Accurate positioning and shape visualization of balloon catheter ablation tags

Information

  • Patent Grant
  • 12137967
  • Patent Number
    12,137,967
  • Date Filed
    Tuesday, October 27, 2020
    4 years ago
  • Date Issued
    Tuesday, November 12, 2024
    a month ago
Abstract
Embodiments of the present invention include generating a 3D model of a body cavity, and receiving, from a position transducer associated with a medical probe configured to be inserted into the cavity and having at least one elongated electrode disposed along a distal end of the probe, signals indicating orientation and location coordinates of the distal end within the body cavity. Based on the model and the signals, while parts of the given electrode other than the identified segment are not in contact with the inner surface of the cavity, a segment along a length of a given electrode that is in contact with tissue at a site on an inner surface of the cavity is identified. A graphical representation of the model with a visual marker at a location on the model corresponding to the site contacted by the segment of the given electrode is rendered to a display.
Description
FIELD OF THE INVENTION

The present invention relates generally to medical imaging, and specifically to visualizing an area of tissue in contact with an ablation electrode.


BACKGROUND OF THE INVENTION

Arrhythmias are abnormal heart rhythms that are typically caused by a small area of cardiac tissue that produces irregular heartbeats. Cardiac ablation is a medical procedure that can be performed to treat an arrhythmia by destroying the area of the cardiac tissue causing the irregular heartbeats.


In some instances, cardiac ablation can be performed using a balloon catheter. A balloon catheter comprises an inflatable balloon at its distal end that can be inflated and deflated as necessary. The balloon typically comprises multiple electrodes configured to deliver ablation energy to tissue in contact with the electrodes. The balloon is typically deflated while the catheter is inserted into a body cavity (e.g., a heart) of a patient, inflated in order to perform the necessary procedure, and deflated again upon completing the procedure.


U.S. Pat. No. 6,514,249 to Maguire et al., describes a positioning system for orienting an ablation element within a pulmonary vein ostium. The system includes a position monitoring assembly that can be used to position a circumferential ablation member along a circumferential region of tissue at a location where a pulmonary vein extends from a left atrium.


U.S. Patent Application 2008/0275300 to Rothe et al., describes a complex shape steerable tissue visualization and manipulation catheter. The catheter includes a steering mechanism that can adjust a position of a visualization hood or membrane through which underlying tissue may be visualized.


The description above is presented as a general overview of related art in this field and should not be construed as an admission that any of the information it contains constitutes prior art against the present patent application.


SUMMARY OF THE INVENTION

There is provided, in accordance with an embodiment of the present invention, an apparatus including an invasive medical probe configured to be inserted into a body cavity and including a distal end having at least one elongated electrode disposed along the distal end, a position transducer associated with the medical probe, a memory configured to store a three-dimensional (3D) model of the body cavity, a display, and a processor configured to receive, from the position transducer, signals indicative of orientation and location coordinates of the distal end within the body cavity, to identify, based on the 3D model and the signals, a segment along a length of a given elongated electrode that is in contact with tissue at a site on an inner surface of the body cavity, while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity, and to render to the display a graphical representation of the 3D model with a visual marker at a location on the 3D model corresponding to the site contacted by the segment of the given elongated electrode.


In some embodiments, the at least one elongated electrode is disposed longitudinally along the distal end of the medical probe.


In an additional embodiment, the invasive medical probe may also include an inflatable balloon that extends from a lumen in the distal end of the medical probe. In one embodiment, the at least one elongated electrode is disposed longitudinally on a surface of the balloon.


In another embodiment, the apparatus may also include an ablation module configured to deliver ablation energy to the at least one elongated electrode, thereby ablating the tissue that is in contact with the at least one electrode. In one embodiment, the visual marker corresponds to the site ablated by the segment of the given elongated electrode.


In a supplemental embodiment, processor can be configured, to receive, prior to receiving the signals, 3D model data for the body cavity, and to generate, using the 3D model data, the 3D model. In some embodiments, wherein the 3D model data can be selected from a list consisting of anatomical mapping data, computed tomography data, magnetic resonance imaging data and ultrasound data.


In a further embodiment, the processor can be configured to determine, based on the 3D model and the signals, an engagement contour of the segment along the length of the given elongated electrode that is in contact with the tissue, and wherein the processor is configured to render the visual marker at a location on the 3D model by presenting, at the location on the 3D model, a visual marker contour corresponding to the engagement contour.


There is also provided, in accordance with an embodiment of the present invention, a method including generating a three-dimensional (3D) model of a body cavity, receiving, from a position transducer associated with a medical probe configured to be inserted into the body cavity and including a distal end having at least one elongated electrode disposed along the distal end, signals indicative of orientation and location coordinates of the distal end within the body cavity, identifying, based on the 3D model and the signals, a segment along a length of a given elongated electrode that is in contact with tissue at a site on an inner surface of the body cavity, while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity, and rendering to the display a graphical representation of the 3D model with a visual marker at a location on the 3D model corresponding to the site contacted by the segment of the given elongated electrode.


There is further provided, in accordance with an embodiment of the present invention, a computer software product operated in conjunction with a medical probe configured to be inserted into a body cavity and including a distal end having at least one elongated electrode disposed along the distal end, the product including a non-transitory computer-readable medium, in which program instructions are stored, which instructions, when read by a computer, cause the computer to generate a three-dimensional (3D) model of a body cavity, to receive, from a position transducer associated with the medical probe, signals indicative of orientation and location coordinates of the distal end within the body cavity, to identify, based on the 3D model and the signals, a segment along a length of a given elongated electrode that is in contact with tissue at a site on an inner surface of the body cavity, while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity, and to render to the display a graphical representation of the 3D model with a visual marker at a location on the 3D model corresponding to the site contacted by the segment of the given elongated electrode.





BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure is herein described, by way of example only, with reference to the accompanying drawings, wherein:



FIG. 1 is a schematic, pictorial illustration of a medical system comprising a medical console configured to generate a three-dimensional (3D) model of a body cavity, and a medical probe whose distal end comprises a balloon, in accordance with an embodiment of the present invention;



FIG. 2 is a schematic pictorial illustration of the distal end comprising multiple elongated electrodes mounted on the balloon, in accordance with an embodiment of the present invention;



FIG. 3 is a schematic cutaway view of the distal end of the medical probe, in accordance with an embodiment of the present invention;



FIG. 4 is a schematic pictorial illustration of voxels that can be used to generate a 3D model of the body cavity, in accordance with an embodiment of the present invention;



FIG. 5 is a block diagram showing an example of the 3D model of the body cavity, in accordance with an embodiment of the present invention;



FIG. 6 is a schematic pictorial illustration of voxels that can be used to generate a 3D model of the balloon, in accordance with an embodiment of the present invention;



FIG. 7 is a block diagram showing an example of the 3D model of the balloon, in accordance with an embodiment of the present invention;



FIG. 8 is a flow diagram that schematically illustrates a method of presenting, on the 3D model of the body cavity, visual markers that correspond to engagement areas where the elongated electrodes engage tissue in the body cavity, in accordance with an embodiment of the present invention;



FIGS. 9-11 are schematic pictorial illustrations showing examples of the elongated electrodes engaging tissue in the body cavity, in accordance with an embodiment of the present invention;



FIG. 12 is a schematic pictorial illustration of a graphical representation of the 3D model and the visual markers, in accordance with a first embodiment of the present invention;



FIG. 13 is a schematic pictorial illustration of the graphical representation of the 3D model and the visual markers, in accordance with a second embodiment of the present invention; and



FIG. 14 is a schematic pictorial illustration of the graphical representation of the 3D model and the visual markers, in accordance with a third embodiment of the present invention.





DETAILED DESCRIPTION OF EMBODIMENTS
Overview

Embodiments of the present invention describe a system and a method for presenting visual markers indicating areas of tissue being treated during a medical procedure such as cardiac ablation. As described hereinbelow, the system comprises an invasive medical probe configured to be inserted into a body cavity and comprising a distal end having at least one elongated electrode disposed along the distal end. For example, the medical probe may comprise an intracardiac catheter having a balloon affixed to the distal end, wherein the one or more elongated electrodes are mounted on an outer surface of the balloon


The system also comprises a position transducer associated with the medical probe. In some embodiments, as described hereinbelow, the position transducer may comprise a magnetic field sensor affixed to the distal end of the medical probe.


The system additionally comprises a display and a memory configured to store a three-dimensional (3D) model of the body cavity. In some embodiments, as described hereinbelow, the 3D model may be derived from an anatomical map, computerized tomography (CT) image data, magnetic resonance imaging (MRI) image data, or ultrasound image data.


The system further comprises a processor configured to receive, from the position transducer, signals indicative of orientation and location coordinates of the distal end within the body cavity, and to identify, based on the 3D model and the signals, a segment along a length of the elongated electrode that is in contact with tissue at a site on an inner surface of the body cavity, while parts of the elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity. The processor is also configured to render to the display a graphical representation of the 3D model with a visual marker at a location on the 3D model corresponding to the site contacted by the segment of the elongated electrode.


By identifying respective segments of the elongated electrodes that are engaging tissue on the inner surface of the body cavity, systems implementing embodiments of the invention can aid a medical professional to accurately target areas of tissue for treatment. For example, if the elongated electrodes are configured to deliver ablation energy, systems implementing embodiments of the invention can accurately present the visual markers (e.g., ablation tags) that indicate locations in the tissue where the ablation energy is being delivered by the elongated electrodes during an ablation procedure.


System Description


FIG. 1 is a schematic pictorial illustration of a medical system 20 comprising a medical probe 22 (e.g., an intracardiac catheter) and a control console 24, FIG. 2 is a schematic pictorial illustration of a distal end 26 of the medical probe, and FIG. 3 is a schematic cutaway view of the distal end 26, in accordance with an embodiment of the present invention. System 20 may be based, for example, on the CARTO® system, produced by Biosense Webster Inc. (33 Technology Drive, Irvine, CA 92618 USA). In embodiments described hereinbelow, it is assumed that probe 22 is used for diagnostic or therapeutic treatment, such as performing ablation of heart tissue in a heart 28. Alternatively, probe 22 may be used, mutatis mutandis, for other therapeutic and/or diagnostic purposes in the heart or in other body organs.


Probe 22 comprises an insertion tube 30 and a handle 32 coupled to a proximal end of the insertion tube. By manipulating handle 32, a medical professional 34 can insert probe 22 into a body cavity in a patient 36. For example, medical professional 34 can insert probe 22 through the vascular system of patient 36 so that distal end 26 of probe 22 enters a chamber of heart 28 and engages endocardial tissue at a desired location or locations.


In a first embodiment of the configuration shown in FIG. 1, system 20 uses magnetic position sensing to determine position coordinates indicate a location and an orientation of distal end 26 in a coordinate system 38 comprising an X-axis 40, a Y-axis 42 and a Z-axis 44. To implement magnetic based position sensing, control 24 comprises a driver circuit 46 which drives field generators 48 to generate magnetic fields within the body of patient 36. Typically, field generators 48 comprise coils, which are placed below the patient's torso at known positions external to patient 36. These coils generate magnetic fields in a predefined working volume that contains heart 28.


System 20 also comprises a position transducer 50 that is associated with medical probe 22, and a processor 52 in medical console 24. In embodiments described herein, position transducer 50 comprises a component of medical system 20 that generates and conveys position signals indicating a current position (i.e., location and orientation) of distal end 26, and processor 52 is configured to receive and process the conveyed position signals in order to compute, in coordinate system 38, orientation and location coordinates of distal end 26.


In the first embodiment of the configuration shown in FIG. 1, position transducer 50 comprises a magnetic field sensor within distal end 26 of probe 22. In this embodiment, the magnetic field sensor generates electrical signals in response to the magnetic fields from the coils, thereby enabling console to determine the position of distal end 26 within the chamber.


In this embodiment, system 20 measures the position of distal end 26 using magnetic-based sensors. Magnetic position tracking techniques are described, for example, in U.S. Pat. Nos. 5,391,199, 5,443,489, 6,788,967, 5,558,091, 6,172,499 and 6,177,792. The methods of location sensing described hereinabove are implemented in the above-mentioned CARTO® system and are described in detail in the patents cited above.


In addition to driver circuit 46 and processor 52, control console 24 also comprises a memory 54 and an input/output (I/O) communications interface 56. In embodiments described herein, memory 54 stores a 3D model 58 of heart 28 that processor 52 can generate based on 3D data such as anatomical mapping data received from a mapping catheter, computed tomography (CT) data, magnetic resonance imaging (MRI) data and ultrasound data. In some embodiments, memory 54 can also store a 3D model 60 of distal end 26, as described in the description referencing FIG. 8 hereinbelow.


In operation, I/O communications interface 56 enables control console 24 to receive signals from position transducer 50. Based on signals received from position transducer 50, processor 52 can process these signals in order to determine the position coordinates of distal end 26, typically comprising both location and orientation coordinates. As described in the description referencing FIG. 8 hereinbelow, processor 52 can update 3D model 58 based on the determined position coordinates.


During the procedure, processor 52 can present, to medical professional 34, a graphical representation 62 of 3D model 58 on a display 64. In some embodiments, medical professional 34 can manipulate graphical representation 62 using one or more input devices 66. In alternative embodiments, display 64 may comprise a touchscreen that can be configured to accept inputs from medical professional 34, in addition to presenting graphical representation 62.


Processor 52 may comprise real-time noise reduction circuitry 68 typically configured as a field programmable gate array (FPGA), followed by an analog-to-digital (A/D) signal conversion integrated circuit 70. The processor can be programmed to perform one or more algorithms disclosed herein, each of the one or more algorithms comprising steps described hereinbelow. The processor uses circuitry 68 and circuit 70 as well as features of modules which are described in more detail below, in order to perform the one or more algorithms.


Memory 54 may comprise any suitable volatile and/or non-volatile memory, such as random access memory, a solid-state drive or a hard disk drive.


Medical probe 22 comprises a balloon 72 having multiple elongated electrodes 74 that can be used to ablate tissue in a body cavity such as heart 28. Balloon 72 and electrodes 74 are described in the description referencing FIG. 2 hereinbelow.


Control console 24 further comprises an irrigation module that controls the inflation of balloon 72 and an ablation module 78 that controls the delivery of ablation energy to elongated electrodes 74.


In a second embodiment of the configuration shown in FIG. 1, medical system 20 may use impedance-based location sensing to determine location coordinates of distal end 26 in coordinate system 38. To implement impedance-based location sensing, control console 24 is connected, by a cable 80, to body surface electrodes, which typically comprise adhesive skin patches 82 that are affixed to patient 36. In the configuration shown in FIG. 1, cable 80 also connects field generators 48 to console 24.


Control console 24 also comprises a current tracking module that, in conjunction with processor 52, determines position coordinates of distal end 26 inside heart 28 based on impedances and/or currents measured between adhesive skin patches 82 and electrodes 74. When using impedance-based location sensing to determine location coordinates of distal end 26 in coordinate system 38, position transducer 50 may comprise a selected electrode 74 operating with adhesive patches 82.


Impedance-based and current-based position tracking techniques are described, for example, in U.S. Pat. Nos. 5,983,126, 6,456,864 and 5,944,022. The methods of position sensing described hereinabove are implemented in the above-mentioned CARTO® system and are described in detail in the patents cited above.


In operation, irrigation module 76 can use irrigation fluid to inflate balloon 72, and can control the inflation of the balloon by controlling a flow rate of the irrigation fluid into the balloon. Balloon 72 is typically formed from bio-compatible material such as polyethylene terephthalate (PET), polyurethane, Nylon, or Pebax. In some embodiments, balloon 72 may comprise multiple small fenestrations (not shown) that allow the irrigation fluid to exit the balloon. These fenestrations are typically 0.025-0.500 millimeters in diameter.


Ablation module 78 is configured to monitor and control ablation parameters such as the level and the duration of ablation power (e.g., radio-frequency energy) conveyed to elongated electrodes 74 via I/O interface 56.


In the configuration shown in FIG. 2, balloon 72 comprises elongated electrodes 74 that are disposed longitudinally on the exterior surface of the balloon, and the balloon is affixed to a tubular shaft 90. Balloon 72 is configured to extend from a distal end of a lumen 92 of insertion tube 30, and the balloon can be deployed through the lumen into a body cavity such as heart 28. For simplicity, connections of elongated electrodes 74 to I/O interface 56 and ablation module 78 are not shown. In some embodiments, the connections are made by wires (not shown) running from the inside of the balloon to the outer surface of the balloon. The electrical connections can be formed with conductive epoxy or welding.


Elongated electrodes 74 can be fabricated with the balloon and typically comprise gold overlaying the exterior wall of balloon 72. In embodiments of the present invention, the elongated electrodes have respective lengths 94 that are at least twice as long as their respective widths 96.


As shown in FIG. 3, medical probe 22 also comprises an extender shaft 100 that is contained within tubular shaft 90, and is coupled to a distal end 102 of balloon 72. In operation, medical professional 34 can control a length 104 of balloon 72 (i.e., once the balloon is deployed from the lumen) by extending or retracting extender shaft 100 and the operator can control a width 106 of the balloon by specifying, to irrigation module 76, the flow rate of the irrigation fluid into the balloon.


In the configuration shown in FIG. 3, a magnetic field sensor 108 that is affixed to extender shaft 100 acts as a position transducer. In operation, processor 52 can process signals received from magnetic field sensor 108 in order to determine, in coordinate system 38, location coordinates of the magnetic field sensor. In some embodiments, as described hereinbelow, processor 52 can determine the current shape of balloon 72 (e.g., length 104 and width 106) based on the determined location coordinates that indicate the length of the balloon and the irrigation fluid flow rate that (i.e., combined with the current length of the balloon) indicates the current width of the balloon.


As shown in FIG. 3, Balloon 72 has a generally spherical shape when inflated. During a medical procedure, medical professional 34 may maneuver distal end 26 so that balloon 72 engages tissue 110 in a body cavity (e.g., heart 28) of patient 36. Balloon 72 can typically retain its generally spherical shape (and not have any distortion in the generally spherical shape) if a force 112 of the irrigation fluid on an inside surface 114 of the balloon is equal to or greater than a force 116 of tissue 110 on an outer surface 118 of the balloon.


In embodiments described hereinbelow, tissue 110 can be differentiated by appending a letter to the identifying numeral, so that the tissue comprises cardiac tissue 110A in heart 28, ostial tissue 110B in a pulmonary vein ostia 120, and intravenous tissue 110C in a pulmonary vein 122.


While the configuration of medical probe 22 presented in FIGS. 1-3 shows the medical probe comprising a balloon catheter having elongated electrodes 74 mounted on balloon 72, using any other type of medical probe 22 comprising any number of elongated electrodes configured to engage tissue in any body cavity in patient 36 is considered to be within the spirit and scope of the present invention.



FIG. 4 is a schematic pictorial illustration of voxels 130 that processor 52 can use to generate 3D model 58 of heart 28, in accordance with an embodiment of the present invention. In embodiments described herein, voxels 130 correspond to three-dimensional data points within tissue 110.


To generate model 58, processor 52 receives three-dimensional data for tissue 110, and then segments the received three-dimensional data into a set of voxels 130, wherein each given voxel 130 corresponds to a respective set of 3D location coordinates in coordinate system 38. As described supra, examples of the 3D data include anatomical mapping data received from a mapping catheter, computed tomography (CT) data, magnetic resonance imaging (MRI) data and ultrasound data.



FIG. 5 is a block diagram showing an example of 3D model 58, in accordance with an embodiment of the present invention. In the example shown in FIG. 5, model 58 comprises a plurality of tissue coordinate records 140 having a one-to-one correspondence with voxels 130. Each given record 140 comprises a set of 3D coordinates (i.e., in coordinate system 38) 142 for the corresponding voxel 130.



FIG. 6 is a schematic pictorial illustration of voxels 150 that processor 52 can use to generate 3D model 60 of heart balloon 72, in accordance with an embodiment of the present invention. In embodiments described herein, voxels 150 correspond to three-dimensional data points within balloon 72 and elongated electrodes 74.



FIG. 7 is an example of 3D model 60, in accordance with an embodiment of the present invention. In the example shown in FIG. 7, model 60 comprises an electrode definition 160 and a plurality of balloon coordinate records 162 having a one-to-one correspondence with voxels 150. In some embodiments, electrode definition 160 comprises dimensions of electrodes 74.


Each given record 162 comprises a set of 3D coordinates (i.e., in coordinate system 38) 164 for the corresponding voxel 150, and an electrode flag 166. In some embodiments, processor can set electrode flag 166 (e.g., to “True”) in a given record 162 if electrode definition 160 indicates that coordinates 164 in the given record correspond to the coordinates of a given elongated electrode 74.


When balloon 72 is inflated, the location coordinates that processor 52 computes for a given elongated electrode 74 (i.e., based on impedances and/or currents between adhesive skin patches 82 and the given elongated electrode) may comprise the location coordinates of a centroid of the given electrode. The centroid is herein assumed to be on the equator of balloon 72.


As described supra, balloon 72 has a generally spherical shape when inflated. Therefore, processor can use the location coordinates of the centroids of elongated electrodes to “model” balloon 72 so as to identify which voxels 150 correspond to the balloon, as described hereinbelow. In some embodiments, processor 52 can identify which voxels 150 correspond to elongated electrodes 74 based on the location coordinates of the centroids of the electrodes and electrode definition 160.



FIG. 8 is a flow diagram that schematically illustrates a method of presenting, on display 64, visual markers that correspond to location coordinates where elongated electrodes 74 engage an inner surface (i.e., tissue) in a body cavity such as heart 28, in accordance with an embodiment of the present invention. In a first model generation step 170, processor 52 generates 3D model 58. For example, processor 52 can generate 3D model 58 of a body cavity such as heart 28 or a pulmonary vein (as shown in FIGS. 9-11 and described hereinbelow) based on mapping points previously acquired by a mapping catheter (not shown). In some embodiments, processor 52 can augment (and increase the accuracy) of 3D model 58 with 3D image data received from a 3D imaging system such as a computed tomography (CT) scanner, a magnetic resonance imaging (MRI) scanner, or an ultrasound scanner.


In an insertion step 172, medical professional 34 inserts distal end 26 of medical probe 22 into the body cavity. Upon inserting distal end into the body cavity, the medical professional can inflate balloon 72 using methods described hereinabove.


In a positioning step 174, the medical professional manipulates handle 32 so that one or more elongated electrodes 74 engage tissue (e.g., tissue 110) on an inner surface of the body cavity. For example, medical professional can position distal end 26 so that at least one elongated electrode 74 engages tissue 110A in heart 28.


In a receive step 176, processor 52 receives, from position transducer 50, signals indicative of an orientation 196 and location coordinates 198 of distal end 26, and in a computation step 178, the processor computes the orientation and the location coordinates (i.e., in coordinate system 38) of the distal end. In a first location computation embodiment, magnetic field sensor 108 conveys, to processor 52, electrical signals in response to the magnetic fields generated by the coils in field generators 48, and upon receiving the electrical signals, the processor can compute a position (i.e., location coordinates and an orientation) of the magnetic field sensor (and thereby the position of distal end 26) within the body cavity.


In a second location computation embodiment, processor 52 determines location coordinates of distal end 26 inside the body cavity based on impedances and/or currents measured between adhesive skin patches 82 and elongated electrodes 74. As described supra, elongated electrodes 74 are disposed longitudinally on the exterior surface of balloon 72. When balloon 72 is inflated, processor 52 can compute (as described supra) the 3D location coordinates for each given elongated electrode 74 as a centroid of the given electrode. In some embodiments, processor 52 can compute an orientation of distal end 26 based on the 3D location coordinates of electrodes 74.


In a second model generation step 179, processor 52 generates model 60 for balloon 72. Since balloon 72 has a generally spherical shape when inflated and elongated electrodes 74 are disposed on the outer surface of the balloon, processor can compute a center of balloon 72 as an average of the location coordinates corresponding to the respective centroids of elongated electrodes 74, and then compute a radius of the balloon based on the computed center and the location coordinates of the electrodes. Using the computed radius and center, processor 52 can then compute sets of 3D location coordinates for balloon 72 in coordinate system 38, segment the computed sets of 3D location coordinates into a set of voxels 150, and store, to the respective balloon coordinate record 162 for each given voxel 150, the computed 3D location coordinates to coordinates 164.


As described supra, distal end comprises balloon 72 and elongated electrodes 74. Based on the location coordinates for the centroids of elongated electrodes 74 and the dimension information stored in electrode definition 160, processor 52 can compute sets of 3D location coordinates for the electrodes, and set the electrode flags in the balloon coordinate records whose coordinates 164 match any of the computed sets of 3D location coordinates for the electrodes. In other words, processor 52 can identify which voxels 150 correspond to the 3D location coordinates of the elongated electrodes.



FIGS. 9-11 are schematic pictorial illustrations showing examples of elongated electrodes engaging tissue on an inner surface of a body cavity such as heart 28, in accordance with an embodiment of the present invention. As shown in FIGS. 9 and 10, medical professional 34 inserts, via a chamber of heart 28, distal end 26 of medical probe 22 into pulmonary vein 122. Upon inserting balloon 72 into pulmonary vein 122 and extending extender shaft 100 into the pulmonary vein, medical professional 34 inflates (i.e., via irrigation module 76) balloon 72 so that respective segments 192 of one or more elongated electrodes 74 engage intravenous tissue 110C at respective engagement areas 194 (also referred to herein as sites), having respective contours 200, as shown in FIG. 10.


While a given elongated electrode 74 engages intravenous tissue 110C (or any other tissue 110 in a body cavity in patient 36), a given segment 192 of the given elongated electrode engages (i.e., is in contact with) the intravenous tissue at a given engagement area 194 on the intravenous tissue, while parts of the given elongated electrode other than the identified segment are not in contact with the intravenous tissue. In an identification step 180, processor 52 identifies respective segments 192 of the elongated electrodes engaging engagement areas 194 on the intravenous tissue.


In one embodiment, processor 52 can detect engagement areas 194 based on models 58 and 60. In this embodiment, processor 52 can use a collision detection algorithm on coordinate sets 142 and 164 to identify which voxels 150 are within a minimum distance threshold to any voxel 130. The identified voxels correspond to the location coordinates for engagement areas 194.


In the examples shown in FIGS. 9 and 10, medical professional 34 inserted distal end 26 into pulmonary vein 122 at different respective orientations 196. Due to the different orientations 196, the segment of a given elongated electrode 74 that engages intravenous tissue 110C in the example shown in FIG. 9 typically differs from the segment of the given elongated electrode that engages the intravenous tissue in the example shown in FIG. 10.


In some embodiments, as described hereinbelow, medical professional can instruct ablation module 78 to deliver ablation energy to elongated electrodes 74, thereby ablating intravenous tissue at engagement areas 194. In these embodiments, a line 190 connecting all engagement areas 194 may also be referred to as ablation line 190.


While the examples in FIGS. 9 and 10 show balloon 72 deployed in pulmonary vein 122, deploying the balloon in other organs of patient 36 and determining the locations of any tissue engaged by elongated electrodes 74 is considered to be within the spirit and scope of the present invention. For example, FIG. 11 shows segments 192 of elongated electrodes 74 engaging ostial tissue 110B at respective engagement areas 194.


Returning to the flow diagram, in a rendering step 182, processor 52 renders, to display 64, graphical representation 62 of 3D model 58, with visual markers at respective locations in the 3D model corresponding to the engagement areas on intravenous tissue 110C. In some embodiments (as shown in FIGS. 13 and 14 and described hereinbelow), processor 52 can render the visual markers using display contours corresponding to contours 200 of engagement areas 194.



FIG. 12 is a schematic pictorial illustration of graphical representation 62 of 3D model 58 representing heart 28, in accordance with a first embodiment of the present invention. In the first embodiment presented in FIG. 12, processor 52 renders graphical representation 62 with visual markers 210 that have circular display contours and correspond to engagement areas 194 on intravenous tissue 110C. While the example in FIG. 12 shows processor 52 rendering visual markers 210 as circular display contours, presenting the visual markers using other contours is considered to be within the spirit and scope of the present invention.



FIG. 13 is a schematic pictorial illustration of graphical representation 62 of 3D model 58 representing heart 28, in accordance with a second embodiment of the present invention. In the second embodiment presented in FIG. 13, processor 52 renders graphical representation 62 with visual markers 220 that have trapezoidal contours 222 that are similar to contours 200 of their corresponding engagement areas 194.


The examples shown in FIGS. 12 and 13 correspond to orientation 196 of distal end 26 shown in FIG. 9 where the orientation of balloon 72 at the distal end is aligned with pulmonary vein 122. In some embodiments, the orientation of distal end 26 can be considered to be aligned with pulmonary vein 122 when orientation 196 is within 15 degrees of parallel with a section of the pulmonary vein comprising engagement area(s) 194. When balloon 72 is aligned with pulmonary vein 122, visual markers 220 may have similar contours 222, as shown in FIG. 13.



FIG. 14 is a schematic pictorial illustration of graphical representation 62 of 3D model 58 representing heart 28, in accordance with a third embodiment of the present invention. The example shown in FIG. 14 corresponds to orientation 196 of distal end 26 shown in FIG. 10, where the orientation of balloon 72 at the distal end is not aligned with pulmonary vein 122. When balloon 72 is not aligned with pulmonary vein 122, processor 52 can generate visual markers 230 that have differing contours 232 corresponding to contours 200 of their respective engagement areas 194, as shown in the third embodiment.


Returning to the flow diagram, in a first decision step 184, if the engaged intravenous tissue comprises intravenous tissue 110C targeted for ablation, then in an ablation step 186, ablation module 78 conveys ablation energy to elongated electrodes 74, thereby ablating the intravenous tissue engaged by the elongated electrodes. In some embodiments, ablation module 78 can convey ablation energy to elongated electrodes 74 in response to input received from medical professional 34 (e.g., via input devices 66).


In some embodiments, processor 52 can render each given visual marker 210, 220 or 230 in response to ablation module 78 delivering ablation energy to elongated electrodes 74. In these embodiments, the visual markers comprise ablation tags that indicate ablation locations on intravenous tissue 110C.


In a second decision step 188, if the medical procedure is not complete, then the method continues with step 174. If the medical procedure is complete, then the method ends.


Returning to step 184, if the engaged intravenous tissue does not comprise intravenous tissue 110C targeted for ablation, then the method continues with step 188.


It will be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons skilled in the art upon reading the foregoing description and which are not disclosed in the prior art.

Claims
  • 1. An apparatus, comprising: an invasive medical probe configured to be inserted into a body cavity and comprising a distal end having at least one elongated electrode disposed along the distal end;a position transducer associated with the medical probe;a memory configured to store a three-dimensional (3D) model of the body cavity;a display; anda processor configured: to receive, from the position transducer, signals indicative of orientation and location coordinates of the distal end within the body cavity,to identify, based on the 3D model and the signals, a segment along a length of a given elongated electrode that is in contact with tissue at a site on an inner surface of the body cavity, while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity,to determine, based on the 3D model and the signals, an engagement contour of the segment along the length of the given elongated electrode that is in contact with the tissue, the engagement contour being indicative of an alignment between the distal end and the site, andto render to the display a graphical representation of the 3D model with a visual marker contour at a location on the 3D model corresponding to the engagement contour and to the site contacted by the segment of the given elongated electrode.
  • 2. The apparatus according to claim 1, wherein the at least one elongated electrode is disposed longitudinally along the distal end of the medical probe and comprises a width and a length that is at least twice as long as the width.
  • 3. The apparatus according to claim 1, and comprising an inflatable balloon that extends from a lumen in the distal end of the medical probe.
  • 4. The apparatus according to claim 3, wherein the at least one elongated electrode is disposed longitudinally on a surface of the balloon and comprises a width and a length that is at least twice as long as the width.
  • 5. The apparatus according to claim 1, and further comprising an ablation module configured to deliver ablation energy to the at least one elongated electrode, thereby ablating the tissue that is in contact with the at least one electrode.
  • 6. The apparatus according to claim 5, wherein the visual marker corresponds to the site ablated by the segment of the given elongated electrode.
  • 7. The apparatus according to claim 1, wherein the processor is further configured, to receive, prior to receiving the signals, 3D model data for the body cavity, and to generate, using the 3D model data, the 3D model.
  • 8. The apparatus according to claim 7, wherein the 3D model data is selected from a list consisting of anatomical mapping data, computed tomography data, magnetic resonance imaging data and ultrasound data.
  • 9. The apparatus of claim 1, the visual marker contour comprising: a first contour when the distal end and the tissue are aligned; anda second contour, different from the first contour, when the distal end and the tissue are not aligned.
  • 10. A method, comprising: generating a three-dimensional (3D) model of a body cavity;receiving, from a position transducer associated with a medical probe configured to be inserted into the body cavity and comprising a distal end having at least one elongated electrode disposed along the distal end, signals indicative of orientation and location coordinates of the distal end within the body cavity;identifying, based on the 3D model and the signals, a segment along a length of a given elongated electrode that is in contact with tissue at a site on an inner surface of the body cavity, while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity;determining, based on the 3D model and the signals, an engagement contour of the segment along the length of the given elongated electrode that is in contact with the tissue, the engagement contour being indicative of an alignment between the distal end and the site; andrendering to the display a graphical representation of the 3D model with a visual marker contour at a location on the 3D model corresponding to the engagement contour and to the site contacted by the segment of the given elongated electrode.
  • 11. The method according to claim 10, wherein the at least one elongated electrode is disposed longitudinally along the distal end of the medical probe and comprises a width and a length that is at least twice as long as the width.
  • 12. The method according to claim 10, wherein the medical probe comprises an inflatable balloon that extends from a lumen in the distal end of the medical probe.
  • 13. The method according to claim 12, wherein the at least one elongated electrode is disposed longitudinally on a surface of the balloon and comprises a width and a length that is at least twice as long as the width.
  • 14. The method according to claim 10, and further comprising delivering, by an ablation module, ablation energy to the at least one elongated electrodes, thereby ablating the tissue that is in contact with the at least one electrode.
  • 15. The method according to claim 14, wherein the visual marker corresponds to the site ablated by the segment of the given elongated electrode.
  • 16. The method according to claim 10, and comprising receiving, prior to receiving the signals, 3D model data for the body cavity, and to generate, using the 3D model data, the 3D model.
  • 17. The method according to claim 16, wherein the 3D model data is selected from a list consisting of anatomical mapping data, computed tomography data, magnetic resonance imaging data and ultrasound data.
  • 18. The method of claim 10, the visual marker contour comprising: a first contour when the distal end and the tissue are aligned; anda second contour, different from the first contour, when the distal end and the tissue are not aligned.
  • 19. A computer software product, operated in conjunction with a medical probe configured to be inserted into a body cavity and comprising a distal end having at least one elongated electrode disposed along the distal end, the product comprising a non-transitory computer-readable medium, in which program instructions are stored, which instructions, when read by a computer, cause the computer: to generate a three-dimensional (3D) model of a body cavity;to receive, from a position transducer associated with the medical probe, signals indicative of orientation and location coordinates of the distal end within the body cavity;to identify, based on the 3D model and the signals, a segment along a length of a given elongated electrode that is in contact with tissue at a site on an inner surface of the body cavity, while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity;to determine, based on the 3D model and the signals, an engagement contour of the segment along the length of the given elongated electrode that is in contact with the tissue, the engagement contour being indicative of an alignment between the distal end and the site; andto render to the display a graphical representation of the 3D model with a visual marker contour at a location on the 3D model corresponding to the engagement contour and to the site contacted by the segment of the given elongated electrode.
  • 20. The computer software product of claim 19, the visual marker contour comprising: a first contour when the distal end and the tissue are aligned; anda second contour, different from the first contour, when the distal end and the tissue are not aligned.
PRIORITY

This application claims the benefits of priority under the Paris Convention as well as 35 USC § 119 from earlier filed U.S. Provisional Patent Application Ser. No. 62/934,331 filed on Nov. 12, 2019, titled “Accurate Positioning and Shape Visualization of Balloon Catheter Ablation Tags” which is hereby incorporated by reference as if set forth verbatim.

US Referenced Citations (263)
Number Name Date Kind
D123782 Paul Dec 1940 S
3316896 Louis May 1967 A
4276874 Wolvek et al. Jul 1981 A
4587975 Salo et al. May 1986 A
4709698 Johnston et al. Dec 1987 A
4805621 Heinze et al. Feb 1989 A
5178957 Kolpe et al. Jan 1993 A
5391199 Ben-Haim Feb 1995 A
5429617 Hammersmark et al. Jul 1995 A
5443489 Ben-Haim Aug 1995 A
5558091 Acker et al. Sep 1996 A
5582609 Swanson et al. Dec 1996 A
5584830 Ladd et al. Dec 1996 A
5702386 Stern et al. Dec 1997 A
5718241 Ben-Haim et al. Feb 1998 A
5797903 Swanson et al. Aug 1998 A
5860974 Abele Jan 1999 A
5944022 Nardella et al. Aug 1999 A
5971983 Lesh Oct 1999 A
5983126 Wittkampf Nov 1999 A
6012457 Lesh Jan 2000 A
6024740 Lesh et al. Feb 2000 A
6042580 Simpson Mar 2000 A
6123718 Tu et al. Sep 2000 A
6164283 Lesh Dec 2000 A
6171275 Webster, Jr. Jan 2001 B1
6172499 Ashe Jan 2001 B1
6176832 Habu et al. Jan 2001 B1
6177792 Govari et al. Jan 2001 B1
6198974 Webster, Jr. Mar 2001 B1
6226542 Reisfeld May 2001 B1
6301496 Reisfeld Oct 2001 B1
6322558 Taylor et al. Nov 2001 B1
6380957 Banning Apr 2002 B1
6402740 Ellis et al. Jun 2002 B1
D462389 Provence et al. Sep 2002 S
6456864 Swanson et al. Sep 2002 B1
6471693 Carroll et al. Oct 2002 B1
6514249 Maguire et al. Feb 2003 B1
6522930 Schaer et al. Feb 2003 B1
6656174 Hegde et al. Dec 2003 B1
6788967 Ben-Haim et al. Sep 2004 B2
6814733 Schwartz et al. Nov 2004 B2
6893433 Lentz May 2005 B2
6986744 Krivitski Jan 2006 B1
6987995 Drysen Jan 2006 B2
6997924 Schwartz et al. Feb 2006 B2
7142903 Rodriguez et al. Nov 2006 B2
7156816 Schwartz et al. Jan 2007 B2
7274957 Drysen Sep 2007 B2
7340307 Maguire et al. Mar 2008 B2
7377906 Selkee May 2008 B2
7442190 Abbound et al. Oct 2008 B2
7536218 Govari et al. May 2009 B2
7591799 Selkee Sep 2009 B2
7593760 Rodriguez et al. Sep 2009 B2
7720517 Drysen May 2010 B2
7756576 Levin Jul 2010 B2
7842031 Abboud et al. Nov 2010 B2
7853302 Rodriguez et al. Dec 2010 B2
8000765 Rodriguez et al. Aug 2011 B2
8021327 Selkee Sep 2011 B2
8048032 Root et al. Nov 2011 B2
8231617 Satake Jul 2012 B2
8267932 Baxter et al. Sep 2012 B2
8275440 Rodriguez et al. Sep 2012 B2
8348888 Selkee Jan 2013 B2
8357152 Govari et al. Jan 2013 B2
D682289 Dijulio et al. May 2013 S
D682291 Baek et al. May 2013 S
D690318 Kluttz et al. Sep 2013 S
D694652 Tompkin Dec 2013 S
8641709 Sauvageau et al. Feb 2014 B2
8721590 Seward et al. May 2014 B2
8777161 Pollock et al. Jul 2014 B2
D716340 Bresin et al. Oct 2014 S
8852181 Malecki et al. Oct 2014 B2
D720766 Mandal et al. Jan 2015 S
D721379 Moon et al. Jan 2015 S
D724618 Shin Mar 2015 S
8998893 Avitall Apr 2015 B2
D729263 Ahn et al. May 2015 S
9089350 Willard Jul 2015 B2
D736780 Wang Aug 2015 S
9126023 Sahatjian et al. Sep 2015 B1
D740308 Kim et al. Oct 2015 S
D743424 Danielyan et al. Nov 2015 S
D744000 Villamor et al. Nov 2015 S
9173758 Brister et al. Nov 2015 B2
D747742 Fan et al. Jan 2016 S
D750644 Bhutani et al. Mar 2016 S
9283034 Katoh et al. Mar 2016 B2
9289141 Lowery et al. Mar 2016 B2
D753690 Vazquez et al. Apr 2016 S
9320631 Moore et al. Apr 2016 B2
9345540 Mallin et al. May 2016 B2
D759673 Looney et al. Jun 2016 S
D759675 Looney et al. Jun 2016 S
D764500 Wang Aug 2016 S
D765709 Gagnier Sep 2016 S
D767616 Jones et al. Sep 2016 S
D768696 Gagnier Oct 2016 S
D783037 Hariharan et al. Apr 2017 S
9655677 Salahieh et al. May 2017 B2
D791805 Segars Jul 2017 S
9795442 Salahieh et al. Oct 2017 B2
9907610 Beeckler et al. Mar 2018 B2
9956035 Govari et al. May 2018 B2
10413185 Boveja et al. Sep 2019 B1
D861717 Brekke et al. Oct 2019 S
10688278 Beeckler et al. Jun 2020 B2
10751121 Govari et al. Aug 2020 B2
20010031961 Hooven Oct 2001 A1
20020002369 Hood Jan 2002 A1
20020065455 Ben-Haim et al. May 2002 A1
20020068931 Wong et al. Jun 2002 A1
20020077627 Johnson et al. Jun 2002 A1
20020160134 Ogushi et al. Oct 2002 A1
20030018327 Truckai et al. Jan 2003 A1
20030028183 Sanchez et al. Feb 2003 A1
20030050637 Maguire et al. Mar 2003 A1
20030060820 Maguire et al. Mar 2003 A1
20030144658 Schwartz et al. Jul 2003 A1
20040122445 Butler et al. Jun 2004 A1
20040147920 Keidar Jul 2004 A1
20040225285 Gibson Nov 2004 A1
20050070887 Taimisto et al. Mar 2005 A1
20050119686 Clubb Jun 2005 A1
20060013595 Trezza et al. Jan 2006 A1
20060106375 Werneth et al. May 2006 A1
20060135953 Kania et al. Jun 2006 A1
20070071792 Varner et al. Mar 2007 A1
20070080322 Walba Apr 2007 A1
20070083194 Kunis et al. Apr 2007 A1
20070287994 Patel Dec 2007 A1
20080009700 Dumoulin Jan 2008 A1
20080018891 Hell et al. Jan 2008 A1
20080021313 Eidenschink et al. Jan 2008 A1
20080051707 Phan et al. Feb 2008 A1
20080140072 Stangenes et al. Jun 2008 A1
20080183132 Davies et al. Jul 2008 A1
20080188912 Stone et al. Aug 2008 A1
20080202637 Hector et al. Aug 2008 A1
20080208186 Slater Aug 2008 A1
20080249463 Pappone et al. Oct 2008 A1
20080262489 Steinke Oct 2008 A1
20080275300 Rothe et al. Nov 2008 A1
20080281312 Werneth et al. Nov 2008 A1
20090163890 Clifford et al. Jun 2009 A1
20090182318 Abboud et al. Jul 2009 A1
20090270850 Zhou et al. Oct 2009 A1
20100069836 Satake Mar 2010 A1
20100114269 Wittenberger et al. May 2010 A1
20100204560 Salahieh et al. Aug 2010 A1
20100256629 Wylie et al. Oct 2010 A1
20100324552 Kauphusman et al. Dec 2010 A1
20110118632 Sinelnikov et al. May 2011 A1
20110130648 Beeckler et al. Jun 2011 A1
20110282338 Fojtik Nov 2011 A1
20110295248 Wallace et al. Dec 2011 A1
20110301587 Deem et al. Dec 2011 A1
20110313286 Whayne et al. Dec 2011 A1
20120019107 Gabl et al. Jan 2012 A1
20120029511 Smith et al. Feb 2012 A1
20120065503 Rogers et al. Mar 2012 A1
20120071870 Salahieh et al. Mar 2012 A1
20120079427 Carmichael et al. Mar 2012 A1
20120101413 Beetel et al. Apr 2012 A1
20120101538 Ballakur et al. Apr 2012 A1
20120143177 Avitall Jun 2012 A1
20120143293 Mauch et al. Jun 2012 A1
20120191079 Moll et al. Jul 2012 A1
20120209260 Lambert et al. Aug 2012 A1
20130085360 Grunewald Apr 2013 A1
20130090649 Smith et al. Apr 2013 A1
20130109982 Sato et al. May 2013 A1
20130116550 Ishii et al. May 2013 A1
20130150693 D'Angelo et al. Jun 2013 A1
20130165916 Mathur et al. Jun 2013 A1
20130165941 Murphy Jun 2013 A1
20130165990 Mathur et al. Jun 2013 A1
20130169624 Bourier et al. Jul 2013 A1
20130261692 Cardinal et al. Oct 2013 A1
20130274562 Ghaffari et al. Oct 2013 A1
20130274658 Steinke et al. Oct 2013 A1
20130282084 Mathur et al. Oct 2013 A1
20130318439 Landis et al. Nov 2013 A1
20140012242 Lee et al. Jan 2014 A1
20140018788 Engelman et al. Jan 2014 A1
20140031813 Tellio et al. Jan 2014 A1
20140058197 Salahieh et al. Feb 2014 A1
20140121470 Scharf et al. May 2014 A1
20140148805 Stewart et al. May 2014 A1
20140227437 Deboer et al. Aug 2014 A1
20140243821 Salahieh et al. Aug 2014 A1
20140275993 Ballakur Sep 2014 A1
20140276756 Hill Sep 2014 A1
20140276811 Koblish et al. Sep 2014 A1
20140288546 Sherman et al. Sep 2014 A1
20140330266 Thompson et al. Nov 2014 A1
20140357956 Salahieh et al. Dec 2014 A1
20150005799 Lindquist et al. Jan 2015 A1
20150025532 Hanson et al. Jan 2015 A1
20150025533 Groff et al. Jan 2015 A1
20150057655 Osypka Feb 2015 A1
20150067512 Roswell Mar 2015 A1
20150080883 Haverkost et al. Mar 2015 A1
20150105774 Lindquist et al. Apr 2015 A1
20150112256 Byrne et al. Apr 2015 A1
20150112321 Cadouri Apr 2015 A1
20150119875 Fischell et al. Apr 2015 A1
20150141982 Lee May 2015 A1
20150157382 Avitall et al. Jun 2015 A1
20150216591 Cao et al. Aug 2015 A1
20150216650 Shaltis Aug 2015 A1
20150265329 Lalonde et al. Sep 2015 A1
20150265339 Lindquist et al. Sep 2015 A1
20150265812 Lalonde Sep 2015 A1
20150272667 Govari et al. Oct 2015 A1
20150327805 Ben-Haim Nov 2015 A1
20150341752 Flynn Nov 2015 A1
20160000499 Lennox et al. Jan 2016 A1
20160051321 Salahieh et al. Feb 2016 A1
20160085431 Kim et al. Mar 2016 A1
20160106499 Ogata et al. Apr 2016 A1
20160166306 Pageard Jun 2016 A1
20160175041 Govari et al. Jun 2016 A1
20160196635 Cho et al. Jul 2016 A1
20160256305 Longo et al. Sep 2016 A1
20160374748 Salahieh et al. Dec 2016 A9
20170042614 Salahieh et al. Feb 2017 A1
20170042615 Salahieh et al. Feb 2017 A1
20170080192 Giasolli et al. Mar 2017 A1
20170143359 Nguyen et al. May 2017 A1
20170164464 Weinkam et al. Jun 2017 A1
20170311829 Beeckler et al. Nov 2017 A1
20170311893 Beeckler et al. Nov 2017 A1
20170312022 Beeckler et al. Nov 2017 A1
20170347896 Keyes et al. Dec 2017 A1
20180064495 Hareland Mar 2018 A1
20180074693 Jones et al. Mar 2018 A1
20180110562 Govari et al. Apr 2018 A1
20180125575 Schwartz et al. May 2018 A1
20180256247 Govari et al. Sep 2018 A1
20180280080 Govari et al. Oct 2018 A1
20180333162 Saab Nov 2018 A1
20180368927 Lyons et al. Dec 2018 A1
20190059818 Herrera et al. Feb 2019 A1
20190060622 Beeckler Feb 2019 A1
20190143079 Beeckler et al. May 2019 A1
20190175262 Govari et al. Jun 2019 A1
20190175263 Altmann et al. Jun 2019 A1
20190183567 Govari et al. Jun 2019 A1
20190201669 Govari et al. Jul 2019 A1
20190217065 Govari et al. Jul 2019 A1
20190297441 Dehe et al. Sep 2019 A1
20190298441 Clark et al. Oct 2019 A1
20190365451 Jung, Jr. Dec 2019 A1
20200001054 Jimenez et al. Jan 2020 A1
20200015693 Beeckler et al. Jan 2020 A1
20200085497 Zhang et al. Mar 2020 A1
20200155226 Valls et al. May 2020 A1
20210169567 Govari et al. Jun 2021 A1
Foreign Referenced Citations (61)
Number Date Country
101422637 May 2009 CN
102271607 Dec 2011 CN
102458566 May 2012 CN
203539434 Apr 2014 CN
104244856 Dec 2014 CN
104546117 Apr 2015 CN
105105844 Dec 2015 CN
105473091 Apr 2016 CN
105473093 Apr 2016 CN
0779059 Jun 1997 EP
1790304 May 2007 EP
2749214 Jul 2014 EP
2865350 Apr 2015 EP
2875790 May 2015 EP
3238646 Nov 2017 EP
3238648 Nov 2017 EP
3251622 Dec 2017 EP
3300680 Apr 2018 EP
3315087 May 2018 EP
3332727 Jun 2018 EP
3 372 276 Sep 2018 EP
3 384 852 Oct 2018 EP
3571983 Nov 2019 EP
3586778 Jan 2020 EP
3653153 May 2020 EP
H06261951 Sep 1994 JP
H1176233 Mar 1999 JP
2000504242 Apr 2000 JP
2005052424 Mar 2005 JP
2010507404 Mar 2010 JP
2012024156 Feb 2012 JP
2013013726 Jan 2013 JP
2013031655 Feb 2013 JP
2013078587 May 2013 JP
2013529109 Jul 2013 JP
2014529419 Nov 2014 JP
2015503365 Feb 2015 JP
2015100706 Jun 2015 JP
2015112113 Jun 2015 JP
2015112114 Jun 2015 JP
2015518776 Jul 2015 JP
2016515442 May 2016 JP
2016116863 Jun 2016 JP
2019034119 Mar 2019 JP
0056237 Sep 2000 WO
02102231 Dec 2002 WO
2005041748 May 2005 WO
2008049087 Apr 2008 WO
2011143468 Nov 2011 WO
2013049601 Apr 2013 WO
2013052919 Apr 2013 WO
2013154776 Oct 2013 WO
2014168987 Oct 2014 WO
2015049784 Apr 2015 WO
2016183337 Nov 2016 WO
2016210437 Dec 2016 WO
2017024306 Feb 2017 WO
2017087549 May 2017 WO
2018106569 Jun 2018 WO
2018129133 Jul 2018 WO
2019095020 May 2019 WO
Non-Patent Literature Citations (36)
Entry
Extended European Search Report issued in European Patent Application No. 20 20 6844 dated Mar. 16, 2021.
Angela O., “AF Symposium 2017: First-in-Man Study Shows Promising Results with a Multi-Electrode Radiofrequency Balloon for Paroxysmal AF Treatment,” Cardiac Rhythm News, Jan. 20, 2017, 2 Pages, [Retrieved on Dec. 16, 2020] Retrieved from URL: https://cardiacrhythmnews.com/fist-in-man-study-shows-promising-results-with-a-multi-electrode-radiofrequency-balloon-for-paroxysmal-af-treatment/.
Casella M., et al., “Ablation Index as a Predictor of Long-Term Efficacy in Premature Ventricular Complex Ablation: A Regional Target Value Analysis,” Heart Rhythm Society, Jun. 2019, vol. 16, No. 6, pp. 888-895.
Co-Pending U.S. Appl. No. 14/578,807, filed Dec. 22, 2014, 21 pages.
Das M., et al., “Ablation Index, a Novel Marker of Ablation Lesion Quality: Prediction of Pulmonary Vein Reconnection at Repeat Electrophysiology Study and Regional Differences in Target Values,” Europace, 2017, Published Online May 31, 2016, vol. 19, pp. 775-783.
Dorobantu M., et al., “Oral Anticoagulation During Atrial Fibrillation Ablation: Facts and Controversies,” Cor et Vasa, 2013, Accepted on Dec. 3, 2012, vol. 55, No. 2, pp. e101-e106, Retrieved from URL: https://www.sciencedirect.com/science/article/pii/S0010865012001415.
Extended European Search Report for Application No. EP17168513.4 mailed Sep. 18, 2017, 11 pages.
Extended European Search Report for European Application No. 15201723.2, mailed May 11, 2016, 07 Pages.
Extended European Search Report for European Application No. 17168393.1 mailed Dec. 15, 2017, 12 Pages.
Extended European Search Report for European Application No. 17168518.3, mailed Sep. 20, 2017, 9 Pages.
Extended European Search Report for European Application No. 17173893.3, mailed Nov. 6, 2017, 8 Pages.
Extended European Search Report for European Application No. 17201434.2, mailed Feb. 1, 2018, 10 Pages.
Extended European Search Report for European Application No. 17205876.0, mailed Jun. 1, 2018, 13 Pages.
Extended European Search Report for European Application No. 19177365.4, mailed Nov. 8, 2019, 07 Pages.
Extended European Search Report for European Application No. 19183327.6, mailed Nov. 21, 2019, 8 Pages.
Extended European Search Report for European Application No. 20153872.5, mailed May 7, 2020, 9 Pages.
Extended European Search Report for European Application No. 20195648.9, mailed Feb. 12, 2021, 8 Pages.
Fornell D., “Multi-Electrode RF Balloon Efficient for Acute Pulmonary Vein Isolation,” Diagnostic and Interventional Cardiology, May 17, 2017, 3 Pages, [Retrieved on Dec. 16, 2020] Retrieved from URL: www.dicardiology.com/article/multi-electrode-rf-balloon-efficient-acute-pulmonary-vein-isolation.
Haines D.E., et al., “The Promise of Pulsed Field Ablation,” Dec. 2019, vol. 19, No. 12, 10 pages.
Honarbakhsh S., et al., “Radiofrequency Balloon Catheter Ablation for Paroxysmal Atrial Fibrillation, Radiance Study—a UK experience,” EP Europace, Oct. 2017, vol. 19, No. 1, p. i21, 3 Pages.
International Search Report and Written Opinion for International Application No. PCT/IB2019/052313, mailed Jul. 22, 2019, 8 Pages.
International Search Report and Written Opinion for International Application No. PCT/IB2019/056381, mailed Dec. 17, 2019, 10 pages.
International Search Report and Written Opinion for International Application No. PCT/IB2019/057743, mailed Dec. 6, 2019, 16 Pages.
International Search Report and Written Opinion issued in corresponding International Application No. PCT/IB2019/057742, dated Nov. 28, 2019, 18 Pages.
Nagashima K., et al., “Hot Balloon Versus Cryoballoon Ablation for Atrial Fibrillation,” Circulation: Arrhythmia and Electrophysiology, May 2018, vol. 11, No. 5, e005861, 9 Pages.
Napoli N., et al., “For Atrial Fibrillation Ablation, Newer Anticoagulant Reduces Major Bleeds,” American College of Cardiology, Mar. 19, 2017, 4 Pages, [Retrieved on Jan. 21, 2022] Retrieved from URL: https://www.acc.org/about-acc/press-releases/2017/03/18/08/47/sun-1045am-for-atrial-fibrillation-ablation-newer-anticoagulant-reduces-major-bleeds.
Okano T., et al., “Wire Perforation Causing Cardiopulmonary Arrest During Radiofrequency Hot Balloon Ablation for Pulmonary Vein Isolation,” Journal of Cardiology Cases, Feb. 15, 2019, vol. 19, No. 5, pp. 169-172.
Partial European Search Report for European Application No. 17168393.1 mailed Sep. 13, 2017, 13 Pages.
Partial European Search Report for European Application No. 17205876.0, mailed Feb. 22, 2018, 10 Pages.
Reddy V.Y., et al., “Balloon Catheter Ablation to Treat Paroxysmal Atrial Fibrillation: What is the Level of Pulmonary Venous Isolation?,” Heart Rhythm, Mar. 2008, vol. 5, No. 3, pp. 353-360, 3 Pages.
Winkle R.A., et al., “Atrial Fibrillation Ablation Using Open-Irrigated Tip Radiofrequency: Experience with Intraprocedural Activated Clotting Times ≤ 210 Seconds,” Heart Rhythm, Jun. 2014, Epub Mar. 27, 2014, vol. 11, No. 6, pp. 963-968.
Youtube:, “Intensity™ CX4 Professional E-Stim/ Ultrasound Combo,” Dec. 22, 2015, 1 Page, [Retrieved on Nov. 19, 2020], Retrieved from URL: https://www.youtube.com/watch?v=76s1QKMWJME].
Youtube: “New Interface TactiCath Contact Force Ablation Catheter,” Nov. 26, 2013, 1 Pages, [Retrieved on Nov. 19, 2020], Retrieved from URL: https: /Avww.youtube.com/watch?v=aYvYO8Hpylg].
Search Reported (English translation) dated Mar. 15, 2024, from corresponding Japanese Application No. 2020-187849.
Notice of Reasons for Refusal (English translation) dated Mar. 19, 2024, from corresponding Japanese Application No. 2020-187849.
Decision to Grant Patent (English translation) dated Jul. 2, 2024, from corresponding Japanese Application No. 2020-187849.
Related Publications (1)
Number Date Country
20210137588 A1 May 2021 US
Provisional Applications (1)
Number Date Country
62934331 Nov 2019 US