Catheter system for valvuloplasty procedures

Abstract

To provide a catheter system for treating a treatment site in or adjacent to a heart valve.SOLUTION: A catheter system 100 includes a source of energy 124 and a plurality of energy guide 122A and balloon assemblies 104, wherein the source of energy 124 generates energy. An energy guide 122A is configured to receive energy from energy sources 124. The balloon assembly 104 has a plurality of balloon 104A portions each positionable adjacent the treatment site 106. Each of the plurality of balloon sidewalls has a balloon 104A 130 defining a balloon interior 146 and is configured to retain a balloon fluid 132 within the balloon interior 146. A portion of at least one energy guide of the plurality of energy guide 122A receiving energy from the energy sources 124 is positioned within the balloon interior 146 of each of the plurality of balloon 104A.SELECTED DRAWING: Figure 2B

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 124,685, filed December 11, 2020, and U.S. Patent Application No. 17 / 543,253, filed December 6, 2021. To the extent permitted, the contents of U.S. Provisional Patent Application No. 63 / 124,685 and U.S. Patent Application No. 17 / 543,253 are incorporated herein by reference in their entirety. [Background technology]

[0002] Vascular lesions, such as calcium deposits in and adjacent to heart valves within the body, can be associated with an increased risk of major adverse events, such as myocardial infarction, embolism, deep vein thrombosis, and stroke. Severe vascular lesions, such as severely calcified vascular lesions, can be difficult for physicians to treat and achieve patency in clinical practice.

[0003] The tricuspid valve, also known as the right atrioventricular valve, has three leaflets that open and close in unison when the valve is functioning properly. The tricuspid valve functions as a one-way valve, opening during ventricular diastole to allow blood to flow from the right atrium to the right ventricle and closing during ventricular systole to prevent blood from flowing back from the right ventricle into the right atrium. Backflow of blood, also known as regression or tricuspid regurgitation, can cause increased ventricular preload because backflow of blood into the atrium increases the volume of blood that must be pumped back into the ventricle during ventricular diastole of the next cycle. Prolonged increased right ventricular preload can lead to right ventricular enlargement (dilation), which, if uncorrected, can progress to right heart failure.

[0004] Calcium deposits on the tricuspid valve, also known as valvular stenosis, can occur adjacent to the tricuspid valve wall and / or on or between the tricuspid valve leaflets. Valvular stenosis can prevent the leaflets from fully opening and closing, thereby causing undesirable tricuspid regurgitation. Over time, such calcium deposits can reduce the mobility of the leaflets and ultimately prevent the heart from adequately supplying blood to the rest of the body.

[0005] Currently, several methods are available that attempt to address valvular stenosis, but these methods are not entirely satisfactory. One such method involves the use of a standard balloon valvuloplasty catheter. Unfortunately, this type of catheter usually does not have sufficient strength to adequately inhibit calcium deposition between the leaflets or at the base of the leaflets. Another such method involves prosthetic tricuspid valve replacement, which can be used to restore tricuspid valve functionality. However, this procedure is highly invasive and very expensive. In another such method, a valve stent may be placed between the leaflets to bypass the leaflets. This procedure is relatively expensive and has been found to not adequately improve the pressure gradient. Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, it is currently desirable to develop improved methodologies for valvuloplasty aimed at more effectively and efficiently destroying calcifications adjacent to the tricuspid valve wall and / or on or between the tricuspid valve leaflets. Additionally, it is desirable that such improved methodologies, in addition to addressing valvular stenosis associated with the tricuspid valve, also effectively address calcifications in other heart valves, such as mitral stenosis in the mitral valve and aortic stenosis in the aortic valve, as well as pulmonary stenosis in the pulmonary valve. [Means for solving the problem]

[0007] The present invention is directed to a catheter system that can be used to treat one or more treatment sites within or adjacent to a heart valve in a patient's body. In various embodiments, the catheter system includes an energy source, multiple energy guides, and a balloon assembly. The energy source generates energy. The multiple energy guides are configured to receive energy from the energy source. The balloon assembly includes multiple balloons, each positionable substantially adjacent to a treatment site. Each of the multiple balloons has a balloon wall defining a balloon interior. Each of the multiple balloons is configured to hold a balloon fluid within the balloon interior. A portion of at least one of the multiple energy guides that receives energy from the energy source is positioned within the balloon interior of each of the multiple balloons to form a plasma in the balloon fluid within the balloon interior.

[0008] In various implementations, the heart valve has a valve wall and at least one of the plurality of balloons is positioned adjacent to the valve wall, hi another implementation, the heart valve has a plurality of leaflets and at least one of the plurality of balloons is positioned adjacent to at least one of the leaflets.

[0009] In some embodiments, each of the plurality of balloons is selectively inflatable with a balloon fluid to expand to an inflated state, and in such embodiments, the balloon wall is configured to be positioned substantially adjacent the treatment site when the balloon is in the inflated state.

[0010] In certain embodiments, the catheter system further comprises a plurality of plasma generators, one positioned near the distal end of each of the plurality of energy guides, configured to generate plasma in a balloon fluid within a balloon interior of each of the plurality of balloons.

[0011] In various embodiments, a guide distal end of at least one energy guide of the plurality of energy guides is positioned within a balloon interior of one of the plurality of balloons at approximately the midpoint of the heart valve.

[0012] In some embodiments, plasma formation causes rapid bubble formation, exerting a pressure wave on the balloon wall of each balloon adjacent the treatment site.

[0013] In certain embodiments, an energy source generates an energy pulse that is guided along each of the plurality of energy guides into the balloon interior of each balloon to induce plasma formation in the balloon fluid within the balloon interior of each balloon.

[0014] In some embodiments, the energy source is a laser source providing laser energy pulses. In certain such embodiments, at least one energy guide of the plurality of energy guides comprises an optical fiber.

[0015] In various embodiments, the energy source is a high-voltage energy source that provides high-voltage pulses, and in such embodiments, at least one of the plurality of energy guides can have an electrode pair having spaced apart electrodes that extend into the interior of the balloon, and high-voltage pulses from the energy source are applied to the electrodes to form an electric arc between the electrodes.

[0016] In certain embodiments, the catheter system further includes a catheter shaft. In such embodiments, a balloon proximal end of each of the plurality of balloons can be coupled to the catheter shaft. In some such embodiments, the catheter system further includes (i) a guide shaft positioned at least partially within the catheter shaft, the guide shaft defining a guidewire lumen, and (ii) a guidewire positioned to extend through the guidewire lumen, the guidewire configured to guide movement of the balloon assembly to position each of the plurality of balloons substantially adjacent the treatment site.

[0017] In various embodiments, the balloon assembly includes three balloons. In other embodiments, the balloon assembly includes two balloons.

[0018] In some embodiments, each of the plurality of balloons is independently operable to be positioned substantially adjacent the treatment site.

[0019] In one embodiment, at least one balloon of the plurality of balloons is formed from a braided Nitinol material.

[0020] The present invention is further directed to a catheter system for treating one or more treatment sites within or adjacent to a heart valve within a patient's body, the catheter system comprising: an energy source that generates energy; a plurality of energy guides configured to receive energy from the energy source; and a balloon assembly having a multi-lobed balloon having a plurality of balloon lobes, each positionable substantially adjacent to the treatment site, the balloon having a balloon wall that defines a balloon interior, the balloon configured to retain balloon fluid within the balloon interior in each of the plurality of balloon lobes, wherein a portion of at least one of the plurality of energy guides that receives energy from the energy source is positioned within the balloon interior of each of the plurality of balloon lobes so as to form plasma in the balloon fluid within the balloon interior.

[0021] Additionally, the present invention is further directed to a method for treating one or more treatment sites within or adjacent to a heart valve within a patient's body, the method comprising: (i) generating energy using an energy source; (ii) receiving energy from the energy source using a plurality of energy guides; (iii) positioning a plurality of balloons substantially adjacent to the treatment site, each of the plurality of balloons having a balloon wall defining a balloon interior, each of the plurality of balloons configured to hold a balloon fluid within the balloon interior; and (iv) positioning at least one energy guide of the plurality of energy guides within the balloon interior of each of the plurality of balloons to receive energy from the energy source to form a plasma in the balloon fluid within the balloon interior.

[0022] Additionally, the present invention is further directed to a method for treating one or more treatment sites within or adjacent to a heart valve within a patient's body, the method comprising: (i) generating energy using an energy source; (ii) receiving energy from the energy source using a plurality of energy guides; (iii) positioning each of a plurality of balloon lobes of a multi-lobe balloon substantially adjacent to the treatment site, the balloon having a balloon wall defining a balloon interior, the balloon being configured to hold balloon fluid within the balloon interior of each of the plurality of balloon lobes; and (iv) positioning at least one energy guide of the plurality of energy guides within the balloon interior of each of the plurality of balloon lobes to receive energy from the energy source to form a plasma in the balloon fluid within the balloon interior.

[0023] This Summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or comprehensive treatment of the present subject matter. Further details may be found in the detailed description and the appended claims. Other aspects will become apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part of this invention. Each of these is not to be construed in a limiting sense. The scope of the present specification is defined by the appended claims and their legal equivalents.

[0024] The novel features of the present invention, as well as the invention itself, both as to its structure and its operation, can be best understood from the accompanying description and drawings in which like reference numerals refer to like parts. [Brief explanation of the drawings]

[0025] [Figure 1] 1 is a schematic cross-sectional view of an embodiment of a catheter system according to various embodiments herein, the catheter system including a valvular lithoplasty balloon system having features of the present invention. [Figure 2A]FIG. 1 is a simplified side view showing a portion of a heart valve and an embodiment of a catheter system having an embodiment of a valvular lithoplasty balloon assembly. [Figure 2B] FIG. 2B is a simplified cross-sectional view showing the heart valve and valvular lithoplasty balloon assembly along line 2B-2B of FIG. 2A. [Figure 3A] FIG. 10 is a simplified side view showing a portion of a heart valve and a portion of another embodiment of a catheter system having another embodiment of a valvular lithoplasty balloon assembly. [Figure 3B] FIG. 3B is a simplified cross-sectional view showing the heart valve and valvular lithoplasty balloon assembly along line 3B-3B of FIG. 3A. [Figure 4A] FIG. 10 is a simplified side view showing a portion of a heart valve and a portion of another embodiment of a catheter system having another embodiment of a valvular lithoplasty balloon assembly. [Figure 4B] FIG. 4B is a simplified cross-sectional view showing the heart valve and valvular lithoplasty balloon assembly along line 4B-4B of FIG. 4A. [Figure 5A] FIG. 10 is a simplified side view showing a portion of a heart valve and a portion of another embodiment of a catheter system having another embodiment of a valvular lithoplasty balloon assembly. [Figure 5B] FIG. 5B is a simplified cross-sectional view showing the heart valve and valvular lithoplasty balloon assembly along line 5B-5B of FIG. 5A. DETAILED DESCRIPTION OF THE INVENTION

[0026] While embodiments of the present invention are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and are herein described in detail. It is to be understood, however, that the scope of the present invention is not limited to the particular embodiments described. On the contrary, it is intended to cover all modifications, equivalents, and alternatives within the spirit and scope of the present invention.

[0027] Treatment of a vascular lesion (sometimes referred to herein as a "treatment site") can reduce major adverse events or death in an affected subject. A major adverse event, as referred to herein, is an event that may occur anywhere in the body due to the presence of a vascular lesion. Major adverse events may include, but are not limited to, major cardiac adverse events, peripheral or central vascular adverse events, cerebral adverse events, muscle tissue adverse events, or any of the internal organs.

[0028] The catheter systems and related methods disclosed herein are configured to incorporate improved methodologies for valvuloplasty, with the goal of more effectively and efficiently destroying any calcified vascular lesions that may develop over time on and / or within a heart valve. More specifically, the catheter systems and related methods generally include a valvular lithoplasty balloon assembly (sometimes simply referred to as a "balloon assembly") that incorporates the use of multiple balloons and / or a single balloon with multiple lobes, where the multiple balloons and / or the single balloon are moved to position within and / or adjacent to the heart valve. Each of the balloons and / or balloon lobes is then anchored in a specific location, allowing energy to be directed to the precise location of the heart valve where needed, such as adjacent the valve wall and / or onto or between adjacent leaflets within the heart valve, to destroy calcified vascular lesions. Although such methodologies are often described herein as being useful for treating valvular stenosis associated with the tricuspid valve, it will be appreciated that such methodologies are also useful for treating calcium deposits in other heart valves, such as mitral stenosis in the mitral valve, aortic stenosis in the aortic valve, and / or pulmonary stenosis in the pulmonary valve.

[0029] In various embodiments, a catheter system can include a catheter configured to be advanced to a vascular lesion located at a treatment site within or adjacent to a heart valve within a patient's body. The catheter includes a catheter shaft and a valvular lithoplasty balloon assembly coupled and / or secured to the catheter shaft. Each balloon of the valvular lithoplasty balloon assembly can have a balloon wall defining a balloon interior. Additionally, in embodiments where the balloon assembly includes a single balloon with multiple lobes, each lobe of the balloon can have a lobe wall (a portion of the balloon wall) that helps define the lobe interior. Each balloon can be configured to receive balloon fluid within the balloon interior and / or lobe interior to expand from a deflated state suitable for advancing the balloon through the patient's vasculature to an inflated state suitable for locking the balloon in place relative to the treatment site.

[0030] The catheter system further utilizes an energy source, e.g., a light source such as a laser source or another suitable energy source, that provides energy guided by an energy guide, e.g., a light guide, to create a localized plasma in the balloon fluid held within the balloon interior of each of the multiple balloons and / or the lobe interior of each of the multiple lobes of a single balloon of a valvular lithoplasty balloon assembly. Thus, the energy guide may sometimes be referred to as, or sometimes may incorporate, a "plasma generator" at or near the guide distal end of the energy guide positioned within the balloon interior and / or the lobe interior.

[0031] Specifically, a portion of at least one energy guide, such as a distal guide end of the energy guide, may be positioned within each balloon and / or each lobe of the balloon assembly. Each energy guide may be configured to generate a pressure wave within the balloon fluid to inhibit the vascular lesion. More specifically, each energy guide may be configured to direct energy from an energy source, such as via a plasma generator, into the balloon interior and / or the lobe interior to generate a local plasma in the balloon fluid at or near the distal guide end of the energy guide disposed within each balloon and / or the lobe interior of each balloon lobe located at the treatment site. Creating the local plasma may initiate the rapid formation of one or more gas bubbles that can rapidly expand to a maximum size and then dissipate via a cavitation event, thereby emitting a pressure wave upon collapse. Thus, the rapid expansion of the plasma-induced bubbles (sometimes simply referred to as "plasma bubbles") can generate one or more pressure waves in the balloon fluid held within the balloon and / or within the lobes of the balloon lobes, which can then be applied over a vascular lesion at a treatment site within or adjacent to a heart valve in the patient's body to induce fracture.

[0032] By selectively positioning the balloon assembly adjacent to the treatment site, energy guides within each balloon and / or each balloon lobe can be applied to disrupt calcified vascular lesions at various precise locations at the treatment site. In some embodiments, the energy source can be configured to provide sub-millisecond pulses of energy to initiate plasma formation in the balloon fluid within the balloon and / or balloon lobes, causing rapid bubble formation and applying pressure waves on the balloon wall at the treatment site. Thus, the pressure waves can transmit mechanical energy to the treatment site through the incompressible balloon fluid to apply a fracture force on the vascular lesion. While not wishing to be bound by any particular theory, it is believed that a rapid change in momentum of the balloon fluid on the balloon wall in contact with the vascular lesion is transmitted to the vascular lesion, thereby inducing fracture of the lesion.

[0033] As described in detail herein, the catheter system of the present invention includes a valvular lithoplasty balloon assembly having multiple balloons, e.g., two, three, or more individual balloons, and / or a single balloon with multiple lobes, e.g., two, three, or more individual lobes within a single balloon, that can be utilized to apply pressure to and induce fractures in calcified vascular lesions adjacent to the valve wall and / or on or between adjacent leaflets in a tricuspid valve (or other heart valve) for the purpose of disrupting the calcified vascular lesions. It will be appreciated that in various embodiments, the number of balloons and the number of balloon lobes within a multi-lobe balloon are intended to correspond to the number of leaflets in the heart valve in which the catheter system is to be used. More specifically, in a tri-leaflet heart valve, the balloon assembly will typically have three individual balloons or three balloon lobes within a single multi-lobe balloon, and in a bi-leaflet heart valve, the balloon assembly will typically have two individual balloons or two balloon lobes within a single multi-lobe balloon. As used herein, the terms "treatment site," "endovascular lesion," and "vascular lesion" may be used interchangeably unless otherwise specified.

[0034] Those skilled in the art will recognize that the following detailed description of the present invention is merely exemplary and is not intended to be limiting in any way. Other embodiments of the present invention will readily suggest themselves to those skilled in the art having the benefit of the present invention. Additionally, other methods of providing energy to a lesion may be utilized, including, but not limited to, current-induced plasma formation. Reference will now be made in detail to implementations of the present invention that are illustrated in the accompanying drawings. Equal or similar nomenclature and / or reference numerals will be used throughout the drawings and the following detailed description to refer to the same or similar parts.

[0035] For clarity, not all common features of the implementations described herein are shown and described. It will be recognized that in the development of any such practical implementation, numerous implementation-specific decisions must be made to achieve the developer's particular goals, such as meeting application-related and business-related constraints, and that these particular goals will vary from implementation to implementation and from developer to developer. It will further be recognized that such a development effort may be complex and time-consuming, but would be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.

[0036] The catheter systems disclosed herein can have many different configurations. Referring now to FIG. 1 , a schematic cross-sectional view of a catheter system 100 according to various embodiments is shown. The catheter system 100 is adapted to apply pressure waves to induce fractures at one or more treatment sites within or adjacent to leaflets in a tricuspid valve or other suitable heart valve. In the embodiment shown in FIG. 1 , the catheter system 100 can include one or more of a catheter 102, an energy guide bundle 122 having one or more energy guides 122A, a source manifold 136, a fluid pump 138, a system console 123 having one or more of the energy sources 124, a power supply 125, a system controller 126, a graphic user interface (GUI) 127, and a handle assembly 128. Additionally, as described herein, the catheter 102 includes a valvular lithoplasty balloon assembly 104 (sometimes referred to herein simply as a "balloon assembly") configured to be selectively positioned adjacent the valve wall 108A (including the annulus and commissures) and / or over or between adjacent leaflets 108B within the heart valve 108 at the treatment site 106. Alternatively, the catheter system 100 may have more or fewer components than those specifically shown and described in connection with FIG.

[0037] Catheter 102 is configured to navigate to treatment site 106 within and adjacent to heart valve 108 in body 107 of patient 109. Treatment site 106 may include one or more vascular lesions 106A, such as, for example, calcified vascular lesions. Additionally or alternatively, treatment site 106 may include vascular lesions 106A, such as fibrous vascular lesions.

[0038] The catheter 102 can include a catheter shaft 110 , a guide shaft 118 , a valvular lithoplasty balloon assembly 104 , and a guidewire 112 .

[0039] The catheter shaft 110 may extend from the proximal portion 114 of the catheter system 100 to the distal portion 116 of the catheter system 100. The catheter shaft 110 may have a longitudinal axis 144. The guide shaft 118 may be positioned at least partially within the catheter shaft 110. The guide shaft 118 may define a guidewire lumen configured to travel over and / or through which the guidewire 112 extends. The catheter shaft 110 may further include one or more inflation lumens (not shown) and / or various other lumens for various other purposes. For example, in one embodiment, the catheter shaft 110 has a separate inflation lumen configured to provide balloon fluid 132 for each balloon and / or each balloon lobe of the balloon assembly 104. Alternatively, in other embodiments, the catheter shaft 110 can have an inflation lumen configured to provide balloon fluid 132 to two or more balloons and / or two or more balloon lobes of the balloon assembly 104. In some embodiments, the catheter 102 can have a distal end opening 120 that can receive and be moved over a guidewire 112 as it is moved to position at or near the treatment site 106.

[0040] A balloon assembly 104 can be coupled to the catheter shaft 110. In some embodiments, the balloon assembly 104 includes multiple balloons 104A, each of which can be positioned adjacent the valve wall 108A and / or on or between adjacent leaflets 108B in the heart valve 108 at the treatment site 106. In one such embodiment, the balloon assembly 104 includes three individual balloons 104A positioned substantially adjacent to one another. Alternatively, in another such embodiment, the balloon assembly 104 can include only two balloons 104A. Still alternatively, in other embodiments, the balloon assembly 104 can include only a single balloon with multiple balloon lobes, i.e., two or three balloon lobes, each of which can be positioned adjacent the valve wall 108A and / or on or between adjacent leaflets 108B in the heart valve 108 at the treatment site 106.

[0041] Each balloon 104A of the balloon assembly 104 can have a balloon proximal end 104P and a balloon distal end 104D. In some embodiments, the balloon proximal end 104P of each balloon 104A can be coupled to the catheter shaft 110. Additionally, in certain embodiments, the balloon distal end 104D of each balloon 104A can be coupled to the guide shaft 118.

[0042] Each balloon 104A has a balloon wall 130 that defines a balloon interior 146. Each balloon 104A can be selectively inflated with a balloon fluid 132 to expand from a deflated state suitable for advancing the catheter 102 through the patient's vasculature to an inflated state (shown in FIG. 1 ) suitable for locking the catheter 102 in place relative to the treatment site 106. Stated differently, when each balloon 104A is in the inflated state, the balloon wall 130 of the balloon 104A is configured to be positioned substantially adjacent various specific areas at the treatment site 106.

[0043] A balloon 104A suitable for use in the balloon assembly 104 in the catheter system 100 includes a balloon that can be passed through a patient's vasculature when in a deflated state. In some embodiments, the balloon 104A is made from silicone. In other embodiments, the balloon 104A is made from a material such as a polymer, such as polydimethylsiloxane (PDMS), polyurethane, PEBAX™ material, nylon, or any other suitable material. In other embodiments, the balloon 104A may be provided in the form of a braided Nitinol balloon. Additionally, in certain embodiments, the balloon 104A is impermeable whether fully inflated or not, such that no openings are intentionally formed in and / or through the balloon wall 130, thereby allowing the passage of any substance, such as the balloon fluid 132 and / or therapeutic agent, therethrough.

[0044] Balloon 104A can have any suitable diameter (inflated state). In various embodiments, balloon 104A can have a diameter (inflated state) ranging from less than 1 millimeter (mm) to up to 25 mm. In some embodiments, balloon 104A can have a diameter (inflated state) ranging from at least 1.5 mm to up to 14 mm. In some embodiments, balloon 104A can have a diameter (inflated state) ranging from at least 2 mm to up to 5 mm.

[0045] In some embodiments, the balloon 104A can have a length ranging from at least 3 mm to 300 mm. More specifically, in some embodiments, the balloon 104A can have a length ranging from at least 8 mm to 200 mm. It will be appreciated that a balloon 104 having a relatively long length can be positioned adjacent a larger treatment site 106 and thus can be used to apply pressure waves onto a larger vascular lesion 106A or multiple vascular lesions 106A at precise locations within the treatment site 106 and induce fractures therein. It will further be appreciated that a longer balloon 104A can also be positioned adjacent multiple treatment sites 106 at any one given time.

[0046] The balloon 104A may be inflated to an inflation pressure of between about 1 atmosphere (atm) and 70 atm. In some embodiments, the balloon 104A may be inflated to an inflation pressure of at least 20 atm and 60 atm. In other embodiments, the balloon 104A may be inflated to an inflation pressure of at least 6 atm and 20 atm. In still other embodiments, the balloon 104A may be inflated to an inflation pressure of at least 3 atm and 20 atm. In other embodiments, the balloon 104A may be inflated to an inflation pressure of at least 2 atm and 10 atm.

[0047] Balloon 104A can have a variety of shapes, including, but not limited to, conical, square, rectangular, spherical, conical / square, conical / spherical, spheroidal, elliptical, tapered, bone-shaped, stepped diameter, offset, or conical offset. Additionally, in certain embodiments, a single multi-lobe balloon can be utilized. In some embodiments, balloon 104A can have a drug-eluting coating or a drug-eluting stent structure. The drug-eluting coating or drug-eluting stent can have one or more therapeutic agents, including anti-inflammatory agents, anti-tumor agents, and anti-angiogenic agents.

[0048] The balloon fluid 132 may be a liquid or a gas. Some examples of balloon fluids 132 suitable for use include, but are not limited to, one or more of water, saline, contrast media, gases such as fluorocarbons, perfluorocarbons, carbon dioxide, or any other suitable balloon fluid 132. In some embodiments, the balloon fluid 132 may be used as a base inflation fluid. In some embodiments, the balloon fluid 132 may include a mixture of saline and contrast media in a volume ratio of approximately 50:50. In other embodiments, the balloon fluid 132 may include a mixture of saline and contrast media in a volume ratio of approximately 25:75. In other embodiments, the balloon fluid 132 may include a mixture of saline and contrast media in a volume ratio of approximately 75:25. However, it will be understood that any suitable ratio of saline to contrast media may be used. The balloon fluid 132 may be adjusted based on its composition, viscosity, etc., to manipulate the speed at which the pressure waves travel. In certain embodiments, balloon fluids 132 suitable for use are biocompatible. The volume of the balloon fluid 132 can be adjusted depending on the energy source 124 selected and the type of balloon fluid 132 used.

[0049] In some embodiments, the contrast agent used in the contrast medium can include an iodine-based contrast agent, such as, but not limited to, an ionic or non-ionic iodine-based contrast agent. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, metrizoate, iothalamic acid salt, and ioxaglate. Some non-limiting examples of non-ionic iodine-based contrast agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based contrast agents can be used. Suitable non-iodine-containing contrast agents can include gadolinium(III)-based contrast agents. Suitable fluorocarbon and perfluorocarbon liquids can include, but are not limited to, agents such as the perfluorocarbon dodecafluoropentane (DDFP, C5F12).

[0050] The balloon fluid 132 can include a balloon fluid containing an absorber capable of selectively absorbing light in the ultraviolet region (e.g., at least 10 nanometers (nm) to 400 nm), visible region (e.g., at least 400 nm to 780 nm), or near-infrared region (e.g., at least 780 nm to 2.5 μm) of the electromagnetic spectrum. Suitable absorbers can include absorbers having an absorption maximum along at least the 10 nm to 2.5 μm spectrum. Alternatively, the balloon fluid 132 can include a balloon fluid containing an absorber capable of selectively absorbing light in the mid-infrared region (e.g., at least 2.5 μm to 15 μm) or far-infrared region (e.g., at least 15 μm to 1 mm) of the electromagnetic spectrum. In various embodiments, the absorber can be an absorber having an absorption maximum that matches the emission maximum of a laser used in the catheter system 100. By way of non-limiting example, various lasers that can be used in the catheter system 100 include a neodymium:yttrium-aluminum-garnet (Nd:YAG (emission maximum=1064 nm)) laser, a holmium:YAG (Ho:YAG (emission maximum=2.1 μm)) laser, and an erbium:YAG (Er:YAG (emission maximum=2.94 μm)) laser. In some embodiments, the absorber may be water-soluble. In other embodiments, the absorber is water-insoluble. In some embodiments, the absorber used in the balloon fluid 132 can be tailored to match the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths of at least 10 nanometers to 1 millimeter are discussed elsewhere herein.

[0051] The catheter shaft 110 of the catheter 102 may be coupled to one or more energy guides 122A of the energy guide bundle 122 in optical communication with the energy source 124. Each energy guide 122A may be disposed along the catheter shaft 110 within one of the balloons 104A or balloon lobes of the balloon assembly 104. In some embodiments, each energy guide 122A may be an optical fiber and the energy source 124 may be a laser. The energy source 124 may be in optical communication with the energy guides 122A in the proximal portion 114 of the catheter system 100.

[0052] In some embodiments, the catheter shaft 110 may be coupled to multiple energy guides 122A, such as a first energy guide, a second energy guide, a third energy guide, etc., which may be disposed at any suitable location about the guide shaft 118 and / or the catheter shaft 110. For example, in certain non-exclusive embodiments, two energy guides 122A may be spaced approximately 180 degrees apart around the circumference of the guide shaft 118 and / or the catheter shaft 110, three energy guides 122A may be spaced approximately 120 degrees apart around the circumference of the guide shaft 118 and / or the catheter shaft 110, or four energy guides 122A may be spaced approximately 90 degrees apart around the circumference of the guide shaft 118 and / or the catheter shaft 110. Further alternatively, the multiple energy guides 122A need not be evenly spaced from one another around the circumference of the guide shaft 118 and / or the catheter shaft 110. More specifically, it will be further appreciated that the energy guide 122A may be evenly or non-uniformly distributed about the guide shaft 118 and / or catheter shaft 110 to achieve the desired effect at the desired location.

[0053] The catheter system 100 and / or energy guide bundle 122 can have any number of energy guides 122A in optical communication with the energy source 124 at the proximal portion 114 and in optical communication with the balloon fluid 132 within the balloon interior 146 of the balloon 104A at the distal portion 116. For example, in some embodiments, the catheter system 100 and / or energy guide bundle 122 can have from one energy guide 122A to 30 or more energy guides 122A.

[0054] The energy guide 122A may have any suitable design intended to generate plasma and / or pressure waves in the balloon fluid 132 within the balloon interior 146 of each balloon 104A. Accordingly, the general description of the energy guide 122A as a light guide is not intended to be limiting in any way, except as set forth in the appended claims. More specifically, although the catheter system 100 is often described with the energy source 124 as a light source and one or more energy guides 122A as light guides, the catheter system 100 may alternatively have any suitable energy source 124 and energy guide 122A intended to generate the desired plasma in the balloon interior 146 of each balloon 104A and / or in the balloon fluid 132 within each balloon lobe. For example, in one non-exclusive alternative embodiment, the energy source 124 may be configured to provide high-voltage pulses, and each energy guide 122A may have an electrode pair with spaced-apart electrodes extending into the balloon interior 146. In such an embodiment, pulses of high voltage are applied to the electrodes, forming an electric arc between the electrodes, which in turn generates a plasma and creates pressure waves within the balloon fluid 132, which are utilized to provide a fracture force on the vascular lesion 106A at the treatment site 106. Further alternatively, the energy source 124 and / or energy guide 122A can have another suitable design and / or configuration.

[0055] In certain embodiments, the energy guide 122A can comprise an optical fiber or a flexible light pipe. The energy guide 122A can be thin and flexible, allowing optical signals to be transmitted with little or no loss of intensity. The energy guide 122A can have a core surrounded by a cladding material around its circumference. In some embodiments, the core can be a cylindrical core or a partially cylindrical core. The core and cladding material of the energy guide 122A can be formed from one or more materials, including, but not limited to, one or more types of glass, silica, or one or more polymers. The energy guide 122A can further comprise a protective coating, such as a polymer. It will be appreciated that the refractive index of the core is greater than the refractive index of the cladding material.

[0056] Each energy guide 122A can guide energy along its length from a proximal guide end 122P to a distal guide end 122D having at least one optical window (not shown) positioned within the balloon interior 146. In one non-exclusive example, the distal guide end 122D of each energy guide 122A can be positioned within the balloon interior 146 such that it is positioned approximately at the midpoint of the heart valve 108. Using such a design, when the balloon 104A expands to an inflated state, pressure waves generated in the balloon fluid 132 can exert pressure on any desired portion of the heart valve 108, such as the valve wall 108A, commissures, annulus, and / or leaflets 108B. Alternatively, the energy guide 122A can have another suitable design, and / or energy from the energy source 124 can be guided into the balloon interior 146 by another suitable method.

[0057] The energy guide 122A can have many configurations about and / or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the energy guide 122A can extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guide 122A can be physically coupled to the catheter shaft 110. In other embodiments, the energy guide 122A can be disposed along the length of the outer diameter of the catheter shaft 110. In other embodiments, the energy guide 122A can be disposed within one or more energy guide lumens within the catheter shaft 110.

[0058] The energy guides 122A may further be disposed at any suitable position around the circumference of the guide shaft 118 and / or the catheter shaft 110, and the guide distal end 122D of each energy guide 122A may be disposed at any suitable longitudinal position relative to the length of the balloon 104A and / or the length of the guide shaft 118.

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

[0060] An optoacoustic transducer 154 is configured to convert optical energy into acoustic waves at or near the distal guide end 122D of the energy guide 122A, and the direction of the acoustic waves can be adjusted by changing the angle of the distal guide end 122D of the energy guide 122A.

[0061] In certain embodiments, the optoacoustic transducer 154 disposed at the guide distal end 122D can have the same shape as the guide distal end 122D of the energy guide 122A. For example, in certain non-exclusive embodiments, the optoacoustic transducer 154 and / or the guide distal end 122D can have a conical shape, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a semicircular shape, an oval shape, etc. The energy guide 122A can further include additional optoacoustic transducers 154 disposed along one or more lateral surfaces of the length of the energy guide 122A.

[0062] In some embodiments, energy guide 122A can further include one or more redirecting structures or “diverters” (not shown in FIG. 1 ) within energy guide 122A configured to direct energy away from energy guide 122A toward a lateral surface, which may be located at or near distal guide end 122D of energy guide 122A, and toward balloon wall 130. The redirecting structure can include any structure in the system that directs energy from energy guide 122A away from its axial path toward a lateral surface of energy guide 122A. Additionally, each of energy guides 122A can include one or more optical windows disposed along a longitudinal or circumferential surface of each energy guide 122A that can be in optical communication with the redirecting structure. In other words, the redirecting structure can be configured to direct energy within energy guide 122A toward a lateral surface at or near guide distal end 122D, the lateral surface being in optical communication with the optical window. The optical window can comprise a portion of energy guide 122A that allows energy from within energy guide 122A to exit energy guide 122A (such as a portion of energy guide 122A that does not have coating material on or around energy guide 122A).

[0063] Examples of redirecting structures suitable for use include reflective elements, refractive elements, and fiber diffusers. Suitable redirecting structures for concentrating energy away from the tip of the energy guide 122A include, but are not limited to, convex surfaces, gradient index (GRIN) lenses, and mirror focusing lenses. Upon contact with the redirecting structure, the energy is redirected within the energy guide 122A toward one or more plasma generators 133 and photoacoustic transducers 154, which are in optical communication with the side surfaces of the energy guide 122A. The photoacoustic transducers 154 then convert the optical energy into acoustic waves, which propagate away from the side surfaces of the energy guide 122A.

[0064] A source manifold 136 may be positioned at or near the proximal portion 114 of the catheter system 100. The source manifold 136 may have one or more proximal end openings that may receive one or more energy guides 122A of the energy guide bundle 122, the guidewire 112, and / or an inflation conduit 140 coupled in fluid communication with a fluid pump 138. The catheter system 100 may further include a fluid pump 138 configured to inflate each balloon 104A of the balloon assembly 104 with balloon fluid 132, i.e., via the inflation conduit 140, as desired.

[0065] As noted above, in the embodiment shown in FIG. 1 , the system console 123 includes one or more of the energy source 124, the power supply 125, the system controller 126, and the GUI 127. Alternatively, the system console 123 may include more or fewer components than those specifically shown in FIG. 1 . For example, in certain non-exclusive alternative embodiments, the system console 123 may be designed without the GUI 127. As a further alternative, one or more of the energy source 124, the power supply 125, the system controller 126, and the GUI 127 may be provided within the catheter system 100, eliminating the need for a separate system console 123.

[0066] As shown, the system console 123 and components included therein are operably coupled to the catheter 102, the energy guide bundle 122, and the remainder of the catheter system 100. For example, in some embodiments, as shown in FIG. 1 , the system console 123 can have a console connection aperture 148 (which may also be generally referred to as a “socket”) through which the energy guide bundle 122 is mechanically coupled to the system console 123. In such embodiments, the energy guide bundle 122 can have a guide connection housing 150 (which may also be generally referred to as a “ferrule”) that houses a portion of each energy guide 122A (e.g., guide proximal end 122P). The guide connection housing 150 is configured to fit into and selectively be retained within the console connection aperture 148 to provide a mechanical coupling between the energy guide bundle 122 and the system console 123.

[0067] The energy guide bundle 122 may further include a guide bundler 152 (or "shell") that brings each individual energy guide 122A closer together, thereby allowing the energy guides 122A and / or energy guide bundle 122 to assume a more compact form as they extend into the heart valve 108 with the catheter 102 during use of the catheter system 100.

[0068] An energy source 124 may optionally and / or alternatively be coupled in optical communication with each energy guide 122A in the energy guide bundle 122, i.e., with the proximal guide end 122P of each energy guide 122A. Specifically, the energy source 124 may be configured to generate energy in the form of a source beam 124A, such as a pulsed source beam, that may optionally and / or alternatively be directed toward and received by each energy guide 122A in the energy guide bundle 122 as a separate guide beam 124B. Alternatively, the catheter system 100 may have two or more energy sources 124. For example, in one non-exclusive alternative embodiment, the catheter system 100 may have a separate energy source 124 for each energy guide 122A in the energy guide bundle 122.

[0069] Energy source 124 can have any suitable design. In certain embodiments, energy source 124 can be configured to provide sub-millisecond energy pulses focused onto a small spot that couples energy source 124 into proximal guide end 122P of energy guide 122A. Such energy pulses are then directed and / or guided along energy guide 122A to a location within the balloon interior of each balloon 104 and / or balloon lobe, thereby inducing plasma formation in balloon fluid 132 within balloon interior 146 of each balloon 104 and / or balloon lobe via plasma generator 133, which can be located at or near distal guide end 122D of energy guide 122A. Specifically, energy emitted at distal guide end 122D of energy guide 122A activates plasma generator 133 to form plasma within balloon fluid 132 within balloon interior 146 of each balloon 104A and / or balloon lobe. This plasma formation causes rapid bubble formation, exerting a pressure wave over the treatment site 106. An exemplary plasma-induced bubble 134 is shown in FIG.

[0070] In various non-exclusive alternative embodiments, sub-millisecond energy pulses from energy source 124 may be provided to treatment site 106 at frequencies between about 1 Hertz (Hz) and 5000 Hz, about 30 Hz and 1000 Hz, about 10 Hz and 100 Hz, or about 1 Hz and 30 Hz. Alternatively, sub-millisecond energy pulses may be provided to treatment site 106 at frequencies greater than 5000 Hz or less than 1 Hz, or any other suitable range of frequencies.

[0071] Although the energy source 124 is typically utilized to provide pulses of energy, it will be appreciated that the energy source 124 may also be described as providing a single source beam 124A, i.e., a single pulsed source beam.

[0072] Suitable energy sources 124 for use may include various types of light sources, including lasers and lamps. Alternatively, energy source 124 may include any suitable type of energy source.

[0073] Suitable lasers include short-pulse lasers on the submillisecond time scale. In some embodiments, the energy source 124 can include a laser on the nanosecond (ns) time scale. Lasers can further include short-pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (us) time scales. It will be appreciated that there are numerous combinations of laser wavelengths, pulse widths, and energy levels that can be employed to obtain a plasma in the balloon fluid 132 of the catheter 102. In various non-exclusive alternative embodiments, the pulse width can include pulse widths within a range including at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range can be used.

[0074] Exemplary nanosecond lasers can include lasers ranging from approximately 10 nanometers (nm) to 1 millimeter (mm) in wavelength, ranging from the UV to IR spectrum. In some embodiments, an energy source 124 suitable for use in the catheter system 100 can include an energy source capable of producing light with wavelengths of at least 750 nm to 2000 nm. In other embodiments, the energy source 124 can include an energy source capable of producing light with wavelengths of at least 700 nm to 3000 nm. In still other embodiments, the energy source 124 can include an energy source capable of producing light with wavelengths of at least 100 nm to 10 micrometers (μm). Nanosecond lasers can include lasers having repetition rates up to 200 kHz.

[0075] In some embodiments, the laser can include a Q-switched thulium:yttrium-aluminum-garnet (Tm:YAG) laser, while in other embodiments, the laser can include a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser, a holmium:yttrium-aluminum-garnet (Ho:YAG) laser, an erbium:yttrium-aluminum-garnet (Er:YAG) laser, an excimer laser, a helium-neon laser, a carbon dioxide laser, as well as a doped laser, a pulsed laser, or a fiber laser.

[0076] The catheter system 100 is capable of generating 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 be determined by the energy source 124, the absorber material, the bubble expansion, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter system 100 is capable of generating pressure waves having a maximum pressure in the range of at least about 2 MPa to 50 MPa, at least about 2 MPa to 30 MPa, or at least about 15 MPa to 25 MPa.

[0077] When the catheter 102 is positioned at the treatment site 106, pressure waves may be applied onto the treatment site 106 from a distance extending radially from the energy guide 122A ranging from at least about 0.1 millimeters (mm) to about 25 mm or more. In various non-exclusive alternative embodiments, when the catheter 102 is positioned at the treatment site 106, pressure waves may be applied onto the treatment site 106 from a distance extending radially from the energy guide 122A ranging from at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm. In other embodiments, pressure waves may be applied onto the treatment site 106 from another suitable distance different from the above ranges. In some embodiments, pressure waves may be applied onto the treatment site 106 from a distance of at least about 0.1 mm to 10 mm, in a range of at least about 2 MPa to 30 MPa. In some embodiments, pressure waves may be applied over the treatment site 106 from a range of at least about 2 MPa to 25 MPa at a distance of at least about 0.1 mm to 10 mm. Further alternatively, other suitable pressure ranges and distances may be used.

[0078] A power supply 125 is electrically coupled to and configured to provide the necessary power to each of the energy source 124, the system controller 126, the GUI 127, and the handle assembly 128. The power supply 125 may have any suitable design for these purposes.

[0079] The system controller 126 is electrically coupled to and receives power from the power source 125. Additionally, the system controller 126 is coupled to each of the energy source 124 and the GUI 127 and configured to control their operation. The system controller 126 may include one or more processors or circuits for the purpose of controlling the operation of at least the energy source 124 and the GUI 127. For example, the system controller 126 may control the energy source 124 to generate energy pulses at any desired firing rate and / or as desired. Additionally, the system controller 126 may operate the treatment system 124 to effectively and efficiently provide a desired fracture force adjacent to and / or on or between adjacent leaflets 108B within the heart valve 108 at the treatment site 106.

[0080] The system controller 126 may also be configured to control the operation of other components of the catheter system 100, such as positioning the catheter 102 adjacent the treatment site 106 and inflating each balloon 104A with balloon fluid 132. Additionally or alternatively, the catheter system 100 may include one or more additional controllers that may be positioned in any suitable manner for purposes of controlling various operations of the catheter system 100. For example, in certain embodiments, the additional controllers and / or portions of the system controller 126 may be positioned within and / or incorporated within the handle assembly 128.

[0081] The GUI 127 is accessible by a user or operator of the catheter system 100. Additionally, the GUI 127 is electrically connected to the system controller 126. Using such a design, the GUI 127 can be used by the user or operator to ensure that the catheter system 100 is efficiently utilized to apply pressure onto the vascular lesion 106A at the treatment site 106 to induce fractures in the vascular lesion. The GUI 127 can provide the user or operator with information that can be used before, during, and after use of the catheter system 100. In one embodiment, the GUI 127 can provide the user and / or operator with static visual data and / or information. Additionally or alternatively, the GUI 127 can provide the user or operator with dynamic visual data and / or information, such as video data or any other data that changes over time during use of the catheter system 100. In various embodiments, the GUI 127 can have one or more colors, different sizes, varying brightness, etc., which can serve as a warning to the user or operator. Additionally or alternatively, the GUI 127 may provide acoustic data or information to the user or operator. The details of the GUI 127 may vary depending on the design requirements of the catheter system 100, i.e., the particular needs, specifications, and / or desires of the user or operator.

[0082] 1, a 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, the handle assembly 128 is coupled to the balloon assembly 104 and positioned spaced apart from the balloon assembly 104. Alternatively, the handle assembly 128 may be positioned in another suitable location.

[0083] 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 structural components of the handle assembly 128 can vary to suit the design requirements of the catheter system 100. In the embodiment shown in FIG. 1 , the handle assembly 128 is separate from, but in electrical and / or fluid communication with, one or more of the system controller 126, the energy source 124, the fluid pump 138, and the GUI 127. In some embodiments, the handle assembly 128 can integrate and / or include at least a portion of the system controller 126 within the handle assembly 128. For example, as shown, in certain such embodiments, the handle assembly 128 can include circuitry 156 that can form at least a portion of the system controller 126. In one embodiment, circuitry 156 may comprise a printed circuit board having one or more integrated circuits, or any other suitable circuitry. In alternative embodiments, circuitry 156 may be eliminated or may be included within system controller 126, which may, in various embodiments, be located outside of handle assembly 128, such as within system console 123. It will be understood that handle assembly 128 may have fewer or additional components than those specifically shown and described herein.

[0084] Various embodiments and implementations of the balloon assembly 104 and a description of their uses are described in detail hereinafter, as shown in Figures 2A-5B. However, it will be further recognized that alternative embodiments and implementations may be employed as will be apparent to those skilled in the art based on the teachings provided herein. Accordingly, the scope of the embodiments and implementations of the present invention is not intended to be limited to only those specifically described herein, except as set forth in the appended claims.

[0085] 2A is a simplified side view of a portion of a heart valve 108, including a valve wall 108A and leaflets 108B, and a portion of an embodiment of a catheter system 200, including an embodiment of a valvular lithoplasty balloon assembly 204. The balloon assembly 204 is similarly configured to be selectively positioned adjacent the valve wall 108A and / or between adjacent leaflets 108B within the heart valve 108 at a treatment site 106, including a vascular lesion 106A, within a body 107 and a patient 109.

[0086] Similar to the previous embodiment, catheter system 200 includes a catheter 202 having a catheter shaft 210, a guide shaft 218, and a guidewire 212, as described above, and a balloon assembly 204. In addition, catheter system 200 will generally include various other components, as shown and described in connection with Figure 1. However, such additional components are not shown in Figure 2A for clarity.

[0087] 2A , the balloon assembly 204 includes three individual balloons, a first balloon 204A, a second balloon 204B, and a third balloon 204C, each of which may be positioned adjacent to the treatment site 106 to disrupt the vascular lesion 106A at a different precise location within the treatment site 106. Each balloon 204A, 204B, 204C may have a proximal balloon end 204P and a distal balloon end 204D. As shown, in certain implementations, the proximal balloon end 204P of each balloon 204A, 204B, 204C may be coupled to the catheter shaft 210, and the distal balloon end 204D of each balloon 204A, 204B, 204C may be coupled to the guide shaft 218.

[0088] 2A along line 2B-2B. As shown, each of the three balloons 204A, 204B, 204C of the balloon assembly 204 can be positioned at a different specific location within the heart valve 108, i.e., adjacent the valve wall 108A and / or between adjacent leaflets 108B within the heart valve 108. Additionally, each balloon 204A, 204B, 204C is shown positioned substantially adjacent to the guide shaft 218, thereby providing a conduit through which the guidewire 212 extends in this non-exclusive implementation. In some embodiments, the balloon assembly 204 may further include one or more steerable shafts (not shown), such as one steerable shaft for each balloon 204A, 204B, 204C, that are useful for assisting in steering each balloon 204A, 204B, 204C to a desired location within the heart valve 108. Using such a design, each of the balloons 204A, 204B, 204C may be independently steerable to be positioned at a desired location within the heart valve 108. Furthermore, in certain embodiments, the catheter 202 and / or balloon assembly 204 may further incorporate the use of an imaging channel (not shown) configured to enable real-time imaging of the treatment site 106 (shown in FIG. 2A ) during positioning of the balloon assembly 204 and also during application of a therapeutic procedure.

[0089] Additionally, each balloon 204A, 204B, 204C can have a balloon wall 230 defining a balloon interior 246 and configured to receive balloon fluid 232 (shown in FIG. 2A) within the balloon interior 246. Thus, each balloon 204A, 204B, 204C can be selectively inflated with balloon fluid 232 to expand from a deflated state to an inflated state (as shown in FIG. 2B).

[0090] 2B also illustrates multiple energy guides 222A. A portion, i.e., a guide distal end 222D, of each energy guide 222A may be positioned in the balloon fluid 232 within the balloon interior 246 of one of the balloons 204A, 204B, and 204C, such that each balloon 204A, 204B, and 204C has at least one energy guide 222A guide distal end 222D. More specifically, in this embodiment, the catheter system 200 includes three energy guides 222A, with the guide distal end 222D of each of the three energy guides 222A positioned in the balloon fluid 232 within the balloon interior 246 of a different balloon 204A, 204B, and 204C. In one non-exclusive embodiment, the guide distal ends 222D of the three energy guides 222A may be substantially evenly spaced about 120 degrees from one another around the guide shaft 218. Alternatively, the catheter system 200 can have four or more energy guides 222A, where the guide distal end 222D of at least one energy guide 222A is positioned within each balloon 204A, 204B, 204C.

[0091] Energy guides 222A are configured to guide energy from energy source 124 (shown in FIG. 1 ) to induce plasma formation in balloon fluid 232 within balloon interior 246 of each balloon 204A, 204B, 204C, for example, via plasma generator 233 located at or near guide distal end 222D of each energy guide 222A. Plasma formation causes rapid bubble formation, applying pressure waves and / or fracture forces onto treatment site 106. Such pressure waves and / or fracture forces are utilized to disrupt vascular lesion 106A (shown in FIG. 2A ) at specific, precise locations within heart valve 108 at treatment site 106. More specifically, by selectively positioning the balloon assembly 204 adjacent to the treatment site 106, the energy guides 222A within each balloon 204A, 204B, 204C can be applied to disrupt the calcified vascular lesion 106A at different precise locations at the treatment site 106.

[0092] It will be appreciated that by using three individual balloons 204A, 204B, 204C to apply pressure waves and / or fracture forces to specific locations within the heart valve 108, as shown in FIG. 2B, there will be sufficient spacing 260 available between the contours of the balloons 204A, 204B, 204C and within the heart valve 108 to allow for continued blood flow while applying the therapeutic treatment.

[0093] 3A is a simplified side view of a portion of a heart valve 108, including a valve wall 108A and leaflets 108B, and a portion of another embodiment of a catheter system 300, including another embodiment of a valvular lithoplasty balloon assembly 304. In this embodiment, the balloon assembly 304 is similarly configured to be selectively positioned adjacent the valve wall 108A and / or between adjacent leaflets 108B within the heart valve 108 at a treatment site 106, including a vascular lesion 106A, within a body 107 and a patient 109.

[0094] Similar to the above embodiment, catheter system 300 similarly includes a catheter 302 having a catheter shaft 310, a guide shaft 318, and a guidewire 312, as described above, and a balloon assembly 304. In addition, catheter system 300 similarly includes various other components, as generally shown and described in connection with Figure 1. However, such additional components are not shown in Figure 3A for clarity.

[0095] As shown in the embodiment depicted in FIG. 3A (and more clearly shown in FIG. 3B), the balloon assembly 304 includes a single balloon 304A having a multi-lobe configuration. More specifically, in this embodiment, the balloon 304A is shaped to include three individual balloon lobes: a first balloon lobe 304L1, a second balloon lobe 304L2, and a third balloon lobe 304L3. Each of the balloon lobes 304L1, 304L2, and 304L3 can be positioned adjacent the treatment site 106 to disrupt the vascular lesion 106A at a different precise location within the treatment site 106. Additionally, the balloon 304A can have a proximal balloon end 304P and a distal balloon end 304D. As shown, in certain embodiments, the proximal balloon end 304P can be coupled to the catheter shaft 310, and the distal balloon end 304D can be coupled to the guide shaft 318.

[0096] 3A along line 3B-3B. As shown, each of the three balloon lobes 304L1, 304L2, 304L3 of the balloon 304A can be positioned at a different specific location within the heart valve 108, i.e., adjacent to the valve wall 108A and / or between adjacent leaflets 108B within the heart valve 108. Additionally, the balloon 304A is shown positioned substantially adjacent to and surrounding the guide shaft 318, thereby providing a conduit through which the guidewire 312 extends in this non-exclusive implementation. In some embodiments, the balloon assembly 304 may further include one or more steerable shafts (not shown) that are useful for assisting in steering the balloon 304A and / or each of the balloon lobes 304L1, 304L2, 304L3 to a desired location within the heart valve 108. Additionally, in certain embodiments, the catheter 302 and / or balloon assembly 304 may further incorporate the use of an imaging channel (not shown) configured to enable real-time imaging of the treatment site 106 (shown in FIG. 3A ) during positioning of the balloon assembly 304 and also during application of the therapeutic procedure.

[0097] Additionally, balloon 304A can have a balloon wall 330 defining a balloon interior 346 and configured to receive balloon fluid 332 (shown in FIG. 3A) within balloon interior 346. It will be appreciated that by using balloon 304A having a multi-lobe design with a single balloon interior 346, each of balloon lobes 304L1, 304L2, 304L3 will substantially simultaneously receive balloon fluid 332. Thus, balloon 304A, and thus each of balloon lobes 304L1, 304L2, 304L3, can be selectively inflated with balloon fluid 332 to expand from a deflated state to an inflated state (as shown in FIG. 3B).

[0098] 3B also shows multiple energy guides 322A. A portion, i.e., a distal guide end 322D, of each energy guide 322A can be positioned in the balloon fluid 332 within the balloon interior 346 of one of the balloon lobes 304L1, 304L2, and 304L3, such that each balloon lobe 304L1, 304L2, and 304L3 has at least one distal guide end 322D of the energy guide 322A. More specifically, in this embodiment, the catheter system 300 has three energy guides 322A, and the distal guide end 322D of each of the three energy guides 322A is positioned in the balloon fluid 332 within the balloon interior 346 of a different balloon lobe 304L1, 304L2, and 304L3. In one non-exclusive example, the guide distal ends 322D of the three energy guides 322A may be substantially evenly spaced about 120 degrees from each other around the guide shaft 318. Alternatively, the catheter system 300 may have four or more energy guides 322A, where the guide distal end 322D of at least one energy guide 322A is positioned within each balloon lobe 304L1, 304L2, 304L3.

[0099] The energy guides 322A are configured to direct energy from the energy source 124 (shown in FIG. 1 ) to induce plasma formation in the balloon fluid 332 within the balloon interior 346 of each balloon lobe 304L1, 304L2, 304L3, for example, via a plasma generator 333 located at or near the guide distal end 322D of each energy guide 322A. The plasma formation causes rapid bubble formation, applying pressure waves and / or fracture forces onto the treatment site 106. Such pressure waves and / or fracture forces are utilized to disrupt the vascular lesion 106A (shown in FIG. 3A ) at specific, precise locations within the heart valve 108 at the treatment site 106. More specifically, by selectively positioning the balloon assembly 304 adjacent to the treatment site 106, the energy guides 322A within each balloon lobe 304L1, 304L2, 304L3 can be applied to disrupt the calcified vascular lesion 106A at different precise locations at the treatment site 106.

[0100] It will be appreciated that by using a balloon 304A having three individual balloon lobes 304L1, 304L2, 304L3 to apply pressure waves and / or fracture forces to specific locations within the heart valve 108, as shown in FIG. 3B, there will be sufficient spacing 360 available between the contours of the balloon lobes 304L1, 304L2, 304L3 and within the heart valve 108 to allow for continued blood flow while applying the therapeutic treatment.

[0101] 4A is a simplified side view of a portion of a heart valve 108, including a valve wall 108A and leaflets 108B, and a portion of another embodiment of a catheter system 400, including another embodiment of a valvular lithoplasty balloon assembly 404. The balloon assembly 404 is similarly configured to be selectively positioned adjacent the valve wall 108A and / or between adjacent leaflets 108B within the heart valve 108 at a treatment site 106, including a vascular lesion 106A, within a body 107 and a patient 109.

[0102] Similar to the above embodiment, catheter system 400 similarly includes a catheter 402 having a catheter shaft 410, a guide shaft 418, and a guidewire 412, as described above, and a balloon assembly 404. In addition, catheter system 400 will generally include various other components, as shown and described in connection with Figure 1. However, such additional components are not shown in Figure 4A for clarity.

[0103] 4A, the balloon assembly 404 includes two individual balloons, a first balloon 404A and a second balloon 404B, each of which can be positioned adjacent the treatment site 106 to disrupt the vascular lesion 106A at a different precise location within the treatment site 106. Each balloon 404A, 404B can have a proximal balloon end 404P and a distal balloon end 404D. As shown, in certain embodiments, the proximal balloon end 404P of each balloon 404A, 404B can be coupled to a catheter shaft 410, and the distal balloon end 404D of each balloon 404A, 404B can be coupled to a guide shaft 418.

[0104] 4B is a simplified cross-sectional view of a heart valve 108, including a valve wall 108A and leaflets 108B, taken along line 4B-4B of FIG. 4A, and a valvular lithoplasty balloon assembly 404. As shown, each of the two balloons 404A, 404B of the balloon assembly 404 can be positioned at a different specific location within the heart valve 108, i.e., adjacent the valve wall 108A and / or between adjacent leaflets 108B within the heart valve 108. Furthermore, each balloon 404A, 404B is shown positioned substantially adjacent to a guide shaft 418, thereby providing a conduit through which a guidewire 412 extends in this non-exclusive implementation. In some embodiments, the balloon assembly 404 may further include one or more steerable shafts (not shown), such as one steerable shaft for each balloon 404A, 404B, that are useful in assisting in steering each balloon 404A, 404B to a desired location within the heart valve 108. Additionally, in certain embodiments, the catheter 402 and / or balloon assembly 404 may further incorporate the use of an imaging channel (not shown) configured to enable real-time imaging of the treatment site 106 (shown in FIG. 4A ) during positioning of the balloon assembly 404 and also during application of the therapeutic procedure.

[0105] Additionally, each balloon 404A, 404B can have a balloon wall 430 defining a balloon interior 446 and configured to receive balloon fluid 432 (shown in FIG. 4A) within the balloon interior 446. Thus, each balloon 404A, 404B can be selectively inflated with balloon fluid 432 to expand from a deflated state to an inflated state (as shown in FIG. 4B).

[0106] 4B also illustrates multiple energy guides 422A. A portion, i.e., a distal guide end 422D, of each energy guide 422A can be positioned in the balloon fluid 432 within the balloon interior 446 of one of the balloons 404A, 404B, such that each balloon 404A, 404B has at least one distal guide end 422D of the energy guide 422A. More specifically, in this embodiment, the catheter system 400 includes two energy guides 422A, with the distal guide end 422D of each of the two energy guides 422A positioned in the balloon fluid 432 within the balloon interior 446 of a different balloon 404A, 404B. In one non-exclusive embodiment, the distal guide ends 422D of the two energy guides 422A can be substantially evenly spaced about 180 degrees from each other around the guide shaft 418. Alternatively, the catheter system 400 can have three or more energy guides 422A, where the guide distal end 422D of at least one energy guide 422A is positioned within each balloon 404A, 404B.

[0107] The energy guides 422A are configured to guide energy from the energy source 124 (shown in FIG. 1 ) to induce plasma formation in the balloon fluid 432 within the balloon interior 446 of each balloon 404A, 404B, for example, via a plasma generator 433 located at or near the guide distal end 422D of each energy guide 422A. The plasma formation causes rapid bubble formation, applying pressure waves and / or fracturing forces onto the treatment site 106. Such pressure waves and / or fracturing forces are utilized to break up the vascular lesion 106A (shown in FIG. 4A ) at specific, precise locations within the heart valve 108 at the treatment site 106. More specifically, by selectively positioning the balloon assembly 404 adjacent the treatment site 106, the energy guides 422A within each balloon 404A, 404B can be applied to break up the calcified vascular lesion 106A at different, precise locations at the treatment site 106.

[0108] It will be appreciated that by using two separate balloons 404A, 404B to apply pressure waves and / or fracture forces to specific locations within the heart valve 108, as shown in FIG. 4B, there will be sufficient spacing 460 available between the contours of the balloons 404A, 404B and within the heart valve 108 to allow for continued blood flow while applying the therapeutic treatment.

[0109] 5A is a simplified side view of a portion of a heart valve 108, including a valve wall 108A and leaflets 108B, and a portion of another embodiment of a catheter system 500 including another embodiment of a valvular lithoplasty balloon assembly 504. In this embodiment, the balloon assembly 504 is similarly configured to be selectively positioned adjacent the valve wall 108A and / or between adjacent leaflets 108B within the heart valve 108 at a treatment site 106, including a vascular lesion 106A, within a body 107 and a patient 109.

[0110] Similar to the above embodiment, catheter system 500 similarly includes a catheter 502 having a catheter shaft 510, a guide shaft 518, and a guidewire 512, as described above, and a balloon assembly 504. In addition, catheter system 500 similarly includes various other components, as generally shown and described in connection with Figure 1. However, such additional components are not shown in Figure 5A for clarity.

[0111] As shown in the embodiment depicted in FIG. 5A (and more clearly shown in FIG. 5B), the balloon assembly 504 includes a single balloon 504A having a multi-lobe configuration. More specifically, in this embodiment, the balloon 504A is shaped to include two separate balloon lobes: a first balloon lobe 504L1 and a second balloon lobe 504L2. Each of the balloon lobes 504L1, 504L2 can be positioned adjacent the treatment site 106 to disrupt the vascular lesion 106A at a different precise location within the treatment site 106. Additionally, the balloon 504A can have a proximal balloon end 504P and a distal balloon end 504D. As shown, in certain implementations, the proximal balloon end 504P can be coupled to a catheter shaft 510, and the distal balloon end 504D can be coupled to a guide shaft 518.

[0112] 5B is a simplified cross-sectional view of a heart valve 108, including a valve wall 108A and leaflets 108B, taken along line 5B-5B of FIG. 5A, and a valvular lithoplasty balloon assembly 504. As shown, each of the two balloon lobes 504L1, 504L2 of the balloon 504A can be positioned at a different specific location within the heart valve 108, i.e., adjacent to the valve wall 108A and / or between adjacent leaflets 108B within the heart valve 108. Additionally, the balloon 504A is shown positioned substantially adjacent to and surrounding the guide shaft 518, thereby providing a conduit through which a guidewire 512 extends in this non-exclusive implementation. In some embodiments, the balloon assembly 504 may further include one or more steerable shafts (not shown) that are useful for assisting in steering the balloon 504A and / or each of the balloon lobes 504L1, 504L2 to a desired location within the heart valve 108. Additionally, in certain embodiments, the catheter 502 and / or balloon assembly 504 may further incorporate the use of an imaging channel (not shown) configured to enable real-time imaging of the treatment site 106 (shown in FIG. 5A ) during positioning of the balloon assembly 504 and also during application of the therapeutic procedure.

[0113] Additionally, balloon 504A can have a balloon wall 530 defining a balloon interior 546 and configured to receive balloon fluid 532 (shown in FIG. 5A) within balloon interior 546. It will be appreciated that by using balloon 504A having a multi-lobe design with a single balloon interior 546, each of the balloon lobes 504L1, 504L2 will receive balloon fluid 532 substantially simultaneously. Thus, balloon 504A, and thus each of the balloon lobes 504L1, 504L2, can be selectively inflated with balloon fluid 532 to expand from a deflated state to an inflated state (as shown in FIG. 5B).

[0114] 5B also shows multiple energy guides 522A. A portion, i.e., a distal guide end 522D, of each energy guide 522A can be positioned in the balloon fluid 532 within the balloon interior 546 of one of the balloon lobes 504L1, 504L2, and 504L3, such that each balloon lobe 504L1, 504L2 has at least one distal guide end 522D of the energy guide 522A. More specifically, in this embodiment, the catheter system 500 has two energy guides 522A, and the distal guide end 522D of each of the two energy guides 522A is positioned in the balloon fluid 532 within the balloon interior 546 of a different balloon lobe 504L1, 504L2. In one non-exclusive example, the guide distal ends 522D of two energy guides 522A can be substantially evenly spaced about 180 degrees from each other around the guide shaft 518. Alternatively, the catheter system 500 can have four or more energy guides 522A, where the guide distal end 522D of at least one energy guide 522A is positioned within each balloon lobe 504L1, 504L2.

[0115] The energy guides 522A are configured to guide energy from the energy source 124 (shown in FIG. 1 ) to induce plasma formation in the balloon fluid 532 within the balloon interior 546 of each balloon lobe 504L1, 504L2, for example, via a plasma generator 533 located at or near the guide distal end 522D of each energy guide 522A. The plasma formation causes rapid bubble formation, applying pressure waves and / or fracture forces onto the treatment site 106. Such pressure waves and / or fracture forces are utilized to disrupt the vascular lesion 106A (shown in FIG. 5A ) at specific, precise locations within the heart valve 108 at the treatment site 106. More specifically, by selectively positioning the balloon assembly 504 adjacent the treatment site 106, the energy guides 522A within each balloon lobe 504L1, 504L2 can be applied to disrupt the calcified vascular lesion 106A at different precise locations at the treatment site 106.

[0116] It will be appreciated that by using a balloon 504A having two separate balloon lobes 504L1, 504L2 to apply pressure waves and / or fracture forces to specific locations within the heart valve 108, as shown in FIG. 5B, there will be sufficient spacing 560 available between the contours of the balloon lobes 504L1, 504L2 and within the heart valve 108 to allow for continued blood flow while applying the therapeutic treatment.

[0117] 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 content and / or context clearly dictates otherwise.

[0118] It should also be noted that the phrase "configured to," as used herein and in the appended claims, describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or to assume a particular configuration. The phrase "configured to" may be used interchangeably with other similar phrases, such as arranged and configured, constructed and arranged, and constructed, manufactured, and arranged.

[0119] The headings used herein are provided to conform to the spirit of 37 CFR 1.77 or to provide organizational direction. These headings should not be considered to limit or characterize the invention(s) governing any claim that may issue from this disclosure. For example, a description of a technology in the "Background" section is not an admission that the technology is prior art to any invention(s) in this disclosure. Also, a "Summary" or "Abstract" should not be considered a feature of the invention(s) described in any claim that may issue.

[0120] The examples 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 examples are chosen and described to enable those skilled in the art to appreciate and understand the principles and practices. Accordingly, aspects have been described with reference to various specific and preferred examples and techniques. However, it should be understood that many variations and modifications can be made while remaining within the spirit and scope of the description.

[0121] Although many different embodiments of catheter systems have been shown and described herein, it will be understood that one or more features of any one embodiment may be combined with one or more features of one or more of the other embodiments, so long as the combination meets the intent of the present invention.

[0122] While numerous exemplary aspects and embodiments of the catheter system have been discussed above, those skilled in the art will recognize certain modifications, permutations, additions, and subcombinations thereof. Accordingly, the following appended claims, as well as the claims set forth hereinafter, are intended to be construed to include all such modifications, permutations, additions, and subcombinations that fall within the true spirit and scope of the present invention, and are not intended to be limited to only the details of construction or design shown herein.

Claims

1. 1. A catheter system for treating a vascular lesion within or adjacent to a heart valve within a patient's body, comprising: a plurality of energy guides configured to receive energy from an energy source; a balloon assembly including a multi-lobe balloon including a plurality of balloon lobes each positionable substantially adjacent the vascular lesion, the balloon having a balloon wall defining a balloon interior, the balloon configured to retain a balloon fluid within the balloon interior in each of the plurality of balloon lobes; a portion of at least one of the plurality of energy guides that receives the energy from the energy source is positioned within the interior of the balloon of each of the plurality of balloon lobes so as to form a plasma in the balloon fluid within the balloon.

2. The catheter system of claim 1 , further comprising a guide shaft, wherein the balloon assembly surrounds the guide shaft.

3. The catheter system of claim 2 , wherein a distal balloon end of the multi-lobe balloon is coupled to the guide shaft.

4. 3. The catheter system of claim 1, wherein the heart valve includes a valve wall, and at least one of the plurality of balloon lobes is positioned adjacent to the valve wall.

5. 3. The catheter system of claim 1, wherein the heart valve includes a plurality of leaflets, and at least one of the plurality of balloon lobes is positioned adjacent to at least one of the plurality of leaflets.

6. 3. The catheter system of claim 1, wherein the balloon is selectively inflatable with the balloon fluid to expand to an inflated state, and wherein when the balloon is in the inflated state, the balloon wall of each of the plurality of balloon lobes is configured to be positioned substantially adjacent the vascular lesion.

7. 3. The catheter system according to claim 1, further comprising a plurality of plasma generators, wherein a particular plasma generator among the plurality of plasma generators is positioned near a guide distal end of each of the plurality of energy guides, and the particular plasma generator is configured to generate the plasma in the balloon fluid within the balloon interior of each of the plurality of balloon lobes.

8. 8. The catheter system of claim 7, wherein the guide distal end of at least one energy guide of the plurality of energy guides is configured to be positioned within the balloon interior of one balloon lobe of the plurality of balloon lobes at approximately a midpoint of the heart valve.

9. 3. The catheter system of claim 1, wherein the plasma formation is configured to induce rapid bubble formation and exert a pressure wave on the balloon wall of each of the balloon lobes adjacent the vascular lesion.

10. The catheter system of claim 1 or 2, further comprising an energy source (124) configured to generate energy.

11. 11. The catheter system of claim 10, wherein the energy source generates pulses of energy that are guided along each of the plurality of energy guides into the balloon interior of each balloon lobe to induce the plasma formation in the balloon fluid within the balloon interior of each balloon lobe.

12. 11. The catheter system of claim 10, wherein the energy source is a laser source that provides pulses of laser energy or a high-voltage energy source that provides pulses of high voltage, and at least one energy guide of the plurality of energy guides includes an electrode pair including spaced apart electrodes that extend into the interior of the balloon, and the high-voltage pulses from the energy source are applied to the electrodes to form an electric arc between the electrodes.

13. The catheter system according to claim 1 or 2, further comprising a catheter shaft, wherein a balloon proximal end of the balloon is coupled to the catheter shaft.

14. the guide shaft is at least partially disposed within the catheter shaft, the guide shaft defining a guidewire lumen; the catheter system further comprising a guidewire positioned to extend through the guidewire lumen; 14. The catheter system of claim 13, wherein the guidewire is configured to guide movement of the balloon assembly to position each of the plurality of balloon lobes substantially adjacent the vascular lesion.

15. 3. The catheter system of claim 1, wherein at least one of the balloon and each of the balloon lobes is independently steerable.

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