Dynamic therapy annotation

Abstract

An example medical system includes an ablation catheter including one or more sensors. The ablation catheter is configured to deliver ablation energy to tissue. The medical system includes processing circuitry configured to receive one or more signals from the one or more sensors of the catheter during a period of application of ablation energy to the tissue. The processing circuitry is configured to generate a representation of the tissue including an annotation based on the one or more signals, the annotation including at least one visual property. The processing circuitry is configured to receive information indicative of movement of the catheter during the period of application of ablation energy. The processing circuitry is configured to modify the at least one visual property of the annotation at least in part based on the information indicative of movement of the catheter.

Description

DYNAMIC THERAPY ANNOTATION

[0001] This application claims priority to, and the benefit of, U.S. Provisional Application No. 63 / 665,543, filed June 28, 2024, and entitled “DYNAMIC THERAPY ANNOTATION,” the entire contents of which is incorporated herein by reference.TECHNICAL FIELD

[0002] The disclosure relates to ablation of cardiac tissue.BACKGROUND

[0003] Cardiac ablation is a procedure that may be employed to treat an irregular heart rhythm (e.g., an arrhythmia). Cardiac ablation may involve alteration of heart tissue to disrupt generation and / or propagation of faulty electrical signals causing the arrhythmia. Ablation devices may include catheters with one or more electrodes. The electrodes may be configured to direct ablation energy to tissue of a patient to cause a lesion in the tissue, for example to block unwanted propagation of electrical signals.SUMMARY

[0004] This disclosure describes example medical devices and systems configured to generate information about therapeutic energy (e.g., ablation energy, also referred to as ablation therapy herein) delivered to tissue (e.g., cardiac tissue), and related methods. The devices and systems described herein are configured to generate and store information indicating areas of tissue which have received energy, as well as a level (e.g., dose) of energy, among other information. The devices and systems herein may be configured to sense and / or receive one or more signals from tissue and / or signals from a therapy delivery device (e.g., a catheter) in order to generate (e.g., for display to a user) information about energy delivery.

[0005] In examples described herein, a medical system includes one or more catheters and processing circuitry operably coupled to the one or more catheters. At least one catheter includes one or more sensors configured to sense and / or receive information (e.g., signals), such as from tissue of a patient. The medical system also includes a catheter configured to deliver therapeutic energy (e.g., ablation energy), such as via one or more therapy delivery elements (e.g., electrodes, transducers, structures configured to transmit energy, and the like). The medical system includes processing circuitry operably coupled to the sensors and / or energy delivery elements of the one or more catheters. The processing circuitry is configured to control energydelivery and / or receive information from the sensors. In some examples, the medical system includes a positioning subsystem configured to track and record positions of one or more the catheter, the energy delivery elements, the sensors, and / or or other suitable components of the medical system.

[0006] The processing circuitry can determine and / or generate (e.g., display) information for a user based on information received from the sensors, such as to indicate to a user information about tissue, energy delivery, and / or related information. For example, the processing circuitry can generate annotations (e.g., therapy annotations) that indicate to a user one or more of a size, location, efficacy, or another parameter about energy delivery (e.g., ablation energy) delivered to tissue of a patient. The annotations can include visual properties including, but not limited to, one or more of a shape, orientation, color, gradient, hue, shading, highlighting, pattern, and transparency of the annotation. In examples described herein, the processing circuitry may be configured to generate annotations and subsequently modify (e.g., continuously or at one or more time intervals) the visual properties of the annotations.

[0007] In some examples described herein, the processing circuitry is configured to modify (e.g., continuously or at one or more time intervals) a visual property of an annotation based on an indication of movement (e.g., displacement) of the therapy delivery elements (e.g., electrodes) and / or other parts of the catheter. For example, the processing circuitry may be configured to generate an annotation and modify a size of an annotation, such as to generate a continuous “drawn” annotation. Such annotations can be used for instances where one or more electrodes and / or the catheter move relative to (e.g., along), but remain within at least a threshold distance proximity of (e.g., relatively close to and / or in contact with), tissue during a period of therapy delivery. By updating annotations based on movement of the therapy delivery elements and / or other parts of the catheter, the system produces a relatively more accurate representation of energy actually delivered to a patient. In some examples, this relatively more accurate representation of energy delivered to the patient can reduce the necessity of additional delivery of energy in certain locations on tissue, reduce procedure time, and / or instill confidence that target areas have received sufficient therapeutic energy.

[0008] In some examples described herein, the processing circuitry is configured to generate an annotation and modify (e.g., continuously or at one or more time intervals) a visual property of the annotation based on a location of energy delivery and / or an indication of efficacy of therapy (e.g., based on cumulative energy delivery, temperature, and / or another suitable indication of efficacy of therapy delivery). For example, the processing circuitry may be configured to generate the annotation with at least one visual property at a first time (e.g., based on a first set of one or more signals), and later modify (e.g., at a second time after the first time)the visual property (e.g., based on a second set of one or more signals). As another example, the processing circuitry may be configured to generate an annotation and modify (e.g., continuously or at one or more time intervals) at least one visual property of the annotation based on a cumulative effect of ablation. In some examples, the cumulative effect of ablation is determined based on one or more of energy, temperature, time, and / or another parameter (e.g., during a period of energy delivery). By updating annotations (e.g., continuously or at one or more time intervals) based on an indication of efficacy of therapy, the system produces a relatively more accurate representation of energy actually delivered to a patient. In some examples, this relatively more accurate representation of therapy delivery can reduce the necessity of additional delivery of energy in certain locations on tissue, reduce procedure time, and / or instill confidence that target areas have received sufficient therapy.

[0009] In some examples, a medical system includes one or more catheters including one or more sensors and configured to deliver ablation energy to tissue; and processing circuitry configured to: receive one or more signals from the one or more sensors of the one or more catheters during a period of application of ablation energy to the tissue; generate a representation of the tissue including an annotation based on the one or more signals, the annotation including at least one visual property; receive information indicative of movement of at least one catheter of the one or more catheters during the period of application of ablation energy; and modify the at least one visual property of the annotation at least in part based on the information indicative of movement of the at least one catheter.

[0010] In some examples, a method includes receiving, by processing circuitry, one or more signals from one or more sensors of one or more catheters during a period of application of ablation energy to tissue; generating, by the processing circuitry and for presentation to a user, a representation of the tissue including an annotation based on the one or more signals, the annotation including at least one visual property; receiving, by the processing circuitry, information indicative of movement of at least one catheter of the one or more catheters during the period of application of ablation energy; and modifying, by the processing circuitry, the at least one visual property of the annotation at least in part based on the information indicative of movement of the at least one catheter.

[0011] In some examples, a medical system includes one or more catheters including one or more sensors and configured to deliver ablation energy to tissue; and processing circuitry configured to: receive a first set of one or more signals for a first time period from one or more sensors of the one or more catheters during a period of application of ablation energy to tissue; generate a representation of the tissue including an annotation based on the first set of one or more signals, the annotation including at least one visual property; receive a second set of one ormore signals for a second time period after the first time period from the one or more sensors; and modify, based on the second set of one or more signals, the at least one visual property of the annotation.

[0012] In some examples, a method includes receiving, by processing circuitry, a first set of one or more signals for a first time period from one or more sensors of one or more catheters during a period of application of ablation energy to tissue; generating, by the processing circuitry and for presentation to a user, a representation of the tissue including an annotation based on the first set of one or more signals, the annotation including at least one visual property; receiving, by the processing circuitry, a second set of one or more signals for a second time period after the first time period from the one or more sensors; and modifying, by the processing circuitry and based on the second set of one or more signals, the at least one visual property of the annotation.

[0013] The details of one or more examples of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims.BRIEF DESCRIPTION OF DRAWINGS

[0014] FIG. 1 is partially conceptual diagram illustrating an example system to deliver ablation energy as well as to detect and / or sense signals.

[0015] FIG. 2A and FIG. 2B are conceptual diagrams illustrating examples of ablation catheters configured to deliver ablation energy and / or measure signals.

[0016] FIG. 3 is a block diagram illustrating an example interface unit of an ablation system, in accordance with one or more aspects of this disclosure.

[0017] FIG. 4A and FIG. 4B are conceptual diagrams illustrating examples of information displayed before, during, and / or after movement of a therapy device in accordance with one or more techniques of this disclosure.

[0018] FIG. 5A and FIG. 5B are conceptual diagrams illustrating examples of information displayed before, during, and / or after movement of a therapy device in accordance with one or more techniques of this disclosure.

[0019] FIG. 6 is a conceptual diagram of a single annotation including variations of a visual property within the single annotation.

[0020] FIG. 7 is a conceptual diagram of an annotation including a visual property including variation of at least one visual property of an annotation overtime.

[0021] FIG. 8 is a conceptual diagram illustrating examples of annotations including at least one visual property.

[0022] FIG. 9 is a flow diagram illustrating an example technique for modifying at least one visual property of an annotation according to the techniques of this disclosure.

[0023] FIG. 10 is a flow diagram illustrating an example technique for modifying at least one visual property of an annotation according to the techniques of this disclosure.DETAILED DESCRIPTION

[0024] This disclosure describes devices, systems, and methods relating to medical device systems, including system used during medical procedures such as ablation of tissue (e.g., cardiac tissue) to treat one or more patient conditions (e.g., arrythmias). In such medical procedures including ablation therapy, therapy in the form of energy can be delivered to one or more regions of tissue via devices (e.g., catheters) at discreate points (e.g., discreate locations). Energy can include radiofrequency (RF), pulsed field (PF), cryogenic energy (e.g., cryoablation), microwave, laser, another suitable therapy, and / or a combination thereof configured to treat one or more patient conditions. In some examples, energy can include includes combinations of therapeutic energy modalities (e.g., such that the system or a user toggles between different therapeutic energy delivery modalities, and / or such that multiple modalities are delivered together). In some examples, systems are configured to generate feedback to an operator (e.g., a clinician) about energy delivered at each of the discrete locations at which energy is delivered (e.g., where a lesion is created). Some systems are configured to generate and present, via a display, annotations overlaid on a representation of an anatomical structure (e.g., tissue, such as a heart of a portion thereof) that include one or more properties. These annotation (e.g., therapy annotations) can indicate a size, location, efficacy, or another parameter about therapy (e.g., ablation energy) delivered to tissue of a patient. The one or more visual properties of annotations can indicate further details to a user, such as details about therapy delivery parameters and / or therapy effects. Therapy delivery parameter and / or effects may include, but are not limited to, one or more of a level of applied energy (e.g., dose), lesion depth, therapy efficacy, or another parameter about therapy (e.g., ablation therapy) delivered to tissue of a patient. In some cases, annotations, including the one or more visual properties of annotations, are static (e.g., do not update in response to catheter movement or more recent information sensed at the therapy delivery location).

[0025] Feedback about therapy delivery, including annotations presented to a user, can enable a user (e.g., a clinician) to determine whether previously delivered energy is sufficient, or whether further (e.g., more) energy should be delivered. While static annotations provide some level of feedback as to where energy has been delivered (e.g., which portions of tissues have been ablated), static annotations may not fully and / or accurately reflect energy actually deliveredto tissue. For example, in cases where movement of a therapy delivery element (e.g., electrode, catheter, etc.) occurs during a period of energy delivery, a static annotation may not fully reflect the entire portion of tissue which received energy during the period of energy delivery. Additionally, while static annotations may provide some level of feedback as to the efficacy of the therapy, static annotations may not fully and / or accurately reflect efficacy of therapy. For example, static annotations associated with a given area of tissue may not take into account differences in a level of ablation actually applied to the given area of tissue.

[0026] In examples described herein, a medical system includes one or more catheters and processing circuitry operably coupled to the one or more catheters. At least one catheter includes one or more sensors configured to sense and / or receive information (e.g., signals) regarding a measurable parameter. The medical system also includes a catheter configured to deliver therapeutic energy (e.g., ablation energy), such as via one or more therapy delivery elements (e.g., electrodes, one or more balloons, structures configured to transmit energy, and the like). In some examples, a single catheter includes the one or more sensors and one or more therapy delivery elements, however separate catheters each respectively having sensors and / or therapy delivery elements can be used. In some examples, one or more catheters include therapy delivery elements where therapy is delivered between therapy delivery elements on the same catheter or between therapy delivery elements on different catheters (e.g., electrodes of different polarity on two different catheters). In some examples, energy is delivered between therapy delivery elements (e.g., electrodes) of one or more catheters and an external reference electrode and / or ground patch. In some examples, energy is delivered between therapy delivery elements (e.g., electrodes) of one or more catheters and an internal patch (e.g., in epicardium). The medical system includes processing circuitry operably coupled to the sensors and / or therapy delivery elements of the catheter(s) configured to control therapy delivery and / or receive information from the sensors.

[0027] In some examples, the medical system includes a positioning subsystem configured to track and record positions of one or more the catheter, the therapy delivery elements, the sensors, and / or or other suitable components of the medical system. In some examples, the positioning subsystem is used for the generation of annotations, as described more fully below.

[0028] In some examples, the processing circuitry is configured to determine and / or generate (e.g., display) information for a user based on information (e.g., signals) received from the sensors, such as to indicate to a user information about tissue, therapy delivery, and / or related information. For example, the processing circuitry may generate annotations that indicate to a user one or more of an energy dose, lesion size, lesion location, a therapeutic effectiveness, or another parameter about therapy (e.g., ablation therapy) delivered to tissue of a patient.Annotations can include visual properties including, but not limited to, one or more of a shape, orientation, color, gradient, hue, shading, highlighting, pattern, and transparency of the annotation. In examples described herein, processing circuitry may be configured to generate annotations and subsequently modify (e.g., continuously or at one or more time intervals) the visual properties of the annotations.

[0029] In some examples described herein, the processing circuitry is configured to modify (e.g., continuously or at one or more time intervals) a visual property of an annotation based on an indication of movement (e.g., displacement) of the therapy delivery elements (e.g., electrodes) and / or other parts of the catheter. For example, the processing circuitry may be configured to generate and modify (e.g., update) a size and / or shape of an annotation, such as to generate a continuous “drawn” annotation, in instances where electrodes and / or the catheter move relative to (e.g., along), but remain within a threshold distance of (e.g., relatively close to and / or in contact with), tissue during a period of therapy delivery. By updating annotations based on movement of the therapy delivery elements and / or other parts of the catheter, the system produces a relatively more accurate representation of energy actually delivered to a patient (e.g., as compared to static annotations). In some examples, this relatively more accurate representation of therapy delivery delivered to the patient can reduce the necessity of additional delivery of energy in certain locations on tissue, reduce procedure time, and / or instill confidence that target areas have received sufficient therapy.

[0030] In some examples, if excessive movement (e.g., of the catheter) is detected during therapy delivery, feedback as to insufficient therapy delivery may be determined and / or generated. In some examples, processing circuitry is configured to determine a stability index of the catheter, which can indicate whether the catheter was stable during energy delivery. In some examples, processing circuitry may receive a user-defined threshold for an acceptable amount of movement during therapy delivery. In some examples, biophysical signals (e.g. impedance, EGM, temperature, or the like) can be used to determine (e.g., calculate) such stability index.

[0031] In some examples described herein, the processing circuitry is configured to generate and / or modify (e.g., continuously or at one or more time intervals) a visual property of an annotation based on an indication of efficacy of therapy (e.g., based on cumulative energy delivery, temperature, and / or another suitable indication of efficacy of therapy delivery). For example, the processing circuitry may be configured to generate the annotation with at least one visual property at a first time and / or for a first time period (e.g., based on a first set of one or more signals), and later modify (e.g., at a second time and / or for a second time period) the visual property. In some examples, the modification of the annotation is based on a second set of one or more signals different than the first set of one or more signals. As another example, theprocessing circuitry may be configured to generate an annotation and modify (e.g., continuously or at one or more time intervals) at least one visual property of the annotation based on a cumulative effect of ablation. In some examples, the cumulative effect of ablation is determined based on one or more of energy (e.g., energy delivered to tissue), temperature (e.g., of tissue, therapy delivery elements, or another part of the medical system), time (e.g., a duration of time of therapy delivery and / or time between one or more discrete, non-overlapping instances of therapy delivery), tissue warming and / or tissue cooling (e.g., thermal recovery, which may be calculated based on, at least in part, biophysical properties of tissue), another parameter, and / or a suitable combination thereof. By updating annotations (e.g., continuously or at one or more time intervals) based on an indication of efficacy of therapy, the system produces a relatively more accurate representation of energy actually delivered to a patient. In some examples, this relatively more accurate representation of therapy delivery can reduce the necessity of additional delivery of energy in certain locations on tissue, reduce procedure time, and / or instill confidence that target areas have received sufficient therapy.

[0032] FIG. 1 is a partially conceptual diagram illustrating an example system 100 according to the techniques of this disclosure. System 100 includes a catheter 102 (e.g., a minimally invasive ablation catheter configured to navigate into a heart of a patient and treat cardiac arrhythmias), an interface unit 104, and an anatomical information device(s) 107. System 100 may be configured to deliver ablation therapy, as well as map and / or record signals from a patient 101. In general, to deliver ablation therapy, a user (e.g., clinician, electrophysiologist, interventional cardiologist, etc.) may insert one or more of catheter 102 into patient 101 and cause interface unit 104 to deliver, via catheter 102, energy (e.g., ablation energy) to target tissue 103 of patient 101. In some examples, ablation energy is delivered to multiple areas to create multiple lesions. For example, a clinician may use interface unit 104 to cause ablation energy to be delivered via catheter resulting in multiple overlapping lesions.

[0033] Ablation energy (which may otherwise be referred to as ablation therapy) may include one or more of pulsed field ablation (PF or PF A) energy, radiofrequency (RF) ablation energy, laser ablation, thermal ablation, cryoablation or cryogenic ablation, microwave energy, carbon ion beam ablation, cryoablation energy, ultrasound energy, and / or another suitable energy and / or therapy. In some examples, delivered ablation energy includes combinations of different types of energy (e.g., such that the system or a user toggles between different energy modalities, and / or such that multiple energy modalities are delivered together). Ablation may cause lesions in target tissue 103 (e.g., cardiac tissue) which may mitigate, stop, and / or prevent cardiac arrhythmias or other types of patient conditions. As ablation causes lesions to tissue 103, it may be desirable for a system to provide information to a clinician regarding ablation parameters and response oftissue 103 to ablation. Such information can include an indication of locations where therapy was delivered and / or suggested locations to position catheter 102. In some examples, the information indicates an energy dose (e.g., an amount of energy to be delivered during ablation).

[0034] In some examples, catheter 102 is configured to deliver ablation therapy to tissue 103. In some examples, catheter 102 includes one or more therapy delivery elements 110 (shown individually as therapy delivery element 110A and therapy delivery element HOB and collectively referred to herein as therapy delivery elements 110). Each of therapy delivery elements 110 may include an electrode (e.g., in the case of a RF or PFA catheter), a cryogenic element (e.g., in the case of a cryoablation catheter), an ultrasound transducer (e.g., in the case of an ultrasound catheter), or another suitable therapy delivery element. In some examples, therapy delivery elements 110 are disposed on, or carried by, an elongated structure 112 of catheter 102.

[0035] Catheter 102 may generally include features that enable insertion of catheter 102 into patient 101, as well as navigation of catheter 102 to a target tissue site (e.g., adjacent tissue 103). In some examples, elongated structure 112 includes a distal portion 106 and a proximal portion 108. Therapy delivery elements 110 may be positioned at distal portion 106, while a proximal portion 108 may be connected to interface unit 104. Proximal portion 108 may be configured to be positioned outside of the body of the patient while the distal portion 106 is positioned within the body the patient (e.g., during a period of ablation therapy).

[0036] Therapy delivery elements 110 may be of any suitable geometry. In examples, where therapy delivery elements 110 include one or more electrodes, geometries of electrodes include, but are not necessarily limited to, circular (e.g., ring) electrodes surrounding the body of catheter 102, conformable electrodes, cuff electrodes, segmented electrodes (e.g., electrodes disposed at different circumferential positions around catheter 102 instead of a continuous ring electrode), or any combination thereof (e.g., ring electrodes and segmented electrodes). In some examples, catheter 102 includes an expandable structure at distal portion 106. In some examples, therapy delivery elements 110 are disposed on the expandable structure. In some examples, one or more of therapy delivery elements 110 includes an expandable structure (e.g., an expandable lattice structure formed from a conductive material).

[0037] Therapy delivery elements 110 may be axially distributed along longitudinal axis LA of elongated structure 112 or in several other configurations. In some examples, catheter 102 may include one or more therapy delivery elements 110 positioned at different axial and radial positions relative to elongated structure 112. In some examples, therapy delivery elements 110 are disposed around an expandable structure (e.g., a balloon, basket, splines, etc.), which may be expanded when performing ablation and compressed when navigating catheter 102 to targettissue 103. The therapy delivery elements 110 may also be in a circular form, in an array, along multiple splines, or in other configurations.

[0038] In some examples, as discussed previously, catheter 102 includes an expandable structure. In some examples, the expandable structure includes a self-expanding structure. In some examples, the expandable structure is manually activated (e.g., via pullwire, inflation, or another suitable expansion mechanism).

[0039] In some examples, system 100 includes one or more sensors 111 (shown individually as sensor 111A and sensor 11 IB and collectively referred to herein as sensors 111). Sensors 111 may be configured to detect, sense, and / or transmit information about patient 101 and / or operating parameters of system 100. For example, interface unit 104 may be configured to receive signals that indicate one or more measurable parameters associated with catheter 102 and / or therapy delivered via catheter 102, including one or more of temperature, voltage, delivered current, and / or tissue contact. In some examples, interface unit 104 may be configured to receive signals corresponding to one or more characteristics of tissue 103, such as temperature of tissue 103, electrogram (EGM) waveforms, monophasic action potentials, impedance (e.g., tissue impedance), or the like. Interface unit 104 may be configured to monitor, record, or otherwise receive measurements or conditions via sensors 111 of catheter 102, other components of system 100, and / or the ambient environment at the distal portion of the energy delivery device (e.g., from tissue 103 of patient 101). Sensors 111 may be in communication with interface unit 104 for initiating or triggering one or more alerts or ablation energy delivery modifications during operation of the energy delivery device. In some examples, sensors 111 may be part of interface unit 104, and / or anatomical information device(s) 107.

[0040] In some examples, elongated structure 112 includes conductors (e.g., wires, trace elements, and / or the like) configured to carry electrical signals between therapy delivery elements 110 and interface unit 104 as well as between sensors 111 and interface unit 104. In some examples, elongated structure 112 may include a separate conductor for each of therapy delivery elements 110 and / or for each of sensors 111. In the example of FIG. 1, where system 100 includes two therapy delivery elements 110, elongated structure 112 may include two separate conductors. In this way, elongated structure 112 may enable each of therapy delivery elements 110 to be driven with a different signal from interface unit. In other examples, multiple therapy delivery elements 110 may share a common conductor. For instance, therapy delivery element 110A and therapy delivery element 110B may be connected to a same (e.g., a common) conductor.

[0041] In some examples, interface unit 104 is configured to couple to a therapy generator configured to provide therapy (e.g., electrical energy, cryogenic therapy, or another suitable formof therapy, and / or a combination thereof) to therapy delivery elements 110 to perform an ablation procedure to tissue 103 of patient 101. In other examples, interface unit 104 and a therapy generator are part of a single capital system. In some examples, tissue 103 includes cardiac tissue, such as tissue proximate the pulmonary vein, or tissue within a chamber of the heart. While the examples discussed in this disclosure are primarily in the context of cardiac tissue, tissue 103 can include any suitable tissue within the patient’s body, such as renal tissue, airway tissue, and other organs. 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., “pulsed field ablation” or “pulsed electric field ablation”) and / or pulsed or non-pulsed radiofrequency ablation. In some examples, the energy generator may be configured and programmed for achieving desired cryogenic ablation. In some examples, the energy generator is configured as an acoustic generator and programmed to deliver ultrasound energy, such as for achieving ultrasound ablation.

[0042] In some examples, interface unit 104 includes a positioning subsystem configured to track and record positions of one or more of catheter 102, therapy delivery elements 110, sensors 111, or other suitable components of system 100. In some examples, the positioning subsystem is configured to track one or more of catheter 102, therapy delivery elements 110, and / or sensors 111 via an electromagnetic signal, injected current signals, fluoroscopy, or the like. In some examples, interface unit includes one or more of an electromagnetic signal and / or electromagnetic field generator, a generator to inject current, and / or another mapping / navigation system for tracking a position of one or more of catheter 102, therapy delivery elements 110, and / or sensors 111. In some examples, one or more portions of catheter 102, therapy delivery elements 110, and / or sensors 111 are radiopaque and may be tracked via a suitable imaging modality. In some examples, sensors 111 include accelerometers or other sensors (e.g., position sensors, such as electromagnetic coils) configured to facilitate tracking of relative movement of sensors 111 or movement relative to a reference position. In some examples, sensors 111 include force sensors, which may be configured to sense force (e.g., contact force) and / or pressure between at least a portion of catheter 102 and tissue 103.

[0043] In some examples, the positioning subsystem is configured to measure, determine, and / or record biophysical information (e.g. temperature, impedance, EGM signal amplitudes).

[0044] As discussed in other portions of this disclosure, the positioning subsystem of interface unit 104 may enable and / or facilitate generation and / or modification of annotations, as the positioning subsystem can provide a location of a portion of catheter 102 (e.g., a tissue contacting portion of catheter 102, a portion of catheter 102 configured to deliver therapy to tissue 103, or another suitable portion of catheter 102) throughout a period of ablation therapy.Interface unit 104 may be configured to generate annotations (e.g., overlaid on a representation of tissue 103) at a location indicated by the positioning subsystem. As discussed herein, the positioning subsystem may be configured to track movement of catheter 102, which may enable interface unit 104 to modify annotations based on the movement of catheter 102.

[0045] In some examples, one or more sensors 111 of the catheter 102 (e.g., at distal portion 106) include position sensors for enabling interface unit 104 to track the position, as well as a shape and / or an orientation, of catheter 102 (e.g., including distal portion 106, therapy delivery elements 110, and / or sensors 111). In some examples, one or more position sensors of catheter 102 include sensors configured to detect one or more signals or one or more fields, such as (but not limited to) electromagnetic signals, electromagnetic fields, magnetic fields, or another suitable position tracking signal or field. For example, an electromagnetic position sensor may include one or more induction coils that induce a current to detect signals emanating from electromagnetic field generators. One or more coils for determining position with five or six degrees of freedom can be used. The magnetic field detected by the electromagnetic position sensor may be used to determine the location (e.g., position, orientation, and / or shape) of a portion of catheter 102, such as distal portion 106 according to one or more methods commonly known in the art such as, for example, methods based on using a magnetic sensor to sense magnetic fields and using a look-up table to determine location of the magnetic position sensor. Accordingly, because other portions of catheter 102, including elongated structure 112, therapy delivery elements 110 and / or other sensors 111 may have a fixed relationship to the magnetic position sensor, the magnetic position sensor may also provide the location (e.g., position, orientation, and / or shape) these other portions of catheter 102. Other position sensing methods can additionally or alternatively be used. For example, the location (e.g., position, orientation, and / or shape) one or more portions of catheter 102 can be additionally, or alternatively, be tracked based on impedance, ultrasound, and / or imaging (e.g., real time magnetic resonance imaging (MRI) or fluoroscopy).

[0046] In some examples, interface unit 104 includes a user interface 105. In some examples, user interface 105 includes a screen, display, and / or another visual output medium (e.g., augmented reality display or virtual reality display). In some examples, user interface 105 includes a button or keypad, lights, a speaker for voice commands, and the display can include one or more of a liquid crystal (LCD), light-emitting diode (LED), or organic light-emitting diode (OLED) display.

[0047] In some examples, interface unit 104 is configured to generate and present (e.g., display), via user interface 105, information about one or more of patient 101, tissue 103, catheter 102, therapy delivered to tissue 103 via therapy delivery elements 110, and / or signalssensed by sensors 111. In some examples, interface unit 104 is configured to generate and present (e.g., display), via user interface 105, a representation of tissue 103 of patient 101. The representation of tissue can include a portion of an organ (e.g., a heart) of patient 101. For example, the representation of tissue can include a “shell” representing the boundary of an organ (e.g., the heart of patient 101). In some examples, interface unit 104 is configured to generate and present (e.g., display), via user interface 105, a representation of catheter 102, therapy delivery elements 110, and / or sensors 111. The representation of catheter 102, therapy delivery elements 110, and / or sensors 111 may enable a user (e.g., a clinician) to determine a spatial relationship between tissue 103 and catheter 102 (e.g., one or more of distal portion 106, therapy delivery elements 110, and / or sensors 111). For example, interface unit 104 may enable a user (e.g., a clinician) to know which portion of tissue 103 is in contact with catheter 102, which may indicate where therapy will be delivered during a period of therapy delivery via therapy delivery elements 110. In some examples, interface unit 104 may enable a user (e.g., a clinician) to know a distance between one or more portions of catheter 102 and tissue 103 (e.g., in examples where one or more portions of catheter 102 is not touching a portion of tissue 103).

[0048] Anatomical information device(s) 107 includes one or more devices that enable visualization of portions of tissue 103 of patient 101. Anatomical information device(s) can additionally or alternatively enable virtualization of one or more portions of catheter 102. In some examples, anatomical information device(s) include one or more of a computed tomography (CT) device, a magnetic resonance imaging (MRI) device, an ultrasound (U / S) device, a pacing device, an electrophysiology (EP) mapping device, and / or a non-invasive mapping device. Anatomical information device(s) 107 may be used by system 100 to inform interface unit 104 of the anatomy of a patient, as well as physical and / or electrical characteristics of the anatomy, and / or a location of catheter 102 during delivery of catheter 102 into the anatomy of a patient. In some examples, interface unit 104 may include one or more of anatomical information device(s) 107. In some examples, anatomical information device(s) 107 provide or otherwise enable interface unit 104 to generate a representation of tissue 103 of patient 101. In some examples, interface unit 104 is configured to receive anatomical information from anatomical information device(s) 107 and generate, based on the anatomical information, the representation of tissue (e.g., tissue 103).

[0049] In some examples, interface unit 104 is configured to identify sensitive structures (e.g., areas of tissue 103) and generate indications of the sensitive structures to a user (e.g., a clinician). In some examples, sensitive structures include areas of tissue 103 where ablation therapy is to be avoided (e.g., a sinoatrial node, or “SA” node). In some examples, interface unit 104, based on information from anatomical information device(s) 107, is configured to determinea location of a sensitive structure, and generate (e.g., via user interface 105) an indication of the location of the sensitive structure to a user (e.g., a clinician). Information of the location of sensitive structures relative to other tissue of tissue 103 can enable to a clinician to avoid delivery of ablation therapy to such sensitive structures. In some examples, the indications of locations of sensitive structures include annotations (e.g., that represent the sensitive structure) overlaid on a representation of tissue 103, similar to how annotations are generated and presented to a user in accordance with the techniques of this disclosure. In some examples, annotations that indicate sensitive structures include one or more visual properties, e.g., that enable a user (e.g., a clinician) to visualize the location of the sensitive structure (e.g., in relation to target tissue for ablation therapy).

[0050] In some examples, interface unit 104, which may be configured for ablating target tissue 103 (e.g., a target tissue area or volume) of a patient 101, includes memory configured to store at least one of anatomical information of a patient or physiological information (e.g., temperature and / or cardiac electrophysiological information) of patient 101. In some examples, the memory of interface unit 104 is configured to store information of annotations and / or information used to modify and / or update annotations as discussed throughout this disclosure.

[0051] In some examples, interface unit 104 is configured to generate and present (e.g., display), via user interface 105, indications of energy delivered to tissue 103 of patient 101 (e.g., via therapy delivery elements 110 of catheter 102). In some examples, indications of therapy delivery include one or more annotations. In some examples, interface unit 104 generates annotations based on signals from catheter 102 (e.g., including signals from one or more of therapy delivery elements 110, sensors 111, and / or other relevant elements of catheter 102). Annotations can be displayed with a representation of tissue 103 (e.g., annotations are overlaid on the representation of tissue 103). Annotations may indicate a location on tissue 103 where therapy was delivered. For example, annotation may indicate which portion of tissue 103, including an approximate area (e.g., surface area), that was ablated during a period (e.g., a continuous period) of therapy delivery. As discussed herein, a continuous period of therapy delivery may include a period during which an ablation waveform is being generated and applied via a catheter, where this ablation waveform has one or more predetermined pauses between ablation pulses (e.g., pauses between pulses of ablation). As discussed herein, a period of continuous application of ablation therapy to the tissue can include a period of time of ablation therapy (e.g., energy) delivered to portion of tissue 103. In some examples, the period of continuous application of ablation therapy to the tissue is a predetermined period of discrete length (e.g., about 1 second to about 10 seconds, such as about 5 seconds). In some examples, the period of continuous application of ablation therapy is predetermined, and / or controlled byprocessing circuitry of interface unit 104. In some examples, the period of continuous ablation therapy is not predetermined, and controlled by user (e.g., clinician) input, such as input to interface unit 104. In some examples, the period of continuous application of ablation therapy includes delivery of a waveform of energy that may have short pauses between pulses of energy.

[0052] In some examples, interface unit and / or catheter 102 are configured to deliver ablation to multiple locations over multiple instances of ablation (e.g., multiple periods of continuous application of ablation therapy). In some examples, each instance of therapy delivery is defined by the period of continuous application of ablation therapy. In some examples, a user (e.g., a clinician) initiates each instance of therapy delivery via a control (e.g., button) on one or more of catheter 102 and / or interface unit 104.

[0053] In some examples, as discussed in connection with later examples, annotations (e.g., therapy annotations) include at least one visual property, where the visual property is based on the one or more signals sensed via therapy delivery elements 110 (which may be electrodes) and / or sensors 111. In some examples, the at least one visual property of the annotation includes one or more of a shape, orientation, color, gradient, hue, shading, highlighting, pattern, and / or transparency of the annotation. The shape of annotations can include one or more of a two- dimensional component (e.g., parallel to a surface of tissue 103) as well as a “depth” (e.g., a depth in a direction perpendicular to a surface of tissue 103). Thus, the shape of annotations can be two-dimensional or three-dimensional. In some examples, the visual properties indicate various parameters of ablation therapy. In some examples, annotations include a combination of different visual properties. In some examples, a visual property of an annotation can indicate to a user one or more of a size (e.g., lesion size), location, efficacy, or another parameter about therapy (e.g., ablation therapy) delivered to tissue 103 of patient 101. In some examples, the visual property of an annotation can indicate a temperature of tissue 103 and / or temperature of catheter 102 (e.g., including therapy delivery elements 110). In some examples, since ablation energy is delivered to tissue 103 via therapy delivery elements 110, the temperature at, or proximate to, therapy delivery elements 110 may reflect (e.g., be a proxy for) temperature of the portion of tissue 103 proximate therapy delivery elements 110.

[0054] In some examples, processing circuitry of interface unit 104 is configured to generate multiple, discrete annotations. In some examples, the multiple discrete annotations form a therapy map indicating where therapy has been delivered and properties of the therapy delivery at multiple locations of therapy delivery. In some examples, processing circuitry of interface unit 104 is configured to generate and display a therapy map (e.g., similar to an electroanatomic map) without generating multiple, individual discrete annotations. For example, even though therapy may have been delivered to multiple discrete locations over multiple, discrete instances oftherapy delivery, processing circuitry of interface unit 104 may be configured to generate a therapy map (e.g., a continuous map) with one or more visual properties (e.g., color) to indicate the locations and / or extent (e.g., level) of therapy delivery.

[0055] To generate and / or modify annotations, processing circuitry of interface unit 104 may be configured to receive one or more signals (e.g., from sensors 111 of catheter 102) during a period of continuous application of ablation therapy to tissue 103. The signals that interface unit 104 receives to generate annotation may include signals that indicate one or more of location and / or level (e.g., efficacy) of the ablation, as well as other parameters about delivered energy. In some examples, the signals (e.g., from therapy delivery elements and / or sensors 111) may indicate a location of catheter 102 (e.g., a location relative to tissue 103 or an absolute location in three-dimensional space). For example, as discussed throughout this disclosure, interface unit 104 may include a positioning subsystem configured to, in conjunction with elements of catheter 102, provide signals that indicate a position and / or movement (e.g., a change in position over time) of catheter 102. In some examples, interface unit 104 generates annotations based on signals from the positioning subsystem. In some examples, the signals from catheter 102 and the positioning subsystem indicate a location and / or movement of therapy delivery relative to tissue 103 (e.g., a location of a portion of tissue 103 that receives therapy based on the location of therapy delivery elements 110).

[0056] In some examples, processing circuitry of interface unit 104 may be configured to receive other signals which can be used by processing circuitry of interface unit 104 for generating and / or modifying annotations. For example, processing circuitry of interface unit 104 can be configured to receive signals indicative of movement of the tissue 103 and / or information indicative of relative movement between catheter 102 and tissue 103. In some examples, while catheter 102 may remain stationary in absolute three-dimensional space, tissue 103 (e.g., which can include cardiac tissue) may move relative to catheter 102 (e.g., closer to or farther away from catheter 102). Processing circuitry of interface unit 104 can be configured to receive signals indicative of a position and / or movement of tissue 103 in absolute space, for example, via electrodes or other position sensors affixed to a surface of tissue 103 or another portion of tissue. In some examples, processing circuitry of interface unit 104 can receive information of patient respiration, general patient movement, electrode and / or position sensor signal quality, and / or other information for determining a position and / or movement of catheter 102 and / or tissue 103, as well as for determining relative positioning and / or relative movement between catheter 102 and tissue 103. In some examples, processing circuitry of interface unit 104 receives information about a shape of tissue 103 (e.g., information of the shape of a cardiac chamber in which catheter102 is positioned and / or information of how the shape of the cardiac chamber changes over time).

[0057] Other signals used by (e.g., received by) interface unit 104 to generate annotations include signals that indicate a level and / or effectiveness of delivered energy. In some examples, the signals indicate one or more of a temperature, electrogram (EGM), a current, a power, impedance, a contact force, and / or another measurable parameter (e.g. tissue viability). In some examples, the signals additionally or alternatively indicate one or more of proximity (e.g., of a portion of catheter 102 to tissue), contact impedance, catheter stability, temperature dynamics, tissue thickness, tissue conductivity, and / or combinations thereof. For example, processing circuitry of interface unit 104 may be configured to receive information indicating tissue contact (e.g., impedance signals) by distal portion 106 of catheter 102. As another example, processing circuitry of interface unit 104 may be configured to receive information of temperature (e.g., a rise in temperature reflecting therapy delivery) from sensors 111. In some examples, processing circuitry of interface unit 104 may be configured to receive information (e.g., from an energy generator and / or positioning subsystem of interface unit 104) that indicates energy delivery to tissue 103, and generate an annotation on a representation of tissue 103 based on the information. The generated annotation, which may be overlaid on a representation of tissue 103, may generally indicate a location (e.g., on tissue 103) where energy was delivered as well as a level of energy, distribution of energy, or another index of energy delivery to tissue 103. In some examples, annotations indicate whether therapeutically effective energy was delivered to tissue (e.g., whether a sufficient level of ablation energy was delivered to tissue 103 to correct an arrhythmia).

[0058] As discussed in more detail in relation to later examples, interface unit 104 may be configured to generate as well as modify (e.g., update) annotations, which may facilitate a relatively more accurate representation of energy actually delivered to tissue (e.g., tissue 103) or patient 101. In some examples, interface unit 104 is configured to modify (e.g., continuously or at one or more time intervals) a visual property of an annotation based on an indication of movement (e.g., displacement) of the therapy delivery elements 110 and / or other parts of the catheter 102. To modify the visual property of the annotation, interface unit may be configured to alter the appearance of the annotation displayed via user interface 105. For example, the interface unit 104 may be configured to generate and modify (e.g., update) a size of an annotation, such as to generate a continuous “drawn” annotation, in instances where therapy delivery elements 110 and / or catheter 102 move relative to (e.g., along), but remain within a threshold distance proximity of (e.g., relatively close to and / or in contact with), tissue 103 during a period of therapy delivery. By updating annotations based on movement of therapy delivery elements 110and / or other parts of catheter 102, the interface unit 104 produces a relatively more accurate representation of energy actually delivered to a patient (e.g., as compared to static annotations). In some examples, this relatively more accurate representation of therapy delivery delivered to the patient can reduce the necessity of additional delivery of energy in certain locations on tissue 103, reduce procedure time, and / or instill confidence that target areas (e.g., of tissue 103) have received sufficient therapy.

[0059] In some examples, where interface unit 104 is configured to generate as well as modify (e.g., update) annotations, including visual properties thereof, processing circuitry of interface unit 104 may be configured to store information (e.g., via memory of interface unit 104) related to the modification and / or updating of annotations. In some examples, memory of interface unit 104 is configured to store information related to the modification and / or updating of annotations even where interface unit does not actually update and / or modify existing annotations for display. For example, interface unit 104 may be configured to receive input (e.g., via a user) to operate in a dynamic annotation mode in which annotations are modified and updated, or operate in a static annotation mode in which annotations are static and not dynamically modified or updated. As another example, interface unit 104 can be configured to toggle between display of static annotations and dynamically updated annotations (e.g., at a later time, after one or more periods of therapy delivery where multiple annotations have been generated).

[0060] In accordance with the techniques of this disclosure, processing circuitry (e.g., of interface unit 104) is configured to generate and modify (e.g., continuously or at one or more time intervals) a visual property of an annotation based on an indication of efficacy of therapy (e.g., based on cumulative energy delivery, temperature, or another suitable indication of efficacy of therapy delivery). For example, processing circuitry of interface unit 104 may be configured to generate the annotation with at least one visual property (e.g., based on a first set of one or more signals for a first time period), and later modify the visual property (e.g., based on a second set of one or more signals for a second time period after the first time period). In some examples, processing circuitry of interface unit 104 may be configured to receive the first set of signals for the first time period and the second set of signals for the second time period from sensors 111. In some examples, the first set and the second set of one or more signals include at least some of the same types of signal(s) (e.g., a temperature signal, and impedance signal, a signal indicative of delivered current, or any of the other signals discussed in connection with this disclosure). In some examples, one or more of the first time period or the second time period include periods of continuous application of ablation therapy to tissue 103. In some examples, the first time period and / or the second time period are associated with different, discrete periods of therapy delivery.In some examples, only one of the first time period and / or the second time period are associated with a period continuous application of ablation therapy to tissue 103.

[0061] In accordance with the techniques of this disclosure, processing circuitry of interface unit 104 may be configured to generate and / or modify (e.g., continuously or at one or more time intervals) at least one visual property of an annotation based on a cumulative effect of ablation. In some examples, the cumulative effect of ablation is determined based on one or more of energy, temperature, time (e.g., a time of one or more continuous periods of energy delivery), a number and / or duration of previous instances of energy delivery at a given location of tissue 103, and / or another parameter. In some examples, processing circuitry of interface unit 104 determines the cumulative effect of ablation at a given location of tissue 103 by accessing historical data (e.g., historical data of energy, historical temperature data, time, and / or another parameter) for the given location of tissue 103, which can be associated with a previous annotation. By updating annotations based on a cumulative effect of ablation, such as continuously updating or at one or more time intervals (e.g., which may correspond to one or more discrete instances of therapy delivery), interface unit 104 produces a relatively more accurate representation of energy actually delivered to a patient (e.g., as compared to static annotations). In some examples, this relatively more accurate representation of therapy delivery delivered to the patient can reduce the necessity of additional delivery of energy in certain locations on tissue 103, reduce procedure time, and / or instill confidence that target areas (e.g., of tissue 103) have received sufficient therapy.

[0062] In some examples, processing circuitry of interface unit 104 determines the cumulative effect of ablation based on a determined (e.g., measured and / or calculated) thermal recovery of tissue. A calculated thermal recovery of issue can be used instead of, or in conjunction with, measured temperature of tissue at a given location of tissue 103. Thermal recovery of tissue, and / or temperature regression, can be determined (e.g., calculated) based on, at least in part, (1) known biophysical properties of tissue (e.g., tissue 103), (2) time of a given period of continuous ablation therapy, and / or (3) time between discrete periods of ablation therapy. For example, a particular area of tissue 103 to which ablation therapy is applied may cool between discrete periods of ablation therapy applied to the particular area of tissue 103, such that a cumulative effect of ablation can depend on the time between multiple discrete periods of therapy delivery when cooling of tissue occurs. In some examples, processing circuitry of interface unit 104 determines a relatively greater cumulative effect of ablation based on a relatively shorter time periods between successive, discrete periods of ablation therapy (e.g., less than or equal to 5 seconds apart, such as about 1 second between successive, discreate periods of therapy delivery) at a given location of tissue 103. In some examples, processing circuitry ofinterface unit 104 determines a relatively lesser cumulative effect of ablation based on a relatively longer time period between successive, discrete periods of ablation therapy (e.g., more than 5 seconds apart, more than 10 seconds, more than 20 seconds, and / or more than 20 minutes, etc., between successive, discreate periods of therapy delivery).

[0063] In the foregoing examples, processing circuitry of interface unit 104 may be configured to determine a time between the succussive, discrete periods and / or instances of ablation applied to the particular area of tissue 103, e.g., in order to determine the cumulative effect of ablation to a particular area of tissue associated with one or more discrete periods and / or instances of ablation therapy. For example, interface unit 104 can include a memory configured to store, for later recall, information (e.g., time and location) about previous periods and / or instances of ablation applied to the particular area of tissue 103 by catheter 102.

[0064] Interface unit 104 may be configured to store, in a memory, other parameters and / or information for determining the cumulative effect of ablation for a particular area of tissue 103. For example, interface unit 104 can include a memory configured to store information associated with biophysical properties and parameters associated with thermal recovery of tissue 103. Such parameters can be patient-specific parameters (e.g., disease state, history of previous medical procedure, including information of previous ablation procedures) or generalized parameters (e.g., that are general to a particular class of patients). In some examples, interface unit 104 can be configured to access, from the memory, and use such parameters and / or information for determining the cumulative effect of ablation for a particular area of tissue 103.

[0065] In some examples, processing circuitry (e.g., of interface unit 104) is configured to modify a visual property of annotations based on feedback (e.g., signals) from catheter 102, including therapy delivery elements 110 and / or sensors 111. In some examples, processing circuitry of interface unit 104 receives an indication of movement of catheter 102, including movement of therapy delivery elements 110 and / or sensors 111 from the positioning subsystem discussed previously. In some examples, processing circuitry of interface unit 104 is configured to receive information indicative of movement of catheter 102 and modify at least one visual property of the annotation based on the indication of movement of catheter 102. In some examples, processing circuitry of interface unit 104 receives the information indicative of movement of catheter 102 during a period of continuous ablation therapy, such that processing circuitry of interface unit 104 modifies the visual property of the annotation during the period of continuous ablation therapy.

[0066] The information indicative of movement of catheter 102 may be based on signals from catheter 102 and / or signals from a positioning subsystem of interface unit 104. In some examples, information indicative of movement of catheter 102 includes a change in a signal (animpedance signal, a temperature signal, a current signal, a power signal, an EGM signal, a force signal, a contact force signal, another suitable signal, and / or a combination thereof) indicative of movement of catheter 102 (e.g., movement of distal portion 106 of catheter 102 relative to tissue 103). For example, changes in impedance that indicate movement of catheter 102 can be sensed by one or more of therapy delivery elements 110 and / or sensors 111, and received by the positioning subsystem of interface unit 104. As another example, changes in temperate indicative of movement of catheter 102 can be sensed by thermocouples at a distal portion (e.g., a distalmost portion, as illustrated in FIG. 2A and FIG. 2B) of catheter 102. In some examples, one or more signals (e.g., impedance signal, temperature signal, EGM signal, a force signal, a contact force signal, position signal, another suitable signals, and / or a combination thereof) indicate contact between a portion of catheter 102 (e.g., therapy delivery elements 110 and / or sensors 111) and tissue 103. In some examples, a change in a signal (e.g., an impedance signal, a temperature signal, a current signal, a power signal, an EGM signal, a force signal, a contact force signal, another suitable signals, and / or a combination thereof) reflects catheter 102 contacting a different part of tissue 103. In some examples, a change in a signal (e.g., impedance signal, temperature signal, EGM signal, another suitable signals, and / or a combination thereof) reflects catheter 102 (e.g., distal portion 106) moving from a position in which catheter 102 is in contact with, or at least in relatively close proximity to, tissue 103 to a position in which catheter 102 (e.g., distal portion 106) is not in contact with, or a relatively further proximity from, tissue 103.

[0067] While the example of FIG. 1 is primarily discussed in the context of a single catheter 102 configured for both therapy delivery and sensing, the techniques of this disclosure may include using two or more separate catheters, e.g., a catheter to deliver ablation energy and a separate diagnostic catheter. For example, a first catheter (e.g., a mapping or diagnostic catheter), can be inserted into patient 101 to detect and measure information (e.g., temperature, EGM data) about tissue 103 of patient 101. A second catheter (e.g., catheter 102) can be inserted into patient101 to perform an ablation procedure, e.g., to target tissue identified by the first catheter, which may be a portion of tissue 103 as shown in the example of FIG. 1. Additionally or alternatively, while the example of FIG. 1 shows all of therapy delivery elements 110 on a single catheter 102, some of therapy delivery elements 110 can be disposed and / or carried by another catheter (e.g., like catheter 102) or another suitable structure. For example, a second, different catheter (e.g., like catheter 102) can be inserted into patient 101 (e.g., into a heart of patient 101, outside of heart of patient 101, or at another suitable location), such that therapy is delivered by and / or between therapy delivery elements 110 disposed on and / or carried by each of the first catheter102 and the second catheter. In some examples, system 100 additionally or alternatively includesone or more external reference electrodes and / or ground patches, e.g., such that therapy is delivered between therapy delivery elements 110 of one or more of catheter 102 and the one or more external reference electrode and / or one or more ground patches. In some examples, therapy is delivered between delivery elements 110 of one or more of catheter 102 and an internal patch (e.g., in epicardium).

[0068] FIG. 2A and FIG. 2B are conceptual diagrams illustrating example ablation and / or mapping catheters. Catheter 202 of FIG. 2A and catheter 252 of FIG. 2B are each examples of catheter 102 described above in relation to FIG. 1. Components of catheter 202 and catheter 252 may have the same or similar characteristics and functions as described above for ablation catheter 102. Catheter 202 of FIG. 2A and catheter 252 of FIG. 2B may additionally be examples of other catheters described in this disclosure (e.g., catheter 402, catheter 502, catheter 602, catheter 702, and / or catheter 802).

[0069] FIG. 2A illustrates ablation catheter 202 that may be configured for ablation therapy, sensing, and / or mapping. Catheter 202 may be configured to pass through vasculature of a patient (e.g., patient 101 of FIG. 1) and be positionable proximate to a target tissue (e.g., within in a heart) region for diagnosis or treatment. Catheter 202 may include a proximal portion (not shown in the example of FIG. 2A) and a distal portion 206. In some examples, catheter 202 also may include one or more lumens disposed within catheter 202, which may provide mechanical, electrical, and / or fluid communication, e.g., saline irrigation, between the proximal portion of catheter 202 and the distal portion 206. The distal portion 206 may generally define the one or more treatment region(s) configured to monitor, diagnose, and / or treat a portion of a patient, as described above in relation to FIG. 1.

[0070] In the example of FIG. 2A, catheter 202 includes a distal electrode 210A, a proximal electrode 210B, a distal ring electrode 210C, and a proximal ring electrode 210D (collectively referred to herein as electrodes 210). One or more of electrodes 210 can be examples of therapy delivery elements 110 from the example of FIG. 1. A therapy generator (e.g., of interface unit 104 in the example of FIG. 1) may be configured to deliver ablation therapy (e.g., RF, PFA, etc.) via electrodes 210.

[0071] In the example of FIG. 2A, catheter 202 also includes distal thermocouples 222A and proximal thermocouples 222B (collectively referred to as thermocouples 222). One or more of electrodes 210, and / or thermocouples 222 can be examples of sensors 111 from the example of FIG. 1. As shown in the example of FIG. 2A, electrodes 210 and thermocouples 222 are located at a distal portion 206 of catheter 202. In other examples, ablation catheter 202 may include one or more other electrodes and / or other sensors not shown in FIG. 2A (e.g., at a more proximal portion of catheter 202, such as proximal to distal portion 206).

[0072] In some examples, catheter 202 is configured for sensing signals, which may indicate patient parameters and / or system parameters. Processing circuitry (e.g., processing circuitry of interface unit 104 in the example of FIG. 1) may be configured to sense and / or record signals via electrodes 210 of catheter 202. Signals indicative of patient parameters or system parameters (e.g., temperature, tissue electrical activity, impedance, force, or the like) may be recorded by or between one or more of electrodes 210 in any suitable configuration. Recording may be via unipolar, bipolar, or other suitable configurations of electrodes 210. For example, recording may be between the distal electrode 210A and one or more different electrodes, including one or more of proximal electrode 210B, distal ring electrode 210C, and / or proximal ring electrode 210D. Tissue electrical activity may also be recorded between one or more of electrodes 210 and a common reference such as Wilson’s Central Terminal. In some examples, one or more of a power, a voltage and / or a current are measured between the proximal electrode 210B and distal electrode 210A.

[0073] In some examples, signals from one or more of distal electrode 210A and / or proximal electrode 210B provides information about an organ of a patient, including intracardiac signals. In some examples, intracardiac signals include intracardiac electrograms (iEGMs), which may include bipolar and / or unipolar iEGMs. Other intracardiac signals include monophasic action potentials. Signals from one or more of distal electrode 210A and / or proximal electrode 210B, along with a voltage reference (e.g., a return electrode, not shown in the example of FIG. 2A), may be used for determining impedance.

[0074] In some examples, thermocouples 222 sense temperature. For example, catheter 202 can additionally or alternatively include different sensors other than thermocouples 222 as described in other examples throughout this disclosure. Processing circuitry (e.g., processing circuitry of interface unit 104 in the example of FIG. 1) may receive signals from thermocouples 222 indicating a temperature.

[0075] As described above in relation to FIG. 1, interface unit 104 may be configured to receive signals via one or more electrodes 210 and / or thermocouples 222. Interface unit 104 may be configured provide an indication of impedance, electrical properties, temperature, or other parameters of the cardiac tissue proximate to the target lesion site based on the received signals.

[0076] FIG. 2B is a conceptual diagram illustrating a second example ablation catheter 252, which may also be used for sensing and / or mapping. As with catheter 102 and catheter 202 of FIG. 1 and FIG. 2A respectively, catheter 252 may be configured to pass through a patient’s vasculature and be positionable proximate to a target tissue (e.g., within in a heart) region for diagnosis or treatment. Catheter 252 may include a proximal portion (not shown in FIG. 2B) and a distal portion 256. In some examples, as described above in relation to FIG. 2A, catheter 252may also include one or more lumens disposed within catheter 252, which may provide mechanical, electrical, and / or fluid communication, e.g., saline irrigation, between the proximal portion of catheter 252 and the distal portion 256. The distal portion 256 may generally define the one or more treatment region(s) configured to monitor, diagnose, and / or treat a portion of a patient, as described above in relation to FIG. 1.

[0077] In some examples, catheter 252 includes an expandable structure 260 at distal portion 256 of catheter 252. In some examples, expandable structure 260 is configured to transition between a delivery (e.g., compressed) configuration and an expanded configuration. In the expanded configuration, expandable structure 260 can include a spherical lattice structure. In some examples, expandable structure 260 is configured to act as a therapy delivery element (e.g., an electrode), such as to deliver ablation therapy to target tissue (such as target tissue 103 in the example of FIG. 1).

[0078] In some examples, catheter 252 includes a distal ring electrode 261 A and a proximal ring electrode 261B. Distal ring electrode 261A and proximal ring electrode 261B may be configured in a similar manner as distal ring electrode 210C and a proximal ring electrode 210D in the example of FIG. 2A.

[0079] In some examples, the expandable structure 260 includes a plurality of surface elements 262 (for example, nine surface elements 262, as shown in FIG. 2B) that are configured to act as sensors and / or therapy delivery elements. Surface elements 262 may be configured to act as thermocouples, like thermocouples 222 as described in connection with FIG. 2A.

[0080] FIG. 3 is a block diagram illustrating an example interface unit 300 of an ablation system, in accordance with one or more aspects of this disclosure. Interface unit 300 of FIG. 3 may be an example of interface unit 104 of FIG. 1. As shown in FIG. 3, interface unit 300 may include an energy generator 302, processing circuitry 304, a user interface 305, a storage device 308, a positioning subsystem 316, and telemetry circuitry 320.

[0081] Energy generator 302 may be configured to control therapy delivery elements (e.g., therapy delivery elements 110 of catheter 102) such as to provide electrical energy to electrodes (e.g., therapy delivery elements 110) to perform an ablation procedure to cardiac tissue or other tissues within the patient’s body, including but not limited to renal tissue, airway tissue, bones, organs, or tissue within the cardiac space or the pericardial space. For instance, energy generator 302 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 pulsed radiofrequency ablation. In another example, energy generator 302 may be configured to control one or more cryogenic energy delivery elements to achieve desired cryogenic ablation. In some examples, energy generatorincludes multiple energy generators that are each capable of generating ablation signals in parallel. In some examples, interface unit 300 includes energy generators of different types, such as a pulsed field energy generator, a radiofrequency energy generator, and / or a cryogenic energy generator.

[0082] Processing circuitry 304 may be configured to control energy generator 302 to deliver ablation therapy according to one or more ablation parameters 318. Ablation parameters 318 may include a combination of energy delivery elements (e.g., a subset of therapy delivery elements 110) to the target tissue, a suggested positioning for one or more therapy delivery elements 110, a suggested energy level to be delivered, an energy modality (e.g., RF, cryogenic, PFA, etc.) or combination of modalities, or the like. In some examples, processing circuitry 304 is configured to, automatically and / or via user input, cause energy generator 302 to toggle between therapy delivery modalities (e.g., in examples where energy generator 302 is configured to delivery multiple different types of energy and / or therapy). In some examples, processing circuitry 304 is configured to, automatically and / or via user input, cause energy generator 302 deliver (e.g., simultaneously deliver) multiple energy and / or therapy modalities together.

[0083] Processing circuitry 304 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 304 herein may be embodied as firmware, hardware, software or any combination thereof. Processing circuitry 304 controls energy generator 302 to generate signals according to various parameters (e.g., according to ablation parameters 318). In some examples, processing circuitry 304 may execute other instructions stored in storage device 308 to perform ablation based at least in part on anatomical information 310, which can be received from one or more anatomical information devices (e.g., anatomical information device(s) 107 in the example of FIG. 1).

[0084] Storage device 308 may be configured to store information received by interface unit 300. Storage device 308 may include a computer-readable storage medium or computer-readable storage device. In some examples, storage device 308 includes one or more of a short-term memory or a long-term memory. Storage device 308 may include, for example, random-access memories (RAM), dynamic random-access memories (DRAM), static random-access memories (SRAM), ferroelectric random-access memories (FRAM), 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 308 is used to store data indicative of instructions, e.g., for execution by processing circuitry 304, respectively.Storage device 308 may be configured to store anatomical information 310, ablation parameters 318, as well as other suitable information.

[0085] Anatomical information 310 may be patient specific anatomical information, typical patients’ anatomies, and / or a combination of the two, enabling augmentation of the patient specific anatomical information. For example, one patient may have a different anatomy than another patient. Anatomical information 310 may be generated by a computed tomography (CT) device, a magnetic resonance imaging (MRI) device, an ultrasound (U / S) device, or from electrical characterization, such as from a pacing device, an electrophysiology (EP) mapping device, and / or a non-invasive mapping device (which may be examples of anatomical information device(s) 107). In some examples, anatomical information includes a model of an organ (e.g., a heart). In some examples, the model includes a “shell” representing the boundary of an organ (e.g., the heart).

[0086] User interface 305 may be an example of user interface 105 as discussed in the example of FIG. 1. Interface unit 300 may be configured to generate and present, via user interface 305, representations of medical devices (e.g., catheter 102, therapy delivery elements 110, and / or sensors 111 as described in connection with FIG. 1), such as in relation to tissue of patient 101. As discussed in connection with FIG. 1, interface unit 300 may be configured to generate and present, via user interface 305 indications of therapy delivered to tissue 103 of patient 101 (e.g., by therapy delivery elements 110 of catheter 102). Representations of tissue may be generated based on information from anatomical information 310 from storage device 308. In some examples, indications of therapy delivery include one or more annotations. In some examples, at least one visual property of the annotation includes one or more of a shape, orientation, color, gradient, hue, shading, highlighting, pattern, and transparency of the annotation.

[0087] Telemetry circuitry 320 may include any suitable hardware, firmware, software or any combination thereof for communicating with another device, such as anatomical information device(s) 107. Telemetry circuitry 320 may be configured to communicate using any of a variety of wireless communication schemes, such as Bluetooth® or Bluetooth Low Energy®, WiFi, 4G, or 5G, or a wired communication scheme such as ethemet. Under the control of processing circuitry 304, telemetry circuitry 320 may receive downlink telemetry from, and / or send uplink telemetry to, external devices, with the aid of an internal or external antenna, or via wires.

[0088] In some examples, interface unit 300 includes a positioning subsystem 316 configured to track and record positions of a catheter or components of a catheter, such as catheter 102 as discussed in the example of FIG. 1. For example, as discussed in relation to the components of catheter 102 in the example of FIG. 1, positioning subsystem 316 may track a position of one ormore of catheter 102, therapy delivery elements 110, and / or sensors 111. In some examples, the positioning subsystem 316 is configured to track one or more of catheter 102, therapy delivery elements 110, and / or sensors 111 via signals and / or fields, such as magnetic fields, electromagnetic signals, injected current signals, and / or the like. In some examples, the positioning subsystem 316 includes one or more of an electromagnetic signal and / or field generator, a generator to inject current, and / or another generator for tracking a position of one or more of catheter 102, therapy delivery elements 110, and / or sensors 111. In some examples, positioning subsystem 316 additionally or alternatively includes one or more of an ultrasound generator for tracking.

[0089] FIGS. 4A, 4B, 5A, 5B, 6, 7, and 8 are conceptual diagrams illustrating examples of information displayed on a user interface (e.g., user interface 105 of FIG. 1, user interface 305 of FIG. 3), including annotations generated and displayed by processing circuitry of a suitable ablation interface unit (e.g., interface unit 104 in the example of FIG. 1).

[0090] FIG. 4A and FIG. 4B are conceptual diagrams illustrating examples of information displayed by a user interface (e.g., user interface 105 of FIG. 1, user interface 305 of FIG. 3) in response to movement of a therapy device (e.g., a catheter 402 as shown, which may be an example of as catheter 102 in the example of FIG. 1). Processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) is configured to receive one or more signals from one or more of a therapy delivery element 410A, a therapy delivery element 410B (collectively referred to herein as therapy delivery elements 410, which may include electrodes), a sensor 411A, and / or a sensor 41 IB (collectively referred to herein as sensors 411) to generate annotation 414A of FIG. 4A and / or annotation 414B of FIG. 4B. Each of annotation 414A and annotation 414B includes at least one visual property. Each of annotation 414A and annotation 414B can be examples of any of the annotations discussed herein.

[0091] In the example of FIG. 4A, a representation of tissue 403 includes an annotation 414A with at least one visual property. Annotation 414A indicates a location of therapy delivery by one or more of therapy delivery element 410A and / or therapy delivery element 410B of catheter 402. As shown in the example of FIG. 4A, annotation 414A has a generally circular shape. The location and shape of annotation 414A may indicate the location on tissue 403 where therapy was delivered by therapy delivery elements 410. In some examples, annotation 414A also includes one or more visual properties, which may one or more of an orientation (e.g., orientation relative to tissue 403), color, gradient, hue, shading, highlighting, pattern, and / or transparency. The visual properties can indicate a level (e.g., effectiveness) of therapy delivered to tissue 403.

[0092] FIG. 4B illustrates annotation 414B, which may be a modified version of annotation 414A from the example of FIG. 4A. For example, processing circuitry of an ablation interfaceunit (e.g., interface unit 104 as discussed in connection with FIG. 1) generates and presents annotation 414A of FIG. 4A at a first time period and subsequently modifies, at a second time, annotation 414A to annotation 414B as shown in the example of FIG. 4B. In the example of FIG. 4B, annotation has an elongated shape that is larger (e.g., covers more area) than annotation 414A from the example of FIG. 4A. The modification of annotation 414A to annotation 414B may be based on movement of catheter 402 during a period of continuous ablation therapy. For example, in instances during delivery of ablation therapy where catheter 402 remains in at least relatively close proximity to (e.g., in contact with) tissue 403, processing circuitry of an ablation interface unit (e.g., interface unit 104) modifies the circular shape of annotation 414A in the example of FIG. 4A to the elongated shape of annotation 414B in the example of FIG. 4B. In this way, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to receive an indication of movement of catheter during a period of continuous ablation therapy and modify at least one visual property of annotation (e.g., as shown in the modification between annotation 414A and annotation 414B). In the examples of FIG. 4A and FIG. 4B, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates a continuous “drawn” annotation.

[0093] In the example of FIG. 4A and FIG. 4B, the movement of catheter 402 is shown as a displacement of a distal portion of catheter 402. In some examples, the distal portion of catheter 402 includes a portion configured to deliver therapy (e.g., including therapy delivery elements 410), a portion of catheter 402 that is configured to be a tissue contacting portion (e.g., that contacts tissue 403, and can remain in contact with tissue 403 or at least in a close proximity to tissue 403), and / or a portion of catheter that is configured to be within at least a threshold proximity (e.g., distance) from tissue 403. In some examples, the distal portion of catheter 402 includes one or more of a distalmost end of catheter 402, one or more of therapy delivery elements 410 and / or one or more of sensors 411. In some examples, the displacement of the distal portion of catheter 402 is the spatial displacement of the distal portion of catheter 402 between at least a first location and a second location (e.g., during a period of continuous application of ablation therapy). For example, a distal portion of catheter 402 is at a first location (e.g., in relation to tissue 403) in the example of FIG. 4A and subsequently moves in a direction indicated by arrow 430. In the example of FIG. 4B, the distal portion of catheter 402 is at a second location (e.g., in relation to tissue 403) after movement of catheter 402 from the first location. Information indicative of movement of catheter 402 can include an indication of a displacement, for example, the displacement between the first location in the example of FIG. 4A and the second location in the example of FIG. 4B. The displacement of the distal portion ofcatheter 402 can be the displacement between two or more locations (e.g., three, four, five, six, ten, one hundred, one thousand, or more locations).

[0094] In some examples, information indicative of movement of catheter 402 additionally or alternatively includes an indication of a stability (e.g., a stability index) of catheter 402. In some examples, catheter stability of catheter 402 refers to a greatest displacement from an initial location over a period of continuous application of ablation therapy. For example, where a distal portion of catheter 402 moves to multiple spatial locations during a period of continuous application of ablation therapy, a measure of catheter stability may include a measure related to displacement of each of the multiple locations to an initial location of the distal portion of catheter 402 at the start of the continuous period of ablation therapy. For example, the measure of catheter stability (e.g., stability index) can include a greatest displacement from an initial location during a period of ablation therapy (e.g., a single, continuous period of application of ablation therapy). In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) may be configured to modify a visual property of annotation 414A and / or annotation 414B based on a measure of catheter stability, which may include a greatest displacement from an initial location during a period of ablation therapy. In some examples, biophysical signals (e.g. impedance, EGM, temperature, or the like) can be used to determine (e.g., calculate) the indication of catheter stability (e.g., the stability index).

[0095] In some examples, information indicative of movement of catheter 402 additionally or alternatively includes an indication of a change of an orientation of catheter 402. In some examples, an orientation includes an angle of catheter 402 relative to a surface of tissue 403. A change in orientation relative to a surface of tissue 403 (e.g., perpendicular to not perpendicular, or not perpendicular to perpendicular, etc.) can change a therapeutic effect of therapy on tissue 403. Thus, processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) may be configured to modify a visual property of annotation 414A and / or annotation 414B based on the orientation and / or change of orientation of catheter 402 relative to a surface of tissue 403.

[0096] With reference to the example of FIG. 4A, the circular shape of annotation 414A may indicate catheter 402 being perpendicular (or at least substantially perpendicular) to a surface of tissue 403 during delivery of ablation therapy. In some examples, when catheter 402 is not perpendicular to tissue 403 (e.g., at an angle less than 90 degrees, such as about 45 degrees), processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to generate a non-circular (e.g., oblong, oval, amorphous, or the like) annotation. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to modify a visual property (e.g., a shape) of annotation (e.g., annotation 414) based on signals sensed frommultiple sensors at a distalmost portion of catheter 402 (e.g., thermocouples 222A as discussed in the example of FIG. 2A). For example, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to receive a sensed signal from each of multiple sensors (e.g., thermocouples 222A and / or thermocouples 222B in the example of FIG. 2A), and generate and / or modify a visual property of annotation 414A based on signals from each of the multiple sensors. In some examples, the difference in signals from such sensors can indicate an orientation of catheter 402 relative to tissue 403, which may cause processing circuitry of an ablation interface unit (e.g., interface unit 104) to cause and / or modify at least one visual property (e.g., a shape) of annotation 414A.

[0097] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) generates and / or modifies the visual property (e.g., the shape or size) of an annotation (e.g., annotation 414A and / or annotation 414B) based on movement of catheter 402. For example, as shown in the example of FIG. 4A and FIG. 4B, processing circuitry (e.g., interface unit 104) modifies the first size and the first shape of annotation 414A in FIG. 4A to the second, different size and the second, different shape of annotation 414B in FIG. 4B based on the movement of catheter 402 during a period of continuous ablation therapy. In this way, interface unit 104 may be configured to produces a relatively more accurate representation of energy actually delivered to a patient (e.g., as compared to static annotations that do not change size or shape in response to movement of a catheter).

[0098] In some examples, processing circuitry (e.g., of interface unit 104) modifies annotation (e.g., annotation 414A) based on a level (e.g., amount) of movement of catheter 402. In some examples, the level of movement of a catheter is a relative spatial displacement between a first location and a second location of a given portion of catheter 402. For example, where a movement of catheter 402 meets a predefined movement threshold (e.g., is below and / or above one or more predefined movement thresholds), processing circuitry of an ablation interface unit (e.g., interface unit 104) may modify an existing annotation (e.g., as shown in the modification of annotation 414A to annotation 414B). In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) modifies an existing annotation (e.g., annotation 414A) if movement of catheter 402 is between a first predefined threshold (e.g., a predefined minimum movement threshold, such as a predefined minimum displacement threshold) and a second predefined threshold (e.g., a predefined maximum movement threshold, such as a predefined maximum displacement threshold). In some examples, where a movement of catheter 402 is below the first predefined threshold (e.g., the minimum movement threshold, such as the minimum displacement threshold), processing circuitry of an ablation interface unit (e.g.,interface unit 104) will not modify an existing annotation, such as in examples of slight movements of catheter 402 that does not effectively change a location of therapy delivery via therapy delivery elements 410 on tissue 403. In some examples, where a movement of catheter 402 is above the predefined maximum threshold (e.g., the maximum movement threshold, such as the maximum displacement threshold), processing circuitry of an ablation interface unit (e.g., interface unit 104) will not modify an existing annotation, but instead generates a new annotation (e.g., as discussed in connection with FIG. 5A and FIG. 5B).

[0099] In some examples, any of the predefined threshold discussed in this disclosure can be user-defined (e.g., defined by a user such as a clinician). For example, processing circuitry processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) may be configured to receive user input of a predefined threshold (predefined movement thresholds). In this way, processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) may be able to accommodate to the preferences of clinicians and / or accommodate different use cases in generating annotations.

[0100] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) generates and / or modifies the visual property (e.g., the shape or size) of an annotation (e.g., annotation 414A and / or annotation 414B) based on an indication of contact and / or relatively close proximity between catheter 402 and tissue 403 during the period of continuous application of ablation therapy. For example, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to receive an indication of contact between catheter 402 and tissue 403 during a period of continuous application of ablation and modify annotation 414A based on the indication of contact. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is additionally or alternatively configured to receive an indication that catheter 402 is in a relatively close proximity to tissue 403 (e.g., less than about 10 mm, such as less 5 mm or about 5mm). In some examples, the indication of contact includes an indication of a signal (e.g., impedance signal, temperature signal, a force signal, a contact force signal, and / or another suitable signal) above a predefined signal threshold (e.g., to indicate sufficient contact). In some examples, an indication of relatively close proximity between catheter 402 and tissue 403 includes an indication of a signal (e.g., which may the same signal used to assess contact) above a predefined signal threshold (e.g., to indicate that a portion of catheter 402 and tissue 403 are within a relatively close proximity to each other). In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) modifies an annotation (e.g., annotation 414A) if catheter 402 remains in relatively close proximity to and / or in contact with tissue 403 for the entirety of, or at least a substantial portion of, the period of therapy delivery via catheter 402. In this way,processing circuitry of an ablation interface unit (e.g., interface unit 104) can more accurately reflect, via annotation 414A and / or 414B, energy actually delivered to tissue 403, such as during a period of continuous application of ablation therapy where catheter 402 moves relative to, but remains in relatively close proximity to and / or in contact with, a portion of tissue 403.

[0101] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) generates and / or modifies the visual property (e.g., the shape or size) of an annotation (e.g., annotation 414A and / or annotation 414B) based on both the indication of contact between catheter 402 and tissue 403 the information indicative of movement of the catheter during the period of continuous application of ablation therapy. For example, where catheter 402 is displaced (e.g., moves), but remains in relatively close proximity to and / or in contact with tissue 403, such as during a period of continuous application of ablation therapy, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates a modified annotation (e.g., annotation 414B, as shown in the example of FIG. 4B). In some examples, the modified annotation (e.g., annotation 414B) reflects the path of movement along tissue 403 of catheter 402 during the period of continuous application of ablation therapy. In this way, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates a continuous “drawn” annotation 414B based on an indications of movement of catheter 402 as well as an indication of contact between catheter 402 and tissue 403, such as during a period of continuous application of ablation therapy.

[0102] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) generates and / or modifies the visual property (e.g., the shape or size) of an annotation (e.g., annotation 414A and / or annotation 414B) by at least performing an integration operation over space and / or time. In some examples, the integration over space includes an integration over the area of tissue 403, such as an area traversed and / or contacted by catheter 402 during a period of continuous ablation therapy delivery. In some examples, the integration over time includes integration of the period of time of continuous ablation therapy delivery and / or another time period corresponding to the movement of catheter 402. In some examples, each instance (e.g., period) of continuous ablation therapy delivery is about 1 second to about 10 seconds, such as about 5 seconds. However, shorter or longer periods of continuous ablation therapy can be used. Time periods corresponding to periods of movement of catheter 402 can be longer, the same as, or shorter than the period of continuous application of ablation therapy. For example, a time period corresponding to movement of catheter 402 may be on the order of a few seconds.

[0103] As shown in the example of FIG. 4B, annotation 414B has a generally elongated shape compared to annotation 414A of FIG. 4A. However, other visual properties, including oneor more of an orientation, color, gradient, hue, shading, highlighting, pattern, and / or transparency, remain unchanged between annotation 414A and annotation 414B. In this way, modification of annotation 414A can include modifying a first visual property of annotation 414A indicative of a first therapy parameter (e.g., lesion location) while not modifying a second visual property of annotation 414A indicative of a second therapy parameter (e.g., therapy efficacy).

[0104] FIG. 5A and FIG. 5B are conceptual diagrams illustrating examples of information displayed by a user interface (e.g., user interface 105 of FIG. 1, user interface 305 of FIG. 3) in response to movement of a therapy device (e.g., a catheter 502 as shown, which may be an example of as catheter 102 in the example of FIG. 1). Processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) is configured to receive one or more signals from one or more of a therapy delivery element 510A and a therapy delivery element 510B (collectively referred to herein as therapy delivery elements 510), a sensor 511A, and / or a sensor 51 IB (collectively referred to herein as sensors 511) to generate annotation 514A of FIG. 5A and / or annotation 514B of FIG. 5B. Each of annotation 514A and annotation 514B includes at least one visual property. Each of annotation 514A and annotation 514B can be examples of any of the annotations discussed herein.

[0105] In the example of FIG. 5A, a representation of tissue 503 includes an annotation 514A with at least one visual property. Annotation 514A indicates a location of energy delivery by one or more of therapy delivery element 510A and / or therapy delivery element 510B of catheter 502. As shown in the example of FIG. 5 A, annotation 514A has a generally circular shape. In some examples, annotation 514A also includes one or more of an orientation (e.g., orientation relative to tissue 503), color, gradient, hue, shading, highlighting, pattern, and / or transparency.

[0106] FIG. 5B illustrates annotation 514A at a first location, annotation 514B at a second location different than the first location, and an intermediate portion 516 connecting annotation 514A and annotation 514B. Processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) generates and present annotation 514A, annotation 514B, as well as intermediate portion 516. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates annotation 514A, annotation 514B, as well as intermediate portion 516 based on and / or in response to movement of catheter 502.

[0107] In some examples, where a movement of catheter 502 meets a predefined movement threshold (e.g., a predefined movement threshold, such as a maximum displacement threshold), processing circuitry of an ablation interface unit (e.g., interface unit 104) generates and presents at least a first annotation 514A and a second annotation 514B, as shown in the example of FIG. 5B. In this way, where catheter 502 moves a relatively large distance (e.g., above a predefinedmovement threshold, such as a maximum displacement threshold) during a period of continuous application of ablation therapy, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to generate at least a first annotation 514A and a second annotation 514B. Because therapeutically effective therapy may not be delivered to tissue 503 during movement of catheter 502 over large distance (e.g., where the movement occurs in a relatively short amount of time), creating multiple annotations can more accurately reflect energy actually delivered to tissue 503, e.g., as compared to a single, continuous “drawn” annotation as discussed in relation to the example of FIG. 4A and FIG. 4B.

[0108] Additionally or alternatively, where a movement of catheter 502 between the first location of annotation 514A and the second location of annotation 514B occurs quickly (e.g., in a period of time less than a predetermined threshold time period) processing circuitry of an ablation interface unit (e.g., interface unit 104) generates and presents at least a first annotation 514A and a second annotation 514B, as shown in the example of FIG. 5B. For example, even where the movement of catheter 502 does not meet predefined movement threshold (e.g., a maximum displacement threshold), a relatively fast movement of catheter 502 may cause processing circuitry of an ablation interface unit (e.g., interface unit 104) to generate at least a first annotation 514A and a second annotation 514B based on relative speed of movement of catheter 502.

[0109] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to generate intermediate portion 516 between at least a first annotation (e.g., annotation 514A) and a second annotation (e.g., annotation 514B). In some examples, intermediate portion 516 indicates an area of tissue 503 traversed by catheter 502 (e.g., during a period of continuous application of ablation therapy to tissue 503). In some examples, intermediate portion 516 includes a visual property (e.g., a color, shading, transparency shape, etc.) that is different than the visual property of one or more of annotation 514A and / or annotation 514B. In this way, the visual property of intermediate portion 516 may distinguish intermediate portion 516 from one or more of annotation 514A and / or annotation 514B. In this way, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to a portion that did not receive therapeutically effective ablation, e.g., by generating an intermediate portion 516 which has a different visual appearance and / or different visual properties as compared to annotation 514A and / or annotation 514B.

[0110] In some examples, the difference in the visual property of intermediate portion 516 as compared to annotation 514A and / or annotation 514B indicates a difference in a level of therapy (e.g., efficacy of therapy) received by tissue associated with each respective region. For example, the visual property of intermediate portion 516 indicates that the portion of tissue 503 associatedwith intermediate portion 516 did not receive a therapeutically effective level of therapy. In some examples, the difference in the visual property of intermediate portion 516 as compared to annotation 514A and / or annotation 514B indicates that the portion of tissue 503 associated with intermediate portion 516 received less effective therapy as compared to portions of tissue 503 associated with annotation 514A and / or annotation 514B. In this way, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to generate annotations (e.g., annotation 514A and annotation 514B) that indicate a therapeutic effectiveness of ablation therapy to the tissue, as compared to other portions (e.g., intermediate portion 516).[oni] FIG. 6 is a conceptual diagram illustrating an example of information displayed by a user interface (e.g., user interface 105 of FIG. 1, user interface 305 of FIG. 3), including an annotation 614 associated with a representation of tissue 603. Processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) is configured to receive one or more signals from one or more of a therapy delivery element 610A, a therapy delivery element 610B (collectively referred to herein as therapy delivery elements 610), a sensor 611A, and / or a sensor 61 IB (collectively referred to herein as sensors 611) to generate annotation 614 of FIG. 6. Annotation 614 includes at least one visual property. Annotation 614 may be an example of any of the annotations discussed herein.

[0112] In the example of FIG. 6, annotation 614 includes a first area 618A, a second area 618B, and a third area 618C. In some examples, the visual property of annotation 614 includes a first variation in first area 618A, a second variation in second area 618B, and a third variation in third area 618C of annotation 614. In some examples, the variations in the visual property of annotation 614 between first area 618A, second area 618B, and third area 618C reflects a difference in measurable parameter associated with ablation therapy between each of the first area 618A, second area 618B, and third area 618C. In some examples, variations in the visual property of annotation 614 between first area 618A, second area 618B, and third area 618C reflects a difference in the therapeutical effectiveness of ablation therapy provided to the area of tissue 603 associated with annotation 614. In some examples, first area 618A, second area 618B, and third area 618C represents a gradient of the visual property within a given annotation (e.g., annotation 614). In some examples, each of the variations of the visual property of annotation 614 in first area 618A, second area 618B, and third area 618C are based on signals from received catheter 102. In this way, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to generate more than one variation of the visual property for a given annotation 614, which may reflect differences in therapy delivered to tissue 603 within the area of tissue 603 associated with the given (e.g., single) annotation 614.

[0113] In some examples, at least one visual property of annotation 614 is based on a combination of one or more a level of therapy (e.g., temperature as sensed by catheter), a duration of therapy (e.g., a time duration of therapy at a given location on tissue 603 associated with annotation 614), a level of contact between tissue 603 and catheter 602, and / or another parameter. For example, in some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates annotation 614, including the overall size (e.g., radius, or maximum dimension) and shape of annotation 614, based on a combination of a temperature at a distal portion of catheter 602, and a duration of time that therapy delivery elements 610 deliver therapy to an area or region of tissue associated with annotation 614. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates annotation 614 based on total time at a given temperature. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates annotation 614 based on a measure of temperature over time (e.g., a maximum temperature over a predefined time period, an average temperature over a predefined time period, etc.). In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates annotation 614 based on total time at a specific current density.

[0114] In some examples, the variation of one or visual properties of annotation 614 (e.g., the color, shading, etc.) are also based on a combination a temperature at a distal portion of catheter 602, and a duration of time that therapy delivery elements 610 deliver therapy to an area of region of tissue associated with annotation 614.

[0115] In some examples, each of the variations of the visual property of annotation 614 in first area 618A, second area 618B, and third area 618C of annotation 614 are based on a predetermined (e.g., known) distribution of therapy (e.g., ablation energy) delivered to each of first area 618A, second area 618B, and third area 618C. For example, in homogenous tissue, ablation energy may be delivered to tissue at a location and dissipate radially outward from the location. Each of first area 618A, second area 618B, and third area 618C may correlate to a known distribution of therapy (ablation energy), such as a known dissipation of ablation energy radially outward from a radial center of a therapy delivery location. In some examples, first area 618A, second area 618B, and third area 618C together reflect a gradient of a measurable parameter associated with ablation therapy (e.g., temperature, a level of ablation energy delivered to tissue, or another suitable parameter).

[0116] As an illustrative example, first area 618A may be at a center (e.g., a radial center) of annotation 614 and associated with a highest level of therapy (e.g., ablation therapy). First area 618A of annotation 614 may correlate with an area of tissue 603 directly contacted by catheter 602 (e.g., including therapy delivery element 610) during a period of continuous application ofablation therapy. Second area 618B of annotation 614 may be an area located radially outside of first area 618A. Second area 618B of annotation 614 may correlate with an area of tissue 603 at least partially in contact with catheter 602 (e.g., including therapy delivery element 610) or at least adjacent catheter 602 during a period of continuous application of ablation therapy. Third area 618C may be an area located radially outside of both first area 618A and second area 618B. Third area 618C of annotation 614 may correlate with an area of tissue 603 not in contact with catheter 602 (e.g., including therapy delivery element 610), but still receives some therapy (e.g., ablation energy) during a period of continuous application of ablation therapy.

[0117] In some examples, each of first area 618A, second area 618B, and third area 618C of annotation 614 are based, at least in part, on an orientation of catheter 602. For example, as shown in the example of FIG. 6, annotation 614, as well as each of first area 618A, second area 618B, and third area 618C generally have a circular uniform, circular shape, which may indicate that catheter 602 was perpendicular to the surface of tissue 603 associated with annotation 614 during delivery of ablation therapy. However, as discussed previously, a shape of annotation 614, as well as each of first area 618A, second area 618B, and third area 618C, may be different based on an orientation (e.g., angle) of catheter 602 relative to tissue 603. For example, if catheter 602 is at an angle (e.g., an angle greater than 0 degrees but less than 90 degrees) relative to tissue 603, annotation 614, as well as each of first area 618A, second area 618B, and third area 618C may not have uniform, circular shapes. Rather, annotation 614, as well as each of first area 618A, second area 618B, and third area 618C may define non-circular shapes (e.g., oblong, oval, amorphous, or the like).

[0118] FIG. 7 is a conceptual diagram illustrating an example of information displayed by a user interface (e.g., user interface 105 of FIG. 1 and / or user interface 305 of FIG. 3), including an annotation 714 associated with a representation of tissue 703. Processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) is configured to receive one or more signals from one or more of a therapy delivery element 710A, a therapy delivery element 710B (collectively referred to herein as therapy delivery elements 710), a sensor 711A, and / or a sensor 71 IB (collectively referred to herein as sensors 711) to generate annotation 714 of FIG. 7. Annotation 714 includes at least one visual property. Annotation 714 may be an example of any of the annotations discussed herein.

[0119] As shown in the example of FIG. 7, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to generate and / or modify the visual property of annotation 714. For example, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to generate annotation 714 including a first presentation 720A of the visual property of annotation 714. In some examples, processing circuitry of an ablation interface unit (e.g.,interface unit 104) is configured to modify annotation 714 to include one or more of a second presentation 720B of the visual property, a third presentation 720C of the visual property, . . . and / or an “Nth” presentation 720N of the visual property (wherein “N” is a real number). Each of first presentation 720A, second presentation 720B, third presentation 720C, . . . and / or “Nth” presentation 720N of the visual property may be an example of a different color, a different pattern, a different shading, and / or a different transparency associated with annotation 714. Each of first presentation 720A, second presentation 720B, third presentation 720C, . . . and / or “Nth” presentation 720N of the visual property are examples of how a given visual property of an annotation (e.g., annotation 714) may change (e.g., be created, be modified, and or be updated) over one or more periods of time. For example, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to modify the visual property of annotation 714 between at least first presentation 720A and second presentation 720B. Similarly, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to modify the visual property of annotation 714 between at least second presentation 720B and third presentation 720C, and so on.

[0120] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to determine whether a signal value based on the one or more signals (e.g., from one or more of therapy delivery elements 710 and / or sensors 711) meets a predefined threshold, e.g., for initially generating annotation 714. For example, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates annotation 714 including first presentation 720A of the visual property based on whether a signal (e.g., temperature, energy, current, voltage, impedance, power or the like), meets a predefined threshold. In this way, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to generate an annotation (e.g., annotation 714), including the at least one visual property, based on whether the signal value meets the predefined threshold.

[0121] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) does not generate an annotation if the signal does not meet the predefined threshold (e.g., even though ablation energy is emitted from catheter 102). For example, where ablation therapy is emitted from catheter 102, but catheter does not have sufficient contact with tissue 703, processing circuitry of an ablation interface unit (e.g., interface unit 104) may not generate an annotation (e.g., annotation 714).

[0122] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to receive multiple sets of signals (e.g., from one or more of therapy delivery elements 710 and / or sensors 711) to generate and / or modify annotation 714. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) receives atleast a first set of one or more signals for a first time period and a second set of one or more signals for a second time period. In some examples, the second time period is after the first time period. In some examples, the first time period is during a beginning portion of a period of continuous application of ablation therapy and the second time period is at a later portion of a period of continuous application of ablation therapy after the first time period. In some examples, the first time period is during a portion of a period of continuous application of ablation therapy and the second time period is during after the period of continuous application of ablation therapy. In the example of FIG. 7, each of first presentation 720A of the visual property, second presentation 720B of the visual property, and so on, can be associated with a set of signals from a respective time period (e.g., a first time period, a second time period, and so on). In some examples, as described more fully below, processing circuitry of an ablation interface unit (e.g., interface unit 104) is additionally or alternative configured to generate and / or modify annotation 714 based on a time duration between time periods of continuous ablation therapy (e.g., based on a duration of time between at least a first period of continuous application of ablation therapy and a second, separate period of continuous application of ablation therapy).

[0123] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates annotation 714 including first presentation 720A of the visual property based on the first set of one or more signals. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) receives the second set of one or more signals and generates annotation 714 including second presentation 720B of the visual property based on the second set of one or more signals. In this way, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to modify the at least one visual property of annotation 714 based on the second set of one or more signals. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to modify the at least one visual property of annotation 714 based on both the first set of signals and the second set of signals.

[0124] In examples where processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to receive multiple sets of signals (e.g., a least a first set of signals and a second set of signals) for generating an annotation 714 and / or modifying a visual of annotation 714, the processing circuitry (e.g., of interface unit 104) may be configured to perform one or more operations based on the multiple sets of signals. The operations based on the multiple sets of signals may enable processing circuitry (e.g., of interface unit 104) to determine whether to modify annotation 714. In some examples, processing circuitry (e.g., of interface unit 104) is configured to determine a rate of change of a measurable parameter (e.g., rate of temperature change) based on the first set of one or more signals and the second set of one or more signals. In some examples, processing circuitry (e.g., of interface unit 104) is configured to modifyannotation 714 (including the at least one visual property of annotation 714) based on the rate of change of the measurable parameter.

[0125] In some examples, processing circuitry (e.g., of interface unit 104) is configured to determine whether a difference between the first set and the second set of one or more signals meets a predefined threshold (e.g., a signal difference threshold). For example, processing circuitry (e.g., of interface unit 104) may be configured to determine a difference in magnitude between the first set and the second set of one or more signals (e.g., a signal indicative of temperature, EGM signals, or another signal indicative of therapy delivered to tissue 703 via catheter 702). In some examples, processing circuitry (e.g., of interface unit 104) determines a difference between the first set and the second set of one or more signals within a particular frequency range. In some examples, if the difference between the first set and the second set of one or more signals meets a predefined threshold (e.g., is above a predefined minimum difference threshold), processing circuitry (e.g., of interface unit 104) is configured to modify the visual property of annotation 714 (e.g., between first presentation 720A, and a different presentation, such as second presentation 720B). In some examples, if the difference between the first set and the second set of one or more signals does not meet a predefined threshold (e.g., is below a predefined minimum difference threshold), processing circuitry (e.g., of interface unit 104) is configured to not modify the visual property of annotation 714. In this way, processing circuitry (e.g., of interface unit 104) is configured to modify the at least one visual property of annotation 714 based on whether the difference between the first set and the second set of one or more signals meets the predefined signal difference threshold.

[0126] In some examples, the predefined signal difference threshold is based on a number of previous instances of ablation therapy delivered to tissue (e.g., tissue 703). As ablation therapy can have decreasing therapeutic effectiveness with successive instances of ablation therapy to a particular area of tissue, the predefined signal difference threshold may be based on a number (e.g., quantity) of previous instances of ablation therapy delivered to the particular area tissue, e.g., such as to take into account the decreasing effectiveness of ablation therapy to a given area of tissue 703. In some examples, ablation therapy (e.g., RF ablation therapy, PF ablation therapy) causes edema, which can lead to multiple successive but discrete instances of ablation therapy being less effective at a particular area of tissue. In some examples, the predefined signal difference threshold used by processing circuitry (e.g., of interface unit 104) to update and / or modify annotations includes multiple predefined signal difference thresholds, such as multiple unique predefined signal difference thresholds (e.g., signal difference threshold values) based on a number of previous instances of ablation therapy at the particular area of tissue.

[0127] In some examples, the predefined signal difference threshold is based on the therapy delivery modality and / or combination of therapy delivery modalities. In some examples, a therapeutic effectiveness of successive instances of ablation therapy delivered to a particular area of tissue may be different for different therapy delivery modalities (e.g., RF, cryoablation, PF) and / or combination of modalities. In some examples, by processing circuitry (e.g., of interface unit 104) is configured to select a suitable predefined signal difference threshold based on therapy delivery modality and / or combination of therapy delivery modalities.

[0128] In some examples, processing circuitry (e.g., of interface unit 104) is configured to determine a time (e.g., duration) between the first set of signals and the second set of signals, e.g., for generating an annotation 714 and / or modifying a visual property of annotation 714. In some examples, processing circuitry (e.g., of interface unit 104) is configured to generate and / or modify annotation 714 and / or a visual property of annotation 714 based on the time between the first set of signals and the second set of signals. In some examples, to modify the at least one visual property of annotation 714 based on the second set of one or more signals, processing circuitry (e.g., of interface unit 104) is configured to modify the at least one visual property of annotation 714 based on a determined thermal recovery of the tissue (e.g., cooling of tissue between multiple discrete instances of therapy delivery). In some examples, processing circuitry (e.g., of interface unit 104) is configured to calculate thermal recovery of tissue based on known biophysical properties tissue (e.g., tissue 703) and a time between the first set of signals and the second set of signals (e.g., a time between receiving the first set of signals and the second set of signals). As described above, thermal recovery based on biophysical properties of the tissue can be a function of time, such that processing circuitry (e.g., of interface unit 104) can be configured to determine thermal recovery of tissue (e.g., tissue 703) based a time (e.g., time between the first set of signals and the second set of signals) and modify annotation 714 at least in part based on the calculated thermal recovery of tissue 703.

[0129] In examples where processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to receive multiple sets of signals for generating an annotation 714 and / or modifying a visual of annotation 714, the multiple sets of signals may be received from a common area of tissue (e.g., a common area of tissue 703). For example, as shown in the example of FIG. 7, annotation 714 is associated with a portion (e.g., area) of tissue 703 (e.g., as indicated by the area of tissue 703 that annotation 714 overlays). In some examples, as described previously, processing circuitry of an ablation interface unit (e.g., interface unit 104) initially generates annotation 714 based on a first set of signals associated with a portion of tissue associated with annotation 714. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) subsequently modifies annotation 714 based on a second set ofsignals associated with the same area of tissue 703. In this way, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to update an annotation (e.g., annotation 714) during a period of continuous application of ablation therapy and / or in response to multiple instances of therapy delivery at the common area of tissue. Additionally, in this way, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to update an annotation (e.g., annotation 714) for a given area of tissue without creating multiple annotations associated with the same area of tissue 703. In some examples, updating the visual properties of previous (e.g., existing) annotation without creating new annotations (e.g., for the same area of tissue 703) may be a relatively more accurate way of displaying a therapeutic effectiveness of ablation therapy delivered to tissue 703. In some examples, updating the visual properties of previous (e.g., existing) annotation without creating new annotations (e.g., for the same area of tissue 703) may be a relatively more accurate way of presenting to a user (e.g., a clinician) a predicted tissue response to ablation therapy.

[0130] As described herein, a common area of tissue can include partially overlapping areas of tissue or completely overlapping areas of tissue. For example, where a subsequent annotation would completely overlap or substantially overlap (e.g., more than 50 percent overlap) with a previous annotation and the associated area of tissue thereof, processing circuitry of an ablation interface unit (e.g., interface unit 104) may update the prior annotation (e.g., annotation 714) rather than replacing the prior annotation (e.g., annotation 714) with a new annotation. In some examples, where a subsequent annotation would not substantially overlap (e.g., less than 50 percent overlap) with a previous annotation and the associated area of tissue thereof, processing circuitry of an ablation interface unit (e.g., interface unit 104) may create a new, additional annotation rather than modifying a prior annotation (e.g., annotation 714).

[0131] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to determine a cumulative effect of ablation to tissue 703, e.g., for modifying the visual property of annotation 714. For example, processing circuitry of an ablation interface unit (e.g., interface unit 104) modifies the visual property (e.g., between one or more of first presentation 720A, second presentation 720B, third presentation 720C . . . “Nth” presentation 720N) based the cumulative effect of ablation. In some examples, the cumulative effect of ablation includes a cumulative level of a signal (e.g., temperature, energy, current, voltage, impedance, ablation energy power, another suitable signal, or a combination thereof). The cumulative effect of ablation may include a measure of a signal over a time period (e.g., over one or more periods of continuous application of ablation therapy, which can include one or more non-overlapping, discrete periods of continuous application of ablation therapy). In this way, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to modifythe at least one visual property of an annotation (e.g., annotation 714) based on the cumulative effect of ablation to tissue (e.g., tissue 703). By reflecting the cumulative effect of ablation to tissue, annotation 714 indicates a therapeutic effectiveness of ablation therapy to the tissue. Displaying a cumulative effect of ablation on tissue 703 via a single annotation 714 may be a relatively more accurate way of reflecting therapy delivered to tissue, such as compared to system that instead generate multiple annotations for a single area of tissue for one or more instances of ablation therapy.

[0132] In some examples, the cumulative effect of ablation includes a cumulative effect over multiple, discrete, instances of therapy delivery (e.g., where each instance of therapy delivery includes a respective period continuous application of ablation therapy). Such instances of multiple, discrete instances of therapy delivery can be non-overlapping and time separated (e.g., separated by a finite length of time of little or no therapy delivery). For example, in instances where processing circuitry of an ablation interface unit (e.g., interface unit 104) receives at least a first set of one or more signals for a first time period and a second set of one or more signals for a second time period, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to determine the cumulative effect of ablation based on at least the first set of one or more signals and the second set of one or more signals. However, processing circuitry of an ablation interface unit (e.g., interface unit 104) may additionally or alternatively be configured to determine a cumulative effect of ablation delivered to tissue 703 over a single instance (e.g., continuous period) of delivery of ablation therapy to tissue 703.

[0133] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to perform one or more operations to generate and / or modify an annotation (e.g., annotation 714). In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) performs an integration operation of a signal over one or more time periods to generate and / or modify an annotation (e.g., to determine the cumulative effect of ablation). In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) performs a summation operation of one or more signal values (e.g., energy) corresponding to one or more time periods to generate and / or modify an annotation (e.g., to determine the cumulative effect of ablation). In the example of FIG. 7, the visual property of annotation 714 (e.g., between one or more of first presentation 720A, second presentation 720B, third presentation 720C . . . “Nth” presentation 720N) is based the integration operation and / or summation operation.

[0134] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to update a previous annotation (e.g., not the most current annotation). In some examples, updating a previous annotation (e.g., annotation 714) is based on subsequenttherapy delivery to a location associated with the previous annotation. For example, as discussed previously, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates annotation 714 including a visual property with first presentation 720A at a first time and based on a first set of one or more signals. After generating annotation 714 including the visual property with first presentation 720A, catheter 702 can be moved away from the area of tissue 703 associated with annotation 714, e.g., to create additional, separate annotations based on therapy delivery to additional, separate areas of tissue 703. Subsequently, catheter 702 can be moved back (e.g., by a clinician) to the area of tissue 703 associated with annotation 714. Once catheter 702 is moved back to the area of tissue associate with annotation 714, processing circuitry of an ablation interface unit (e.g., interface unit 104) may update the visual property of annotation 714 (e.g., to a second presentation 720B, third presentation 720C, or “Nth” presentation 720N) based on a second set of one or more signals.

[0135] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to update a previous annotation based on a threshold time (e.g., a predefined threshold time). For example, if the time between creation of the initial annotation 714 and the subsequent movement of catheter 702 back to the area of tissue 703 associated with annotation 714 is below the threshold time (e.g., between 1 second and 5 seconds, such as about 2 seconds), processing circuitry of an ablation interface unit (e.g., interface unit 104) updates annotation 714 based on the second set of signals. In some examples, if the time between creation of the initial annotation 714 and the subsequent movement of catheter 702 back to the area of tissue 703 associated with annotation 714 is above threshold time, processing circuitry of an ablation interface unit (e.g., interface unit 104) will not update annotation 714 based on the second set of signals. Rather, processing circuitry of an ablation interface unit (e.g., interface unit 104) may instead create a new annotation (e.g., at the location of tissue associated with annotation 714) if the creation of annotation 714 and subsequent movement back to the area associated with annotation 714 is above the threshold time.

[0136] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to update annotation 714 based on the time between creation of the initial annotation 714 and the subsequent movement of catheter 702 back to the area of tissue 703 associated with annotation 714. For example, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to modify the cumulative effect describe elsewhere in this disclosure based on the on the time between creation of the initial annotation 714 and the subsequent movement of catheter 702 back to the area of tissue 703 associated with annotation 714. In instances of a relatively short time between creation of the initial annotation 714 and the subsequent movement of catheter 702 back to the area of tissue 703 associated with annotation714, a cumulative effect of ablation to the area of tissue 703 associated with annotation 714 may be relatively greater, and processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to generate update annotation 714 accordingly.

[0137] While processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to modify one or more visual properties of annotation 714 during a period of continuous application of ablation therapy to the tissue, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be additionally or alternatively configured to update one or more visual properties of annotation 714 at a later time (e.g., wherein the later time is a time after a period of continuous ablation therapy during which annotation 714 was initially created). For example, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to modify annotation 714 based on multiple instances of therapy delivery. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to modify annotation 714 at a later time, even in instances where subsequent therapy is not delivered to the location of tissue 703 associated with annotation 714. For example, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to modify annotation 714 during a subsequent sensing and / or measuring period, such as when a user (e.g., a clinician) moves catheter 402 over annotation 714.

[0138] While the visual property of annotation 714 in the example of FIG. 7 is depicted as a shading, it is understood that the same principles discussed in connection with FIG. 7 can apply to other visual properties, including, but not limited to, shape, orientation, color, gradient, hue, highlighting, pattern, transparency, and / or other properties of annotation 714.

[0139] FIG. 8 is a conceptual diagram illustrating examples of information displayed by a user interface (e.g., user interface 105 of FIG. 1, user interface 305 of FIG. 3) including a first annotation 814A and a second annotation 814B associated with a representation of tissue 803. Processing circuitry of an ablation interface unit (e.g., interface unit 104 as discussed in connection with FIG. 1) is configured to receive one or more signals from one or more of a therapy delivery element 810A, a therapy delivery element 810B (collectively referred to herein as therapy delivery elements 810), a sensor 811A, and / or a sensor 81 IB (collectively referred to herein as sensors 811) to generate each of annotation 814A and annotation 814B. Each of annotation 814A and annotation 814B includes at least one visual property. Each of annotation 814A and annotation 814B can be examples of any of the annotations discussed herein.

[0140] In the example of FIG. 8, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates a tissue annotation 819 between at least two annotations (e.g., annotation 814A and annotation 814B). Tissue annotation 819 may indicate to a user (e.g., a clinician) that at least a portion of tissue 803 between first annotation 814A and secondannotation 814B has not received sufficient ablation therapy (e.g., where sufficient ablation therapy stops the conduction of unwanted propagation of electrical signals). In some examples, tissue annotation 819 reflects an area of tissue 803 that has not received therapeutically effective ablation therapy. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) is configured to determine a distance between at least first annotation 814A and second annotation 814B, e.g., for generating tissue annotation 819. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) compares the distance between first annotation 814A and second annotation 814B to a threshold distance (e.g., a predefined threshold distance) and generates tissue annotation 819 based on the comparison. In some examples, the distance between first annotation 814A and second annotation 814B includes a distance measured from a respective edge of first annotation 814A and second annotation 814B. For example, the distance between first annotation 814A and second annotation 814B corresponding to area of tissue 803 associated with tissue annotation 819 is based on a distance between areas of tissue that has received therapeutically effective ablation therapy. Thus, rather than being based on an arbitrary distance between first annotation 814A and second annotation 814B, tissue annotation 819 reflects an area of tissue 803 that has not received therapeutically effective ablation therapy. In this way, presentation of one or more of tissue annotation 819 can help a clinician more accurately identify areas of tissue 803 that need ablation therapy (e.g., in instances where creation of a “line” of ablated tissue is needed to correct an arrhythmia).

[0141] In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates tissue annotation 819 based on one or more signals. For example, processing circuitry of an ablation interface unit (e.g., interface unit 104) may be configured to generate tissue annotation 819 based on one or more of a signal indictive of temperature (e.g., from sensors 811), impedance signals, or the like. In some examples, processing circuitry of an ablation interface unit (e.g., interface unit 104) generates a tissue annotation 819 based on an indication that the portion of tissue 803 associated with tissue annotation 819 has not reached a sufficient therapeutically effective temperature (e.g., as sensed by sensors 811 of catheter 802).

[0142] While the functions performed by processing circuitry of an ablation interface unit (e.g., interface unit 104 in the example of FIG. 1) are shown as separate examples in FIGS. 4A, 4B, 5A, 5B, 6, 7, 8A, and 8B, it should be understood that the actions and / or operations illustrated in foregoing diagrams can be performed sequentially, simultaneously, and / or or in any suitable combination or sub-combination.

[0143] An example technique for generating and / or modifying an annotation according to this disclosure is illustrated in FIG. 9. The technique is described with reference to system 100 of FIG. 1 and processing circuitry 304 of interface unit 300 (which may be an example of interfaceunit 104) as discussed in connection with FIG. 3. However, the technique may be applied to other medical systems in other examples.

[0144] The technique includes receiving, by processing circuitry 304, one or more signals from one or more sensors (e.g., therapy delivery elements 110 and / or sensors 111) of catheter 102 (e.g., an ablation catheter) during a period of continuous application of ablation therapy to tissue 103 via catheter 102 (900). In some examples, the signals include one or more signals that indicate one or more of temperature, delivered voltage, delivered current, tissue contact, or the like. In some examples, the signals include signals for measuring and monitoring one or more tissue characteristics, such as temperature, electrogram (EGM) waveforms, monophasic action potentials, impedance (e.g., tissue impedance), or the like. The one or more signals indicate a therapeutic effect (e.g., a cumulative effect) of ablation therapy on tissue 103. In general, the one or more signals can indicate a location of ablation therapy (e.g., relative to other portions of tissue 103) and / or and effectiveness (e.g., level) of ablation therapy delivered to at least a portion of tissue 103.

[0145] The technique includes generating, by processing circuitry 304 and for presentation to a user (e.g., a clinician), a representation of the tissue 103 including an annotation based on the one or more signals, the annotation including at least one visual property (902). The representation of tissue 103 may include a “shell” representing at least a portion of a boundary of an organ (e.g., the heart of patient 101). The at least one visual property of the annotation can include one or more of a shape, orientation, color, gradient, hue, shading, highlighting, pattern, transparency, or another suitable characteristic of the annotation. In some examples, the annotation indicates a size, location, efficacy, or another parameter about therapy (e.g., ablation therapy) delivered to tissue 103 of a patient 101. In some examples, the one or more visual properties of the annotation reflect further details about therapy delivery, including therapy dose (e.g., level of therapy delivered), lesion depth, therapy efficacy, and / or another parameter about therapy (e.g., ablation therapy) delivered to tissue 103 of a patient 101.

[0146] The technique includes receiving, by processing circuitry 304, information indicative of movement of catheter 102 (e.g., a distal portion of catheter 102), information indicative of movement of the tissue 103, and / or information indicative of relative movement between catheter 102 and tissue 103 (904). In some examples, information indicative of movement of catheter 102 (e.g., a distal portion of catheter 102), information indicative of movement of the tissue 103, and / or information indicative of relative movement between catheter 102 and tissue 103 can be received by processing circuitry 304 during, throughout, and or after a period of application of ablation energy (e.g., a continuous period of application of ablation energy). In some examples, information indicative of movement of the catheter includes signals received by processingcircuitry 304 from catheter 102 and / or signals from positioning subsystem 316. In some examples, information indicative of movement of the catheter 102 includes an indication of displacement of a distal portion (e.g., tissue contacting portion and / or another portion configured to deliver ablation therapy) of the catheter 102 (e.g., displacement between at least a first location and a second location). In some examples, information indicative of movement of catheter 102 includes a measure of catheter stability, such as a stability index (e.g., a greatest displacement from an initial location over a period of continuous application of ablation therapy). In some examples, information indicative of movement of catheter 102 includes an indication of a change of an orientation of the catheter 102 (e.g., relative to tissue 103).

[0147] While this disclosure is primarily discussed with respect to receiving information indicative of movement of catheter 102, information of other types of movement of different structures and / or tissue can be used by processing circuitry 304, e.g., for the modification of properties (e.g., visual properties) of annotations (e.g., therapy annotations). For example, in some examples, while catheter 102 may remain stationary in absolute three-dimensional space, tissue 103 (e.g., which can include cardiac tissue) may move relative to catheter 102 (e.g., closer to or farther away from catheter 102), such as during a period of delivery of ablation energy, which can affect the therapeutic effect of delivered ablation energy. Thus, processing circuitry 304 may additionally or alternatively receive information indicative of a position and / or movement of tissue 103 in absolute space (e.g., via electrodes or other position sensors affixed to a surface of tissue 103 or another portion of tissue). In some examples, processing circuitry 304 may additionally or alternatively information indicative of relative movement between catheter 102 and tissue 103. For example, processing circuitry 304 may receive information indicative of movement of both catheter 102 and tissue 103, e.g., in order that processing circuitry 304 determines relative movement between catheter 102 and tissue 103.

[0148] The technique includes modifying, processing circuitry 304, the at least one visual property of the annotation at least in part based on the information indicative of movement of the catheter, information indicative of movement of the tissue 103, and / or information indicative of relative movement between catheter 102 and tissue 103 (906). For example, in some examples, processing circuitry 304 modifies one or more visual properties (e.g., a size and shape) of an annotation based on (e.g., in response to) the information indicative of movement of catheter 102 (e.g., during a period of continuous ablation therapy). In this way, by modifying the visual property (e.g., shape and / or or size) of the annotation, processing circuitry 304 may be configured to generate a continuous “drawn” annotation. By updating the visual properties of an annotation, processing circuitry 304 may facilitate a relatively more accurate representation of energy actually delivered to a patient (e.g., as compared to static annotations). In some examples,this relatively more accurate representation of therapy delivery delivered to the patient can reduce the necessity of additional delivery of energy in certain locations on tissue 103, reduce procedure time, and / or instill confidence that target areas (e.g., of tissue 103) have received sufficient therapy.

[0149] Another example technique for generating and / or modifying an annotation according to this disclosure is illustrated in FIG. 10. The technique is described with reference to system 100 of FIG. 1 and processing circuitry 304 of interface unit 300 (which may be an example of interface unit 104) as discussed in connection with FIG. 3. However, the technique may be applied to other medical systems in other examples.

[0150] The technique includes receiving, by processing circuitry 304, a first set of one or more signals for a first time period from one or more sensors 111 of catheter 102 (e.g., an ablation catheter) during a period of continuous application of ablation therapy to tissue 103 via catheter 102 (1000). In some examples, the signals include one or more signals that indicate one or more of temperature, delivered voltage, delivered current, tissue contact, or the like. In some examples, the signals include signals for measuring and monitoring one or more tissue characteristics, such as temperature, electrogram (EGM) waveforms, monophasic action potentials, impedance (e.g., tissue impedance), or the like. The one or more signals can indicate a therapeutic effect (e.g., a cumulative effect) of ablation therapy on tissue 103. In general, the one or more signals can indicate a location of ablation therapy (e.g., relative to other portions of tissue 103) and / or and effectiveness (e.g., level) of ablation therapy delivered to at least a portion of tissue 103. In some examples, the first time period includes a period during a period of continuous application of ablation therapy.

[0151] The technique includes generating, by processing circuitry 304 and for presentation to a user (e.g., a clinician), a representation of the tissue 103 including an annotation based on the first set of one or more signals, the annotation including at least one visual property (1002). The representation of tissue 103 may include a “shell” representing at least a portion of a boundary of an organ (e.g., the heart of patient 101). The at least one visual property of the annotation can include one or more of a shape, orientation, color, gradient, hue, shading, highlighting, pattern, transparency, or another suitable characteristic of the annotation. In some examples, the annotation indicates a size, location, efficacy, or another parameter about therapy (e.g., ablation therapy) delivered to tissue 103 of a patient 101. In some examples, the one or more visual properties of the annotation reflect further details about therapy delivery, including therapy dose (e.g., level of therapy delivered), lesion depth, therapy efficacy, and / or another parameter about therapy (e.g., ablation therapy) delivered to tissue 103 of a patient 101.

[0152] The technique includes receiving, by processing circuitry, a second set of one or more signals for a second time period after the first time period from the one or more sensors (1004). As discussed in relation to previous examples, both of the first time period and the second time period may occur during a period of continuous application of ablation therapy. However, in other examples, the second time period may be after the period of continuous application of ablation therapy. In some examples, the first set of one or more signals and the second set of one or more signals are associated with a common portion of tissue 103. In some examples, the first set and the second set of one or more signals include at least some of the same types of signal(s) (e.g., a temperature signal, and impedance signal, a signal indicative of delivered current, or any of the other signals discussed in connection with this disclosure).

[0153] The technique includes modifying, by processing circuitry 304 and based on the second set of one or more signals, the at least one visual property of the annotation (1006). For example, while processing circuitry 304 generates the annotation with at least one visual property based on the first set of signals, processing circuitry 304 may modify the annotation and the at least one visual property based on the second set of signals. In this way, processing circuitry 304 may be configured to update an annotation during a period of period of continuous application of ablation therapy and / or in response to multiple instances of therapy delivery at the common area of tissue 103. Additionally, in this way, processing circuitry 304 may be configured to update an annotation for a given area of tissue without creating multiple annotations associated with the same area of tissue 103. In some examples, updating the visual properties of previous (e.g., existing) annotation without creating new annotations may be a relatively more accurate way of displaying a therapeutic effectiveness of ablation therapy delivered to tissue 703.

[0154] In some examples the technique further includes determining, by processing circuitry 304, cumulative effect of ablation based on at least the first set of one or more signals and the second set of one or more signals. In some examples, modifying the at least one visual property of the annotation based on the second set of one or more signals reflects the cumulative effect of ablation on tissue 103.

[0155] The techniques described in this disclosure, including those attributed to system 100, interface unit 104, interface unit 300, processing circuitry 304, and / or various constituent components, may be implemented, at least in part, in hardware, software, firmware or any combination thereof. For example, various aspects of the techniques may be implemented within one or more processors, including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field-programmable gate array (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, embodied in programmers, such as clinician or patient programmers, medicaldevices, or other devices. Processing circuitry, control circuitry, and sensing circuitry, as well as other processors and controllers described herein, may be implemented at least in part as, or include, one or more executable applications, application modules, libraries, classes, methods, objects, routines, subroutines, firmware, and / or embedded code, for example. In addition, analog circuits, components and circuit elements may be employed to construct one, some or all of the processing circuitry, instead of or in addition to the partially or wholly digital hardware and / or software described herein. Accordingly, analog or digital hardware may be employed, or a combination of the two.

[0156] The term “processor,” and “processing circuitry” as used herein, such as may refer to any of the foregoing structure or any other structure suitable for implementation of the techniques described herein. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0157] The techniques of this disclosure may be implemented in a wide variety of devices or apparatuses, including a wireless handset, an integrated circuit (IC) or a set of ICs (e.g., a chip set). Various components, modules, or units are described in this disclosure to emphasize functional aspects of devices configured to perform the disclosed techniques, but do not necessarily require realization by different hardware units. Rather, as described above, various units may be combined in a hardware unit or provided by a collection of interoperative hardware units, including one or more processors as described.

[0158] In one or more examples, the functions described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on, as one or more instructions or code, a computer- readable medium and executed by a hardware-based processing unit. The computer-readable medium may be an article of manufacture including a non-transitory computer-readable storage medium encoded with instructions. Instructions embedded or encoded in an article of manufacture including a non-transitory computer-readable storage medium encoded, may cause one or more programmable processors, or other processors, to implement one or more of the techniques described herein, such as when instructions included or encoded in the non-transitory computer-readable storage medium are executed by the one or more processors. Example non- transitory computer-readable storage media may include random-access memory (RAM), readonly memory (ROM), programmable ROM (PROM), erasable programmable ROM (EPROM), electronically erasable programmable ROM (EEPROM), flash memory, a hard disk, a compact disc ROM (CD-ROM), a floppy disk, a cassette, magnetic media, optical media, or any other computer readable storage devices or tangible computer readable media.

[0159] In some examples, a computer-readable storage medium includes a non-transitory medium. The term “non-transitory” may indicate that the storage medium is not embodied in a carrier wave or a propagated signal. In certain examples, a non-transitory storage medium may store data that can, overtime, change (e.g., in RAM or cache).

[0160] The functionality described herein may be provided within dedicated hardware and / or software modules. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated within common or separate hardware or software components. Also, the techniques could be fully implemented in one or more circuits or logic elements.

[0161] This disclosure includes the following non-limiting examples.

[0162] Example 1: A medical system includes one or more catheters including one or more sensors and configured to deliver ablation energy to tissue; and processing circuitry configured to: receive one or more signals from the one or more sensors of the one or more catheters during a period of application of ablation energy to the tissue; generate a representation of the tissue including an annotation based on the one or more signals, the annotation including at least one visual property; receive information indicative of movement of at least one catheter of the one or more catheters during the period of application of ablation energy; and modify the at least one visual property of the annotation at least in part based on the information indicative of movement of the at least one catheter.

[0163] Example 2: The medical system of example 1, wherein the at least one visual property of the annotation includes one or more of a shape, orientation, color, gradient, hue, shading, highlighting, pattern, and transparency of the annotation.

[0164] Example 3: The medical system of any of examples 1 and 2, wherein the ablation energy includes one or more of radiofrequency (RF) ablation energy, pulsed field (PF) ablation energy, cryoablation energy, microwave ablation, and / or laser ablation.

[0165] Example 4: The medical system of any of examples 1 through 3, wherein the one or more signals indicate one or more of a location of the one or more catheters, a temperature, an electrogram (EGM), a current, a power, a contact force, and an impedance.

[0166] Example 5: The medical system of any of examples 1 through 4, wherein movement of the at least one catheter includes displacement of a distal portion of the at least one catheter.

[0167] Example 6: The medical system of example 5, wherein the distal portion of the at least one catheter is a tissue contacting portion of the at least one catheter.

[0168] Example 7: The medical system of any of examples 1 through 6. wherein movement of the at least one catheter includes a change of an orientation of the at least one catheter.

[0169] Example 8: The medical system of any of examples 1 through 7, wherein the information indicative of movement of the at least one catheter includes an indication of catheter stability.

[0170] Example 9: The medical system of any of examples 1 through 8, wherein the information indicative of movement of the at least one catheter includes an indication of movement above a predefined movement threshold.

[0171] Example 10: The medical system of any of examples 1 through 9, wherein the processing circuitry is configured to display the representation of the tissue including the annotation via a display of a user interface.

[0172] Example 11: The medical system of any of examples 1 through 10, wherein the processing circuitry is configured to receive an indication of contact between the at least one catheter and the tissue during the period of application of ablation energy, and wherein the processing circuitry is configured to modify the at least one visual property of the annotation based on the information indicative of movement of the at least one catheter and the indication of contact between the at least one catheter and the tissue during the period of application of ablation energy.

[0173] Example 12: The medical system of any of examples 1 through 11, wherein to generate the representation of tissue including the annotation, the processing circuitry is configured to: determine whether a signal value based on the one or more signals meets a predefined threshold; and generate the annotation including the at least one visual property based on whether the signal value meets the predefined threshold.

[0174] Example 13: The medical system of any of examples 1 through 12, wherein the processing circuitry is configured to: determine a cumulative effect of ablation energy during the period of application of ablation energy; and modify the at least one visual property of the annotation based on the cumulative effect of ablation energy.

[0175] Example 14: The medical system of any of examples 1 through 13, wherein the annotation indicates a therapeutic effectiveness of ablation energy to the tissue.

[0176] Example 15: The medical system of any of examples 1 through 14, wherein the one or more signals is a first set of one or more signals for a first time period; and wherein the processing circuitry is configured to: receive a second set of one or more signals for a second time period after the first time period from the one or more sensors; and modify, based on the second set of one or more signals, the at least one visual property of the annotation.

[0177] Example 16: The medical system of example 15, wherein the first set of one or more signals and the second set of one or more signals are received from a common area of the tissue.

[0178] Example 17: The medical system of any of examples 15 and 16, wherein to modify the at least one visual property of the annotation based on the second set of one or more signals, the processing circuitry is configured to: determine whether a difference between the first set and the second set of one or more signals meets a predefined signal difference threshold; and modify the at least one visual property of the annotation based on whether the difference between the first set and the second set of one or more signals meets the predefined signal difference threshold.

[0179] Example 18: The medical system of any of examples 15 and 16, wherein to modify the at least one visual property of the annotation based on the second set of one or more signals, the processing circuitry is configured to: determine a time between receiving the first set of signals and the second set of signals; determine a thermal recovery of the tissue based on the time; and modify the at least one visual property of the annotation based on the determined thermal recovery of the tissue.

[0180] Example 19: A method includes receiving, by processing circuitry, one or more signals from one or more sensors of one or more catheters during a period of application of ablation energy to tissue; generating, by the processing circuitry and for presentation to a user, a representation of the tissue including an annotation based on the one or more signals, the annotation including at least one visual property; receiving, by the processing circuitry, information indicative of movement of at least one catheter of the one or more catheters during the period of application of ablation energy; and modifying, by the processing circuitry, the at least one visual property of the annotation at least in part based on the information indicative of movement of the at least one catheter.

[0181] Example 20: The method of example 19, wherein the at least one visual property of the annotation includes one or more of a shape, orientation, color, gradient, hue, shading, highlighting, pattern, and transparency of the annotation.

[0182] Example 21: The method of any of examples 19 and 20, wherein the ablation energy includes one or more of radiofrequency (RF) ablation energy, pulsed field (PF) ablation energy, cryoablation energy, microwave ablation energy, and / or laser ablation.

[0183] Example 22: The method of any of examples 19 through 21, wherein the one or more signals indicate one or more of a location of the one or more catheters, a temperature, an electrogram (EGM), a current, a power, a contact force, and an impedance.

[0184] Example 23: The method of any of examples 19 through 22, wherein movement of the at least one catheter includes displacement of a distal portion of the at least one catheter.

[0185] Example 24: The method of example 23, wherein the distal portion of the at least one catheter is a tissue contacting portion of the at least one catheter.

[0186] Example 25: The method of any of examples 19 through 24, wherein movement of the at least one catheter includes a change of an orientation of the catheter.

[0187] Example 26: The method of any of examples 19 through 25, wherein the information indicative of movement of the at least one catheter includes an indication of catheter stability.

[0188] Example 27: The method of any of examples 19 through 26, wherein the information indicative of movement of the at least one catheter includes an indication of movement above a predefined movement threshold.

[0189] Example 28: The method of any of examples 19 through 27, wherein generating the representation of the tissue including the annotation includes displaying the representation of the tissue including the annotation via a display of a user interface.

[0190] Example 29: The method of any of examples 19 through 28, further includes receiving, by the processing circuitry, an indication of contact between the at least one catheter and the tissue during the period of application of ablation energy, wherein modifying the at least one visual property of the annotation is based on the information indicative of movement of the at least one catheter and the indication of contact between the at least one catheter and the tissue during the period of application of ablation energy.

[0191] Example 30: The method of any of examples 19 through 29, wherein generating the representation of tissue including the annotation comprises: determining whether a signal value based on the one or more signals meets a predefined threshold; and generating the annotation including the at least one visual property based on determining whether the signal value meets the predefined threshold.

[0192] Example 31 : The method of any of examples 19 through 30, further includes determining a cumulative effect of ablation energy during the period of application of ablation energy, wherein modifying, by the processing circuitry, the at least one visual property of the annotation is based on the cumulative effect of ablation energy.

[0193] Example 32: The method of any of examples 19 through 31, wherein the annotation indicates a therapeutic effectiveness of ablation energy to tissue.

[0194] Example 33: The method of any of examples 19 through 32, wherein the one or more signals is a first set of one or more signals for a first time period; and wherein the method further includes: receiving, by the processing circuitry, a second set of one or more signals for a second time period after the first time period from the one or more sensors; and modifying, by the processing circuitry and based on the second set of one or more signals, the at least one visual property of the annotation.

[0195] Example 34: The method of example 33, wherein the first set of one or more signals and the second set of one or more signals are received from a common area of the tissue.

[0196] Example 35: The method of any of examples 33 and 34, wherein modifying, by the processing circuitry, the at least one visual property of the annotation based on the second set of one or more signals comprises: determining whether a difference between the first set and the second set of one or more signals meets a predefined signal difference threshold; and modifying the at least one visual property of the annotation based on determining whether the difference between the first set the second set of one or more signals meets the predefined signal difference threshold.

[0197] Example 36: The method of any of examples 33 and 34, wherein modifying, by the processing circuitry, the at least one visual property of the annotation based on the second set of one or more signals comprises: determining a time between receiving the first set of signals and the second set of signals; determining a thermal recovery of the tissue based on the time; and modifying the at least one visual property of the annotation based on the determined thermal recovery of the tissue.

[0198] Example 37: A non-transitory computer readable medium comprising instructions that, when executed, cause processing circuitry to perform the method of any of examples 19-36.

[0199] Example 38: A medical system includes one or more catheters including one or more sensors and configured to deliver ablation energy to tissue; and processing circuitry configured to: receive a first set of one or more signals for a first time period from one or more sensors of the one or more catheters during a period of application of ablation energy to tissue; generate a representation of the tissue including an annotation based on the first set of one or more signals, the annotation including at least one visual property; receive a second set of one or more signals for a second time period after the first time period from the one or more sensors; and modify, based on the second set of one or more signals, the at least one visual property of the annotation.

[0200] Example 39: A method includes receiving, by processing circuitry, a first set of one or more signals for a first time period from one or more sensors of one or more catheters during a period of application of ablation energy to tissue; generating, by the processing circuitry and for presentation to a user, a representation of the tissue including an annotation based on the first set of one or more signals, the annotation including at least one visual property; receiving, by the processing circuitry, a second set of one or more signals for a second time period after the first time period from the one or more sensors; and modifying, by the processing circuitry and based on the second set of one or more signals, the at least one visual property of the annotation.

[0201] Example 40: The medical system of example 13, wherein the determined cumulative effect of ablation energy is relatively greater if succussive periods of application of ablationenergy are less than or equal to 5 seconds apart, and wherein the determined cumulative effect of ablation energy is relatively lesser if the succussive periods of application of ablation energy are greater than 5 seconds apart.

[0202] Example 41: The medical system of example 13, wherein the determined cumulative effect of ablation energy is based on a determined thermal recovery of the tissue.

[0203] Various examples of the disclosure have been described. These and other examples are within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A medical system comprising: one or more catheters including one or more sensors and configured to deliver ablation energy to tissue; and processing circuitry configured to: receive one or more signals from the one or more sensors of the one or more catheters during a period of application of ablation energy to the tissue; generate a representation of the tissue including an annotation based on the one or more signals, the annotation including at least one visual property; receive information indicative of movement of at least one catheter of the one or more catheters during the period of application of ablation energy; and modify the at least one visual property of the annotation at least in part based on the information indicative of movement of the at least one catheter.

2. The medical system of claim 1, wherein the at least one visual property of the annotation includes one or more of a shape, orientation, color, gradient, hue, shading, highlighting, pattern, and transparency of the annotation.

3. The medical system of any of claims 1 and 2, wherein the ablation energy includes one or more of radiofrequency (RF) ablation energy, pulsed field (PF) ablation energy, cryoablation energy, microwave ablation, and / or laser ablation.

4. The medical system of any of claims 1 through 3, wherein the one or more signals indicate one or more of a location of the one or more catheters, a temperature, an electrogram (EGM), a current, a power, a contact force, and an impedance.

5. The medical system of any of claims 1 through 4, wherein movement of the at least one catheter includes displacement of a distal portion of the at least one catheter.

6. The medical system of claim 5, wherein the distal portion of the at least one catheter is a tissue contacting portion of the at least one catheter.

7. The medical system of any of claims 1 through 6, wherein movement of the at least one catheter includes a change of an orientation of the at least one catheter.

8. The medical system of any of claims 1 through 7, wherein the information indicative of movement of the at least one catheter includes an indication of catheter stability.

9. The medical system of any of claims 1 through 8, wherein the information indicative of movement of the at least one catheter includes an indication of movement above a predefined movement threshold.

10. The medical system of any of claims 1 through 9, wherein the processing circuitry is configured to receive an indication of contact between the at least one catheter and the tissue during the period of application of ablation energy, and wherein the processing circuitry is configured to modify the at least one visual property of the annotation based on the information indicative of movement of the at least one catheter and the indication of contact between the at least one catheter and the tissue during the period of application of ablation energy.

11. The medical system of any of claims 1 through 10, wherein to generate the representation of tissue including the annotation, the processing circuitry is configured to: determine whether a signal value based on the one or more signals meets a predefined threshold; and generate the annotation including the at least one visual property based on whether the signal value meets the predefined threshold.

12. The medical system of any of claims 1 through 11, wherein the processing circuitry is configured to: determine a cumulative effect of ablation energy during the period of application of ablation energy; and modify the at least one visual property of the annotation based on the cumulative effect of ablation energy.

13. The medical system of any of claims 1 through 12, wherein the one or more signals is a first set of one or more signals for a first time period; and wherein the processing circuitry is configured to:receive a second set of one or more signals for a second time period after the first time period from the one or more sensors; and modify, based on the second set of one or more signals, the at least one visual property of the annotation.

14. The medical system of claim 13, wherein to modify the at least one visual property of the annotation based on the second set of one or more signals, the processing circuitry is configured to: determine whether a difference between the first set and the second set of one or more signals meets a predefined signal difference threshold; and modify the at least one visual property of the annotation based on whether the difference between the first set and the second set of one or more signals meets the predefined signal difference threshold.

15. The medical system of claim 13, wherein to modify the at least one visual property of the annotation based on the second set of one or more signals, the processing circuitry is configured to: determine a time between receiving the first set of signals and the second set of signals; determine a thermal recovery of the tissue based on the time; and modify the at least one visual property of the annotation based on the determined thermal recovery of the tissue.

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