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WO2025179067A1 - Systèmes et procédés d'ablation intramyocardique - Google Patents

Systèmes et procédés d'ablation intramyocardique

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Publication number
WO2025179067A1
WO2025179067A1 PCT/US2025/016665 US2025016665W WO2025179067A1 WO 2025179067 A1 WO2025179067 A1 WO 2025179067A1 US 2025016665 W US2025016665 W US 2025016665W WO 2025179067 A1 WO2025179067 A1 WO 2025179067A1
Authority
WO
WIPO (PCT)
Prior art keywords
ablation
microcatheter
electrode
catheter
accessor
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/016665
Other languages
English (en)
Inventor
Robert Jay LEDERMAN
Rim Nabil HALABY
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.)
National Institutes of Health NIH
Original Assignee
National Institutes of Health NIH
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Filing date
Publication date
Application filed by National Institutes of Health NIH filed Critical National Institutes of Health NIH
Publication of WO2025179067A1 publication Critical patent/WO2025179067A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
    • 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
    • A61B2018/00571—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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00839—Bioelectrical parameters, e.g. ECG, EEG
    • 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
    • A61B2018/1472—Probes or electrodes therefor for use with liquid electrolyte, e.g. virtual electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation

Definitions

  • FIG. 6 depicts a magnified view of a proximal end of the accessor catheter
  • FIG. 12 schematically shows an example kit including aspects of the guiding catheter system as disclosed herein;
  • FIG. 13 depicts a second view of the ablation catheter of the catheter system of FIG. 1;
  • FIG. 16 depicts a fifth view of the ablation catheter of the catheter system of FIG. 1; and [0020] FIG. 17 depicts a sixth view of the ablation catheter of the catheter system of FIG. 1
  • FIGS. 18 and 19 show cross-sectional views of various ablation electrode configurations
  • FIG. 20 depicts a seventh view of the ablation catheter of the catheter system of FIG. 1;
  • FIGS. 21 and 22 depict views of electrodes having coupling extensions that may be incorporated into the ablation catheter of the catheter system of FIG. 1;
  • FIG. 23 shows the ablation catheter of the catheter system of FIG. 1 without incorporation of the electrodes
  • FIGS. 30 and 31 schematically show example kits including aspects of the second, third, and/or fourth catheter systems.
  • septal scoring along the midline endocardium is a transcatheter myotomy procedure that may be used to relieve or prevent a left ventricular outflow tract (LVOT) obstruction by splaying the circumferential myofibers of the septal myocardium with a flying-V laceration surface formed by an ensnared guidewire tip previously navigated through the interventricular septum.
  • LVOT left ventricular outflow tract
  • the effector delivered by the guiding catheter system may include an ablation catheter system for treating VT that comprises an electrically insulated electrodeguidewire and an ablation microcatheter, at least in some examples.
  • the effector/ablation catheter system may hereafter be referred to as VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms).
  • VT can originate from damaged or scarred tissue or areas of abnormal automaticity located within the ventricles of the heart that disrupt electrical function necessary for normal heart function. For example, regions of scar and slow conduction can form the substrate for reentrant conduction pathways underlying VT.
  • Ablation of key scarred or damaged tissue targets with radio-frequency (RF) energy may block the transmission of pathological electrical signals thereby treating VT.
  • Current systems of ablation have their own limitations. For example, endocardial monopolar ablation may have difficulty reaching deep targets whereas epicardial monopolar ablation is hindered by the presence of thick epicardial fat and the threat of injury to nearby coronary arteries.
  • the VINTAGE system disclosed herein addresses these issues via guidewire navigation to intramyocardial targets and ablation in the myocardium with an ablation electrode.
  • the VINTAGE system may include an ablation microcatheter including an ablation electrode and one or more mapping/tracking electrodes, and configured for coaxial arrangement with a navigation guidewire.
  • the ablation microcatheter may be sized to accommodate the navigation guidewire in a central lumen and may include a fenestrated or segmented ablation electrode to facilitate irrigation, via irrigant in the central lumen, during ablation.
  • the VINTAGE system may be guided to the myocardium and supported while traversing the myocardium by the guiding catheter system.
  • the guiding catheter system may include an accessor catheter coaxially arranged in an outer catheter, with the accessor catheter configured to deliver an anchor system and an effector (e.g., the VINTAGE system).
  • the accessor catheter and/or outer catheter may be deflectable to control the angle of engagement with the myocardium
  • the anchor system may include a myocardial engagement component configured to engage the myocardium and provide support while the VINTAGE system is deployed into the myocardium for ablation, as shown in FIGS. 7-11.
  • the ablation microcatheter and the navigation guidewire of the VINTAGE system may be used to traverse the myocardium to reach an ablation target, guided by electrograms detected from the electrodes on the ablation microcatheter and guidewire, or by position information encoded on electromagnetic fields generated by electroanatomic mapping systems. Irrigation with an electrolyte may be performed via the flush port and fenestrations/openings of the ablation microcatheter and ablation performed with the ablation electrode to alter the electrical and/or physicochemical characteristics of the target myocardial substrate. Aspects of the VINTAGE system, including the ablation microcatheter and the navigation guidewire and/or the accessor catheter, may be packaged in a kit, as shown in FIG. 12.
  • FIG. 1 depicts an example of an effector in the form of an ablation catheter system 100 (also referred to as a VINTAGE system), in a first configuration.
  • FIG. 1 (as well as FIGS. 2-10) includes a Cartesian coordinate system 199 to orient each view of the ablation catheter system 100 provided herein.
  • FIG. 1 depicts an example of an effector in the form of an ablation catheter system 100 (also referred to as a VINTAGE system), in a first configuration.
  • FIG. 1 (as well as FIGS. 2-10) includes a Cartesian coordinate system 199 to orient each view of the ablation catheter system 100 provided herein.
  • FIG. 1 includes a Cartesian coordinate system 199 to orient each view of the ablation catheter system 100 provided herein.
  • the y-axis may be a vertical axis (e.g., extending parallel to gravity with the positive y direction pointing in the direction of the arrow, away from ground)
  • the x-axis of coordinate system 199 may be a longitudinal axis (e.g., horizontal axis)
  • the z-axis of coordinate system 199 may be a lateral axis, in one example.
  • the axes may have other orientations, in other examples.
  • positive may refer to in the direction of the arrow of the x-axis, y-axis, and z-axis and negative may refer to in the opposite direction of the arrow of the x-axis, y-axis, and z- axis.
  • An unfilled circle may represent an arrow and an axis facing away, or negative to, a view.
  • the ablation catheter system 100 may be held or used in any orientation without departing from the scope of this disclosure.
  • the term distal end may refer to a first end of the ablation catheter system 100 configured to be positioned within a heart of a patient and the term proximal end may refer to a second end of the ablation catheter system 100 configured to remain external to the patient.
  • the patient may be human, however in other examples the patient may be nonhuman.
  • the ablation catheter system 100 includes an ablation microcatheter 102 that includes a shaft 101 (e.g., a polymer tube) including a body 103 and a tapered nosecone 106.
  • the ablation microcatheter 102 further includes a first mapping electrode 104 coupled to the shaft 101 at a distal end of the ablation microcatheter 102, a fenestrated, conductive ablation electrode 108 coupled to the shaft 101 at the distal end (e.g., proximal the first mapping electrode 104), and a second mapping electrode 109 coupled to the shaft 101 proximal the ablation electrode 108.
  • the ablation microcatheter 102 may have a generally cylindrical shape with a hollow interior to facilitate a coaxial arrangement of a navigation guidewire 110.
  • the shaft 101, and specifically the tapered nosecone 106 may terminate at a distal tip 105 that has an opening through which the navigation guidewire 110 may extend.
  • the ablation microcatheter 102 may have a first inner cross-sectional diameter (e.g., along the z axis) in a range of 0.014-0.018 inches.
  • the tapered nosecone 106 may taper in width/cross-sectional area along the x axis (and specifically may taper in the negative x direction).
  • the ablation microcatheter 102 may have a larger cross-sectional area in the body 103 (e.g., proximal of the first mapping electrode 104) than at the distal tip 105.
  • the ablation microcatheter 102, along its entirety other than the tapered nosecone 106, may have a second inner cross-sectional diameter (e g., along the z axis) in a range of 0.021-0.035 inches and an outer cross-sectional diameter in a range of 0.025-0.038 inches.
  • Each of the first mapping electrode 104 and the second mapping electrode 109 may be surface ring electrodes that extend radially around an entire circumference of the shaft 101 and have inner and outer diameters that match the inner and outer diameters of the ablation microcatheter mentioned above.
  • first mapping electrode 104 and the second mapping electrode 109 may be semi-circular such that the electrode(s) extends radially around only half the circumference of the shaft 101. In the example illustrated in FIGS.
  • the first mapping electrode 104 may be positioned between the tapered nosecone 106 and the ablation electrode 108, though the first mapping electrode 104 may be positioned elsewhere on the ablation microcatheter 102 without departing from the scope of this disclosure. Further, in some examples, more than two mapping electrodes may be provided.
  • the ablation microcatheter 102 may have a suitable length (e.g., along the x axis) to facilitate placement of the ablation microcatheter 102 in a patient and specifically to facilitate placement of the distal end of the ablation microcatheter 102 in a heart of the patient while the proximal end of the ablation microcatheter 102 remains external to the patient.
  • the ablation microcatheter 102 may include an opening at the distal tip 105 to allow insertion and removal of the navigation guidewire 110 as well as an opening at the proximal end. At the proximal end, the ablation microcatheter 102 may include and/or be coupled to various hardware 112 to facilitate navigation of the ablation microcatheter 102 as well as fluid irrigation during an ablation procedure.
  • the hardware 112 may include an irrigation port 112a, electrode connectors, an RF connector, and a hemostatic valve.
  • the hemostatic valve may be integrated with the ablation microcatheter 102, or the hemostatic valve may be detachable and the ablation microcatheter 102 may include a connector (e.g., a Luer lock connector) to facilitate coupling of the hemostatic valve.
  • the electrode connectors may be configured to couple to a signal processor, for example, via one or more first connections 118 (e.g., signal wires).
  • EDEN provides real-time, depth-specific unipolar intramyocardial electrogram patterns that indicate intramural radial position during microcatheter and guidewire navigation based on output from the first mapping electrode 104, the second mapping electrode 109, and/or an exposed conductor of the navigation guidewire, explained below.
  • the RF connector may facilitate coupling to an RF generator 208, explained below.
  • the ablation microcatheter 102 may be electrically insulated from the navigation guidewire and any surrounding catheters and media.
  • the ablation microcatheter 102 may have a "short" rotating hemostatic valve/adaptor (e.g., of less than 2cm) and allows coaxial placement of the navigation guidewire 110 as well as a sidearm (e.g., the irrigation port 112a) to allow electrolyte infusion.
  • the ablation microcatheter 102 may have a length of 135-175 cm.
  • the navigation guidewire 110 may comprise a thin (e.g., having an outer diameter in a range from 0.01 inches to 0.02 inches) cylindrical material having a stiffness (or flexibility) that enables insertion into and navigation within the myocardium.
  • the navigation guidewire 110 may comprise stainless steel and/or nickel -titanium alloy (e.g., Nitinol) and/or another suitable biocompatible alloy, and may have customized or variable stiffness and diameter along its length for increased pushability and kink resistance.
  • a length of the navigation guidewire 110 is electrically insulated except for an exposed conductor 111 at the distal end of the navigation guidewire 110 and a connection point at the proximal end of the navigation guidewire 110.
  • ablation of the target may be performed via the ablation electrode 108.
  • the relatively large diameter of the ablation microcatheter 102 (and the irrigation port 112a) relative to the relatively small diameter of the navigation guidewire 110, as well as fenestrations of the ablation electrode 108, may facilitate irrigation of the target with an electrolyte prior to and during ablation.
  • the irrigation may be facilitated by an irrigation pump 206 fluidly coupled to the irrigation port 112a.
  • the ablation electrode 108 may be comprised of a hollow, circular segment of metal that has a length along the x axis of 10-15 mm.
  • the ablation electrode 108 include a plurality of fenestrations (e.g., apertures), such as first fenestration 128, that extend through the metal of the ablation electrode.
  • the number, size, shape, and placement of the fenestrations may be non-limiting and may be selected based on a desired irrigation rate, position of the target, and other considerations.
  • the fenestrations may be circular and of equal diameter (e.g., 0.5-1 mm).
  • the fenestrations may be arranged around the ablation electrode 108 in an even, repeating pattern.
  • the fenestrations may be arranged into a plurality of rows that extend longitudinally (e.g., along the x axis). Each row may include the same number of longitudinally-aligned, evenly-spaced fenestrations (e.g., six). The rows may be axially offset from each other in an alternating pattern. For example, a first row may be axially offset relative to a second row, such that a first fenestration of the first row (e.g., the first fenestration 128) is closer to a distal edge of the ablation electrode 108 than a first fenestration of the second row (e.g., second fenestration 129).
  • the fenestrations are distributed into a plurality of radial groups that are longitudinally offset in an alternating pattern.
  • the first fenestration 128 may be included in a first radial group of circumferentially-aligned fenestrations that are evenly spaced around the circumference of the ablation electrode 108.
  • the second fenestration 129 may be included in a second radial group of circumferentially-aligned fenestrations that are evenly spaced around the circumference of the ablation electrode 108.
  • the first fenestration 128 is not longitudinally-aligned with any fenestrations in the second radial group, but is instead longitudinally-aligned with a fenestration in a third radial group, a fifth radial group, etc.
  • the ablation electrode 108 may include a portion of metal between each pair of adjacent, longitudinally-aligned fenestrations and between each pair of adjacent, circumferentially-aligned fenestrations.
  • the fenestrations may be distanced from each terminal edge of the ablation electrode by a suitable amount, such as 0.5-1 mm.
  • the fenestrations may be distributed such that more fenestrations (or all of the fenestrations) are located on one side of the ablation electrode 108 to facilitate directed, asymmetrical irrigation.
  • the body 103 may include longitudinal grooves inside the inner lumen (e.g., on an inner surface of the body 103/polymer tube) to enhance irrigation fluid delivery.
  • the ablation electrode may include one or more openings to facilitate irrigation during ablation.
  • the one or more openings may be static (e.g., fixed in size and position) or dynamic (e.g., the size of each opening may be adjustable and/or the one or openings may be exposed upon actuation of a particular component) and may be of any suitable shape, including but not limited to circular, semi-circular, oval, rectangular, spiral, helical, sinusoidal, clamshell, and the like.
  • the second mapping electrode 109 may have the same length as the first mapping electrode 104 (e.g., a length along the x axis of 1-2 mm).
  • the second mapping electrode 109 may be separated from the ablation electrode 108 by a third insulating segment 205 (e.g., a third section ofthe polymer tube).
  • the tapered nosecone 106, first insulating segment 202, the second insulating segment 204, the third insulating segment 205, and the body 103 may collectively form the shaft 101 (e.g., the polymer tube).
  • the first insulating segment 202, the first mapping electrode 104, the second insulating segment 204, the ablation electrode 108, the third insulating segment 205, the second mapping electrode 109, and the body 103 may all be circular and hollow with the same or substantially similar (e.g., within 5-10%) inner diameter, to thereby create an inner lumen that extends from the proximal/hub end of the body 103 (shown in FIG. 4 and described in more detail below) to the tapered nosecone 106.
  • the tapered nosecone 106, the first insulating segment 202, the second insulating segment 204, the third insulating segment 205, and the body 103 may be comprised of the same material (e.g., polymer), at least in some examples.
  • the first mapping electrode 104, the ablation electrode 108, and the second mapping electrode 109 may all be comprised of the same material, such as platinum-iridium alloy, stainless steel alloy, titanium, gold-plate, etc. In some examples, molybdenum-rhenium may be used to allow a lower profile.
  • the mapping electrodes may be partial ring electrodes, spiral electrodes (e.g., coils), strip electrodes, or have another suitable configuration.
  • the shaft 101 may extend along the ablation electrode to form a lining on an inner surface of the ablation electrode. In such examples, the lining may include openings that match the openings of the ablation electrode.
  • the navigation guidewire 110 can be seen within the inner lumen of the ablation microcatheter 102 via the fenestrations of the ablation electrode 108.
  • the size mismatch between the navigation guidewire 110 e.g., diameter of 0. 1-0.2 inches, such as 0.014 inches
  • central lumen e.g., diameter of 0.021-0.035 inches
  • the navigation guidewire 110 may extend out of the distal tip 105.
  • the accessor catheter 304 may be coaxially arranged in the outer catheter 302, and the anchor shaft 306 may be arranged in the accessor catheter 304 along with the ablation microcatheter 102 and navigation guidewire 110 of the ablation catheter system 100.
  • the guiding catheter system 300 may be flexible and deflectable, with each of the outer catheter 302, the accessor catheter 304, and the anchor shaft 306 being comprised of or including regions of flexible and/or deflectable material.
  • the outer catheter 302 may have a cylindrical shape with a hollow interior to slidingly receive the accessor catheter 304.
  • the outer catheter 302 may have an outer diameter in a range of 2.6-2.8mm (e.g., 8-8.5 F; 0.10-0.11 inches), a usable length in a range of 100-130 cm, and an opening at the distal end though which the accessor catheter 304 is configured to extend.
  • the outer catheter 302 may include a distal deflectable portion with a variable radius of deflection (e.g., of 2-5 cm) and a deflection angle of 0-135 degrees.
  • the accessor catheter 304 may have a cylindrical shape with at least one hollow lumen to slidingly receive the anchor shaft 306 and/or the ablation microcatheter 102.
  • the accessor catheter 304 may have two hollow, non-concentric lumens, one to accommodate the anchor shaft 306 and another to accommodate the ablation microcatheter 102.
  • the accessor catheter 304 may have one lumen to accommodate both the anchor shaft 306 and the ablation microcatheter 102.
  • the accessor catheter 304 may have an outer diameter of 1.95-2.75mm (e.g., 6-8.3 F; 0.07-0.107 inches), a usable length of 110-135 cm, and two openings at each of the proximal and the distal ends to provide access to the two hollow lumens.
  • the accessor catheter 304 may have deflectable capabilities with a distal deflectable portion that has a radius of deflection (e.g., of 2-5 cm) and deflection angle 0-135 degrees.
  • the accessor catheter 304 may have a fixed, 90-degree distal deflection.
  • the accessor catheter 304 may include at least one distal electrode for EAM and/or EDEN.
  • the anchor shaft 306 may comprise a thin (e.g., having an outer diameter in a range from 0.01 inches to 0.02 inches) cylindrical material terminating at myocardial engagement component 312 at a distal end of the anchor shaft 306.
  • the myocardial engagement component 312 may include a set of prongs, such as two or more sharp prongs (e.g., three, as shown) each having a length of approximately 10- 15mm and appropriate curvature to form fish-hook shaped prongs when deployed.
  • the set of anchor prongs may be configured to retract and deploy, such that the set of anchor prongs may be held along/in alignment with the anchor shaft 306 during navigation of the guiding catheter system 300 to the myocardium and then deployed to the position shown in FIG. 3 in order to engage the myocardium and anchor the guiding catheter system 300.
  • myocardial engagement components such as a corkscrew/helix with fixed or variable pitch and/or diameter.
  • the anchor system may include a flexible hinge mechanism 314 that allows the accessor catheter 304 to be torqued, angled, and/or pivoted as desired without displacing the anchor shaft 306.
  • the hinge mechanism 314 is located at the proximal end of the myocardial engagement component 312 and distal end of the anchor shaft 306.
  • the hinge mechanism 314 may comprise two semi-loops passing through each other, one permanently and rigidly connected to the anchor shaft 306, and the other one permanently and rigidly connected to the proximal end of the myocardial engagement component 312.
  • the hinge mechanism 314 may comprise a spring, with one end of the spring permanently attached to the proximal end of the myocardial engagement component 312 and the other end tensioned around and permanently attached to the distal end of the anchor shaft 306.
  • the hinge mechanism 314 may comprise a permanent attachment between the myocardial engagement component 312 and the anchor shaft 306, mechanically reducing the outer diameter of the joint section to allow mechanical flexibility for deflection. All of the above examples of the hinge mechanism 314 provide torquability and pushability while the myocardial engagement component 312 is contained within the accessor catheter 304, and flexibility and deflection while the myocardial engagement component 312 is deployed.
  • FIG. 4 schematically shows the proximal/hub end of the ablation microcatheter 102 and navigation guidewire 110 as well as the hub end of the guiding catheter system 300.
  • the ablation microcatheter 102 may terminate at a hub, which may include or be the hardware 112 of FIG. 1.
  • the hardware 112 may facilitate coupling between elements of the ablation microcatheter 102 and electrode connectors and an RF connector, as explained above with respect to FIG. 1.
  • the hardware 112 is coupled to an RF connector 422, a positive electrode connector 424, and a negative electrode connector 426.
  • the two entry lumens may include a first entry lumen 406 configured to accommodate the ablation microcatheter 102 and a second entry lumen 408 configured to accommodate the anchor shaft 306.
  • the anchor shaft 306 may terminate at the proximal end at a pusher 410 that may be moved along the x axis to move the anchor shaft 306 and deploy or retract the myocardial engagement component 312.
  • the exit lumen 409 is present at the distal end of the handle 400.
  • the outer catheter 302 extends outward from the distal end of the handle 400 and the accessor catheter 304 extends out of the handle 400 via the exit lumen 409, which is shown in FIG. 5 and explained in more detail below.
  • a method for VINTAGE using the herein described microcatheter use may include: percutaneous access to the femoral vein; use of a commercially available deflectable sheath to get into the right ventricle through the tricuspid valve; engagement of the right ventricular septum using the accessor catheter, the angle of engagement is controlled by either deflectable characteristics of the accessor catheter or the deflectable outer catheter; the accessor catheter is registered within the EAM and/or EDEN to confirm location; release of the myocardial engagement component of the anchor system in the myocardium for support and counter-traction; right ventricular septum entry through the second lumen of the accessor catheter, using a stiff 0.014” guidewire housed inside the effector; navigation of the 0.014” guidewire within the myocardium in tandem with the VINTAGE effector; once at target, intramyocardial irrigation and ablation is performed through the fenestrated/segmented ablation electrode.
  • the electrode strips may be wound partially around a central axis of the ablation electrode in a helicallike fashion such that when the strips bend/flex, helical openings are formed.
  • the ablation electrode may be comprised of a continuous segment of material that is wound around the central axis of the ablation electrode to form a single helical opening that spans the length of the ablation electrode, as shown in FIGS. 16 and 17.
  • the ablation electrode may be coupled to the polymer tube in an end-to-end fashion, such that the polymer tube does not extend in the region where the ablation electrode is located, as shown in FIG. 18. In other examples, as shown in FIG. 19, the polymer tube may extend along an inner surface of the ablation electrode.
  • FIGS. 13 and 14 provide additional example configurations for segmented ablation electrodes.
  • FIG. 13 shows a second ablation electrode 1302 that may be incorporated into ablation microcatheter 102.
  • Second ablation electrode 1302 may be positioned on the ablation microcatheter 102 similarly to ablation electrode 108, and may be comprised of the same material(s), have the same length, and have the same inner diameter as the ablation electrode 108.
  • the second ablation electrode 1302 may include a main body 1304 supporting a plurality of tines, such as a first tine 1306 and a second tine 1308.
  • the second tine 1308 may be shaped and sized to be accommodated within a second opening 1312, and may move outward from the second opening 1312 to facilitate fluidic coupling between the inner lumen of the ablation microcatheter 102 and the surrounding environment, via the second opening 1312.
  • the plurality of tines may include six tines and the second ablation electrode 1302 may include six openings.
  • the openings may be strip-like in shape (e.g., have a length along the x axis that is larger than a radial width of the opening around the circumference of the second ablation electrode 1302), with square corners or rounded comers.
  • the openings may be arranged in two radial groups that are offset from each other (e.g., the openings in the two groups are not aligned along the x axis) so that, looking down the ablation microcatheter 102 when the tines are positioned in the outward position as shown in FIG. 13, the tines are arranged radially around the second ablation electrode 1302 in an evenly spaced manner.
  • the main body 1304 may extend around each opening so as to be electrically continuous.
  • the tines may be extensible or retractable tines to increase the electric field size of the ablation electrode and that allow the tines to be withdrawn from an initial low-profile intramyocardial delivery tract.
  • each strip may be bendable/flexible to allow the strips to move from being extended (e.g., at full length) to being bent outward, away from the central axis of the ablation microcatheter 102, to thereby form a plurality of helical-like openings.
  • the ablation microcatheter 102 may include pull-cables or another actuation mechanism that, when actuated, pulls the first ring segment 1504 (and components of the ablation microcatheter 102 distal of the first ring segment 1504) closer to the second ring segment 1506.
  • each strip of the plurality of strips is held in close alignment with neighboring strips along the outer circumference of the ablation microcatheter 102.
  • each strip of the plurality of strips bends outward to form an opening between each pair of neighboring strips, such as first opening 1512.
  • the openings may be considered to have a helical-like shape due the winding of each opening around the central axis.
  • the size of each opening may be controlled by controlling the distance between the first ring segment 1504 and the second ring segment 1506.
  • FIG. 16 shows a fifth ablation electrode 1602 that may be incorporated into ablation microcatheter 102.
  • Fifth ablation electrode 1602 may be positioned on the ablation microcatheter 102 similarly to ablation electrode 108, and may be comprised of the same material(s), have the same length, and have the same inner diameter as the ablation electrode 108.
  • the fifth ablation electrode 1602 may be a helical electrode comprised of an electrode strip 1604 having a constant width that is wound around the central axis of the ablation microcatheter in a helical fashion.
  • the inner lumen of the ablation microcatheter 102 may be fluidly coupled to ambient via the helical opening 1606 and the amount of irrigant directed out of the fifth ablation electrode 1602 may be a function of the size of the helical opening 1606. Accordingly, the size of the helical opening may be selected based on desired irrigation properties during ablation, and the helical pitch of the electrode strip may be set to create the helical opening of the desired size. It is to be appreciated that the helical opening may be wider than shown in FIG. 16, or may be smaller, as shown in FIG. 17 and discussed below.
  • the ablation electrode 1908 may have an inner diameter of 0.018 inches and an outer diameter of 0.025 inches and the lining 1902 may have an inner diameter of 0.015 inches and an outer diameter of 0.018 inches.
  • the ablation electrode 1908 may have an inner diameter of 0.022 inches and an outer diameter of 0.025 inches and the lining 1902 may have an inner diameter of 0.015 inches and an outer diameter of 0.022 inches.
  • the ablation electrode 1908 may have an inner diameter of 0.024 inches and an outer diameter of 0.025 inches and the lining 1902 may have an inner diameter of 0.015 inches and an outer diameter of 0.024 inches.
  • FIG. 20 shows another magnified view of the distal end of the ablation microcatheter 102, showing the distal tip 105, tapered nosecone 106, first mapping electrode 104, ablation electrode 108, second mapping electrode 109, and body 103.
  • the ablation microcatheter 102 shown in FIG. 20 is similar to the ablation microcatheter shown in FIG. 2.
  • the first mapping electrode 104 of the ablation microcatheter 102 of FIG. 20 is positioned on the tapered nosecone 106.
  • the first mapping electrode 104 in FIG. 20 likewise tapers and may be spaced apart from the ablation electrode 108 by a larger amount than the first mapping electrode 104 in FIG. 2.
  • the first extension 2104 may be a helical extension made of the same material as the ring electrode segment 2102 and including a suitable number of turns (e.g., one and a half). In some examples, the entirety of the first extension 2104 may have the same inner and outer diameter as the ring electrode segment 2102. In other examples, the first extension 2104 may taper (e.g., narrow) in a direction away from the ring electrode segment 2102.
  • FIG. 21 may be a front-side view of the mapping electrode 2100, and the first extension 2104 may extend out of the ring electrode segment 2102 on an opposite, back side of the mapping electrode 2100.
  • FIG. 22 shows an example ablation electrode 2200 with helical extensions.
  • Ablation electrode 2200 is a non-limiting example of the ablation electrode 108 of FIG. 1 and may be included on the ablation microcatheter 102.
  • the ablation electrode 2200 may include an ablation electrode segment 2202 that comprises a hollow, circular (e.g., annular) electrode with fenestrations or segmentations, as explained above with respect to the ablation electrode 108, for example.
  • the ablation electrode 2200 may further include a first extension 2204 and a second extension 2206, each extending out from a respective side of the ablation electrode segment 2202.
  • the first extension 2204 and the second extension 2206 may be similar to the first extension 2104 and the second extension 2106 of FIG. 21, and thus the description of the first extension 2104 and the second extension 2106 provided above likewise applies to the first extension 2104 and the second extension 2106.
  • FIG. 23 shows an example ablation catheter 2302 with electrodes removed to allow visualization of the connecting components of the ablation catheter 2302 that facilitate coupling of the electrodes to the ablation catheter 2302.
  • the first mapping electrode and the second mapping electrode are electrodes with coupling extensions (such as the mapping electrode 2100 of FIG. 21) and thus the ablation catheter 2302 includes coupling sections to facilitate enhanced bonding of the electrode extensions.
  • the coupling sections include a first section 2310 coupled to the nosecone 2306 and a second section 2312, wherein the first section 2310 and the second section 2312 are configured to couple to the first mapping electrode (not shown in FIG. 23, but shown in FIG. 24).
  • the first section 2310 is a non-limiting example of the first insulating segment 202 and the second section 2312 is a non-limiting example of the second insulating segment 204.
  • the coupling sections additionally include a third section 2314 and a portion of the body 2303, wherein the third section 2314 and the portion of the body 2303 are configured to couple to the second mapping electrode.
  • the third section 2314 is a non-limiting example of the third insulating segment 205 and the body 2303 is a non-limiting example of the body 103.
  • the second section 2312 and the third section 2314 are additionally configured to couple to an ablation electrode 2308, which is a non-limiting example of the ablation electrode 108. In the illustrated example, the ablation electrode 2308 does not include extensions.
  • the first section 2310, the second section 2312, the third section 2314, and the portion of the body 2303 each include a helical gap that is shaped and sized to accommodate a respective electrode extension.
  • FIG. 24 shows the ablation catheter 2302 with electrodes coupled the ablation catheter 2302.
  • a first mapping electrode 2304 is coupled to the first section 2310 on a first side and to the second section 2312 on a second side.
  • the first mapping electrode 2304 may be a non-limiting example of the mapping electrode 2100 and thus includes two extensions.
  • the first extension of the first mapping electrode 2304 may be coupled to the first section 2310 and the second extension of the first mapping electrode 2304 may be coupled to the second section 2312.
  • the first extension may fit into the helical gap of the first section 2310 and the second extension of the first mapping electrode 2304 may fit into the helical gap of the second section 2312.
  • the second mapping electrode 2309 may be coupled to the third section 2314 and the portion of the body 2303 in a similar manner.
  • the inclusion of the electrode extensions may increase the surface area over which the electrodes are coupled to the connecting elements of the ablation catheter, thereby increasing the durability of the bonding. It is to be appreciated that the electrode extensions may taper/narrow in diameter in a direction away from the ring electrode component, as explained above.
  • the mapping electrodes may be coupled to the microcatheter shaft during reflowing or extruding of the shaft material segments distal and proximal the mapping electrodes. In doing so, the electrode surface may be aligned with the shaft surface almost perfectly for a smooth profile and the mapping electrodes may be embedded into the shaft to provide a smoother mechanical transition, preventing kinks and detachment of the electrodes, and further enhancing EAM tracking functionality.
  • the electrode extensions may be fully or partially embedded in the shaft/polymer tube.
  • the electrode segment of the mapping electrode may not be covered by the polymer tube and thus an outer surface of the electrode segment may be exposed to ambient.
  • the electrode extensions are tapered and thus narrow in cross-sectional diameter in a direction away from the electrode segment, the amount of polymer on the outside and the inside of the extensions may vary along the extensions. For example, the thickness of the polymer on the outer side of the extension may increase in a direction away from the electrode segment.
  • the electrodes may be coupled to the polymer tube during formation of the polymer tube (e.g., via reflowing or extruding), the helical gaps in the polymer tube described above may not be pre-formed but may reflect areas where the electrode extensions are included on and/or within the polymer tube.
  • the example ablation catheter system described above includes an ablation electrode with openings in the ablation electrode itself to facilitate irrigation before and/or during ablation.
  • a VINTAGE system may include the ablation electrode being carried on a separate catheter with irrigation provided via a gap between coaxially arranged catheters.
  • the ablation catheter system may include a first microcatheter including a first electrode, a second microcatheter including a second electrode, a navigation guidewire including a third electrode, and an ablation electrode configured for coaxial arrangement.
  • the first microcatheter may be sized to accommodate the second microcatheter and alternately the ablation electrode, and the second microcatheter may be sized to accommodate the navigation guidewire.
  • the ablation catheter system may include a first microcatheter, a removable dilator, a navigation guidewire, and an ablation electrode configured for coaxial arrangement. At least the first microcatheter and the navigation guidewire may be used to traverse the myocardium to reach an ablation target, guided by electrograms generated from the electrodes on the first microcatheter and navigation guidewire, at which point the navigation guidewire may be removed and replaced with the ablation electrode. Irrigation with an electrolyte may be performed via the first microcatheter and ablation performed with the ablation electrode. Aspects of the VINTAGE system, including the first microcatheter, the navigation guidewire, and the ablation electrode may be packaged in a kit, as shown in FIGS. 30 and 31.
  • FIG. 25 depicts a second example ablation catheter system 2500 (also referred to as a VINTAGE system), in a first configuration 2501.
  • the catheter system 2500 includes a first microcatheter 2502 that includes a first electrode 2504 (e.g., a surface ring electrode) at a distal end of the first microcatheter 2502.
  • the first microcatheter 2502 may have a generally cylindrical shape with a hollow interior to facilitate a coaxial arrangement of a second microcatheter 2506.
  • the first microcatheter 2502 may include a distal tip 2505 that has an opening through which the second microcatheter 2506 may extend.
  • the first microcatheter 2502 may have a first cross-sectional diameter (e.g., along the z axis) of at least 0.035 inches (e.g., 0.9 mm).
  • the first cross-sectional diameter may be in a range of 0.035-8 inches.
  • the distal tip 2505 may taper in width/cross-sectional area along the x axis (and specifically may taper in the negative x direction).
  • the first microcatheter 2502 may have a larger cross-sectional area in the body/main shaft portion (e.g., proximal of the first electrode 2504) than at the distal tip 2505.
  • the first electrode 2504 may be positioned adjacent the distal tip 2505, though the first electrode 2504 may be positioned elsewhere on the first microcatheter 2502 without departing from the scope of this disclosure.
  • the first microcatheter 2502 may have a suitable length (e g., along the x axis) to facilitate placement of the first microcatheter 2502 in a patient and specifically to facilitate placement of the distal end of the first microcatheter 2502 in a heart of the patient while the proximal end of the first microcatheter 2502 remains external to the patient.
  • the first microcatheter 2502 may include an opening at the distal tip 2505 to allow insertion and removal of the second microcatheter 2506 as well as an opening at the proximal end.
  • the first microcatheter 2502 may include and/or be coupled to various hardware 112 to facilitate navigation of the first microcatheter 2502 as well as fluid irrigation during an ablation procedure, similar to the hardware explained above with respect to the ablation catheter system 100.
  • the first microcatheter 2502 includes a surface ring electrode allowing intramyocardial EAM tracking.
  • the first microcatheter 2502 is capable of delivering and tracking the second microcatheter 2506, is capable of intramyocardial pacing, is capable of deep intramyocardial positioning under x-ray/EAM guidance, and is capable of infusing electrolyte around an ablation guidewire/catheter (as explained below).
  • the first microcatheter 2502 includes an electrode connector for EAM.
  • the first microcatheter 2502 may be electrically insulated from coaxial microcatheters and surrounding catheters and media.
  • the first microcatheter 2502 may have a "short" rotating hemostatic valve/adaptor (e.g., of less than 2cm) and allows coaxial placement of the second microcatheter 2506 as well as a sidearm (e.g., the irrigation port 112a) to allow electrolyte infusion.
  • the first microcatheter 2502 may have a length of 110cm.
  • the second microcatheter 2506 may include a second electrode 2508 at the distal end of the second microcatheter 2506 (e.g., a surface ring electrode). Similar to the first microcatheter 2502, the second microcatheter 2506 may have a generally cylindrical shape with a hollow interior to facilitate a coaxial arrangement of a navigation guidewire 110, which is the same or similar to the navigation guidewire 110 of the ablation catheter system 100. The second microcatheter 2506 may include a distal tip 2509 that has an opening through which the navigation guidewire 110 may extend.
  • the second microcatheter 2506 may have a second cross-sectional diameter (e.g., along the z axis) of less than 0.035 inches (e.g., 0.9mm), such as 0.014 inches (e.g., 0.35mm) or another diameter that is smaller than the first cross-sectional diameter of the first microcatheter 2502, so that the second microcatheter 2506 may be housed within and move relative to the first microcatheter 2502, with the second cross-sectional diameter being large enough to accommodate the navigation guidewire 110.
  • 0.035 inches e.g., 0.9mm
  • 0.014 inches e.g. 0.35mm
  • the second microcatheter 2506 may have a suitable length (e.g., along the x axis) to facilitate placement of the second microcatheter 2506 in the heart of the patient while the proximal end of the second microcatheter 2506 remains external to the patient, which may include the second microcatheter 2506 being longer than the first microcatheter 2502.
  • the second microcatheter 2506 may include various hardware 114 to facilitate navigation of the second microcatheter 2506 during an ablation procedure.
  • the hardware 114 may include a second electrode connector and/or a hemostatic valve.
  • the second electrode connector may be coupled to the signal processor, for example, via a third connection 120 (e.g., a signal wire) and may be similar to the first electrode connector.
  • a length of the navigation guidewire 110 is electrically insulated except for an exposed conductor 111 at the distal end of the navigation guidewire 110 and a connection point at the proximal end of the navigation guidewire 110.
  • the navigation guidewire 110 may be coated with one or more insulators except for the exposed conductor 111 and the connection point that electrically couples the exposed conductor to the electrode connector 116 via the electrically conductive transmission line.
  • the navigation guidewire 110 may include an insulated region and an uninsulated region (e.g., the exposed conductor 111).
  • the electrode of the navigation guidewire (e.g., the exposed conductor 111) may be a unipolar electrode in some examples.
  • the electrode connector 116 may be coupled to the signal processor, for example, via the second connection 122 (e g., a signal wire), as explained previously.
  • the third electrode connector may be configured to limit the mechanical limitation on the operator torqueing the navigation guidewire during operation/advancement/retraction, to ensure tactile feedback and to minimize physical constraints on torque/advancement/withdrawal.
  • the distal tip of the navigation guidewire 110 has an insulation- free segment ⁇ lmm in length, for EAM/EDEN; the proximal tip of the navigation guidewire 110 has an insulation-free segment ⁇ 10mm in length, for attachment to a detachable electrode connector 116 to allow EAM/EDEN.
  • the length of the navigation guidewire 110 may be 200- 300cm, in some examples.
  • the catheter system 2500 in the first configuration 2501 includes a coaxial arrangement of the first microcatheter 2502, the second microcatheter 2506, and the navigation guidewire 110, with the navigation guidewire 110 accommodated within the second microcatheter 2506 and the second microcatheter 2506 accommodated within the first microcatheter 2502.
  • the catheter system 2500 in the first configuration 2501 may be navigated to the heart (e.g., via a guiding sheath and/or catheter in some examples, or via the accessor catheter described above) and advanced into the myocardium, to any target within the wall of the left ventricle, for example.
  • Navigation of the catheter system 2500 may be guided by biplane x-ray fluoroscopy, EAM, EDEN, and/or intracardiac echocardiography (ICE).
  • ICE intracardiac echocardiography
  • the catheter system 2500 includes the first microcatheter 2502 and an ablation electrode 2602 accommodated within the first microcatheter 2502.
  • the ablation electrode 2602 may be a guidewire comprised of stainless steel and coated in in an insulating coating (e.g., PTFE) other than at a distal tip and a proximal tip of the ablation guidewire.
  • the RF generator 208 may include micro-second or nano-second RF pulse trains intended to achieve non-thermal permanent tissue injury, sometimes described as "pulsed field ablation.” Some examples may allow automatic modulation and cessation of energy based on pre-specified changes in impedance.
  • the remaining features of the first microcatheter 2702 may be identical to the first microcatheter 2502 and thus the description of the first microcatheter 2502 applies to the first microcatheter 2702.
  • the first microcatheter 2702 may be include and/or be coupled to hardware 2712 including a first electrode connector, a hemostatic valve/adapter, and an irrigation port 2712a, similar to the hardware 112, with a connection 2718 between the first electrode connector and a signal processor, similar to the one or more first connections 118.
  • the catheter system 2700 includes a second microcatheter 2706.
  • the second microcatheter 2706 may be identical to the second microcatheter 2506, other than inclusion of a plurality of electrically-isolated electrodes at the distal end, such as a fifth electrode 2706a and a sixth electrode 2706b.
  • Each of the electrodes on the second microcatheter 2706 may be surface ring electrodes.
  • the remaining features of the second microcatheter 2706 e.g., the distal tip, openings, cross-section diameter, length, etc.
  • the second microcatheter 2706 may be include and/or be coupled to hardware 2714 including a second electrode connector and/or a hemostatic valve/adapter, similar to the hardware 114, with a connection 2720 between the second electrode connector and the signal processor, similar to third connection 120.
  • the catheter system 2700 further includes a navigation guidewire 2710 that may be identical to the navigation guidewire 110, other than inclusion of one or more additional electrodes at the distal end, in some examples. Thus, the description of the navigation guidewire 110 applies to the navigation guidewire 2710. Further, while not shown in FIG. 27, the catheter system 2700 may include an electrode connector coupled to the navigation guidewire 2710.
  • the catheter system 2700 may include an ablation electrode, similar to the ablation electrode 2602, as well as an irrigation pump and RF generator, and may be placed into a second configuration by replacing the second microcatheter 2706 and navigation guidewire 2710 with the ablation electrode, as explained above with respect to FIG. 26.
  • the catheter system 2700 may include components that are the same or similar to the catheter system 2500 other than inclusion of multiple electrodes on the microcatheters and/or navigation guidewire.
  • the microcatheters and/or navigation guidewire may incorporate multiple electrically isolated insulator-conductor subassemblies for connection of multiple electrical channels to independent or multiplexed transmission line systems.
  • the catheter system 2700 may function the same as the catheter system 2500 other than the multiple electrodes may allow for collection of local bipolar electrograms.
  • the catheter system 2500 or the catheter system 2700 provide for coaxial arrangement of a 0.014" traversal and navigation guidewire (e.g., the navigation guidewire 110 or navigation guidewire 2710); a 0.014" compatible tracking microcatheter with one or more electrodes (e g., the second microcatheter 2506 or the second microcatheter 2706); an -0.035" (typically 0.035-0.038") compatible tracking/infusion microcatheter with one or more electrodes (e.g., the first microcatheter 2502 or the first microcatheter 2702); and an -0.025" diameter (typically 0.020-0.026”) ablation guidewire or catheter (e.g., the ablation electrode 2602).
  • a 0.014" traversal and navigation guidewire e.g., the navigation guidewire 110 or navigation guidewire 2710
  • a 0.014" compatible tracking microcatheter with one or more electrodes e.g., the second microcatheter 2506 or the second microcatheter 27
  • the microcatheters may be low-profile, have lumens that closely match the device they are intended to deliver in coaxial fashion, have tapered tips to mitigate "size step-up" as they are advanced over coaxial devices/guidewires, and have braided metallic wire skeletons surrounded by electrically insulating and often lubricious polymer materials. Blood contacting surfaces of the microcatheters may be biocompatible. Polymers and/or markers of the microcatheters may be radiopaque to impart fluoroscopic conspicuity. The microcatheters may incorporate electrical transmission lines. The ring electrodes of the microcatheters may be short (l-2mm) for tracking or longer (5-10mm) for tracking and RF ablation.
  • the second microcatheter is described as having an inner diameter of 0.014 inches, which may indicate that the lumen of the second microcatheter has dimensional tolerances intended to allow the second microcatheter to slidingly receive/engage the navigation guidewire and allow free advancement and manipulation of the navigation guidewire within the second microcatheter, wherein the navigation guidewire has an outer diameter of 0.014 inches.
  • the second microcatheter is configured to fit tightly over the navigation guidewire, and the second microcatheter and navigation guidewire allow the larger, first microcatheter to track over the second microcatheter and navigation guidewire, so that the navigation guidewire and second microcatheter can create a path for the larger, first microcatheter to traverse the myocardium.
  • the second microcatheter and navigation guidewire can be removed to exchange for the ablation electrode, which is larger in diameter than the navigation guidewire.
  • This configuration may allow for the first microcatheter to have a sufficiently large diameter/lumen space to allow irrigation and facilitate introduction/navigation of the ablation electrode to the target (e.g., within the myocardium).
  • a dilator 2806 Accommodated within the first microcatheter 2802 is a dilator 2806 having a cross-sectional/inner diameter large enough to accommodate a navigation guidewire 2810, which may be identical to the navigation guidewire 110 or the navigation guidewire 2710 and thus be coupled to an electrode connector 2816 and connection 2822 to the signal processor.
  • the dilator 2806 may be hollow and have a tapered tip.
  • the dilator 2806 may have an inner diameter in the body of the dilator 2806 that is 0.035 inches or less and may taper to an opening that has an inner diameter 0.014 inches or slightly more (e.g., 0.015 or 0.016 inches).
  • the catheter system 2800 in a second configuration 2901 may include the dilator 2806 and navigation guidewire 2810 being replaced with an ablation electrode 2902.
  • the ablation electrode 2902 includes a tip 2904 (e.g., which may be the uninsulated region that serves as the electrode) of increased thickness on a relative thin shaft 2906.
  • the tip 2904 may have a diameter of 0.035 inches and a length of 1 cm, and the shaft 2906 may have a diameter of 0.014 inches.
  • the ablation electrode 2902 may be coupled to an electrode connector 2905 that is configured to couple to a connection 2907 (e.g., to the signal processor) and to an RF generator, similar to the ablation electrode 2602.
  • the second microcatheter or dilator may be omitted altogether when the ablation electrode is configured similarly to ablation electrode 2902.
  • thick tip 2904 may be introduced "flush" with the first microcatheter during navigation to the target.
  • the ablation electrode 2902 may be extended by a suitable amount (e.g., 2 cm), and the remaining thin shaft 2906 may create space to allow irrigation through the first microcatheter.
  • the catheter system 2500, the catheter system 2700, and the catheter system 2800 were described as including surface ring electrodes, other electrode configurations are possible, such as one or more of the electrodes being a spiral electrode, one or more strips, or a partial ring electrode. Further, one or more of the electrodes may include helical, feathered, dentate, and/or tapered extensions to facilitate embedding of the electrode extensions in the microcatheter shaft, as explained above. [0137] In some examples, aspects of the VINTAGE system may be assembled into a kit 3000 as shown schematically in FIG. 30.
  • the kit 3000 may include a packaging 3002 housing the first microcatheter 2502 (including the first electrode 2504), the second microcatheter 2506 (including the second electrode 2508), the navigation guidewire 110 (including exposed conductor 111), and the ablation electrode 2602.
  • the packaging 3002 may be sterile packaging.
  • each of the first microcatheter 2502, the second microcatheter 2506, the navigation guidewire 110, and the ablation electrode 2602 may be packaged in individual, sterile packages, and the packaging 3002 may not be sterile.
  • the kit 3000 may include the components of the second kit 1201, including the packaging 1204 housing the accessor catheter 304 (optionally including the first electrode 308 and the second electrode 310, one or more or each or none of which may include helical, feathered, dentate, and/or tapered extensions) and the anchor system (including the anchor shaft 306, the myocardial engagement component 312, and hinge mechanism 314), either as separate components or with the anchor system integrated in the accessor catheter 304.
  • the kit 3000 may include other components for delivering the ablation catheter system, such as a curved or deflectable guiding sheath, a curved or deflectable guiding catheter, and/or an anchor guidewire.
  • the kit 3000 may include one or more electrode connectors 3006.
  • the kit 3000 may include connectors, signal wires, and/or other components for connecting the first microcatheter, the second microcatheter, the navigation guidewire, and the ablation electrode to an EAM and/or EDEN signal processor and/or for connecting the ablation guidewire to the RF generator.
  • the catheter tube includes the tapered nosecone that tapers in cross-sectional diameter near and at the distal tip, such that a third cross-sectional diameter at the distal tip substantially matches the second cross-sectional diameter.
  • the microcatheter further comprises: one or more mapping electrodes coupled to the catheter tube.
  • the one or more mapping electrodes includes a first mapping electrode coupled between the ablation electrode and the distal tip of the catheter tube.
  • the ablation electrode includes one or more tines, each tine shaped and sized to fit in a respective opening of the one or more openings when in a first position and configured to move outward to a second position to expose the respective opening
  • the ablation electrode includes one or more first electrode strips, each first electrode strip configured to extend along a longitudinal axis of the microcatheter in a first position and configured to bend outward to a second position to expose the one or more openings
  • the ablation electrode includes one or more second electrode strips, each second electrode strip winding at least partially around a longitudinal axis of the microcatheter, each second electrode strip configured to bend outward from a first position to a second position to expose the one or more openings
  • the one or more openings of the ablation electrode include a continuous helical opening formed by an electrode strip that winds around a longitudinal axis of the microcatheter in a helical fashion.
  • the disclosure also provides support for a method for an ablation procedure, comprising: navigating an ablation microcatheter to an ablation target via a navigation guidewire, the navigation guidewire housed within the ablation microcatheter, the ablation microcatheter including an ablation electrode comprising one or more openings, irrigating the ablation target with an electrolyte via the one or more openings of the ablation microcatheter, and ablating the ablation target with radiofrequency (RF) energy via the ablation electrode while continuing to irrigate the ablation target.
  • RF radiofrequency
  • navigating the ablation microcatheter to the ablation target comprises navigating the ablation microcatheter to the ablation target based on electrograms detected by one or more electrodes positioned on the navigation guidewire and/or the ablation microcatheter.
  • navigating the ablation microcatheter to the ablation target comprises navigating the ablation microcatheter to the ablation target based on electromagnetic fields encoding geometric position and time from an electroanatomic mapping system detected by one or more electrodes positioned on the navigation guidewire and/or the ablation microcatheter.
  • ablating the ablation target with RF energy via the ablation electrode comprises activating an RF generator coupled to the ablation electrode.
  • the ablation target is an intramyocardial ablation target of a non-human or human patient.
  • navigating the ablation microcatheter to the ablation target via the navigation guidewire comprises: navigating the ablation microcatheter and navigation guidewire to an entry point on a myocardial surface with an accessor catheter, deploying a myocardial engagement component of an anchor system from the accessor catheter into myocardium at the entry point, extending the navigation guidewire out of the accessor catheter and to the ablation target in the myocardium and tracking the ablation microcatheter over the navigation guidewire and to the ablation target.

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Abstract

L'invention concerne un système de cathéter pour effectuer une ablation intramyocardique. Dans un exemple, un microcathéter comprend un tube de cathéter flexible ayant une coiffe arrondie ou effilée et une électrode d'ablation conductrice couplée au tube de cathéter à proximité d'une pointe distale du tube de cathéter, l'électrode d'ablation comprenant une ou plusieurs ouvertures pour permettre l'administration de fluide hors de l'électrode d'ablation.
PCT/US2025/016665 2024-02-20 2025-02-20 Systèmes et procédés d'ablation intramyocardique Pending WO2025179067A1 (fr)

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US20130310823A1 (en) * 2012-04-24 2013-11-21 Mark Gelfand Endovascular Catheters and Methods for Carotid Body Ablation
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