EP4601571A1 - Procédés et dispositifs de cathéter d'ablation et de détection à entretoises multiples - Google Patents

Procédés et dispositifs de cathéter d'ablation et de détection à entretoises multiples

Info

Publication number
EP4601571A1
EP4601571A1 EP23805392.0A EP23805392A EP4601571A1 EP 4601571 A1 EP4601571 A1 EP 4601571A1 EP 23805392 A EP23805392 A EP 23805392A EP 4601571 A1 EP4601571 A1 EP 4601571A1
Authority
EP
European Patent Office
Prior art keywords
electrode
arms
treatment
electrodes
elongate body
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
EP23805392.0A
Other languages
German (de)
English (en)
Inventor
Roman Turovskiy
David R. Kirkland
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.)
Pulse Biosciences Inc
Original Assignee
Pulse Biosciences Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/046,784 external-priority patent/US12408976B2/en
Priority claimed from US18/353,867 external-priority patent/US12564440B2/en
Application filed by Pulse Biosciences Inc filed Critical Pulse Biosciences Inc
Priority claimed from PCT/US2023/076866 external-priority patent/WO2024081897A1/fr
Publication of EP4601571A1 publication Critical patent/EP4601571A1/fr
Pending legal-status Critical Current

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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/05—Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radio waves
    • A61B5/053—Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0538—Measuring electrical impedance or conductance of a portion of the body invasively, e.g. using a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
    • A61B5/062—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body using magnetic field
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; Determining position of diagnostic devices within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A61B5/068—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe using impedance sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/367—Electrophysiological study [EPS], e.g. electrical activation mapping or electro-anatomical mapping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4836—Diagnosis combined with treatment in closed-loop systems or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6853—Catheters with a balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6856—Catheters with a distal loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A61B5/6858—Catheters with a distal basket, e.g. expandable basket
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/0016—Energy applicators arranged in a two- or three dimensional array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00357—Endocardium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00375—Ostium, e.g. ostium of pulmonary vein or artery
    • 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
    • A61B2018/00577—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
    • 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
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar
    • 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
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop
    • 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
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • 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
    • A61B2018/1475—Electrodes retractable in or deployable from a housing

Definitions

  • Short, high-field strength electric pulses have been described for electromanipulation of biological cells.
  • electric pulses may be used in treatment of human cells and tissue.
  • the voltage induced across a cell membrane may depend on the pulse length and pulse amplitude.
  • Pulses longer than about 1 microsecond may charge the outer cell membrane and may lead to permanent opening of pores. Permanent openings may result in instant or near instant cell death.
  • Pulses shorter than about 1 microsecond may affect the cell interior without adversely or permanently affecting the outer cell membrane and result in a delayed cell death with intact cell membranes.
  • Such shorter pulses with a field strength varying in the range, for example, of 10 kV/cm to 100 kV/cm may trigger apoptosis (i.e.
  • programmed cell death in some or all of the cells exposed to the described field strength and pulse duration.
  • These higher electric field strengths and shorter electric pulses may be useful in manipulating intracellular structures, such as nuclei, endoplasmic reticulum and mitochondria.
  • sub-microsecond (e.g., nanosecond) high voltage pulse generators have been proposed for biological and medical applications.
  • two or more electrodes are used to deliver electric pulses, including high- field strength electric pulses to a selected treatment area.
  • the two electrodes may be configured for bipolar operation.
  • the electrodes are placed in contact with tissue in the area to receive treatment.
  • the treatment area may have a varying or irregular shape.
  • the treatment area may transition from a first diameter to a second diameter. The varying diameters and/or irregular shapes may make it difficult for the electrodes to maintain constant and uniform contact.
  • an anatomical structure such as a body passage, cavity or vessel (e.g., a vein, artery, vessel, heart, trachea, pharynx, larynx, bronchi, ureter, urethra, fallopian tubes, cervix, uterus, intestine (large and/or small), gallbladder, pancreas, rectum, liver, esophagus, stomach, nasal cavity, seminal vesicles, vas deference, etc.) using pulsed electrical fields, including (but not limited to) nanosecond pulsed electrical fields, microsecond pulsed electrical fields, etc.
  • pulsed electrical fields including (but not limited to) nanosecond pulsed electrical fields, microsecond pulsed electrical fields, etc.
  • Electrodes that may conform to the body vessels may include a first electrode and a second electrode configured to deploy from a catheter and conform, for example, to a portion of a wall of a body vessel and provide sub-microsecond (e.g., nanosecond) pulsed electrical fields in a localized manner that limits or prevents damage to deeper, non-targeted regions.
  • the electrodes described herein may be equivalently referred to as electrode assemblies; these electrodes (e.g., electrode assemblies) may include one or more active regions configured to apply energy to a tissue and one or more insulated regions.
  • vascular treatments such as vascular angioplasty treatments
  • other body lumen in which lumen narrowing may be a problem For example, lungs (airways), gastric chambers, ducts, or the like may be treated as described herein.
  • the distal end may be steerable (e.g., may articulate) in some examples.
  • the apparatuses described herein include devices that may be referred to as applicator tools, and typically include an applicator (or applicator region) at or near a distal end region for applying energy.
  • the first electrode and the second electrode may each be formed of a wire, e.g., a wire having a diameter of less than about 0.2 mm (less than about 0.19 mm, less than about 0.18 mm, less than about 0.17 mm, less than about 0.16 mm, less than about 0.15 mm, etc.).
  • the first and second electrodes are configured to flexibly conform to body lumen, so that the active regions may extend circumferentially around the perimeter of the lumen.
  • arranged or configured to circumscribe the body lumen may refer to at least partially extending around the circumference of a body lumen (e.g., traveling in an arc of less than 360 degrees, e.g., between about 270 degrees or more, e.g., 300 degrees or more, 320 degrees or more, 330 degrees or more, 340 degrees or more, 340 degrees or more, about 360 degrees).
  • a first active region that is arranged to circumscribe the body lumen may include an active region that extends completely or almost completely around the circumference of the lumen (about 270 degrees around the circumference of the lumen or more, about 300 degrees or more, about 320 degrees or more, about 330 degrees or more, about 340 degrees or more, about 340 degrees or more, about 360 degrees, etc.).
  • the first active region is configured to circumscribe the body lumen in a nearly complete circle.
  • any of the apparatuses described herein may be configured so that the at least one of the first active region and the second active region is configured to circumscribe the wall of the anatomical structure in a partial, nearly complete or complete circle.
  • apparatus for delivering pulsed electric fields comprising: an elongate body; a first electrode comprising a first wire loop, wherein the first wire loop flexibly extends from the elongate body, the first electrode has a first active region extending along the length of the first wire loop; and a second electrode comprising a second wire loop, wherein the second wire loop flexibly extends from the elongate body, the second electrode has a second active region extending along the length of the second wire loop, wherein the first electrode is either radially offset, laterally offset or both radially and laterally offset from the second electrode.
  • any of these apparatuses may include a plurality of mapping and/or sensing electrodes on the first electrode outside of the first active region and/or on the second electrode outside the second active region.
  • apparatuses for delivering pulsed electric fields may include: an elongate body; an expandable member (e.g., balloon), which may be at a distal end region of the elongate body; a first electrode assembly comprising a first plurality of wire loops, each wire loop of the first plurality of wire loops forms a petal having a first active region, wherein the first active regions of each of the first plurality of wire loops are arranged around the expandable member and extend around all or at least a portion of a circumference of the expandable member; and a second electrode assembly comprising a second plurality of wire loops, each wire loop of the second plurality of wire loops forms a petal having a second active region, wherein the second active regions of each of the second plurality of wire loops are arranged around the expandable member and extend around all or at least a portion of a circumference of the expandable member, wherein the first electrode assembly is laterally offset from the second electrode assembly along
  • the expandable member may comprise an expandable balloon.
  • the first electrode assembly and the second electrode assembly may extend from the elongate body over the expandable member.
  • the first plurality of wire loops may comprise any number of loops (e.g., between 2 and 10 loops, between 2 and 8 loops, between 2 and 5 loops, between 2 and 4 loops, etc.) and the second plurality of wire loops may comprise any number of loops (which may be equal to the number of loops in the first plurality of loops, e.g., between 2 and 10 loops, between 2 and 8 loops, between 2 and 5 loops, between 2-4 loops, etc.).
  • Each of the first active regions and each of the second active regions may comprise one or more flexible bend; in some examples the angle of the flexible bend may be configured to expand as the balloon is expanded.
  • Each wire loop of the first plurality of wire loops and each wire loop of the second plurality of wire loops may be coupled to an outer surface of the expandable balloon at one or more spots.
  • each wire loop of the first plurality of wire loops and each wire loop of the second plurality of wire loops may be slidably coupled to an outer surface of the expandable balloon.
  • each of the first active regions and each of the second active regions may be bounded on either side by insulated regions.
  • the first and second electrode assemblies are not attached to the expandable member (e.g., balloon) but may reside adjacent to the expandable member.
  • first and second electrode assemblies may be shape set into a radially collapsed or constricted configuration so that expanding the expandable member (e.g., balloon) radially expands the electrode assemblies and contraction of the expandable member allows the first and second electrode assemblies to return to the radially collapsed (or constricted) configuration.
  • expandable member e.g., balloon
  • the first active region of each wire loop of the first plurality of wire loops may be spaced apart from the second active region of a wire loop of the second plurality of wire loops by a fixed distance.
  • the first electrode assembly and the second electrode assembly may be configured to flexibly conform to a wall of an anatomical structure.
  • the apparatus is configured to convert from an undeployed state (e.g., unexpanded configuration) to a deployed state (e.g., expanded or treatment configuration), while in other examples the apparatus is configured to already be in the deployed state (e.g., treatment configuration) and does not convert into an undeployed state.
  • the mapping and/or sensing electrodes may be positioned radially outwardly of the first treatment electrode; in some examples, at least some of the mapping and/or sensing electrodes are positioned radially outwardly from the second treatment electrode.
  • the structure including the plurality of arms, the treatment electrodes and the mapping and/or sensing electrodes may be referred to herein as an applicator of the apparatus.
  • any of these apparatuses may include an extension region on the arm(s).
  • the extension region may extend radially outward of all of the treatment electrodes when apparatus is in a deployed state.
  • the arms of the plurality of arms may be insulated hollow members within or through which at least a portion of the first electrode and the second electrode and/or electrical connectors (e.g., wires) may extend. This configuration may permit the collapse and expansion of the applicator while ensuring that, in the expanded or deployed state, the treatment electrodes maintain a consistent shape and spacing, which may be particularly helpful for providing consistent and complete treatment.
  • an apparatus for delivering pulsed electric fields may include: an elongate body; a plurality of arms configured to extend from the elongate body at an angle when the apparatus is in a deployed state; a first plurality of electrode lengths extending between the plurality of arms and forming a first treatment electrode; a second plurality of electrode lengths extending between the plurality of arms and forming a second treatment electrode that is radially outward of the first treatment electrode in the deployed state; and a plurality of mapping electrodes on an extension region of each arm of the plurality of arms that is radially outward from the second treatment electrode in the deployed state and on an intermediate region of each arm of the plurality of arms that is between the first treatment electrode and the second treatment electrode.
  • any of these apparatuses may include a spacer at a distal end region of the elongate body configured to maintain a spacing of each arm of the plurality of arms within the distal end region of the elongate body.
  • the spacer may be axially moveable relative to the distal end region of the elongate body.
  • the elongate body may be configured as a sheath, as described above.
  • any of the apparatuses described herein may include one or more electromagnetic (EM) sensors coupled to one or more arms of the plurality of arms, including coupled to or positioned on the extension region of one or more arms of the plurality of arms.
  • the apparatus may include an EM sensor within the extension region of one or more arms of the plurality of arms.
  • An apparatus as described herein may include a third (or more, e.g., fourth, fifth, etc.) plurality of electrode lengths extending between the plurality of arms and forming a third treatment electrode that is radially outward of the first treatment electrode and the second treatment electrode (e.g., when the apparatus is deployed).
  • the mapping/sensing electrode(s) may comprise cylindrical electrodes. In some examples, the mapping/sensing electrodes may be on an outer surface of the arms of the plurality of arms.
  • the first plurality of electrode lengths and the second plurality of electrode lengths may each be formed of a wire having a diameter of 0.2 mm or less.
  • an apparatus for delivering pulsed electric fields may include: an elongate body; a first plurality of arms configured to extend from the elongate body at an angle (e.g., when in a deployed state); a second plurality of arms configured to extend from the elongate body at an angle (e.g., in the deployed state); a first plurality of electrode lengths extending between the first plurality of arms and forming a first treatment electrode; a second plurality of electrode lengths extending between the second plurality of arms and forming a second treatment electrode that is axially separated from the first treatment electrode; and a plurality of mapping and/or sensing electrodes.
  • any of the apparatuses described herein may include one or more electrodes on the shaft
  • the arms of the first plurality of arms and the second plurality of arms may be configured to extend from the elongate body at an angle, for example, of between 20 and 90 degrees relative to the elongate body.
  • the arms of the first and second plurality of arms are configured to transition from a longitudinally-extending configuration at least partially within the elongate body into an extended or deployed state wherein each arm of the first and second plurality of arms extends at an angle from the elongate body when extended distally from the elongate body.
  • any of these apparatuses may include a central electrode.
  • the central electrode may be configured to extend distally from a distal end of the elongate body.
  • the central electrode may comprise a mapping or/or sensing electrode.
  • first plurality of electrode lengths and the second plurality of electrode lengths are each formed of a wire having a diameter of 0.2 mm or less.
  • the first treatment electrode may comprise an anode and the second treatment electrode may comprise a cathode, wherein the apparatus is configured to deliver a pulsed energy between the first treatment electrode and the second treatment electrode.
  • FIG. 1 illustrates one example of a system for delivering high voltage, fast pulses of electrical energy.
  • FIG. 2A is an example of an apparatus for delivering energy (e.g., nanosecond pulsed electrical energy) within a body vessel either as a single shot or point-by -point.
  • energy e.g., nanosecond pulsed electrical energy
  • FIG. 2C is another example of an apparatus for delivering energy (e.g., nanosecond pulsed electrical energy) within a body vessel.
  • energy e.g., nanosecond pulsed electrical energy
  • FIGS. 3A-3B illustrate another example of an applicator including treatment electrodes and sensing/mapping sensors.
  • FIG. 3 A shows a distal end view and
  • FIG. 3B shows a side perspective view.
  • FIG. 6 is an example of an apparatus for delivering pulsed electric fields with a multi-tier configuration.
  • FIG. 7 shows an example of animal model tissue showing ablation of discrete regions of the tissue using an apparatus similar to that shown in FIGS. 4A-4C.
  • FIGS. 8A and 8B show an example of one wire loop with an active region forming a portion of an electrode assembly as described herein, illustrating expansion of the active region of the wire loop at a flexible bend.
  • FIGS. 8D-8E illustrate the expansion of an apparatus such as that shown in FIG. 8C.
  • FIGS. 9A-9C show examples of apparatus similar to those shown in FIGS. 8C-8E.
  • FIG. 9A shows an example with a transparent expandable member (e.g., balloon).
  • FIG. 9B shows an example with an opaque expandable member.
  • FIG. 9C is an enlarged view of an example of the active regions of some of the wire loops of the electrode assemblies of FIG. 9B.
  • the pulsed electrical treatment may be microsecond pulsed treatment, or submicrosecond pulsed treatment, including nanosecond pulses.
  • nanosecond pulsed electric fields treatment may refer to the application of relatively high voltages (in some cases 5kV or greater) for a relatively short amount of time (in some cases between about 1 nanosecond and 999 ns). These high voltages and short duration times create a pulsed electric field in the region where the voltages are applied.
  • nanosecond pulsing may induce apoptosis within cellular structures which may reduce a cells’ inflammatory response.
  • these apparatuses and methods may be used to treat the walls of vessels or other lumen that are not necessarily tapered or are only slightly tapered.
  • these methods and apparatuses may be used to treat the walls of a vascular or respiratory lumen.
  • these methods and apparatuses may be used to treat arterial stenosis, including in combination with a stent or angioplasty procedure.
  • these methods may be performed within the first 2-4 days following angioplasty and/or stenting.
  • Untreated, smooth muscle cells (SMCs) at the luminal surface in deendothelialized areas may continue to proliferate at a low rate. The methods and apparatuses described herein may prevent or reduce this.
  • SMCs smooth muscle cells
  • FIG. 1 illustrates one example of a system 100 (also referred to herein by way of example as a sub-microsecond generation system) for delivering fast pulses of electrical energy.
  • a system 100 may include an elongate applicator tool 102, a pulse generator 107, footswitch 103, and user interface 104.
  • Footswitch 103 is connected to housing 105 (which may enclose the electronic components) through a cable and connector 106.
  • the elongate applicator tool 102 may include electrodes and may be connected to housing 105 and the electronic components therein through a cable 137 and high voltage connector 112.
  • the system 100 may also include a handle 110 and storage drawer 108.
  • the applicator tool may be any of the apparatuses for delivery pulsed electrical fields within a body vessel, as described in detail herein. These apparatuses may generally include an elongate, flexible body (generically referred to herein as an elongate body, a catheter or elongate catheter body) at the end of which are one or more electrodes, including electrodes forming one or more loops, that may apply pulsed electrical fields to the body.
  • the elongate applicator tool 102 includes one or more imaging sensors, such as one or more cameras and/or fiber optics at or near the distal end of the elongate applicator tool 102.
  • the camera(s) (not shown for simplicity) may be forward-facing and/or side facing.
  • the system 100 may be configured to display images (in real time, and/or recorded) taken by the elongate applicator tool 102, in order to identify the target treatment area(s) and/or region(s).
  • a human operator may select a number of pulses, amplitude, pulse duration, and frequency information, for example by inputting such parameters into a numeric keypad or a touch screen of user interface 104.
  • the pulse width can be varied.
  • a microcontroller may send signals to pulse control elements within the system 100.
  • fiber optic cables are used which allow control signaling while also electrically isolating the contents of the metal cabinet (e.g., the housing 105) with a sub-microsecond pulse generation system 100, e.g., the high voltage circuit, from the outside.
  • system 100 may be battery powered instead of being powered from a wall outlet.
  • the first and second rings may be referred to as electrode rings, or simply “electrodes”.
  • the first electrode is configured to have one or more lengths or loops, and includes an electrically active region (“active region”) that is formed on the one or more lengths or loops.
  • the active region is the electrically conductive region that is configured to contact target tissue and between which the pulsed electrical field is applied.
  • the active region may be exposed (e.g., may include a conductive surface) and uninsulated, as compared to the other region of the loop. All of these conductive regions are electrically connected, e.g., forming a single electrode.
  • the active region is therefore typically long and narrow, e.g., formed from the wire of a portion of the one or more loops.
  • the apparatuses include two rings of electrodes, an inner ring and outer ring, which may be used for treatment of tissue, including (but not limited to) myocardial tissue in the antrum and/or antrum-ostium.
  • additional rings may be used.
  • FIG. 2A shows an apparatus including three rings
  • FIG. 2B shows an example having four rings
  • FIG. 2C illustrates an example having two rings with a center electrode.
  • These configurations may allow for adaptability to the patient anatomy as well and may assist in achieving both single shot treatment (e.g., treatment of the whole region such as circumference of the vessel in one treatment, including ablation) and point-by -point treatment (e.g., treatment of small portions of the body vessel one at a time, including ablation).
  • single shot treatment e.g., treatment of the whole region such as circumference of the vessel in one treatment, including ablation
  • point-by -point treatment e.g., treatment of small portions of the body vessel one at a time, including ablation
  • the same apparatus may also include a third ring 265 that is concentrically arranged relative to the second ring and may similarly be formed of a plurality of subregions that may be electrically coupled to provide the first polarity.
  • the third ring has a diameter of approximately 16mm.
  • the outer and middle rings may be used for treating larger antrums and/or ostiums, while a second configuration may use the second and third rings for applying treatment in smaller antrums and/or ostiums.
  • Varying sizes of the diameters and/or number of rings may allow the system to select which pairs of rings to designate (at which polarities) in order to provide greater adjustment and fit when treating different sized tissue regions, such as (but not limited to) antrums and/or ostiums.
  • the apparatus includes four concentrically arranged rings.
  • the outer electrode (ring 281) may be formed of a plurality of subregions that may be electrically coupled together to apply a first polarity; in some examples individual subregions may be independently activated.
  • 2C may also include a single central electrode 495 that may be configured to apply a polarity that is opposite of the polarity applied to either the larger outer ring (or a subregion of the outer ring) or to the inner ring (or a subregion of the inner ring).
  • the sensing and/or mapping electrodes may be used to isolate the position(s) of the applicator relative to the tissue or relative to a map of the tissue.
  • sensing/mapping electrodes 1, 3, 5, 7 and 9 may provide an outline of the outer ring
  • sensing/mapping electrodes 2, 4, 6, 8 and 10 may provide an outline of the inner ring.
  • Combination of the sensing/mapping electrodes e.g., 1-2, 3-4, 5-6, 7-8, 9-10 or other combinations
  • the sensing/mapping electrodes may be used for position detection without requiring tissue contact.
  • the apparatuses may also include one or more magnetic sensors 342 (e.g., magnetic coils, rods, etc.).
  • the magnetic sensors are attached to a distal section of the catheter body 340 and are centrally located relative to the treatment electrodes. This may increase the precision of the location of the catheter.
  • any of these apparatuses can be used as a distal part of an elongate body (such as a catheter) and may be used in treatment of, for example, atrial fibrillation.
  • Treatment of atrial fibrillation can include various target sites including but not limited to: Pulmonary Vein (PV) antrums, PV ostiums, and heart wall muscle/tissue.
  • PV Pulmonary Vein
  • these apparatuses may be useful for treating a large area (e.g., a single shot application of sub-microsecond pulsed energy), for example, for treating varying sized Pulmonary Vein antrums/ostiums and/or the ability to provide point-by -point tissue treatment (e.g., ablation) throughout the anatomy of the heart.
  • distal may generally refer to a portion closest to the distal end of the applicator (and closest to a treatment tissue/surface), and the term “proximal” may generally refer to a portion that is relatively further from the distal end of the applicator and the treatment tissue/surface.
  • proximal and distal rings may be referred to as a first and second rings.
  • the rings may be formed from any conformable material.
  • the proximal and distal rings may be formed from Nitinol (e.g., nickel titanium).
  • Nitinol e.g., nickel titanium
  • any other feasible material may be used, such as stainless steel.
  • the proximal ring may have a larger diameter than the distal ring. In other examples, the proximal ring may have a smaller diameter than the distal ring.
  • the ring electrodes are not deployed from within the catheter body but may be housed together with the catheter body within a delivery catheter; the distal end of the apparatus (e.g., the ring electrodes in this example) may be deployed out of the delivery catheter once at or near the target treatment location in the body.
  • the entire apparatus including the catheter body and the electrodes
  • the guiding sheath may already be in the patient, so that the distal end of the sheath is positioned near the target region (e.g., at or near the left or right atrium in some examples).
  • the system 100 may be configured for monopolar operation.
  • the proximal and distal rings may be electrically coupled to each other, and a signal may be applied between them and a return electrode (e.g., another conductor such as a portion of the elongate catheter body, or a conductive pad or electrode) that may be in contact with the patient.
  • a return electrode e.g., another conductor such as a portion of the elongate catheter body, or a conductive pad or electrode
  • the applicator may be moved to another area of the body vessel or removed from the patient.
  • the apparatuses described herein may have radially separated active regions (and in some examples, a central electrode). These active regions may be formed of a flexible wire that is exposed (uninsulated) along all or a portion of the circumferentially-extending length forming the “petal” or loop shape.
  • the applicator may be any appropriate size; for example, the length of the active region of each petal may be between 5 mm and 3 cm (e.g., between 7 mm and 1.5 cm, between 8 mm and 12 mm, etc.) and the diameter of the (optional) central electrode may be between 0.5 mm and 5 mm (e.g., between 1 mm and 3 mm, etc.).
  • the apparatus may include one or more sensors, including electrical sensors (e.g., sensing electrodes) and/or imaging sensors, etc.
  • the apparatus may integrate data from these one or more sensors with one or more maps of the tissue to be treated.
  • These electro-anatomical maps may be generated by a separate mapping system, including commercially available mapping systems, or apparatuses described herein may include an integrated mapping system or sub-system into the apparatus.
  • the sensors are configured as electrodes that may be used as sensors for a mapping (e.g., 3D electro-anatomical mapping) system or sub-system and in combination with one or more patches that may be applied to the patient and connected to the mapping system/sub-system.
  • a mapping e.g., 3D electro-anatomical mapping
  • the elongate body may be part of an outer delivery catheter.
  • the applicator 400 may be configured to be held completely or partially within the elongate body in an undeployed state (not shown) that has a low profile to allow it to be easily inserted through the body and expanded by extending out of the elongate catheter body and/or retracting the elongate catheter body.
  • the applicator may include a plurality of arms 430, 430’, 430” that are configured to extend from the elongate body at an angle when in the deployed state.
  • the apparatus also includes a first plurality of electrode lengths 411, 411 ’, 411” extending between the plurality of arms and forming a first treatment electrode 410.
  • the first treatment electrode in some examples is also referred to as “an inner electrode” or “inner ring electrode” (when the applicator is deployed).
  • Each of the first plurality of electrode lengths forms an arc that together form a ring that may be approximately transverse to the long axis of the elongate body in FIG. 4A-4C.
  • the apparatus also includes a second plurality of electrode lengths 421, 421’, 421” extending, e.g., in an arc, between the plurality of arms and forming a second treatment electrode 420 that is radially outward of the first treatment electrode when the applicator is expanded or deployed.
  • the apparatus may include at least one sensor (e.g., an electromagnetic sensor 487) within the arm, including, for example, within the extension region 431, 431’, 431” of one or more (e.g., all) of the arms.
  • at least one sensor e.g., an electromagnetic sensor 487 within the arm, including, for example, within the extension region 431, 431’, 431” of one or more (e.g., all) of the arms.
  • the applicators described herein may be configured for bipolar operation. Pulsed energy may be transmitted, for example, between the first ring and the second ring.
  • the first ring 410 may be associated with a signal having first polarity (e.g., a positive signal) and the second ring 420 may be associated with a signal having second polarity (e.g., a negative signal).
  • the first ring 410 may be associated with a signal having a negative signal and the second ring 420 may be associated with a signal having a positive signal.
  • the applicator 400 may be configured for monopolar operation.
  • the first and second rings 410 and 420 may both be electrically coupled together and a return electrode (e.g., on the elongate catheter body 403 or a conductive pad) may be used.
  • FIG. 5 illustrates one example of an apparatus configured as an applicator having three arms, similar to FIGS. 4A-4C, along with mapping and/or sensing electrodes coupled to each arm 530, 530’, 530”, and three treatment electrodes 510, 520, 540, forming an inner, middle and outer ring of electrodes, respectively.
  • each treatment electrode may be formed of a plurality of electrode lengths 511, 521, 541.
  • the apparatus for delivering pulsed electric fields shown in FIG. 6 includes an elongate body 603 that may be the same or similar to that described above, and may be configured in some examples so that the applicator (including the electrodes) may be at least partially withdrawn into the distal end region of the elongate body for delivery or navigation to the heart or other target body region.
  • the apparatus may also include a first plurality of arms 630, 630’, 630” that are configured to extend from the elongate body at an angle when deployed, and a second plurality of arms 631 , 631’, 631 ” that are configured to extend from the elongate body at an angle when deployed.
  • the apparatus may also include a first plurality of electrode lengths 614, 614’, 614”, 614’”, 614””, 614’”” extending between the first plurality of arms 630, 630’, 630” and forming a first treatment electrode610, and a second plurality of electrode lengths 612, 612’, 612”, 612’”, 612””, 612’”” extending between the second plurality of arms 631, 631’, 631” and forming a second treatment electrode 620 that is axially separated (e.g., axially spaced) from the first treatment electrode by the plurality of struts.
  • FIG. 7 illustrates an example of tissue ablation using an apparatus similar to those shown in the examples of FIGS. 4A-4C, 5 or 6 and described above.
  • FIG. 7 shows an example of a porcine heart tissue) that has been treated by the application of energy as described herein to form ablated regions.
  • Three exemplary ablation regions are shown 742, 742’, 742”. The energy was applied against the surface of the tissue and was applied by bi-polar application between either a center electrode and one or more of the circumferential treatment electrodes, or between two (or more) of the circumferential treatment electrodes.
  • the electrode assemblies may include multiple petals, which may be arranged circumferentially, as shown in FIG. 8C.
  • the electrode assemblies may be arranged adjacent to each other along the length of the expandable member. The spacing between adjacent active regions of the electrode assemblies may be approximately the same along the length of the active regions(s) in both the un-expanded and expanded configurations, e.g., as the expandable member is expanded.
  • a desired length of the ablation region is 10 mm and a distance between the active regions of the electrode assemblies is 1mm, then 11 electrode assemblies (wires) may be arranged on the balloon.
  • wires any appropriate number of wires and distances between the wires can be implemented.
  • the apparatuses described herein can include or be included as part of a catheter used during a minimally invasive procedure or a part of a device utilized during surgery.
  • the apparatuses described herein may be used to treat a body lumen by applying pulsed submicrosecond (e.g., nanosecond) energy.
  • these apparatuses may be used to treat arterial stenosis or re-stenosis.
  • these apparatuses may be used to treat Barret’s esophagus.
  • the methods and apparatuses described herein may be used to apply sub-sub- microsecond (e.g., nanosecond) pulsed energy.
  • any of the apparatuses described herein may also be configured to apply other types of energy, e.g. RF or micro-pulsed based electrical field energy.
  • diameter dimensions of the first and second electrode may be reversed such that the diameter of the first electrode is relatively larger than the diameter of the second electrode.
  • the use of such applicators may be well suited for treating regions of tissue that begins with a relatively smaller region and transitions to a relatively larger region.
  • One example of usage of the applicators described herein is to deliver a single-shot ablation for pulmonary vein isolation in the left atrium to treat atrial fibrillation.
  • a puncture of the femoral vein may be performed using a needle under fluoroscopic and/or ultrasound guidance. After the puncture, under fluoroscopic guidance a 0.032-inch J-tip guidewire may be advanced.
  • the proper positioning of the electrodes can be aided by the deflectable or fully articulated distal end of the elongate catheter body, controlled via mechanism in the elongate handle and pull-wires located within the shaft of the elongate catheter body.
  • the proper location of the catheter can be verified using fluoroscopy and/or ultrasound (TEE and/or ICE), as well as impedance and/or magnetic localization enabled by additional electrodes and/or magnetic sensor(s) of the catheter.
  • TEE and/or ICE fluoroscopy and/or ultrasound
  • impedance and/or magnetic localization enabled by additional electrodes and/or magnetic sensor(s) of the catheter.
  • the proper contact between electrodes of the applicator and left atrium wall can be verified via impedance readings enabled by sending, for example, low amplitude non-therapeutic electrical “test” signals.
  • the tissue, and in particular, the tissue around the electrodes may be mapped 1011 using mapping electrodes on the apparatus, including, for example, on radially opposite sides of the treatment electrodes as seen in FIGS. 3-6.
  • a robotic system may include a movable (robotic) arm to which elongate applicator tool is coupled.
  • Various motors and other movement devices may be incorporated to enable fine movements of an operating tip of the elongate applicator tool in multiple directions.
  • the robotic system and/or elongate applicator tool may further include at least one image acquisition device (and preferably two for stereo vision, or more) which may be mounted in a fixed position or coupled (directly or indirectly) to a robotic arm or other controllable motion device.
  • the image acquisition device(s) may be incorporated into the elongate applicator tool.
  • Examples of the methods of the present disclosure may be implemented using computer software, firmware, or hardware.
  • Various programming languages and operating systems may be used to implement the present disclosure.
  • the program that runs the method and system may include a separate program code including a set of instructions for performing a desired operation or may include a plurality of modules that perform such sub-operations of an operation or may be part of a single module of a larger program providing the operation.
  • the modular construction facilitates adding, deleting, updating and/or amending the modules therein and/or features within the modules.
  • a user may select a particular method or example of this application, and the processor will run a program or algorithm associated with the selected method.
  • various types of position sensors may be used.
  • a non- optical encoder may be used where a voltage level or polarity may be adjusted as a function of encoder signal feedback to achieve a desired angle, speed, or force.
  • Certain examples may relate to a machine-readable medium (e.g., computer-readable media) or computer program products that include program instructions and/or data (including data structures) for performing various computer-implemented operations.
  • a machine-readable medium may be used to store software and data which causes the system to perform methods of the present disclosure.
  • the above-mentioned machine-readable medium may include any suitable medium capable of storing and transmitting information in a form accessible by processing device, for example, a computer.
  • Some examples of the machine-readable medium include, but not limited to, magnetic disc storage such as hard disks, floppy disks, magnetic tapes. It may also include a flash memory device, optical storage, random access memory, etc.
  • the data and program instructions may also be embodied on a carrier wave or other transport medium. Examples of program instructions include both machine code, such as produced by a compiler, and files containing higher level code that may be executed using an interpreter.
  • Any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to perform or control performing of any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like.
  • hardware may be used in combination with software instructions to implement the present disclosure.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

Landscapes

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

Abstract

L'invention concerne des procédés et des appareils permettant d'appliquer un traitement électrique pulsé (y compris une énergie pulsée submicroseconde à haute tension) à un tissu, notamment un tissu cardiaque. L'appareil peut comprendre des électrodes déployables qui épousent la forme de surfaces de transition. Ces appareils peuvent comprendre des niveaux simples ou multiples de boucles de fil formant des électrodes de type pétale et des électrodes de détection (par exemple, de cartographie, de navigation, etc.), y compris des électrodes de détection disposées radialement sur chaque côté des électrodes utilisées à des fins thérapeutiques.
EP23805392.0A 2022-10-14 2023-10-13 Procédés et dispositifs de cathéter d'ablation et de détection à entretoises multiples Pending EP4601571A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US18/046,784 US12408976B2 (en) 2021-04-26 2022-10-14 Circumferential ablation devices and methods
US18/353,867 US12564440B2 (en) 2021-04-26 2023-07-17 Multi-strut ablation and sensing catheter devices and methods
PCT/US2023/076866 WO2024081897A1 (fr) 2022-10-14 2023-10-13 Procédés et dispositifs de cathéter d'ablation et de détection à entretoises multiples

Publications (1)

Publication Number Publication Date
EP4601571A1 true EP4601571A1 (fr) 2025-08-20

Family

ID=95066143

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23805392.0A Pending EP4601571A1 (fr) 2022-10-14 2023-10-13 Procédés et dispositifs de cathéter d'ablation et de détection à entretoises multiples

Country Status (6)

Country Link
EP (1) EP4601571A1 (fr)
JP (1) JP2025533743A (fr)
KR (1) KR20250067144A (fr)
CN (1) CN120035406A (fr)
AU (1) AU2023358773A1 (fr)
IL (1) IL319602A (fr)

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN119732732A (zh) * 2017-04-28 2025-04-01 波士顿科学医学有限公司 用于将脉冲电场消融能量递送到心内膜组织的系统、装置和方法

Also Published As

Publication number Publication date
AU2023358773A1 (en) 2025-03-27
KR20250067144A (ko) 2025-05-14
CN120035406A (zh) 2025-05-23
JP2025533743A (ja) 2025-10-09
IL319602A (en) 2025-05-01

Similar Documents

Publication Publication Date Title
US12408976B2 (en) Circumferential ablation devices and methods
US12564440B2 (en) Multi-strut ablation and sensing catheter devices and methods
WO2024081897A1 (fr) Procédés et dispositifs de cathéter d'ablation et de détection à entretoises multiples
AU2021383848B2 (en) Braided or woven electrodes
US20100049191A1 (en) Tissue ablator
JP2015524310A (ja) 可撓性のある拡張可能な電極及びパルスパワーを管腔内送達する方法
WO2023076641A1 (fr) Circuits d'électrode bipolaire, dispositifs, systèmes et procédés
CN119587150A (zh) 用于医疗导管的包括延伸远侧端部的可扩张电极组件
US12446944B2 (en) Mapping and ablation applicators
AU2023358773A1 (en) Multi-strut ablation and sensing catheter devices and methods
HK40122996A (zh) 多撑条消融和感测导管装置及方法
CN117241752A (zh) 周向消融装置和方法
HK40103041A (zh) 周向消融装置和方法
WO2025165983A1 (fr) Appareils et procédés de cathéter d'ablation
US20260123974A1 (en) Electrophysiology catheter system with expandable ablation member for complete circumferential ablation of tubular regions and related methods
CN121987325A (zh) 具有用于对管状区域进行完全周向消融的可膨胀消融构件的电生理导管系统及相关方法

Legal Events

Date Code Title Description
STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: UNKNOWN

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE

PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE

17P Request for examination filed

Effective date: 20250506

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC ME MK MT NL NO PL PT RO RS SE SI SK SM TR

DAV Request for validation of the european patent (deleted)
DAX Request for extension of the european patent (deleted)