Energy manifolds used to guide and concentrate energy within lithotripsy devices.

Abstract

A catheter system (100) for treating vascular lesions (106A) within or adjacent to the vessel wall (108A) of a patient (109) (107) includes a catheter fluid (132), an energy source (124) for generating energy, an energy guide (122A), and an energy manifold (129). The energy guide (122A) includes a distal end (122D) selectively positioned near the vascular lesion (106A). The energy guide (122A) is configured to receive energy from the energy source (124) and generate plasma bubbles (134) within the catheter fluid (132). The energy manifold (129) is coupled to the energy guide (122A) near the distal end (122D). The energy manifold (129) includes: (i) a manifold body (260) defining a body chamber (266) configured to retain at least some of the catheter fluid (132); and (ii) a manifold orifice (262) extending through the manifold body (260). The energy manifold (129) directs energy from the plasma bubble (134) out of the body chamber (266) and toward the vascular lesion (106A) through the manifold orifice (262).

Description

[0001] Related applications

[0002] This application claims priority to the following: U.S. Provisional Application Serial No. 62 / 939,409, filed November 22, 2019, entitled "ENERGY MANIFOLDFOR LASER-DRIVEN LITHOPLASTY DEVICE"; and U.S. Patent Application Serial No. 17 / 091,050, filed November 6, 2020, entitled "ENERGY MANIFOLD FORDIRECTING AND CONCENTRATING ENERGY WITHIN A LITHOPLASTY DEVICE". To the extent permitted, the contents of U.S. Provisional Application Serial No. 62 / 939,409 and U.S. Patent Application Serial No. 17 / 091,050 are incorporated herein by reference in their entirety. Background Technology

[0003] Vascular lesions within the body's blood vessels may be associated with an increased risk of major adverse events, such as myocardial infarction, embolism, deep vein thrombosis, and stroke. For physicians in a clinical setting, severe vascular lesions (such as severely calcified vascular lesions) can be difficult to treat and achieve patency.

[0004] Interventions can be used to treat vascular lesions. Examples of interventions include medication, balloon angioplasty, plaque resection, stent placement, and bypass grafting. These interventions may not always be ideal, or may require follow-up treatments to resolve the lesions.

[0005] Lithotripsy is a recently used method that has successfully broken down vascular lesions within blood vessels throughout the body. Lithotripsy utilizes a combination of intravascular pressure waves and bubble dynamics generated within a fluid-filled balloon catheter. Specifically, during lithotripsy, a high-energy source is used to generate plasma within a fluid-filled balloon, ultimately producing pressure waves and rapid bubble expansion to break up calcifications at the treatment site, which may contain one or more vascular lesions, within the vascular system. The associated rapid bubble formation induced by the plasma and the resulting localized fluid velocity within the balloon transfer mechanical energy through the incompressible fluid, imparting a rupture force to the intravascular calcium opposite the balloon wall. The rapid change in fluid momentum that occurs immediately after impact with the balloon wall is known as hydraulic shock or water hammer.

[0006] The aim is to more accurately and precisely guide and / or concentrate the energy generated within a fluid-filled balloon in order to apply pressure to the vascular lesion within or adjacent to the vessel wall and induce rupture therein.

[0007] The ongoing goal is to improve vascular patency and optimize treatment delivery parameters within lithotripsy catheter systems. Summary of the Invention

[0008] This invention relates to a catheter system for placement within a blood vessel having a vessel wall. The catheter system can be used to treat vascular lesions within or adjacent to the vessel wall within a patient's body. The catheter system includes a catheter fluid and an energy source for generating energy. In various embodiments, the catheter system includes an energy guide and an energy manifold. The energy guide includes a distal end of the guide selectively positioned near the vascular lesion. The energy guide is configured to receive energy from the energy source and generate plasma bubbles within the catheter fluid. The energy manifold is coupled to the energy guide near the distal end of the guide. The energy manifold includes: (i) a manifold body defining a body chamber configured to retain at least some of the catheter fluid; and (ii) a manifold orifice extending through the manifold body. The energy manifold directs energy from the plasma bubbles out of the body chamber and toward the vascular lesion through the manifold orifice.

[0009] In some embodiments, the energy manifold includes a plurality of manifold orifices extending through a manifold body. In such embodiments, the energy manifold is configured to direct energy from the plasma bubble out of the body chamber and toward the vascular lesion through each of the plurality of manifold orifices. In one such embodiment, the plurality of manifold orifices are positioned in a radial pattern around the periphery of the manifold body. In another such embodiment, the plurality of manifold orifices are arranged in a helical pattern along the length of the manifold body. In yet another such embodiment, the plurality of manifold orifices are positioned along the length of the manifold body.

[0010] In some embodiments, the energy guide generates one or more pressure waves within the catheter fluid, which exert force on the vascular lesion. Furthermore, the energy guide may include an optical fiber.

[0011] In some embodiments, the catheter system further includes a balloon with a balloon wall defining an interior. The balloon is configured to retain catheter fluid within the balloon interior. A distal guide and an energy manifold are positioned within the balloon interior. In some such embodiments, the balloon can be selectively inflated with catheter fluid to inflate to an inflated state. When the balloon is inflated, the balloon wall is configured to be positioned substantially adjacent to the vascular lesion. Furthermore, in some such embodiments, the energy manifold is configured to direct energy from the plasma bubble through a manifold orifice out of the body chamber and toward the balloon wall.

[0012] In some embodiments, the manifold body includes a manifold proximal end, and the guide distal end of the energy guide is fixed to the manifold proximal end of the manifold body.

[0013] In one embodiment, the manifold body is a substantially cylindrical tubular shape and defines a substantially cylindrical body chamber. In another embodiment, the manifold body includes a proximal manifold end and an opposing distal manifold end, and the body chamber is tapered, such that the body chamber is larger near the proximal manifold end and smaller near the distal manifold end.

[0014] In some embodiments, the catheter system further includes a guide end protector coupled to the distal end of the guide, the guide end protector being configured to protect the distal end of the guide from the energy from plasma bubbles generated in the body chamber.

[0015] In some embodiments, the energy manifold further includes an energy deflector that directs energy from a plasma bubble generated in the body chamber toward the manifold orifice. In some such embodiments, the manifold body includes a distal manifold end, and the energy deflector is positioned adjacent to the distal manifold end.

[0016] In some embodiments, the energy manifold further includes an optical element configured to focus energy directed from the distal end of the energy guide. In one embodiment, the optical element is formed of sapphire, although it should be understood that the optical element can be formed of other suitable materials. In alternative embodiments, the optical element may be directly coupled to the distal end of the energy guide, the optical element may be directly formed on the distal end of the energy guide, or the optical element may be positioned spaced apart from the distal end of the energy guide to define an air space between the distal end of the guide and the optical element. In some embodiments, the air space is sealed and isolated from the remainder of the body chamber such that no conduit fluid is retained within the air space.

[0017] In some embodiments, the conduit system further includes a guide cap that is directly coupled to the distal end of the energy guide. In such embodiments, an optical element may be directly coupled to the guide cap. Further, in some such embodiments, at least one of the guide cap and the optical element is formed of glass. Still further, in some embodiments, the manifold body includes a proximal manifold end, and the proximal manifold end is secured to the optical element.

[0018] In some embodiments, the conduit fluid includes one of a wetting agent and a surfactant.

[0019] In some embodiments, the conduit system further includes an extension tube coupled to a distal end of an energy guide and extending away from the distal end of the energy guide, the extension tube being configured to retain at least some of the fluid in the conduit. In such embodiments, energy from an energy source is transferred through the extension tube after being guided by the energy guide.

[0020] The present invention further relates to a method for treating vascular lesions within or adjacent to the wall of a blood vessel in a patient's body, the method comprising the steps of: (A) generating energy with an energy source; (B) positioning a distal end of an energy guide near the vascular lesion; (C) connecting an energy manifold to the energy guide near the distal end of the guide, the energy manifold comprising: (i) a manifold body defining a body chamber configured to retain at least some of a catheter fluid; and (ii) a manifold orifice extending through the manifold body; (D) receiving energy from the energy source with the energy guide; (E) generating a plasma bubble in the catheter fluid with the energy from the energy guide; and (F) guiding the energy from the plasma bubble out of the body chamber and toward the vascular lesion through the manifold orifice with the energy manifold.

[0021] This invention summary is an overview of some of the teachings of this application and is not intended to be an exclusive or exhaustive treatment of the subject matter. Further details are found in the detailed description and the appended claims. Other aspects will be apparent to those skilled in the art after reading and understanding the following detailed description and examining the accompanying drawings, which form a part of it (none of which are to be regarded in a limiting sense). The scope of this document is defined by the appended claims and their legal equivalents. Attached Figure Description

[0022] The novel features of the invention, and the invention itself, in terms of both its structure and operation, will be best understood from the accompanying drawings and description, wherein similar reference numerals denote similar parts, and wherein:

[0023] Figure 1 This is a schematic cross-sectional view of an embodiment of a catheter system according to various embodiments, the catheter system including an energy guide and an energy manifold;

[0024] Figure 2 This is a schematic cross-sectional view of a portion of an embodiment of a conduit system including an energy manifold;

[0025] Figure 3 This is a schematic cross-sectional view of another embodiment of the energy guide and energy manifold;

[0026] Figure 4 This is a schematic cross-sectional view of another embodiment of the energy guide and energy manifold;

[0027] Figure 5 This is a schematic cross-sectional view of another embodiment of an energy guide and an energy manifold;

[0028] Figure 6 This is a schematic cross-sectional view of another embodiment of the energy guide and energy manifold;

[0029] Figure 7 This is a schematic cross-sectional view of another embodiment of an energy guide and an energy manifold;

[0030] Figure 8 This is a schematic cross-sectional view of yet another embodiment of an energy guide and energy manifold;

[0031] Figure 9A A schematic cross-sectional view of an alternative embodiment of an energy guiding component that can be used within a conduit system; and

[0032] Figure 9B This is a schematic cross-sectional view of another alternative embodiment of the energy guiding component.

[0033] While embodiments of the invention are readily adaptable to various modifications and alternatives, their details have been shown by way of example and in the accompanying drawings and are described in detail herein. However, it should be understood that the scope of this document is not limited to the specific embodiments described. Rather, it is intended to cover modifications, equivalents, and alternatives that fall within the spirit and scope of this document. Detailed Implementation

[0034] Treatment of vascular lesions can reduce major adverse events or death in affected subjects. As mentioned herein, a major adverse event is an adverse event that can occur anywhere in the body due to the presence of vascular lesions. Major adverse events may include, but are not limited to, major adverse cardiac events, major adverse events in the peripheral or central vascular system, major adverse events in the brain, major adverse events in muscle tissue, or major adverse events in any internal organ.

[0035] In various embodiments, the catheter systems and related methods disclosed herein may include a catheter configured to advance to a vascular lesion (such as a calcified or fibrotic vascular lesion) at a treatment site located within or adjacent to a blood vessel in a patient's body. The catheter includes a catheter shaft and an inflatable balloon coupled to and / or secured to the catheter shaft. The balloon may include a balloon wall defining an interior. The balloon may be configured to receive catheter fluid within its interior to inflate from a deflated state suitable for advancing the catheter through the patient's vasculature to an inflated state suitable for anchoring the catheter in place relative to the treatment site.

[0036] In some embodiments, the catheter system and related methods utilize an energy source (e.g., a light source such as a laser or another suitable energy source) that provides energy guided by one or more energy guides (e.g., optical guides such as optical fibers) positioned along the catheter axis within the balloon to generate localized plasma within the catheter fluid held within the balloon. Thus, the energy guides may sometimes be referred to, or can be described as incorporating a "plasma generator" at or near the distal end of the energy guide, positioned within the balloon at the treatment site. The generation of localized plasma can induce pressure waves and can induce the rapid formation of one or more bubbles, which can rapidly expand to their maximum size and then dissipate via cavitation events, emitting pressure waves upon rupture. The rapid expansion of plasma-induced bubbles (sometimes simply referred to as "plasma bubbles") can generate one or more pressure waves within the catheter fluid held within the balloon and thereby impart pressure waves to the vascular lesion within or adjacent to the vessel wall in the patient's body, inducing rupture therein. In some embodiments, the energy source can be configured to provide submillisecond energy (e.g., light energy) pulses to induce plasma formation in the catheter fluid within the balloon, thereby causing rapid bubble formation and imposing a pressure wave on the balloon wall at the treatment site. Thus, the pressure wave can transfer mechanical energy to the treatment site through the incompressible catheter fluid to induce rupture at the endovascular lesion. Without wishing to be bound by any particular theory, it is believed that rapid changes in the momentum of the catheter fluid on the balloon wall in contact with the endovascular lesion are transferred to the lesion to induce rupture.

[0037] The catheter systems and related methods disclosed herein further include an energy manifold positioned within a balloon and coupled to and / or secured to an energy guide. The energy manifold is configured to guide and / or concentrate energy generated within a catheter fluid (which is held within the balloon and at least partially within the energy manifold) to apply pressure to a vascular lesion within or adjacent to a blood vessel and induce rupture therein. More specifically, the energy manifold guides and / or concentrates acoustic and mechanical energy generated by a lithotripsy device (such as a laser-driven pressure wave generator) to apply pressure to a vascular lesion within or adjacent to a blood vessel in the patient's body and induce rupture therein.

[0038] As used herein, unless otherwise noted, the terms “intracranial lesion” and “vascular lesion” are used interchangeably. Therefore, intravascular lesions and / or vascular lesions are sometimes referred to simply as “lesions” in this document.

[0039] Those skilled in the art will recognize that the following detailed description of the invention is merely illustrative and not intended to be limiting in any way. Other embodiments of the invention will readily come to mind for those skilled in the art upon receiving this disclosure. Reference will now be made in detail to embodiments of the invention as illustrated in the accompanying drawings. Throughout the drawings and the following detailed description, the same or similar nomenclature and / or reference numerals will be used to refer to the same or similar parts.

[0040] For clarity, not all conventional features of the embodiments described herein are shown or described. It should be understood that in the development of any such practical implementation, numerous implementation-specific decisions must be made to achieve the developer's specific goals, such as compliance with application-related and business-related constraints, and these specific goals will vary depending on the implementation and the developer. Furthermore, it should be recognized that such development work can be complex and time-consuming, but will remain a routine engineering task for those skilled in the art who will benefit from this disclosure.

[0041] The catheter systems disclosed herein can include many different forms. Now refer to Figure 1 A schematic cross-sectional view of a catheter system 100 according to various embodiments is shown. The catheter system 100 is adapted to deliver a pressure wave to induce rupture in one or more vascular lesions located within or adjacent to the vessel wall. Figure 1 In the embodiments shown, the catheter system 100 may include one or more of the following: a catheter 102; an energy guide bundle 122 including one or more energy guides 122A; a source manifold 136; a fluid pump 138; a system console 123 including one or more of an energy source 124, a power supply 125, a system controller 126, and a graphical user interface 127 (“GUI”); a handle assembly 128; and an energy manifold 129. Alternatively, the catheter system 100 may have more than [the following information is missing from the original text]. Figure 1 The specific components shown and described may include more or fewer components.

[0042] The catheter 102 is configured to move within or adjacent to the wall 108A of a blood vessel 108 within the body 107 of the patient 109. For example, the treatment site 106 may include one or more vascular lesions 106A, such as calcified vascular lesions. Additionally, or alternatively, the treatment site 106 may include vascular lesions 106A, such as fibrotic vascular lesions.

[0043] The catheter 102 may include an inflatable balloon 104 (sometimes simply referred to herein as a "balloon"), a catheter shaft 110, and a guidewire 112. The balloon 104 may be coupled to the catheter shaft 110. The balloon 104 may include a proximal balloon 104P and a distal balloon 104D. The catheter shaft 110 may extend from a proximal portion 114 of the catheter system 100 to a distal portion 116 of the catheter system 100. The catheter shaft 110 may include a longitudinal axis 144. The catheter shaft 110 may also include a guidewire lumen 118 configured to move on the guidewire 112. As utilized herein, the guidewire lumen 118 defines a conduit through which the guidewire 112 extends. The catheter shaft 110 may further include an inflatable lumen (not shown) and / or various other lumens for various other purposes. In some embodiments, the catheter 102 may have a distal opening 120 and may accommodate a guidewire 112 and be tracked on the guidewire as the catheter 102 moves and is positioned at or near the treatment site 106.

[0044] Balloon 104 includes a balloon wall 130 defining a balloon interior 146. Balloon 104 can be selectively inflated with catheter fluid 132 to expand from a deflated state suitable for advancing catheter 102 through the patient's vasculature to an inflated state suitable for anchoring catheter 102 in place relative to treatment site 106 (e.g., Figure 1 (As shown in the diagram). Alternatively, when balloon 104 is inflated, the balloon wall 130 of balloon 104 is configured to be positioned substantially adjacent to the treatment site 106. It should be understood that, although... Figure 1 The balloon wall 130 of balloon 104 is shown as spaced apart from the treatment site 106 of blood vessel 108 when inflated, but this is done for ease of illustration. It should be understood that when balloon 104 is inflated, the balloon wall 130 of balloon 104 will typically be substantially directly adjacent to and / or adjacent to the treatment site 106.

[0045] A balloon 104 suitable for use in the catheter system 100 includes a balloon that, when deflated, can pass through a patient's vascular system. In some embodiments, the balloon 104 is made of silicone. In other embodiments, the balloon 104 may be made of a variety of materials, such as polydimethylsiloxane (PDMS), polyurethane, polymers (such as PEBAX™ material), nylon, or any other suitable material.

[0046] The balloon 104 can have any suitable diameter (in the inflated state). In various embodiments, the balloon 104 can have a diameter ranging from less than 1 mm up to 25 mm (in the inflated state). In some embodiments, the balloon 104 can have a diameter ranging from at least 1.5 mm up to 14 mm (in the inflated state). In some embodiments, the balloon 104 can have a diameter ranging from at least 2 mm up to 5 mm (in the inflated state).

[0047] In some embodiments, balloon 104 may have a length ranging from at least 3 mm to 300 mm. More particularly, in some embodiments, balloon 104 may have a length ranging from at least 8 mm to 200 mm. It should be understood that a balloon 104 with a relatively long length may be positioned adjacent to a larger treatment site 106, and therefore may be useful for applying pressure waves to a larger vascular lesion 106A or multiple vascular lesions 106A at a precise location within the treatment site 106 and inducing rupture therein. It should be further understood that a longer balloon 104 may also be positioned adjacent to multiple treatment sites 106 at any given time.

[0048] The balloon 104 can be inflated to an inflation pressure between approximately 1 atmosphere (atm) and 70 atm. In some embodiments, the balloon 104 can be inflated to an inflation pressure from at least 20 atm to 60 atm. In other embodiments, the balloon 104 can be inflated to an inflation pressure from at least 6 atm to 20 atm. In still other embodiments, the balloon 104 can be inflated to an inflation pressure from at least 3 atm to 20 atm. In yet still other embodiments, the balloon 104 can be inflated to an inflation pressure from at least 2 atm to 10 atm.

[0049] The balloon 104 can have various shapes, including but not limited to conical, square, rectangular, spherical, conical / square, conical / spherical, extended spherical, oval, conical, bone-shaped, stepped diameter, offset, or conical offset shapes. In some embodiments, the balloon 104 may include a drug-eluting coating or a drug-eluting stent structure. The drug-eluting coating or drug-eluting stent may include one or more therapeutic agents, including anti-inflammatory agents, antitumor agents, anti-angiogenic agents, etc.

[0050] The catheter fluid 132 can be a liquid or a gas. Some examples of suitable catheter fluids 132 may include, but are not limited to, one or more of the following: water, saline, contrast agent, fluorocarbon, perfluorocarbon, gas (such as carbon dioxide), or any other suitable catheter fluid 132. In some embodiments, the catheter fluid 132 can be used as a base swelling fluid. In some embodiments, the catheter fluid 132 may comprise a mixture of saline and contrast agent in a volume ratio of approximately 50:50. In other embodiments, the catheter fluid 132 may comprise a mixture of saline and contrast agent in a volume ratio of approximately 25:75. In still other embodiments, the catheter fluid 132 may comprise a mixture of saline and contrast agent in a volume ratio of approximately 75:25. However, it should be understood that any suitable ratio of saline to contrast agent can be used. The catheter fluid 132 can be customized based on composition, viscosity, etc., to appropriately manipulate the travel rate of the pressure wave. In some embodiments, the suitable catheter fluid 132 is biocompatible. The volume of the conduit fluid 132 can be customized by selecting the energy source 124 and the type of conduit fluid 132 used.

[0051] In some embodiments, the conduit fluid 132 may include a wetting agent or a surfactant. These compounds can reduce the surface tension between solid and liquid substances. These compounds can act as emulsifiers, dispersants, detergents, and water penetrants. The wetting agent or surfactant reduces the surface tension of the liquid and allows the liquid to fully wet and contact optical components (such as, multiple energy guides 122A) and mechanical components (such as, multiple energy manifolds 129). This reduces or eliminates the accumulation of bubbles and gas pockets or gas inclusions within the energy manifolds 129. Non-exclusive examples of chemicals that can be used as wetting agents include, but are not limited to, benzalkonium chloride, benzyl chloride, hexadecylpyridine chloride, poloxamer 188, poloxamer 407, polysorbate 20, polysorbate 40, etc. Non-exclusive examples of surfactants may include, but are not limited to, ionic and nonionic detergents and sodium stearate. Another suitable surfactant is 4-(5-dodecyl)benzenesulfonate. To give a few examples, other examples could include docusate (sodium dioctyl sulfosuccinate), alkyl ether phosphates, and perfluorooctane sulfonic acid (PFOS).

[0052] Direct liquid contact with the energy guide 122A, achieved through the use of a wetting agent or surfactant, allows for more efficient conversion of energy into plasma. Furthermore, achieving greater (or complete) wetting is less challenging when the wetting agent or surfactant is used in conjunction with small optical and mechanical components used in the energy manifold 129 and other parts of the conduit 102. Reducing the surface tension of the liquid makes it easier to effectively wet such small structures and thus nearly or completely immerse them. Significant improvements in device efficiency can occur by reducing or eliminating air bubbles or other bubbles adhering to the optical and mechanical structures and the energy guide 122A.

[0053] The specific percentage of wetting agent or surfactant can vary to suit the design parameters of the conduit system 100 and / or energy manifold 129 in use. In one embodiment, the percentage of wetting agent or surfactant per volume of conduit fluid 132 can be less than about 50%. In non-exclusive alternative embodiments, the percentage of wetting agent or surfactant per volume of conduit fluid 132 can be less than about 40%, 30%, 20%, 10%, 5%, 2%, 1%, 0.1%, or 0.01%. Alternatively, the percentage of wetting agent or surfactant can fall outside the aforementioned ranges.

[0054] In some embodiments, the contrast agent used in the contrast agent may include, but is not limited to, iodine-based contrast agents, such as ionic or nonionic iodine-based contrast agents. Some non-limiting examples of ionic iodine-based contrast agents include diatrizoate, methastatin, iodophthalate, and iodoxycycline. Some non-limiting examples of nonionic iodine-based contrast agents include iopamidol, iohexol, ioxilan, iopromide, iodixanol, and iofluoxetine. In other embodiments, non-iodine-based contrast agents may be used. Suitable non-iodine-containing contrast agents may include gadolinium(III)-based contrast agents. Suitable fluorocarbons and perfluorocarbon formulations may include, but are not limited to, formulations such as perfluorocarbon dodecylfluoropentane (DDFP, C5F12).

[0055] The conduit fluid 132 may include a conduit fluid with absorbents that selectively absorb 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 absorbents may include absorbents having a maximum absorption value along the spectrum from at least 10 nm to 2.5 μm. Alternatively, the conduit fluid 132 may include a conduit fluid with absorbents that selectively absorb 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 absorbent may be an absorbent having a maximum absorption value that matches the maximum emission value of the laser used in the conduit system 100. As a non-limiting example, various lasers that may be used in the conduit system 100 may include a neodymium-doped yttrium aluminum garnet (Nd:YAG - maximum emission = 1064 nm) laser, a holmium-doped YAG (Ho:YAG - maximum emission = 2.1 μm) laser, or an erbium-doped YAG (Er:YAG - maximum emission = 2.94 μm) laser. In some embodiments, the absorbent may be water-soluble. In other embodiments, the absorbent is not water-soluble. In some embodiments, the absorbent used in the conduit fluid 132 may be tailored to match the peak emission of the energy source 124. Various energy sources 124 having emission wavelengths ranging from at least 10 nanometers to 1 millimeter are discussed elsewhere herein.

[0056] The catheter shaft 110 of catheter 102 can be coupled to one or more energy guides 122A in the energy guide bundle 122, which are optically in communication with energy source 124. Multiple energy guides 122A can be disposed within balloon 104 along catheter shaft 110. In some embodiments, each energy guide 122A can be an optical fiber, and the energy source 124 can be a laser. The energy source 124 can be optically in communication with the energy guides 122A at the proximal portion 114 of the catheter system 100.

[0057] In some embodiments, the catheter shaft 110 may be coupled to a plurality of energy guides 122A (such as a first energy guide, a second energy guide, a third energy guide, etc.), which may be positioned at any suitable location around the guidewire lumen 118 and / or the catheter shaft 110. For example, in some non-exclusive embodiments, two energy guides 122A may be spaced approximately 180 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110; three energy guides 122A may be spaced approximately 120 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110; or four energy guides 122A may be spaced approximately 90 degrees apart around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. Alternatively, the plurality of energy guides 122A need not be uniformly spaced apart from each other around the circumference of the guidewire lumen 118 and / or the catheter shaft 110. More specifically, it should be understood that the energy guide 122A can be uniformly or non-uniformly positioned around the guidewire lumen 118 and / or the catheter shaft 110 to achieve the desired effect in the desired location.

[0058] The catheter system 100 and / or the energy guide bundle 122 may include any number of energy guides 122A, which are optically in communication with the energy source 124 at the proximal portion 114 and with 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 may include from one energy guide 122A to more than 30 energy guides 122A.

[0059] The energy guide 122A can have any suitable design to achieve the purpose of generating plasma and / or pressure waves in the conduit fluid 132 within the balloon interior 146. Therefore, 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 conduit system 100 is often described as having an energy source 124 as a light source and one or more energy guides 122A as light guides, the conduit system 100 can alternatively include any suitable energy source 124 and energy guide 122A to achieve the purpose of generating a desired plasma in the conduit fluid 132 within the balloon interior 146. For example, in a 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 comprising spaced-apart electrodes extending into the balloon interior 146. In such embodiments, each high-voltage pulse is applied to the electrode and forms an electric arc at both ends of the electrode. The arc then generates plasma and creates pressure waves within the catheter fluid 132. These pressure waves are used to deliver a rupture force to the vascular lesion 106A at the treatment site 106. Alternatively, the energy source 124 and / or the energy guide 122A may have another suitable design and / or configuration.

[0060] In some embodiments, the energy guide 122A may include an optical fiber or a flexible optical tube. The energy guide 122A may be thin and flexible, and may allow the transmission of optical signals with very little intensity loss. The energy guide 122A may include a core surrounded by a cladding around its circumference. In some embodiments, the core may be a cylindrical core or a partially cylindrical core. The core and cladding of the energy guide 122A may be formed of one or more materials, including but not limited to one or more types of glass, silica, or one or more polymers. The energy guide 122A may also include a protective coating, such as a polymer. It should be understood that the refractive index of the core will be greater than the refractive index of the cladding.

[0061] Each energy guide 122A can guide energy along its length from the proximal end 122P of the guide to the distal end 122D of the guide, which has at least one optical window (not shown) positioned within the balloon interior 146.

[0062] Alternatively, the energy guide 122A may have another suitable design and / or energy from the energy source 124 may be guided into the balloon interior 146 by another suitable method. For example, in some non-exclusive alternative embodiments, guiding energy from the energy source 124 into the balloon interior 146 can be performed using both: energy guide assembly 978A (in... Figure 9A(shown in the image), the energy guiding assembly may include an energy guide 122A similar to the energy guides described in various embodiments; and an extension tube 980A (in the image). Figure 9A (As shown in the image), the extension tube is coupled to and / or secured to the distal end 122D of the energy guide 122A. In such embodiments, the extension tube 980A may be a hollow tube configured to be filled with conduit fluid 132. In some such embodiments, the extension tube 980A may include a tube wall 982A (in... Figure 9A (As shown in the image), the refractive index of these tube walls is lower than the refractive index of the conduit fluid 132 that can be held within the extension tube 980A. Additionally, in alternative embodiments of this type, the extension tube 980A may be formed of a polymer material, or the extension tube 980A may comprise a rigid and / or metallic substrate having a dielectric coating 984B disposed on the inner surface of the extension tube 980A (in... Figure 9B (As shown in the middle). Will be combined Figure 9A and Figure 9B Let us describe some of these alternative embodiments in more detail.

[0063] The energy guide 122A can be configured in a variety of ways around and / or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the energy guide 122A may extend parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guide 122A may be physically coupled to the catheter shaft 110. In other embodiments, the energy guide 122A may be disposed along the length of the outer diameter of the catheter shaft 110. In yet another embodiment, the energy guide 122A may be disposed within one or more energy guide lumens within the catheter shaft 110.

[0064] The energy guide 122A can also be positioned at any suitable location around the circumference of the guidewire lumen 118 and / or the catheter shaft 110, and the distal end 122D of each energy guide 122A can be positioned at any suitable longitudinal location relative to the length of the balloon 104 and / or relative to the length of the guidewire lumen 118.

[0065] In some embodiments, the energy guide 122A may include one or more photoacoustic transducers 154, wherein each photoacoustic transducer 154 may be optically communicated with the energy guide 122A in which it is disposed. In some embodiments, the photoacoustic transducer 154 may be optically communicated with a guide distal end 122D of the energy guide 122A. Additionally, in such embodiments, the photoacoustic transducer 154 may have a shape corresponding to and / or conforming to the guide distal end 122D of the energy guide 122A.

[0066] The photoacoustic transducer 154 is configured to convert light energy into sound waves at or near the distal end 122D of the energy guide 122A. The direction of the sound waves can be customized by changing the angle of the distal end 122D of the energy guide 122A.

[0067] In some embodiments, the photoacoustic transducer 154 disposed at the distal end 122D of the energy guide 122A may have the same shape as the distal end 122D of the energy guide 122A. For example, in some non-exclusive embodiments, the photoacoustic transducer 154 and / or the distal end 122D may have a conical shape, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a semi-circular shape, an oval shape, etc. The energy guide 122A may further include additional photoacoustic transducers 154 disposed along one or more side surfaces along the length of the energy guide 122A.

[0068] In some embodiments, the energy guide 122A may further include one or more steering features or "steering gears" within the energy guide 122A. Figure 1 (Not shown in the diagram), the one or more steering features or "steering devices" are configured to direct energy toward a side surface and toward the balloon wall 130 away from the energy guide 122A, the side surface of which may be located at or near the guide distal end 122D of the energy guide 122A. The steering feature may include any feature of the system that deflects energy from the energy guide 122A away from its axial path toward the side surface of the energy guide 122A. Additionally, each of the energy guides 122A may include one or more optical windows disposed along a longitudinal or circumferential surface of each energy guide 122A and in optical communication with the steering feature. Alternatively, the steering feature may be configured to direct energy in the energy guide 122A toward a side surface at or near the guide distal end 122D, wherein the side surface is in optical communication with the optical window. The optical window may include a portion of the energy guide 122A that allows energy to leave the energy guide 122A from within the energy guide 122A, such as a portion of the energy guide 122A that lacks cladding material on or around the energy guide 122A.

[0069] Examples of suitable deflection features include reflective elements, refractive elements, and / or fiber diffusers. Deflection features suitable for focusing energy away from the end of energy guide 122A may include, but are not limited to, deflection features with convex surfaces, gradient refractive index (GRIN) lenses, and specular focusing lenses. Upon contact with the deflection feature, energy is deflected within energy guide 122A to one or more of plasma generator 133 and photoacoustic transducer 154, which is optically connected to the side surface of energy guide 122A. Photoacoustic transducer 154 then converts the light energy into sound waves that extend away from the side surface of energy guide 122A.

[0070] Additionally, or in alternatives, in some embodiments, the steering features that may be incorporated into the energy guide 122A may also be incorporated into the design of the energy manifold 129 to direct and / or concentrate acoustic and mechanical energy toward a specific area of ​​the balloon wall 130 that is in contact with the vascular lesion 106A at the treatment site 106, so as to apply pressure to such vascular lesion 106A and induce rupture therein.

[0071] The source manifold 136 may be located at or near the proximal portion 114 of the catheter system 100. The source manifold 136 may include one or more proximal openings that may receive one or more energy guides 122A, guidewires 112, and / or inflatable conduits 140 from the energy guide bundle 122, the inflatable conduits being connected in fluid communication with a fluid pump 138. The catheter system 100 may also include a fluid pump 138 configured to inflate the balloon 104 as needed with catheter fluid 132 (i.e., via the inflatable conduit 140).

[0072] As mentioned above, in Figure 1 In the embodiment shown, the system console 123 includes one or more of an energy source 124, a power supply 125, a system controller 126, and a GUI 127. Alternatively, the system console 123 may include more than Figure 1 The components shown may have more or fewer components. For example, in some non-exclusive alternative embodiments, the system console 123 may be designed without a GUI 127. Alternatively, in the absence of a specific requirement for the system console 123, one or more of an energy source 124, a power supply 125, a system controller 126, and a GUI 127 may be provided within the conduit system 100.

[0073] As shown in the figure, the system console 123 and its included components are operatively coupled to the conduit 102, the energy guide bundle 122, and the remainder of the conduit system 100. For example, in some embodiments, such as Figure 1As shown, the system console 123 may include a console connection port 148 (sometimes also commonly referred to as a "jack") through which the energy guide bundle 122 is mechanically coupled to the system console 123. In such embodiments, the energy guide bundle 122 may include a guide coupling housing 150 (sometimes also commonly referred to as a "ring") that accommodates a portion of each of the energy guides 122A (e.g., the proximal end 122P of the guide). The guide coupling housing 150 is configured to be fitted and selectively held within the console connection port 148 to provide mechanical coupling between the energy guide bundle 122 and the system console 123.

[0074] The energy guide bundle 122 may also include a guide bundle 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 take on a more compact form during use of the catheter system 100 as it extends into the blood vessel 108 together with the catheter 102.

[0075] Energy source 124 may be selectively and / or alternatively coupled to be optically connected to each of the energy guides 122A in the energy guide bundle 122, i.e., coupled to the proximal end 122P of each of the energy guides 122A. Specifically, energy source 124 is configured to generate energy (e.g., a pulsed source beam) in the form of a source beam 124A, which may be selectively and / or alternatively directed to and received by each of the energy guides 122A in the energy guide bundle 122 as a separate guide beam 124B. Alternatively, catheter system 100 may include more than one energy source 124. For example, in a non-exclusive alternative embodiment, catheter system 100 may include a separate energy source 124 for each of the energy guides 122A in the energy guide bundle 122.

[0076] Energy source 124 can have any suitable design. In some embodiments, energy source 124 can be configured to provide submillisecond energy pulses that are focused onto a small spot to connect it to the proximal end 122P of the energy guide 122A. Such energy pulses are then guided / directed along energy guide 122A to a location within balloon interior 146 of balloon 104, thereby inducing plasma formation in the conduit fluid 132 within balloon interior 146 of balloon 104, for example, via a plasma generator 133 that may be located at the distal end 122D of the energy guide 122A. Specifically, energy emitted at the distal end 122D of the energy guide 122A excites plasma generator 133 to form plasma within the conduit fluid 132 within balloon interior 146. Plasma formation causes rapid bubble formation and imparts pressure waves to treatment site 106. Figure 1 An exemplary plasma-induced bubble 134 is shown in the figure.

[0077] In various non-exclusive alternative embodiments, submillisecond energy pulses from energy source 124 may be delivered to treatment site 106 at frequencies between approximately 1 Hz and 5000 Hz, between approximately 30 Hz and 1000 Hz, between approximately 10 Hz and 100 Hz, or between approximately 1 Hz and 30 Hz. Alternatively, submillisecond energy pulses may be delivered to treatment site 106 at frequencies greater than 5000 Hz or less than 1 Hz, or any other suitable frequency range.

[0078] It should be understood that although the energy source 124 is typically used to provide energy pulses, the energy source 124 can still be described as providing a single source beam 124A, i.e., a single pulse source beam.

[0079] The energy source 124 suitable for use may include various types of light sources, including lasers and lamps. Alternatively, the energy source 124 may include any suitable type of energy source.

[0080] Suitable lasers may include short-pulse lasers operating on a sub-millisecond timescale. In some embodiments, energy source 124 may include a laser operating on a nanosecond (ns) timescale. Lasers may also include short-pulse lasers operating on picosecond (ps), femtosecond (fs), and microsecond (µs) timescales. It should be understood that many combinations of laser wavelengths, pulse widths, and energy levels are possible to achieve plasma in the conduit fluid 132 of conduit 102. In various non-exclusive alternative embodiments, the pulse width may include pulse widths falling within the range of at least 10 ns to 3000 ns, at least 20 ns to 100 ns, or at least 1 ns to 500 ns. Alternatively, any other suitable pulse width range may be used.

[0081] Exemplary nanosecond lasers may include nanosecond lasers spanning the UV to IR spectrum (wavelengths from about 10 nanometers (nm) to 1 millimeter (mm)). In some embodiments, an energy source 124 suitable for use in the conduit system 100 may include an energy source capable of generating light at wavelengths from at least 750 nm to 2000 nm. In other embodiments, energy source 124 may include an energy source capable of generating light at wavelengths from at least 700 nm to 3000 nm. In still other embodiments, energy source 124 may include an energy source capable of generating light at wavelengths from at least 100 nm to 10 micrometers (μm). Nanosecond lasers may include nanosecond lasers having a repetition rate of up to 200 kHz.

[0082] In some embodiments, the laser may include a Q-switched thulium-doped yttrium aluminum garnet (Tm:YAG) laser. In other embodiments, the laser may include a neodymium-doped yttrium aluminum garnet (Nd:YAG) laser, a holmium-doped yttrium aluminum garnet (Ho:YAG) laser, an erbium-doped yttrium aluminum garnet (Er:YAG) laser, an excimer laser, a helium-neon laser, a carbon dioxide laser, and doped, pulsed, or fiber lasers.

[0083] In yet another embodiment, energy source 124 may include a plurality of lasers grouped together in series. In still another embodiment, energy source 124 may include one or more low-energy lasers fed into a high-energy amplifier (such as a master oscillator power amplifier (MOPA)). In yet another embodiment, energy source 124 may include a plurality of lasers that may be connected in parallel or in series to provide the energy required to generate plasma bubbles 134 in the duct fluid 132.

[0084] The catheter system 100 can generate a pressure wave with a maximum pressure ranging from at least 1 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 system 100 can generate a pressure wave with a maximum pressure ranging from 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.

[0085] When the catheter 102 is placed at the treatment site 106, a pressure wave can be applied to the treatment site 106 from a distance ranging from at least about 0.1 mm to more than about 25 mm extending radially from the self-energy guide 122A. In various non-exclusive alternative embodiments, when the catheter 102 is placed at the treatment site 106, a pressure wave can be applied to the treatment site 106 from a distance ranging from at least about 10 mm to 20 mm, at least about 1 mm to 10 mm, at least about 1.5 mm to 4 mm, or at least about 0.1 mm to 10 mm extending radially from the self-energy guide 122A. In other embodiments, a pressure wave can be applied to the treatment site 106 from another suitable distance different from the foregoing ranges. In some embodiments, a pressure wave can be applied to the treatment site 106 at a distance ranging from at least about 0.1 mm to 10 mm, within a range of at least about 2 MPa to 30 MPa. In some embodiments, a pressure wave may be applied to the treatment site 106 at a distance of at least about 0.1 mm to 10 mm, ranging from at least about 2 MPa to 25 MPa. Alternatively, other suitable pressure ranges and distances may be used.

[0086] Power supply 125 is electrically connected to and configured to provide the necessary power to each of energy source 124, system controller 126, GUI 127, and handle assembly 128. Power supply 125 can have any suitable design for such purposes.

[0087] System controller 126 is electrically connected to power supply 125 and receives power from it. Additionally, system controller 126 is coupled to energy source 124 and GUI 127 and is configured to control the operation of each of them. System controller 126 may include one or more processors or circuits to achieve the purpose of controlling the operation of at least energy source 124 and GUI 127. For example, system controller 126 may control energy source 124 to generate energy pulses as needed and / or at any desired firing rate.

[0088] The system controller 126 can also be configured to control the operation of other components of the catheter system 100, such as positioning the catheter 102 adjacent to the treatment site 106, inflating the balloon 104 with catheter fluid 132, etc. Further, or in an alternative, the catheter system 100 may include one or more additional controllers that can be positioned in any suitable manner to achieve the purpose of controlling various operations of the catheter system 100. For example, in some embodiments, an additional controller and / or a portion of the system controller 126 may be positioned and / or incorporated within the handle assembly 128.

[0089] The GUI 127 is accessible to the user or operator of the catheter system 100. Additionally, the GUI 127 is electrically connected to the system controller 126. In this design, the user or operator can use the GUI 127 to ensure that the catheter system 100 is effectively utilized to apply pressure to the vascular lesions 106A at the treatment site 106 and induce rupture within these vascular lesions. The GUI 127 can provide the user or operator with information that can be used before, during, and after the use of the catheter system 100. In one embodiment, the GUI 127 can provide the user or operator with static visual data and / or information. 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 the use of the catheter system 100. In various embodiments, the GUI 127 may include one or more colors, different sizes, different brightness levels, etc., which can serve as an alert to the user or operator. Additionally, or alternatively, the GUI 127 can provide the user or operator with audio data or information. The details of GUI 127 may vary depending on the design requirements of the conduit system 100 or the specific needs, specifications and / or expectations of the user or operator.

[0090] like Figure 1 As shown, the handle assembly 128 can 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 104 and positioned spaced apart from the balloon 104. Alternatively, the handle assembly 128 can be positioned at another suitable location.

[0091] The handle assembly 128 is held and used by a user or operator to operate, position, and control the catheter 102. The design and specific features of the handle assembly 128 can be varied to suit the design requirements of the catheter system 100. Figure 1In the embodiments shown, the handle assembly 128 is separate from, but electrically and / or fluidly connected to, one or more of the system controller 126, power source 124, fluid pump 138, and GUI 127. In some embodiments, the handle assembly 128 may integrate and / or include at least a portion of the system controller 126 within the handle assembly 128. For example, as shown, in some such embodiments, the handle assembly 128 may include a circuitry 156 that may form at least a portion of the system controller 126. In one embodiment, the circuitry 156 may include a printed circuit board having one or more integrated circuits, or any other suitable circuitry. In alternative embodiments, the circuitry 156 may be omitted, or it may be included within the system controller 126, which in various embodiments may be located external to the handle assembly 128, for example, within the system console 123. It should be understood that the handle assembly 128 may include fewer or additional components than those specifically shown and described herein.

[0092] The energy manifold 129 is configured to guide and / or concentrate energy generated within the catheter fluid 132 within the balloon interior 146, so as to apply pressure to the vascular lesion 106A within the vessel wall 108A of the vessel 108 or at the treatment site 106 adjacent to the vessel wall and induce rupture therein. More specifically, the energy manifold 129 is configured to concentrate and guide acoustic and / or mechanical energy toward a specific area of ​​the balloon wall 130 in contact with the vascular lesion 106A at the treatment site 106, to enhance the delivery of such energy to the treatment site 106. Therefore, the energy manifold 129 can effectively improve the efficacy of the catheter system 100.

[0093] It should be understood that in some embodiments, a single energy manifold 129 may be included and / or incorporated into each individual energy guide 122A. Alternatively, in other embodiments, a single energy manifold 129 may be configured to operate in conjunction with more than one energy guide 122A. Still alternatively, each energy guide 122A does not need to have an energy manifold 129 incorporated therein or associated with it.

[0094] The design and / or specific positioning of the energy manifold 129 can vary to suit the requirements of the catheter system 100. In various embodiments, the energy manifold 129 may be coupled to and / or secured to the energy guide 122A, i.e., at or near the guide distal end 122D of the energy guide 122A. Alternatively, the energy manifold 129 may be separate from and / or spaced apart from the energy guide 122A.

[0095] In some embodiments, the energy manifold 129 may include a manifold body 260 (e.g., in...). Figure 2 (as shown in the image) and one or more manifold orifices 262 (e.g., in...) Figure 2 (As shown in the diagram), the one or more manifold orifices are positioned within and / or extend through the manifold body 260 to guide acoustic and / or mechanical energy (in the form of plasma already generated within the catheter fluid 132) toward the balloon wall 130 positioned adjacent to the treatment site 106. The one or more manifold orifices 262 can be provided in any suitable size, shape, orientation, and pattern to guide acoustic and / or mechanical energy as needed. For example, in some embodiments, the manifold orifice 262 can be circular, square, rectangular, triangular, or have other suitable shapes specifically designed to guide and concentrate acoustic and / or mechanical energy to a specific location within the balloon 104.

[0096] Additionally, the energy manifold 129 may include any suitable number of manifold orifices 262. For example, in some embodiments, the energy manifold 129 may include only a single manifold orifice 262, which may be positioned above, within, or along the manifold body 260 of the energy manifold 129. Alternatively, in other embodiments, the energy manifold 129 may include multiple manifold orifices 262, such as two, three, four, or more than four manifold orifices 262, which may be positioned in any suitable pattern above, within, or along the manifold body 260 of the energy manifold 129. In one non-exclusive embodiment of this type, the manifold orifices 262 may be positioned in a radial pattern around the circumference of the energy manifold 129. In another non-exclusive embodiment of this type, the manifold orifices 262 may be arranged in a helical pattern extending along the length of the energy manifold 129. In yet another non-exclusive embodiment of this type, the manifold orifices 262 may be staggered along the length of the energy manifold 129 to emit in alternating directions. Alternatively, the manifold orifices 262 may be arranged in another suitable manner above, within, or along the manifold body 260 of the energy manifold 129.

[0097] Various alternative embodiments of the energy manifold 129 are shown and described in detail in the following figures.

[0098] Figure 2 This is a schematic cross-sectional view of a portion of an embodiment of a conduit system 200, including an energy manifold 229. The design of the conduit system 200 can vary. In various embodiments, such as Figure 2As shown, the catheter system 200 may include: a catheter 202 including a catheter shaft 210; a balloon 204 having a balloon wall 230 defining a balloon interior 246, a proximal balloon 204P and a distal balloon 204D, and catheter fluid 232 substantially retained within the balloon interior 246; an energy guide 222A; and an energy manifold 229. Alternatively, in other embodiments, the catheter system 200 may include more or fewer components than those specifically shown and described herein. For example, Figure 1 Certain components shown (e.g., guidewire 112, guidewire lumen 118, source manifold 136, fluid pump 138, energy source 124, power supply 125, system controller 126, GUI 127, and handle assembly 128) are not included for clarity purposes. Figure 2 It is specifically shown in the diagram, but will likely be included in any embodiment of the catheter system 200.

[0099] The design and function of the catheter shaft 210, balloon 204, catheter fluid 232, and energy guide 222A are substantially similar to those shown and described above. Therefore, a detailed description of such components will not be repeated.

[0100] Balloon 204 is again in a deflated state suitable for advancing catheter 202 through the patient's vasculature and suitable for positioning catheter 202 relative to treatment site 106 (at Figure 1 (As shown in the diagram) The balloon can be selectively moved between inflated states at the appropriate location. In some embodiments, the proximal end 204P of the balloon can be coupled to the catheter shaft 210, and the distal end 204D of the balloon can be coupled to the guidewire lumen 118 (in... Figure 1 (As shown in the image). The balloon 204 can be refilled with fluid from the catheter 232 (e.g., from the fluid pump 138). Figure 1 (as shown in the image) is inflated, and the fluid in the conduit is inflated via the inflatable conduit 140 (in the image). Figure 1 (As shown in the image) It is guided into the balloon interior 246 of balloon 204.

[0101] Similar to the previous embodiments, the energy guide 222A may include one or more photoacoustic transducers 254. Figure 2The diagram shows only one photoacoustic transducer 254, wherein each photoacoustic transducer 254 may be optically communicated with an energy guide 222A in which it is disposed. In some embodiments, the photoacoustic transducer 254 may be optically communicated with a guide distal end 222D of the energy guide 222A. Additionally, in such embodiments, the photoacoustic transducer 254 may have a shape corresponding to and / or conforming to the guide distal end 222D of the energy guide 222A. The photoacoustic transducer 254 is configured to convert light energy into sound waves at or near the guide distal end 222D of the energy guide 222A. The direction of the sound waves can be customized by changing the angle of the guide distal end 222D of the energy guide 222A.

[0102] In various embodiments, the energy manifold 229 is configured to guide and / or concentrate energy generated in the catheter fluid 232 within the balloon interior 246 to deliver pressure to the vascular lesion 106A at the treatment site 106. Figure 1 (As shown in the illustration) and induce rupture therein. More specifically, the energy manifold 229 is configured to direct and concentrate acoustic and / or mechanical energy toward a specific area of ​​the balloon wall 230 that contacts the vascular lesion 106A at the treatment site 106, to enhance the delivery of such energy to the treatment site 106. Further, as shown in this embodiment, the energy manifold 229 is located inside the balloon 204, which may be filled with catheter fluid 232.

[0103] As in Figure 2 As shown in the embodiment illustrated, the power manifold 229 is coupled to and / or fixed to the power guide 222A. Alternatively, the power manifold 229 may be separate from and / or spaced apart from the power guide 222A.

[0104] The design of the energy manifold 229 can be varied. In some embodiments, such as Figure 2As shown, the energy manifold 229 includes a manifold body 260 and one or more manifold orifices 262, which are positioned within and / or extend through the manifold body to guide energy (in the form of plasma already generated within the catheter fluid 232) toward the balloon wall 230 positioned adjacent to the treatment site 106. Specifically, the one or more manifold orifices 262 are configured such that the energy generated within the catheter fluid 232 is directed outward (e.g., radially) toward the balloon wall 230 by using an energy guide 222A away from the energy guide 222A and the energy manifold 229. The energy manifold 229 and / or the manifold orifices 262 may be further configured and / or positioned in a manner that guides and concentrates energy to most effectively apply pressure to the vascular lesion 106A at a precise location within the vessel wall or adjacent to the treatment site 106 and induce rupture therein. Additionally, or in an alternative, the energy manifold 229 may include a ratio of Figure 2 The components shown in the diagram are further examples. In many embodiments, the energy manifold 229 may further include certain additional features that further affect the overall operation of the energy manifold 229 and thus may improve the overall effectiveness of the catheter system 200. For example, in other embodiments, the energy manifold 229 may include one or more of a guide end protector, an energy deflector, and an optical element, and may be used to more effectively concentrate and direct energy through the manifold orifice 262 and toward a desired location within the treatment site 106 as needed.

[0105] The manifold body 260 and manifold orifice 262 can have any suitable design, size, shape, and orientation. In its simplest form, the manifold body 260 is provided as a perforated, elongated, cylindrical tube, including one or more manifold orifices 262 as annotated perforations strategically positioned within and / or extending through the manifold body. (As in...) Figure 2 As shown in the embodiments illustrated, the manifold orifice 262 can be positioned in a radial pattern around the periphery 260C or circumference of the manifold body 260. Additionally, or in alternatives, the manifold orifice 262 can be positioned relative to the manifold body 260 in another suitable manner. For example, in some non-exclusive embodiments, the manifold orifice 262 can also be positioned spaced apart from each other along the length 260L of the manifold body 260 and / or the manifold orifice 262 can be arranged in a spiral pattern extending along the length 260L of the manifold body 260. Alternatively, the manifold body 260 can have another suitable design and / or the manifold orifice 262 can be positioned in another suitable manner.

[0106] like Figure 2As shown, the energy guide 222A can be located at or near the manifold proximal end 260P of the manifold body 260, that is, the guide distal end 222D of the energy guide 222A is inserted into the manifold proximal end 260P of the elongated manifold body 260. For example, in Figure 2 As shown in the embodiments illustrated, the energy guide 222A may have a generally hemispherical, spherical guide distal end 222D through which energy is guided out of the energy guide 222A. Alternatively, the guide distal end 222D may have another suitable shape, such as a flat, split end, or any other suitable shape. In some embodiments, the energy guide 222A may be secured (e.g., directly secured) to the manifold body 260. The energy guide 222A may be secured to the manifold body 260 in any suitable manner. However, it should be understood that the energy guide 222A does not need to be directly secured to the manifold body 260. In some embodiments, the energy guide 222A may include a guide sheath 264 configured to surround and protect the energy guide 222A along its substantial length.

[0107] As shown, the manifold body 260 defines a generally cylindrical body chamber 266 (or "body cavity") that extends away from the distal guide end 222D of the energy guide 222A and toward the distal manifold end 260D of the manifold body 260. Alternatively, the manifold body 260 may define a body chamber 266 with another suitable shape, such as a slightly tapered design, a segmented chamber, and / or a body chamber 266 other than a generally cylindrical shape.

[0108] During use of the catheter system 200, the catheter fluid 232 used to inflate the balloon 204 is also allowed to enter from inside the balloon 246 through one or more manifold orifices 262 into at least a portion of the body chamber 266 defined by the manifold body 260. Subsequently, pulsed energy guided by the energy guide 222A generates plasma-induced bubbles 134 in front of the distal end 222D of the guide and within the catheter fluid 232 present in the body chamber 266 of the energy manifold 229. Figure 1 (As shown in the diagram). As bubble 134 expands, it drives the conduit fluid 232 ahead of it down the length of the body chamber 266. Thus, the expanding bubble 134 is guided through the body chamber 266 and is allowed to selectively escape as it passes through and / or through manifold orifices 262, which are formed in and extend through the manifold body 260. Consequently, manifold orifices 262 direct and concentrate the energy from the plasma-induced bubble 134 outward toward the balloon wall 230 and deliver there the energy (e.g., acoustic energy from the photoacoustic transducer 254).

[0109] In this embodiment, the distal manifold 260D is substantially flat and sealed, thereby blocking and redirecting energy generated within the body chamber 266, such as any energy initially passing through the manifold orifice 262 within the body chamber 266 and returning toward the manifold orifice 262. Therefore, energy can be more effectively directed through the manifold orifice 262 and toward the balloon wall 230 adjacent to the treatment site 106.

[0110] In this design, energy generated by an energy guide 222A can be distributed through the long, narrow balloon 204 of the catheter assembly 200 and can be guided (e.g., radially) through the manifold orifice 262 and toward the balloon wall 230. Therefore, energy from an energy guide 222A and / or an energy source 124 (especially in a longer balloon 204) can simultaneously treat multiple areas of the treatment site 106 (or multiple treatment sites 106).

[0111] It should be understood that the manifold orifice 262 can vary in size, shape, and orientation to distribute energy uniformly along the length 260L of the manifold body 260 as the energy within the bubble 134 dissipates over the propagation distance. For example, in some embodiments, the manifold orifice 262 may be smaller toward the manifold proximal end 260P of the manifold body 260 and larger toward the manifold distal end 260D of the manifold body 260. In various non-exclusive embodiments, the manifold orifice 262 may be substantially circular, elliptical, square, rectangular, or another suitable shape.

[0112] The manifold body 260 may include any suitable number of manifold orifices 262 to direct energy toward (multiple) vascular lesions at the treatment site 106 as needed.

[0113] Figure 3 This is a schematic cross-sectional view of another embodiment of the energy guide 322A and the energy manifold 329. As shown in this embodiment, the energy manifold 329 is designed, positioned, and functionally similar to that of the energy guide 322A and the energy manifold 329. Figure 2The energy manifold 229 shown and described is substantially similar. For example, the energy manifold 329 again includes: a manifold body 360 including a manifold proximal end 360P coupled to and / or fixed to a guide distal end 322D of the energy guide 322A and a substantially flat, sealed manifold distal end 360D; and one or more manifold orifices 362 formed in and / or extending through the manifold body 360. In this embodiment, the energy manifold 329 is again configured to channel acoustic and / or mechanical energy from a body chamber 366, as defined by the manifold body 360, through the manifold orifices 362 toward the balloon wall 230 (in Figure 2 (as shown in the image) and treatment site 106 (in the image) Figure 1 Vascular lesion 106A (as shown in the image) at the location shown in the image. Figure 1 (As shown in the image) Specific areas of contact are guided and concentrated to enhance the delivery of such energy to the treatment site 106.

[0114] However, in this embodiment, the distal end 322D of the energy guide 322A has a slightly different shape than in the previous embodiment. Specifically, as... Figure 3 As shown, the energy guide 322A may have a flat, cleaved guide distal end 322D (through which energy is guided out of the energy guide 322A and into the body chamber 366), rather than a generally hemispherical, spherical end as shown in the previous embodiments. In non-exclusive alternative embodiments, the guide distal end 322D may be conical, wedge-shaped, or pyramidal. Alternatively, the guide distal end 322D may have any other suitable geometry, shape, or configuration.

[0115] Figure 4 This is a schematic cross-sectional view of another embodiment of the energy guide 422A and the energy manifold 429. (See attached image) Figure 4 As shown, the energy manifold 429 is slightly similar in design, positioning, and function to the previous embodiment. For example, the energy manifold 429 again includes: a manifold body 460, which includes a manifold proximal end 460P coupled to and / or fixed to the distal end 422D of the energy guide 422A; and one or more manifold orifices 462 formed in and / or extending through the manifold body 460, i.e., at various points along the length 460L of the manifold body 460 and / or around the perimeter 460C of the manifold body 460. In this embodiment, the energy manifold 429 is again configured to channel acoustic and / or mechanical energy from the body chamber 466 defined by the manifold body 460 through the manifold orifices 462 toward the balloon wall 230 (in Figure 2 (as shown in the image) and treatment site 106 (in the image) Figure 1Vascular lesion 106A (as shown in the image) at the location shown in the image. Figure 1 (As shown in the diagram) Specific areas of contact are guided and concentrated to enhance the delivery of such energy to the treatment site 106. It should be understood that at least a portion of the catheter fluid 432 and / or plasma positioned and / or generated within the body chamber 466 of the manifold body 460 is also... Figure 4 It is displayed in the middle.

[0116] However, as in Figure 4 As shown in the embodiment illustrated, the energy manifold 429 and / or energy guide 422A further include a guide end protector 468 and an energy deflector 470.

[0117] Guide end protector 468 is coupled to the distal guide end 422D of energy guide 422A. Guide end protector 468 is configured to at least substantially completely surround or encircle the distal guide end 422D to protect the distal guide end 422D from fluid in conduit 232 (in Figure 2 The effects of plasma and pressure waves generated within the energy guide 422A are illustrated in the diagram. However, the guide end protector 468 is formed in such a manner that energy can still be emitted from the guide distal end 422D of the energy guide 422A as needed. The guide end protector 468 can have any suitable design and / or can be formed from any suitable material. For example, in some non-exclusive embodiments, the guide end protector 468 may include one or more of the following and / or be formed from one or more of the following: silicone, polymethyl methacrylate (PMMA), epoxy resin, or other suitable polymers.

[0118] In some embodiments, as shown, the manifold body 460 (e.g., the manifold proximal end 460P of the manifold body 460) may be directly fixed and / or coupled to the guide end protector 468. Alternatively, in such embodiments, at least a portion of the guide end protector 468 is positioned between the manifold proximal end 460P and the energy guide 422A. Additionally, or in an alternative, at least a portion of the manifold proximal end 460P of the manifold body 460 may be substantially directly fixed and / or coupled to the energy guide 422A.

[0119] The energy diverter 470 is configured to divert energy generated within the conduit fluid 232 within the body chamber 466, so that such energy is directed more accurately toward the manifold orifice 462 formed in the manifold body 460. The energy diverter 470 can have any suitable size, shape, and design to achieve the purpose of diverting and directing energy toward the manifold orifice 462 as needed. Figure 4In the embodiment shown, the energy steering unit 470 is slightly conical and has a substantially flat, angled outer surface, and is positioned adjacent to the manifold distal end 460D such that energy is deflected away from the manifold distal end 460D and directed toward a manifold orifice 462 located near the manifold distal end 460D. Additionally, in some embodiments, the energy steering unit 470 may include one or more of a reflective element, a refractive element, and a fiber diffuser. Alternatively, the energy steering unit 470 may have another suitable size, shape, or design, or be adapted to... Figure 4 The different positioning methods are specifically illustrated. For example, in some embodiments, the energy steering unit 470 may include a convex surface, a concave surface, be slightly spherical, or have another suitable shape.

[0120] Figure 5 This is a schematic cross-sectional view of another embodiment of the energy guide 522A and the energy manifold 529. (See attached image.) Figure 5 As shown, the energy manifold 529 is slightly similar in design, positioning, and function to the previous embodiment. For example, the energy manifold 529 again includes: a manifold body 560 including a manifold proximal end 560P coupled to and / or fixed to the distal end 522D of the energy guide 522A; and one or more manifold orifices 562 formed in and / or extending through the manifold body 560. In this embodiment, the energy manifold 529 is again configured to channel acoustic and / or mechanical energy from a body chamber 566, as defined by the manifold body 560, through the manifold orifices 562 toward the balloon wall 230 (in Figure 2 (as shown in the image) and treatment site 106 (in the image) Figure 1 Vascular lesion 106A (as shown in the image) at the location shown in the image. Figure 1 (As shown in the image) Specific areas of contact are guided and concentrated to enhance the delivery of such energy to the treatment site 106.

[0121] and Figure 4 Similar to the embodiment shown, the energy manifold 529 may again include an energy diverter 570 positioned adjacent to the distal end 560D of the manifold, such that energy is deflected away from the sealed distal end 560D and deflected toward the manifold orifice 562. In this embodiment, the energy diverter 570 is substantially spherical. Alternatively, the energy diverter 570 may have, in addition to Figure 5 Another suitable size, shape, or design other than the size, shape, or design shown in the document.

[0122] However, in this embodiment, the energy manifold 529 and / or energy guide 522A may further include an optical element 572 (e.g., a lens or another suitable type of optical element) directly coupled to and / or formed directly on the guide distal end 522D of the energy guide 522A. Additionally, as shown, the optical element 572 may be positioned to extend into a body chamber 566, as defined by the manifold body 560. In some embodiments, the optical element 572 may be an energy-resistant optical element configured to focus energy (e.g., light energy) guided from the guide distal end 522D. Additionally, the optical element 572 may be further configured to enhance the flow in the conduit fluid 232 (in... Figure 2 The energy required to form plasma is concentrated within the conduit (as shown in the diagram), and the fluid in the conduit can be held within the manifold body 560, i.e., within the body chamber 566. In some such embodiments, the optical element 572 may be formed of sapphire. Alternatively, the optical element 572 may be formed of one or more other suitable materials.

[0123] As shown in the figure, in some embodiments, the optical element 572 and a portion of the manifold proximal end 560P can also form a protective housing for the guide distal end 522D of the energy guide 522A, i.e., to interact with... Figure 4 The guide end protector 468 shown in the image is in a slightly similar manner.

[0124] exist Figure 5 In the illustrated embodiment, the body chamber 566 may have a generally tapered design, such that the body chamber 566 is larger and / or wider near the manifold proximal end 560P, the energy guide 522A, and the optical element 572, and smaller and / or thinner near the manifold distal end 560D and the manifold orifice 562. For such a design, the body chamber 566 may include and / or be divided into the following: a bubble initiation chamber 556A, which is substantially adjacent to the optical element 572, and in which the plasma bubble 134 (in...) Figure 1 (As shown in the diagram) can be formed within the catheter fluid 232; and a focusing chamber 556B, substantially adjacent to the distal manifold 560D and the energy diverter 570, and configured to more effectively focus and concentrate the mechanical and / or acoustic energy from the plasma bubbles 134 toward the distal manifold 560D as the plasma bubbles 134 expand. Furthermore, manifold orifices 562 (in this embodiment, at least some of these orifices are located near the distal manifold 560D) can more effectively concentrate and guide the mechanical and / or acoustic energy of the bubbles 134 outward in a radial pattern toward a specific area of ​​the balloon wall 230 that contacts the vascular lesion 106A at the treatment site 106, to enhance the delivery of such energy to the treatment site 106.

[0125] Figure 6 This is a schematic cross-sectional view of another embodiment of the energy guide 622A and the energy manifold 629. (See attached image) Figure 6 As shown, the energy manifold 629 is slightly similar in design, positioning, and function to the previous embodiment. For example, the energy manifold 629 again includes: a manifold body 660 including a manifold proximal end 660P coupled to and / or secured to a distal end 622D of the energy guide 622A; and one or more manifold orifices 662 formed in and / or extending through the manifold body 660. In this embodiment, the manifold body 660 includes only a single manifold orifice 662 positioned near a substantially flat, sealed distal end 660D. Alternatively, the energy manifold 629 may include more than one manifold orifice 662, which may be positioned spaced apart along the length 660L of the manifold body 660 and / or radially positioned around the periphery 660C or circumference of the manifold body 660 in any suitable pattern.

[0126] In this embodiment, the manifold body 660 is slightly thicker in the region where it is joined and / or secured (bonded) to the distal end 622D of the energy guide 622A to provide strain relief. Alternatively, as shown in the figure, the wall of the manifold body 660 at or near the proximal end 660P of the manifold and substantially adjacent to the energy guide 622A is slightly thicker than the rest of the manifold body 660 wall.

[0127] Additionally, the energy manifold 629 is again configured to channel acoustic and / or mechanical energy from the body chamber 666, as defined by the manifold body 660, through the manifold orifice 662 and toward the balloon wall 230 (in Figure 2 (as shown in the image) and treatment site 106 (in the image) Figure 1 Vascular lesion 106A (as shown in the image) at the location shown in the image. Figure 1 (As shown in the image) Specific areas of contact are guided and concentrated to enhance the delivery of such energy to the treatment site 106.

[0128] like Figure 6 As shown, in this embodiment, the energy manifold 629 again includes an optical element 672 configured to focus and concentrate energy guided from the distal end 622D of the guide to the fluid in the conduit 232 (in Figure 2Plasma is formed within the manifold body 660 (as shown in the diagram), and the conduit fluid can be held within the manifold body 660, i.e., within the body chamber 666. However, in this embodiment, the optical element 672 is positioned spaced apart from the distal end 622D of the energy guide 622A to define an air space 674 between the distal end 622D and the optical element 672. In one embodiment, the optical element 672 may be a spherical lens press-fitted into the body chamber 666 defined by the manifold body 660. Press-fitting the optical element 672 within the body chamber 666 effectively seals the air space 674 and isolates it from the portion of the body chamber 666 where the conduit fluid 232 is held. With this design, the sealed air space 674 allows energy from the energy guide 622A to expand before the energy guide is coupled to the optical element 672 without initiating plasma within the air space 674. It should be understood that the region of the body chamber 666 distal to the optical element 672 will be immersed in the conduit fluid 232 to achieve the purpose of generating plasma therein. In such embodiments, the optical element 672 may be formed of sapphire. Alternatively, the optical element 672 may have a different design and / or be formed of one or more other suitable materials. Additionally, or in alternatives, in some non-exclusive embodiments, the air space 674 may be filled with a transparent optical medium (such as PMMA, epoxy resin, etc.) to connect the energy guide 622A to the optical element 672. Still alternatively, the air space 674 may also comprise a transparent refractive index-matching liquid, oil, or another suitable fluid.

[0129] Figure 7 This is a schematic cross-sectional view of another embodiment of the energy guide 722A and the energy manifold 729. (See attached image.) Figure 7 As shown, the energy manifold 729 is slightly similar in design, positioning, and function to the previous embodiment. For example, the energy manifold 729 again includes: a manifold body 760, which includes a manifold proximal end 760P coupled to and / or fixed to the distal end 722D of the energy guide 722A; and one or more manifold orifices 762 formed in and / or extending through the manifold body 760. In this embodiment, the energy manifold 729 is again configured to channel acoustic and / or mechanical energy from a body chamber 766, as defined by the manifold body 760, through the manifold orifices 762 toward the balloon wall 230 (in Figure 2 (as shown in the image) and treatment site 106 (in the image) Figure 1 Vascular lesion 106A (as shown in the image) at the location shown in the image. Figure 1 (As shown in the image) Specific areas of contact are guided and concentrated to enhance the delivery of such energy to the treatment site 106.

[0130] In this embodiment, the energy manifold 729 includes only a single manifold orifice 762, which is positioned near an angled, sealed distal end 760D of the manifold. As shown in this embodiment, the manifold orifice 762 may be slightly larger and / or wider than in previous embodiments to guide plasma-induced bubbles 134 outward in a radial direction away from the manifold body 760. Figure 1 (i.e., the mechanical and / or acoustic energy of the plasma-induced bubble 134 as shown in the illustration). More specifically, the shape of the manifold orifice 762 in this embodiment guides the bubble 134, as well as the mechanical and / or acoustic energy, outward in a concentrated, highly directional pattern. Alternatively, the energy manifold 729 may include more than one manifold orifice 762, which may be positioned spaced apart along the length 760L of the manifold body 760 and / or radially positioned around the perimeter 760C or circumference of the manifold body 760 in any suitable pattern. Still alternatively, the distal end 760D of the manifold may have, in addition to Figure 7 Another suitable design and / or shape other than the design and / or shape shown.

[0131] Additionally, in this embodiment, the manifold body 760 is again slightly thicker in the region where it is joined and / or secured (bonded) to the distal end 722D of the energy guide 722A. However, the manifold body 760 further has a smaller perimeter 760C or circumference in that region adjacent to the distal end 722D, but then tapers outwards away from the distal end 722D to have a slightly larger perimeter 760C or circumference throughout the rest of the manifold body 760. This design is again utilized to provide strain relief.

[0132] like Figure 7 As shown, in this embodiment, the energy manifold 729 again includes an optical element 772 configured to focus and concentrate energy guided from the distal end 722D of the guide to the fluid in the conduit 232 (in Figure 2 Plasma is formed within the manifold body 760 (as shown in the diagram), and the fluid in the conduit can be held within the manifold body 760, i.e., within the body chamber 766. Figure 6Similarly, in this embodiment, the optical element 772 is again positioned spaced apart from the distal end 722D of the energy guide 722A to define an air space 774 between the distal end 722D and the optical element 772. In one embodiment, the optical element 772 may be a sapphire lens incorporated into the manifold body 760 to effectively seal the air space 774 and isolate it from the portion of the body chamber 766 that holds the conduit fluid 232. With this design, the sealed air space 774 again allows energy from the energy guide 722A to expand before it is coupled to the optical element 772 without initiating plasma in the air space 774. In such embodiments, the region of the body chamber 766 distal to the optical element 772 is immersed in the conduit fluid 232 to achieve the purpose of generating plasma therein. Alternatively, the optical element 772 may have a different design and / or be formed of one or more other suitable materials. Additionally, or in alternative embodiments, in some non-exclusive embodiments, the air space 774 may be refilled with a transparent optical medium (such as PMMA, epoxy resin, etc.) to connect the energy guide 722A to the optical element 772.

[0133] Figure 8 This is a schematic cross-sectional view of yet another embodiment of the energy guide 822A and the energy manifold 829. (See attached image.) Figure 8 As shown, the energy manifold 829 is somewhat similar in design, positioning, and function to the previous embodiment. For example, the energy manifold 829 again includes: a manifold body 860 including a manifold proximal end 860P coupled to and / or secured to a distal end 822D of the energy guide 822A; and one or more manifold orifices 862 formed in and / or extending through the manifold body 860. In this embodiment, the energy manifold 829 includes manifold orifices 862 that are radially positioned around the periphery 860C or circumference of the manifold body 860 near the substantially flat, sealed distal end 860D of the manifold body 860. Alternatively, the energy manifold 829 may include any suitable number of manifold orifices 862, which may be positioned spaced apart along the length 860L of the manifold body 860 and / or radially positioned around the perimeter 860C or circumference of the manifold body 860 in any suitable pattern.

[0134] In this embodiment, the energy manifold 829 is again configured to channel acoustic and / or mechanical energy from the body chamber 866, as defined by the manifold body 860, through the manifold orifice 862 toward the balloon wall 230 (in Figure 2 (as shown in the image) and treatment site 106 (in the image) Figure 1 Vascular lesion 106A (as shown in the image) at the location shown in the image. Figure 1 (As shown in the image) Specific areas of contact are guided and concentrated to enhance the delivery of such energy to the treatment site 106.

[0135] However, as Figure 8 As shown, the energy manifold 829 (i.e., manifold body 860) is coupled to the energy guide 822A in a manner different from that in the previous embodiments. Specifically, as illustrated, the energy manifold 829 and / or the energy guide 822A further include a guide end cap 876 and an optical element 872 (e.g., a lens). More specifically, as shown... Figure 8 As shown, the guide cap 876 is substantially directly coupled to the guide distal end 822D of the energy guide 822A, and the optical element 872 is substantially directly coupled to the guide cap 876. Additionally, as shown, the manifold body 860 (i.e., the manifold proximal end 860P of the manifold body 860) is fixed (attached) to the optical element 872. Thus, the body chamber 866 is defined by the manifold body 860 between the optical element 872 and the manifold distal end 860D of the manifold body 860; and the manifold body 860 is positioned spaced apart from the guide distal end 822D of the energy guide 822A.

[0136] In some embodiments, the guide end cap 876 and the optical element 872 may be formed of silicon dioxide or any other type of glass that can be effectively bonded to the guide distal end 822D of the energy guide 822A. Bonding can be accomplished by melting the glass using a CO2 laser or an arc discharge power source. Alternatively, bonding can be accomplished using a polymer adhesive (such as a UV-cured epoxy or acrylate). Still alternatively, bonding can be accomplished in another suitable manner. And again alternatively, the guide end cap 876 and / or the optical element 872 may be formed of other suitable materials.

[0137] As with some of the embodiments described above, the guide cap 876 and the optical element 872 are configured to focus and concentrate the energy guided from the distal end 822D of the guide to the fluid in the conduit 232 (in Figure 2 Plasma is formed within the manifold body 860 (as shown in the diagram), allowing the fluid in the conduit to be held within the body chamber 866. Subsequently, plasma-induced bubbles 134 (in...) Figure 1 (As shown in the diagram) (i.e., the mechanical energy and / or acoustic energy of the plasma-induced bubble 134) can be guided outward in a radial direction away from the manifold body 860 through the manifold orifice 862 and toward a specific area of ​​the balloon wall 230 that contacts the vascular lesion 106A at the treatment site 106.

[0138] Figure 9A This is a schematic cross-sectional view of an alternative embodiment of an energy guiding component 978A that can be used within a conduit system 100. Specifically, Figure 9A The diagram illustrates an energy guiding assembly 978A comprising an energy guide 922A, an extension tube 980A coupled to and / or fixed to the energy guide 922A, and a plasma generator 933A. Alternatively, the energy guiding assembly 978A may include... Figure 9A The components shown and described in the text may have more or fewer components.

[0139] The energy conductor 922A is substantially similar to the energy conductors previously described in detail. Therefore, the energy conductor 922A will not be described in detail again. As shown, the energy conductor 922A includes a core 986A surrounded by a cladding 988A. The core 986A and the cladding 988A of the energy conductor 922A can be formed of one or more materials, including but not limited to one or more types of glass, silicon dioxide, or one or more polymers. The core 986A and the cladding 988A are configured such that energy from the energy source 124 (in...) Figure 1 The energy (shown as energy beam 990A) from the near end of the guide (as shown in the image) is emitted from the proximal end of the guide. Figure 9A (Not shown) is effectively guided along the length of energy guide 922A to the distal end 922D of guide. Additionally, as shown, in some embodiments, energy guide 922A may further include a guide sheath 964A configured to surround and protect energy guide 922A along its substantial length.

[0140] The extension tube 980A is coupled to and / or secured to the energy guide 922A and extends away from the energy guide 922A. More specifically, as shown, the extension tube 980A may be coupled to and / or secured to the distal end 922D of the energy guide 922A and extends away from the distal end 922D of the energy guide 922A. In various embodiments, the extension tube 980A is substantially hollow and configured to carry the balloon 104 (in Figure 1 The balloon inside 146 (as shown in the image) Figure 1 Some conduit fluid 932A is shown in the diagram. In some embodiments, extension tube 980A includes tube walls 982A formed of a polymeric non-conductive or dielectric material surrounding the distal end 922D of the energy conductor 922A. For example, extension tube 980A and / or tube walls 982A may be formed of one or more of the following: Polytetrafluoroethylene (PTFE), polyethylene, Or other suitable materials.

[0141] As shown in the figure, it should be understood that in some embodiments, the extension tube 980A may further include a tube inlet 992A through which the conduit fluid 932A enters the extension tube 980A.

[0142] Importantly, in such embodiments, the wall 982A of the extension tube 980A has a refractive index that is less than that of the conduit fluid 932A at the wavelength of the energy 990A from the energy source 124. For example, in some such embodiments, the conduit fluid 932A may have a refractive index between approximately 1.50 and 1.60, and the wall 982A of the extension tube 980A may have a refractive index between approximately 1.30 and 1.50.

[0143] The refractive index difference between the fluid 932A and the wall 982A causes total internal reflection of light incident on the inner surface of the wall 982A, thus guiding it back along the axis of the extension tube 980A. The numerical aperture NA for this configuration is given by the following formula:

[0144]

[0145] Ideally, the NA of the extension tube 980A will be equal to or greater than the NA of the energy guide 922A. This will ensure that all light energy 990A transmitted to the distal end 922D of the energy guide 922A will be captured and transmitted to the plasma generator 933A. When the NA of the extension tube 980A is equal to or greater than the NA of the energy guide 922A, all energy 990A entering the extension tube 980A will be captured and transmitted forward (i.e., toward the plasma generator 933A).

[0146] The physical behavior of energy 990A within extension tube 980A is essentially the same as that within energy conductor 922A itself, except that the material inside extension tube 980A is fluid and is not susceptible to damage from plasma-induced bubbles or pressure waves. Unlike the robust materials typically used to form energy conductor 922A, polymers or dielectric materials are compliant. In some cases, such materials in energy conductor 922A can be easily broken or fragmented by acousto-mechanical energy or impacts from high-speed particles. Extension tube 980A can also transmit optical energy very close to plasma generator 933A, thereby improving its conversion efficiency. The compliant nature of the material forming extension tube 980A and the fact that the main conductor (i.e., conduit fluid 932A) is liquid allow it to be protected from energy and the resulting pressure waves from localized plasma to a degree far greater than that achievable with rigid, brittle materials.

[0147] It should be understood that the energy guide 922A and the extension tube 980A can have any suitable length. For example, in some embodiments, the energy guide 922A may extend substantially into the balloon 104 and the extension tube 980A may extend only within the balloon interior 146 of the balloon 104. Alternatively, in other embodiments, the extension tube 980A may extend in length and potentially pass through the catheter 102 (in Figure 1 The energy carrier is the main part of the structure shown in the image.

[0148] Plasma generator 933A is configured to generate plasma when energy 990A, transmitted through energy guide 922A and extension tube 980A, contacts the plasma generator. Plasma generator 933A can have any suitable design and / or can be made of any suitable material. For example, in some embodiments, plasma generator 933A can be formed of either a metallic or ceramic material. Alternatively, plasma generator 933A can be made of other suitable materials.

[0149] It should be understood that by including the extension tube 980A, the distal end 922D of the energy guide 922A can be more effectively kept spaced from the plasma generated within the conduit fluid 932A. Therefore, this design provides a means to improve the durability and lifespan of the distal end 922D of the energy guide 922A. More specifically, the advantages of this method may include, but are not limited to: 1) removing the distal end 922D of the energy guide 922A from the point of localized plasma generation, thereby minimizing the destructive effects from bubbles and plasma without degrading performance;

[0150] 2) It provides a simple means of transferring energy to the plasma generator 933A; 3) It allows a concentrated energy beam to be transmitted directly to the plasma generator 933A with minimal spacing, which improves conversion efficiency and the pressure wave generation capability of the energy guiding component 978A; and 4) It simplifies the design of the plasma generator 933A by reducing the dependence on the optical and mechanical properties of the energy guiding component 922A.

[0151] In various embodiments, the energy guiding component 978A is further coupled to embodiments of an energy manifold, such as those described in detail above. More specifically, the energy guiding component 978A can be used with any of the previously described embodiments of an energy manifold. Alternatively, in some embodiments, the energy guiding component 978A can be utilized without being coupled to an energy manifold.

[0152] Figure 9BThis is a schematic cross-sectional view of another alternative embodiment of the energy guiding assembly 978B. As shown, the energy guiding assembly 978B is substantially similar to the energy guiding assembly shown in the previous embodiments. For example, the energy guiding assembly 978B again includes an energy guide 922B and a plasma generator 933B that are substantially similar to those in the previous embodiments. Additionally, the energy guiding assembly 978B again includes an extension tube 980B that is coupled to and / or secured to the guide distal end 922D of the energy guide 922B and extends away from the guide distal end 922D of the energy guide 922B.

[0153] However, in this embodiment, the extension tube 980A differs slightly from that in the previous embodiment. More specifically, in Figure 9B In the illustrated embodiment, the wall 982B of the extension tube 980B can be formed of a rigid material (such as a metal or ceramic material), and a dielectric or polymer coating 984B can be applied to the inner surface 994B of the wall 982B. For such a design, the wall 982B can provide a stronger mechanical structure and resistance to compression and damage caused by plasma and acousto-mechanical energy. The coating 984B on the inner surface 994B of the wall 982B can provide a lower refractive index relative to the fluid 932B in the conduit, thereby producing total internal reflection of the transmitted energy 990B.

[0154] It should be understood that coating 984B can be added to the inner surface 994B of tube wall 982B by any suitable method. For example, coating 984B can be added to the inner surface 994B of tube wall 982B using solvent film or chemical vapor deposition (CVD). Many options exist for coating a uniform thin film onto a rigid substrate. A basic requirement will be that the thickness of coating 984B is ten times or more the wavelength of energy 990B.

[0155] In various embodiments, energy manifolds can be used to address many problems present in more conventional conduit systems. For example:

[0156] 1) Energy manifolds allow the use of a single energy guide (e.g., a single laser pressure wave generator) to treat multiple areas (multiple lesions) within the treatment site that are in contact with a long balloon catheter, eliminating the need for multiple energy guides or multiple connected energy sources (e.g., laser energy sources).

[0157] 2) In traditional catheter systems, pressure wave energy emitted from the end of a single energy guide or fiber optic source is directed into a complete spherical volume, thus contacting a cylindrical region inside the balloon. This may make the single energy guide method effective only for rupturing calcified lesions with a perfectly circular cross-section. However, energy manifolds can concentrate and target mechanical energy to specific areas by selectively modifying the design of the manifold body and the size, shape, and number of manifold orifices within the manifold body. As a result, this is far more effective for rupturing lesions with discontinuous or semi-circular cross-sections.

[0158] 3) In various embodiments, the mechanical assembly of the energy manifold itself provides a means of protecting the distal end of the energy guide from the reaction forces and pressures generated by the expanding bubbles.

[0159] It should be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural indicators unless the content and / or context clearly specify otherwise. It should also be noted that, unless the content or context clearly specifies otherwise, the term “or” is generally used to mean “and / or.”

[0160] It should also be noted that, as used in this specification and the appended claims, the phrase “configured” describes a system, device, or other structure that is constructed or configured to perform a particular task or employ a particular configuration. The phrase “configured” may be used interchangeably with other similar phrases, such as “arranged and configured,” “constructed and arranged,” “constructed,” “manufactured and arranged,” etc.

[0161] The headings used herein are provided for the purpose of maintaining consistency with the recommendations of 37 CFR 1.77 or otherwise providing organizational guidance. These headings should not be construed as limiting or characterizing any invention(s) set forth in any of the claims that may be made in this disclosure. For example, the description of the technology in the “Background Art” section is not an admission that the technology is prior art to any of the invention(s) set forth in this disclosure. Nor are the “Summary” or “Abstract” considered as characterization of any of the invention(s) set forth in the proposed claims.

[0162] 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, these embodiments have been chosen and described to enable those skilled in the art to understand and comprehend the principles and practices. Consequently, various aspects have been described with reference to specific and preferred embodiments and techniques. However, it should be understood that many variations and modifications can be made while remaining within the spirit and scope of this document.

[0163] It should be understood that although many different embodiments of the catheter system have been shown and described herein, one or more features of any one embodiment may be combined with one or more features of one or more other embodiments, provided that such combination satisfies the intent of the invention.

[0164] While many exemplary aspects and embodiments of the catheter system have been discussed above, those skilled in the art will recognize certain modifications, arrangements, additions, and sub-combinations thereof. Therefore, it is intended that the appended claims and the claims described below be construed as including all such modifications, arrangements, additions, and sub-combinations as they are in their true spirit and scope, and are not intended to limit the details of the constructions or designs shown herein.

Claims

1. A catheter system for treating vascular lesions within or adjacent to a blood vessel in a patient's body, the catheter system comprising a catheter fluid and an energy source for generating energy, the catheter system comprising: A balloon, comprising a balloon wall defining an interior of the balloon, the balloon being configured to retain catheter fluid within the balloon, the balloon being selectively inflatable with the catheter fluid to an inflated state, wherein, when the balloon is in the inflated state, the balloon wall is configured to be positioned substantially adjacent to the vascular lesion; An energy guide, comprising a distal end of a guide selectively positioned near the vascular lesion, the energy guide being configured to receive energy from the energy source and generate plasma bubbles within the catheter fluid; and An energy manifold comprising: (i) a manifold body defining a body chamber, the manifold body including a manifold proximal end fixed to a distal end of the guide, the body chamber being configured to retain at least some of the conduit fluid in the conduit fluid; and (ii) a manifold orifice extending through the manifold body. The distal end of the guide and the energy manifold are positioned inside the balloon; and The energy manifold guides the energy from the plasma bubble out of the main body chamber through the manifold orifice, away from the energy guide, and outward toward the balloon wall that is substantially adjacent to the vascular lesion.

2. The catheter system according to claim 1, wherein, The energy manifold includes a plurality of manifold orifices extending through the manifold body; and wherein the energy manifold is configured to direct energy from the plasma bubble out of the body chamber and toward the vascular lesion through each of the plurality of manifold orifices.

3. The catheter system according to claim 2, wherein, The multiple manifold orifices are positioned in a radial pattern around the periphery of the manifold body.

4. The catheter system according to claim 2, wherein, The multiple manifold orifices are arranged in a spiral pattern along the length of the manifold body.

5. The catheter system according to claim 2, wherein, The multiple manifold orifices are positioned along the length of the manifold body.

6. The catheter system according to claim 1, wherein, The energy guide generates one or more pressure waves within the fluid in the catheter, which exert force on the vascular lesion.

7. The catheter system according to claim 1, wherein, The energy guide includes optical fibers.

8. The catheter system according to claim 1, wherein, The manifold body is a substantially cylindrical tube and defines a substantially cylindrical body chamber.

9. The catheter system according to claim 1, wherein, The manifold body also includes a corresponding distal manifold end; and wherein the body chamber tapers toward the distal manifold end.

10. The catheter system of claim 1, further comprising: A guide end protector is attached to the distal end of the guide, and the guide end protector is configured to protect the distal end of the guide from the energy of the plasma bubble generated in the body chamber.

11. The catheter system according to claim 1, wherein, The energy manifold further includes an energy deflector that directs energy from plasma bubbles generated in the body chamber toward the manifold orifice.

12. The catheter system according to claim 11, wherein, The manifold body includes a manifold distal end, wherein the energy steering unit is positioned adjacent to the manifold distal end.

13. The catheter system according to claim 1, wherein, The energy manifold further includes an optical element configured to focus energy directed from the distal end of the energy guide.

14. The catheter system according to claim 13, wherein, The optical element is made of sapphire.

15. The catheter system according to claim 13, wherein, The optical element is directly connected to the distal end of the energy guide.

16. The catheter system according to claim 13, wherein, The optical element is formed directly onto the distal end of the energy guide.

17. The catheter system according to claim 13, wherein, The optical element is positioned spaced apart from the distal end of the energy conductor to define an air space between the distal end of the conductor and the optical element.

18. The catheter system according to claim 17, wherein, The air space is sealed and isolated from the rest of the body chamber, so that no conduit fluid is retained within the air space.

19. The catheter system according to claim 17, wherein, The air space is filled with a transparent optical medium.

20. The catheter system according to claim 1, wherein, The fluid in the conduit includes either a wetting agent or a surfactant.

21. The catheter system of claim 1, further comprising: An extension tube is connected to the distal end of the energy guide and extends away from the distal end of the energy guide. The extension tube is configured to retain at least some of the fluid in the conduit, wherein energy from the energy source is transmitted through the extension tube after being guided by the energy guide.

22. The catheter system according to claim 1, wherein, The balloon includes a drug-eluting coating.

Images