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WO2025128583A2 - Systèmes et procédés pour un cathéter à ultrasons - Google Patents

Systèmes et procédés pour un cathéter à ultrasons Download PDF

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Publication number
WO2025128583A2
WO2025128583A2 PCT/US2024/059395 US2024059395W WO2025128583A2 WO 2025128583 A2 WO2025128583 A2 WO 2025128583A2 US 2024059395 W US2024059395 W US 2024059395W WO 2025128583 A2 WO2025128583 A2 WO 2025128583A2
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
ultrasound
retriever
basket
distal
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2024/059395
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English (en)
Other versions
WO2025128583A3 (fr
Inventor
Jacob Clark RUPRECHT
Bradley James STRINGER
John William RANSHAW
Kevin Holbrook
Craig NICHOLS
David Feddema
Amy Hanenburg
Katie BATMAN
Lucas HARDER
Zoey SLETTEHAUGH
Leslie Segal Purcell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sonovascular Inc
Original Assignee
Sonovascular Inc
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Filing date
Publication date
Application filed by Sonovascular Inc filed Critical Sonovascular Inc
Publication of WO2025128583A2 publication Critical patent/WO2025128583A2/fr
Publication of WO2025128583A3 publication Critical patent/WO2025128583A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B17/2202—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • the present disclosure relates generally to a catheter system, and more specifically, in certain embodiments, a catheter system with an ultrasound catheter that in certain embodiments utilizes an aspiration catheter or an aspiration sheath and/or a retriever catheter.
  • ultrasound catheters are used to deliver ultrasonic energy and therapeutic compounds to a treatment site within a patient’s vasculature.
  • Such ultrasound catheters can comprise an elongated member configured to be advanced through a patient’s vasculature and an ultrasound assembly that is positioned near a distal portion of the elongated member.
  • the ultrasound assembly is configured to emit ultrasonic energy.
  • Such ultrasound catheters can include a fluid delivery lumen that is used to deliver a therapeutic compound to the treatment site. In this manner, ultrasonic energy is delivered to the treatment site to enhance the penetration effect and/or delivery of the therapeutic compound.
  • the ultrasound catheter described herein can have a proximal end, a distal end, the catheter including a body positioned between the proximal end and the distal end; and an ultrasound radiating element, the ultrasound radiating element including a piezoelectric stack that includes at least two hexagonal piezoelectric layers.
  • a ratio of a diameter of the piezoelectric stack and a total number of layers of the at least two hexagonal piezoelectric layers determines a power of the ultrasound radiating element.
  • the total number of layers determines a thickness of the ultrasound radiating element.
  • the ratio is tunable to be user specific.
  • At least one side of each of the at least two hexagonal piezoelectric layers is longer than another side of each of the at least two hexagonal piezoelectric layers.
  • the piezoelectric stack includes four hexagonal piezoelectric layers.
  • the piezoelectric stack is positioned in the body, the piezoelectric stack configured to expand within the body. 8.
  • the ultrasound catheter described herein can have a proximal end, a distal end, the catheter including: a body positioned between the proximal end and the distal end; an ultrasound radiating element positioned at the distal end of the body within a ultrasound transer cavity; a compound lumen cavity extending through the body towards the distal end of the body to a compound lumen exit, and a guidewire lumen cavity extending through the body towards the distal end of the body to a guide wire lumen exit; wherein the guidewire lumen exit and the compound lumen exit are positioned such that a longitudinal center of an ultrasound transducer cavity is positioned above or below or on one side of the longitudinal centers of the guide wire lumen exit and the compound lumen exit.
  • the compound lumen cavity transitions to the compound lumen exit formed on a distal face of the catheter; and wherein the compound lumen exit has an aspect ratio greater than 1 or between 1 to 5.
  • the guidewire lumen cavity transitions to a guidewire lumen exit formed on a distal face of the catheter, the guidewire lumen exit having an aspect ratio greater than 1 or between 1 to 5.
  • the ultrasound catheter described herein can have a proximal end, a distal end, the catheter including: a body positioned between the proximal end and the distal end; an ultrasound radiating element positioned at the distal end of the body; a compound lumen cavity extending through the body towards the distal end of the body, the compound lumen cavity transitioning to a compound lumen exit formed on a distal face of the catheter.
  • the compound lumen exit has an aspect ratio greater than 1 or between 1 to 5.
  • the ultrasound catheter can include a guidewire lumen cavity extending through the body towards the distal end of the body, the guidewire lumen cavity transitioning to a guidwire lumen exit formed on a distal face of the catheter, the guidewire lumen exit having an aspect ratio greater than 1 or between 1 to 5.
  • the ultrasound radiating clement is configured to emit ultrasound energy in a forward and centered direction.
  • the ultrasound catheter can include a deflectable portion of the body configured to articulate to change a direction of emitted ultrasound energy by the ultrasound radiating element.
  • the deflectable portion is configured to articulate at an angle of greater than 30 degrees and less than or equal to 45 degrees.
  • the ultrasound catheter can include a therapeutic agent delivery element.
  • the ultrasound catheter can include a microbubble delivery element. In some examples, the ultrasound catheter can include a nanodroplet delivery element. In some examples, the catheter system described herein can include an ultrasound catheter; and an aspiration catheter. In some examples, the catheter system described herein can include an ultrasound catheter; and a retriever catheter. In some examples, the catheter system described herein can include an ultrasound catheter; an aspiration catheter; and a retriever catheter.
  • the catheter system described herein can include an ultrasound catheter having a proximal end, a distal end, and a body positioned between the proximal end and the distal end, the ultrasound catheter configured to insert through an introducer, the ultrasound catheter including: an ultrasound radiating element, the ultrasound radiating element including a piezoelectric stack that includes at least two hexagonal piezoelectric layers; and a second catheter having a proximal end, a distal end, and a shaft positioned between the proximal end and the distal end, the second catheter configured to insert through the introducer.
  • the second catheter is a retriever catheter.
  • the second catheter is an aspiration catheter.
  • the ultrasound catheter and the second catheter are configured to insert through the introducer simultaneously.
  • a method for treating a patient with a thromboembolism can include advancing an ultrasound catheter to a first treatment site; emitting ultrasound energy from the ultrasound catheter in a forward direction to a first portion of a thromboembolism, wherein the thromboembolism is distal to the ultrasound catheter; advancing the ultrasound catheter to a second treatment site; and emitting ultrasound energy from the ultrasound catheter in the forward direction to a second portion of the thromboembolism, wherein the second portion of the thromboembolism is distal to the ultrasound catheter.
  • the second treatment site is a location of a dissolved portion of the first portion of the thromboembolism.
  • the first portion of the thromboembolism is a front of the thromboembolism.
  • the second portion of the thromboembolism is a portion distal to the front of the thromboembolism.
  • the method can include emitting ultrasound energy to the first portion of the thromboembolism for 40-50 seconds and advancing the ultrasound catheter to the second portion of the thromboembolism.
  • the method can include capturing an image of the thromboembolism.
  • a method for treating a patient with a thromboembolism can include advancing an ultrasound catheter to a treatment site; articulating a deflectable portion of the ultrasound catheter; after articulating the deflectable portion of the ultrasound catheter, rotating the ultrasound catheter; and while rotating the ultrasound catheter, emitting ultrasound energy from the ultrasound catheter in a forward direction to a thromboembolism.
  • the ultrasound energy is emitted in front of a distal end of the ultrasound catheter.
  • the method can include emitting ultrasound energy from the ultrasound catheter while advancing the ultrasound catheter.
  • the method can include inserting the ultrasound catheter through an introducer.
  • the method can include advancing an aspiration catheter having a first end, a second end, and a body positioned between the first end and the second end into a patient's vascular system.
  • the method can include inserting the ultrasound catheter and the aspiration catheter through an introducer.
  • the method can include retrieving a thromboembolism from the treatment site with a retriever catheter.
  • the method can include inserting the ultrasound catheter and the retriever catheter through an introducer.
  • the aspiration catheter includes an expandable funnel at the second end.
  • the method can include delivering a therapeutic compound to the treatment site through a lumen of the ultrasound catheter, wherein the therapeutic compound includes at least one of a lytic, microbubbles or nanodroplets.
  • the ultrasound energy is emitted in a forward and centered direction.
  • the method can include articulating a distal end of the ultrasound catheter and delivering a targeted ultrasound treatment to the thromboembolism.
  • the method can include rotating the retriever catheter to control movement of a retriever to retrieve the thromboembolism from the treatment site.
  • the method can include aspirating through an aspiration catheter and retracting the retriever catheter prior to aspirating the thromboembolism at the treatment site.
  • the ultrasound energy is emitted from a piezoelectric stack including at least two piezoelectric elements.
  • the piezoelectric elements are hexagonal piezoelectric elements.
  • the catheter system described herein can include an aspiration catheter having a first end, a second end, and a body positioned between the first end and the second end, the aspiration catheter including a funnel; an ultrasound catheter having a proximal end, a distal end, and a body positioned between the proximal end and the distal end, the ultrasound catheter configured to insert through the body of the aspiration catheter; and a retriever catheter having a proximal end, a distal end, and a shaft positioned between the proximal end and the distal end, the retriever catheter configured to insert through the body of the aspiration catheter.
  • the funnel is connected to the second end of the aspiration catheter.
  • a proximal end of the funnel is embedded into an element of the aspiration catheter.
  • the funnel is a braided funnel.
  • the funnel is self-expanding.
  • a funnel diameter gradually increases from a first end of the funnel to a second end of the funnel.
  • the first end of the funnel is configured to mate with a proximal end of a basket of the retriever catheter.
  • an aspiration catheter can include a first end; a second end; a body positioned between the first end and the second end; and a funnel located at the second end of the body.
  • the funnel is a braided funnel.
  • the funnel is self-expanding.
  • a funnel diameter gradually increases from a first end of the funnel to the second end of the funnel.
  • the catheter system described herein can include an aspiration catheter having a first end, a second end, and a body positioned between the first end and the second end; an ultrasound catheter having a proximal end, a distal end, and a body positioned between the proximal end and the distal end, the ultrasound catheter configured to insert through the body of the aspiration catheter, the ultrasound catheter including an ultrasound radiating element; and a retriever catheter having a proximal end, a distal end, and a shaft positioned between the proximal end and the distal end, the retriever catheter configured to insert through the body of the aspiration catheter.
  • the ultrasound radiating element includes a piezoelectric stack that includes at least two hexagonal piezoelectric layers.
  • a ratio of a diameter of the piezoelectric stack and a total number of layers of the at least two hexagonal piezoelectric layers determines a power of the ultrasound radiating element.
  • the total number of layers determines a thickness of the ultrasound radiating element.
  • the ratio is tunable to be user specific.
  • at least one side of each of the at least two hexagonal piezoelectric layers is longer than another side of each of the at least two hexagonal piezoelectric layers.
  • an ultrasound radiating element including a piezoelectric stack can include at least two hexagonal piezoelectric layers.
  • a ratio of a diameter of the piezoelectric stack and a total number of layers of the at least two hexagonal piezoelectric layers determines a power of the ultrasound radiating element. In some examples, the ratio is tunable to be user specific. In some examples, at least one side of each of the at least two hexagonal piezoelectric layers is longer than another side of each of the at least two hexagonal piezoelectric layers. 71. 72. 73. 74. 75.
  • the catheter system described herein can include an aspiration catheter having a first end, a second end, and a body positioned between the first end and the second end; an ultrasound catheter having a proximal end, a distal end, and a body positioned between the proximal end and the distal end, the ultrasound catheter configured to insert through the body of the aspiration catheter; and a retriever catheter having a proximal end, a distal end, and a shaft positioned between the proximal end and the distal end, the retriever catheter configured to insert through the body of the aspiration catheter, the retriever catheter including a retriever.
  • the retriever includes a basket configured to capture at least part of a thrombus.
  • the basket is bonded to the shaft of the retriever catheter.
  • the basket is made of self-expanding nitinol braid.
  • the basket is laser cut.
  • the basket includes a pattern configured to allow at least a part of a thrombus to enter the basket at a proximal end of the retriever and prevent at least a part of the thrombus from exiting the basket.
  • the pattern includes a plurality of open cells and a plurality of closed cells.
  • the plurality of open cells includes a plurality of large openings, the plurality of open cells is located at the proximal end of the retriever and is configured to allow at least a part of the thrombus to enter the basket.
  • the plurality of closed cells includes a plurality of small openings, the plurality of closed cells is located distal to the plurality of open cells.
  • a diameter of a distal portion of the distal portion of the retriever is less than a diameter of a middle portion of the retriever, and the diameter of the middle portion of the retriever is less than a diameter of a proximal portion of the retriever.
  • the plurality of closed cells includes a plurality of small openings, the plurality of closed cells is located distal to the plurality of open cells.
  • the retriever catheter described herein can have a proximal end, a distal end, the retriever catheter including: a shaft positioned between the proximal end and the distal end, a basket positioned on the distal end of the shaft, the basket including a plurality of cells and wherein a diameter of a distal portion of the basket is less than a maximum diameter of middle portion of the basket, and the maximum diameter of the proximal portion of the basket 5% to 75% greater than a maximum diameter of a middle portion of the basket.
  • FIG. 1 illustrates a side view of an embodiment of a catheter system that includes an aspiration catheter, an ultrasound catheter and a retriever catheter.
  • FIG. 2A illustrates another embodiment of an aspiration catheter that can be used with the ultrasound catheter system of FIG. 1.
  • FIG. 3B is a block diagram of a feedback control system for use with the ultrasound catheter of FIG. 3.
  • FIG. 3D is a schematic illustration of an electrical connection to an ultrasound element of the ultrasound catheter of Figure 3.
  • FIG. 4 illustrates a side view of the retriever catheter of FIG. 1.
  • FIG. 5 illustrates another example embodiment of a catheter system that includes an aspiration catheter and a retriever catheter in combination with an ultrasound catheter.
  • FIG. 7 illustrates a side view of the retriever catheter in combination with an ultrasound catheter of FIG. 5.
  • FIG. 9A schematically illustrates an embodiment of a catheter system that includes an aspiration catheter and an ultrasound catheter being advanced to a treatment site.
  • FIG. 9B schematically illustrates an embodiment of an ultrasound catheter being advanced through a clot at a treatment site.
  • FIG. 9C schematically illustrates an embodiment of an aspiration catheter and a retriever catheter at a treatment site.
  • FIG. 10 illustrates a side view of another embodiment of an ultrasound catheter.
  • FIG. 11 A illustrates an example embodiment of a cross sectional view of a distal end of the ultrasound catheter taken along line 11A-11A of FIG. 11C.
  • FIG. 11B illustrates an example embodiment of a cross sectional view of a proximal end of the ultrasound catheter taken along line HB-l lB of FIG. 11C.
  • FIG. 11C illustrates the distal end of the ultrasound catheter.
  • FIG. 1 ID illustrates an example embodiment of a distal end of an ultrasound catheter.
  • FIG. 12A illustrates a front face of a distal end of the ultrasound catheter.
  • FIG. 12B illustrates a side view of a distal end of the ultrasound catheter.
  • FIG. 12C illustrates internal components of a distal end of an ultrasound catheter.
  • FIG. 13B illustrates a proximal end of a retriever catheter.
  • FIG. 14 illustrates an aspiration catheter.
  • FIG. 15B illustrates a funnel of an aspiration catheter.
  • FIG. 15C illustrates a funnel of an aspiration catheter.
  • FIG. 16 illustrates a retriever catheter in combination with an aspiration catheter.
  • FIG. 17 illustrates a retriever catheter in combination with a funnel of an aspiration catheter.
  • FIG. 18 illustrates a zoomed in view of a funnel.
  • FIG. 19 illustrates an ultrasound radiating element.
  • FIG. 20 illustrates a cross sectional view of an ultrasound radiating element.
  • FIG. 21 illustrates a catheter system.
  • FIG. 22A illustrates a catheter system in use.
  • FIG. 22B illustrates a catheter system in use.
  • FIG. 22C illustrates a catheter system in use.
  • FIG. 23A illustrates a catheter system in use.
  • FIG. 23B illustrates a catheter system in use.
  • FIG. 23C illustrates a catheter system in use.
  • ultrasonic energy is used broadly, includes its ordinary meaning, and further includes mechanical energy transferred through compression and rarefaction waves with a frequency greater than about 20 kHz. Ultrasonic energy waves can have a center frequency between about 20 kHz and about 25 MHz. In some embodiments, ultrasound transducers may use a multiplicity of ultrasound energy frequencies to enhance cavitation. For example, multiple ultrasound transducers can be used in parallel or series to enhance cavitation. Additionally, ultrasound transducers may operate at different frequencies to produce a broadband of frequencies.
  • the term “catheter” is used broadly, includes its ordinary meaning, and further includes an elongated flexible tube configured to be inserted into the body of a patient, such as into a body pail, cavity, duct or vessel (both arterial vessels and venous vessels).
  • therapeutic compound is used broadly, includes its ordinary meaning, and encompasses drugs, medicaments, dissolution compounds, genetic materials, and other substances capable of effecting physiological functions. A mixture comprising such substances is encompassed within this definition of “therapeutic compound”.
  • suitable therapeutic compounds include, but are not limited to, an aqueous solution containing heparin, urokinase, streptokinase, and/or rtPA, antiinflammatory drugs, and in certain aspects, “therapeutic compound” include but are not limited to micro or nano bubbles as described herein.
  • ultrasonic energy is often used to enhance the delivery and/or effect of a therapeutic compound.
  • ultrasonic energy has been shown to increase enzyme mediated thrombolysis by enhancing the delivery of thrombolytic agents into a thrombus, where such agents lyse the thrombus by degrading the platelets of the thrombus.
  • the thrombolytic activity of the agent is enhanced in the presence of ultrasonic energy in the thrombus because, for example, the ultrasonic energy can create additional binding cites for the therapeutic compound.
  • the present disclosure should not be limited to the mechanism by which the ultrasound enhances treatment unless otherwise stated.
  • ultrasonic energy has also been shown to enhance transfection of gene-based drugs into cells, and augment transfer of chemotherapeutic drugs into tumor cells.
  • Ultrasonic energy delivered from within a patient’ s body has been found to be capable of producing nonthermal effects that increase biological tissue permeability to therapeutic compounds by up to or greater than an order of magnitude.
  • Microbubbles and/or metastable phase change nanodroplets may be added to the therapeutic compound.
  • the microbubbles and/or metastable phase change nanodroplets may be driven to cavitation by the ultrasound energy delivered by the ultrasound catheter.
  • the microbubbles may be 500 nm - 10 pm in diameter. In some aspects, the microbubbles may have a diameter of lpm-3pm.
  • the metastable phase change nanodroplets may be 100 nm to 1 pm in diameter. In some aspects, the nanodroplets may have a diameter of 100 nm to 300 nm.
  • the microbubbles and/or metastable phase change nanodroplets may be used in combination with or carry therapeutic agents, such as blood clot lysing agents.
  • the microbubbles and/or metastable phase change nanodroplets may be concentrated at 10 A 4 microbubbles/mL to 10 A l 1 microbubbles/mL.
  • the microbubbles and/or metastable phase change nanodroplets may be concentrated at approximately 10 A 8 - 10 A 9 microbubbles/mL.
  • this mixture may contain 0 mg to 30 mg of rtPA.
  • the microbubbles and/or nanodroplets can enhance the effectiveness of the ultrasound energy delivered to the treatment site.
  • ultrasound energy can be applied to the blood clot, including the microbubbles and/or metastable phase change nanodroplets within and/or surrounding the clot, causing the mctastablc phase change nanodroplcts or microbubblcs to oscillate, cavitate (both inertially and non-inertially), vaporize, and lyse the clot from within and/or surrounding the clot.
  • Bioeffects may be achieved in result of the activation of the microbubbles from the ultrasound, which can include sonoporation, microstreaming and/or microjetting.
  • microbubbles and/or metastable phase change nanodroplets to enhance sonothrombolysis can allow blood clots to be lysed more effectively and allows for the use of a reduced dosage of the therapeutic agent while the effectiveness of the treatment remains enhanced.
  • therapeutic agents e.g., rtPA
  • the methods and systems for microbubbles and/or metastable phase change nanodroplets are further described in US 2020/0405258 and US 2021/0007759 the entirety of which is hereby incorporated herein by reference.
  • the catheter system can be used to treat the formation of a blood clot inside of a blood vessel (which can be referred to as a treatment site), which is obstructing the flow of blood through the circulatory system.
  • Thrombosis can occur in veins (i.e., venous thrombosis) or in arteries (i.e., arterial thrombosis).
  • venous thrombosis leads to congestion of the affected part of the body, while arterial thrombosis may affect the blood supply to a part of the body which can lead to damage of the tissue supplied by the affected artery (e.g., ischemia and necrosis).
  • venous thrombosis may lead to reduced blood supply to the lungs (i.e., pulmonary embolism) that could result in hemodynamic instability.
  • Conditions that may arise from thrombosis and/or reduced blood flow can include deep vein thrombosis, peripheral artery disease, peripheral artery occlusion, and critical limb ischemia.
  • the catheter system can be used to treat treatment sites that include deep vein thrombosis, where a thrombus has formed in a deep vein, for example, in the legs or pelvis, or to treat pulmonary embolisms, where a thrombus has become embedded in the pulmonary vasculature, or for cranial vessels.
  • the catheter system can also include a mechanical retriever catheter to assist in the removal of clot if needed.
  • the catheter system may be used to treat acute, subacute, and/or chronic clots.
  • the chronic clots may not include collagen.
  • An acute clot may be softer or the softest of the three types of clots mentioned.
  • an acute clot may be the youngest (i.e., approximately 1 - 3 days) or newest clot and most porous clot.
  • a chronic clot may be harder or the hardest of the three types of clots mentioned.
  • a chronic clot may be the oldest (i.e., approximately greater than 14 days) clot and least porous clot.
  • the catheter can form a multi-mechanism thrombectomy system that in certain embodiments utilizes microbubble-mediated cavitation as a mechanism of action to more effectively treat blood clots, without the increased risk of bleeding complications, and can combine four complementary mechanisms of action delivered through an integrated catheter system: (i) ultrasound, (ii) microbubbles (and/or nanodroplets), (iii) thrombolytic drug, and (iv) aspiration.
  • a catheter system can also minimize blood loss and vessel wall damage arising from multiple passes of alternative thrombectomy devices.
  • the catheter system can combine the benefits of mechanical thrombectomy and sonothrombolysis, while improving the reduction of thrombus burden and minimizing bleeding complications, blood loss, and vessel wall damage due to multiple passes resulting from alternative thrombectomy devices.
  • the catheter or catheter system can form a multimechanism thrombectomy system that in certain embodiments utilizes microbubble-mediated cavitation as a mechanism of action to more effectively treat blood clots, without the increased risk of bleeding complications, and can combine five complementary mechanisms of action delivered through an integrated catheter system: (i) ultrasound, (ii) microbubbles (and/or nanodroplets), (iii) thrombolytic drug, (iv) aspiration and (v) a mechanical clot retriever.
  • the catheter or catheter system can be used without microbubblcs (and/or nanodroplets),
  • an ultrasound catheter may be introduced to a treatment site within a patient.
  • the treatment site may have a clot (e.g., a thrombus) that may require treatment.
  • the ultrasound catheter may be introduced through the blood vessels until it reaches the treatment site.
  • the ultrasound catheter may include an ultrasound transducer element which can deliver ultrasound energy directly to the treatment site to treat the thrombus.
  • the ultrasound transducer element may come in direct contact with the thrombus at the treatment site and/or be positioned near or adjacent to the thrombus such that ultrasound energy can be directed towards the thrombus.
  • the ultrasound transducer element may deliver ultrasound energy and the catheter can also deliver microbubbles and/or lytic to the thrombus before, after and/or during delivery of ultrasound energy.
  • the ultrasound catheter can be advanced through the thrombus site and continue to deliver ultrasound energy, microbubbles, and/or lytic to the thrombus.
  • the ultrasound catheter can be advanced through the length of the thrombus until the length of the thrombus is minimized and the thrombus is entirely or almost entirely fragmented and/or dissolved.
  • a distal end of the ultrasound catheter may be configured to articulate. This may allow a targeted ultrasound treatment to be delivered to the treatment site. Articulation of the distal end of the ultrasound catheter may allow for the thrombus to be treated from different angles and/or may allow for a greater area of the treatment site to be treated more effectively.
  • This articulation and targeted ultrasound treatment can occur as the ultrasound catheter is advanced through the clot.
  • the distal end of the ultrasound catheter can be articulated to direct ultrasound energy to the identified residual clot.
  • An advantage of targeted ultrasound can be the enhanced mechanical assistance/action in engaging thrombus for better/improved treatment which may allow new regions for treatment, more microchannels, and/or greater binding sites for lytic leading to improved performance and outcomes.
  • the ultrasound transducer element can operate at a frequency of approximately 20 kHz - 25 MHz and in certain embodiments the frequency can be in the range of 450 kHz - 850 kHz and in certain aspects 650 kHz.
  • the frequency at which the ultrasound transducer element may operate may be based on the location of the treatment site, the distribution of microbubblcs, and/or the location of the thrombus within the treatment site.
  • the frequency range of the ultrasound transducer may allow the generated ultrasonic waves to penetrate deeper into tissue where the treatment site may be located.
  • the frequency range of the ultrasound transducer may allow the generated ultrasonic waves to penetrate a shallow depth of the tissue where the treatment site may be located.
  • the ultrasound catheter may be removed from the treatment site.
  • the ultrasound catheter may remain at the treatment site.
  • An aspiration catheter or aspiration sheath or sheath (used interchangeably throughout) may be advanced into the patient’s vascular system and advanced towards the treatment site.
  • the aspiration catheter may be advanced to an area near the treatment site.
  • the aspiration catheter may be advanced to an area between an insertion site and the treatment site.
  • an aspiration catheter can be used to gain access from outside the body to inside the body and in such embodiments, the aspiration catheter can be used as an access sheath through which other devices can be inserted. In some aspects, the aspiration catheter can be used in treating deep vein thrombosis. In some aspects, an aspiration catheter can be used to track location of the treatment provided (e.g., a pulmonary embolism). In some aspects, this may be used when treating a pulmonary embolism.
  • the aspiration catheter or aspiration sheath or sheath are used interchangeably herein in all embodiments and aspects.
  • the aspiration catheter may be used in combination with a retriever catheter and the ultrasound catheter.
  • the aspiration catheter can be referred to as an aspiration sheath and in certain embodiments aspiration can be applied to the vascular system through the aspiration catheter, however, in some aspects the aspiration need not be applied and the aspiration catheter/sheath can be used as an introducer catheter to deliver other instruments and catheter through the lumen of the aspiration sheath/catheter.
  • the aspiration catheter may be introduced into the patient’s vascular system prior to the ultrasound catheter being introduced into the patient such that the ultrasound catheter is advanced through the aspiration catheter and then advanced to the treatment site. In this manner, the ultrasound catheter may be inserted through the aspiration catheter.
  • the ultrasound catheter may be inserted through an introducer, such as an off-the-shelf introducer.
  • a second catheter for example an aspiration catheter or a retriever catheter, can be inserted through the introducer.
  • the ultrasound catheter and the second catheter can be inserted through the introducer simultaneously.
  • the ultrasound catheter may be used with external thrombectomy devices.
  • the aspiration catheter may include a funnel with an expanded opening that can guide elements of the fragmented and/or dissolved thrombus as the treatment site is aspirated.
  • the retriever catheter may be inserted through the ultrasound catheter. The retriever catheter may extend passed the distal end of the ultrasound catheter.
  • the ultrasound catheter may be removed from the aspiration catheter to allow for the retriever catheter to be inserted through the aspiration catheter. This may be further described below with reference to FIGS. 9A and 9C.
  • the retriever catheter may include a retriever that can engage the thrombus and/or elements of the fragments and/or dissolved thrombus. The retriever may break the thrombus further apart and/or dislodge it from the vessel wall to remove the thrombus from the treatment site as the retriever is withdrawn into the aspiration catheter. The retriever can capture the thrombus and the fragmented and/or dissolved thrombus elements.
  • the aspiration catheter can be used to aspirate the area and/or treatment site. This can help to ensure the treatment site is effectively treated and the thrombus is effectively removed from the treatment site. Once the retriever removes the thrombus from the treatment site and the aspiration catheter can aspirate the area and/or the treatment site before, during, and/or after the removal of the thrombus. In other aspects, the aspiration catheter may not aspirate the area or treatment site.
  • the aspiration catheter, introducer, or sheath can be used to provide access to the vascular system and can be used to introduce other devices (such as, for example, the ultrasound catheter or retriever catheter).
  • Aspiration of the area and/or treatment site may be based on the effectiveness of the removal of thrombus by the retriever.
  • the combination of catheters can help to maximize the effectiveness of the removal of the thrombus from the treatment site and restore blood flow to the blood vessels.
  • features of the aspiration catheter and/or retriever can be combined with the ultrasound catheter.
  • the ultrasound catheter can be advanced through the aspiration catheter such that the aspiration catheter is positioned within the patient during treatment with the ultrasound, drug (c.g., lytic) and/or microbubblcs (and/or nanodroplcts).
  • the ultrasound catheter can be removed from the aspiration catheter and then the retriever catheter can be advanced through the aspiration catheter after removal of the ultrasound catheter.
  • a retriever can be positioned on the ultrasound catheter and the retriever on the ultrasound catheter can be used to withdraw and/or dislodge the clot after treatment.
  • an aspiration catheter may be introduced into the vascular system through an access site and in certain embodiments advanced towards the treatment site and in certain embodiments advanced to the treatment site (which may include an obstruction, as described above, to the flow of blood through the circulatory system.).
  • an ultrasound catheter (according to aspects described herein) may be introduced to the treatment site as well.
  • the ultrasound catheter and aspiration catheter can be introduced together into the vascular system.
  • the ultrasound catheter may be advanced through the aspiration catheter to then be introduced to the treatment site.
  • the distal end of the aspiration catheter can be positioned near the treatment site or further away from the treatment site, such as, closer to the access site.
  • the ultrasound catheter may deliver microbubbles and/or metastable phase change nanodroplets and rtPA or other therapeutic compounds (e.g., a lytic) to the treatment site.
  • the microbubbles and/or metastable phase change nanodroplets and rtPA or other therapeutic compounds (e.g., a lytic) can be delivered through a lumen in the ultrasound catheter and/or through another passage in the catheter system. This can allow for treatment of the thrombus located at the treatment site. For example, delivering microbubbles and/or metastable phase change nanodroplets can create microchannels within the thrombus.
  • the ultrasound catheter can then deliver ultrasound energy or ultrasound treatment to the thrombus.
  • the ultrasound catheter can continue to deliver treatment to the thrombus (ultrasound and/or microbubbles and/or metastable phase change nanodroplets and rtPA or other therapeutic compounds (e.g., a lytic) to the treatment site) as it is advanced through the length of the thrombus.
  • the ultrasound catheter is first positioned near the thrombus or within the beginning of the thrombus and then after treatment with ultrasound and a therapeutic compound begins, the ultrasound catheter can be advanced into (or further into) the thrombus and further treatment can be provided with ultrasound and a therapeutic compound.
  • Ultrasound can be provided within the frequency and power ranges described herein.
  • the ultrasound transducer element can operate at a frequency of approximately 20 kHz - 25 MHz and in certain embodiments the frequency can be in the range of 450 kHz - 850 kHz and in certain aspects 650 kHz.
  • the microbubbles and/or metastable phase change nanodroplets and rtPA or other therapeutic compounds (e.g., a lytic) in combination with the ultrasound may aid in boring a hole or passage through the clot.
  • the ultrasound catheter can be advanced 25% through length of thrombus, 50% through length of thrombus, 100% through length of thrombus and deliver treatment all throughout. The ultrasound catheter can then be removed from the treatment site.
  • a retriever catheter (according to aspects described herein) may then be introduced to the treatment site.
  • the retriever catheter can be advanced through the aspiration catheter to be introduced to the treatment site.
  • the retriever catheter may be advanced to the most outer end of the treatment (e.g., entirely or substantially through the clot) site and deploy a retriever.
  • the retriever may capture the degraded and/or residual thrombus at the treatment site.
  • the retriever catheter may then retract the retriever from the treatment site and into the aspiration catheter.
  • the aspiration catheter may then aspirate the area and/or treatment site to direct the degraded and/or residual thrombus into the aspiration catheter. In other aspects, the aspiration catheter may not aspirate the area or treatment site.
  • Aspiration of the area and/or treatment site may be based on the effectiveness of the removal of thrombus by the retriever.
  • the advancement of the retriever catheter, deployment of the retriever, retraction of retriever, and aspiration of the treatment site may be repeated until the treatment site is free or mostly free of thrombus.
  • the retriever catheter can be inserted through the ultrasound catheter or alongside the ultrasound catheter such that the ultrasound catheter does not need to be removed before the retriever catheter is used to remove the clot.
  • FIG.l illustrates an example of a catheter system 100 configured for use at a treatment site within a patient.
  • the catheter system 100 includes an ultrasound catheter 300, an aspiration catheter 200, and a retriever catheter 400.
  • the catheter system 100 can be used to deliver ultrasound energy to a treatment site within a patient to assist in dissolving or lysing a thrombus located at the treatment site.
  • the catheter system 100 can also be used to aspirate the thrombus at the treatment site. Additionally, or alternatively, the catheter system 100 can be used to mechanically retrieve the thrombus from the treatment site with the retriever catheter 400.
  • the catheter system 100 can also include at least one valve 311 that may be used to connect the various elements of the catheter system 100.
  • the valve can include a Tuohy-Borst adapter, or a hemostasis valve, which can minimize fluid loss during use of the catheter system 100.
  • the hemostasis valve can include side port tubing.
  • the aspiration catheter 200 can include a flared end 230.
  • the flared end 230 can aspirate a greater area of the thrombus at once and can aid in withdrawing a clot or thrombus retrieved by the retriever catheter 400 into the aspiration catheter 200.
  • the flared end 230 may be a funnel that is connected or bonded to the aspiration catheter 200.
  • the ultrasound catheter 300 can include an ultrasound element (described in more detail below) that may deliver ultrasound energy to a treatment site within a patient.
  • the ultrasound catheter 300 can include a knob 320, which can control the deflection of a distal tip of the ultrasound catheter 300 (as will be explained in more detail below). This may allow the catheter system 100 to more accurately direct or control where ultrasound energy is delivered. Additionally, this may allow the ultrasound catheter 300 to more effectively be advanced to the treatment site and the length of the thrombus. This may further allow the ultrasound catheter 300 to more effectively deliver ultrasound treatment to a thrombus that is relatively more lodged in the blood vessel.
  • the retriever catheter 400 can include a retriever 410 located at a distal end of the retriever catheter 400.
  • the retriever catheter 400 may include an actuator that can be rotated (or otherwise actuated) to cause the retriever 410 to selectively expand or collapse. The expansion and collapsing of the retriever 410 may assist in the removal of the blood clot from the treatment site of the patient.
  • the retriever 410 can be self-expandable once it is advanced past the distal end of the aspiration catheter 200 or ultrasound catheter 300.
  • FIG. 1A illustrates a schematic cross section of the catheter system 100 with reference to FIG. 1.
  • the aspiration catheter 200, ultrasound catheter 300, and retriever catheter 400 may be concentric.
  • the aspiration catheter may include at least one aspiration lumen 201 (schematically illustrated in FIG 1A).
  • the ultrasound catheter 300 may be inserted through the at least one aspiration lumen 201 of the aspiration catheter 200.
  • the ultrasound catheter 300 may include at least one lumen 301 (schematically illustrated in FIG 1A) which can be used to deliver a therapeutic compound to the treatment site.
  • the lumen 301 can also be used to advance the ultrasound catheter over a guidewire.
  • the ultrasound catheter can include multiple lumens.
  • the retriever catheter 400 may be inserted through the at least one lumen 301.
  • the retriever catheter 400 may be inserted into a proximal end of the ultrasound catheter 300 and extend through the at least one lumen 201 of the ultrasound catheter 300.
  • the retriever catheter 400 may be inserted through the at least one aspiration lumen 201 as described above.
  • the retriever catheter can be configured to be inserted into a proximal end of the aspiration catheter 200 and extend through the aspiration lumen 201 after the ultrasound catheter 300 is removed from the aspiration catheter 200.
  • the retriever catheter can be inserted along the side of the ultrasound catheter 300 within the aspiration lumen 201.
  • the retriever catheter 400 may extend through the at least one lumen 301 of the ultrasound catheter 300 and extend passed a distal end of the ultrasound catheter 300.
  • the ultrasound catheter 300 may be inserted into a proximal end of the aspiration catheter 200.
  • the ultrasound catheter 300 may extend through the aspiration lumen 201 of the aspiration catheter 200 and extend past a distal end of the aspiration catheter 200.
  • the retriever catheter 400 may be inserted through the at least one lumen 301 of the ultrasound catheter 300 as the ultrasound catheter 300 is inserted through the aspiration lumen 201 of the aspiration catheter 200.
  • the retriever catheter 400 may have a larger diameter and be configured to extend passed the aspiration catheter 200 when the ultrasound catheter 300 is removed from the aspiration catheter.
  • the ultrasound catheter 300 can extend from the retriever catheter 400.
  • the retriever catheter 400 can extend from the ultrasound catheter 300.
  • FIG. 2 illustrates the aspiration catheter 200 as referred to in FIG. 1, but now shown in isolation.
  • the aspiration catheter 200 has a first (distal) end, a second (proximal) end, a handle 210 at the proximal end, a body formed by a shaft or extrusion 220 positioned between the distal and proximal end of the aspiration catheter 200, and an expandable funnel or flared end 230 at the second (distal) end of the aspiration catheter 200.
  • the extrusion 220 can extend through the handle 210 and connect to a distal interface 240 of the aspiration catheter 200.
  • the distal interface 240 can be molded and bonded to the extrusion 220 and the flared end 230.
  • the distal interface 240 can be radiopaque.
  • the flared end 230 can be bonded to the distal interface 240.
  • the flared end 230 may have a first diameter and a second diameter; the first diameter may be smaller than the second diameter.
  • the flared end 230 may include a body that connects the first diameter to the second diameter.
  • the flared end 230 can function as a lead-in feature of the aspiration catheter 200. The flared end 230 can help to maximize the amount of thrombus that is removed from the treatment site.
  • the Hared end 230 can be collapsible and expand to the treatment site of the patient.
  • the flared end 230 can expand to a vessel wall of the treatment site of the patient. This can help to ensure the thrombus and/or debris is effectively removed from the treatment site.
  • the flared end 230 can direct aspiration of the aspiration catheter.
  • the flared end 230 can be open or closed to direct the aspiration.
  • the flared end 230 can be actively deployable.
  • the flared end (expandable funnel) 230 can be self-expandable.
  • the flared end 230 may include radiopaque features.
  • the flared end 230 may include nitinol. In some examples, the flared end 230 may have finger-like structures that may be connected by film which may or may not be perforated. In some examples, the flared end 230 may be actuated by use of an outer cover or tube that may slide over or cover and cause the finger-like structures to draw closer together until the structures are in an isodiametric arrangement.
  • the aspiration catheter can also include tubing 250, a one-way stop cock 260, and a vacuum syringe port 270 to assist in aspiration. In some examples, the tubing 250 can include flexible, large bore tubing.
  • the aspiration catheter 200 defines an aspiration lumen (not shown) that can extend through the aspiration catheter 200.
  • FIG. 2A illustrates an alternative embodiment of the aspiration catheter 200 as referred to in FIG. 2.
  • the aspiration catheter 200 can include a knob 280 that may articulate a distal interface 240 of the aspiration catheter.
  • the extrusion 220 can include pull wires that connect to the knob 280 and the distal interface 240 that may allow for 180-degree articulation of the aspiration catheter 200 and/or active expansion and/or contraction of the distal end of the aspiration catheter 200.
  • the distal interface 240 can be molded and bonded to the extrusion 220 and the flared end 230.
  • FIG. 3 illustrates an ultrasound catheter 300 as referred to in FIG. 1, but now shown in isolation.
  • the ultrasound catheter 300 can include the handle 310, a knob 320, and an extrusion 330.
  • the extrusion 330 can have a proximal end 340 and a distal end with a body positioned between the distal end and proximal end 340.
  • the distal end 340 may be articulated by rotation of knob 320.
  • the handle 310 may have a length of approximately 3.0 in. - 5.0 in. This can allow for a steerable ultrasound catheter.
  • a user can rotate the knob 320 (e.g., clockwise or counterclockwise direction) to control the deflection of the distal end 340.
  • the articulation of the distal end 340 can better direct the delivery of the ultrasound energy to the treatment site within the patient.
  • articulation of the distal end 340 can help to better dislodge the thrombus from the treatment site by better targeting ultrasound towards a portion of the thrombus that may require additional treatment to dislodge or fragment.
  • articulation of the distal end 340 can better target the thrombus located in the treatment site as well. This can allow for treatment of the thrombus by visualization and/or target searching.
  • the extrusion 330 can be a multi-lumen extrusion that includes one or more pull-wires 335 extending along the length of the catheter configured to articulate the distal end 340 by connecting the distal end 340 and the knob 320.
  • the pull-wires 335 can allow articulation of the distal end 340 by approximately + or - 180 degrees from the longitudinal axis of the catheter and in some embodiments + or - 45 degrees longitudinal axis of the catheter.
  • Figure 3C schematically illustrates pull wires 335 which are connected to the distal end 340 for providing articulation.
  • the ultrasound catheter 300 can further include at least one lumen 350 and a pigtail cable 360 connected to a proximal end of the ultrasound catheter 300.
  • the lumen 350 for example, a female luer, can extend through the ultrasound catheter 300 to allow for an introduction of fluids to the patient.
  • the fluids may consist of a therapeutic compound, flush, radiopaque contrast agents, etc.
  • the fluids may enter the ultrasound catheter through the at least one lumen 350 or another lumen of the ultrasound catheter.
  • the lumen 350 may be welded or otherwise secured to the catheter 300.
  • the ultrasound catheter 300 may have a length of approximately 1.0m- 1.5m and a diameter of 15.24mm-20.32mm in.
  • the ultrasound catheter 300 can include an ultrasound element (also referred to herein as an ultrasound radiating element) 370 connected to the distal end 340.
  • FIG. 3 A illustrates a zoomed in view of the distal end 340 as referred to in FIG. 3.
  • the ultrasound element 370 can be bonded to a molded interface 370 which may be bonded to the extrusion 330. As explained above, the bonding can assist in allowing articulation of the distal end 340. This connection can further provide fluid ports for the distal end 340.
  • the ultrasound element 370 can be cylindrical and hollow and include a concave lens 390. In certain embodiments, the concave lens 390 may assist in focusing the ultrasonic field to assist in treatment or removal of the thrombus at the treatment site.
  • the distal end 340 of the ultrasound catheter 300 can include the ultrasound radiating element 370 (also referred to herein as an ultrasound element).
  • the ultrasound radiating element 370 comprises an ultrasound transducer, which may be radiopaque, which converts energy, for example, electrical energy into ultrasound energy.
  • the ultrasound energy can be generated by an ultrasound transducer that is remote from the ultrasound radiating element 370 and the ultrasound energy can be transmitted via, for example, a wire to the ultrasound radiating element 370.
  • ultrasound energy may be radiated by use of a vibrating wire, transducer or a laser.
  • ultrasound energy is generated from electrical power supplied to the ultrasound radiating element 370.
  • the electrical power can be supplied through a connector, which is connected to a pair of wires 362, 364 (shown schematically in Figure 3D) that extend through the body of the ultrasound catheter 300.
  • the first wire 362 can be connected to the hollow center of the ultrasound radiating element 370 while the second wire 364 is connected to the outer periphery of the ultrasound radiating element 370.
  • the ultrasound catheter includes at least one lumen 350 extending through the catheter and through the ultrasound radiating element 370.
  • a guidewire can be inserted through the at least one lumen 350 or another lumen of the ultrasound catheter.
  • the therapeutic compound and/or microbubbles and/or nanodroplets can be delivered to the treatment site through the at least one lumen 350 of the ultrasound catheter 300, or another lumen of the ultrasound catheter.
  • the lumen 350 can also be used to advance the ultrasound catheter over a guide wire in certain embodiments.
  • a fenestrated ultrasound radiating element 370 can be used.
  • a solid ultrasound radiating element 370 may be used, in which case the first wire can be connected to the outer periphery of the of the ultrasound radiating element 370.
  • the ultrasound radiating element 370 is preferably, but not limited to, a transducer formed of a piezoelectric ceramic oscillator or a similar material.
  • Piezoelectric ceramic oscillators typically comprise a crystalline material, such as quartz, that can change shape when an electrical current is applied to the material. This change in shape, when made oscillatory by an oscillating driving signal, can create ultrasonic sound waves.
  • ultrasonic energy can be generated by an ultrasonic transducer that is remote from the ultrasound radiating member, and the ultrasonic energy can be transmitted, via, for example, a wire that is coupled to the ultrasound radiating member such as that described in U.S. Patent No. 8,668,709, the entirety which is hereby incorporated by reference herein.
  • the temperature sensor and/or force sensor can be located on or near- the ultrasound radiating element 370.
  • Suitable temperature sensors include but are not limited to, diodes, thermistors, thermocouples, resistance temperature detectors (RTDs), fiber Bragg gratings, and fiber optic temperature sensors such as a Fabry-Perot sensor that uses thermochromic liquid crystals.
  • Suitable force sensors include, among others, Fabry-Perot, fiber Bragg gratings, resistors, load cells, and strain gauges.
  • the temperature sensor and/or force sensor can operatively connect to a control box (not shown) through a control wire, which extends through the ultrasound catheter.
  • the temperature sensor can be used to sense the temperature of the ultrasound radiating element 370 which can help to limit damage to the surrounding tissue.
  • FIG. 3B illustrates a feedback control system 68 that can be used with the ultrasound catheter as described with reference to FIG. 3 and FIG. 3A.
  • the feedback control system 68 can allow the temperature at a temperature sensor 20 to be monitored and allows the output power of ultrasound radiating element to be adjusted accordingly.
  • the feedback control system 68 can include an energy source 70 (i.e., ultrasound energy source) and power circuits 72 that may be coupled to the ultrasound radiating element 40.
  • a thermometer device 76 may be coupled to the temperature sensor 20 in the body.
  • a processing unit 78 may be coupled to the power calculation device 74, the power circuits 72 and a user interface 80.
  • the thermometer device 76 may measure the temperature at the location of the temperature sensor 20. The measured temperature may be received by the processing unit 78 to then be displayed to the user. Additional sensors (e.g., a force sensor) can also be connected to the processing unit 78.
  • the power circuits 72 may adjust the power level, frequency, duty cycle, , pulse repetition rate, voltage, phase and/or current of the electrical energy supplied to the ultrasound radiating element 40 from the energy source 70. For example, the power may be reduced if the measured temperature at the location of the temperature sensor 20 is higher than the desired or safe temperature. Similarly, for example, the power may be increased if the measured temperature at the location of the temperature sensor 20 is lower than the maximum allowable temperature. As the power is adjusted, the processing unit 78 may monitor the temperature sensor 20. [0096] In general, the feedback control system 68 can be used to more efficiently provide treatment to the treatment site by helping to ensure the ultrasound radiating clement 40 remains at a desired temperature so that surrounding tissue is not damages and can remain at a desired temperature.
  • the feedback control system 68 may control the mode in which the ultrasound radiating element 40 may operate in.
  • the ultrasound radiating element 40 may operate in a pulsed mode or a continuous mode.
  • the mode in which the ultrasound radiating element 40 operates in may determine the power that is supplied to the ultrasound radiating element 40.
  • the retriever catheter 400 can be inserted through the aspiration catheter 200 alongside the ultrasound catheter 300 or after the ultrasound catheter 300 has been removed.
  • the retriever catheter 400 can include a handle 410 and a stylet 420 that connects to a retriever 430 located at the distal end of the retriever catheter 400.
  • the handle 410 can facilitate an action stop to prevent the stylet 420 from advancing too far into the retriever catheter.
  • the handle 410 can facilitate a push, pull, twist, etc. action.
  • the retriever 430 can be bonded or welded to the stylet at a first end 440 of the retriever and may have a free end at a second end 450 of the retriever.
  • the second end 450 can be a free end to allow the retriever to slide along the stylet 420.
  • the retriever 430 can passively self-expand to retrieve a thrombus from the treatment site within the patient.
  • the retriever 430 may include a spiral basket 435 that may include at least one spline 438 (e.g., having six spiral splines, having two spiral splines, etc.).
  • the basket may contain nitinol.
  • the stylet 420 may be a guidewire. Tn some examples the guidewire may have a diameter of approximately 0.02 in. to approximately 0.04 in.
  • the retriever 430 can be formed of a variety of materials such as, for example, nickel titanium alloy (also known as nitinol).
  • the catheter system may be used to remove a thrombus from the treatment site of the patient.
  • the treatment site can be treated with ultrasound energy by use of the ultrasound catheter 300.
  • the treatment site may further be treated with an agent (e.g., a therapeutic compound).
  • the agent may include microbubbles and/or phase change nanodroplets that may assist in lysing the thrombus.
  • the agent may be delivered to the treatment site by use of the ultrasound catheter and/or a separate catheter or device in certain combinations. A user can rotate the knob located on the ultrasound catheter, as described above, to direct the ultrasound energy (for example, at the frequencies described above) at various portion of the thrombus. This may soften or loosen the thrombus.
  • the ultrasound catheter may delivery ultrasound energy at a power range of approximately 1 mW - 25 W.
  • the ultrasound transducer element can operate at a frequency of approximately 20 kHz - 25 MHz and in certain embodiments the frequency can be in the range of 450 kHz - 850 kHz and in certain aspects 650 kHz.
  • the user can advance the ultrasound catheter through the length of the thrombus and continue to treat the thrombus with ultrasound energy as it is advanced. This can help to ensure the thrombus is effectively treated by delivering ultrasound energy to approximately the entire length of the thrombus.
  • the user can then insert the retriever catheter 400 and use the retriever to retrieve the thrombus and/or debris from the treatment site.
  • the retriever catheter 400 can be inserted through the aspiration catheter 200.
  • the user can use the aspiration catheter 200 to aspirate the clot/thrombus, or any element of the clot/thrombus, into the aspiration catheter. This may help to more effectively remove the thrombus and/or debris from the treatment site. This may also help to ensure any fragment of the clot/thrombus and/or debris captured by the retriever remains in the retriever as the retriever is removed from the treatment site.
  • the ultrasound catheter may remain at the treatment site within the patient. In some examples, the ultrasound catheter can automatically rotate.
  • FIG. 5 illustrates another embodiment of catheter system 500 that includes an aspiration catheter 600 and embodiment of an ultrasound catheter in combination with a retriever catheter 700.
  • the catheter system 500 can be used to deliver ultrasound energy to a treatment site within a patient to assist in dissolving or lysing a thrombus located at the treatment site similar to the embodiment described above.
  • the catheter system 500 can also be used to aspirate the thrombus at the treatment site. Additionally or alternatively, the catheter system 500 can be used to mechanically retrieve the thrombus from the treatment site.
  • the aspiration catheter 600 as described with respect to FIG. 6, can include at least one valve that may be used to connect the various elements of the catheter system 500.
  • the valve can include a hemostasis valve, which can minimize fluid loss during use of the catheter system 500.
  • the hemostasis valve includes side port tubing.
  • the catheter system 500 may further include an aspiration catheter with a flared end 630 which can be configured similar as the aspiration catheter and funnel described above.
  • the flared end can aspirate a greater area of the thrombus at once.
  • the ultrasound catheter in combination with the retriever catheter 700 can include an ultrasound element / ultrasound radiating element as described in the embodiments described above that may deliver ultrasound energy to a treatment site within a patient.
  • the ultrasound catheter in combination with the retriever catheter 700 can include a dial 720, which can control the deflection or movement of a distal tip of the ultrasound catheter in combination with the retriever catheter 700 through, for example, a pull wire as described in the embodiment described above. This may allow the catheter system 500 to more accurately direct or control where ultrasound energy is delivered.
  • the ultrasound catheter in combination with the retriever catheter 700 can include a knob 750 that may be used to control the expansion or collapsing of a retriever 740 located at a distal end of the ultrasound catheter in combination with the retriever catheter 700.
  • FIG. 6 illustrates the aspiration catheter 600.
  • the aspiration catheter 600 can be similar to the aspiration catheter described above with reference to FIG. 2 and FIG. 2A.
  • the aspiration catheter 600 includes a handle 610, an extrusion 620, and a flared end 630.
  • the extrusion 620 can extend through the handle 610 and connect to a distal interface 640 of the aspiration catheter.
  • the distal interface 640 can be molded and bonded to the extrusion 620 and the flared end 630.
  • the distal interface 640 can be radiopaque.
  • the flared end 630 can be bonded to the distal interface 640.
  • the flared end 630 can function as a lead-in feature of the aspiration catheter 600.
  • the flared end 630 can be collapsible and expand to the treatment site of the patient.
  • the flared end 630 can expand to a vessel wall of the treatment site of the patient.
  • the flared end 630 can direct aspiration of the aspiration catheter.
  • the flared end 630 can be open or closed to direct the aspiration.
  • the flared end 630 can be actively deployable.
  • the flared end 630 may include radiopaque features.
  • the flared end 630 may include nitinol.
  • the flared end 630 may have finger-like structures that may be connected by film, and may or may not be perforated. In some examples, the flared end 630 may be actuated by use of an outer cover or tube that may slide over or cover and cause the finger-like structures to draw closer together until the structures are in an isodiametric arrangement.
  • the aspiration catheter can also include tubing 650, a one-way stop cock 660, and a vacuum syringe port 670 to assist in aspiration.
  • the tubing 650 can include flexible, large bore tubing.
  • the aspiration catheter can be articulated as explained with reference to FIG. 2A.
  • FIG. 7 illustrates an ultrasound catheter in combination with a retriever catheter 700.
  • the ultrasound catheter handle 310 of ultrasound catheter in combination with a retriever catheter 700 can be similar to the ultrasound catheter described above.
  • the ultrasound catheter handle 310 can include an ultrasound element that may deliver ultrasound energy to the treatment site within the patient.
  • the ultrasound catheter handle 310 can include a dial 720.
  • the dial 720 may be a level, knob, slider, etc.
  • the dial 720 may articulate a distal tip 730 of the ultrasound catheter handle 310. The articulation of the distal tip 730 may direct where at the treatment site the ultrasound energy is delivered.
  • the articulation of the distal end 730 can better direct the delivery of the ultrasound energy to the treatment site within the patient. For example, articulation of the distal end 730 can help to better dislodge the thrombus from the treatment site by better targeting a portion of the thrombus that may require additional treatment to dislodge or fragment. Additionally, articulation of the distal end 730 can better target the thrombus located in the treatment site as well.
  • an extrusion 740 of the ultrasound catheter handle 310 can include pull wires that can allow + or -180-degree articulation of the distal tip 730.
  • the retriever catheter element can include a knob 750 that may be located on the ultrasound catheter handle 310.
  • the knob 750 can be rotated to expand or collapse a retriever 760 located at the distal end of the ultrasound catheter in combination with a retriever catheter 700.
  • the retriever 760 can be used to retrieve a thrombus from the treatment site within the patient.
  • FIG. 8 illustrates a zoomed in view of the retriever 760 as referred to in FIG. 7.
  • a distal end 810 of the retriever 760 may be connected to the distal tip 730 of the ultrasound catheter element.
  • the distal end 810 can be molded and bonded to an inner extrusion 820 of the ultrasound catheter element.
  • a proximal end 830 of the retriever 760 may be molded and bonded to an outer extrusion 840 of the ultrasound catheter element.
  • the retriever and the outer extrusion can have radiopaque features and/or irrigation ports.
  • the distal tip 730 can include an ultrasound element 850.
  • the ultrasound element 850 can be hollow, cylindrical, and include radiopaque features and/or irrigation ports.
  • the distal tip 730 can further include a concave lens 860.
  • the concave lens may be made of polycarbonate, ABS, PP, poly sulfone, mylar, polystrene, EPO-TEK (r) 301, epoxy doped with alumina, syntactic foam, HDPE, glass, Perspex, parylene, or other materials of the like.
  • the material of the concave lens may have a phase velocity greater than blood. This can allow the ultrasound energy to be focused towards the front of the ultrasound radiating element.
  • the concave lens 860 may assist in focusing the field to assist in treatment or removal of the thrombus at the treatment site.
  • the retriever 760 may include a nitinol basket 865 and a plurality of splines 868, or a sries of interconnected struts.
  • the basket 865 can be guided by nitinol, for example the leading edge driven by nitinol and the basket being made of a softer material.
  • the retriever 760 can include multiple heat set splines 868.
  • the retriever 760 may be actively expanded by rotation of the knob 750.
  • the knob 750 may be in a rack and pinion gearset configuration.
  • the retriever catheter may include an inner catheter shaft that includes a perpendicular protruding shaft, which can form a T- shape with the inner catheter.
  • the knob 750 can be molded to have, on the inner portion, material removed in the pattern of threads (i.e., threads of a nut).
  • the inner shaft can be placed within the knob 750 where the protruding perpendicular shaft inserts into the threads. As the knob 750 is rotated, it can cause linear movement of the inner shaft for expansion or collapsing of the retriever 760.
  • the retriever can be a self-expanding element that is retained within a sheath that when positioned over the retriever constrains the retriever and when removed from the retriever causes the retriever to expand.
  • the catheter system may be used to remove a clot/thrombus from the treatment site of the patient.
  • the treatment site can be treated with ultrasound energy by use of the ultrasound catheter element of the ultrasound catheter in combination with the retriever catheter.
  • the user can articulate the ultrasound catheter element of the ultrasound catheter in combination with the retriever catheter to direct the delivery of ultrasound energy at the treatment site.
  • the treatment site may further be treated with an agent.
  • the agent may include microbubbles or phase change nanodroplets that can assist in lysing the thrombus.
  • a user can rotate the knob located on the ultrasound catheter, as described above, to direct the ultrasound energy at various portions of the thrombus. This may soften or loosen the thrombus.
  • the user can then control the retriever catheter of the ultrasound catheter in combination with the retriever catheter to expand or collapse the retriever.
  • the expansion or collapsing of the retriever can help to retrieve the thrombus from the treatment site.
  • the user can use the aspiration catheter to aspirate the thrombus into the aspiration catheter.
  • the ultrasound catheter in combination with the retriever catheter may remain at the treatment site within the patient.
  • an aspiration catheter 200 (which can be according to aspects and embodiments described herein) may be introduced into a patient’s vascular system through an access site and then advanced to the treatment site 900.
  • the aspiration catheter 200 may be advanced to an area near the treatment site.
  • the aspiration catheter may be advanced to an area between an insertion site and the treatment site.
  • an ultrasound catheter 300 (which can be according to aspects and embodiments described herein) may be introduced through the aspiration catheter 200 and advanced to the treatment site.
  • the ultrasound catheter can be advanced over a guidewire.
  • the ultrasound catheter 300 may be advanced through the aspiration catheter 200 to then be introduced to the treatment site 900 which includes a clot 901 (e.g., a thrombus).
  • the ultrasound catheter 300 may be used to deliver ultrasound (through the ultrasound element), and/or deliver microbubbles and/or metastable phase change nanodroplcts and rtPA or other therapeutic compounds as described herein (e.g., a lytic) to the treatment site as described above, for example, through the lumen 301 of the ultrasound catheter or through other passages in the catheter system or ultrasound catheter. This can allow for treatment of the thrombus located at the treatment site.
  • delivering microbubbles and/or metastable phase change nanodroplets can create microchannels within the thrombus.
  • the ultrasound catheter can deliver ultrasound energy or ultrasound treatment to the thrombus.
  • the ultrasound catheter may deliver ultrasound energy at a power range of approximately 1 mW - 25 W.
  • the ultrasound transducer element can operate at a frequency of approximately 20 kHz - 25 MHz and in certain embodiments the frequency can be in the range of 450 kHz - 850 kHz and in certain aspects 650 kHz.
  • the ultrasound and therapeutic compound can be delivered simultaneously and/or not simultaneously.
  • the ultrasound catheter 300 can continue to deliver treatment to the thrombus as it is advanced through the length of the thrombus at the treatment site 900 (see Figure 9B).
  • the ultrasound catheter is first positioned near the thrombus or within the beginning of the thrombus and then after treatment with ultrasound and a therapeutic compound begins, the ultrasound catheter can be advanced into (or further into) the thrombus.
  • the microbubbles and/or metastable phase change nanodroplets and rtPA or other therapeutic compounds (e.g., a lytic) in combination with the ultrasound may aid in boring a hole or passage through the clot.
  • the ultrasound and microbubbles and/or metastable phase change nanodroplets and rtPA or other therapeutic compounds can be delivered together or sequentially with each other.
  • the ultrasound catheter can be advanced 25% through length of thrombus, 50% through length of thrombus, 100% through length of thrombus and then further treatment with ultrasound and/or therapeutic compound can be conducted such that the length of the thrombus can be treated..
  • the ultrasound catheter can then be removed from the treatment site.
  • a distal end of the ultrasound catheter 300 may be configured to articulate. This may allow a targeted ultrasound treatment to be delivered to the treatment site particularly as the ultrasound catheter is advanced through a length of thrombus. Articulation of the distal end of the ultrasound catheter may allow for the thrombus to be treated from different angles and/or may allow for a greater area of the treatment site to be treated more effectively. This articulation and targeted ultrasound treatment can occur as the ultrasound catheter at the beginning of treatment (e.g., at the front of the clot or obstruction) and/or as the ultrasound catheter is advanced through the clot (and/or withdrawn or moved through the treatment site after an initial treatment period).
  • the distal end of the ultrasound catheter can be articulated between + or - 180 degrees from a longitudinal axis of the catheter and in certain aspects between + or - 90 degrees longitudinal axis of the catheter and in certain aspects between + or - 45 degrees longitudinal axis of the catheter to direct ultrasound energy to the identified residual clot.
  • This targeted treatment can be conducted as the ultrasound catheter is advanced through the clot and/or before initially advancing the ultrasound catheter through the clot and/or after a segment of clot /obstruction has been treated and the ultrasound catheter is being removed.
  • a retriever catheter 400 (according to aspects described herein) may then be introduced to the treatment site.
  • the retriever catheter 400 can be advanced through the aspiration catheter 200 to be introduced to the treatment site 900.
  • the retriever catheter may be advanced to the most outer end of the treatment (e.g., entirely or substantially through the clot) site and deploy a retriever.
  • the retriever may capture the degraded and/or residual thrombus at the treatment site.
  • the retriever catheter may then retract the retriever from the treatment site and into the aspiration catheter.
  • aspiration is applied through the aspiration catheter as the retriever is withdrawn into the aspiration catheter.
  • the aspiration catheter may then aspirate the treatment site to direct the degraded and/or residual thrombus into the aspiration catheter.
  • the advancement of the retriever catheter, deployment of the retriever, retraction of retriever, and aspiration of the treatment site may be repeated until the treatment site is free or mostly free of thrombus.
  • aspiration may not be applied as the retriever is withdrawn into the aspiration catheter and, in certain embodiments, aspiration may not be applied as the retriever captures the thrombus during treatment.
  • the retriever catheter can be advanced through the ultrasound catheter or alongside the ultrasound catheter through thcaspiration catheter.
  • the retriever can be formed or attached to a portion of the ultrasound catheter as described above.
  • FIGS. 10-21 illustrates components of another embodiment of a catheter system which can be used to remove a clot/thrombus from the treatment site of the patient.
  • FIG. 10 illustrates an embodiment of an ultrasound catheter 1000.
  • the ultrasound catheter 1000 can be similar to the ultrasound catheter 200 described with respect to FIG. 3.
  • the ultrasound catheter 1000 includes a handle 1002.
  • the handle 1002 may be gripped by a user administering a treatment.
  • the handle 1002 may be made of molded or 3D printed plastic pails.
  • a guide wire lumen 1004, a therapeutic compound delivery lumen 1006, and a cable 1008 are located at the proximal end of the handle 1002.
  • the cable 1008 may be an electrical cable that runs from the proximal end of an ultrasound radiating element to the connector at the proximal end of the cable extending from the handle 1002.
  • the cable 1008 may transmit the electrical signal to the ultrasound radiating element as described with reference to FIG. 3B.
  • the handle 1002 may or may not have a button or switch (not shown here) that allows the user to directly turn ultrasound output on/off.
  • a guidewire (not shown) can enter through the guidewire lumen 1004 from either the proximal or distal end.
  • a therapeutic compound or agent i.e., microbubbles, phase change nanodroplets, and/or lytic
  • the guidewire lumen 1004 provides a continuous path for the user to pass a guidewire through the device as will be explained in more detail below.
  • the guidewire lumen can be used to inject contrast over the guide wire if or when performing a venogram is desired.
  • the compound lumen 1006 provides a continuous path for the therapeutic compound to reach the distal portion of the ultrasound catheter (as will be explained in more detail below) without leaking into other areas of the ultrasound catheter.
  • the compound lumen 1006 may be designed such that the therapeutic compound does not exceed a pressure threshold that may cause damage.
  • the guidewire lumen 1004 and compound lumen 1006 may transition to luer connectors on the proximal end of the device (not illustrated). Additionally, a cable strain relief 1010 may couple the connection between the cable 1008 and the handle 1002, and a shaft strain relief 1020 may couple the connection between the catheter shaft 1016 and the handle 1002. This may protect a catheter shaft 1016 and cable 1008 of the ultrasound catheter 1000 from stress concentrations.
  • the handle 1002 further includes a deflection mechanism 1012, a control knob 1014, and a catheter shaft 1016.
  • the catheter shaft 1016 may be made of a braid reinforced polymer shaft.
  • the catheter shaft 1016 may include at least two lumens, each of which can or can not contain a PTFE liner.
  • one of the lumens may route the cable 1008, the guidewire lumen 1004, and the compound lumen 1006.
  • the other of the lumens may be embedded within a wall of the catheter shaft 1016 between the braid wire and PTFE or polymer liner (each of which make up the catheter shaft 1016 as explained above).
  • This secondary lumen may route at least one pull wire from a distal portion of the catheter shaft 1016 through the handle 1002. While the illustrated embodiment utilizes two lumens (one for the guide wire and one for the therapeutic compound), modified embodiments may include a single lumen for the guide wire and one for the therapeutic compound).
  • the catheter shaft 1016 may include more than one material.
  • the catheter shaft 1016 may be made of a soft material and a stiffer material.
  • a distal portion 1015 of the catheter shaft may be made of a soft material, (i.e., 45D pebax, or the like).
  • the soft material may help to allow the distal portion 1015 to deflect or move as directed.
  • a proximal portion 1017 of the catheter shaft may be made of a stiffer material (i.e., VESTAMID (r) , or the like).
  • the stiffer material may help to provide strength and rigidity to the catheter shaft 1016.
  • the transition between the softer material and the stiffer material may be smooth by including multiple transitions to ensure a smooth transition in materials.
  • the deflection mechanism 1012 and the control knob 1014 may be located on the face of the handle 1002.
  • the deflection mechanism 1012 and the control knob 1014 may be used to control the catheter shaft 1016 by use of at least one pull wire (described below with reference to FIG. 11D).
  • the deflection mechanism 1012 may be used to control the direction and degree of deflection of a distal tip 1018 of the catheter shaft 1016. More specifically, the deflection mechanism 1012 may actuate at least one pull wire that connects to the distal tip 1018 and the control knob 1014 may control the resistance to movement of the deflection mechanism 1012. This may help to ensure the distal tip 1018 is positioned in a desired position.
  • the control knob 1014 may lock the distal tip 1018 in a desired position.
  • a user administering the treatment may use a combination of the deflection mechanism 1012 and the control knob 1014 to maneuver and/or advance the ultrasound catheter 1000 to the desired location or position.
  • the catheter shaft 1016 may be include a layer of braided material.
  • a catheter strain relief 1020 may couple the connection between the catheter shaft 1016 and the handle 1002.
  • the catheter shaft 1016 may extend distally from a distal end of the handle 1002.
  • FIG. HA illustrates a distal cross section of the ultrasound catheter 1000 as described with reference to FIG. 10, the crosssection taken at line 11A-11A in FIG. 11C.
  • the distal tip 1018 includes a catheter mount 1102 that is bonded to the distal tip 1018.
  • the catheter mount 1102 includes cavities that provide space for various elements of the device. As shown in FIG.
  • the catheter mount 1102 can include a guidewire lumen cavity 1104 (which is in communication with the guidewire lumen 104), a compound lumen cavity 1106 (which is in communication with the compound lumen 106 and can also be referred to in as a therapeutic compound cavity and can be used to deliver a therapeutic compound which can include a drug and/or microbubbles and/or nanodroplets), and an ultrasound transducer cavity 1108.
  • the guidewire lumen cavity 1104 and the compound lumen cavity 1106 may be various sizes and may be generally circular or elliptical in shape.
  • the ultrasound transducer cavity 1108 may be larger than the guidewire lumen cavity 1104 and the compound lumen cavity 1106.
  • the ultrasound transducer cavity 1108 may provide enough space for the cable 1008 to transition to the ultrasound transducer. It can be beneficial to provide a separate and fitted space for each the ultrasound transducer cavity 1108, guidewire lumen cavity 1104, and the compound lumen cavity 1106 so that a more effective treatment can be provided to the treatment site as all three cavities can be used and occupied at once without interfering with another.
  • the guidewire lumen cavity 1104, and the compound lumen cavity 1106 are positioned on the same side of the catheter opposite the transducer cavity 1108.
  • the guidewire lumen 1004 and/or compound lumen 1006 can have visual indicators to distinguish them from one another.
  • FIG. 11 B illustrates a proximal cross section of the ultrasound catheter of FIG. 10, the cross-section taken at line 11B-11B in FIG. 11C.
  • the ultrasound catheter may include a jacket 1110 (i.e., a pebax jacket which can extend to the distal end of the catheter), a braided wire 1114, PTFE liners 1112 and at least one pull wire 1056.
  • the at least one pull wire 1056 may connect the deflection mechanism 1012 and control knob 1014 (FIG. 10) to the distal tip 1018 so that the direction of the distal tip 1018 and the degree of deflection of the distal tip 1018 can be controlled. As further shown in FIG. 1 IB, the guidewire lumen 1004 and compound lumen 1006 extend through the length of the catheter.
  • FIG. 11C illustrates a perspective view of the distal tip 1018 of the ultrasound catheter 1000 of FIG. 10 with the catheter shaft removed for illustrative purposes.
  • a catheter mount 1102 is the outer most layer of the distal tip 1018.
  • the catheter mount 1102 is located at the distal portion of the distal tip 1018.
  • An anchor ring 1154 can anchor at least one pull wire 1056 that connects to the deflecting mechanism and control knob (not shown). This can allow the distal tip 1018 to deflect when the user actuates the deflection mechanism by transferring tension through the at least one pull wire 1056 to the distal tip 1018.
  • the anchor ring 1154 may be located internal to the catheter mount 1102.
  • the at least one pull wire 1056 may be made of stainless steel and have a rectangular cross section that may be laser welded to the anchor ring 1154.
  • the anchor ring 1154 may be bonded to the distal tip 1018 or catheter mount 1102.
  • the cable 1008, guidewire lumen 1004, and compound lumen 1006 extend from the catheter handle to the distal tip.
  • the guidewire lumen 1004, compound lumen 1006, and cable 1008 are located internal to the anchor ring 1154.
  • FIG. 11D illustrates an isometric view of the distal tip 1018 of the ultrasound catheter lOOO of FIG. 10 with the catheter shaft removed for illustrative purposes.
  • the at least one pull wire 1008 connects to the anchor ring 1154.
  • the guidewire lumen 1004, compound lumen 1006, and the cable 1008 extend passed the anchor ring 1154 and into the distal tip 1018.
  • FIG. 12A illustrates a front face of the distal tip 1018 shown in FIG. 10.
  • the front face of the distal tip 1018 may be circular in shape.
  • the front face of the distal tip 1018 can include a guidewire lumen exit 1222 and a compound lumen exit 1224.
  • the guidewire lumen exit 1222 can allow the guidewire to exit the distal tip 1018 of the catheter. This can help to ensure that the ultrasound catheter 1000 is directed to the treatment site.
  • the compound lumen exit 1224 can allow the therapeutic compound to exit the distal tip 1018 of the catheter. This can help to ensure that the therapeutic compound is delivered to the treatment site.
  • the guide wire lumen exit 1222 and the compound lumen exit 1224 may have an aspect ratio (with aspect ratio equaling the width/height with the height being in the radial direction with respect to the longitindal axis of the catheter shaft and the width ) between 1 and 5 and an certain embodiments also be elliptical, oval, or triangular in cross-sectional shape with or without rounded edges in shape.
  • the shape of the guide wire lumen exit 1222 and the compound lumen exit 1224 can be designed to maintain a low fluid pressure. This can allow the pressure of the therapeutic compound to be controlled as it exits the ultrasound catheter to the treatment site.
  • the shape of the guidewire lumen exit 1222 and the compound lumen exit 1224 may be designed to taper throughout the length of the ultrasound catheter and flare outwards at the front face of the distal tip 1018.
  • the guidewire lumen cavity 1104 and a compound lumen cavity 1106 can be circular or generally circular along a majority or substantially all of the length of the catheter, which can be to help ensure the lumens fit within the ultrasound catheter.
  • the guidewire lumen cavity 1104 and a compound lumen cavity 1106 can transition such that they form the shape of the guidewire lumen exit 1222 and the compound lumen exit 1224 described above.
  • the shape of the guidewire lumen exit 1222 and the compound lumen exit 1224 with an aspect ratio greater than 1 or between 1 and 5 can help to better distribute lytic and microbubbles by having a wider opening at the face of the distal tip 1018 compared to an opening at a cross section of the lumens which can advantageously help the lytic and microbubbles be distributed in a fan-like manner.
  • the guidewire lumen exit 1222 and the compound lumen exit 1224 can have a circular cross-sectional shape and in certain embodiments only one of the compound exit 1124 or the guide wre lumen exit 1222 can have the an aspect ratio of greater than 1 or between 1 and 5.
  • the guide wire lumen exit 1222 and the compound lumen exit 1224 may be located near the edge of the front face of the distal tip 1018.
  • the guidewire lumen exit 1222 and the compound lumen exit 1224 may be parallel to each other.
  • the guidewire lumen exit 1222 and the compound lumen exit 1224 may be angled so that a first end of the guidewire lumen exit 1222 is positioned higher than a second end of the guidewire lumen exit 1222 and a first end of the compound lumen exit 1224 is positioned higher than a second end of the compound lumen exit 1224.
  • the guidewire lumen exit 1222 and the compound lumen exit 1224 may be located on the same portion of the front face of the distal tip.
  • the guidewire lumen exit 1222 and the compound lumen exit 1224 may be located above or below the ultrasound transducer cavity 1226.
  • the guidewire lumen exit 1222 and the compound lumen exit 1224 may be located radially outwardly from a center point of the front face of the distal tip 1018.
  • the guidewire lumen exit 1222 and the compound lumen exit 1224 may be located circumferentially outward on the front face of the distal tip 1018.
  • the guide wire lumen exit 1222 and the compound lumen exit 1224 may extend the length of the distal tip 1018.
  • the front face of the distal tip 1018 may further include an ultrasound transducer cavity 1226.
  • the ultrasound transducer cavity 1226 may be circular in shape and may be located off-center from the front face of the distal tip 1018. As shown in FIG. 10, the ultrasound transducer cavity 1226 is filled or occupied by an ultrasound radiating element (described in more detail below with respect to FIG. 19) comprises an ultrasound transducer, which can convert energy, for example, electrical energy or optical into ultrasound energy as described above.
  • the ultrasound transducer cavity 1226 may occupy a majority of the front face of the distal tip 1018 and may be located above the guidewire lumen exit 1222 and the compound lumen exit 1224 such that the longitudinal center of the ultrasound transducer cavity 1226 is positioned above or below (or on one side) of the longitudinal centers of the guide wire lumen exit 1222 and the compound lumen exit 1224 and in an embodiment the guidewire lumen exit 1222 and the compound lumen exit 1224 are entirely positioned on one side or below or above the longitudinal center of the ultrasound transducer cavity 1226.
  • the ultrasound transducer cavity 1226 may extend the length of the distal tip 1018.
  • the ultrasound transducer cavity 1226 may have a longitudinal center that is radially offset from the longitudinal axis of the cavity.
  • FIG. 12B illustrates a side view of the distal tip 1018 as described with reference to FIG. 10.
  • the ultrasound transducer 1202 may extend pass the length of the distal tip 1018.
  • the ultrasound transducer 1202 may be flush with the distal tip 1018.
  • the perimeter of the distal tip 1018 may bevel or chamfer.
  • the distal tip 1018 includes the catheter mount 1102 and the anchor ring 1154.
  • the catheter mount 1102 may include cavities (not shown), which include the guidewire lumen exit 1222, the compound lumen exit 1224 and the ultrasound transducer cavity 1226.
  • the distal tip 1018 may further include a deflectable section 1206 at the proximal end of the distal tip 1018.
  • the deflectable section 1206 can be controlled or manipulated by the deflection mechanism 1012 and the control knob 1014.
  • At least one pull wire may extend from the deflection mechanism 1012 to the anchor ring 1154.
  • the anchor ring 1154 can anchor the at least one pull wire and allow the deflectable section 1206 to deflect. Articulating the deflectable section 1206 can change the direction of ultrasound energy emitted by the ultrasound radiating element, as the distal end of the catheter can face a different direction.
  • FIG. 12C illustrates internal components of the distal tip 1018 shown in FIG. 10.
  • the distal tip, anchor ring, and deflectable section are removed for clarity.
  • internal components of the distal tip 1018 include the ultrasound transducer 1202 with attached circuit board for electrical connections, the cable 1008, the guidewire lumen 1004, and the compound lumen 1006.
  • the ultrasound transducer 1202 is described with respect to FIG. 19 and 20.
  • the guidewire lumen 1004 can be a part of the distal tip that goes under the pull ring to support the guidewire as the catheter shaft is deflected.
  • FIG. 13A illustrates a retriever catheter 1300 which can be used with the ultrasound catheter 1000 described above or with the other catheter embodiments disclosed above.
  • FIG. 13A shows a distal portion of the retriever catheter 1300.
  • the retriever catheter 1300 includes a guidewire lumen 1302 that extends through the retriever catheter 1300.
  • the guidewire lumen 1302 extends from a proximal end 1304 of the retriever catheter 1300 to a distal end 1306 of the retriever 1301.
  • the retriever 1301 may extend from an inner catheter shaft 1308.
  • the inner catheter shaft 1308 may be a reinforced catheter shaft, such as a braid reinforced polymer shaft with a PTFE or polymer liner, or a laser cut hyotube reinforced construct, or a hybrid.
  • the inner catheter shaft 1308 may be secured to the retriever catheter handle (not shown).
  • the inner catheter shaft 1308 may be located inside an outer catheter shaft 1310. In other words, the retriever 1301 and the inner catheter shaft 1308 may telescope from the outer catheter shaft 1310.
  • the retriever 1301 may be pushed through the outer catheter shaft 1310.
  • the retriever 1301 When the retriever 1301 reaches a first point as it is pushed through the outer catheter shaft 1310, the inner catheter shaft 1308 will extend past the outer catheter shaft 1310.
  • the mechanical retriever 1300 may reach a further second point which may cause the retriever 1301 to extend pass the inner catheter shaft 1308.
  • the outer catheter shaft 1310 may be a braid reinforced polymer shaft.
  • the outer catheter shaft 1310 may include a flared distal tip to allow smooth deployment or retraction of the retriever 1301.
  • the retriever catheter 1300 may include an atraumatic tip 1314 located at the distal end of the retriever 1301 to help to ensure surrounding tissue is not damaged as the retriever 1301 is telescoped.
  • the atraumatic tip 1314 may be a molded polymer component, which may be bonded to the distal end of the mechanical retriever and guidewire lumen.
  • the atraumatic tip 1314 may include a through hole which can allow the guidewire to pass through the atraumatic tip 1314.
  • the atraumatic tip 1314 may be tapered to allow the atraumatic tip 1314 to be inserted into the treatment site of the patient.
  • the atraumatic tip 1314 includes a reduced diameter at the proximal end of the atraumatic tip 1314 to mate with the outer catheter shaft 1310 when the mechanical retriever is retracted.
  • the retriever 1301 may include a basket 1312.
  • the basket 1312 may be bonded to the distal end of the inner catheter shaft 1308. In use, the basket 1312 may capture or contain at least part of a thrombus or any debris, fragmented, or residual thrombus remaining after administration of treatment.
  • the basket 1312 may be wholly or partially constructed of a self-expanding ni tinol basket that may also be laser cut.
  • the basket 1312 may include a variable pattern that can allow the thrombus or at least a part of the thrombus, or debris to enter the basket 1312 near the proximal end of the retriever.
  • the basket 1312 may be heat set to the desired profile and then electropolished to the desired surface finish. Additionally, the variable pattern can help to prevent the thrombus or at least the part of the thrombus that is captured within the basket 1312 from escaping or exiting the basket 1312 prior to removal of the retriever 1301 from the treatment site.
  • the variable pattern may be elongated, or have large cells or openings, near the proximal end of the retriever 1301 and the variable pattern may be tight, or have small cells or openings, near the distal end of the mechanical retriever. This can help to keep the captured thrombus or debris inside of the retriever 1301.
  • the distal portion of the basket 1312 may have a high cell density and the proximal portion 1303 of the basket 1312 may have a low cell density.
  • the cell size of the majority of cells in the proximal portion of the basket, or area of opening for a given cell can be 200-2000% larger than the size of the majority of cell openings at the distal end or distal portion of the basket.
  • the cell size of the majority of cells in the proximal portion of the basket can be 100-500% larger than the size of the majority of cell openings at the middle end or middle portion of the basket.
  • the maximum cell size in the proximal portion of the basket can be 200-2000% larger than the minimum cell size in the distal end or distal portion of the basket.
  • the maximum cell size in the proximal portion of the basket can be 200-2000% larger than the cell size of the majority of cells in the distal end or distal portion of the basket. In certain embodiments, the maximum cell size in the proximal portion of the basket can be 100-500% larger than the cell size of the majority of cells in the middle portion of the basket. In certain embodiments, the maximum cell size in the proximal portion of the basket can be 100-500% larger than the minimum cell size of the middle portion of the basket.
  • the proximal cells can have a number of cells or struts that bisect the opening.
  • the distal basket section can include a perforated polymer material.
  • the device can include a less dense metallic basket while having a finer and less dense flexible mesh holding thrombus back.
  • the material can pass blood cells and still retain a clot of any size.
  • the device can have a frame supporting a fine mesh screen.
  • the cells on the proximal end of the basket may be between 50% and 600% larger than the cells on the distal end of the basket.
  • the diameter of a distal portion of the retriever 1305 is less than the diameter of a proximal portion of the retriever 1307. This can help to ensure the retriever may not apply unnecessary or excessive pressure or force on the vessel the retriever may access the treatment site through. This can also help to ensure the retriever can travel through and exit the vessel as well.
  • the diameter can be smaller distally with a reduction in distal radial force through a weaker frame constructs. Additionally, this can help to ensure the captured thrombus may not escape from the basket 1312.
  • a middle portion 1303 of the retriever may have a reduced diameter compared to the diameter D 1 of the proximal portion of the retriever 1307 and a larger diameter compared to the diameter D2 of the distal portion of the retriever 1305 and in certain embodimens the proximal portion 1307 has diameter DI that is 5% greater, 10% greater or 15% greater and in certain embodiments between 5%-30% greater, 5% to 40% 5%-75% greater, 10% to 75% greater and in certain embodiments 15% to 75% greater than the middle portion (with the diameter being measured perpendicular to the longitudinal axis of the retriever 1301 and the length being measured parallel to the longitudinal axis of the retriever 1301).
  • the ranges of the ratios defined herein between the diameters of the proximal and middle portions can be defined by the ratios in diameters between the maximum diameter of each section (the proximal portion and the middle portion) or in certain embodiments the average diameter of each section so that ratios based on both the maximum diameter of each section or the average diameter of each section can be claimed.
  • the proximal and middle sections can be cylindrical or substantially cylindrical but in certain embodiments these sections can taper or otherwise have a diameter that varies along the length by less than 5%, less than 10% and less than 15% in certain mobidments.
  • the enlarged proximal portion may help the retriever to retain the captured thrombus.
  • the retriever 1301 may have a length between approximately 80- 180mm.
  • the retriever 1301 may have a length of 160mm.
  • Each portion of the retriever, distal portion 1305, middle portion 1303, and proximal portion 1307 may be uniform and symmetric throughout each respective portion. This can help to ensure the retriever can more easily travel through the vessel to and from the treatment site. Smooth elongated transitions can help with smooth lower force transitions into and out of the outer catheter shaft. Additionally, there may be smooth transitions between each of the portions of the retriever which can also help to ensure that the retriever more easily travels through the vessel to and from the treatment site.
  • the proximal portion 1307 can be connected to the inner catheter shaft 1308 (also referred to as a shaft) by struts 1309.
  • the struts 1309 can be open cells to allow at least a part of the thrombus to enter the retriever 1301.
  • the proximal portion 1307 can have a diameter of approximately 18.0 mm. In some embodiments, the proximal portion 1307 can have a diameter of approximately 10-30 mm. In some embodiments, the proximal portion 1307 can have a diameter of approximately 5-50 mm. In some embodiments, the middle portion 1303 can have a diameter of approximately 12.6 mm. In some embodiments, the middle portion 1303 can have a diameter of approximately 10-30 mm. In some embodiments, the middle portion 1303 can have a diameter of approximately 5-50 mm . In some embodiments, the distal portion 1305 can have a diameter that tapers from the diameter of the middle portion 1303 to approximately a closed end.
  • the proximal portion 1307 and middle portion 1303 can be used in combination with the relationship between the diameters proximal portion 1307 and middle portion 1303 described herein.
  • the proximal portion 1307 can have a larger diameter than the middle portion 1303 at the greatest diameter of the middle portion 1303.
  • the struts in the middle portion 1303 can be about 50%, or 30%-60%, thicker than the struts in the distal section 1305 to allow for higher local radial force.
  • the middle portion 1303 can have a diameter that is 70% of the diameter of the proximal portion 1307.
  • the middle portion 1303 can have a diameter that is 40 - 90% of the diameter of the proximal portion 1307 in some embodiments 70 - 99% of the diameter of the proximal portion 1307 and in some embodiments 70 -95% of the diameter of the proximal portion 1307 (with the diameter being measured perpendicular to the longitudinal axis of the retriever 1301 and the length being measured parallel to the longitudinal axis of the retriever 1301) wherein as noted above the ranges of the ratios defined herein between the diameters of the proximal and middle portions can be defined by the ratios in diameters between the maximum diameter of each section (the proximal portion and the middle portion) or in certain embodiments the average diameter of each section so that ratios based on both the maximum diameter of each section or the average diameter of each section can be claimed.
  • the middle portion 1303 can have a diameter that is 25 - 90% of the diameter of the proximal portion 1307. Additionally, the overall length of the middle portion can be between 100% and 500% of the length of the proximal portion.
  • the distal portion 1305 can have a diameter that tapers to approximately 10% of the diameter of the proximal portion 1307. In some embodiments, the distal portion 1305 can have a diameter that tapers to approximately 5% of the diameter of the proximal portion 1307 wherein the diameter of the proximal portion 1307 can be the maximum diameter or the average diameter along the length of the proximal portion.
  • the distal portion 1305 can have a diameter that tapers to approximately 1% of the diameter of the proximal portion 1307 wherein the diameter of the proximal portion 1307 can be the maximum diameter or the average diameter along the length of the proximal portion. Additionally, the overall length of the distal portion can be between 100% and 500% of the length of the proximal portion. In some embodiments, the proximal portion 1307 and middle portion 1303 can vary up to 10% in diameter over their lengths. The ranges of length between the various portions described herein can be used alone or in combination with other features fo the basket incluinding but limited to the ranges of diameters described herein and/or the cell sizes described herein.
  • the proximal portion 1307 can have a length, not including the struts 1309, of approximately 20 mm. In some embodiments, the proximal portion 1307 can have a length, not including the struts 1309, of approximately 10-30 mm. In some embodiments, the proximal portion 1307 can have a length, not including the struts 1309, of approximately 5-50 mm. In some embodiments, the middle portion 1303 can have a length of approximately 70 mm. In some embodiments, the middle portion 1303 can have a length of approximately 50-90 mm. In some embodiments, the middle portion 1303 can have a length of approximately 20-120 mm.
  • the distal portion 1305 can have a length of approximately 30 mm. In some embodiments, the distal portion 1305 can have a length approximately 10-50 mm. In some embodiments, the distal portion 1305 can have a length of approximately 1-100 mm.
  • the length between the various portions described herein can be used alone or in combination with other features of the basket described herein including but limited to the the ranges of diameters described herein and/or the cell sizes described herein.
  • the total length of the retriever 1301 can be approximately 140 mm from the proximal end of the struts 1309 to the distal end of the distal portion 1305. In some embodiments, the total length of the retriever 1301 can be approximately 100-200 mm. In some embodiments, the total length of the retriever 1301 can be approximately 50-500 mm.
  • a closed cell portion of the retriever can include the proximal portion 1307, the middle portion 1303, and the distal portion 1305. The closed cell portion may have a length of 100 mm. In some embodiments, the closed cell portion can have a length of 50-150 mm. In some embodiments, the closed cell portion can have a length of 25-200 mm.
  • the closed cell portion can have a length of 25-450 mm.
  • the struts 1309 can have a length of 40 mm. In some embodiments, the struts 1309 can have a length of 10-100 mm. In some embodiments, the struts 1309 can have a length of 1-200 mm.
  • the distal portion 1305 can exhibit 75% less radial force per unit length compared to the radial force exhibited by the proximal portion 1307. In some embodiments, the distal portion 1305 can exhibit 50-90% less radial force per unit length compared to the radial force exhibited by the proximal portion 1307. In some embodiments, the distal portion 1305 can exhibit 25-90% less radial force per unit length compared to the radial force exhibited by the proximal portion 1307. In certain embodmients, the distal portion of the basket can exhibit 25-90% or in certain embodiments 50-90% less radial force per unit length compared to the radial force per unit length exhibited by the proximal portion of the basket.
  • the middle portion of the basket can exhibit 25-90% or in in certain embodimeetns 50% - 90% less radial force per unit length compared to the radial force per unit length exhibited by the proximal portion of the basket.
  • the ranges of radial force per unit length described herein can be used independently or in combination with other features described herein including but not limited to the relationship between the diameters of the various portions of the baseket, the strut thickness and the lenghts of the various portions and/or the cell sizes of the various portions.
  • FIG. 13B shows a proximal portion of the retriever catheter 1300.
  • the proximal portion of the retriever catheter 1300 includes a handle 1315.
  • the handle 1315 includes a slider 1316.
  • the slider 1316 can control the deployment of the retriever 1301. For example, as the slider 1316 is slid towards the proximal portion of the retriever catheter 1300, then the retriever 1301 can begin to telescope outwardly as the outer shaft 1310 is retracted. Similarly, as the slider 1316 is slid towards from the distal portion of the retriever catheter 1300, then the retriever 1301 can begin to retract or telescope inwardly as the outer shaft 1310 is advanced.
  • the handle 1315 includes a luer fitting 1318.
  • the luer fitting may be used for hemostasis management in the guidewire lumen.
  • the handle 1315 includes at least one flush port for hemostasis management.
  • the retriever catheter handle may include a catheter strain relief to help prevent stress concentrations on the mechanical retriever catheter 1300.
  • the guidwire lumen that floats coaxially within the inner lumen and attached to the distal end of the basket can move the basket relative to the outer lumen.
  • the radial force and forshortening of the basket can make it difficult to advance the catheter, so the guidewire lumen may be pushed on (pulling the basket in effect) to make this easier to deliver.
  • the guidewire lumen In retraction (retrieval or loading) the guidewire lumen may be loaded forward relative to the inner catheter to reduce forces of transition.
  • the basket can forshorten approximately 30mm when deployed.
  • FIG. 14 illustrates an aspiration catheter 1400 that can be used with the embodiments described above.
  • the aspiration catheter 1400 includes a handle 1402 and an outer shaft 1404 and an inner shaft (not shown) that extends from the handle 1402.
  • the outer shaft 1404 may be a braid or coil reinforced polymer tube and provide a lumen for introducing other devices.
  • the inner shaft can connect to a funnel 1406 located at the distal end of the device.
  • the funnel 1406 has a larger diameter at the distal end of the funnel 1406 and a smaller diameter at the proximal end of the funnel 1406.
  • the braid of the funnel 1406 can be embedded into the inner shaft, for example by melting the funnel 1406 into the inner shaft.
  • the proximal end of the funnel 1406 can be positioned between layers of the inner shaft. In another embodiment, the proximal end of the funnel 1406 can be coupled to the inner shaft using adhesive. In another embodiment, the proximal end of the funnel 1406 can be coupled to the inner shaft with a hook. In another embodiment, the proximal end of the funnel 1406 can be molded onto the inner shaft. In another embodiment, the proximal end of the funnel 1406 can be integrally formed with the inner shaft. While the illustrated embodiment is shown as being braided, other configurations for the funnel could be used including laser cut structures.
  • the funnel 1406 can be retained within the outer shaft 1404.
  • the funnel 1406 may be a self-expanding nitinol funnel.
  • the handle 1402 further includes a slider 1408.
  • the slider 1408 can control the deployment of the funnel 1406. For example, as the slider 1408 is slid towards the proximal portion of the aspiration catheter 1400, the funnel 1406 can begin to exit the outer shaft 1404 as the outer shaft is retracted with the slider. Similarly, as the slider 1408 is slid away from the proximal portion of the aspiration catheter 1400, then the funnel 1 06 can begin to retract or telescope inwardly as the outer shaft 1404 is advanced.
  • the handle 1402 may further include at least one side port 1410 for aspiration or fluid infusion and a hemostasis valve 1412.
  • the hemostasis valve 1412 may be sealed at the baseline and capable of sealing on the catheters after they are inserted.
  • the handle 1402 may be able to open the hemostasis valve 1412 to the diameter of the main shaft to remove the retriever catheter that is filled with clot after use.
  • FIG. 15A and FIG. 15B illustrate an example of the funnel 1406 as described with reference to FIG. 14.
  • the funnel 1406 may be connected or bonded to the aspiration catheter 1400.
  • the funnel 1406 may be made of self-expanding braided nitinol wire.
  • the funnel 1406 has a distal end 1510 and a proximal end 1520. As shown, the diameter of the distal end 1510 is larger than the diameter of the proximal end 1520.
  • the diameter of the distal end 1510 may be between approximately 5 mm- 15 mm.
  • the diameter of the distal end 1510 may be approximately equal to 10 mm.
  • the diameter of the proximal end 1520 may be between approximately 4 mm-8 mm.
  • the diameter of the proximal end 1520 may be equal to approximately 5 mm.
  • a body 1515 may connect the distal end 1510 and the proximal end 1520. The body 1515 may maintain the diameter of the proximal end 1520 until a first point at which the body may expand or funnel outward.
  • the distal end 1510 is a closed braid. This helps to ensure that any surrounding tissue is not damaged by the funnel 1406. This can help prevent unbraiding.
  • the funnel 1406 may have a length between approximately 30 mm-50 mm. In some aspects, the funnel 1406 has a length of approximately 40 mm.
  • FIG. 15C illustrates the funnel 1406 inserted into a dilator 1530 and the outer shaft 1404 of the aspiration catheter.
  • FIG. 15C shows an alternative embodiment for removing the thrombus from the treatment site.
  • the dilator 1530 on the distal end can cover the funnel 1406.
  • the dilator 1530 can be removed, for example pushed off the aspiration catheter, to release the funnel 1406.
  • the funnel 1406 can expand radially outward when the dilator 1530 is removed.
  • FIG. 16 illustrates the interaction between the funnel 1406, as described with reference to FIG. 14, and the retriever catheter 1300, as described with reference to FIG. 13A-13B.
  • the retriever catheter 1300 can be inserted through the outer shaft 1404 of the aspiration catheter 1400.
  • the retriever 1301 can extend past the funnel 1406.
  • the funnel 1406 can be larger than the basket 1312 of the retriever 1301.
  • the funnel 1406 can have a diameter greater than the diameter of the basket 1312 of the retriever 1301.
  • the funnel 1406 and/or the basket 1312 can be self-expanding.
  • the funnel 1406 can be in contact with the vessel wall atraumatically.
  • FIG. 17 illustrates an example embodiment of the interaction between the funnel 1406, as described with reference to FIG. 14, and the retriever catheter 1300, as described with reference to FIG. 13A-13B.
  • the retriever 1301 can mate with the funnel 1406.
  • the proximal end of the retriever 1301 can mate with the distal end of the funnel 1406.
  • the diameter of the distal end of the funnel 1406 may be approximately equal to the diameter of the proximal end of the retriever 1301, or it may be sized relative to the anatomy. This allows the funnel 1406 to help maximize the amount of the thrombus, debris, or residual thrombus that is removed from the treatment site.
  • the funnel 1406 allows the funnel 1406 to limit the amount of thrombus that may escape from the retriever 1301.
  • the taper of the proximal end of the retriever 1301 can be the same as the taper of the funnel 1406 or be within 5% of the taper.
  • FIG. 18 illustrates a zoomedin view of the funnel 1406.
  • the funnel 1406 includes the braided nitinol wire as discussed above.
  • the distal end of the funnel 1406 is a closed end.
  • the funnel taper angle can change to provide length in the contact area with the vessel and revent acute pressure against the vessel wall.
  • the funnel 1406 can be radially loaded against the vessel wall, and can lack a cylindrical profile such that the loading does not fore the distal end of the funnel 1406 to a smaller diameter than the vessel diameter.
  • FIG. 19 illustrates an embodiment of an ultrasound radiating element 1202 which can be positioned in the distal end of the ultrasound catheter 1000 of FIG. 10 or other embodiments of the ultrasound catheters describe here.
  • the ultrasound radiating element 1202 includes a piezoelectric stack 1902 of four piezoelectric elements 1902a,b,c,d and an electrical connector 1904 that connects to or couples the piezoelectric stack 1902.
  • An electrical cable 1906 connects to the electrical connector 1904 that provides power to the electrical connector 1904.
  • the piezoelectric stack 1902 may include hexagonal piezoelectric materials (see FIG. 20) that can deform or vibrate oscillate when the electrical connector 1904 applies an electric field to the piezoelectric stack 1902.
  • the piezoelectric stack 1902 is arranged in a manner that allows the positive and negative terminals of each piezoelectric material to complement each other.
  • a first piezoelectric material may be arranged in the piezoelectric stack 1902 positive terminal to negative terminal
  • a second piezoelectric material may be arranged in the piezoelectric stack 1902 positive terminal to negative terminal. This will allow for generation of ultrasonic waves.
  • the ultrasound radiating element 1202 may include any number of piezoelectric elements in a stacked layer arrangement. The number of piezoelectric elements layers that are included in the arrangement may determine the power of the ultrasound radiating element 1202.
  • each of the piezoelectric elements stacked layers may also vary.
  • the thickness of each individual stacked layer may affect the frequency of the ultrasonic energy emitted from the ultrasound transducer 1202.
  • the ratio of the diameter of the number of stacked layers to the number of stacked layers can also determine the power of the ultrasound radiating element 1202. This ratio can be unique and finely tuned to produce sufficient power from the ultrasound radiating element 1202.
  • the ultrasound radiating element 1202 further includes a matching layer 1908 and a backing layer 1910.
  • the matching layer 1908 is flush with the and contacts the piezoelectric stack 1902.
  • the matching layer 1908 is an acoustic impedance matching layer.
  • the backing layer 1910 surrounds the electrical connector 1904 and the piezoelectric stack 1902.
  • the backing layer 1910 allows the generated energy to be reflected. This can maximize the amount of energy that may be directed towards the treatment site.
  • the backing layer 1910 can expand and contract as the piezoelectric stack 1902 oscillates.
  • the backing layer 1910 may be surrounded by a case 1911 that can secure the elements of the ultrasound transducer element 1202. With reference to FIGS.
  • ultrasound radiating element 1202 can be positioned within the ultrasound transducer cavity 1226 such that the matching layer 1908 is positioned at the distal end of the catheter 1000.
  • the assembly of the ultrasound transducer element 1202 may begin with mounting the matching layer 1908 using a mounting adhesive.
  • the piezoelectric stack 1902 may then be primed with a primer and allowed to flash off for approximately 30 minutes.
  • the piezoelectric stack 1902 may then be arranged and bonded to a positive side of the matching layer 1908.
  • the backing layer 1910 may then be added to the ultrasound transducer element 1202.
  • the ultrasound transducer element 1202 may then be loaded onto the electrical connection 1904 and electrical cable 1906 prior to soldering the ultrasound transducer element 1202.
  • FIG. 20 illustrates a cross-sectional view of the ultrasound transducer element 1202 as described with references to FIG. 19.
  • the piezoelectric stack 1902 is hexagonal in shape and surrounded by the backing layer 1910.
  • at least one side of each of the hexagon shaped piezoelectric elements within the piezoelectric stack 1902 may be longer than the other five sides of each of the hexagon shaped piezoelectric elements within the piezoelectric stack 1902.
  • the longer side of the hexagon can accommodate the electrical connection to provide power to the ultrasound radiating element 1202.
  • each of the hexagon shaped piezoelectric elements within the piezoelectric stack 1902 may not be symmetrical.
  • the backing layer 1910 is flush with the piezoelectric stack 1902 so that the amount of energy that is directed towards the treatment site is maximized.
  • the case 1911 surrounds the backing layer 1910.
  • the hexagonal shape of the piezoelectric elements can maximize the surface area of contact between the elements in the piezoelectric stack 1902.
  • the piezoelectric elements can significantly fill the space within the ultrasound catheter while allowing enough room for expansion of the piezoelectric elements within the catheter.
  • the piezoelectric elements can be round, square, rectangular, triangular, pentagonal, or octagonal.
  • the piezoelectric elements can be sized and shaped to maximize surface area within the catheter while allowing room for expansion.
  • FIG. 21 illustrates a catheter system 2100 that can used to treat a vascular obstruction such as a clot, in in certain embodiments a thrombus.
  • the catheter system 2100 includes an ultrasound catheter 1000, an aspiration catheter 1400, and a retriever catheter 1300.
  • the ultrasound catheter 1000, aspiration catheter 1400, and the retriever catheter 1300 can be used in combination to administer treat a thrombus.
  • the catheter system 2100 can include other embodiments of an ultrasound catheter, an aspiration catheter, a retriever catheter, as well as other catheters, funnels, and retrievers.
  • FIG. 22A, FIG. 22B, and FIG. 22C illustrates an ultrasound catheter 1000 introduced to a thrombus that may be located at the treatment site.
  • the ultrasound catheter 1000 is first advanced to the front of the thrombus.
  • the ultrasound catheter 1000 may be advanced until resistance is felt by the user.
  • the resistance felt may indicate that the ultrasound catheter 1000 has reached the front of the thrombus or the treatment site.
  • the ultrasound catheter 1000 may come in direct contact or position with the front of the thrombus, which can help ensure that the ultrasound treatment is administered directly to the treatment site. This can help to break up or treat the thrombus more effectively.
  • the catheter is advanced to the obstruction and once contact is made the catheter is withdrawn a certain distance from the obstructions to allow some space between the exit lumens of the catheter and the obstruction.
  • the ultrasound catheter 1000 can deliver lytic, microbubbles, and/or ultrasound waves to the clot at the same or separate times.
  • the ultrasound catheter 1000 may first deliver ultrasound waves to the treatment site and then delivery lytic and microbubbles, or vice versa.
  • the ultrasound catheter 1000 may deliver ultrasound waves, microbubbles, and lytic at the same time.
  • the treatment is delivered to the treatment site in a forward and centered direction. This can allow the clot to be treated from the inside out. In other words, the treatment can be provided to the center of the thrombus and radiate outwardly.
  • the ultrasound catheter 1000 can be advanced through the thrombus as the thrombus is continued to be treated. For example, the ultrasound catheter 1000 can begin to deliver lytic, microbubbles, and ultrasound waves at a start of the thrombus and continue to deliver lytic, microbubbles, and ultrasound waves as the ultrasound catheter 1000 advances through the length of the thrombus. This can help to ensure that the clot is effectively treated.
  • the ultrasound catheter 1000 may begin to deliver treatment to the front of the thrombus for approximately 40-50 seconds, or, for example, 10-300 seconds, 30-120 seconds, or 40-60 seconds.
  • the ultrasound catheter 1000 may then capture an image of the treatment site and then advance forward to the next portion of the thrombus where the ultrasound catheter 1000 can deliver treatment to for approximately 40-50 seconds. As explained above, this process can repeated until the ultrasound catheter 1000 is advanced through the length of the thrombus.
  • the ultrasound catheter 1000 may be torqued and/or advanced toward the thrombus. In some examples, the ultrasound catheter can be torqued and/or advanced toward the thrombus while delivering ultrasound waves in the forward direction, or in front of the ultrasound catheter 1000.
  • the ultrasound catheter can be torqued and/or advanced toward the remaining thrombus while delivering ultrasound waves in the forward direction, or in front of the ultrasound catheter 1000.
  • the ultrasound catheter 1000 can be advanced to a first treatment site.
  • the ultrasound catheter 1000 can emit ultrasound energy in a forward direction to a first portion of a thromboembolism.
  • the ultrasound catheter 1000 can advance to a second treatment site and emit ultrasound energy from the ultrasound catheter in the forward direction to a second portion of the thromboembolism.
  • the ultrasound catheter 1000 can emit ultrasound energy in front of a distal end of the ultrasound catheter.
  • the second treatment site can be a location of a dissolved portion of the first portion of the thromboembolism.
  • the ultrasound catheter 1000 can emit ultrasound energy while advancing.
  • the distal end of the ultrasound catheter 1000 can be articulated to change a direction of the ultrasound energy emitted.
  • the first portion of the thromboembolism can be a front of the thromboembolism.
  • the second portion of the thromboembolism can be a portion distal to the front of the thromboembolism.
  • the ultrasound catheter 1000 can emit ultrasound energy to the first portion of the thromboembolism for 40-50 seconds and advancing the ultrasound catheter to the second portion of the thromboembolism.
  • the user can capture an image of the thromboembolism, for example using a non-contrast venogram.
  • the second portion of the thromboembolism can be 0.5- 1.5 cm in length.
  • the second portion of the thromboembolism can be 0.1-2 cm in length.
  • the second portion of the thromboembolism can be 0.01-5 cm in length.
  • the ultrasound catheter 1000 can be advanced and/or used to emit ultrasound energy for between 0 seconds and 5 minutes. In some examples, the ultrasound catheter 1000 can be advanced and/or used to emit ultrasound energy for between 15 seconds and 1 minute. In some examples, the ultrasound catheter 1000 can be advanced and/or used to emit ultrasound energy for between 20 seconds and 45 seconds. In some examples, the ultrasound catheter 1000 can rotate after deflection or articulation of the deflectable portion of the ultrasound catheter 1000. Rotation of the ultrasound catheter 1000 with the deflectable portion articulated can allow the emitted ultrasound energy to be delivered to a greater area within the vessel.
  • the ultrasound radiating element can be positioned on the distal end of the ultrasound catheter 1000 and emit ultrasound energy in a forward and centered direction, and articulation of the deflectable portion of the ultrasound catheter 1000 can cause the forward and centered direction to change to a particular angle.
  • Rotation of the ultrasound catheter 1000 during emission of ultrasound energy can cause the forward and centered direction of the ultrasound radiating element to cover a particular diameter based on the angle of articulation.
  • rotation of the ultrasound catheter 1000 during emission of ultrasound energy can allow the ultrasound catheter 1000 to treat a larger diameter of the thromboembolism.
  • the ultrasound catheter 1000 can be rotated without advancing the ultrasound catheter 1000 while emitting ultrasound energy.
  • the ultrasound catheter 1000 can be advanced to a second treatment site.
  • the ultrasound catheter 1000 can emit ultrasound energy in a forward and centered direction targeting a second portion of the thromboembolism with a deflectable portion of the ultrasound catheter 1000 articulated and while rotating the ultrasound catheter 1000.
  • the deflectable portion of the ultrasound catheter 1000 can be articulated to an angle of at least 30 degrees and/or less than or equal to 45 degrees before rotating the ultrasound catheter 1000 and emitting ultrasound energy.
  • the deflectable portion of the ultrasound catheter 1000 can be articulated to an angle of at least 15 degrees and/or less than or equal to 60 degrees before rotating the ultrasound catheter 1000 and emitting ultrasound energy.
  • the ultrasound catheter 1000 may be advanced approximately 1 cm per treatment segment, or, for example, 1 - 20 mm, 5 - 15 mm, or 10 mm.
  • the distal tip of the ultrasound catheter 1000 may be articulated in any direction. The direction in which the distal tip may be articulated can be based on images or data captured by the ultrasound catheter 1000 during administration of the treatment. FIG.
  • FIG. 22C shows the ultrasound catheter 1000 advanced into the clot having treated at least a portion of the clot and continuing to treat the remaining portion of the clot.
  • FIG. 23A-B illustrate an aspiration catheter 1400 in combination with a retriever catheter 1300 introduced to the treatment site.
  • an aspiration catheter 1400 in combination with the retriever catheter 1300 may be introduced to the treatment site.
  • the distal tip of the ultrasound catheter may deliver treatment in a sweeping manner to target specific areas of the vessel.
  • the distal tip of the ultrasound catheter may be articulated from the center of the vessel to the edge of the vessel as the ultrasound catheter is being removed from the vessel.
  • the treatment provided by the ultrasound catheter 1000 explained with reference to FIG. 22A, may have sufficiently broken up the thrombus where removal of the clot debris of the thrombus may not be needed. This may be due to the treatment provided breaking up the thrombus to small enough pieces so there is no risk that a broken piece of the thrombus will get stuck in the vessel.
  • the retriever catheter 1300 may telescope outward of the aspiration catheter to allow a retriever 2135 of the retriever catheter 1300 to telescope and extend outward of the retriever catheter 1300.
  • the retriever 2135 may extend passed the treatment site.
  • the retriever 2135 may retract and capture the thrombus, residual thrombus, or debris that it may come in contact with as it is retracted.
  • the aspiration catheter 1400 may aspirate the treatment site.
  • FIG. 23B illustrates the retriever 2135 retracting back into the retriever catheter 1300 and the aspiration catheter 1400.
  • a funnel 2125 connected to the aspiration catheter 1400 can help to aspirate the treatment site and help to direct and maximize the thrombus that is removed from the treatment site.
  • FIG. 23C illustrates the funnel 2125 telescoping into the aspiration catheter 1400 as the thrombus has been removed from the treatment site.
  • one or more acts, events, or functions of any of the algorithms, methods, or processes described herein can be performed in a different sequence, can be added, merged, or left out altogether (e.g., not all described acts or events are necessary for the practice of the algorithm).
  • Algorithms, modules, blocks, steps, boxes, elements, features, etc. may be stored in machine-readable memory.
  • acts or events can be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially.
  • no element, feature, block, box, or step, or group of elements, features, blocks, boxes, or steps, are necessary or indispensable to each example.
  • a machine such as a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein.
  • DSP digital signal processor
  • ASIC application specific integrated circuit
  • FPGA field-programmable gate array
  • a general purpose processor can be a microprocessor, but in the alternative, the processor can be a controller, microcontroller, or state machine, combinations of the same, or the like.
  • a processor can also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
  • a software module can reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, an optical disc (e.g., CD- ROM or DVD), or any other form of volatile or non-volatile computer-readable storage medium known in the art.
  • a storage medium can be coupled to the processor such that the processor can read information from, and write information to, the storage medium.
  • the storage medium can be integral to the processor.
  • the processor and the storage medium can reside in an ASIC.
  • the ASIC can reside in a user terminal.
  • the processor and the storage medium can reside as discrete components in a user terminal.
  • Conditional language used herein such as, among others, “can,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that some examples include, while other examples do not include, certain features, elements, and/or states. Thus, such conditional language is not generally intended to imply that features, elements, blocks, and/or states are in any way required for one or more examples or that one or more examples necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular example.
  • the methods disclosed herein may include certain actions taken by a practitioner; however, the methods can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “advancing a catheter” include “instructing advancing a catheter.”
  • ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof.
  • Language such as “up to,” “at least,” “greater than,” “less than,” “between,” and the like includes the number recited. Numbers preceded by a term such as “about” or “approximately” include the recited numbers and should be interpreted based on the circumstances (e.g., as accurate as reasonably possible under the circumstances, for example ⁇ 5%, ⁇ 10%, ⁇ 15%, etc.).
  • “about” or “approximately” 1 mm” includes “1 mm” such that the range can or value described or associated with the terms “about” or “approximately” can be claimed without or with the term “about” or “approximately” such that the phrase “approximately 1 to 5mm” supports claiming “1 to 5mm” or “approximately 1 to 5mm” and “about 50mm” supports claming “50mm”. Phrases preceded by a term such as “substantially” include the recited phrase and should be interpreted based on the circumstances (e.g., as much as reasonably possible under the circumstances).
  • substantially parallel includes “parallel.” Unless stated otherwise, all measurements are at standard conditions including temperature and pressure.
  • the phrase “at least one of’ is intended to require at least one item from the subsequent listing, not one type of each item in the subsequent listing.
  • “at least one of A, B, and C” can include A, B, C, A and B, A and C, B and C, or A, B, and C.

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  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un système de cathéter qui comprend un cathéter d'aspiration ayant une première extrémité, une seconde extrémité et un corps positionné entre la première extrémité et la seconde extrémité. L'invention concerne également un cathéter à ultrasons ayant une extrémité proximale, une extrémité distale et un corps positionné entre l'extrémité proximale et l'extrémité distale. Le cathéter à ultrasons est conçu pour être inséré à travers le corps du cathéter d'aspiration. L'extrémité distale du cathéter à ultrasons est conçue pour être articulée. Un cathéter de récupération a une extrémité proximale, une extrémité distale et un tube positionné entre l'extrémité proximale et l'extrémité distale. Le cathéter de récupération est conçu pour être inséré à travers le corps du cathéter d'aspiration.
PCT/US2024/059395 2023-12-11 2024-12-10 Systèmes et procédés pour un cathéter à ultrasons Pending WO2025128583A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202363608762P 2023-12-11 2023-12-11
US63/608,762 2023-12-11
US202363609174P 2023-12-12 2023-12-12
US63/609,174 2023-12-12

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WO2025128583A2 true WO2025128583A2 (fr) 2025-06-19
WO2025128583A3 WO2025128583A3 (fr) 2025-07-17

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120259314A1 (en) * 2011-04-11 2012-10-11 Medtronic Vascular, Inc. Apparatus and Methods for Recanalization of a Chronic Total Occlusion
US11419620B2 (en) * 2012-10-03 2022-08-23 The University Of Toledo Minimally invasive thrombectomy
US10470748B2 (en) * 2017-04-03 2019-11-12 C. R. Bard, Inc. Ultrasonic endovascular catheter with expandable portion
WO2021198790A1 (fr) * 2020-04-03 2021-10-07 Stelect Pty. Ltd. Dispositif et procédé de mesure de vaisseau
US11844647B2 (en) * 2021-08-10 2023-12-19 Siemens Medical Solutions Usa, Inc. Ultrasound catheter with adjustable apertures for multi-plane imaging

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