Removable ablation tip for left atrial appendage closure devices

Abstract

The present disclosure generally relates to devices, systems, and methods for ablation and occlusion of a body lumen or cavity, including implementations for occluding the left atrial appendage of the 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 on the connector assembly distal end, the expandable frame having a plurality of deployed positions including a first deployed position in which the expandable frame is in a focal configuration and a second deployed position in which the expandable frame is in a wide configuration, the connector assembly being operably connected to the expandable frame and configured to enable movement of the expandable frame between the plurality of deployed positions.

Description

[Technical field]

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

[0002] Atrial fibrillation (AF) is a common sustained cardiac arrhythmia that affects people worldwide. It can have serious consequences for those affected by AF. AF is an irregular, disorganized beating of the upper chambers of the heart in which electrical impulses are released so rapidly that the atrial muscles quiver, or fibrillate. AF episodes can last for minutes or days. A serious consequence of AF is an ischemic stroke. Most AF patients require treatment to reduce their risk of stroke, regardless of the severity of their symptoms or the frequency of their episodes.

[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 sac-like protrusion located in the upper left chamber of the heart. Clots that break away from this area can travel through the blood vessels and eventually block smaller blood vessels in the brain or heart, resulting in a stroke or heart attack. It is known that the majority of clots in patients with AF are found in the LAA.

[0004] Treatment of AF may include surgically closing the LAA, epicardial LAA ligation, or delivering a device or mechanism across or within the LAA to occlude the LAA. Occlusion devices for addressing AF typically use metal "cages" and / or fabric grafts that, upon deployment, form a circular shape across and / or within the LAA. They are delivered to the treatment site via a catheter system.

[0005] FIG. 1 shows a cross-sectional view of a human heart. FIG. 1 also shows a general technique for inserting a catheter through the vascular system into the heart to deliver an occlusion device to the LAA. Ideally, when the device is properly positioned within the LAA, the occlusion device forms a seal with the walls of the LAA to prevent emboli or thrombi from returning to the bloodstream. However, many known occlusion devices include an expandable frame that is sufficient to support a filter or membrane, but does not have sufficient circumferential and / or radial strength to resist the deforming forces that the LAA exerts on the occlusion device. As a result, as the expandable frame is bent into a more elliptical shape by the LAA, the seal that such devices form with the inner walls of the LAA is compromised. As a result, such devices may allow some material to exit the LAA and return to the bloodstream.

[0006] Unintended pericardial adhesions may delay or prevent successful occlusion procedures. Self-expanding nitinol frame structures with fixation barbs and permeable polyterephthalate membranes covering the atrial surface are known in the art. These occlusion devices may be useful in hybrid ablation procedures. For example, implantation of an occlusion device in a hybrid AF ablation setting (i.e., a combination of epicardial surgery and endocardial catheter ablation under thoracoscopic guidance) may be a reliable option when surgical LAA occlusion is not applicable. Summary of the Invention

[0007] Disclosed herein are methods and devices for navigating a patient's anatomy. These aspects are useful for surgical procedures requiring such navigation and can optionally be used to perform certain surgical procedures when navigated to a treatment site. One schematic aspect ("Example 1") includes an assembly for navigating the heart. The 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 on the connector assembly distal end, the expandable frame having a plurality of deployment positions including a first deployment position in which the expandable frame is in a focal configuration and a second deployment position in which the expandable frame is in a wide configuration, the connector assembly being operably connected to the expandable frame and configured to enable movement of the expandable frame between the plurality of deployment positions. Implementations of the described 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.

[0008] In another example ("Example 2"), an ablation catheter can include an elongate hollow shaft having a proximal shaft end, a distal shaft end, and a lumen, the lumen extending along the elongate hollow shaft, a handle disposed at the proximal shaft end, and an assembly as in Example 1, where the assembly is disposed relative to the elongate hollow shaft and a connector assembly extends from the handle to the expandable frame operably connecting the handle to the expandable frame such that actuation of the handle moves the expandable frame among a plurality of deployed positions, and the ablation catheter is configured to deliver energy to the expandable frame to ablate tissue at or around the location of the expandable frame.

[0009] In another example ("Example 3"), further to Example 2, the expandable frame can include a threaded socket, the connector assembly can include a threaded wire that can be received within the threaded socket, and the expandable frame can be attached by screwing the connector assembly onto the expandable frame and removed by unscrewing the connector assembly from 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"), further to Example 2, the handle includes a housing and a deployment assembly disposed with the housing such that actuation of the handle moves the expandable frame between a plurality of deployed positions.

[0012] In another example ("Example 6"), further to Example 5, the deployment assembly includes a switch and a translator operably connected to both the switch and the connector assembly such that actuating the handle can include actuating the switch, and the translator enables movement of the connector assembly relative to the elongated hollow shaft to move the expandable frame between a plurality of deployment positions.

[0013] In another example ("Example 7"), in addition to Example 5, the deployment assembly can include a torque knob for detaching the expandable frame from the ablation catheter. Implementations of the described techniques 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 cover is disposed over at least a portion of the expandable frame. In another example ("Example 9"), further to Example 8, the expandable frame can include electrodes capable of delivering ablation energy to create a region of ablated tissue having a shape and size corresponding to the deployed position of the expandable frame.

[0015] In another example ("Example 10"), in addition to Examples 8 or 9, the occlusion implant delivery system can include an ablation catheter as in Example 1 and a generator operably connected to the ablation catheter such that the ablation catheter generates ablation energy at the location of the expandable frame.

[0016] In one example ("Example 11"), one general aspect includes a method for occluding a portion of the heart comprising delivering an ablation catheter into the heart such that an intracardiac portion of the ablation catheter is positioned adjacent the portion of the heart to be ablated, the ablation catheter may include an elongate hollow shaft having a proximal shaft end, a distal shaft end, and a lumen, the lumen extending along the elongate hollow shaft, an expandable frame removably 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 focal configuration and a second deployed position in which the expandable frame is in a global configuration, and a handle disposed at the proximal shaft end and operably connected to the expandable frame, actuation of the handle moving the expandable frame between the plurality of deployed positions, the ablation catheter configured to deliver energy to the expandable frame to ablate tissue at or around the location of the expandable frame. The method also includes deploying the expandable frame within the portion of the heart to be ablated. Other embodiments of this aspect include corresponding computer systems, apparatus, and a plurality of computer programs stored on one or more computer storage devices, each configured to perform the operations of the method. Implementations may include one or more of the following features.

[0017] In another example ("Example 12"), further to Example 11, the method can include positioning an unfolded 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 location of the expandable frame.

[0018] In another example ("Example 13"), in addition to Example 12, the method can include moving the expandable frame to at least one of a focal configuration and a global configuration. In another example ("Example 14"), further to Example 13, the ablation catheter includes 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 on the handle to move the expandable frame among a plurality of deployed positions in response to actuating the handle, the deployment assembly including a switch and a translator operably connected to both the switch and the connector assembly such that actuating the handle can include actuating the switch, the translator enabling movement of the connector assembly relative to the elongated hollow shaft to move the expandable frame among the plurality of deployed positions, and the step of moving the expandable frame to at least one of the focal and global configurations can include actuating the handle.

[0019] In another example ("Example 15"), further to Examples 11-14, the step of deploying the expandable frame within the portion of the heart to be ablated can include detaching the expandable frame within the portion of the heart to be occluded.

[0020] In one example ("Example 16"), one schematic embodiment includes an assembly for navigating the heart. The assembly also 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 connector assembly distal end, the expandable frame having a plurality of deployed positions including a first deployed position in which the expandable frame is in a focal configuration and a second deployed position in which the expandable frame is in a wide configuration, the connector assembly being operably connected to the expandable frame and configured to enable movement of the expandable frame between the plurality of deployed positions. Implementations of the described 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.

[0021] In another example ("Example 17"), further to Example 16, the ablation catheter can include an elongate hollow shaft having a proximal shaft end, a distal shaft end, and a lumen, the lumen extending along the elongate hollow shaft, a handle disposed at the proximal shaft end, and an assembly, the assembly being disposed relative to the elongate hollow shaft and operably connecting the handle to the expandable frame, a connector assembly extending from the handle to the expandable frame such that actuation of the handle moves the expandable frame between a plurality of deployed positions, and the ablation catheter is configured to deliver energy to the expandable frame to ablate tissue at or around the location of the expandable frame.

[0022] In another example ("Example 18"), in addition to Example 17, the expandable frame can include a threaded socket, the connector assembly can include a threaded wire that can be received within the threaded socket, and the expandable frame can be attached by screwing the connector assembly onto the expandable frame and removed by unscrewing the connector assembly from the expandable frame.

[0023] 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.

[0024] In another example ("Example 20"), further to Example 17, the handle includes a housing and a deployment assembly disposed with the housing such that actuation of the handle moves the expandable frame between a plurality of deployed positions.

[0025] In another example ("Example 21"), further to Example 20, the deployment assembly includes a switch and a translator operably connected to both the switch and the connector assembly such that actuating the handle can include actuating the switch, and the translator enables movement of the connector assembly relative to the elongated hollow shaft to move the expandable frame between a plurality of deployment positions.

[0026] In another example ("Example 22"), in addition to Example 20, the deployment assembly can include a torque knob for detaching the expandable frame from the ablation catheter. In another example ("Example 23"), further to Example 16, a biocompatible cover is disposed over at least a portion of the expandable frame.

[0027] In another example ("Example 24"), further to Example 16, the expandable frame can include electrodes capable of delivering ablation energy to create a region of ablated tissue having a shape and size corresponding to the deployed position of the expandable frame.

[0028] In another example ("Example 25"), in addition to Example 16, the expandable frame is formed as a closed basket with an ablation electrode disposed at a distal end of the expandable frame.

[0029] In one example ("Example 26"), one general aspect includes a method for occluding a portion of the heart comprising 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 may include an elongate hollow shaft having a proximal shaft end, a distal shaft end, and a lumen, the lumen extending along the elongate hollow shaft, an expandable frame removably 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 focal configuration and a second deployed position in which the expandable frame is in a wide configuration, and a handle disposed at the proximal shaft end and operably connected to the expandable frame, the handle being actuated to move the expandable frame between the plurality of deployed positions. The method also includes where the ablation catheter is configured to deliver energy to the expandable frame to ablate tissue at or around the location of the expandable frame. The method also includes the step of deploying the expandable frame within the portion of the heart to be ablated. Other embodiments of this aspect include corresponding computer systems, apparatus, and a plurality of computer programs stored on one or more computer storage devices, each configured to perform the operations of the method. Implementations of the described 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.

[0030] In another example ("Example 27"), further to Example 26, the method can include positioning an unfolded 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 location of the expandable frame.

[0031] In another example ("Example 28"), in addition to Example 27, the method can include moving the expandable frame to at least one of a focal configuration and a global configuration. In another example ("Example 29"), further to Example 28, the ablation catheter includes 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 on the handle to move the expandable frame among a plurality of deployed positions in response to actuating the handle, the deployment assembly including a switch and a translator operably connected to both the switch and the connector assembly such that actuating the handle can include actuating the switch, the translator enabling movement of the connector assembly relative to the elongated hollow shaft to move the expandable frame among the plurality of deployed positions, and the step of moving the expandable frame to at least one of the focal and global configurations can include actuating the handle.

[0032] In another example ("Example 30"), further to Example 27, the step of deploying the expandable frame within the portion of the heart to be ablated can include detaching the expandable frame within the portion of the heart to be occluded.

[0033] In one example ("Example 31"), one general embodiment may include an ablation catheter, the ablation catheter may include an elongate hollow shaft having a proximal shaft end, a distal shaft end, and a lumen, the lumen extending along the elongate hollow shaft, an expandable frame removably 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 focal configuration and a second deployed position in which the expandable frame is in a wide configuration, and a handle disposed at the proximal shaft end and operably connected to the expandable frame, actuation of the handle moving the expandable frame between the plurality of deployed positions, the ablation catheter configured to deliver energy to the expandable frame to ablate tissue at or around the location of the expandable frame. The system also includes a generator operably connected to the ablation catheter to cause the ablation catheter to generate ablation energy at the location of the expandable frame. Implementations of the described 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.

[0034] In another example ("Example 32"), in addition to Example 31, the system further includes the generator and the ablation catheter configured to perform pulsed field ablation. In another example ("Example 33"), further to Example 32, the expandable frame can be formed as a closed basket and include an ablation electrode at a distal end of the expandable frame.

[0035] In another example ("Example 34"), in addition to Example 31, the generator and the ablation catheter are configured to perform bi-polar pulsed field ablation.

[0036] In another example ("Example 35"), in addition to Example 34, the expandable frame is formed as a closed basket and includes an ablation electrode at a distal end of the expandable frame, and the ablation catheter is disposed on the elongated hollow shaft and includes a second ablation catheter proximal to the ablation electrode.

[0037] While multiple embodiments are disclosed, still 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 invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief description of the drawings]

[0038] [Figure 1] FIG. 1 is a cross-sectional view of a human heart showing the left atrial appendage (LAA) and a mode of access by a catheter assembly in which one or more embodiments of the present disclosure may be deployed. [Figure 2A] 1 is a plan view of an ablation catheter in accordance with the principles of the present disclosure; [Figure 2B] 2B is a cross-sectional view of a handle of the ablation catheter of FIG. 2A in accordance with the principles of the present disclosure. [Diagram 3] 1 is a perspective view of a handle for an ablation catheter in accordance with the principles of the present disclosure; FIG. [Figure 4] FIG. 4 is an exploded perspective view of a switch and a translator included in the handle shown in FIG. 3. [Diagram 5] FIG. 13 is a plan view of an expandable frame with counter-inverted proximal and distal hubs in accordance with the principles of the present disclosure. [Figure 6] FIG. 13 is a plan view of an expandable frame with an inverted proximal hub and an externally exposed distal hub, in accordance with the principles of the present disclosure. [Figure 7] FIG. 6 is a plan view of the expandable frame of FIG. 5 with a biocompatible cover. [Figure 8] FIG. 7 is a plan view of the expandable frame of FIG. 6 with a biocompatible cover. [Figure 9] 1 is a flow chart of a method for performing a hybrid ablation procedure in accordance with the principles of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the specific embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

[0040] For the purpose of promoting an understanding of the principles of the present disclosure, reference is made to the examples shown in the drawings described below. The illustrative 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. Rather, these exemplary embodiments have been selected and described to enable those skilled in the art to use their teachings. It is not beyond the scope of the present disclosure to use multiple (e.g., all) features in a given example across all examples. Thus, any figure should not be interpreted as having any dependency or requirement related to any single component or combination of components shown. In addition, various components shown in a given figure may be integrated in some examples with various of the other components shown (and / or components not shown), all of which are considered to be within the scope of the present disclosure.

[0041] The terms "couples," "coupled," "connected," "attached," and the like, along with variations thereof, are used to include both arrangements in which two or more components are in direct physical contact and arrangements in which two or more components are not in direct contact with each other (e.g., the components are "coupled" through at least a third component), but yet still cooperate or interact with each other.

[0042] Throughout this disclosure and in the claims, numerical terms such as first and second are used in reference to various components or features. Such use is not intended to indicate an ordering of the components or features. Rather, the numerical terms are used to aid the reader in identifying the component or feature being referenced and should not be interpreted narrowly as providing a particular ordering of the components or features.

[0043] For purposes of this disclosure, like reference numbers in the figures shall refer to like features unless otherwise indicated. For example, reference number 100 refers to the expandable frame of FIG. 2A and also refers to the expandable frame of FIG. 3 and FIG. 4.

[0044] Generally, disclosed herein are devices, systems, and methods for the treatment of cardiac conditions associated with fibrillation, such as left atrial appendage fibrillation (LAAF). In this regard, some examples of the disclosure include occlusion implant delivery systems. These systems can perform hybrid ablation procedures using a single device. Such systems can include an ablation catheter as shown herein, for example, an ablation catheter with a removable ablation occlusion device (e.g., occlusion implant) with an expandable frame that can be manipulated during a procedure to perform a hybrid ablation procedure using different forms of ablation depending on the procedure. For example, the device can have several configurations, including a focal configuration (see Configuration A in FIG. 2A) and an expanded configuration (e.g., a wide shot configuration in Configuration B in FIG. 2A) that corresponds to the deployment position of the occlusion device. At least one of these configurations 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) operatively connected to the ablation catheter 10 for generating ablation energy at and / or around the device. These generators may be similar to those known in the art, such as generators configured to perform PFA and RF ablation. These and more other examples of the principles of the present disclosure are described below.

[0045] In one or more aspects of the present disclosure, an occlusion device may include an expandable frame and a biocompatible cover disposed over at least a portion of the expandable frame. Such an occlusion device of the present disclosure may be used, for example, to occlude the left atrial appendage (LAA) of the heart, for example, for the treatment of persistent cardiac arrhythmias (e.g., atrial fibrillation). When an occlusion device of the present disclosure is properly positioned within the LAA, the occlusion device may have sufficient circumferential and / or radial strength to form a seal with the wall of the LAA (and resist deforming forces that the LAA may exert on the occlusion device), for example, to prevent emboli or thrombi from returning to the bloodstream.

[0046] Further details regarding the ablation catheter 10 are described with reference to Figures 2A and 2B. As shown herein, the ablation catheter 10 includes an elongate hollow shaft 12 having a proximal shaft end 14, a distal shaft end 16, and a lumen 18 (the lumen 18 extends along the elongate hollow shaft 12), an expandable frame 100 removably disposed at the distal shaft end 16, and a handle 110 disposed at the proximal shaft end 14. The expandable frame 100 has multiple deployment positions, which may include a first deployment position in which the expandable frame 100 is in a focal (e.g., narrow) configuration (e.g., Configuration A) and a second deployment position in which the expandable frame 100 is in a wide configuration (e.g., Configuration B). Other deployment positions (e.g., between Configurations A and B or slightly beyond Configurations A and B) are also contemplated and are within the scope of the present disclosure. As described further below, in some examples, ablation catheter 10 is configured to deliver energy to expandable frame 100 to ablate tissue at or around the location of expandable frame 100. Optionally, when expandable frame 100 is formed as an occlusion device (see, e.g., FIGS. 7 and 8), ablation catheter 10 is further configured to deploy the occlusion device by removing the occlusion device from ablation catheter 10, as described in more detail below.

[0047] The connector assembly 120 operably connects the expandable frame 100 to the handle 110. In some examples, the connector assembly 120 extends from the handle 110 to the expandable frame 100 to operably connect the handle 110 to the expandable frame 100. As shown in FIG. 2A, the expandable frame 100 is disposed at a distal end of the connector assembly 120, and the handle 110 is disposed at a proximal end of the connector assembly 120. As described below, the connector assembly 120 can include one or more interconnected connector components (e.g., tubes, wires, or other connectors). Under these circumstances, the connector assembly 120 can perform various functions, such as assisting in the deployment operation of the ablation catheter 10, as described further below. Of course, one or more connector components can be integrally formed.

[0048] 2A, 2B, 3, and 4, operation of the ablation catheter 10 may be aided by a deployment assembly 130 included in the handle 110. More specifically, as shown in the example illustrated in FIGS. 2A and 2B, the handle 110 includes a housing having a deployment assembly 130 disposed therein. The deployment assembly 130 includes a switch 132 and a translator 134 operably connected to both the switch 132 and the connector assembly 120. The switch 132 is disposed in a corresponding slot 136 in the housing. Illustratively, the translator 134 is formed as an extension of the switch 132, which is connected to the connector assembly 120 via a bearing 138. In this regard, actuating the handle 110 may include actuating the switch 132 (e.g., proximally and / or distally relative to the housing). The translator 134 enables movement of the connector assembly 120 relative to the elongated hollow shaft 12, thereby moving the expandable frame 100 between a plurality of deployment positions. In this regard, actuation of the handle 110 moves the expandable frame 100 between a number of deployed positions.

[0049] The deployment assembly 130 can be manipulated to allow for deployment of the expandable frame 100 when the expandable frame 100 is an occlusion device. For example, with continued reference to FIGS. 2A and 2B , the expandable frame 100 can include a threaded socket 141 and the connector assembly 120 can include a connector 143 with a threaded portion 145 (e.g., at a distal end of the connector 143). The connector 143 can thus be received within the threaded socket 141, and the expandable frame 100 can be attached by threading the connector 143 to the expandable frame 100 (e.g., using the threaded portion 145) and removed by unscrewing the connector 143 from the expandable frame 100. The deployment assembly 130 can include a torque knob 147 for removing the expandable frame 100 from the ablation catheter 10. In some examples, the connector 143 is at least partially formed as a hypotube extending through the handle 110 and a threaded connector 143 or threaded portion 145 that is attached to the hypotube and the expandable frame 100 to provide a connection between the hypotube and the expandable frame 100.

[0050] As described above, the ablation catheter 10 can generate electrical energy within the expandable frame 100 for the 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 deliver ablation energy to enable generation of an area of ​​ablated tissue of a shape and size corresponding to the deployed position of the expandable frame 100. The expandable frame 100 is formed as a closed basket shape with the ablation electrode 149 disposed at a distal end of the expandable frame 100. In the ablation system, the ablation catheter 10 can be connected to the generator via a coupler 150 at a proximal end of the handle 110. The ablation catheter 10 and the generator together are configured to generate energy for performing, for example, pulsed field ablation. The flex connector 152 can ensure that the coupler 150 remains connected to the expandable frame 100 (e.g., via the connector 143 and / or wires extending from the expandable frame 100 to the flex connector 152) even during actuation of the connector assembly 120 (e.g., via movement of the switch 132 and / or the translator 134).

[0051] Multiple electrodes may be disposed within the ablation catheter 10 to perform multipolar ablation. In some instances, the electrode 149 may be a subcomponent of an electrode assembly. In this regard, the electrode assembly may include first and second ablation electrodes 149, 153. Illustratively, one of the first and second electrodes 149, 153 is disposed at a distal end of the expandable frame 100, and the other is disposed proximal to the ablation electrode 149 (e.g., on the expandable frame 100, the elongated hollow shaft 12, or the connector 143). Of course, other arrangements of electrodes within the electrode assembly are contemplated. For example, in some instances, the ablation electrode is disposed at a proximal end of the expandable frame 100.

[0052] Certain design considerations are useful in constructing an expandable frame for use during surgery, e.g., during a cryoablation procedure. Visualization in rhythmia can be performed through the integration of navigational sensors, as known in the art. Some implementations can use fluorescence and TEE / ICE for visualization. Additionally, the expandable frame can be constructed from a rigid material that is navigable through a body lumen and does not have any adverse effects on long-term left atrial appendage closure (LAAO).

[0053] The expandable frame 100 will now be described in more detail with reference to Figures 5-8. In particular, Figure 5 is a side view of one or more embodiments of the expandable frame 100 of the present disclosure having closed proximal and distal ends. Illustratively, the ends are formed by an inverted proximal hub and an inverted distal hub. Figure 6 is a side view of one or more embodiments of the expandable frame 100 of the present disclosure having closed proximal and distal ends. Illustratively, the ends are formed by an exposed proximal hub and an inverted distal hub (or vice versa). Figures 7 and 8 are similar to Figures 5 and 6, respectively, except that the expandable frame 100 is implantable as an occlusion device.

[0054] As shown, the occlusion device can include an expandable frame 100 formed, for example, from a sheet. The expandable frame 100 can be suitable for use as a component of an occlusion device, which can also include a cover 590 (e.g., a filter graft, a membrane, etc.). Such a cover 590 can be supported by the expandable frame 100 (e.g., the cover 590 can cover the proximal end of the expandable frame 100 and extend from the proximal end toward the distal end of the expandable frame 100). The occlusion device (including the expandable frame 100 and cover 590) can include other components and be combined with a delivery system for delivering the occlusion device to the LAA or other body lumen. In one or more examples, the expandable frame 100 is shown after manufacture, prior to being loaded into a catheter, or prior to being deployed.

[0055] 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 a first hub 520 to a first circumferentially extending row 540 of strut pairs 542 and a second segment 538 extending from the first circumferentially extending row 540 of strut pairs 542 to another (e.g., second, third, fourth, etc.) circumferentially extending row 540 of strut pairs 542.

[0056] Illustratively, the expandable frame 100 includes a first hub 520 (e.g., a proximal cap or ring) from which extend longitudinally a plurality of beams 530 (e.g., support beams 530). 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 a majority of the length of the first segment 532 may extend radially outward from the first hub 520 when the expandable frame 100 is expanded. In the collapsed state, the expandable frame 100 may be substantially flat or significantly compressed compared to the expanded state.

[0057] As shown in FIGS. 5-8, the first segment 532 of the beam 530 can include a first longitudinally extending region 534 immediately adjacent the first hub 520. The first longitudinally extending region 534 can transition to a radially extending region 536 at an inner curve 535. In one or more examples, the radially extending region 536 can then transition or fold back longitudinally at an outer curve 537. One or more examples of the present disclosure can include an expandable frame 100 including multiple beams 530 that terminate at a second hub 570 (e.g., a distal cap or ring). In at least one example, the distal end of the expandable frame 100 can include a second hub 570 (e.g., the end can be closed), such that the longitudinally extending beams 530 bend radially inward to a distal cap or ring near the distal end of the device. In examples, the expandable frame 100 can be a self-expanding frame, while in other examples, the expandable frame 100 is a mechanically expanding frame. These examples are only a few of the many examples disclosed herein.

[0058] In some examples, in the deployed or expanded state, the first hub 520 (e.g., proximal ring) may be longitudinally adjacent (external) to the entire length of the beams 530 such that the beams 530 extend longitudinally away from the first hub 520 in a single longitudinal direction (distal direction). In one or more examples, the first hub 520 is inverted (inwardly) such that the beams 530 first extend in a first (proximal) longitudinal direction away from the first hub 520, and then the beams 530 turn and extend radially outward such that the beams 530 bend in the opposite (distal) longitudinal direction above the first hub 520. In one or more examples in which the device has a second hub 570 (e.g., distal ring), the second hub 570 may be configured in an internal configuration (see, e.g., FIGS. 5 and 7) or an external configuration (see, e.g., FIGS. 6 and 8). The internal or external arrangement 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 and second hubs 520, 570 may be inverted. For example, the first hub 520 and the second hub 570 may be internally arranged (inverted), as in the examples shown in Figures 5 and 7. One hub (e.g., the first hub 520) may be externally arranged and the other hub (e.g., the second hub 570) may be inverted, as in the examples shown in Figures 6 and 8. At least a portion of the beam 530 may be hook-shaped (e.g., J-shaped or C-shaped).

[0059] In examples where both the proximal and distal ends are closed, such as in the manner described herein, the rows 540 of strut pairs 542 may have a uniform orientation (all apexes "pointing" in the same direction) or may have an opposite orientation relative to one or more other rows 540, as shown. In yet other examples, the expandable frame 100 may include closed ends and may include engagement anchors in the form of protrusions, depressions, or other features on the expandable framework 100. For example, the framework may include one or more radially extending anchors (e.g., engagement barbs or other features) to more securely secure the framework to the surrounding tissue (e.g., the inner wall of the LAA) when the device is deployed.

[0060] Examples of the present disclosure include an expandable frame 100 including a biocompatible covering 590 disposed over at least a portion of the expandable frame 100. In one or more examples, the covering 590 may take any of a wide variety of forms known to those of skill 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 around and cover a majority of the proximal end of the expandable frame 100. For example, the covering 590 may be substantially bowl-shaped with an opening that extends around the portion of the occlusion device that has the largest diameter in the second configuration. In one or more examples including anchors as described above, the anchors may penetrate the covering 590 in both the first and second configurations (e.g., the unexpanded and expanded states) to secure the covering 590 onto the expandable frame 100. The covering 590 may be any of a wide variety of biocompatible fibers, meshes, membranes, or materials known to those of skill in the art. For example, the cover 590 may be constructed from one or more layers of polyethylene terephthalate (PET). It should be appreciated that the covers described herein may be applicable to any of the examples of expandable frame 100 shown or described herein.

[0061] Other suitable cover 590 materials may be used as well, including, but not limited to, polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene (including expanded polytetrafluoroethylene (ePTFE)), fluorinated ethylene propylene, polyvinyl acetate, polystyrene, poly(ethylene terephthalate), naphthalene, dicarboxylate derivatives (such as polyethylene naphthalate, polybutylene naphthalate, polytrimethylene naphthalate, and trimethylene diol naphthalate), polyurethane, polyurea, silicone rubber, polyamide, polyimide, polycarbonate, polyaldehyde, polyether ether ketone, natural rubber, polyester copolymers, styrene-butadiene copolymers, polyethers (such as fully or partially halogenated polyethers), and copolymers and combinations thereof.

[0062] In accordance with the principles of the present disclosure, ablation and occlusion methods are also disclosed herein. Each of these methods may use an ablation catheter similar to those disclosed elsewhere herein. For example, as shown in FIG. 9, a method 900 and related methods for performing a hybrid ablation procedure are disclosed. At step 910, the method 900 may include advancing a distal end of a catheter through the patient's vasculature to a region of interest, such as the heart, to deliver an occlusion device to the LAA. Continuing with the heart example in this regard, the ablation catheter may be positioned adjacent to the cardiac tissue to be ablated. At step 920, the method 900 may include generating scar tissue in the heart via one or more ablation techniques (e.g., RF ablation and / or PFA ablation). If it is desired to deploy an occlusion device, the method 900 may include advancing the occlusion device to the LAA at step 930 and deploying the device within the LAA at step 940. When the device is properly positioned within the LAA, the occlusion device forms a seal with the walls of the LAA to prevent emboli and / or thrombi from returning to the bloodstream.

[0063] Using the ablation catheters disclosed elsewhere herein, the expandable frame employed in these methods may be used for ablation, occlusion, or both. For example, as described above, the practitioner may have the option of using both narrow and wide area ablation with the expandable frame. Ablation is typically performed before the expandable frame is deployed depending on the application. Transitioning the expandable frame between the narrow and expanded states (or from one state to the other) may correspond to actuating the connector assembly of the ablation catheter. In this regard, a distal to proximal movement (e.g., of a switch) may transition the expandable frame from a pre-expanded state within the elongate shaft of the ablation catheter to a narrow state just outside the elongate shaft, and further advancement in the same direction may transition the expandable frame to a wide area state further outside the elongate shaft. Of course, there are instances where other movements (e.g., distal to proximal, rotation, etc.) of the connector assembly may similarly advance the expandable frame. Deploying the device in step 940 may include removing the occlusion device from the ablation catheter using the deployment assembly. In this regard, this step 940 may include unscrewing the occlusion device from a connector that is threadably engaged with the occlusion device. The connector may be in the form of a hypotube operably connected to a torque knob at the proximal end of the ablation catheter, such that it is easily accessible, and that rotating the torque knob rotates the connector to thread / unscrew the occlusion device. Other attachment / detachment methods are contemplated, as known in the art and disclosed elsewhere herein.

[0064] It is understood that unless expressly or impliedly stated to the contrary in the description or claims themselves, the order recited does not limit the scope of the claims, including methods including one or more steps. It is also understood that the illustrated methods are only some examples of many disclosed, and that certain steps can be added or omitted without departing from the scope of the present disclosure. Such steps may include incorporating devices, systems, or methods, or components thereof, as well as those that are well understood, routine, and conventional in the art.

[0065] The connecting lines shown in the various figures contained herein are intended to represent example functional relationships and / or physical couplings between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may exist in an actual system. However, benefits, advantages, solutions to a problem, and any elements that may give rise to or make more prominent any benefit, advantage, or solution should not be construed as critical, necessary, or essential features or elements. Thus, the scope should not be limited by anything other than the scope of the appended claims, and references to elements in the singular are not intended to mean "only one" unless expressly so stated, but rather "one or more." Furthermore, 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 to mean that only A may be present in an embodiment, that only B may be present in an embodiment, that only C may be present in an embodiment, or that any combination of elements A, B, or C may be present in a single embodiment, e.g., A and B, A and C, B and C, or A and B and C.

[0066] In the detailed description of this specification, references to "one embodiment," "an embodiment," "exemplary embodiment," and the like indicate that the described embodiment may include a particular feature, structure, or characteristic, but not all embodiments necessarily include the particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same embodiment. Moreover, when a particular feature, structure, or characteristic is described in relation to an embodiment, it is within the knowledge of a person skilled in the art having the benefit of this disclosure to affect such feature, structure, or characteristic in relation to other embodiments, whether or not explicitly described. After reading the description, it will be apparent to a person skilled in the art how to implement the present disclosure in alternative embodiments.

[0067] Furthermore, no element, component, or method step of this disclosure is intended to be dedicated to the public, regardless of whether that element, component, or method step is expressly recited in a claim. No claim element herein is to be construed under the provisions of 35 U.S.C. 112(f) unless that element is expressly recited using the phrase "means for." As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus comprising a list of elements may include other elements not expressly recited or elements inherent to such process, method, article, or apparatus, rather than including only those elements.

[0068] While the present disclosure has been described as having an exemplary design, the present invention can be further modified within the spirit and scope of the present disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the present invention using its principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains.

Claims

1. 1. An assembly for navigating a heart, comprising: 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 at opposite ends of the connector assembly; an expandable frame removably disposed on the connector assembly distal end, the expandable frame having a plurality of deployed positions including a first deployed position in which the expandable frame is in a focal configuration and a second deployed position in which the expandable frame is in a global configuration; The connector assembly is operatively connected to the expandable frame and configured to enable movement of the expandable frame between the plurality of deployed positions.

2. 1. An ablation catheter comprising: an elongated hollow shaft having a proximal shaft end, a distal shaft end, and a lumen, the lumen extending along the elongated hollow shaft; a handle disposed at a proximal end of the shaft; 2. The assembly of claim 1, wherein the connector assembly is disposed relative to the elongate hollow shaft and operatively connects the handle to the expandable frame such that actuation of the handle moves the expandable frame between the plurality of deployed positions, the connector assembly extending from the handle to the expandable frame; The ablation catheter is configured to deliver energy to the expandable frame to ablate tissue at or around the location of the expandable frame.

3. 3. The ablation catheter of claim 2, wherein the expandable frame comprises a threaded socket and the connector assembly comprises a threaded wire that can be received within the threaded socket, such that the expandable frame is attached by threading the connector assembly onto the expandable frame and the expandable frame is removed by unthreading the connector assembly from the expandable frame.

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

5. The ablation catheter of claim 2 , wherein 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. 6. The ablation catheter of claim 5, wherein the deployment assembly includes a switch and a translator operably connected to both the switch and the connector assembly such that actuating the handle includes actuating the switch, the translator enabling movement of the connector assembly relative to the elongated hollow shaft to move the expandable frame between the plurality of deployment positions.

7. The ablation catheter of claim 5 , wherein the deployment assembly comprises a torque knob for detaching the expandable frame from the ablation catheter.

8. The ablation catheter of claim 2 , wherein a biocompatible covering is disposed over at least a portion of the expandable frame.

9. 10. The ablation catheter of claim 8, wherein the expandable frame comprises electrodes capable of delivering ablation energy to create a region of ablated tissue having a shape and size corresponding to a deployed position of the expandable frame.

10. 1. An occlusion implant delivery system comprising: The ablation catheter according to claim 8 or 9, a generator operatively connected to the ablation catheter such that the ablation catheter generates ablation energy at the location of the expandable frame.

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