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WO2025214839A1 - Cathéter à ultrasons diagnostique et thérapeutique à transducteur unique - Google Patents

Cathéter à ultrasons diagnostique et thérapeutique à transducteur unique

Info

Publication number
WO2025214839A1
WO2025214839A1 PCT/EP2025/058938 EP2025058938W WO2025214839A1 WO 2025214839 A1 WO2025214839 A1 WO 2025214839A1 EP 2025058938 W EP2025058938 W EP 2025058938W WO 2025214839 A1 WO2025214839 A1 WO 2025214839A1
Authority
WO
WIPO (PCT)
Prior art keywords
transducer
medical device
catheter
distal end
disposed
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/EP2025/058938
Other languages
English (en)
Inventor
Arjen VAN DER HORST
Megan Ann MIEZWA
Sergey Yuryevich SHULEPOV
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.)
Koninklijke Philips NV
Original Assignee
Koninklijke Philips NV
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 Koninklijke Philips NV filed Critical Koninklijke Philips NV
Publication of WO2025214839A1 publication Critical patent/WO2025214839A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/06—Measuring blood flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4483—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4483—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer
    • A61B8/4494—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device characterised by features of the ultrasound transducer characterised by the arrangement of the transducer elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A61B8/488—Diagnostic techniques involving Doppler signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/54—Control of the diagnostic device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • 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
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0891—Clinical applications for diagnosis of blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4427—Device being portable or laptop-like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4477—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device using several separate ultrasound transducers or probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/46—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
    • A61B8/467—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient characterised by special input means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/54—Control of the diagnostic device
    • A61B8/546—Control of the diagnostic device involving monitoring or regulation of device temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0043—Ultrasound therapy intra-cavitary
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0052—Ultrasound therapy using the same transducer for therapy and imaging

Definitions

  • Ultrasound has been used clinically to measure flow velocity to diagnose various conditions such as coronary microvascular disease. It is also useful to provide relevant diagnostic information to clinicians treating disease in the peripheral vasculature. In the peripheral vasculature there are opportunities for diagnostic information to add value throughout the clinical procedure. For example, flow measurements may be helpful in diagnosing clinical significance of a lesion prior to treatment, or whether adequate flow has been restored following treatment. Flow measurements may also benefit the clinician between treatment modalities, for example in venous interventions following thrombectomy and high pressure venoplasty to determine whether there is adequate inflow to support placement of an iliac stent.
  • ultrasound has been used clinically or in research applications to in therapeutic applications via thermal or cavitation treatment.
  • ultrasound can be used to heat and ablate the nerves surrounding the renal artery.
  • a medical device comprising: a catheter body comprising a lumen comprising a distal end and a proximal end; and a transducer disposed at or near the distal end of the catheter body.
  • the transducer is adapted to emit ultrasound waves to treat tissue and/or emit and receive ultrasound waves measure blood velocity and/or image tissue with the same transducer.
  • a method of carrying out a medical procedure comprises: providing a catheter body comprising a lumen comprising a distal end and a proximal end; providing a transducer disposed at or near the distal end of the catheter body; and emitting ultrasound waves to treat tissue and/or emit and receive ultrasound waves measure blood velocity and/or image tissue with the same transducer.
  • FIG. 1 A is a perspective view of a catheter lab comprising a medical system comprising a medical device in accordance with a representative embodiment.
  • FIG. IB is a simplified block diagram of a medical system comprising a medical device in accordance with a representative embodiment.
  • FIG. 2A is a perspective view of a catheter lab comprising a medical system comprising a medical device in accordance with a representative embodiment.
  • FIG. 2B is a simplified block diagram of a medical system comprising a medical device in accordance with a representative embodiment.
  • FIG. 3 is a simplified block diagram of front-end and back-end electronics used in A-line imaging in a medical system in accordance with a representative embodiment
  • FIG. 4A is a conceptual view of a medical device deployed for treatment of a patient in accordance with a representative embodiment.
  • Fig. 4B is a close-up view of the portions of the medical device of Fig. 4A in accordance with a representative embodiment.
  • Fig. 4C is a perspective view in partial cross-section a transducer of a medical device in accordance with another representative embodiment.
  • Fig. 5A is a perspective view in partial cross-section of a transducer of a medical device in accordance showing excitation of transducer elements in accordance with a representative embodiment.
  • Fig. 5B is a graph of acoustic pressure versus frequency of a transducer in accordance with a representative embodiment.
  • Fig. 6A shows an acoustic pressure (Pa) profile of a medical device without a guide wire disposed in a catheter in accordance with another representative embodiment.
  • Fig. 6B shows a temperature profile (°C) of the medical device of Fig. 5A in accordance with a representative embodiment.
  • Fig. 7A shows an acoustic profile (Pa) versus angle and distance of a transducer of a medical device in accordance with a representative embodiment.
  • Fig. 7B shows A-line image generation of a transducer of a medical device in accordance with a representative embodiment.
  • Fig. 8A is a perspective view in partial cross-section of three concentric ring transducers of a medical device showing excitation of the three ring transducer elements in accordance with a representative embodiment.
  • Fig. 8B is a graph of acoustic pressure versus frequency of the medical device of Fig. 9 A in accordance with a representative embodiment.
  • Fig. 9A is a perspective view in partial cross-section of a transducer of a medical device in accordance with another representative embodiment.
  • Fig. 9B shows an acoustic pressure (Pa) versus frequency of a transducer in accordance with a representative embodiment profile of a medical device comprising the transducer of Fig. 9A.
  • Fig. 10 is a cross-sectional view of a medical device comprising a ring transducer and an acoustically transparent element disposed at a distal end of the transducer in accordance with a representative embodiment.
  • a medical device is adapted to measure blood velocity rates to provide diagnostic information to the clinician, both in venous and arterial peripheral vascular procedures while also incorporating a therapeutic solution to treat the disease that is identified.
  • the medical device comprises a catheter having a ring transducer at its distal end that can be used for both ultrasound-based treatment (e.g., tissue ablation or cavitation to treat lesion and cross total occlusion (CTO, 1ST), or mild hyperthermia for collagen softening, or cauterization for vessel closure) and measure blood flow velocity (blood velocity).
  • ultrasound-based treatment e.g., tissue ablation or cavitation to treat lesion and cross total occlusion (CTO, 1ST), or mild hyperthermia for collagen softening, or cauterization for vessel closure
  • blood flow velocity blood velocity
  • the same transducer may be used to provide imaging (e.g., A-line imaging). This imaging can be done before a treatment is begun to facilitate the treatment, as well as during the treatment and/or blood velocity measurement thereby providing direct feedback on therapy effectiveness and blood flow.
  • the medical device of the various representative embodiments reduces the number of catheter exchanges required in known medical devices in order to use a different transducer for thermal treatment, blood velocity measurement, and/or imaging. Reducing the number of catheter exchanges in turn streamlines the procedure and allows the clinician to provide therapy in response to the diagnostic results.
  • the medical device of the various representative embodiments enables a therapeutic procedure (e.g., ablation, cavitation, hyperthermia, cauterization) and diagnostic procedure (measurement of blood flow velocity, or imaging, or both) with the same ring transducer disposed at or near the distal end of a catheter.
  • a comparatively wide ultrasound beam suitable for Doppler flow sensing is generated using the transducer of the medical device.
  • the catheter can be deployed without a guide wire extending from the distal end.
  • the same transducer used to create the comparatively wide ultrasound beam is adapted to focus the ultrasound waves and generate a comparatively high intensity spot in-front of the transducer to perform, for example, a thermal procedure such as ablation, or cauterization or cavitation.
  • the medical device of the various representative embodiments enables the streamlining of the medical procedures and allow the clinician to provide therapy in response to the diagnostic results such as blood flow measured and images gathered by the device.
  • the medical devices of the present teachings improve workflow of the treatment, imaging and blood velocity measurements.
  • other known medical devices will require the use of multiple medical devices for the various procedures, and the need to exchange catheters for each procedure.
  • FIG. 1A is a perspective view of a catheter lab 100 comprising a medical system 102 comprising a medical device (not shown in Fig. 1 A) in accordance with a representative embodiment.
  • the catheter lab 100 comprises a C-arm 101 or similar structure commonly used in a catheter lab to carry out various medical procedures.
  • a patient 103 is shown on a table 105 with a display 109 disposed as shown.
  • the medical device is connected via a connector 106 to a patient interface module (PIM) 108, which in turn is connected to a console 110 of the medical system 102.
  • the console 110 is local to the controller 116.
  • the console 110 comprises a graphic user interface (GUI) and is connected to the controller 116 via a local wired interface such as an Ethernet cable or via a local wireless interface such as a Wi-Fi connection.
  • GUI graphic user interface
  • the console 110 may comprise a display, and through the GUI enables a user (e.g., a clinician/user) to provide inputs via the console 110 to the medical device 130.
  • the console 110 be interfaced with other user input devices by which users can input instructions, including mouses, keyboards, thumbwheels and so on.
  • the display 112 of the console 110 may be a monitor such as a computer monitor, a display on a mobile device (e.g., part of the user input 214 described below), an augmented reality display, a television, an electronic whiteboard, or another screen configured to display electronic imagery.
  • the console 110 may also include one or more input interface(s) such as those noted above that may connect to other elements or components, as well as an interactive touch screen configured to display prompts to users and collect touch input from users. These interfaces may also be icons (not shown) on a display (not shown in Fig. 1A) via the GUI.
  • the PIM 108 is configured to send signal to and receive signals from the console 110 during deployment of the medical device and attendant procedures performed thereby.
  • the console also comprises a display 112, which may comprise, for example, a GUI.
  • Fig. IB is a simplified block diagram the medical system 102 comprising a medical device 130 disposed in a vessel 132 in accordance with a representative embodiment.
  • the medical device comprises a transducer 134 disposed at or near a distal end of a catheter 136.
  • the transducer 134 comprises a ring transducer disposed at the distal end of the catheter 136, with the ring transducer having an inner radius that is substantially the same dimension as an inner radius of the catheter 136 and an outer radius having substantially the same dimension as an outer radius of the catheter 136.
  • the transducer 134 comprises a ring transducer near the distal end of the catheter with ring transducer having an inner radius substantially the same dimension as the outer radius of the catheter 136.
  • the console 110 is connected to the display 112, which may also comprise a display.
  • the display 112 may comprise a graphic user interface (GUI) that enables the clinician or other operator to control the function of the medical device 130, carry out the desired medical procedures and gather data and images from the medical device 130 as described more fully herein.
  • GUI graphic user interface
  • the display 112 may be one of a number of common devices used to provide inputs to the various components of the console 110 to carry out the various procedures.
  • the console 110 may comprise a keyboard, a mouse and a separate display, for example, to enable the clinician or other operator to control the function of the medical device 130, carry out the desired medical procedures and gather data and images from the medical device 130.
  • the console 110 comprises a user input 114.
  • the user input 114 allows the clinician to select the mode of operation of the medical device 130, and to select parameters to carry out various medical procedures using the medical device 130.
  • the user input 114 may be a physical button/switch or a software-based GUI.
  • the user input 114 allows the user to initiate medical procedures and select various parameters to carry out the medical procedures.
  • the user input 114 enables the clinician to carry out various actions during the medical procedure, including switching between a diagnostic mode such as blood flow sensing and blood velocity measurement and imaging, and a therapeutic mode such as tissue ablation.
  • various parameter may be input to carry out these modes of operation via the user input (e.g., user input 114 described below).
  • the user input 114 allows the user to select between a diagnostic mode and a therapeutic mode.
  • the user input 114 also enables the user to select to measure blood flow (blood velocity) or to capture images, wherein in a therapeutic mode, the user input would allow the user to select an ultrasound-based therapy procedure such as ablation, cavitation, hyperthermia or cauterization.
  • the ability to switch from one mode to another affords a significant improvement to the field of medical diagnosis and treatment.
  • the user input 114 allows the user to capture images with the medical device via the transducer.
  • These images may then be provided to the display 112 and used by the clinician to carry out a therapeutic procedure, such as ablating a lesion in the vessel 132 using the same transducer in the medical device 130.
  • the clinician may again switch to measuring the blood flow (velocity) to determine whether the ablation was successful in improving the blood flow.
  • the user switches the function of the transducer 134 from a therapeutic mode to a diagnostic mode to measure the blood flow.
  • the parameters selected by the clinician via the user input 114 are based on the selected procedure and provide a wide variety of options to the user when selecting therapeutic treatment or diagnostic measurement/imaging.
  • the parameters selected may include the desired acoustic power and therefore the needed electric power, the frequency of the ultrasound waves needed for the ablation step, continuous ultrasound wave or pulsed ultrasound wave ,the desired pulse repetition frequency and duty cycle, which, among other benefits described below, may be useful to prevent overheating of the transducer.
  • the parameters may be selected for a particular diagnostic procedure. For example, Doppler imaging may be desired.
  • the gating of the signal may be selected, so the bursts of ultrasound energy have a desired pulse repetition frequency, duration and frequency.
  • the selection of these and other various parameters not only allow the selection of the mode of operation (therapeutic or diagnostic), but also allows the particular characteristics of the selected procedure to be set.
  • the selected mode and parameters provided at the user input are provided to a controller 116, which comprises a processor (not shown as part of the controller 116), and a memory (not shown as part of the controller 116), which stores computer-executable instructions (code).
  • these instructions when executed by the processor carry out various functions of representative embodiments described herein.
  • the memory may store a set of software instructions that can be executed to cause the medical system 102 to perform some or all aspects of certain methods or computer-based functions.
  • the controller 116 may be implemented by a computer that includes more elements than the controller of Fig. IB.
  • the controller may be remote to the medical system 102, and is adapted to control various aspects of the medical system 102 remotely via connections including both wired and wireless connections and protocols.
  • the controller 116 at least in part, is a specialty or particular computer useful in controlling the medical system 102.
  • the controller 116 may operate as a standalone device or may be connected, for example, using a network to other computer systems or peripheral devices.
  • the medical system 102 performs logical processing based on digital signals received via an analog-to-digital converter.
  • the controller 116 can also be implemented as or incorporated into various devices, such as a workstation that includes a controller, a stationary computer, a mobile computer, a personal computer (PC), a laptop computer, a tablet computer, or any other machine capable of executing a set of software instructions (sequential or otherwise) that specify actions to be taken by that machine.
  • the controller 116 can be incorporated as or in a device that in turn is in an integrated system that includes additional devices.
  • the controller 116 can be implemented in a device that also provides video or data communication. Moreover, the controller 116 may be connected to components of the system via a local wired interface such as an Ethernet cable or via a local wireless interface such as a Wi-Fi connection.
  • the processor may be considered a representative example of a processor of the controller 116 and executes instructions to implement some or all aspects of methods and processes described herein.
  • the processor is tangible and non-transitory.
  • the term “non-transitory” is to be interpreted not as an eternal characteristic of a state, but as a characteristic of a state that will last for a period.
  • the term “non-transitory” specifically disavows fleeting characteristics such as characteristics of a carrier wave or signal or other forms that exist only transitorily in any place at any time.
  • the processor is an article of manufacture and/or a machine component.
  • the processor is configured to execute software instructions to perform functions as described in the various embodiments herein.
  • the processor may be a general-purpose processor or may be part of an application specific integrated circuit (ASIC).
  • the processor may also be a microprocessor, a microcomputer, a processor chip, a controller, a microcontroller, a digital signal processor (DSP), a state machine, or a programmable logic device.
  • the processor may also be a logical circuit, including a programmable gate array (PGA), such as a field programmable gate array (FPGA), or another type of circuit that includes discrete gate and/or transistor logic.
  • the processor may be a central processing unit (CPU), a graphics processing unit (GPU), or both. Additionally, any processor described herein may include multiple processors, parallel processors, or both. Multiple processors may be included in, or coupled to, a single device or multiple devices.
  • processor encompasses an electronic component able to execute a program or machine executable instruction. References to a processor should be interpreted to include more than one processor or processing core, as in a multi-core processor. A processor may also refer to a collection of processors within a single computer system or distributed among multiple computer systems.
  • the memory may include a main memory and/or a static memory, where memories in the medical system 102 communicate with each other and the processor via a bus (not shown).
  • the memory may be considered a representative example of a memory of the controller 116, and store instructions used to implement some or all aspects of methods and processes described herein.
  • Memories described herein are tangible storage mediums for storing data and executable software instructions and are non-transitory during the time software instructions are stored therein. As used herein, the term “non-transitory” is to be interpreted not as an eternal characteristic of a state, but as a characteristic of a state that will last for a period.
  • non- transitory specifically disavows fleeting characteristics such as characteristics of a carrier wave or signal or other forms that exist only transitorily in any place at any time.
  • the memory is an article of manufacture and/or machine components.
  • the memory is a computer-readable medium from which data and executable software instructions can be read by a computer (e.g., by the processor of the controller 116).
  • the memory may be implemented as one or more of randomaccess memory (RAM), read only memory (ROM), flash memory, electrically programmable read only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), registers, a hard disk, a removable disk, tape, compact disk read only memory (CD- ROM), digital versatile disk (DVD), floppy disk, Blu-ray disk, or any other form of storage medium known in the art.
  • RAM randomaccess memory
  • ROM read only memory
  • EPROM electrically programmable read only memory
  • EEPROM electrically erasable programmable read-only memory
  • registers a hard disk, a removable disk, tape, compact disk read only memory (CD- ROM), digital versatile disk (DVD), floppy disk, Blu-ray disk, or any other form of storage medium known in the art.
  • the memory may be volatile or non-volatile, secure and/or encrypted, unsecure and/or unencrypted.
  • inventive concepts also encompass a computer readable medium that stores instructions
  • a computer readable medium is defined herein to be any medium that constitutes patentable subject matter under 35 U.S.C. ⁇ 101 and excludes any medium that does not constitute patentable subject matter under 35 U.S.C. ⁇ 101.
  • Examples of such media include non-transitory media such as computer memory devices that store information in a format that is readable by a computer or data processing system. More specific examples of non-transitory media include computer disks and non-volatile memories.
  • the memory is an example of a computer-readable storage medium.
  • Computer memory is any memory which is directly accessible to a processor. Examples of computer memory include, but are not limited to RAM memory, registers, and register files. References to “memory” should be interpreted as possibly being multiple memories. The memory may for instance be multiple memories within the same computer system. The memory may also be multiple memories distributed amongst multiple computer systems or computing devices.
  • Software instructions when executed by the processor, perform one or more steps of the methods and processes as described herein. In an embodiment, the software instructions may reside all or in part within the memory and/or the processor during execution by the controller 116.
  • US signals received at the transducer 134 of the medical device 130 are provided to the receiver 121, and a processor 126 and a memory 128 are used to provide images and data to the display 112.
  • the console 110 is connected to the PIM 108, which in turn is connected to the connector 106.
  • the connector 106 provides the necessary electrical connections to the transducer 134 of the medical device 130 so that the signals from the transmitter 118 are provided to the transducer 134 for emission of US signals for the procedure being carried out, and the reflected US signals from the transducer 134 are provided to the receiver 122 for processing and display at the display 112.
  • the PIM 108 provides a relay function. Specifically, the PIM provide a location to connect the connector 106 at the bed-side.
  • the PIM described in connection with a representative embodiment of Fig. 2B provides additional functionality, as described below.
  • FIG. 2A is a perspective view of a catheter lab 200 comprising a medical system 202 comprising a medical device (not shown in Fig. 2A) in accordance with a representative embodiment. Certain aspects and details of the catheter lab 200 and medical system 202 are common to those described in connection with representative embodiments of Figs. 1 A and IB. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments.
  • the catheter lab 200 comprises a C-arm 201 or similar structure commonly used in a catheter lab to carry out various medical procedures.
  • a patient 203 is shown on a table 205 with an imaging display 209 disposed as shown.
  • the medical device is connected via a connector 206 to a patient interface module (PIM) 208, which in turn is connected to a console 210 of the medical system 202.
  • the console 210 is local to the controller 116.
  • the console 210 comprises a GUI and is connected to the controller 116 via a local wired interface such as an Ethernet cable or via a local wireless interface such as a Wi-Fi connection.
  • the console 210 may comprise a display, and through the GUI enables a user (e.g., a clinician/user) to provide inputs via the console 119 to the medical device 230.
  • the console 210 be interfaced with other user input devices by which users can input instructions, including mouses, keyboards, thumbwheels and so on.
  • the display of the console 210 may be a monitor such as a computer monitor, a display on a mobile device, an augmented reality display, a television, an electronic whiteboard, or another screen configured to display electronic imagery.
  • the console 210 may also include one or more input interface(s) such as those noted above that may connect to other elements or components, as well as an interactive touch screen configured to display prompts to users and collect touch input from users. These interfaces may also be icons (not shown) on a display (not shown in Fig. 2A) via the GUI.
  • the PIM 208 is configured to send signal to and receive signals from the console 210 during deployment of the medical device and attendant procedures performed thereby.
  • the console also comprises a display 212, which may comprise, for example, a graphic user interface (GUI).
  • GUI graphic user interface
  • the display 212 enables the clinician to carry out various actions during the medical procedure, including switching between a diagnostic mode such as blood flow sensing and blood velocity measurement and imaging, and a therapeutic mode such as tissue ablation. Moreover, various parameter may be input to carry out these modes of operation via the display 212.
  • the medical system 202 also comprises a table side module 223. As described more fully below, the table side module 223 allows the clinician to carry out a number of steps to carry out the desired procedures noted above. These include selection of and switching between diagnostic mode and therapeutic mode as well as selecting the various parameters for the selected diagnostic and therapeutic procedure being carried out.
  • these parameters are based on the selected procedure and provide a wide variety of options to the user when selecting therapeutic treatment or diagnostic measurement/imaging.
  • the parameters selected may include the desired acoustic power and therefore the needed electric power, the frequency of the ultrasound waves needed for the ablation step, continuous ultrasound wave or pulsed ultrasound wave , the desired pulse repetition frequency and duty cycle, which, among other benefits described below, may be useful to prevent overheating of the transducer.
  • the parameters may be selected for a particular diagnostic procedure. For example, Doppler imaging may be desired. In this case, the gating of the signal may be selected, so the bursts of ultrasound energy have a desired, pulse repetition frequency, duration and frequency.
  • Fig. 2B is a simplified block diagram the medical system 102 comprising a medical device 230 disposed in a vessel 232 in accordance with a representative embodiment.
  • the medical device comprises a transducer 234 disposed at or near a distal end of a catheter 236.
  • the transducer 234 comprises a ring transducer disposed at the distal end of the catheter 236, with the ring transducer having an inner radius that is substantially the same dimension as an inner radius of the catheter 236 and an outer radius having substantially the same dimension as an outer radius of the catheter 236.
  • the transducer 234 comprises a ring transducer near the distal end of the catheter with ring transducer having an inner radius substantially the same dimension as the outer radius of the catheter 236.
  • the console 210 is connected to the display 212, which may also comprise a display.
  • the display 212 may comprise a graphic user interface (GUI) that enables the clinician or other operator to control the function of the medical device 230, carry out the desired medical procedures and gather data and images from the medical device 230 as described more fully herein.
  • GUI graphic user interface
  • the display 212 may be one of a number of common devices used to provide inputs to the various components of the console 210 to carry out the various procedures.
  • the console 210 may comprise a keyboard, a mouse and a separate display, for example, to enable the clinician or other operator to control the function of the medical device 230, carry out the desired medical procedures and gather data and images from the medical device 230.
  • the PIM 208 comprises certain components disposed in the console 110 of Figs. 1 A-1B.
  • US signals received at the transducer 234 of the medical device 230 are provided to the receiver 221, and a processor 226 and a memory 228 are used to provide images and data to the display 212.
  • the console 210 is connected to the PIM 208, which in turn is connected to the connector 206.
  • the connector 206 provides the necessary electrical connections to the transducer 234 of the medical device 230 so that the signals from the transmitter 218 are provided to the transducer 234 for emission of US signals for the procedure being carried out, and the reflected US signals from the transducer 234 are provided to the receiver 222 for processing and display at the display 212.
  • the medical system 202 comprises table side module 240, which comprises a user input 214.
  • the table side module 240 is a portable device (e.g., a tablet computer or mobile phone) that is used by the clinician to carry out the desired medical procedure, including switching between modes of operation, and selecting parameters via the user input 214.
  • the user input 214 allows the clinician to select the mode of operation of the medical device 230, and to select parameters to carry out various medical procedures using the medical device 230.
  • the user input 214 allows the user to initiate medical procedures and select various parameters to carry out the medical procedures.
  • the user input 214 enables the clinician to carry out various actions during the medical procedure, including switching between a diagnostic mode such as blood flow sensing and blood velocity measurement and imaging, and a therapeutic mode such as tissue ablation.
  • various parameter may be input to carry out these modes of operation via the user input (e.g., user input 214 described below).
  • the user input 214 allows the user to select between a diagnostic mode and a therapeutic mode.
  • the user input 214 also enables the user to select to measure blood flow (blood velocity) or to capture images, wherein in a therapeutic mode, the user input would allow the user to select a therapeutic ultrasound procedure such as ablation, cavitation, hyperthermia or cauterization.
  • the user input 214 allows the user to capture images with the medical device via the transducer. These images may then be provided to the display 212 and used by the clinician to carry out a therapeutic procedure, such as ablating a lesion in the vessel 232 using the same transducer in the medical device 230. After completing the ablation step, the clinician may again switch to measuring the blood flow (velocity) to determine whether the ablation was successful in improving the blood flow. Again, via the user input 214, the user switches the function of the transducer 234 from a therapeutic mode to a diagnostic mode to measure the blood flow.
  • the parameters selected by the clinician via the user input 214 are based on the selected procedure and provide a wide variety of options to the user when selecting therapeutic treatment or diagnostic measurement/imaging.
  • the parameters selected may include the desired acoustic power and therefore the needed electric power, the frequency of the ultrasound waves needed for the ablation step, continuous ultrasound wave or pulsed ultrasound wave , the desired pulse repetition frequency and duty cycle, which, among other benefits described below, may be useful to prevent overheating of the transducer.
  • the parameters may be selected for a particular diagnostic procedure. For example, Doppler imaging may be desired.
  • the gating of the signal may be selected, so the bursts of ultrasound energy have a desired, repetition frequency, duration and frequency.
  • the selection of these and other various parameters not only allow the selection of the mode of operation (therapeutic or diagnostic), but also allows the particular characteristics of the selected procedure to be set.
  • the selected mode and parameters provided at the user input are provided to a controller 216, which comprises a processor (not shown as part of the controller 216), and a memory (not shown as part of the controller 216), which stores computer-executable instructions (code).
  • these instructions when executed by the processor carry out various functions of representative embodiments described herein.
  • the memory may store a set of software instructions that can be executed to cause the medical system 102 to perform some or all aspects of certain methods or computer-based functions.
  • the controller 216 may be implemented by a computer that includes more elements than the controller of Fig. 2B.
  • the controller may be remote to the medical system 102, and is adapted to control various aspects of the medical system 102 remotely via connections including both wired and wireless connections and protocols.
  • the controller 216 at least in part is a specialty or particular computer useful in controlling the medical system 102.
  • the controller 216 may operate as a standalone device or may be connected, for example, using a network to other computer systems or peripheral devices.
  • the medical system 102 performs logical processing based on digital signals received via an analog-to-digital converter.
  • the controller 216 can also be implemented as or incorporated into various devices, such as a workstation that includes a controller, a stationary computer, a mobile computer, a personal computer (PC), a laptop computer, a tablet computer, or any other machine capable of executing a set of software instructions (sequential or otherwise) that specify actions to be taken by that machine.
  • the controller 216 can be incorporated as or in a device that in turn is in an integrated system that includes additional devices.
  • the controller 216 can be implemented in a device that also provides video or data communication. Moreover, the controller 216 may be connected to components of the system via a local wired interface such as an Ethernet cable or via a local wireless interface such as a Wi-Fi connection.
  • a local wired interface such as an Ethernet cable
  • a local wireless interface such as a Wi-Fi connection.
  • the processor may be considered a representative example of a processor of the controller 216 and executes instructions to implement some or all aspects of methods and processes described herein.
  • the processor is tangible and non-transitory.
  • the term “non-transitory” is to be interpreted not as an eternal characteristic of a state, but as a characteristic of a state that will last for a period.
  • the term “non-transitory” specifically disavows fleeting characteristics such as characteristics of a carrier wave or signal or other forms that exist only transitorily in any place at any time.
  • the processor is an article of manufacture and/or a machine component.
  • the processor is configured to execute software instructions to perform functions as described in the various embodiments herein.
  • the processor may be a general-purpose processor or may be part of an application specific integrated circuit (ASIC).
  • the processor may also be a microprocessor, a microcomputer, a processor chip, a controller, a microcontroller, a digital signal processor (DSP), a state machine, or a programmable logic device.
  • the processor may also be a logical circuit, including a programmable gate array (PGA), such as a field programmable gate array (FPGA), or another type of circuit that includes discrete gate and/or transistor logic.
  • the processor may be a central processing unit (CPU), a graphics processing unit (GPU), or both. Additionally, any processor described herein may include multiple processors, parallel processors, or both. Multiple processors may be included in, or coupled to, a single device or multiple devices.
  • processor encompasses an electronic component able to execute a program or machine executable instruction. References to a processor should be interpreted to include more than one processor or processing core, as in a multi-core processor. A processor may also refer to a collection of processors within a single computer system or distributed among multiple computer systems.
  • the memory may include a main memory and/or a static memory, where memories in the medical system 102 communicate with each other and the processor via a bus (not shown).
  • the memory may be considered a representative example of a memory of the controller 216, and store instructions used to implement some or all aspects of methods and processes described herein.
  • Memories described herein are tangible storage mediums for storing data and executable software instructions and are non-transitory during the time software instructions are stored therein.
  • the term “non-transitory” is to be interpreted not as an eternal characteristic of a state, but as a characteristic of a state that will last for a period.
  • the term “non- transitory” specifically disavows fleeting characteristics such as characteristics of a carrier wave or signal or other forms that exist only transitorily in any place at any time.
  • the memory is an article of manufacture and/or machine components.
  • the memory is a computer-readable medium from which data and executable software instructions can be read by a computer (e.g., by the processor of the controller 216).
  • the memory may be implemented as one or more of randomaccess memory (RAM), read only memory (ROM), flash memory, electrically programmable read only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), registers, a hard disk, a removable disk, tape, compact disk read only memory (CD- ROM), digital versatile disk (DVD), floppy disk, Blu-ray disk, or any other form of storage medium known in the art.
  • RAM randomaccess memory
  • ROM read only memory
  • EPROM electrically programmable read only memory
  • EEPROM electrically erasable programmable read-only memory
  • registers a hard disk, a removable disk, tape, compact disk read only memory (CD- ROM), digital versatile disk (DVD), floppy disk, Blu-ray disk, or any other form of storage medium known in the art.
  • the memory may be volatile or non-volatile, secure and/or encrypted, unsecure and/or unencrypted.
  • inventive concepts also encompass a computer readable medium that stores instructions
  • a computer readable medium is defined herein to be any medium that constitutes patentable subject matter under 35 U.S.C. ⁇ 101 and excludes any medium that does not constitute patentable subject matter under 35 U.S.C. ⁇ 101.
  • Examples of such media include non-transitory media such as computer memory devices that store information in a format that is readable by a computer or data processing system. More specific examples of non-transitory media include computer disks and non-volatile memories.
  • the memory is an example of a computer-readable storage medium.
  • Computer memory is any memory which is directly accessible to a processor. Examples of computer memory include, but are not limited to RAM memory, registers, and register files. References to “memory” should be interpreted as possibly being multiple memories. The memory may for instance be multiple memories within the same computer system. The memory may also be multiple memories distributed amongst multiple computer systems or computing devices.
  • Software instructions when executed by the processor, perform one or more steps of the methods and processes as described herein. In an embodiment, the software instructions may reside all or in part within the memory and/or the processor during execution by the controller 216.
  • Fig. 3 is a simplified block diagram of front-end and back-end electronics 322 used in A- line imaging in a medical system in accordance with a representative embodiment. Notably, Fig. 3 provides further detail of the receivers 122, 222 described above.
  • the front-end and back-end electronics 322 are connected to a transducer 334, such as transducers 134, 234, and in further detail in connection with various representative embodiments.
  • the front-end and back-end electronics 322 enable not only Doppler flow velocity sensing (blood velocity measurements) and thermal treatment (e.g., tissue ablation and hyperthermia), but also may be used in an imaging mode as described above.
  • Standard A-line (similar as B-mode) imaging can be done to create an M-mode-like image. This generates a rudimentary image that shows the tissue in front of the catheter 136, 236.
  • imaging fosters real-time monitoring without a catheter exchange. For example, when ablating tissue, imaging enables checking the tissue type in-front of the catheter to prevent ablating undesired locations. For example, it can avoid penetrating the vessel wall. This can be particularly beneficial when using the medical device to cross a total occlusion, for example in-stent thrombosis. This ability of the medical devices of the present teachings to switch from therapeutic mode to imaging mode without a catheter exchange, and using the same transducer for both the imaging and treatment provides a clear improvement to the field of medicine.
  • the front-end and back-end electronics 322 comprise a front-end subsystem 301, which is connected to the transducer 334, and a back-end subsystem 303.
  • the front-end subsystem 301 typically comprises a beam former 302, a time gain compensation device 304, and a radio frequency (RF) modulator/demodulator 306.
  • the components of the front-end subsystem 301 are known to one of ordinary skill in the art of US imaging.
  • the various components of front-end and back-end electronics 322 are common components for Doppler and (A-line) imaging modalities, and can be realized in software and hardware. As such, the various components shown in Fig.
  • the back-end subsystem 303 comprises an envelope detection stage 308, a dynamic range compression stage 310, a signal filtering stage (e.g., axial/lateral filtering in case of imaging modality, and bandpass filtering for Doppler) 312, a persistence processing stage 314 (when applicable), a scan conversion stage 315 that is image modality specific, a gamma correction stage 316, and is output to a display 312.
  • the components of the back-end subsystem 303 are known to one of ordinary skill in the art of US imaging. Again, like the components noted above, the various components are known elements of the back-end system, which may have specific details and realizations, and are mostly realized through the software implementation, adapted to cause the processor to carry out the various functions.
  • FIG. 4A is a conceptual view of a medical device 430 deployed for treatment of a patient in accordance with a representative embodiment.
  • Various aspects and details of the medical device 430 are common to those described above in connection with Figs. 1 A-2B and may not be repeated in order to avoid obscuring the presently described representative embodiments.
  • further aspects and details of the medical device 430 are described in connection with the representative embodiments described in connection with Figs. 5-12 below.
  • the medical device 430 is disposed in a vessel 432 through which fluid (e.g., blood) flows as shown.
  • the medical device 430 comprises a transducer 434, which is illustratively a ring transducer.
  • the medical device 430 comprises a catheter 436, which is adapted to receive a guidewire 438.
  • the guidewire 438 is not disposed in the catheter 436 during use of the medical device 430, whereas in other representative embodiments, the guidewire 438 is disposed in the catheter.
  • the guidewire can be inserted and removed from the catheter to enable various functions of the medical device 430 to be carried out.
  • Fig. 4B is a close-up view of the portions of the medical device 430 of Fig. 4A in accordance with a representative embodiment. Specifically, the transducer 434 is shown disposed at or near a distal end 404 of the catheter 436. The transducer 434 is adapted to emit and receive ultrasound waves to treat tissue and/or measure blood velocity and/or image tissue with the same transducer.
  • the transducer 434 is a ring transducer disposed in a housing (e.g., stainless steel) (not shown) and embedded in an epoxy (e.g. masterbond) (not shown).
  • a housing e.g., stainless steel
  • an epoxy e.g. masterbond
  • the front and the back of the transducer 434 are connected to an electrical lead to connect the transducer to the medical device 430 (e.g., via the connector 106 in Fig. IB or the PIM 208 in Fig. 2B).
  • the catheter 436 comprises a lumen 406 comprising a distal end 407 and a proximal end (e.g., at the point of insertion of the guidewire 438 shown in Fig. 4A).
  • the lumen 406 can be throughout the catheter (Over-The-Wire - OTW) or can be of the rapid exchange (Rx) type with a side hole (not shown) such that the guide wire in only inside the catheter at the tip side.
  • the lumen 406 provides a conduit for the introduction of fluids, which may be useful during a procedure using the medical device.
  • the presence and absence of the guidewire 438 in the lumen results in difference focal points, beam shapes and intensity of the ultrasound waves generated by the transducer 434.
  • the medical device 430 can provide different US beams depending on a desired function through the insertion and withdrawal of the guidewire 438, but using the same transducer and without exchanging the catheter 436.
  • the transducer 434 is disposed at or near a distal end 404 of the catheter 436.
  • “near the distal end” has different meanings.
  • “near the distal end” means the transducer can be located on the catheter 436 up to approximately 10 mm away from the distal end 404 or preferably up to 5 mm from the distal end 404.
  • “near the distal end” means the transducer the transducer 434 can be located on the catheter 436 up to approximately 100 mm away from the distal end 404 or preferably up to 50 mm from the distal end 404.
  • the transducer 434 comprises a ring transducer disposed at or near the distal end of the catheter 436 as shown, with the ring transducer having an inner radius that is substantially the same dimension as an inner radius of the catheter 436 (and the lumen 406) and an outer radius having substantially the same dimension as an outer radius of the catheter 436.
  • the transducer 434 comprises a ring transducer near the distal end of the catheter 436 with ring transducer having an inner radius substantially the same dimension as the outer radius of the catheter 436.
  • the transducer 434 comprises a ring transducer.
  • the ring transducer comprises a piezoelectric element.
  • the piezoelectric element made comprise lead zirconium titanate (PZT), capacitive micromachined ultrasonic transducer (CMUT) and a single crystal piezoelectric material.
  • PZT lead zirconium titanate
  • CMUT capacitive micromachined ultrasonic transducer
  • CMUT capacitive micromachined ultrasonic transducer
  • CMUT capacitive micromachined ultrasonic transducer
  • CMUT capacitive micromachined ultrasonic transducer
  • One other potential issue when using PZT for the ring transducer relates to heating. Specifically, in certain representative embodiments described below, it is useful to focus the US beam comparatively close (e.g., 1 mm) from the transducer 434 disposed at or near the distal end of the catheter. This can cause heating of the PZT and via electrodes providing the electrical connections to the transducer 434. Ultimately this heating can impact the wavelength of the US waves being emitted, and thus the performance of the diagnostic and/or therapeutic procedure being performed. In order to mitigate if not prevent runaway due to heating, in certain representative embodiments, the duty cycle of the transmitters 118, 218 are controlled (e.g., shortened). Alternatively, or additionally, in accordance with certain representative embodiments, a cooling fluid may be provided via the lumen 406 to help control heating of the transducer 434 to mitigate or eliminate this heating as well.
  • a cooling fluid may be provided via the lumen 406 to help control heating of the transducer 434 to mitigate or eliminate this heating as
  • CMUT for the ring transducer is beneficial because of ease of manufacture.
  • the ring transducer can be made of a single or plurality of CMUT elements disposed over the distal end of the catheter 436.
  • the electrical impedance of CMUT ring transducers is low compared to the that of PZT, and results in less complex electronics required for driving the ring transducer and less susceptibility to heating.
  • the acoustic impedance of a CMUT ring transducer is better-matched to the fluid (blood) in the vessel 432, resulting in improved performance as well.
  • Fig. 4C is a perspective view in partial cross-section the transducer 434 of the medical device 430 in accordance with another representative embodiment.
  • a piezoelectric element 408 is disposed over a backing layer 410 and beneath a matching layer 412.
  • the backing layer 410 beneficially dampens the acoustic waves transmitted to the back side and reduces the transmittance of the waves via the piezoelectric element 408 back to the receiver 122, 222 (not shown in Fig. 4C), and thereby improves the overall performance of the medical device 430.
  • the backing layer 410 may comprise particle- filled epoxies or foam-like materials within the purview of one of ordinary skill in the art, and having a thickness of approximately 0.05 mm to approximately 10 mm.
  • the matching layer 412 improves the acoustic impedance matching of the piezoelectric material to the fluid in the vessel 432.
  • the matching layer comprises a layer of suitable epoxy approximately 30pm thick.
  • the matching layer 412 may comprise epoxies, particle filled epoxy (e.g., graphite-filled epoxy), rubber like materials, Teflon and similar materials within the purview of one of ordinary skill in the art .
  • the thickness of the matching layer is selected according to the frequency of the US waves and the particular material selected for the matching layer.
  • the matching layer 412 incorporating these illustrative materials has a thickness in the range of approximately 20 pm to approximately 80 pm.
  • Fig. 5A is a perspective view in partial cross-section a transducer 534 of a medical device in accordance showing excitation of transducer elements in accordance with a representative embodiment.
  • Various aspects and details of the transducer 534 of the representative embodiments are common to those described in connection with Figs. 1 A-4C. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments.
  • the transducer 534 comprises a piezoelectric element 508 is disposed over a backing layer 510 and beneath a matching layer 512.
  • the backing layer 510 beneficially reduces transmittance of mechanical waves from the piezoelectric element 508 back the receiver 122, 222 (not shown in Fig. 5 A), and thereby improves the overall performance of the medical device comprising the transducer 534.
  • the matching layer 512 improves the acoustic impedance matching of the piezoelectric material to the fluid in the vessel (e.g. vessels 142, 242, 342 and 432).
  • the transducer 534 has a width of approximately 100 pm and a thickness of approximately 100 pm. In accordance with various representative embodiments, the transducer 534 has a thickness in a range of approximately 50 pm to approximately 500 pm and a thickness of approximately 50 pm to approximately 500 pm. In still other representative embodiments, the transducer 534 has a thickness in a range of approximately 50 pm to approximately 300 pm and a thickness of approximately 50 pm to approximately 300 pm.
  • Vibration of the transducer 534 is shown at 540, and the damping of acoustic waves is shown at 542, where it can be seen that the waves generated extended into the backing layer 510 to a point, but not through the thickness of the backing layer 510 not to allow acoustic energy to return to the receiver (not shown in Fig. 5A).
  • Fig. 5B is a graph of acoustic pressure (Pa) versus frequency (MHz) of the transducer 534 in accordance with a representative embodiment.
  • the transducer 534 has dimensions and material selected to provide a resonance peak 544 of approximately 1.85 x 10 5 Pa at approximately 12 MHz.
  • this operational frequency is often selected for Doppler flow sensing.
  • the total acoustic absolute pressure shown in Fig. 5B at is at a distance of 5 mm from the distal end of the transducer 534 when 10 V is applied.
  • the transducer 534 is adapted to function in two operational modes without the need to exchange the catheter of the medical device at or near the distal end of the catheter.
  • the device can be operated in two modes.
  • the medical device comprising transducer 534 does not have a guidewire disposed in the lumen of the catheter (not shown in Fig. 5A).
  • the medical device comprising transducer 534 creates a focal point of the US waves in a region in front of the transducer, and comparatively close (e.g., approximately 0.5 mm to approximately 10 mm to the end of the transducer 534 (see also Figs 6A-6B, and their attendant descriptions below).
  • the guidewire (not shown in Fig. 5A) is used to move the medical device comprising the transducer 534 to a point where a thermal procedure (e.g., ablation of tissue) is desired.
  • a thermal procedure e.g., ablation of tissue
  • the transducer 534 may be switched to an imaging mode to determine where to move the medical device to carry out properly the desired procedure (e.g., moved proximate to a lesion to be ablated, and not proximate to tissue that is not to be ablated). Moreover, after the medical device is moved to the desired location, the transducer 534 may be in an imaging mode to make confirm the proper positioning of the medical device to carry out the ultrasound treatment.
  • the transducer 534 can again be switched to an imaging mode, to determine if the ultrasound treatment was successful, or if another treatment is required.
  • an imaging mode to determine if the ultrasound treatment was successful, or if another treatment is required.
  • a catheter exchange is not required, and not only is the procedure streamlined, but also less expensive in terms of needed equipment and clinician time.
  • switching between different modes can be carried out intermittently, for example, before a treatment is completed, such as for monitoring the progression of the treatment.
  • the medical device comprising transducer 534 has a guidewire disposed in the lumen of the catheter (not shown in Fig. 5A).
  • the guidewire extends from the distal end of the lumen of the catheter.
  • the guide wire is effectively blocking the center where the US focusses when the guide wire is not extending past the distal end of the catheter.
  • the medical device comprising transducer 534 creates a US beam, which compared to the US beam created without the guidewire disposed in the lumen, is comparatively wide and its energy is less focused.
  • the medical device operates in a flow sensing mode.
  • the clinician can set the transducer to a flow sensing mode as described above, and a flow sensing (e.g., fluid (blood) velocity measurement) procedure can be carried out.
  • a flow sensing e.g., fluid (blood) velocity measurement
  • the acoustic power provided in this configuration is not great enough to carry out many thermal procedures (e.g., tissue ablation)
  • sufficient acoustic power is transmitted to the vessel for moderate heating tissue or to generate cavitation effects using microbubbles that can be used in a medical procedure.
  • the microbubbles may be infused to destroy the tissue via the cavitation effect.
  • This therapeutic embodiment can also work in combination with the configuration with the guidewire in place.
  • the therapeutic ultrasound mode could be used to deliver drug-loaded microbubbles via the lumen 506 to achieve the desired therapeutic effect.
  • the medical device can again be switched to flow sensing mode (e.g., via the user input) and inserting the guidewire to measure the flow (e.g., blood velocity) to gauge the effectiveness of the ablation step.
  • flow sensing mode e.g., via the user input
  • measure the flow e.g., blood velocity
  • Fig. 6A shows an acoustic pressure (Pa) profile of a medical device without a guide wire disposed in a catheter in accordance with another representative embodiment.
  • a acoustic pressure
  • a focal point 602 of the ultrasound beam is comparatively close to the distal end of the transducer 634, and provides sufficient power to carry out the desired thermal procedure.
  • Fig. 6B shows a temperature profile (°C) of the medical device in accordance with a representative embodiment.
  • the temperature of the tissue reaches a level greater than 62.5° and thereby provides sufficient heat to carry out the desired thermal procedure (e.g., tissue ablation).
  • the temperature can be increased by increasing the driving voltage.
  • Fig. 7A shows an acoustic profile (Pa) versus angle and distance of a transducer of a medical device in accordance with a representative embodiment.
  • Various aspects and details of the transducer 734 of the representative embodiments are common to those described in connection with Figs. 1 A-6B. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments.
  • the medical device is set for an imaging procedure.
  • the US beam 704 has lobes at various angles, but has its greatest energy at 702 directly above (or in front) of the transducer 734 at 0°.
  • the US beam 704 provides images in first, second and third regions 706, 708 and 710.
  • Fig. 7B shows A-line image generation of a transducer of a medical device with US beam 704 as located as shown in Fig. 7A.
  • the x-axis is the time axis.
  • Fig. 7B shows an A-line image showing reflected intensities at a first region 706 (blood at approximately 0.0 to approximately 5 mm from the distal end of the catheter), second region (thrombus at approximately 5 mm to 10 mm from the distal end of the catheter) and third region (blood at approximately 10 mm to 15 mm from the distal end of the catheter.
  • Fig. 8A is a perspective view in partial cross-section a transducer 834 of a medical device in accordance showing excitation of transducer elements in accordance with a representative embodiment.
  • Various aspects and details of the transducer 834 of the representative embodiments are common to those described in connection with Figs. 1 A-7B. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments.
  • the transducer 834 comprises three concentric piezoelectric elements 803, 804, 805 to form concentric ring transducers disposed over a backing layer 810 and beneath a matching layer 812.
  • the backing layer 810 beneficially reduces transmittance of mechanical waves from the piezoelectric three concentric piezoelectric elements 803, 804, 805 back the receiver 122, 222 (not shown in Fig. 8A), and thereby improves the overall performance of the medical device comprising the transducer 834.
  • the matching layer 812 improves the acoustic impedance matching of the piezoelectric material to the fluid in the vessel (e.g. vessels 142, 242, 342 and 432).
  • Vibration of the transducer 834 is shown at 840, and the damping of acoustic waves is shown at 842, where it can be seen that the waves generated extended into the backing layer 510 to a point, but not through the thickness of the backing layer 810 not to allow acoustic energy to return to the receiver (not shown in Fig. 8A).
  • each of the piezoelectric elements 803, 804 and 805 have a width of approximately 100 pm and a thickness of approximately 100 pm.
  • each of the piezoelectric elements 803, 804 and 805 has a thickness in a range of approximately 50 pm to approximately 500 pm and a thickness of approximately 50 pm to approximately 500 pm.
  • the each of the piezoelectric elements 803, 804 and 805 has a thickness in a range of approximately 50 pm to approximately 300 pm and a thickness of approximately 50 pm to approximately 300 pm.
  • the 8B is a graph of acoustic pressure (Pa) versus frequency (MHz) of the transducer 834 in accordance with a representative embodiment. As shown, the transducer 834 has dimensions and material selected to provide a resonance peak 844 of approximately 6.7 x 10 5 Pa at approximately 12 MHz. As will be appreciated from a comparison of the acoustic power provided by the transducer 534, the use of three concentric piezoelectric elements 803, 804, 805 significantly not only acoustic power provided by the transducer 834, but also increases sensitivity of the transducer 834 in receiving the US signals reflected from the subject.
  • the use of multiple concentric piezoelectric elements enables beam steering through control of the individual piezoelectric elements.
  • two or three concentric (ring) piezoelectric elements can be disposed in the catheter.
  • a time delay is applied to each of the piezoelectric elements, resulting in a US beam focused at a certain distance from the distal end of the catheter.
  • the clinician can select a distance (e.g., at the user input of the console or the GUI) for the region of interest (ROI).
  • Fig. 9A is a perspective view in partial cross-section a transducer 934 of a medical device in accordance showing excitation of transducer elements in accordance with a representative embodiment.
  • Various aspects and details of the transducer 934 of the representative embodiments are common to those described in connection with Figs. 1 A-4C. These common aspects and details may not be repeated to avoid obscuring the presently described representative embodiments.
  • the transducer 934 comprises a piezoelectric element 908 is disposed over a backing layer 910 and beneath a matching layer 912.
  • the backing layer 910 beneficially dampens the acoustic waves transmitted to the back side and reduces transmittance of waves via the piezoelectric element 908 back to the receiver 122, 222 (not shown in Fig. 9A), and thereby improves the overall performance of the medical device comprising the transducer 934.
  • the matching layer 912 improves the acoustic impedance matching of the piezoelectric material to the fluid in the vessel (e.g. vessels 142, 242, 342 and 432).
  • Vibration of the transducer 934 is shown at 940, and the damping of acoustic waves is shown at 942, where it can be seen that the waves generated extended into the backing layer 910 to a point, but not through the thickness of the backing layer 910 to allow acoustic energy to return to the receiver (not shown in Fig. 9A).
  • the dimensions of the piezoelectric element 908 of the ring transducer are chosen such that there are multiple resonance frequencies. Providing multiple resonance frequencies enables switching between the frequencies and hence changing the focal point depth and intensity of the ultrasound beam in therapy. Moreover, for Doppler flow sensing the signal strength and penetration depth can also be adjusted by changing the driving frequency. For imaging the resolution and penetration depth can be adjusted in a similar way.
  • the transducer 934 has a width of approximately 280 pm and a thickness of approximately 100 pm. In accordance with various representative embodiments, the transducer 934 has a thickness in a range of approximately 50 pm to approximately 500 pm and a thickness of approximately 50 pm to approximately 500 pm. In still other representative embodiments, the transducer 934 has a thickness in a range of approximately 50 pm to approximately 300 pm and a thickness of approximately 50 pm to approximately 300 pm.
  • Fig. 9B is a graph of acoustic pressure (Pa) versus frequency (MHz) of the transducer 934 in accordance with a representative embodiment.
  • the transducer 934 has dimensions and material selected to provide resonance peaks 922, 924, 926 and 928. These resonance peaks are at different frequencies and thereby can be used to select the depth of a thermal treatment, with the higher frequency resonance modes being used to increase the focal depth of the ultrasound.
  • increased frequency can provide improved resolution when the transducer 934 is used in imaging mode.
  • Fig. 10 is a cross-sectional view of a medical device 1030 comprising a ring transducer and an acoustically transparent element 1040 disposed at a distal end of the transducer in accordance with a representative embodiment.
  • a medical device 1030 comprising a ring transducer and an acoustically transparent element 1040 disposed at a distal end of the transducer in accordance with a representative embodiment.
  • Various aspects and details of the medical device 1030 are common to those described in connection with the representative embodiments of Figs. 1 A-9B. These common aspects and details may not be repeated to avoid obscuring the description of the presently described representative embodiment.
  • the medical device 1030 is disposed in a vessel 1032 through which fluid (e.g., blood) flows as shown.
  • the medical device 1030 comprises a transducer 1034, which is illustratively a ring transducer.
  • the medical device 1030 comprises a catheter 1036, which is adapted to receive a guidewire 1038.
  • the guidewire 1038 is not disposed in the catheter 1036 during use of the medical device 1030, whereas in other representative embodiments, the guidewire 1038 is disposed in the catheter.
  • the guidewire can be inserted and removed from the catheter to enable various functions of the medical device 1030 to be carried out.
  • the transducer 1034 is disposed at or near a distal end 1004 of the catheter 1036.
  • the acoustically transparent element 1040 is disposed at the distal end of the transducer 1034.
  • the acoustically transparent element 1040 has acoustic properties substantively identical to those of blood and tissue.
  • the acoustically transparent element enables ultrasound waves to be transmitted through the tip of the element.
  • the tip of the acoustically transparent element is tapered as shown. Among other benefits, the tapered tip fosters less resistive navigation of the medical device 1030 through tight lesions and may be less traumatic to the vessel wall.
  • inventions of the disclosure may be referred to herein, individually and/or collectively, by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any particular invention or inventive concept.
  • inventions merely for convenience and without intending to voluntarily limit the scope of this application to any particular invention or inventive concept.
  • specific embodiments have been illustrated and described herein, it should be appreciated that any subsequent arrangement designed to achieve the same or similar purpose may be substituted for the specific embodiments shown.
  • This disclosure is intended to cover any and all subsequent adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the description.

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  • Health & Medical Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • Gynecology & Obstetrics (AREA)
  • Hematology (AREA)
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Abstract

L'invention concerne un dispositif médical (1030). Le dispositif médical (1030) comprend un corps de cathéter (1036) ayant une lumière (406) avec une extrémité distale (1004) et une extrémité proximale. Un transducteur (1034) est disposé au niveau ou à proximité de l'extrémité distale (1004) du corps de cathéter (1036), et le transducteur (1034) est conçu pour émettre et recevoir des ondes ultrasonores afin de traiter un tissu et/ou mesurer la vitesse du sang et/ou imager un tissu avec le même transducteur (1034).
PCT/EP2025/058938 2024-04-10 2025-04-02 Cathéter à ultrasons diagnostique et thérapeutique à transducteur unique Pending WO2025214839A1 (fr)

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US63/632,029 2024-04-10

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030236443A1 (en) * 2002-04-19 2003-12-25 Cespedes Eduardo Ignacio Methods and apparatus for the identification and stabilization of vulnerable plaque
US20110257523A1 (en) * 2010-04-14 2011-10-20 Roger Hastings Focused ultrasonic renal denervation
US20130261455A1 (en) * 2008-11-17 2013-10-03 Vytronus, Inc. Systems and methods for ablating body tissue
WO2014022777A1 (fr) * 2012-08-03 2014-02-06 Sound Interventions, Inc. Procédé et appareil pour le traitement de l'hypertension à travers un cathéter d'imagerie/thérapie ultrasonore

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030236443A1 (en) * 2002-04-19 2003-12-25 Cespedes Eduardo Ignacio Methods and apparatus for the identification and stabilization of vulnerable plaque
US20130261455A1 (en) * 2008-11-17 2013-10-03 Vytronus, Inc. Systems and methods for ablating body tissue
US20110257523A1 (en) * 2010-04-14 2011-10-20 Roger Hastings Focused ultrasonic renal denervation
WO2014022777A1 (fr) * 2012-08-03 2014-02-06 Sound Interventions, Inc. Procédé et appareil pour le traitement de l'hypertension à travers un cathéter d'imagerie/thérapie ultrasonore

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