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WO2025222080A1 - Dispositifs médicaux conçus pour une électroporation thérapeutique à température régulée - Google Patents

Dispositifs médicaux conçus pour une électroporation thérapeutique à température régulée

Info

Publication number
WO2025222080A1
WO2025222080A1 PCT/US2025/025299 US2025025299W WO2025222080A1 WO 2025222080 A1 WO2025222080 A1 WO 2025222080A1 US 2025025299 W US2025025299 W US 2025025299W WO 2025222080 A1 WO2025222080 A1 WO 2025222080A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical device
lumen
expandable elements
elongate member
wall
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/US2025/025299
Other languages
English (en)
Inventor
Robert S. Schwartz
Landy Toth
Marco Bedoya
Liem Vu
Timothy W. Robinson
Richard Wisdom
Elizabeth LING
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.)
Autonomix Medical Inc
Original Assignee
Autonomix Medical Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Autonomix Medical Inc filed Critical Autonomix Medical Inc
Publication of WO2025222080A1 publication Critical patent/WO2025222080A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/00267—Expandable means emitting energy, e.g. by elements carried thereon having a basket shaped structure
    • 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
    • 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
    • A61B2018/00434—Neural system
    • 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
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • 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
    • A61B2018/00791—Temperature
    • A61B2018/00797—Temperature measured by multiple temperature sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance

Definitions

  • the present disclosure relates to medical devices, such as delivery catheters, and to systems and methods for performing therapeutic electroporation of biologic tissues using such medical devices.
  • Illustrative embodiments provide medical devices configured for performing temperature-controlled therapeutic electroporation of biologic tissues.
  • a medical device comprises an elongate member, one or more expandable elements positioned on the elongate member, the one or more expandable elements being configured to expand radially outward from the elongate member, the one or more expandable elements having inner surfaces facing the elongate member and outer surfaces opposite the inner surfaces, at least a portion of the one or more expandable elements providing a radiofrequency ablation electrode, and a set of temperature sensors attached to the inner surfaces of at least one of the one or more expandable elements.
  • the elongate member may comprise a delivery catheter.
  • the one or more expandable elements may comprise a wire cage.
  • the wire cage may comprise a plurality of struts, the set of temperature sensors being attached to inner surfaces of at least two different ones of the plurality of struts.
  • the at least two different ones of the plurality of struts on which the set of temperature sensors are attached may be arranged such that when the one or more expandable elements are expanded radially outward from the elongate member, the set of temperature sensors are at two or more different positions of a circumference of the wire cage.
  • the set of temperature sensors may comprise at least four temperature sensors.
  • the set of temperature sensors may comprise thermocouples.
  • the medical device may further comprise one or more return electrodes, wherein the radiofrequency ablation electrode and at least one of the one or more return electrodes are configured to perform bipolar radiofrequency ablation.
  • the at least one of the one or more return electrodes may be disposed on the elongate member, on a guide sheath in which the elongate member is inserted, or on a flexible circuit surrounding at least a portion of the one or more expandable elements.
  • the medical device may further comprise a pull wire coupled to a distal tip of the elongate member, the pull wire being configured for retracting the distal tip of the elongate member to expand the one or more expandable elements radially outward from the elongate member.
  • the medical device may further comprise a controller configured to controllably expand the one or more expandable elements to bring the radiofrequency ablation electrode into contact with a wall of a lumen, to monitor a temperature of target tissues in a vicinity of the wall of the lumen utilizing the set of temperature sensors, and to control, based at least in part on the monitored temperature of the target tissues in the vicinity of the wall of the lumen, a current applied to the radiofrequency ablation electrode.
  • the controller may be further configured to monitor a tissue impedance of the target tissues in the vicinity of the wall of the lumen, and the current applied to the radiofrequency ablation electrode may be further controlled based at least in part on the monitored tissue impedance.
  • the medical device may further comprise a flexible circuit surrounding at least a portion of the one or more expandable elements.
  • the flexible circuit may comprise a plurality of struts, each of at least a subset of the plurality of struts comprising one or more sensing electrodes.
  • the medical device may further comprise an isolation layer disposed between the plurality of struts and the one or more expandable elements.
  • the medical device may further comprise one or more return electrodes disposed on the flexible circuit.
  • the medical device may further comprise a controller configured to controllably expand the one or more expandable elements to bring the radiofrequency ablation electrode into contact with a wall of a lumen, and to utilize the one or more sensing electrodes of the subset of the plurality of struts of the flexible circuit to determine an extent of ablation of different portions of target tissues in a vicinity of the wall of the lumen, the different portions being positioned at different locations of a circumference of the wall of the lumen.
  • the controller may be further configured to control, based at least in part on the determined extent of the ablation of the different portions of the target tissues, a current applied to the radiofrequency ablation electrode.
  • the one or more sensing electrodes of the subset of the plurality of struts may be configured for selective operation in a therapeutic mode, and the controller may be further configured to operate at least one of the one or more sensing electrodes of at least one of the plurality of struts in the therapeutic mode to apply current for radiofrequency ablation of at least one location of the circumference of the wall of the lumen based at least in part on the determined extent of the ablation of the different portions of the target tissues.
  • a medical device comprises an elongate member, one or more expandable elements positioned on the elongate member, the one or more expandable elements being configured to expand radially outward from the elongate member, the one or more expandable elements having inner surfaces facing the elongate member and outer surfaces opposite the inner surfaces, at least a portion of the one or more expandable elements providing a radiofrequency ablation electrode, and a flexible circuit surrounding at least a portion of the outer surfaces of the one or more expandable elements, the flexible circuit comprising a set of temperature sensors.
  • the elongate member may comprise a delivery catheter.
  • the one or more expandable elements may comprise a wire cage.
  • the set of temperature sensors may comprise at least four temperature sensors.
  • the set of temperature sensors may comprise thermocouples.
  • the medical device may further comprise one or more return electrodes, wherein the radiofrequency ablation electrode and at least one of the one or more return electrodes are configured to perform bipolar radiofrequency ablation.
  • the at least one of the one or more return electrodes may be disposed on the elongate member, on a guide sheath in which the elongate member is inserted, or on the flexible circuit.
  • the medical device may further comprise a pull wire coupled to a distal tip of the elongate member, the pull wire being configured for retracting the distal tip of the elongate member to expand the one or more expandable elements radially outward from the elongate member.
  • the medical device may further comprise a controller configured to controllably expand the one or more expandable elements to bring the radiofrequency ablation electrode into contact with a wall of a lumen, to monitor a temperature of target tissues in a vicinity of the wall of the lumen utilizing the set of temperature sensors, and to control, based at least in part on the monitored temperature of the target tissues in the vicinity of the wall of the lumen, a current applied to the radiofrequency ablation electrode.
  • the controller may be further configured to monitor a tissue impedance of the target tissues in the vicinity of the wall of the lumen, and the current applied to the radiofrequency ablation electrode may be further controlled based at least in part on the monitored tissue impedance.
  • the flexible circuit may comprise a plurality of struts, each of at least a subset of the plurality of struts comprising one or more sensing electrodes.
  • the medical device may further comprise an isolation layer disposed between the plurality of struts and the one or more expandable elements.
  • the set of temperature sensors may be attached to at least two different ones of the plurality of struts of the flexible circuit such that when the one or more expandable elements are expanded radially outward from the elongate member, the set of temperature sensors are at two or more different positions of a circumference of a wall of a lumen in which the medical device is deployed.
  • the medical device may further comprise a controller configured to controllably expand the one or more expandable elements to bring the radiofrequency ablation electrode into contact with a wall of a lumen, and to utilize the one or more sensing electrodes of the subset of the plurality of struts of the flexible circuit to determine an extent of ablation of different portions of target tissues in a vicinity of the wall of the lumen, the different portions being positioned at different locations of a circumference of the wall of the lumen.
  • the controller may be further configured to control, based at least in part on the determined extent of the ablation of the different portions of the target tissues, a current applied to the radiofrequency ablation electrode.
  • the one or more sensing electrodes of the subset of the plurality of struts may be configured for selective operation in a therapeutic mode, and the controller may be further configured to operate at least one of the one or more sensing electrodes of at least one of the plurality of struts in the therapeutic mode to apply current for radiofrequency ablation of at least one location of the circumference of the wall of the lumen based at least in part on the determined extent of the ablation of the different portions of the target tissues.
  • a method comprises delivering an elongate member of a medical device to a target site within a lumen, expanding one or more expandable elements positioned on the elongate member radially outward from the elongate member such that outer surfaces of the one or more expandable elements contact a wall of the lumen, at least a portion of the one or more expandable elements providing a radiofrequency ablation electrode, monitoring a temperature of target tissues in a vicinity of the wall of the lumen utilizing a set of temperature sensors attached to inner surfaces of at least one of the one or more expandable elements, and controlling a current applied to the radiofrequency ablation electrode based at least in part on the monitored temperature of the target tissues in the vicinity of the wall of the lumen.
  • the one or more expandable elements may comprise a wire cage, the wire cage may comprise a plurality of struts, and the set of temperature sensors may be attached to inner surfaces of at least two different ones of the plurality of struts.
  • the at least two different ones of the plurality of struts on which the set of temperature sensors are attached may be arranged such that when the one or more expandable elements are expanded radially outward from the elongate member, the set of temperature sensors are at two or more different positions of a circumference of the wire cage.
  • Expanding the one or more expandable elements radially outward from the elongate member may comprise retracting a pull wire coupled to a distal tip of the elongate member.
  • the method may further comprise determining an extent of ablation of different potions of target tissues in a vicinity of the wall of the lumen utilizing sensing electrodes disposed on at least a subset of a plurality of struts of a flexible circuit surrounding at least a portion of the one or more expandable elements, the different portions being positioned at different locations of a circumference of the wall of the lumen. Controlling the current applied to the radiofrequency ablation electrode may be further based at least in part on the determined extent of the ablation of the different portions of the target tissues.
  • the one or more sensing electrodes of the subset of the plurality of struts may be configured for selective operation in a therapeutic mode, and the method may further comprise operating at least one of the one or more sensing electrodes of at least one of the plurality of struts in the therapeutic mode to apply current for radiofrequency ablation of at least one location of the circumference of the wall of the lumen based at least in part on the determined extent of the ablation of the different portions of the target tissues.
  • the method may further comprise monitoring a tissue impedance of the target tissues in the vicinity of the wall of the lumen, and the current applied to the radiofrequency ablation electrode may be further controlled based at least in part on the monitored tissue impedance.
  • a method comprises delivering an elongate member of a medical device to a target site within a lumen, expanding one or more expandable elements positioned on the elongate member radially outward from the elongate member such that outer surfaces of the one or more expandable elements contact a wall of the lumen, at least a portion of the one or more expandable elements providing a radiofrequency ablation electrode, monitoring a temperature of target tissues in a vicinity of the wall of the lumen utilizing a set of temperature sensors attached to a flexible circuit surrounding at least a portion of the outer surfaces of the one or more expandable elements, and controlling a current applied to the radiofrequency ablation electrode based at least in part on the monitored temperature of the target tissues in the vicinity of the wall of the lumen.
  • the one or more expandable elements may comprise a wire cage.
  • the flexible circuit may comprise a plurality of struts, and the set of temperature sensors may be attached to at least two different ones of the plurality of struts of the flexible circuit such that when the one or more expandable elements are expanded radially outward from the elongate member, the set of temperature sensors are at two or more different positions of a circumference of a wall of a lumen in which the medical device is deployed.
  • the method may further comprise determining an extent of ablation of different potions of target tissues in a vicinity of the wall of the lumen utilizing sensing electrodes disposed on at least a subset of a plurality of struts of the flexible circuit, the different portions being positioned at different locations of a circumference of the wall of the lumen. Controlling the current applied to the radiofrequency ablation electrode may be further based at least in part on the determined extent of the ablation of the different portions of the target tissues.
  • the one or more sensing electrodes of the subset of the plurality of struts may be configured for selective operation in a therapeutic mode, and the method may further comprise operating at least one of the one or more sensing electrodes of at least one of the plurality of struts in the therapeutic mode to apply current for radiofrequency ablation of at least one location of the circumference of the wall of the lumen based at least in part on the determined extent of the ablation of the different portions of the target tissues.
  • the method may further comprise monitoring a tissue impedance of the target tissues in the vicinity of the wall of the lumen, and the current applied to the radiofrequency ablation electrode may be further controlled based at least in part on the monitored tissue impedance.
  • FIGS. 1A and IB show aspects of medical devices configured for therapeutic electroporation of target tissues in an illustrative embodiment.
  • FIG. 2 shows a block diagram of hardware components of a medical device in an illustrative embodiment.
  • FIG. 3 shows a method for operating a medical device for therapeutic electroporation of target tissues in an illustrative embodiment.
  • FIG. 4 shows examples of locations in which medical devices may be deployed for therapeutic electroporation of target tissues in an illustrative embodiment.
  • FIGS. 5A-5D show examples of ganglia locations and spatial relationships between a celiac trunk and a superior mesenteric artery in an illustrative embodiment.
  • FIGS. 6 A and 6B show a medical device with expandable elements configured with integrated temperature sensors enabling power-controlled and temperature-controlled therapeutic electroporation of target tissues in an illustrative embodiment.
  • FIG. 7 shows a medical device with expandable elements configured with integrated temperature sensors enabling power-controlled and temperature-controlled therapeutic electroporation deployed near to target tissues in an illustrative embodiment.
  • FIG. 8 shows a medical device with expandable elements and a flexible circuit with electrodes configurable for sensing and therapeutic applications surrounding the expandable elements in an illustrative embodiment.
  • FIG. 9 shows a medical device with expandable elements and a flexible circuit with electrodes configurable for sensing and therapeutic applications surrounding the expandable elements deployed near to target tissues in an illustrative embodiment.
  • FIGS. 10A and 10B show a guide sheath for a medical device with return electrodes positioned on the guide sheath to contact different regions of vessel walls in an illustrative embodiment.
  • Some embodiments provide catheter-based approaches which are more flexible than conventional structures, and include flexible sensing tips or other deployable mechanical structures for managing tortuosity and reduced diameter of vessels near to target treatment regions.
  • guide sheaths are integrated with catheter-based approaches for delivery to difficult or hard-to-reach locations.
  • Some embodiments also or alternatively utilize alternative insertion locations, possibly simultaneous insertion locations of multiple catheter-based devices, such as femoral and brachial, femoral and radial, etc.
  • a combined femoral and radial insertion approach is leveraged due to higher caseload and commonality among practitioners. This, however, may require increasing the length of the catheter-based devices which are used.
  • Another technical challenge is related to stenosis in vessels, which reduces their inner diameter and presents challenges for delivery of catheter-based devices. Stenosis may be a result of tumor growth.
  • these challenges are addressed through utilizing a compact construction of catheter-based devices.
  • catheter-based devices may be designed with an outer diameter that is 5 French gauge (Fr) or smaller.
  • Fr French gauge
  • These challenges may also or alternatively be addressed through the use of alternative insertion locations as described above (e.g., brachial, radial, etc.), which may result in increasing the length of the catheter-based devices which are used.
  • electroporation or other ablation techniques are utilized where both anterior and posterior walls of a vessel are ablated, which increases the chances of hitting the target ganglia.
  • Such processing is achieved in some embodiments through the use of increased flexibility at the catheter tip level (e.g., a type “A” curvature), the use of a soft expandable tip to bring anterior and posterior portions of a basket or other deployable structure into contact with the vessel at the same time, and/or the use of electrode structures with at least a designated threshold length (e.g., 4 millimeter (mm) or longer electrode structures).
  • a designated threshold length e.g., 4 millimeter (mm) or longer electrode structures.
  • Electroporation or other ablation techniques may, in some cases, result in activation of the Vagus nerve of a subject which could fire temporary pain to posterior upper-level muscles like the shoulder blade, upper back, etc.
  • Such undesirable activation of the Vagus nerve may be addressed, in some embodiments, through limiting the duration of the electroporation or other ablation process (e.g., to no longer than a minute or some other designated threshold, which may be shortened at the clinician’s discretion).
  • Such challenges may also be addressed through the use of electroporation, pulsed field ablation (PF A) or other radio frequency (RF)-based nonthermal and thermal ablation processes which have less impact on the Vagus nerve during treatment.
  • PF A pulsed field ablation
  • RF radio frequency
  • catheter-based devices which facilitate electrode contact at various sections along a circumference of the vessels (e.g., the “top” and “bottom” sections of the vessels) in which the devices are deployed.
  • the catheter-based devices advantageously have a small tip diameter (e.g., a 5Fr maximum), with a tip curve style that matches type “A”, which is non-irrigated, and has increased flexibility when compared with conventional catheter devices.
  • the catheter-based devices in some embodiments eliminate articulation, irrigation ports and extra stiffness.
  • a medical device may include one or more expandable elements, such as a wire cage, a balloon, etc.
  • the one or more expandable elements of the medical device are formed such that, upon expansion near to one or more target regions that are to be treated, the expandable elements contact an inner diameter or surface of a vessel in which the medical device is deployed.
  • Regions which may be accessed and/or targeted using the medical devices described herein include, but are not limited to: tubes or vessels (e.g., arteries, veins, lymphatic vessels, etc.) including bifurcated vessels, near to a bifurcation, between vessels near a bifurcation, between adjacent arteries and veins; vessels within an organ, within soft tissues, chamber walls (e.g., through the thickness of a chamber wall); into vessels within a wall of the heart; vessel entrances and/or exits to one or more chambers (e.g., of the heart or other organs or target tissues); microvasculature; within the vasculature and/or microvasculature of a bone; within the marrow of a bone; along a vessel as and down into an organ or other target tissues; a lobe of an organ, a region within an organ, a tumor, the vasculature serving a tumor, etc.
  • tubes or vessels e.g., arteries, veins, lymphatic vessels,
  • the medical device may include means for measuring the impedance of the tissue interface, where such measurement may be performed prior to and between delivery of therapeutic energy thereto. Such an approach may be used to limit the potential for arching and/or barotrauma in the vicinity of target treatment sites.
  • the medical device includes one or more sensors configured to determine impedance between a target treatment region and a return path.
  • the impedance may be used to dictate or control the energy delivered during one or more PFA or other therapeutic pulses.
  • the impedance may also be used to monitor for changes in the impedance of nearby tissues as pulse trains are delivered (e.g., to determine the changes from pulse to pulse in the train, during breaks between pulse trains, combinations thereof, etc.).
  • the medical device may also or alternatively include one or more sensors configured to determine the local temperature near the target treatment region, such that the temperature may be used as feedback to limit and/or regulate delivery of therapy to the target treatment region.
  • the medical device may further or alternatively include one or more sensors configured to tailor the energy delivery in a pulse (e.g., to the level needed to establish a therapeutic field gradient in the tissues adjacent to the target treatment region).
  • a system may include means for measuring cardiac ventricular activity, the system including an algorithm configured to apply pulses in synchronization with the measured activity so as to prevent ventricular fibrillation or other proarrhythmic effects during therapy.
  • the system may include an algorithm to tailor the pulses and pulse trains to minimize and/or eliminate local skeletal muscle contraction and pain associated with application of therapeutic pulses.
  • Such pulse characteristics may be adjusted to a period of less than 100 microseconds (ps), less than 20ps, less than lOps, less than 5ps, less than 2ps, less than Ips, less than 0.4ps, or the like.
  • the pulse width may be variable between 0.2ps and lOps throughout the pulse train.
  • Each pulse may be formed as preferably an asymmetrical bipolar signal, the asymmetric bipolar signal changing in polarity throughout the pulse train, and the pulse spacing may be on the order of less than 1,000 milliseconds (ms), less than 100ms, less than 5ms, less than 1ms, less than 500ps, less than lOOps, less than 25ps, less than lOps, less than 2ps, or the like.
  • Such pulse trains may be used to limit the need for general anesthesia/paralytics and intubation of patients prior to therapy.
  • the asymmetrical pulses may be applied in reverse polarity throughout the pulse chain, to minimize changes of muscle contraction while increasing the produced ablation volumes.
  • the asymmetrical pulses may be adjusted throughout the train such that charge delivery is initially biased in a first polarity (e.g., a positive polarity), then in a second, opposite polarity (e.g., a negative polarity), with the timespan of the variation between first and second opposite polarities changing on a scale that is sufficiently rapid so as to minimize long-term charging of tissues, but yet long enough so as to maximize local electroporation of nearly tissues.
  • a changing polarity bias may change at a rate of greater than 100Hz, greater than 1,000Hz, 10,000Hz or the like.
  • the amplitude of the bias may be adjusted in real-time during pulse delivery to minimize long-term charging of remote tissues from the treatment site.
  • the amplitude of the bias may be adjusted from +/-100% (e.g., essentially a monophasic pulse train), through to 0% (e.g., a balanced biphasic pulse train).
  • the amplitude of the bias may be adjusted based on charge measurements made from one or more remote sites on and/or in the body of the subject (e.g., from a remote internally placed electrode, from a patch electrode on the body, etc.).
  • the bias may be adjusted so as to prevent stimulation of nerves and/or muscles in such tissues, thus potentially obviating the need for general anesthesia and/or application of paralytic agents during a procedure.
  • ablation volumes may be increased by a factor of at least 2x, and often up to 5x, that of a symmetric pulse train.
  • Asymmetric pulses imply a biphasic pulse where a positive and negative amplitude and/or pulse width may be different from each other.
  • the pulse train may be configured such that asymmetry of the pulse train changes from primarily longer positive polarity pulses to primarily longer negative polarity pulses over the overall delivery period of the pulse train.
  • the frequency with which the asymmetry shifts from positive to negative and back may be on the order of greater than 1kHz, greater than 10kHz, greater than 100kHz, or the like.
  • the shifting asymmetry throughout the pulse train allows for the application of asymmetric pulses to the tissue (e.g., thus potentially lowering the ablation thresholds thereof), while providing short-term charge asymmetry to the target tissues, maintaining a long-term neutral overall energy delivery and minimizing long-term charge imbalance around the treatment site.
  • tailoring of the electrically applied pulses to focus on ultra-high frequency pulse application may significantly improve the field gradients around the intended target tissues, while limiting procedural times and risk to the patient during such procedures.
  • Electrical pulses may be applied in such a manner so as to establish field gradients in the target tissue of greater than 500 volts per centimeter (V/cm), greater than 700V/cm, greater than l,500V/cm, greater than 4,000V/cm, or the like.
  • the pulses may be provided as bipolar pulses, and may be provided as asymmetrically bipolar pulses to maximize local charge fluctuations in adjacent tissues, thus potentially lowering the therapeutic threshold in such tissues and more easily establishing irreversible changes with minimal input energy.
  • the medical devices described herein may be used in approaches for applying treatment to a tumor.
  • a medical device for treating a region of target tissue may include an elongate catheter, the elongate catheter shaped with a tip so as to be delivered into the local arterial supply of the target tissue.
  • the medical device also includes one or more electrodes, the one or more electrodes attached to the tip of the catheter or an extendable component thereof (e.g., a guidewire).
  • the one or more electrodes are positioned along the outer surface of the catheter tip (or the extendable component thereof) to couple electrically within a region surrounding the catheter tip (or the extendable component thereof).
  • the medical device may further include one or more expandable elements, the one or more expandable elements being configured (when expanded) so as to contact an inner surface of a vessel in which the catheter tip is deployed during expansion thereof.
  • the expandable elements may provide at least one of the one or more electrodes attached to the tip of the catheter.
  • the medical device may include or be coupled to a generator, configured to accommodate delivery of pulses (e.g., PFA pulses) through the generator to at least one of the one or more electrodes of the medical device during use.
  • pulses e.g., PFA pulses
  • a system including the medical device provides a means (e.g., a generator) for controllably delivering electrical pulses to one or more of the electrodes.
  • the generator may be coupled to deliver electrical pulses, through the one or more electrodes, to the adjacent target tissues.
  • the system may include one or more sensing electrodes (e.g., which may be on the catheter or guidewire of the medical device) which are used, for example, in monitoring the local temperature at different locations, for monitoring an effect of an ablation process, etc.
  • sensing electrodes e.g., which may be on the catheter or guidewire of the medical device
  • Electric fields provide the principal therapeutic mechanism for biologic cell membrane modification. Electric fields across cell membranes result in membrane permeability, which is generally proportional to field strength and temporal duration of membrane-field exposure. Electric field strength may be measured in volts per meter (V/m), where one V/m is the electrical potential difference of 1 volt (V) at two points separated by one meter. Electric flux intensity measures may also be used. Electroporation may be ablative and/or therapeutic, allowing drugs or biomolecules to cross the cell membrane and interact with the cytosolic components and the nucleus. Electroporation may also initiate cell death if membrane pores are large enough and present long enough to allow intracellular and/or nucleus death.
  • the systems and medical devices described herein enable creation and modification of electric fields in three spatial dimensions, and also enable application of time dependent electric field strength variation.
  • the flexibility of these methods may be used to optimize field strength (e.g., in space and time), and result in vastly improved therapeutic effects.
  • Such therapeutic effects may entail optimizing effective formation of pores in the target cells, affecting the size of the pores formed in the cells, increasing the number of pores formed in the cell walls, and/or lengthening the time that pores remain open after application of the fields for either therapy or toxicity (e.g., resulting in degraded cell function or cell death).
  • Electric fields may be delivered to target tissues using spatial field shaping, allowing optimal field strength matched to create maximal therapeutic or toxic effect.
  • the temporal field changes are independent of spatial changes, permitting time-varying electric fields of optimal shape.
  • Biologic and medical applications may require therapy at a multiplicity of internal bodily sites, with different tissues to be treated. Electric fields for electroporation and other therapy must be delivered to various target sites within the body.
  • the medical devices described herein provide catheter systems for traversing the required paths, with the catheter systems including one or more electrically conductive wires. Because the target biologic tissues may be of irregular 3D shapes, optimal delivery requires electric fields that can conform to and/or encompass the target tissue.
  • systems and medical devices use one or more RF electrodes and return electrodes (possibly along with various sensing electrodes as described elsewhere herein), where such electrodes may have a multiplicity of components having opposite polarity (e.g., positive and negative).
  • electrodes of 3D configuration are used, where the RF electrodes are, for example, positioned at the terminus (e.g., the distal tip) of a delivery catheter (e.g., on expandable elements thereof).
  • the medical device may include a guidewire configured to guide the delivery catheter and electrodes to a target site, provide electric potential to the distal tip (e.g., where the RF electrodes may be positioned), etc.
  • the 3D configuration of the one or more RF electrodes, combined with complementary return electrodes guides the pattern of delivery of energy (e.g., for PF A).
  • the voltage applied controls the field strength, while temporal variation in field strength may be used to modulate biologic effects.
  • Electrodes may be used, including front firing, lateral firing (e.g., where the field has a component perpendicular to the delivery catheter/guidewire), etc.
  • the electrodes may also be positioned on flat opposing surfaces, which may or may not be parallel, including clamp configurations which can grasp tissue and apply an electric field.
  • Additional electrode configurations which may be used include torus, spherical, ribbon and pyramidal configurations.
  • the medical devices described herein may be used for providing therapy to various target regions, including various organs, tissues, nerves, tumors, ganglion sites, etc.
  • Therapy may include innervation along a target anatomy, innervation within the organ parenchyma, smooth muscle innervation in arteries, fluid transfer into the microvasculature around vessels, targeting organ resurfacing, ganglion access which may be combined with recordings for ganglia localization.
  • Internal vessel and external approaches are enabled.
  • the medical devices described herein may be used with methods for determining when a procedure or therapy is completed, for providing bipolar asymmetrically undulating PFA pulses, etc.
  • a pulse train used for PFA includes asymmetric pulses of opposite polarity.
  • Positive voltage pulses with amplitude V p may be applied for a time ti, with each of the positive voltage pulses being followed by a negative voltage pulse with amplitude V n that is applied for a time t2 (e.g., where t2 ⁇ ti).
  • the negative voltage pulses are applied at a time t3 from a beginning of time ti.
  • the time between the sets of asymmetric pulses is denoted time t4.
  • the pulse train may include a changing polarity bias from an amplitude of Ebi (e.g., +100%) through to an amplitude of Eb2 (e.g., -100%) over a time period denoted ts.
  • Negative voltage pulses with amplitude V n are applied for a time te, with each of the negative voltage pulses being followed by a positive voltage pulse with amplitude V p that is applied for a time t? (e.g., where t? ⁇ te).
  • the positive voltage pulses are applied at a time ts from a beginning of time te.
  • the time between the sets of asymmetric pulses is denoted time t9.
  • Overall signal bias may be adjusted by altering the ratio between the positive pulse voltage and negative pulse voltage, by adjusting the ratio between the positive pulse width and negative pulse width, or the like. Such alterations may be completed at a frequency with which the bias shifts from positive to negative and back, and may be on the order of greater than 1kHz, greater than 10kHz, greater than 100kHz, or the like.
  • the shifting asymmetry throughout the pulse train allows for the application of asymmetric pulses to the tissue (e.g., thus potentially lowering the ablation thresholds thereof), while providing short-term charge asymmetry to the target tissues, maintaining a long-term neutral overall energy delivery and minimizing long-term charge imbalance around the treatment site.
  • one or more sensors may be applied to the body of the subject, the sensors configured to monitor for changes in local charge accumulation and/or electric field during the application of pulses to the subject.
  • the bias of the pulse train may be adjusted to prevent the long-range charge accumulation and/or potential from increasing beyond a threshold, such as a threshold needed to stimulate muscles, muscle endplates, and/or nerves in the far field regions of the body of the subject.
  • the applied pulses may be substantially square wave in nature.
  • the shape and frequency content of the waveform may be adjusted to selectively target tissue types within the target tissues (e.g., stem cells, bone cells, blood cells, muscle cells, fat cells, skin cells, nerve cells, endothelial cells, sex cells, pancreatic cells, and/or cancer cells).
  • tissue types e.g., stem cells, bone cells, blood cells, muscle cells, fat cells, skin cells, nerve cells, endothelial cells, sex cells, pancreatic cells, and/or cancer cells.
  • FIG. 1A shows a medical device 100 (e.g., a catheter-based medical device) which includes one or more lumens 121 which are coupled to a handle 110 and contained within catheter walls 123.
  • the lumens 121 may include a catheter body, one or more guidewires (e.g., guidewire 126 shown in FIG. IB) configured to extend from a tip of the catheter body, etc.
  • the medical device 100 further includes an expandable element 122 configured to expand 125, the expandable element 122 being proximate a distal end of the lumens 121.
  • the handle 110 includes a connector that provides a mechanical and electrical interface between the medical device 100 and one or more other modules of a system, such as a control unit 130 configured to accept one or more signals from the medical device 100, communicate one or more control signals thereto, etc.
  • the handle 110 may also or alternatively include or be coupled with one or more operator input devices (e.g., a foot pedal, an advancing slider, a torquing mechanism, a recording button, an ablation button, etc.).
  • the control unit 130 may be connected to a display (not shown) configured to present one or more aspects of recorded signals from the medical device 100 to an operator.
  • the control unit 130 may also or alternatively be coupled to a surgical subsystem (not shown) configured to perform a surgical procedure on a target region.
  • surgical procedures include an ablation, such as electroporation, PFA or other RF-based non-thermal and thermal ablation procedures.
  • the control unit 130 may be configured to influence, direct, control and/or provide feedback based on signals conveyed by the medical device 100 and/or other devices which are configured to monitor a subject.
  • FIG. IB shows additional aspects of the medical device 100, including a guidewire 126 that extends through the lumens 121.
  • FIG. 2 shows a hardware block diagram of a medical device 200, which includes a processor, memory, clock, peripherals, signal conditioning circuitry, power, a controller, one or more sensors, and a pulse generator (e.g., for applying pulses or energy to electrodes which are part of the expandable element 122).
  • the medical devices described herein may be used for providing therapy to various target regions, including various organs, tissues, nerves, tumors, ganglion sites, etc.
  • Therapy may include innervation along a target anatomy, innervation within the organ parenchyma, smooth muscle innervation in arteries, fluid transfer into the microvasculature around vessels, targeting organ resurfacing, ganglion access which may be combined with recordings for ganglia localization. Internal vessel and external approaches are enabled.
  • FIG. 3 shows a method 300 which may be performed using a medical device described herein. The method 300 begins with accessing target tissues, such as by delivering a catheter via one or more vessels of a subject to access a region proximate the target tissues.
  • the method continues with deploying expandable elements of the catheter, such that electrodes on the expandable elements contact multiple locations around a circumference of the inner surface (e.g., “top” and “bottom” surfaces) of a vessel proximate the target tissues. Energy is then applied to the electrodes on the expandable elements (e.g., application of energy pulses) to perform an ablation procedure.
  • energy is then applied to the electrodes on the expandable elements (e.g., application of energy pulses) to perform an ablation procedure.
  • FIG. 4 shows non-limiting examples of locations in which the medical devices described herein may be deployed, including the abdominal aorta, celiac trunk, common hepatic artery, left gastric artery, right gastric artery, hepatic artery proper, gastroduodenal artery, duodenal branch, superior pancreaticoduodenal artery, inferior pancreaticoduodenal artery, superior mesenteric artery, splenic artery (including the pancreatic branch of the splenic artery), left gastro-epiploic artery, and the right gastro-epiploic artery. Renal (both left and right) arteries are also examples of target anatomies.
  • FIGS. 5A-5D illustrate ganglia locations and spatial relationships between celiac ganglia (CG), both left (L-CG) and right (R-CG), the celiac trunk (CT) and the superior mesenteric artery (SMA).
  • CG celiac ganglia
  • L-CG left
  • R-CG right
  • CT celiac trunk
  • SMA superior mesenteric artery
  • FIG. 5B shows how a portion of the CG protrudes below the origin of the SMA, sometimes reaching the level of the left renal vein.
  • FIG. 5C shows that only a small number of CF protrude (markedly or slightly) above the level of the CT, sometimes extending also below the SMA (distinctly or slightly) as shown in FIG. 5D.
  • a medical device includes a deployable RF basket with integrated temperature sensors to monitor power-controlled, temperature-controlled and/or impedance-controlled RF during an ablation procedure (e.g., electroporation, PF A, etc.).
  • the medical device is configured to monitor temperature utilizing the temperature sensors, and it configured to measure tissue impedance between the “active” or RF ablation electrodes and the “return” electrodes. In the case of monopolar RF ablation, the tissue impedance measurement is taken between the active or RF ablation electrodes (e.g., the deployable RF basket) and a return pad (e.g., placed on the patient’s back).
  • the return electrode may be placed on a ringlet near to the deployable RF basket, elsewhere on the catheter body, or on a guide sheath, and the tissue impedance measurement is taken between the active electrode and the return electrode (e.g., where there are multiple return electrodes, a closest one to the active electrode that is able to make the measurement).
  • the tissue impedance measurement is taken between the active electrode and the return electrode (e.g., where there are multiple return electrodes, a closest one to the active electrode that is able to make the measurement).
  • the tissue impedance measurement is taken between the active electrode and the return electrode (e.g., where there are multiple return electrodes, a closest one to the active electrode that is able to make the measurement).
  • the return pads are significantly larger than the active electrode size, to prevent energy concentration at the return site and therefore prevent burns.
  • FIGS. 6 A and 6B show a portion of a medical device 600, including a catheter body 601, a first ringlet 603, a second ringlet 605, a pull wire 607, and a deployable basket 609.
  • the deployable basket 609 may include a longitudinal wire cage with struts 690 that are connected through the catheter body 601 to an operating fixture, a control circuit, a signal conditioning circuit, a handheld control unit, a surgical robot, a coupling, etc.
  • the struts 690 are connected to the first ringlet 603 and the second ringlet 605, and are arranged along the inside of the catheter body 601 (or a guide sheath disposed over the delivery catheter).
  • the struts 690 may have pre-biased shapes, such that upon retraction of the pull wire 607 within the catheter body 601, the struts 690 of the deploy able basket 609 deploy radially outward towards an anatomical site of interest (e.g., a surgical site, a tissue surface, a lumen wall, etc.) as shown in FIG. 6B.
  • the deployable basket 609 may be formed of a metal material, nitinol, etc. When an electrical current is applied to the deployable basket 609, the struts 690 thereof heat up and provide an RF electrode for performing an ablation procedure.
  • the first ringlet 603 and the second ringlet 605 are configured to accommodate passage of the pull wire 607 and the deployable basket 609 through the catheter body 601.
  • the first ringlet 603 and/or the second ringlet 605 may also provide return electrodes for enabling bipolar RF or PFA energy modes.
  • the struts 690 of the deployable basket 609 are arranged such that, upon deployment (e.g., as shown in FIG. 6B), the struts 690 contact the inner surface of a lumen or vessel wall. Such a configuration may be advantageous to maintain contact between one or more of the struts 690 with the lumen walls during a procedure without inhibiting flow of fluids through lumen.
  • the wire cage may be advanced and/or retracted, along a lumen (not explicitly shown) and/or expanded/contracted as part of a procedure, a deployment, and/or a retraction procedure within the lumen during procedures related to searching for anatomical sites of interest, performing sensing, mapping, surgical treatments, ablation, etc.
  • one or more of the struts 690 are equipped with a set of thermocouples or other integrated temperature sensors (e.g., thermocouples) 611-1, 611-2, 611-3 and 611-4 (collectively, temperature sensors 611).
  • FIG. 6B shows an arrangement with four temperature sensors 611, this is not a requirement. More or fewer temperature sensors may be utilized as desired in order to provide monitoring of temperature at desired locations during an ablation procedure performed utilizing the medical device 600. Further, the particular locations (e.g., which of the struts 690) that the temperature sensors 611 are attached to may vary.
  • the temperature sensors 611 are illustratively mounted on an interior of the deployable basket 609 (e.g., such that when the deployable basket 609 is deployed as shown in FIG. 6B, the struts 690 contact the interior surface of the lumen or vessel wall and the temperature sensors 611 are behind the struts 690).
  • RF energy is controllably delivered along the struts 690 of the deployable basket 609 for performing an ablation procedure (e.g., RF, PF A, etc.).
  • the temperature sensors 611 are configured to monitor ablation temperatures around an inner circumference of a vessel or lumen in which the medical device 600 is deployed. This facilitates both power-controlled and temperature-controlled RF modes for application of RF energy to the deployable basket 609.
  • return electrodes are installed at different locations, such as on the first ringlet 603 and/or the second ringlet 605, on an outer surface of the catheter body 601 (e.g., return electrodes 613 shown in dashed outline), a guide sheath through which the catheter body 601 is deployed. This enables bipolar RF or PFA energy modes.
  • the deployable basket 609 ensures that the medical device 600 provides contact across a circumference of an interior wall of a vessel or other lumen in which the medical device 600 is deployed, when the deployable basket 609 is in a deployed position as shown in FIG. 6B.
  • the thickness and number of the struts 690 in the deployable basket 609 may be selected so as to match the surface area requirement of a desired ablation procedure, so as to ensure proper current density going into the vessel tissue in order to target nerve tissue irreversible damage. Further, the pattern of the struts 690 is selected to allow high flexibility while maintaining a contact surface equivalent to ensure desired current density into the tissue.
  • FIG. 7 shows an example where a medical device 700 (e.g., similar to the medical device 600 shown in FIGS. 6A and 6B) is deployed within vessels 70 and 75 of a subject.
  • the medical device 700 includes a catheter body 701, a first ringlet 703, a second ringlet 705, a pull wire 707, a deployable basket 709, and temperature sensors 711-1, 711-2, 711-3 and 711-4 (collectively, temperature sensors 711) deployed at different locations on inner surfaces of struts of the deployable basket 709.
  • the medical device 700 includes a deployment mechanism with a biased deflection at the tip level to navigate tortuous vessel paths and constrictions (e.g., as shown by the path of the vessels 70 and 75).
  • the deflection angle 725 at the tip level is achieved by a combination of a memory shaped metal wire installed at the tip (but disconnected from the rest), allowing a most distal curvature without need of an articulation system.
  • An external sheath (not shown) of the medical device 700 is formed of a variant durometer to prevent buckling (e.g., more proximally rigid) and highly flexible at the distal sections.
  • FIG. 8 shows a medical device 800, which similar to the medical device 600 includes a catheter body 801, a first ringlet 803, a second ringlet 805, a pull wire 807, and a deployable basket 809 (e.g., a longitudinal wire cage with struts that are connected through the catheter body 801 to an operating fixture, a control circuit, a signal conditioning circuit, a handheld control unit, a surgical robot, a coupling, etc.).
  • the struts of the deployable basket 809 are connected to the first ringlet 803 and the second ringlet 805, and are arranged along the inside of the catheter body 801 (or a guide sheath disposed over the delivery catheter).
  • the struts may have pre-biased shapes, such that upon retraction of the pull wire 807 within the catheter body 801, the struts of the deployable basket 809 deploy radially outward towards an anatomical site of interest (e.g., a surgical site, a tissue surface, a lumen wall, etc.).
  • the deployable basket 809 may be formed of a metal material, nitinol, etc. When an electrical current is applied to the deployable basket 809, the struts thereof heat up and provide an RF electrode for performing an ablation procedure.
  • the first ringlet 803 and the second ringlet 805 are configured to accommodate passage of the pull wire 807 through the catheter body 801.
  • the first ringlet 803 and/or the second ringlet 805 may also provide return electrodes for enabling bipolar RF or PFA energy modes, in addition to or in place of optional return electrodes (e.g., return electrode 813) positioned on an outer surface of the catheter body 801.
  • return electrodes e.g., return electrode 813
  • the medical device 800 further enables nerve potential sensing, through the addition of a flexible circuit 815 wrapping around the deployable basket 809 in specific areas.
  • the flexible circuit 815 includes a set of splines 817-1, 817-2, 817-3 and 817-4 (collectively splines 817) which hug the outside of the deployable basket 809.
  • the splines 817 may include an isolation layer on portions of surfaces thereof which contact the struts of the deployable basket 809.
  • the splines 817 include sensing electrodes positioned on outer surfaces thereof (e.g., the surfaces of the splines 817 which will contact the inner surface of the vessel or other lumen in which the deployable basket 809 has been deployed).
  • spline 817-4 includes electrodes 819-1 and 819-2 (collectively, electrodes 819).
  • the other splines 817 similarly include sets of electrodes.
  • FIG. 8 shows an example where each of the splines 817 includes two electrodes, this is not a requirement. Different ones of the splines 817 may include different numbers of electrodes, some of the splines 817 may not include any electrodes, etc.
  • Adding the flexible circuit 815 may require masking of the deployable basket 809 from the RF energy which is applied via the struts thereof, which may be addressed through the addition of a thin insulator layer (not shown in FIG. 8) between the splines 817 and the outside of the deployable basket 809 (e.g., the struts thereof).
  • the flexible circuit 815 may be formed of polyimide or another suitable flexible semiconductor material.
  • the electrodes 819 are configurable in sensing and therapeutic modes.
  • the electrodes 819 may operate as sensing electrodes to perform monitoring (e.g., of temperature, electrophysiological signals, etc.) before, during and/or after an ablation procedure applied via the deployable basket 809. This may include nerve sensing or other electrophysiological sensing to determine the extent of ablation in different areas or regions of the circumference of the vessel or other lumen in which the medical device 800 is deployed.
  • the electrodes on one or more of the splines 817 may be configured to operate in a therapeutic mode in which RF ablation current is applied to such electrodes to perform additional ablation in such areas or regions which need additional ablation.
  • FIG. 9 shows an example where a medical device 900 (e.g., similar to the medical device 800 shown in FIG. 8) is deployed within vessels 90 and 95 of a subject.
  • the medical device 900 includes a catheter body 901, a first ringlet 903, a second ringlet 905, a pull wire 907, a deployable basket 909, a flexible circuit 915 surrounding the deployable basket 909, the flexible circuit 915 including splines 917 on which electrodes 919 are mounted.
  • the medical device 900 includes a deployment mechanism with a biased deflection at the tip level to navigate tortuous vessel paths and constrictions (e.g., as shown by the path of the vessels 90 and 95).
  • the deflection angle 925 at the tip level is achieved by a combination of a memory shaped metal wire installed at the tip (but disconnected from the rest), allowing a most distal curvature without need of an articulation system.
  • An external sheath (not shown) of the medical device 900 is formed of a variant durometer to prevent buckling (e.g., more proximally rigid) and highly flexible at the distal sections.
  • a catheter-based medical device may utilize a guide sheath (e.g., surrounding a catheter body such as catheter body 601, 701, 801 or 901).
  • Local and return electrodes are arranged so as to target specific ganglia (e.g., near the base of the celiac trunk) enabling bipolar RF or PFA ablation.
  • the return electrodes are installed at the guide sheath level, biasing the current to the root of the trunk and further focusing the target (e.g., the celiac ganglia).
  • Return electrodes at the guide sheath level may be deployable to ensure surface contact with inner walls of the vessels in which the guide sheath is placed (e.g., the root of the celiac trunk), as the guide sheath is placed to enable entry for a catheter-based medical device (e.g., medical device 600, 700, 800 or 900) into more distal vessel structures.
  • the return electrodes may thus be expanded along the root of the ostium of the celiac trunk or other vessel in which the guide sheath is positioned.
  • FIGS. 10A and 10B show an example of a guide sheath device 1000 including a guide sheath body 1001 on which a set of return electrodes 1003-1, 1003-2 and 1003-3 (collectively, return electrodes 1003) are attached.
  • return electrodes 1003 By placing the return electrodes 1003 at multiple locations on the guide sheath body 1001, this enables flexibility for allowing contact of at least one of the return electrodes 1003 with inner walls of different vessels based on the placement and advancement of the guide sheath device 1000.
  • FIGS. 10A and 10B show an example of a guide sheath device 1000 including a guide sheath body 1001 on which a set of return electrodes 1003-1, 1003-2 and 1003-3 (collectively, return electrodes 1003) are attached.
  • return electrodes 1003 By placing the return electrodes 1003 at multiple locations on the guide sheath body 1001, this enables flexibility for allowing contact of at least one of the return electrodes 1003 with inner walls of different vessels based on the placement and advancement of the guide
  • 10A and 10B also show a catheter device 1050 which is routed through the guide sheath body 1001, with a distal tip of the catheter device 1050 providing an active electrode 1055 for performing bipolar RF or PFA ablation using the active electrode 1055 and one or more of the return electrodes 1003 of the guide sheath device 1000.
  • the return electrode 1003-3 contacts an inner wall of vessel 15 and the return electrode 1003-2 contacts the inner wall where the vessel 10 and vessel 15 branch.
  • the return electrode 1003-1 contacts the inner wall of vessel 10. This approach will maximize energy delivery to the regions of the ganglia around the celiac trunk (e.g., vessel 10) as well as along the vessels (e.g., dual targeting of nerves along the vessel trunk and direct targeting of ganglia).
  • such a system e.g., a combination of one of the medical devices 600, 700, 800 or 900 and the guide sheath device 1000
  • a system allows for targeting energy delivery to ganglia which are not located along the celiac artery and distal arterial branches.
  • the overall system is simplified as no return patch electrodes are needed on the subject.
  • the construction of an electrode basket e.g., deployable basket 609, 709, 809, 909 is designed to minimize impact on flexibility and tortuous vessel maneuvering, and enables easy integration of RF/PFA and a sensing electrode array (e.g., such as that provided using the flexible circuit 815, 915).
  • the entire deployable basket is exposed as a large, full contact electrode enabling directed energy delivery to regions of ganglia in which associated devices are deployed.
  • PFA ablation such systems will also advantageously reduce muscular spasm as the current delivery is collocated along the catheter body and does not deviate to form inductive pathways.
  • ganglia For subjects with cancer, having the ability to target desired ganglia opens various opportunities, depending on where a tumor is located and which nerve pathways are being engaged by the tumor. Ganglia are often organized along the aorta near the target plexuses, so the ability to bring energy delivery to those regions in an easy way will help with these and other types of therapies (e.g., including therapies for cancer treatment, for treatment of cancer pain, etc.).
  • therapies e.g., including therapies for cancer treatment, for treatment of cancer pain, etc.

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Abstract

La présente invention concerne un dispositif médical qui comprend un élément allongé et un ou plusieurs éléments extensibles positionnés sur l'élément allongé, le ou les éléments extensibles étant conçus pour s'étendre radialement vers l'extérieur à partir de l'élément allongé. Le ou les éléments extensibles comportent des surfaces internes tournées vers l'élément allongé et des surfaces externes opposées aux surfaces internes. Au moins une partie du ou des éléments extensibles fournit une électrode d'ablation par radiofréquence. Un ensemble de capteurs de température est fixé aux surfaces internes d'au moins l'un du ou des éléments extensibles, ou sur un circuit souple entourant au moins une partie des surfaces externes du ou des éléments extensibles.
PCT/US2025/025299 2024-04-19 2025-04-18 Dispositifs médicaux conçus pour une électroporation thérapeutique à température régulée Pending WO2025222080A1 (fr)

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