be formed in the first and second housing sections 262, 264 of the emitter housing 260, respectively.

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 may be introduced to effectively secure the first housing section 262 to a portion of the energy director 222A, such as at or near the director distal end 222D of the energy director 222A; and (ii) a second housing port 480 formed in the second housing section 264 of the emitter housing 260, through which second housing port 480 an adhesive material can be introduced to effectively secure the second housing section 264 to the plasma generator 233.

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

Fig. 5 is a simplified schematic perspective view of the emitter assembly 229 shown in fig. 2, the emitter assembly 229 being secured to a guidewire lumen 518 of the catheter system 200 (shown in fig. 2).

As shown in this embodiment, the guidewire lumen 518 can include one or more grooves 582 formed along the outer surface 518A of the guidewire lumen 518 and/or formed in the outer surface 518A of the guidewire lumen 518. The emitter assembly 229 may then be positioned within one of the grooves 582, and may be held in place within the groove 582 by one or more assembly attachments 584 (two assembly attachments are shown in fig. 5). As shown, the first assembly attachment 584 can be positioned substantially adjacent to the first housing section 262 of the emitter housing 260 and the second assembly attachment 584 can be positioned substantially adjacent to the second housing section 264 of the emitter housing 260 so as to effectively retain the emitter assembly 229 in place within the groove 582 formed in the outer surface 518A of the guidewire lumen 518.

The assembly attachment 584 can have any suitable design. In some embodiments, as shown in fig. 5, the assembly attachment 584 may be provided in the form of a heat-shrink attachment. Alternatively, the assembly attachment 584 may have another suitable design.

It is to be appreciated that the second emitter assembly 229 is also shown in fig. 5 as being held in place within another recess 582 formed in the outer surface 518A of the guidewire lumen 518.

Fig. 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, positioning and function to the previous embodiments. In this embodiment, the emitter assembly 629 likewise includes at least a portion of the energy director 622A, the plasma generator 633 and the emitter housing 660. The transmitter housing 660 also includes: (i) A first housing section 662, the first housing section 662 comprising a guide bore 662A, the guide bore 662A being configured to at least substantially surround a portion of the energy guide 622A, such as a portion at or near a guide distal end 622D of the energy guide 622A; (ii) a second housing section 664; and (iii) a connector section 666, the connector section 666 also including a section opening 672, the section opening 672 being coupled with the first and second housing sections 662, 664, integrally formed with the first and second housing sections 662, 664 and/or extending between the first and second housing sections 662, 664. In this embodiment, the emitter assembly 629 is also configured to efficiently direct and/or concentrate energy generated in catheter fluid 232 (shown in fig. 2) retained within balloon 204 (shown in fig. 2) so as to apply pressure to vascular lesion 106A (shown in fig. 1) at treatment site 106 (shown in fig. 1) and induce a break in vascular lesion 106A.

However, as shown in the embodiment of fig. 6, the plasma generator 633 is integrally formed with the second housing section 664 of the emitter housing 660, rather than being positioned and/or secured within the second housing section on the substrate as in the previous embodiments.

With such a design, the transmitter housing 660 may be manufactured by machining a single rod rather than from a hypotube (as is commonly used with the embodiment of the transmitter housing 260 shown in FIG. 2). Machining of the emitter housing 660 may be accomplished using any suitable machining process. For example, in certain non-exclusive embodiments, machining of the emitter housing 660 may be accomplished by electric discharge machining or micro-machining using milling or swiss thread machining techniques.

It will be appreciated that this design may have some key advantages over hypotube designs. First, this integrated design of the emitter housing 660 formed of a single rod allows the guide bore 662A formed in the first housing section 662 and configured to receive and retain a portion of the energy guide 622A to be offset (shown in fig. 7) by an offset distance 786 relative to a central axis 688 of the emitter housing 660, thus allowing the connector section 666 to be thicker in size. Second, this integrated design maximizes the cross-sectional area of the plasma generator 633 because it is made of the same material as the second housing segment 664, whereas in a hypotube design, the plasma generator material and hypotube material may be different, so the hypotube wall reduces the plasma generator cross-sectional area. It is desirable to maximize the cross section of the plasma generator 633 to reduce the need for precise alignment of the pilot distal end 622D of the energy pilot 622A relative to the plasma generator 633. Third, as shown, the first and second housing sections 662, 664 may include cutouts 690, 692, respectively, to accommodate component attachments 584 (shown in fig. 5) that are spliced to the inner member shaft, such as heat-shrink attachments, which may be manufactured to reduce cross-section (cross-section) of the balloon catheter component. Fourth, in some embodiments, a first housing port 678, such as an added glue port (glue port) for receiving adhesive material between the first housing section 662 and the energy director 622A, may be combined with a cutout 690 in the first housing section 662 to allow for internal wicking (wick instrument) of adhesive to achieve a consistent bond. Fifth, radius 694 may cut into the emitter housing 660 to reduce the number of sharp edges on the emitter housing 660, thereby inhibiting potential damage to the balloon 204. Finally, in contrast to the hypotube design, there is no need to bond the plasma generator into the emitter housing 660 because the plasma generator 633 is already integrated in the second housing section 664 of the emitter housing 660.

Fig. 7 is a simplified schematic end view of a portion of the emitter assembly 629 illustrated in fig. 6. In particular, fig. 7 is a simplified end view looking directly into the first housing section 662 of the emitter housing 660, which shows a guide aperture 662A that has been formed in the emitter housing 660 for receiving and retaining a portion of the energy guide 622A (shown in fig. 6). As shown, the pilot bore 662A is offset from a central axis 688 (which is illustrated as a small circle) of the transmitter housing 660 by an offset distance 786, thus allowing the connector section 666 (shown in fig. 6) to be thicker in size. In certain non-exclusive embodiments, the pilot bore 662A may be offset relative to the central axis 688 of the transmitter housing 660 by an offset distance 786 of between approximately 0.010 inches and 0.020 inches. In one such embodiment, the pilot bore 662A may be offset from the central axis 688 of the transmitter housing 660 by an offset distance 786 of approximately 0.015 inches. Alternatively, the pilot bore 662A may be offset from the central axis 688 of the transmitter housing 660 by an offset distance 786 that is greater than 0.020 inches or less than 0.010 inches.

Fig. 8 is a simplified schematic perspective view of yet another embodiment of an emitter assembly 829. In this embodiment, the emitter assembly 829 is also configured to efficiently direct and/or concentrate energy generated in catheter fluid 232 (shown in fig. 2) that is retained within balloon 204 (shown in fig. 2) in order to apply pressure to the vascular lesion 106A (shown in fig. 1) at the treatment site 106 (shown in fig. 1) and induce a break in the vascular lesion 106A.

As shown in fig. 8, the emitter assembly 829 is somewhat similar in design, positioning, and function to the embodiment shown in fig. 6, and thus is capable of achieving most, if not all, of the same advantages described above. For example, in this embodiment, the emitter assembly 829 likewise includes at least a portion of the energy director 822A, the plasma generator 833, and the emitter housing 860. The emitter housing 860 also includes: (i) A first housing section 862, the first housing section 862 comprising a pilot hole 862A, the pilot hole 862A configured to at least substantially surround a portion of the energy pilot 822A, such as a portion at or near a pilot distal end 822D of the energy pilot 822A; (ii) A second housing section 864, the second housing section 864 being integrally formed with the plasma generator 833; and (iii) a connector section 866, the connector section 866 also including a section opening 872, the section opening 872 coupled to the first housing section 862 and the second housing section 864, integrally formed with the first housing section 862 and the second housing section 864 and/or extending between the first housing section 862 and the second housing section 864.

With such a design, the transmitter housing 860 may likewise be manufactured by machining a single rod rather than from hypotubes (as is commonly used with the embodiment of the transmitter housing 260 shown in FIG. 2). Machining of the emitter housing 860 may be accomplished using any suitable machining process. For example, in certain non-exclusive embodiments, machining of the emitter housing 860 may be accomplished by electro-discharge machining or micro-machining using milling or swiss thread machining techniques.

However, as shown in the embodiment illustrated in fig. 8, the emitter assembly 829 further includes a stiffening cover 896, the stiffening cover 896 being positioned around the emitter housing 860, placed over the emitter housing 860, and/or substantially surrounding the emitter housing 860. In some embodiments, the reinforcement cover 896 may be provided in the form of a polyimide tube that may be slotted to match the design of the emitter housing 860, and positioned around the emitter housing 860, placed over the emitter housing 860, and/or substantially surrounding the emitter housing 860 and bonded in place (e.g., with a UV curable adhesive), as shown. Alternatively, the reinforcing cover 896 may be formed from other materials and/or have another suitable design.

The reinforcement cover 896 serves to strengthen the structure of the solid emitter housing 860 and/or the plasma generator 833 against repeated forces (acoustic pressure created by plasma initiation) applied during normal device function. In addition, in the event that the solid emitter housing 860 and/or the plasma generator 833 do fail, the reinforcement cover 896 may also be configured to contain any fragments or debris that may be generated, thereby preventing them from completely separating from the emitter housing 860.

As with the previous embodiments, the emitter housing 860 and/or the plasma generator 833 may be formed of 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 metals (such as titanium, stainless steel, tungsten, etc.). Alternatively, the emitter housing 860 and/or the plasma generator 833 may be formed from other suitable materials.

It is also understood that in certain non-exclusive alternative embodiments, the reinforcement cover 896 may also be used with one or more other embodiments of the emitter assemblies shown and described in detail herein.

In various embodiments, the catheter systems and related methods disclosed herein may include a catheter configured to be advanced to a vascular lesion, such as a calcified vascular lesion or a fibrotic vascular lesion, at or adjacent to a blood vessel or heart valve within a patient's body. The catheter includes a catheter shaft and an expandable balloon coupled and/or secured to the catheter shaft. The balloon may include a balloon wall defining a balloon interior. The balloon may be configured to receive catheter fluid within the balloon interior to expand from a contracted state suitable for advancing the catheter through the patient's vasculature to an expanded state suitable for anchoring the catheter in position relative to the treatment site. The present technology also relates to methods for treating a treatment site within or adjacent to a vessel wall, which methods utilize the devices disclosed herein.

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

It should also be noted that, as used in this specification and the appended claims, the phrase "configured" describes a system, apparatus, or other structure that is constructed or arranged to perform a particular task or to employ a particular configuration. The phrase "configured" may be used interchangeably with other similar phrases such as arrangement and configuration, construction and arrangement, construction, manufacture and arrangement, and the like.

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

The title is used herein to keep pace with the recommendation under 37cfr 1.77, or to otherwise provide organizational cues. These headings should not be construed as limiting or characterizing the invention(s) listed in any claim(s) that may be issued by the present disclosure. As an example, a description of a technology in the "background" does not constitute an admission that the technology is prior art to any invention in this disclosure. Neither "summary" nor "abstract" is to be considered as a feature of the invention(s) described in the issued claims.

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 were chosen and described so that others skilled in the art may recognize and understand the principles and practices. Thus, various aspects have been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications may be made while remaining within the spirit and scope herein.

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

While many exemplary aspects and embodiments of catheter systems have been discussed above, those of skill in the art will recognize certain modifications, permutations, additions and sub-combinations thereof. It is therefore intended that the following appended claims and claims hereafter introduced are interpreted to include all such modifications, permutations, additions and sub-combinations as are within their true spirit and scope, and not to limit the specifics of the structure or design shown herein.

Claims (30)

1. A catheter system for treating a treatment site within or adjacent a blood vessel or heart valve within a patient's body, the catheter system comprising:

an energy source that generates energy;

a catheter fluid; and

a transmitter assembly, the transmitter assembly comprising: (i) at least a portion of an energy director having a director distal end, the director distal end being selectively positioned proximate to a treatment site, (ii) a plasma generator, and (iii) an emitter housing secured to each of the energy director and the plasma generator to maintain a relative positioning between the director distal end of the energy director and the plasma generator, the energy director being configured to receive energy from the energy source and direct the energy toward the plasma generator to generate plasma bubbles in the catheter fluid, and the plasma generator being configured to direct energy from the plasma bubbles toward the treatment site.

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

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

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 as a result of a change in environmental conditions.

5. The catheter system of any of claims 2-4, wherein the first housing section includes a guide aperture within which at least a portion of the energy guide is secured.

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

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

8. The catheter system of any of claims 2-7, wherein the second housing section is substantially cylindrical.

9. 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 as a result of a change in environmental conditions.

10. The catheter system of any of claims 2-9, wherein the second housing section includes a generator aperture within which at least a portion of the plasma generator is secured.

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

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

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

14. The catheter system of any of claims 2-13, wherein the connector section comprises a section opening, the plasma generator configured to direct energy from the plasma bubble through the section opening and toward the treatment site.

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

16. The catheter system of any one of claims 14-15, wherein the plasma generator has a proximal end that is beveled such that the plasma generator is configured to direct energy from the plasma bubbles through the segment opening and toward the treatment site.

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

18. The catheter system of any one of claims 1-17, further comprising a stiffening cover positioned to substantially surround the emitter housing.

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

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

21. The catheter system of claim 20, further comprising a first component attachment positioned adjacent the first housing section and a second component attachment positioned adjacent the second housing section, the component attachments configured to retain the emitter housing within the groove formed along an outer surface of the guidewire lumen.

22. The catheter system of any one of claims 1-21, 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 wherein the introducer distal end, the plasma generator, and the emitter housing are positioned within the balloon interior.

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

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

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

26. The catheter system of claim 1, wherein the energy director 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 comprises one of a wetting agent and a surfactant.

29. A method for treating a treatment site within or adjacent a blood vessel or heart valve in a patient, the method utilizing the catheter system of any one of claims 1-28.

30. A method for treating a treatment site within or adjacent a blood vessel or heart valve in a patient, the method comprising the steps of:

generating energy using an energy source;

positioning an emitter assembly within a catheter fluid in proximity to the treatment site, the emitter assembly comprising: (i) at least a portion of an energy director having a director distal end, the director distal end being selectively positioned adjacent the treatment site, (ii) a plasma generator, and (iii) an emitter housing secured to each of the energy director and the plasma generator to maintain relative positioning between the director distal end of the energy director and the plasma generator;

receiving energy from the energy source with the energy director;

generating plasma bubbles in the catheter fluid using the energy from the energy director directed to the plasma generator; and

energy from the plasma bubbles is directed to the treatment site using the plasma generator.