Dynamic ablation catheter
The system optimizes ablation energy delivery by sensing and adjusting based on catheter position and tissue contact, improving lesion formation and energy efficiency.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- MEDTRONIC IRELAND MFG UNLIMITED CO
- Filing Date
- 2025-10-23
- Publication Date
- 2026-04-30
AI Technical Summary
Current ablation systems are limited in their ability to sense and measure parameters to determine the optimal type of ablation energy delivery, leading to inefficient use of energy on non-target tissue and suboptimal lesion formation.
A system that includes sensors and processing circuitry to determine the position of energy delivery elements relative to target tissue, adjusting the type of ablation energy delivery based on contact or proximity, and outputting messages to indicate the appropriate energy type for each element.
Improves lesion formation by matching energy delivery type with catheter positioning and target tissue location, enhancing energy efficiency and patient outcomes by ensuring preferred ablation energy is used.
Smart Images

Figure EP2025080667_30042026_PF_FP_ABST
Abstract
Description
DYNAMIC ABLATION CATHETER
[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 712,203, filed October 25, 2024, the entire content of which is incorporated herein by reference.TECHNICAL FIELD
[0002] The present technology is related to ablation catheters. In particular, various examples of the present technology are related to ablation techniques using medical systems including ablation catheters.BACKGROUND
[0003] Tissue ablation is a medical procedure commonly used to treat conditions such as cardiac arrhythmias, which includes atrial fibrillation. For treating cardiac arrhythmias, ablation can be performed to modify tissue, such as to stop aberrant electrical propagation and / or disrupt aberrant electrical conduction through cardiac tissue. Ablation techniques include pulsed field ablation (PF A), cryoablation, laser ablation, radioablation and radiofrequency (RF) ablation.
[0004] Cardiac arrhythmias are a group of conditions that cause an irregular heartbeat or conduction pattern. Ablation may be used to create a safe and effective lesion or set of lesions at the origin of the irregular heartbeat or in regions that aid in the termination of arrhythmias without causing damage to adjacent structures or surrounding tissue, ideally resulting in no need for a maintenance treatment regimen, such as medications or cardioversions.SUMMARY
[0005] In general, aspects of this disclosure are directed to devices, systems, and methods for determining what type of ablation energy delivery to use to create a desired lesion. Example systems include one or more ablation catheters each including one or more energy delivery elements, and one or more sensors configured to sense and / or measure one or more parameters indicative of a position of an energy delivery element relative to target tissue. The system may be configured to determine, based on theposition of one or more of the energy delivery elements, whether to deliver pulsed field ablation (PF A) energy via one or more of the energy delivery elements, whether to deliver radio frequency (RF) ablation energy via one or more of the energy delivery elements, whether to deliver cryoablation energy via one or more of the energy delivery elements, or whether to not deliver ablation energy via one or more of the energy delivery elements.
[0006] In some examples, the one or more sensors may also be configured to sense and / or measure one or more parameters indicative of whether an energy delivery element is in contact with target tissue, or whether the energy delivery element is proximate to target tissue but not in contact with the target tissue. If the energy delivery element is in contact with the target tissue, the system may output a message indicating that one or more types of ablation energy delivery, e.g., RF, PF A, or cryoablation, may be used, whereas if the energy delivery element is proximate to, but not in contact with, the target tissue, the system may output a message indicating that PF A, but not RF or cryoablation, may be used. In some examples, even if the energy delivery element is in contact with the target tissue, the location of the energy delivery element or the target tissue may be such that it may be more appropriate to deliver PFA energy than RF ablation energy or cryoablation energy, or it may not be appropriate to deliver RF ablation energy or cryoablation energy. For example, the target tissue may be within certain portions of the heart of the patient for which it may be more appropriate to deliver PFA energy compared to RF ablation energy or cryoablation energy. The system may then output a message indicating that PFA may be used and / or preferred rather than RF ablation or cryoablation. In other examples, the location of the energy delivery element or the target tissue may be such that it may be more appropriate to deliver RF ablation energy or cryoablation energy than PFA energy.
[0007] Aspects of this disclosure may provide one or more technical advantages and solve one or more technical problems. For example, aspects of this disclosure may provide for changes in the type of ablation energy delivery to improve the lesion formation by improving the match between ablation energy delivery type with the positioning and configuration of one or more energy delivery elements of one or more ablation catheters relative to target tissue, as well as the location of the particular target tissue and desired lesion to be formed in the target tissue. In some examples, aspects ofthis disclosure may provide for improved energy efficiency via adjusting delivery of the type of ablation energy to target tissue, or not delivering ablation energy to non-target tissue. In some examples, aspects of this disclosure may provide for improved patient outcomes by indicating what types of ablation energy delivery are preferred (e.g., what types may have a preferred safety profile, based on sensed and / or measured parameters of the particular arrangement of ablation catheters, energy delivery elements, and target tissue locations).
[0008] In one example, this disclosure describes a method of ablating target tissue of a patient, the method including: determining, by processing circuitry and based on a sensor signal, a first position of an energy delivery element of an ablation catheter relative to the target tissue; determining, by the processing circuitry and based on the first position of the energy delivery element, to not deliver at least one of pulsed field ablation (PF A) energy or radio frequency (RF) energy; outputting, by the processing circuitry, a first message indicating to not deliver PFA or RF energy via the energy delivery element; determining, by the processing circuitry and based on the sensor signal, a second position of the energy delivery element of the ablation catheter relative to the target tissue; determining, by the processing circuitry and based on the second position of the energy delivery element, to deliver at least one of PFA energy or RF energy; and outputting, by the processing circuitry, a second message indicating to deliver at least one of PFA or RF energy via the energy delivery element.
[0009] In another example, this disclosure describes a system including: an ablation catheter including an energy delivery element; a processor; and a memory in communication with the processor and storing instructions that, when executed by the processor, cause the processor to: determine, based on a sensor signal, a first position of the energy delivery element of the ablation catheter relative to the target tissue; determine, based on the first position of the energy delivery element, to not deliver at least one of pulsed field ablation (PFA) energy or radio frequency (RF) energy; output a first message indicating to not deliver PFA or RF energy via the energy delivery element; determine, based on the sensor signal, a second position of the energy delivery element of the ablation catheter relative to the target tissue; determine, based on the second position of the energy delivery element, to deliver at least one of PFA energy or RF energy; andoutput a second message indicating to deliver at least one of PFA or RF energy via the energy delivery element.
[0010] In another example, this disclosure describes a computer readable medium including instructions that, when executed by one or more processors, cause the one or more processors to: determine, based on a sensor signal, a first position of an energy delivery element of an ablation catheter relative to a target tissue of a patient; determine, based on the first position of the energy delivery element, to not deliver at least one of pulsed field ablation (PFA) energy, radio frequency (RF) energy, or not to deliver energy via the energy delivery element; output a first message indicating to not deliver PFA energy or RF energy via the energy delivery element; determine, based on the sensor signal, a second position of the energy delivery element of the ablation catheter relative to the target tissue; determine, based on the second position of the energy delivery element, to deliver at least one of PFA energy or RF energy; and output a second message indicating to deliver at least one of PFA or RF energy via the energy delivery element.
[0011] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. l is a conceptual diagram illustrating an example system for delivering ablation.
[0013] FIG. 2 is a flow diagram illustrating an example method of ablating target tissue of a patient.
[0014] FIG. 3 is a flow diagram illustrating another example method of ablating target tissue of a patient.
[0015] FIG. 4 is a conceptual diagram illustrating contact of one or more ablation energy delivery elements of an ablation catheter.
[0016] FIG. 5 is a block diagram illustrating an example controller of an ablation system.DETAILED DESCRIPTION
[0017] Tissue ablation may be used to treat conditions such as cardiac arrhythmias, which includes atrial fibrillation. For treating cardiac arrhythmias, ablation may be performed to modify tissue, such as to stop aberrant electrical propagation and / or disrupt aberrant electrical conduction through cardiac tissue. Ablation techniques may include pulsed field ablation (PF A) and radiofrequency (RF) ablation.
[0018] Cardiac arrhythmias are a group of conditions that cause an irregular heartbeat or conduction pattern. Ablation may be used to create a safe and effective lesion or set of lesions at the origin of the irregular heartbeat or in regions that aid in the termination of arrhythmias without causing damage to adjacent structures or surrounding tissue, ideally resulting in no need for a maintenance treatment regimen, such as medications or cardioversions.
[0019] Current systems may be limited by not being able to sense and / or measure certain parameters, or not being able to use certain sensed and / or measured parameters, to determine and indicate whether one type of ablation energy delivery type is favored or other ablation energy delivery types. As such, system design may limit lesion depth and shape and multiple applications can be required to optimize lesion morphology, e.g., size, width, depth and / or shape, and ablation energy may be inefficiently used on non-target tissue.
[0020] In accordance with one or more aspects of this disclosure, a system may determine what type of ablation energy delivery to use to create a desired lesion based on a sensed and / or measured parameter indicative of a position of an energy delivery element relative to target tissue, whether the energy delivery element is in contact with the target tissue, and / or the location of the target tissue, e.g., within the patient. For example, a system may include processing circuitry configured to determine, based on a sensor signal such as a contact force, an impedance, an EGM signal and / or waveform, or any suitable sensor signal, a position of an energy delivery element (e.g., an electrode) of an ablation catheter. The processing circuitry may be configured to determine whether to deliver PFA energy, RF ablation energy, or cryoablation energy via the energy delivery element based on the determined position of the energy delivery element. The processing circuitry may be configured to then output a message indicating whether to deliver PFA energy, RF energy, or not to deliver energy via the energy delivery element.
[0021] For example, the processing circuitry may determine that ablation energy should not be delivered based on the position of the energy delivery element not being in contact with or proximate to target tissue. In some examples, the processing circuitry may determine that PFA energy should be delivered for an energy delivery element that is proximate to, but not in contact with, target tissue. The processing circuitry may determine that PFA energy should be delivered by an energy delivery element that is in contact with target tissue. As one example, the processing circuitry may determine that PFA energy should be delivered by an energy delivery element in contact with target tissue responsive to determining that the location of the target tissue and / or energy delivery element may not be appropriate for RF ablation or cryoablation. As another example, the processing circuitry may determine that PFA energy should be delivered by an energy delivery element in contact with target tissue responsive to determining that a safety profile of PFA for that location is greater than RF ablation or cryoablation. The processing circuitry may determine that RF ablation energy or cryoablation energy is recommended for an energy delivery element that is in contact with target tissue and at a location appropriate for RF ablation energy.
[0022] FIG. 1 is a conceptual diagram illustrating an example system 100 for delivering ablation. System 100 includes a catheter 102, a controller 104, and an anatomical information device 114. In general, to deliver ablation, a practitioner (e.g., electrophysiologist, interventional cardiologist, etc.) may insert one or more of catheter 102 into a patient and cause controller 104 to deliver, via catheter 102, energy (e.g., pulsed field ablation energy and / or radiofrequency ablation energy) to target tissue of a patient. Ablation may cause lesions in target cardiac tissue which may mitigate or stop cardiac arrhythmias. As ablation causes lesions in the target tissue, it may be desirable for system 100 to safely and accurately provide information to a clinician regarding ablation parameters, such as a suggested location where to position one or more energy delivery elements 110 of one or more catheters 102, an amount of energy to be delivered during ablation, or which tissue would be ablated after delivery of ablation energy via the at least one energy delivery element 110. Targe tissue may include cardiac tissue, septal tissue and / or a septum, renal tissue, airway tissue, organs or tissue within the cardiac space or the pericardial space, or any tissue suitable for delivering ablation energy.
[0023] Catheter 102 may be an ablation catheter, and may include elongated structure 112 carrying a plurality of energy delivery elements 110A-110H (collectively “energy delivery elements 110”) and one or more sensors 124A-124D (collectively “sensors 124”). An energy delivery element 110 may include an electrode (e.g., in the case of a PFA catheter), a radiofrequency element (e.g., in the case of a radiofrequency ablation catheter), or both (e.g., in the case of a PFA and RF catheter), or another energy delivery element. In some examples, sensors 124 and energy delivery elements 110 may be the same elements, e.g., multi-functional elements configured to sense a parameter and deliver ablation energy. In some examples, sensors 124 may be proximate to energy delivery elements 110 (as shown in FIG. 1), and in other examples, sensors 124 may be adjacent to or co-positioned (e.g., along elongated structure 112) with energy delivery elements 110. For example, sensors 124 may be positioned beneath (e.g., radially towards LA) one or more of energy delivery elements 110. In some examples, one or more of energy delivery elements 110 may include different energy delivery elements (that are proximate to each other), e.g., an energy delivery element 110 may include a first energy delivery element configured to delivery RF ablation energy and / or PFA energy and a second energy delivery element configured to delivery cryoablation energy.
[0024] While the techniques of this disclosure are applicable to any ablation catheter, the example of FIG. 1 is directed to a PFA, RF ablation, or cryoablation catheter. Catheter 102 may generally include features that enable insertion of catheter 102 into a patient and navigation of catheter 102 to a target tissue site. Elongated structure 112 may include a distal portion 106 and a proximal portion 108. Energy delivery elements 110 may be generally positioned at distal portion 106, while proximal portion 108 may be connected to controller 104. Energy delivery elements 110 may be of any suitable geometry. Example geometries of energy delivery elements include, but are not necessarily limited to, circular (e.g., ring) electrodes surrounding the body of the catheter, conformable electrodes, cuff electrodes, button electrodes, segmented electrodes (e.g., electrodes disposed at different circumferential positions around the lead instead of a continuous ring electrode), any combination thereof (e.g., ring electrodes and segmented electrodes). Energy delivery elements 110 may be axially distributed along longitudinal axis LA of elongated structure 112 or in severalother configurations. In some examples, catheter 102 may include one or more energy delivery elements 110 and the geometry of the one or more energy delivery elements 110 may include a balloon, which may be inflated when performing ablation and deflated when navigating catheter 102 to the target tissue. The delivery elements 110 may also be in a circular form, in an array, along multiple splines, or in other configurations.
[0025] In some examples, sensors 124 may be configured to sense an electrogram (EGM) signal indicative of electrical activity of tissue of the patient (e.g., a target tissue of the patient) and output the EGM signal to controller 104, e.g., to sensing circuitry of controller 104. In some examples, sensors 124 may be contact sensors configured to sense a contact with tissue of the patient (e.g., a target tissue of the patient) and output a signal indicative of a contact to controller 104, e.g., to sensing circuitry of controller 104. The sensing circuitry and / or processing circuitry 418 may be configured to determine whether an energy delivery element 110A-H is in contact with the target tissue based on the signal. In some examples, sensors 124 may include both EGM and contact sensors. For example, each of sensors 124A-D include one or both of an EGM sensor and / or contact sensor.
[0026] Elongated structure 112 may include conductors configured to carry electrical signals between energy delivery elements 110 and controller 104. In some examples, elongated structure 112 may include a separate conductor for each of energy delivery elements 110. For instance, in the example of FIG. 1 where energy delivery elements 110 includes eight electrodes, elongated structure 112 may include eight separate conductors. In this way, elongated structure may enable each electrode of energy delivery elements 110 to be driven with a different signal from controller 104. In other examples, multiple electrodes of energy delivery elements 110 may share a common conductor. For instance, energy delivery elements 110C and HOD may be connected to a same (e.g., a common) conductor. While such a common conductor arrangement may reduce energy delivery element flexibility (e.g., as electrodes connected to the common conductor may be driven with a same signal), such an arrangement may reduce manufacturing complexity and / or cost and may increase the structural flexibility of catheter 102.
[0027] As shown in FIG. 1, energy delivery elements 110 may include a tip electrode (e.g., energy delivery element 110A), which may be a ring electrode with a “cap” covering at least a portion of a tip of elongated structure 112. In some examples, the tip electrode may be chamfered or otherwise rounded (e.g., to enable easier passage of catheter 102 through anatomy of the patient). Energy delivery elements 110 may include a ring electrode (e.g., energy delivery element HOB) that is adjacent to the tip electrode. This ring electrode may be separated (axially along LA) from the tip electrode. Energy delivery elements 110 may include one or more pairs of ring electrodes. A pair of ring electrodes may include two adjacently closely spaced electrodes of energy delivery elements 110. For instance, in the example of FIG.1, energy delivery elements 110C and HOD may form a first pair of ring electrodes, energy delivery elements 110E and 110F may form a second pair of ring electrodes, and energy delivery elements 110G and 110H may form a third pair of ring electrodes. In general, the first pair of ring electrodes (i.e., energy delivery elements 110C and 110D) may be accompanied by one or more additional electrodes. The one or more additional electrodes may include any combination of pairs of ring electrodes and coil electrodes (e.g., electrodes that include conductors that spiral around elongated structure 112).
[0028] In the example of FIG. 1, energy delivery elements 110 are illustrated as has having a larger diameter than elongated structure 112. In some examples, one or more of energy delivery elements 110 may have a diameter that is approximately equal to or less than the diameter of elongated structure 112. For instance, energy delivery elements 110 may be recessed in elongated structure 112 such that the combination results in a relatively smooth outer surface.
[0029] Controller 104 may include an energy generator configured to provide electrical pulses to energy delivery elements 110 (or to control the delivery of radio frequency energy or cryogenic energy by energy delivery elements 110) to perform ablation delivery to cardiac tissue, a septum or septal tissue, or other tissues within the patient's body, such as renal tissue, airway tissue, and organs or tissue within the cardiac space or the pericardial space. For instance, the energy generator may be configured and programmed to deliver pulsed, high-voltage electric fields appropriate for achieving desired pulsed, high-voltage ablation, e.g., PF A, “pulsed electric fieldablation,” and / or radiofrequency ablation. Controller 104 may include sensor(s) 126 configured to sense a parameter of the patient, a tissue of the patient, or a parameter of system 100. For example, sensor(s) 126 may include an impedance sensor configured to sense an impedance of one or more energy delivery elements 110, impedance of tissue of the patient (e.g., a tissue impedance), and / or an impedance of system 100 or a component of system 100, e.g., catheter 102 and / or components of catheter 102.Sensor(s) 126 may be configured to sense complex impedances, e.g., impedance magnitudes and phases.
[0030] Anatomical information device(s) 114 may include a computed tomography (CT) device, a magnetic resonance imaging (MRI) device, an ultrasound (U / S) device, a pacing device, an electrophysiology (EP) mapping device, a biophysical property sensing device, e.g., such as a nicotinamide adenine dinucleotide (NADH) sensing device, and / or a non-invasive mapping device. Information sensed by anatomical information device(s) 114 may be used by system 100 to inform controller 104 of the anatomy of a patient, physical or electrical characteristics of the anatomy, and / or a location of catheter 102 during delivery of catheter 102 into the anatomy of a patient. Anatomical information device(s) 114 may sense one or more ablation markers, e.g., electrical, optical, and / or physical properties of a lesion, and / or the morphology of a lesion, e.g., size, width, depth and / or shape of a lesion. Controller 104 may determine an ablation marker, and determine whether a lesion satisfies target lesion criteria (e.g., electrical, optical, physical properties and / or morphology) based at least in part on an ablation marker, or information indicative of an ablation marker, sensed by anatomical information device(s) 114. In some examples, controller 104 may include one or more of anatomical information device(s) 114.
[0031] In accordance with one or more aspects of this disclosure, a system 100 for use in ablating target tissue of a patient includes controller 104 including non-transitory computer readable medium (e.g., memory) communicatively coupled processing circuitry and / or one or more processors in communication with one or more sensors 124 and sensors 126 configured to patient and / or system 100 parameters, the processing circuitry and / or one or more processors being configured to control ablation parameters of catheter 102. For example, the storage device 422 (FIG. 5) may include instructions that, when executed by processing circuitry 418 (FIG. 5), may cause processingcircuitry 418 to: cause sensors 124 and / or sensor(s) 126 to sense a parameter of the target tissue and / or system 100, determine a position of an energy delivery element 110A-H of catheter 102 based on the sensed parameter (e.g., position of the energy delivery element 110A-H relative to the target tissue), determine whether to deliver PFA energy or RF energy via the energy delivery element 110A-H based on the determined position of the energy and / or a location of the target tissue (e.g., location within the patient), and output a message indicating whether to deliver PFA energy, RF energy, or not to deliver energy via the energy delivery element.
[0032] The techniques of this disclosure may provide for changes in the type of ablation energy delivery to improve the lesion formation by improving the match between ablation energy delivery type with the positioning and configuration of one or more energy delivery elements of one or more ablation catheters relative to target tissue, as well as the location of the particular target tissue and desired lesion to be formed in the target tissue. In some examples, the techniques of this disclosure may provide for improved energy efficiency via adjusting delivery of the type ablation energy to target tissue, or not delivering ablation energy to non-target tissue. In some examples, the techniques of this disclosure may provide for improved patient outcomes by indicating what types of ablation energy delivery are preferred, e.g., what types may have a preferred safety profile, based on sensed and / or measured parameters of the particular arrangement of ablation catheters, energy delivery elements, and target tissue locations.
[0033] Although not shown, system 100 may include one or more sensors, in addition to sensors 124 and sensors 126, to monitor operating parameters through system 100, such as a temperature of tissue of the patient or of a component of system 100, a voltage and / or current of energy delivery elements 110. System 100 may include the one or more additional sensors for measuring and monitoring one or more tissue characteristics, such as monophasic action potentials, or the like, in addition to monitoring, recording, or otherwise conveying measurements or conditions within the catheter 102 or other component of system 100 or the ambient environment at the distal portion 106 of catheter 102. The sensor(s) may be in communication with controller 104 for initiating or triggering one or more notifications and / or alerts, or ablation energy delivery modifications such as repositioning catheter 102. In some examples, such sensors may be part of controller 104 and / or catheter 102.
[0034] FIGS. 2 and 3 are flow diagrams illustrating an example method of ablating target tissue of a patient. FIGS. 2 and 3 are described with respect to system 100, catheter 102, sensors 124, and sensor(s) 126 of FIG. 1, and processing circuitry 418 of controller 404 of FIG. 5. However, other devices may be used to perform techniques of FIG. 2. In the example shown, (204) through (210) may be performed in a loop iterating through one or more of the energy delivery elements 110 of catheter 102, e.g., to select and / or configure the ablation type, dose amount, and dosing strategy for each individual energy delivery element 110, and the ablation type, dose amount, and dosing strategy may be different or the same as one or more of the other energy delivery elements 110.
[0035] A clinician may start an ablation procedure (202). For example, a clinician may navigate catheter 102 to a target location within a patient to ablate target tissue, and initiate controller 404 and processing circuitry 418 to begin an ablation procedure.
[0036] Processing circuitry 418 may determine a position of an energy delivery element 110 based on a sensor signal (204). In some examples, processing circuitry 418 may receive a sensor signal indicative of a sensed and / or measured parameter by sensors 124 and / or 126, and determine, based on the sensor signal, whether energy delivery element 110 is in contact with, proximate to but not in contact with, or not proximate to and not in contact with target tissue of the patient.
[0037] For example, with reference to FIG. 3, processing circuitry 418 may receive an impedance signal from sensor 126 and determine whether the sensed and / or measured impedance indicates tissue contact (302). For example, processing circuitry 418 may determine a difference between a first measured impedance for which it is known that the energy delivery element 110 is not in contact with tissue (e.g., a baseline impedance) and a second impedance sensed and / or measured with the ablation catheter is navigated to the target location. Processing circuitry 418 may receive impedance signals indicative of the first and second impedances, and may determine the magnitude of the difference between the first and second impedances, e.g., the absolute difference between the first and second impedances. In some examples, if processing circuitry 418 determines a difference between the first and second impedances to be greater than a threshold amount, processing circuitry 418 may determine that the energy delivery element 110 is in contact with the tissue. In some examples, the threshold amount may be at least a 10% (10percent), e.g., a difference between the sensed impedances by 10% or more, or the threshold amount may be at least 10 Ohms, e.g., the difference between the magnitudes of the sensed impedances of 10 Ohms or more.
[0038] If processing circuitry 418 determines that the impedance does not indicate tissue contact (the NO branch at 302), processing circuitry 418 may determine whether mapping indicates that the energy delivery element 110 is proximate to the target tissue at (310) described below. If processing circuitry 418 determines that the impedance does indicate tissue contact (the YES branch at 302), processing circuitry 418 may determine whether the location of the energy delivery element 110 and / or the target tissue is appropriate for delivery of RF ablation or cryoablation energy at (312) described below, or may receive other sensed signals, e.g., in addition to the impedance such as for confirmation that the energy delivery element 110 is in contact with the target tissue.
[0039] For example, processing circuitry 418 may receive an EGM signal from sensor 124 and determine whether the sensed and / or measured EGM amplitude of the EGM signal indicates tissue contact (304). Processing circuitry 418 may determine a difference between a first measured EGM amplitude for which it is known that the energy delivery element 110 is not in contact with tissue (e.g., a baseline EGM amplitude) and a second EGM amplitude sensed and / or measured with the ablation catheter is navigated to the target location. Processing circuitry 418 may receive EGM signals indicative of the first and second EGM amplitudes, and may determine the magnitude of the difference between the first and second EGM amplitudes, e.g., the absolute difference between the first and second EGM amplitudes. In some examples, if processing circuitry 418 determines a difference between the first and second EGM amplitudes to be greater than a threshold amount, processing circuitry 418 may determine that the energy delivery element 110 is in contact with the tissue.
[0040] If processing circuitry 418 determines that the EGM amplitudes does not indicate tissue contact (the NO branch at 304), processing circuitry 418 may determine whether mapping indicates that the energy delivery element 110 is proximate to the target tissue at (310) described below. If processing circuitry 418 determines that the EGM amplitudes does indicate tissue contact (the YES branch at 304), processing circuitry 418 may determine whether the location of the energy delivery element 110 and / or the target tissue is appropriate for delivery of RF ablation energy or cryoablation energy at (312)described below. In some examples, the method may advance to (312) from (304) alone, e.g., processing circuitry 418 may determine that the energy delivery element 110 is in contact with the target tissue based on the EGM amplitude alone at (304). In other examples, processing circuitry 418 may receive other sensed signals, e.g., in addition to the EGM amplitude, or in addition to both the EGM amplitudes and impedance, such as for confirmation that the energy delivery element 110 is in contact with the target tissue.
[0041] For example, processing circuitry 418 may receive a contact force signal from sensor 124 and determine whether the sensed and / or measured contact force of the contact force signal indicates tissue contact (306). In some examples, if processing circuitry 418 determines the sensed and / or measured contact force to be greater than a threshold amount, processing circuitry 418 may determine that the energy delivery element 110 is in contact with the tissue.
[0042] If processing circuitry 418 determines that the contact force does not indicate tissue contact (the NO branch at 306), processing circuitry 418 may determine whether mapping indicates that the energy delivery element 110 is proximate to the target tissue at (310) described below. If processing circuitry 418 determines that the contact force does indicate tissue contact (the YES branch at 306), processing circuitry 418 may determine whether the location of the energy delivery element 110 and / or the target tissue is appropriate for delivery of RF ablation energy or cryoablation energy at (312) described below. In some examples, the method may advance to (312) from (306) alone, e.g., processing circuitry 418 may determine that the energy delivery element 110 is in contact with the target tissue based on the contact force alone at (306). In other examples, processing circuitry 418, determine whether the sensed and / or measured contact force indicates that the ablation catheter and / or the energy delivery element 110 is stable (308). For example, processing circuitry 418 may determine that the contact force is changing by a threshold amount at a threshold frequency, even if the contact force at any one time, or an average contact force, still indicates tissue contact.
[0043] Referring back to FIG. 2, processing circuitry 418 may determine whether to deliver PFA energy, RF ablation energy, cryoablation energy, or not to deliver ablation energy, via energy delivery element 110, based on the position of energy delivery element 110 (206). For example, with reference to FIG. 3 and as stated above, if processing circuitry 418 determines that any one of, or all of, the sensed and / or measuredimpedance, EGM amplitude, or contact force do not indicate tissue contact (the NO branch at any or all of 302, 304, or 306), or if processing circuitry 418 determines that the contact force does not indicate that the ablation catheter or energy delivery element 110 is stable (the NO branch at (308), processing circuitry 418 may determine whether mapping indicates that the energy delivery element 110 is proximate to the target tissue at (310). For example, processing circuitry 418 may determine whether the energy delivery element 110 is positioned proximate to target tissue based information from anatomical information devices 114, e.g., imaging such as CT, MRI, U / S, and / or mapping such as EP mapping. In some examples, processing circuitry 418 may determine if energy delivery element 110 is positioned proximate to target tissue based on input from the clinician. For example, the clinician may view imaging and / or mapping and input, via user interface 420, whether energy delivery element 110 is positioned proximate to target tissue.
[0044] Responsive to determining that the energy delivery element 110 is not proximate to the target tissue (the NO branch at 310), processing circuitry 418 may deactivate the energy delivery element 110 (314). Responsive to determining that the energy delivery element 110 is proximate to the target tissue (the YES branch at 310), processing circuitry 418 may determine that the energy delivery element 110 should delivery PFA energy (316).
[0045] In some examples, if processing circuitry 418 determines that any one of, or all of, the sensed and / or measured impedance, EGM amplitude, or contact force do indicate tissue contact (the YES branch at any or all of 302, 304, or 306), or if processing circuitry 418 determines that the contact force does indicate that the ablation catheter or energy delivery element 110 is stable (the YES branch at (308), processing circuitry 418 may determine whether the location of the target tissue and / or the energy delivery element 110 is appropriate for RF ablation or cryoablation (312).
[0046] Responsive to determining that the location is not appropriate for RF ablation or cryoablation (the NO branch at 312), processing circuitry 418 may determine that the energy delivery element 110 should delivery PFA energy (316). Responsive to determining that the location is appropriate for RF ablation or cryoablation (the YES branch at 312), processing circuitry 418 may determine that the energy delivery element 110 should delivery RF ablation energy or cryoablation energy (318).
[0047] Processing circuitry 418 may output a message indicating whether to deliver PFA energy, RF energy, or not to deliver energy via the energy delivery element at (208) in FIG. 2 or at (320) in FIG. 3. For example, processing circuitry 418 may output a message via user interface 420. In some examples, processing circuitry 418 may output the message indicating to deactivate the energy delivery element 110, e.g., responsive to determining that the energy delivery element 110 is not proximate to, or in contact with, the target tissue. In some examples, processing circuitry 418 may output the message indicating to deliver PFA energy via the energy delivery element 110, e.g., responsive to determining that the energy delivery element 110 is proximate to the target tissue, or responsive to determining that the energy delivery element 110 is in contact with target tissue and the target tissue location is not appropriate for delivery of RF energy. In some examples, processing circuitry 418 may output the message indicating to deliver RF energy via the energy delivery element 110, e.g., responsive to determining that the energy delivery element 110 is in contact with target tissue and the target tissue location is appropriate for delivery of RF energy.
[0048] In some examples, processing circuitry 418 may determine an ablation delivery type, or whether not to deliver ablation energy, for a plurality of individual energy delivery elements 110. For example, after determining whether to deliver ablation energy, and if so what type of ablation energy to deliver, for energy delivery element 110A, processing circuitry 418 may determine whether to deliver ablation energy, and if so what type of ablation energy to deliver, for energy delivery element HOB, e.g., the method may repeat electrode by electrode. In some examples, processing circuitry 418 may determine whether there is a next energy delivery element 110 for which to determine the type of ablation energy to deliver, or not to deliver ablation energy (210) in FIG. 2 or (322) in FIG. 3. Responsive to determining that there is another energy delivery element 110 for which to determine the energy delivery type or not to deliver ablation energy (the YES branch at 210 or 322), processing circuitry 418 may repeat the method at 204 or 302 for the next energy delivery element 110. Responsive to determining that there is not another energy delivery element 110 for which to determine the energy delivery type or not to deliver ablation energy (the NO branch at 210 or 322), the method may end at (212) in FIG. 2 or at (324) in FIG. 3.
[0049] In some examples, processing circuitry 418 may determine whether there is a next energy delivery element 110 for which to determine the type of ablation energy to deliver, or not to deliver ablation energy at (210) or (322) before outputting a message at (208) or (320). For example, processing circuitry may determine the type of ablation energy to deliver, or not to deliver ablation energy, for a plurality of energy delivery elements 110 and then output a message indicating whether to deliver PF A energy, RF energy, or not to deliver energy via the energy delivery element 110 for each energy delivery element 110 at (210) or (322), e.g., within the same message or via a plurality of messages.
[0050] In some examples, the plurality of processing circuitry 418 may determine an ablation delivery type, or whether not to deliver ablation energy, for a plurality of individual energy delivery elements 110 of a plurality of ablation catheters. For example, processing circuitry 418 may determine positions of two or more energy delivery elements 110 at (204) in FIG. 2 or at (310) and / or (312) in FIG. 3, and determine whether to deliver at least one of bipolar PFA energy or bipolar RF energy, e.g., via the two or more energy delivery elements 110. Processing circuitry 418 may then output the message at (208) or (320) indicating whether to deliver bipolar PFA energy, bipolar RF energy, or not to deliver energy, e.g., via the two or more energy delivery elements 110. For example, processing circuitry 418 may determine an ablation type and / or whether to deliver ablation energy for a first electrode upon a first iteration of the method of FIG. 2 or 3. At a second iteration of the method of FIGS. 2 or 3, processing circuitry 418 may determine that a second electrode is not proximate the target tissue. Responsive to determining that a second energy delivery element 110 is not proximate to the target tissue, processing circuitry 418 may deactivate the second energy delivery element 110. In some examples, processing circuitry 418 may determine that the second electrode is proximate the target tissue. Responsive to determining that a second energy delivery element 110 is proximate to the target tissue, processing circuitry 418 may output the message to indicate to deliver bipolar PFA energy. In some examples, processing circuitry 418 may determine that the second electrode is in contact with the target tissue, and that the target tissue location is appropriate for delivery of RF energy. Responsive to determining that the second energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, processingcircuitry 418 may output the message to indicate to deliver bipolar RF energy. In some examples, processing circuitry 418 may determine that the second electrode is in contact with the target tissue, and that the target tissue location is not appropriate for delivery of RF energy. Responsive to determining that the second energy delivery element is in contact with the target tissue and the target tissue location is not appropriate for delivery of RF energy, processing circuitry 418 may output the message to indicate to deliver bipolar PFA energy.
[0051] In some examples, processing circuitry 418 may cause one or more energy delivery elements 110 to deliver ablation energy to the target tissue according to an indicated energy type. In some examples, processing circuitry 418 may receive a response indicating whether to deliver ablation energy via an indicated energy type including at least one of PFA energy, RF energy, or not to deliver ablation energy, e.g., a response that is in response to the message output by processing circuitry 418. For example, the clinician may indicate, via user interface 420, whether to deliver ablation energy via an indicated energy type including at least one of PFA energy, RF energy, or not to deliver ablation energy via one or more of the energy delivery elements 110. In some examples, processing circuitry 418 may cause one or more energy delivery elements 110 to deliver ablation energy to the target tissue according to the indicated energy type.
[0052] FIG. 4 is a conceptual diagram illustrating contact of one or more ablation energy delivery elements 110 of an ablation catheter 102. FIG. 4 is described with respect to system 100 and catheter 102, and impedance sensors(s) 124 of FIG. 1, and processing circuitry 418 of controller 404 of FIG. 5. However, other devices may be used to determine contact of an ablation energy delivery element 110 and tissue.
[0053] In the example shown, catheter 102 is positioned at a first position relative to tissue 340 of a patient. Catheter 102 may be substantially similar to catheter 102 described above. Tissue 340 may be, or may include, target tissue of the patient.Tissue 340 may be cardiac tissue, renal tissue, airway tissue, organs or tissue within the cardiac space or the pericardial space, or any tissue suitable for delivering ablation energy.
[0054] System 100 including catheter 102 and sensors 124, 126, and / or sensors integrated into the ablation catheters, may be configured to adjust, or allow a physicianto adjust based on information from system 100, which electrodes are active and to change the type of ablation energy delivery, e.g., RF ablation energy delivery, cryoablation energy delivery, or PFA energy delivery, based on proximity and / or contact of energy delivery elements 110 with tissue 340.
[0055] In the example shown, each of energy delivery elements 110A-110H are proximate to tissue 340, but only energy delivery elements 110A-110F are in contact with tissue 340. Processing circuitry 418 may cause energy delivery elements HOG and 11 OH to be deactivated, and cause energy delivery elements 110A-110F to delivery ablation energy via RF ablation energy delivery or cryoablation energy delivery. Processing circuitry 418 may cause energy delivery elements HOG and 11 OH to be activated and to deliver ablation energy via PFA energy delivery, e.g., before or after causing energy delivery elements 110A-110F to delivery ablation energy. In some examples, processing circuitry 418 may cause all of the proximate energy delivery elements, e.g., energy delivery elements 110A-110H to delivery ablation energy via PFA energy delivery.
[0056] FIG. 5 is a block diagram illustrating an example controller 404 of an ablation system, e.g., system 100 of FIG. 1. Controller 404 of FIG. 5 may be an example of controller 104 of FIG. 1. As shown in FIG. 5, controller 404 includes energy generator 416, processing circuitry 418, user interface 420, storage devices 422, and sensing circuitry 424.
[0057] Energy generator 416 may be configured to provide electrical pulses to energy delivery elements and / or electrodes (e.g., energy delivery elements 110 of FIG.1) to ablate target tissue of a patient via PFA, RF ablation, and / or cryoablation, e.g., cardiac tissue, renal tissue, airway tissue, and organs or tissue within the cardiac space or the pericardial space. For instance, energy generator 416 may be configured and programmed to deliver pulsed, high-voltage electric fields appropriate for achieving desired pulsed, high-voltage ablation (referred to as “pulsed field ablation” or “pulsed electric field ablation”) and / or radiofrequency ablation. While shown in the example of FIG. 5 as a single energy generator, energy generator 416 is not so limited. For instance, controller 404 may include multiple energy generators 416 that are each capable of generating ablation signals in parallel.
[0058] Processing circuitry 418 may include one or more processors, such as any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), discrete logic circuitry, or any other processing circuitry configured to provide the functions attributed to processing circuitry 418 herein may be embodied as firmware, hardware, software or any combination thereof. Processing circuitry 418 controls energy generator(s) 416 to generate signals according to various settings (e.g., linear settings 430 or focal settings 432). In some examples, processing circuitry 418 may execute other instructions stored in storage device 422 to perform PF A, RF ablation, and / or cryoablation.
[0059] Sensing circuitry 424 may be configured to receive signals from energy delivery elements 110 and / or one or more sensors to monitor the operating parameters through system 100, such as impedance, temperature, delivered voltage, or the like, and for measuring and monitoring one or more tissue characteristics, such as EGM waveforms, monophasic action potentials, tissue impedance, or the like.
[0060] Storage device 422 may be configured to store information within controller 404, respectively, during operation. Storage device 422 may include a non-transitory computer-readable storage medium or computer-readable storage device. In some examples, storage device 422 includes one or more of a short-term memory or a longterm memory. Storage device 422 may include, for example, random access memories (RAM), dynamic random access memories (DRAM), static random access memories (SRAM), magnetic discs, optical discs, flash memories, or forms of electrically programmable memories (EPROM) or electrically erasable and programmable memories (EEPROM). In some examples, storage device 422 is used to store data indicative of instructions, e.g., for execution by processing circuitry 418, respectively.
[0061] User interface 420 may include a button or keypad, lights, a speaker for voice commands, a display, such as a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED). In some examples, the display includes a touch screen. User interface 420 may be configured to display any information related to the performance of PF A. User interface 420 may also receive user input (e.g., selection of linear or focal PF A mode) via user interface 420. The user input may be,for example, in the form of pressing a button on a keypad or selecting an icon from a touch screen.
[0062] Accordingly, although example systems and techniques have been shown and described, it is to be understood that all the terms used herein are descriptive rather than limiting, and that many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention. The following examples are examples of systems, devices, and methods described herein.
[0063] Example 1 : A method of ablating target tissue of a patient, the method including: determining, by processing circuitry and based on a sensor signal, a first position of an energy delivery element of an ablation catheter relative to the target tissue; determining, by the processing circuitry and based on the first position of the energy delivery element, to not deliver at least one of pulsed field ablation (PF A) energy or radio frequency (RF) energy; outputting, by the processing circuitry, a first message indicating to not deliver PFA or RF energy via the energy delivery element; determining, by the processing circuitry and based on the sensor signal, a second position of the energy delivery element of the ablation catheter relative to the target tissue; determining, by the processing circuitry and based on the second position of the energy delivery element, to deliver at least one of PFA energy or RF energy; and outputting, by the processing circuitry, a second message indicating to deliver at least one of PFA or RF energy via the energy delivery element.
[0064] Example 2: The method of example 1, wherein the sensor signal comprises at least one of a contact force signal, an impedance signal, or an electrogram signal.
[0065] Example 3 : The method of example 1 or example 2, further including: determining, by the processing circuitry and based on the first position of the energy delivery element, that the energy delivery element is not proximate to the target tissue; and responsive to determining that the energy delivery element is not proximate to the target tissue, deactivating, by the processing circuitry, the energy delivery element.
[0066] Example 4: The method of example 1 or example 2, further including: determining, by the processing circuitry and based on the second position of the energy delivery element, that the energy delivery element is proximate to the target tissue, wherein outputting the second message comprises outputting, responsive todetermining that the energy delivery element is proximate to the target tissue, the message indicating to deliver PFA energy.
[0067] Example 5: The method of example 1 or example 2, further including: determining, by the processing circuitry and based on the second position of the energy delivery element, that the energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that the energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, the message indicating to deliver RF energy.
[0068] Example 6: The method of example 1 or example 2, further including: determining, by the processing circuitry and based on the second position of the energy delivery element, that the energy delivery element is in contact with the target tissue and a target tissue location is not appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that the energy delivery element is in contact with the target tissue and the target tissue location is not appropriate for delivery of RF energy, the second message indicating to deliver PFA energy.
[0069] Example 7: The method of example 1 or example 2, wherein the energy delivery element is a first energy delivery element, the method further including: determining, by the processing circuitry and based on the sensor signal, a third position of a second energy delivery element of the ablation catheter relative to the target tissue; determining, by the processing circuitry and based on the third position of the second energy delivery element, to not deliver at least one of bipolar PFA energy or bipolar RF energy, wherein outputting the first message comprises outputting, by the processing circuitry, the message indicating to not deliver bipolar PFA energy or bipolar RF energy; determining, by the processing circuitry and based on the sensor signal, a fourth position of the second energy delivery element of the ablation catheter relative to the target tissue; and determining, by the processing circuitry and based on the fourth position of the second energy delivery element, to deliver at least one of bipolar PFA energy or bipolar RF energy, wherein outputting the second message comprises outputting, by the processing circuitry, the first second indicating to deliver at least one of bipolar PFA energy or bipolar RF energy.
[0070] Example 8: The method of example 7, further including: determining, by the processing circuitry and based on the third position of the second energy delivery element, that the second energy delivery element is not proximate to the target tissue; and responsive to determining that the second energy delivery element is not proximate to the target tissue, deactivating, by the processing circuitry, the second energy delivery element.
[0071] Example 9: The method of example 7, further including: determining, by the processing circuitry and based on the fourth position of the second energy delivery element, that the second energy delivery element is proximate to the target tissue; and wherein outputting the second message comprises outputting, responsive to determining that the second energy delivery element is proximate to the target tissue, the second message to indicate to deliver bipolar PFA energy.
[0072] Example 10: The method of example 7, further including: determining, by the processing circuitry and based on the fourth position of the second energy delivery element, that the second energy delivery element is in contact with the target tissue and a target tissue location is appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that the second energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, the second message indicating to deliver bipolar RF energy.
[0073] Example 11 : The method of example 7, further including: determining, by the processing circuitry and based on the fourth position of the second energy delivery element, that the second energy delivery element is in contact with the target tissue and a target tissue location is not appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that the second energy delivery element is in contact with the target tissue and the target tissue location is not appropriate for delivery of RF energy, the message indicating to deliver bipolar PFA energy.
[0074] Example 12: The method of example 7, wherein a second ablation catheter different from the first ablation catheter comprises the second energy delivery element.
[0075] Example 13: The method of any one of examples 1-12, wherein the target tissue comprises a septum.
[0076] Example 14: The method of example any one of examples 1-13, further including: receiving, by the processing circuitry, a response indicating whether to deliver ablation energy via an indicated energy type including at least one of PF A energy, RF energy, or not to deliver ablation energy; and causing, by the processing circuitry, the energy delivery element to deliver ablation energy to the target tissue according to the indicated energy type.
[0077] Example 15: A system includes: an ablation catheter including an energy delivery element; a processor; and a memory in communication with the processor and storing instructions that, when executed by the processor, cause the processor to: determine, based on a sensor signal, a first position of the energy delivery element of the ablation catheter relative to the target tissue; determine, based on the first position of the energy delivery element, to not deliver at least one of pulsed field ablation (PF A) energy or radio frequency (RF) energy; output a first message indicating to not deliver PFA or RF energy via the energy delivery element; determine, based on the sensor signal, a second position of the energy delivery element of the ablation catheter relative to the target tissue; determine, based on the second position of the energy delivery element, to deliver at least one of PFA energy or RF energy; and output a second message indicating to deliver at least one of PFA or RF energy via the energy delivery element.
[0078] Example 16: The system of example 15, wherein the sensor signal comprises at least one of a contact force signal, an impedance signal, or an electrogram signal.
[0079] Example 17: The system of example 15 or example 16, the memory storing instructions that, when executed by the processor, further cause the processor to: determine, based on the first position of the energy delivery element, that the energy delivery element is not proximate to the target tissue; and responsive to determining that the energy delivery element is not proximate to the target tissue, deactivate the energy delivery element.
[0080] Example 18: The system of example 15 or example 16, the memory storing instructions that, when executed by the processor, further cause the processor to: determine, based on the second position of the energy delivery element, that the energy delivery element is proximate to the target tissue, wherein outputting the secondmessage comprises outputting, responsive to determining that the energy delivery element is proximate to the target tissue, the second message indicating to deliver PFA energy.
[0081] Example 19: The system of example 15 or example 16, the memory storing instructions that, when executed by the processor, further cause the processor to: determine, based on the second position of the energy delivery element, that the energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that the energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, the message indicating to deliver RF energy.
[0082] Example 20: The system of example 15 or example 16, the memory storing instructions that, when executed by the processor, further cause the processor to: determine, based on the second position of the energy delivery element, that the energy delivery element is in contact with the target tissue and a target tissue location is not appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that the energy delivery element is in contact with the target tissue and the target tissue location is not appropriate for delivery of RF energy, the second message indicating to deliver PFA energy.
[0083] Example 21: The system of example 15 or example 16, wherein the energy delivery element is a first energy delivery element, the memory storing instructions that, when executed by the processor, further cause the processor to: determine, based on the sensor signal, a third position of a second energy delivery element of the ablation catheter relative to the target tissue; determine, based on the third position of the second energy delivery element, to not deliver at least one of bipolar PFA energy or bipolar RF energy, wherein outputting the first message comprises outputting the first message indicating to not deliver bipolar PFA energy; determine, based on the sensor signal, a fourth position of the second energy delivery element of the ablation catheter relative to the target tissue; and determine, based on the fourth position of the second energy delivery element, to deliver at least one of bipolar PFA energy or bipolar RF energy, wherein outputting the second message comprises outputting, the second message indicating to deliver at least one of bipolar PFA energy or bipolar RF energy.
[0084] Example 22: The system of example 21, the memory storing instructions that, when executed by the processor, further cause the processor to: determine, based on the second position of the third energy delivery element, that the second energy delivery element is not proximate to the target tissue; and responsive to determining that the second energy delivery element is not proximate to the target tissue, deactivate the second energy delivery element.
[0085] Example 23: The system of example 21, the memory storing instructions that, when executed by the processor, further cause the processor to: determine, based on the fourth position of the second energy delivery element , that the second energy delivery element is proximate to the target tissue; and wherein outputting the second message comprises outputting, responsive to determining that the second energy delivery element is proximate to the target tissue, the second message to indicate to deliver bipolar PFA energy.
[0086] Example 24: The system of example 21, the memory storing instructions that, when executed by the processor, further cause the processor to: determine, based on the fourth position of the second energy delivery element , that the second energy delivery element is in contact with the target tissue and a target tissue location is appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that the second energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, the second message indicating to deliver bipolar RF energy.
[0087] Example 25: The system of example 21, the memory storing instructions that, when executed by the processor, further cause the processor to: determine, based on the fourth position of the second energy delivery element , that the second energy delivery element is in contact with the target tissue and a target tissue location is not appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that the second energy delivery element is in contact with the target tissue and the target tissue location is not appropriate for delivery of RF energy, the second message indicating to deliver bipolar PFA energy.
[0088] Example 26: The system of example 21, wherein a second ablation catheter different from the first ablation catheter comprises the second energy delivery element.
[0089] Example 27: The system of any one of examples 15-26, wherein the target tissue comprises a septum.
[0090] Example 28: The system of any one of examples 21-27, the memory storing instructions that, when executed by the processor, further cause the processor to: receive a response indicating whether to deliver ablation energy via an indicated energy type including at least one of PF A energy, RF energy, or not to deliver ablation energy; and cause the energy delivery element to deliver ablation energy to the target tissue according to the indicated energy type.
[0091] Example 29: A computer readable medium including instructions that, when executed by one or more processors, cause the one or more processors to: determine, based on a sensor signal, a first position of an energy delivery element of an ablation catheter relative to a target tissue of a patient; determine, based on the first position of the energy delivery element, to not deliver at least one of pulsed field ablation (PF A) energy, radio frequency (RF) energy, or not to deliver energy via the energy delivery element; output a first message indicating to not deliver PFA energy or RF energy via the energy delivery element; determine, based on the sensor signal, a second position of the energy delivery element of the ablation catheter relative to the target tissue; determine, based on the second position of the energy delivery element, to deliver at least one of PFA energy or RF energy; and output a second message indicating to deliver at least one of PFA or RF energy via the energy delivery element.
[0092] Example 30: The computer readable medium of example 29, wherein the sensor signal comprises at least one of a contact force signal, an impedance signal, or an electrogram signal.
[0093] Example 31 : The computer readable medium of example 29 or example 30, further including instructions that, when executed by one or more processors, cause one or more processors to: determine, based on the first position of the energy delivery element, that the energy delivery element is not proximate to the target tissue; and responsive to determining that the energy delivery element is not proximate to the target tissue, deactivate the energy delivery element.
[0094] Example 32: The computer readable medium of example 29 or example 30, further including instructions that, when executed by one or more processors, cause one or more processors to: determine, based on the second position of the energy deliveryelement, that the energy delivery element is proximate to the target tissue, wherein outputting the second message comprises outputting, responsive to determining that the energy delivery element is proximate to the target tissue, the second message indicating to deliver PF A energy.
[0095] Example 33: The computer readable medium of example 29 or example 30, further including instructions that, when executed by one or more processors, cause one or more processors to: determine, based on the second position of the energy delivery element, that the energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that the energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, the second message indicating to deliver RF energy.
[0096] Example 34: The computer readable medium of example 29 or example 30, further including instructions that, when executed by one or more processors, cause one or more processors to: determine, based on the second position of the energy delivery element, that the energy delivery element is in contact with the target tissue and a target tissue location is not appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that the energy delivery element is in contact with the target tissue and the target tissue location is not appropriate for delivery of RF energy, the second message indicating to deliver PF A energy.
[0097] Example 35: The computer readable medium of example 29 or example 30, wherein the energy delivery element is first energy delivery element, further including instructions that, when executed by one or more processors, cause one or more processors to: determine, based on the sensor signal, a third position of a second energy delivery element of the ablation catheter relative to the target tissue; determine, based on the third position of the second energy delivery element, to not deliver at least one of bipolar PF A energy or bipolar RF energy, wherein outputting the first message comprises outputting the first message indicating whether to deliver bipolar PFA energy, bipolar RF energy, or not to deliver energy; determine, based on the sensor signal, a fourth position of the second energy delivery element of the ablation catheterrelative to the target tissue; determine, based on the fourth position of the second energy delivery element, to deliver at least one of bipolar PF A energy or bipolar RF energy, wherein outputting the second message comprises outputting the second message indicating to deliver at least one of bipolar PF A energy or bipolar RF energy.
[0098] Example 36: The computer readable medium of example 35, further including instructions that, when executed by one or more processors, cause one or more processors to: determine, based on the third position of the energy delivery element, that the second energy delivery element is not proximate to the target tissue; and responsive to determining that the second energy delivery element is not proximate to the target tissue, deactivate the second energy delivery element.
[0099] Example 37: The computer readable medium of example 35, further including instructions that, when executed by one or more processors, cause one or more processors to: determine, based on the fourth position of the second energy delivery element, that the second energy delivery element is proximate to the target tissue; and wherein outputting the second message comprises outputting, responsive to determining that the second energy delivery element is proximate to the target tissue, the second message to indicate to deliver bipolar PFA energy.
[0100] Example 38: The computer readable medium of example 35, further including instructions that, when executed by one or more processors, cause one or more processors to: determine, based on the fourth position of the second energy delivery element, that the second energy delivery element is in contact with the target tissue and a target tissue location is appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that the second energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, the second message indicating to deliver bipolar RF energy.
[0101] Example 39: The computer readable medium of example 35, further including instructions that, when executed by one or more processors, cause one or more processors to: determine, based on the fourth position of the second energy delivery element, that the second energy delivery element is in contact with the target tissue and a target tissue location is not appropriate for delivery of RF energy, wherein outputting the second message comprises outputting, responsive to determining that thesecond energy delivery element is in contact with the target tissue and the target tissue location is not appropriate for delivery of RF energy, the second message indicating to deliver bipolar PFA energy.
[0102] Example 40: The computer readable medium of example 35, wherein a second ablation catheter different from the first ablation catheter comprises the second energy delivery element.
[0103] Example 41 : The computer readable medium of any one of examples 29-40, wherein the target tissue comprises a septum.
[0104] Example 42: The computer readable medium of any one of examples 29-41, further includes receive a response indicating whether to deliver ablation energy via an indicated energy type including at least one of PFA energy, RF energy, or not to deliver ablation energy; and cause the energy delivery element to deliver ablation energy to the target tissue according to the indicated energy type.
[0105] The techniques described in this disclosure may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the described techniques may be implemented within processing circuitry, which may include one or more processors, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. The term “processor” or “processing circuitry” may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry. A control unit including hardware may also form one or more processors or processing circuitry configured to perform one or more of the techniques of this disclosure.
[0106] Such hardware, software, and firmware may be implemented, and various operation may be performed within same device, within separate devices, and / or on a coordinated basis within, among or across several devices, to support the various operations and functions described in this disclosure. In addition, any of the described units, circuits or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of different features as circuits or units is intended to highlight different functional aspects and does not necessarily imply that such circuits or units must be realized by separate hardware or software components.Rather, functionality associated with one or more circuits or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components. Processing circuitry described in this disclosure, including a processor or multiple processors, may be implemented, in various examples, as fixed-function circuits, programmable circuits, or a combination thereof. Fixed-function circuits refer to circuits that provide particular functionality with preset operations. Programmable circuits refer to circuits that can be programmed to perform various tasks and provide flexible functionality in the operations that can be performed. For instance, programmable circuits may execute software or firmware that cause the programmable circuits to operate in the manner defined by instructions of the software or firmware. Fixed-function circuits may execute software instructions (e.g., to receive stimulation parameters or output stimulation parameters), but the types of operations that the fixed-function circuits perform are generally immutable. In some examples, one or more of the units may be distinct circuit blocks (fixed-function or programmable), and in some examples, one or more of the units may be integrated circuits.
[0107] The techniques described in this disclosure may also be embodied or encoded in a computer-readable medium, such as a computer-readable storage medium, containing instructions that may be described as non-transitory media. Instructions embedded or encoded in a computer-readable storage medium may cause a programmable processor, or other processor, to perform the method, e.g., when the instructions are executed. Computer readable storage media may include random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), flash memory, a hard disk, a CD-ROM, a floppy disk, a cassette, magnetic media, optical media, or other computer readable media.
Claims
WHAT IS CLAIMED IS:
1. A system comprising:an ablation catheter comprising an energy delivery element;a processor; anda memory in communication with the processor and storing instructions that, when executed by the processor, cause the processor to:determine, based on a sensor signal, a first position of the energy delivery element of the ablation catheter relative to the target tissue;determine, based on the first position of the energy delivery element, to not deliver at least one of pulsed field ablation (PF A) energy or radio frequency (RF) energy;output a first message indicating to not deliver PFA or RF energy via the energy delivery element;determine, based on the sensor signal, a second position of the energy delivery element of the ablation catheter relative to the target tissue;determine, based on the second position of the energy delivery element, to deliver at least one of PFA energy or RF energy; andoutput a second message indicating to deliver at least one of PFA or RF energy via the energy delivery element.
2. The system of claim 1, wherein the sensor signal comprises at least one of a contact force signal, an impedance signal, or an electrogram signal.
3. The system of claim 1 or claim 2, the memory storing instructions that, when executed by the processor, further cause the processor to:determine, based on the first position of the energy delivery element, that the energy delivery element is not proximate to the target tissue; andresponsive to determining that the energy delivery element is not proximate to the target tissue, deactivate the energy delivery element.
4. The system of claim 1 or claim 2, the memory storing instructions that, when executed by the processor, further cause the processor to:determine, based on the second position of the energy delivery element, that the energy delivery element is proximate to the target tissue,wherein outputting the second message comprises outputting, responsive to determining that the energy delivery element is proximate to the target tissue, the second message indicating to deliver PFA energy.
5. The system of claim 1 or claim 2, the memory storing instructions that, when executed by the processor, further cause the processor to:determine, based on the second position of the energy delivery element, that the energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy,wherein outputting the second message comprises outputting, responsive to determining that the energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, the message indicating to deliver RF energy.
6. The system of claim 1 or claim 2, the memory storing instructions that, when executed by the processor, further cause the processor to:determine, based on the second position of the energy delivery element, that the energy delivery element is in contact with the target tissue and a target tissue location is not appropriate for delivery of RF energy,wherein outputting the second message comprises outputting, responsive to determining that the energy delivery element is in contact with the target tissue and the target tissue location is not appropriate for delivery of RF energy, the second message indicating to deliver PFA energy.
7. The system of claim 1 or claim 2, wherein the energy delivery element is a first energy delivery element, the memory storing instructions that, when executed by the processor, further cause the processor to:determine, based on the sensor signal, a third position of a second energy delivery element of the ablation catheter relative to the target tissue;determine, based on the third position of the second energy delivery element, to not deliver at least one of bipolar PF A energy or bipolar RF energy,wherein outputting the first message comprises outputting the first message indicating to not deliver bipolar PFA energy;determine, based on the sensor signal, a fourth position of the second energy delivery element of the ablation catheter relative to the target tissue; and determine, based on the fourth position of the second energy delivery element, to deliver at least one of bipolar PFA energy or bipolar RF energy,wherein outputting the second message comprises outputting, the second message indicating to deliver at least one of bipolar PFA energy or bipolar RF energy.
8. The system of claim 7, the memory storing instructions that, when executed by the processor, further cause the processor to:determine, based on the second position of the third energy delivery element, that the second energy delivery element is not proximate to the target tissue; and responsive to determining that the second energy delivery element is not proximate to the target tissue, deactivate the second energy delivery element.
9. The system of claim 7, the memory storing instructions that, when executed by the processor, further cause the processor to:determine, based on the fourth position of the second energy delivery element , that the second energy delivery element is proximate to the target tissue; and wherein outputting the second message comprises outputting, responsive to determining that the second energy delivery element is proximate to the target tissue, the second message to indicate to deliver bipolar PFA energy.
10. The system of claim 7, the memory storing instructions that, when executed by the processor, further cause the processor to:determine, based on the fourth position of the second energy delivery element , that the second energy delivery element is in contact with the target tissue and a target tissue location is appropriate for delivery of RF energy,wherein outputting the second message comprises outputting, responsive to determining that the second energy delivery element is in contact with the target tissue and the target tissue location is appropriate for delivery of RF energy, the second message indicating to deliver bipolar RF energy.
11. The system of claim 7, the memory storing instructions that, when executed by the processor, further cause the processor to:determine, based on the fourth position of the second energy delivery element , that the second energy delivery element is in contact with the target tissue and a target tissue location is not appropriate for delivery of RF energy,wherein outputting the second message comprises outputting, responsive to determining that the second energy delivery element is in contact with the target tissue and the target tissue location is not appropriate for delivery of RF energy, the second message indicating to deliver bipolar PFA energy.
12. The system of claim 7, wherein a second ablation catheter different from the first ablation catheter comprises the second energy delivery element.
13. The system of any one of claims 1-12, wherein the target tissue comprises a septum.
14. The system of any one of claims 1-13, the memory storing instructions that, when executed by the processor, further cause the processor to:receive a response indicating whether to deliver ablation energy via an indicated energy type including at least one of PFA energy, RF energy, or not to deliver ablation energy; andcause the energy delivery element to deliver ablation energy to the target tissue according to the indicated energy type.
15. A computer readable medium comprising instructions that, when executed by one or more processors, cause the one or more processors to:determine, based on a sensor signal, a first position of an energy delivery element of an ablation catheter relative to a target tissue of a patient;determine, based on the first position of the energy delivery element, to not deliver at least one of pulsed field ablation (PF A) energy, radio frequency (RF) energy, or not to deliver energy via the energy delivery element;output a first message indicating to not deliver PFA energy or RF energy via the energy delivery element;determine, based on the sensor signal, a second position of the energy delivery element of the ablation catheter relative to the target tissue;determine, based on the second position of the energy delivery element, to deliver at least one of PFA energy or RF energy; andoutput a second message indicating to deliver at least one of PFA or RF energy via the energy delivery element.
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