SURGICAL LEFT ATRIAL APPENDAGE CLOSURE DEVICES AND METHODS FOR DELIVERY

Surgical devices and methods for excluding the left atrial appendage (LAA) via a thoracoscopic approach or at the time of open heart surgery. The device includes a trocar for accessing the LAA and a delivery system for implantation of the occlusion implant through the trocar. The occlusion implant can be an expandable metal clip or an expandable metal-framed occlusion device that includes a tissue scaffold. The trocar is placed through an opening in the tip of the LAA, then the occlusion implant is delivered through it and placed near the ostium of the LAA to seal it off from the left atrium. The hole in the tip of the LAA is then closed. Other associated surgical devices and methods are described.

BACKGROUND

Field

This development relates generally to excluding the left atrial appendage (LAA). In particular, surgical devices and methods for excluding the left atrial appendage (LAA), via a thoracoscopic approach or at the time of open heart surgery, are described.

SUMMARY

The embodiments disclosed herein each have several aspects no single one of which is solely responsible for the disclosure's desirable attributes. Without limiting the scope of this disclosure, its more prominent features will now be briefly discussed. After considering this discussion, and particularly after reading the section entitled “Detailed Description,” one will understand how the features of the embodiments described herein provide advantages over existing systems, devices and methods for left atrial appendage (LAA) occlusion.

The following disclosure describes non-limiting examples of some embodiments. For instance, other embodiments of the disclosed systems and methods may or may not include the features described herein. Moreover, disclosed advantages and benefits can apply only to certain embodiments and should not be used to limit the disclosure.

Devices and methods for occluding the left atrial appendage are described herein. In some implementations, the techniques described herein relate to a device for closing off a left atrial appendage (LAA) of a patient. The device can include a proximal hub; one or more fronds extending distally from the proximal hub; one or more anchors disposed at the distal end of the one or more fronds, the one or more anchors configured to engage an ostium of the LAA; and a collar disposed around the one or more fronds. The collar may move distally along the one or more fronds, causing the one or more anchors to be pulled toward a central longitudinal axis into a closed position and close the ostium of the LAA.

In some implementations, the collar may lock the one or more fronds in the closed position. In some implementations, the one or more fronds may include a first bump feature. In some implementations, the collar may move distally along the one or more fronds and over the first bump feature. The first bump feature may retain the collar in a distal position relative to the first bump feature.

In some implementations, the one or more fronds may include a second bump feature disposed distally from the first bump feature. In some implementations, the collar may move distally along the one or more fronds and over the first bump feature, causing the one or more fronds to be pulled a first distance toward the central longitudinal axis and into a partially closed position. The collar may move distally along the one or more fronds and over the second bump feature causing the one or more fronds to be pulled a second distance toward the central longitudinal axis and into the closed position.

In some implementations, the one or more fronds can include at least two fronds or at least four fronds. In some implementations, the collar may include a notch configured to secure the collar to a delivery device. In some implementations, the proximal hub may include a pin that can be disposed proximal to the collar and may move distally into a central lumen of the collar, causing the one or more fronds to be deployed. In some implementations, the pin may include a step configured to prevent the pin from extending beyond the collar.

In some aspects, the techniques described herein relate to a method for occluding a left atrial appendage (LAA) of a patient. The method may include providing an implant within a delivery device. The implant may include: an expandable tubular body having a compressible open cell foam sidewall, an occlusive end, an open end, and a longitudinal axis extending therethrough; and a self-expandable support carried within the expandable tubular body, the self-expandable support including a plurality of struts forming a plurality of apexes. The method may also include creating an incision at a tail of the LAA of the patient; inserting the delivery device with the implant through the incision into the LAA; deploying the implant within the LAA to allow the self-expandable support and the tubular body to expand such that the foam sidewall contacts the wall of the LAA and provides a cushion between the support and the wall of the LAA; securing the implant; and closing the incision at the tail of the LAA.

In some implementations, the implant may also include a suture tether attached to the self-expandable support. The suture tether may collapse the support when tension is applied to the suture tether. In some implementations, the implant may include attaching the suture tether to the LAA. In some implementations, the delivery device may include a grappling hook device. The grappling hook device may include a plurality of hooks coupled to the plurality of apexes of the support. In some implementations, the grappling hook device may also include a plurality of spring elements attached to the plurality of hooks, the plurality of spring elements configured to extend radially and expand the self-expandable support.

In some implementations, the method may also include inverting the implant such that the occlusive end of the expandable tubular body passes through the open end of the expandable tubular body.

In some implementations, the techniques described herein relate to a method for occluding a left atrial appendage (LAA) of a patient. The method may include providing an implant within a delivery device. The implant may include a foam body. The method may also include: creating an incision at a tail of the LAA of the patient; inserting the delivery device with the implant through the incision into the LAA; deploying the implant within the LAA; securing the implant with the LAA; and closing the incision at the tail of the LAA.

In some implementations, the foam body may include a solid plug configured to self-expand and occlude the LAA.

In some implementations, the implant may also include a first support and a second support disposed within the foam body. The first support may include a first plurality of struts forming a first plurality of apexes. The second support may include a second plurality of struts forming a second plurality of apexes.

In some implementations, the implant may also include a suture that may encircle an exterior of an ostium of the LAA and may secure the implant within the ostium of the LAA. The foam body may include a cork shape that may be placed in the ostium of the LAA and may resist compression by the suture.

DETAILED DESCRIPTION

The following detailed description is directed to certain specific embodiments of the development. In this description, reference is made to the drawings wherein like parts or steps may be designated with like numerals throughout for clarity. Reference in this specification to “one embodiment,” “an embodiment,” or “in some embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrases “one embodiment,” “an embodiment,” or “in some embodiments” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but may not be requirements for other embodiments. Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.

Surgical approaches for occluding the LAA, such as via a thoracoscopic approach or at the time of open heart surgery, are described herein. The system may include an LAA occlusion device or implant, a trocar, and a delivery system for implantation of the LAA occlusion device through the trocar. Various embodiments of the system and the LAA occlusion device are described. Surgical approaches involving a surgical clip device, a purse string/lasso device, a grappling hook device, a marshmallow-like device, various implants with modified frames, and a champagne cork-like device are described.

Further, LAA occlusion devices having one or more similar structural features of some transcatheter delivered LAA occlusion devices may be used in the surgical approaches described herein. For example, the various systems, devices and methods for the surgical approaches described herein, such as the various devices used in the surgical procedures shown and described with respect toFIGS.35-57, may include the same or similar features and/or functionalities as other transcatheter LAA occlusion systems or devices, such as those described, for example, in U.S. application Ser. No. 17/675,779 entitled “MULTIFUNCTIONAL LEFT ATRIAL APPENDAGE (LAA) OCCLUDER,” and filed on Feb. 18, 2022, in U.S. application Ser. No. 17/183,160 entitled “DEVICES AND METHODS FOR EXCLUDING THE LEFT ATRIAL APPENDAGE” and filed on Feb. 23, 2021, in U.S. application Ser. No. 16/782,871 entitled “DEVICES AND METHODS FOR EXCLUDING THE LEFT ATRIAL APPENDAGE” and filed on Feb. 5, 2020, in U.S. application Ser. No. 15/795,083 entitled “DEVICES AND METHODS FOR EXCLUDING THE LAA” and filed on Oct. 26, 2017, and/or as described in U.S. application Ser. No. 15/969,654 entitled “DEVICES AND METHODS FOR EXCLUDING THE LAA” and filed on May 2, 2018, the entire disclosure of each of which is incorporated herein by reference for all purposes and forms a part of this specification.

A cross-section of a human heart100is shown inFIG.1with a left atrial appendage (LAA)102, which is a cavity emanating from the left atrium (LA)104.FIG.2shows one embodiment of an LAA occlusion device124occluding the LAA102. The LAA102is quite variable in shape in all dimensions. If the heart is not beating normally, a condition called atrial fibrillation, blood within the LAA becomes stagnant which promotes clot formation. If blood clots within the LAA, the clots may pass from the LAA102to the LA104, to the left ventricle106and out of the heart100into the aorta. Vessels that bring blood to the brain branch off the aorta. If the clot passes to the brain via these vessels, it may get stuck and occlude a small vessel in the brain which then causes an ischemic stroke. Strokes have severe morbidities associated with them. The opening of the LAA102to the LA104is called an ostium110. The ostium110is oval, highly variable and dependent on loading conditions, e.g., left atrial pressure. An object of the LAA occlusion devices described herein is to occlude the ostium110thereby sealing off the LA104from the LAA102.

The devices and related methods are described herein in connection with use in occluding, i.e. excluding, a left atrial appendage (LAA) via a surgical procedure. The system may include a trocar for accessing the LAA and a delivery system for implantation of the occlusion implant through the trocar. The occlusion implant can be an expandable metal clip or an expandable metal-framed occlusion device that includes a tissue scaffold. The trocar is placed through an opening in the tip of the LAA, then the occlusion implant is delivered through it and placed near the ostium of the LAA to seal it off from the left atrium. The hole in the tip of the LAA is then closed. Other various embodiments and features thereof are described.

Various embodiments of LAA occlusion devices that may be used in the surgical approaches described herein are shown and described with respect toFIGS.9A-61, including a surgical clip device, a purse string/lasso device, a grappling hook device, a marshmallow-like device, various implants with modified frames, and a champagne cork-like device. Other embodiments of LAA devices having a compressible outer foam and supporting inner frame with anchors and that may be used in the surgical approaches described herein are shown and described with respect to some of the above figures and as well as inFIGS.3A-8D. Numerous options for occluding the LAA of the heart directly during open heart surgery or via a thorascopic approach are described. The LAA can be entered externally from what would be considered the distal end of the LAA during an interventional closure procedure (e.g. the tip of the LAA).

For surgically placed LAA closure, transesophageal echocardiography (TEE) may be conducted at the start of the surgical procedure, prior to placing the patient on bypass. This can be done to confirm there is no thrombus in the LAA and to size the appendage in multiple views in a pressurized, beating heart. Certain embodiments of LAA closure procedures described herein occur in a beating, pressurized heart after the heart has been re-started and brought to body temperature.

Alternatively, the LAA may be closed while the patient is on bypass. In certain embodiments, expansion of an implant frame (e.g., a Nitinol) may be challenging in a cold heart. During bypass surgery, hypothermia of the entire body is induced to preserve the heart muscle, brain, and other vital organs. The heart is cooled to well below room temperature and Nitinol implants, as commonly designed, may not fully expand after release from the delivery catheter. The hypothermia induced during cardiac surgery is typically <20° C. whereas current-day Nitinol implants are typically designed to come to their fully expanded diameter at body temperature, approximately 37° C. Nitinol at body temperature is in its austenitic state and displays good rigidity and is very springy, which is a property referred to as superelasticity. When Nitinol implants are collapsed within a catheter, they briefly convert to a martensitic phase, induced by the stress placed on the implant frame to collapse it. While some current-day devices can partially expand at temperatures as low as room temperature (˜25° C.), they typically do not come to their full diameter due to the typically available Austenitic finish (Af) temperatures, the temperature above which Nitinol is in a rigid state. Certain embodiments described herein may overcome these challenges by heating the implant or utilizing other implantable metals which can have consistent properties across a wider temperature range such as MP35N, Elgiloy, stainless steel, etc.

The LAA occlusion devices described herein for the surgical approach can include multiple functionalities. For example, the devices may include open internal spaces or cavities that provide a location for the incorporation of additional electronic devices or systems such as pacers, biosensors, drug delivery systems, defibrillators, pressure sensors, motion sensors, and/or any other suitable devices or systems. The LAA occlusion devices can include anchoring systems or components, such as an anchor or frame, that can also function as a staging or docking point to secure the additional devices or systems within the LAA occlusion devices.

The anchor or frame can be formed of one or more metals. For example, the anchor or frame can be formed of one or more of Nitinol, MP35, Elgiloy, stainless steel, or any other suitable metal. In some embodiments, the anchor or frame is fabricated from a laser-cut Nitinol tube. In some embodiments, the anchor is fabricated from woven or braided metals. The anchor or frame can be covered by a scaffold, such as a foam body. The foam body may be cylindrical in shape. The foam may be tubular in shape. The body can include an open cell foam material. There may be an expanded Polytetrafluoroethylene (“ePTFE”) layer on the proximal end.

In certain embodiments, the device can include an open or openable proximal end that can allow for delivery of the additional devices or systems (e.g., pacing devices or systems, defibrillator devices or systems, sensing devices or systems, drug delivery devices or systems, etc.) into the LAA occlusion device and which proximal end may then be closed to occlude the LAA opening. In other embodiments, the device can include one or more openings within the scaffold and/or frame of the device that can allow for delivery of additional devices or systems (e.g., pacing devices or systems, defibrillator devices or systems, sensing devices or systems, drug delivery devices or systems, etc.) through the LAA occlusion device. In other embodiments, additional devices or systems (e.g., pacing devices or systems, defibrillator devices or systems, sensing devices or systems, drug delivery devices or systems, etc.) may be deployed within the LAA before the LAA occlusion device or in combination with the LAA occlusion device. For example, additional devices or systems (e.g., pacing devices or systems, defibrillator devices or systems, sensing devices or systems, drug delivery devices or systems, etc.) may be coupled to the LAA occlusion device prior to delivery to LAA. In certain embodiments, these additional devices or systems (e.g., pacing devices or systems, defibrillator devices or systems, sensing devices or systems, drug delivery devices or systems, etc.) can be placed in patients having other cardiac diseases in addition to atrial fibrillation in order to address those other cardiac diseases by adding additional functionality to the LAA occlusion device, for example, to provide electrical isolation/ablation of the LAA, deliver drugs, provide pacing, and/or measure pressure.

In embodiments in which the additional devices or systems are pacing systems, the frame of the LAA occlusion device can provide an electrical connection between the pacing system and the atrial myocardium. For example, the portions of the frame, anchors, and/or alternative structures incorporated into the frame can contact the atrial myocardium in a penetrating or a non-penetrating manner to provide an electrical connection between the pacing system and the myocardium.

FIG.2shows the LAA occlusion device124placed within the LAA102at its opening to the LA122. It is understood that the device124may have the same or similar features as other implantable “devices” or “implants” described herein, such as the device3000, and vice versa. The device124may thus have an expandable foam body carrying a support structure or frame with anchors, as described herein, for example with respect to the device3000andFIGS.3A-8D. The device124may have any of the features of the various implants described herein with respect toFIGS.35-57.

The device124may be cylindrical in shape in an unconstrained expansion, but it may also be conical for example with its distal end smaller than the proximal end or reversed. It could also be oval in cross section to better match the opening of the LAA.

The device124is oversized radially in an unconstrained expansion to fit snuggly into the LAA and may be 5-50 mm in diameter depending on the diameter of the target LAA. The compliance and thickness of the foam are designed to provide a good seal against the tissue with minimal compression. While other devices require significant oversizing relative to the width of the LAA to obtain a seal, the implants described herein may require only ≤1 mm of oversizing. In some embodiments, the implant may require only ≤2 mm, ≤3 mm, or ≤4 mm, or ≤5 mm. In a free, unconstrained state, the axial length “L” of the plug is less than its outer diameter “D” such that the L/D ratio is less than 1.0. In some embodiments, this ratio may be greater than 1.0. The compliance of the foam material is designed such that it pushes on the walls of the LAA with sufficient force to maintain the device124in place but without overly stretching the LAA wall. The foam and/or skin also conforms to the irregular surfaces of the LAA as it expands, to provide a complementary surface structure to the native LAA wall to further enhance anchoring and promote sealing. Thus, the expandable foam implant described herein conforms to the native configuration of the LAA. In one embodiment, the structure of the foam may be fabricated such that squeezing axially on the opposing ends of the foam causes the foam to increase in diameter.

An outer ePTFE layer may be formed as a sheet. The sheet may have a wall thickness between 0.0001″ and about 0.003″ thick and serves to allow one to collapse and pull on the device124without tearing the foam material. The sheet may be formed from multiple sheets welded together using heat. It may also have one or more layers of electrospun material (e.g., electrospun ePTFE) to enhance tissue ingrowth. In other embodiments, an outer ePTFE layer may be formed from a tube with a diameter about the same diameter of the foam plug and a wall thickness between about 0.0001″ and about 0.003″ thick and serves to allow one to collapse and pull on the device124without tearing the foam material. The ePTFE material also serves as the blood contacting surface facing the LA126and has pores or nodes such that blood components coagulate on the surface and an intimal or neointimal covering of tissue grows across it and anchors tightly to the material. Pore sizes within the range of from about 4μ to about 110μ, ideally 5-35μ are useful for formation and adherence of a neointima.

The outer covering126may be constructed of materials other than ePTFE such as woven fabrics, meshes or perforated films made of FEP, polypropylene, polyethylene, polyester or nylon. The covering126should have a low compliance (non-elastic), at least longitudinally, be sufficiently strong as to permit removal of the plug, a low coefficient of friction, and be thromboresistant. The outer covering126serves as a matrix to permit plug removal as most foams are not sufficiently strong to resist tearing when pulled. The plug124can also be coated with or contain materials, such as PTFE. Such materials may enhance the plug's124ultrasonic echogenic profile, thromboresistance, and/or lubricity. The plug124can also be coated with or contain materials to facilitate echocardiographic visualization, promote cellular ingrowth and coverage.

The outer covering126may have holes in it to permit contact of the LAA tissue with the device124to encourage ingrowth of tissue into the foam plug pores and/or allow blood flow therethrough. These holes may be 1 to 5 mm in diameter or may also be oval with their long axis aligned with the axis of the foam plug, the length of which may be 80% of the length of the foam plug and the width may be 1-5 mm. The holes may be as large as possible such that the outer covering maintains sufficient strength to transmit the tensile forces required for removal. The holes may be preferentially placed along the device. In one embodiment, holes are placed distally to enhance tissue ingrowth from the LAA wall.

The device124or3000(as described below) may be anchored and secured in place in the LAA by anchoring features. In some embodiments, the device124or3000may also be anchored by tissue ingrowth.

Deployment of the occlusion device may be via direct surgical access or various minimally invasive access pathways (e.g. jugular vein). For example, the area overlying the xiphoid and adjacent costal cartilage may be prepared and draped using standard techniques. A local anesthetic may be administered and skin incision may be made, typically about 2 cm in length. The percutaneous penetration passes beneath the costal cartilage, and a sheath may be introduced into the pericardial space. The pericardial space may be irrigated with saline, preferably with a saline-lidocaine solution to provide additional anesthesia and reduce the risk of irritating the heart. The occlusion device may thereafter be introduced through the sheath, and through an access pathway created through the wall of the LAA. Closure of the wall and access pathway may thereafter be accomplished using techniques understood in the art.

Various features for LAA occlusion may be included in the LAA occlusion devices, systems, and methods described herein, such as those described, for example, in U.S. patent application Ser. No. 15/290,692, filed Oct. 11, 2016 and titled DEVICES AND METHODS FOR EXCLUDING THE LAA, and in U.S. patent application Ser. No. 14/203,187, filed Mar. 10, 2014 and titled DEVICES AND METHODS FOR EXCLUDING THE LAA, the entire disclosure of each of which is hereby expressly incorporated by reference for all purposes and forms a part of this specification. The embodiments described in the sections below may include the same or similar features and/or functionalities as the embodiments described above, and vice versa, except as otherwise noted or indicated by context.

B. LAA Occlusion Device with Compressible Foam Body and Compliant Frame

FIGS.3A-8Dshow an embodiment of an LAA occlusion device3000that may be used in the surgical approaches described herein. The device3000described herein may have the same or similar features and/or functionalities as other LAA occlusion devices described herein, and vice versa. Any of the features of the device3000described with respect toFIGS.3A-8Dmay therefore apply to features of the devices described with respect toFIG.2, such as the device204, or to any other devices described herein, and vice versa.

FIGS.3A-3Cshow the LAA occlusion device3000having a scaffold or foam body3002, an expandable support or frame3040, and a proximal cover3100.FIG.3Dshows the LAA occlusion device3000additionally having an interior cover3101and proximal markers3023A.FIGS.4A-4Cshow the foam body3002, with the body3002shown in cross-section inFIGS.4B and4C.FIG.4Cadditionally includes the full view (i.e. non-cross section) of the frame3040. The device3000is shown in an expanded configuration in these figures. The device3000has a longitudinal axis as shown, which may be defined by the foam body3002, as further described.

The body3002is formed from a compressible material, such as foam. The body3002may be a foam formed from reticulated (e.g. net-like) polycarbonate polyurethane-urea. The body3002may be cut, formed or assembled into a cup shape, as further described. The body3002may have a thickness and compressibility sufficient to engage the surrounding tissue and conform to the anatomic irregularities under radial force applied by the inner frame, as further described. The use of a compressible material such as foam for the body3002provides a complete seal of the LAA and superior performance for LAA occlusion over existing devices, as further described. The structure of the foam of the body3002comprises a three-dimensional network of interconnected reticulations, spaced apart to form a network of interconnected open pores, as further described. The reticulations can carry a coating, such as PTFE, while preserving the open pores, as further described.

The foam material of the body3002has a high porosity. “Porosity” as used herein has its usual and customary meaning and refers to open void content between the interconnected reticulations of the foam. The porosity of the body3002may be at least about 65%, at least about 70% at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95% or more. The porosity may be within the range of approximately 90-95%. The porosity may be approximately 90%. The porosity may be approximately 95%. The porosity may be 90%, 91%, 92%, 93%, 94%, or 95%. The high porosity promotes quick and tenacious tissue ingrowth, allows it to be compressed into a small catheter, and/or allows blood to pass if the implant embolizes, among other advantages.

The foam body3002has pores or cells formed between the interconnected reticulations of the foam material. The foam body3002has cells with sizes in the range of from about 250 μm to about 500 μm. The foam may have a cell size from about 125 μm to about 750 μm, from about 175 μm to about 650 μm, from about 200 μm to about 600 μm, from about 225 μm to about 550 μm, from about 275 μm to about 450 am, less than 125 μm, or greater than 750 μm. These sizes may refer to the size of the cell prior to application of any coating, such as PTFE. The cell size may thus change, e.g. decrease, after application of the coating. The desired porosity and/or cell size may be determined based on allowing the passage of blood while blocking debris of a size capable of potentially causing ischemic stroke. The allowable size of such debris may drive the selection of the particular porosity and/or cell size. For example, the cell size from about 250 μm to about 500 μm may be based on prevention of debris of a particular size from passing through the body3002.

In an embodiment, the foam body3002is made from a non-resorbable, reticulated, cross-linked, polycarbonate polyurethane-urea matrix, structurally designed to support fibrovascular tissue ingrowth, with a fully interconnected, macroporous morphology with over 90-95% void content and cell sizes ranging from 250 to 500 m.

The body3002has a proximal end3004and a distal end3006. In some embodiments, the axial length of the device3000from the proximal end to the distal end in a free, unconstrained state is 20 mm. As used herein, the “free, unconstrained” state, and the like, refers to a state of the device3000without any external forces applied to the device3000other than a normal or reactive force from a surface (e.g. table top) on which the device3000is placed. In some embodiments, this axial length may be from about 10 mm to about 30 mm, from about 12 mm to about 28 mm, from about 14 mm to about 26 mm, from about 16 mm to about 24 mm, from about 18 mm to about 22 mm, or about 20 mm. The body3002may have any of these lengths regardless of outer diameter of the body3002.

The proximal end3004of the body3002has a proximal end wall or face3008. The proximal face3008faces generally toward the LA when the device3000is implanted into the LAA. The device3000may be implanted off-axis, as further described, in which case the proximal face3008may not reside at a perpendicular to a longitudinal axis of the LA. The proximal face3008thus provides a closed proximal end3004of the body3002. The closed proximal end3004is configured to span the ostium but the porosity, as further described, is sufficient to permit the passage of blood while blocking debris of a size capable of potentially causing ischemic stroke. This membrane may be formed by the body3002and/or the cover3100. In some embodiments, the proximal face3008or portions thereof may be open. For example, there may not be a proximal face3008, there may be a partial proximal face3008, there may be a proximal face3008with portions removed, etc. In some embodiments, the proximal face3008or portions thereof is/are not included and any opening or openings is/are covered by the cover3100. The size of any such openings in the proximal face3008may be driven by the desired size of embolic debris to be prevented from escaping the LAA, as further described.

The proximal face3008is flat or generally flat and generally perpendicular to the longitudinal axis of the device3000. The proximal face3008has a circular or generally circular shape as viewed from the proximal end3004in an unconstrained expansion. In some embodiments, the proximal face3008may be flat, rounded, segmented, angled with respect to the longitudinal axis, other shapes, or combinations thereof. The proximal face3008may have a non-circular, polygonal, other rounded shape, other shapes, or combinations thereof, as viewed from the proximal end3004.

The proximal face3008has an outer surface3010and an opposite inner surface3012. The outer surface3010faces proximally away from the device3000and the inner surface3012faces distally toward the frame3040. The surfaces3010,3012may define outer and inner sides of the proximal face3008. The thickness of the proximal face3008may be measured axially between the outer surface3010to the inner surface3012. This thickness in a free, unconstrained state (e.g. uncompressed and expanded) may be from about 0.5 mm to about 5 mm, from about 1 mm to about 4 mm, from about 2 mm to about 3 mm, about 2.5 mm, or 2.5 mm. In some embodiments, the thickness may be less than 0.5 mm or greater than 5 mm. The thickness of the proximal face3008may be uniform or non-uniform. Thus, the thickness may be greater or smaller in different regions of the proximal face3008.

The body3002includes a sidewall3014extending distally from the proximal face3008. The sidewall3014extends circumferentially about a perimeter of the proximal face3008to form a closed cross-section (i.e. extends circumferentially 360 degrees about the axis). The sidewall3014extends axially to define a tubular body concentric about the longitudinal axis of the device3000. The longitudinal axis extends through a geometric center of the tubular body defined by sidewall3014. The sidewall3014is tubular or generally tubular, e.g. cylindrical, along the axis. In some embodiments, the sidewall3014may be conical or frustoconical, for example where the proximal end is wider than the distal end or vice versa. The sidewall3014may have an outer profile at the proximal end thereof, and as viewed from the proximal or distal end, to match that of the outer perimeter of the proximal face3008.

In some embodiments, the cross-section of the sidewall3014may not be closed, for example where there are openings in the sidewall3014. Thus, cross-sections taken at various locations along the longitudinal axis may or may not show a closed section. In some embodiments, the sidewall3014may be non-tubular, non-cylindrical, non-circular, polygonal, other rounded shapes, other shapes, or combinations thereof. In some embodiments, as shown, the sidewall3014may extend continuously for the entire length from the proximal end3004to the distal end3006. In some embodiments, the sidewall3014may not extend continuously for the entire length from the proximal end3004to the distal end3006. For example, the sidewall3014may include a plurality of disconnected sections, such as annular portions of the sidewall, located and spaced along the longitudinal axis and connected to the frame3040.

The sidewall3014has an outer surface3016and an opposite inner surface3018. The outer surface3016faces radially outward from the axis. The inner surface3018faces radially inward toward the axis. The thickness of the sidewall3014may be measured radially between the outer surface3016to the inner surface3018. This thickness in a free, unconstrained state (e.g. uncompressed) may be from about 0.5 mm to about 5 mm, from about 1 mm to about 4 mm, from about 2 mm to about 3 mm, about 2.5 mm, or 2.5 mm. In some embodiments, the thickness may be less than 0.5 mm or greater than 5 mm. The thickness of the sidewall3014may be uniform or non-uniform. Thus, the thickness may be greater or smaller in different regions of the sidewall3014. The thickness of the sidewall3014may be the same or different as the thickness of the proximal face3008. In some embodiments, the thickness of the proximal face3008is 2.5 mm and the thickness of the sidewall3014is 2.5 mm. In some embodiments, the thickness of the proximal face3008is about 2.5 mm and the thickness of the sidewall3014is about 2.5 mm.

The sidewall3014has a distal free end3020having a distal surface3022. The distal surface3022is flat or generally flat and perpendicular to the longitudinal axis of the device3000. In some embodiments, the distal surface3022is non-flat, angled with respect to the axis of the device3000, curved, rounded, segmented, other shapes, or combinations thereof.

The body3002may have a distal opening3024. The opening3024is formed by the distal free end3020of the sidewall3014. The opening3024is at a distal end of an internal central volume or cavity3028of the body3002that is formed at least partially by the sidewall3014, the proximal face3008and/or the shoulder3030. The frame3040may reside within the cavity3028, as further described. The distal opening3024may be completely open. In some embodiments, the distal opening3024may be mostly open, partially open, or closed, for example where the body3002has a distal face similar to the proximal face3008to enclose or partially enclose the cavity3028.

The body3002has a shoulder3030, shown as a bevel, that extends between the proximal face3008to the sidewall3014. The shoulder3030may be an intersection of a proximal end of the sidewall3014and the proximal face3008. The shoulder3030extends circumferentially about the entire perimeter of the intersection. The shoulder3030has an outer surface3032. The outer surface3032may be a beveled surface. The outer surface3032is flat or generally flat in an axial direction. The outer surface3032extends circumferentially about the entire perimeter of the shoulder3030. In some embodiments the shoulder3030and/or outer surface3032may be non-flat, rounded, other shapes in an axial direction, or combinations thereof. The shoulder3030and/or outer surface3032may extend circumferentially less than the entire perimeter of the shoulder3030. The thickness of the shoulder3030may be measured inward perpendicularly to the outer surface3032. The thickness of the shoulder3030may be the same as the thicknesses of the proximal face3008and/or the sidewall3014, as described herein. In some embodiments, the thickness of the shoulder3030may be different from the thicknesses of the proximal face3008and/or the sidewall3014. The shoulder3030may function as a recapture ramp, to facilitate drawing the implant proximally into the deployment catheter.

The compressibility of the body3002contributes to the superior sealing capability of the device3000. The foam may be compressible to provide a larger radial “footprint” and spread out the radial forces from struts on the frame3040, as further described. The foam body3002may have a compressive strength of at least 1 pound per square inch (psi) or within a range of about 1 psi to about 2 psi, or no more than about 2 psi. The “compressive strength” here refers to the pressure to compress the foam to 50% strain. With some foam materials for the body3002, the pressure may not change from 50% strain through at least 80% strain, and the relation of pressure versus strain may be flat or generally flat. Thus, even with thicker foams for the body3002, the body3002will not exert much more outward force on the tissue due to the increased thickness by itself. In an embodiment, the foam body3002is a reticulated, cross-linked matrix having at least about 90% void content, an average cell size within the range of from about 250-500 microns, a wall thickness of at least about 2 mm and a compressive strength of at least about 1 psi. In an embodiment, the body3002is formed from a foam material having or substantially having the material properties indicated in Table 1. In some embodiments, the body3002is formed from materials described in, for example, U.S. Pat. No. 7,803,395, issued Sep. 28, 2010, and titled “Reticulated elastomeric matrices, their manufacture and use in implantable devices,” or U.S. Pat. No. 8,337,487, issued Dec. 25, 2012, and titled “Reticulated elastomeric matrices, their manufacture and use in implantable devices,” the entire disclosures of which are incorporated herein by reference.

TABLE 1Example material properties for an embodiment of foammaterial that may be used for the foam body 3002.Material PropertyValuePermeability311DarcyAverage Cell Size377μmDensity2.7lb/ft3Compressive Strength1.1psiTensile Strength Parallel68psiTensile Strength Perpendicular32psiElongation Parallel219%Elongation Perpendicular243%

The device3000may include markers3023(seeFIGS.3B and5D; for clarity only some of the markers3023are labelled in the figures) to facilitate visualization during delivery. The markers3023may be radiopaque marker bands sewn into the distal free end3020of the body3002. The markers3023may be for visualization using fluoroscopy imaging of the distal end3006of the device3000during delivery. There may be a series of the markers3023located circumferentially along the distal surface3022of the body3002(for clarity, only some of the markers3023are labelled inFIG.3B). In some embodiments, the markers3023may additionally or alternatively be located in other areas of the body3002and/or on other parts of the device, such as the cover3100or frame3040.

In some embodiments, four platinum iridium (PtIr) radiopaque (RO) tubular markers3023are sewn onto the distal end3006of the foam body3002to enable visualization of the distal edge of the device3000under fluoroscopy. In some embodiments, a PtIr marker3023is attached to the foam body3002at the location of the proximal shoulder3030to use as a marker during recapture of the device3000. Visualization of the proximal and/or distal markers3023may facilitate with identifying the amount of recapture. If the device3000is recaptured up to but not including the anchors proximal3090inside the access sheath, the device3000can be redeployed and reused. If the proximal anchors3090are recaptured into the access sheath, the device3000may be removed and discarded due to permanent deformation of the anchors3090. In some embodiments, other materials may be used for the markers3023, such as gold or other suitable materials.

As shown inFIGS.3D and5D, the device3000may include one or more markers3023A. As one example only, there are three markers3023A shown. In some embodiments, there may be one marker3023A. There may be two, four, five or more markers3023A. In some embodiments, there is one proximal marker3023A and ten of the distal markers3023. The markers3023A may have the same or similar features and/or functionalities as other markers described herein, for example the marker3023, and vice versa, except as otherwise noted. The markers3023A may be located at or near the proximal end of the device3000. As shown, the markers3023A are located on an inner surface3012of the proximal end3004of the foam body3002. The markers3023A may be located at or near an inner surface of a shoulder3030(seeFIG.4B) of the foam body3002. The markers3023A may be distributed circumferentially, for example equidistant or equiangular, relative to each other, or they may be at different relative distances from each other. They may be radially located at the same or different location relative to each other. In some embodiments, there is only one marker3023A. There may be one proximal marker3023A and four of the distal markers3023. The one or more markers3023A may be on the inside, outside, or within the foam body3002, or combinations thereof. The one or more markers3023A may be located on or at the distal surface3022of the foam body3022. The markers3023A may be elongated circumferentially as shown. In some embodiments, the markers3023A may be linear when the device3000is viewed from a particular angle, such as a side view. The markers3023A may be aligned or oriented in the same or similar orientation, or in different orientations. Some, none, or all of the markers3023A may be oriented circumferentially, laterally, axially (for example along an inner surface3018of the sidewall3014), other orientations, or combinations thereof.

As further shown inFIG.5D, there may be one or more markers3023B. The one or more markers3023B may have the same or similar features and/or functionalities as the other markers described herein, such as the marker3023or3023A and vice versa, except as otherwise noted. The markers3023B may be located along the sidewall3014of the body3002. There may be one or more markers3023B located along an inner surface3018of the sidewall3014.

As shown, two markers3023B are visible on either side of the interior of the foam body3002. The markers3023B are attached through the foam and around the frame3040. The marker3023B may be attached, for example sutured, around a proximal face3060member of the frame3040, such as one of the struts3061. The marker3023B may be attached to the frame3040just proximally of one of the proximal apexes3084of the frame3040, for example at an outer curved portion3066of the strut3061. There may be only one marker3023B, or two, three, four or more markers3023B. There may be one of the markers3023B for each strut3061. The markers3023B may be used additionally to connect the frame3040with the foam body3002. The markers3023B may be sutures as described herein.

The one or more markers3023A and/or3023B at or near the proximal end of the device3000provide various desirable features. For instance, the marker3023A at the shoulder3030facilitates visualization of the device3000during and after implantation. The typically non-circular shape of the opening of the LAA (ostium) may compress the proximal end3004of the device and cause the proximal end3004to protrude slightly in the proximal direction. However, the shoulder3030may provide a location for the marker3023A where linear bulging of the foam body3002in the proximal direction is reduced or prevented. Thus, the marker3023A in that location can provide a more useful visualization of the positioning of the device3000and reduce complexity. For example, in some embodiments, the marker3023A at the shoulder3030(e.g. on an inner surface as shown) may be particularly useful during delivery, allowing for delivery using fluoroscopy imaging only without the need for echo or other ultrasound imaging. The one or more markers3023B may provide similar benefits.

As further shown inFIGS.3D and5D, the device3000may include an inner cover3101. The inner cover3101may have the same or similar features and/or functionalities as the cover3100(described in further detail below, see section “Proximal Cover”), except as otherwise described. The inner cover3101may be a cover for the hub3050(see, e.g.,FIGS.4C and7A-8C). The inner cover3101may be formed from expanded Polytetrafluoroethylene (“ePTFE”). The inner cover3101may be a separate portion of the same material as the proximal cover3100.

The inner cover3101may be located between the foam body3002and the frame3040. As shown, the inner cover3101is located between the inner surface3012of the foam body3002and a proximal end of the hub3050of the frame3040. The inner cover3101may be circular or other shapes. The inner cover3101may have an area sufficient to provide a barrier in between the hub3050and the proximal end3004of the foam body3002. In some embodiments, the inner cover3101may extend radially to an outer circumference of the hub3050, or it may extend radially to the sidewall3014such as to an inner surface3018of the foam body3002, or to any radial locations in between. The inner cover3101may have a diameter from about 4 mm to about 22 mm, from about 5 mm to about 15 mm, from about 6 mm to about 10 mm, about 8 mm, or 8 mm. The inner cover3101may be flat or generally flat. The inner cover3101may have a thickness from about 0.0001″-0.0020″, from about 0.0002″-0.0010″, about 0.0005″, or 0.0005″ thick. The inner cover3101may include one or more openings3103such as holes therethrough. The inner cover3101may include two holes3103to receive therethrough a tether3240. The two holes3103in the cover3101may align the tether3240, such as a suture, that extends distally into the hub3050through one hole3103in the inner cover3101and exits proximally back out of the hub3050through the other hole3103of the inner cover3101.

The inner cover3101may prevent the hub3050and/or other features of the frame3040from directly contacting the foam material. The cover3101may protect the integrity of the foam body3002from stresses that may be imparted by the hub3050on the foam material. This protection may be desirable for example during loading, deployment, retrieval, re-deployment, etc. of the device3000. The inner cover3101may prevent or reduce damage to the foam body3002from the hub3050.

The foam body3002may be attached to various features of the device3000. The body3002may be attached to the frame3040at numerous points, including for example the center of the proximal end of the frame3040, as further described herein. Attachment can be done using suture, such as polypropylene monofilament suture, although other methods known in the art such as adhesive bonding could be utilized. The proximal row of proximal anchors3090may be individually attached to (e.g. inserted through) the foam body3002to prevent relative movement between the foam body3002and the frame3040. In other embodiments, the foam body3002could be formed around the endoskeleton so that the metallic frame is within the foam body3002, eliminating the need for a secondary attachment step. Attachment of the body3002to the frame3040promotes retrieval without damage to the foam body3002, among other advantages. The attachment also ensures that a bumper3026, further described herein, extends beyond the frame3040at all times, including during initial exposure of the device3000upon proximal retraction of the delivery sheath.

As shown inFIG.5D, the device3000may include one or more attachments3001. The attachments3001may connect the frame3040with the foam body3002. The attachments3001may be sutures. Other suitable attachment structures may be used, including staples, ties, wires, components of the frame3040, other mechanical attachments, adhesives, other suitable means, or combinations thereof. The attachments3001may extend around the frame3040and through the foam body3002, for example through the sidewall3014.

As shown, four attachments3001are visible inFIG.5D. There are two proximal attachments3001and two distal attachments3001visible. The proximal attachments3001are each located at the base of a respective proximal anchor3090. The distal attachments3001are each located at the base of a respective distal anchor3094. There may be one, two, three, four, five, six, seven, eight, or more attachments3001. There may be twenty attachments3001. There may be one of the attachments3001for each anchor3090,3094of the device3000. The attachments3001may each be located at a proximal apex3084or at a distal apex3088of the frame3040, as further described herein, for example with respect toFIG.7A. For example, the attachments3001may be wrapped around one or more of the struts3082,3086, as further described herein. The attachments3001may locally compress the foam body3002at and/or around the location of attachment. The attachment3001, such as a suture, may extend from within the cavity3028, through the foam body3002, exit the foam body3002and extend along the outer surface3016of the foam body3002, extend back into and through the foam body3002into the cavity3028, and be tied or otherwise connected together around the frame3040. In some embodiments a similar routing of the attachments3001may be used with the attachment3001tied or otherwise connected together around and outside the foam body3002. In some embodiments the attachments3001may also extend through the cover3300, or other covers as described herein. The attachments3001may extend through the material of the cover3300. The attachments3001may extend through openings in the cover3300, such as the side openings3324, or windows3177(see, e.g.,FIGS.6B-6E). As shown, the proximal attachments3001may extend through the foam body3002and through openings in the cover3300, and the distal attachments3001may not extend through the cover3300but only through the foam body3002.

The foam body3002may include a coating. In some embodiments, there may not be a coating. In embodiments with a coating, the coating is applied to the interconnected reticulations of the foam material. The body3002may be coated with pure polytetrafluoroethylene (PTFE). The PTFE coating minimizes the thrombogenicity of the LA surface, while also reducing the friction of the foam body3002against the delivery system to facilitate ease of deployment and retrieval. The body3002may be coated with conformable, vacuum deposited, pure PTFE. In addition or alternatively, the body3002may be coated with a coating other than PTFE. The coating, whether PTFE or otherwise, may be about 0.5 μm thick, and covers at least a portion of the surface of the interconnected reticulations of the foam without occluding the pores. The coating may be applied to some or all of the foam body3002. The coating may be applied to some or all of the outer surfaces of the foam body3002.

In some embodiments, the thickness of the coating is from about 0.1 μm to about 1 μm, from about 0.2 μm to about 0.9 μm, from about 0.3 μm to about 0.8 μm, from about 0.4 μm to about 0.7 μm, about 0.4 μm to about 0.6 μm, or about 0.5 μm thick. In some embodiments, greater or smaller thicknesses of the coating may be applied. The coating has a uniform or substantially uniform thickness. In some embodiments, the coating may have a non-uniform thickness. For example, the portion of the body3002facing the LA when implanted, such as the proximal face3008and/or shoulder3030, may have a thicker coating relative to a coating along the sidewall3014of the body3002. In some embodiments, the outer surface3010of the proximal face3008has a PTFE coating and the proximal face3008also has a ePTFE cover3100.

The coating is applied using a vapor deposition process. In some embodiments, the coating is applied through coating, vapor deposition, plasma deposition, grafting, other suitable processes, or combinations thereof. The coating is applied to the outer surfaces3010,3032and3016of, respectively, the proximal face3008, the shoulder3030and the sidewall3014. In some embodiments the coating is applied to the outer surfaces3010,3032and only partially on the outer surface3016. In some embodiments the coating is applied to outer and inner surfaces of the body3002.

In some embodiments, other biocompatible, thromboresistant and/or lubricious materials could be applied to the surface(s) of the foam body3002and/or the cover3100. These materials may encourage tissue ingrowth. Such materials may include, for example, heparin, albumin, collage, polyethylene oxide (PEO), hydrogels, hyaluronic acid, materials that release nitric oxide, oxygen, nitrogen, amines, bioabsorbable polymers, and other biomaterials, pharmacologic agents, and surface modification materials. Additionally, the surface(s) of the body3002could be roughened, textured, or otherwise modified or coated to promote healing or to make it more echogenic.

The device3000may include a cover3100, which may be an ePTFE cover as further described. Other embodiments for this outer cover3100are described herein, for example the cover3101,3300,3150,3151, etc. The various embodiments of the cover may have the same or similar features and/or functionalities as each other, except as otherwise noted. The cover3100may have a series of openings. In some embodiments, the cover3100may be solid and not have any openings. In some embodiments, the cover3100may only have openings to receive anchors and/or a tether therethrough, as further described herein. In some embodiments, the device3000may include an inner cover such as an inner cover3101, as shown and described with respect toFIG.3D.

The outer cover3100is a generally flat material applied over and covering at least a portion of the body3002. The cover3100is on the proximal end3004of the device3000. The cover3100covers the proximal face3008of the body3002and at least part of the sidewall3014. The cover3100covers a proximal portion of the sidewall3014. The cover3100has a proximal surface3102that at least partially faces the LA when implanted. The cover3100has an outer edge3104forming outer vertices3106(for clarity, only some of the outer edges3104and outer vertices3106are labelled in the figures). In some embodiments, the cover3100may cover only the proximal face3008or portions thereof. In some embodiments, the cover3100may extend over more of the sidewall3014, such as the middle or distal portion thereof, or the entire sidewall3014.

The cover3100may have a thickness measured perpendicularly from the proximal surface3102to an opposite distal surface of the cover3100that faces the body3002. The cover3100may have a thickness of 0.001″ (inches). In some embodiments, the cover3100may have a thickness from about 0.00025″ to about 0.005″, from about 0.0003″ to about 0.004″, from about 0.0004″ to about 0.003″, from about 0.0006″ to about 0.002″, from about 0.0008″ to about 0.0015″, or about 0.001″. In some embodiments, the cover3100may have a thickness of 0.0005″. In some embodiments, the cover3100may have a thickness from about 0.0002″ to about 0.0008″, from about 0.0003″ to about 0.0007″, from about 0.0004″ to about 0.0006″, or about 0.0005″.

The cover3100may be attached to the frame3040through the foam body3002. The cover3100may in addition or alternatively be attached to the body3002. The cover3100may be attached at least two or four or six or more of the outer vertices3106. The cover3100may be attached to the frame3040and/or body3002at various locations, including at the outer vertices3106, through the proximal surface3100, at the proximal face3008of the body3002, other locations, or combinations thereof. The cover3100may cover the entire foam body or some of the foam body may be directly exposed to the blood. For example, in some embodiments, the cover3100can be recessed proximally from a distal end of the sidewall3014by about 5 mm. In some embodiments, the cover3100can be recessed proximally from a distal end of the sidewall3014by between 1 mm and 15 mm, between 2 mm and 10 mm, between 3 mm and 8 mm, between 4 mm and 6 mm, or any other suitable distance. The cover3100is attached using mechanical attachments, such as sutures. In some embodiments, polypropylene 6-0 sutures are used throughout the device to attach the foam body3002, proximal cover3100, and RO markers3023to the foam body3002and/or frame3040. In some embodiments, the cover3100is attached to the frame3040via standard braided or monofilament suture material, such as polypropylene, ePTFE, or polyester. In some embodiments, a polypropylene monofilament is utilized. Proximal anchors3090of the frame3040(further described herein) may extend through the outer vertices3106of the cover3100. Such penetrating anchors3090may further secure the cover3100in place relative to the body3002. In some embodiments, the cover3100may be attached to the various parts of the device3000with mechanical attachments, fasteners, adhesives, chemical bonds, other suitable techniques, or combinations thereof.

As shown, the cover3100is formed from expanded Polytetrafluoroethylene (“ePTFE”). An ePTFE cover3100provides many advantages. For example, the ePTFE cover3100may enhance the ability to recapture the device3000in vivo by distributing the proximal retraction forces applied by the catheter. The cover3100may be an ePTFE material approximately 0.001″ thick, with the appropriate porosity to encourage healing and minimize thrombus formation, similar to the underlying PTFE coated foam.

An ePTFE cover3100may assist in recapture of the implant into the access sheath while providing a smooth, thromboresistant surface which encourages tissue coverage and integration. The ePTFE may cover the entire proximal face and partially covers the sides, as shown inFIG.3C. The ePTFE cover3100is fabricated from a previously laminated sheet comprised of two or more sheets of oriented material, offset to form a biaxially orientated material. Alternatively, one could use a tube, preferably biaxially oriented, that is then cut to form a sheet. The thickness of the final construct can be from 0.0005″-0.005″ but is preferably about 0.001″.

In some embodiments, the cover3100is fabricated from other thromboresistant, high strength, biocompatible materials, such as knitted or woven polyester fabrics, polypropylene, polyethylene, non-woven vascular scaffolds, porous films, or bioabsorbable scaffolds such as polylactic acid, polyglycolic acid, and co-polymers. The shape of the cover prior to attachment with the device3000, such as shown inFIGS.6A and6B, minimizes wrinkling and provides a smooth surface following attachment to the implant. This shape may be a star shape, an outer pointed shape, or other shapes.

The cover3100may be perforated with a series of openings3120(for clarity, only some of the openings3120are labelled in the figures). The openings3120are perforations or holes formed in the cover3100via laser or mechanical cutting. The openings3120include proximal openings3122and side openings3124(for clarity, only some of the proximal openings3122and side openings3124are labelled in the figures). When the cover3100is assembled with the body3002, the proximal openings3122are located over the proximal face3008and/or shoulder3030, and the side openings3124are located over the sidewall3014. In some embodiments, the cover3100includes forty proximal openings3122. In some embodiments, the cover3100includes forty side openings3124. The number of openings3120located over the proximal face3008and/or shoulder3030when assembled with the body3002may range from ten to eighty, from twenty to seventy, from thirty to sixty, from thirty five to fifty, or forty openings3120. The number of openings3120located over the sidewall3014may range from ten to eighty, from twenty to seventy, from thirty to sixty, from thirty five to fifty, or forty openings3120.

The openings3120may have a variety of sizes. The openings3120are 0.070″ in width, e.g. minor axis, or diameter for circular openings. The openings3120may have a width from about 0.010″ to about 0.200″, from about 0.020″ to about 0.150″, from about 0.030″ to about 0.110″, from about 0.040″ to about 0.100″, from about 0.050″ to about 0.090″, from about 0.060″ to about 0.080″, or about 0.070″. In some embodiments, the width may be less than 0.010″ or greater than 0.200″, such as 0.25″, 0.5″ or greater. These widths may apply to circular as well as non-circular shaped openings3120.

In some embodiments, the openings3120may be various shapes. The openings3120may be elongated slots. The openings3120may extend radially along the cover3100from or near a center portion of the proximal surface3102toward and/or to the outer edge3104. The openings3120may be annular openings extending circumferentially along the cover3100and having varying radial positions. The openings3120may be of uniform size and shape. Some of the openings3120may have varied sizes and/or shapes with respect to other of the openings3120. The openings3120may have various distributions or concentrations about the cover3100. For example, the openings3120may be more densely located in various areas, such as along the proximal surface3102that faces the LA, along the shoulder3030, etc.

The openings3120enable blood to flow through the device3000. The openings3120may allow blood to adequately flow through the device3000and thereby mitigate the risk of occlusion in the bloodstream should the device3000embolize within the vasculature system. In some embodiments, should the device3000embolize, it may act as a stationary filter at low pressures but may pass through the bloodstream at higher pressures. In some embodiments, the device3000allows for about two to about fourteen liters, from about four to about twelve liters, from about six to about ten liters, or from about eight liters per minute of blood to pass at ≤30 mmHg pressure drop to prevent shock in the event of a device embolization. In some embodiments, there are forty circular openings3120each having a diameter of 0.070″, and allowing for approximately eight liters per minute of blood to pass at <30 mmHg pressure drop. In some embodiments, the proximal end of the device3000may be a foam layer such as the foam proximal face3008or a membrane such as the cover3100or both, enclosing the cavity3028defined within the tubular side wall3014of the body3002.

In one implementation, having both the foam proximal face3008and the cover3100, the foam body3002has the open cell structure further discussed herein that can permit the passage of blood but block escape of embolic debris. The cover3100may be occlusive to blood flow, and is present to provide structural integrity and reduced friction for retracting the expanded body3002back into the deployment catheter. In one implementation, the cover3100is ePTFE in a form that is substantially occlusive to blood flow, as described. In this embodiment, the cover3100is therefore provided with a plurality of perfusion windows or openings3120, so that blood can pass through the open cell foam and cover3100but the device3000still benefits from the other properties of the cover3100.

In some embodiments, the device3000may allow for a particular flow rate of water at specified conditions, to test the perfusion performance of the device3000. The device3000may have the foam body3002and cover3100configured to allow for a flow rate of water axially through the device3000of at least 2.8 liters per minute. The water may be at sixty-eight degrees Fahrenheit (F) or about sixty-eight degrees f and an upstream pressure of twenty-eight millimeters of Mercury (mmHg) or about twenty-eight mmHg. In some embodiments, the device3000may be configured to allow for flow rates under such conditions from about 2.8 liters to about 19.6 liters, from 4.2 liters to about 5.6 liters, from about 4.76 liters to about 5.6 liters, from about 5.6 liters to about 16.8 liters, from about 8.4 liters to about 14 liters, more than 2.8 liters, more than 5.6 liters, more than 8.4 liters, or more than 11.2 liters of water per minute.

In some embodiments, the foam and cover are configured to allow for a flow rate of water axially through the device of between 4.2 liters per minute and 5.6 liters per minute (for example, in embodiment of a 27 mm diameter implant), with the water at about sixty-eight degrees Fahrenheit (F) and an upstream pressure of about twenty-eight millimeters of Mercury (mmHg). In some embodiments, the foam and cover are configured to allow for a flow rate of water axially through the device of between 4.76 liters per minute and 5.6 liters per minute (for example, in embodiment of a 35 mm diameter implant), with the water at about sixty-eight degrees Fahrenheit (F) and an upstream pressure of about twenty-eight millimeters of Mercury (mmHg).

The particular flow rate may depend on the porosity of the foam body3002and the open area of the cover3100. The particular flow rate may depend on the inner cover3101features as well. The cover3100may have particular percentages of the cover area open with the series of openings, as further described herein, to attain a particular desired flow rate. The flow rate of water at the specified conditions may be used to extrapolate or otherwise calculate the corresponding expected flow rate of blood in the body through the device3000should it embolize, as described herein. In some embodiments, the device3000may be configured to allow for a flow rate of blood axially through the device3000of at least 1 liter per minute (for example, in embodiment of a 27 mm diameter implant at room temperature with an upstream pressure of about 15 inches of water head). The device3000may allow for a cardiac output from about 4.2 to 8 liters per minute. The average body surface area is 1.6 square meters for females and 1.9 square meters for males. The device3000may allow for a cardiac index from about 2.2 to 5 or from about 2.6 to 4.2 liters per minute per square meter. The device3000may have these and other flow rate capabilities either aligned or approximately aligned with the direction of flow of the fluid, or off-axis where the device3000is angled with respect to the direction of flow of the fluid (a flow axis), as further discussed herein for example in the section “Off-Axis Delivery and Deployment.”

FIGS.5A-5Cdepict an embodiment of the LAA occlusion device3000having another embodiment of a cover3300. The device3000includes the foam body3002and the frame3040, and features thereof, as described herein, and additionally includes the cover3300. The cover3300may have the same or similar features and/or functionalities as the cover3100, and vice versa. The cover3300is on the proximal end3004of the device3000. The cover3300covers the proximal face3008of the body3002and a proximal part of the sidewall3014. The cover3300has a proximal surface3302. The cover3300has an outer edge3304forming a plurality of at least two or four or six or eight or ten or more outer vertices3306(for clarity, only some of the outer vertices3306are labelled in the figures). The cover3300is attached to the body3002at the outer vertices3306. The proximal anchors3090extend through side openings3324in the outer vertices3106of the cover3100.

The cover3300includes a series of openings3320. The openings3320include proximal openings3322, shoulder openings3323, and the side openings3324. The proximal openings3322are located over the proximal end3004of the body3002. The shoulder openings3323are located over the shoulder3030, e.g. a bevel, of the body3002. The side openings3324are located over a proximal portion of the sidewall3014of the body3002. The proximal anchors3090may extend through the side openings3324that are located in the outer vertices3106. The openings3320may have the same or similar features and/or functionalities as the openings3120, and vice versa. In some embodiments, the proximal anchors3090may extend through the cover3300material at or near the outer vertices3106.

FIG.6Ashows another embodiment of a cover3150that may be used with the device3000. The cover3150may have the same or similar features and/or functionalities as the cover3100and/or cover3300, and vice versa. The cover3150may be used to cover the proximal face3008of the body3002and part of the sidewall3014. The cover3150has a proximal surface3152. The cover3150has an outer edge3154forming outer vertices3156. The cover3150may be attached to the body3002at the outer vertices3156. The proximal anchors3090may extend through the outer vertices3156of the cover3100. The cover3150includes a series of openings3170. The openings3170include proximal openings3172and side openings3174(for clarity, only some of the openings3170,3172,3174are labelled in the figures). When the cover3150is assembled with the body3002, the proximal openings3172are located over the proximal end3004and the side openings3174are located over the sidewall3014. As shown, the openings3174may be substantially uniformly located along the cover3150except for a center region of the proximal surface3152.

FIG.6Bis a top view of another embodiment of a proximal cover3151that may be used with the various LAA occlusion devices described herein.FIG.6Cis a top view showing the cover3151assembled with the device3000. The cover3151may have the same or similar features and/or functionalities as other covers described herein, such as the cover3100and/or cover3300, and vice versa, except as otherwise noted. For example, the cover3151may include the proximal surface3152and outer edge3154forming outer vertices3156.

The cover3151further includes another embodiment of a series of openings3171. The openings3171include smaller openings3175and larger openings3173. The openings3175,3173may have the same or similar features and/or functionalities as other cover openings described herein, such as the openings3120,3122,3124,3320,3322,3324,3170,3172and/or3174, and vice versa. The smaller openings3175may be relatively smaller, in width and/or area, than the larger openings3173. There may be openings with widths or areas smaller than that of the smaller openings3175, larger than that of the larger openings3173, or anywhere in between. As shown, the openings3173,3175may be generally uniformly distributed about the proximal surface3152of the cover3151. The openings3173,3175may be circumferentially evenly spaced or approximately evenly spaced about the cover3151.

There may be a variety of different quantities of each of the openings3173,3175. There may be a total of ten, twenty, thirty, forty, fifty, sixty, seventy, eighty, ninety, one hundred, one hundred fifty, two hundred, three hundred, four hundred, or more openings of the series of openings3171, or any lesser, greater or in between number of openings. The series of openings3171may be holes as shown. They may have circular shapes. They may have other shapes, including non-circular, segmented, other shapes, or combinations thereof. The openings3171may all have the same general shape or different shapes. In some embodiments, there may not be any holes in the cover3151.

When the cover3151is assembled with the foam body3002, the large and small openings3173,3175may be located over the proximal end3004and/or the sidewall3014of the foam body3002. When assembled with the foam body3002, on the proximal-facing portion of the cover3151, there may be a collective total of one hundred forty or about one hundred forty openings3173,3175. On this proximal-facing portion of the cover3151, there may be a collective total from about ten to about three-hundred, from about fifty to about two hundred fifteen, from about one hundred ten to about one hundred seventy, from about one hundred twenty to about one hundred sixty, from about one hundred thirty to about one hundred fifty, or from about one hundred thirty-five to about one hundred forty-five openings3173,3175. On this proximal-facing portion of the cover3151, there may be from about thirty to about fifty, from about thirty-five to about forty-five, about forty, or forty of the larger openings3173. On this proximal-facing portion of the cover3151, there may be from about sixty to about one hundred forty, from about eighty to about one hundred twenty, from about ninety to about one hundred ten, about one hundred, or one hundred of the smaller openings3175.

When assembled with the foam body3002, on the portion of the cover3151located over and/or near the shoulder3030, such as over the outer surface3032of the foam body3002(see, e.g.,FIG.4B), there may be from about five to about eighty, from about ten to about forty, from about fifteen to about thirty, about twenty, or twenty of the smaller openings3175. In some embodiments, at this same portion of the cover3151, there may be from about five to about eighty, from about ten to about forty, from about fifteen to about thirty, about twenty, or twenty of the larger openings3173.

When assembled with the foam body3002, on the portion of the cover3151located over and/or near the sidewall3014, such as over the outer surface3016of the foam body3002(see, e.g.,FIG.4B), there may be from about five to about eighty, from about ten to about forty, from about fifteen to about thirty, about twenty, or twenty of the larger openings3173. In some embodiments, at this same portion of the cover3151, there may be from about five to about eighty, from about ten to about forty, from about fifteen to about thirty, about twenty, or twenty of the smaller openings3175.

The larger and smaller openings3173,3175may have a variety of different sizes, for example as described herein with respect to the openings3122. In some embodiments, the openings3173,3175may have diameters ranging from about 0.025 inches to about 0.040 inches. In some embodiments, the larger openings3173may be 0.040 inches or about 0.040 inches in diameter. The larger openings3173may be from about 0.030 inches to about 0.050 inches, or from about 0.035 inches to about 0.045 inches, in diameter. These values may also refer to the widths, for example maximum widths, of non-circular larger openings3173. In some embodiments, the smaller openings3175may be 0.025 inches or about 0.025 inches, in diameter. The smaller openings3175be from about 0.015 inches to about 0.035 inches, or from about 0.020 inches to about 0.030 inches, in diameter. These values may also refer to the widths, for example maximum widths, of non-circular smaller openings3175.

The series of openings3171may be configured to provide a desired amount of open area through the cover3151. This open area refers to the total area of certain openings in the cover3151. The cover3151may be covering a proximal face3008at the proximal end3004of the foam body3002. The open area may refer to openings through the portion of the cover that is over the proximal face3008of the foam body3002when assembled with the foam body3002. The series of openings in the various covers described herein may collectively provide the open area. For example, the series of openings3171in the cover3151over the proximal face of the foam may collectively provide an open area. This is the sum of the area of the openings in the cover3151over the proximal face. As further example, the open area may be the sum of the proximal openings3122of the cover3100. As further example, the open area may be the sum of the proximal openings3322of the cover3300.

The open area may be at least five percent of the area of the proximal face3008of the foam body3002. The open area may be at least six, at least seven, at least eight, at least nine, at least ten, at least eleven, at least twelve, at least thirteen, at least fourteen percent, at least fifteen, at least sixteen, at least seventeen, at least eighteen, at least nineteen, at least twenty, at least twenty-five, at least thirty, at least forty, or at least fifty percent, of the area of the proximal face3008. The open area may be from about one to about fifty percent, from about five to about twenty percent, from about eight to about fifteen percent, from about ten to about twelve percent, or about eleven percent, of the area of the proximal face3008. The “area” of the proximal face3008is understood here to refer to an area equal to Pi×R2, where R is the radius of the proximal face3008and extends perpendicularly from the longitudinal axis of the device3000. Further, “R” may be measured to the inner boundary of the shoulder3030, to the outer boundary of the shoulder3030, or to the outer surface3016of the sidewall3014. Further, as mentioned, some embodiments may not include a cover at all.

The cover3151may include one or more windows3177. As shown, there may be ten windows3177. There may be one window3177for each proximal anchor3090. There may be four, six, eight, twelve, fourteen or more windows3177, or any lesser or in between number. The windows3177may be openings in the cover3151. The windows3177may be located at or near the outer edge3154of the cover3151. The windows3177may be located along portions of the outer edge3154, for example at or near the outer vertices3156. The windows3177may have a shape conforming to the shape of the cover3151at the respective portions of the outer edge3154. As shown, the window3177may be diamond or generally diamond shaped. The window3177may be square, rectangular, triangular, rounded, circular, segmented, flattened diamond, other polygonal shapes, other shapes, or combinations thereof. The cover3150may be attached to the body3002at the outer vertices windows3177. The windows3177may have the same or similar feature and/or functionalities as the side openings3324, described and shown inFIG.5B. The proximal anchors3090may extend through the windows3177of the cover3151to retain the cover3151on the device3000.

FIG.6D-6Eare side and perspective views, respectively, of another embodiment of a proximal cover3153shown assembled with the device3000, that may be used with the various LAA occlusion devices described herein. The cover3153may have the same or similar features and/or functionalities as other covers described herein, such as the cover3100,3151, and/or cover3300, and vice versa, except as otherwise noted. For example, the cover3151may include the proximal surface3152, outer edge3154forming outer vertices3156, and windows3177.

The device3000with cover3151may have proximal anchors3090extending through the windows3177. The proximal anchor3090may extend through the opening of the respective window3177. The proximal anchor3090may extend through a distal portion of the window3177, for example to contribute to securing the cover3153on the device3000. The proximal anchors3090may extend through the window3177at a distal edge or distal vertex of the window3177. In some embodiments, the proximal anchor3090may extend through the cover3151material, for example through material adjacent (such as distal) to the window3177. In some embodiments, the proximal anchor3090may extend through various other locations within, adjacent or near the window3177. Some of the proximal anchors3090may extend through first locations and other of the proximal anchors3090may extend through second locations of the cover3153different from the first locations. For instance, one or more anchors3090may extend through a first region of the window3177, one or more other anchors3090may extend through a second region of the window3177, still one or more other anchors3090may extend through other regions, such as through the cover3153material, etc.

The cover3153may include proximal vertices3155. The proximal vertices3155may be formed by the outer edge3154. The proximal vertices3155may be indentations along the outer edge3154of the cover3153, for example angled as shown or other shapes, configurations, etc. The proximal vertices3155may define a region3016A of the outer surface3016of the sidewall3014. The region3016A may be partially enveloped by the outer edge3154of the cover3153. The region3016A may receive one or more of the distal anchors3094therethrough. The distal anchor3094may extend through a distal portion of the region3016A, or in other locations within, adjacent, or near the region3016A. In some embodiments, the distal anchor3094may not extend through or near the region3016. There may be multiple such regions3016A of the foam body3002defined circumferentially about the device3000by the cover3153.

The cover3153may include the series of openings3320, for example as described with respect toFIG.5A. The series of openings3320may include the proximal openings3172, the shoulder openings3323, and/or the side openings3174. The cover3153may include different patterns, sizes, distributions, etc. of the openings3320, for example as shown and described with respect toFIGS.6B-6C.

The expandable and compliant support or frame3040is shown, for example, inFIGS.3B,3D,4C and5C-E. Further,FIGS.7A and7Bare side and proximal perspective views, respectively, of the frame3040shown in a deployed configuration and in isolation from the rest of the device3000. The frame3040provides a compliant structure with anchors to facilitate delivery, anchoring, retrieval and to enable the foam body3002to compress against the LAA tissue to facilitate sealing, among other things, as further described. The frame3040is located inside the cavity3028formed by the foam body3002. In some embodiments, the frame3040may be located partially or entirely inside one or more portions of the body3002, e.g. within the proximal face3008and/or the sidewall3014, as further described. For example, the frame3040may be partially located within the sidewall3014as shown inFIG.5C.

The frame3040has a proximal end3042and an opposite distal end3004. The frame3040may be tubular, e.g. cylindrical, in a free, unconstrained state. Thus the width of the proximal end3042may be the same or similar to the width of the distal end3004in the free, unconstrained state. In some embodiments, the frame3040or portions thereof may be conical or frustoconical, e.g. where in the free, unconstrained state the width of the proximal end3042is greater than the width of the distal end3004or vice versa.

At the proximal end3042, the frame3040has a proximal hub3050, shown as a cylindrical nipple. The hub3050is a rounded, structural end piece. The hub3050may be tubular, e.g. circular and having the cylindrical shape as shown, or may be rounded, non-circular, segmented, other shapes, or combinations thereof. The hub3050extends axially and may have a central lumen. The hub3050may be wider than it is long, or vice versa. The hub3050is hollow and has a sidewall defining a space therethrough, such as a longitudinal opening. In some embodiments, the hub3050may be partially hollow, solid, or other configurations. The hub3050facilitates delivery and retrieval of the device3000, as further described. The hub3050may provide a central structural attachment, as further described herein. The hub3050may be located within the cavity3028at a proximal end thereof. In some embodiments, the hub3050may be located partially or entirely within the foam body3002, e.g. within the proximal face3008.

A pin3051is located within the hub3050(shown inFIGS.7A and7B). The pin3051is an elongated, rounded structural element extending laterally across the central lumen. “Lateral” here refers to a direction perpendicular or generally perpendicular to the longitudinal axis. The pin3051has a cylindrical shape. The pin3051provides a rounded outer surface configured to provide a smooth engagement surface with a tether, as further described. The pin3051provides a high strength connection with the frame3040to allow for pulling on the device3000with sufficient force to re-sheath the device3000. The pin3051may be formed from Nitinol. The pin3051is secured across the width, e.g. diameter, of the proximal hub3050. The pin3050may be secured at its two opposite ends with the sidewall of the hub. The pin3051is configured to be engaged by a tether3240, which is wrapped around the pin3051in sliding engagement for temporary attachment to a delivery catheter, as further described. In some embodiments, the pin3051is assembled with a cap3180, as further described herein, for example with respect toFIGS.8A-8C.

The frame3040at the proximal end3042includes a proximal face3060. The proximal face3060may be located within the cavity3028at a proximal end thereof. In some embodiments, the proximal face3060may be located partially or entirely within the foam body3002, e.g. within the proximal face3008and/or sidewall3014. The proximal face3060includes a series of recapture or reentry struts3061. The struts3061are located at a proximal end of the cavity3028. In some embodiments, the struts3061or portions thereof may be located partially or entirely within the foam body3002, e.g. within the proximal face3008and/or sidewall3014.

The struts3061are elongated structural members. The struts3061may have rectangular, circular or other shaped cross-sections. In some embodiments, the struts3061have a cross-section, e.g. rectangular, with a width that is greater than a thickness such that the struts3061are stiffer in one direction compared to another direction. This width may be in the lateral direction or a direction generally perpendicular to the longitudinal axis of the device3000when the device3000is in the expanded configuration, with the thickness perpendicular to the width. The struts3061may be less stiff in the direction of flexing or bending, for example to facilitate contraction and expansion of the device3000in the delivery and expanded configurations. The struts3061may be elongated pins. The struts3061may extend from the hub3050, for example, and incline radially outwardly in the distal direction from the hub3050. The struts3061may be attached inside, outside, and/or at the end of the sidewall of the hub3050. The struts3061may be separate parts that are then attached to the hub3050, for example welding, bonding, fastening, other suitable means, or combinations thereof. In some embodiments, some or all of the struts3061and the hub3050may be a single, continuous structure formed from the same raw material such as a laser cut hypotube. Some or all of the struts3061may be attached, e.g. with sutures as described herein, to the body3002and/or the cover3100at one or more attachment locations.

Each recapture strut3061may include an inner curved portion3062connected to a distal end of the hub3050, a middle straight portion3064, and/or an outer curved portion3066(for clarity, only some of the portions3062,3064,3066are labelled in the figures). In the deployed configuration, the inner curved portion3062extends from the hub3050primarily in a distal direction and then curves to face more outwardly radially. The middle straight portion3064extends from the inner curved portion3062primarily radially but also slightly distally. The outer curved portion3066extends from the middle straight portion3064primarily in the radial direction and then curves toward the distal direction. The portions may have different shapes in the delivery configuration inside a delivery catheter. In the delivery configuration, the portions may extend primarily distally. The portions may then take the deployed configuration as described upon deployment from the delivery catheter. In some embodiments, the struts3061may include fewer or more than the portions3062,3064,3066.

The device3000may include ten of the proximal recapture struts3061. Such configuration may accompany a device3000having a foam body3002with an outer diameter of 27 mm in the free, unconstrained state. Such configuration may accompany a device3000having a foam body3002with an outer diameter of 35 mm in the free, unconstrained state. In some embodiments, the device3000may have from about two to about thirty, from about four to about twenty, from about six to about eighteen, from about eight to about sixteen, from about ten to about fourteen, or other numbers of struts3061. In some embodiments, the device3000has twelve of the proximal recapture struts3061, for example for the 35 mm diameter device.

In the deployed configuration, each strut3061may extend radially outward and distally at an angle to the axis. This angle, measured relative to a portion of the axis that extends distally from the device3000, may be from about 60° to about 89.9°, from about 65° to about 88.5°, from about 70° to about 85°, from about 72.5° to about 82.5°, from about 750 to about 80°, or other angular amounts. This angle may be much smaller when the device3000is in the delivery catheter. The struts3061may bend or flex when transitioning between, or when positioned in, the delivery and expanded configurations. The struts3061may bend or flex at the inner curved portion3062, the middle straight portion3064, and/or the outer curved portion3066.

The proximal end3042of the frame3040, such as the proximal face3060, may therefore have a conical shape in the expanded configuration. The conical proximal face3060may facilitate with recapture of the device3000back into the delivery catheter. For example, the orientation of the struts3061inclining distally and radially outward from the hub3050in the expanded configuration provides an advantageous conical shape to the proximal face3008such that distal advance of the delivery sheath over the device3000will bias the struts3061inward and cause the device3000to stow back toward the delivery configuration and size for retrieval within the catheter.

The proximal face3060foreshortens considerably upon expansion of the device3000relative to the delivery configuration. “Foreshortening” here refers to the difference in axial length of the proximal face3060between the reduced delivery configuration and the expanded configuration (expanded either freely or as implanted). This length may be measured axially from the distal or proximal end of the hub3050to the distal ends of the outer curved portions3066of the recapture struts3061. The proximal face3060may foreshorten by 50%, 60%, 70%, 80%, 90% or more. The proximal face3060has significantly more foreshortening upon expansion than the tubular body3080, the latter of which may be referred to as the “working length” or “landing zone.” The landing zone is further described with respect to the tubular body3080herein.

As shown, the struts3061are angularly spaced about the axis in even angular increments. That is, looking at the frame3040from the distal or proximal end, the angles between the struts may be equal. In some embodiment, the struts3061may not be evenly angularly spaced about the axis as described. The struts3061may or may not be symmetrically disposed about the axis or about a plane that includes the axis.

In some embodiments, portions of the frame3040may be at various distances from the proximal end of the foam body3002, such as the proximal end wall having the proximal face3008. As shown inFIG.5D, there may be a gap of size Z in the axial direction between the proximal face3060of the frame3040and the inner surface3012of the proximal face3008. The length of Z may be one, two, three, four, five, six, seven, eight, nine, ten, or more millimeters. The length of Z may vary depending on the radial distance at which it is measured. For instance, the length of Z may decrease, increase, or combinations thereof, as measured along the length of the strut3061. In some embodiments, the length of Z may be zero at more or points along the length of the strut3061. As shown inFIG.5E, the proximal face3060or portions thereof may contact the proximal inner surface3012of the foam body3002. The inner curved portion3062, the straight portion3064, and/or the outer curved portion3066may contact the proximal end wall such as the inner surface3012and/or other portions of the foam body3002. The hub3050may compress the proximal face3008or proximal end wall of the foam body3002slightly in a proximal direction as shown. The proximal face3008may therefore have a smaller thickness in this compressed region as compared to other portions of the proximal face3008, for example portions adjacent to this compressed portion. The hub3050may be located based on the axial location of connection of the anchors3090,3094to the sidewall3014, as described herein. In some embodiments, the hub300may not compress the foam body3002as shown. In some embodiments, the proximal face3060may extend radially outwardly as shown. For instance, the struts3061, or portions thereof for instance the straight portions3064, may extend radially outwardly perpendicularly or generally perpendicularly to the longitudinal axis of the device3000. The proximal face3060may extend radially outwardly and incline in a distal direction, as described herein, or it may incline in a proximal direction. The device3000may have any of these features in the constrained, unconstrained and/or implanted configurations.

The frame3040includes a tubular body3080. The body3080provides a mechanical base structure for the device3000, as further described. The tubular body3080is attached to a distal end of the proximal face3060of the frame3040. The tubular body3080extends to the distal end3044of the frame3040. The tubular body3080is attached at a proximal end to the outer curved portions3066of the recapture struts3061, as further described. The tubular body3080may be attached to other portions of the recapture struts3061. The tubular body3080of the frame3040may be attached to the body3002and/or the cover3100, e.g. with sutures as described herein, at one or more attachment locations, as further described. The tubular body3080may be located within the cavity3028. In some embodiments, the tubular body3080may be located partially or entirely within the foam body3002, e.g. within the sidewall3014.

The tubular body3080includes a series of proximal struts3082and distal struts3086(for clarity, only some of the struts3082,3086are labelled in the figures). The proximal struts3082and/or distal struts3086may have rectangular, circular or other shaped cross-sections. In some embodiments, the proximal struts3082and/or distal struts3086have a cross-section, e.g. rectangular, with a width that is greater than a thickness, or vice versa, such that the struts3061are stiffer in one direction compared to another direction. The struts3061may be less stiff in the direction of flexing or bending, for example to facilitate contraction and expansion of the device3000in the delivery and expanded configurations. Proximal ends of pairs of adjacent proximal struts3082join at proximal apexes3084. Each proximal strut3082is connected at a respective proximal apex3084to a respective outer curved portion3066of one of the recapture struts3061. Each distal end of the proximal struts3082connects to a distal end of an adjacent proximal strut3082and to proximal ends of two distal struts3086at an intermediate vertex3087. Pairs of adjacent distal struts3086extend distally to join at a respective distal apex3088. A repeating pattern3089, shown as a diamond shape, may be formed by adjacent pairs of proximal struts3082and adjacent pairs of distal struts3086. Some or all of the proximal struts3082and/or distal struts3086may be attached, e.g. with sutures as described herein, to the body3002and/or the cover3100at one or more attachment locations. Some or all of the proximal struts3082and/or distal struts3086may be located within the cavity3028. In some embodiments, some or all of the proximal struts3082and/or distal struts3086may be located partially or entirely within the foam body3002, e.g. within the sidewall3014.

There are the same number of proximal apexes3084as distal apexes3088. As shown, there are eleven proximal apexes3084and eleven distal apexes3088. The number of proximal and distal apexes3084,3088may each be at least seven, at least eight, at least nine, at least ten, at least eleven, at least twelve, at least thirteen, at least fourteen, at least fifteen, at least sixteen, or fewer or more apexes. In some embodiments, there may not be the same number of proximal apexes3084as distal apexes3088. In some embodiments, there may be more than one row of the pattern, e.g. diamond pattern, formed by the proximal struts3082and distal struts3086. There may be two, three, four or more rows of the pattern. Some or all of the proximal apexes3084and/or distal apexes3088may be attached, e.g. with sutures as described herein, to the body3002and/or the cover3100at one or more attachment locations.

The body3080may be tubular, e.g. cylindrical or generally cylindrical, in the expanded configuration. The tubular body3080may be cylindrical, rounded, segmented, polygonal, tube-like, other shapes, or combinations thereof, all of which are subsumed non-exhaustively under the category “tubular.” The tubular shape is formed by the proximal struts3082and distal struts3086in the expanded configuration. The tubular shape may also be formed by the outer curve portions3066of the recapture struts3061in the expanded configuration. The tubular shape may also be formed by the foam body3002exerting an outward radial force on the frame3040. The frame3040may therefore have a proximal conical section and a cylindrical working length. In some embodiments, the body3080may be conical or frustoconical, for example where the distal end is wider than the proximal end or vice versa.

The tubular body3080may be referred to as a “landing zone,” as described. This landing zone may refer to the axial length of the body3080, from a distal-most end to a proximal-most end at the transition to recapture struts3061, in the expanded configuration. The landing zone may have an axial length as measured from the proximal apex3084to the distal apex3088. The length of the landing zone may be 10 mm or about 10 mm. The landing zone may have a length from about 5 mm to about 15 mm, from about 6 mm to about 14 mm, from about 7 mm to about 13 mm, from about 8 mm to about 12 mm, from about 9 mm to about 11 mm, or other lengths. The tubular body3080may foreshorten slightly upon expansion of the device3000relative to the delivery configuration. The tubular body3080has significantly less foreshortening upon expansion than the length of the proximal face3060. The tubular body3080may foreshorten by no more than about 5%, 10%, 15%, 20% or 30%.

The frame3040self-expands upon delivery from the sheath. The proximal face3060and the tubular body3080will self-expand. Upon expansion, the radially outward portions of the tubular body3080will contact and compress the foam body3002against tissue of the LAA wall. The tubular body3080, for example the proximal struts3082and distal struts3086, will contact the inner surface3018of the sidewall3014and press against the sidewall3014so that the outer surface3016of the sidewall3014contacts and compresses against the LAA wall.

When compressed against the LAA wall, the foam body3002provides a larger “footprint” than the skeletal frame3040components and forms a complete seal. Thus, the sidewall3014acts as a force dissipation layer, spreading radial force out from the struts3082,3086of the frame3040over a larger area than just the area of the individual struts3082,3086(e.g. a larger area than just the area of the radially outer surfaces of the struts3082,3086). The use of the foam material in the body3002and the thickness of that foam, such as 2.5 mm, provide advantages in this regard over devices with thinner and less resilient materials than foam. For example, thin fabrics or similar materials that are pressed against the LAA wall with a skeletal frame will not spread the radial force out, and may even sag or otherwise bend, creating gaps and an unsealed portion of the LAA wall. The foam body3002as described herein will take the shape of the LAA wall to create a complete circumferential seal and will also spread out the radial forces from the frame3040to create a stronger seal and retention with the foam body3002.

Further, the device3000described herein with the compressible body3002allows for a structural frame3040that is compliant due to the smaller required radial force from the frame3040. For example, existing devices with a non-compressible fabric material will have a less effective seal, and so the structural elements of those devices must provide larger radial forces to compensate and ensure an effective seal, resulting in a less compliant device. In contrast, the current device3000provides advantages in this regard by having the compressible foam body3002, allowing for among other things smaller radial forces from, and thus better compliance of, the frame3040, while still providing an effective seal. This structural configuration has a cascading effect in terms of performance advantages. For instance, the compliance of the device3000allows for delivery off-axis while still providing an effective seal, among other advantages as further described herein.

The frame3040includes a series of proximal anchors3090. Each proximal anchor3090extends from a respective intermediate vertex3087. The proximal anchors3090may extend from other portions of the tubular body3080. As shown, in the deployed configuration, the proximal anchors3090extend from the tubular body3080radially and proximally. The proximal anchors3090may extend into an adjacent region of the sidewall3014. The proximal anchors3090may extend through the outer surface3016of the sidewall3014to penetrate tissue adjacent the device3000.

The frame3040includes a series of distal anchors3094. Each distal anchor3094extends from a respective distal apex3088. The distal anchors3094may extend from other portions of the tubular body3080. As shown, in the deployed configuration, the distal anchors3094extend from the tubular body3080radially and proximally. The distal anchors3094may extend into an adjacent region of the sidewall3014. The distal anchors3094may extend through the outer surface3016of the sidewall3014to penetrate tissue adjacent the device3000. The anchors3090,3094may incline radially outward in a proximal direction to engage the tissue to resist proximal movement of the device3000.

The anchors3090,3094are elongated structural members. The tips of the anchors3090,3094may be sharpened to facilitate tissue engagement and penetration. The anchors3090,3094may be straight, extending generally along a local axis thereof. The anchors3090,3094may have a curved or other non-straight proximal portion where they attach to the tubular body3080. In some embodiments, the anchors3090,3094or portions thereof may be non-straight, curved, rounded, segmented, other trajectories, or combinations thereof. In some embodiments, the tissue engaging tips may be curved. In some embodiments, the anchors3090,3094may have engagement features extending radially away from the anchor3090,3094, such as barbs, hooks, or other features.

The cross-section of the anchors3090,3094may be rectangular. In some embodiments, the cross-section may be circular, rounded, non-rounded, square, rectangular, polygonal, other shapes, or combinations thereof. The cross-sections may or may not be uniform along the length of the anchor3090,3094. The anchors3090,3094may be about 0.006″ thick and about 0.008″ wide. The anchors3090,3094may range from about 0.003″ to about 0.009″ in thickness and from about 0.003″ to about 0.015″ in width. The cross-section of the anchors3090,3094may reduce in size, for example taper, toward the distal tip.

In some embodiments, the anchors3090,3094in the deployed configuration are inclined at an incline angle of about 300 relative to a portion of the central axis that extends proximally from the device3000. This incline angle may be from about 10 degrees to about 50°, from about 15° to about 45°, from about 20° to about 40°, from about 25° to about 35°, or about 30°. This incline angle of the anchors3090,3094in the delivery configuration may be smaller than in the deployed configuration. The deployed anchors3090,3094may have the angle B.

The anchors3090,3094may have various lengths. The length of the anchor3090,3094is measured from a proximal end that connects to the tubular body3080to a distal tissue engaging tip of the anchor. In some embodiments, the length of the anchors3090,3094may be from about 0.5 mm to about 10 mm, from about 1 mm to about 9 mm, from about 2 mm to about 8 mm, from about 3 mm to about 7 mm, from about 4 mm to about 6 mm, about 5 mm, or other greater or lesser lengths. In some embodiments, the anchors3090,3094are 5 mm long. In some embodiments, the anchors3090,3094are about 5 mm long. In some embodiments, the anchors3090,3094have a length of at least 2.5 mm, at least 3 mm, at least 3.5 mm, at least 4 mm, at least 4.5 mm, at least 5 mm or more. The anchors3090,3094may each be the same or similar length. In some embodiments, the anchors3090,3094may not be the same length. In some embodiments, some or all of the proximal anchors3090may have lengths that are less than or greater than some or all of the lengths of the distal anchors3094. The anchors3090,3094may have the length L. Further, the outer tips of the deployed anchors3090,3094may extend to an outer radial location that is less than, the same as, or more than a radially outermost surface of the foam body3002.

In the expanded configuration, the anchors3090,3094extend for a length outside of the uncompressed sidewall3014. This length of the anchor3090,3094is measured along a local longitudinal axis of the anchor from the outer surface3016of the body3002to the distal tip of the anchor. The anchors3090,3094may extend through the sidewall3014and/or the cover3100, and then be trimmed so that the anchors3090,3094extend beyond the sidewall3014and/or cover3100by the desired length. In a free, unconstrained state, the anchors3090,3094extend about 0.5 mm beyond the outer surface3016of the sidewall3014. In some embodiments, in the free, unconstrained state, the anchors3090,3094extend beyond the outer surface3016of the sidewall3014for a length of from about 0.1 mm to about 1.5 mm, from about 0.2 mm to about 1.25 mm, from about 0.3 mm to about 1.0 mm, from about 0.4 mm to about 0.8 mm, from about 5 mm to about 0.6 mm, or other greater or lesser lengths. In a compressed state, such as in the delivery configuration or after implantation, the anchors3090,3094extend about 1.0 mm beyond the outer surface3016of the sidewall3014. In some embodiments, in the compressed state, the anchors3090,3094extend beyond the outer surface3016of the sidewall3014for a length of from about 0.25 mm to about 2.5 mm, from about 0.5 mm to about 2 mm, from about 0.75 mm to about 1.5 mm, from about 0.875 mm to 1.125 mm, or other greater or lesser lengths.

The geometry of the anchors3090,3094provides several advantages. For example, the relatively long length allows for flexibility of the anchors3090,3094. This provides for potentially less trauma to the LAA tissue should the device3000need to be unanchored and/or retrieved. The anchors3090,3094are less susceptible to loss of strength with off-axis orientation within the LAA. Further, the anchors3090,3094provide high resistance to pull out. For instance, the device3000may provide at least about 0.5 lb-force of dislodgment resistance from the LAA. Such pullout tests may be simulated with in vitro or benchtop models, as further described below.

The anchors3090,3094in the illustrated embodiment are located in two circumferential rows. One row is located proximal to the other distal row. Each row has ten anchors each. This configuration may be incorporated, for example, in the device3000having a foam body3002with a free, unconstrained outer diameter of 27 mm. Each row may have fourteen anchors each. This configuration may be incorporated, for example, in the device3000having a foam body3002with a free, unconstrained outer diameter of 35 mm. In some embodiments, a single row of anchors3090,3094may have twelve anchors. In some embodiments, a single row of anchors3090,3094may have from two to twenty-four, from four to twenty-two, from five to twenty, from six to eighteen, from seven to sixteen, from eight to fifteen, from nine to fourteen, from ten to thirteen anchors, or greater or fewer amounts of anchors3090or3094. In some embodiments, there may only be one row or greater than two rows of anchors. The anchors3090,3094may be spaced circumferentially in a single row. In some embodiments, the device has twenty-four total anchors3090,3094, with each row having twelve anchors, and twelve of the proximal recapture struts3061, for example for the 35 mm diameter device3000. In some embodiments, the device has twenty total anchors3090,3094, with each row having ten anchors, and ten of the proximal recapture struts3061, for example for the 27 mm diameter device3000.

In embodiments with multiple rows of anchors3090,3094, the rows may be circumferentially offset, as shown. That is, as viewed from the proximal or distal end of the device3000, the anchors3090,3094are angularly spaced apart from each other about the axis. The anchors3090,3094may not be circumferentially offset, e.g. they may be evenly angularly spaced when viewed as described. The anchors3090,3094are located axially at or near a middle portion of the sidewall3014. The anchors3090,3094may be located such that the tips of the anchors3090,3094extend to adjacent tissue at a middle portion of the sidewall3014. The offset and middle locations of the anchors3090,3094may ensure engagement with the LAA tissue distal to the ostium. Having the anchors3090,3094located at the largest width, increases the stability of the device3000. With a cylindrical or generally cylindrical shaped device3000, the anchors3090,3094effectively sit on the largest diameter of the device3000. The cylindrical shape provides advantages over typical LAA occluders which taper distally thus decreasing implant stability and locating the anchors on a smaller diameter than the ostial diameter of the occluding surface. In addition to adding stability, the cylindrical shape of the device3000along the axial length helps with dislodgement resistance by allowing the anchors3090,3094to be placed on the largest diameter section of the device3000. In some embodiments, the anchors3090,3094may be located proximal, distal, or centrally along the length of the frame body3080. In some embodiments, the anchors3090,3094may not be offset and/or may not be angularly evenly spaced.

The anchors3090,3094may provide advantageous flexibility, as demonstrated by pullout tests and in comparison to existing devices. For example, the device3000was tested to determine the force required to dislodge the device3000from a simulated tissue model by pulling the device3000proximally outward from the model. A low durometer silicone tube with a circular inner diameter (ID) was used as the model. For the device3000having a foam body3002with a 27 mm outer diameter in a free unconstrained state, tubes with ID's of 16.5 mm, 21 mm and 25 mm were tested. The pullout forces for existing devices drop off significantly going up to a 21 mm model, whereas the forces for the device3000drop only slightly.

In the largest diameter (25 mm) model, where there is not a lot of interference in the fit, the forces for the existing devices approach zero as the device does not engage the model wall because the anchors are sitting at a smaller diameter on a trailing edge of the device. The device3000consistently resists dislodgment with about 0.7 lbs of force. Since there is very little friction resisting pullout, that force is almost entirely resisted by the anchors3090,3094. When examining failure modes, all devices eventually begin to slide out of the model. Upon failure, the anchors3090,3094fold backward or sideways before slipping starts. Assuming 0.7 lbs force is required to cause all twenty anchors3090,3094to fold backward, then the force per anchors is estimated to be about 0.035 lbs.

The frame3040may be laser cut. The tubular body3080may be laser cut from a single tube. The body3080may be cut from a tube having a thickness from about 0.002″ to about 0.014″, or about 0.008″. The tube may have an outer diameter (OD) from about 0.05″ to about 0.30″. The tube may have an outer diameter (OD) of 0.124″ for the 27 mm device3000(i.e. the embodiment of the device3000having a foam body3002with an OD of 27 mm in the unconstrained, free state). The tube may have an OD of 0.163″ for the 35 mm device3000(i.e. the embodiment of the device3000having a foam body3002with an OD of 35 mm in the unconstrained, free state).

In some embodiments, the body3080is laser cut from a superelastic nitinol tube, however, numerous other biocompatible metallic materials can be utilized such as shape memory Nitinol, stainless steel, MP35N, or Elgiloy®. The frame3040is self-expandable. In some embodiments, a balloon-expandable frame3040could be utilized. Additionally, the body3080could be fabricated from drawn wire as opposed to being laser cut from a tube.

As shown, an embodiment of the device3000includes the frame3040having ten proximal recapture struts3061and twenty total anchors3090,3094, with the foam body3002having an outer diameter of 27 mm. In some embodiments, the device3000may include the frame3040having fourteen proximal recapture struts3061and twenty-eight total anchors3090,3094, with the foam body3002having an outer diameter of 35 mm.

In one embodiment, the frame3040includes a proximal hub3050, tether pin3051, front face with ten or fourteen recapture struts3061, a diamond pattern cylindrical body3080, and twenty or twenty-eight anchors3090,3094. The frame proximal face3060supports recapture, the frame body3080supports the foam cylinder body3002, and the anchors3090,3094located on the cylinder provide resistance to embolization.

The design of the device3000provides numerous advantages, some of which have been described. As further example, the frame3040provides many advantages, including but not limited to: 1) implant radial stiffness/compliance—the frame3040provides enhanced radial stiffness while still being sufficiently compliant to allow for off-axis implantation, recapture, etc.; 2) dislodgement resistance—the frame3040provides for high pullout strength, as described; 3) transcatheter delivery—the frame3040can be compressed into a delivery catheter and then fully expand when delivered; 4) recapture—the frame3040allows for recapture/retrieval into the delivery catheter after deployment or even after implantation in the LAA; and 5) mechanical integrity—the frame3040has acute and long term structural integrity, for example the ability to withstand loading into the delivery catheter, deployment from the catheter, and cyclic loading/fatigue. The frame3040also provides a conformable structure to enable the foam body3002to compress against the LAA tissue to facilitate sealing and anchoring with minimal compression (oversizing). The resulting compliance of the frame3040provides better anchoring than existing solutions, as described.

As further example, the device3000seals against irregularly shaped LAA ostia and necks. For instance, a combination of a Nitinol frame3040with a foam body3002having a coating of PTFE and cover3100of ePTFE contribute to ability of the device3000to conform to the anatomy and seal against irregular projections and shapes, while providing a smooth thromboresistent LA surface.

As further example, the device3000provides for controlled & safe delivery. The design of the combined frame3040and foam body3002facilitates delivery in a controlled fashion by slowing the speed of expansion. The bumper3026acts as an atraumatic leading edge portion when delivering the implant into the LAA mitigating the risk of injury. The user has the ability to recapture and redeploy the device3000, if necessary. A flexible tether3240attachment, as further described, from the delivery catheter to the device3000permits the device3000to sit tension free immediately following implantation so the user can ensure final appropriate positioning prior to release of the device3000.

As further example, the device3000provides for simplified placement. The foam-covered cylindrical design makes alignment of the device3000with the central axis of the LAA during delivery non-critical (by allowing deployment up to, for example, 45 degrees off-axis), which is designed to simplify the implantation procedure, as further described.

As further example, the device3000provides for simple sizing. The foam and frame design contributes to the ability to need only two diameters (e.g., 27 mm and 35 mm) to seal the range of expected LAA configurations and diameters (e.g. targeting LAA diameters of 16 to 33 mm). The conformability of the foam and frame allow the 20 mm long implant to fit into LAA's as short as 10 mm deep. The short landing zone requirement (LAA depth) of the device3000, combined with the need for only two implant diameters, enables treatment of a wide range of LAA anatomies with minimal need for burdensome echo and CT sizing. The conforming nature of the implant is key to facilitating a simple to use product platform that is adaptable to a variety of anatomic structures.

As further example, the device3000provides thromboresistant materials and design. The removable tether leaves a smooth, metal-free surface in the LA. Thromboresistant materials (PTFE-coated foam and an ePTFE cover) create a smooth LA face (no metal attachment connection) to reduce anticoagulation needs, enhance thromboresistance, and encourage endothelialization.

As further example, the device3000provides thin, low profile anchors3090,3094around the midpoint of the device3000to provide secure yet atraumatic anchoring.

The foam body3002has a distal bumper3026, for example as shown inFIG.4C. The bumper3026may be a foam distal region of the body3002, such as a distal portion of the sidewall3014. The bumper3026may be a portion of the foam body3002that extends beyond the distal end3044of the frame3040. The bumper3026may extend beyond the distal end3044of the frame3040in the delivery configuration and in the deployed configuration. The body3002may be attached to the frame3040in various locations such that the body3002may stretch in some embodiments, for example in the delivery configuration, to ensure the bumper3026extends beyond the frame3040upon initially retracting the sheath during delivery.

The device3000can conform both in length and diameter due to conformability of both the foam body3002and the frame3040. This allows for the device3000to accommodate most patient LAA anatomies with only a couple or few different sizes of the device3000, such as 27 mm and 35 mm outer diameter body3002as described herein, and one length, such as 20 mm. The frame3040may thus be shorter than the foam body3002, resulting in some embodiments in about 5 mm of foam bumper3026distal to the distal-most end of the frame3040. The distal bumper3026acts as an atraumatic tip during delivery of the device3000and can be compressed following implantation to allow the device3000to conform to appendages with a depth (landing zone) as short as 10 mm. This ability to conform both in length and diameter is due to the conformability of both the foam body3002and the frame3040.

The length of the bumper3026may be measured axially from the distal-most end of the frame3040to the distal surface3022of the body3002. For example, the bumper3026may extend from the distal apexes3088to the distal surface3022. The bumper3026may have a length of 5 mm or about 5 mm. The bumper3026may have a length of about 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm or more. The bumper3026may have a length from about 2.5 mm to about 7.5 mm, from about 3 mm to about 7 mm, from about 3.5 mm to about 6.5 mm, from about 4 mm to about 6 mm, from about 4.5 mm to about 5.5 mm.

In some embodiments, the bumper3026may fold in response to axial and/or radial compression of the device3000. The bumper3026may fold inward, for example radially inward. The folds may be in the axial or approximately in the axial direction. The folds may be circumferential or approximately in the circumferential direction. The folds may be combinations of the radial and circumferential directions, or angled with respect thereto. The folding of the bumper3026is further discussed herein, for example in the section “Device Compliance.”

FIGS.8A-8Care proximal perspective views of the frame3040having a cap3180.FIG.8Dis a distal perspective view of the cap3180. In some embodiments, the pin3051is placed across the proximal hub3050diameter and serves to engage the delivery catheter tether3240(e.g. a suture), which is wrapped around the pin3051for temporary attachment to the delivery catheter3220, as described further herein for example with respect toFIGS.7A-7B. As shown, the hub3050has a pair of opposite side openings3053extending through a sidewall of the hub3050. The cap3180has a corresponding pair of opposite side openings3190extending through a sidewall3184of the cap3180. When the cap3180is assembled with the hub3050, the pin3051may be inserted through the aligned pairs of openings3053,3182. The assembly can be further secured by welding the ends of the pin3051to the hub3050.

As shown inFIG.8D, the cap3180includes a proximal end3182and a distal end3184. The cap3180includes a rounded sidewall3186extending from the proximal end3182to the distal end3184. The sidewall3186defines a longitudinal opening3188through the cap3180. The sidewall3186includes a pair of lateral openings3190located opposite each other. The cap3180includes a flange3192at the proximal end3182extending radially outward.

The cap3180is formed from titanium and the pin3051is formed from Nitinol or superelastic Nitinol. In some embodiments, the cap3180and/or pin3051may be formed from other materials, for example numerous biocompatible metallic or polymeric materials such as shape memory Nitinol, stainless steel, MP35N, Elgiloy, polycarbonate, polysulfone, polyether ether keytone (PEEK), or polymethyl methylacrylate (PMMA) or other materials.

The cap3180and pin3051facilitate attachment to the tether3240. The cap3180and pin3051also mitigate damage to the foam body3002during recapture of the device3000. The cap3180also creates an atraumatic surface for the hub3050of the frame3040. For example, the cap3180may prevent the hub3050from cutting through the foam body3002as the device3000is collapsed into an access sheath. Without the cap3180, the sharp edges of the hub3050may shear through the foam body3002during recapture of the device3000into the access sheath.

The various embodiments of the LAA devices shown and described with respect toFIGS.1-8Dmay be used in the surgical devices and methods described herein, such as those shown and described with respect toFIGS.9A-61.

C. Surgical Clip and Delivery System

Various embodiments of LAA occlusion devices may be used in various surgical approaches, as further described. A surgical clip embodiment is described in this section with respect toFIGS.9A-34. Other embodiments for occluding the LAA of the heart are described in following sections and with respect toFIGS.35-61. For the surgical approaches, the LAA can be entered externally from what would be considered the distal end of the LAA during an interventional closure procedure (e.g. the tip of the LAA), etc. as described above.

In some embodiments, a Surgical Left Atrial Appendage Closure (SLAAC) clip200or device may be implemented to close the LAA. SLAAC-clips and similar devices may be used surgically via a thoracoscopic approach or during open heart surgery.

The SLAAC-clip200can be placed within the left atrium under transesophageal echocardiography (TEE) guidance. In some embodiments, the SLAAC-clip200is a multi-leg metal clip with distal anchors that can be attached to a delivery catheter which is placed though a trocar. When the clip is placed within the LAA, the clip can be opened and the trocar withdrawn. As the trocar is withdrawn, the anchors embed into the tissue of the LAA and close off the ostium. In some embodiments, the SLAAC-clip can be further anchored in place with a suture tether that can be fixed to the exterior wall of the LAA. This external fixation device can also seal the entry site. The clip can be fabricated from 2 to 10 anchors or fronds. It is expanded within the LAA. To place the clip into a closed configuration after engagement with the ostial tissue, a collar is moved up the frond and over a locking bump.

FIGS.9A and9Bdepict a delivery system300and an SLAAC-clip200, which can be loaded within the delivery system300. When the SLAAC-clip200is loaded within the delivery system300, the combination may be referred to as a combined SLAAC-clip/delivery system101. The delivery system300can be used for delivering the SLAAC-clip200through the tip of the LAA.

As depicted inFIG.9A, the SLAAC-clip200may be configured to fit within the delivery system300for deployment at the delivery site where the SLAAC-clip200is pushed out of the distal end of the delivery system300. After the SLAAC-clip200is positioned in the LAA, the empty delivery system is removed. In some embodiments, the delivery system is removed by disassembling some of the components.FIG.9Bdepicts the SLAAC-clip200outside of and detached from the delivery system after release.

As shown inFIG.10A-10C, the SLAAC-clip200can include one or more fronds215, anchors218, a collar220, and/or a pin230. The SLAAC-clip200may have various configurations to fit the needs of the implantation process. For example,FIG.10Adepicts an open configuration, andFIG.10Bdepicts a closed configuration. The collar220may have a radial notch around the perimeter for coupling to the delivery system. The pin230may be positioned in a channel within the middle of the collar220in the open configuration. The fronds215may extend from the pin230. For example,FIG.10Adepicts the SLAAC-clip200in an open configuration with two fronds fully extended from the collar and pin. The ends of the fronds215may curve into anchors for hooking into the tissue at the LAA.FIG.10Bdepicts the SLAAC-clip200in a closed configuration with the collar220advanced relative to the pin230. Upon deployment of the SLAAC-clip200, the anchors may be embedded in the LAA ostium in an open position. As the SLAAC-clip200transitions to the closed configuration, the anchors may be brought together with the ostium, closing off the LAA.

In some embodiments, such as depicted inFIG.10C, the SLAAC-clip200may have more than two fronds215. There may be two, three, four, five, six, seven, eight, nine, ten or more fronds215extending from the collar220. Fronds215may extend radially and equidistance apart from the perimeter of the collar220. More fronds215may increase the number of sites that the SLAAC-clip200embeds into the ostium.

FIGS.11A-11Gdepict the components of the delivery system300.FIG.11Ais an internal view of the delivery system300. The delivery system may have an internal tube1102running longitudinally to the device. Fronds215and pin230of the SLAAC-clip200may be constrained within the inner tube of the delivery system.FIG.11Bis a side view of the delivery system showing an outer tube330and pincers340. The pincers340may run along the length of the outer tube330with angulated distal ends. The angulated distal ends can couple to the collar220at the radial notch1104. Squeeze points1106may be positioned at the proximal ends of the pincers340. When the squeeze points are depressed, the hooks at the distal ends move apart.FIG.11Cdepicts a side view of the delivery system when the pincers are depressed which may release the collar220and SLAAC-clip200. Pincers340may be coupled to the delivery device300via multiple methods. As depicted, each pincer may extend through slits324in the outer tube330, depicted inFIG.11D, to a fulcrum point allowing the pincer to open and close when depressed. The fulcrum point may be attached in several ways, such as elastically, a pivot pin, interlocking parts, or the like.

In another embodiment, the pincers340may open via a collet-like mechanism where the pincers340are naturally spring loaded outward and another tube is slid over them. The additional tube allows the pincers to be gathered together.

FIG.11Ddepicts a side view of the outer tube330. A central lumen322may run along the longitudinal axis of the outer tube330. The outer tube330may have a distal region, a middle region, and a proximal region. Each of the regions of the outer tube may have varying thicknesses and components. For example,FIG.11Eillustrates a cross-section of the distal region of the outer tube330having a first thickness.FIG.11Fillustrates a cross section of the middle region which may have slits to accommodate the pincers340.FIG.11Gdepicts a cross section of the proximal region where the thickness of the outer tube330is greater than that depicted inFIG.11E. When the outer tube330has an increased thickness, the central lumen322may have a reduced diameter to accommodate an inner tube320as described with respect toFIGS.12A-12C.

As depicted inFIGS.12A-12C, inner components of the delivery system can couple together for deploying the SLAAC-clip200.FIG.12Adepicts the inner tube320of the delivery system300. The inner tube320may be a simple tube with a central lumen321running longitudinally. At the distal end, the inner tube320may have a threaded outer contour325.FIG.12Bdepicts several individual components of the delivery system. A side view of the collar220is shown with a central lumen. The central lumen222of the collar220may be in continuity with the central lumen of the inner tube when paired together. As previously discussed, the collar220may have a radial notch225around the outer perimeter to engage the pinchers340of the delivery system. The collar220may also have a threaded central lumen227. The threaded outer contour325of the inner tube320may engage with the threaded central lumen227of the collar220.

The delivery system300may also contain a push rod310. A threaded element315may be at the distal end of the push rod310. The threaded element315may engage with a threaded central lumen within the pin230. In some embodiments, the pin230may be cylindrical in shape. The pin230may be designed as to prevent the pin230from extending beyond the collar220as it is pushed from inside the delivery system. In an example embodiment, the pin230may be stepped in diameter with a wider proximal end to prevent it from passing completely through the collar220.

FIGS.13A-13Jdepict various configurations of the delivery system300as it deploys the SLAAC-clip200. The delivery system300as depicted may be used, either alone or in combination, with any of the delivery system components described herein. InFIG.13A, the SLAAC-clip200and delivery system300are in an initial configuration that may be provided to the operator/user. The fronds215of the SLAAC-clip200are pictured fully within the delivery system and constrained by the inner tube320. The push rod310and the connected pin230are retracted.FIG.13Bdepicts the fronds215being expelled from the collar220at the distal end of the delivery system. The fronds may be expelled as the push rod310is advanced into the inner tube towards the distal end. As the pin230is pushed further into the delivery device, the fronds extend further from the distal end, as pictured inFIG.13C. The push rod310can be advanced until the leading edge of the pin230meets the distal tip of the collar220through the central lumen, as pictured inFIG.13D. The inner tube320may then be disengaged form the collar220by rotating to release from the threads as previously discussed. The delivery system with the inner tube320disengaged and removed is depicted inFIG.13E. The fronds may be embedded into the tissue of the ostium, and the operator may close the fronds by retracting the pin230back through the collar220. As depicted inFIG.13F, the push rod310can be retracted back through the proximal end of the delivery system. As a result, the pin230is also pulled back through the proximal end of the collar220. Retraction of the push rod310and pin230may cause the fronds to retract back through the collar220within the delivery system, as shown inFIGS.13G and13H. As the fronds215, are withdrawn proximal to the proximal end of the collar220, the fronds215can lock in place by allowing the proximal ends of the fronds to take on their unconstrained configuration within the delivery device, which can occur in the absence of the inner tube320. In the unconstrained configuration, the proximal portion of the fronds may form a locking bump1302or locking barrier that prevents further distal movement of the fronds into the collar220. The anchor portion of the fronds may be drawn together, pulling together any tissue in which they are embedded. An operator may determine if the fronds have been retracted sufficiently so that they are locked in place and/or that the clip is in a desired position by a number of various visualization tools and techniques, such as radiography, echography, guiding markings on the delivery system, direct visualization, and the like. Once the operator is satisfied with the position of the clip and the fronds, the push rod310may be released by unscrewing from the threading element at the pin230, as depicted inFIG.1. After the push rod310is retracted from the delivery system, the outer tube is removed by squeezing the pincers340.FIG.13Jshows the pincers disengaging from the radial notch of the collar and the delivery system being removed from the SLAAC-clip200.

As shown inFIGS.14A and14B, the SLAAC-clip200may have an open configuration and a closed/locked position. When the SLAAC-clip200is in the open configuration inFIG.14A, the fronds215are unconstrained by the inner tube or delivery device. The closed/locked position inFIG.14Boccurs when the pin230in retracted with the fronds through the collar220, and the fronds215are able to assume their unconstrained configuration (e.g., by fold) at the proximal end of the collar.

In some embodiments, like pictured inFIGS.14C-14E, the SLAAC-clip200may have an additional bump feature219in each of the fronds.FIG.14Cdepicts the SLAAC-clip200in the open configuration1402with another bend in the fronds which may allow for additional configurations of the SLAAC-clip200. When in an open configuration, distance X0is measured between an apex on each frond anchor.FIG.14Ddepicts a partially closed configuration1404of the SLAAC-clip200where the fronds are pulled back through the collar up to the bump feature1406. The distance between apexes on the anchors of the fronds is now XPCin the partially closed configuration. Drawing the fronds and the bump feature completely through the collar220may result in a fourth configuration, the fully closed configuration1408as inFIG.14E. The distance between apexes of the fronds is now XC. Additional configurations such as the partially closed and fully closed may accommodate variability in the size of the LAA opening and thickness of tissue across patients.

FIGS.15-34depict various features that may be used, either alone or in combination, with any of the LAA occlusion devices and methods described herein. In particular,FIGS.15-34show sequential views of an embodiment of a process for delivering and implanting the SLAAC-clip200via the delivery system.

As shown inFIG.16, the procedure for inserting the SLAAC-clip is initiated with the surgeon making an incision in the tail of the LAA1602. The size of the incision may be large enough to accommodate the outer tube of the delivery system.

FIG.17depicts the delivery system300being inserted through the incision1702and positioned with the distal end in the LAA. An internal view of the delivery system shows that it is loaded with the SLAAC-clip200in the constrained position with the fronds in the inner tube. The outer tube is positioned far enough into the incision site and the LAA so that the SLAAC-clip deploys into the ostium.

As depicted inFIG.18, a purse string suture1802may be placed around the SLAAC-clip200and delivery system300. The purse string suture1802may provide the option of sealing the tissue around the delivery system300to prevent excessive bleeding during the procedure. Additionally, including a purse string suture1802can help close the incision when the procedure is complete.

FIG.19depicts the delivery system300advancing towards the ostium1902to position the distal end1904for deployment of the SLAAC-clip200.FIG.20depicts the delivery device300as the clip200is deployed within the ostium. Once the operator positions the delivery device, the proximal end of the push rod (not pictured) is pushed into the delivery system as the fronds215of the SLAAC-clip200begin to emerge out the distal end1904into the ostium.

FIG.21depicts the fronds215extending through the collar220in the ostium. The push rod has been inserted just enough so that the pin230has reached the collar220. As the fronds215advance through the collar220, they extend away from the delivery system300.

As pictured inFIG.22, the SLAAC-clip200is in the open configuration once the push rod has been full inserted. The fronds215are extended from the collar220and the inner tube2202can be removed. As previously disclosed, the inner tube320is rotated to disengage the threading element (not pictured) with the collar220. Once decoupled, the inner tube320can be removed from the proximal end of the delivery system300. The pin230may be fully inserted into the center of the collar at this point in the deployment process.

FIGS.23-26depict the delivery system300being retracted from the LAA through the suture site with the fronds215fully extended. In some embodiments, positioning of inner components within the delivery system300does not change as the entire device is retracted back through the suture site of the LAA. Due to the removal of the inner tube, there is now space within the delivery device300for the fronds215to transition to an unconstrained configuration if retracted proximally into the outer tube330. The delivery system300may be slowly removed from the LAA through the incision site.

FIG.27illustrates the anchors of the fronds215engaging with tissue of the ostium upon retraction of the delivery system300. The open configuration of the SLAAC-clip allows the fronds215to engage with the tissue as the delivery system is retracted. In some embodiments, the delivery system300may be angled upon retraction from the LAA to ensure that the fronds215engage with the tissue in the desired location. Once the fronds215are engaged with the tissue of the ostium, the push rod310may be retracted through the proximal end of the outer tube. The pin coupled to the push rod310may be pulled back out of the collar220as the outer tube330remains is held in place.

As shown inFIG.28, the push rod310may be retracted manually away from the LAA. In some embodiments, the push rod310may be retracted so that the pin230is pulled closer to the proximal end of the outer tube330. As the pin230is pulled inside the outer tube330, the fronds215may also be pulled into the delivery system300. The length of the fronds215outside the delivery system may shorten and pull the ostium together and closed.

The fronds215may be pulled tight into the delivery system300as the collar220advances toward the ostium, as depicted inFIG.29. In one embodiment, the push rod310can be retracted until the fronds215are pulled tight against the ostium. As the push rod310is pulled, the collar220and outer tube330of the delivery system can be advanced towards the now closed ostium. The portion of the fronds215pulled inside the delivery system300can transition to the unconstrained configuration. The SLAAC-clip may collapse inside the delivery system300due to the lack of inner tube. When the fronds215are pulled tight, the clip may be in a locked position indicating that the ostium has been closed.

In some embodiments, after the SLAAC-clip has been pulled into the locked, unconstrained configuration, the delivery system300may be removed, as depicted inFIGS.30-32. AsFIG.30illustrates, once the ostium has been pulled closed, the operator may remove the push rod310from the delivery system. In some embodiments, the push rod310is rotated to uncouple the distal end from the thread element of the pin230.

FIG.31depicts the push rod310completely uncoupled from the pin230. In some embodiments, once unscrewed, the push rod310may be removed from the proximal end of the outer tube.

As shown inFIG.32, the remaining components of the delivery system300may be removed from the LAA. In some embodiments, the operator may squeeze the pincers340so the distal ends of the pincer arms disengage from the radial notch3202of the collar220. The pincers and outer tube340can be fully released from the SLAAC-clip. The outer tube340and attached pincers can be removed from the incision site of the LAA. The SLAAC-clip with the attached collar220and pin230remain embedded in the ostium tissue.

After removal of the delivery system from the LAA, the incision site may be closed as shown inFIG.33. The ostium remains closed together due to the deployment of the SLAAC-clip.

In some embodiments, as pictured inFIG.34, a tether400may connect the pin230to the LAA wall. For example, the SLAAC-clip may be loaded into the delivery system300with a tether400connected to the proximal end of the pin230. When the SLAAC-clip is deployed and the delivery system is removed from the LAA, the tether400may feed through the incision site to the outside of the LAA. In some embodiments, a pledgeted suture can be used to secure the tether to the outer LAA wall. The tether400helps keep the SLAAC-clip200and the fronds215in place in the ostium. In some embodiments, the externally fixated tether400can seal the incision site.

FIGS.35-43depict sequential views of an LAA and delivery system for a delivery method for percutaneously delivering an LAA occlusion implant (such as the device3000) through a transseptal puncture approach. Generally, the method can include a puncture or slit3502made in the back of the LAA3504. A trocar3508containing the implant3506and delivery catheter can be positioned through the access site3502. Once positioned inside the LAA, TEE imaging can be used to precisely orient the trocar at the ostium of the LAA. The implant3506can be deployed with a suture tether3510for attachment around the internal frame. The tether3510can work like a lasso in facilitating both repositioning and recapture of the implant. For example, in a situation where the implant3506needs to be collapsed, a pusher3512can be advanced from the delivery system to the tether3510. The tether3510can be retracted to collapse the implant3506. Once positioning of the implant3506is corrected, the trocar and delivery catheter can be retracted and the suture tether3510can be removed.

FIGS.35-43depict various features that may be used, either alone or in combination, with any of the LAA occlusion devices and methods described herein. In particular,FIGS.35-43show sequential views of an embodiment of a process for delivering an implant3506using a purse string or lasso suture3510for repositioning or retrieval. The device used for the purse string/lasso approach described with respect toFIGS.35-43may include any features of the devices shown and described with respect toFIGS.3A-8D.

As depicted inFIG.35, the procedure for inserting the implant3506with the purse string3510may initiate with the surgeon making an incision3502in the back of the LAA3504. The size of the incision3502may be large enough to accommodate the trocar3508. In some embodiments, the incision site is on the side of the LAA. In an alternative embodiment, the incision site is at the tip of the LAA.

FIG.36shows the trocar loaded with the implant3506near the incision in the LAA wall. The implant may be compressed within the delivery system3508and may expand upon deployment into the LAA.

FIG.37shows the distal end of the trocar3508entering the LAA through the incision site. In some embodiments, the trocar3508is inserted into the LAA until the opening at the distal end of the trocar3508is at the ostium of the LAA. Various imaging techniques may be used to place the trocar3508. For example, radiography, echography, guided markings on the delivery system, directed visualization, or a combination of any may be used by the operator.

As depicted inFIG.38, when the trocar3508is properly positioned, the implant3506may be deployed into the LAA through the distal end of the trocar3508. A suture3510attachment, as previously discussed, may facilitate repositioning and retrieval of the implant3506if required. In some embodiments, the suture3510may be connected to the frame of the implant3506. For example, the suture3510may weave in and out of the frame diamonds as depicted inFIG.38. Alternatively, eyelets could be added to the frame of the implant3506to accommodate the suture3510passing through.

After deployed from the trocar3508, the implant3506may expand and fill the space between tissue in the ostium. The trocar3508may remain proximal to the deployed implant3506with the suture3510attached to the pusher3512within the delivery system. The trocar3508may still be positioned fully within the incision site of the LAA.

In some embodiments, the pusher3512may be advanced into the implant3506for implant collapse, as pictured inFIG.39. Radial collapse of the implant3506may be actuated by suture tension pulling from the center of the implant3506. The suture3510may be coupled to the end of the pusher3512. As the pusher3512is inserted into the center of the implant3506and suture tension is applied, the implant3506collapses around the tip of the pusher3512. The suture3510may be threaded through the frame of the implant3506so that when tension is applied, the frame collapses and the implant3506compresses.

FIG.40depicts the frame and implant3506collapsed around the distal tip of the trocar3508. In this configuration, the implant3506may be repositioned within the LAA before deploying again. Alternatively, the trocar3508with the attached implant3506may be withdrawn from the LAA for complete removal and retrieval.

Once the implant is deployed into the desired position within the LAA, the delivery system may be removed through the incision, as depicted inFIG.41. The suture3510may still be attached to both the frame of the implant3506and the pusher3512within the trocar3508. In some embodiments, certain checks may be conducted to ensure the implant3506is situated as intended. Once the checks are complete, the delivery system may be removed from the body. For example, certain imaging modalities may be utilized to inspect position of the implant3506. In another example, pushing on the implant3506may help verify positioning.

FIG.42depicts the delivery system and suture attachment3510being removed from the LAA. In some embodiments, once the positioning of the implant3506is checked, the suture attachment3510may be severed and removed from the frame of the implant3506. The trocar3508can be removed from the body. The incision site in the LAA may be closed and the surgery completed.

In an alternative embodiment, the implant3506may be additionally secured by a pledget mechanism3514outside the LAA as depicted inFIG.43. As the incision of the LAA is closed, a suture3516connected to the implant may be fastened to the outer wall of the LAA for additional security. The addition of the pledget3514may prevent embolization of the implant3506. In some embodiments, a tulip-style or flared inner tube can be used to assist with retrieval. A similar mechanism was described in relation toFIG.34.

Similar to the purse-string lasso concept, the grappling hook concept is a method to deliver an implant4402(such as device3000) percutaneously through a transseptal puncture approach, however, via thorascopic or a direct surgical approach. In this approach, a grappling hook style device4404with fingers4406(e.g. hooks) is used to attach to the edges of the internal metal frame4408. In some embodiments, such as when operating on a cold heart, the grappling hook device4404can be utilized to assist in expansion of the metal frame4408.

FIGS.44-47depict various features that may be used, either alone or in combination, with any of the LAA occlusion devices and methods described herein. In particular,FIGS.44-47show sequential views of an embodiment of a process for delivering an implant4402using a grappling hook technique. The device used for the grappling hook approach described with respect toFIGS.44-47may include any features of the devices shown and described with respect toFIGS.3A-8D or35-43.

FIG.44depicts deployment of an implant4402(such as device3000) from the LAA tip. The implant frame4408can be attached to the delivery system. Attachment of the frame4408to the delivery system may occur through grappling hooks4406coupled to the apexes of the frame. The grappling hooks4406can couple to the frame4408via mechanical means, for example, curling around the frame4408by an open hook, a closed hook with an eyelet, a loop, etc.

In some embodiments the grappling hook4406may not be removed after deployment. After deployment of the implant4402with the grappling hook4404, the shaft4410may be unscrewed from the central hub4412. The hooks4406may be detached from the delivery system and left with the implant4402.

FIG.45depicts the first step if the implant4402needs to be collapsed for repositioning. The pusher4414can be advanced up to the tip of the grappling hook assembly4404. The pusher4414may be advanced into the center of the implant4402.

FIG.46depicts the implant4402collapsed around the pusher4414for repositioning or removal.

FIG.47depicts an alternative embodiment for attaching the grappling hooks4406to the implant4402. In this embodiment, the grappling hooks4406are spring elements which can act to expand the implant frame4402. The radial elements may be spring-like material that can apply outward radial force to the frame or inner walls of the implant4402. The spring-like material can be made of stainless steel, CoCr, or other metal that would have ample stiffness to expand the implant4402even in a cold environment. This embodiment can be useful for deployment of Nitinol in a cold heart. A Nitinol frame may not expand well in a cold environment, so the grappling hook assembly4404may be implemented to assist in deployment.

The inversion resheath concept can also be utilized to deliver an implant4802(such as device3000) percutaneously through a transseptal puncture approach, however, via thorascopic or a direct surgical approach. The implant4802can be attached to the delivery catheter via a suture or other method known on the art. If recapture is desired, a pusher4806can be advanced within the implant4802to the central hub4808, the point of attachment, and the implant4802can be inverted for removal.

FIGS.48-50depict various features that may be used, either alone or in combination, with any of the LAA occlusion devices and methods described herein. In particular,FIGS.48-50show sequential views of an embodiment of a process for delivering an implant4802using an inversion resheath. The device used for the inversion resheath approach described with respect toFIGS.48-50may include any features of the devices shown and described with respect toFIGS.3A-8D or35-47.

FIG.48depicts a procedure for implantation of an implant4802(such as device3000) from the distal tip of the LAA. Resheathing of the implant4802may be required after deployment. Resheathing can be accomplished by inverting the implant. InFIG.48, the pusher4806may be placed adjacent to the LA tip from within the frame4810.

InFIG.49, the outer trocar4804can be placed within the frame4810, coaxial to the pusher.

FIG.50depicts the implant4802inverted for repositioning or retrieval. The implant4802can be held by a suture4812from the back. Inversion may occur when the suture4812is pulled into the trocar and the implant4802inverts. The implant4802may invert similar to an umbrella being pulled into a smaller opening without first closing. Inversion may occur when pushing forward on the trocar4804and pulling back on the suture4812at the same time.

The marshmallow concept consists of delivery through a trocar5102of a conformable soft foam or elastomeric cylindrical plug5104with an attachment point on the side adjacent to the LAA inner wall/tip. Following implantation, the plug5104can then be anchored in place either through the side wall of the appendage, using sutures, and/or via a suture attached to a pledget outside the LAA tip, which can also be utilized to close the entry site. In some embodiments, the marshmallow design may not have a frame. The implant5104can expand on its own because it is a solid plug made of foam instead of a cup. When deployed, the marshmallow implant5104can spring back to its original diameter or as constrained by the anatomy at the implant site.

FIGS.51-54depict various features that may be used, either alone or in combination, with any of the LAA occlusion devices and methods described herein. In particular,FIGS.51-54show sequential views of an embodiment of a process for delivering a marshmallow-like implant through a delivery system.

FIG.51depicts a marshmallow-shaped LAA closure implant5104being delivered through a trocar5102from the distal LAA tip.

FIG.52depicts advancement of the pusher5106through the delivery system. As the pusher5106is advanced, the closure implant5104may exit the delivery system and expand.

FIG.53depicts one embodiment for securing the implant5104within the LAA after deployment of the implant5104and removal of the trocar5102. This embodiment includes suturing through foam near the ostium of the LAA, incorporating a tail tether5108, or a combination of anchoring methods. Additionally, pledgets5110can be added outside the LAA for extra security.

FIG.54depicts the final deployed implant5104, secured in place by sutures.

H. Implant with Modified Frame—Dual Hubs

The dual hub embodiment inFIG.55has one hub5502that faces the LA and provides a flat, smooth surface. There may be a second hub5504facing the LAA tip that can be utilized to facilitate repositioning and recapture. The device used for the dual hub embodiment described with respect toFIG.55may include any features of the devices shown and described with respect toFIGS.3A-8D or35-54.

FIG.55depicts an embodiment of an implant5506. The open distal end of an implant5506, such as device3000, is replaced by a second hub5504. This allows the first hub5502—positioned near the LAA ostium—to provide a flat surface in the LAA while the second hub5504—positioned near the LAA tip—allows for attachment during delivery and repositioning or retrieval. The anchors can be similar to those of other embodiments described herein, such as device3000. After deployed, the implant5506protruding into the LA may disrupt flow of blood in the LA. Disruption of blood flow can increase probability of thrombus formation, so a flat face on the implant may be preferable.

In some embodiments, a flat face can also be formed with the 1 hub facing away from the LA (seeFIG.56). One potential benefit of 2 hubs is that the radial elements protruding from the hub on the LA-facing side may help to maintain a more effective seal at the ostium.

The proximal (non-LA facing) hub embodiment may have a hub5602facing the LAA tip to help facilitate repositioning and recapture. The proximal LA face can be just the tissue scaffold. The device used for the proximal hub embodiment described with respect toFIG.56may include any features of the devices shown and described with respect toFIGS.3A-8D or35-55.

In all of these embodiments, the tissue scaffold can be fabricated from a foam material, ePTFE, PET or another biocompatibile material. It can also be a composite of foam covered with a material such as ePTFE or PET.

FIG.56depicts a modified implant5604(such as device3000) where the hub of the internal frame5602does not face the left atrium (LA). It faces the LAA tip to facilitate delivery and repositioning or retrieval. The tip of the frame5602is splayed outward to facilitate anchoring of the implant5604. The open end of the frame5602is covered by foam which can also have an ePTFE cover, with or without perforations. If the implant5604is left open, thrombus could form inside it and then escape causing stroke. Closing it off would prevent thrombus forming inside the implant, or rather it would trap it so it can't come loose and cause stroke.

J. Implant with Modified Frame—External Anchors

The external anchors embodiment is an anchoring concept which can be used with any of the designs described in this disclosure. The anchors are attached to the LAA tip side of the implant5702and exit through the LAA wall, securing the implant5702in place.

FIG.57depicts an embodiment of the dual-hub implant5702with external anchors5704. In this embodiment, a distal anchor5704that extends outside the LAA tip is employed. This type of anchor can be added to any of the implant designs in this disclosure. The external anchor5704can be applied to multiple different embodiments. As pictured inFIG.57, the external anchors5704can be applied to a double-hub frame embodiment that was previously disclosed inFIG.55.

The device used for the external anchor embodiment described with respect toFIG.57may include any features of the devices shown and described with respect toFIGS.3A-8D or35-56.

The champagne cork concept depicted inFIGS.58-61is designed to be implanted in a cold heart. The tip of the LAA5810is slit and the cork5802is positioned in the appropriate spot in the LAA through the use of the external alignment device5804. This device has a suture5806that encircles the exterior of the LAA which is attached to metal arms5808for positioning. The arms5808contact the exterior of the heart to help position the external suture5806around the cork implant5802, fixing it in place. The implant5802is fabricated from an elastomer or a dense foam that can take odd shapes but resists being crushed by the suture. Following placement of the cork5802and securing it by tightening of the external suture5806, the access point is sutured closed.

FIG.58depicts a slit5812placed in the distal LAA5810tip of a cold heart to open it up to allow delivery of the implant5802. The implant5802is loaded into the delivery system.

FIG.59depicts placement of the implant5802in an expanded shape. Alignment arms5808on the delivery system help to find the proper location for the suture lasso5806which is placed around the implant5802from outside the LAA.

FIG.60depicts how this concept is different from other LAA closure methods which expand to fill a pressurized LAA. In this embodiment the LAA5810is brought down in contact with the implant5802from exterior to the LAA. The implant5802is fixed in place and can also bring anchors in touch with the interior LAA wall for additional fixation.

FIG.61depicts the final implant placement with the tip of the LAA5810sutured closed while also showing how the implant5802material is highly conformable to different shapes of LAA ostia.

Certain features that are described in this specification in the context of separate implementations also can be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation also can be implemented in multiple implementations separately or in any suitable sub-combination.

It will be understood by those within the art that, in general, terms used herein are generally intended as “open” terms (e.g., the term “including” should be interpreted as “including but not limited to,” the term “having” should be interpreted as “having at least,” the term “includes” should be interpreted as “includes but is not limited to,” etc.).