Cardiac ablation systems and methods

Abstract

The invention relates to a cardiac ablation system which comprises a catheter and a head, the head is an ablation action end of the cardiac ablation system on cardiac tissues, the catheter is a flexible tubular connector of the cardiac ablation system for connecting the head, and the head is provided with a plurality of independent ablation elements; each ablation element is provided with a contact surface used for making contact with heart tissue and a flexible supporting body used for supporting the contact surface, and an energy acting part is arranged on the contact surface; the ablation elements have two working states of contraction and extension at the head position of the cardiac ablation system, in the contraction state, the multiple mutually independent ablation elements are mutually gathered and present the minimum size, in the extension state, one or more mutually independent ablation elements are opened, and in the extension state, the ablation elements are separated from each other. And various shape changes at the contacted parts of the heart tissue are fit through the contact surface on each ablation element in an adaptive manner.

Description

[0001] This application is a divisional application. The application number of the original application is 202011005029.0, the application date is 2020.09.22, and the name of the invention is “Cardiac ablation system and method” Technical Field

[0002] The present invention relates to the treatment of abnormal heart diseases such as atrial fibrillation. In particular, the present invention relates to a cardiac ablation system for use in a procedure that injures or destroys heart tissue that produces incorrect electrical signals that cause abnormal heart rhythms. Background Art

[0003] Treatment for abnormal heart conditions such as atrial fibrillation involves "cardiac ablation" - a procedure that injures or destroys the heart tissue that produces the incorrect electrical signals that cause the abnormal heart rhythm.

[0004] The catheter is advanced through the patient's blood vessels toward the heart and is then positioned near the ostium of the pulmonary vein (PV). Electrical pulses are triggered and directed to the tissue through electrodes at the distal end of the catheter to electrically isolate the PV by creating a peripheral lesion. The following difficulties arise when the vessel surface has curvature: the opening is a non-uniform circular opening. Current delivery systems fail to take into account the actual anatomy and are designed under the assumption that the vessel is a uniform tube with a uniform circular opening.

[0005] Furthermore, current methods involving radiofrequency (RF) energy can cause tissue damage due to the nonspecific and thermal energy source. Furthermore, current methods are time consuming and require a highly skilled EP to perform the procedure.

[0006] Finally, if current devices are improperly positioned, there is a risk of permanent damage, so accuracy of deployment is very important. Summary of the invention

[0007] In a first aspect, the present invention provides a cardiac ablation system for treating cardiac tissue, comprising a catheter and a head, wherein the head is the ablation end of the cardiac ablation system for the cardiac tissue, and the catheter is a flexible tubular connector for connecting the head of the cardiac ablation system. The innovation of the present invention is as follows: The head includes a pair of independent elongated link-shaped ablation elements, the ablation elements including pivotally connected and linearly arranged segments, the ablation elements being arranged to extend radially from the center of the head; Each ablation element is provided with a contact surface for contacting cardiac tissue and a flexible support body for supporting the contact surface, wherein an energy application portion is provided on the contact surface; at least some of the ablation elements are arranged to be elastically coupled to the tissue; the elastic coupling includes one or both of elastic deformation and elastic displacement; The ablation element has two working states at the head position of the cardiac ablation system: contraction and extension. In the contraction state, multiple independent ablation elements are gathered together and present a minimum volume. In the extension state, one or more independent ablation elements are opened and conform to various shape changes of the contacted cardiac tissue in an adaptive manner through the contact surfaces on each ablation element.

[0008] Thus, the present invention provides an ablation head for delivering electrodes to tissue, the head having individually operable ablation elements. In addition, the ablation elements are arranged for resilient engagement to apply a preload to the tissue that exceeds that provided by the operator.

[0009] The energy application portion may be arranged to provide electrical pulses, radio frequency (RF) energy or cryogenic energy.

[0010] The present invention provides several advantages over the prior art, including: 1. In some embodiments, the device may be able to address the unique asymmetric anatomy of the PV ostium and vasculature, and accommodate circumferential oval and circular anatomy. Therefore, the present invention is intended to take into account unique anatomy to deliver energy to achieve optimal results.

[0011] 2. In some embodiments, the present invention can provide pulsed electric field (PEF) ablation and point ablation (as needed) in the circumferential direction through flexible positioning of electrodes based on ablation needs.

[0012] 3. Prior art treatments use a "point-by-point" approach to ablate lesions. This approach requires EP skills to precisely control the tool to ensure a continuous "ablation path" to achieve complete electrical isolation. The present invention allows an electrophysiologist (EP) to perform support and auxiliary isolation independent of EP skills. The present invention also allows continuous lesion ablation that does not require point-by-point ablation.

[0013] 4. The treatment methods of the prior art require a lot of time to position and deliver radio frequency (RF) or other thermal ablation energy. Due to the above reasons, the present invention only takes a small amount of time to perform the treatment action. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] It will be convenient to further describe the invention with respect to the accompanying drawings which illustrate possible arrangements of the invention. Other arrangements of the invention are possible, and therefore the particularity of the accompanying drawings should not be understood as superseding the generality of the preceding description of the invention.

[0015] Figures 1A to 1G are various views according to a third embodiment of the present invention; Figures 2A to 2G are various views according to a fourth embodiment of the present invention; 3A to 3H are various views according to a fifth embodiment of the present invention; FIG. 4A to FIG. 4E are various views according to a sixth embodiment of the present invention; FIG. 5A to FIG. 5F are various views according to a seventh embodiment of the present invention; FIG. 6A to FIG. 6B are various views according to an eighth embodiment of the present invention; FIG. 6C to FIG. 6D are various views according to a ninth embodiment of the present invention; FIG. 6E to FIG. 6F are various views according to a tenth embodiment of the present invention; FIG. 6G to FIG. 6H are various views according to an eleventh embodiment of the present invention; FIG. 6I to FIG. 6K are various views according to a twelfth embodiment of the present invention; FIG. 7A to FIG. 7B are various views according to a thirteenth embodiment of the present invention; FIG. 7C to FIG. 7D are various views according to a fourteenth embodiment of the present invention; FIG. 8A to FIG. 8H are various views according to a sixteenth embodiment of the present invention; 9A to 9F are various views according to a seventeenth embodiment of the present invention; FIG. 10A to FIG. 10B are various views according to an eighteenth embodiment of the present invention; FIG. 10C to FIG. 10D are various views according to a nineteenth embodiment of the present invention; Fig.10E is an isometric view of a twentieth embodiment according to the present invention; Fig.10F is an isometric view of a twenty-first embodiment according to the present invention; FIG. 11A to FIG. 11K are various views according to a twenty-second embodiment of the present invention; FIG. 12A to FIG. 12Care various views according to a twenty-third embodiment of the present invention; FIG. 13A to FIG. 13O are various views according to a twenty-fourth embodiment of the present invention; FIG. 14A to FIG. 14D are various views according to a twenty-sixth embodiment of the present invention; Fig.15A is a schematic diagram of electroporation voltage delivery (PV cross section) after application of pulsed energy ablation device; Fig. 15B is a schematic diagram of the ablation energy (PV cross section) after application of the pulsed energy ablation device; Fig. 15C is a schematic diagram of an ablation pattern using conventional RF therapy (left) and an ablation pattern using pulse ablation of the device of the present invention; FIG. 16A to FIG. 16F are various flow charts of processes according to various embodiments of the present invention. DETAILED DESCRIPTION

[0016] The present invention will be further described below in conjunction with the accompanying drawings and embodiments: The present invention is intended to deliver pulsed energy to destroy tissue within the heart that generates incorrect electrical signals. For example, the tip of the present invention is delivered via a catheter into the left atrium (LA) of the heart. Depending on anatomical specifications or operator preference, the device can be deployed to the ostium of a pulmonary vein (PV) or into the PV via a catheter system to treat patients with atrial fibrillation.

[0017] The pulse energy can be in different forms including cryogenic energy, radio frequency (RF) or electric pulses, so the energy application part can be arranged as a site for providing electric pulses, radio frequency (RF) energy or cryogenic energy, wherein the radio frequency energy can be provided by a radio frequency generator, and the energy application part can adopt electrodes; the pulse energy can be provided by a direct current generator, and the energy application part can adopt electrodes; the cryogenic energy can be provided by an argon generator, and the energy application part can be arranged in a manner similar to a cryogenic probe. The energy application part is located on each element corresponding to the type of energy to be utilized. Therefore, it should be understood that although the following embodiments generally involve transmitting electric pulses, instead, these arrangements can be equally suitable for use in the case of transmitting other forms of energy, including but not limited to cryogenic energy and RF pulse systems.

[0018] An important feature of the present invention is its ability to provide elastic engagement with tissue. Essentially, the ablation element provides effective pressure on the tissue to achieve better engagement, shaping the tissue (elastic deformation) or positioning the tissue (elastic displacement). In either case, the ablation element acts alone by deformation or displacement to find a balanced position to achieve better contact. This is particularly advantageous considering the variability of the shape of the tissue and the need for better engagement for more effective treatment. Due to the elastic engagement, the operator does not need to make small and / or repeated position changes to obtain the optimal position. When the elastic equilibrium position is found, the ablation element will automatically position itself around the tissue.

[0019] Taking the energy application part as an example, referring to the following embodiments, in order to deploy the device to the PV port, various embodiments of the present invention include: 1. Devices with multiple electrodes (with or without force sensors); 2. Devices with multiple electrodes + features that help better align the electrodes with the vessel wall; 3. A device with multiple electrodes + features that help better align the electrodes with the vessel wall + anchoring features.

[0020] To deploy the device into the PV vessel, various embodiments of the present invention include: 4. Devices with multiple electrodes (with or without force sensors) + separate anchoring features; 5. A device having multiple electrodes deployed simultaneously with anchors; A device having an electrode design that achieves good adhesion to the vessel wall as the operator manipulates it.

[0021] Once the tip of the device (with electrodes and / or sensors) is positioned over the PV ostium or PV vessel, direct pulse energy is applied via the generator and this step is repeated until the erroneous electrical signal is completely isolated.

[0022] In a first embodiment, the ablation device includes an ablation head mounted to a catheter. The catheter is used to insert the ablation head into a position within the heart, and specifically around the tissue of the pulmonary veins, wherein the area between the cross-sectional tissue to the cross-sectional tissue is the tissue treatment area.

[0023] The head is inserted uninflated until in place, whereupon the ablation element is inflated by passing a fluid, such as air (or other gas) or water (or other liquid), through the catheter.

[0024] It should be noted that the head includes a plurality of ablation elements, and in one case of this embodiment, six ablation elements are positioned around the central periphery of the head. The ablation elements include electrodes on the contact surface of the ablation elements. When expanded, the ablation elements provide elastic engagement with the tissue to be destroyed through elastic deformation of the elements, causing the tissue to be destroyed as part of the intended treatment.

[0025] Each ablation element includes an electrode embedded in a contact surface for delivering electrical pulses to the electrode. When in contact with tissue, according to the above method and also related to FIG. 16A to FIG. 16F In the method defined in, electrical pulses are guided through electrodes. In this embodiment, a force sensor is also included, which is arranged to provide feedback to the operator on the extent of contact with the tissue and the elastic engagement applied to the tissue, which can help ensure full contact of the ablation element with the tissue and thus promote faster and more effective treatment. Data from the sensor can help determine the position and fit of the electrode. It should be understood that, although optional, sensors can be included but are not limited to within the network for temperature monitoring, contact force monitoring, impedance monitoring and tactile feedback.

[0026] In the second embodiment, only some of the ablation elements have been expanded, and therefore only the expanded side provides elastic deformation against the tissue, and the other ablation elements remain unexpanded, thereby providing the head with an irregular shape to fit the irregularities of the anatomical structure of the ostium tissue of the pulmonary vein. Therefore, for this embodiment, the selective expansion of the ablation elements and the ability to therefore keep some ablation elements unexpanded provide the ablation head with the ability to fit a variety of shapes, thereby expanding its applicability, compared to the uniform shape adopted by the devices of the prior art.

[0027] Figures 1A to 1G Another device 80 is shown in accordance with an embodiment of the present invention, being a third embodiment. This device 80 differs significantly from the devices of the first two embodiments in that the inflated ablation elements are replaced with relatively stiff elongated ablation elements 105. These elements are not completely "rigid" and may have elastic properties such that they are able to "bend" when a force is applied, in which case they may return to their original shape once the force is removed. These elements may be made of an elastomer / silicone. The head 95 of the device 80 includes a plurality of elongated ablation elements 105 mounted to the catheter 90. The elongated ablation elements 105 are flexibly spring loaded to extend radially from the center 102 of the head 95 and thereby elastically displace around the tissue 60, Figure 1B The arrow in FIG. 7 indicates the elastic displacement force direction 70 of the ablation element 105. Figure 1G The arrows in the figure indicate the movement direction of the housing 160 when performing actions 1120 and 130. Delivery to the heart requires restraint of the elongated ablation element 105, so a selectively movable housing 100 is used. When an action 120 is performed by the operator, the housing 100 is arranged to control the movement of the elongated ablation element 105 from the first position 115 to the intermediate position 125, and then an action 130 is performed to move the housing 100 to the proximal position 135 of the fully deployed arrangement. In this embodiment, the performance of the action involves retracting the housing 100 from the distal position toward the proximal position of the catheter 90.

[0028] Once in position, electrodes 110 in the contact surface of elongate ablation element 105 direct electrical pulses as already described.

[0029] Figures 2A to 2G Shown with Figures 1A to 1G The fourth embodiment of the present invention is similar to the embodiment of the present invention, in which the device 145 has a head 150 mounted to a catheter 155. The head 150 includes an elongated ablation element 165, however, the elongated ablation element 165 does not generally extend forward toward the distal end of the device. In this embodiment, the elongated ablation element 165 extends toward the proximal end. Again, when released from the housing 160 to the distal position 200, the elongated ablation element 165 is flexibly elastically loaded to extend radially so as to elastically displace around the tissue 60. As the elongated ablation element 165 extends in a direction opposite to that of the previous embodiment, the housing of the restraining element moves toward the distal end of the device to release the elongated ablation element 165. In this case, the operator pushes the release mechanism forward to perform actions 185, 195 to move the housing 160, and once in the appropriate position, the housing 160 is moved so that the housing is located in the proximal position 180, the intermediate position 190, and the distal position 200 to fully deploy the head 150. Figure 2B and Figure 2G The arrow in FIG. 1 indicates the elastic displacement force direction 175 of the ablation element 165. Figure 2E The arrow in the figure indicates the moving direction of the shell 160 when performing actions 185 and 195.

[0030] 3A to 3H A further embodiment is shown, which is a fifth embodiment of the present invention. Here, the device 215 comprises a flower-shaped head 220 having a petal-shaped ablation element 235 extending radially from the center of the head 220. The petal-shaped ablation element 235 is bent to form a flexural elastic body and thus elastically deforms against the tissue 230 in such a way that Figure 3G and Figure 3H The arrow in indicates the elastic displacement force direction 280 of the ablation element 235 .

[0031] In view of the wider head, to facilitate insertion, the petal-shaped element is constrained by the housing 242 until it is properly positioned. Once in the proper position, the housing 242 is moved and actions 240, 250, and 260 are performed, thereby gradually removing the constraints to be in the first position 245, the second position 255, and the third position 265 to fully deploy the head 220.

[0032] The flat shape of the petal-shaped ablation element 235 allows for various styles of electrodes, such as the first style 270, the second style 275. Specifically, in the first style 270, the flat shape allows the use of strain gauges for the force sensors. In this arrangement, contact with the tissue involves bending of the ablation element 235, thereby triggering a response to an action performed by the operator through the strain gauge. The second style 275 shows the use of a thin film force sensor as an alternative. It should be understood that several different methods of providing force detection are possible, wherein the scope of the present invention is not limited by any one method.

[0033] exist FIG. 4A to FIG. 4E A further embodiment is shown in , which is the sixth embodiment of the present invention. Here, the device 285 comprises a head 290 having an ablation element 300 in the form of a connecting rod.

[0034] Ablation element 300 includes a series of segments 335 pivotally connected in series, allowing articulation between segments 335 and thereby flexing ablation element 300 within a plane.

[0035] When inserted, the ablation element 300 is parallel to the outer surface of the catheter 295. Once in place, deployment is performed using a force applied to the end of the link connected to the catheter 295. As the force increases to perform actions 315, 320, 325, and 330, the link element is gradually expanded to adopt a curved arrangement similar to an arc of a circle, up to 180°, imitating a "scorpion tail" shape. Electrodes 305 can be attached along segments 330 of the link (although not necessarily all segments), and the element is thus able to apply electrical pulses along the curved surface of the link. The pivot connection between the segments also allows elastic displacement when in contact with tissue. Figure 4B and Figure 4D The oblique arrow in FIG. 3 indicates the elastic displacement force direction 310 of the ablation element 165. Figure 4D The vertical downward arrows in indicate the action directions of actions 315 , 320 , 325 , and 330 .

[0036] Thus, the head 290 can provide a very wide curved surface to contact tissue. Thus, an advantage of this arrangement is the ability to allow for significant variability in the width of the tissue to be treated. The span covered by the ablation element 300 depends only on the number of segments 335 added to the length of the link-type ablation element 300. The retracted position of the ablation element 300, which is theoretically parallel to the catheter 295 upon insertion, means that the link-type ablation element 300 can be very long and therefore has a considerable ablation width once deployed.

[0037] FIG. 5A to FIG. 5F An embodiment similar to that of Figs. 1 and 2 is shown, being a seventh embodiment of the invention. Respective ablation heads 360, 358, 380, 405 are formed using an elongated ablation element. However, in these embodiments, an inflatable balloon is included centrally to the elongated ablation element. During deployment, the shell is retracted and the elongated ablation element extends outwardly with the aid of expansion of the balloon 350, 370, 390, 415. Thus, these embodiments illustrate two elastic combinations of displacement by ablation and deformation by the balloon.

[0038] In these embodiments, there is a three-step process for deployment. In one step, the housing is retracted, then the elongated element is radially expanded, and the balloon changes from an unexpanded state 345, 365 to an expanded state 350, 370. Fig. 7A and Figure 5B The arrows in FIG. 3 indicate the elastic and force directions 355 and 375 of the ablation element, respectively. The balloon may be a single ring (not shown) or may be a plurality of balloons placed around a center.

[0039] An interesting aspect about these embodiments is that there are different balloons placed around the center. In some cases, upon expansion, the elastic engagement changes, with smaller balloons providing less expansion of the elongated ablation element, while larger balloons provide greater expansion. This in turn provides a differential elastic engagement, with smaller balloons having less displacement 395, 420, and larger balloons having greater displacement 400, 425, to accommodate the anatomical angles of the ostium / PV. Thus, these embodiments also provide for variations in the shape and size of the tissue to be treated.

[0040] FIG. 6A to FIG. 6G as well as FIG. 7A to FIG. 7D Various embodiments are shown that are similar to the flower-shaped embodiment of Figure 3. The embodiments generally differ from Figure 3 in the ablation elements. Although petal-shaped, the ablation elements in these embodiments are more elongated, similar to tentacles.

[0041] FIG. 6A to FIG. 6Bare various views according to an eighth embodiment of the present invention, Fig. 6A and Figure 6B An ablation element 426 is shown having electrodes 432 and sensors located within the tip of the catheter and mounted on a pneumatic layer 430 .

[0042] FIG. 6C to FIG. 6D are various views according to a ninth embodiment of the present invention, Figure 6C and Fig.6D An ablation element 435 is shown without electrodes and sensors, wherein there are multiple channels in each ablation element 435, multiple channels are interconnected, and there is a rigid material at the base layer 440 of the ablation element 435, and a pneumatic layer with multiple channels is set on the top of the ablation element 435.

[0043] FIG. 6E to FIG. 6F are various views according to a tenth embodiment of the present invention, Fig. 6E and Fig. 6F An ablation element 445 is shown having a "mini muscle" shaped protrusion 455 - the protrusion has a corrugated shape running along the contact surface - and having electrodes 450 and sensors mounted on the contoured contact surface attached to the tip of the catheter and mounted on the pneumatic layer.

[0044] Figure 6G and Figure 6H The raised structure of the "small muscle" in the ablation element 460 is shown, where multiple channels in each "small muscle" segment are interconnected to other "small muscle" segments and its surface does not include electrodes and sensors. The "small muscle" segment structure includes a rigid material at the base layer 465 and a multi-channel pneumatic layer on top.

[0045] FIG. 6I to FIG. 6K are various views according to a twelfth embodiment of the present invention, FIG. 6I to FIG. 6K Various approaches to a pneumatic system 485 are shown, including an internal multiple channel pneumatic arrangement 470, an internal multiple channel and external electrode arrangement pneumatic arrangement 475, and an external electrode arrangement pneumatic arrangement 480.

[0046] FIG. 7A to FIG. 7B are various views according to a thirteenth embodiment of the present invention, FIG. 7A to FIG. 7B A single "tentacle" structure is shown, Fig. 7A shows the structure 490 with the pneumatic system 495 and the electrode 500 attached to the housing prior to deployment, Figure 7B The structure 505 is shown after deployment with the internal pneumatic system 510 and the electrode 500 attached to the housing.

[0047] FIG. 7C to FIG. 7D are various views according to a fourteenth embodiment of the present invention, FIG. 7C to FIG. 7D A single "tentacle" structure is shown, Figure 7C The structure 515 with the internal pneumatic system 520 and the outer shell is shown before deployment, Fig.7D The structure 525 is shown with the internal pneumatic system 530 and the outer shell structure after deployment.

[0048] In a fifteenth embodiment of the present invention, this embodiment uses a combination of a non-compliant balloon (with pressure-expanded polyester / nylon material as a candidate) and a compliant balloon (with volume-expanded polyurethane / silicone material as a candidate) as an ablation element to achieve better contact with tissue.

[0049] There are several different types of expandable array combinations, of which the following three are examples: 1) Use of non-compliant balloons (pressure-expandable polyester / nylon materials are candidates); Compliant balloons (volume-expanding polyurethane / silicone materials are candidates); and A combination of both compliant and non-compliant balloons.

[0050] In this arrangement, the head includes a ring of elements having alternating expandable non-compliant balloon elements and compliant balloon elements. When expanded, the differentiated elements expand the ring to match the shape of the port, whether it is round or oval tissue.

[0051] When the ablation element is expanded to the state, the variable expansion causes a combination of elastic displacement by the rigid element, the compliant balloon element, and elastic deformation by the expandable element, the non-compliant balloon element.

[0052] FIG. 8A to FIG. 8H are various views according to a sixteenth embodiment of the present invention, FIG. 8A to FIG. 8H Several embodiments are shown, as well as additional features for use with other embodiments.

[0053] First, the cardiac ablation device 575 includes a head 580 having an expandable array ablation element 585, and the ablation element 585 has electrodes and sensors (electrodes and sensors are not shown in FIG. Fig.8D ablation element 605 in the Figure 8C The ablation element 595 can be seen before expansion. Fig. 8E The ablation element 600 can be seen after expansion.

[0054] It is worth noting that Figure 8C and Fig. 8EAlso shown is the effect of selective expansion, in this case for shaping the head 580 to the shape of the PV ostium and thus being able to adapt to both the tissue of the round ostium 60 and the tissue of the oval ostium 62. This selective expansion means that the ablation element can be maintained in an unexpanded state 620, a partially expanded state 630, or a fully expanded state 625 to obtain the desired shape and corresponding elastic engagement, in Figure 8C , Fig. 8E and Figure 8F The force directions 610, 615, 628, and 632 of the ablation element and tissue elasticity are respectively shown.

[0055] Fig.8D and Figure 8G Another embodiment shown in is to have an anchor 590 in the form of a balloon at the distal end of the catheter and is positioned to wedge the device 575 into place by selectively expanding the anchor 590 further away from the mouth in the pulmonary vein. In this embodiment, the balloon is annular to provide an annular elastic engagement with the vein wall, but allows blood to flow through the annular hole. It will be understood and described later that a complete balloon that can seal the vein can also be used. This can have the advantage of greater elastic force being applied, and therefore greater anchoring force may be provided. Each of these anchor embodiments can be used with any one or most of the embodiments described herein, and is not limited to the embodiment shown in Figure 8.

[0056] 9A to 9F 60 , 670 . The ablation elements 640 are various views according to a seventeenth embodiment of the present invention, wherein the device 635 comprises an ablation element 640 at a head, wherein some or each ablation element 640 has a rigid portion 650, 665 and an expandable portion 645, 655, 660, 670. When the ablation element 640 is expanded, the rigid portion prevents uniform expansion and thus deforms the ablation element. In addition, the elements may include separate cavities in each ablation element which, when selectively expanded (partially or completely or not at all), may provide for partial deformation of, for example, the expandable portions 645, 660 or more severe, for example, greater deformation of the expandable portions 655, 670. As with the previous embodiments, this adaptability allows the head 640 to adapt to the circular oral tissue 60 or the oval oral tissue 62 and to provide different elastic deformations, Fig.9F The elastic deformation force directions 580 and 685 of the ablation element to adapt to different tissues are shown.

[0057] FIG. 10A to FIG. 10F Various combinations of the previously described anchoring balloon embodiments used with other device embodiments are shown. FIG. 10A to FIG. 10B are various views according to an eighteenth embodiment of the present invention, FIG. 10C to FIG. 10Dare various views according to a nineteenth embodiment of the present invention, Fig.10E is an isometric view of a twentieth embodiment according to the present invention, Fig.10F is an isometric view of a twenty-first embodiment of the present invention, comprising: 1) Annular anchoring balloon 695, 725, 732 which provides holes to allow blood flow through, see Fig. 10A , Fig. 10B , Fig.10E ; Complete anchoring balloon 725, 735, see Fig. 10C , Fig. 10D , Fig.10F .

[0058] exist Fig. 10A The device 690 has a balloon 700 and a balloon 705, Fig. 10C The device 710 includes a balloon 715 and a balloon 720, and their functions are described in the seventh embodiment. Fig.10E and Fig.10F For the device 730, reference may be made to the description of the sixth embodiment.

[0059] FIG. 11A to FIG. 11K are various views according to a twenty-second embodiment of the present invention, FIG. 11A to FIG. 11J Yet another embodiment of a device 740 is shown having an elongated head 745. In this embodiment, ablation elements 755 may extend laterally and connect to the head 745 on branches 760. In this case, there are two ablation elements 755 extending laterally on opposite sides of the elongated head 745, with branches 760 being used to provide a resilient engagement and through which energy pulses may be delivered, and also as a conduit for data transmission if a sensor is used.

[0060] In order to facilitate transportation, when Fig.11A When in the retracted position shown in Fig.11E , these ablation elements 755 are in a flush position 770 with the head, thereby forming a distal cap of the elongated head 745. When in place, these ablation elements 755 extend and simultaneously open the distal hole of the head 745. From the distal hole, the anchoring balloon 765 can be deployed from a collapsed state 775 within the head to an expanded position state 785 extending distally from the head. Once the balloon is fully deployed and the elements are fully extended to the expanded position state 785, ablation can begin.

[0061] This embodiment also illustrates the process of anchoring balloon deployment, in this case for a complete anchoring balloon 750, but can also be used for annular anchoring balloons.

[0062] Balloon 765 is uninflated within head 745 in a flush position 770. As ablation element 755 is deployed laterally from head 745, this opens the housing forming head 745 to allow advancement of balloon 765 in an advanced position 775, through a transitional position 780, and to expanded position states 785, 790 to complete full deployment.

[0063] Thus, during operation of heart 795, anchoring balloon 750 anchors device 740 such that lateral deployment of ablation element 755 is aligned with tissue 60 to initiate treatment.

[0064] Figure 11K Yet another embodiment of an anchoring balloon 754 is shown. In this embodiment, the actual balloon 754 is similar to the balloons described with respect to the other embodiments. It should be appreciated that during the ablation procedure, it is highly desirable to maintain blood flow through the vein. As Fig.10E Alternatively to the annular anchoring balloon 735 in other embodiments, the catheter 756 has been adjusted at the distal end to allow blood to flow through the catheter, thereby preventing the blockage caused by the balloon 754. Specifically, the catheter 756 at the distal end includes a hole 758 for receiving blood flow, which passes through the catheter and exits through the hole 762 to form a bypass that allows blood to flow through. Figure 11K Middle arrow 764 indicates the direction of blood flow inlet, and arrow 766 indicates the direction of blood flow outlet. Thus, the use of this arrangement of bypass balloon 754 is used for limited blood flow interruption once appropriate.

[0065] FIG. 12A to FIG. 12C These are various views of the twenty-third embodiment of the present invention, in which the device 800 includes an ablation element 805 and a balloon 810, wherein the ablation element 805 is another embodiment of a hinged rigid element, which is laterally deployed in a pivotal manner and then released and deployed to states 815, 820, 825, 830, and 835.

[0066] FIG. 13A to FIG. 13O are various views according to a twenty-fourth embodiment of the present invention, FIG. 13A to FIG. 13OAnother embodiment of the device 840 is shown, which also shows the complete balloon anchor 845. In this embodiment of the lateral deployment of the ablation element 850, the connection to the catheter is via an extension assembly 855. The extension assembly 855 includes a sliding connection and a fixed connection, the sliding connection portion is composed of an end assembly 860, a spline assembly 865, a separation assembly 870, a spline assembly 875 and a fixed assembly 880, so that the assembly can deploy the ablation element 850 laterally in a triangular mechanism, wherein the end assembly 860 is used to fix the spline assembly 865 and spline assembly 875 together in place, the spline assembly 865 and spline assembly 875 are connected to the electrode 852 to slide the motor (to achieve folding / expansion), the separation assembly 870 is used to support the separation between the two spline assemblies of the electrode 852, and the fixed assembly 880 fixes the spline assembly and the end assembly 860 in place. The extension assembly 855 provides electrical connection to the electrode 852 (plus a sensor if necessary) through each part of the electrical isolation assembly.

[0067] The ablation elements can take several different shapes and orientations including: semi-circular disks 890 with adjacent polar quarters; annular rings 895; semi-cylinders 900, 905, 915 with various groove configurations 930, 935, 940 for sensor placement and semi-circular blocks 910. Laterally deployed elements are used to locally treat tissue 925.

[0068] In a twenty-fifth embodiment of the invention, wherein the head comprises a plurality of elongated expandable ablation elements aligned parallel to the catheter. The position of the expandable ablation elements can be moved by elastic engagement between insertion on the round mouth tissue or the oval mouth tissue. Two different embodiments are shown, wherein the first embodiment has a catheter with a single conduit to uniformly expand the ablation elements; and a second embodiment of the device, wherein the catheter comprises a plurality of conduits to selectively expand the ablation elements of the elongated balloons and thereby further enhance the ability to deform the head to better contact tissues of different shapes.

[0069] FIG. 14A to FIG. 14D are various views according to a twenty-sixth embodiment of the present invention, FIG. 14A to FIG. 14DAnother embodiment of a laterally deployed ablation element is shown, the device 1064 includes an ablation element and a housing 1075, wherein the ablation element is coupled to the housing 1075 of the catheter. The ablation element has a jaw 1065 shaped like a crane grab, so that when inserted, the jaw 1065 is closed and opened to laterally pivotally deploy the ablation element. The jaws 1065 each have a surface arranged to face the tissue when opened, wherein the surface carries an electrode. The jaws 1065 can be sized to expand the size of the vein to improve contact. To this end, the degree of opening of the jaws 1065 can be selectively controllable, and thus the partial opening of the jaws 1065 can provide sufficient elastic engagement with the tissue to be treated.

[0070] Alternatively, the jaws are flexible between the pivots and can therefore bend over the entire surface to produce an elastic deformation.

[0071] The opening of the jaw 1065 can be achieved by a pull rod 1070 , so that when the pull rod 1070 is pulled by performing action 1080 , the jaw 1065 will open while resisting elastic deformation to maintain the closing tendency of the jaw 1065 .

[0072] Fig.15A Electroporation voltage delivery 1140 is shown following application of a pulsed energy ablation device (PV cross-sectional tissue 62). Fig. 15B Ablation energy 1142 (PV cross-sectional tissue 62) is shown after application of a pulsed energy ablation device. Fig. 15C A heart 1145 is shown indicating both an ablation pattern 1150 using conventional RF therapy and an ablation pattern 1152 using pulsed ablation according to the device of the present invention.

[0073] Fig.16A is a flow chart showing a method of deploying a device for tissue ablation in a PV ostium / vessel, for a device having multiple electrodes (with or without force sensors), comprising the following steps: 1230. Introducing the device into the left atrium (e.g., right femoral vein / right internal jugular vein); 1235. deploying the device to a desired location (e.g., PV ostium) based on the visible marker; 1240. Confirmation of device placement is performed (e.g., fluoroscopy); 1245. Confirmation of good electrode attachment (e.g., fluoroscopy or force sensor or impedance readings); 1250. Pulse energy ablation is applied; 1255. The device is repositioned (e.g., sequential angle changes or expansion-collapse of expandable members or deployment-collapse features of the device that can be adjusted at an operator handle); 1260. Perform reapplication of pulse ablation until the pulmonary veins are successfully isolated.

[0074] Fig. 16B is a flow chart showing a method of deploying a device for tissue ablation in a PV ostium / vessel, for a device having multiple electrodes and features that facilitate better alignment of the electrodes with the vessel wall, comprising the following steps: 1265. Introducing the device into the left atrium (e.g., right femoral vein / right internal jugular vein); 1270. deploying the device to a desired location (e.g., PV ostium) based on the visible marker; 1275. Confirmation of device placement is performed (e.g., fluoroscopy); 1280. Deployment features (expandable or actuated or physical features) to aid in attaching the electrode to the wall; 1285. Confirmation of good electrode attachment (e.g., fluoroscopy or force sensor or impedance readings); 1290, pulse energy ablation is applied; 1295. The device is repositioned (e.g., sequential angle changes or expansion-collapse of expandable members or deployment-collapse features of the device that can be adjusted at an operator handle); 1300. Perform reapplication of pulse ablation until the pulmonary veins are successfully isolated.

[0075] Fig. 16C is a flow chart showing a method of deploying a device for tissue ablation in a PV ostium / vessel, for a device having independent anchoring features, multiple electrodes, features that facilitate better alignment of the electrodes with the vessel wall, comprising the following steps: 1305. Introducing the device into the left atrium (e.g., right femoral vein / right internal jugular vein); 1310. Deploy the device to a desired location (e.g., PV ostium) based on the visible marker; 1315. Confirmation of device placement is performed (e.g., fluoroscopy); 1320. The device is anchored using the deployment feature and the placement is reconfirmed; 1325. Deployment features (expandable or actuated or physical features) to aid in attaching the electrode to the wall; 1330. Confirmation of good electrode attachment (e.g., fluoroscopy or force sensor or impedance readings); 1335. Pulse energy ablation is applied; 1340, the device is repositioned (e.g., sequential angle changes or expansion-collapse of expandable members or deployment-collapse features of the device adjustable at an operator handle); Reapplication of pulsed ablation is performed until the pulmonary veins are successfully isolated.

[0076] Fig.16D is a flow chart showing a method of deploying a device for tissue ablation in a PV vessel, for a device having multiple electrodes (with or without force sensors) and independent anchoring features, comprising the following steps: 1350. Introducing the device into the left atrium (e.g., right femoral vein / right internal jugular vein); 1355. Deploy the device to a desired location (e.g., PV ostium) based on visible markings; 1360. Confirmation of device placement is performed (e.g., fluoroscopy); 1365. The device is anchored using the deployment feature and the placement is reconfirmed; 1370. Confirmation of good electrode attachment (e.g., fluoroscopy or force sensor or impedance readings); 1375. Pulse energy ablation is applied; 1380, the device is repositioned (e.g., sequential angle changes or expansion-collapse of expandable members or deployment-collapse features of the device adjustable at an operator handle); Reapplication of pulsed ablation is performed until the pulmonary veins are successfully isolated.

[0077] Fig.16E is a flow chart showing a method of deploying a device for tissue ablation in a PV vessel for a device having multiple electrodes (with or without force sensors) and a simultaneous anchoring feature, comprising the following steps: 1390. Introducing the device into the left atrium (e.g., right femoral vein / right internal jugular vein); 1395. Deploy the device to a desired location (e.g., PV ostium) based on visible markings; 1400. Confirmation of device placement is performed (e.g., fluoroscopy); 1405. deploying an expandable feature to have a push electrode attached to the wall; 1410. Confirmation of good electrode attachment (e.g., fluoroscopy or force sensor or impedance readings); 1415. Pulse energy ablation is applied; 1420, the device is repositioned (e.g., sequential angle changes or expansion-collapse of expandable members or deployment-collapse features of the device adjustable at an operator handle); Reapplication of pulsed ablation is performed until the pulmonary veins are successfully isolated.

[0078] Fig.16Fis a flow chart showing a method of deploying a device for tissue ablation in a PV vessel, for a device having electrodes designed to achieve good adhesion to the vessel wall when manipulated by an operator, comprising the following steps: 1430. Introducing the device into the left atrium (e.g., right femoral vein / right internal jugular vein); 1435. deploying the device to a desired location (e.g., PV ostium) based on the visible marker; 1440. Confirmation of device placement is performed (e.g., fluoroscopy); 1445. The device is placed with the electrode tip touching the PV ostium or PV vessel; 1450, pulse energy ablation is applied; 1455. Rotating the distal end of the device (with the electrode) at a predetermined angle; 1460. Perform reapplication of pulse ablation until the pulmonary veins are successfully isolated.

[0079] The above embodiments are only for illustrating the technical concept and features of the present invention, and their purpose is to enable people familiar with the technology to understand the content of the present invention and implement it accordingly, and they cannot be used to limit the protection scope of the present invention. Any equivalent changes or modifications made according to the spirit of the present invention should be included in the protection scope of the present invention.

Claims

1. A cardiac ablation system for treating cardiac tissue, comprising a catheter and a head, wherein the head is the ablation end of the cardiac ablation system for the cardiac tissue, and the catheter is a flexible tubular connector used to connect the head of the cardiac ablation system, characterized in that: The head includes a pair of independent elongated link-shaped ablation elements, the ablation elements including pivotally connected and linearly arranged segments, the ablation elements being arranged to extend radially from the center of the head; Each ablation element is provided with a contact surface for contacting cardiac tissue and a flexible support body for supporting the contact surface, wherein an energy application portion is provided on the contact surface; at least some of the ablation elements are arranged to be elastically coupled to the tissue; the elastic coupling includes one or both of elastic deformation and elastic displacement; The ablation element has two working states at the head position of the cardiac ablation system: contraction and extension. In the contraction state, multiple independent ablation elements are gathered together and present a minimum volume. In the extension state, one or more independent ablation elements are opened and conform to various shape changes of the contacted cardiac tissue in an adaptive manner through the contact surfaces on each ablation element.

2. The system according to claim 1, wherein: The ablation elements are each connected to the head at an end thereof and are arranged to move from a position parallel to the catheter to a radially extended position upon application of a pulling force at the end thereof.

3. A cardiac ablation system for treating cardiac tissue, comprising a catheter and a head, wherein the head is the ablation end of the cardiac ablation system for the cardiac tissue, and the catheter is a flexible tubular connector used to connect the head of the cardiac ablation system, characterized in that: The head includes a plurality of independent curved ablation elements, the ablation elements being curved and arranged to extend radially from a center of the head; Each ablation element is provided with a contact surface for contacting cardiac tissue and a flexible support for supporting the contact surface, wherein the contact surface is provided with an energy application portion; at least some of the ablation elements are arranged for elastic engagement with the tissue; the elastic engagement comprises elastic deformation of the ablation element; the ablation element further comprises a pneumatic portion, the contact surface is located on the pneumatic portion; The ablation element has two working states at the head position of the cardiac ablation system: contraction and extension. In the contraction state, multiple independent ablation elements are gathered together and present a minimum volume. In the extension state, one or more independent ablation elements are opened and conform to various shape changes of the contacted cardiac tissue in an adaptive manner through the contact surfaces on each ablation element.

4. The system according to claim 3, wherein: The contact surface has a convex profile.

5. A cardiac ablation system for treating cardiac tissue, comprising a catheter and a head, wherein the head is the ablation end of the cardiac ablation system for the cardiac tissue, and the catheter is a flexible tubular connector for connecting the head of the cardiac ablation system, characterized in that: The head has a plurality of mutually independent ablation elements arranged to move from a retracted position flush with the head to a laterally extended position, the ablation elements being attached to the head via branches; Each ablation element is provided with a contact surface for contacting cardiac tissue and a flexible support body for supporting the contact surface, wherein an energy application portion is provided on the contact surface; at least some of the ablation elements are arranged to be elastically coupled to the tissue; the elastic coupling includes one or both of elastic deformation and elastic displacement; The ablation element has two working states at the head position of the cardiac ablation system: contraction and extension. In the contraction state, multiple independent ablation elements are gathered together and present a minimum volume. In the extension state, one or more independent ablation elements are opened and conform to various shape changes of the contacted cardiac tissue in an adaptive manner through the contact surfaces on each ablation element.

6. The system of claim 5, further comprising an anchoring balloon arranged to move from a collapsed position within the head to a deployed position extending in a distal direction from the head.

7. The system of any one of claims 1 to 6, further comprising an anchor for securing the head relative to the tissue.

8. The system according to claim 7, wherein: The anchor includes an expandable anchoring balloon coupled to the catheter, the expandable anchoring balloon being arranged to engage a wall of a vein adjacent to the tissue, the anchoring balloon being annular with pores arranged to allow blood flow therethrough.

9. A cardiac ablation system and method for use with a device having independent anchoring features, a plurality of electrodes, and features that facilitate better alignment of the electrodes with a vessel wall, the method comprising: introducing the device into the left atrium; deploying the device to a desired location based on the visible marker; Confirmation of device placement is performed; The device was anchored using the deployment feature and placement was reconfirmed; deploying expandable or actuable or physical features to aid in attaching the electrode to the wall; Confirmation of good adhesion of electrodes; Pulsed energy ablation is applied; The device was repositioned; Reapplication of pulsed ablation is performed until the pulmonary veins are successfully isolated.

10. A cardiac ablation system and method for use with an apparatus having electrodes designed to achieve good adhesion to a vessel wall when manipulated by an operator, the method comprising: introducing the device into the left atrium; deploying the device to a desired location based on the visible marker; Confirmation of device placement is performed; The device is placed with the electrode tip touching the PV ostium or PV vasculature; Pulsed energy ablation is applied; rotating a distal end of the device having an electrode by a predetermined angle; Reapplication of pulsed ablation is performed until the pulmonary veins are successfully isolated.

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