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WO2024026322A1 - Ensemble de routage pour système de cathéter de lithotripsie intravasculaire - Google Patents

Ensemble de routage pour système de cathéter de lithotripsie intravasculaire Download PDF

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Publication number
WO2024026322A1
WO2024026322A1 PCT/US2023/070970 US2023070970W WO2024026322A1 WO 2024026322 A1 WO2024026322 A1 WO 2024026322A1 US 2023070970 W US2023070970 W US 2023070970W WO 2024026322 A1 WO2024026322 A1 WO 2024026322A1
Authority
WO
WIPO (PCT)
Prior art keywords
routing
guide
energy
assembly
degrees
Prior art date
Application number
PCT/US2023/070970
Other languages
English (en)
Inventor
Eric Schultheis
Alvin Salinas
Peter Dahl
Original Assignee
Bolt Medical, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/357,947 external-priority patent/US20240032995A1/en
Application filed by Bolt Medical, Inc. filed Critical Bolt Medical, Inc.
Priority to CN202380049620.1A priority Critical patent/CN119343100A/zh
Priority to EP23757471.0A priority patent/EP4561481A1/fr
Publication of WO2024026322A1 publication Critical patent/WO2024026322A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/26—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00184—Moving parts
    • A61B2018/00196—Moving parts reciprocating lengthwise
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00369—Heart valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2205—Characteristics of fibres
    • A61B2018/2211—Plurality of fibres
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/26—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
    • A61B2018/263—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy the conversion of laser energy into mechanical shockwaves taking place in a liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/26—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy
    • A61B2018/266—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor for producing a shock wave, e.g. laser lithotripsy the conversion of laser energy into mechanical shockwaves taking place in a part of the probe
    • G—PHYSICS
    • G02—OPTICS
    • G02B—OPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B6/00—Light guides; Structural details of arrangements comprising light guides and other optical elements, e.g. couplings
    • G02B6/24—Coupling light guides
    • G02B6/36—Mechanical coupling means
    • G02B6/3616—Holders, macro size fixtures for mechanically holding or positioning fibres, e.g. on an optical bench
    • G02B6/3624—Fibre head, e.g. fibre probe termination

Definitions

  • Vascular lesions within vessels in the body can be associated with an increased risk for major adverse events, such as myocardial infarction, embolism, deep vein thrombosis, stroke, and the like. Severe vascular lesions, such as severely calcified vascular lesions, can be challenging to treat and achieve patency for a physician in a clinical setting.
  • vascular lesions may be treated using interventions such as drug therapy, balloon angioplasty, atherectomy, stent placement, and vascular graft bypass, to name a few. Such interventions may not always be ideal or may require subsequent treatment to address the lesion.
  • Intravascular lithotripsy is one method that has been recently used with some success for breaking up vascular lesions within vessels in the body.
  • Intravascular lithotripsy utilizes a combination of pressure waves and bubble dynamics that are generated intravascularly in a fluid-filled balloon catheter.
  • a high energy source is used to generate plasma and, ultimately, pressure waves as well as a rapid bubble expansion within a fluid-filled balloon to crack calcification at a treatment site within the vasculature that includes one or more vascular lesions.
  • the associated rapid bubble formation from the plasma initiation and resulting localized fluid velocity within the balloon transfers mechanical energy through the incompressible fluid to impart a fracture force on the intravascular calcium, which is opposed to the balloon wall.
  • the rapid change in fluid momentum upon hitting the balloon wall is known as hydraulic shock, or water hammer.
  • the present invention is directed toward a catheter system for treating a treatment site within or adjacent to a vessel wall or a heart valve within a body of a patient.
  • the catheter system includes a first energy guide, a second energy guide, and a routing assembly.
  • the routing assembly defines a routing space that retains a routing length of each of the energy guides.
  • the routing assembly includes an inner routing guide that is positioned within the routing space.
  • the routing length of each of the energy guides is positioned at least partially about the inner routing guide.
  • the routing space is configured so that the routing length of at least one of the energy guides is adjustable.
  • each of the energy guides includes an optical fiber.
  • each of the energy guides includes a guide distal end and a guide proximal end.
  • the guide proximal end is fixed relative to the routing assembly.
  • the guide distal end is movable relative to the routing assembly.
  • each energy guide is positioned at least approximately 90 degrees about the inner routing guide.
  • the catheter system further includes an adapter assembly that houses the inner routing guide.
  • the catheter system further includes an electrical cable that is positioned about the inner routing guide.
  • each energy guide includes an optical guide that protects each energy guide.
  • the catheter system further includes a handle assembly that is usable by a user to selectively position the energy guides near the treatment site, the routing assembly being positioned outside of the handle assembly.
  • the catheter system further includes a connector assembly that brings each of the energy guides closer together so that the energy guides are in a more compact form, the routing assembly being positioned within the connector assembly.
  • the catheter system includes a first energy guide and a second energy guide, a handle assembly, and a routing assembly.
  • the handle assembly is usable by a user to selectively position the energy guides near the treatment site.
  • the routing assembly defines a routing space that retains a routing length of each of the energy guides.
  • the routing assembly is positioned outside of the handle assembly.
  • the routing assembly includes an inner routing guide that is positioned within the routing space.
  • the routing length of each of the energy guides is positioned at least partially about the inner routing guide.
  • the routing space is configured so that the routing length of at least one of the energy guides is adjustable.
  • the catheter system further comprises a connector assembly that brings each of the energy guides closer together so that the energy guides are in a more compact form, the routing assembly being positioned within the connector assembly.
  • each of the energy guides includes an optical fiber.
  • each of the energy guides includes a guide distal end and a guide proximal end.
  • the guide proximal end is fixed relative to the routing assembly.
  • the guide distal end is movable relative to the routing assembly.
  • each of the energy guides is positioned at least approximately 90 degrees about the inner routing guide.
  • the catheter system further comprises an adapter assembly that houses the inner routing guide.
  • the catheter system includes a first energy guide and a second energy guide, a handle assembly, a connector assembly, and a routing assembly.
  • the handle assembly is usable by a user to selectively position the energy guides near the treatment site.
  • the connector assembly brings each of the energy guides closer together so that the energy guides are in a more compact form.
  • the routing assembly defines a routing space that retains a routing length of each of the energy guides, the routing assembly is positioned outside of the handle assembly.
  • the routing assembly includes an inner routing guide that is positioned within the routing space.
  • the routing length of each of the energy guides is positioned at least partially about the inner routing guide.
  • the routing space is configured so that the routing length of at least one of the energy guides is adjustable.
  • Each of the energy guides is positioned at least approximately 90 degrees about the inner routing guide.
  • Figure 1 is a simplified schematic cross-sectional view of an embodiment of a catheter system in accordance with various embodiments, the catheter system including a handle assembly having features of the present invention
  • Figure 2A is a simplified schematic view of a portion of an embodiment of the catheter system, including a handle assembly and an adapter assembly;
  • Figure 2B is a simplified schematic cross-sectional view of the embodiment of the adapter assembly in Figure 2A, including a routing assembly;
  • Figure 3 is a perspective view of an embodiment of an optical guide for use in the catheter system.
  • Figure 4A is a simplified schematic cross-sectional view of an embodiment of a connector assembly, including the routing assembly;
  • Figure 4B is a simplified schematic cross-sectional view of the routing assembly in Figure 4A;
  • Figure 40 is a cross-sectional view of the routing assembly taken on lines 4C-4C in Figure 4B;
  • Figure 5 is a simplified top view illustration of an embodiment of the connector assembly.
  • vascular lesions can reduce major adverse events or death in affected subjects.
  • a major adverse event is one that can occur anywhere within the body due to the presence of a vascular lesion.
  • Major adverse events can include, but are not limited to, major adverse cardiac events, major adverse events in the peripheral or central vasculature, major adverse events in the brain, major adverse events in the musculature, or major adverse events in any of the internal organs.
  • intravascular lesion As used herein, the terms "treatment site, "intravascular lesion,” and “vascular lesion” are used interchangeably unless otherwise noted. As such, the intravascular lesions and/or the vascular lesions are sometimes referred to herein simply as “lesions.”
  • the catheter systems disclosed herein can include many different forms.
  • FIG 1 a simplified schematic cross-sectional view illustration is shown of a catheter system 100 in accordance with various embodiments.
  • the catheter system 100 is suitable for imparting pressure waves to induce fractures in one or more vascular lesions within or adjacent to a vessel wall of a blood vessel or on or adjacent to a heart valve within a body of a patient.
  • the catheter system 100 can include one or more of a catheter 102, an energy guide bundle 122 including one or more energy guides 122A, a fluid pump 138, a system console 123 including one or more of an energy source 124, a power source 125, a system controller 126, and a graphic user interface 127 (a "GUI"), and a handle assembly 128 that includes a source manifold 136 integrated therein.
  • the catheter system 100 can include more components or fewer components than those specifically illustrated and described in relation to Figure 1.
  • the catheter 102 is configured to move to the treatment site 106 within or adjacent to a vessel wall 108A of a blood vessel 108 within a body 107 of a patient 109.
  • the treatment site 106 can include one or more vascular lesions 106A, such as calcified vascular lesions, for example. Additionally, or in the alternative, the treatment site 106 can include vascular lesions 106A, such as fibrous vascular lesions. Still alternatively, in some implementations, the catheter 102 can be used at a treatment site 106 within or adjacent to a heart valve within the body 107 of the patient 109.
  • the catheter 102 can include an inflatable balloon 104 (sometimes referred to herein simply as a "balloon"), a catheter shaft 110, and a guidewire 112.
  • the balloon 104 can be coupled to the catheter shaft 110.
  • the balloon 104 can include a balloon proximal end 104P and a balloon distal end 104D.
  • the catheter shaft 110 can extend from a proximal portion 114 of the catheter system 100 to a distal portion 116 of the catheter system 100.
  • the catheter shaft 110 can include a longitudinal axis 144.
  • the catheter 102 and/or the catheter shaft 110 can also include a guidewire lumen 118, which is configured to move over the guidewire 112. As utilized herein, the guidewire lumen 118 defines a conduit through which the guidewire 112 extends.
  • the catheter shaft 110 can further include an inflation lumen (not shown) and/or various other lumens for various other purposes.
  • the catheter 102 can have a distal end opening 120 and can accommodate and be tracked over the guidewire 112 as the catheter 102 is moved and positioned at or near the treatment site 106.
  • the balloon proximal end 104P can be coupled to the catheter shaft 110, and the balloon distal end 104D can be coupled to the guidewire lumen 118.
  • the balloon 104 includes a balloon wall 130 that defines a balloon interior 146.
  • the balloon 104 can be selectively inflated with a catheter fluid 132 to expand from a deflated state suitable for advancing the catheter 102 through a patient's vasculature, to an inflated state (as shown in Figure 1 ) suitable for anchoring the catheter 102 in position relative to the treatment site 106.
  • the balloon wall 130 of the balloon 104 is configured to be positioned substantially adjacent to the treatment site 106.
  • Figure 1 illustrates the balloon wall 130 of the balloon 104 being shown spaced apart from the treatment site 106 of the blood vessel 108 when in the inflated state, this is done for ease of illustration. It is recognized that the balloon wall 130 of the balloon 104 will typically be substantially directly adjacent to and/or abutting the treatment site 106 when the balloon 104 is in the inflated state.
  • the balloon 104 suitable for use in the catheter system 100 includes those that can be passed through the vasculature of a patient 109 when in the deflated state.
  • the balloons 104 are made from silicone.
  • the balloon 104 can be made from materials such as polydimethylsiloxane (PDMS), polyurethane, polymers such as PEBAXTM material, nylon, or any other suitable material.
  • PDMS polydimethylsiloxane
  • polyurethane polymers such as PEBAXTM material, nylon, or any other suitable material.
  • the balloon 104 can have any suitable diameter (in the inflated state). In various embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from less than one millimeter (mm) up to 25 mm. In some embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from at least 1 .5 mm up to 14 mm. In some embodiments, the balloon 104 can have a diameter (in the inflated state) ranging from at least two mm up to five mm.
  • the balloon 104 can have a length ranging from at least three mm to 300 mm. More particularly, in some embodiments, the balloon 104 can have a length ranging from at least eight mm to 200 mm. It is appreciated that a balloon 104 having a relatively longer length can be positioned adjacent to larger treatment sites 106, and, thus, may be usable for imparting pressure waves onto and inducing fractures in larger vascular lesions 106A or multiple vascular lesions 106A at precise locations within the treatment site 106. It is further appreciated that a longer balloon 104 can also be positioned adjacent to multiple treatment sites 106 at any one given time.
  • the balloon 104 can be inflated to inflation pressures of between approximately one atmosphere (atm) and 70 atm. In some embodiments, the balloon 104 can be inflated to inflation pressures of from at least 20 atm to 60 atm. In other embodiments, the balloon 104 can be inflated to inflation pressures of from at least six atm to 20 atm. In still other embodiments, the balloon 104 can be inflated to inflation pressures of from at least three atm to 20 atm. In yet other embodiments, the balloon 104 can be inflated to inflation pressures from at least two atm to ten atm.
  • the balloon 104 can have various shapes, including, but not to be limited to, a conical shape, a square shape, a rectangular shape, a spherical shape, a conical/square shape, a conical/spherical shape, an extended spherical shape, an oval shape, a tapered shape, a bone shape, a stepped diameter shape, an offset shape, or a conical offset shape.
  • the balloon 104 can include a drug-eluting coating or a drug-eluting stent structure.
  • the drug-eluting coating or drug-eluting stent can include one or more therapeutic agents including anti-inflammatory agents, anti-neoplastic agents, anti-angiogenic agents, and the like.
  • the catheter fluid 132 can be a liquid or a gas.
  • the catheter fluid 132 suitable for use can include, but are not limited to one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases, such as carbon dioxide, or any other suitable catheter fluid 132.
  • the catheter fluid 132 can be used as a base inflation fluid.
  • the catheter fluid 132 can include a mixture of saline to contrast medium in a volume ratio of approximately 50:50.
  • the catheter fluid 132 can include a mixture of saline to contrast medium in a volume ratio of approximately 25:75.
  • the catheter fluid 132 can include a mixture of saline to contrast medium in a volume ratio of approximately 75:25. However, it is understood that any suitable ratio of saline to contrast medium can be used.
  • the catheter fluid 132 can be tailored on the basis of composition, viscosity, and the like so that the rate of travel of the pressure waves is appropriately manipulated.
  • the catheter fluids 132 suitable for use are biocompatible.
  • a volume of catheter fluid 132 can be tailored by the chosen energy source 124 and the type of catheter fluid 132 used.
  • the contrast agents used in the contrast media can include, but are not to be limited to, iodine-based contrast agents, such as ionic or non-ionic iodine-based contrast agents.
  • ionic iodine-based contrast agents include diatrizoate, metrizoate, iothalamate, and ioxaglate.
  • non-ionic iodine-based contrast agents include iopam idol, iohexol, ioxilan, iopromide, iodixanol, and ioversol. In other embodiments, non-iodine-based contrast agents can be used.
  • Suitable non-iodine containing contrast agents can include gadolinium (lll)-based contrast agents.
  • Suitable fluorocarbon and perfluorocarbon agents can include, but are not to be limited to, agents such as the perfluorocarbon dodecafluoropentane (DDFP, C5F12).
  • the catheter fluids 132 can include those that include absorptive agents that can selectively absorb light in the ultraviolet region (e.g., at least ten nanometers (nm) to 400 nm), the visible region (e.g., at least 400 nm to 780 nm), or the near-infrared region (e.g., at least 780 nm to 2.5 pm) of the electromagnetic spectrum.
  • absorptive agents can include those with absorption maxima along the spectrum from at least ten nm to 2.5 pm.
  • the catheter fluids 132 can include those that include absorptive agents that can selectively absorb light in the mid-infrared region (e.g., at least 2.5 pm to 15 pm), or the far-infrared region (e.g., at least 15 pm to one mm) of the electromagnetic spectrum.
  • the absorptive agent can be those that have an absorption maximum matched with the emission maximum of the laser used in the catheter system 100.
  • the absorptive agents can be water-soluble. In other embodiments, the absorptive agents are not water-soluble. In some embodiments, the absorptive agents used in the catheter fluids 132 can be tailored to match the peak emission of the energy source 124.
  • the catheter shaft 110 of the catheter 102 can be coupled to the one or more energy guides 122A of the energy guide bundle 122 that are in optical communication with the energy source 124.
  • the energy guide(s) 122A can be disposed along the catheter shaft 110 and within the balloon 104.
  • each energy guide 122A can be an optical fiber, and the energy source 124 can be a laser.
  • the energy source 124 can be in optical communication with the energy guides 122A at the proximal portion 114 of the catheter system 100.
  • the catheter shaft 110 can be coupled to multiple energy guides 122A, such as a first energy guide, a second energy guide, a third energy guide, etc., which can be disposed at any suitable positions about and/or relative to the guidewire lumen 118 and/or the catheter shaft 110.
  • energy guides 122A such as a first energy guide, a second energy guide, a third energy guide, etc., which can be disposed at any suitable positions about and/or relative to the guidewire lumen 118 and/or the catheter shaft 110.
  • two energy guides 122A can be spaced apart by approximately 180 degrees about the circumference of the guidewire lumen 118 and/or the catheter shaft 110; three energy guides 122A can be spaced apart by approximately 120 degrees about the circumference of the guidewire lumen 118 and/or the catheter shaft 110; four energy guides 122A can be spaced apart by approximately 90 degrees about the circumference of the guidewire lumen 118 and/or the catheter shaft 110; six energy guides 122A can be spaced apart by approximately 60 degrees about the circumference of the guidewire lumen 118 and/or the catheter shaft 110; eight energy guides 122A can be spaced apart by approximately 45 degrees about the circumference of the guidewire lumen 118 and/or the catheter shaft 110; or ten energy guides 122A can be spaced apart by approximately 36 degrees about the circumference of the guidewire lumen 118 and/or the catheter shaft 110.
  • multiple energy guides 122A need not be uniformly spaced apart from one another about the circumference of the guidewire lumen 118 and/or the catheter shaft 110. More particularly, it is further appreciated that the energy guides 122A can be disposed uniformly or non-uniformly about the guidewire lumen 118 and/or the catheter shaft 110 to achieve the desired effect in the desired locations.
  • the catheter system 100 and/or the energy guide bundle 122 can include any number of energy guides 122A in optical communication with the energy source 124 at the proximal portion 114, and with the catheter fluid 132 within the balloon interior 146 of the balloon 104 at the distal portion 116.
  • the catheter system 100 and/or the energy guide bundle 122 can include from one energy guide 122A to greater than 30 energy guides 122A.
  • the catheter system 100 and/or the energy guide bundle 122 can include greater than 30 energy guides 122A.
  • the energy guides 122A can have any suitable design for purposes of generating plasma and/or pressure waves in the catheter fluid 132 within the balloon interior 146.
  • the general description of the energy guides 122A as light guides is not intended to be limiting in any manner, except for as set forth in the claims appended hereto. More particularly, although the catheter systems 100 are often described with the energy source 124 as a light source, and the one or more energy guides 122A as light guides, the catheter system 100 can alternatively include any suitable energy source 124 and energy guides 122A for purposes of generating the desired plasma in the catheter fluid 132 within the balloon interior 146.
  • the energy source 124 can be configured to provide high voltage pulses, and each energy guide 122A can include an electrode pair including spaced-apart electrodes that extend into the balloon interior 146.
  • each pulse of high voltage is applied to the electrodes and forms an electrical arc across the electrodes, which, in turn, generates the plasma and forms the pressure waves in the catheter fluid 132 that are utilized to provide the fracture force onto the vascular lesions 106A at the treatment site 106.
  • the energy source 124 and/or the energy guides 122A can have another suitable design and/or configuration.
  • the energy guides 122A can include an optical fiber or flexible light pipe.
  • the energy guides 122A can be thin and flexible and can allow light signals to be sent with very little loss of strength.
  • the energy guides 122A can include a core surrounded by a cladding about its circumference.
  • the core can be a cylindrical core or a partially cylindrical core.
  • the core and cladding of the energy guides 122A can be formed from one or more materials, including but not limited to one or more types of glass, silica, or one or more polymers.
  • the energy guides 122A may also include a protective coating, such as a polymer. It is appreciated that the index of refraction of the core will be greater than the index of refraction of the cladding.
  • Each energy guide 122A can guide energy along its length from a guide proximal end 122P to the guide distal end 122D having at least one optical window (not shown) that is positioned within the balloon interior 146.
  • the energy guides 122A can assume many configurations about and/or relative to the catheter shaft 110 of the catheter 102. In some embodiments, the energy guides 122A can run parallel to the longitudinal axis 144 of the catheter shaft 110. In some embodiments, the energy guides 122A can be physically coupled to the catheter shaft 110. In other embodiments, the energy guides 122A can be disposed along a length of an outer diameter of the catheter shaft 110. In yet other embodiments, the energy guides 122A can be disposed within one or more energy guide lumens within the catheter shaft 110.
  • the energy guides 122A can also be disposed at any suitable positions about the circumference of the guidewire lumen 118 and/or the catheter shaft 110, and the guide distal end 122D of each of the energy guides 122A can be disposed at any suitable longitudinal position relative to the length of the balloon 104 and/or relative to the length of the guidewire lumen 118 to more effectively and precisely impart pressure waves for purposes of disrupting the vascular lesions 106A at the treatment site 106.
  • the energy guides 122A can include one or more photoacoustic transducers 154, where each photoacoustic transducer 154 can be in optical communication with the energy guide 122A within which it is disposed.
  • the photoacoustic transducers 154 can be in optical communication with the guide distal end 122D of the energy guide 122A.
  • the photoacoustic transducers 154 can have a shape that corresponds with and/or conforms to the guide distal end 122D of the energy guide 122A.
  • the photoacoustic transducer 154 is configured to convert light energy into an acoustic wave at or near the guide distal end 122D of the energy guide 122A.
  • the direction of the acoustic wave can be tailored by changing an angle of the guide distal end 122D of the energy guide 122A.
  • the photoacoustic transducers 154 disposed at the guide distal end 122D of the energy guide 122A can assume the same shape as the guide distal end 122D of the energy guide 122A.
  • the photoacoustic transducer 154 and/or the guide distal end 122D can have a conical shape, a convex shape, a concave shape, a bulbous shape, a square shape, a stepped shape, a half-circle shape, an ovoid shape, and the like.
  • the energy guide 122A can further include additional photoacoustic transducers 154 disposed along one or more side surfaces of the length of the energy guide 122A.
  • the energy guides 122A can further include one or more diverting features or "diverters" (not shown in Figure 1 ), such as within the energy guide 122A and/or near the guide distal end 122D of the energy guide 122A, that are configured to direct energy from the energy guide 122A toward a side surface which can be located at or near the guide distal end 122D of the energy guide 122A, before the energy is directed toward the balloon wall 130.
  • a diverting feature can include any feature of the system that diverts energy from the energy guide 122A away from its axial path toward a side surface of the energy guide 122A.
  • the energy guides 122A can each include one or more optical windows disposed along the longitudinal or circumferential surfaces of each energy guide 122A and in optical communication with a diverting feature.
  • the diverting features can be configured to direct energy in the energy guide 122A toward a side surface that is at or near the guide distal end 122D, where the side surface is in optical communication with an optical window.
  • the optical windows can include a portion of the energy guide 122A that allows energy to exit the energy guide 122A from within the energy guide 122A, such as a portion of the energy guide 122A lacking a cladding material on or about the energy guide 122A.
  • Examples of the diverting features suitable for use include a reflecting element, a refracting element, and a fiber diffuser.
  • the diverting features suitable for focusing energy away from the tip of the energy guides 122A can include, but are not to be limited to, those having a convex surface, a gradient-index (GRIN) lens, and a mirror focus lens.
  • the energy is diverted within the energy guide 122A to one or more of a plasma generator 133 and the photoacoustic transducer 154 that is in optical communication with a side surface of the energy guide 122A.
  • the photoacoustic transducer 154 converts light energy into an acoustic wave that extends away from the side surface of the energy guide 122A.
  • the system console 123 includes one or more of the energy source 124, the power source 125, the system controller 126, and the GUI 127.
  • the system console 123 can include more components or fewer components than those specifically illustrated in Figure 1 .
  • the system console 123 can be designed without the GUI 127.
  • one or more of the energy source 124, the power source 125, the system controller 126, and the GUI 127 can be provided at any suitable location within the catheter system 100 without the specific need for the system console 123.
  • the system console 123 is operatively coupled to the catheter 102, the energy guide bundle 122, and the remainder of the catheter system 100.
  • the system console 123 can include a console connection aperture 148 (also sometimes referred to generally as a "socket") by which the energy guide bundle 122 is mechanically coupled to the system console 123.
  • the energy guide bundle 122 can include a guide coupling housing 150 (also sometimes referred to generally as a "ferrule”) that houses a portion, such as the guide proximal end 122P, of each of the energy guides 122A.
  • the guide coupling housing 150 is configured to fit and be selectively retained within the console connection aperture 148 to provide the mechanical coupling between the energy guide bundle 122 and the system console 123.
  • the energy guide bundle 122 can also include a connector assembly 152 (or "shell") that connects each of the individual energy guides 122A with the system console 123.
  • the energy source 124 can be selectively and/or alternatively coupled in optical communication with each of the energy guides 122A, such as to the guide proximal end 122P of each of the energy guides 122A, in the energy guide bundle 122.
  • the energy source 124 is configured to generate energy in the form of a source beam 124A, such as a pulsed source beam, that can be selectively and/or alternatively directed to and received by each of the energy guides 122A in the energy guide bundle 122 as an individual guide beam 124B.
  • the catheter system 100 can include more than one energy source 124.
  • the catheter system 100 can include a separate energy source 124 for each of the energy guides 122A in the energy guide bundle 122.
  • the energy source 124 can have any suitable design.
  • the energy source 124 can be configured to provide sub-millisecond pulses of energy from the energy source 124 that are focused onto a small spot in order to couple it into the guide proximal end 122P of the energy guide 122A. Such pulses of energy are then directed and/or guided along the energy guides 122A to a location within the balloon interior 146 of the balloon 104, thereby inducing plasma formation in the catheter fluid
  • the energy emitted at the guide distal end 122D of the energy guide 122A is directed toward and energizes the plasma generator 133 to form the plasma in the catheter fluid 132 within the balloon interior 146.
  • the plasma formation causes rapid bubble formation, and imparts pressure waves upon the treatment site 106.
  • An exemplary plasma-induced bubble 134 is illustrated in Figure 1.
  • the sub-millisecond pulses of energy from the energy source 124 can be delivered to the treatment site 106 at a frequency of between approximately one hertz (Hz) and 5000 Hz, between approximately 30 Hz and 1000 Hz, between approximately ten Hz and 100 Hz, or between approximately one Hz and 30 Hz.
  • the sub-millisecond pulses of energy can be delivered to the treatment site 106 at a frequency that can be greater than 5000 Hz or less than one Hz, or any other suitable range of frequencies.
  • the energy source 124 is typically utilized to provide pulses of energy, the energy source 124 can still be described as providing a single source beam 124A, i.e. , a single pulsed source beam.
  • the energy sources 124 suitable for use can include various types of light sources, including lasers and lamps. Alternatively, the energy sources 124 can include any suitable type of energy source.
  • Suitable lasers can include short pulse lasers on the sub-millisecond timescale.
  • the energy source 124 can include lasers on the nanosecond (ns) timescale.
  • the lasers can also include short pulse lasers on the picosecond (ps), femtosecond (fs), and microsecond (us) timescales. It is appreciated that there are many combinations of laser wavelengths, pulse widths, and energy levels that can be employed to achieve plasma in the catheter fluid 132 of the catheter 102.
  • the pulse widths can include those falling within a range including from at least ten ns to 3000 ns, at least 20 ns to 100 ns, or at least one ns to 500 ns. Alternatively, any other suitable pulse width range can be used.
  • Exemplary nanosecond lasers can include those within the UV to IR spectrum, spanning wavelengths of about ten nanometers (nm) to one millimeter (mm).
  • the energy sources 124 suitable for use in the catheter systems 100 can include those capable of producing light at wavelengths of from at least 750 nm to 2000 nm.
  • the energy sources 124 can include those capable of producing light at wavelengths of from at least 700 nm to 3000 nm.
  • the energy sources 124 can include those capable of producing light at wavelengths of from at least 100 nm to ten micrometers (pm).
  • Nanosecond lasers can include those having repetition rates of up to 200 kHz.
  • the laser can include a Q-switched thuliurmyttrium- aluminum-garnet (Tm:YAG) laser.
  • the laser can include a neodymium :yttrium-aluminum-garnet (Nd:YAG) laser, holmium:yttrium-aluminum-garnet (Ho:YAG) laser, erbium:yttrium-aluminum-gamet (Er:YAG) laser, excimer laser, heliumneon laser, carbon dioxide laser, as well as doped, pulsed, fiber lasers.
  • Nd:YAG neodymium :yttrium-aluminum-garnet
  • Ho:YAG holmium:yttrium-aluminum-garnet
  • Er:YAG erbium:yttrium-aluminum-gamet
  • the energy source 124 can include a plurality of lasers that are grouped together in series. In yet other embodiments, the energy source 124 can include one or more low energy lasers that are fed into a high energy amplifier, such as a master oscillator power amplifier (MOPA). In still yet other embodiments, the energy source 124 can include a plurality of lasers that can be combined in parallel or in series to provide the energy needed to create the plasma bubble 134 in the catheter fluid 132.
  • MOPA master oscillator power amplifier
  • the catheter system 100 can generate pressure waves having maximum pressures in the range of at least one megapascal (MPa) to 100 MPa.
  • MPa megapascal
  • 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.
  • the catheter systems 100 can generate pressure waves having maximum pressures in the range of at least approximately two MPa to 50 MPa, at least approximately two MPa to 30 MPa, or approximately at least 15 MPa to 25 MPa.
  • the pressure waves can be imparted upon the treatment site 106 from a distance within a range from at least approximately 0.1 millimeters (mm) to greater than approximately 25 mm, extending radially from the energy guides 122A when the catheter 102 is placed at the treatment site 106.
  • the pressure waves can be imparted upon the treatment site 106 from a distance within a range from at least approximately ten mm to 20 mm, at least approximately one mm to ten mm, at least approximately 1 .5 mm to four mm, or at least approximately 0.1 mm to ten mm extending radially from the energy guides 122A when the catheter 102 is placed at the treatment site 106.
  • the pressure waves can be imparted upon the treatment site 106 from another suitable distance that is different than the foregoing ranges.
  • the pressure waves can be imparted upon the treatment site 106 within a range of at least approximately two MPa to 30 MPa at a distance from at least approximately 0.1 mm to ten mm.
  • the pressure waves can be imparted upon the treatment site 106 from a range of at least approximately two MPa to 25 MPa at a distance from at least approximately 0.1 mm to ten mm.
  • other suitable pressure ranges and distances can be used.
  • the power source 125 is electrically coupled to and is configured to provide the necessary power to each of the energy source 124, the system controller 126, the GUI 127, and the handle assembly 128.
  • the power source 125 can have any suitable design for such purposes.
  • the system controller 126 is electrically coupled to and receives power from the power source 125.
  • the system controller 126 is coupled to and is configured to control operation of each of the energy source 124 and the GU1 127.
  • the system controller 126 can include one or more processors or circuits for purposes of controlling the operation of at least the energy source 124 and the GUI 127.
  • the system controller 126 can control the energy source 124 for generating pulses of energy as desired and/or at any desired firing rate.
  • the system controller 126 can also be configured to control the operation of other components of the catheter system 100, such as the positioning of the catheter 102 adjacent to the treatment site 106, the inflation of the balloon 104 with the catheter fluid 132, etc.
  • the catheter system 100 can include one or more additional controllers that can be positioned in any suitable manner for purposes of controlling the various operations of the catheter system 100.
  • an additional controller and/or a portion of the system controller 126 can be positioned and/or incorporated within the handle assembly 128.
  • the GU1 127 is accessible by the user or operator of the catheter system 100.
  • the GUI 127 is electrically connected to the system controller 126. With such a design, the GUI 127 can be used by the user or operator to ensure that the catheter system 100 is effectively utilized to impart pressure onto and induce fractures into the vascular lesions 106A at the treatment site 106.
  • the GUI 127 can provide the user or operator with information that can be used before, during, and after using the catheter system 100.
  • the GUI 127 can provide static visual data and/or information to the user or operator.
  • the GU1 127 can provide dynamic visual data and/or information to the user or operator, such as video data or any other data that changes over time during the use of the catheter system 100.
  • the GUI 127 can include one or more colors, different sizes, varying brightness, etc., that may act as alerts to the user or operator. Additionally, or in the alternative, the GUI 127 can provide audio data or information to the user or operator. The specifics of the GUI 127 can vary depending upon the design requirements of the catheter system 100, or the specific needs, specifications, and/or desires of the user or operator.
  • the handle assembly 128 can be positioned at or near the proximal portion 114 of the catheter system 100.
  • the handle assembly 128 is coupled to the balloon 104 and is positioned spaced apart from the balloon 104.
  • the handle assembly 128 can be positioned at another suitable location.
  • the handle assembly 128 is attached to the catheter shaft 110 and is handled and used by the user or operator to operate, position, and control the catheter 102.
  • the design and specific features of the handle assembly 128 can vary to suit the design requirements of the catheter system 100.
  • the handle assembly 128 is separate from, but in electrical and/or fluid communication with one or more of the system controller 126, the energy source 124, the fluid pump 138, and the GUI 127.
  • the handle assembly 128 can integrate and/or include at least a portion of the system controller 126 within an interior of the handle assembly 128.
  • the handle assembly 128 can include circuitry 156, which is electrically coupled between catheter electronics and the system console 123, and which can form at least a portion of the system controller 126.
  • the circuitry 156 can include a printed circuit board having one or more integrated circuits, or any other suitable circuitry.
  • the circuitry 156 can be omitted, or can be included within the system controller 126, which in various embodiments can be positioned outside of the handle assembly 128, such as within the system console 123. It is understood that the handle assembly 128 can include fewer or additional components than those specifically illustrated and described herein.
  • an energy activation member 157 (also sometimes referred to herein simply as an "energy activator”), such as an energy activation button, that can be coupled to the circuitry 156 within the handle assembly 128 which forms a part of the system controller 126.
  • the energy activator 157 is configured to enable the user or operator to selectively activate the catheter system 100 as desired.
  • the source manifold 136 can be integrated and/or incorporated within the handle assembly 128, and can be positioned at or near the proximal portion 114 of the catheter system 100.
  • the source manifold 136 can include one or more openings that can receive an inflation conduit 140 that is coupled in fluid communication with the fluid pump 138, the guidewire 112 and/or the guidewire lumen 118, one or more energy guides 122A of the energy guide bundle 122, and/or the catheter shaft 110. More particularly, the source manifold 136 can include one or more of a media inflation port 158, a guidewire lumen port 160, an energy guide port 162, and a catheter shaft port 164.
  • the catheter system 100 can also include the fluid pump 138 that is configured to inflate the balloon 104 with the catheter fluid 132 as needed.
  • Figure 2A is a simplified schematic view of a portion of an embodiment of the catheter system 200 including a handle assembly 228, a connector assembly 252, and an adapter assembly 285.
  • each of the handle assembly 228, the connector assembly 252, and the adapter assembly 285 are separated and/or excluded from one another.
  • elements of the handle assembly 228, the connector assembly 252, and/or the adapter assembly 285 are mutually exclusive from one another.
  • the handle assembly 228 can include the energy activator 257, an assembly housing 266, including and/or defining one or more of an inflation conduit inlet 268, a guidewire inlet 270, and a handle distal outlet 276.
  • the handle assembly 228 can include more components or fewer components than those specifically illustrated and described herein, with the exception of the components of the connector assembly 252, the routing assembly 280, and/or the adapter assembly 285.
  • the assembly housing 266 can be formed from two housing members 266A (only one of which is shown in Figure 2A), formed as a first housing side and a second housing side that are selectively coupled together to form the complete assembly housing 266.
  • the inflation conduit inlet 268 is configured to couple the inflation conduit 240 into the assembly housing 266.
  • the guidewire inlet 270 is configured to couple the guidewire 212 into the assembly housing 266.
  • the energy guide inlet 272 is configured to couple the energy guide bundle 122, including the one or more energy guides 222A (illustrated in Figure 2B), into the assembly housing 266.
  • the electrical inlet 274 is configured to couple an electrical cable 280 (as illustrated in Figure 2B) into the assembly housing 266.
  • the energy guide inlet 272 and the electrical inlet 274 can be formed together into a single inlet.
  • the energy guides 222A and an electrical cable 281 can be shrouded within an optical/electrical cable 278 as the energy guides 222A and the electrical cable 281 enter into the assembly housing 266 through the energy guide inlet 272 and the electrical inlet 274, respectively.
  • the energy guide inlet 272 and the electrical inlet 274 can be formed independently of one another.
  • the handle distal outlet 276 provides an outlet from the assembly housing 266 for each of the inflation conduit 240, the catheter shaft 210, the guidewire 112 (illustrated in Figure 1 ), the guidewire lumen 118 (illustrated in Figure), the energy guides 122A (Illustrated in Figure 1 ), as such components extend toward the balloon 104 (illustrated in Figure 1 ).
  • An optical guide 283 can guide the energy guides 222A from the connector assembly 252 to the routing assembly 280.
  • the connector assembly 252 is spaced apart, positioned away, and/or entirely separate from the handle assembly 228 and the adapter assembly 285.
  • An electrical guide 284 can guide the electrical cable 281 from the electrical connector 286 to the routing assembly 280.
  • the adapter assembly 285 can house the components of the routing assembly 280.
  • the adapter assembly 285 can interconnect the optical/electrical cable 278, the optical guide 283, and/or the electrical guide 284.
  • the adapter assembly 285 can include a housing distal end 285D (illustrated in Figure 2B) and a housing proximal end 285P (illustrated in Figure 2B).
  • the adapter assembly 285 can include a y-adapter.
  • the adapter assembly 285 is spaced apart, positioned away, and/or entirely separate from the handle assembly 228 and the connector assembly 252.
  • the electrical connector 286 can connect the electrical cable 281 and/or the electrical guide 284 to the handle assembly 228 and/or the adapter assembly 285.
  • the electrical connector 286 can also connect to an external power source (such as the energy source 124, illustrated in Figure 1 ).
  • Figure 2B is a simplified schematic cross-sectional view of the embodiment of the adapter assembly 285 in Figure 2A, including a routing assembly 280.
  • the adapter assembly 285 can include the optical/electrical cable 278, the electrical cable 281 , the routing assembly 280, including an inner routing guide 287, the optical guide 283, and/or the electrical guide 284.
  • the routing assembly 280, the energy guides 222A, the optical/electrical cable 278, the optical guide 283, the electrical guide 284, and/or the adapter assembly 285 shown in Figure 2B can be somewhat similar to the embodiments shown and described herein.
  • the routing assembly 280 can be configured to reduce the mechanical strain on the energy guides 222A and/or the electrical cable 281 .
  • the routing assembly 280 can route the energy guides 222A and/or the electrical cable 281 in any suitable direction throughout the catheter system 200.
  • the specifics of the routing assembly 280 can vary depending upon the design requirements of the catheter system 200, or the specific needs, specifications, and/or desires of the user or operator. It is appreciated that the routing assembly 280 can include additional or fewer elements than illustrated in Figure 2B.
  • the routing assembly 280 can be positioned within any suitable location in the catheter system 100.
  • the routing assembly 280 is spaced apart from and/or outside of the handle assembly 228.
  • the optical/electrical cable 278 can be coupled between the routing assembly 280 and the handle assembly 228.
  • the guide distal end 122D (illustrated in Figure 1 ) and/or the guide proximal end 122P (illustrated in Figure 1) can be fixed relative to the routing assembly 280. In some embodiments, the guide distal end 122D is movable relative to the routing assembly 280.
  • the electrical cable 281 guides power from the electrical connector 286 (illustrated in Figure 2A) through the optical/electrical cable 278, the electrical guide 284, the adapter assembly 285 to the handle assembly 228 (illustrated in Figure 2A).
  • the electrical cable 281 can connect the handle assembly 228 to any suitable source of power (such as the energy source 124, illustrated in Figure 1 ).
  • the routing assembly 280 can include a routing space 282.
  • the routing space 282 defines a space for the routing, positioning, and/or movement of the energy guides 222A inside of the routing assembly 280. Movement of the energy guides 222A throughout the catheter system 100 and/or the routing space 282 can result in alternating periods of slack and tension on the energy guides 222A, which can cause axial and longitudinal movement of the guides and cables. Such movement may result in the undesired cramping and/or twisting of the energy guides 222A of the catheter system 200 and may cause the degradation of the energy guides 222A.
  • the routing space 282 retains a routing length 222L of each of the energy guides 222A.
  • the routing length 222L includes the length of the energy guides 222A that is positioned within the routing space 282 during operation and use of the catheter system 200.
  • the routing length 222L is a portion of the total length of the energy guides 222A..
  • the routing length 222L is shown with dashed lines to illustrate the routing length 222L that is inside of the routing assembly 280.
  • the routing space 282 can be configured so that the routing length 222L of at least one of the energy guides 222A is adjustable.
  • the inner routing guide 287 can be positioned in and/or within the routing space 282.
  • the routing length 222L of each of the energy guides can be positioned about, around, and/or near the inner routing guide 287.
  • the energy guides 222A can loop greater than approximately 5 degrees around the inner routing guide 287 and less than approximately 1080 degrees around the inner routing guide 287.
  • the energy guides 222A can loop approximately 5 degrees, 10 degrees, 15 degrees, 20 degrees, 25 degrees, 30 degrees, 35 degrees, 40 degrees, 45 degrees, 50 degrees, 55 degrees, 60 degrees, 65 degrees, 70 degrees, 75 degrees, 80 degrees, 85 degrees, 90 degrees, 95 degrees, 100 degrees, 105 degrees, 110 degrees, 115 degrees, 120 degrees, 125 degrees, 130 degrees, 135 degrees, 140 degrees, 145 degrees, 150 degrees, 155 degrees, 160 degrees, 165 degrees, 170 degrees, 175 degrees, 180 degrees, 185 degrees, 190 degrees, 195 degrees, 200 degrees, 205 degrees, 210 degrees, 215 degrees, 220 degrees, 225 degrees, 230 degrees, 235 degrees, 240 degrees, 245 degrees, 250 degrees, 255 degrees, 260 degrees, 265 degrees, 270 degrees, 275 degrees, 280 degrees, 285 degrees, 290 degrees, 295 degrees,
  • the inner routing guide 282 can guide at least one of the movement and positioning of the energy guides 222A within the routing assembly 280.
  • the inner routing guide 287 can reduce the mechanical strain on the energy guides 222A, various cables, guides, and/or other components within the routing assembly 280.
  • the routing space 282 includes the routing length 222L of the energy guides 222A, in order to reduce the mechanical strain and/or mechanical forces that may impact the routing length 222L of the energy guides 222A.
  • the adapter assembly 285 can cooperate with the routing space 282 so that a user can service the energy guides 222A.
  • the adapter assembly 285 can be at least partially removable to expose the energy guides 222A and/or the routing space 282 so that an operator can service, repair, and/or remove the energy guides 222A (or any other component of the routing assembly 280).
  • the inner routing guide 287 and/or the routing space 282 can (i) provide a storage area for the energy guides 222A and/or (ii) maintain the organization of the energy guides 222A.
  • the specifics of the inner routing guide 287 can vary depending upon the design requirements of the catheter system 100, the handle assembly 228, the routing assembly 280, and/or the specific needs, specifications, and/or desires of the user or operator.
  • the inner routing guide 287 can position components such as the energy guides 222A.
  • the inner routing guide 287 can position the energy guides 222A in a somewhat circular pattern. It is appreciated that the inner routing guide 287 can take the form of any suitable number of geometric structures at any suitable sizes.
  • the inner routing guide 287 is shown as a circle in Figure 2B merely for ease of understanding.
  • the inner routing guide 287 can cooperate with an outer routing guide 288 to define a path that is able to receive a portion of the energy guides 222A so that the portion can be positioned around, about, and/or near the inner routing guide 287.
  • the outer routing guide 288 can be substantially similar to the inner routing guide 287 in form and/or function. While the outer routing guide 288 is illustrated in Figure 2B as an arc, it is appreciated that the outer routing guide 288 can take the form of any suitable number of geometric structures at any suitable sizes.
  • the inner routing guide 287 and/or the outer routing guide 288 can be configured to enable movement of the guide distal end 122D relative to the routing assembly 280 due to changes in the routing length 222L stored in the routing space 282.
  • the inner routing guide 287 and/or the outer routing guide 288 increases the likelihood that the routing length 222L remains in a looped orientation such that tension or axial movement experienced by the energy guides 222A does not cause the energy guides 222A to kink or otherwise bend at an undesirable angle. This reduces the possibility of damage to the energy guides 222A.
  • the inner routing guide 287 and/or the outer routing guide 288 can include a post or other structure having a width, thereby maintaining a spacing or diameter of the routing length 222L positioned within the routing space 282.
  • the width of the inner routing guide 287 and/or the outer routing guide 288 may be larger than a bend or kink radius of the energy guides 222A, which may depend on the particular material from which the energy guides 222A are constructed.
  • the energy guides 222A such as optical fibers, are positioned into the adapter assembly 285 through the optical guide 283 into the routing space 282 around, about, and/or near the inner routing guide 287. Subsequently, the energy guides 222A are directed out of the adapter assembly 285 toward the optical/electrical cable 278 in combination with the electrical cable 281 at the housing distal end 285D.
  • the electrical cable 281 can be (i) directed through the optical/electrical cable 278 via the adapter assembly 285, (ii) directed through the routing assembly 280, and/or (iii) directed out of the adapter assembly 285 and towards the housing distal end 285D through the optical/electrical cable 278.
  • the routing length 222L of the energy guides 222A can be positioned in a loop within the routing space 282, i.e., an increase in the diameter of the looped portion will occur as shown in FIG. 2B, thereby reducing the likelihood of kinking, as well as reducing any excess force on the energy guides 222A that may cause a shift in positioning.
  • the inner routing guide 287 be rotatably coupled to the housing, the routing length 222L of the energy guides 222A may be taken up by rotating the inner routing guide 287 either automatically or manually.
  • the diameter of the expanded loop-portion of the energy guides 222A may expand to a width of the housing without contacting an angled surface which could cause kinking or bending of the energy guides 222A.
  • the separate inlet portions of the optical guide 283 and the electrical guide 284 allow for separate and independent routing of the energy guides 222A and the electrical cable 281 , allowing for ease of connectivity and manipulation of the energy guides 222A and/or the electrical cable 281 and their connection points.
  • Figure 3 is a perspective view of an embodiment of an optical guide 383 utilized by various embodiments of the energy guides 222A (illustrated in Figure 2B), the routing assembly 280 (illustrated in Figure 2B), and the adapter assembly 285 (for example, as illustrated in Figure 2B).
  • the optical guide 383 can guide and/or protect the energy guides 222A (illustrated in Figure 2B) from damage.
  • the optical guide 383 can include a flexible cable that reduces spring energy build-up when the guides and/or cables are coiled or bent.
  • the specifics of the optical guide 383 can vary depending upon the design requirements of the catheter system 200, the handle assembly 228, the routing assembly 280, the adapter assembly 285, and/or the specific needs, specifications and/or desires of the user or operator.
  • the optical guide 383 can include a protector tubing 383T.
  • the protector tubing 383T can be configured to allow the free movement of the guides and/or cables within the optical guide 383.
  • the protector tubing 383T can be spiral-cut (such as shown in the various embodiments illustrated by Figure 3).
  • the protector tubing 383T can be at least partially formed from Polytetrafluoroethylene and/or any suitable polymer.
  • the optical guide 383 and/or the protector tubing 383T can be at least partially formed from light-absorbing materials (with or without fillers) that at least partially inhibit and/or absorb unwanted light and/or energy from escaping from the optical guide 383 and/or the protector tubing 383T in the event of damage to the energy guides 222A and/or electrical cables 281 .
  • Figure 4A is a simplified schematic cross-sectional view of an embodiment of the connector assembly 452, including the routing assembly 480.
  • the routing assembly 480 may include an outer routing guide 488 for routing the routing length 222L (for example, as illustrated in Figure 2B), thereby positioning the energy guides 422A between the inner routing guide 487 and the outer routing guide 488 in the routing space 482.
  • the outer routing guide 488 can be displaced from the inner routing guide 487, about which the energy guides 422A are positioned around, about, and/or near.
  • the inner routing guide 487 and/or the outer routing guide 488 cooperate to define the positioning and/or the routing of the individual energy guides 422A through the routing assembly 480.
  • outer routing guide 488 can vary depending upon the design requirements of the catheter system 100 (illustrated in Figure 1 ), the connector assembly 452, the routing assembly 480, and/or the specific needs, specifications and/or desires of the user or operator.
  • the routing assembly 480 may include a channel, groove, depression, aperture, or similar passage in the body of routing assembly 480, between the inner routing guide 487 and the outer routing guide 488.
  • this space between the inner routing guide 487 and the outer routing guide 488 may define multiple paths for receiving the routing length 222L of the energy guides 422A to aid in managing and positioning the energy guides 422A through the length of the catheter system 100 to reduce the likelihood of tangling, kinking, or the like to the energy guides 422A.
  • the inner routing guide 487 and/or the outer routing guide 488 can also include a guide retainer 489A.
  • the guide retainer 489A can retain the energy guides 422A between the inner routing guide 487 and the outer routing guide 488 and reduces the likelihood that the energy guides 422A exit the routing space 482 during the operation of the catheter system 100, including the movement of the energy guides 422A.
  • the design of the guide retainer 489A can vary depending on the design requirements of the routing assembly 480, the inner routing guide 487, and/or the outer routing guide 488. While the guide retainers 489A, 489B are shown in Figure 4A as specific rectangular shapes, it is appreciated that any suitable geometric structure of any suitable size that is capable of retaining the individual energy guides 422A within the routing space 482 may be used.
  • Figure 4B is a simplified schematic cross-sectional view of the routing assembly 480 in Figure 4A.
  • a plurality of guide retainers 489A, 489B are spaced apart from one another along the path of the energy guides 422A within the routing space 482 (illustrated Figure 4A).
  • the energy guides 422A can be retained by the guide retainers of 489A, 489B in a somewhat infinity loop and/or figure eight orientation in the routing space 482 about two inner routing guides 487A, 487B. This orientation limits the amount of mechanical strain placed on the energy guides 422A as they move within the routing space 482.
  • the inner routing guides 487A, 487B and/or the outer routing guide 488 can include any suitable number, size, structure, and/or distribution of the guide retainers 489A, 489B depending on the design requirements of the routing assembly 480.
  • the inner routing guides 487A, 487B have varying geometric shapes and sizes to accommodate the infinity loop and/or figure eight orientation of the routing length 222L (illustrated in Figure 2B) of the energy guides 222A in the routing space 482.
  • one inner routing guide 487 is somewhat O-shaped, and the other inner routing guide 487 is somewhat D-shaped.
  • the routing assembly 480 can also include an assembly aperture 490A.
  • the assembly aperture 490A can be formed in various locations of the routing assembly 480. For example, in the embodiments illustrated in Figure 4B, a plurality of assembly apertures 480A, 490B, are positioned directly below corresponding guide retainers 489A.
  • the positioning of the assembly aperture 490A allows for the accommodation of additional routing length 222L of energy guides 422A and/or reduced stress/tension applied to the guide retainers 489A, 489B when the energy guides 422A are positioned therebetween.
  • the assembly apertures 490A, 490B provide space for the movement of the energy guides 422A whilst retaining the position of the energy guides 422A in the routing space 482.
  • the portion of the routing length 222L positioned toward the center of the routing assembly 480 can become crowded due to a crossing and/or looping of the energy guides 422A.
  • the assembly aperture 490A positioned in the center area of the routing assembly 480 can have an increased area to accommodate this crowding.
  • the inner routing guides 487A, 487B can include multiple guide retainers 489C that are directly positioned over the central assembly aperture 490B.
  • Figure 4C is a cross-sectional view of the routing assembly 480 taken on lines 4C- 4C in Figure 4B.
  • the routing assembly 480 can include cross- sectional spaces defined between the inner routing guides 487A, 487B, the inner routing guide 487A and the outer routing guide 488, and/or the inner routing guide 487B and the outer routing guide 488.
  • These cross-sectional spaces are illustrated as substantially u- shaped in Figure 4C, but it is understood that any suitable number of cross-sectional spaces, shapes, and/or sizes can be used to define the routing space 482 illustrated in the various embodiments illustrated by Figures 4A-4C.
  • Figure 5 is a simplified top view illustration of an embodiment of the connector assembly 552. More specifically, Figure 5 illustrates various internal components and features that can be included in various embodiments of the connector assembly 552. As shown in Figure 5, in certain embodiments, the connector assembly 552 can internally include a portion of the one or more energy guides 522A (e.g., the routing length 222L illustrated in Figure 2B) and a routing assembly 580.
  • the connector assembly 552 can internally include a portion of the one or more energy guides 522A (e.g., the routing length 222L illustrated in Figure 2B) and a routing assembly 580.
  • the connector assembly 552 can be configured to provide strain relief as it brings each of the individual energy guides 522A closer together so that the energy guides 522A and/or the energy guide bundle 522 can be in a more compact form as it extends with the catheter 102 (illustrated in Figure 1 ) into the blood vessel 108 (illustrated in Figure 1 ) during use of the catheter system 100 (illustrated in Figure 1).
  • the plurality of individual energy guides 522A is shown as one energy guide bundle 522 for ease of understanding. It is appreciated that the individual energy guides 522A do not necessarily require bundling, such as shown in various embodiments illustrated by Figure 4A.
  • each of the individual energy guides 522A and/or energy guide bundle 522 can include a protector tube 583 (also illustrated in Figure 3) within which all of the energy guides 522A are maintained as the energy guides 522A extend with the catheter 102 toward the balloon 104 (illustrated in Figure 1 ).
  • the connector assembly 552 can also include a locking crimp 588 that is configured to tightly bunch the energy guides 522A together in a controlled manner to form the energy guide bundle 522.
  • the connector assembly 552 can be at least partially removable to expose the energy guides 522A and/or the routing space 582 so that an operator can service, repair, and/or remove the energy guides 522A (or any other component of the connector assembly 552).
  • the inner routing guide 587C can position components such as the routing length 222L (illustrated in Figure 2B) of the energy guides 522A in the routing space 582.
  • the inner routing guide 587C can position the routing length 222L of the energy guides 522A in a somewhat circular pattern. It is appreciated that the inner routing guide 587C can take the form of any suitable geometric structure and that the inner routing guide 587C is shown as a circle in Figure 5 merely for ease of understanding.
  • the inner routing guide 587C can define a path that is able to receive the routing length 222L of the energy guides 522A so that the routing length 222L can form a loop around the inner routing guide 587C.
  • the inner routing guide 587C can be configured to enable movement of the guide distal end 122D (illustrated in Figure 1 ) relative to the connector assembly 552.
  • the inner routing guide 587C increases the likelihood that a portion of the energy guides 522A (e.g., the routing length 222L) remains in a looped orientation such that tension or axial movement experienced by the energy guides 522A does not cause the energy guides 522A to kink or otherwise bend at an undesirable angle. This reduces the possibility of damage to the energy guides 522A.
  • the inner routing guide 587C can include a post or other structure having a width, thereby maintaining a spacing or diameter of the portion of the energy guides 522A located within the routing space 582.
  • the width of the inner routing guide 587C may be larger than a bend or kink radius of the energy guides 522A, which may depend on the particular material from which the energy guides 522A are constructed.
  • the routing assembly 580 may also include an outer routing guide 488 (for example, as shown in Figure 4 with respect to the routing assembly 480) for receiving a portion of the energy guides 522A, thereby positioning the energy guides 522A within the routing space 582.
  • the outer routing guide 488 can be displaced from a portion of the inner routing guide 587C, about which the energy guides 522A have looped around, thereby providing a spacing between the energy guides 522A within the connector assembly 552.
  • the outside housing of the connector assembly 552 can also function as the outer routing guide 488, depending on the design requirements of the routing assembly 580.
  • the catheter systems and related methods disclosed herein can include a catheter configured to advance to a vascular lesion, such as a calcified vascular lesion or a fibrous vascular lesion, at a treatment site located within or adjacent to a blood vessel within a body of a patient.
  • the catheter includes a catheter shaft, and an inflatable balloon that is coupled and/or secured to the catheter shaft.
  • the balloon can include a balloon wall that defines a balloon interior.
  • the balloon can be configured to receive a catheter fluid within the balloon interior to expand from a deflated state suitable for advancing the catheter through a patient's vasculature, to an inflated state suitable for anchoring the catheter in position relative to the treatment site.
  • the catheter systems and related methods utilize an energy source, e.g., a light source such as a laser or another suitable energy source, which provides energy that is guided by one or more energy guides, e.g., light guides such as optical fibers, which are disposed along the catheter shaft and within the balloon interior of the balloon to create a localized plasma in the catheter fluid that is retained within the balloon interior of the balloon.
  • the energy guide can be used in conjunction with a plasma generator that is positioned at or near a guide distal end of the energy guide within the balloon interior of the balloon located at the treatment site.
  • the creation of the localized plasma can initiate a pressure wave and can initiate the rapid formation of one or more bubbles that can rapidly expand to a maximum size and then dissipate through a cavitation event that can launch a pressure wave upon collapse.
  • the rapid expansion of the plasma-induced bubbles (also sometimes referred to simply as "plasma bubbles") can generate one or more pressure waves in the catheter fluid retained within the balloon interior of the balloon and thereby impart pressure waves onto and induce fractures in the vascular lesions at the treatment site within or adjacent to the blood vessel wall within the body of the patient.
  • the energy source can be configured to provide sub-millisecond pulses of energy, e.g., light energy, to initiate the plasma formation in the catheter fluid within the balloon to cause the rapid bubble formation and to impart the pressure waves upon the balloon wall at the treatment site.
  • energy e.g., light energy
  • the pressure waves can transfer mechanical energy through an incompressible catheter fluid to the treatment site to impart a fracture force on the intravascular lesion.
  • the catheter systems and related methods disclosed herein can further include a handle assembly that is attached to the catheter shaft, and that is handled and used by the user or operator to operate, position, and control the catheter.
  • the handle assembly has a source manifold incorporated and/or integrated therein.
  • the source manifold can include one or more of a manifold housing, a pressure sensor that is coupled to and/or integrated into the manifold housing, and a media inflation port, a guidewire lumen port, an energy guide port, and a catheter shaft port that is formed into and/or coupled to the manifold housing.
  • the pressure sensor is configured to sense a fluid pressure of the catheter fluid within the catheter system.
  • the pressure sensor can be configured to sense a fluid pressure within the balloon interior or at any desired location along an inflation conduit.
  • the media inflation port is configured to couple the inflation conduit into and/or through the manifold housing so that the catheter fluid can be directed as desired through the handle assembly and into the balloon interior.
  • the guidewire lumen port is configured to couple a guidewire lumen, which defines a conduit through which a guidewire extends, into, from, and/or through the manifold housing, so that the guidewire lumen can thus extend from the handle assembly into and/or through the balloon interior.
  • the energy guide port is configured to couple the one or more energy guides into and/or through the manifold housing, so that the energy guides can guide energy from the energy source, through the handle assembly, and into the balloon interior.
  • the catheter shaft port is configured to couple the catheter shaft to the manifold housing so that the user can effectively control the positioning of the catheter shaft, with the balloon attached thereto, substantially adjacent to the vascular lesion(s) at the treatment site via manipulation of the handle assembly.
  • the phrase “configured” describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration.
  • the phrase “configured” can be used interchangeably with other similar phrases such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, and the like.

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  • Physics & Mathematics (AREA)
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  • Surgery (AREA)
  • Optics & Photonics (AREA)
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  • Engineering & Computer Science (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

Selon la présente invention, un système de cathéter (100) pour traiter un site de traitement (106) situé à l'intérieur ou à côté d'une paroi de vaisseau (108A) d'un vaisseau sanguin (108) à l'intérieur du corps (107) d'un patient (109) comprend un premier guide d'énergie (222A), un second guide d'énergie (222A) et un ensemble de routage (280). L'ensemble de routage (280) définit un espace de routage (282) qui conserve une longueur de routage (222L) de chacun des guides d'énergie (222A), l'ensemble de routage (280) comprenant un guide de routage interne (287) qui est positionné à l'intérieur de l'espace de routage (282), la longueur de routage (222L) de chacun des guides d'énergie (222A) étant chacune positionnée au moins partiellement autour du guide de routage interne (287), l'espace de routage (282) étant conçu de telle sorte que la longueur de routage (222L) d'au moins l'un des guides d'énergie (222A) est réglable.
PCT/US2023/070970 2022-07-26 2023-07-25 Ensemble de routage pour système de cathéter de lithotripsie intravasculaire WO2024026322A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CN202380049620.1A CN119343100A (zh) 2022-07-26 2023-07-25 用于血管内碎石导管系统的布线组件
EP23757471.0A EP4561481A1 (fr) 2022-07-26 2023-07-25 Ensemble de routage pour système de cathéter de lithotripsie intravasculaire

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US202263392342P 2022-07-26 2022-07-26
US63/392,342 2022-07-26
US202263395853P 2022-08-07 2022-08-07
US63/395,853 2022-08-07
US18/357,947 US20240032995A1 (en) 2022-07-26 2023-07-24 Routing assembly for intravascular lithotripsy catheter system
US18/357,947 2023-07-24

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WO2024026322A1 true WO2024026322A1 (fr) 2024-02-01

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118502029A (zh) * 2024-07-17 2024-08-16 沈阳东镭光电技术有限公司 一种光波导连接器

Citations (3)

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Publication number Priority date Publication date Assignee Title
US5764843A (en) * 1993-09-08 1998-06-09 N.V. Raychem S.A. Optical fibre organizer
US20190072378A1 (en) * 2016-05-06 2019-03-07 Olympus Corporation Shape sensor system
US20210137598A1 (en) * 2019-11-13 2021-05-13 Bolt Medical, Inc. Dynamic lithoplasty device with movable energy guide

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5764843A (en) * 1993-09-08 1998-06-09 N.V. Raychem S.A. Optical fibre organizer
US20190072378A1 (en) * 2016-05-06 2019-03-07 Olympus Corporation Shape sensor system
US20210137598A1 (en) * 2019-11-13 2021-05-13 Bolt Medical, Inc. Dynamic lithoplasty device with movable energy guide

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118502029A (zh) * 2024-07-17 2024-08-16 沈阳东镭光电技术有限公司 一种光波导连接器

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