Removable ablation tip for left atrial appendage occlusion device

Abstract

The present disclosure generally relates to devices, systems, and methods for ablating and occluding a body cavity or cavity, including those embodiments for occluding the left auricle of a heart. An exemplary assembly includes a connector assembly having a connector assembly proximal end and a connector assembly distal end, the connector assembly proximal end and the connector assembly distal end being opposite ends of the connector assembly; and an expandable frame removably disposed at the distal end of the connector assembly, the expandable frame having a plurality of deployed positions, including a first deployed position in which the expandable frame is in a collapsed arrangement and a second deployed position in which the expandable frame is in a wide range arrangement; and wherein the connector assembly is operably connected to the expandable frame and configured to facilitate movement of the expandable frame between a plurality of deployed positions.

Description

Technical Field

[0001] The present disclosure relates generally to devices, systems and methods for ablating and occluding body lumens or cavities, and more particularly to devices, systems and methods for occluding the left atrial appendage of the heart. Background Art

[0002] Atrial fibrillation (AF) is a common, sustained heart rhythm disorder that affects people worldwide. People affected by AF can face serious consequences. AF is the irregular, chaotic beating of the heart's upper chambers. Electrical impulses are rapidly discharged within the heart, causing the atrial muscles to quiver or tremble. Episodes of AF can last from minutes to days. A serious consequence of AF is ischemic stroke. Most people with AF, regardless of the severity of their symptoms or the frequency of their episodes, require treatment to reduce their risk of stroke.

[0003] In patients with AF, blood tends to pool and form clots in an area of ​​the heart called the left atrial appendage (LAA). The LAA is a pouch-like extension located in the upper part of the heart's left ventricle. Blood clots that break away from this area may migrate through blood vessels and eventually block smaller blood vessels in the brain or heart, leading to a stroke or heart attack. It is well known that most blood clots in patients with AF appear in the LAA.

[0004] Treatment of AF may include surgical closure of the LAA, epicardial LAA ligation, or delivery of a device or mechanism through or into the LAA to occlude it. Occlusion devices used to treat AF typically employ metal "cages" and / or fabric grafts that, when deployed, form a circular shape through and / or within the LAA. They are delivered to the treatment site via a catheter system.

[0005] exist Figure 1 , a cross-sectional view of a human heart is shown. Figure 1 A common technique is also described in which a catheter is passed through the vascular system and into the heart to deliver the occluding device to the LAA. Ideally, when the device is correctly positioned in the LAA, the occluding device forms a seal with the wall of the LAA to prevent embolism or blood clots from flowing back into the bloodstream. However, many known occluding devices are equipped with expandable frames that are sufficient to support filters or membranes, but their circumferential and / or radial strengths are insufficient to resist the torsional forces exerted by the LAA on the occluding device. As a result, when the expandable frame is bent into a more elliptical shape by the LAA, the seal formed by this device with the inner wall of the LAA is destroyed. Therefore, this device may allow some substances to leave the LAA and re-enter the bloodstream.

[0006] Unexpected pericardial adhesions may delay or prevent successful closure surgery. Known in the prior art are self-expanding nitinol frame structures with fixed barbs and a permeable polyester terephthalate membrane covering the atrial surface. These closure devices can be used in hybrid ablation procedures. For example, in cases where surgical LAA closure methods cannot be applied, implanting a closure device in a hybrid AF ablation setting (i.e., combining thoracoscopic epicardial surgery and endocardial catheter ablation) may be a reliable option. Summary of the invention

[0007] Disclosed herein are methods and devices for guiding patient anatomical structures. These aspects are useful for surgical procedures requiring such guidance, and can optionally be used to perform certain surgical procedures when guided to a treatment site. One general aspect ("Example 1") includes a component for guiding a heart. The component includes a connector assembly having a proximal end of a connector assembly and a distal end of a connector assembly, the proximal end of the connector assembly and the distal end being opposite ends of the connector assembly; and an expandable frame detachably disposed at the distal end of the connector assembly, the expandable frame having a plurality of deployment positions, including a first deployment position in which the expandable frame is in a clustered arrangement and a second deployment position in which the expandable frame is in a wide range arrangement; and wherein the connector assembly is operably connected to the expandable frame and is configured to facilitate moving the expandable frame between a plurality of deployment positions. Implementations of the technology may include hardware, methods or processes, or computer software on a computer-accessible medium. Implementations may include one or more of the following features.

[0008] In another example ("Example 2"), an ablation catheter may include: an elongated hollow shaft having a proximal end, a distal end, and a lumen extending along the elongated hollow shaft; a handle disposed at the proximal end of the shaft; an assembly as described in Example 1, arranged relative to the elongated hollow shaft such that a connector assembly extends from the handle to an expandable frame to operably connect the handle to the expandable frame, such that actuation of the handle moves the expandable frame between a plurality of expanded positions, and wherein the ablation catheter is configured to direct energy to the expandable frame to ablate tissue at or around the expandable frame.

[0009] In another example ("Example 3"), in addition to Example 2, the expandable frame may include a threaded socket, and the connector assembly may include a threaded wire that can be accommodated in the threaded socket, so that the expandable frame is attached by screwing the connector assembly into the expandable frame and is removed by screwing the connector assembly off the expandable frame.

[0010] In another example ("Example 4"), in addition to Example 2, the connector assembly includes a hypotube extending through the handle and a threaded wire attached to the hypotube and the expandable frame.

[0011] In another example ("Example 5"), in addition to Example 2, the handle includes a housing and a deployment assembly disposed with the housing such that actuating the handle moves the expandable frame between a plurality of deployed positions.

[0012] In another example ("Example 6"), in addition to Example 5, the deployment assembly includes a switch and a converter, which is operably connected to the switch and the connector assembly, so that the actuation handle may include an actuation switch, and the converter facilitates movement of the connector assembly relative to the slender hollow shaft, thereby moving the expandable frame between multiple deployment positions.

[0013] In another example ("Example 7"), in addition to Example 5, the deployment assembly can include a torque knob that is used to detach the expandable frame from the ablation catheter. Implementations of the technology can include hardware, methods or processes, or computer software on a computer accessible medium.

[0014] In another example ("Example 8"), in addition to Examples 2-7, a biocompatible covering is disposed on at least a portion of the expandable frame.

[0015] In another example ("Example 9"), in addition to Example 8, the expandable frame can include electrodes that facilitate delivery of ablation energy to produce a volume of ablated tissue having a shape and size corresponding to the expanded position of the expandable frame.

[0016] In another example ("Example 10"), in addition to Example 8 or 9, an occlusive implant delivery system can include: a one-piece ablation catheter and a generator operably connected to the ablation catheter to cause the ablation catheter to generate ablation energy at the expandable frame.

[0017] In one example ("Example 11"), a general aspect includes a method for occluding a portion of a heart, the method delivering an ablation catheter into the heart so that the intracardiac portion of the ablation catheter is positioned adjacent to the portion of the heart to be ablated, the ablation catheter may include: an elongated hollow shaft having a proximal shaft end, a distal shaft end, and a lumen extending along the elongated hollow shaft; an expandable frame detachably disposed at the distal shaft end, the expandable frame having a plurality of deployed positions, including a first deployed position in which the expandable frame is in a clustered arrangement and a second deployed position in which the expandable frame is in a wide area arrangement; and a handle disposed at the proximal shaft end and operably connected to the expandable frame, such that actuation of the handle moves the expandable frame between the plurality of deployed positions, and wherein the ablation catheter is configured to direct energy to the expandable frame, thereby ablating tissue at or around the expandable frame. The method also includes deploying the expandable frame into the portion of the heart to be ablated. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.Implementations may include one or more of the following features.

[0018] In another example ("Example 12"), in addition to Example 11, the method may include positioning an expanded portion of the expandable frame adjacent to tissue to be ablated, and generating ablation energy at the expandable frame to ablate tissue at or around the expandable frame.

[0019] In another example ("Example 13"), in addition to Example 12, the method may include moving the expandable frame into at least one of a clustered arrangement and a wide area arrangement.

[0020] In another example ("Example 14"), in addition to Example 13, the ablation catheter also includes: a connector assembly extending from the handle to the expandable frame to operably connect the handle to the expandable frame; and an expansion assembly arranged at the handle to actuate the handle accordingly to guide the expandable frame to move between multiple expansion positions, the expansion assembly including a switch and a converter, the converter operably connected to the switch and the connector assembly, so that the actuation handle may include an actuation switch, and the converter facilitates movement of the connector assembly relative to the slender hollow shaft, thereby moving the expandable frame between multiple expansion positions; and wherein, moving the expandable frame to at least one of a clustered arrangement and a wide area arrangement may include an actuation handle.

[0021] In another example ("Example 15"), in addition to Examples 11-14, deploying the expandable frame into the portion of the heart to be ablated can include disassembling the expandable frame into the portion of the heart to be occluded.

[0022] In one example ("Example 16"), a general aspect includes an assembly for guiding the heart. The assembly also includes a connector assembly having a proximal end of the connector assembly and a distal end of the connector assembly, the proximal end and the distal end of the connector assembly being opposite ends of the connector assembly; and an expandable frame detachably disposed at the distal end of the connector assembly, the expandable frame having a plurality of deployment positions, including a first deployment position in which the expandable frame is in a clustered arrangement and a second deployment position in which the expandable frame is in a wide range arrangement; and wherein the connector assembly is operably connected to the expandable frame and is configured to facilitate moving the expandable frame between a plurality of deployment positions. Implementations of the technology may include hardware, methods or processes, or computer software on a computer-accessible medium. Implementations may include one or more of the following features.

[0023] In another example ("Example 17"), in addition to Example 16, an ablation catheter may include: an elongated hollow shaft having a proximal end, a distal end, and a lumen extending along the elongated hollow shaft; a handle disposed at the proximal end of the shaft; an assembly arranged relative to the elongated hollow shaft such that a connector assembly extends from the handle to the expandable frame, thereby operably connecting the handle to the expandable frame, so that actuation of the handle moves the expandable frame between a plurality of expanded positions, and wherein the ablation catheter is configured to direct energy to the expandable frame to ablate tissue at or around the expandable frame.

[0024] In another example ("Example 18"), in addition to Example 17, the expandable frame may include a threaded socket, and the connector assembly may include a threaded wire that can be accommodated in the threaded socket, so that the expandable frame is attached by screwing the connector assembly into the expandable frame and is removed by screwing the connector assembly off the expandable frame.

[0025] In another example ("Example 19"), in addition to Example 17, the connector assembly includes a hypotube extending through the handle and a threaded wire attached to the hypotube and the expandable frame.

[0026] In another example ("Example 20"), in addition to Example 17, the handle includes a housing and a deployment assembly disposed with the housing such that actuating the handle moves the expandable frame between a plurality of deployed positions.

[0027] In another example ("Example 21"), in addition to Example 20, the deployment assembly includes a switch and a converter, which is operably connected to the switch and the connector assembly, so that the actuation handle may include an actuation switch, and the converter facilitates movement of the connector assembly relative to the slender hollow shaft, thereby moving the expandable frame between multiple deployment positions.

[0028] In another example ("Example 22"), in addition to Example 20, the deployment assembly can include a torque knob that is used to detach the expandable frame from the ablation catheter.

[0029] In another example ("Example 23"), in addition to Example 16, a biocompatible covering is disposed on at least a portion of the expandable frame.

[0030] In another example ("Example 24"), in addition to Example 16, the expandable frame can include electrodes that facilitate delivery of ablation energy to produce a volume of ablated tissue having a shape and size corresponding to the expanded position of the expandable frame.

[0031] In another example ("Example 25"), in addition to Example 16, the expandable frame is formed as a closed basket, and the ablation electrode is located at a distal end of the expandable frame.

[0032] In one example ("Example 26"), a general aspect includes a method for occluding a portion of a heart, the method delivering an ablation catheter into the heart so that the intracardiac portion of the ablation catheter is positioned adjacent to the portion of the heart to be ablated, the ablation catheter may include: an elongated hollow shaft having a proximal end of the shaft, a distal end of the shaft, and a lumen extending along the elongated hollow shaft; an expandable frame detachably disposed at the distal end of the shaft, the expandable frame having a plurality of deployed positions, including a first deployed position in which the expandable frame is in a clustered arrangement and a second deployed position in which the expandable frame is in a wide area arrangement; and a handle disposed at the proximal end of the shaft and operably connected to the expandable frame, such that actuation of the handle moves the expandable frame between the plurality of deployed positions. The method also includes configuring the ablation catheter to direct energy to the expandable frame to ablate tissue at or around the expandable frame. The method also includes deploying the expandable frame into the portion of the heart to be ablated. Other embodiments of this aspect include corresponding computer systems, devices, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method. Implementations of the techniques may include hardware, methods or processes, or computer software on a computer-accessible medium. Implementations may include one or more of the following features.

[0033] In another example ("Example 27"), in addition to Example 26, the method may include positioning an expanded portion of the expandable frame adjacent to tissue to be ablated and generating ablation energy at the expandable frame to ablate tissue at or around the expandable frame.

[0034] In another example ("Example 28"), in addition to Example 27, the method may include moving the expandable frame into at least one of a clustered arrangement and a wide area arrangement.

[0035] In another example ("Example 29"), in addition to Example 28, the ablation catheter also includes: a connector assembly extending from the handle to the expandable frame to operably connect the handle to the expandable frame; and an expansion assembly arranged at the handle to actuate the handle accordingly to guide the expandable frame to move between multiple expansion positions, the expansion assembly including a switch and a converter, the converter operably connected to the switch and the connector assembly, so that the actuation handle may include an actuation switch, and the converter facilitates movement of the connector assembly relative to the slender hollow shaft, thereby moving the expandable frame between multiple expansion positions; and wherein, moving the expandable frame to at least one of a clustered arrangement and a wide area arrangement may include an actuation handle.

[0036] In another example ("Example 30"), in addition to Example 27, deploying the expandable frame into the portion of the heart to be ablated can include disassembling the expandable frame into the portion of the heart to be occluded.

[0037] In one example ("Example 31"), a general aspect includes an ablation catheter, which may include: an elongated hollow shaft having a proximal shaft end, a distal shaft end, and a lumen extending along the elongated hollow shaft; an expandable frame detachably disposed at the distal shaft end, the expandable frame having a plurality of deployed positions, including a first deployed position in which the expandable frame is in a clustered arrangement and a second deployed position in which the expandable frame is in a wide area arrangement; and a handle disposed at the proximal shaft end and operably connected to the expandable frame, such that actuation of the handle moves the expandable frame between the plurality of deployed positions, and wherein the ablation catheter is configured to direct energy to the expandable frame to ablate tissue at or around the expandable frame. The system also includes a generator operably connected to the ablation catheter so that the ablation catheter generates ablation energy at the expandable frame. Implementations of the technology may include hardware, methods or processes, or computer software on a computer-accessible medium. Implementations may include one or more of the following features.

[0038] In another example ("Example 32"), in addition to Example 31, the generator and ablation catheter in the system are configured to perform pulsed field ablation.

[0039] In another example ("Example 33"), in addition to Example 32, the expandable frame is formed as a closed basket and can include an ablation electrode located at a distal end of the expandable frame.

[0040] In another example ("Example 34"), in addition to Example 31, the generator and the ablation catheter are configured to perform bipolar pulsed field ablation.

[0041] In another example ("Example 35"), in addition to Example 34, the expandable frame is formed as a closed basket and includes an ablation electrode located at a distal end of the expandable frame, and wherein the ablation catheter includes a second ablation catheter located on the elongated hollow shaft and proximate to the ablation electrode.

[0042] Although multiple embodiments are disclosed, other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the present invention. Therefore, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 is a cross-sectional view of a human heart depicting a left atrial appendage (LAA) and an approach mode of a catheter assembly through which one or more embodiments of the present disclosure may be deployed;

[0044] Figure 2A is a plan view of an ablation catheter according to the principles of the present disclosure;

[0045] Figure 2B According to the principles of the present disclosure Figure 2A A cross-sectional view of a handle in an ablation catheter;

[0046] Figure 3 is a perspective view of a handle for an ablation catheter according to the principles of the present disclosure;

[0047] Figure 4 is included in Figure 3 An isolated perspective view of the switch and converter in the handle is shown;

[0048] Figure 5 is a plan view of an expandable frame having dual inverted proximal and distal hubs in accordance with the principles of the present disclosure;

[0049] Figure 6 is a plan view of an expandable frame having an inverted proximal hub and an outer distal hub in accordance with the principles of the present disclosure;

[0050] Figure 7 yes Figure 5 A plan view of an expandable frame with a biocompatible cover; and

[0051] Figure 8 yes Figure 6A plan view of an expandable frame with a biocompatible cover; and

[0052] Fig. 9 is a flow chart of a method for performing a hybrid ablation procedure in accordance with the principles of the present disclosure.

[0053] Although the present invention is applicable to various modifications and alternative forms, specific embodiments are shown by way of example in the accompanying drawings and are described in detail below. However, the present invention is not limited to the specific embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents and alternatives falling within the scope of the present invention defined by the appended claims. DETAILED DESCRIPTION

[0054] To promote understanding of the principles of the present disclosure, reference is now made to the examples shown in the accompanying drawings, which are described below. The illustrated examples disclosed herein are not intended to be exhaustive or to limit the present disclosure to the precise forms disclosed in the following detailed description. On the contrary, these exemplary embodiments are selected and described so that other persons skilled in the art can use their teachings. It is not beyond the scope of the present disclosure that multiple (e.g., all) features in a given example are used for all examples. Therefore, any one of the accompanying drawings should not be interpreted as having any dependency or requirement on any single component or combination of components shown therein. In addition, in the examples, the various components depicted in a given figure can be integrated with various other components (and / or components not shown) depicted therein, all of which are considered to be within the scope of the present disclosure.

[0055] The terms "coupled," "coupled," "connected," "attached," and the like and variations thereof are intended to include arrangements where two or more components are in direct physical contact and arrangements where two or more components are not in direct contact with each other (e.g., the components are "coupled" via at least a third component) but still cooperate or interact with each other.

[0056] Throughout this disclosure and claims, numerical terms (such as first and second) are used to refer to various components or features. This usage is not intended to indicate an order of components or features. Instead, the numerical terms are used to help the reader identify the referenced components or features and should not be narrowly interpreted as providing a specific order of components or features.

[0057] For purposes of this disclosure, like reference numerals in the drawings will refer to like features unless otherwise specified. For example, reference numeral 100 refers to Figure 2A The expandable framework in Figure 3 and Figure 4 The expandable framework in .

[0058] In general, devices, systems, and methods for treating cardiac conditions associated with fibrillation, such as left atrial appendage fibrillation (LAAF), are disclosed herein. In this regard, examples of the disclosure include occlusive implant delivery systems. These systems can perform hybrid ablation procedures using a single device. Such systems can include an ablation catheter as described herein, such as an ablation catheter having a removable ablation, occlusive device (e.g., an occlusive implant), having an expandable frame that can be manipulated during operation to perform a hybrid ablation procedure using different forms of ablation depending on the procedure. For example, the device can take a variety of arrangements, including a clustered arrangement (see Figure 2A A) and expansion arrangement (e.g. Figure 2A The system also includes a wide angle arrangement at configuration B in the middle), which corresponds to the deployed position of the occlusion device. At least one of these arrangements can use one or more ablation techniques, such as radio frequency (RF) ablation and pulsed field ablation (PFA). In this regard, the system also includes a generator (not shown) that is operably connected to the ablation catheter 10 so that the ablation catheter 10 generates ablative energy at and / or around the device. These generators can be similar to those known in the art, such as those configured to perform PFA and RF ablation. These and more examples of the principles of the present disclosure are discussed below.

[0059] In one or more aspects of the present disclosure, the occluding device may include an expandable frame and a biocompatible covering disposed on at least a portion of the expandable frame. Such occluding devices of the present disclosure may be used, for example, to occlude the left atrial appendage (LAA) of the heart for the treatment of, for example, persistent arrhythmias (e.g., atrial fibrillation). When the occluding device of the present disclosure is properly positioned within the LAA, the occluding device may have sufficient circumferential and / or radial strength to form a seal with the wall of the LAA (and to resist the torsional forces that the LAA may exert on the occluding device), for example, to prevent emboli or blood clots from flowing back into the bloodstream.

[0060] Will refer to Figure 2A and Figure 2BDiscuss more details about the ablation catheter 10. As shown herein, the ablation catheter 10 includes an elongated hollow shaft 12 having a shaft proximal end 14, a shaft distal end 16, and a lumen 18 extending along the elongated hollow shaft 12; an expandable frame 100, which is removably disposed at the shaft distal end 16; and a handle 110, which is disposed at the shaft proximal end 14. The expandable frame 100 has a plurality of deployed positions, which may include a first deployed position, in which the expandable frame 100 is in a gathered (e.g., narrow) arrangement (e.g., configuration A), and a second deployed position, in which the expandable frame 100 is in a wide area arrangement (e.g., configuration B). Other deployed positions (such as positions between configurations A and B or positions just beyond configurations A and B) are also contemplated and within the scope of the present disclosure. As discussed further below, in an example, the ablation catheter 10 is configured to direct energy to the expandable frame 100 so as to ablate tissue at or around the expandable frame 100. Optionally, when the expandable frame 100 is formed as an occlusion device (see, e.g., Figure 7 and Figure 8 ), the ablation catheter 10 is also configured to deploy the occluding device by detaching the occluding device from the ablation catheter 10, as discussed in more detail below.

[0061] The connector assembly 120 operably connects the expandable frame 100 to the handle 110. In an embodiment, the connector assembly 120 extends from the handle 110 to the expandable frame 100, thereby operably connecting the handle 110 to the expandable frame 100. Figure 2A As shown, the expandable frame 100 is disposed at the distal end of the connector assembly 120, and the handle 110 is disposed at the proximal end of the connector assembly 120. As described below, the connector assembly 120 may include one or more interconnected connector components (e.g., tubes, wires, or other connectors). In these cases, the connector assembly 120 may perform various functions, such as assisting the deployment operation of the ablation catheter 10, as further discussed below. Of course, one or more connector components may be integrally formed.

[0062] refer to Figure 2A , Figure 2B , Figure 3 and Figure 4 , the operation of the ablation catheter 10 can be facilitated via the deployment assembly 130 included in the handle 110. More specifically, as Figure 2A and Figure 2BAs shown in the example shown in , the handle 110 includes a housing in which an expansion assembly 130 is arranged. The expansion assembly 130 includes a switch 132 and a converter 134, which is operably connected to the switch 132 and the connector assembly 120. The switch 132 is disposed in a corresponding slot 136 in the housing. Exemplarily, the converter 134 is formed as an extension of the switch 132, which is connected to the connector assembly 120 via a support 138. At this point, the actuation handle 110 may include an actuation switch 132 (e.g., proximally and / or distally actuated relative to the housing). The converter 134 facilitates movement of the connector assembly 120 relative to the elongated hollow shaft 12, thereby moving the expandable frame 100 between a plurality of expansion positions. At this point, the actuation handle 110 moves the expandable frame 100 between a plurality of expansion positions.

[0063] When the expandable frame 100 is an occlusion device, the deployment assembly 130 may be manipulated to facilitate the deployment of the expandable frame. Figure 2A and Figure 2B , the expandable frame 100 may include a threaded socket 141, and the connector assembly 120 may include a connector 143 having a threaded portion 145 (e.g., at a distal end of the connector 143). Thus, the connector 143 may be received within the threaded socket 141 such that the expandable frame 100 is attached by screwing the connector 143 (e.g., using the threaded portion 145) into the expandable frame 100 and is removed by screwing the connector 143 off the expandable frame 100. The deployment assembly 130 may include a torque knob 147, which is used to remove the expandable frame 100 from the ablation catheter 10. In an embodiment, the connector 143 is at least partially formed as a hypotube extending through the handle 110 and the threaded connector 143 or threaded portion 145 is attached to the hypotube and the expandable frame 100 so as to be coupled between the hypotube and the expandable frame 100.

[0064] As described above, the ablation catheter 10 can generate electrical energy in the expandable frame 100 for use in an ablation procedure. In this regard, illustratively, the expandable frame 100 includes an electrode 149 (e.g., an ablation electrode 149). The generator is configured to facilitate delivery of ablation energy to produce a volume of ablated tissue having a shape and size corresponding to the deployed position of the expandable frame 100. The expandable frame 100 is formed as a closed basket, and the ablation electrode 149 is located at the distal end of the expandable frame 100. In the ablation system, the ablation catheter 10 can be connected to the generator via a connector 150 at the proximal end of the handle 110. The ablation catheter 10 and the generator are configured together to generate energy to perform, for example, pulsed field ablation. Even during actuation of connector assembly 120 (e.g., via movement of switch 132 and / or converter 134), flex connector 152 is able to ensure that connector 150 is connected to expandable frame 100 (e.g., via connector 143 and / or wires extending from expandable frame 100 to flex connector 152).

[0065] Multiple electrodes can be set in the ablation catheter 10 to perform multipolar ablation. In an example, the electrode 149 can be a subcomponent of the electrode assembly. In this regard, the electrode assembly can include a first ablation electrode 149 and a second ablation electrode 153. Illustratively, one of the first electrode 149 and the second electrode 153 is set at the distal end of the expandable frame 100, and the other is set at the proximal end of the ablation electrode 149 (for example, set on the expandable frame 100, the elongated hollow shaft 12 or the connector 143). Of course, other arrangements of electrodes in the electrode assembly can also be considered. For example, there is an example in which the ablation electrode is set at the proximal end of the expandable frame 100.

[0066] When constructing an expandable frame for use during surgery (e.g., during a cryoablation procedure), certain design considerations are useful. Visualization of rhythmia can be performed via guidance sensor integration known in the prior art. Some embodiments can use fluoroscopy and TEE / ICE for visualization. In addition, the expandable frame can be constructed of a rigid material that can be guided through a body cavity without any negative effects on long-term LAAO.

[0067] Now refer to Figure 5-Figure 8 Discuss more details about the expandable frame 100. Specifically, Figure 5 1 is a side view of one or more embodiments of an expandable frame 100 of the present disclosure having closed proximal and distal ends. Illustratively, the ends are defined by an inverted proximal hub and an inverted distal hub. Figure 61 is a side view of one or more embodiments of an expandable frame 100 of the present disclosure having closed proximal and distal ends. Illustratively, the ends are defined by an outer proximal hub and an inverted distal hub (or vice versa). Figure 7 and Figure 8 Similar to Figure 5 and Figure 6 In addition to the expandable frame 100, the expandable frame 100 can be implanted as an occlusive device.

[0068] As shown, the occluding device may include an expandable frame 100 formed by, for example, a sheet. The expandable frame 100 may be suitable for use as a component of the occluding device, which may also include a covering 590 (e.g., a filtering graft, a membrane, etc.). This covering 590 may be supported by the expandable frame 100 (e.g., the covering 590 may extend from the proximal end of the expandable frame 100 toward the distal end of the expandable frame 100 and extend thereon). The occluding device (including the expandable frame 100 and the covering 590) may include other components and may be combined with a delivery system for delivering the occluding device to the LAA or other body cavities. In one or more embodiments, an expandable frame 100 is depicted after manufacture but before being loaded onto a catheter or deployed.

[0069] In the present disclosure, the support members or beams 530 of the expandable frame 100 may include multiple segments. For example, each beam 530 may include a first segment 532 extending from the first hub 520 to a first circumferentially extending longitudinal column 540 of the strut pair 542, and a second segment 538 extending from the first circumferentially extending longitudinal column 540 of the strut pair 542 to another (e.g., second, third, fourth, etc.) circumferentially extending longitudinal column 540 of the strut pair 542.

[0070] Exemplarily, the expandable frame 100 includes a first hub 520 (e.g., a proximal cap or ring) from which a plurality of beams 530 (e.g., support beams 530) extend longitudinally. A first segment 532 (e.g., a proximal portion) of each beam 530 may also be considered a radial component of the beam 530 because, when the expandable frame 100 is expanded, a major length of the first segment 532 may extend radially outward from the first hub 520. When deflated, the expandable frame 100 may be substantially flat or significantly compact relative to the expanded state.

[0071] like Figure 5-Figure 8As shown, the first segment 532 of the beam 530 may include a first longitudinal extension region 534 proximate to the first hub 520. The first longitudinal extension region 534 may transition to a radial extension region 536 at an inner bend 535. In one or more examples, the radial extension region 536 may then transition or turn back to the longitudinal direction at an outer bend 537. One or more examples of the present disclosure may include an expandable frame 100 that includes a plurality of beams 530 terminated at a second hub 570 (e.g., a distal cap or ring). In at least one embodiment, the distal end of the expandable frame 100 may include a second hub 570 (e.g., the end may be closed) such that the longitudinally extending beams 530 turn radially inward to the distal cap or ring near the distal end of the device. In examples, the expandable frame 100 may be a self-expanding frame, while in other examples, the expandable frame 100 is a mechanically expandable frame. These examples are only some of the many examples disclosed herein.

[0072] In some examples, in the deployed or expanded state, the first hub 520 (e.g., a proximal ring) can be longitudinally adjacent (outside) the entire length of the beam 530, such that the beam 530 extends longitudinally away from the first hub 520 in a single longitudinal (distal) direction. In one or more examples, the first hub 520 can be inverted (inside), such that the beam 530 initially extends in a first (proximal) longitudinal direction away from the first hub 520, and then as the beam 530 turns and extends radially outward, the beam 530 bends back on the first hub 520 in an opposite (distal) longitudinal direction. In one or more examples where the device has a second hub 570 (e.g., a distal ring), the second hub 570 can be configured with an internal structure (e.g., see Figure 5 and Figure 7 ) or external structures (see, for example, Figure 6 and Figure 8 ). The interior or exterior positioning of the first hub 520 and the second hub 570 may be the same or different. That is, in one or more examples, at least one of the first hub 520 and the second hub 570 may be inverted. For example, the first hub 520 and the second hub 570 may be located inside (inverted), such as Figure 5 and Figure 7 One hub (e.g., first hub 520) may be located externally, while the other hub (e.g., second hub 570) may be inverted, such as in Figure 6 and Figure 8 In the example shown, at least a portion of the beam 530 may be hook-shaped (eg, J-shaped or C-shaped).

[0073] In examples where both the proximal and distal ends are closed, such as in the manner described herein, the columns 540 of the strut pairs 542 can have a consistent orientation (all peaks "pointing" in the same direction), or, as shown, have an opposite orientation relative to one or more other columns 540. In other examples, the expandable frame 100 can include closed ends and also include engagement anchors in the form of protrusions, indentations, or other features of the expandable frame 100. For example, the frame can include one or more radially extending anchors (e.g., engagement barbs or other features) for improving fixation of the frame to surrounding tissue (e.g., the inner wall of the LAA) when the device is deployed.

[0074] Examples of the present disclosure include an expandable frame 100 including a biocompatible covering 590 disposed on at least a portion of the expandable frame 100. In one or more examples, the covering 590 may take any of a variety of forms known to those skilled in the art. For example, the covering 590 may include a graft and / or a membrane, and may include one or more layers. In one or more examples, a membrane or other covering 590 may be disposed on a majority of the proximal end of the expandable frame 100 and around a majority of the proximal end of the expandable frame. For example, the covering 590 may be substantially bowl-shaped, with an opening extending around a portion of the occlusion device having a maximum diameter in a second configuration. In one or more examples including an anchor as described above, the anchor may penetrate the covering 590 in a first configuration and a second configuration (e.g., an unexpanded state and an expanded state) to secure the covering 590 to the expandable frame 100. The covering 590 may be any of a variety of biocompatible fabrics, meshes, films, or materials known to those skilled in the art. For example, the cover 590 can be constructed from one or more layers of polyethylene terephthalate (PET).It should be appreciated that the covers described herein can be applied to any of the examples of expandable frames 100 shown or described herein.

[0075] Other suitable materials for the cover 590 may also be used. Examples may include, but are not limited to, polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, including expanded polytetrafluoroethylene (ePTFE), fluorinated ethylene propylene, polyvinyl acetate, polystyrene, polyethylene terephthalate, naphthalene, dicarboxylate derivatives such as polyethylene naphthalate, polybutylene naphthalate, polytrimethylene naphthalate, and propylene naphthalate, polyurethane, polyurea, silicone rubber, polyamide, polyimide, polycarbonate, polyaldehyde, polyetheretherketone, natural rubber, polyester copolymers, styrene-butadiene copolymers, polyethers, such as fully or partially halogenated polyethers, and copolymers and combinations thereof.

[0076] According to the principles of the present disclosure, ablation and occlusion methods are also disclosed herein. Each of these methods can use an ablation catheter similar to that disclosed elsewhere herein. For example, Fig. 9 As shown, method 900 and related methods for performing a hybrid ablation procedure are disclosed. Method 900 may include, at step 910, advancing the distal end of a catheter through the patient's vasculature to a target area, such as to the heart, to deliver a closure device to the LAA. In this regard, continuing this heart example, the ablation catheter may be positioned adjacent to cardiac tissue to be ablated. Method 900 may include step 920 of generating scar tissue within the heart via one or more ablation techniques (e.g., RF and / or PFA ablation). When it is necessary to deploy the closure device, method 900 may include step 930 of advancing the closure device to the LAA, and step 940 of deploying the device in the LAA. When the device is properly positioned within the LAA, the closure device forms a seal with the wall of the LAA to prevent embolism and / or blood clots from flowing back into the bloodstream.

[0077] Using the ablation catheter disclosed elsewhere herein, the expandable frame used in these methods can be used for ablation, occlusion, or both ablation and occlusion. For example, as described above, the operator can choose to use the expandable frame for narrow area ablation and wide area ablation. Ablation usually occurs before the expandable frame is deployed, depending on the application. The conversion between the narrow state and the expanded state of the expandable frame (or from one state to another) can correspond to the connector assembly of the actuated ablation catheter. At this point, the distal to proximal translation (e.g., of a switch) can move the expandable frame from a pre-expanded state within the slender shaft of the ablation catheter to a narrow state just outside the slender shaft, and further advancement in the same direction can further move the expandable frame to a wide area state outside the slender shaft. Of course, there are also examples of other movements of the connector assembly (e.g., from distal to proximal, rotation, etc.) that similarly advance the expandable frame. In step 940, the deployment device may include using the deployment assembly to remove the occlusion device from the ablation catheter. At this point, the step 940 may include unscrewing the occlusion device from the connector threadedly engaged with the occlusion device. The connector can be in the form of a hypotube operably connected to a torque knob at the proximal end of the ablation catheter for easy access, such that rotating the torque knob rotates the connector to screw the occlusion device in / out. Other attachment / detachment methods, such as those known in the art and disclosed elsewhere herein, are also contemplated.

[0078] It is well known that the method includes one or more steps, and the order listed is not a limitation on the claims unless there is an explicit or implicit statement to the contrary in the specification or the claims themselves. It is also well known that the methods shown are only some examples of many examples disclosed, and certain steps may be added or omitted without departing from the scope of the present disclosure. These steps may include combined devices, systems or methods or components thereof, as well as those known, conventional and conventional in the art.

[0079] The connecting lines shown in the various figures included herein are intended to represent exemplary functional relationships and / or physical connections between the various elements. It should be noted that there may be many alternative or additional functional relationships or physical connections in the actual system. However, benefits, advantages, solutions to problems, and any elements that may cause any benefits, advantages, or solutions to appear or become more significant should not be interpreted as key, essential, or necessary features or elements. Therefore, the scope of the present disclosure is not subject to any restrictions except for the appended claims, in which, unless explicitly stated, the elements in the singular form do not mean "one and only one", but "one or more". In addition, when a phrase similar to "at least one of A, B, or C" is used in the claims, the phrase is intended to be interpreted as meaning that A can exist alone in an embodiment, B can exist alone in an embodiment, C can exist alone in an embodiment, or any combination of elements A, B, or C can exist in a single embodiment; such as A and B, A and C, B and C, or A and B and C.

[0080] In the detailed description herein, references to "one embodiment," "an embodiment," "an exemplary embodiment," and the like indicate that the described embodiment may include a particular feature, structure, or characteristic, but that each embodiment does not necessarily include the particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Furthermore, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it is considered that such feature, structure, or characteristic may be implemented in conjunction with other embodiments within the knowledge of those skilled in the art who would benefit from the present disclosure, whether or not explicitly described. After reading the specification, it will be clear to those skilled in the relevant art how to implement the present disclosure in alternative embodiments.

[0081] In addition, no element, component, or method step in the present disclosure is intended to be dedicated to the public, regardless of whether the element, component, or method step is explicitly stated in the claims. Unless the element is explicitly stated using the phrase "means for...", the claim elements herein will not be interpreted in accordance with the provisions of 35 U.S.C. 112 (f). As used herein, the terms "comprises," "comprising," or any other variant thereof are intended to cover non-exclusive inclusions, such that a process, method, article, or device that includes a series of elements includes not only those elements, but may also include other elements that are not explicitly listed or inherent to such a process, method, article, or device.

[0082] Although the present disclosure has been described as having an exemplary design, the present disclosure can be further modified within the spirit and scope of the present disclosure. Therefore, the present application is intended to cover any changes, uses or modifications of the present disclosure using its general principles. In addition, the present application is intended to cover deviations from the present disclosure in known or conventional practices in the field to which the present disclosure belongs.

Claims

1. A component for guiding a heart, the component include: a connector assembly having a connector assembly proximal end and a connector assembly distal end, the connector assembly proximal end and the distal end being opposite ends of the connector assembly; as well as an expandable frame removably disposed at a distal end of the connector assembly, the expandable frame having a plurality of deployed positions, including a first deployed position in which the expandable frame is in a clustered arrangement and a second deployed position in which the expandable frame is in a wide area arrangement; and Wherein, the connector assembly is operably connected to the expandable frame and is configured to facilitate moving the expandable frame between a plurality of deployed positions.

2. An ablation catheter, include: an elongated hollow shaft having a shaft proximal end, a shaft distal end, and a lumen extending along the elongated hollow shaft; a handle disposed at the proximal end of the shaft; The assembly of claim 1, said assembly being arranged relative to said elongated hollow shaft such that said connector assembly extends from said handle to said expandable frame to operably connect said handle to said expandable frame such that actuation of said handle moves said expandable frame between said plurality of deployed positions, and Wherein, the ablation catheter is configured to direct energy to the expandable frame to ablate tissue at or around the expandable frame.

3. The ablation catheter according to claim 2, in, The expandable frame includes a threaded socket, and the connector assembly includes a threaded wire that can be received in the threaded socket, so that the expandable frame can be attached by screwing the connector assembly into the expandable frame, and the expandable frame can be removed by screwing the connector assembly off the expandable frame.

4. The ablation catheter according to claim 2, in, The connector assembly includes a hypotube extending through the handle and a threaded wire attached to the hypotube and the expandable frame.

5. The ablation catheter according to claim 2, in, The handle includes a housing and a deployment assembly disposed with the housing such that actuation of the handle moves the expandable frame between the plurality of deployed positions.

6. The ablation catheter according to claim 5, in, The deployment assembly includes a switch and a converter, wherein the converter is operably connected to the switch and the connector assembly so that actuating the handle includes actuating the switch, and the converter facilitates movement of the connector assembly relative to the slender hollow shaft, thereby moving the expandable frame between the multiple deployment positions.

7. The ablation catheter according to claim 5, in, The deployment assembly includes a torque knob that is used to detach the expandable frame from the ablation catheter.

8. The ablation catheter according to any one of claims 2 to 7, in, A biocompatible covering is disposed over at least a portion of the expandable frame.

9. The ablation catheter according to claim 8, in, The expandable frame includes electrodes that facilitate delivery of ablative energy to produce a volume of ablated tissue having a shape and size corresponding to the deployed position of the expandable frame.

10. An occlusive implant delivery system, include: The ablation catheter according to any one of claims 8 or 9, and A generator is operably connected to the ablation catheter to cause the ablation catheter to generate ablation energy at the expandable frame.

11. A method for occluding a portion of a heart, the method include: Delivering an ablation catheter into the heart such that an intracardiac portion of the ablation catheter is positioned adjacent to a portion of the heart to be ablated, the ablation catheter comprising: an elongated hollow shaft having a shaft proximal end, a shaft distal end, and a lumen extending along the elongated hollow shaft; an expandable frame removably disposed at the distal end of the shaft, the expandable frame having a plurality of deployed positions, including a first deployed position in which the expandable frame is in a clustered arrangement and a second deployed position in which the expandable frame is in a wide area arrangement; and a handle disposed at the proximal end of the shaft and operably connected to the expandable frame such that actuation of the handle moves the expandable frame between the plurality of deployed positions, and wherein the ablation catheter is configured to direct energy to the expandable frame to ablate tissue at or around the expandable frame; and The expandable frame is deployed into the portion of the heart to be ablated.

12. The method of claim 11, further comprising positioning the expanded portion of the expandable frame adjacent to tissue to be ablated, and generating ablation energy at the expandable frame to ablate tissue at or around the expandable frame.

13. The method of claim 12, further comprising moving the expandable frame into at least one of a clustered arrangement and a wide area arrangement.

14. The method according to claim 13, in, The ablation catheter further comprises: a connector assembly extending from the handle to the expandable frame to operably connect the handle to the expandable frame; and a deployment assembly disposed at the handle to actuate the handle in response to directing movement of the expandable frame between the plurality of deployed positions, the deployment assembly comprising a switch and a converter operably connected to the switch and the connector assembly such that actuating the handle comprises actuating the switch and the converter facilitates movement of the connector assembly relative to the elongated hollow shaft to move the expandable frame between the plurality of deployed positions; and Wherein moving the expandable frame to at least one of the clustered configuration and the wide-range configuration comprises actuating the handle.

15. The method according to any one of claims 11 to 14, in, Deploying the expandable frame into the portion of the heart to be ablated includes disassembling the expandable frame into the portion of the heart to be occluded.

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