WO2025144394A1

WO2025144394A1 - Balloon with emitter for intravascular lithotripsy device

Info

Publication number: WO2025144394A1
Application number: PCT/US2023/085996
Authority: WO
Inventors: Christopher A. Cook; Eric Schultheis
Original assignee: Bolt Medical Inc
Current assignee: Bolt Medical Inc
Priority date: 2023-12-27
Filing date: 2023-12-27
Publication date: 2025-07-03
Anticipated expiration: 2026-06-27

Abstract

An energy director (1055) for a catheter system (100) for treating a treatment site (106) within or adjacent to a vessel wall (108A) or heart valve within a body (107) of a patient (109). The catheter system (100) includes an energy source (124) that generates energy, a balloon (104) having a balloon distal region (1004DR) that has a varying diameter, and a balloon proximal region (1004PR) having a substantially constant diameter, and an energy guide (122A) including a guide distal end (122D), the energy guide (122A) being configured to receive the energy from the energy source (124). The energy director (1055) can include a guide sleeve (1057) that is secured to the energy guide (122), the guide sleeve at least partially (1057) encircling the guide distal end (122D) of the energy guide (122A). The guide sleeve (1057) extends distally from the guide distal end (122D) in a direction toward the balloon distal region (1004DR).

Description

BALLOON WITH EMITTER FOR INTRAVASCULAR LITHOTRIPSY DEVICE

BACKGROUND

Vascular lesions within vessels in the body can be associated with an increased risk for major adverse events, such as myocardial infarction, embolism, deep vein thrombosis, stroke, and the like. Severe vascular lesions, such as severely calcified vascular lesions, can be difficult to treat and achieve patency for a physician in a clinical setting.

Vascular lesions may be treated using interventions such as drug therapy, balloon angioplasty, atherectomy, stent placement, and vascular graft bypass, to name a few. Such interventions may not always be ideal or require subsequent treatment to address the lesion.

Lithoplasty is one method that has been recently used with some success for breaking up vascular lesions within vessels in the body. Lithoplasty utilizes a combination of pressure waves and bubble dynamics that are generated intravascularly in a fluid-filled balloon catheter. In particular, during a lithoplasty treatment, a high energy source is used to generate plasma and, ultimately, pressure waves, as well as a rapid bubble expansion within a fluid-filled balloon to crack calcification at a treatment site within the vasculature that includes one or more vascular lesions. The associated rapid bubble formation from the plasma initiation and resulting localized fluid velocity within the balloon transfers mechanical energy through the incompressible fluid to impart a fracture force on the intravascular calcium, which is opposed to the balloon wall. The rapid change in fluid momentum upon hitting the balloon wall is known as hydraulic shock, or water hammer.

It is desired to more accurately and precisely direct and/or concentrate energy generated within the fluid-filled balloon so as to impart pressure onto and induce fractures in vascular lesions at a treatment site within or adjacent to a blood vessel wall. There is an ongoing desire to enhance vessel patency and optimization of therapy delivery parameters within a lithoplasty catheter system.

SUMMARY

The present invention is directed toward an energy director for a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve within a body of a patient, the catheter system including (i) an energy source that generates energy, (ii) a balloon having a balloon distal region that has a varying diameter, and a balloon proximal region having a substantially constant diameter, and (iii) an energy guide including a guide distal end, the energy guide being configured to receive the energy from the energy source. In various embodiments, the energy director includes a guide sleeve that is secured to the energy guide, the guide sleeve at least partially encircling the guide distal end of the energy guide, the guide sleeve extending distally from the guide distal end in a direction toward the balloon distal region, the guide sleeve directing the energy received by the energy guide so that the energy generates a plasma in the direction toward the balloon distal region.

In some embodiments, the guide sleeve is at least partially formed from one of a metal, a ceramic, and a polymer.

In various embodiments, the guide sleeve has a sleeve inner diameter that is substantially constant.

In certain embodiments, the guide sleeve has a sleeve inner diameter and the energy guide has a guide outer diameter that is approximately equal to the sleeve inner diameter.

In some embodiments, the guide sleeve has a sleeve inner diameter that defines a sleeve interior, the energy guide being configured to guide the energy so that the energy diverges within the sleeve interior of the guide sleeve and contacts the guide sleeve so that the plasma is initiated within the sleeve interior of the guide sleeve.

In various embodiments, the guide sleeve includes a sleeve wall including a sleeve opening that is in fluid communication with a balloon interior of the balloon.

In certain embodiments, the sleeve opening includes a port formed into the sleeve wall. In some embodiments, the sleeve opening includes a notch formed into the sleeve wall at the sleeve distal end.

In various embodiments, the guide sleeve includes a sleeve distal end, the sleeve distal end being positioned in the balloon proximal region.

The present invention is also directed toward an energy director for a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve within a body of a patient, the catheter system including (i) an energy source that generates energy, (ii) a balloon having a balloon distal region that has a varying diameter, and a balloon proximal region having a substantially constant diameter, and (iii) an energy guide including a guide distal end, the energy guide being configured to receive the energy from the energy source, the energy director includes a guide sleeve that is secured to the energy guide, the guide sleeve at least partially encircling the guide distal end of the energy guide, the guide sleeve extending distally from the guide distal end in a direction toward the balloon distal region, the guide sleeve including a sleeve distal end that is positioned in the balloon proximal region.

In certain embodiments, the guide sleeve directs the energy received by the energy guide so that the energy generates a plasma in the direction toward the balloon distal region.

In some embodiments, the guide sleeve is at least partially formed from one of a metal, a ceramic, and/or a polymer.

In various embodiments, the guide sleeve has a sleeve inner diameter and the energy guide has a guide outer diameter, the sleeve inner diameter being approximately equal to the guide outer diameter.

In certain embodiments, the energy guide guides the energy so that the energy diverges within a sleeve interior of the guide sleeve.

In some embodiments, the energy contacting the guide sleeve initiates a plasma within a sleeve interior of the guide sleeve.

The present invention is further directed toward an energy director for a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve within a body of a patient, the catheter system including (i) an energy source that generates energy, (ii) a balloon having a balloon distal region that has a varying diameter, a balloon proximal region having a substantially constant diameter, and (iii) an energy guide including a guide distal end and a guide outer diameter, the energy guide being configured to receive the energy from the energy source, In various embodiments, the energy director includes a guide sleeve that is secured to the energy guide. The guide sleeve includes a sleeve inner diameter that is substantially the same as the guide outer diameter. The guide sleeve includes a sleeve wall and a sleeve distal end. The guide sleeve at least partially encircling the guide distal end of the energy guide. The guide sleeve extending distally from the guide distal end in a direction toward the balloon distal region. The guide sleeve directs the energy received by the energy guide so that the energy generates a plasma in the direction toward the balloon distal region. The sleeve distal end being positioned in the balloon proximal region. The sleeve wall includes a sleeve opening that is in fluid communication with the balloon interior.

The guide sleeve includes a sleeve distal end and a sleeve inner diameter that is substantially the same as the guide outer diameter. The guide sleeve encircles the guide distal end of the energy guide and extends distally from the guide distal end in a direction toward the balloon distal region. The guide sleeve directs energy received by the energy guide so that the energy generates a plasma in the direction toward the balloon distal region. The sleeve distal end is positioned in the balloon proximal region. The guide sleeve includes a sleeve opening that is in fluid communication with the balloon interior.

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

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of this invention, as well as the invention 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 similar reference characters refer to similar parts, and in which:

Figure 1 is a schematic cross-sectional view of an embodiment of a catheter system in accordance with various embodiments, the catheter system including an energy guide and an energy director including a guide sleeve;

Figure 2 is a schematic cross-sectional view of a portion of an embodiment of the catheter system including the energy director including the guide sleeve;

Figure 3 is a schematic cross-sectional view of a portion of the energy guide and another embodiment of the energy director including the guide sleeve;

Figure 4A is a schematic cross-sectional view of a portion of the energy guide and another embodiment of the guide sleeve, shown at a time before energy is emitted by the energy guide;

Figure 4B is a schematic cross-sectional view of a portion of the energy guide and the embodiment of the guide sleeve illustrated in Figure 4A, shown at a time after energy beams are guided away from the energy guide into the guide sleeve;

Figure 4C is a schematic cross-sectional view of a portion of the energy guide and the embodiment of the guide sleeve illustrated in Figure 4A, shown at a time when a plasma is formed in a sleeve interior of the guide sleeve and acoustic pressure waves are directed away from the guide sleeve;

Figure 4D is a schematic cross-sectional view of a portion of the energy guide and the embodiment of the guide sleeve illustrated in Figure 4A, shown at a time when a plasma bubble is formed away from the sleeve distal end;

Figure 5 is a schematic cross-sectional view of a portion of the energy guide and still another embodiment of the guide sleeve; Figure 6 is a schematic cross-sectional view of a portion of the energy guide and yet another embodiment of the guide sleeve; and

Figure 7 is a schematic cross-sectional view of a portion of the energy guide and still yet another embodiment of the guide sleeve.

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

DESCRIPTION

Treatment of vascular lesions can reduce major adverse events or death in affected subjects. As referred to herein, a major adverse event is one that can occur anywhere within the body due to the presence of a vascular lesion. Major adverse events can include, but are not limited to, major adverse cardiac events, major adverse events in the peripheral or central vasculature, major adverse events in the brain, major adverse events in the musculature, or major adverse events in any of the internal organs.

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

In certain embodiments, the catheter systems and related methods utilize an energy source, e.g., a light source such as a laser source or another suitable energy source, which provides energy that is guided by one or more energy guides, e.g., light guides such as optical fibers, which are disposed along the catheter shaft and within the balloon interior of the balloon to create a localized plasma in the catheter fluid that is retained within the balloon interior of the balloon. As such, the energy guide can sometimes be referred to as, or can be said to incorporate a "plasma generator" at or near a guide distal end of the energy guide that is positioned within the balloon interior of the balloon located at the treatment site. The creation of the localized plasma can initiate a pressure wave and can initiate the rapid formation of one or more bubbles that can rapidly expand to a maximum size and then dissipate through a cavitation event that can launch a pressure wave upon collapse. The rapid expansion of the plasma-induced bubbles (also sometimes referred to simply as "plasma bubbles") can generate one or more pressure waves within the catheter fluid retained within the balloon interior of the balloon and thereby impart pressure waves onto and induce fractures in the vascular lesions at the treatment site within or adjacent to the blood vessel wall within the body of the patient. In some embodiments, the energy source can be configured to provide submillisecond pulses of energy, e.g., light energy, to initiate the plasma formation in the catheter fluid within the balloon to cause the rapid bubble formation and to impart the pressure waves upon the balloon wall at the treatment site. Thus, the pressure waves can transfer mechanical energy through an incompressible catheter fluid to the treatment site to impart a fracture force on the intravascular lesion. Without wishing to be bound by any particular theory, it is believed that the rapid change in catheter fluid momentum upon the balloon wall that is in contact with the intravascular lesion is transferred to the intravascular lesion to induce fractures to the lesion.

Importantly, the catheter systems and related methods disclosed herein further include an energy director, including a guide sleeve that is positioned within the balloon and that is coupled to and/or secured to the energy guide. The guide sleeve is configured to direct and/or concentrate energy generated within the catheter fluid that is retained within the balloon, and is at least partially retained within the guide sleeve, so as to impart pressure onto and induce fractures in the vascular lesion at the treatment site within or adjacent to the blood vessel. More particularly, the guide sleeve directs and/or concentrates acoustic and mechanical energy produced by a lithoplasty device, such as a laser-driven pressure wave generating device, to impart pressure onto and induce fractures in the vascular lesion (including those in total and/or partial occlusions/blockages) at the treatment site within or adjacent to the blood vessel within the body of the patient.

As used herein, the terms "intravascular lesion" and "vascular lesion" are used interchangeably unless otherwise noted. As such, the intravascular lesions and/or the 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 present invention will readily suggest themselves to such skilled persons having the benefit of this disclosure. Reference will now be made in detail to implementations of the present invention, as illustrated in the accompanying drawings. The same or similar nomenclature and/or reference indicators will be used throughout the drawings, and the following detailed description to refer to the same or like parts.

In the interest of clarity, not all of the routine features of the implementations described herein are shown and described. It is appreciated that in the development of any such actual implementation, numerous implementation-specific decisions must be made in order to achieve the developer's 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 is recognized 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 can include many different forms. Referring now to Figure 1 , a schematic cross-sectional view is shown of a catheter system 100 in accordance with various embodiments. The catheter system 100 is suitable for imparting pressure waves to induce fractures in one or more vascular lesions within or adjacent to a vessel wall of a blood vessel. In the embodiment illustrated in Figure 1 , the catheter system 100 can include one or more of a catheter 102, an energy guide bundle 122 including one or more energy guides 122A, a fluid pump 138, a system console 123 including one or more of an energy source 124, a power source 125, a system controller 126, and a graphic user interface 127 (a "GUI"), a handle assembly 128, and an energy director 155. Alternatively, the catheter system 100 can have more components or fewer components than those specifically illustrated and described in relation to Figure 1.

The catheter 102 is configured to move to a treatment site 106 within or adjacent to a vessel wall 108A of a blood vessel 108 within a body 107 of a patient 109. The treatment site 106 can include one or more vascular lesions 106A, such as calcified vascular lesions, for example. Additionally, or in the alternative, the treatment site 106 can include vascular lesions 106A, such as fibrous vascular lesions.

The catheter 102 can include an inflatable balloon 104 (sometimes referred to herein simply as a "balloon"), a catheter shaft 110, and a guidewire 112. The balloon 104 can be coupled to the catheter shaft 110. The balloon 104 can include a balloon proximal end 104P and a balloon distal end 104D. The catheter shaft 110 can 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 can include a longitudinal axis 144. The catheter shaft 110 can also include a guidewire lumen (not shown) which is configured to move over the guidewire 112. As utilized herein, the guidewire lumen (not shown) defines a conduit through which the guidewire 112 extends. The catheter shaft 110 can further include an inflation lumen (not shown) and/or various other lumens for various other purposes. In some embodiments, the catheter 102 can have a distal end opening (not shown) and can accommodate and be tracked over the guidewire 112 as the catheter 102 is moved and positioned at or near the treatment site 106.

The balloon 104 includes a balloon wall 130 that defines a balloon interior 146. The balloon 104 can be selectively inflated with a catheter fluid 132 to expand from a deflated state suitable for advancing the catheter 102 through a patient's vasculature, to an inflated state (as shown in Figure 1 ) suitable for anchoring the catheter 102 in position relative to the treatment site 106. Stated in another manner, when the balloon 104 is in the inflated state, the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. It is appreciated that although Figure 1 illustrates the balloon wall 130 of the balloon 104 being shown spaced apart from the treatment site 106 of the blood vessel 108 when in the inflated state, this is done for ease of illustration. It is recognized that the balloon wall 130 of the balloon 104 will typically be substantially directly adjacent to and/or abutting the treatment site 106 when the balloon 104 is in the inflated state. The balloon 104 suitable for use in the catheter system 100 includes those that can be passed through the vasculature of a patient when in the deflated state. In some embodiments, the balloons 104 are made from silicone. In other embodiments, the balloon 104 can be made from materials such as polydimethylsiloxane (PDMS), polyurethane, polymers such as PEBAX™ material, nylon, or any other suitable material.

The balloon 104 can have any suitable diameter (in the inflated state). In various embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from less than one millimeter (mm) up to 25 mm. In some embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from at least 1 .5 mm up to 14 mm. In some embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from at least two mm up to five mm.

In some embodiments, the balloon 104 can have a length ranging from at least three mm to 300 mm. More particularly, in some embodiments, the balloon 104 can have a length ranging from at least eight mm to 200 mm. It is appreciated that a balloon 104 having a relatively longer length can be positioned adjacent to larger treatment sites 106, and, thus, may be usable for imparting pressure waves onto and inducing fractures in larger vascular lesions 106A or multiple vascular lesions 106A at precise locations within the treatment site 106. It is further appreciated that a longer balloon 104 can also be positioned adjacent to multiple treatment sites 106 at any one given time.

The balloon 104 can be inflated to inflation pressures of between approximately one atmosphere (atm) and 70 atm. In some embodiments, the balloon 104 can be inflated to inflation pressures of from at least 20 atm to 60 atm. In other embodiments, the balloon 104 can be inflated to inflation pressures of from at least six atm to 20 atm. In still other embodiments, the balloon 104 can be inflated to inflation pressures of from at least three atm to 20 atm. In yet other embodiments, the balloon 104 can be inflated to inflation pressures of from at least two atm to ten atm.

The balloon 104 can have various shapes, including, but not to be limited to, a conical shape, a square shape, a rectangular shape, a spherical shape, a conical/square shape, a conical/spherical shape, an extended spherical shape, an oval shape, a tapered shape, a bone shape, a stepped diameter shape, an offset shape, or a conical offset shape. In some embodiments, the balloon 104 can include a drug eluting coating or a drug eluting stent structure. The drug eluting coating or drug eluting stent can include one or more therapeutic agents including anti-inflammatory agents, anti-neoplastic agents, anti-angiogenic agents, and the like.

The catheter fluid 132 can be a liquid or a gas. Some examples of the catheter fluid 132 suitable for use can include, but are not limited to one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases, such as carbon dioxide, or any other suitable catheter fluid 132. In some embodiments, the catheter fluid 132 can be used as a base inflation fluid. In some embodiments, the catheter fluid 132 can include a mixture of saline to contrast medium in a volume ratio of approximately 50:50. In other embodiments, the catheter fluid 132 can include a mixture of saline to contrast medium in a volume ratio of approximately 25:75. In still other embodiments, the catheter fluid 132 can include a mixture of saline to contrast medium in a volume ratio of approximately 75:25. However, it is understood that any suitable ratio of saline to contrast medium can be used. The catheter fluid 132 can be tailored on the basis of composition, viscosity, and the like so that the rate of travel of the pressure waves are appropriately manipulated. In certain embodiments, the catheter fluids 132 suitable for use are biocompatible. A volume of catheter fluid 132 can be tailored by the chosen energy source 124 and the type of catheter fluid 132 used.

In certain embodiments, the catheter fluid 132 can include a wetting agent or surface-active agent (surfactant). These compounds can lower the tension between solid and liquid matter. These compounds can act as emulsifiers, dispersants, detergents, and water infiltration agents. Wetting agents or surfactants reduce surface tension of the liquid and allow it to fully wet and come into contact with optical components (such as the energy guide(s) 122A) and mechanical components (such as the guide sleeve 157). This reduces or eliminates the accumulation of bubbles and pockets or inclusions of gas within the guide sleeve 157. Nonexclusive examples of chemicals that can be used as wetting agents include, but are not limited to, Benzalkonium Chloride, Benzethonium Chloride, Cetylpyridinium Chloride, Poloxamer 188, Poloxamer 407, Polysorbate 20, Polysorbate 40, and the like. Non-exclusive examples of surfactants can include but are not limited to, ionic and non-ionic detergents, and Sodium stearate. Another suitable surfactant is 4-(5-dodecyl) benzenesulfonate. Other examples can include docusate (dioctyl sodium sulfosuccinate), alkyl ether phosphates, and perfluorooctanesulfonate (PFOS), to name a few.

By using a wetting agent or surfactant, direct liquid contact with the energy guide 122A allows the energy to be more efficiently converted into a plasma. Further, using the wetting agent or surfactant with the small dimensions of the optical and mechanical components used in the guide sleeve 157 and other parts of the catheter 102, it is less difficult to achieve greater (or complete) wetting. Decreasing the surface tension of the liquid can decrease the difficulty for such small structures to be effectively wetted by the liquid and therefore be nearly or completely immersed. By reducing or eliminating air or other gas bubbles from adhering to the optical and mechanical structure and energy guides 122A, considerable increase in efficiency of the device can occur.

The specific percentage of the wetting agent or surfactant can be varied to suit the design parameters of the catheter system 100 and/or the guide sleeve 157 being used. In one embodiment, the percentage of the wetting agent or surfactant can be less than approximately 50% by volume of the catheter fluid 132. In non-exclusive alternative embodiments, the percentage of the wetting agent or surfactant can be less than approximately 40%, 30%, 20%, 10%, 5%, 2%, 1 %, 0.1%, or 0.01 % by volume of the catheter fluid 132. Still, alternatively, the percentage of the wetting agent or surfactant can fall outside of the foregoing ranges.

In some embodiments, the contrast agents used in the contrast media can include, but are not to be limited to, iodine-based contrast agents, such as ionic or non-ionic iodine-based contrast agents. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, metrizoate, iothalamate, and ioxaglate. Some non-limiting examples of non-ionic iodine-based contrast agents include iopam idol, 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 (lll)-based contrast agents. Suitable fluorocarbon and perfluorocarbon agents can include, but are not to be limited to, agents such as the perfluorocarbon dodecafluoropentane (DDFP, C5F12).

The catheter fluids 132 can include those that include absorptive agents that can selectively absorb light in the ultraviolet region (e.g., at least ten nanometers (nm) to 400 nm), the visible region (e.g., at least 400 nm to 780 nm), or the near-infrared region (e.g., at least 780 nm to 2.5 pm) of the electromagnetic spectrum. Suitable absorptive agents can include those with absorption maxima along the spectrum from at least ten nm to 2.5 pm. Alternatively, the catheter fluids 132 can include those that include absorptive agents that can selectively absorb light in the mid-infrared region (e.g., at least 2.5 pm to 15 pm) or the far-infrared region (e.g., at least 15 pm to one mm) of the electromagnetic spectrum. In various embodiments, the absorptive agent can be those that have an absorption maximum matched with the emission maximum of the laser used in the catheter system 100. By way of non-limiting examples, various lasers usable in the catheter system 100 can include neodymium:yttrium-aluminum-garnet (Nd:YAG - emission maximum = 1064 nm) lasers, holmium:YAG (Ho:YAG - emission maximum = 2.1 pm) lasers, or erbiurmYAG (Er:YAG - emission maximum = 2.94 pm) lasers. In some embodiments, the absorptive agents can be water-soluble. In other embodiments, the absorptive agents are not water-soluble. In some embodiments, the absorptive agents used in the catheter fluids 132 can be tailored to match the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths of at least ten nanometers to one millimeter are discussed elsewhere herein.

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

In some embodiments, the catheter shaft 110 can be coupled to multiple energy guides 122A, such as a first energy guide, a second energy guide, a third energy guide, etc., which can be disposed at any suitable positions about the guidewire lumen (not shown) and/or the catheter shaft 110. For example, in certain non-exclusive embodiments, two energy guides 122A can be spaced apart by approximately 180 degrees about the circumference of the guidewire lumen (not shown) and/or the catheter shaft 110; three energy guides 122A can be spaced apart by approximately 120 degrees about the circumference of the guidewire lumen (not shown)and/or the catheter shaft 110; or four energy guides 122A can be spaced apart by approximately 90 degrees about the circumference of the guidewire lumen (not shown)and/or the catheter shaft 110. Still, alternatively, multiple energy guides 122A need not be uniformly spaced apart from one another about the circumference of the guidewire lumen (not shown) and/or the catheter shaft 110. More particularly, it is further appreciated that the energy guides 122A can be disposed of uniformly or non-uniformly about the guidewire lumen (not shown) and/or the catheter shaft 110 to achieve the desired effect in the desired locations.

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

The energy guides 122A can have any suitable design for purposes of generating plasma and/or pressure waves in the catheter fluid 132 within the balloon interior 146. Thus, the general description of the energy guides 122A as light guides is not intended to be limiting in any manner, except for as set forth in the claims appended hereto. More particularly, although the catheter systems 100 are often described with the energy source 124 as a light source, and the one or more energy guides 122A as light guides, the catheter system 100 can alternatively include any suitable energy source 124 and energy guides 122A for purposes of generating the desired plasma in the catheter fluid 132 within the balloon interior 146. For example, in one non-exclusive alternative embodiment, the energy source 124 can be configured to provide high voltage pulses, and each energy guide 122A can include an electrode pair including spaced apart electrodes that extend into the balloon interior 146. In such embodiment, each pulse of high voltage is applied to the electrodes and forms an electrical arc across the electrodes, which, in turn, generates the plasma and forms the pressure waves within the catheter fluid 132 that are utilized to provide the fracture force onto the vascular lesions 106A at the treatment site 106. Still, alternatively, the energy source 124 and/or the energy guides 122A can have another suitable design and/or configuration. In certain embodiments, the energy guides 122A can include an optical fiber or flexible light pipe. The energy guides 122A can be thin and flexible and can allow light signals to be sent with very little loss of strength. The energy guides 122A can include a core surrounded by a cladding about its circumference. In some embodiments, the core can be a cylindrical core or a partially cylindrical core. The core and cladding of the energy guides 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 guides 122A may also include a protective coating, such as a polymer. It is appreciated that the index of refraction of the core will be greater than the index of refraction of the cladding.

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

The energy guides 122A can assume many configurations about and/or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the energy guides 122A can run parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guides 122A can be physically coupled to the catheter shaft 110. In other embodiments, the energy guides 122A can be disposed along a length of an outer diameter of the catheter shaft 110. In yet other embodiments, the energy guides 122A can be disposed within one or more energy guide lumens within the catheter shaft 110.

The energy guides 122A can also be disposed at any suitable positions about the circumference of the guidewire lumen (not shown)and/or the catheter shaft 110, and the guide distal end 122D of each of the energy guides 122A can be disposed at any suitable longitudinal position relative to the length of the balloon 104 and/or relative to the length of the guidewire lumen 118.

Additionally, or in the alternative, in certain embodiments, diverting features that can be incorporated into the energy guides 122A, can also be incorporated into the design of the guide sleeve 157 for purposes of directing and/or concentrating acoustic and mechanical energy toward specific areas of the balloon wall 130 in contact with the vascular lesions 106A at the treatment site 106 to impart pressure onto and induce fractures in such vascular lesions 106A. The source manifold 136 can be positioned at or near the distal portion 114 of the catheter system 100. The source manifold 136 can include one or more proximal end openings that can receive the one or more energy guides 122A of the energy guide bundle 122, the guidewire 112, and/or an inflation conduit 140 that is coupled in fluid communication with the fluid pump 138. The catheter system 100 can also include the fluid pump 138 that is configured to inflate the balloon 104 with the catheter fluid 132, i.e., via the inflation conduit 140, as needed.

As noted above, in the embodiment illustrated in Figure 1 , the system console 123 includes one or more of the energy source 124, the power source 125, the system controller 126, and the GUI 127. Alternatively, the system console 123 can include more components or fewer components than those specifically illustrated in Figure 1 . For example, in certain non-exclusive alternative embodiments, the system console 123 can 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 can be provided within the catheter system 100 without the specific need for the system console 123.

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

The energy guide bundle 122 can also include a guide bundler 152 (or "shell") that brings each of the individual energy guides 122A closer together so that the energy guides 122A and/or the energy guide bundle 122 can be in a more compact form as it extends with the catheter 102 into the blood vessel 108 during use of the catheter system 100.

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

The energy source 124 can have any suitable design. In certain embodiments, the energy source 124 can be configured to provide sub-millisecond pulses of energy from the energy source 124 that are focused onto a small spot in order to couple it into the guide proximal end 122P of the energy guide 122A. Such pulses of energy are then directed and/or guided along the energy guides 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation in the catheter fluid 132 within the balloon interior 146 of the balloon 104. In particular, the energy emitted at the guide distal end 122D of the energy guide 122A energizes to form the plasma within the catheter fluid 132 within the balloon interior 146. The plasma formation causes rapid bubble formation, and imparts pressure waves upon the treatment site 106.

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

It is appreciated that although the energy source 124 is typically utilized to provide pulses of energy, the energy source 124 can still be described as providing a single source beam 124A, i.e., a single pulsed source beam.

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

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

Exemplary nanosecond lasers can include those within the UV to IR spectrum, spanning wavelengths of about ten nanometers (nm) to one millimeter (mm). In some embodiments, the energy sources 124 suitable for use in the catheter systems 100 can include those capable of producing light at wavelengths of from at least 750 nm to 2000 nm. In other embodiments, the energy sources 124 can include those capable of producing light at wavelengths of from at least 700 nm to 3000 nm. In still other embodiments, the energy sources 124 can include those capable of producing light at wavelengths of from at least 100 nm to ten micrometers (pm). Nanosecond lasers can include those having repetition rates of up to 200 kHz. In some embodiments, the laser can include a Q-switched thulium:yttrium-aluminum-garnet (Tm:YAG) laser. In other embodiments, the laser can include a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser, holmium:yttrium-aluminum-garnet (Ho:YAG) laser, erbiumyttrium-aluminum- garnet (ErYAG) laser, excimer laser, helium-neon laser, carbon dioxide laser, as well as doped, pulsed, fiber lasers.

The catheter system 100 can generate pressure waves having maximum pressures in the range of at least one 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 bubble expansion, the propagation medium, the balloon material, and other factors. In various non-exclusive alternative embodiments, the catheter systems 100 can generate pressure waves having maximum pressures in the range of at least approximately two MPa to 50 MPa, at least approximately two MPa to 30 MPa, or approximately at least 15 MPa to 25 MPa.

The pressure waves can be imparted upon the treatment site 106 from a distance within a range from at least approximately 0.1 millimeters (mm) to greater than approximately 25 mm, extending radially from the energy guides 122A when the catheter 102 is placed at the treatment site 106. In various non-exclusive alternative embodiments, the pressure waves can be imparted upon the treatment site 106 from a distance within a range from at least approximately ten mm to 20 mm, at least approximately one mm to ten mm, at least approximately 1 .5 mm to four mm, or at least approximately 0.1 mm to ten mm extending radially from the energy guides 122A when the catheter 102 is placed at the treatment site 106. In other embodiments, the pressure waves can be imparted upon the treatment site 106 from another suitable distance that is different than the foregoing ranges. In some embodiments, the pressure waves can be imparted upon the treatment site 106 within a range of at least approximately two MPa to 30 MPa at a distance from at least approximately 0.1 mm to ten mm. In some embodiments, the pressure waves can be imparted upon the treatment site 106 from a range of at least approximately two MPa to 25 MPa at a distance from at least approximately 0.1 mm to ten mm. Still, alternatively, other suitable pressure ranges and distances can be used.

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

The system controller 126 is electrically coupled to and receives power from the power source 125. Additionally, the system controller 126 is coupled to and is configured to control operation of each of the energy source 124 and the GUI 127. The system controller 126 can include one or more processors or circuits for purposes of controlling the operation of at least the energy source 124 and the GU1 127. For example, the system controller 126 can control the energy source 124 for generating pulses of energy as desired and/or at any desired firing rate.

The system controller 126 can also be configured to control operation of other components of the catheter system 100 such as the positioning of the catheter 102 adjacent to the treatment site 106, the inflation of the balloon 104 with the catheter fluid 132, etc. Further, or in the alternative, the catheter system 100 can include one or more additional controllers that can be positioned in any suitable manner for purposes of controlling the various operations of the catheter system 100. For example, in certain embodiments, an additional controller and/or a portion of the system controller 126 can be positioned and/or incorporated within the handle assembly 128.

The GUI 127 is accessible by the user or operator of the catheter system 100. Additionally, the GU1 127 is electrically connected to the system controller 126. With such design, the GUI 127 can be used by the user or operator to ensure that the catheter system 100 is effectively utilized to impart pressure onto and induce fractures into the vascular lesions 106A at the treatment site 106. 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 static visual data and/or information to the user or operator. In addition, or in the alternative, the GUI 127 can provide dynamic visual data and/or information to the user or operator, such as video data or any other data that changes over time during the use of the catheter system 100. In various embodiments, the GUI 127 can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the user or operator. Additionally, or in the alternative, the GU1 127 can provide audio data or information to the user or operator. The specifics of the GUI 127 can vary depending upon the design requirements of the catheter system 100, or the specific needs, specifications and/or desires of the user or operator.

As shown in Figure 1 , the handle assembly 128 can be positioned at or near the proximal portion 11 of the catheter system 100, and/or near the source manifold 136. In this embodiment, the handle assembly 128 is coupled to the balloon 104 and is positioned spaced apart from the balloon 104. Alternatively, the handle assembly 128 can be positioned at another suitable location.

The handle assembly 128 is handled and used by the user or operator to operate, position, and control the catheter 102. The design and specific features of the handle assembly 128 can vary to suit the design requirements of the catheter system 100. In the embodiment illustrated in Figure 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 an interior of the handle assembly 128. For example, as shown, in certain such embodiments, the handle assembly 128 can include circuitry 156 that can form at least a portion of the system controller 126. In one embodiment, the circuitry 156 can include a printed circuit board having one or more integrated circuits, or any other suitable circuitry. In an alternative embodiment, the circuitry 156 can be omitted, or can be included within the system controller 126, which in various embodiments can be positioned outside of the handle assembly 128, e.g., within the system console 123. It is understood that the handle assembly 128 can include fewer or additional components than those specifically illustrated and described herein.

The energy director 155 directs energy from the energy guide 122A to locations within the balloon 104 of the catheter system 100. The design of the energy director 155 can be varied. As provided herein, the energy director 155 can include a guide sleeve 157. The guide sleeve 157 directs energy received via the energy guide 122A so that the energy generates one of a plasma, a pressure wave, and an acoustic wave in the direction toward the balloon distal region 104D, indicated by an arrow 173 in Figure 1. In various embodiments, the guide sleeve 157 can be secured directly to the energy guide 122A. Alternatively, the guide sleeve 157 can be coupled or indirectly secured to the energy guide 122A. The guide sleeve 157 can at least partially, if not fully, encircle the guide distal end 122D of the energy guide 122A. In the embodiment illustrated in Figure 1 , the guide sleeve 157 can extend distally from the guide distal end 122D in a direction toward the balloon distal region 104D. The shape and size of the guide sleeve 157 can vary depending on the design requirements of the energy director 155.

The guide sleeve 157 can be in optical communication with the energy guide 122A within which it is disposed. In some embodiments, the guide sleeve 157 can be in optical communication with the guide distal end 122D of the energy guide 122A. Additionally, in such embodiments, the guide sleeve 157 can have a shape that corresponds with and/or conforms to the guide distal end 122D of the energy guide 122A.

In certain embodiments, the guide sleeve 157 disposed at the guide distal end

of the energy guide 122A. For example, in certain non-exclusive embodiments, the guide sleeve 157 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 half-circle shape, an ovoid shape, and the like.

Various alternative embodiments of the guide sleeve 157 are illustrated and described in detail herein below within subsequent Figures.

Figure 2 is a schematic cross-sectional view of a portion of an embodiment of the catheter system 200 at the distal portion 216 near the treatment site 206 of the body 207 of the patient 109 (illustrated in Figure 1 ). The design of the catheter system 200 can be varied. The catheter system 200 can include a balloon 204 having a balloon proximal end 204P and a balloon distal end 204D, the balloon 204 including a balloon wall 230, a catheter shaft 210, an energy guide 222A, a catheter fluid 232, and an energy director 255 including a guide sleeve 257. The guide sleeve 257 directs energy received via the energy guide 222A so that the energy generates one of a plasma, a pressure wave, and an acoustic wave in the direction toward the balloon distal region 204D, indicated by an arrow 273 in Figure 1 .

It is recognized that the catheter system 200 can include additional components that have been omitted from Figure 2 for clarity and ease of understanding. It is also recognized that the catheter system 200 can omit certain components illustrated in Figure 2. For example, the catheter system 200 can include certain additional components that were previously illustrated and/or described herein.

The design and function of the balloon 204, the energy guide 222A, and the energy director 255 are substantially similar to that illustrated and described previously herein. Accordingly, a detailed description of such components will not be repeated to the extent that they are similar to those previously described.

Figure 3 is a schematic cross-sectional view of a portion of the catheter system 300 including the energy guide 322A, and another embodiment of the energy director 355 including the guide sleeve 357. The design of the catheter system 300 can be varied. In the embodiment illustrated in Figure 3, the catheter system 300 can include a balloon 304, a catheter shaft 310, an energy guide 322A, a catheter fluid 332, and an energy director 355. The balloon 304 includes a balloon wall 330 that defines a balloon interior 346, a balloon proximal end 304P, and a balloon distal end 304D. The catheter fluid 332 is selectively retained and or circulated substantially within the balloon interior 346. It is recognized that the catheter system 300 can include additional components that have been omitted from Figure 3 for clarity and ease of understanding. It is also recognized that the catheter system 300 can omit certain components illustrated in Figure 3. For example, the catheter system 300 can include certain additional components that were previously illustrated and/or described herein.

The design and function of the balloon 304, the energy guide 322A, and the catheter fluid 332 are substantially similar to that illustrated and described previously herein. Accordingly, a detailed description of such components will not be repeated to the extent that they are similar to those previously described.

In some embodiments, the balloon proximal end 304P can be coupled to the catheter shaft 310, and the balloon distal end 304D can be coupled to the guidewire lumen (not shown).

In the embodiment illustrated in Figure 3, the balloon 304 can include three distinct regions: (i) a balloon pre-proximal region 304PPR having a pre-proximal region diameter 304PPRD that varies, (ii) a balloon distal region 304DR having a distal region diameter 304DRD that varies, and (iii) a balloon proximal region 304PR having a proximal region diameter 304PRD that is substantially constant. In this embodiment, the balloon proximal region 304PR is positioned between the balloon pre-proximal region 304PPR and the balloon distal region 304DR.

In an alternative embodiment, the balloon 304 can omit the balloon pre-proximal region 304PPR so that the balloon proximal region 304PR is coupled directly to the catheter shaft 310 and has a proximal region diameter 304PRD that is substantially constant from its connection at the catheter shaft 310 until the balloon proximal region 304PR transitions to the balloon distal region 304DR, at which location the balloon diameter would change. Stated another way, in this embodiment, the balloon 304 would have only two distinct regions: the balloon proximal region 304PR having a proximal region diameter 304PRD that is substantially constant, and the balloon distal region 304DR having a distal region diameter 304DRD that varies. The guide sleeve 357 includes a sleeve distal end 357D and a sleeve interior 365. The sleeve distal end 357D is positioned distally relative to the guide distal end 322D. The sleeve interior 365 is positioned proximally relative to the sleeve distal end 357D and is defined by a space within the guide sleeve 357 and bounded by the guide distal end 322D and the sleeve distal end 357D. The sleeve distal end 357 includes at least one opening that allows the sleeve interior 365 to be in fluid communication with the catheter fluid 332 inside of the balloon interior 346. In the embodiment illustrated in Figure 3, the sleeve distal end 357D is positioned within the balloon proximal region 304PR of the balloon interior 346. In alternative embodiments, the sleeve distal end 357D can be positioned within the balloon distal region 304DR or the balloon pre-proximal region 304PPR of the balloon interior 346. Dashed line 357DL in Figure 3 illustrates that the sleeve distal end 357D is positioned within the balloon proximal region 304PR.

In the embodiment illustrated in Figure 3, the guide sleeve 357 can have a substantially tubular and/or cylindrical shape. Alternatively, the guide sleeve 357 can have a different configuration. The guide sleeve 357 can be at least partially formed at least partially from one or more of a metal, a ceramic, a composite material, and/or a polymer.

Figure 4A is a schematic cross-sectional view of a portion of the energy guide 422A and another embodiment of the guide sleeve 457 of the catheter system 400, shown at a time before energy is emitted by the energy guide 422A. As illustrated in Figure 4A, the energy guide 422A has a guide diameter 422GD, and the guide sleeve 457 includes (i) a sleeve wall 457W that forms the body of the guide sleeve 457 and (ii) a sleeve inner diameter 458. In some embodiments, the sleeve inner diameter 458 can be substantially similar or equal to the guide diameter 422GD. It is recognized, however, that the sleeve inner diameter 458 can be slightly larger than, although still substantially similar to, the guide diameter 422GD in the event that an adhesive (not shown) or other bonding agent is used to bond the guide sleeve 457 to the energy guide 422A.

In various non-exclusive embodiments, the guide diameter 422GD can be greater than approximately 10 micrometers and less than approximately 1000 micrometers. Somewhat similarly, in various embodiments, the guide inner diameter 458 can be greater than approximately 10 micrometers and less than approximately 1000 micrometers. In other embodiments, the guide diameter 422GD and/or the sleeve inner diameter 458 can be less than approximately 10 micrometers or greater than approximately 1000 micrometers.

The sleeve distal end 457D can extend past the guide distal end 422D so that a sleeve interior length 465L of the sleeve interior 465, defined as a distance between the sleeve distal end 457D and the guide distal end 422D, is greater than approximately 0.05mm and less than approximately 5.00mm. In alternative embodiments, the sleeve interior length 465L between the sleeve distal end 457D and the guide distal end 422D is less than approximately 0.05mm or greater than approximately 5.00mm.

In all embodiments, the guide sleeve 457 overlaps the energy guide 422A. A sleeve overlap 467 is defined by a distance between a sleeve proximal end 457P and the guide distal end 422D. The sleeve overlap 467 can be greater than approximately 0.1 mm and less than approximately 25mm. In other embodiments, the sleeve overlap 467 can be less than approximately 0.1 mm or greater than approximately 25mm.

Figure 4B is a schematic cross-sectional view of a portion of the energy guide 422A and the embodiment of the guide sleeve 457 of the catheter system 400 illustrated in Figure 4A, shown at a time after energy beams 490A, 490B extend away from the guide distal end 422D of the energy guide 422A into the sleeve interior 465 of the guide sleeve 457. In this embodiment, the time illustrated in Figure 4B is subsequent to the time displayed in Figure 4A.

As shown in Figure 4B, the energy guide 422A can guide the energy beams 490A, 490B, so that they contact the guide sleeve 457. In this embodiment, the energy beams 490A, 490B, can diverge within the guide sleeve 457 and contact the sleeve wall 457W away from the guide distal end 422D. Upon contact with the guide sleeve 457, the energy beams 490A, 490B, can cause a reaction that generates a plasma 459 in the sleeve interior 465. In this embodiment, due to the divergence of the energy beams 490A, 490B, one or more plasmas 459 (two plasmas 459 are illustrated in Figure 4B) can be initiated within the guide sleeve 457, as illustrated in Figure 4B. In other embodiments, it is appreciated that any number of energy beams can be directed and/or guided to contact any suitable portion of the guide sleeve 457, resulting in any suitable number of plasmas 459 being initiated within the sleeve interior 465. Figure 4C is a schematic cross-sectional view of a portion of the energy guide 422A and the embodiment of the guide sleeve 457 of the catheter system 400 illustrated in Figure 4A, shown at a time when the plasma 459 is formed in the sleeve interior 465 of the guide sleeve 457, and acoustic pressure waves 461 are directed away from the guide sleeve 457. The time illustrated in Figure 4C is subsequent to the time displayed in Figure 4B.

As shown in Figure 4C, the plasma 459 can increase in size as the energy beams 490A, 490B (illustrated in Figure 4B) continue to react with the sleeve wall 457W (illustrated in Figure 4B) within the sleeve interior 465. Eventually, the plasma 459 becomes large enough to expand inside the sleeve interior 465 and in a distal direction out of the sleeve distal end 457D. In one embodiment, the increasing energy and size of the plasma 459 can generate acoustic pressure waves 461 that also propagate in the distal direction toward the balloon distal region 304DR (illustrated in Figure 3).

Figure 4D is a schematic cross-sectional view of a portion of the energy guide 422A and the embodiment of the guide sleeve 457 of the catheter system 400 illustrated in Figure 4A, shown at a time when a plasma bubble 463 is formed in a distal direction away from the sleeve distal end 457D. The time illustrated in Figure 4D is subsequent to that illustrated in Figure 4C.

As shown in Figure 4D, the generation of the plasma 459 (shown in Figure 4C) can initiate the acoustic pressure waves 461 (shown in Figure 4C), which in turn can initiate the rapid formation of one or more additional plasma bubbles 463 that can rapidly expand and then dissipate through a cavitation event that can launch another pressure wave upon collapse. The rapid expansion of the plasma bubbles 463 can generate one or more pressure waves 461 within the catheter fluid 1032 (illustrated in Figure 10) retained within the balloon interior 1046 (illustrated in Figure 10) of the balloon 1004 (illustrated in Figure 10), thereby imparting pressure waves 461 onto and inducing fractures in the vascular lesions 106A (illustrated in Figure 1 ) at the treatment site 106 (illustrated in Figure 1 ) within or adjacent to the blood vessel wall 108A (illustrated in Figure 1 ) within the body 107 (illustrated in Figure 1 ) of the patient 109 (illustrated in Figure 1 ).

Figure 5 is a schematic cross-sectional view of a portion of another embodiment of the catheter system 500 including an energy guide 522A and another embodiment of a guide sleeve 557. In the embodiment illustrated in Figure 5, the guide sleeve 557 includes a sleeve opening 557A that is formed in the sleeve wall 557W of the guide sleeve 557 near the sleeve distal end 557D. In this embodiment, the sleeve opening 557A allows for better flow of the catheter fluid 332 (illustrated in Figure 3) that is in fluid communication with the sleeve interior 565 of the guide sleeve 557. For example, the catheter fluid 1032 can be received inside of the sleeve interior 565 via the sleeve opening 557A and/or the sleeve distal end 557D. The sleeve opening 557A can allow for a portion of the catheter fluid 332 and/or saline contrast media to flow and/or move along a first axis 569 (shown as a cross in Figure 5, showing the first axis 569 that goes into and out of the page) and/or along a second axis (illustrated as arrow 571 ) out of the sleeve distal end 557D.

The size, number, and/or positioning of sleeve openings 557A can vary depending on the design requirements of the guide sleeve 557 and/or the sleeve wall 557W. For example, while only one sleeve opening 557A is illustrated in Figure 5, it is appreciated that a plurality of sleeve openings 557A can be formed with varying shapes and/or sizes in any suitable portion of the guide sleeve 557.

Figure 6 is a schematic cross-sectional view of a portion of another embodiment of the catheter system 600 including an energy guide 622A and another embodiment of a guide sleeve 657. In the embodiment illustrated in Figure 6, the guide sleeve 657 includes a sleeve opening 657A that is formed into a sleeve wall 657W on the sleeve distal end 657D.

In this embodiment, the sleeve opening 657A allows for better flow of the catheter fluid 332 (illustrated in Figure 3) that is in fluid communication with the sleeve interior 665 of the guide sleeve 657. In the embodiment illustrated in Figure 6, the sleeve opening extends to the sleeve distal end 657D of the guide sleeve 657.

The size, number, and/or positioning of sleeve openings 657A can vary depending on the design requirements of the guide sleeve 657. For example, while only one sleeve opening 657A is illustrated in Figure 6, it is appreciated that a plurality of sleeve openings 657A can be formed with varying shapes and/or sizes in any suitable portion of the guide sleeve 657. Additionally, while the sleeve opening 657A is illustrated in Figure 6 as being substantially u-shaped, it is appreciated that any suitable number of sleeve openings 657A can take the form of any suitable shape. For example, the sleeve opening 657 A can include notches, slits, or other suitable configurations that extend to the sleeve distal end 657D.

Figure 7 is a schematic cross-sectional view is a schematic cross-sectional view of a portion of another embodiment of the catheter system 700 including an energy guide 722A and another embodiment of a guide sleeve 757. In this embodiment, the guide sleeve 757 includes a sleeve proximal region 757PR and a sleeve distal region 757D. The guide sleeve 757 is formed by a first sleeve component 757X, and a second sleeve component 757Y. The first sleeve component 757X is positioned in the sleeve proximal region 757PR of the guide sleeve 757, and the second sleeve component 757Y is positioned in the sleeve distal region 757DR of the guide sleeve 757.

In one embodiment, the first sleeve component 757X can be formed from a first sleeve material. In the embodiment illustrated in Figure 7, the first sleeve component 757X can be at least partially formed from a polymer material. In non-exclusive alternative embodiments, the first sleeve component can be at least partially formed from a metal, a ceramic, and/or a composite material, or any other suitable material.

The second sleeve component 757Y can be at least partially formed from a second sleeve material. For example, in one embodiment, the second sleeve material can include a metal material. In non-exclusive alternative embodiments, the second sleeve material can include a ceramic, a composite material, and/or a polymer, or any other suitable material. In one embodiment, the first sleeve component 757X, is at least partially formed from a polymer, and the second sleeve component, 757Y, is at least partially formed from a metal. With this design, generation of the plasma 763 is inhibited in the first sleeve component 757X because an index of refraction is lower for the polymeric material, and the generation of the plasma 763 is more likely near the second sleeve component 757Y due to a heightened index of refraction of the metallic material used. Stated another way, the plasma 763 is generated more distally away from the energy guide 722A, and more toward the balloon distal region 304DR (illustrated in Figure 3).

The shape, size, material composition, and/or positioning of the sleeve components 757X, 757Y can vary depending on the design requirements of the guide sleeve 757. For example, in an alternative embodiment, the first sleeve component 757X can be positioned in the sleeve distal region 757DR, and the second sleeve component 757Y can be positioned in the sleeve proximal region 757PR.

For ease of understanding and clarity, the sleeve components 757X, 757Y are illustrated in Figure 7 to have a distinct change in material composition where the sleeve components 757X, 757Y meet. However, in an alternative embodiment, the change in material composition of the guide sleeve 757 can be gradual, such as a polymer that gradually incorporates a metallic material toward the sleeve distal end 757D. For example, in another alternative embodiment, the guide sleeve 757 can be formed by a single component (e.g., only the first sleeve component 757X) that gradually changes in material composition from a polymer (or other suitable material) in the sleeve proximal region 757PR to a metal (or other suitable material) in a distal directed toward the distal region 757DR.

In various embodiments, the mechanical assemblage of the energy director itself provides a means to protect the guide distal end of the energy guide from the reaction forces and pressure produced by the expanding bubble.

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 or 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 configured to perform a particular task or adopt a particular configuration. The phrase "configured" can be used interchangeably with other similar phrases such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, and the like.

The headings used herein are provided for consistency with suggestions under 37 CFR 1.77 or otherwise to provide organizational cues. These headings shall not be viewed to limit or characterize the invention(s) set out in any claims that may issue from this disclosure. As an example, a description of a technology in the "Background" is not an admission that technology is prior art to any invention(s) in this disclosure. Neither is the "Summary" or "Abstract" to be considered as a characterization of the invention(s) set forth in 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 are chosen and described so that others skilled in the art can appreciate and understand the principles and practices. As such, aspects have been described with reference to various specific 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 understood that although a number of different embodiments of the catheter systems have been illustrated and described herein, one or more features of any one embodiment can be combined with one or more features of one or more of the other embodiments, provided that such combination satisfies the intent of the present invention.

While a number of exemplary aspects and embodiments of the 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 no limitations are intended to the details of construction or design herein shown.

Claims

What is claimed is:

1 . An energy director for a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve within a body of a patient, the catheter system including (i) an energy source that generates energy, (ii) a balloon having a balloon distal region that has a varying diameter, and a balloon proximal region having a substantially constant diameter, and (iii) an energy guide including a guide distal end, the energy guide being configured to receive the energy from the energy source, the energy director comprising: a guide sleeve that is secured to the energy guide, the guide sleeve at least partially encircling the guide distal end of the energy guide, the guide sleeve extending distally from the guide distal end in a direction toward the balloon distal region, the guide sleeve directing the energy received by the energy guide so that the energy generates a plasma in the direction toward the balloon distal region.

2. The energy director of claim 1 wherein the guide sleeve is at least partially formed from one of a metal, a ceramic, and a polymer.

3. The energy director of any of claims 1-2 wherein the guide sleeve has a sleeve inner diameter that is substantially constant.

4. The energy director of any of claims 1-3 wherein the guide sleeve has a sleeve inner diameter and the energy guide has a guide outer diameter that is approximately equal to the sleeve inner diameter.

5. The energy director of any of claims 1-4 wherein the guide sleeve has a sleeve inner diameter that defines a sleeve interior, the energy guide being configured to guide the energy so that the energy diverges within the sleeve interior of the guide sleeve and contacts the guide sleeve so that the plasma is initiated within the sleeve interior of the guide sleeve.

6. The energy director of any of claims 1-5 wherein the guide sleeve includes a sleeve wall including a sleeve opening that is in fluid communication with a balloon interior of the balloon.

7. The energy director of claim 6 wherein the sleeve opening includes a port formed into the sleeve wall.

8. The energy director of claim 6 wherein the sleeve opening includes a notch formed into the sleeve wall at the sleeve distal end.

9. The energy director of any of claims 1-8 wherein the guide sleeve includes a sleeve distal end, the sleeve distal end being positioned in the balloon proximal region.

10. The energy director of any of claims 1 -9 wherein the guide sleeve is formed by a first sleeve component and a second sleeve component.

11 . The energy director of claim 10 wherein the guide sleeve includes a sleeve proximal region and a sleeve distal region, the first sleeve component being positioned in the sleeve proximal region and the second sleeve component being positioned in the sleeve distal region.

12. The energy director of any of claims 10-11 wherein the sleeve components are at least partially formed from a sleeve material including one of a polymer material, a metal material, a ceramic material, and/or a composite material.

13. The energy director of claim 12 wherein the first sleeve component is at least partially formed from a first sleeve material including the polymer material and the second sleeve component is at least partially formed from a second sleeve material including the metal material.

14. The energy director of any of claims 10-13 wherein the first sleeve component has a first index of refraction that is lower than a second index of refraction of the second sleeve component.

15. The energy director of any of claims 10-14 wherein the sleeve components are configured to cooperate to increase the likelihood that the plasma is generated the direction toward the balloon distal region.

16. The energy director of any of claims 10-15 wherein the guide sleeve includes a sleeve proximal end and a sleeve distal end, a material composition of the guide sleeve changing from the sleeve proximal end to the sleeve distal end.

17. The energy director of claim 16 wherein the material composition gradually changes from a polymer material at the sleeve proximal end to a metallic material and the sleeve distal end.

18. An energy director for a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve within a body of a patient, the catheter system including (i) an energy source that generates energy, (ii) a balloon having a balloon distal region that has a varying diameter, and a balloon proximal region having a substantially constant diameter, and (iii) an energy guide including a guide distal end, the energy guide being configured to receive the energy from the energy source, the energy director comprising: a guide sleeve that is secured to the energy guide, the guide sleeve at least partially encircling the guide distal end of the energy guide, the guide sleeve extending distally from the guide distal end in a direction toward the balloon distal region, the guide sleeve including a sleeve distal end that is positioned in the balloon proximal region.

19. The energy director of claim 18 wherein the guide sleeve directs the energy received by the energy guide so that the energy generates a plasma in the direction toward the balloon distal region.

20. The energy director of any of claims 18-19 wherein the guide sleeve is at least partially formed from one of a metal, a ceramic, and a polymer.

21 . The energy director of any of claims 18-20 wherein the guide sleeve has a sleeve inner diameter and the energy guide has a guide outer diameter, the sleeve inner diameter being approximately equal to the guide outer diameter.

22. The energy director of any of claims 18-21 wherein the energy guide guides the energy so that the energy diverges within a sleeve interior of the guide sleeve.

23. The energy director of any of claims 18-22 wherein the energy contacting the guide sleeve initiates a plasma within a sleeve interior of the guide sleeve.

24. The energy director of any of claims 18-23 wherein the guide sleeve includes a sleeve wall including a sleeve opening that is in fluid communication with a balloon interior of the balloon.

25. The energy director of claim 24 wherein the sleeve opening includes a port formed into the sleeve wall.

26. The energy director of claim 24 wherein the sleeve opening includes a notch formed into the sleeve wall at the sleeve distal end.

27. The energy director of any of claims 18-26 wherein the guide sleeve has a sleeve inner diameter that is substantially constant.

28. The energy director of claim 18 wherein the guide sleeve includes a sleeve proximal region and a sleeve distal region, the first sleeve component being positioned in the sleeve proximal region and the second sleeve component being positioned in the sleeve distal region.

29. The energy director of any of claims 18-28 wherein the sleeve components are at least partially formed from a sleeve material including one of a polymer material, a metal material, a ceramic material, and/or a composite material.

30. The energy director of claim 29 wherein the first sleeve component is at least partially formed from a first sleeve material including the polymer material and the second sleeve component is at least partially formed from a second sleeve material including the metal material.

31. The energy director of any of claims 18-30 wherein the first sleeve component has a first index of refraction that is lower than a second index of refraction of the second sleeve component.

32. The energy director of any of claims 18-31 wherein the sleeve components are configured to cooperate to increase the likelihood that the plasma is generated the direction toward the balloon distal region.

33. The energy director of any of claims 18-32 wherein the guide sleeve includes a sleeve proximal end and a sleeve distal end, a material composition of the guide sleeve changing from the sleeve proximal end to the sleeve distal end.

34. The energy director of claim 33 wherein the material composition gradually changes from a polymer material at the sleeve proximal end to a metallic material and the sleeve distal end.

35. An energy director for a catheter system for treating a treatment site within or adjacent to a vessel wall or heart valve within a body of a patient, the catheter system including (i) an energy source that generates energy, (ii) a balloon having a balloon interior, a balloon distal region that has a varying diameter, and a balloon proximal region having a substantially constant diameter, and (iii) an energy guide including a guide distal end and a guide outer diameter, the energy guide being configured to receive the energy from the energy source, the energy director comprising: a guide sleeve that is secured to the energy guide, the guide sleeve including a sleeve inner diameter that is substantially the same as the guide outer diameter, the guide sleeve including a sleeve wall and a sleeve distal end, the guide sleeve at least partially encircling the guide distal end of the energy guide, the guide sleeve extending distally from the guide distal end in a direction toward the balloon distal region, the guide sleeve directing the energy received by the energy guide so that the energy generates a plasma in the direction toward the balloon distal region, the sleeve distal end being positioned in the balloon proximal region, the sleeve wall including a sleeve opening that is in fluid communication with the balloon interior.