Alignment aid for ablation procedure

Abstract

A method comprising registering multiple locations of ablated sites on a human organ. The method includes manipulating a catheter having multiple electrodes in close proximity to the organ, the electrodes configured to further ablate selected sites on the organ. The method further includes rendering on a display organ icons indicating the locations of the organ and multiple ablated sites, and catheter icons indicating the multiple electrodes, and providing on the display a display of the quality of alignment between the multiple electrodes and the locations of the multiple ablated sites.

Description

Technical Field

[0001] The present disclosure generally relates to ablation, and more particularly to ablation of organs of a human subject.

Background Art

[0002] To ablate an area of an organ of a human subject, such as a portion of the heart, a probe having means for ablation can be navigated to the area. The probe, when navigated, can be tracked, for example, by an electromagnetic tracking system, to ensure that the probe has reached the desired area. However, when the probe is inserted through a vein or artery of the subject, the flexibility of the probe and the typically tortuous path taken by the probe mean that it is not trivial to manipulate the probe to reach the desired area.

Brief Description of the Drawings

[0003] [Figure 1] Schematic diagram of a catheter-based electrophysiological mapping and ablation system. [Figure 2] Flow diagram of steps followed during an ablation procedure performed using the system of FIG. 1. [Figure 3A] Schematic diagram showing each step. [Figure 3B] Schematic diagram showing each step. [Figure 3C] Schematic diagram showing each step. [Figure 3D] Schematic diagram showing each step. [Figure 4A] Schematic diagram showing each step. [Figure 4B] Schematic diagram showing each step.

Mode for Carrying Out the Invention

[0004] Overview The objective of ablation procedures for pulmonary vein (PV) pores is to prevent the transmission of electrical signals between the PV and the ventricle to which the vein is connected. This objective can be achieved by a specialist performing a series of ablations along a closed circular line over the pore, ensuring there are no gaps and that this line is located approximately within the plane surrounding the pore. Often, the "first ablation pass" leaves some gaps, requiring repeated ablations to seal these gaps.

[0005] This can also be true for catheters designed to assist in the creation of a closed circumferential line. Such catheters are called "lasso" catheters, and a specialist can position this catheter within a small hole so that its electrodes are positioned in an arc. After the initial set of ablations has been performed with the catheter, the lasso can be rotated so that, in the new position, the new arc of the electrodes is in the initial plane and completes the line around the small hole, and as a result, ablations with the newly positioned electrodes should form a set of gapless ablations.

[0006] However, as mentioned above, manipulating and positioning the catheter, or keeping it stable during ablation, is no trivial task for a specialist. As a result, many ablation procedures create gaps, and these gaps need to be sealed.

[0007] An example of the present disclosure assists a physician by presenting on a display the void in an already performed ablation. Icons indicating the position and orientation of the ablation catheter are also shown on the icon, along with at least one number and / or at least one color, to assist the physician in aligning the catheter with the existing ablation site so that the catheter is in the plane of the site. Once aligned, the lasso catheter can be rotated in the plane so that the electrodes of the catheter are in the void, and these electrodes can then be actuated to ablate each section of the pore to seal the void.

[0008] System Description In the following description, similar elements are identified by the same number and, where necessary, distinguished by adding a letter as a suffix to the number.

[0009] Herein, we refer to Figure 1, which shows a catheter-based electrophysiological mapping and ablation system 10. The system 10 includes multiple catheters that are percutaneously inserted by a physician 24 through the patient's vascular system into the ventricles or vascular structures of the heart 12. Typically, a delivery sheath catheter is inserted into the left or right atrium near the desired location in the heart 12. Multiple catheters can then be inserted into the delivery sheath catheter to reach the desired location. The multiple catheters may include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary catheter 14 configured for ablation is shown herein. The physician 24 brings the distal tip 28 of the catheter 14 into contact with the heart wall to ablate the target site in the heart 12.

[0010] Catheter 14 is an exemplary lasso catheter including multiple electrodes 26 dispersed around a distal tip 28. Catheter 14 may additionally include a position sensor 29 embedded in or near the distal tip 28 to track the position and orientation of the distal tip 28. Optionally, the position sensor 29 is a magnetic-based position sensor including three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0011] A magnetic-based position sensor 29 may operate in conjunction with a position pad 25 which includes a plurality of magnetic coils 32 configured to generate a magnetic field within a given working volume. The real-time position of the distal tip 28 of the catheter 14 may be tracked based on the magnetic field generated by the position pad 25 and sensed by the magnetic-based position sensor 29. Details of magnetic-based position sensing technology are described in U.S. Patents 5,5391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091.

[0012] System 10 includes one or more electrode patches 38 positioned for skin contact on a patient 23 to establish a position reference for the position pad 25 and impedance-based tracking of the electrodes 26. For impedance-based tracking, a current is directed to the electrodes 26 and sensed in the electrode skin patches 38, thereby allowing the position of each electrode to be triangulated through the electrode patches 38. Details of impedance-based position tracking technology are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182.

[0013] The recorder 11 displays electromagnetism 21 captured by the body surface ECG electrodes 18 and intracardiac electromagnetism (IEGM) that can be captured by the electrodes 26 of the catheter 14. The recorder 11 may include pacing capability for pacing the rhythm of the heart and / or may be electrically connected to a standalone pacer.

[0014] System 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more of the electrodes 26. The energy generated by the ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed-field ablation (PFA) energy, which may include unipolar or bipolar high-voltage DC pulses that can be used to perform irreversible electroporation (IRE), or a combination thereof.

[0015] The patient interface unit (PIU) 30 is an interface configured to establish electrical communication between the catheter, the electrophysiological equipment, the power supply, and the workstation 55 for controlling the operation of the system 10. The electrophysiological equipment of the system 10 may include, for example, multiple catheters, position pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally, and preferably, the PIU 30 additionally includes processing capabilities for performing real-time calculations of catheter position and performing ECG calculations.

[0016] The workstation 55 includes memory, a processor 22 having memory or storage device containing appropriate operating software, and user interface functions. The workstation 55 may optionally provide several functions, including (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering the model or anatomical map 20 for display on a display device 27, (2) displaying an activation sequence (or other data) compiled from a recorded electrophoresis diagram 21 on the display device 27 as a representative visual representation or image superimposed on the rendered anatomical map 20, (3) displaying the real-time position and orientation of the distal tip 28 within the ventricle, and (4) displaying areas of interest on the display device 27, such as the location where ablation energy has been applied. One commercially available product embodying the elements of system 10 is available as the CARTO® 3 system from Biosense Webster, Inc. (31A Technology Drive, Irvine, CA 92618).

[0017] Figure 2 is a flowchart 200 of the steps followed by the processor 22 and the physician 24 during an ablation procedure performed using system 10, and Figures 3A to 3D and 4A to 4B are schematic diagrams showing each step.

[0018] In the initial step 202 of the flowchart, it is assumed that the system 10 has already been used to ablate an organ of patient 23, which is assumed in this specification to include a small hole in the pulmonary vein (PV) of patient 23, and a symbol 104 indicating the location of the initial ablation site is displayed on the representation 108 of the exemplary organ, PV, presented on the device 27, as shown in Figure 3A. The representation 108 is also referred to herein as the pulmonary vein icon 108. From the location of the symbol 104 recorded during each ablation, the processor 22 uses interpolation to fit a curve 112 to the ablated symbol, which may also be displayed on the device 27.

[0019] In analysis step 206, processor 22 examines the recorded ablation symbol positions and searches for gaps between the symbols. In one example, if the separation between adjacent ablation symbol positions is greater than a preset value that is assumed herein to be 5 mm, a gap is assumed to be present. However, the preset value may be greater than or less than 5 mm. Processor 22 can indicate the presence and location of the gap by coloring an appropriate section of curve 112 with a color different from the color used in the initial step.

[0020] Furthermore, since the curve connecting the ablation symbols of the small holes should be a closed curve, gaps can also be indicated by adding an arc to the interpolated curve of step 202 to close the curve. As schematically shown in FIG. 3B, processor 22 has added such an arc, arc 116, to curve 112, and the arc indicates that there is a gap between symbols 104A and 104J.

[0021] Processor 22 can determine that there are two or more gaps between symbols 104, and in this case, in the next step of the flowchart, physician 24 can be prompted to select the gap to be closed. In the following description, it is assumed that the gap to be closed includes the gap represented by arc 116, and those skilled in the art can make the necessary modifications for other gaps to adapt the description.

[0022] In operation step 210, physician 24 operates the lasso catheter 14 in proximity to the ablation site location. When catheter 14 is operated, processor 22 records the position and orientation of the catheter, and the processor positions and orients catheter icon 120 in the vicinity of PV icon 108 and symbol 104 on device 27 using the recorded values, as also schematically shown in FIG. 3B. Presenting catheter icon 120 and PV icon 108 together with symbol 104 assists physician 24 in navigating catheter 14 to the desired region of the PV, e.g., the gap indicated by arc 116.

[0023] As described above, accurately manipulating the lasso catheter to a desired region is no small feat. In an example of the present disclosure, a display 122 is provided on the catheter icon 120 to assist physician 24 in aligning the electrodes of the catheter with an existing ablation site. (Once well-aligned, in a subsequent operation step 214 described below, physician 24 can rotate the lasso catheter so that at least one of its electrodes is aligned with the gap.)

[0024] The display 122 may be alphanumeric and / or graphical. In the example of the present disclosure shown in FIG. 3C, the display includes numerical values of the distances from the selected electrodes 26 of the catheter 14 to the curve 112. The numerical values are positioned proximate to the respective representations 124 of the selected electrodes on the icon 120. Thus, as shown in FIG. 3C, representation 124G indicates that its electrode 26 is at a distance of 25 mm from the curve 112, and representation 124C indicates that its electrode is 9 mm from the curve, and thus the electrode of representation 124C is closer to the curve than the electrode of representation 124G.

[0025] In one example of this disclosure, also shown in Figure 3C, the representation 122 also includes a color change between a first color indicating proximity and a second color indicating greater distance. In the disclosed example, the first color is green and the second color is red, but it will be understood that other colors may be used in other examples. In the disclosed example, section 128 of icon 120 between representations 124 is colored 100% red, except for the section that is within a preset distance from curve 112, which is colored with a mixture of red and green, and 100% green at closer distances. In one example of this disclosure, the preset distance is 15 mm and the closer distance is 5 mm, but in other examples, the preset distance and closer distance values ​​may differ from 15 mm and 5 mm. In the figure, the increase in green is indicated by using a darker gray shading. Thus, as shown in Figure 3C, section 128G adjacent to representation 124G is red, while section 128C adjacent to representation 124C is green.

[0026] Figure 3D is a set of schematic diagrams 132 of the display device 27 as the catheter 14 is manipulated to improve its alignment with the initial ablation site indicated by symbol 104 on the curve 112. Figure 132A shows poor alignment between the lasso catheter and the existing ablation site. For example, the distance of the electrode with representation 124I is large, 33, and the surrounding area is red. As shown in Figures 132B and 132C, the distance decreases to 17, then to 8, and the surrounding area becomes green. Figure 132D shows that the catheter 14 is well aligned with the ablation site, as all the electrode distance numbers have low values.

[0027] In the well-aligned state shown in Figure 132D, the position of the electrode of catheter 14 is close to the position of the initial ablation site. Subsequently, the plane encompassing the electrode of catheter 14 and the plane encompassing the initial ablation site have a common orientation.

[0028] In a subsequent operation step 214, if the physician 24 manipulates the catheter 14 so that it has a common orientation with the initial ablation site, as shown in Figure 132D, the physician may reorient the catheter so that at least one electrode covers the ablation site gap indicated by the curve 116. Reorientation is assumed herein to involve the physician 24 rotating the catheter 14 in its plane so that at least one electrode of the catheter is aligned with the identified gap, and the processor indicates the rotation on the device 27.

[0029] Two examples of rotation are shown in Figures 4A and 4B. In both figures, the catheter icon 120, which normally overlaps arc 116 and curve 112, is shown displaced vertically downward from its actual position for clarity.

[0030] Figure 4A shows that the catheter 14 has been rotated so that the electrode indicated by representation 124J covers the arc 116. Figure 4B shows that the catheter 14 has been rotated further so that the electrodes indicated by representations 124I and 124J cover the arc 116.

[0031] As the catheter 14 is rotated, the physician 24 can activate the appropriate electrode to ablate the area of ​​the curve 116 covered by the electrode, as illustrated by Figure 4A or Figure 4B.

[0032] It will be understood that the 200 steps may be repeated as needed to ensure that no gaps remain between the ablation sites. [Examples]

[0033] Example 1: A method, To register multiple locations of ablated sites (104) of human organs, The procedure involves manipulating a catheter (14) having multiple electrodes (26) positioned close to an organ, wherein the electrodes are configured to further ablate a selected area of ​​the organ. A method comprising rendering organ icons (108) indicating multiple locations of organs and ablated sites, catheter icons (120) indicating multiple electrodes on a display (27), and providing on the display a display (122) of the quality of alignment between the multiple electrodes and multiple locations of ablated sites.

[0034] Example 2: The method according to Example 1, comprising identifying a gap at a location, further manipulating the catheter so that at least one of a plurality of electrodes aligns with a section of the gap when the indicator shows good alignment, and activating at least one electrode to ablate the section.

[0035] Example 3: The method of Example 2, further comprising the fact that multiple positions of the ablated site define an ablation site plane, and multiple electrodes define an electrode plane, and the method is such that the positions and orientations of the ablation site plane and the electrode plane correspond for good alignment.

[0036] Example 4: The method according to Example 2, wherein identifying gaps includes identifying adjacent locations from among registered locations that are farther apart than a predetermined distance.

[0037] Example 5: The method according to Example 2, wherein the organ includes a pulmonary vein of a human subject, and identifying the gaps includes fitting a closed curve to the location of the ablated site and showing on the display at least one site of the closed curve where adjacent locations are separated by a distance greater than a predetermined threshold distance.

[0038] Example 6: The method according to Example 1, wherein multiple electrodes are configured to be further ablated using at least one of high-frequency current and irreversible electroporation.

[0039] Example 7: The catheter is the same as in Example 1, and includes a lasso catheter.

[0040] Example 8: The method according to Example 1, wherein the display includes at least one of the following: the numerical values ​​of the distances between multiple electrodes and multiple positions, and the color indicating the value of the distance.

[0041] Example 9: Apparatus, Display device (27) and, A catheter (14) having multiple electrodes (26) configured to ablate a selected site of a human organ, A processor (22) is provided, and the processor is Register multiple locations of the ablated areas of the organ, Record the manipulation of the catheter in close proximity to the organ. On the display device, organ icons (108) indicating the locations of multiple organs and ablated sites, and catheter icons (120) indicating multiple electrodes are rendered. An apparatus configured to provide on a display device an indication (122) of the quality of alignment between multiple electrodes and multiple locations of the ablated site.

[0042] Example 10: A processor is provided, and the processor is When identifying a gap in position and indicating that the display has good alignment, Record further manipulation of the catheter so that at least one of the multiple electrodes is aligned with the section of the gap. The apparatus according to Example 9, configured to activate at least one electrode to ablate a section.

[0043] Example 11: The apparatus according to Example 10, wherein multiple positions of the ablated area define the ablation site plane, multiple electrodes define the electrode plane, and the positions and orientations of the ablation site plane and the electrode plane correspond for good alignment.

[0044] Example 12: The apparatus according to Example 10, wherein identifying gaps includes identifying adjacent locations from among registered locations that are farther apart than a predetermined distance.

[0045] Example 13: The apparatus according to Example 10, wherein the organ includes a pulmonary vein of a human subject, and identifying the interstitial space includes fitting a closed curve to the location of the ablated site and indicating on a display device at least one site of the closed curve where adjacent sites are separated by a distance exceeding a predetermined threshold distance.

[0046] Example 14: The apparatus according to Example 9, wherein multiple electrodes are configured to perform ablation using at least one of high-frequency current and irreversible electroporation.

[0047] Example 15: The apparatus according to claim 9, wherein the catheter includes a lasso catheter.

[0048] Example 16: The apparatus according to Example 9, wherein the display includes at least one of the following: numerical values ​​for the distances between multiple electrodes and multiple positions, and a color indicating the value of the distance.

[0049] The embodiments described above are illustrative examples, and it should be understood that this disclosure is not limited to those specifically illustrated and described above. Rather, the scope of this disclosure 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 may be conceived by those skilled in the art by reading the foregoing description.

[0050] [Implementation Method] (1) A method, To register multiple locations of ablated areas in human organs, The operation involves manipulating a catheter having multiple electrodes positioned in close proximity to the organ, wherein the electrodes are configured to further ablate a selected area of ​​the organ. A method comprising rendering organ icons indicating the plurality of locations of the organ and the ablated site, and catheter icons indicating the plurality of electrodes on a display, and providing on the display a display of the quality of alignment between the plurality of electrodes and the plurality of locations of the ablated site. (2) The method according to Embodiment 1, comprising: identifying a gap at the position;, if the indication indicates good alignment, further manipulating the catheter so that at least one of the plurality of electrodes aligns with the section of the gap; and activating the at least one electrode to ablate the section. (3) The method of Embodiment 2, further comprising the plurality of positions of the ablated site defining an ablation site plane, the plurality of electrodes defining an electrode plane, and the method wherein the positions and orientations of the ablation site plane and the electrode plane correspond for the good alignment. (4) The method according to Embodiment 2, wherein identifying the gap includes identifying adjacent positions from among the registered positions that are farther apart than a predetermined distance. (5) The method of Embodiment 2, wherein the organ includes the pulmonary veins of the human subject, and identifying the gap includes fitting a closed curve to the location of the ablated site and showing on the display at least one site of the closed curve where adjacent sites are separated by a distance greater than a predetermined threshold distance.

[0051] (6) The method according to any one of embodiments 1 to 5, wherein the plurality of electrodes are configured to be further ablated using at least one of high-frequency current and irreversible electroporation. (7) The catheter is a lasso catheter, as described in any one of embodiments 1 to 5. (8) The method according to any one of embodiments 1 to 5, wherein the display includes at least one of the numerical values ​​of the distances between the plurality of electrodes and the plurality of positions, and a color indicating the value of the distance. (9) A device, Display devices and, A catheter having multiple electrodes configured to ablate selected sites of human organs, A processor is provided, and the processor is Multiple locations of the ablated areas of the aforementioned organ are registered, The operation of the catheter in close proximity to the organ is recorded. On the display device, the following are rendered: organ icons indicating the multiple locations of the organ and the ablated area, and catheter icons indicating the multiple electrodes. An apparatus configured to provide on a display device an indication of the quality of alignment between the plurality of electrodes and the plurality of positions on the ablated site. (10) The processor comprises the processor, When the gap at the aforementioned position is identified and the indication shows that there is good alignment, Further manipulation of the catheter is recorded so that at least one of the plurality of electrodes is aligned with the section of the gap. The apparatus according to embodiment 9, configured to activate the at least one electrode to ablate the section.

[0052] (11) The apparatus according to Embodiment 10, wherein the plurality of positions of the ablated area define an ablation site plane, the plurality of electrodes define an electrode plane, and the positions and orientations of the ablation site plane and the electrode plane correspond for the good alignment. (12) The apparatus according to Embodiment 10, wherein identifying the gap includes identifying adjacent positions from among the registered positions that are farther apart than a preset distance. (13) The apparatus according to Embodiment 10, wherein the organ includes the pulmonary veins of the human subject, and identifying the gap includes fitting a closed curve to the location of the ablated site and showing on the display device at least one site of the closed curve where adjacent sites are separated by a distance greater than a predetermined threshold distance. (14) The apparatus according to any one of embodiments 9 to 13, wherein the plurality of electrodes are configured to be ablated using at least one of high-frequency current and irreversible electroporation. (15) The apparatus according to any one of embodiments 9 to 13, wherein the catheter includes a lasso catheter.

[0053] (16) The apparatus according to any one of embodiments 9 to 13, wherein the display includes at least one of the numerical values ​​of the distances between the plurality of electrodes and the plurality of positions, and a color indicating the value of the distance.

Claims

1. It is a device, Display devices and, A catheter having multiple electrodes configured to ablate selected sites of human organs, A processor is provided, and the processor is Multiple locations of the ablated areas of the aforementioned organ are registered, The operation of the catheter in close proximity to the organ is recorded. On the display device, the following are rendered: organ icons indicating the multiple locations of the organ and the ablated area, and catheter icons indicating the multiple electrodes. An apparatus configured to provide on a display device an indication of the quality of alignment between the plurality of electrodes and the plurality of positions on the ablated site.

2. The system comprises the aforementioned processor, and the processor is When the gap at the aforementioned position is identified and the indication shows that there is good alignment, Further manipulation of the catheter is recorded so that at least one of the plurality of electrodes is aligned with the section of the gap. The apparatus according to claim 1, configured to activate the at least one electrode to ablate the section.

3. The apparatus according to claim 2, wherein the plurality of positions of the ablated area define an ablated area plane, the plurality of electrodes define an electrode plane, and the positions and orientations of the ablated area plane and the electrode plane correspond for the good alignment.

4. The apparatus according to claim 3, wherein identifying the gap includes identifying adjacent positions from among the registered positions that are farther away than a predetermined distance.

5. The apparatus according to claim 3, wherein the organ includes the pulmonary veins of the human subject, and identifying the gap includes fitting a closed curve to the location of the ablated site and showing on the display device at least one site of the closed curve where adjacent sites are separated by a distance exceeding a preset threshold distance.

6. The apparatus according to any one of claims 1 to 5, wherein the plurality of electrodes are configured to perform ablation using at least one of high-frequency current and irreversible electroporation.

7. The apparatus according to any one of claims 1 to 5, wherein the catheter includes a lasso catheter.

8. The apparatus according to any one of claims 1 to 5, wherein the display includes at least one of the numerical values ​​of the distances between the plurality of electrodes and the plurality of positions, and a color indicating the value of the distance.

9. It is a method, To register multiple locations of ablated areas in human organs, The operation involves manipulating a catheter having multiple electrodes positioned in close proximity to the organ, wherein the electrodes are configured to further ablate a selected area of ​​the organ. A method comprising rendering organ icons indicating the plurality of locations of the organ and the ablated site, and catheter icons indicating the plurality of electrodes on a display, and providing on the display a display of the quality of alignment between the plurality of electrodes and the plurality of locations of the ablated site.

10. The method according to claim 9, comprising: identifying a gap at the aforementioned location; further manipulating the catheter so that at least one of the plurality of electrodes aligns with a section of the gap if the indication indicates good alignment; and activating the at least one electrode to ablate the section.

11. The method according to claim 10, wherein the plurality of positions of the ablated area define an ablation site plane, the plurality of electrodes define an electrode plane, and the method further comprises the position and orientation of the ablation site plane and the electrode plane corresponding for the good alignment.

12. The method according to claim 10, wherein identifying the gap includes identifying adjacent positions from among the registered positions that are farther apart than a predetermined distance.

13. The method according to claim 10, wherein the organ includes the pulmonary veins of the human subject, and identifying the gap includes fitting a closed curve to the location of the ablated site and showing on the display at least one site of the closed curve where adjacent sites are separated by a distance exceeding a predetermined threshold distance.

14. The method according to any one of claims 9 to 13, wherein the plurality of electrodes are configured to be further ablated using at least one of high-frequency current and irreversible electroporation.

15. The method according to any one of claims 9 to 13, wherein the catheter includes a lasso catheter.

16. The method according to any one of claims 9 to 13, wherein the display includes at least one of the numerical values ​​of the distances between the plurality of electrodes and the plurality of positions, and a color indicating the value of the distance.

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