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WO2025169158A1 - Transducteur ultrasonore thérapeutique à haute intensité (hitu) basé sur un cathéter avec circuit souple - Google Patents

Transducteur ultrasonore thérapeutique à haute intensité (hitu) basé sur un cathéter avec circuit souple

Info

Publication number
WO2025169158A1
WO2025169158A1 PCT/IB2025/051350 IB2025051350W WO2025169158A1 WO 2025169158 A1 WO2025169158 A1 WO 2025169158A1 IB 2025051350 W IB2025051350 W IB 2025051350W WO 2025169158 A1 WO2025169158 A1 WO 2025169158A1
Authority
WO
WIPO (PCT)
Prior art keywords
transducer
hitu
catheter assembly
flex circuit
retaining clip
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/IB2025/051350
Other languages
English (en)
Inventor
Diana TASKER
Liang ZHAI
Peter GABEL
Daniel Vuich
Shruthi Thirumalai
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.)
Otsuka Medical Devices Co Ltd
Original Assignee
Otsuka Medical Devices Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Otsuka Medical Devices Co Ltd filed Critical Otsuka Medical Devices Co Ltd
Publication of WO2025169158A1 publication Critical patent/WO2025169158A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
    • 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
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
    • A61N7/022—Localised ultrasound hyperthermia intracavitary
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • 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
    • A61B2017/22051—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22062—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0056—Beam shaping elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0056—Beam shaping elements
    • A61N2007/0065—Concave transducers

Definitions

  • TECHNICAL FIELD This description generally relates to minimally invasive apparatuses, systems, and methods that provide energy delivery to a targeted anatomical location of a subject, and more specifically, to catheter-based, intraluminal devices and systems configured to deliver ultrasonic energy to treat tissue, such as nerve tissue.
  • BACKGROUND High blood pressure, also known as hypertension, commonly affects adults. Left untreated, hypertension can result in renal disease, arrhythmias, and heart failure. Treatment of hypertension has focused on interventional approaches to inactivate the renal nerves surrounding a renal artery. Autonomic nerves tend to follow blood vessels to the organs that they innervate.
  • Intraluminal devices such as catheters
  • catheters may reach specific structures, such as the renal nerves, that are proximate to the lumens in which the catheters travel.
  • catheter-based systems can deliver energy from within the lumens to inactivate the renal nerves in and/or surrounding the vessel walls.
  • RF energy is delivered to a catheter having multiple electrodes placed against the intima of the renal artery to create an electrical field in the vessel wall and surrounding tissue.
  • the electrical field results in resistive (ohmic) heating of the tissue to ablate the tissue and the renal nerve passing through that tissue.
  • a system having an ultrasound transducer that emits one or more therapeutic doses of unfocused ultrasound energy has advantages over RF systems.
  • the ultrasound transducer can be mounted at a distal end of the catheter, and the unfocused ultrasound energy can heat tissue adjacent to a body lumen within which the catheter (and the transducer) is disposed.
  • the POMD04490SEC_WO01 unfocused ultrasound energy system may also include a balloon mounted at the distal end of the catheter around the ultrasound transducer. A cooling fluid can be circulated through the balloon to cool the transducer and body lumen during ultrasound energy delivery.
  • Such an unfocused ultrasound energy system may, for example, ablate target nerves surrounding the body lumen, without damaging non-target tissue such as the inner lining of the body lumen or unintended organs outside of the body lumen.
  • Such a design enables creation of one or more ablation zones sufficient to achieve long-term nerve inactivation at different locations around the circumference of the blood vessel.
  • Catheters that output ultrasound energy advantageously allow ablative energy to be distributed around a vessel wall at greater depths than permissible with a radiofrequency ablative catheter.
  • Ultrasound energy can be applied to nerves arranged around the vessel. For instance, ultrasound energy can be applied to the renal nerves surrounding the renal artery in order to deactivate these nerves.
  • the arrangement of the nerves can change from patient to patient and can be at different locations around the vessel.
  • the vessel can be located near tissues and/or organs. As a result, it would be desirable to be able to limit the application of ultrasound energy to the targeted nerves while eliminating or reducing the application of ultrasound energy to the tissues and/or organs in order to optimize procedural efficacy and safety.
  • the vessels can include features such as calcification or plaque. Depending on the conditions, it may be desirable to apply ultrasound energy to the feature or to avoid the feature. As a result, it is desirable to be able to control the application of ultrasound energy within the vessel.
  • implementations provide a catheter assembly comprising: a high intensity therapeutic ultrasound (HITU) transducer shaped as a cylindrical shell that includes an inner surface defining a chamber, an outer shell for launching ultrasound waves outward, a proximal rim and a distal rim ⁇ ⁇ and a flex circuit comprising at least one signal pad electrically connected the outer shell of the HITU transducer and at least one ground pad electrically connected to the post structure.
  • HITU high intensity therapeutic ultrasound
  • implementations provide a method to manufacture a catheter assembly, the method comprising: providing a high intensity therapeutic ultrasound (HITU) transducer shaped as a cylindrical shell that includes an inner surface defining a chamber, an POMD04490SEC_WO01 outer shell for launching ultrasound waves outward, a proximal rim and a distal rim between ⁇ positioning a post structure in the chamber, wherein the ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ ⁇ electrically connecting at least one signal pad of a flex circuit to the outer shell of the HITU transducer and at least one ground pad of the flex circuit to the post structure.
  • HITU high intensity therapeutic ultrasound
  • a catheter assembly comprising: a high intensity therapeutic ultrasound (HITU) transducer shaped as a cylindrical shell that includes an inner surface defining a chamber, an outer shell for launching ultrasound waves outward, a proximal rim and a distal rim between the inner surface and the outer shell; and an electrically-conductive ring adapter, comprising a retaining clip, and a mounting surface extending proximally from the retaining clip; wherein an inner surface of the retaining clip contacts the outer shell of the HITU transducer.
  • HITU high intensity therapeutic ultrasound
  • FIG. 1 illustrates a side view of a catheter system, in accordance with some implementations.
  • FIG.2 illustrates a side view of a hub of a catheter system, in accordance with some implementations.
  • FIG. 1 illustrates a side view of a catheter system, in accordance with some implementations.
  • FIG. 3 illustrates a section view along line 1C of the catheter shaft in FIG. 2, in accordance with many implementations.
  • FIG.4 illustrates an example transducer, in accordance with many implementations.
  • FIG. 5 illustrates an example post structure, in accordance with many implementations.
  • FIG.6 illustrates a longitudinal cross-sectional view of a distal portion of a water- POMD04490SEC_WO01 backed transducer tissue treatment catheter, in accordance with some implementations.
  • FIG.7 illustrates a longitudinal cross-sectional view of a transducer, wherein both the inner and the outer electrodes of the transducer are selectively insulated, in accordance with some implementations.
  • FIG.8 illustrates a radial cross-sectional view of the transducer of FIG.7, wherein both the inner and the outer electrodes of the transducer are selectively insulated, in accordance with some implementations.
  • FIG. 9 illustrates an example of connecting flex circuit pads to the transducer of FIG.4, in accordance with some implementations.
  • FIG. 10 illustrates an example interconnecting the transducer of FIG. 16 and a micro-coaxial cable using a flex circuit, in accordance with some implementations.
  • FIG.11 illustrates an example of a micro-coaxial cable terminated on flex pads on a flex circuit, in accordance with some implementations.
  • FIG. 12 illustrates an example of signal pad and ground pad on a flex circuit, in accordance with some implementations.
  • FIG. 13 illustrates an example of providing signal pads and ground pads on a flex circuit, in accordance with some implementations.
  • FIG.14 illustrates an example of mounting a flex circuit using an embodiment of a ring adapter, in accordance with some implementations.
  • FIG. 15 illustrates an example of mounting a flex circuit using a second embodiment of a ring adapter, in accordance with some implementations
  • FIG.16 illustrates an example of mounting a flex circuit using a third embodiment of a ring adapter, in accordance with some implementations.
  • FIG.17 illustrates an example of mounting a flex circuit using a fourth embodiment of a ring adapter, in accordance with some implementations
  • FIG. 18 illustrates a saline compatible transducer, in accordance with many implementations.
  • FIG. 19 is a flow chart illustrating a process for manufacturing a high-power transducer using the ring adapter configuration, according to many implementations.
  • Like reference numbers and designations in the various drawings indicate like elements.
  • the disclosed technology is directed to systems and methods for providing a catheter assembly that includes a HITU transducer and a flex circuit directly connected to the HITU transducer (e.g., on the proximal side).
  • the HITU transducer is generally shaped as a cylindrical shell with a central void and an outer shell.
  • the implementations incorporate a flex circuit, which can be an interposer that interconnects the HITU transducer and a micro- coaxial cable so that a driving circuit can provide sufficient electrical current to power the operation of the HITU transducer.
  • the flex circuit can also connect the HITU transducer directly to the driving circuit without the micro-coaxial cable.
  • the flex circuit can include a matching and tuning network including, for example, series and shunt passive energy storage components (such as capacitors and inductors) based on surface mount technology (SMT).
  • the matching and tuning network refers to a collection of circuit components (such as capacitors and inductors) designed to tune a resonant frequency of HITU transducer and perform impedance matching to allow for efficient coupling between the driving circuit and the HITU transducer so that acoustic output power can be improved while reducing dissipative heating.
  • the flex circuit may include a thermocouple layer incorporation, a junction of two or more metals so that the temperature at the junction can be sensed based on, for example, a voltage signal between the metals.
  • the compact form factor along with the flexibility of the flex circuit (e.g., bend ratio), can improve the surgeon’s ability to maneuver the catheter assembly when navigating the tortuosity of human vasculature so that the catheter assembly can easily reach the target vessel (e.g., renal artery) after the catheter assembly is inserted into the human body through a vascular entry point on the human body (e.g., femoral artery).
  • the flex circuit can be disposed on a flexible surface of a ring adapter mounted on the proximal rim of the HITU transducer.
  • Suitable materials for the balloon 14 may include, but are not limited to nylon, polyimide films, thermoplastic elastomers such as those marked under the trademark PEBAXTM, medical-grade thermoplastic polyurethane elastomers such as those marketed under the trademark PELLETHANETM, pellethane, isothane, and other suitable polymers or any combination thereof.
  • the catheter system for ablating target tissue may comprise an ultrasound energy generator (electronics) 22 and a catheter 10 coupled to the ultrasound energy generator 22.
  • the ultrasound energy generator 22 may also be referred to as the generator 22, the driving circuit and/or the controller.
  • the catheter 10 may be configured to be advanceable through at least one bodily vessel to a position at or near the target tissue.
  • the catheter 10 may comprise a catheter shaft 12 and an ablation element on a distal portion of the catheter 10.
  • the ablation element may comprise a piezoelectric component, e.g., a HITU transducer 200, a post structure 210, and a chamber 231 therebetween, where the chamber 231 can include air or a liquid, such as water.
  • the ultrasound energy generator 22 may be operatively coupled to the ablation element to energize the HITU transducer 200 (e.g., a high intensity therapeutic ultrasound transducer) to deliver energy to the target tissue, ablating the target tissue.
  • the target tissue may comprise one or more nerves or nerve branches.
  • the target tissue may comprise nerves or nerve branches starting within more than 0.3 mm to 10 mm from the lumen of the blood vessel, e.g., 0.5 mm to 6 mm, or 1 mm to 6 mm of the lumen of one or more blood vessels, e.g., a renal artery, hepatic artery, and/or pulmonary artery.
  • the target tissue may include cardiac tissue, e.g., electrically conductive cardiac tissue.
  • the catheter 10 can have a handle 16 at the proximal end of the catheter shaft 12.
  • the handle 16 can include one or more electrical couplings 18 for connecting the catheter 10 to one or more external electrical conductors 20 that are each in electrical communication with the generator 22 and/or other electronics.
  • Suitable external electrical conductors 20 include, but are not limited to, wires, cables, and Flexible Printed Circuits (FPC).
  • Suitable electrical conductors include, but are not limited to, wires, insulated wires, cables, and Flexible Printed Circuits (FPC).
  • FPC Flexible Printed Circuits
  • a suitable electrical conductor carrier can be an electrically insulating jacket.
  • an electrical conductor carrier carries a single electrical conductor 20
  • an electrical insulator on the electrical conductor can serve as the electrical conductor carrier.
  • the handle 16 can include one or more fluid ports 24 for connecting the catheter to a conduit 26.
  • Suitable conduits 26 include, but are not limited to, tubes and hoses.
  • a conduit 26 can provide fluid communication between the fluid port 24 and a fluid source 28.
  • Suitable fluid sources 28 include, but are not limited to, pumps, tanks, reservoirs, and vessels.
  • the catheter shaft 12 can include one or more fluid lumens 239.
  • Each of the fluid lumens 239 can POMD04490SEC_WO01 be in fluid communication with one of the fluid ports 24 along a longitudinal length of the catheter shaft 12 toward a distal end of the catheter shaft 12.
  • Each fluid lumen 239 may be in fluid communication with a different fluid port, or at least one fluid lumen 239 may be in fluid communication with the same fluid port 24 as at least one other fluid lumen 239.
  • the handle 16 can include one or more guidewire ports 30 for receiving a guidewire 31.
  • the catheter shaft 12 can include a guidewire lumen 301.
  • the guidewire lumen 301 can extend along a longitudinal length of the catheter shaft 12 toward a distal end of the catheter shaft 12.
  • the imaging depth can be up to approximately 12 mm and can be used to size the vessel, image anatomy, pathology, lesion formation, temperature changes, heat sinks such as lymph nodes, vessel walls, plaques, calcification, tissue layers and nerves.
  • the imaging frequency can be approximately 20 MHz – 35 MHz, the bandwidth can be equal or greater to 10 MHz, and/or the array size can comprise 16 to 256 elements, however, these characteristics are descriptive, not restrictive.
  • the array element dimension can be 0.5 mm – 1.5 mm in length and 0.5 – 2 wavelengths in width. Multiple-row cylindrical array can help reduce the image slice thickness to achieve better contrast resolution.
  • the elements may be individually controlled to transmit and receive, for example, by an ASIC circuit, to reduce the number of cables needed.
  • the generator 22 controls the catheter 10 to sweep the operating frequency and control the durations of the individual and total treatment time to control the temperature in the ablation zones, and shape the tissue lesion caused by the application of ultrasound to tissue.
  • Application of lower frequency ultrasound by the HITU transducer 200 may be used to aim at deeper regions, when it is determined that nerves are located in the deeper regions.
  • Application of higher frequency ultrasound by the HITU transducer 200 may be used to target shallower regions, when it is determined that nerves are located in the shallower regions. Additional details are disclosed in US Application No.: 18/451,044 filed on August 16, 2023, which is incorporated herein by reference in its entirety. [0044] Some implementations provide a tissue treatment catheter 10 that includes a therapy intravascular ultrasound transducer assembly 211.
  • the back of the HITU transducer 200 is coupled to a chamber that includes a gas or liquid.
  • the HITU transducer 200 can be constructed as an air-backed or water-backed transducer, e.g., that includes a chamber inside an inner shell of a cylindrical tube.
  • the chamber 231 may be filled with a gas, such as air, to form an air-backed transducer.
  • a gas such as air
  • POMD04490SEC_WO01 “air-backed” is not limited to the use of air alone, and is expressly defined to include other suitable gases, such as helium, argon, and/or nitrogen.
  • An inner electrode 502 may be formed on an inner surface of the cylindrical tube of the HITU transducer 200 and an outer electrode may be formed on an outer surface of the cylindrical tube of the HITU transducer 200, in any suitable manner.
  • the interface between the medium within the chamber 231, e.g., air or a liquid, and the body of the HITU transducer 200 can be highly reflective.
  • the interface can be highly reflective because, e.g., gas or liquid may have an acoustic impedance far lower than that of the ceramic of the piezoelectric material.
  • This interface can serve as a backing interface and can help to direct acoustic vibrations through the outer surface of the cylindrical tube, which serves as the front or emitting surface of the transducer.
  • the HITU transducer 200 may withstand the levels of power required to ablate target tissue, e.g., renal nerves, for example, up to about 150 W/cm 2 or more across the outer surface area of the HITU transducer 200, such that the HITU transducer 200 is configured to deliver sufficient acoustic energy during sonication such as to thermally induce modulation of neural fibers surrounding the blood vessel, the thermally induced modulation being sufficient to improve a measurable physiological parameter corresponding to a diagnosed condition of the patient, while being sufficiently small to fit in a renal artery and/or permit radial access using a 5F or smaller catheter.
  • target tissue e.g., renal nerves
  • Implementations of the present disclosure incorporate various ring adapter configurations for connecting, for example, a proximal end of the HITU transducer 200, to a micro-coaxial cable 270.
  • the implementations are not limited to air-backed or water-backed transducers.
  • the catheter shaft 12 has an outer diameter of 5 French or less.
  • the catheter shaft 12 may include a water-backed HITU transducer 200 that may emit ultrasound energy at a frequency of about 9 MHz.
  • the HITU transducer 200 is configured to emit ultrasound energy in a frequency range of 8.5 to 9.5 MHz.
  • the generator 22 is configured to output to the HITU transducer 200, via the POMD04490SEC_WO01 external electrical conductors 20, a power of about 25 W to 50 W at 7 to 10 seconds on, resulting in an output frequency from the HITU transducer 200 of about 8.5-9.5 MHz.
  • the catheter shaft 12 has an outer diameter of 4 French or less.
  • the catheter shaft 12 may include a water-backed HITU transducer 200 that may emit ultrasound energy at a frequency of about 12-16 MHz.
  • the HITU transducer 200 may emit ultrasound energy at a frequency between 16 MHz and 20 MHz, e.g., 8.5 MHz to 9.5 MHz, 10 MHz, 12 MHz, or 15 MHz, or at a frequency of between 6 MHz and 20 MHz, e.g., 8.5 MHz to 9.5 MHz, 10 MHz, 12 MHz, or 15 MHz.
  • the catheter shaft 12 may have a working length of at least 155 cm or at least 145 cm.
  • the generator 22 is configured to output to the HITU transducer 200, via the external electrical conductors 20, a power of about 15 W to 35 W at 7 to 12 seconds on, having an output frequency of about 12-16 MHz.
  • the catheter is a 4 F catheter and the generator 22 is configured to output to the HITU transducer 200, via the external electrical conductors 20, a power of about 15 W to 35 W at 7 to 12 seconds on, resulting in an output frequency from the HITU transducer 200 of about 12-16 MHz.
  • the HITU transducer 200 is configured to produce an acoustic output power within a range of 25 to 50 Watts, in response to an input electrical power within a range of 10 to 80 Watts received from the generator 22 via the external electrical conductors 20.
  • the backing member 507 may include one or more stand-off posts 212.
  • the stand-off POMD04490SEC_WO01 assemblies 512 may define one or more annular openings through which cooling fluid 403 may enter the space of the HITU transducer 200 (which may be selectively insulated as described with respect to FIGS. 7-8) between the backing member 507 and the inner electrode 502.
  • the backing member 507 may serve as a fluid barrier between the cooling fluid 403 circulated within an interior 506 of the balloon 112 and the lumen of the backing member 507 that receives the guidewire 31.
  • the stand-off posts 212 are electrically conductive, so as to electrically couple the inner electrode 502 of the HITU transducer 200 to the backing member 507.
  • One or more conductors of the electrical cabling 230 may be electrically coupled to the backing member 507.
  • the controller 120 may activated, current may be delivered from the electrical cabling 230 to the inner electrode 502 of the HITU transducer 200 via the backing member 507 and the stand-off posts 212, which advantageously eliminates the need to couple the cabling 230 directly to the inner electrode 502 of the HITU transducer 200.
  • the backing member 507 and the stand-off assemblies 512 are made of one or more electrical insulator material(s), or if made of an electrically conductive material(s), are coated with one or more electrical insulator material(s).
  • one or more electrical conductors of the cabling 230 are directly coupled (e.g., soldered) to the inner electrode 502 of the HITU transducer 200.
  • the backing member 507 may have an isolation tube 520 disposed along its interior surface so as to prevent or reduce the likelihood of electrical conduction between the guidewire 31 and the backing member 507, for use in embodiments where such an electrical conduction is not desired.
  • the isolation tube 520 can be formed of a non-electrically conductive material (e.g., a polymer, such as polyimide), which can also be referred to as an electrical insulator. As illustrated in FIGS. 5A and 5B, the isolation tube 520 may extend through the lumen of the backing member 507 within the HITU transducer 200 toward the catheter tip 404. [0053] FIGS.
  • FIG. 7-8 illustrate, respectively, a longitudinal cross-sectional view and a radial- cross sectional view, of an embodiment of a water-backed HITU transducer 200 where both an inner electrode 502 and an outer electrode 504 (which are located on inner and outer surfaces, respectively, of a tubular HITU transducer 200) are covered by electrical insulators. More specifically, the inner electrode 502 is covered by the inner electrical insulator 1302, and the outer electrode 504 is covered by the outer electrical insulator 1304. Both the inner and outer POMD04490SEC_WO01 electrodes 502, 504 may be insulated with insulators 1302, 1304. In other embodiments, only one of the inner electrode 502 and the outer electrode 504, is insulated with the corresponding insulator 1302, 1304.
  • FIG. 5 illustrates the post structure 210 for the HITU transducer 200 of FIG. 16.
  • the post structure 210 may include at least a first conductive part 212, e.g., a first stand-off post 212, at the distal end of the post structure 210 and at least a second conductive part 212, e.g., a second stand-off post 212, at the proximal end of the post structure 210.
  • the HITU transducer 200 may optionally be mounted to at least the first and second stand-off posts 212 of the post structure 210 to define the chamber 231 adjacent the inner surface 207, the chamber 231 being insulated to prevent entry of a substance, such as an outside fluid, into the chamber 231 during use, such as to prevent entry of electrically conductive fluid.
  • the device can be saline compatible, that is, the HITU transducer 200 can operate when immersed in electrically conductive fluid to deliver sufficient acoustic energy during sonication such as to thermally induce modulation of neural fibers surrounding the blood vessel sufficient to improve a measurable physiological parameter corresponding to a diagnosed condition of the patient, e.g., to create an ablation zone 3 mm to 6 mm wide, e.g., 5 mm wide, and 0.5 mm to 10 mm, e.g., 1 mm to 6 mm, in depth from the lumen of the blood vessel.
  • FIGS.9 to 13 illustrate various configurations for directly connecting, for example, the proximal end of the HITU transducer 200, to the flex circuit 240.
  • flex pad 241 on flex circuit 240 is soldered to a signal electrode 200A of the HITU transducer 200.
  • the signal electrode 200A is located towards the proximal rim where the outer shell may be chamfered or depressed inward so that, after soldering, the HITU transducer 200 may generally retain the original dimension or form factor.
  • the outer diameter of the HITU transducer 200 after soldering may remain between about 0.015” (0.381 mm) and about 0.118” (3 mm), as before soldering.
  • FIG. 10 shows the flex circuit 240 connected to the HITU transducer 200 with micro-coaxial cable 270. At the distal end, the flex circuit 240 is electrically connected to POMD04490SEC_WO01 signal electrodes 200A on the HITU transducer 200. One or more signal conductors on the flex circuit 240 can be interconnected to the outer shell of the HITU transducer 200. In some cases, more than one signal electrode 200A can be arranged on the outer shell of the HITU transducer 200.
  • the body of the flex circuit 240 may take various forms including, for example, multi-pronged configurations with a central stem where the prongs are branches extending distally (e.g., to connect with the HITU transducer 200) and proximally (to connect with micro-coaxial cable 270). Such configurations may improve the flexibility of the catheter assembly when navigating the tortuosity of human vessels.
  • the flex circuit 240 can include one or more layers of conductor traces (e.g., signal trace and ground trace).
  • the flex circuit 240 can include series (within the signal trace) and/or shunt (between the signal and ground trace) surface mount components such as capacitors and inductors.
  • capacitors and inductors can be either in series or in parallel with the HITU transducer 200 to form a tuning and matching network 244.
  • the HITU transducer 200 can resonate at a frequency substantially tuned to, for example, the driving frequency provided by the generator 22 of FIG. 1.
  • the HITU transducer 200 may exhibit an impedance substantially matched to that of the driving circuit so that acoustic output generated by the HITU transducer 200 can be significantly increased and potentially maximized without dissipating significant power over the micro-coaxial cable 270 and the flex circuit 240.
  • the tuning and matching network may include additional control traces to operate digitally tunable capacitors--the capacitance of which can be varied according to a control voltage--so that the HITU transducer 200 can be dynamically tuned to operate a multitude of resonating frequencies.
  • the flex circuit 240 can also include a thermocouple layer 243 configured for temperature sensing.
  • Thermocouple layer 243 may include a junction formed by at least two metal traces. By monitoring a voltage generated at the junction in response to varying POMD04490SEC_WO01 temperature, the thermocouple layer can sense the temperature at the junction.
  • Thermocouple layer 243 can be more distally located than the tuning and matching network 244.
  • thermocouple layer 243 can be disposed in a vicinity of the HITU transducer 200.
  • thermocouple layer 243 can be routed more distally so that the junction is placed in the immediate vicinity of the HITU transducer 200 (e.g., the proximal end of the HITU transducer 200).
  • the junction of the thermocouple layer 243 can be routed through the inner space of post structure 210 to reach the distal side of the HITU transducer 200.
  • thermocouple layer can be routed more distally than the proximal connection of the flex circuit 240 to reach the transducer’s distal side either through the chamber space between the HITU transducer 200 and the post structure 210, or inside the lumen of post structure 210. In either case, the arrangement does not interfere with the guidewire for the catheter assembly.
  • the thermocouple layer can be routed to reach the balloon surface or inside the balloon volume.
  • FIG. 11 illustrates an example in which micro-coaxial cable 270 is terminated at pads on the flex circuit 240.
  • the micro-coaxial cable 270 is distally terminated to the flex circuit 240 at the proximal end of the flex circuit 240 to facilitate packaging the catheter 10.
  • the proximal end of the micro-coaxial cable 270 can then be terminated directly to the proximal connector or the integrated cable printed wire board (both not shown) for connecting to the generator 22 of FIG.1.
  • the flex circuit 240 is short enough to improve the flexibility of the catheter 10.
  • the remaining pads on the flex circuit 240 can allow for transducer performance testing without having to terminate the micro-coaxial cable 270.
  • additional cable pads may then allow termination of the micro-coaxial cable 270 to the flex circuit 240.
  • the micro-coaxial cable 270 can be terminated to the flex circuit 240 at the proximal end of the micro-coaxial cable 270 so that there would be no need to reprepare the proximal end of the micro-coaxial cable 270 in order to install it in the catheter lumen.
  • the proximal end of the flex circuit 240 can then be terminated directly to the proximal connector or the integrated cable printed wire board.
  • the flex circuit 240 trace cross sectional area can be increased using thicker copper layers and/or wider traces. Either or both POMD04490SEC_WO01 of these approaches may be employed to achieve the desired electrical performance.
  • the flex circuit 240 copper layer can be characterized by at least one ounce copper (Cu) and the trace widths can be 200 microns or more to support the excitation voltages and currents of the transducer.
  • FIGS.12 and 13 illustrate example arrangements of pads on flex circuit 240 (shown in FIGS. 9 to 11) to achieve the desired form factor. As illustrated in FIG. 12, signal pad 241 and ground pad 242 are disposed on a flexible substrate.
  • Ground pad 242 can be 0.030” (0.762 mm) in height and 0.008” (0.203 mm) in width.
  • Signal pad 241 (smaller than ground pad 242) can be offset from ground 242 by 0.01475” (0.37465 mm) laterally and 0.05675” (1.44145 mm) vertically.
  • the signal pad 241 and the ground pad 242 on the flex circuit 240 can be soldered to the transducer signal electrode 200A and the post structure 210 respectively.
  • the signal pad 241 and the ground pad 242 can be bonded, using conductive adhesive, to the transducer signal electrode 200A and the post structure 210 respectively.
  • FIG. 10 In the example depicted in FIG.
  • FIG. 13 includes an upper panel showing area 250 encircling a signal pad 241 and a ground pad 242. As illustrated, the signal pad 241 is shaped as square of 0.0065” (0.1651 mm) by 0.0065” (0.1651 mm), and the ground pad 242 is measured in 0.04” (1.016 mm) in height and 0.02275” (0.57785 mm) in width. [0063] FIG. 13 also includes a lower panel showing an interposer arrangement 251 with two (2) signal pads 241 and two ground pads 242.
  • an end of one of the wires 271, 272 to the outer electrode 504 increases the outer diameter of the HITU transducer 200, which may be undesirable where the HITU transducer 200 is used to treat one or more blood vessels where the diameter of the blood vessel lumen is small.
  • the micro-coaxial cable 270 may be connected to the electrodes 502, 504 via a ring adapter 260.
  • An exemplary ring adapter 260 may include a retaining clip 263 configured to fit around the proximal end of the HITU transducer 200.
  • the retaining clip 263 may be shaped as an interrupted ring, allowing for the retaining clip 263 to flex at least slightly.
  • the retaining clip 263 may be flexed to a more-open configuration, placed over the HITU transducer 200, then released to engage the outer surface of the HITU transducer 200.
  • the retaining clip 263 may be configured to have an inner circumference, prior to placement on the HITU transducer 200, slightly less than the outer circumference of the HITU transducer 200. In this way, when the retaining clip 263 is released, the retaining clip 263 may apply a compressive force to the HITU transducer 200, assisting in holding the retaining clip 263 in place.
  • the retaining clip 263 may be substantially rigid, and/or may be shaped as an uninterrupted ring.
  • the ring adapter 260 may have one or more tabs 264 arranged, for example, in two instances on the distal edge of retaining clip 263, oriented toward the center of the retaining clip 263.
  • the tab(s) 264 contact a proximal end of the HITU transducer 200 in order to place the retaining clip 263 at the proximal end of the HITU transducer 200.
  • the ring adapter 260 may be placed at a consistent location relative to the HITU transducer 200, facilitating the manufacturing process.
  • a mounting surface 262 extends outward from the retaining clip 263.
  • the mounting surface 262 extends from the opposite end of the retaining clip 263 from which the tabs 264 extend.
  • the mounting surface 262 extends along part of the circumference of the retaining clip 263 and may have the same inner radius of curvature as the inner surface of the retaining clip 263 and the same outer radius of curvature as the outer surface of the retaining clip 263.
  • at least one wire 271 of the micro-coaxial cable 270 extends along the mounting surface 262, and the mounting surface 262 extends proximally from the HITU transducer 200.
  • solder may be applied to the at least one wire 271 and the mounting surface 262 to secure the at least one wire 271 to the mounting surface 262.
  • the ring adapter 260 is electrically conductive.
  • the solder connection between the at least one wire 271 and the mounting surface 262 electrically connects the at least one wire 271 to the retaining clip 263 and the surface of the HITU transducer 200 as well.
  • the use of the mounting surface 262 provides for a relatively large contact surface for the at least one wire 271 and provides for a solder location radially inward from the outer circumference of the HITU transducer 200. In this way, manufacturing may be simplified and the overall diameter of the HITU transducer 200 and the connected at least one wire 271 may be reduced compared to existing manufacturing methods. Other and/or additional methods of electrical connection than solder may be utilized.
  • two or more apertures 265 may be defined through the mounting surface 262, and the at least one wire 271 may be threaded through longitudinally- adjacent apertures 265 in order to hold the at least one wire 271 in place during manufacturing and provide additional security for the at least one wire 271 after manufacturing.
  • one or more notches 266 may be defined in one or more lateral edges of the mounting surface 262 to break an otherwise continuous surface so that mounting surface 262 is more flexible and bendable. In this way, the flexibility of the distal end of the catheter 10 is enhanced, thereby enhancing steerability of the catheter 10 within a patient’s vasculature.
  • FIG. 15 another embodiment of a ring adapter 260 is shown. This embodiment omits the apertures 265 and the notches 266 in the mounting surface 262 described above with regard to the embodiment of FIG. 14. In this way, manufacturability of the ring adapter 260 may be simplified.
  • FIG. 16 another embodiment of a ring adapter 260 is shown. This embodiment omits the apertures 265 and the notches 266 in the mounting surface 262 described above with regard to the embodiment of FIG. 14.
  • the mounting surface 262 is substantially solid.
  • a pocket 268 is defined in the mounting surface 262 along at least a portion of its length.
  • the pocket 268 extends from the proximal end 269 of the mounting surface 262 to a location at or near the junction between the mounting surface 262 and the retaining clip 263.
  • the pocket 268 is a depression in the outer surface of the mounting surface 262 toward the longitudinal centerline of the retaining clip 263.
  • the pocket 268 is configured to hold the end of at least one wire 271, and solder that is applied to the at least one wire 271.
  • the orientation of the pocket 268 allows for soldering to be performed, during manufacturing, on an outer surface of the ring adapter 260, providing for better clearance and accessibility for the soldering process.
  • FIG. 17 another embodiment of a ring adapter 260 is shown.
  • This embodiment omits the apertures 265 and the notches 266 in the mounting surface 262 described above with regard to the embodiment of FIG. 14.
  • the mounting surface 262 is substantially solid, and is flexible.
  • a flex lead 273 is defined in or attached to the mounting surface 262, and that flex lead 273 may extend onto and/or across the retaining clip 263 to a distal end of the retaining clip 263.
  • an end of at least one wire 271 may extend onto the mounting surface 262, where that at least one wire 271 may be soldered thereon in order to provide an electrical connection to the HITU transducer 200.
  • at least the mounting surface 262 is flexible, to improve steerability of the catheter 10.
  • the micro-coaxial cable 170 may connect to the ring adapter 260, and the mounting surface 262 of the ring adapter 260 can hold at least one wire 271 of the flex circuit 240.
  • Additional and alternative arrangements are available because the physical and/or electrical constraints on the connecting cable dictated by direct termination to the transducer are no longer relevant with implementations of the present disclosure.
  • the flex circuit can allow for surface mount tuning elements (such as a series capacitor with a parallel inductor, a series inductor with a parallel capacitor, or a Pi- or T-network that are composed of capacitors and inductors) to match the electrical parameters of the generator 22, the micro-coaxial cable 270, and the HITU transducer 200.
  • the flex circuit 240 of the present disclosure may not require preparation to terminate the flex circuit 240 distally to the transducer or to at least one electrical coupling 18.
  • the proximal end of the flex circuit 240 can include a feature for pulling the flex circuit 240 into the catheter cable lumen.
  • FIG. 18 illustrates a side view of a transducer assembly that is saline compatible. As illustrated, the inner shell of the HITU transducer 200 includes a backing design.
  • the HITU transducer 200 can be isolated from fluid (i.e., fluid within a balloon 14 or body fluid, e.g., blood, in a balloon-less implementation) to render the catheter saline compatible.
  • the adhesive POMD04490SEC_WO01 303 and 304 that can be used to keep the seal intact may include a bond that adheres to and seals flex circuit 240 that connects to micro-coaxial cable 270 to the HITU transducer 200 and post structure 210, as illustrated above.
  • the adhesive is generally durable because vibrations can cause the adhesive to delaminate.
  • An example of an applicable adhesive is epoxy.
  • FIG. 19 is a flow chart illustrating a process 400 for manufacturing a catheter assembly.
  • the process 400 may include providing a HITU transducer 200, for example, a high-power air-backed or water-backed transducer shaped as a cylindrical shell with a central void and an outer shell.
  • the ultrasonic transducer 200 is capable of generating an average acoustic that exceeds 30 watts/cm 2 , exceeds 50 W/cm 2 , or exceeds 150 W/cm 2 .
  • the cylindrical shell can have a length less than about 10 mm, or less than about 6 mm, and has a diameter between about 1 and about 3 mm, or in some implementations about 1.5 mm.
  • process 400 may include positioning a post structure 210 inside the central void of the cylindrical shell with the post 212 extending axially outside the cylindrical shell.
  • the post structure 210 can be shaped as a cylinder positioned inside the central void of the cylindrical shell, and, in some implementations, coaxial with respective to the cylindrical shell of the ultrasonic transducer 200.
  • the post structure 210 may be positioned such that an outer surface of the post structure 210 is within 200 ⁇ m of an inner surface of the central void of the cylindrical shell.
  • the outer surface of the post structure 210 and the inner surface of the central void of the cylindrical shell may be separated by a gas or liquid, e.g., water, air, or other gas.
  • process 400 may include connecting the flex circuit 240 to a signal electrode 200A on the HITU transducer 200 (e.g., the HITU transducer 200 in FIGS. 9 to 13) and the post structure 210 (e.g., post structure 210 in FIGS.9 to 13).
  • the implementations can use soldering for making the electrical connection. Additionally, or alternatively, the implementations may use epoxy or adhesive to, for example, connect the signal pad to the transducer, and connect the ground pad to the post structure 210.
  • the implementations may also apply laser welding to connect the signal pad to the HITU transducer 200 and connect the ground pad to the post structure 210.
  • the flex circuit 240 may include multiple signal pads disposed over an underlying signal trance.
  • the flex circuit 240 may include multiple POMD04490SEC_WO01 ground pads disposed over an underlying ground trance that is separate and distinct from the signal trace. As discussed above with reference to FIGS.
  • flex circuit 240 in conjunction with a HITU transducer 200
  • the flex circuit 240 described herein may be utilized with a lower- power ultrasound transducer as well.
  • the terms rear surface, inner surface, and inner diameter of the active element refer to the same region of the active element of the transducer.

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Abstract

L'invention concerne un ensemble cathéter comprenant : un transducteur ultrasonore thérapeutique à haute intensité (HITU) en forme d'enveloppe cylindrique qui comporte une surface interne définissant une chambre, une enveloppe externe permettant de lancer des ondes ultrasonores vers l'extérieur, un rebord proximal et un rebord distal entre la surface interne et l'enveloppe externe ; une structure à plots située dans la chambre et connectée électriquement à la surface interne de l'enveloppe cylindrique ; et un circuit souple comprenant au moins un plot de signal connecté électriquement à l'enveloppe externe du transducteur HITU et au moins un plot de masse connecté électriquement à la structure à plots.
PCT/IB2025/051350 2024-02-09 2025-02-08 Transducteur ultrasonore thérapeutique à haute intensité (hitu) basé sur un cathéter avec circuit souple Pending WO2025169158A1 (fr)

Applications Claiming Priority (4)

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US202463552018P 2024-02-09 2024-02-09
US63/552,018 2024-02-09
US202463554061P 2024-02-15 2024-02-15
US63/554,061 2024-02-15

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020002371A1 (en) * 2000-03-24 2002-01-03 Acker David E. Apparatus and methods for intrabody thermal treatment
US10230041B2 (en) 2013-03-14 2019-03-12 Recor Medical, Inc. Methods of plating or coating ultrasound transducers
US10456605B2 (en) 2013-03-14 2019-10-29 Recor Medical, Inc. Ultrasound-based neuromodulation system
US20200109994A1 (en) * 2015-06-10 2020-04-09 Ekos Corporation Ultrasound catheter
US20230021354A1 (en) 2021-07-19 2023-01-26 Otsuka Medical Devices Co., Ltd. Transmitting acoustic and electromagnetic signals from a catheter balloon
US20230293229A1 (en) 2022-03-15 2023-09-21 Otsuka Medical Devices Co., Ltd. Using characteristics of native or evoked sensed neural activity to select denervation parameters

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020002371A1 (en) * 2000-03-24 2002-01-03 Acker David E. Apparatus and methods for intrabody thermal treatment
US10230041B2 (en) 2013-03-14 2019-03-12 Recor Medical, Inc. Methods of plating or coating ultrasound transducers
US10456605B2 (en) 2013-03-14 2019-10-29 Recor Medical, Inc. Ultrasound-based neuromodulation system
US20200109994A1 (en) * 2015-06-10 2020-04-09 Ekos Corporation Ultrasound catheter
US20230021354A1 (en) 2021-07-19 2023-01-26 Otsuka Medical Devices Co., Ltd. Transmitting acoustic and electromagnetic signals from a catheter balloon
US20230293229A1 (en) 2022-03-15 2023-09-21 Otsuka Medical Devices Co., Ltd. Using characteristics of native or evoked sensed neural activity to select denervation parameters

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