WO2024110800A1 - Détection de défaillances de cathéter d'ablation - Google Patents

Détection de défaillances de cathéter d'ablation Download PDF

Info

Publication number
WO2024110800A1
WO2024110800A1 PCT/IB2023/060973 IB2023060973W WO2024110800A1 WO 2024110800 A1 WO2024110800 A1 WO 2024110800A1 IB 2023060973 W IB2023060973 W IB 2023060973W WO 2024110800 A1 WO2024110800 A1 WO 2024110800A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
energy
pulse
conductor
electrical energy
Prior art date
Application number
PCT/IB2023/060973
Other languages
English (en)
Inventor
Matthew J. Hoffman
Jeffrey D. Wilkinson
Original Assignee
Medtronic, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medtronic, Inc. filed Critical Medtronic, Inc.
Publication of WO2024110800A1 publication Critical patent/WO2024110800A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00613—Irreversible electroporation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00898—Alarms or notifications created in response to an abnormal condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0809—Indication of cracks or breakages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0266—Operational features for monitoring or limiting apparatus function
    • A61B2560/0276—Determining malfunction

Definitions

  • BACKGROUND Tissue ablation is a medical procedure commonly used to treat conditions such as cardiac arrhythmias, which includes atrial fibrillation. For treating cardiac arrhythmias, ablation can be performed to modify tissue, such as to stop aberrant electrical propagation and/or disrupt aberrant electrical conduction through cardiac tissue.
  • Ablation techniques include irreversible electroporation (IRE), cryoablation, laser ablation, thermal ablation, radioablation and radiofrequency (RF) ablation.
  • Cardiac arrhythmias are a group of conditions that cause an irregular heartbeat or conduction pattern.
  • Ablation may be used to create a safe and effective lesion or set of lesions at the origin of the irregular heartbeat or in regions that aid in the termination of arrhythmias without causing damage to adjacent structures or surrounding tissue, ideally resulting in no need for a maintenance treatment regimen, such as medications or cardioversions.
  • a maintenance treatment regimen such as medications or cardioversions.
  • Irreversible electroporation such as Pulsed Field Ablation (PFA)
  • PFA Pulsed Field Ablation
  • IRE is an ablation therapy that irreversibly electroporates cardiac tissue through the application of pulsed electric fields, with the energy being delivered via PFA ablation catheters.
  • the energy used to create transmural lesions can be in excess of 1500V.
  • imperfections or faults in the conductors or insulation of a PFA ablation catheter Atty Ref. No. A0007491WO01 or associated cabling, or connectivity failures between system components could result in undesirable events during delivery of ablation therapy via the PFA ablation catheter (e.g., sub-optimal therapy).
  • a device may perform one or more operations to automatically detect faults in a PFA ablation catheter.
  • a device may output a signal onto a conductor of a PFA ablation catheter and measure a reflected signal resulting from the output signal.
  • the device may detect faults in the PFA ablation catheter based on the reflected signal (e.g., using time domain reflectometry). For instance, as changes in impedance cause changes in a fraction of the signal that is reflected, artifacts in the reflected signal may indicate faults (e.g., open circuits) in the conductor. In this way, a device may detect faults in a PFA ablation catheter.
  • a method for accessing catheter integrity outputting, by a device and onto a first conductor of a plurality of conductors of a catheter for use in performing PFA of target tissue of a patient, a pulse of electrical energy; measuring, by the device and at the first conductor, a reflected electrical energy signal resulting from the pulse of electrical energy; determining, by the device and based on the measured reflected electrical energy signal, a health statistic of the catheter; and outputting, by the device, a representation of the statistic.
  • a device in another example, includes a memory; a signal generator; and processing circuitry configured to cause the signal generator to output, onto a first conductor of a plurality of conductors of a catheter for use in performing PFA of target tissue of a patient, a pulse of electrical energy; receive, at the first conductor, a reflected electrical energy signal resulting from the pulse of electrical energy; determine, by the device and based on the received reflected electrical energy signal, a health statistic of the catheter; and output a representation of the statistic.
  • a non-transitory computer-readable storage medium stores instructions that, when executed cause processing circuitry to cause a signal generator to output, onto a first conductor of a plurality of conductors of a catheter for use in performing PFA of target tissue of a patient, a pulse of electrical energy; receive, at the first conductor, a reflected electrical energy signal resulting from the pulse of electrical energy; determine, by the device and based on the received reflected electrical energy signal, a health statistic of the catheter; and output a representation of the statistic.
  • FIG.1 is a conceptual diagram illustrating an example system for delivering ablation and detecting catheter failures, in accordance with one or more aspects of this disclosure.
  • FIG.2 is a block diagram illustrating an example controller of an ablation system, in accordance with one or more aspects of this disclosure.
  • FIGS.3A and 3B are graphs illustrating example measured reflected signals from a catheter, in accordance with one or more aspects of this disclosure.
  • FIG.4 is a flowchart illustrating an example ablation catheter health assessment technique, in accordance with one or more techniques of this disclosure.
  • FIG.1 is a conceptual diagram illustrating an example system for delivering ablation and detecting catheter failures, in accordance with one or more aspects of this disclosure.
  • System 100 includes a catheter 102 and a controller 104.
  • a practitioner e.g., electrophysiologist, interventional cardiologist, etc.
  • controller 104 may deliver, via catheter 102, energy (e.g., pulsed field ablation energy, radiofrequency ablation energy, and the like) to target tissue of a patient.
  • energy e.g., pulsed field ablation energy, radiofrequency ablation energy, and the like
  • Ablation may cause lesions in target cardiac tissue which may mitigate or stop cardiac arrhythmias.
  • Catheter 102 may include elongated structure 112 carrying a plurality of energy delivery elements 110A-110H (collectively “energy delivery elements 110”).
  • energy delivery elements 110 An energy Atty Ref. No.
  • A0007491WO01 delivery element may include an electrode (e.g., in the case of a pulsed field ablation catheter), a radiofrequency element (e.g., in the case of a radiofrequency ablation catheter), or another energy delivery element. While the techniques of this disclosure are applicable to any ablation catheter, the example of FIG.1 is directed to a pulsed field ablation catheter.
  • Catheter 102 may generally include features that enable insertion of catheter 102 into a patient and navigation of catheter 102 to a target tissue site.
  • Elongated structure 112 may include a distal portion 106 and a proximal portion 108.
  • Energy delivery elements 110 may be generally positioned at distal portion 106, while proximal portion 108 may be connected to controller 104.
  • Energy delivery elements 110 may be of any suitable geometry.
  • Example geometries of electrodes include, but are not necessarily limited to, circular (e.g., ring) electrodes surrounding the body of the lead, conformable electrodes, cuff electrodes, segmented electrodes (e.g., electrodes disposed at different circumferential positions around the lead instead of a continuous ring electrode), any combination thereof (e.g., ring electrodes and segmented electrodes).
  • Energy delivery elements 110 may be axially distributed along longitudinal axis LA of elongated structure 112 or in several other configurations.
  • catheter 102 may include one or more energy delivery elements 110 and the geometry of the one or more energy delivery elements 110 may include a balloon, which may be inflated when performing ablation and deflated when navigating catheter 102 to the target tissue.
  • the delivery elements 110 may also be in a circular form, in an array, along multiple splines, or in other configurations.
  • Elongated structure 112 may include conductors 114A-114N (collectively, “conductors 114”) that may be configured to carry electrical signals between energy delivery elements 110 and controller 104 (shown in an expanded view). Examples of conductors 114 include, but are not necessarily limited to, wires (e.g., solid, braded, etc.), traces, and the like.
  • elongated structure 112 may include a separate conductor of conductors 114 for each of energy delivery elements 110.
  • elongated structure 112 may include eight separate conductors (e.g., conductor 114A may carry electrical signals for energy delivery element 110A, conductor 114B may carry electrical signals for energy delivery element 110B, ... , and conductor 114H may carry electrical signals for energy delivery element 110H.
  • conductor 114A may carry electrical signals for energy delivery element 110A
  • conductor 114B may carry electrical signals for energy delivery element 110B
  • conductor 114H may carry electrical signals for energy delivery element 110H.
  • elongated structure may enable each electrode of energy delivery elements 110 to be driven with a different signal Atty Ref. No. A0007491WO01 from controller 104.
  • multiple electrodes of energy delivery elements 110 may share a common conductor.
  • energy delivery elements 110C and 110D may be connected to a same (e.g., a common) conductor of conductors 114. While such a common conductor arrangement may reduce energy delivery element flexibility (e.g., as electrodes connected to the common conductor may be driven with a same signal), such an arrangement may reduce manufacturing complexity and/or cost and may increase the structural flexibility of catheter 102.
  • catheter 102 may be directly connected to controller 104.
  • catheter 102 may be connected to controller 104 via cabling.
  • a cable may connect to a connector of catheter 102 and to a connector of controller 104.
  • the cabling may include conductors configured to transfer electrical energy between controller 104 and catheter 102.
  • energy delivery elements 110 may include a tip electrode (e.g., electrode 110A), which may be a ring electrode with a “cap” covering at least a portion of a tip of elongated structure 112.
  • the tip electrode may be chamfered or otherwise rounded (e.g., to enable easier passage of catheter 102 through anatomy of the patient).
  • Energy delivery elements 110 may include a ring electrode (e.g., electrode 110B) that is adjacent to the tip electrode. This ring electrode may be separated (axially along LA) from the tip electrode.
  • Energy delivery elements 110 may include one or more pairs of ring electrodes. A pair of ring electrodes may include two adjacently closely spaced electrodes of energy delivery elements 110.
  • energy delivery elements 110C and 110D may form a first pair of ring electrodes
  • energy delivery elements 110E and 110F may form a second pair of ring electrodes
  • energy delivery elements 110G and 110H may form a third pair of ring electrodes.
  • the first pair of ring electrodes i.e., energy delivery elements 110C and 110D
  • the one or more additional electrodes may include any combination of pairs of ring electrodes and coil electrodes (e.g., electrodes that include conductors that spiral around elongated structure 112).
  • energy delivery elements 110 are illustrated as has having a larger diameter than elongated structure 112.
  • one or more of energy delivery elements 110 may have a diameter that is approximately equal to or less than the diameter of elongated structure 112.
  • energy delivery elements 110 Atty Ref. No. A0007491WO01 may be recessed in elongated structure 112 such that the combination results in a relatively smooth outer surface.
  • Controller 104 may include an energy generator configured to provide electrical pulses to energy delivery elements 110 to perform an ablation procedure to cardiac tissue or other tissues within the patient's body, such as renal tissue, airway tissue, and organs or tissue within the cardiac space or the pericardial space.
  • the energy generator may be configured and programmed to deliver pulsed, high-voltage electric fields appropriate for achieving desired pulsed, high-voltage ablation (referred to as “pulsed field ablation” or “pulsed electric field ablation”) and/or pulsed radiofrequency ablation.
  • conductors 114 may carry electrical signals between controller 104 and energy delivery elements 110. Due to various circumstances, one or more of conductors 114, cabling, or other components may become damaged (e.g., improper handling). Such imperfections or faults could result in undesirable events during delivery of energy (e.g., PFA ablation therapy) via catheter 102. As such, it may be desirable to determine whether catheter 102 (or associated cabling) has any imperfections or faults.
  • controller 104 may perform one or more operations to automatically detect faults in catheter 102. For instance, controller 104 may output a signal onto a conductor of conductors 114 of catheter 102 and measure a reflected signal resulting from the output signal. Controller 104 may detect faults in catheter 102 based on the reflected signal (e.g., using time domain reflectometry). A signal incident on a conductor will propagate along it at a large fraction of the speed of light, with the velocity determined by the impedance characteristics of the conductor. When the propagating signal encounters a change in impedance a fraction of the signal continues to propagate in the forward direction and the remaining energy is reflected in the reverse direction.
  • the time course of the signal at the source end of the conductor reveals the magnitude of the impedance changes and, according to their time delay from the start of the source pulse, their location along the conductor. Abrupt changes in impedance, such as caused by an open or shorted conductor, result in large increases and decreases in the detected amplitude, respectively. As such, by monitoring Atty Ref. No. A0007491WO01 the signal at the source end of the conductor of conductors 114, controller 104 may detect these changes and localize their position along the conductor of conductors 114. Furthermore, in some examples, controller 104 may detect more subtle variations in impedance, such as poor connections or stressed conductors, via further analysis of the detected waveform.
  • FIG.2 is a block diagram illustrating an example controller of an ablation system, in accordance with one or more aspects of this disclosure.
  • Controller 200 of FIG. 2 may be an example of controller 104 of FIG.1.
  • controller 200 may include energy generator 202, processing circuitry 204, user interface 206, and storage device 208.
  • Energy generator 202 may be configured to control energy delivery elements 110 of catheter 102 (FIG.1) such as to provide electrical pulses to electrodes (e.g., energy delivery elements 110) to perform an electroporation procedure or other ablation procedure to cardiac tissue or other tissues within the patient's body, including but not limited to renal tissue, airway tissue, bones, organs, or tissue within the cardiac space or the pericardial space.
  • energy generator 202 may be configured and programmed to deliver pulsed, high-voltage electric fields appropriate for achieving desired pulsed, high-voltage ablation (referred to as “pulsed field ablation” or “pulsed electric field ablation”) and/or pulsed radiofrequency ablation.
  • energy generator 202 may be referred to as a PFA signal generator.
  • controller 200 may include multiple energy generators that are each capable of generating ablation signals in parallel.
  • controller 200 may include energy generators of different types, such as a pulsed field energy generator and/or a radio frequency energy generator.
  • Processing circuitry 204 may include one or more processors, such as any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functions attributed to processing circuitry 210 herein may be embodied as firmware, hardware, software or any combination thereof.
  • Processing circuitry 204 may execute instructions to control energy generator 202 to generate signals according to various settings (e.g., ablation module 222 Atty Ref. No. A0007491WO01 to deliver PFA ablation energy).
  • processing circuitry 204 may execute other instructions stored in storage device 208 (e.g., catheter health module 218) to perform catheter testing/fault detection.
  • Storage device 208 may be configured to store information within controller 200, respectively, during operation.
  • Storage device 208 may include a computer-readable storage medium or computer-readable storage device.
  • storage device 208 includes one or more of a short-term memory or a long-term memory.
  • Storage device 208 may include, for example, random-access memories (RAM), dynamic random-access memories (DRAM), static random-access memories (SRAM), ferroelectric random-access memories (FRAM), magnetic discs, optical discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable memories (EEPROM).
  • RAM random-access memories
  • DRAM dynamic random-access memories
  • SRAM static random-access memories
  • FRAM ferroelectric random-access memories
  • magnetic discs e.g., optical discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable memories (EEPROM).
  • EPROM electrically programmable memories
  • EEPROM electrically erasable and programmable memories
  • storage device 208 is used to store data indicative of instructions, e.g., for execution by processing circuitry 204, respectively.
  • Storage device 208 may be configured to store catheter health module 218 and/or ablation module 222.
  • User interface 206 may include a button or keypad, lights, a speaker for voice commands, a display, such as a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED).
  • a display such as a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED).
  • the display may be configured to display a representation of a catheter health statistic, as described in further detail herein.
  • processing circuitry 204 may execute catheter health module 218 to perform testing of a catheter (e.g., catheter 102 of FIG.1) and/or associated cabling, and output the results (e.g., present a graphical user interface) via user interface 206.
  • the display may be used to guide the clinician in positioning the at least one energy delivery element to a position in contact with or near the suggested target tissue such that during the delivery of energy to the at least one energy delivery element, the target tissue is ablated.
  • the display may display a representation of the target tissue that will be ablated after delivery of ablation energy via the at least one energy delivery element.
  • Processing circuitry 204 may then output for display to user interface 206 a representation of the tissue that was ablated.
  • the display includes a touch screen.
  • User interface 206 may be configured to display any information related to the performance of ablation. User interface 206 may also receive user input (e.g., selection of target tissue) via user interface 206.
  • Telemetry circuitry 220 may include any suitable hardware, firmware, software or any combination thereof for communicating with another device. Telemetry circuitry 220 may be configured to communicate using any of a variety of wireless communication schemes, such as Bluetooth® or Bluetooth Low Energy®, WiFi, 4G, or 5G, or a wired communication scheme such as ethernet.
  • wireless communication schemes such as Bluetooth® or Bluetooth Low Energy®, WiFi, 4G, or 5G, or a wired communication scheme such as ethernet.
  • Measurement circuitry 224 may include any suitable hardware, firmware, software or any combination thereof for measuring electrical signals from a catheter connected to controller 200.
  • measurement circuitry 224 may include one or more analog-to-digital converters (ADC) configured to convert analog voltage measurements (e.g., voltage levels of signals measured at proximal ends of conductors of a catheter) into digital values, which may be processed by processing circuitry 204.
  • ADC analog-to-digital converters
  • processing circuitry 204 may execute catheter health module 218 to perform catheter testing/fault detection.
  • processing circuitry 204 may execute catheter health module 218 to cause energy generator 202 to output, onto a proximal end of a first conductor of a plurality of conductors of a catheter for use in performing pulse field ablation (PFA) of target tissue of a patient, a pulse of electrical energy.
  • energy generator 202 may output the electrical pulse onto a conductor of conductors 114 of catheter 102 of FIG.1.
  • a return path may be established using one or more other conductors of conductors 114.
  • the pulse of electrical energy may have a voltage level less than N volts (e.g., 50 millivolts, 0.5 volts, 1 volt, 2 volts, 3 volts, 4 volts, 5 volts).
  • the pulse may be a square wave pulse.
  • more complex signals may be used (e.g., single-cycle or half-cycle sinusoids).
  • the pulse may propagate along the conductor until reaching any changes in impedance. As discussed above, changes in impedance may result in a fraction of the signal being reflected back to the proximal end of the conductor.
  • Measurement circuitry 224 may measure, at the first conductor, a reflected electrical energy signal resulting from the pulse of electrical energy.
  • an ADC of measurement circuitry 224 may convert Atty Ref. No. A0007491WO01 voltage levels at the proximal end of the first conductor into a stream of digital values, and provide the digital values to processing circuitry 204.
  • Controller 200 may determine, based on the measured reflected electrical energy signal, a health statistic of the catheter.
  • a health statistic is a measurement representative of a viability of conductors.
  • processing circuitry 204 may execute catheter health module 218 to analyze the digital values to determine the health statistic, e.g., whether the conductor has any faults.
  • controller 200 may utilize a single pulse to perform the catheter testing/fault detection.
  • controller 200 may utilize a plurality of pulses (and their corresponding return signals) to perform the catheter testing/fault detection (e.g., the pulse may be periodically repeated and measured so that signal averaging or other processing steps may be utilized to improve detection accuracy).
  • controller 200 may determine a temporal displacement between a first time at which the pulse of electrical energy is output and a second time at which the reflected electrical energy signal is received. The temporal displacement between the first time and the second time may be indicative of a location of a change in impedance along the catheter.
  • controller 200 may use template matching of morphologies (e.g., templates of “good” and “bad” states) to determine presence of faults. Controller 200 may determine the health statistic to indicate that the catheter has faults or does not have faults. Where controller 200 determines the health statistic as indicating that the catheter has one or more faults, the health statistic may indicate a location of the fault on the catheter (e.g., 30 cm from the proximal end). In some examples, controller 200 may perform the signal output and measurement on a single conductor of the catheter.
  • morphologies e.g., templates of “good” and “bad” states
  • controller 200 may perform the signal output and measurement on a plurality of conductors of the catheter. For instance, controller 200 may output a respective pulse of the plurality of pulses onto respective conductor of the plurality of conductors, and measure, at each respective conductor of the plurality of conductors, a respective reflected energy signal of a plurality of reflected energy signals. As such, in some examples, controller 200 may determine a Atty Ref. No. A0007491WO01 single health statistic that represents all the conductors (e.g., determine the health statistic of the catheter based on the plurality of reflected energy signals). Controller 200 may output a representation of the statistic.
  • processing circuitry 204 may cause user interface 206 to display a binary representation of whether the catheter has a fault or not.
  • processing circuitry 204 may cause user interface 206 to display a graphical user interface (GUI) that indicates whether the catheter has a fault or not, which conductors of the catheter have faults, and/or a location of the faults.
  • GUI graphical user interface
  • controller 200 may perform one or more actions. As one example, responsive to the health statistic of the catheter indicating a fault in the catheter, controller 200 may prevent the delivery of ablation energy (e.g., PFA ablation energy) via the catheter.
  • ablation energy e.g., PFA ablation energy
  • FIGS. 3A and 3B are graphs illustrating example measured reflected signals from a catheter, in accordance with one or more aspects of this disclosure.
  • FIG. 3A illustrates an example reflected signal from a conductor of a catheter with an impedance matched termination at a distal end.
  • FIG.3A illustrates a measured reflected signal from a 2 meter (m), 50-ohm coax cable with a 50-ohm termination at its distal end that is stimulated with a 10 MHz square wave with a 30 picosecond (ps) rise time. The flat top of the signal of FIG. 3A.
  • FIG.3B illustrates an example reflected signal from a conductor of a catheter with an open distal end.
  • FIG.3B illustrates a measured reflected signal from the same cable as FIG.3A, but with the distal end unterminated.
  • FIG.4 is a flowchart illustrating an example ablation catheter health assessment technique, in accordance with one or more techniques of this disclosure.
  • the technique of FIG.4 may be performed by a controller, such as controller 104 of FIG.1 or controller 200 of FIG.2.
  • Atty Ref. No. A0007491WO01 Controller 200 may output, onto a first conductor of a plurality of conductors of a catheter for use in performing irreversible electroporation (IRE), such as pulse field ablation (PFA), of target tissue of a patient, a pulse of electrical energy (402).
  • IRE irreversible electroporation
  • PFA pulse field ablation
  • 402 pulse of electrical energy
  • controller 104 may cause a signal generator to output a pulse of electrical energy onto a proximal end of conductor 114A (e.g., while a distal end of conductor 114A, or an electrode connected thereto, is connected to one or more other conductors of conductors 114, or electrodes connected thereto).
  • Controller 200 may measure, at the first conductor, a reflected electrical energy signal resulting from the pulse of electrical energy (404).
  • controller 104 may sense voltage levels at the proximal end of conductor 114A.
  • an ADC may convert the sensed voltage levels into digital values.
  • Controller 200 may determine, based on the measured reflected electrical energy signal, a health statistic of the catheter (406).
  • controller 104 may perform time domain reflectometry (TDR) to analyze the measured reflected electrical energy signal and determine whether there are any faults along conductor 114A.
  • the health statistic may indicate whether any faults were detected by controller 104.
  • controller 104 may perform TDR on multiple conductors of the catheter, or may perform TDR on a single conductor of the catheter. As such, the statistic may represent a health of one or more of the conductors.
  • Controller 200 may output a representation of the statistic (408). As one example, controller 104 may cause a user 206 to display a binary representation of whether the catheter has a fault or not.
  • controller 104 may cause the user interface to display a graphical user interface (GUI) that indicates whether the catheter has a fault or not, which conductors of the catheter have faults, and/or a location of the faults.
  • Controller 200 may perform the ablation catheter health assessment at one or more points in the catheter lifecycle. As one example, controller 200 may perform the ablation catheter health assessment after the system components are connected, which may be referred to as a system connection check (e.g., to assess connectivity). As another example, controller 200 may perform the ablation catheter health assessment after the catheter is placed, which may be referred to as a conductor break check (e.g., to assess whether or not an effective therapy is likely to occur or if there is an issue with a catheter Atty Ref. No.
  • a conductor break check e.g., to assess whether or not an effective therapy is likely to occur or if there is an issue with a catheter Atty Ref. No.
  • controller 200 may perform the ablation catheter health assessment after the therapy delivery is attempted, which may be referred to as a therapy integrity check (e.g., in order to determine if the conductors were damaged during the therapy delivery).
  • controller 104 may individually connect the pulse source to each electrode terminal (e.g., each conductor) in turn. All other terminals may be connected together and are used as a signal return path. As noted above, an abrupt rise in the signal amplitude indicates an open condition and its occurrence time relative to the input signal indicates its location.
  • controller 104 may output a system warning that instructs a user on how to mitigate issues, or prevent delivery of therapy via the compromised conductor/electrode. This may also be a mechanism to allow system compatibility of the signal generator with catheter designs with ‘less than the maximum allowed’ electrodes (restricting energy delivery to only connected conductors/electrodes).
  • controller 104 may, using the same measurement scheme as above, may determine a location of a broken (open) conductor based on a rise in the signal amplitude. By examining the time between the source edge and the rise, controller 104 may not only diagnose the presence of a broken connection but to localize it to the CIC or catheter. A short between a conductor and one or more of its neighboring conductors may be detectable based on an abrupt decrease in the signal amplitude. Controller 104 may perform this check may be conducted with the prior to catheter insertion or while it is in place.
  • controller 104 may, using the same measurement scheme as above, perform an assessment of conductivity after the therapy energy is delivered. As such, controller 104 may determine if the conductors were damaged during the therapy delivery. If the conductors were damaged during the therapy delivery, effective therapy may not be guaranteed.
  • the techniques described in this disclosure may be implemented, at least in part, in hardware, software, firmware or any combination thereof.
  • processing circuitry may include one or more processors, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components.
  • processors including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable gate arrays
  • a control unit including hardware may also form one or more processors or processing circuitry configured to perform one or more of the techniques of this disclosure.
  • Such hardware, software, and firmware may be implemented, and various operation may be performed within same device, within separate devices, and/or on a coordinated basis within, among or across several devices, to support the various operations and functions described in this disclosure.
  • any of the described units, circuits or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of different features as circuits or units is intended to highlight different functional aspects and does not necessarily imply that such circuits or units must be realized by separate hardware or software components. Rather, functionality associated with one or more circuits or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components.
  • Processing circuitry described in this disclosure may be implemented, in various examples, as fixed- function circuits, programmable circuits, or a combination thereof.
  • Fixed-function circuits refer to circuits that provide particular functionality with preset operations.
  • Programmable circuits refer to circuits that can be programmed to perform various tasks and provide flexible functionality in the operations that can be performed.
  • programmable Atty Ref. No. A0007491WO01 circuits may execute software or firmware that cause the programmable circuits to operate in the manner defined by instructions of the software or firmware.
  • Fixed-function circuits may execute software instructions (e.g., to receive stimulation parameters or output stimulation parameters), but the types of operations that the fixed-function circuits perform are generally immutable.
  • one or more of the units may be distinct circuit blocks (fixed-function or programmable), and in some examples, one or more of the units may be integrated circuits.
  • the techniques described in this disclosure may also be embodied or encoded in a computer-readable medium, such as a computer-readable storage medium, containing instructions that may be described as non-transitory media. Instructions embedded or encoded in a computer-readable storage medium may cause a programmable processor, or other processor, to perform the method, e.g., when the instructions are executed.
  • Computer readable storage media may include random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), flash memory, a hard disk, a CD-ROM, a floppy disk, a cassette, magnetic media, optical media, or other computer readable media.
  • RAM random access memory
  • ROM read only memory
  • PROM programmable read only memory
  • EPROM erasable programmable read only memory
  • EEPROM electronically erasable programmable read only memory
  • flash memory a hard disk, a CD-ROM, a floppy disk, a cassette, magnetic media, optical media, or other computer readable media.
  • a method for accessing catheter integrity comprising: outputting, by a device and onto a first conductor of a plurality of conductors of a catheter for use in performing irreversible electroporation (IRE) of target tissue of a patient, a pulse of electrical energy; measuring, by the device and at the first conductor, a reflected electrical energy signal resulting from the pulse of electrical energy; determining, by the device and based on the measured reflected electrical energy signal, a health statistic of the catheter; and outputting, by the device, a representation of the statistic.
  • Example 2 The method of Example 1, wherein the device is an IRE signal generator.
  • Example 3 The method of Example 1, wherein the device does not include an IRE signal generator. Atty Ref. No. A0007491WO01 Example 4.
  • outputting the pulse onto the first conductor comprises outputting a first pulse of a plurality of pulses onto the first conductor, the method further comprising: outputting, by the device, a respective pulse of the plurality of pulses onto respective conductor of the plurality of conductors; and measuring, by the device and at each respective conductor of the plurality of conductors, a respective reflected energy signal of a plurality of reflected energy signals, wherein determining the health statistic of the catheter comprises determining the health statistic of the catheter based on the plurality of reflected energy signals.
  • Example 5
  • Example 6 The method of Example 4, wherein the health statistic of the catheter includes a respective health statistic of each of the plurality of conductors such that determining the health statistic comprises determining a plurality of health statistics.
  • Example 6 The method of any of Examples 1-5, wherein accessing the catheter integrity comprises accessing the catheter integrity prior to delivery of IRE ablation energy to a patient via the catheter.
  • Example 7. The method of Example 6, wherein accessing the catheter integrity prior to delivery of IRE ablation energy to the patient via the catheter comprises accessing the catheter integrity after insertion of the catheter into the patient but prior to the delivery of IRE ablation energy.
  • Example 8 The method of Example 6 or Example 7, further comprising: responsive to the health statistic of the catheter indicating a fault in the catheter, preventing the delivery of the IRE ablation energy via the catheter.
  • Example 10 The method of any of Examples 1-5, wherein accessing the catheter integrity comprises accessing the catheter integrity after delivering IRE ablation energy to a patient via the catheter.
  • Example 10 The method of any of Examples 1-9, wherein outputting the pulse of electrical energy comprises outputting the pulse of electrical energy with a voltage level less than 5 volts.
  • Example 11 The method of any of Examples 1-10, further comprising: determining a location of a fault between the pulse generating device and delivery electrodes of the catheter based on a temporal displacement between a first time at which the pulse of Atty Ref. No. A0007491WO01 electrical energy is output and a second time at which the reflected electrical energy signal is received, wherein the health statistic indicates the determined location of the fault.
  • Example 13 A device comprising: a memory; a signal generator; and processing circuitry configured to perform the method of any of Examples 1-12.
  • Example 14 A computer-readable storage medium storing instructions that, when executed, cause a device to perform the method of any of Examples 1-12.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Plasma & Fusion (AREA)
  • Medical Informatics (AREA)
  • Otolaryngology (AREA)
  • Physics & Mathematics (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne, dans un exemple, un procédé pour accéder à l'intégrité d'un cathéter, qui consiste à délivrer en sortie, par un dispositif et sur un premier conducteur d'une pluralité de conducteurs d'un cathéter pour une utilisation dans la réalisation d'une électroporation irréversible (IRE) de tissu cible d'un patient, une impulsion d'énergie électrique ; mesurer, par le dispositif et au niveau du premier conducteur, un signal d'énergie électrique réfléchi résultant de l'impulsion d'énergie électrique ; déterminer, par le dispositif et sur la base du signal d'énergie électrique réfléchi mesuré, une statistique de santé du cathéter ; et délivrer en sortie, par le dispositif, une représentation de la statistique.
PCT/IB2023/060973 2022-11-23 2023-10-31 Détection de défaillances de cathéter d'ablation WO2024110800A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263384903P 2022-11-23 2022-11-23
US63/384,903 2022-11-23

Publications (1)

Publication Number Publication Date
WO2024110800A1 true WO2024110800A1 (fr) 2024-05-30

Family

ID=88697709

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2023/060973 WO2024110800A1 (fr) 2022-11-23 2023-10-31 Détection de défaillances de cathéter d'ablation

Country Status (1)

Country Link
WO (1) WO2024110800A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5231987A (en) * 1992-04-10 1993-08-03 Random Technologies, Inc. Time domain reflectometer-integrity testing system and method for implantable electrode
US20180228528A1 (en) * 2017-02-14 2018-08-16 Medtronic, Inc. Method of confirming safe delivery pathway to patient prior to energy delivery
US20190086465A1 (en) * 2017-09-18 2019-03-21 Biosense Webster (Israel) Ltd. Cable and associated continuity monitoring system and method

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5231987A (en) * 1992-04-10 1993-08-03 Random Technologies, Inc. Time domain reflectometer-integrity testing system and method for implantable electrode
US20180228528A1 (en) * 2017-02-14 2018-08-16 Medtronic, Inc. Method of confirming safe delivery pathway to patient prior to energy delivery
US20190086465A1 (en) * 2017-09-18 2019-03-21 Biosense Webster (Israel) Ltd. Cable and associated continuity monitoring system and method

Similar Documents

Publication Publication Date Title
CN110300559B (zh) 在能量递送前确认到患者的安全递送通路的系统
RU2761291C1 (ru) Динамическая абляция и исследование в зависимости от контакта сегментированных электродов
US20210038283A1 (en) Methods of ensuring pulsed field ablation generator system electrical safety
US9987485B2 (en) Method and apparatus for implantable cardiac lead integrity analysis
US9060778B2 (en) Intermittent short circuit detection on a multi-electrode catheter
US10182742B2 (en) Tissue contact sensing with a multi electrode ablation catheter
US10143399B2 (en) Tissue contact sensing with a multi electrode ablation catheter
US10105073B2 (en) Flexible multiple-arm diagnostic catheter
US20150374427A1 (en) Detecting improper energy transmission configuration in medical device system
IL227017A (en) Real-time ablation assessment of ECG signals
JP2011508628A5 (fr)
JP2015536727A (ja) 電気的及び機械的方法に基づく心臓活性化信号の再構成
US20190059782A1 (en) System and method using cardiac-esophageal impedance mapping to predict and detect esophageal injury during cardiac ablation procedures
WO2024110800A1 (fr) Détection de défaillances de cathéter d'ablation
CN115944272A (zh) 测量多电极导管的组织接近度
CN114305655A (zh) 使用绝对阈值和相对阈值检测电极接触
CN219147881U (zh) 脉冲消融系统
US20230371836A1 (en) Impedance-based ablation index for ire
US20190083162A1 (en) Electrode disconnect detection
JP2023531437A (ja) エレクトロポレーション治療を送達するためのデバイスおよび方法
CN117281608A (zh) 用于球囊导管导航的图形接触质量指标
WO2021202052A1 (fr) Méthode de surveillance d'un patient pour un dommage collatéral du nerf phrénique pendant une procédure d'ablation cardiaque

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 23801533

Country of ref document: EP

Kind code of ref document: A1