Presentation of a quality measure for intravascular tissue ablation using a two-dimensional map.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- BIOSENSE WEBSTER (ISRAEL) LTD
- Filing Date
- 2022-08-10
- Publication Date
- 2026-08-03
Smart Images
Figure 0007898995000001 
Figure 0007898995000002 
Figure 0007898995000003
Abstract
Description
Technical Field
[0001] The present invention generally relates to a graphical user interface (GUI) in a medical system, and more particularly, to a method and system for presenting quality metrics of intravascular tissue ablation using a two-dimensional map.
Background Art
[0002] Various techniques for presenting tissue ablation such as pulmonary vein (PV) isolation have been published.
[0003] For example, International Publication No. 2021 / 001338 describes a system, device, and method for guiding an ablation procedure. For example, in one embodiment, a system for guiding ablation includes a processor circuit that communicates with an electrophysiology (EP) catheter having a plurality of electrodes. The EP catheter is positioned near an ablation balloon while being disposed at an ablation site and is used to detect blood flow within a heart chamber by detecting an electrical signal related to dielectric properties. Next, it can be determined whether there is any gap at the interface between the balloon and the ablation site. For example, the processor circuit can determine whether the balloon occludes a target region based on the detected blood flow. Next, the processor outputs a visualization indicating to a display whether the balloon occludes the target region.
[0004] International Publication No. 2020 / 154543 describes a system, device, and method for generating therapeutic annotations for display on a graphical user interface. In some embodiments, the therapeutic annotation may correspond to the position of the tip portion of the catheter relative to the patient's anatomical structure when the treatment is delivered to an anatomical structure. One or more characteristics of the therapeutic annotation may be based at least in part on signals received from sensors distributed around the tip portion of the catheter and / or other characteristic parts of the treatment delivery. The therapeutic annotation may display, alone or in combination with, a three-dimensional surface representation of the anatomical structure, a representation of the catheter, and / or other visual representations such as the treatment contour, the distance from the nearest treatment site and / or the distance from the most recent treatment site, and / or a representation of the gap between two treatment sites. [Overview of the project] [Means for solving the problem]
[0005] Embodiments of the present invention described herein provide a method comprising receiving multiple signals from a plurality of electrodes positioned along the inner circumference of an ablated blood vessel. Based on the multiple signals, one or more quality measures of the ablated blood vessel are generated. A graphical presentation of one or more quality measures is displayed to the user in a two-dimensional (2D) polar coordinate system.
[0006] In some embodiments, the positions of multiple electrodes are selected by the user along the longitudinal axis of the blood vessel, and the display of the graph presentation includes displaying at least a portion of a circle having a radius indicating the selected positions on the inner circumference along the longitudinal axis. In other embodiments, the radius indicates the distance of the selected positions of the multiple electrodes from a small hole in the blood vessel. In yet another embodiment, the ablation generates damage along the inner circumference, and the display of the graph presentation includes displaying at least a portion of a circle in the inner circumference segment where the damage was generated.
[0007] In one embodiment, in response to identifying an additional segment of the inner circumference where no damage has occurred, displaying a graph presentation includes displaying an opening in a circle that indicates the location of the additional segment. In another embodiment, the blood vessels include pulmonary veins (PVs) that carry blood between the patient's heart and lungs, and the signal indicates waves propagating through or along at least a portion of the tissue of the PVs.
[0008] In some embodiments, one or more quality measures each include multiple amplitudes of multiple signals, and displaying a graph presentation includes displaying a vector representing at least one amplitude of the multiple signals. In other embodiments, the coordinate system has an origin, and displaying a graph presentation includes displaying a graphic object at a certain distance from the origin, which indicates the position of one of the electrodes on the inner circumference and along the longitudinal axis of the blood vessel.
[0009] Furthermore, according to one embodiment of the present invention, a system including a processor and a display unit is provided. The processor is configured to (i) receive a plurality of signals from a plurality of electrodes arranged along the inner circumference of an ablated blood vessel, (ii) generate one or more quality measures of the ablated blood vessel based on the plurality of signals, and (iii) generate a graph presentation showing one or more quality measures in a two-dimensional (2D) polar coordinate system. The display unit is configured to display the graph presentation to the user.
[0010] This invention will be more fully understood by considering the following "Modes for Carrying Out the Invention" in conjunction with the drawings. [Brief explanation of the drawing]
[0011] [Figure 1] This is a schematic diagram of a catheter-based tracking and ablation system according to one embodiment of the present invention. [Figure 2A] This is a schematic diagram of a quality scale presented on a graph of ablated pulmonary veins (PV) according to an embodiment of the present invention. [Figure 2B] This is a schematic diagram of a quality scale presented on a graph of ablated pulmonary veins (PV) according to an embodiment of the present invention. [Figure 2C] This is a schematic diagram of a quality scale presented on a graph of ablated pulmonary veins (PV) according to an embodiment of the present invention. [Figure 2D] This is a schematic diagram of a quality scale presented on a graph of ablated pulmonary veins (PV) according to an embodiment of the present invention. [Figure 3] This flowchart schematically illustrates a method for displaying a graphical representation of one or more quality measures of ablated PV according to one embodiment of the present invention. [Modes for carrying out the invention]
[0012] Overview Ablation procedures typically aim to create damage at a predetermined location within the tissue of a patient's organ, for example, to block the propagation of electrophysiological (EP) waves across the organ. After ablation of the tissue, it is important to verify that the damage is continuous, has the desired dimensions, and blocks the EP waves.
[0013] When ablating tubular tissues such as pulmonary veins (PVs) or other blood vessels connected to the patient's heart, verifying the characteristics of the damage and the effectiveness of the procedure is difficult. Specifically, PV isolation procedures are intended to create continuous, ring-shaped damage along the inner circumference of the PV to prevent or minimize arrhythmias such as atrial fibrillation in the patient's heart. Therefore, verifying the characteristics of the damage and the effectiveness of PV isolation is crucial for patient safety.
[0014] Embodiments of the present invention described below provide an improved technique for presenting quality measures of intravascular tissue ablation, such as PV, across a two-dimensional (2D) map. The quality measures indicate the size, shape, and continuity of the injury, as well as the injury's ability to block the propagation of EP waves along the wall of the PV.
[0015] In some embodiments, a system for performing tissue ablation comprises a catheter having one or more expandable distal end assemblies (DEAs). In this embodiment, the catheter comprises (i) an inflatable balloon DEA having an ablation electrode positioned on the outer surface of a balloon and configured to form a wound when positioned in contact with the target tissue, and (ii) a lasso-shaped DEA having a sensing electrode positioned along an expandable arm of a lasso-shaped assembly and configured to detect an EP signal indicating an EP wave propagating through and / or along the wall of the PV when positioned in contact with the PV tissue. In this embodiment, the intended wound is ring- or circular in shape, but may have any other shape of a closed loop.
[0016] In some embodiments, the system comprises a processor and a display unit. The processor is configured to (i) receive multiple signals from each of multiple sensing electrodes of a lasso-shaped DEA arranged along the inner circumference of the ablated PV, (ii) generate one or more quality measures of the ablated PV based on the multiple signals, and (iii) generate a graph presentation showing one or more quality measures in a two-dimensional (2D) polar coordinate system. In some embodiments, the display unit is configured to display the graph presentation to the user of the system (e.g., a physician).
[0017] In some embodiments, the position of the sensing electrode is selected by the user along the longitudinal axis of the PV, and the processor is configured to generate a graph presentation in at least a portion of a circle having a radius indicating the selected position on the inner circumference along the longitudinal axis of the PV. Furthermore, the radius indicates the distance from the small hole in the PV to the selected position of the sensing electrode.
[0018] In some embodiments, in response to identifying a section of the inner circumference in which no damage has been formed, the processor is configured to generate an opening in a circle indicating the location of the aforementioned section in the graph presentation.
[0019] In some embodiments, the quality metric may include, among other things, the amplitude of the detection signal, and the processor is configured to generate a vector indicating the amplitude of the signal at each of one or more of the detection electrodes for graphical presentation.
[0020] The disclosed technology improves the quality of lesions formed in an ablation treatment section performed in a tubular organ. By improving the geometric characteristics of the lesions and the graphical presentation of the quality metric, the disclosed technology aids in obtaining a successful ablation treatment and shortening the time required for ablation verification.
[0021] Description of the System FIG. 1 is a schematic drawing of a catheter-based tracking and ablation system 20 according to an embodiment of the present invention.
[0022] In some embodiments, the system 20 includes a catheter 22, which in this example is a cardiac catheter, and a control console 24. In the embodiments described herein, the catheter 22 may be used for any suitable therapeutic and / or diagnostic purpose, such as detecting electrophysiological (EP) signals, performing electroanatomical (EA) mapping of the tissue of the heart 26, and ablating the target tissue of the heart 26, but is not limited thereto.
[0023] In some embodiments, the console 24 includes a processor 34, which is typically a general-purpose computer, having suitable front-end circuits and interface circuits for receiving signals via the catheter 22 and controlling the other components of the system 20 described herein. The console 24 further includes a user display unit 35 configured to receive the map 27 of the heart 26 and other graphical presentations from the processor 34 and display the map 27 and graphical presentations.
[0024] In some embodiments, map 27 may include any suitable type of two-dimensional (2D) or three-dimensional (3D) anatomical map generated using any suitable technique. For example, the anatomical map may be generated using anatomical images produced by using a suitable medical imaging system, or using fast anatomical mapping (FAM) technology available in the CARTO® system manufactured by Biosense Webster Inc. (Irvine, Calif.), or using any other suitable technique, or any suitable combination of the above.
[0025] Refer to inset 23 here. In some embodiments, before performing the ablation procedure, physician 30 inserts a catheter 22 through the vascular structure of patient 28 lying on a table 29 to perform EA mapping of the target tissue of the heart 26.
[0026] In some embodiments, after performing tissue ablation, the physician 30 positions one or more electrodes 55 (described in detail below) of the catheter 22 in contact with the target tissue to generate an EA map of the ablated tissue. The physician 30 then uses the generated EA map to evaluate the ablation impact and the state of the ablated tissue. These embodiments are described in detail in Figures 2 and 3 below.
[0027] In some embodiments, the catheter 22 comprises a distal end assembly having a balloon 70 and a lasso-shaped assembly referred to herein as a lasso 44. In these embodiments, the balloon 70 has an ablation electrode (not shown) configured to apply one or more ablation pulses to tissue, and the lasso 44 distal to the balloon 70 has a plurality of sensing electrodes 55. In connection with this disclosure and in the claims, the terms “electrode” and “sensing electrode” referred to as the electrode 55 of the lasso 44 are used interchangeably. Non-sensing electrodes are referred herein as “ablation electrodes” connected to the balloon 70, as described in detail below.
[0028] In some embodiments, in response to the detection of an EP signal in the tissue of the heart 26, such as an electrocardiogram (ECG) signal, each sensing electrode 55 is configured to generate one or more signals indicating the detected EP signal. In the embodiment shown in inset 23, a physician 30 inserts the distal end assembly into a pulmonary vein (PV) 51 that carries blood between the heart 26 and lungs (not shown) of a patient 28. The ablation procedure typically requires at least three steps: (i) a first EA mapping using a lasso 44, (ii) tissue ablation using electrodes on a balloon 70, and (iii) a second EA mapping using the lasso 44. Both the lasso 44 and the balloon are expandable and configured to bring one or more of their electrodes into contact with the tissue of the PV 51. This procedure is described in more detail below.
[0029] In some embodiments, based on a first EA mapping, physician 30 determines one or more locations where tissue ablation is intended to be performed. After ablation of the tissue, physician 30 performs a second EA mapping to check whether the ablation yielded the desired result for treating the arrhythmia of the patient's heart 26.
[0030] Refer here to inset 57, which shows a side view of PV51 and the lasso 44 inserted along the longitudinal axis 59 of PV51. Note that the balloon 70, configured to ablate the tissue of PV51 and connected to the catheter 22 proximal to the lasso 44, is not shown in inset 57.
[0031] In some embodiments, during the ablation procedure, the physician 30 inserts the lasso 44 through the small holes 54 of the PV 51 to perform the detection and tissue ablation action described above. The physician 30 moves the lasso 44 along the longitudinal axis 59 and, once the desired position is obtained, uses a manipulator 32 to expand the lasso 44 so that one or more electrodes 55 of the lasso 44 are in contact with the surface of the inner circumference 62 of the PV 51.
[0032] Refer here to inset 50, a plan view of the lasso 44. In some embodiments, the lasso 44 comprises (i) a flexible arm 52 controlled by a manipulator 32, which (a) expands to conform to the surface of the inner circumference 62 of the PV 51 and (b) deflates to move the lasso 44 within the heart 26 and vascular structure of the patient 28, and (ii) a plurality of electrodes 55 connected to the arm 52 and configured (in embodiments of the present invention) to detect an EP signal and / or ablate the surface of the inner circumference 62 of the PV 51. Note that the electrodes 55 are configured to detect an EP signal, and the electrodes of the balloon 70 (not shown) are configured to apply ablation pulses to the tissue of the inner circumference 62 of the PV 51.
[0033] Here again, refer to inset 23. In some embodiments, physician 30 uses a manipulator 32 to insert the catheter 22 through the sheath 25, to manipulate the catheter 22, and to position the lasso 44 and the distal end of the sheath 25 very close to the small hole 54 of the PV 51. The physician 30 then uses the manipulator 32 to retract the sheath 25 in order to expose and move the balloon 70 and lasso 44 to the desired position within the PV 51. During the first EA mapping, physician 30 applies the manipulator 32 to extend the arm 52, thereby positioning at least some of the electrodes 55 in contact with the surface of the inner circumference 62 of the PV 51. Note that the positioning of the balloon 70 and lasso 44 within the PV 51 is performed using a position tracking system which is described in detail below.
[0034] In some embodiments, after positioning and extending the lasso 44 at a desired location(s) on the PV51, the physician 30 performs a first EA mapping before performing tissue ablation. It should be noted that based on the first EA mapping, the processor 34 may generate and display the first EA map on the display unit 35, and based on the first EA map, the physician 30 may define the ablation site(s) along the inner circumference 62 of the PV51. In this embodiment, the ablation procedure includes a PV isolation procedure in which the tissue on the inner circumference 62 of the PV51 is ablated by the electrodes of the balloon 70 at the target location defined by the physician 30 based on the first EA mapping. The PV isolation is intended to form damage to the tissue in order to prevent or minimize (to a level below the threshold) the propagation of EP waves through and / or along the tissue of the tissue on the inner circumference 62 of the PV51.
[0035] In other words, the term "PV isolation" means blocking EP waves from propagating through and / or along the PV51 wall.
[0036] In some embodiments, in a second EA mapping performed after tissue ablation, the physician 30 moves the lasso 44 along the longitudinal axis 59 and selects one or more positions in which the physician extends the lasso 44 to detect EP signals at the ablation site and also at additional positions, typically along the PV 51. In this embodiment, the ablation pulse is applied to the inner circumference 62 tissue located very close to or directly adjacent to the pore 54, and the second EA mapping is performed at multiple positions along the longitudinal axis 59, between the pore 54 and the PV 51, approximately 2 cm apart.
[0037] In some embodiments, when performing a second EA mapping, the physician 30 checks one or more quality measures of the ablated PV51. One representative quality measure may include the amplitude of the EP signal (e.g., voltage) detected by each electrode 55. The detected EP signal indicates either propagation or blockage of EP waves at the ablated site of PV51. In other words, the second EA mapping checks whether the ablation has achieved the desired electrical isolation of the PV51, thereby the measured amplitude may have a very low value (e.g., zero to about 10 microvolts).
[0038] In some embodiments, once the ablation has achieved the desired level of PV isolation, the physician 30 terminates the ablation procedure by retracting the lasso 44 from the PV 51, inserting the lasso 44 into the sheath 25, and withdrawing the catheter 22 from the patient's body 28. If the amplitude of the detected EP voltage is greater than a predetermined threshold at one or more locations along the inner circumference 62, the physician 30 may need to perform an additional ablation session to obtain the desired level of PV isolation as measured by the amplitude of the detected EP voltage or by any other preferred measured parameter. After performing tissue ablation using the balloon 70, the physician 30 typically repeats a second EA mapping to confirm that the desired level of PV isolation has been achieved.
[0039] Here again, we refer to the overall view of Figure 1. In some embodiments, the proximal end of the catheter 22 is connected, among other things, to an interface circuit (not shown) which transmits and stores the detected EP signals to the memory 38 of the console 24, thereby allowing the processor 34 to use the stored EP signals to perform EA mapping. In some embodiments, based on the detected EP signals, the processor 34 is configured to present a 2D map or a 3D map to the physician 30 (for example, on the display unit 35). Furthermore, the processor 34 is configured to present a graphical representation of one or more of the above quality measures on the 2D map or 3D map.
[0040] In the context of this disclosure and the claims, any numerical or numerical range term "about" or "approximately" indicates a suitable dimensional tolerance that enables a portion or set of components to function in accordance with its intended purpose as described herein.
[0041] In other embodiments, the catheter 22 may have devices other than the balloon 70 for ablating tissue at one or more desired locations along the inner circumference 62 in order to perform the aforementioned PV isolation. Additionally or alternatively, the physician 30 may use a separate catheter for tissue ablation of the PV 51.
[0042] In some embodiments, the position of the distal end assembly within the cardiac cavity and along PV51 is measured using a position sensor 39 of a magnetic position tracking system, which can be connected to the distal end assembly at any preferred position. In this embodiment, the console 24 includes a drive circuit 41, which is configured to drive a magnetic field generator 36 located at a known external position outside the patient 28 lying on the table 29, for example, under the patient's torso. As described above, the position sensor 39 is connected to the distal end and configured to generate a position signal in response to the external magnetic field detected from the field generator 36. The position signal indicates the position of the distal end of the catheter 22 in the coordinate system of the position tracking system.
[0043] This position detection method has been implemented in various medical applications, for example, in the CARTO® system manufactured by Biosense Webster Inc. (Irvine, Calif.), and is described in detail in U.S. Patents 5,391,199, 6,690,963, 6,484,118, 6,239,724, 6,618,612 and 6,332,089, International Publication 96 / 05768, and U.S. Patent Application Publications 2002 / 0065455(A1), 2003 / 0120150(A1) and 2004 / 0068178(A1), all of which are incorporated herein by reference.
[0044] In some embodiments, the coordinate system of the position tracking system is correctly aligned with the coordinate system of system 20 and map 27, so that the processor 34 is configured to display the position of the lasso 44 and / or balloon 70 of the distal end assembly across an anatomical map or EA map (e.g., map 27).
[0045] In some embodiments, the processor 34 is assembled into a suitable computer, which typically includes a general-purpose processor, programmed in software to perform the functions described herein. The software may be downloaded to the computer in electronic form, for example, over a network, or alternatively or additionally, the software may be provided and / or stored in a non-temporary physical medium such as magnetic memory, optical memory, or electronic memory.
[0046] This particular configuration of System 20 is shown as an example to illustrate the specific problems addressed by embodiments of the present invention and to demonstrate the applicability of these embodiments in improving the performance of such systems. However, embodiments of the present invention are by no means limited to this particular type of representative system, and the principles described herein may also be applied to other types of medical systems.
[0047] In other embodiments, the system 20 may have one or more other suitable types of catheters configured to perform the above-mentioned detection and ablation in the PV51, or in any other type of blood vessel, or in any other organ or segment of an organ having a tubular shape or any other shape, instead of or in addition to the lasso 44 and / or balloon 70.
[0048] One or more quality metrics of the ablated PV tissue are presented on a 2D map. Figure 2A is a schematic drawing of a 2D map 61 of PV51 according to one embodiment of the present invention.
[0049] In some embodiments, the map 61 includes a polar coordinate system having an origin 58 that indicates the longitudinal axis 59 of PV51. In such embodiments, the small hole 54 is represented by a circle 53, and a circle 56 represents a second position located approximately 2 cm toward PV51 along the longitudinal axis 59, as shown in Figure 1 above.
[0050] In other embodiments, at least one of the circles 53 and 56 may have an elliptical shape or any other preferred shape instead of a circular shape.
[0051] In some embodiments, the texture of the inner circumference 62 of PV51 is represented by gray donut-shaped elements defined between circles 53 and 56. Note that the polar coordinate system allows for a 2D presentation of the 3D shape of PV51 in map 61, and the distance from the origin 58 indicates the position of any element described herein along the longitudinal axis 59 of PV51.
[0052] In this embodiment, map 61 represents the field of view from a cavity of the heart 26 (e.g., the left atrium) to PV51, so that circle 53 (representing the small hole 54) appears larger than circle 56, which is located approximately 2 cm to PV51 along the longitudinal axis 59.
[0053] Figure 2B is a schematic diagram of the PV isolation state displayed on a 2D map 71 of PV51 according to one embodiment of the present invention.
[0054] In some embodiments, map 71 is based on map 61 in Figure 2A above and includes a circle 77 indicating the isolation level of PV51 based on the EP signal received from electrode 55 of lasso 44.
[0055] In some embodiments, the position of the electrode 55 is selected by the physician 30 (or any other user of the system 20) along the longitudinal axis 59 of the PV 51. In some embodiments, the processor 34 is configured to display at least a portion of a circle having a radius indicating the selected position of the electrode 55 on the inner circumference 62 along the longitudinal axis 59 of the PV 51.
[0056] In the embodiment shown in Figure 2B, the second EA mapping after ablation (described in detail in Figure 1 above) is performed at a distance of approximately 1.8 cm (along the longitudinal axis 59) from the small hole 54, and therefore appears very close to the circle 56, for example, at a distance of approximately 0.2 cm from the circle 56.
[0057] In some embodiments, tissue ablation generates damage along the inner circumference 62, and the processor 34 is configured to generate a circle 77 indicating a quality measure associated with the damage formed during ablation. In some embodiments, the continuity of the circle 77 indicates damage capability that blocks the propagation of EP waves through and / or along the tissue of PV 51.
[0058] In some embodiments, the processor 34 is configured to present at least a portion of the circle in a selected segment of the inner circumference 62 where damage is generated. In this embodiment, the damage completely or completely blocks the EP wave, thereby making the circle 77 complete and continuous (shown by a solid line).
[0059] It should be noted that the 2D presentation of map 71 provides physician 30 with (i) immediate visualization of the location where the second EA mapping was performed, and (ii) immediate visualization of whether the damage is continuous and whether it blocks the propagation of EP waves through and / or along the tissue of PV 51. In other words, the radius and shape of circle 77 provide physician 30 with an indicator of the location of the sensing electrode 55 and the isolation level of PV 51.
[0060] Figure 2C is a schematic diagram of the PV isolation state displayed on a 2D map 81 of PV51 according to one embodiment of the present invention.
[0061] In some embodiments, map 81 is based on map 61 in Figure 2A above and includes a circle 66 indicating the position of the sensing electrode 55 and the isolation level of PV 51. Furthermore, the circle 66 is based on the EP signal received from the electrode 55 of the lasso 44.
[0062] In some embodiments, the radius of circle 66 (from the origin 58) is a dimension between the dimensions of circles 53 and 56. This presentation shows that the electrode 55 of the lasso 44 is positioned along the longitudinal axis 62 at a distance of about 1 cm from the small hole 51.
[0063] In some embodiments, in response to identifying a given section of the inner circumference 62 in which no damage has been generated, the processor 34 is configured to generate an opening in a circle in the graph presentation indicating the location of the given section. In the embodiment of Figure 2C, the circle 66 has an opening 67 indicating an incomplete or undamaged configuration. Thus, the opening 67 indicates insufficient blocking of EP wave propagation through and / or along the tissue of PV 51, or of EP wave propagation across the surface of the inner circumference 62.
[0064] In some embodiments, based on the position of the opening 67, the physician 30 may decide to (i) perform ablation at one or more preferred locations on the surface of the inner circumference 62 of the PV 51, and then (ii) re-run the EA mapping shown in Figure 1 as a “second” EA mapping. The physician 30 may apply this to one or more iterations until the processor 34 displays a circle 66 of a complete and continuous shape.
[0065] In the first embodiment, physician 30 may decide to repeat the PV isolation procedure by applying one or more ablation pulses to selected electrodes of balloon 70 positioned in contact with the tissue on the inner circumference 62 of PV 51. In the second embodiment, physician 30 may repeat the PV isolation procedure by applying one or more ablation pulses to only one or more selected electrodes of balloon 70 in contact with the tissue at a location(s) where a desired injury and “closed” opening 67 can be formed. In the third embodiment, physician 30 may navigate a focal ablation catheter (not shown) and apply ablation pulses to one or more preferred locations where a complete injury and “closed” opening 67 can be formed. In the context of this disclosure, the term “closed opening 67” means the formation of a complete injury at a selected periphery of PV 51 in order to obtain the required level of isolation of PV 51. In the embodiment of Figure 2C, after PV isolation is obtained, the processor 34 is configured to display a complete circle with the opening 67 closed by a solid line, for example, as shown in circle 77 in Figure 2B above.
[0066] In some embodiments, the processor 34 may maintain a threshold indicating the voltage level of the amplitude of the EP signal measured by each electrode 55 during the EA mapping procedure. If the voltage is below the threshold, the circle 66 remains a solid line and continuous. Similarly, if the voltage measured by each one or more electrodes 55 is above the threshold, the processor 34 may present an opening, such as an opening 67, in one or more corresponding sections of the circle 66.
[0067] Figure 2D is a schematic diagram of the PV isolation state displayed on a 2D map 91 of PV51 according to another embodiment of the present invention.
[0068] In some embodiments, map 91 is based on map 61 in Figure 2A above and includes a circle 99 and points 61, which indicate the positions of the arm 52 and the sensing electrode 55 on the surface of the inner circumference 62 of PV 51, respectively.
[0069] In some embodiments, the processor 34 is configured to generate a vector representing at least one amplitude of a plurality of EP signals in the graphical presentation of the map 91. In this embodiment, the processor 34 generates and presents the vector as an arrow 88.
[0070] In some embodiments, the map 91 includes one or more arrows 88 whose origin is located at point 61, and whose dimensions indicate the amplitude voltage of the EP signal received from each electrode 55. In other words, the arrows 88 represent the isolation level of PV 51 at each position of each electrode 55. In the embodiment of Figure 4D, the direction of the arrows 88 may or may not represent the direction of the EP wave(s) propagating within the PV 51 tissue, thereby the length of each arrow 88 indicates the voltage level of the EP signal detected by each electrode 55.
[0071] In some embodiments, arrows 88a, 88b, and 88c indicate the amplitude of the voltage detected by the three electrodes 55 at the locations represented by points 61a, 61b, and 61c, respectively. In such embodiments, the physician 30 may understand that the voltage amplitude at points 61b and 61c is sufficiently small (i.e., lower than a predetermined threshold as shown in Figure 2C above), which indicates, for example, the formation of a desired injury very close to these locations. However, arrow 88a appears to have a dimension (e.g., length) greater than a predetermined length threshold, which indicates that the measured voltage amplitude is higher than a predetermined voltage threshold. In other words, the dimension of arrow 88a indicates that the injury is not formed very close to point 61a, or that the formed injury is insufficient to isolate PV51.
[0072] In some embodiments, maps 81 and 91 in Figures 2C and 2D may be generated by the processor 34 based on the same EP signal received during EA mapping, respectively. Figure 2C shows a two-way presentation of each section, e.g., a solid line or an opening, representing good or insufficient isolation, respectively. However, Figure 2D shows an index of the voltage magnitude measured by each electrode 55, so that when applying a second ablation pulse, the physician 30 may use the system 20 to apply different ablation pulses to each different ablation electrode of the balloon 70 in order to obtain isolation of PV 51 and still prevent over-ablation in areas where there is already damage that needs to be addressed.
[0073] In other embodiments, the processor 34 may present only some of the aforementioned vectors, for example, arrows 88. For example, the processor 34 may present only arrow 88a, and its length may exceed a threshold, and other arrows 88 may not be present in order to reduce extraneous information from the map 91.
[0074] Maps 61, 71, 81, and 91 in Figures 2A, 2B, 2C, and 2D are provided as examples and are not limited to the embodiments described above. In other embodiments, the processor 34 is configured to generate any other preferred map having one or more other quality measures of the ablated PV, or other preferred features indicating any other blood vessel or another organ of the patient 28.
[0075] In other embodiments, instead of solid lines for circles 66 and 77, the processor 34 may generate dashed lines in one or more segments of these circles to indicate partial cutoff of EP waves. Furthermore, the processor 34 may superimpose graph elements to present multiple scales on a single map. For example, the processor 34 may present circles 66 and 77 on a single map of PV 51 and superimpose geometric shapes (e.g., triangles and / or rectangles) representing one or more quality scales of the ablated PV. Furthermore, the processor 34 may reverse the order and dimensions of circles 53 and 56.
[0076] Figure 3 is a flowchart illustrating a method for displaying a graphical representation of one or more quality measures of ablated PV51 according to one embodiment of the present invention.
[0077] This method is initiated in the signal reception step 100 by a processor 34 that receives multiple signals from multiple electrodes 55 positioned along the inner circumference 62 of the ablated blood vessel (e.g., PV51), as shown in Figures 1 and 2B to 2D above.
[0078] In the quality scale generation step 102, the processor 34 generates one or more quality scales of the ablated blood vessels based on multiple signals, as described in detail in Figure 1 and Figures 2B to 2D above.
[0079] In the display step 104 that concludes this method, the processor 34 displays to the physician 30, for example, on the display unit 35, a graph showing the quality measure (e.g., the amplitude of the voltage detected by the electrode 55 in contact with the tissue of PV51) in a 2D polar coordinate system such as the maps 71, 81, and 91 described in Figures 2B, 2C, and 2D, respectively.
[0080] While the embodiments described herein primarily deal with pulmonary vein (PV) isolation procedures performed by tissue ablation of PV, the methods and systems described herein may also be used for other purposes.
[0081] Accordingly, the embodiments described above are cited as examples, and it will be understood that the present invention is not limited to those specifically shown and described above. Rather, the scope of the present invention includes both combinations and partial combinations of the various features described above, as well as variations and modifications thereof not disclosed in the prior art, which would be conceivable to those skilled in the art by reading the foregoing description. Documents incorporated into this patent application by reference shall be considered integral parts of this application, except that, in such incorporated documents, only the definitions provided herein shall be considered to the extent that any term is defined in a manner inconsistent with the definitions provided herein, either explicitly or implicitly.
[0082] [Implementation Method] (1) Receiving multiple signals from multiple electrodes positioned along the inner circumference of the ablated blood vessel, Based on the aforementioned plurality of signals, one or more quality measures of the ablated blood vessels are generated, A method comprising displaying to a user a graph showing one or more quality measures in a two-dimensional (2D) polar coordinate system. (2) The method according to Embodiment 1, wherein the positions of the plurality of electrodes are selected by the user along the longitudinal axis of the blood vessel, and the display of the graph presentation includes displaying at least a portion of a circle having a radius indicating the selected position on the inner circumference along the longitudinal axis. (3) The method according to Embodiment 2, wherein the radius indicates the distance of the selected position of the plurality of electrodes from the small pore of the blood vessel. (4) The method of Embodiment 2, wherein the ablation generates damage along the inner circumference, and the display of the graph includes displaying at least the portion of the circle in the section of the inner circumference where the damage was generated. (5) The method of Embodiment 4, wherein, in response to identifying an additional section of the inner circumference in which the damage has not occurred, the display of the graph presentation includes displaying an opening in the circle that indicates the location of the additional section.
[0083] (6) The method according to Embodiment 1, wherein the blood vessels include pulmonary veins (PVs) that transmit blood between the patient's heart and lungs, and the signal exhibits waves propagating through or along at least a portion of the tissue of the PVs. (7) The method according to Embodiment 1, wherein each of the one or more quality measures includes a plurality of amplitudes of the plurality of signals, and the display of the graph includes displaying a vector representing at least one of the plurality of signals. (8) The method according to Embodiment 1, wherein the coordinate system has an origin, and the display of the graph presentation includes displaying a graphic object located at a certain distance from the origin that indicates the position of one of the electrodes on the inner circumference and along the longitudinal axis of the blood vessel. (9) A system, A processor configured to (i) receive a plurality of signals from a plurality of electrodes arranged along the inner circumference of an ablated blood vessel, (ii) generate one or more quality measures of the ablated blood vessel based on the plurality of signals, and (iii) generate a graph presentation of the one or more quality measures in a two-dimensional (2D) polar coordinate system. A system comprising: a display unit configured to display the aforementioned graph to the user; (10) The system according to Embodiment 9, wherein the positions of the plurality of electrodes are selected by the user along the longitudinal axis of the blood vessel, and the processor is configured to generate, in the graph presentation, at least a portion of a circle having a radius indicating the selected positions on the inner circumference along the longitudinal axis.
[0084] (11) The system according to embodiment 10, wherein the radius indicates the distance of the selected position of the plurality of electrodes from the small pore of the blood vessel. (12) The system according to embodiment 10, wherein the ablation generates damage along the inner circumference, and the processor is configured to generate at least the portion of the circle in the portion of the inner circumference in which the damage was generated in the graph presentation. (13) The system according to embodiment 12, wherein, in response to identifying an additional section of the inner circumference in which no damage has been generated, the processor is configured to generate an opening in the circle in the graph presentation indicating the location of the additional section. (14) The system according to Embodiment 9, wherein the blood vessels include pulmonary veins (PVs) that transmit blood between the patient's heart and lungs, and the signal exhibits waves propagating through or along at least a portion of the tissue of the PVs. (15) The system according to Embodiment 9, wherein each of the one or more quality measures includes a plurality of amplitudes of the plurality of signals, and the processor is configured to generate a vector in the graph presentation that represents at least one of the plurality of signals.
[0085] (16) The system according to Embodiment 9, wherein the coordinate system has an origin, and the processor is configured to generate a graphic object at a certain distance from the origin that indicates the position of one of the electrodes on the inner circumference and along the longitudinal axis of the blood vessel in the graph presentation.
Claims
1. It is a system, A processor configured to (i) receive a plurality of signals from a plurality of electrodes arranged along the inner circumference of an ablated blood vessel, (ii) generate one or more quality measures of the ablated blood vessel based on the plurality of signals, and (iii) generate a graph presentation of the one or more quality measures in a two-dimensional (2D) polar coordinate system. The system comprises a display unit configured to display the aforementioned graph to the user, A system in which the positions of the plurality of electrodes are selected by the user along the longitudinal axis of the blood vessel, and the processor is configured to generate, in the graph presentation, at least a portion of a circle having a radius that indicates the selected positions of the plurality of electrodes arranged along the inner circumference of the blood vessel along the longitudinal axis of the blood vessel.
2. The system according to claim 1, wherein the radius represents the distance from the small pore of the blood vessel to the selected position of the plurality of electrodes along the longitudinal axis of the blood vessel.
3. The system according to claim 1, wherein the ablation generates damage along the inner circumference, and the processor is configured to generate at least the portion of the circle in the portion of the inner circumference where the damage was generated in the graph presentation.
4. The system according to claim 3, wherein, in response to identifying an additional section of the inner circumference where no damage has been generated, the processor is configured to generate an opening in the circle indicating the location of the additional section in the graph presentation.
5. The system according to claim 1, wherein the blood vessels include pulmonary veins (PVs) that transmit blood between the patient's heart and lungs, and the signal represents a wave propagating through or along at least a portion of the tissue of the PVs.
6. The system according to claim 1, wherein each of the one or more quality measures includes a plurality of amplitudes of the plurality of signals, and the processor is configured to generate a vector in the graph presentation that represents at least one of the plurality of signals' amplitudes.
7. The system according to claim 1, wherein the coordinate system has an origin, and the processor is configured to generate a graphic object at a certain distance from the origin that indicates the position of one of the electrodes on the inner circumference and along the longitudinal axis of the blood vessel in the graph presentation.
8. Receiving multiple signals from multiple electrodes positioned along the inner circumference of the ablated blood vessel, Based on the plurality of signals, one or more quality measures of the ablated blood vessels are generated, This includes displaying a graph showing one or more quality measures to the user in a two-dimensional (2D) polar coordinate system, A method wherein the positions of the plurality of electrodes are selected by the user along the longitudinal axis of the blood vessel, and the display of the graph presentation includes displaying at least a portion of a circle having a radius indicating the selected positions of the plurality of electrodes arranged along the inner circumference of the blood vessel along the longitudinal axis of the blood vessel.
9. The method according to claim 8, wherein the radius represents the distance of the plurality of electrodes from the small pores of the blood vessel to the selected positions of the plurality of electrodes along the longitudinal axis of the blood vessel of the plurality of electrodes.
10. The method according to claim 8, wherein the ablation generates damage along the inner circumference, and the display of the graph includes displaying at least the portion of the circle in the section of the inner circumference where the damage was generated.
11. The method of claim 10, wherein, in response to identifying an additional section of the inner circumference in which the damage has not occurred, the display of the graph presentation includes displaying an opening in the circle that indicates the location of the additional section.
12. The method according to claim 8, wherein the blood vessel includes a pulmonary vein (PV) that transmits blood between the patient's heart and lungs, and the signal represents a wave propagating through or along at least a portion of the tissue of the PV.
13. The method according to claim 8, wherein each of the one or more quality measures includes multiple amplitudes of the plurality of signals, and the display of the graph includes displaying a vector representing at least one of the plurality of signals.
14. The method according to claim 8, wherein the coordinate system has an origin, and the display of the graph presentation includes displaying a graphic object located at a certain distance from the origin that indicates the position of one of the electrodes on the inner circumference and along the longitudinal axis of the blood vessel.