Left atrial appendage occluder with flexible and variable fit and anchoring

Abstract

A medical device for occluding a left atrial appendage ("LAA") may include a proximal occluding member to cover an ostium of the LAA and a distal occluding member to be received within a cavity of the LAA. A connecting member may connect the proximal occluding member to the distal occluding member. An occluding material may be uncoupled from the proximal occluding member in a delivery condition of the proximal occluding member, and uncoupled from the distal occluding member in a delivery condition of the distal occluding member, the occluding material configured to at least partially fill and occlude the LAA. In some examples, the distal occluding member is entirely excluded, and the medical device includes other anchoring provisions, such as tethers that latch onto a back wall of the LAA.

Description

ABTSJM-0642PCT 15848WOO1Left Atrial Appendage Occluder with Flexible and Variable Fit and AnchoringCross-Reference to Related Applications

[0001] This application claims priority to the filing date of U.S. Provisional Patent Application No. 63 / 736,059, filed December 19, 2024, the disclosure of which is hereby incorporated by reference herein.Field of the Disclosure

[0002] The present disclosure relates generally to medical devices that are used in the human body. In particular, the present disclosure is directed to occlusion devices having configurations that allow for more consistent and stable fitting and / or anchoring of the occlusion device within a tissue cavity.Background

[0003] An occluder is a medical device used to treat (e.g., occlude) tissue at a target site within the human body, such as an abnormality, a vessel, an organ, an opening, a chamber, a channel, a hole, a cavity, a lumen, or the like. For example, an occluder may be used for Left Atrial Appendage (“LAA”) closures. An LAA is a normal anatomical structure in which there is a sac in the muscle wall of the left atrium. When a patient experiences atrial fibrillation (“AFib”), a blood clot may be formed within the LAA which may become dislodged and enter into the blood stream. By occluding the LAA, the release of blood clots from the LAA may be significantly reduced, if not eliminated. Various techniques have been developed to occlude the LAA. For instance, balloon-like devices have been developed that are configured to be implanted completely within the cavity of the LAA, while surgical techniques have also been developed where the cavity of the LAA is inverted and surgically closed.

[0004] Despite these techniques, it would be advantageous to provide an improved occlusion device that offers a reduced risk of adverse events such as embolization.ABTSJM-0642PCT15848WOO1Summary of the Disclosure

[0005] According to one aspect of the disclosure, a medical device for occluding a left atrial appendage (“LAA”) includes a proximal occluding member sized and shaped to cover an ostium of the LAA in an implanted condition of the medical device, a distal occluding member sized and shaped to be received within a cavity of the LAA in the implanted condition of the medical device, a connecting member connecting the proximal occluding member to the distal occluding member, and an occluding material. The occluding material is uncoupled from the proximal occluding member in a delivery condition of the proximal occluding member, and is uncoupled from the distal occluding member in a delivery condition of the distal occluding member. The occluding material is configured to at least partially fill and occlude the LAA. The occluding material may be formed of wire that is configured to have a coiled configuration when the occluding material at least partially fills the LAA. The occluding material may be formed of foam. The distal occluding member may form a disc or a lobe in an expanded condition of the distal occluding member, and in the implanted condition of the medical device, the occluding material may be configured to be maintained between a distal face of the proximal occluding member and a proximal face of the distal occluding member. The distal occluding member may form a lobe in an expanded condition of the distal occluding member, and in the implanted condition of the medical device, the occluding material may be configured to be maintained within an interior of the lobe. A plurality of stabilizing wires may be coupled to the lobe, the stabilizing wires each including a hooked end configured to frictionally engage tissue of the LAA. The distal occluding member may form a cup shape in an expanded condition of the distal occluding member. The cup shape may include a closed proximal face and an open distal face, and in the implanted condition of the medical device, the occluding material may be configured to be maintained distal to the closed proximal face of the cup shape. A plurality of stabilizing wires may be coupled to the side wall of the distal occluding member, the side wall extending distally from the closed proximal face of the cup shape, the stabilizing wires each including a hooked end configured to frictionally engage tissue of the LAA. The distal occluding member may form a lobe in an expanded condition of the distal occluding member, the proximal occluding member may form a disc in an expanded condition of the proximal occluding member, and the disc may be removably coupled to the lobe. The connecting member may be fixed to the disc, and the connecting member may be threadedly coupled to the lobe.ABTSJM-0642PCT 15848WOO1

[0006] According to another aspect of the disclosure, a method of occluding a left atrial appendage (“LAA”) of a patient includes advancing a delivery sheath into the patient until a distal end of the delivery sheath is positioned within or adjacent to the LAA. While the delivery sheath is positioned within or adjacent to the LAA, an occluding material is deployed from the delivery sheath to at least partially fill the LAA. A proximal occluding member is deployed from the delivery sheath so that the proximal occluding member expands and covers an ostium of the LAA. During advancing the delivery sheath, the occluding material is uncoupled from the proximal occluding member. The occluding material may be formed of wire that is configured to have a coiled configuration after being deployed from the delivery sheath and at least partially filling the LAA. The occluding material may be formed of foam. Prior to deploying the proximal occluding member, a distal occluding member may be deployed from the delivery sheath so that the distal occluding member expands within the LAA. Deploying the occluding material from the delivery sheath may be performed after deploying the distal occluding member, but before deploying the proximal occluding member, such that the occluding material is maintained between a proximal face of the distal occluding member and a distal face of the proximal occluding member. The distal occluding member may form a lobe after being deployed, and deploying the occluding material from the delivery sheath may include at least partially filling an interior volume of the lobe with the occluding member after deploying the distal occluding member. The distal occluding member may form a cup shape after being deployed, and the cup shape may include a closed proximal face and an open distal face. Deploying the occluding material from the delivery sheath may include deploying the occluding material into the distal occluding member such that the occluding material at least partially fills the cup shape and such that at least some of the occluding material is in directed contact with tissue of the LAA distal to the closed proximal face of the cup shape. The occluding material may be deployed to at least partially fill the LAA after the proximal occluding member has been deployed and after the distal occluding member has been deployed, and after deploying the occluding material, the proximal occluding member may be decoupled from the distal occluding member and removed from the patient. The proximal occluding member may be reversibly coupled to the distal occluding member via a connecting member that has a first end fixed to the proximal occluding member and a second end that is threadedly coupled to the distal occluding member, and decoupling the proximal occluding member from the distal occluding member may include unthreading the connecting member from the distal occluding member.ABTSJM-0642PCT 15848WOO1Deploying the proximal occluding member from the delivery sheath may include maintaining a connection between the proximal occluding member and the delivery sheath, and the deployed proximal occluding member may be held against the ostium of the LAA while deploying the occluding material into the LAA, and after the LAA is at least partially filled with the occluding material, the proximal occluding member may be retracted into the delivery sheath and removed from the patient.

[0007] According to a further aspect of the disclosure, a medical device for occluding a left atrial appendage (“LAA”) includes a proximal occluding member sized and shaped to cover an ostium of the LAA in an implanted condition of the medical device, a tether having a first end coupled to the proximal occluding member and a second end opposite the first end, the second end of the tether including a tether anchor configured to pierce tissue forming a distal wall of the LAA. The medical device excludes a lobe- shaped occlusion member configured to be positioned within the LAA. The tether anchor may include one or more tines or pincers. The tether anchor may include one or more hooks. The tether anchor may include a helical member configured to screw into the distal wall of the LAA. The proximal occluding member may form a disc, and in an implanted condition of the medial device the tether may be substantially straight between the first end of the tether and the second end of the tether. The proximal occluding member may form a balloon, the balloon being inflatable from a deflated condition to an inflated condition in which the inflated balloon occludes the ostium of the LAA. In an implanted condition of the medical device, the tether may have a serpentine shape between the first end of the tether and the second end of the tether. A seal member may be positioned on the tether proximal to the tether anchor, such that in the implanted condition of the medical device, the seal member abuts the distal wall of the LAA.

[0008] According to another aspect of the disclosure, a medical device for occluding a left atrial appendage (“LAA”) includes a proximal occluding member sized and shaped to cover an ostium of the LAA in an implanted condition of the medical device, and one or more anchor wires each having a first end coupled to the proximal occluding member. The one or more anchor wires collectively have a plurality of contact points with tissue of the LAA in an implanted condition of the medial device. The medical device excludes a lobe- shaped occlusion member configured to be positioned within the LAA. The one or more anchor wires may each include friction-enhancing members. The friction-enhancing members may be tines or barbs. The one or more anchor wires may include only one anchor wire, and the one anchor wire may be configured to have a tangledABTSJM-0642PCT 15848WOO1 configuration in the implanted configuration of the medical device. The one or more anchor wires may include only one anchor wire, and the one anchor wire may be configured to have a helical configuration in the implanted configuration of the medical device. The one or more anchor wires may include a plurality of anchor wires, and the plurality of anchor wires may each be configured to have a curled configuration in the implanted configuration of the medical device in which each of the plurality of anchor wires first extends distally from the proximal occluding member and then curls proximally back toward the proximal occluding member.Brief Description of the Drawings

[0009] Fig. 1 illustrates a known medical device.

[0010] Figs. 2A-2C are a schematic diagram of the known medical device shown in Fig. 1 under radial compression.

[0011] Fig. 3 is a schematic diagram of a delivery system in accordance with the present disclosure.

[0012] Figs. 4A-4D are highly schematic views of a medical device being implanted within an exemplary LAA according to an aspect of the disclosure

[0013] Fig. 5A illustrates a medical device according to another embodiment of the disclosure deployed within an exemplary LAA.

[0014] Fig. 5B illustrates a distal occluding member of the medical device of Fig. 5A shown in isolation.

[0015] Fig. 6A illustrates a medical device according to another embodiment of the disclosure deployed within an exemplary LAA.

[0016] Fig. 6B illustrates a distal occluding member of the medical device of Fig. 6A shown in isolation.

[0017] Figs. 7A-7C illustrate different stages of occluding an LAA according to another example of the disclosure.

[0018] Fig. 7D illustrates an example of a stage in a method of occluding an LAA using a temporary LAA cover.

[0019] Fig. 7E illustrates another example of a stage in a method of occluding an LAA using a temporary LAA cover.ABTSJM-0642PCT 15848WOO1

[0020] Fig. 7F illustrates a further example of a stage in a method of occluding an LAA using a temporary LAA cover.

[0021] Figs. 8A-8C illustrate different stages of occluding an LAA according to a further example of the disclosure.

[0022] Figs. 9A-C illustrate schematic illustrations of lobe-less occluders anchored to the LAA with different tether anchor structures.

[0023] Figs. 9D-G illustrate schematic illustrations of example stages of deployment of a lobeless occluder.

[0024] Fig. 10A illustrates a balloon-based lobe-less occluder anchored to the LAA.

[0025] Figs. 10B-C illustrate two exemplary options for connecting a tether to the balloon occluder of Fig. 10 A.

[0026] Fig. 10D illustrates the occluder of Fig. 10A in an exemplary stage of delivery.

[0027] Fig. 10E illustrates an alternate version of the occluder of Fig. 10A.

[0028] Figs. 10F-H are schematic illustrations of components for filling a balloon occluder having multiple fill chambers.

[0029] Fig. 11A illustrates a lobe-less occluder according to another aspect of the disclosure.

[0030] Fig. 1 IB is a schematic view of the occluder of Fig. 11 A in an implanted condition.

[0031] Fig. 11C is a schematic view of the occluder of Fig. 11 A in a delivery condition.

[0032] Fig. 12A illustrates an LAA occluder deployed within the LAA with an anchor that at least partially fills the chamber of the LAA, according to another aspect of the disclosure.

[0033] Fig. 12B illustrates a portion of the anchor of Fig. 12A.

[0034] Fig. 12C illustrates the LAA occluder of Fig. 12A in a delivery condition.

[0035] Figs. 13A-C illustrate different stages of a lobe-less LAA occluder being deployed into a LAA by feeding an anchor wire into the LAA and then deploying a proximal occluding member.

[0036] Figs. 13D-F illustrate different stages of the lobe-less LAA occluder of Figs. 13A-C being deployed into the LAA by deploying the proximal occluding member and then feeding the anchor wire into the LAA.

[0037] Figs. 14A-B are schematic illustrations of different stages of a lobe-less LAA occluder being deployed into the LAA according to another aspect of the disclosure.

[0038] Figs. 14C-D show isolated view of the lobe-less LAA occluder of Figs. 14A-B.ABTSJM-0642PCT 15848WOO1Detailed Description of the Disclosure

[0039] The present disclosure relates generally to medical devices that are used in the human body. Specifically, the present disclosure provides medical devices including occlusion devices having features to improve the fit of the medical device within the cavity to be occluded. The disclosed embodiments may lead to more consistent and improved patient outcomes. It is contemplated, however, that the described features and methods of the present disclosure as described herein may be incorporated into any number of systems as would be appreciated by one of ordinary skill in the art based on the disclosure herein.

[0040] Although the exemplary embodiment of the medical device is described as treating a target site including a LAA, it is understood that the use of the term “target site” is not meant to be limiting, as the medical device may be configured to treat any target site, such as an abnormality, a vessel, an organ, an opening, a chamber, a channel, a hole, a cavity, or the like, located anywhere in the body. The term “vascular abnormality,” as used herein is not meant to be limiting, as the medical device may be configured to bridge or otherwise support a variety of vascular abnormalities. For example, the vascular abnormality could be any abnormality that affects the shape of the native lumen, such as an atrial septal defect, a lesion, a vessel dissection, or a tumor. Embodiments of the medical device may be useful, for example, for occluding a patent foramen ovalis (“PFO”), atrial septal defect (“ASD”), ventricular septal defect (“VSD”), or patent ductus arteriosus (“PDA”), as noted above. Furthermore, the term “lumen” is also not meant to be limiting, as the vascular abnormality may reside in a variety of locations within the vasculature, such as a vessel, an artery, a vein, a passageway, an organ, a cavity, or the like. As used herein, the term “proximal” refers to a part of the medical device or the delivery device that is closest to the operator, and the term “distal” refers to a part of the medical device or the delivery device that is farther from the operator at any given time as the medical device is being delivered through the delivery device. In addition, the terms “deployed” and “implanted” may be used interchangeably herein.

[0041] Some embodiments of the present disclosure provide an improved percutaneous catheter directed intravascular occlusion device for use in the vasculature in patients' bodies, such as blood vessels, channels, lumens, a hole through tissue, cavities, and the like, such as a LAA. Other physiologic conditions in the body occur where it is also desirous to occlude a vessel or otherABTSJM-0642PCT 15848WOO1 passageway to prevent blood flow into or therethrough. These device embodiments may be used anywhere in the vasculature where the anatomical conditions are appropriate for the design.

[0042] The medical device may include one or more layers of occlusive material, wherein each layer may be comprised of any material that is configured to substantially preclude or occlude the flow of blood so as to facilitate thrombosis. As used herein, “substantially preclude or occlude flow” shall mean, functionally, that blood flow may occur for a short time, but that the body's clotting mechanism or protein or other body deposits on the occlusive material results in occlusion or flow stoppage after this initial time period.

[0043] Some embodiments of the present disclosure may be formed by a plurality of wire strands having a predetermined relative orientation with respect to one another. However, it is understood that according to additional embodiments of the present disclosure, that the medical device could be etched or laser cut from a tube, or the device could comprise an occlusion material coupled to a scaffolding structure or a plurality of slices of a tubular member coupled together.

[0044] The present disclosure now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the disclosure are shown. Indeed, this disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout.

[0045] In at least some conventional or known medical devices used for the occlusion of abnormalities, such as a medical device 50 shown in Fig. 1, medical device 50 includes a proximal end 52 and a distal end 54, with a disc 56 at proximal end 52 and a lobe 58 at distal end 54. The lobe 58 has a proximal edge 60 (also referred to as a proximal face), a distal edge 62 (also referred to as a distal face), and a middle or central portion 64 that define a cavity 66. As used herein, the term “lobe” may refer to a generally cylindrical shape having a meaningful length (or height) compared to the diameter of one or both faces of the cylinder shape, although it should be understood that the shape need not be perfectly cylindrical. In other words, a disc may not be considered a lobe. The medical device 50 also includes stabilizing wires 68 secured to a radially outer or circumferential surface of middle portion 64. The stabilizing wires 68 terminate in a hook 70 at free ends thereof, and thereby facilitate retention of the medical device 50 at a target site and preventing the medical device 50 from becoming dislodged from the target site after deployment.ABTSJM-0642PCT 15848WOO1

[0046] In this known medical device 50, proximal edge 60 and distal edge 62 adjoin middle portion 64 at a first relatively blunt or sharp (e.g., non-rounded) transition 72 and a second blunt transition 74, respectively. First blunt transition 72 connects proximal edge 60 to middle portion 64 by an approximately 90 degree angle. Likewise, second blunt transition 74 connects distal edge 62 to middle portion 64 by an approximately 90 degree angle. First blunt transition 72 and second blunt transition 74 partially define a generally rectangular cross section to lobe 58. leading to relatively blunt circumferential edges of the device and relatively high radial force applied to the surrounding tissue.

[0047] Turning now to Figs. 2A-2C, medical device 50 before and after undergoing radial compression is depicted. Before radial compression (Fig. 2A) is applied to lobe 58, the outer surface of middle portion 64 is linear or extends generally perpendicular to proximal and distal faces 60, 62. Each hook 70 of a corresponding stabilizing wire 68 is at a first angle 76 with respect to a generally longitudinal direction 77. When radial compression is applied to lobe 58 (Figs. 2B and 2C), proximal and distal faces 60, 62 flex and bow outwardly (e.g., axially outward), and middle portion 64 of lobe 58 flexes and bows inwardly, in response to the applied force. The approximately 90 degree angle of first blunt transition 72 and second blunt transition 74 force the outer surface of middle portion 64 to transition from linear to concave when proximal and distal faces 60, 62 bow outwardly. The concave shape adopted by lobe 58 also shifts the position of stabilizing wires 68, such that stabilizing wires 68 at least partially contract and hooks 70 transition from first angle 76 to a second, greater angle 78. At second angle 78, hooks 70 are oriented more directly towards the adjacent tissue, than when hooks 70 are at first angle 76.

[0048] The medical devices of the present disclosure may include a rounded lobe, for example as described in greater detail in U.S. Patent Application Publication No. 2022 / 0008050, the disclosure of which is hereby incorporated by reference herein. The use of a more rounded lobe may lead to a more uniform radial compression, reduction in radial force applied to surrounding tissue, and reduction in variability of the hook angle of the stabilizing wires, minimizing potential disadvantages of known medical devices.

[0049] Turning now to Fig. 3, a schematic diagram of a delivery system 100 is shown. Delivery system 100 includes a delivery device 102 including a catheter 104 and a coupling member 106 configured to couple a distal end of a delivery cable 108 to a medical device 110 (which may be any of the occluders described herein) for facilitating the deployment of medical device 110 at aABTSJM-0642PCT 15848WOO1 target site. Medical device 110 is deployed to treat the target site, and, in the example embodiment, is an occlusion device (“occluder”).

[0050] The shape and size of the LAA among different patients is typically highly variable. In order to successfully occlude a patient’s LAA, careful evaluation of patient anatomy is desirable, as well as careful sizing and selection of the desired occluder to help ensure optimal closure of the LAA. Appropriate sizing is important for the current generation of LAA occlusion (“LAAO”) devices used for this preventative procedure to help keep the risk of stroke in patients with non- valvular atrial fibrillation (“AF” or “AFib”) low.

[0051] Selecting an appropriately-sized occluder device may help ensure that the LAAO procedure is free from complications such as device embolization, pericardial effusion, incomplete closure, peri-device leaks, and / or thrombus formation. For most LAAO devices, a range of device sizes is available for the implanter to choose from based on factors including (i) patient anatomy, (ii) standard imaging-based LAAO size measurements per the protocol for the device, and / or (iii) LAAO orientation and configuration. Often, more than one size occluder may be suitable for a given patient anatomy, and the final device size is selected based on implanter experience. In some instances, the LAAO procedure is attempted with more than one implant size which can lead to additional procedural risk. In view of these considerations, it may be preferable to provide a flexible and variable LAAO device that can be adapted to a range of LAA sizes, orientations, and configurations. For at least some embodiments described below, the LAAO device may be deployed through largely conventional means, while allowing the final size to be customized after the LAAO device is placed within the LAA to help ensure appropriate and patient-specific device optimization.

[0052] At least some of the LAAO devices described below may include a lobe and disc configuration, for example generally similar to that described in connection with Fig. 1, to assist in providing a complete or “double” seal of the LAA (e.g. sealing within the cavity of the LAA as well as sealing at the ostium leading to the LAA). At least some of the LAAO devices described below may include an adjustable lobe that can conform to the anatomy, and the shape of the lobe may be varied through additional material that can be inserted into the lobe to change the final dimensions of the lobe (including via an iterative process) to fit the patient’s specific anatomy. At least some of the LAAO devices described below include fixation features such as hooks or anchors (e.g. generally similar to stabilizing wires 68) that are configured to frictionally engageABTSJM-0642PCT 15848WOO1 tissue of the LAA to provide enhanced stability and secure placement of the LAAO device. In some examples, the adjustment of the size and / or shape of the lobe may help provide sufficient force to engage such fixation features with the tissue of the LAA.

[0053] Fig. 4A illustrates a cut-away view of a human heart H. Fig. 4A provides exemplary illustrations of various anatomical features of the heart H, including the superior vena cava SVC, inferior vena cava IVC. tricuspid valve TV, mitral valve MV, right atrium RA, left atrium LA, atrial septum AS, left atrial appendage LAA, and the ostium O leading to the LAA. Fig. 4A illustrates an exemplary delivery route for delivery a LAAO device, which may include advancing a catheter 200 through the patient’s vasculature (e.g. by entering the vasculature at the femoral vein), through the inferior vena cava IVC, into the right atrium RA and through the atrial septum AS (e.g. via a puncture made within the atrial septum) into the left atrium LA, where a distal end of the catheter 200 may be positioned within or adjacent to the left atrial appendage LAA (and / or the ostium O thereof). As shown in Fig. 4B, once the distal end of the catheter 200 is positioned within or adjacent to the LAA, a distal occluding member 310 of a LAA occluder 300 may be deployed into the LAA. In some examples, prior to this deployment, a distal end of the catheter 200 (which may be an outer, delivery sheath component that may have fixed curvature or steerability) is deflected or otherwise steered to have a desired alignment with (e.g. substantially coaxial with) the LAA and / or the ostium O thereof. The catheter 200 may also include an interior catheter which may be the device delivery catheter which couples to the LAAO device. In the illustrated embodiment, the distal occluding member 310 may take the form of a lobe, for example similar to lobe 58 of medical device 50, similar to disc 56 of medical device 50, or another generally similar shape. In addition to being similar in shape to lobe 58 or disc 56, distal occluding member 310 may also be similar in configuration, for example by being formed of strands of nitinol wire braided together into a mesh structure. In the absence of applied forces, the distal occluding member 310 may have a generally cylindrical shape, including one with a small length (in which case the distal occluding member 310 may be more disc-shaped) or with a large length (in which case the distal occluding member 310 may be more lobe-shaped). If the distal occluding member 310 includes fixation members or anchor such as hooks or stabilizing wires (such as stabilizing wires 68), those hooks may at least begin to frictionally engage tissue within the LAA as the distal occluding member 310 transitions from its collapse condition within the catheter 200 to its expanded condition within the LAA. As shown in Fig. 4B, a connector 320 may have a distalABTSJM-0642PCT 15848WOO1 end coupled to (which may include being integrally formed with) the distal occluding member 310. In some examples, the connector 320 is formed from wires of nitinol (or another shapememory material) braided together to have a generally cylindrical shape in the absence of applied forces, with a diameter that is smaller than that of the distal occluding member 310 and the proximal occluding member 330 (described in greater detail below) when those components are in their expanded condition in the absence of applied forces. In these examples, the connector 320 may be substantially similar to the corresponding connector shown in Fig. 1. In other examples, the connector 320 may be as simple single wire or tether that mechanically couples distal occluding member 310 to the proximal occluding member 330. As best shown in Fig. 4D, the distal occluding member 310 may include a fastener 312 which may be used to gather strand ends of the braided mesh forming the distal occluding member 310 and / or to serve as a point of coupling to the connector 320.

[0054] Referring now to Fig. 4C, after the distal occluding member 310 is partially or fully expanded within and / or secured to the LAA, and while the proximal occluding member 330 remains partially or fully collapsed within the catheter 200, occlusion material 340 may be deposited into the LAA, proximal to the distal occluding member 310, from the catheter 200. The occlusion material 340 is preferably a biocompatible material, and is preferably highly conformable and able, at least in the aggregate, to substantially take the shape of the volume in which it is deposited. Examples of suitable types of occlusion material 340 may include flexible coils or foam. In some examples, the occlusion material 340 may be passed through a lumen that exists between the inner surface of the outer delivery sheath of catheter 200, and an outer surface of the inner device delivery catheter that couples (e.g. directly couples) to the LAA occluder 300. In some examples, the occlusion material 340 is stable enough to remain positioned within the LAA prior to deployment of the proximal occluding member 330. In other examples, the proximal occluding member 330 may be deployed first, with the occlusion material 340 being pushed through a lumen in the proximal occluding member 330 (e.g. through a lumen within fastener 332), with the deployed proximal occluding member 330 helping to prevent seepage or leakage of the occlusion material 340 back into the left atrium LA. In this example, after a given volume of the occlusion material 340 has been deposited between the proximal occluding member 330 and distal occluding member 310, tension on the connector 320 may be created to maintain tension between the proximal occluding member 330 and the distal occluding member 310.ABTSJM-0642PCT 15848WOO1

[0055] Fig. 4D illustrates an enlarged cut-away view of the LAA, including a representation of an exemplary position of the circumflex artery CX, after the LAA has been filled with occlusion material 340. After completing the filling, the proximal occluding member 330 may be deployed from the catheter 200 and allowed to expand (e.g. self-expand) to seal the ostium O of the LAA. In the illustrated example, the proximal occluding member 330 may be generally disc-shaped and may be formed similarly or identically to the proximal disc 56 of medical device 50. When expanded, the proximal occluding member 330 is preferably slightly larger than the size of the ostium O to help ensure the proximal occluding member 330 covers the ostium O instead of getting pulled into the LAA through the ostium O, as tension on the connector 320 may tend to pull the proximal occluding member 330 into close contact with the tissue forming the ostium O. In some examples, a fastener 332 may be coupled to the proximal occluding member 330. The fastener 332 may be threaded (e.g. internally threaded) so that a correspondingly threaded (e.g. externally threaded) member of a delivery system (e.g. a delivery cable with a coupling member similar to delivery cable 108 and coupling member 106) can reversibly couple to the fastener 332. Further, the delivery cable and the fastener 332 may be configured to at least temporarily be positioned within catheter 200. With such a configuration, after final placement of the LAA occluder 300 is confirmed, the LAA occluder 300 may be fully released from the delivery system by unthreading the delivery cable from the fastener 332. As should be understood in connection with LAA occluder 300, the use of a highly conformable occlusion material 340 within the LAA, trapped between the distal occluding member 310 and the proximal occluding member 330, may help enhance the closure of the LAA compared to similar medical devices that omit such a highly conformable occlusion material 340. In some examples, the desired amount of occlusion material 340 to be inserted into the LAA may be estimated during pre-procedural planning, for example by taking into account dimensions of the LAA. During the procedure, the occlusion material 340 may be deployed under any suitable imaging modality (e.g. fluoroscopy or echocardiography) to help confirm that the LAA is filled such that the distal occluding member 310 and proximal occluding member 330 are under tension (e.g. via the connector 320) and secured in place such that the proximal occluding member 330 is fully covering the ostium O of the LAA.

[0056] Fig. 5A is an enlarged view of a LAA after another embodiment of an LAA occluder 400 has been implanted into the LAA. LAA occluder 400 may be substantially similar to LAA occluder 300, with the main difference being that the distal occluding member 410 has a lobe shape (insteadABTSJM-0642PCT 15848WOO1 of having the option of being disc-shaped), and the occlusion material 440 (which may be similar or identical in form to occlusion material 340) is placed inside the distal occluding member 410, instead of being positioned between the proximal occluding member 430 and the distal occluding member 410. In some embodiments, the distal occluding member 410 may be formed similarly or identically to lobe 58 of medical device 50. In some embodiments, the distal occluding member 410 may have a shape that is generally similar to lobe 58, but be formed with even higher conformability. If an increase in conformability is desired in comparison to lobe 58, such an increase in conformability may be achieved by adjusting the thickness of the braided wires forming the mesh (e.g. decreased wire thickness generally corresponds to increased conformability) and / or via a different braid configuration. In other examples, the actual material from which the wires are formed may be selected to have greater conformability if desired. In one example, the delivery and deployment steps shown in Figs. 4A-4D would apply to LAA occluder 400, with the exception that the occlusion material 440 is inserted into the interior of distal occluding member 410, either during or after allowing the distal occluding member 410 to expand within the LAA. In some examples, the distal occluding member 410 may self-expand to a first set size and / or shape upon deployment, and the occlusion material 440 may be inserted into the distal occluding member 410 until the distal occluding member 410 is substantially filled with the occlusion material 440. In some examples, as the occlusion material 440 fills the distal occluding member 410, both the occlusion material 440 and the distal occluding member 410 (or portions thereof) will be forced to take the shape of the portion(s) of the LAA occupied by the distal occluding member 410, which may provide for an enhanced seal. In some examples, the distal occluding member 410 will conform to the anatomy at least in part due to the force applied from the occlusion material 440 (e.g. self-expansion forces of a coil member; filling forces from a foam material, etc.) In other examples, as a similar concept to LAA occluder 900 described in greater detail below, the distal occluding member 410 may be formed as an inflatable balloon that is filled with a biocompatible material (e.g. a fluid, coil, wires, foams, etc.) that provides sufficient force to perpetually remain engaged with the wall(s) of the LAA. In some examples, the occlusion material 440 may be passed through any available lumen space within the catheter 200 (including for example through the space between an outer delivery sheath and an inner device delivery catheter) to fill the interior space of the distal occluding member 410. In some examples, the packing of the occlusion material 440 within the distal occluding member 410 will help produce an outward force that tends toABTSJM-0642PCT 15848WOO1 frictionally engage the distal occluding member 410 with tissue of the LAA for enhanced securement. In examples in which the distal occluding member 410 includes hooks or anchors 460, this force may help the hooks or anchors frictionally engage the tissue of the LAA. For example, Fig. 5B shows an example of distal occluding member 410 in isolation with a single row of hooks or anchors 460 (although more than one row of hooks or anchors 460 may be provided instead), which may be similar or identical to stabilizing wires 68. which may help with securing the position of the distal occluding member 410, and thus the entire LAA occluder 400, within the LAA. Similar to LAA occluder 300, LAA occluder 400 may include a proximal occluding member 430, which may be a disc similar or identical to proximal occluding member 330, to seal against the ostium O of the LAA after full deployment of the LAA occluder 400. Also, similar to LAA occluder 300, LAA occluder 400 may include a distal fastener 412 and a proximal fastener 432, as well as connecting member 420 which may be in the form of a simple wire, or a braided mesh similar to the member shown in Fig. 1 connecting the lobe 58 of medical device 50 to the disc 56 of medical device 50.

[0057] Fig. 6A is an enlarged view of a LAA after another embodiment of an LAA occluder 500 has been implanted into the LAA. LAA occluder 500 may be substantially similar to LAA occluder 400, with the main difference being that the distal occluding member 510 has a cup shape (e.g. a lobe shape that omits a distal face, instead of having a closed lobe shape), and the occlusion material 540 (which may be similar or identical in form to occlusion material 340 or 440) is placed on the distal side of the distal occluding member 510, instead of being positioned solely within the distal occluding member 410. This cup shape may include a generally flat or disc-shaped proximal wall, and a generally cylindrical portion extending distally therefrom, with the distal end of the cylindrical portion forming a generally circular distal opening. In some embodiments, the distal occluding member 510 may be formed similarly or identically to lobe 58 of medical device 50 (e.g. via braiding strands of nitinol or other shape-memory wire together), while omitting the distal face 62 of the lobe 58. In one example, the distal occluding member 510 may be formed with two layers, the first layer being coupled to or integral with the connecting member 520, and the second layer doubling back on the first layer, with the second layer being secured to fastener 512. In another example, the distal occluding member 510 may be formed as a single layer of braided mesh, with strand ends capped or covered in any suitable fashion, including via fasteners, crimping members, or any other suitable member at the distal open end of the distal occluding member 510.ABTSJM-0642PCT 15848WOO1In still other examples, the distal occluding member 510 may be formed as a lobe using a stent or frame-type structure with a fabric mesh sealing feature. In one example, the delivery and deployment steps shown in Figs. 4A-4D would apply to LAA occluder 500, with the exception that the occlusion material 540 is inserted into the interior of distal occluding member 510, either during or after allowing the distal occluding member 510 to expand within the LAA. However, unlike LAA occluder 400, in which the occlusion material 440 may be fully contained within the distal occluding member 410, the open distal end of the occluding member 510 allows for the occlusion material 540 to fill portions of the LAA that are distal to the proximal face of the distal occluding member 510. This is shown in Fig. 6A, in which the occlusion material 540 is positioned not only within the distal occluding member 510, but also exterior to the distal occluding member 510 and in direct contact with the LAA, distal to the distal occluding member 510. In some examples, the occlusion material 540 within the distal occluding member 510 will help produce an outward force that tends to frictionally engage the distal occluding member 510 with tissue of the LAA for enhanced securement. In examples in which the distal occluding member 510 includes hooks or anchors 560, this force may help the hooks or anchors further frictionally engage the tissue of the LAA,. For example, Fig. 6B shows an example of distal occluding member 510 in isolation with a single row of hooks or anchors 560 (although more than one row of hooks or anchors 560 may be provided instead), which may be similar or identical to stabilizing wires 68, which may help with securing the position of the distal occluding member 510, and thus the entire LAA occluder 500, within the LAA. Similar to LAA occluder 300, LAA occluder 500 may include a proximal occluding member 530, which may be a disc similar or identical to proximal occluding member 330. to seal against the ostium O of the LAA after full deployment of the LAA occluder 500. LAA occluder 500 may include a distal fastener 512 and a proximal fastener 532, as well as connecting member 520 which may be in the form of a simple wire, or a braided mesh similar to the member shown in Fig. 1 connecting the lobe 58 of medical device 50 to the disc 56 of medical device 50. Whereas distal fastener 412 of distal occluding member 410 is positioned at or near the distal end of the LAA occluder 400, the distal fastener 512 of distal occluding member 510 may be positioned at or near a proximal face of the distal occluding member. For example, if the distal occluding member 510 is formed by braiding strands of nitinol or other shape memory alloy together, some or all of the terminal ends of the strands may be captured and secured by the distal fastener 512. In some examples, when the distal occluding member 510 is formed as a double layerABTSJM-0642PCT 15848WOO1 of braided mesh, both terminal ends of the strands may be secured by the distal fastener 512, or one group of terminal ends may be secured by the distal fastener 512, with the other ends of the strands forming the connector 520 and the proximal occluding member 530, with the other terminal ends being secured by the proximal fastener 532. However, it should be understood that these specific constructions are merely examples of possible suitable configurations.

[0058] Figs. 7A-7C illustrate different stages of occluding an LAA according to another aspect of the disclosure in which the only structure remaining after treatment is the occlusion material 640 (which may be substantially the same or identical to the other occlusion materials described herein). In this example, a temporary proximal occluding member 610 may have a shape generally similar to the other proximal occluding members described herein, including the disc 56 of medical device 50. However, the connector and distal occluding member may be omitted, such that the proximal occluding member 610 is a substantially closed disc with a proximal end that can be fixedly coupled to a delivery cable (with or without the ability to decoupled from the delivery cable). As with other examples described herein, the proximal occluding member 610 may in some examples be formed of braided nitinol strands (or strands of other shape memory alloy) so that the proximal occluding member 610 may self-expand to cover (temporarily in the case of Figs. 7A- 7C) the ostium O of the LAA, as shown in Fig. 7A. It should be understood that the delivery cable (or other delivery catheter that is coupled to proximal occluding member 610) is omitted from the view of Figs. 7A-7B, but it may be substantially similar to any delivery devices described above, including that shown in Fig. 3.

[0059] In an exemplary method of Figs. 7A-7C, after the proximal occluding member 610 is temporarily deployed to cover the ostium O of the LAA, as shown in Fig. 7A, occlusion material 640 may be inserted through the proximal occluding member 610 and into the LAA. As with other embodiments described above, the occlusion material 640 may be passed through any available lumen in the catheter 200, including the lumen between an outer delivery sheath and an inner device delivery catheter, and through a lumen in the proximal occluding member 610. As best shown in Fig. 7B, the occlusion material 640 may be continued to be passed into the LAA to fill the LAA. Once the occlusion material 640 has filled the LAA, the proximal occluding member 610 may be removed, for example by retracting the proximal occluding member 610 back into the delivery catheter via retracting the delivery cable coupled to the proximal occluding member 610, and then removing the delivery catheter from the patient. As shown in Fig. 7C, after the proximalABTSJM-0642PCT 15848WOO1 occluding member 610 is removed, the occlusion material 640 fills the LAA and is maintained within the LAA to occlude the LAA without any structure remaining within the LAA other than the occlusion material 640. In some examples, (i) friction between contact of portions of the occlusion material 640 with itself, (ii) friction between contact of portions of the occlusion material 640 with the tissue of the LAA, (iii) swelling of the occlusion material 640, and / or (iv) at least partial clotting of blood around the occlusion material 640 may serve to help secure the occlusion material 640 within the LAA after the proximal occluding member 610 is removed. If the occlusion material 640 is foam or a similar material, the LAA occlusion may be completed without leaving any metal material at all within the heart. If the occlusion material 640 is formed of a metal, such as coils, the LAA occlusion may be completed without leaving any metal components exposed to the left atrium. For example, if the medical device 50 of Fig. 1 is implanted into the LAA, at least the proximal face of the disc 56 will remain exposed within the left atrium, which may be avoided in the example of Figs. 7A-7C.

[0060] Fig. 7D illustrates another example of using a temporary occluding member or temporary cover in connection with occluding the LAA. For example, as shown in Fig. 7D, a temporary cover 610d (which may also be referred to as a temporary proximal occluding member which may be similar to proximal occluding member 610) may be delivered to the LAA and deployed to cover the ostium O via a delivery catheter D (the distal end of which is shown in Fig. 7D). In some examples, the temporary cover 610d may be a braided nitinol structure or similar structure as described in connection with proximal occluding member 610. In some examples, the temporary cover 610d may be formed with a flexible material (e.g. polymer or fabric) which may include supports such as nitinol struts that assist with expanding the flexible material once inside the left atrium in order to cover the ostium O of the LAA. As shown in Fig. 7D, the temporary cover 610d may include a channel or injection port 61 Id at or near the radial center of the temporary cover 610d. With this configuration, similar to that described in connection with Figs. 7A-7C, a material 640d may be injected through the delivery catheter D, through the injection port 61 Id, and into the LAA while the temporary cover 610d is expanded to cover the ostium O of the LAA to ensure that the material 640d remains within the LAA. In some examples, the material 640d may be an occluding material similar to any of the other occluding materials described herein, including for example a gel, a cement, a polymer, or a foam. In some examples the material 640d may be (or include) thrombin or another other clot-initiating factor to induce the blood present within the LAAABTSJM-0642PCT 15848WOO1 to become a clot. The material 640d may harden or otherwise solidify, including in combination with clotted blood, to form a solid bolus that is incapable of escaping the LAA, even during normal beating of the heart. After the LAA is occluded, for example by being filled with material 640d that occludes the LAA and / or causes the blood within the LAA to clot to occlude the LAA, the temporary cover 610d may be removed from the body, for example by retracting and collapsing the temporary cover 610d into the delivery catheter D, leaving behind the occluded LAA, similar to what is shown in Fig. 7C. As with the embodiment of Figs. 7A-7C, the embodiment shown and described in connection with Fig. 7D may be advantageous because the material 640d (and / or the resulting clotted blood) would conform the anatomy of the LAA, which can be highly varied between patients. Also similar to other embodiments described herein, the resulting occlusion may present a smooth surface to the left atrium with no exposed metal or other thrombogenic features.

[0061] Fig. 7E illustrates an example that is identical to that shown and described in connection with Fig. 7D, with the exception that a support member 620d is provided. The components and method of use shown in Fig. 7E may be identical to those shown and described in connection with Fig. 7D, with the exception that a permanent support member 620d may be inserted into the LAA via the port 61 Id in the temporary cover 610d. The permanent support member 620d may include a distal anchor 622d, which may be similar to any of the anchors 822a-c described below, or which may be any other suitable structure to couple the permanent support member 620d to the wall of the LAA. The permanent support member 620d may be deployed while the temporary cover 610d covers the ostium O of the LAA, and after the permanent support member 620d is anchored to the LAA, the material 640d may be injected into the LAA. Once deployed, the permanent support member 620d may be straight, curved, helically coiled, non-helically coiled, for example. The permanent support member 620d may serve as a solid surface onto which the material 640d is able to latch (including if the material 640d induces the blood to clot, with the clot anchoring to the solid surface of the permanent support member 620d). With this configuration, the material that occludes the LAA (whether gel, cement, foam, other filler and / or clotted blood) may be more secure and more likely to stably remain within the LAA after the temporary cover 61 Od is removed, leaving the permanent support member 620d and the occlusion material within the LAA.

[0062] Fig. 7F illustrates an example that is identical to that shown and described in connection with Fig. 7E, with the exception that the cover 610d is a permanent cover instead of a temporary cover, and the permanent cover 610d may include an additional feature facing into the LAA. TheABTSJM-0642PCT 15848WOO1 method described in connection with Fig. 7E may apply with equal force to the method of use in connection with Fig. 7F, except that the permanent cover 61 Od may be decoupled from the delivery catheter D prior to removing the delivery catheter D. In some examples, one end of the permanent support member 620d (opposite the location of the anchor 622d) may be fixed to the permanent cover 610d to assist in maintain the position of the cover 610d, for example similar to embodiments described below in connection with Figs. 9A-9G and 11A-14D. The distal face (e.g. the surface facing into the LAA) of the permanent occluder 610d may include a texturized or roughened surface 613d, including for example a pile fabric, which may further help the occluded material (whether gel, cement, foam, other filler and / or clotted blood) to entangle with the permanent cover 610d, which may provide stability for keeping the permanent cover 610d in place against the ostium O (whether or not the permanent cover 610d is also secured to the permanent support member 620d).

[0063] In another exemplary method shown in Figs. 8A-8C, an LAA occluder 700 similar to medical device 50 may be deployed into the LAA, along with occlusion material 740. but at least part of the LAA occluder 700 may be removed so that no metal is exposed to the left atrium. For example, as shown in Fig. 8A, the LAA occluder 700 may include a distal occlusion member 730 which may be a lobe similar to lobe 58 of medical device 50, a proximal occlusion member 710 which may be a disc similar to disc 56 of medical device 50, with the two components coupled by a connecting member 720 which may be similar to the corresponding connector of medical device 50. The distal occlusion member 730 may include hooks or anchors 760 similar to other embodiments described herein. The main difference between the LAA occluder 700 shown in Fig. 8A and the medical device 50 shown in Fig. 1 is that, as described in greater detail below, a part of the LAA occluder 700 may be removable so that no metal remains exposed to the left atrium following the occlusion procedure.

[0064] In an exemplary occlusion procedure shown in Figs. 8A-8C, the LAA occluder 700 may first be deployed within the LAA using standard techniques, including those described above. However, although the delivery device is not shown in Figs. 8A-8C, it should be understood that the delivery device (e.g. a delivery cable) remains coupled to the proximal occlusion member 710 during this procedure. After the LAA occluder 700 has been deployed, similar to as shown in Fig. 8A, occlusion material 740 (which may be substantially similar or identical to the other occlusion materials described herein) may be passed from the delivery device into the LAA to occupy openABTSJM-0642PCT 15848WOO1 space within the LAA and to enhance occlusion of the LAA. In some examples, the occlusion material 740 may be introduced through a lumen and / or opening in connector 720 such that the occlusion material 740 is on one side (e.g. proximal) of the distal occluding member 730 to provide a non-thrombogenic seal to the distal occluding member 730 while eliminating communication between distal portions of the LAA and the proximal portions of the LAA. The occlusion material 740 may provide a barrier to blood flow and a substrate for endothelialization. In such cases, the proximal occluding member 710 may serve as a temporary barrier before the occlusion material 740 forms a seal, for example via solidifying or hardening, either alone or in combination with blood clotting onto the occlusion material 740 to form a solid bolus that is unable to become dislodged from the LAA. As best shown in Fig. 8B, the occlusion material 740 may be continued to be passed into the LAA to fill the LAA. The seal, in some examples, can be confirmed by imaging and / or via contrast injection. Once the occlusion material 740 has filled the LAA, the proximal occluding member 710 may be disconnected from the distal occluding member 730. For example, the distal occluding member 730 may include a threaded or similar connection 732 such that the proximal occluding member 710 and connector 720 (which may have a corresponding threaded or similar connector) may be removed from the connection 732, for example by rotating the delivery cable (and thus rotating the proximal occlusion member 710 and the connector 720) in an unthreading direction. Once the proximal occlusion member 710 and connector 720 are decoupled from the distal occlusion member 730, the components may be removed from the body, for example by withdrawing the delivery cables back into a sheath of a delivery catheter. As shown in Fig. 8C, after the proximal occluding member 710 and connector 720 are removed, the distal occluding member 730 and the occlusion material 740 fills the LAA without any structure remaining that is exposed to the LAA. The distal occluding member 730, which remains in the LAA and which may be anchored (e.g. via hooks or anchors 760 in addition to self-expansion forces) may help to further stabilize the occlusion material 740 within the LAA. This additional stability of the occlusion material 740 provided by the distal occluding member 730 may be particularly helpful if the LAA remodels or otherwise changes shape over time.

[0065] The examples shown and described in connection with Figs. 4A-8C have at least one feature in common in which an occlusion material is used (with or without additional structural occluders) to achieve occlusion of the LAA, regardless of the shape or size of the LAA, due at least in part to the highly conformable nature of the occlusion material. For more traditional LAAABTSJM-0642PCT 15848WOO1 occluders, such as medical device 50 that includes both a lobe 58 and a disc 56, the success of the seal and / or occlusion created by the medical device 50 within the LAA may be reliant at least in part on the ability of the lobe 58 to reliably anchor within the LAA. For example, reliable anchoring of the lobe 58 may result in reliable placement of the disc 56 over the ostium O of the LAA, and thus reliable sealing of the LAA at the ostium O. If the lobe 58, on the other hand, is unstable and the position of the lobe 58 shifts, the position of the disc 56 may also shift and the seal of the ostium O by the disc 56 may be lost. Thus, in some examples, it may be useful to make the effective positioning and / or sealing of the disc 56 independent of the lobe 58 (or another lobe-like structure). Various examples are provided below in which the disc 56 (or an element similar to the disc 56) is capable of sealing the LAA at the ostium O, with the position of the disc 56 being maintained by a feature other than the lobe 58, such as by a tether or tether-like structure.

[0066] Although various specific examples are described below in which a LAA occluder excludes a lobe-type structure for anchoring within the LAA, one or more benefits may generally result from the omission of the lobe-type structure from the LAA occluder.

[0067] A first example of a potential benefit of a lobe-less occluder is easier sizing compared to a lobed occluder. When selecting an occluder, such as medical device 50, for a patient, the size of the landing zone of the patient’s LAA may need to be considered when choosing the appropriately sized disc 56 for the ostium O of the LAA. At least one commercially available LAA occluder that is similar to medical device 50 in configuration is provided with eight differently sized lobes 58 to accommodate various sizes of patient anatomies. Each individual size of lobe 58 may be accompanied by a disc 56 that has a diameter that is about 6-7mm larger than the diameter of the lobe 58. With such devices, the physician may need to account for the size of both the LAA landing zone (e.g. choosing an appropriately sized lobe 58) and the ostium O of the LAA (e.g. choosing an appropriately sized disc 56). If the ostium O is larger than the size of the disc 56 for the appropriate size of the lobe 58, then the physician may need to consider using a larger sized occluder to achieve a complete seal on the ostium O with the disc 56. However, this increase in lobe size can have adverse consequences on lobe fit in the LAA landing zone. While it may be possible in theory to provide a nearly unlimited combination of sizes of discs 56 and lobes 58 to adapt to nearly any patient anatomy, such an undertaking may be commercially and / or logistically impractical.ABTSJM-0642PCT 15848WOO1

[0068] A second example of a potential benefit of a lobe-less occluder is removing challenges related to highly variable LAA morphologies / shapes. The LAA has a highly variable shape between patients, and example categories of LAA shapes include the chicken wing shape, broccoli shape, windsock shape, and cactus shape. The specific shape of a particular patient’s LAA can have a significant effect on the stability of the lobe 58 of the medical device 50. For example, the “windsock” LAA shape may be characterized as conical and may be a challenge when dying to size / anchor cylindrical lobes (e.g. lobe 58 of medical device 50) within the LAA. The “chicken wing” shape, on the other hand, may create challenges when using medical device 50, as LAAs with this shape may have a short landing zone.

[0069] A third example of a potential benefit of a lobe-less occluder is decreasing adverse events associated with the hooks / anchors. such as stabilizing wires 68 on the lobe 58. If the lobe 58 is omitted, and thus stabilizing wires 68 on the lobe 58 are also omitted, certain risks of LAA occlusion may be omitted, such as interaction of stabilizing wires 68 with nearby structures (e.g. the pulmonary artery which has been known to cause tamponade if perforated) and migration / device embolization. As should become clear from the description below, one or more of the above-described benefits may be achieved from use of a lobe-less LAA occluder.

[0070] The embodiments described in greater detail below generally relate to LAA occluders that utilizes a disc only to cover the ostium O of the LAA for complete sealing / occlusion of the LAA. Anchoring and stability of the disc or disc-like structure may be achieved, at least in some examples, by a tether or tether-like structure that itself can anchor in different ways. It should be understood that, in some examples, the disc may be placed first and then the anchor engaged second, but the opposite approach may also be utilized in which the anchor is first engaged and then the disc is positioned second. Two general groups of lobe-less occluders are described below including (i) discs that are anchored with a tether-like structure to a wall (e.g. the distal wall) of the LAA, and (ii) discs that are anchored with a tether-like structure that fills the cavity of the LAA.

[0071] Figs. 9A, 9B, and 9C are schematic illustrations of LAA occluders 800a. 800b, 800c, respectively, in an implanted condition. Each LAA occluder 800a, 800b, 800c may include a proximal occluding member 810a, 810b, 810c, respectively. Each proximal occluding member 810a-810c may take the form of a disc or disc-like structure, which may be formed as a braided mesh similar or identical to disc 56 of medical device 50. Proximal occluding members 810a-810cABTSJM-0642PCT 15848WOO1 may be sized and shaped to cover the ostium O of the LAA. To secure the proximal occluding member 810a-810c in place, rather than use a structure similar to lobe 58 of medical device 50, each LAA occluder 800a. 800b, 800c may include a tether 820a, 820b. 820c, respectively. In the illustrated examples, each tether 820a-820c is formed as a generally straight wire-like structure, with a first end coupled to the respective proximal occluding member 810a-810c via a respective fastener 812a, 812b. 812c. The only difference between the examples shown in Figs. 9A-9C is the structure found at the second end of the respective tether 820a-820c (opposite the first end attached to the respective fastener 812a-812c). For example, the tether 820a may terminate at its second end with a two- or multi-prong (or multi-tine) anchor 822a, the multi-prong anchor 822a configured to engage or pierce tissue at the distal wall of the LAA to secure the occluder 800a to the LAA, including securing the proximal occluding member 810a against the ostium O of the LAA. In some embodiments, the multi-prong anchor 822a may have a pincer-like feature in which the prongs of the anchor 822a, after piercing or otherwise engaging tissue of the LAA, contract or bias toward each other to “grab” the tissue for enhanced anchoring. The tether 820b, on the other hand, may terminate at its second end with a screw-type or helical anchor 822b, the helical anchor 822b configured to engage or pierce tissue at the distal wall of the LAA to secure the occluder 800b to the LAA, including securing the proximal occluding member 810b against the ostium O of the LAA. In order to secure the helical anchor 822b, it may be rotated about its central longitudinal axis to “screw” the helical anchor 822b into the tissue of the LAA for enhanced anchoring. In a third example, the tether 820c may terminate at its second end with one or more hooks to form a hook anchor 822c, the hook anchor 822c configured to engage or pierce tissue at the distal wall of the LAA to secure the occluder 800c to the LAA, including securing the proximal occluding member 810c against the ostium O of the LAA. In order to secure the hook anchor 822c, the hooks 822c may be maintained with a terminal end pointing distally while in a delivery catheter to allow for easy piercing of (or engagement with) the tissue of the LAA, and as the delivery catheter is withdrawn, the hooks of the hook anchor 822c may return to a hooked shape, for example via shape memory attributes of the hook anchor 822c. In some examples, the length of the tether 820a-820c may be individualized for the patient based on LAA anatomy, for example via pre-procedural imaging of the LAA to determine a desired length. In some example, the length of the tether 820a-820c may not be individualized (or otherwise may come in set sizes), and the tether 820a-820c may be formed of an elastic material so that the tether 820a-820c may stretch, ifABTSJM-0642PCT 15848WOO1 needed, while maintaining tension. In other examples, as described in greater detail below, the tether 820a-820c may be cut to length during the procedure to have an individualized tether length for the particular procedure.

[0072] Figs. 9D-9G are schematic illustrations of different stages of an exemplary deployment of LAA occluder 800c, but it should be understood that similar or identical delivery could be used for other devices, including for example LAA occluders 800a-800b. Fig. 9D illustrates proximal occluding member 810c having been deployed and / or unsheathed from an outer delivery sheath 210 of a delivery catheter 200. while the proximal occluding member 810c is still coupled to a device delivery catheter 220 that is slidably received within the outer delivery sheath 210. The device delivery catheter 220 may include an inner lumen through which a tether delivery catheter 230, shown in Fig. 9E, may be passed. As shown in Fig. 9E, while the expanded proximal occluding member 810c is maintained in contact against the ostium O of the LAA (for example by maintaining a distally-directed force on device delivery catheter 220), the tether delivery catheter 230, which may include a portion of the tether 820c therein, may be passed through an opening (e.g. a central opening) in the proximal occluding member 810c and into the LAA toward the distal wall of the LAA. The tether delivery catheter 230 may be advanced until the anchor 822c is driven and / or secured to the wall of the LAA, shown in Fig. 9E, at which point the tether delivery catheter 230 is withdrawn in the proximal direction P back through the opening in the proximal occluding member 810c. As the tether delivery catheter 230 is withdrawn, more of the tether 820c becomes exposed, as shown in Fig. 9F. In some examples, the tether 820c may be provided with a pre-set length based on the expected length needs for the patient, and may include for example an enlarged proximal end that cannot slip through the opening in the proximal occluding member 810c. The enlarged proximal end could be any suitable mechanism, including an expandable mechanism (e.g. a small expanding shape-memory alloy construct, such as a stent or braided mesh. In other examples, the proximal end of the tether 820c may include a member that is crimped over the tether 820c with the crimping member having a larger diameter than the opening in the proximal occluding member 810c. In still other examples, a friction-fit plug may be coupled to the proximal end of the tether 820c with the plug having a size and shape that will frictionally engage the proximal occluding member 810c via the opening. In other examples, instead of a friction-fit plug, the plug may be threaded. In some examples, if the distal end of the device delivery catheter 220 includes threading to threadedly connect to the proximal occluder 810c, the threaded plug (ifABTSJM-0642PCT 15848WOO1 included) may include reverse threads so that, as the device delivery catheter 220 is rotated to unthread from the proximal occluding member 810c, the threaded plug on the proximal end of the tether 820c is simultaneously threaded to couple to the proximal occluding member 810c. Fig. 9G shows an example after the proximal end of the tether 820c has engaged with the proximal occluding member 810c at the opening, and the remainder of the catheter 200 (including a portion of the tether 820c which may have been cut) is detached from the proximal occluding member 810c and is in the process of being removed from the patient. In other words, Fig. 9G shows that, instead of using a fixed length tether 820c, the tether 820c may be cut to length during the procedure. The cutting may be performed in any suitable fashion, including via application of heat using a heating device through the tether catheter 230, via application of mechanical force such as cutting using a cutting tool advanced through the tether catheter 230, etc. In such examples, the opening in the proximal occluder 810c may include proximally extending hooks that allow for unidirectional movement of the tether 820c through the opening to achieve a rachet effect in which the tether 820c cannot slip into the LAA from the opening of the occluder 810c. Various types of suitable tether ratcheting-type mechanisms are described in more detail in U.S. Patent Application Publication No. 2021 / 0298894, the disclosure of which is hereby incorporated by reference herein.

[0073] Although the tethers 820a-820c are shown as being straight, in other examples the tethers could have a serpentine (and / or spring) shape (e.g. similar to that shown in connection with Figs. 11 A-C and described in greater detail below) or may have a coiled shape (e.g. similar to that shown in connection with Figs. 12A-14D and described in greater detail below). The tethers 820a-820c may be formed of any suitable material, including for example, a suture (or suture-like material), silicone, shape-memory alloys such as nitinol. and the like. The other tethers described below may similarly be formed of any of these materials. Further, the anchors 822a-822c may each be formed of any suitable material, including for example stainless steel, platinum, tantalum, or a shapememory material such as nitinol. The other tether anchors described below may similarly be formed of any of these materials.

[0074] Fig. 10A is a schematic illustration of another example of an LAA occluder 900 in an implanted condition. LAA occluder 900 includes a proximal occluding member 910. Unlike proximal occluding members 810a-810c, which may be formed as braided members having a disc shape, proximal occluding member 910 may be formed as a non-braided. inflatable balloon. The balloon 910 may be inflatable, by passing inflation media through an inflation lumen of theABTSJM-0642PCT 15848WOO1 delivery catheter into the balloon 910, from a deflated low-profile condition to an inflated condition in which the balloon 910 fills the space of the ostium O of the LAA. In the particular example shown in Fig. 10A, balloon 910 is generally round or spherical. However, in other examples, balloon 910 may be disc-shaped and inflated at the ostium O in a generally flat disclike shape. In some examples, the balloon 910 includes a single inflation chamber. In other examples, the balloon 910 has multiple inflation chambers that fill from the center and out to help control the size of the inflated balloon 910, for example to allow more fine-tuning of the size of the inflated balloon 910 for the patient being treated.

[0075] To secure the proximal occluding member 910 in place, rather than use a structure similar to lobe 58 of medical device 50, LAA occluder 900 may include a tether 920. The tether 920 may be similar or identical to any of the tethers shown in and described in connection with Figs 9A-C and Figs. 11 A-14D, and is thus not described again in further detail here, other to say that the tether 920 may include a first end coupled to the balloon 910 and an opposite second end with an anchor 922. Although the anchor 922 is not illustrated in Fig. 10A as having any particular structure, it should be understood that the anchor 922 may be similar or identical to any of anchors 822a, 822b, 822c, or otherwise any tether anchoring mechanism shown in and described in connection with any of Figs. 11A-14D.

[0076] Although tether 920 may be fixed to the balloon 910 with any suitable mechanism, two exemplary options are shown in Figs. 10B-C. In the example of Fig. 10B, an overlying layer of material 911 may be positioned over the balloon 910, and one or more tethers 920 may have first ends sandwiched between the balloon 910 and the overlying layer 911. If multiple tethers 920 are used, in some examples, they may be braided or woven together to form a single tether member which may include an anchor 922 at a second end opposite the first end(s). For example, if multiple tethers 920 are included, each tether may be substantially separate from the other tethers 920 between the balloon 910 and the overlaying layer 911, but after extending away from the balloon 910, the various tethers 920 may be grouped (e.g. by weaving them together or any other mechanism including clamping, tying, etc.) so as to effectively act as a single tether, with one or more of the grouped tethers including the anchor 922. In some examples, the various tethers 920 may exit the overlying layer 911 at the same (or about the same) location, but in other examples, the various tethers 920 may exit the overlying layer 911 at different locations. In the example of Fig. 10C, a first end of the tether 920 may originate from a connector piece 913, which may beT1ABTSJM-0642PCT 15848WOO1 molded to the balloon 910 to attach the tether 920 to the balloon 910. Fig. 10C also shows an outer layer 911 which may help secure the connector piece 913 to the balloon 910, although in other embodiments that outer layer 911 may be omitted.

[0077] In one exemplary use of occluder 900, the occluder may be delivered into the LAA with the tether anchor 922 first secured to the distal wall of the LAA (e.g. by using tines, pincers, a helical screw-type member, hooks, etc.) and then after the tether anchor 922 is secured, the proximal occluding member 910 may be inflated by passing inflation media from the delivery device into the fill chamber of the balloon 910. If the balloon 910 has a single fill chamber, it may be inflated until the balloon 910 occludes the ostium O of the LAA. If the balloon 910 has multiple fill chambers, a central fill chamber may be inflated first, with additional fill chamber positioned radially outwardly of the central fill chamber being filled sequentially, as necessary, until the balloon 910 occludes the ostium of the LAA.

[0078] Fig. 10D shows a highly schematic view of an example stage of deployment of occluder 900. In the example of Fig. 10D, a delivery catheter 201 (which may be substantially similar to delivery catheter 200) is shown including an outer delivery sheath 211 (which may be substantially similar to outer delivery sheath 210), a device delivery catheter 221 (which may be substantially similar to device delivery catheter 220), and an inflation catheter 231 (which may be generally similar to tether catheter 230). In use, the device delivery catheter 221 may be delivered to the LAA through the outer delivery sheath 211 while the balloon 910 is deflated within the device delivery catheter 221 and while the tether 920 is positioned at least partially within the device delivery catheter 221. The device delivery catheter 221 and inflation catheter 231 may be advanced simultaneously until the anchor 922 is coupled to the wall of the LAA, and then both the device delivery catheter 221 and inflation catheter 231 may be withdrawn until the balloon 910 exits the device delivery catheter 221. As the balloon 910 exits the device delivery catheter 221, it may be retracted relative to the inflation catheter 231. After the balloon 910 exits the device delivery catheter 221, the balloon 910 may be inflated by advancing inflation media through the inflation lumen 231 and into the balloon 910. After inflation is completed (which may be completed, for example, through a one-way valve in the balloon 910), the inflation catheter 231 may be disconnected from the balloon 910 and withdrawn with the remaining portions of catheter 201. In some examples, the inflation catheter 231 may be coupled to the balloon 910 by a friction fit which can be released by retracting the inflation catheter 231 relative to the balloon 910 with enoughABTSJM-0642PCT 15848WOO1 force. Tn other examples, an active reversible attachment, such as a threaded attachment, may be used to temporarily connect, and allow for disconnection, between the inflation catheter 231 and the balloon 910. Although a one-way valve is described above as one option for maintaining inflation media within the balloon 910 after disconnection of the inflation catheter 231, other options may be suitable. For example, an adhesive may be delivered to the balloon 910 after delivering the inflation media to seal the balloon 910. a crimp tube or similar crimp device or plug may be used to mechanically close the opening used to fill the balloon 910 with inflation media, or the balloon 910 may be self-sealing, for example via an O-ring or gasket that is biased closed and is kept only temporarily open via the inflation catheter 231 passing through the O-ring.

[0079] Although the embodiments shown and described in connection with Figs. 10A-D generally contemplate an occluder that is implanted with the tether 920 being fixed to the LAA prior to inflation of the balloon 910, it should be understood that the balloon 910 may be inflated first prior to fixation of the tether 920 to the LAA. For example, Fig. 10E illustrates an occluder 900’ that includes an inflatable balloon 910’ coupled to a tether 920’ which has an anchor 922’, similar to occluder 900. However, unlike balloon 910, balloon 910’ may include an interior channel 915’ extending through the balloon 910’. On one end of the channel 915’, opposite the anchor 922’, a connector piece 913’ (which may be similar or identical to connector piece 913) may be fixed to the balloon 910’, with one end of the tether 920’ (opposite the end with the anchor 922’) being attached to the connector piece 913’. The tether 920’ may extend through the channel 915’, and exit the other side of the channel 915’. With this configuration, the balloon 910’ may be inflated first (e.g. using an inflation catheter similar to inflation catheter 231), and then another catheter e.g. one similar to device delivery catheter 212) may pass through the channel 915’ to help force the anchor 922’ into the wall of the LAA for anchoring.

[0080] Although the embodiments of balloon 910 and 910’ shown above are generally shown as having a single fill chamber, in other embodiments, the balloon may have two or more individual fill chambers in order to allow for adjustable inflation of the balloon. For example, Fig. 10F illustrates a balloon 910” of an occluder that may be identical to balloon 910 or 910’, with the exception that balloon 910” is shown with two fill chambers 917a”, 917b”, although it should be understood that more than two fill chambers may be provided. In the illustrated example, the two fill chambers 917a”, 917b” may be separated by a fluid-impermeably membrane, and the balloon 910” may include an insert 919” which may be generally cylindrical with internal threading. AsABTSJM-0642PCT 15848WOO1 shown in Fig. 10H, the insert 919” may include two ports 919a”, 919b”, which lead, respectively, to fill chambers 917a”, 917b”. The inflation catheter 231”, shown in Figs. 10F-G, may include a connector end 231a” which may be externally threaded and configured to be screwed or threaded into the insert 919”. As best shown in Fig. 10G, the connector end 231a” may include a port 231b” to allow for inflation media to exit. When the inflation catheter 231” is fully threaded into the insert 919”, the port 231b” may align with the port 919a”. such that inflation media passed through the inflation catheter 231” will fill the first fill chamber 917a”, but not the second fill chamber 917b”. After inflation of the first fill chamber 917a” is completed, the inflation catheter 231” may be completely removed from the insert 919” via unthreading if it is not desired to also fill the second fill chamber 917b”. However, if it is desired to fill the second fill chamber 917b”, the connector end 231a” may be only partially unthreaded from the insert 919”, until the port 231b” aligns with the port 919b”, at which more inflation media may be passed through the inflation catheter 231” to fill the second inflation chamber 917b”. This configuration, or similar configurations, may be used with a balloon having three, four, or more individual fill chambers.

[0081] Fig. 11A is a schematic illustration of an LAA occluder 1000 according to another aspect of the disclosure. Fig. 11B shows the LAA occluder in an implanted condition within the LAA, and Fig. 11C shows the LAA occluder 1000 in a delivery condition. LAA occluder 1000 may include a proximal occluding member 1010, which may take the form of a disc or disc-like structure, which may be formed as a braided mesh similar or identical to disc 56 of medical device 50. Similar to LAA occluders 800a-800c, to secure the proximal occluding member 1010 in place, rather than use a structure similar to lobe 58 of medical device 50, LAA occluder 1000 may include a tether 1020. Similar to tethers 820a-820c, tether 1020 may have a first end connected to the proximal occluding member 1010, for example at a fastener 1012, and a second opposite end forming a tether anchor 1022. Although tether anchor 1022 is shown with a helical anchor structure, similar to tether anchor 822b, tether anchor 1022 may take any other suitable form for anchoring into tissue of the LAA, including for example structures similar to tether anchor 822a and / or tether anchor 822c.

[0082] There are at least two main differences between LAA occluder 1000 and those shown in and described in connection with Figs. 9A-9C. The first main difference is that, while tethers 820a- 820c are shown as substantially straight members, tether 1020 may have a generally serpentine shape with spring-like functionality. For example, between the first and second ends of the tetherABTSJM-0642PCT 15848WOO11020, the tether 1020 may be generally flat with a plurality of curves forming a generally serpentine shape, although the curves need not (but may) be regular in spacing and amplitude of the curves. In some embodiments, the tether 1020 is not flat but rather the serpentine shape is formed by rotating around a central longitudinal axis so that the tether 1020 has a coiled or springtype of shape. Preferably, the tether 1020 is formed of a material that can have spring-like properties, such as a metal, metal alloy, or polymer. In other words, tether 1020 preferably is not formed of a typical suture or string-like material that is unable to maintain a spring-like shape in the absence of applied forces. The second main difference is that the tether 1020 includes, at or near the proximal end of the tether anchor 1022, a joint and / or seal member 1024. In the illustrated embodiment, the seal member 1024 has a generally frustoconical shape with a relatively large diameter distal face and a relatively small diameter proximal face, although other shapes may be suitable. When the tether anchor 1022 is being anchored into the tissue of the LAA, the seal 1024 may help seal against any blood leaking through a puncture site created by the tether anchor 1022, while also acting as a stop to prevent the tether anchor 1022 from being placed too deeply (or migrating distally after initial placement) into / through the tissue of the LAA. In some embodiments, seal 1024 may include a fabric cover to help assist in enhancing a seal. Although tether 1020 is shown with a serpentine shape, it should be understood that other shapes may produce similar results, such as a helical or coiled shape for the tether 1020.

[0083] Fig. 11B shows an example of the LAA occluder 1000 in an implanted condition. It should be noted that, in Fig. 1 IB, the distal end of the stop 1024 is shown as being a spaced distance from the wall of the LAA. However, this is merely for clarity of illustration, and the distal end of the stop 1024 in some examples would preferably be in direct contact with the tissue forming the distal wall of the LAA. One benefit of the serpentine shape and / or spring-like functionality of the tether 1020 is that, after attaching the tether anchor 1022 to the wall of the LAA, the proximal occluding member 1010 may be deployed within or near the ostium O of the LAA, and the tether 1020 will tend to pull the proximal occluding member 1010 into sealing contact with the LAA. Thus, as long as the natural state of the tether 1020 is shorter (between the two terminal ends of the tether 1020) than the length between the ostium O and the distal wall of the LAA, the tether 1020 will tend to self-adjust to the needed end-to-end length while actively pulling the proximal occluding member 1010 into sealing contact with the LAA at the ostium O of the LAA. Fig. 11C shows LAA occluder 1000 in an exemplary delivery condition, in which the proximal occluding member 1010 isABTSJM-0642PCT 15848WOO1 collapsed within a delivery sheath DS. Tn this example, the helical tether anchor 1022 protrudes from the distal end of the deliver sheath DS, such that rotation of the delivery sheath DS in a first rotational direction R will tend to drive (or “screw”) the tether anchor 1022 into the wall of the LAA. Notably, in the delivery condition shown in Fig. 11C, the serpentine tether 1020 is in a straightened condition, or at least a relatively straightened condition, in which the bends of the serpentine shape have smaller amplitudes such that the end-to-end length of the tether 1020 is shorter than in a natural or unbiased condition. In other words, in the delivery condition shown in Fig. 11C, the tether 1020 may be under tension that at least partially resolves after deployment, resulting in the proximal occluding member 1010 being pulled toward the ostium O of the LAA upon deployment. Prior to full deployment, it may be possible to advance the delivery sheath DS distally and remove the tether anchor 1022 from the wall of the LAA, for example by rotating the delivery sheath DS in a rotational direction opposite of direction R, after which the entire LAA occluder 1000 may be removed from the patient. In such scenarios, the puncture created by the tether anchor 1022 may need to be sealed if the procedure is being aborted. Further, as should be understood from the description above, while the tether anchor 1022 is being inserted into the wall of the LAA via rotation in the rotational direction R, the rotation may continue until the seal 1024 contacts the wall of the LAA, at which point the delivery sheath DS may be retracted to deploy the remainder of the LAA occluder 1000, including the tether 1020 and the proximal occluding member 1010.

[0084] While Figs. 9A-11C illustrate embodiments of lobe-less occluders that are generally anchored via a single tether attached to a distal wall of the LAA, in other embodiments, lobe-less occluders may be anchored within the LAA by a tether or tether- like structure that at least partially fills the chamber of the LAA to assist with anchoring. In these embodiments described in greater detail below, a proximal occluding member may be placed at the ostium O of the LAA, similar to the embodiments described in connection with Figs. 9A-11C. However, rather than anchoring via a single tether, an anchoring member (which may be referred to generally as a tether) attached to the proximal occluding member may be deployed to fill the chamber of the LAA to provide stability

[0085] Figs. 12A is a schematic illustration of a LAA occluders 1100 in an implanted condition. LAA occluder 1100 may include a proximal occluding member 1110, which may take the form of a disc or disc-like structure, which may be formed as a braided mesh similar or identical to disc 56ABTSJM-0642PCT 15848WOO1 of medical device 50. Proximal occluding member 1110 may be sized and shaped to cover the ostium O of the LAA. In some embodiments, the proximal occluding member 1110 may be inflatable like proximal occluding member 910 instead of being an expandable braided mesh disc. To secure the proximal occluding member 1110, rather than using a single tether that attaches to a distal wall of the LAA, LAA occluder 1100 includes an anchor wire 1120 (which may also be referred to as a tether) that can be fed into the LAA to at least partially fill the LAA. In the illustrated example, the anchor wire 1120 has a first end that is coupled to the proximal occluding member 1110, and a second end 1122 opposite the first end. The length of the anchor wire 1120 may be longer (e.g. significantly longer) than any length from the ostium O of the LAA to a distal wall of the LAA. Due to this length, as the anchor wire 1120 fills the LAA, it may take a tangled configuration, similar to that shown in Fig. 12A. In other words, instead of anchoring the anchor wire 1120 by piercing into tissue of the LAA, the anchoring may be achieved, at least in part, based on friction from the anchor wire 1120 tangling upon itself. In some examples, the distal end 1122 of the anchor wire 1120 may include a specific anchoring feature, such as any of those described above in connection with Figs. 9A-11C. However, in other embodiments, the distal end 1122 of the anchor wire 1120 may omit any structure that is specifically configured to pierce the distal wall of the LAA. The anchor wire 1120 may be formed of any suitable material, including for example a shape-memory material, including shape memory metals or metal alloys such as nitinol. If the anchor wire 1120 is formed of a shape memory material, it may be shape set (e.g. via heat treatment) to provide a controlled tangling effect upon deployment of the anchor wire 1120 into the LAA.

[0086] Fig. 12B illustrates an enlarged section of an example of the anchor wire 1120. In some examples, the anchor wire 1120 may include texturization or other friction-enhancing features, although such features may be omitted in other examples. In the example shown in Fig. 12B, the anchor wire 1120 is formed of nitinol and is coated or wrapped in a textured or knurled or barbed material that includes friction-enhancing members 1124. If included, the friction-enhancing members 1124 may create increased friction between tangled portions of the anchor wire 1120, as well as friction between portions of the anchor wire 1120 and the tissue of the LAA in contact with the anchor wire 1120.

[0087] Fig. 12C illustrates LAA occluder 1100 in an exemplary delivery condition. In Fig. 12C, the proximal occluding member 1110 is maintained in a collapsed condition within a deliveryABTSJM-0642PCT 15848WOO1 sheath DS (which may be part of a delivery system similar to that shown in Fig. 3), with the anchor wire 1120 extending distally from the proximal occluding member 1110 toward the leading end of the delivery sheath DS. In the illustrated example, the anchor wire 1120 folds over on itself a single time, such that the distal end 1122 of the anchor wire 1120 is not the distalmost portion of the anchor wire 1120 within the delivery sheath DS. In some examples, the anchor wire 1120 need not be folded at all, and in other examples, two. three, or more folds may be provided. The inclusion of one or more folds may allow for the anchor wire 1120 to be packed into a relatively small length of the delivery sheath DS, despite the entire length of the anchor wire 1120 being large. In some examples, the anchor wire 1120 may be pre-twisted within the delivery sheath DS. Regardless of the particular configuration of the anchor wire 1120 within the delivery sheath DS, once the distal end of the delivery sheath DS is positioned within (or adjacent to) the LAA, the LAA occluder may be advanced distally (and / or the delivery sheath DS may be retracted proximally), to advance the anchor wire 1120 into the cavity of the LAA. As the anchor wire 1120 enters the LAA, it begins to tangle upon itself and into contact with the LAA, creating a large amount of friction tending to maintain the position of the anchor wire 1120 relative to the LAA as the anchor wire 1120 fills the LAA. The proximal occluding member 1110 may be the last part of the LAA occluder 1100 to be deployed from the delivery sheath DS, at which point the anchor wire 1120 has already become tangled within the LAA and created high friction so that, when the proximal occluding member 1110 is deployed to cover the ostium O of the LAA, the position of the proximal occluding member 1110 is maintained and secured via anchoring forces from the anchor wire 1120. It should be understood that, in some examples, the proximal occluding member 1110 may be deployed first with the anchor wire 1120 deployed second, generally similar to the deployment shown and described in connection with Figs. 9D-G.

[0088] Figs. 13A-13C illustrate different stages in one exemplary deployment of LAA occluder 1200 into an LAA. LAA occluder 1200 is substantially similar to LAA occluder 1100, with the main difference being that, instead of the anchor wire 1120 tangling upon itself, LAA occluder 1200 has an anchor wire 1220 that is formed (e.g. shape-set via heat treatment) to form a helixtype of structure. For example, as shown in Fig. 13A, a distal end 1222 of the anchor wire 1220 may be deployed from a delivery sheath DS into the LAA. As the anchor wire 1220 is deployed, it moves from a relatively straight configuration within the delivery sheath DS into a helical configuration, for example because the anchor wire 1220 has a helical configuration in the absenceABTSJM-0642PCT 15848WOO1 of applied forces. The anchor wire 1220 may otherwise be similar or identical to anchor wire 1 120, including for example having a texturized surface with, for example, friction-enhancing members 1224 such as barbs. As shown in Fig. 13B, as more length of the anchor wire 1220 is deployed form the delivery sheath, the anchor wire 1220 continues to coil in a helical shape to create a large amount of surface area contact between the anchor wire 1220 and tissue of the LAA. This large surface area of contact creates significant friction, which may be further increased if frictionenhancing members 1224 are included. As shown in Fig. 13C, after the anchor wire 1220 is completely (or substantially completely) deployed, a proximal occluding member 1210, which may be similar or identical to proximal occluding member 1110, may be deployed from the delivery sheath DS. As with other embodiments described herein, the proximal occluding member 1210 may expand (e.g. via self-expansion) upon exiting the deliver sheath DS until the proximal occluding member 1210 covers the ostium O of the LAA. The end of the anchor wire 1220 opposite the distal end 1222 may be coupled to the proximal occluding member 1210, such that the high friction between the anchor wire 1220 and the LAA secures the proximal occluding member 1210 in the desired position against the ostium O of the LAA. In some examples, the anchor wire 1220 may be shape set to have a large coil or helix diameter in the absence of applied forces, resulting in contact between the anchor wire 1220 and the tissue of the LAA as long as the diameter of the LAA is equal to or smaller than the shape set diameter of the helix. In this sense, the anchor wire 1220 may be self-sizing, capable of properly fitting within any size LAA.

[0089] Figs. 13D-F illustrate a substantially identical LAA occluder 1200 being deployed, except that in the example deployment of Figs. 13D-F, the proximal occluding member 1210 is first deployed from the delivery sheath DS and held against the ostium O of the LAA while the anchor wire 1220 is then fed into the LAA. For example, Fig. 13D illustrates that the proximal occluding member 1210 has been allowed to expand out of the delivery sheath DS into contact with the tissue forming the ostium O of the LAA, and the delivery sheath DS temporarily maintains the proximal occluding member 1210 in the desired position. While the delivery sheath DS maintains the position of the proximal occluding member 1210, as shown in Figs. 13D-E, the distal end 1222 of the anchor wire 1220 may first be passed into the LAA through the proximal occluding member 1210, with the anchor wire 1220 returning to a helical shape in a controlled manner until the anchor wire 1220 is fully deployed as shown in Fig. 13F. When the LAA occluder 1200 is fully deployed, as shown in Fig. 13F, the resulting configuration is substantially identical to the deployment ofABTSJM-0642PCT 15848WOO1LAA occluder 1200 shown in Fig. 13C. It should be understood that, when the proximal occluding member 1210 is deployed first with the anchor wire 1220 deployed second, the method may be generally similar to the deployment shown and described in connection with Figs. 9D-G.

[0090] Figs. 14A-14B illustrate different stages in one exemplary deployment of an LAA occluder 1300 into an LAA. LAA occluder 1300 is substantially similar to LAA occluder 1200, with the main difference being that, instead of the anchor wire 1220 forming a helix that generally spirals around a central longitudinal axis of the ostium O of the LAA, LAA occluder 1300 has an anchor wire (or a plurality of anchor wires) 1320 that is / are formed (e.g. shape-set via heat treatment) to form a curled structure (e.g. tending to curl from a direction substantially parallel to the central axis of the ostium O back toward the ostium O, with the curl(s) contacting the wall of the LAA). For example, as shown in Fig. 14A, in one exemplary delivery method, the proximal occluding member 1310 (which may be similar or identical to proximal occluding member 1210) may be deployed from a collapsed condition within a delivery sheath DS into an expanded condition while being held against the ostium O of the LAA with the delivery sheath DS (and / or with another component of the delivery system), generally similar to the description in connection with Fig. 13D. While the proximal occluding member 1310 is held in place, one or more anchor wires 1320 (preferably, more than one, including two, three, four, five, six or more) are advanced distally through the proximal occluding member 1310 into the LAA. In some examples, the one or more anchor wires 1320 are each formed of a shape memory material, such as a shape memory metal or metal alloy such as nitinol. If formed of shape memory material, the one or more anchor wires 1320 may be shape-set (e.g. via heat treatment) to form a curled shape forming a curl of at least 180 degrees, up to and including 360 degrees or more e.g. including half a loop, a full loop, or more than one full loop). Preferably, when the one or more anchor wires 1320 are curled in the absence of applied forces, the curl has a span of at least half the diameter of the LAA. With this configuration, if two anchor wires 1320 are used and curl in opposite directions, each anchor wire 1320 will curl and eventually contact an inner surface of the LAA. In some examples, if two anchor wires 1320 are used, upon deployment they may preferably curl in generally opposite directions (e.g. one curls “up” toward the “top” of the LAA and one curls “down” toward the “bottom” of the LAA, although both preferably will curl back towards the ostium O). If more than two anchor wires 1320 are used, upon deployment they may preferably curl in different directions at generally equal intervals from each other (e.g., three anchor wires 1320 may curl at 120 degree intervals,ABTSJM-0642PCT 15848WOO1 four anchor wires 1320 may curl at 90 degree intervals, etc.) However, curling at equal (or near equal) intervals is not necessary, and rather the intent is to maximum engagement of the anchor wires 1320 with the LAA to maximize friction and thus stability of the proximal occluding member 1310. After the anchor wires 1320 have been sufficiently deployed to “grab” tissue of the LAA, the proximal occluding member 1310 may be stabilized in the desired position via the friction between the anchor wires 1320 and the LAA. As with anchor wires 1220. anchor wires 1320 may effectively be “self-sizing.” In some examples, if the anchor wires 1320 are being pushed through the proximal occluding member 1310 distally, the proximal ends of the anchor wires 1320 may also curl when released from the delivery sheath DS, with the curled proximal ends hooking into engagement with the proximal occluding member 1310. In other examples, proximal ends of the anchor wires 1320 may include enlarged sections (e.g. a crimp tube) that is too large to pass through the proximal occluding member 1310. Any of the other securing mechanisms, including for example plug inserts, threaded inserts, etc. described in connection with Figs. 9A-9G, may be other suitable mechanisms to couple the proximal ends of the anchor wires 1320 to the proximal occluding member 1310.

[0091] Fig. 14C illustrates an example of LAA occluder 1300 with only two anchor wires 1320 deployed for clarity of illustration. Each anchor wire 1320 may have a first end coupled to the proximal occluding member 1310 (e.g. after being deployed via delivery sheath DS and coupled to the proximal occluding member 1310 as described in connection with Fig. 14B above), and extend in a distal direction generally close to the central longitudinal axis of the proximal occluding member 1310 (and / or of the ostium O of the LAA), and then curl backwards or proximally, in directions away from each other, to a distal terminal end 1322. Similar to anchor wires 1120 and 1220, anchor wires 1320 in some examples include friction-enhancing elements 1324, which may be tines, micro-barbs, or any other suitable friction-enhancer including those described above. Fig. 14D illustrates an example in which four anchor wires 1320 are provided, and in Fig. 14D each anchor wire 1320 has curled more than one full loop (e.g. more than 360 degrees). However, it should be understood that, as described above, any desired number of anchor wires may be used to generate the desired frictional engagement with the LAA to help lock the proximal occluding member 1310 in place against the ostium O of the LAA without needing a lobe to anchor the proximal occluding member 1310.ABTSJM-0642PCT 15848WOO1

[0092] It should be understood that, as with other embodiments described herein, the proximal occluding member 1310 may be deployed first, with the anchor wires 1320 deployed second (e.g. generally similar to the process shown and described in connection with Figs. 9D-G, or the anchor wires 1320 may be deployed first with the occluding member 1310 being deployed after the anchor wires 1320 are in place. And while in some embodiments, the anchor wires 1320 may be delivered or deployed sequentially, in other examples, the anchor wires 1320 may be delivered as a single unit, for example with each anchor wire 1320 fixed at one end to the proximal occluding member 1310, and the anchor wires 1320 transition from a straight condition with the delivery sheath to a curled configuration upon deployment from the delivery sheath.

[0093] Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.

Claims

ABTSJM-0642PCT 15848WOO1CLAIMS1. A medical device for occluding a left atrial appendage (“LAA”), the medical device comprising: a proximal occluding member sized and shaped to cover an ostium of the LAA in an implanted condition of the medical device; a distal occluding member sized and shaped to be received within a cavity of the LAA in the implanted condition of the medical device; a connecting member connecting the proximal occluding member to the distal occluding member; and an occluding material, the occluding material being uncoupled from the proximal occluding member in a delivery condition of the proximal occluding member, and uncoupled from the distal occluding member in a delivery condition of the distal occluding member, the occluding material configured to at least partially fill and occlude the LAA.

2. The medical device of claim 1, wherein the occluding material is formed of wire that is configured to have a coiled configuration when the occluding material at least partially fills the LAA.

3. The medical device of claim 1, wherein the occluding material is formed of foam.

4. The medical device of any of the preceding claims, wherein the distal occluding member forms a disc or a lobe in an expanded condition of the distal occluding member, and in the implanted condition of the medical device, the occluding material is configured to be maintained between a distal face of the proximal occluding member and a proximal face of the distal occluding member.

5. The medical device of any of claims 1-3, wherein the distal occluding member forms a lobe in an expanded condition of the distal occluding member, and in the implanted condition of the medical device, the occluding material is configured to be maintained within an interior of the lobe.ABTSJM-0642PCT 15848WOO16. The medical device of claim 5, further comprising a plurality of stabilizing wires coupled to the lobe, the stabilizing wires each including a hooked end configured to frictionally engage tissue of the LAA.

7. The medical device of any of claims 1-3, wherein the distal occluding member forms a cup shape in an expanded condition of the distal occluding member, the cup shape including a closed proximal face and an open distal face, and in the implanted condition of the medical device, the occluding material is configured to be maintained distal to the closed proximal face of the cup shape.

8. The medical device of claim 7, further comprising a plurality of stabilizing wires coupled to the side wall of the distal occluding member, the side wall extending distally from the closed proximal face of the cup shape, the stabilizing wires each including a hooked end configured to frictionally engage tissue of the LAA.

9. The medical device of any of claims 1-3, wherein the distal occluding member forms a lobe in an expanded condition of the distal occluding member, the proximal occluding member forms a disc in an expanded condition of the proximal occluding member, and the disc is removably coupled to the lobe.

10. The medical device of claim 9, wherein the connecting member is fixed to the disc, the connecting member being threadedly coupled to the lobe.

11. A method of occluding a left atrial appendage (“LAA”) of a patient, the method comprising: advancing a delivery sheath into the patient until a distal end of the delivery sheath is positioned within or adjacent to the LAA; while the delivery sheath is positioned within or adjacent to the LAA, deploying an occluding material from the delivery sheath to at least partially fill the LAA; andABTSJM-0642PCT 15848WOO1 deploying a proximal occluding member from the delivery sheath so that the proximal occluding member expands and covers an ostium of the LAA; wherein during advancing the delivery sheath, the occluding material is uncoupled from the proximal occluding member.

12. The method of claim 11, wherein the occluding material is formed of wire that is configured to have a coiled configuration after being deployed from the delivery sheath and at least partially filling the LAA.

13. The method of claim 11, wherein the occluding material is formed of foam.

14. The method of any of claims claim 11-13, further comprising: prior to deploying the proximal occluding member, deploying a distal occluding member from the deliver}' sheath so that the distal occluding member expands within the LAA.

15. The method of claim 14, wherein deploying the occluding material from the delivery sheath is performed after deploying the distal occluding member, but before deploying the proximal occluding member, such that the occluding material is maintained between a proximal face of the distal occluding member and a distal face of the proximal occluding member.

16. The method of claim 14, wherein the distal occluding member forms a lobe after being deployed, and wherein deploying the occluding material from the delivery sheath includes at least partially filling an interior volume of the lobe with the occluding member after deploying the distal occluding member.

17. The method of claim 14, wherein the distal occluding member forms a cup shape after being deployed, the cup shape including a closed proximal face and an open distal face, and wherein deploying the occluding material from the delivery sheath includes deploying the occluding material into the distal occluding member such that the occluding material at least partially fills the cup shape and such that at least some of the occluding material is in directed contact with tissue of the LAA distal to the closed proximal face of the cup shape.ABTSJM-0642PCT 15848WOO118. The method of claim 14, wherein the occluding material is deployed to at least partially fill the LAA after the proximal occluding member has been deployed and after the distal occluding member has been deployed, wherein after deploying the occluding material, the proximal occluding member is decoupled from the distal occluding member and removed from the patient.

19. The method of claim 18, wherein the proximal occluding member is reversibly coupled to the distal occluding member via a connecting member that has a first end fixed to the proximal occluding member and a second end that is threadedly coupled to the distal occluding member, and wherein decoupling the proximal occluding member from the distal occluding member includes unthreading the connecting member from the distal occluding member.

20. The method of claim 11, wherein deploying the proximal occluding member from the delivery sheath includes maintaining a connection between the proximal occluding member and the delivery sheath, wherein the deployed proximal occluding member is held against the ostium of the LAA while deploying the occluding material into the LAA, and wherein after the LAA is at least partially filled with the occluding material, the proximal occluding member is retracted into the delivery sheath and removed from the patient.

21. A medical device for occluding a left atrial appendage (“LAA”), the medical device comprising: a proximal occluding member sized and shaped to cover an ostium of the LAA in an implanted condition of the medical device; and a tether having a first end coupled to the proximal occluding member, and a second end opposite the first end, the second end of the tether including a tether anchor configured to pierce tissue forming a distal wall of the LAA; wherein the medical device excludes a lobe-shaped occlusion member configured to be positioned within the LAA.ABTSJM-0642PCT 15848WOO122. The medical device of claim 21 , wherein the tether anchor includes one or more tines or pincers.

23. The medical device of claim 21, wherein the tether anchor includes one or more hooks.

24. The medical device of claim 21, wherein the tether anchor includes a helical member configured to screw into the distal wall of the LAA.

25. The medical device of any of claims 21-24, wherein the proximal occluding member forms a disc, and in an implanted condition of the medical device the tether is substantially straight between the first end of the tether and the second end of the tether.

26. The medical device of any of claims 21-24, wherein the proximal occluding member forms a balloon, the balloon being inflatable from a deflated condition to an inflated condition in which the inflated balloon occludes the ostium of the LAA.

27. The medical device of any of claims 21-24, wherein in an implanted condition of the medical device the tether has a serpentine shape between the first end of the tether and the second end of the tether.

28. The medical device of claim 27. further comprising a seal member positioned on the tether proximal to the tether anchor, such that in the implanted condition of the medical device, the seal member abuts the distal wall of the LAA.

29. A medical device for occluding a left atrial appendage (“LAA”), the medical device comprising: a proximal occluding member sized and shaped to cover an ostium of the LAA in an implanted condition of the medical device; andABTSJM-0642PCT 15848WOO1 one or more anchor wires each having a first end coupled to the proximal occluding member, the one or more anchor wires collectively having a plurality of contact points with tissue of the LAA in an implanted condition of the medical device; wherein the medical device excludes a lobe-shaped occlusion member configured to be positioned within the LAA.

30. The medical device of claim 29, wherein the one or more anchor wires each include friction-enhancing members.

31. The medical device of claim 30, wherein the friction-enhancing members are tines or barbs.

32. The medical device of any of claims 29-31, wherein the one or more anchor wires includes only one anchor wire, the one anchor wire configured to have a tangled configuration in the implanted configuration of the medical device.

33. The medical device of any of claims 29-31, wherein the one or more anchor wires includes only one anchor wire, the one anchor wire configured to have a helical configuration in the implanted configuration of the medical device.

34. The medical device of any of claims 29-31, wherein the one or more anchor wires includes a plurality of anchor wires, the plurality of anchor wires each being configured to have a curled configuration in the implanted configuration of the medical device in which each of the plurality of anchor wires first extends distally from the proximal occluding member and then curls proximally back toward the proximal occluding member.

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