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WO2025176533A1 - Ablation intracardiaque du septum interventriculaire et dispositifs, systèmes et procédés associés - Google Patents

Ablation intracardiaque du septum interventriculaire et dispositifs, systèmes et procédés associés

Info

Publication number
WO2025176533A1
WO2025176533A1 PCT/EP2025/053746 EP2025053746W WO2025176533A1 WO 2025176533 A1 WO2025176533 A1 WO 2025176533A1 EP 2025053746 W EP2025053746 W EP 2025053746W WO 2025176533 A1 WO2025176533 A1 WO 2025176533A1
Authority
WO
WIPO (PCT)
Prior art keywords
compliant balloon
electrodes
balloon
aspects
stent
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2025/053746
Other languages
English (en)
Inventor
Thomas John Mcpeak
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Koninklijke Philips NV
Original Assignee
Koninklijke Philips NV
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Filing date
Publication date
Application filed by Koninklijke Philips NV filed Critical Koninklijke Philips NV
Publication of WO2025176533A1 publication Critical patent/WO2025176533A1/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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • 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
    • A61B2018/0022—Balloons
    • A61B2018/0025—Multiple 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
    • A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
    • 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
    • A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
    • A61B2018/00285—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—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

Definitions

  • the subject matter described herein relates to systems, devices, and methods for reducing the size (e.g., volume, area) of the heart’s interventricular septum using electrodebased intracardiac ablation.
  • This interventricular septum ablation system has particular but not exclusive utility for addressing left ventricular outflow tract occlusions (e.g., in valve replacement procedures) and/or treating hypertrophic cardiomyopathy.
  • one option is an alcohol ablation of the septal tissue, which involves gaining catheter access to the coronary arteries, sub-selecting one that supplies the appropriate area of the septum with blood, and then injecting around 2 cc of alcohol to cause necrosis of the septal tissue in the vicinity of the vessel into which the alcohol is injected.
  • necrosis actually kills tissue cells of the septum, some loss of integrity of the septum may occur.
  • necrosis can also lead to swelling and edema, which are contraindicated for the valve replacement procedure.
  • the alcohol can also affect surrounding vascular and nerve cells in undesirable ways, with potentially unpredictable results.
  • SESAME Another option for endovascular implant patients is the SESAME procedure, which involves guiding a wire into the septal wall, and advancing it down towards the apex of the heart and back into the left ventricle. Once the wire exits the septum, it is snared, and both ends are externalized. RF energy is then applied to the wire to cut a slit in the septum that mimics the open surgical technique described above.
  • this procedure is complex and time-consuming, and requires a high degree of skill and training on the part of the surgeon.
  • An interventricular septum ablation system is disclosed that makes endovascular septum volume reduction faster, more predictable, and less technically challenging, by using pulsed field ablation (PF A) on myocardial tissue.
  • PFA pulsed field ablation
  • the interventricular septum ablation system includes a pulsed field generator that provides a pulsed electric field with an amplitude, frequency, and/or pulse duration(s) suitable for reducing the volume of the interventricular septum.
  • the interventricular septum ablation system also includes a balloon catheter, steerable catheter, or a retrievable stent that incorporates electrodes capable of contacting the septal myocardial tissue and delivering the pulsed field energy.
  • the interventricular septum ablation system disclosed herein has particular, but not exclusive, utility for addressing left ventricular outflow tract occlusions (e.g., in valve replacement procedures) and/or treating hypertrophic cardiomyopathy.
  • the apparatus includes a flexible elongate member configured to be advanced through a blood vessel and positioned inside of a heart of a patient; at least one expandable member coupled to a distal portion of the flexible elongate member; and a plurality of electrodes coupled to the at least one expandable member, where, when the at least one expandable member includes an expanded configuration, the at least one expandable member is configured to bring the plurality of electrodes into contact with an interventricular septum of the heart, where, when the plurality of electrodes is in contact with the interventricular septum, the plurality of electrodes is configured to deliver electrical energy to the interventricular septum to reduce a volume of the interventricular septum.
  • the flexible elongate member may include a catheter, where the at least one expandable member may include at least one balloon.
  • the apparatus may include one or more inflation fluid sources configured to inflate the at least one balloon.
  • the one or more inflation fluid sources may include a syringe or an endoflator.
  • the at least one balloon may include at least one of a non-compliant balloon or a compliant balloon.
  • the at least one balloon may include a non- compliant balloon and a compliant balloon, where the plurality of electrodes is coupled to the compliant balloon.
  • the apparatus may include a flexible substrate coupled to the compliant balloon and the plurality of electrodes.
  • the non-compliant balloon when the non- compliant balloon is in the expanded configuration, the non-compliant balloon is configured to contact tissue of the heart such that the flexible elongate member is stationary relative to the heart, and when the compliant balloon is in the expanded configuration, the compliant balloon is configured to cause the plurality of electrodes to conform to a shape of the interventricular septum.
  • the non-compliant balloon is centered relative to the flexible elongate member, and the compliant balloon is laterally offset relative to the flexible elongate member.
  • the electrical energy delivered by the plurality of electrodes may include pulsed field ablation.
  • the flexible elongate member may include a push wire
  • the at least one expandable member may include a retrievable stent coupled to a distal portion of the push wire.
  • the at least one expandable member may include a compliant balloon coupled to the retrievable stent, where the plurality of electrodes is coupled to the compliant balloon.
  • the apparatus may include a flexible substrate coupled to the compliant balloon and the plurality of electrodes.
  • the retrievable stent when the retrievable stent is in the expanded configuration, the retrievable stent is configured to contact tissue of the heart such that the flexible elongate member is stationary relative to the heart, and where, when the compliant balloon is in the expanded configuration, the compliant balloon is configured to cause the plurality of electrodes to conform to a shape of the interventricular septum.
  • the apparatus may include the pulsed field generator.
  • the inflation lumen and the plurality of the electrical lines are received within the retention tube such that the retention tube is configured to allow relative longitudinal movement between: the retention tube; and the inflation lumen and the plurality of the electrical lines.
  • the retrievable stent, the compliant balloon, and the plurality of electrodes are coupled only at a distal portion of the retrievable stent, where the retrievable stent is configured to have a change in length during a transition from an unexpanded configuration to the expanded configuration, and where the change in length is configured to cause the relative longitudinal movement between: the retention tube; and the inflation lumen and the plurality of the electrical lines.
  • the at least one expandable member may include a temporary valve configured to allow blood flow in a first direction and to prevent the blood flow in a second, opposite direction.
  • the processor is configured to activate the pulsed field generator to output the electrical energy to the plurality of electrodes such that the plurality of electrodes provide pulsed field ablation to the interventricular septum to trigger apoptosis in cells of the interventricular septum.
  • Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.
  • One general aspect includes a system.
  • the system includes a processor configured for communication with a pulsed field generator; and a pulsed field ablation catheter that may include a plurality of electrodes configured for communication with the pulsed field generator and to contact vascular tissue, where the processor is configured to activate the pulsed field generator to output electrical energy to the plurality of electrodes such that the plurality of electrodes provide pulsed field ablation to the vascular tissue to trigger apoptosis in cells of the vascular tissue and reduce a volume of the vascular tissue.
  • One general aspect includes a method for reducing the volume of vascular tissue.
  • the method includes: providing a pulsed field generator configured to trigger apoptosis in cells of tissue; providing a processor configured to control the pulsed field generator; providing a flexible elongate member; positioning a plurality of electrodes a distal portion of the flexible elongate member and electrically coupling the plurality of electrodes to the pulsed field generator; and providing a presser configured to press the electrodes against the tissue.
  • activation of the pulsed field generator triggers the apoptosis in the cells of the tissue.
  • One general aspect includes a system for reducing the volume of vascular tissue.
  • the system includes: a pulsed field generator configured to trigger apoptosis in cells of tissue; a processor configured to control the pulsed field generator; a flexible elongate member; a plurality of electrodes positioned at a distal portion of the flexible elongate member and electrically coupled to the pulsed field generator; and a presser configured to press the electrodes against the tissue.
  • a pulsed field generator configured to trigger apoptosis in cells of tissue
  • a processor configured to control the pulsed field generator
  • a flexible elongate member a plurality of electrodes positioned at a distal portion of the flexible elongate member and electrically coupled to the pulsed field generator
  • a presser configured to press the electrodes against the tissue.
  • the system may include the pulsed field generator.
  • the vascular tissue may include an interventricular septum of a heart, where the pulsed field ablation is configured to trigger the apoptosis in myocardial cells of the interventricular septum and not in vascular smooth muscle tissue or nerve tissue.
  • the pulsed field ablation is configured to trigger apoptosis in osteocyte cells of a calcification and not in vascular smooth muscle tissue or nerve tissue.
  • the system may include one or more inflation fluid sources configured to inflate the one or more balloons.
  • the pulsed field ablation catheter further may include one or more balloons, where, when inflated, the one or more balloons are configured to bring the plurality of electrodes into contact with the vascular tissue.
  • the one or more inflation fluid sources may include a syringe or an endoflator.
  • the pulsed field ablation catheter further comprises an expandable stent and a balloon, where, when the expandable stent is expanded and the balloon is inflated, the expandable stent and the balloon are configured to bring the plurality of electrodes into contact with the vascular tissue.
  • the system further includes a temporary valve configured to allow blood to flow through a portion of the pulsed field ablation catheter in a first direction and to prevent blood from flowing in a second, opposite direction.
  • a system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions.
  • One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.
  • Aspects can include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.
  • Figure IB is a cross-sectional front view of a human heart according to aspects of the present disclosure.
  • Figure 2 is a schematic, diagrammatic view, in block diagram form, of a system according to aspects of the present disclosure.
  • Figure 3 is a schematic, diagrammatic side view of an example pulsed field ablation catheter, according to aspects of the present disclosure.
  • Figure 4A is an enlarged view of the distal portion of the pulsed field ablation catheter of Figure 3, according to aspects of the present disclosure.
  • Figure 4B is a lateral cross-sectional view of the distal portion of the pulsed field ablation catheter of Figure 4 along cross-section line 4B-4B in the unexpanded or uninflated state, according to aspects of the present disclosure.
  • Figure 5B is a lateral cross-sectional view of the distal portion of the pulsed field ablation catheter of Figure 5 along cross-section line 5B-5B in the expanded or inflated state, according to aspects of the present disclosure.
  • Figure 6 is a lateral cross-sectional view of the pulsed field ablation catheter of Figure 4A along cut line 6-6, according to aspects of the present disclosure.
  • Figure 8 is an enlarged view of the distal portion of the pulsed field ablation catheter of Figure 3, wherein both the non-compliant balloon and the compliant balloon are in the inflated or expanded state, according to aspects of the present disclosure.
  • Figure 9 is a schematic, diagrammatic representation, in flow diagram form, of an example pulsed field interventricular septum ablation method, according to aspects of the present disclosure.
  • Figure 10 is a schematic, diagrammatic view, in block diagram form, of a system, according to aspects of the present disclosure.
  • Figure 11 is a schematic, diagrammatic side view of an example pulsed field ablation catheter, according to aspects of the present disclosure.
  • Figure 12 is a lateral cross-sectional view of the pulsed field ablation catheter of Figure 11 along cut line 12-12, according to aspects of the present disclosure.
  • Figure 13 is a front cross-sectional view of the heart with a pulsed field ablation catheter positioned within the aortic valve and left ventricular outflow tract, according to aspects of the present disclosure.
  • Figure 14 is a schematic diagram of a processor circuit, according to aspects of the present disclosure.
  • Figure 15 is an enlarged view of the distal portion of the pulsed field ablation catheter (e.g., of Figure 7), according to aspects of the present disclosure.
  • Figure 17 is an enlarged view of the distal portion of the pulsed field ablation catheter of Figure 15, according to aspects of the present disclosure.
  • Figure 18A is a lateral cross-sectional view of the distal portion of the pulsed field ablation catheter of Figure 15 along cross-section line 17-17, in the expanded or inflated state, according to aspects of the present disclosure.
  • Figure 19 is a schematic, diagrammatic view, in block diagram form, of a system according to aspects of the present disclosure.
  • Figure 20 is a schematic, diagrammatic longitudinal cross-sectional side view of an example intracardiac pulsed field ablation device, according to aspects of the present disclosure.
  • Figure 22 is an enlarged view of the distal portion of the intracardiac PFA device of Figure 20 in its expanded state, according to aspects of the present disclosure.
  • Figure 23 is an enlarged view of the distal portion of the intracardiac PFA device in its expanded state, according to aspects of the present disclosure.
  • Figure 24 is an enlarged view of the distal portion of the intracardiac PFA device in its expanded state, according to aspects of the present disclosure.
  • Figure 26 is a lateral cross-sectional view of at least a portion of the intracardiac PFA device, taken along cut line 26-26 of Figure 23, according to aspects of the present disclosure.
  • Figure 28 is an enlarged side view of the distal portion of the intracardiac pulsed field ablation catheter of Figure 24, wherein both the stent and the compliant balloon are in the inflated or expanded state, according to aspects of the present disclosure.
  • Figure 30 is a lateral cross-sectional view of the PFA device, in the expanded configuration, taken along cut line 30-30 of Figure 28, according to aspects of the present disclosure.
  • An interventricular septum ablation system includes a pulsed field generator, energy that is applied by the pulsed field generator, and a catheter to deliver the energy to the tissue.
  • the pulsed field generator described herein operates at a lower energy (e.g., a higher voltage but a much lower current) compared to a radio frequency generator used for electrosurgery.
  • the pulsed field generator may, for example, be a Boston Scientific Farapulse, a Medtronic PulseSelect, or other pulsed field generator capable of generating electrical pulses at the amplitudes (e.g., voltages), frequencies, and pulse durations described herein.
  • Farapulse and PulseSelect are used for disrupting electrical signals in the heart muscle for atrial fibrillation treatment, not to reduce the volume of the heart tissue (as described herein).
  • the outflow tract expansion catheter is advanced, over the wire, through the vasculature (e.g., blood vessels) inside the patient’s body, to the aortic valve, and across the aortic valve.
  • a guide catheter can be introduced over the wire and the guidewire removed, such that the outflow tract expansion catheter is advanced inside the guide catheter.
  • the outflow tract expansion catheter may for example have two balloons and a multitude of electrodes incorporated into it, where one balloon is non-compliant and concentric to the guidewire. This balloon, when inflated, provides a structure for the second, compliant balloon to oppose against in order to bring the electrodes into contact with the septal tissue to be ablated.
  • the non-compliant balloon may for example be made from a polymer or plastic, such as PET or Nylon.
  • the compliant balloon may for example be made from a different polymer or a different plastic.
  • compliant balloon may for example made from urethane or silicone.
  • the flexible substrate may for example be made polymer or plastic, nylon, Pebax, or polyolefin.
  • the electrodes may for example be made of metal or metal alloy, such as platinum, platinum/iridium, gold, etc. Other materials may be used instead or in addition to those listed here.
  • the method 900 includes controlling the inflation of the non- compliant balloon such that the distal portion of the pulsed field ablation catheter is relatively stationary relative to the heart.
  • the heart may be rapid- cycled or rapid-paced during this process, in order to reduce the pressure gradient across the aortic valve. Rapid-pacing need not be performed when the PFA catheter 250 includes the temporary valve 1610 (as described with respect to, e.g., Figs. 15-18B). Execution then proceeds to step 940.
  • the method 900 includes performing additional therapy, such as implantation of a replacement heart valve.
  • additional therapy is performed while the PFA ablation catheter remains inside the body, or shortly after it is removed.
  • the additional therapy may be performed in a separate procedure, e.g., at least 24 hours after treatment by the PFA catheter. The method 900 is now complete.
  • the system 200 may include a console 202 that includes a processor 210 in communication with a memory 205, display device 220 (e.g., an electronic display or monitor), an input device 230 (e.g., a user input device, such as a keyboard, mousejoystick, microphone, and/or other controller or input device), a pulsed field generator 240, and a pulsed field ablation catheter 250.
  • a processor 210 in communication with a memory 205
  • display device 220 e.g., an electronic display or monitor
  • an input device 230 e.g., a user input device, such as a keyboard, mousejoystick, microphone, and/or other controller or input device
  • a pulsed field generator 240 e.g., a pulsed field generator 240
  • a pulsed field ablation catheter 250 e.g., a pulsed field ablation catheter 250.
  • the pulsed field ablation catheter 1050 is guided into the heart over a guidewire 260.
  • the pulsed field ablation catheter 1050 includes a flexible elongate member 1052 as well as electrodes 1054 that are energized by the pulsed field generator 240.
  • the pulsed field ablation catheter 250 may also include one or more pullwires 1010 that can be used to steer, bend, deflect, or otherwise alter the shape of the flexible elongate member 1052.
  • the pullwire(s) are controlled by one or more actuators 1020, such as wheels, dials, knobs, levers, switches, or otherwise.
  • the pull wires may form a presser mechanism that is configured to press the electrodes against the tissue to be ablated.
  • Other types of presser mechanisms are contemplated.
  • Figure 13 is a front cross-sectional view of the heart 100 with a pulsed field ablation catheter 1050 positioned within the aortic valve 124 and left ventricular outflow tract 140, according to aspects of the present disclosure.
  • the flexible elongate member 1052 has been bent or deflected (e.g., by one or more pullwires), such that the electrodes 1054 are pressed against the interventricular septum 130.
  • the PFA catheter 1050 can deliver PFA therapy to the septum 130 in order to shrink it and thus widen the LVOT 140, improving blood flow through the LVOT (e.g., in advance of a valve replacement procedure, for treatment of hypertrophic cardiomyopathy, etc.).
  • the memory 1464 may include a cache memory (e.g., a cache memory of the processor 1460), random access memory (RAM), magnetoresistive RAM (MRAM), readonly memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory.
  • the memory 1464 includes a non-transitory computer-readable medium.
  • the memory 1464 may store instructions 1466.
  • the instructions 1466 may include instructions that, when executed by the processor 1460, cause the processor 1460 to perform the operations described herein.
  • the communication module 1468 can include any electronic circuitry and/or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 1450, and other processors or devices.
  • the communication module 1468 can be an input/output (VO) device.
  • the communication module 1468 facilitates direct or indirect communication between various elements of the processor circuit 1450 and/or the system 200 or 1000.
  • the communication module 1468 may communicate within the processor circuit 1450 through numerous methods or protocols.
  • Serial communication protocols may include but are not limited to United States Serial Protocol Interface (US SPI), Inter-Integrated Circuit (I 2 C), Recommended Standard 232 (RS-232), RS- 485, Controller Area Network (CAN), Ethernet, Aeronautical Radio, Incorporated 429 (ARINC 429), MODBUS, Military Standard 1553 (MIL-STD-1553), or any other suitable method or protocol.
  • Parallel protocols include but are not limited to Industry Standard Architecture (ISA), Advanced Technology Attachment (ATA), Small Computer System Interface (SCSI), Peripheral Component Interconnect (PCI), Institute of Electrical and Electronics Engineers 488 (IEEE-488), IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communications may be bridged by a Universal Asynchronous Receiver Transmitter (UART), Universal Synchronous Receiver Transmitter (US ART), or other appropriate subsystem.
  • UART Universal Asynchronous Receiver Transmitter
  • USB ART Universal Synchronous Receiver Transmitter
  • External communication may be accomplished using any suitable wireless or wired communication technology, such as a cable interface such as a universal serial bus (USB), micro USB, Lightning, or FireWire interface, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections such as 2G/GSM (global system for mobiles) , 3G/UMTS (universal mobile telecommunications system), 4G, long term evolution (LTE), WiMax, or 5G.
  • a Bluetooth Low Energy (BLE) radio can be used to establish connectivity with a cloud service, for transmission of data, and for receipt of software patches.
  • BLE Bluetooth Low Energy
  • the controller may be configured to communicate with a remote server, or a local device such as a laptop, tablet, or handheld device, or may include a display capable of showing status variables and other information. Information may also be transferred on physical media such as a USB flash drive or memory stick.
  • Figure 15 is an enlarged view of the distal portion 370 of the pulsed field ablation catheter 250 of Figure 7, according to aspects of the present disclosure. Visible are the guidewire 260, flexible elongate member 252, electrodes 254, non-compliant balloon 256, and compliant balloon 258. Also visible is a flexible or compliant substrate 410 which supports the electrodes 254. The electrodes 254 may for example be coated, printed, or attached to the substrate 410.
  • the structure shown in Fig. 15 is similar to the structure shown in Fig. 4A.
  • the non-compliant balloon 256, compliant balloon 258, and the electrodes 254 can have equal or non-equal lengths.
  • the compliant balloon 258 and the electrode assembly 1510 have approximately equal lengths LE (e.g., equal to within ⁇ 1%, ⁇ 5%, etc.), but that length LE is only approximately half of the length LB of the non-compliant balloon 256.
  • the non-compliant balloon 256, the compliant balloon 258, and the electrode assembly 1510 are all closer to being equal lengths (though they may not be of exactly equal lengths).
  • the non-compliant balloon 256 can include a proximal portion 1520 and a distal portion 1530.
  • the compliant balloon 258 and the electrode assembly 1510 can be provided only at the distal portion 1530 (and not the proximal portion 1520) of the compliant balloon 258.
  • the compliant balloon 258 and the electrode assembly are centered relative to the non-compliant balloon 256, rather than being biased towards the distal portion 1530 as in Fig. 15.
  • the proximal portion 1520 of the non-compliant balloon 256 can be positioned within the aortic valve (e.g., adjacent to, in contact with, and/or proximate to the valve annulus and/or valve leaflets) and the distal portion 1530 of the non- compliant balloon 256 can be positioned within the LVOT (e.g., adjacent to, in contact with, and/or proximate to interventricular septum) provide ablation to the interventricular septum.
  • the compliant balloon 258 and electrode assembly 1510 can be positioned at the proximal portion 1520 of the non-compliant balloon 256.
  • the valve lumen 1540 can be open space that is defined by surface(s) of the non-compliant balloon 256. These surface(s) can be outer surfaces of the non-compliant balloon 256 in that they are an outer extent of the balloon, but the toroid or toroid-like cross- sectional shape of the balloon is such that these outer surfaces are located towards an interior of the balloon.
  • the temporary valve 610 can be positioned along the length of the non- compliant balloon 256, within the valve lumen 1540.
  • the valve lumen can be laterally offset from the central longitudinal axis of the non-compliant balloon 256 (as shown in Figs. 15, 17A, 18 A, and 18B) or laterally centered.
  • the configuration of the PFA catheter 250 with the temporary valve 1610 and the valve lumen 1540 can be used when no rapid pacing is performed during ablation of the interventricular septum.
  • the temporary valve 1610 can be used in the lumen 1540 along the longitudinal axis of the non-compliant balloon 256, in order to allow for proper control of blood flow in the event that rapid pacing of the heart is not used during the ablation. If rapid pacing is employed, then there would not be any need to allow for blood to flow through or around the non-compliant balloon 256 used to position the electrodes of the PFA device with respect to the aortic valve. If rapid pacing were not utilized, the pressure of the blood trying to exit the left ventricle would push the PFA device out of position with each cardiac cycle. Adding only the lumen 1540 to allow for blood to flow through or around the device partially addresses the issue.
  • the temporary valve 1610 is also provided to stop blood from flowing back through the native aortic valve and/or the lumen 1540 during portions of the cardiac cycle.
  • This configuration of the PFA catheter 250 can be used when no rapid pacing of the heart is performed.
  • the temporary valve 1610 opens to allows blood flow from the left ventricle into to the aorta (during systole) and closes to prevent backwards blood flow from the aorta into the left ventricle (during diastole).
  • the PFA catheter 250 with temporary valve 1610 can be used during the intracardiac procedure in which the electrodes provide ablation to the interventricular septum.
  • the procedure to provide ablation is performed on the patient on a different (earlier) day than the procedure to actually implant the replacement valve (e.g., replacement aortic valve or replacement mitral valve).
  • the ablation procedure can be performed one week earlier than the replacement valve implantation procedure.
  • the ablation procedure treats hypertrophic cardiomyopathy (e.g., thickening of the heart muscle or myocardium, such as the interventricular septum) and/or left ventricular outflow tract occlusions (LVOTO).
  • hypertrophic cardiomyopathy e.g., thickening of the heart muscle or myocardium, such as the interventricular septum
  • LVOTO left ventricular outflow tract occlusions
  • whether or not rapid pacing of the heart is performed can depend on whether the replacement valve is balloon-expanded or self-expanding (not balloon-expanded).
  • rapid pacing is used to minimize the amount of blood flow that can push the replacement valve and/or its associated delivery catheter out of position (e.g., the valve annular).
  • rapid pacing need not be used. For example, because there is no balloon to expand the replacement valve, there is less surface area for the blood flow to push against (to push the replacement valve and/or its associated delivery catheter out of position).
  • the PFA catheter without temporary valve or the PFA catheter with temporary valve can be used.
  • Use of PFA catheter with temporary valve with rapid pacing is not an issue, through the temporary valve does not function much (because not much blood flow is present to open/close the temporary valve).
  • the valve 1610 is called temporary because it is taking the place of the patient’s natural valve during the intracardiac PFA procedure, to allow for aortic valve function during the ablation, assuming rapid pacing of the heart is not employed.
  • Figure 17 is an enlarged view of the distal portion 370 of the pulsed field ablation catheter 250 of Figure 15, according to aspects of the present disclosure. Visible are the guidewire 260, flexible elongate member 252, electrodes 254, non-compliant balloon 256, and compliant balloon 258. Also visible is a flexible or compliant substrate 410 which supports the electrodes 254. The electrodes may for example be coated, printed, or attached to the substrate 410.
  • FIG. 17 shows the unexpanded configuration of the PFA catheter 250 along section line 17-17 of Fig. 15.
  • the structure shown in Figure 17 is similar to the structure shown Fig. 4B, except that the PFA catheter 250 additionally includes the temporary valve 1610.
  • the non-compliant balloon 256 can include one or multiple temporary valves 1610.
  • one temporary valve 1610 is shown.
  • the temporary valve 1610 can be coupled to the non-compliant balloon 256 via a valve lumen that allows blood to flow through the non-compliant balloon 256 (e.g., in a desired direction only), without affecting the inflation state of the non-compliant balloon 256.
  • the temporary valve 1610 may be bonded to outer surface(s) of the non-compliant balloon (which define the valve lumen 1540 in Fig. 15) via thermal bonding, laser bonding, adhesives, other methods, and/or combinations thereof.
  • Figure 18B is a lateral cross-sectional view of the distal portion 370 of the pulsed field ablation catheter 250 of Figure 15 along cross-section line 17-17, in the expanded or inflated state, according to aspects of the present disclosure. Visible are the flexible elongate member 252, guidewire 260, guidewire lumen 420, non-compliant balloon 256, inflation fluid 510, compliant balloon 258, inflation fluid 520, flexible substrate 410, and electrode 254.
  • Figure 18B shows the leaflets 1710 of the temporary valve 1610 in an open configuration. In an example when positioned within the aortic valve, during systole, the valve 1610 opens to allows blood flow from the left ventricle into to the aorta.
  • the intracardiac PF A device 1950 is introduced into the heart of the patient via a sheath 1940.
  • the intracardiac PFA device 1950 utilizes a stent-like design in place of the non-compliant balloon.
  • An example of forming the stent 1920 can include a nitinol tube being laser cut with a cell pattern, expanded, heat set, and attached to a pull wire so that once deployed, it can be retrieved back into the delivery sheath 1940.
  • the stent 1920 may or may not include a temporary valve 1610 that takes the place of the aortic valve, which is held open by the stent 1920 during the ablation procedure and rapid pacing of the heart is not utilized during the treatment.
  • the push wire 1930 can be translated distally (in a longitudinal direction) with the stent 1920 attached, such that the stent 1920 is positioned within the aortic valve (e.g., adjacent to, in contact with, and/or proximate to the valve annulus and/or valve leaflets).
  • a sheath 1940 (also known as an introducer sheath, delivery sheath, etc.) can be used to position the intracardiac PFA device 1950 at the desired location (e.g., within the aortic valve).
  • the sheath 1940 includes a lumen that receives the retrievable stent 1910.
  • the sheath wall (which defines the lumen) maintains the stent 1920 in its constrained configuration while the stent 1920 remains within the sheath.
  • the intracardiac PFA device 1950 and the retrievable stent 1910 can have movement (e.g., translation, rotation) relative to one another.
  • the guidewire 260 can be used to position the sheath 1940 at the desired location (e.g., within the aortic valve). After the sheath 1940 is positioned, then the guidewire 260 can be removed from the sheath lumen, and the intracardiac PFA device 1950 can be introduced into the sheath lumen to be positioned at the desired location.
  • the guidewire 260 can be used to position the intracardiac PFA device 1950.
  • the guidewire 260 can extend longitudinally through the stent 1920 and/or alongside the push wire 1930.
  • the intracardiac pulsed field ablation device 1950, together with the delivery sheath 1940, may be considered an intracardiac pulsed field ablation catheter.
  • Figure 20 is a schematic, diagrammatic longitudinal cross-sectional side view of an example intracardiac pulsed field ablation device 1950, according to aspects of the present disclosure. Visible are the electrodes 254, compliant balloon 258, connector 310, compliant balloon fill port 330 to which the compliant balloon inflation fluid source can be attached (see Figure 2).
  • the connector 310 also includes an electrical connector 340 to which a cable 350 attaches, to provide electrical energy to the electrodes 254.
  • the cable 350 also attaches to a console connector 360 that connects to the console 202 and/or to the pulsed field generator 240 (see Figure 2).
  • the delivery sheath 1940, push wire 1930, and stent 1920 along with a compliant balloon inflation lumen 2010, electrical signal lines 2020, and a rapid exchange (RX) port or retention tube 2030 through which the balloon inflation lumen 2010 and electrical signal lines 2020 pass.
  • RX port or retention tube 2030 is fixedly/tightly attached to the push wire 1930, while the balloon inflation lumen 2010 and electrical signal lines 2020 are free to translate proximally and distally through the rapid exchange port 2030, but are constrained from separating radially from the push wire 1930.
  • the intracardiac PFA device 1950 (including push wire 1930 and stent 1920) includes a distal portion 370 terminating at distal end, and a proximal portion 2040 terminating at proximal end.
  • the sheath 1940 includes a distal portion 2070 terminating at a distal end, a proximal portion 2050 terminating at a proximal end, and a sheath wall 2060 defining a sheath lumen 2080.
  • a user can grip and move (translate/rotate) proximal portion 2040 of the push wire 1930, to cause corresponding movement of the distal portion 370 of the intracardiac PFA device 1950.
  • Figure 21 is an enlarged view of the distal portion 370 of the intracardiac PFA device 1950 of Figure 20 in its constrained or unexpanded state, according to aspects of the present disclosure. Visible are the sheath 1940, sheath wall 2060, sheath lumen 2080, electrical wire 2020, compliant balloon 258, inflation lumen 2010, electrode substrate 410, electrodes 254, stent 1920, and push wire 1930. Also visible are attachment points or couplings 2110 that attach the compliant balloon 258 to the substrate 410 and to the stent 1920. These may be thermal bonds, laser bonds, adhesive bonds, mechanical attachments, or otherwise.
  • the balloon 258 may be attached mechanically to the stent, with a loop that would go around a stent strut and the shaft 2010 of the balloon that is used to inflate the balloon.
  • a short section of the shaft 2010 can extend distally from the balloon, such as how an angioplasty balloon would be constructed.
  • the couplings 2110 are provided only at the distal portion of the stent 1920 (and not at the proximal portion of the stent 1920).
  • the proximal portions of the stent 1920, the compliant balloon 258, and the substrate 410 can have movement relative to one another (which would occur, e.g., when the stent 1920 transitions between un expanded and expanded configurations, as described below).
  • the sheath 1940 is moved in a proximal direction, while the intracardiac PFA device 1950 is stationary, or the intracardiac PFA device 1950 is moved distally while the sheath 1940 is stationary, or both the sheath 1940 is moved proximally and thee intracardiac PFA device 1950 is moved distally.
  • the net result is that the stent is moved outside of the sheath lumen 2080 such that sheath wall 2060 no longer prevents expansion of the stent 1920 (e.g., because there is no contact between stent and sheath wall).
  • the proximal portions of the stent 1920, the compliant balloon 258, and the substrate 410 have movement relative to one another.
  • the proximal portions of the stent 1920, the compliant balloon 258, and the substrate 410 are more aligned in Fig. 21 (with the stent in the expanded configuration), whereas the proximal portion of the stent 1920 is more spaced from the proximal portions of the compliant balloon 258 and the substrate 410 in Fig. 20 (with the stent in the unexpanded/constrained configuration).
  • the intracardiac PF A device 1950 includes the rapid exchange port or retention tube 2030 (e.g., with a retention wall defining a retention lumen).
  • the rapid exchange port or retention tube is coupled to the distal portion of the push wire 1930 (e.g., at the distal end of the push wire 1920 or spaced proximally from the distal end of the push wire 1930).
  • the rapid exchange port receives and loosely couples the compliant balloon inflation lumen 2010, the flexible substrate 410 of the electrode assembly, and the electrical signal lines 2020 to the push wire 1930.
  • Figures 20-22 show that the flexible substrate 410 (part of the electrode assembly 1510 of Figure 15) and the inflation lumen 2010 for the compliant balloon 258 extends between proximal and distal portions of the intracardiac PF A device 1950.
  • Figure 23 is an enlarged view of the distal portion 370 of the intracardiac PFA device 1950 in its expanded state, according to aspects of the present disclosure. Visible are the sheath 1940, sheath wall 2060, sheath lumen 2080, compliant balloon 258, inflation lumen 2010, electrode substrate 410, electrodes 254, stent 1920, push wire 1930, and attachment points or couplings 2110.
  • the structures shown in Figure 23 are similar to those shown in Figure 22, except that the substrate 410 does not extend back to the proximal portion of the intracardiac PFA device 1950. Rather, the substrate 410 is only at the distal portion 370 of the intracardiac PFA device 1950, and the electrical traces or electrical lines 2020 are instead carried by a cable 2320.
  • Figure 24 is an enlarged view of the distal portion 370 of the intracardiac PFA device 1950 in its expanded state, according to aspects of the present disclosure. Visible are the sheath 1940, sheath wall 2060, sheath lumen 2080, compliant balloon 258, inflation lumen 2010, electrode substrate 410, electrodes 254, stent 1920, push wire 1930, attachment points or couplings 2110, and electrical traces or electrical lines 2020 within the electrical cable 2320.
  • the structures shown in Figure 24 are similar to those shown in Figure 23, except that the stent 1920 includes a temporary valve 1610, as described above in Figures 17- 18B.
  • the temporary valve 1610 may for example be stitched/sewn to the stent 1920, to allow for expansion and contraction of the stent 1920 and valve 1610 together, without overconstraining the bonding of the valve 1610 to the stent 1920.
  • the temporary valve 1610 allows blood flow 2410 in a desired direction (e.g., out of the left ventricle and into the aorta) while preventing blood flow in the opposite direction (e.g., out of the aorta and into the left ventricle). This may for example allow the intracardiac PFA device 1950 to be used for septum ablation procedures without rapid pacing of the heart.
  • the temporary valve 1610 prevents unwanted flow of blood back into the heart from the aorta.
  • the stent 1920 need not have a dedicated lumen because the interior of the stent is open. That is, the interior of the stent 1920 is already a lumen to allow blood flow 2410.
  • the stent 1920, compliant balloon 258, and the electrodes 254 can have equal or non-equal lengths, and/or the compliant balloon 258 and/or the electrodes 254 can be longitudinally centered relative to the stent 1920, and/or positioned in only a distal portion or only a proximal portion of the stent 1920.
  • Figs. 20-24 can be partial longitudinal cross-sectional views, in that the RX portion or retention tube 2030 is not shown in cross-section. The lateral cross-sectional view of the RX port or retention tube 2030 is shown in Figs. 25 and 26.
  • Figure 25 is a cross-sectional view of at least a portion of the intracardiac PFA device 1950, taken along cut line 25-25 of Figure 22, according to aspects of the present disclosure. Visible are the push wire or push rod 1930 and the rapid exchange port or retention tube 2030, which are fixedly/tightly coupled by a bond 2530 such as a weld, solder joint, or adhesive, such that there is no relative movement between the push wire 1930 and the RX port or retention tube 2030.
  • the push wire 1930 has a solid cross-section, whereas the rapid exchange port or retention tube 2030 is hollow, with a retention wall 2510 defining a retention lumen 2520. Passing through the retention lumen 2520 are the compliant balloon inflation lumen and the electrode substrate 410, which carries electrical traces or electrical lines 2020 to energize the electrodes.
  • the retention lumen 2520 loosely couples the compliant balloon inflation lumen 2010 and the electrical signal lines 2020 for the electrodes, preventing them from radially separating from the push wire 1930, but allows relative translation between the push wire 1930 on the one hand, and the inflation lumen 2010 and the electrical signal lines 2020 (e.g., the flexible substrate 410) on the other.
  • Figure 26 is a cross-sectional view of at least a portion of the intracardiac PFA device 1950, taken along cut line 26-26 of Figure 23, according to aspects of the present disclosure. Visible are the push wire 1930 and the rapid exchange port or retention tube 2030, which are fixedly/tightly coupled by a bond 2530 such as a weld, solder joint, or adhesive such that there is no relative movement between the push wire 1930 and the RX port or retention tube 2030.
  • the push wire 1930 has a solid cross-section, whereas the rapid exchange port or retention tube 2030 is hollow, with a retention wall 2510 defining a retention lumen 2520.
  • the compliant balloon inflation lumen and the electrical cable 2320 Passing through the retention lumen 2520 are the compliant balloon inflation lumen and the electrical cable 2320, which carries electrical traces or electrical lines 2020 to energize the electrodes.
  • Each of the electrical wires or traces 2020 may have its own insulation layer, and all of the wires or traces 2020 may be surrounded by an outer insulator that forms them into the cable 2320.
  • the outer surface of the retention wall 2510 of the RX port or retention tube 2030 is coupled to the push wire 1930.
  • the outer surface of the retention wall 2510 (defining the retention lumen 2520) is coupled to the push wire 1930.
  • the push wire 1930 would be located inside the retention lumen 2520, in addition to the inflation lumen 2010 and the electrical signal lines 2020.
  • the push wire 1930 is fixedly/tightly coupled to the RX port or retention tube 2030 (no relative movement possible).
  • Figure 27 is an enlarged view of the distal portion 370 of the intracardiac pulsed field ablation catheter 1950 of Figure 23, wherein both the stent 1920 and the compliant balloon 258 are in the inflated or expanded state, according to aspects of the present disclosure. Visible are the push wire 1930, inflation lumen 2010, electrical cable 2320, flexible substrate 410, electrodes 254, stent 1920, and compliant balloon 258. In the example shown in Figure 27, the stent 1920 is in its expanded state, and the compliant balloon 258 is filled with an inflation fluid 520 and is thus also in an expanded state.
  • the PFA device 1950 is rotated until the electrodes 254 are aligned with the interventricular septum 130, and the compliant balloon 258 is inflated with the inflation fluid 520, such that the flexible substrate 410 and the electrodes 254 are pressed against, and comply with the contours of, the septum 130.
  • the electrodes are activated in pulses as described above (e.g., for a period of between 1 second and 5 seconds), such that the pulsed electric field delivers electrical energy to the septum 130 that causes electroporation of cells of the septum 130 that are within a threshold distance of the electrodes (e.g., a given field strength).
  • This electroporation in turn triggers the start of apoptosis or programmed cell death for at least some of the affected cells.
  • This apoptosis (which may take up to 24 hours to complete) has the effect of thinning the interventricular septum and thus widening the left ventricular outflow tract.
  • the stent 1920, compliant balloon 258, and flexible substrate 410 may form a presser mechanism that is configured to press the electrodes against the tissue to be ablated.
  • Other types of presser mechanisms are contemplated. Because the stent 1920 may not conform to the contours of tissue against which it is pressed, a gap 540 may exist between the stent 1920 and the tissue 530.
  • the device shown in Figure 27 may be used in conjunction with rapid pacing of the heart.
  • Figure 28 is an enlarged view of the distal portion 370 of the intracardiac pulsed field ablation catheter 1950 of Figure 24, wherein both the stent 1920 and the compliant balloon 258 are in the inflated or expanded state, according to aspects of the present disclosure. Visible are the push wire 1930, inflation lumen 2010, electrical cable 2320, flexible substrate 410, electrodes 254, stent 1920, compliant balloon 258, septum 130, LVOT wall 530, and gap 540.
  • the structure shown in Figure 24 may be similar to that shown in Figure 23, except that the stent 1920 includes a temporary valve 1610, which allows blood flow 2410 in a desired direction (e.g., out of the left ventricle and into the aorta) and not in the opposite direction (e.g., from the aorta and back into the left ventricle of the heart).
  • a desired direction e.g., out of the left ventricle and into the aorta
  • the opposite direction e.g., from the aorta and back into the left ventricle of the heart.
  • the device shown in Figure 28 may be suitable for use without rapid pacing of the heart.
  • Figure 29 is a lateral cross-sectional view of the PF A device 1950 of Figure 27, in the expanded configuration, taken along cut line 29-29, according to aspects of the present disclosure. Visible are the expanded state stent 1920, the compliant balloon 258, the inflation fluid 520, the flexible substrate 410, and the electrodes 254. Because of the lack of a temporary valve, the device shown in Figure 29 may be suitable for use with rapid pacing of the heart.
  • Figure 30 is a lateral cross-sectional view of the PF A device 1950 of Figure 28, in the expanded configuration, taken along cut line 30-30, according to aspects of the present disclosure. Visible are the expanded state stent 1920, the compliant balloon 258, the inflation fluid 520, the flexible substrate 410, and the electrodes 254.
  • the stent 1920 includes a temporary valve 1610. As described above in Figure 28, the temporary valve 1610 may allow the device 1950 to be used without rapid pacing of the heart.
  • the leaflets 1710 of the temporary valve 1610 can for example be open during diastole (to allow blood flow out of the left ventricle and into the aorta) and closed during systole (to prevent blood flow from the aorta back into the left ventricle, as similarly described with respect to Figs. 18A and 18B.
  • Stitching 3010 can be used to couple the temporary valve 1610 to the stent 1920.
  • the stitching 3010 can attach the outer edges of the leaflets 1710 to the stent 1920.
  • the stitching 3010 can be considered a loose coupling in that it keeps the temporary valve 1610 and the stent 1920 together (preventing the temporary valve 1610 and the stent 1920 from separating), while still allowing the stent 1920 to transition between the unexpanded and expanded configurations without any damage to temporary valve 1610.
  • the temporary valve 1610 is compacted/compressed (a smaller size); when the stent 1920 is inflated, the valve 1610 is uncompressed/expanded (a bigger size)
  • the interventricular septum ablation system advantageously provides an increase to the volume and/or area (e.g., surface area, cross- sectional area) of the left ventricular outflow channel, and thus improves blood flow, without cutting tissue, without triggering inflammation or edema, and without the need to perform an open-heart procedure.
  • volume and/or area e.g., surface area, cross- sectional area
  • some aspects include a compliant balloon with electrodes formed on its outer surface, obviating the need for a non-compliant balloon and flexible substrate. .
  • the interventricular septum ablation system is intended to treat left ventricular outflow tract obstruction (LVOTO), hypertrophic cardiomyopathy, and/or other applications where a reduction in tissue volume is desired.
  • LVOTO left ventricular outflow tract obstruction
  • hypertrophic cardiomyopathy hypertrophic cardiomyopathy
  • triggering apoptosis of the osteocytes could in calcified myocardial or vascular tissue may be a desirable way to treat calcific disease. This may require higher voltages than those required to trigger apoptosis in myocardium cells (e.g., up to 1500 V/cm).
  • the system can also be used for in-stent restenosis (ISR) treatment, which can use a field of up to 1750 Volts/cm at a frequency of up to 1 kHz.
  • ISR in-stent restenosis
  • the technology described herein may be applied to the interventricular septum, interatrial septum, vascular tissue, tissue of the heart, and/or other tissue inside the patient body
  • All directional references e.g., upper, lower, inner, outer, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal are only used for identification purposes to aid the reader’s understanding of the claimed subject matter, and do not create limitations, particularly as to the position, orientation, or use of the interventricular septum ablation system.
  • Connection references e.g., attached, coupled, connected, joined, or “in communication with” are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily imply that two elements are directly connected and in fixed relation to each other.

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Abstract

Un appareil comprend un élément allongé flexible conçu pour être avancé à travers un vaisseau sanguin et positionné à l'intérieur du cœur d'un patient. L'appareil comprend également au moins un élément dilatable, accouplé à une partie distale de l'élément allongé flexible, et une pluralité d'électrodes accouplées audit ou auxdits éléments dilatables. Lorsque le ou les éléments dilatables sont dans une configuration dilatée, le ou les éléments dilatables sont conçus pour amener la pluralité d'électrodes en contact avec le septum interventriculaire du cœur. Lorsque la pluralité d'électrodes est en contact avec le septum interventriculaire, la pluralité d'électrodes est conçue pour délivrer de l'électricité au septum interventriculaire afin d'en réduire le volume.
PCT/EP2025/053746 2024-02-19 2025-02-12 Ablation intracardiaque du septum interventriculaire et dispositifs, systèmes et procédés associés Pending WO2025176533A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120130359A1 (en) * 2010-10-26 2012-05-24 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation cryotherapeutic devices and associated systems and methods
US20160113709A1 (en) * 2013-06-05 2016-04-28 Tel Hashomer Medical Research Infrastructure And Services Ltd Myocardial ablation by irreversible electroporation
EP3656327A1 (fr) * 2018-11-21 2020-05-27 Taupnumedical Co., Ltd Cathéter d'ablation rf pour le traitement de la myocardiopathie hypertrophique et procédé de traitement de la myocardiopathie hypertrophique l'utilisant
US20200197088A1 (en) * 2016-06-07 2020-06-25 Metavention, Inc. Therapeutic tissue modulation devices and methods
US20230372005A1 (en) * 2020-09-22 2023-11-23 Suzhou Innoventures Co., Ltd Cardiac ablation system and method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120130359A1 (en) * 2010-10-26 2012-05-24 Medtronic Ardian Luxembourg S.A.R.L. Neuromodulation cryotherapeutic devices and associated systems and methods
US20160113709A1 (en) * 2013-06-05 2016-04-28 Tel Hashomer Medical Research Infrastructure And Services Ltd Myocardial ablation by irreversible electroporation
US20200197088A1 (en) * 2016-06-07 2020-06-25 Metavention, Inc. Therapeutic tissue modulation devices and methods
EP3656327A1 (fr) * 2018-11-21 2020-05-27 Taupnumedical Co., Ltd Cathéter d'ablation rf pour le traitement de la myocardiopathie hypertrophique et procédé de traitement de la myocardiopathie hypertrophique l'utilisant
US20230372005A1 (en) * 2020-09-22 2023-11-23 Suzhou Innoventures Co., Ltd Cardiac ablation system and method

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
ELEID MACKRAM F ET AL: "Emerging Approaches to Management of Left Ventricular Outflow Obstruction Risk in Transcatheter Mitral Valve Replacement", JACC: CARDIOVASCULAR INTERVENTIONS, ELSEVIER, AMSTERDAM, NL, vol. 16, no. 8, 24 April 2023 (2023-04-24), pages 885 - 895, XP087303435, ISSN: 1936-8798, [retrieved on 20230424], DOI: 10.1016/J.JCIN.2023.01.357 *
GUERRERO MAYRA E. ET AL: "Pre-Emptive Radiofrequency Septal Ablation to Decrease the Risk of Left?Ventricular Outflow Tract Obstruction After TMVR", JACC: CARDIOVASCULAR INTERVENTIONS, vol. 13, no. 9, 1 May 2020 (2020-05-01), AMSTERDAM, NL, pages 1129 - 1132, XP093274047, ISSN: 1936-8798, Retrieved from the Internet <URL:https://pdf.sciencedirectassets.com/276932/1-s2.0-S1936879820X00070/1-s2.0-S1936879820305227/main.pdf?hash=1da1d344e320d3c656584b1dfeda0ecad85eaa039221dbacde9605cc13b8ddd2&host=68042c943591013ac2b2430a89b270f6af2c76d8dfd086a07176afe7c76c2c61&pii=S1936879820305227&tid=spdf-a51f8819-8959-4f4e-b92a-963> DOI: 10.1016/j.jcin.2020.02.016 *
KILLU AMMAR M. ET AL: "A novel technique-Prophylactic septal radiofrequency ablation to prevent left ventricular outflow tract obstruction with transcatheter mitral valve replacement (RADIO-TMVR)", JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY., vol. 31, no. 11, 7 September 2020 (2020-09-07), US, pages 3048 - 3055, XP093274048, ISSN: 1045-3873, Retrieved from the Internet <URL:https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/jce.14720> DOI: 10.1111/jce.14720 *

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