Devices and methods for eliminating the left atrial appendage

Abstract

Devices and methods for occluding the left atrial appendage (LAA) are described. [Solution] The device removes the LAA from the bloodstream, particularly in patients with atrial fibrillation, to prevent blood from forming a blood clot within the LAA and subsequently causing embolism. The implantable device is delivered into the LAA via transcatheter delivery and fixed within the LAA. The implant comprises an expandable compliant frame and an expandable, shape-conforming tubular foam body. The device may have an antithrombotic cover at its proximal end. The frame may have recapture struts that are inclined radially outward from a central hub. The frame may have axially extending sidewall struts, and adjacent pairs of sidewall struts may be joined at one or more vertices. Anchors extend from the frame, penetrate into the foam, and engage with the tissue.

Description

Technical Field

[0001] Incorporation by reference of related applications This application claims priority to International Application No. 15 / 969,654, filed May 2, 2018, entitled "DEVICES AND METHODS FOR EXCLUDING THE LEFT ATRIAL APPENDAGE," which is hereby incorporated by reference in its entirety for all purposes and forms a part of this specification.

[0002] This achievement generally relates to systems, devices, and methods for excluding the left atrial appendage (LAA). In particular, systems, devices, and methods for excluding the LAA using an expandable foam implant with a deployable and compliant frame are described herein.

Background Art

[0003] Atrial fibrillation (Afib) is a condition in which the normal beating of the left atrium (LA) is disordered and ineffective. The left atrial appendage (LAA) is a blind pouch that extends from the LA. In patients with Afib, blood flow stagnates within the LAA, promoting clot formation. These blood clots (or clot fragments) tend to embolize within the LAA or exit the LAA and enter the systemic circulation. A stroke occurs when a clot / clot fragment embolizes and occludes one of the arteries perfusing the brain. Anticoagulants, such as warfarin, have been shown to significantly reduce the stroke risk in Afib patients. These drugs reduce clot formation but also increase the risk of hemorrhagic complications, including hemorrhagic stroke, subdural hematoma, and bleeding within the gastrointestinal tract.

[0004] There are approximately 8 million AFIB patients in the United States and the EU. Of these patients, about 4.6 million are at high risk of stroke and would benefit from anticoagulants. The majority of these patients are unable to take anticoagulants due to an increased risk of bleeding, and their stroke risk remains unresolved. The prevalence of AFIB increases with age.

[0005] Existing devices for occluding the laryngeal aorta (LAA) have drawbacks. They are available in many sizes and must precisely conform to the highly variable anatomical structure of the LAA. This is difficult to achieve using fluoroscopy and often requires supplemental imaging in the form of transesophageal echocardiography (TEE), cardiac CT, and MRI, all of which require three-dimensional reconstruction. If the device is significantly too large, the LAA ostium can be stretched and torn, potentially resulting in bleeding into the pericardial cavity. If the device is too small, it may not properly seal the ostium and may be prone to embolization. Even with the correct size, the device often forces its rounded shape into the oval-shaped LAA ostium, resulting in poor sealing and subsequent leakage of residue from the edges.

[0006] Existing devices require sufficient spring force or rigidity to seal and secure to surrounding tissue. If they are too rigid, these devices can become a source of blood leakage through the tissue into the pericardial cavity, which can cause cardiac tamponade. Furthermore, the geometric shape of these devices hinders repositioning after the implant has fully expanded. Existing devices also make delivery a cumbersome task because they must be positioned within the LAA coaxially with the LAA axis.

[0007] Therefore, an improved LAA occlusion device is needed. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Patent Application No. 14 / 203,187 [Patent Document 2] U.S. Provisional Application No. 62 / 240,124 [Patent Document 3] U.S. Patent Application No. 15 / 290,692 [Patent Document 4] U.S. Patent Application No. 14 / 203,187 [Patent Document 5] European Patent Application No. EP14779640.3 [Patent Document 6] PCT Patent Application No. PCT / US2014 / 022865 [Patent Document 7] U.S. Patent No. 7,803,395 [Patent Document 8] U.S. Patent No. 8,337,487 [Overview of the Initiative] [Problems that the invention aims to solve]

[0009] Each embodiment disclosed herein has several aspects, none of which individually relate to any of the desirable attributes of the disclosure. The more prominent features of this disclosure are then briefly described without limiting its scope. After reviewing this description, and in particular after reading the section titled “Modes for Carrying Out the Invention,” you will understand how the features of the embodiments described herein offer advantages over existing systems, devices, and methods for left atrial appendage (LAA) occlusion.

[0010] The following disclosure describes some non-limiting examples of embodiments. For example, other embodiments of the disclosed systems and methods may or may not include the features described herein. Furthermore, the advantages and benefits disclosed may apply to only some embodiments and should not be used to limit this disclosure. [Means for solving the problem]

[0011] In particular in patients with atrial fibrillation, a device and method are described for preventing blood from forming a blood clot within the laryngeal artery (LAA) and subsequently causing embolism by occluding the LAA and removing it from the bloodstream. The LAA occlusion device is delivered into the LAA via transcatheter delivery and secured using a compliant frame and foam body. Among other advantages, the device conforms to the oval shape of the LAA, which provides excellent sealing, does not require an excessive number of sizes, thus eliminating the need for extensive preoperative imaging, and is delivered off-axis, thereby simplifying the delivery procedure.

[0012] A foam body, which may be tubular in shape, and a compliant frame inside or within the foam body are described, which fold for delivery and then expand in place within the LAA. The foam body may have a coating on at least partially the outer surface of the foam body. The coating may be a layer of polytetrafluoroethylene (PTFE). The device is secured by structural anchors of the frame and / or by tissue growth intrusion from the left atrium (LA) and LAA into the foam body. In some embodiments, it is secured in addition to, or alternatively to, by barbs and / or distal fixation elements, by independent or integrated repositionable anchors. For example, anchors extending from the compliant frame that unfold through a compressible foam plug are described. Embodiments of repositionable, non-invasive anchoring systems, which may be independent structures or integrated with the foam plug and / or skin, are also disclosed in some embodiments.

[0013] The foam body may be at least partially covered by a proximal end cover. The cover may be an stretched polytetrafluoroethylene (ePTFE) cover. The cover offers several advantages, including having sufficient strength to allow handling of the plug without tearing, allowing repositioning and removal of the plug, providing an antithrombotic surface that promotes the formation of neointima within the LA, helping to form an occlusion zone designed to promote coagulation resistance and endothelialization from blood and adjacent tissue, and a fixation zone designed to promote rapid, tenacious tissue growth penetration from adjacent non-blood tissue into the compressible implant, and assisting in closure at the entrance. The cover, for example, a layer, jacket, or skin, may be independent or attached to the foam body, for example, by sutures, adhesive, etc. In some embodiments, one or more removal finials may be attached at one or more locations to assist in the removal of the embolusted device and to enhance radiopaqueness.

[0014] Some embodiments have a guidewire lumen within a foam body that is tracked on a guidewire and expandable to allow for guidewire placement, and then self-closes after guidewire removal. Some embodiments do not require a guidewire lumen. Furthermore, some embodiments are multifunctional and may have features such as ablation, pressure sensing, drug elution, pacing, and electrical shielding.

[0015] In one embodiment, the left atrial appendage occlusion device comprises a tubular foam body and a cover. The tubular foam body extends axially from the proximal end to the distal end. The cover comprises at least a portion that covers the proximal end. The portion covering the proximal end comprises a series of openings that pass through it. The foam and cover are configured to allow a flow rate of water passing axially through the device of at least 4 liters per minute, the water is approximately 68°F, and the upstream pressure is approximately 25 milliliters of mercury (mmHg).

[0016] Various embodiments of various aspects can be implemented. In some embodiments, the body may have compressible side walls extending between a proximal end and a distal end, defining a central cavity. The left atrial appendage occlusion device may further include an expandable support coupled to the body and configured to compress the side walls and press against the wall of the left atrial appendage. The foam body has a proximal surface having a region, and a series of openings within the cover may collectively form an open area which is at least 5% of the area of ​​the proximal surface. The open area may be at least 10% of the area of ​​the proximal surface. The open area may be at least 15% of the area of ​​the proximal surface. The water flow may be along the flow axis, and the tubular foam body may extend axially along the device axis. The device axis may be at an angle of at least 30 degrees with respect to the flow axis. The device may be configured to allow an off-axis flow rate of water passing through the device of at least 4 liters per minute, where the water is about 68°F and the upstream pressure is about 25 milliliters of mercury (mmHg). The off-axis flow may be defined as having an angle of at least 30 degrees from the axial flow.

[0017] In another embodiment, the left atrial appendage occlusion device comprises a tubular foam body and a cover. The tubular foam body extends axially from a proximal end to a distal end. The cover comprises at least a portion that covers the proximal end. The portion covering the proximal end comprises a series of openings that penetrate through it. The foam body has a proximal surface at the proximal end where the region is located. The series of openings in the cover collectively form an open area which is at least 5% of the area of ​​the proximal surface.

[0018] Various embodiments in various aspects can be implemented. In some embodiments, the open area may be at least 10% of the area of the proximal surface. The open area may be at least 15% of the area of the proximal surface. The foam and the cover are configured to allow a flow rate of water passing axially through the device of at least 4 liters per minute, the water being at about 68°F and the upstream pressure being about 25 millimeters of mercury (mmHg). The body portion may include a compressible sidewall extending between a proximal end and a distal end and defining a central cavity. The left atrial appendage occlusion device may further include an expandable support coupled to the body portion and configured to compress the sidewall and press it against the wall of the left atrial appendage.

[0019] In another aspect, a method of loading a left atrial appendage occlusion device into a delivery catheter is described. The method includes placing the proximal end of a loading body portion in a position adjacent to the distal end of the delivery catheter, the loading body portion having a sidewall defining a through-channel and a distal opening at the distal end being larger than a proximal opening at the proximal end. The method further includes pulling the left atrial appendage occlusion device proximally through the loading body portion, thereby radially compressing the device, the device comprising a foam body portion, and receiving the device within the distal end of the delivery catheter.

[0020] Various embodiments in various aspects can be implemented. In some embodiments, the loading body portion may include a frustoconical portion. The loading body portion may be defined as having a central longitudinal axis, and the side wall may extend at an angle of at least 5 degrees with respect to the longitudinal axis. The side wall may extend at an angle of at least 10 degrees with respect to the longitudinal axis. The side wall may extend at an angle of at least 15 degrees with respect to the longitudinal axis. The side wall may define a total angle of at least 10 degrees, at least 20 degrees, or at least 30 degrees. The advancement step may include pulling the tether proximally and passing it through the delivery catheter. The device may be radially compressed within a delivery catheter having an outer diameter of 15 French or less. The inner surface of the loading body portion may be substantially smooth. The method may include radially compressing the device to a radially compressed width within the delivery catheter that is 20% or less of the radially uncompressed width of the device. The radially compressed width within the delivery catheter may be 15 percent or less of the radially uncompressed width of the device.

[0021] In another aspect, the left atrial appendage occlusion device comprises a foam body portion, an expandable support, and at least one anchor. The foam body portion has a tubular side wall that is uncompressed in the radial direction in terms of thickness. The expandable support is coupled to the body portion. The at least one anchor is coupled to the support and penetrates the side wall when the foam of the side wall is compressed, and the at least one anchor has a radial height that is less than or equal to the radially uncompressed thickness of the side wall.

[0022] Various embodiments of the device can be implemented in various ways. In some embodiments, the device may define a central axis, and at least one anchor may be angled with respect to the central axis. At least one anchor may extend radially outward in the proximal direction at an angle of at least 20 degrees with respect to a portion of the central axis extending proximal to the device. This angle may be at least 30 degrees. At least one anchor may penetrate a radially compressed portion of the sidewall having a radial thickness less than the radially uncompressed thickness. The left atrial appendage occlusion device may further include a fixture that connects the support to the sidewall and radially compresses the sidewall at the radially compressed portion. The device may further include a proximal cover that covers at least a portion of the proximal surface of the foam body.

[0023] In another embodiment, the left atrial appendage occlusion device comprises a foam body, an expandable support, and at least one anchor. The foam body has a tubular sidewall comprising at least one first portion having a first radial thickness and at least one second portion having a second radial thickness less than the first radial thickness. The expandable support is coupled to the body. At least one anchor is coupled to the support and at least partially penetrates at least one second portion of the sidewall.

[0024] Various embodiments of various aspects can be implemented. In some embodiments, the device may define a central axis, and at least one anchor may be angled with respect to the central axis. At least one anchor may extend radially outward in the proximal direction at an angle of at least 20 degrees with respect to the central axis. This angle may be at least 30 degrees. At least one anchor may penetrate at least one second portion of the sidewall such that a portion of at least one anchor extends outward beyond the outer surface of at least one second portion of the sidewall. At least one anchor may have a length equal to the uncompressed thickness in the radial direction of the tubular sidewall. The support may include a tubular frame portion configured to expand radially outward after implantation of the device to compress its sidewall and press against the wall of the left atrial appendage. The device may further include a proximal cover that covers at least a portion of the proximal surface of the foam body portion.

[0025] In another embodiment, the left atrial appendage occlusion device comprises a tubular foam body and an expandable support connected to the body. The device is inserted into a non-cylindrical opening of a test body having a non-cylindrical outer shape, extends radially within the non-cylindrical opening, and is configured to conform in shape to the non-cylindrical outer shape at least at the opening of the test body.

[0026] Various embodiments of various models can be implemented. In some embodiments, the device may be configured to conform to a non-cylindrical shape at least at the opening of the test body, leaving no radial gap of more than 5 millimeters between the device and the opening of the test body. The device may not have a radial gap of more than 4, 3, 2, and / or 1 millimeter. The device may be configured to be inserted into a non-cylindrical opening of a test body having a non-cylindrical shape with a size and shape substantially similar to that of a natural left atrial appendage. The device may be inserted into a non-cylindrical opening of a test body having radial rigidity substantially similar to that of a natural left atrial appendage, and may be configured to take on a non-cylindrical shape at least at the opening of the test body after a period of at least 30 days, at least 60 days, and / or at least 120 days. The device may further comprise at least one anchor coupled to a frame and at least partially penetrating into the tubular foam body.

[0027] In some embodiments, the foam body may have compressible side walls extending between its proximal and distal ends, defining a central cavity. The left atrial appendage occlusion device may further include an expandable support coupled to the foam body and configured to compress the side walls and press them against the inner surface of the test body.

[0028] In another embodiment, the left atrial appendage occlusion device comprises a tubular foam body and an expandable support connected to the body. The device has a radially uncompressed width. The device is configured to be radially compressed to a radially compressed width which is 50% or less of the radially uncompressed width.

[0029] Various embodiments of various forms can be implemented. In some embodiments, the radially compressed width may be 40% or less of the radially uncompressed width. The tubular foam body extends along the longitudinal axis, and the radially uncompressed width may extend along the diameter of the foam body perpendicular to the longitudinal axis.

[0030] In another embodiment, the left atrial appendage occlusion device comprises a tubular foam body and an expandable support connected to the body. The device extends axially from a proximal end to a distal end, with the proximal end having an uncompressed width in the radial direction. The distal end is configured to be radially compressed to a radially compressed width that is 50% or less of the uncompressed width of the proximal end in the radial direction.

[0031] Various embodiments of various forms can be implemented. In some embodiments, the distal end may be configured to be radially compressed to a radially compressed width which is 40% or less of the radially uncompressed width of the proximal end. The radially compressed width may be 30%, 20%, 10%, and / or 5% or less of the radially uncompressed width of the proximal end.

[0032] In another embodiment, the left atrial appendage occlusion device comprises a tubular foam body and an expandable support connected to the body. The device has an uncompressed length in the axial direction. The device may be configured to be axially compressible to an axially compressed length which is 50% or less of the uncompressed length in the axial direction.

[0033] Various embodiments of various forms can be implemented. In some embodiments, the axially compressed length may be 40% or less of the axially uncompressed length. The axially uncompressed length may extend from the proximal end to the distal end of the foam body.

[0034] In another embodiment, a left atrial appendage occlusion device is described. The device comprises a shape-conforming tubular foam body, a compressible side wall, and an expandable support. The shape-conforming tubular foam body has a closed proximal end and a distal end. The compressible side wall extends between the proximal and distal ends and defines a central cavity. The expandable support is located within the body and is configured to compress the side wall and press it against the wall of the left atrial appendage.

[0035] In some embodiments, the sidewalls may have an uncompressed thickness of at least about 0.5 mm. The compressible sidewalls may have an uncompressed thickness of at least about 1.5 mm. The compressible sidewalls may have an uncompressed thickness of about 2.5 mm. The compressible sidewalls may extend distally beyond the distal end of the support by at least about 2 mm in an unconstrained expanded state. The compressible sidewalls may extend distally beyond the distal end of the support by about 5 mm in an unconstrained expanded state. The compressible sidewalls may comprise a foam having a plurality of interconnected meshes and voids, and further comprising a PTFE coating on at least a portion of the interconnected meshes. The closed proximal end may comprise a foam end wall. The foam end wall may further comprise a cover. The cover may comprise ePTFE. The expandable support may be self-expandable. The expandable support may be located within a central cavity. The tubular foam body may be substantially cylindrical in an unconstrained expanded state.

[0036] In another embodiment, a self-expandable non-invasive occlusion device is described. The device is configured to conform to the shape of the lateral wall of the left atrial appendage. The device comprises a compressible open-cell foam body, a self-expandable support, and a proximal end wall. The compressible open-cell foam body has tubular foam sidewalls and a central cavity. The expandable support is located within the cavity. The proximal end wall is located on the foam body. The proximal end wall is positioned proximal to the proximal end of the support, and the foam sidewall extends distally beyond the distal end of the support, forming a distal non-invasive buffer to prevent contact between the support and the wall of the left atrial appendage at the implantation site where the central longitudinal axis of the occlusion device is non-parallel to the main longitudinal axis of the left atrial appendage.

[0037] In another embodiment, a left atrial appendage occlusion device is described. The device comprises an expandable tubular foam cup and an expandable frame. The expandable tubular foam cup has a proximal end, a distal end, a tubular side wall, and a proximal end wall. The side wall has a thickness of at least about 1.0 mm and a porosity of at least about 85% open void ratio. The expandable frame is configured to compress the side wall to conform to the shape of the wall of the left atrial appendage.

[0038] In some embodiments, the tubular sidewall may have a thickness of at least about 2 mm. The tubular sidewall may have a porosity of at least about 90%. The tubular sidewall may have an average pore size of at least about 100 microns. The tubular sidewall may have an average pore size of at least about 200 microns. The tubular sidewall may be coated with an antithrombotic coating. The antithrombotic coating may contain PTFE. The proximal end wall may be fitted with an antithrombotic cover. The frame may further comprise at least three recapture struts that are radially inclined in the proximal direction to the hub. The frame may comprise a plurality of axially extending sidewall struts, where adjacent pairs of sidewall struts are joined at the vertices. The frame may comprise at least six proximal-facing vertices and at least six distal-facing vertices. Each recapture strut may be joined to its own proximal-facing vertex on the frame. The recapture strut may be formed integrally with the frame. The device may further comprise a lumen through which the hub passes. The device may further comprise anchors for securing the device to tissue. The anchors may be flexible anchors configured to penetrate the foam sidewall at an angle of inclination.

[0039] In another embodiment, a shape-adjustable LAA occlusion device is described. The device comprises a compressible tubular foam wall. The wall comprises a reticular crosslinking matrix having a porosity of at least about 90%, an average cell size in the range of about 250 to 500 microns, a wall thickness of at least about 2 mm, and a compressive strength of at least about 1 psi. In some embodiments, the compressive strength is in the range of about 1 psi to about 2 psi. In some embodiments, the device may have an expandable support configured to compress the sidewalls and press against the wall of the left atrial appendage.

[0040] In another embodiment, an LAA occlusion device is described. The device comprises an open-cell foam body and an internal locking system. The body has a proximal end, a distal end, and an outer skin. The proximal end is configured to face the left atrium, and the distal end is configured to face the LAA after implantation in the LAA. The body may be compressed for delivery within a delivery catheter and may self-expand when removed from the delivery catheter. The internal locking system is coupled to the body and comprises at least one deployable tissue anchor. The deployable anchor is configured to expand from a constrained configuration shape within the body to an expanded configuration shape that extends outward from the body so that the tissue engagement segment of the anchor securely holds the body within the LAA. The deployable anchor is configured to expand to the expanded configuration shape after the body has expanded within the LAA. The deployable anchor may be retractable from the expanded configuration shape to a retracted configuration shape within the body.

[0041] In some embodiments, the internal locking system further comprises a plurality of deployable anchors rotatably coupled to the main body, the plurality of anchors configured to rotate to an deployed configuration and a retracted configuration. The internal locking system may comprise four of the deployable anchors. In some embodiments, the main body further comprises a plurality of axially extending slots corresponding to the plurality of anchors, each of the plurality of anchors configured to deploy and retract through the corresponding axial slot.

[0042] In some embodiments, the internal locking system further comprises a restraint that restrains the anchor to a constrained configuration shape, and the anchor is unfolded from the constrained configuration shape to an unfolded configuration shape by removing the restraint from the anchor. The restraint may be a sheath that restrains the anchor to a constrained configuration shape by covering the anchor, and the anchor is unfolded from the constrained configuration shape to an unfolded configuration shape by removing the sheath from covering the anchor. The restraint may be a lasso that restrains the anchor to a constrained configuration shape by enclosing the anchor, and the anchor is unfolded from the constrained configuration shape to an unfolded configuration shape by removing the lasso from enclosing the anchor.

[0043] In some embodiments, the internal locking system further comprises a movable mount coupled to the end of the anchor, and the anchor is unfolded from a constrained configuration to an unfolded configuration by moving the mount axially.

[0044] In some embodiments, the internal locking system further comprises a restraining device configured to move over the anchor and retract the anchor. The restraining device may be a ring configured to slide over the anchor and retract the anchor.

[0045] In some embodiments, the skin includes ePTFE.

[0046] In some embodiments, the device further comprises at least one tissue growth entry surface on the side wall of the main body.

[0047] In some embodiments, the device further comprises a plurality of openings within the skin that allow tissue growth to penetrate into the open-cell foam body. The plurality of openings in the skin may be located within a fixed area of ​​the device, which is at least located between the proximal and distal ends of the device, and the device may further comprise an occluded area located at the proximal end of the device, which is configured to promote coagulation resistance and endothelialization from blood and adjacent tissue.

[0048] In another embodiment, an LAA occlusion system is described. The system comprises a delivery catheter and an LAA occlusion device. The delivery catheter comprises an elongated, flexible tubular body having a proximal end, a distal end, and at least one lumen penetrating through them. The LAA occlusion device is compressed within the delivery catheter and configured to self-expand after deployment from the delivery catheter. The device comprises a self-expandable open-cell foam body coupled with an internal locking system. The internal locking system comprises a deployable anchor configured to deploy from a constrained configuration shape to an expanded configuration shape after the body expands within the LAA, and to retract from the expanded configuration shape to a retracted position within the body.

[0049] In some embodiments, the system further comprises an axially movable deployment control unit that penetrates the lumen of the main body for deploying a deployable anchor. The system may further comprise an axially movable deployment control unit that penetrates the lumen of the main body for deploying the foam main body from the distal end of the closure system. The internal locking system may further comprise a restraint that restrains the anchor to a constrained configuration shape, and the anchor is actively deployed from the constrained configuration shape to an expanded configuration shape by removing the restraint from the anchor using an axially movable deployment control unit that penetrates the lumen of the main body. The internal locking system may further comprise a movable mount coupled to the end of the anchor, and the anchor is actively deployed from the constrained configuration shape to an expanded configuration shape by moving the mount axially using an axially movable deployment control unit that penetrates the lumen of the main body.

[0050] In another embodiment, a method for eliminating a laryngeal aneurysm (LAA) is described. This method includes the steps of advancing a guidewire into the LAA, advancing the distal end of a delivery catheter onto the guidewire into the LAA, and deploying an LAA occlusion device from the distal end of the delivery catheter. The device comprises an expandable foam body coupled to an internal locking system having a deployable anchor, the body expanding in the LAA after being deployed from the distal end of the delivery catheter, and this method further includes the step of actively deploying the deployable anchor after the body has expanded in the LAA. The deployable anchor is configured to retract from a deployed configuration to a retracted position within the body. In some embodiments, the method further includes the step of retracting the deployable anchor from a deployed configuration to a retracted position.

[0051] In another embodiment, an LAA occlusion device is described. The device comprises an expandable foam body and an internal locking system. The body may be compressed for delivery within a delivery catheter and may self-expand when removed from the delivery catheter. The internal locking system comprises a deployable anchor coupled to the body and configured to expand from a constrained configuration shape within the body to an expanded configuration shape extending outward from the body so as to securely lock the body within the LAA. The body is configured to expand after removal from the delivery catheter, and the deployable anchor is configured to expand to the expanded configuration shape after the body has expanded.

[0052] In another embodiment, an LAA occlusion device is described. The device comprises an expandable foam body and an internal locking system. The body may be compressed for delivery within a delivery catheter and may self-expand when removed from the delivery catheter. The internal locking system comprises a deployable anchor coupled to the body and configured to unfold from a constrained configuration within the body to an expanded configuration in which an anchor extends outside the body to securely lock the body within the LAA. The deployable anchor is configured to retract from the expanded configuration to a retracted configuration within the body so that the body can be repositioned within the LAA.

[0053] In another embodiment, a LAA occlusion device is described. The device comprises an expandable tubular frame, an expandable tubular foam layer, and a tissue scaffold. The expandable tubular frame has a proximal end, a distal end, and a central lumen. The expandable tubular foam layer is supported by the frame and has a thickness of at least about 0.5 mm. The emboli retention layer is supported by the frame and surrounds the lumen at the proximal end.

[0054] In some embodiments, the foam layer may have a thickness of at least about 1 mm. The foam layer may have a thickness of at least about 2.5 mm. The foam layer may have a porosity of at least about 80%. The foam layer may have a porosity of at least about 90%. The foam layer may have an average pore size of at least about 100 microns. The foam layer may have an average pore size of at least about 200 microns. The foam layer may extend across the proximal end of the frame to form a tissue scaffold. The tissue scaffold may be coated with an antithrombotic coating. The tissue scaffold may be coated with an antithrombotic layer. The antithrombotic coating or layer may contain PTFE. The antithrombotic coating or layer may contain ePTFE. The frame may further comprise at least three recapture struts that are radially inclined in the proximal direction to the hub.

[0055] In some embodiments, the foam layer extends across the proximal end of the frame to form a tissue scaffold, and the frame may comprise a plurality of axially extending sidewall struts, with adjacent pairs of sidewall struts joined at the vertices. The device may comprise at least six proximal-facing vertices and at least six distal-facing vertices. The device may comprise at least three recapture struts joined at the proximal hub, each recapture strut having a distal end joined to the frame. Each recapture strut may be joined to a specific proximal-facing vertex on the frame. The recapture struts may be formed integrally with the frame. The device may further comprise a lumen passing through the hub.

[0056] In some embodiments, the device may include anchors for securing the device to tissue. The anchors may be static anchors configured to deploy after the device has been deployed from the delivery catheter. The anchors may be constrained anchors configured to be controllably released to assume a deployed configuration after the foam has expanded. The anchors may be dynamic anchors configured to deploy from a contracted configuration to a deployed configuration and further configured to retract and return from the deployed configuration to a contracted configuration. These anchors may be further configured to retract and return from a deployed configuration to a contracted configuration.

[0057] The aforementioned and other features of this disclosure will become more fully apparent from the following description and claims by reference to the accompanying drawings. While understanding that these drawings illustrate only some embodiments of this disclosure and should not be considered limitations on its scope, this disclosure is described with additional specificities and details through the use of the accompanying drawings. The following detailed description refers to the accompanying drawings, which form part of the detailed description. Similar symbols in the drawings typically indicate similar components unless otherwise indicated in context. The exemplary embodiments described in the detailed description, drawings, and claims are not intended to limit. Other embodiments may be available, and other modifications may be made without departing from the spirit or scope of the invention presented herein. It will be readily apparent that the aspects of this disclosure, as generally described herein and illustrated in the drawings, can be arranged, substituted, combined, and designed in a variety of different configurations, all of which are explicitly considered and form part of this disclosure. [Brief explanation of the drawing]

[0058] [Figure 1] This diagram shows the anatomical structure of the left atrium (LA) and left atrial appendage (LAA). [Figure 2] This figure shows an LAA with an embodiment of an LAA occlusion device, which uses an adhesive, implanted within the LAA. [Figure 3]This figure shows an X-ray image of one embodiment of an LAA occlusion device. [Figure 4] This figure shows one embodiment of a LAA occlusion device and an LAA in which a distal anchor is implanted within the LA. [Figure 5] This figure shows one embodiment of a screw anchor that may be used with the various LAA occlusion devices described herein. [Figure 6] This is a longitudinal cross-sectional view showing one embodiment of an LAA occlusion device. [Figure 7] These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 8] These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 9] These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 10] These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 11] These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 12]These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 13] These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 14] These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 15] These are sequential schematic cross-sectional views showing one embodiment of an LAA and delivery system, illustrating a delivery and anchoring technique that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 16] This is a side cross-sectional view showing one embodiment of an LAA occlusion device having a foam body, a frame, and a proximal cover. [Figure 17] This is a side cross-sectional view showing one embodiment of an LAA occlusion device having a metal coil and foam. [Figure 18] This is a side view showing one embodiment of an LAA occlusion device having a single metal coil. [Figure 19] This is a side view showing one embodiment of an LAA occlusion device having an expanding distal tip. [Figure 20] This is a side cross-sectional view showing one embodiment of an LAA occlusion device having a proximal cap and a distal cap. [Figure 21] This is a schematic diagram illustrating one embodiment of an implant delivery system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 22]This is a schematic diagram illustrating one embodiment of delivery of an expanded foam system, which may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 23] This is a side view showing a barbed plug that can be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 24] This figure shows one embodiment of an LAA occlusion device having a removable suture attachment, which can be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 25A] This figure shows an embodiment of a distal anchor fixation system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 25B] This figure shows an embodiment of a distal anchor fixation system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 26] This figure shows an embodiment of a distal anchor fixation system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 27A] These are various figures illustrating one embodiment of an LAA occlusion device comprising an internal locking system, which may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 27B] These are various figures illustrating one embodiment of an LAA occlusion device comprising an internal locking system, which may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 27C]These are various figures illustrating one embodiment of an LAA occlusion device comprising an internal locking system, which may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 27D] These are various figures illustrating one embodiment of an LAA occlusion device comprising an internal locking system, which may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 27E] These are various figures illustrating one embodiment of an LAA occlusion device comprising an internal locking system, which may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 27F] These are various figures illustrating one embodiment of an LAA occlusion device comprising an internal locking system, which may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 27G] These are various figures illustrating one embodiment of an LAA occlusion device comprising an internal locking system, which may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 28A] These are various figures showing one embodiment of an internal locking system that can be used with the devices shown in Figures 27A to 27G. [Figure 28B] These are various figures showing one embodiment of an internal locking system that can be used with the devices shown in Figures 27A to 27G. [Figure 28C] These are various figures showing one embodiment of an internal locking system that can be used with the devices shown in Figures 27A to 27G. [Figure 28D] These are various figures showing one embodiment of an internal locking system that can be used with the devices shown in Figures 27A to 27G. [Figure 29A] These are sequential side views showing the release mechanism that can be used with the devices shown in Figures 27A to 27G. [Figure 29B]These are sequential side views showing the release mechanism that can be used with the devices shown in Figures 27A to 27G. [Figure 30] This is a side view showing one embodiment of an LAA occlusion device having a flexible anchor that can be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 31] This is a side view showing one embodiment of an LAA occlusion device having a flexible anchor and reinforcing tubular member configuration that can be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 32] This is a side view showing one embodiment of an LAA occlusion device having a flexible anchor and reinforcing tubular member configuration that can be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 33] This is a side view showing one embodiment of an LAA occlusion device having a discontinuous attachment portion of the outer skin to an inner foam, which can be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 34] This is a side view showing the device of Figure 34, which has an outer rim. [Figure 35] This is a side view showing one embodiment of an LAA occlusion device having an anchor with an extended V-shaped tip, which can be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 36] This is a side view showing one embodiment of an LAA occlusion device having an unfolded anchor with a V-shaped tip, which can be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 37A]These are side views illustrating various embodiments of anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 37B] These are side views illustrating various embodiments of anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 37C] These are side views illustrating various embodiments of anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 38] This is a side view showing one embodiment of an LAA occlusion device implanted inside the LAA. [Figure 39A] This is a perspective view showing one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 39B] This is a perspective view showing one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 40A] This is a perspective view showing one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 40B] This is a perspective view showing one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 41A] This is a perspective view showing one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 41B]This is a perspective view showing one embodiment of a deployable anchor that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 42A] These are various figures illustrating embodiments of external deployable anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 42B] These are various figures illustrating embodiments of external deployable anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 42C] These are various figures illustrating embodiments of external deployable anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 42D] These are various figures illustrating embodiments of external deployable anchors that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 43A] These are sequential side views showing one embodiment of a deployment constraint that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 43B] These are sequential side views showing one embodiment of a deployment constraint that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 43C] These are sequential side views showing one embodiment of a deployment constraint that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 44A] This is a side view showing one embodiment of an adjustable two-stage anchor system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 44B] This is a side view showing one embodiment of an adjustable two-stage anchor system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 44C] This is a side view showing one embodiment of an adjustable two-stage anchor system that may be used with various LAA occlusion devices described herein, including, but not limited to, the devices shown in Figures 85A to 90D. [Figure 45A] This is a cross-sectional view showing one embodiment of an LAA occlusion device, illustrated in an extended configuration, having a foam cup body, a proximal cover, and a deployable frame comprising a hub, a recapture strut, and a tubular body. [Figure 45B] Figure 45A is a distal end view showing the device. [Figure 45C] Figure 45A is a proximal perspective view showing the device. [Figure 46] Figure 45A is a distal end view showing the LAA occlusion device. [Figure 47A] Figure 45A is a perspective view showing an LAA occlusion device having an integrally molded internal frame. [Figure 47B] This is a side view showing the LAA occlusion device of Figure 45A, which has an integrally molded internal frame. [Figure 48] Figure 45A is a perspective view showing the device. [Figure 49] This is a side view showing the device in Figure 45A as it is attached to the delivery catheter shown in the extended configuration embodiment. [Figure 50] This is a side view showing the device in Figure 45A as it is attached to a delivery catheter, as shown in an embodiment of a partially folded configuration. [Figure 51] This is a schematic diagram showing various embodiments of a static barb that can be used with various occlusion devices described herein, such as the device in Figure 45A or Figure 85A. [Figure 52]This is a schematic diagram showing various embodiments of a static barb that can be used with various occlusion devices described herein, such as the device in Figure 45A or Figure 85A. [Figure 53] This is a schematic diagram showing various embodiments of a static barb that can be used with various occlusion devices described herein, such as the device in Figure 45A or Figure 85A. [Figure 54] This is a schematic diagram showing various embodiments of a static barb that can be used with various occlusion devices described herein, such as the device in Figure 45A or Figure 85A. [Figure 55] This is a schematic diagram showing various embodiments of a static barb that can be used with various occlusion devices described herein, such as the device in Figure 45A or Figure 85A. [Figure 56] This is a schematic diagram showing various embodiments of a restricted barb that can be used with various occlusion devices described herein, such as the device shown in Figure 45A or Figure 85A. [Figure 57] This is a schematic diagram showing various embodiments of a restricted barb that can be used with various occlusion devices described herein, such as the device shown in Figure 45A or Figure 85A. [Figure 58] This is a schematic diagram showing various embodiments of a restricted barb that can be used with various occlusion devices described herein, such as the device shown in Figure 45A or Figure 85A. [Figure 59] This is a schematic diagram showing various embodiments of a dynamic barb that can be used with various occlusion devices described herein, such as the device shown in Figure 45A or Figure 85A. [Figure 60] This is a schematic diagram showing various embodiments of a dynamic barb that can be used with various occlusion devices described herein, such as the device shown in Figure 45A or Figure 85A. [Figure 61] This is a schematic diagram showing various embodiments of a dynamic barb that can be used with various occlusion devices described herein, such as the device shown in Figure 45A or Figure 85A. [Figure 62] This is a schematic diagram showing various embodiments of a dynamic barb that can be used with various occlusion devices described herein, such as the device shown in Figure 45A or Figure 85A. [Figure 63] This is a schematic diagram showing various embodiments of a dynamic barb that can be used with various occlusion devices described herein, such as the device shown in Figure 45A or Figure 85A. [Figure 64] This is a schematic diagram showing various embodiments of a dynamic barb that can be used with various occlusion devices described herein, such as the device shown in Figure 45A or Figure 85A. [Figure 65] This is a schematic diagram showing various embodiments of a dynamic barb that can be used with various occlusion devices described herein, such as the device shown in Figure 45A or Figure 85A. [Figure 66A] This is a side view showing the implant with a proximal cover, as shown in Figure 45A. [Figure 66B] This is a side view showing the implant with a proximal cover, as shown in Figure 45A. [Figure 66C] This is a side view showing the implant with a proximal cover, as shown in Figure 45A. [Figure 67] These are a side view and an end view showing one embodiment of an implant having an internal hook anchor. [Figure 68A] This is a side view showing one embodiment of an implant having a thicker distal buffer. [Figure 68B] This is an end view showing one embodiment of an implant having a thicker distal buffer. [Figure 69] This is a side view showing one embodiment of an implant having a constrained anchor that is deployed in a secondary step. [Figure 70] This figure shows an embodiment of an implant having a distal anchor and a proximal deceleration bump. [Figure 71] This figure shows an embodiment of an implant having a distal anchor and a proximal deceleration bump. [Figure 72]This figure shows an embodiment of an implant having a distal anchor and a proximal deceleration bump. [Figure 73] This figure shows an embodiment of an implant having a distal loop. [Figure 74] This figure shows an embodiment of an implant having a distal loop. [Figure 75] This figure shows an embodiment of an implant having a distal loop. [Figure 76] This figure shows an embodiment of an implant having a perfusion element. [Figure 77] This figure shows an embodiment of an implant having a perfusion element. [Figure 78] This is a side view showing one embodiment of an LAA occlusion device having an ablation feature that can be incorporated with the various LAA occlusion devices described herein. [Figure 79] This is a side view showing one embodiment of an LAA occlusion device having a pressure-sensing feature that can be incorporated with various LAA occlusion devices described herein. [Figure 80] This is a side view showing one embodiment of an LAA occlusion device having a drug elution feature that can be incorporated with the various LAA occlusion devices described herein. [Figure 81] This is a side view showing one embodiment of an LAA occlusion device having a pacing / defibrillation feature that can be incorporated with the various LAA occlusion devices described herein. [Figure 82] This figure shows various systems and methods for electrically isolating LAAs that can be used with the various LAA occlusion devices described herein. [Figure 83] This figure shows various systems and methods for electrically isolating LAAs that can be used with the various LAA occlusion devices described herein. [Figure 84] This figure shows various systems and methods for electrically isolating LAAs that can be used with the various LAA occlusion devices described herein. [Figure 85A] This is a proximal view showing one embodiment of an LAA occlusion device having a compressible foam body, an expandable frame, and a proximal cover. [Figure 85B] This is a distal view showing one embodiment of an LAA occlusion device having a compressible foam body, an expandable frame, and a proximal cover. [Figure 85C] This is a side view showing one embodiment of an LAA occlusion device having a compressible foam body, an expandable frame, and a proximal cover. [Figure 85D] Figures 85A to 85C show distal views of an embodiment of the LAA occlusion device, which additionally includes an inner cover and a proximal marker. [Figure 86A] Figures 85A to 85C are side views showing the main body of the compressible foam. [Figure 86B] Figures 85A to 85C are cross-sectional views showing the main body of the compressible foam. [Figure 86C] Figures 85A to 85C show cross-sectional views of the foam body portion equipped with an expandable frame. [Figure 87A] This is a perspective top view showing another embodiment of the LAA occlusion device. [Figure 87B] A side view showing another embodiment of the LAA occlusion device. [Figure 87C] A cross-sectional view showing another embodiment of the LAA occlusion device. [Figure 87D] Figure 85D is a cross-sectional view of various embodiments of the LAA occlusion device. [Figure 87E] Figure 85D is a cross-sectional view of various embodiments of the LAA occlusion device. [Figure 88A] This is a top view showing one embodiment of a proximal cover, shown in a flat configuration, which may be used with the various LAA occlusion devices described herein. [Figure 88B] This is a top view of another embodiment of the proximal cover, illustrated in a flat configuration and assembled with the LAA occlusion device. [Figure 88C]This is a top view of another embodiment of the proximal cover, illustrated in a flat configuration and assembled with the LAA occlusion device. [Figure 88D] This is a side view of another embodiment of the proximal cover, illustrated as being assembled with the LAA occlusion device. [Figure 88E] A perspective view of another embodiment of the proximal cover, illustrated as being assembled with the LAA occlusion device. [Figure 89A] This is a side perspective view showing the frames of Figures 85B and 85C, which are shown in their unfolded configuration. [Figure 89B] This is a proximal perspective view showing the frames of Figures 85B and 86C, which are shown in their unfolded configuration. [Figure 90A] These are sequential proximal perspective views showing one embodiment of a frame, illustrating a cap and pin assembly with a frame that may be used with the LAA occlusion device shown in Figures 85A to 88E. [Figure 90B] These are sequential proximal perspective views showing one embodiment of a frame, illustrating a cap and pin assembly with a frame that may be used with the LAA occlusion device shown in Figures 85A to 88E. [Figure 90C] These are sequential proximal perspective views showing one embodiment of a frame, illustrating a cap and pin assembly with a frame that may be used with the LAA occlusion device shown in Figures 85A to 88E. [Figure 90D] Figures 90A to 90C are distal perspective views showing the caps. [Figure 91] Figures 85A to 88E are side views showing one embodiment of a loading system for loading the devices into a delivery catheter. [Figure 92A] This is a schematic side view showing a transcatheter delivery system for delivering the devices shown in Figures 85A to 88E via artery or vein. [Figure 92B] Figure 92A is a proximal perspective view of the delivery system, illustrating the relevant tether release mechanism and method. [Figure 92C]Figure 92A is a distal perspective view of the delivery system, illustrating the relevant tether release mechanism and method. [Figure 93A] This is a close perspective view showing another embodiment of a tether release system that may be used with the devices shown in Figures 85A to 88E. [Figure 93B] This is a distal perspective view showing another embodiment of a tether release system that may be used with the devices shown in Figures 85A to 88E. [Figure 94A] Figures 85A to 88E show various embodiments of the anchor / foam interface that can be used with the LAA occlusion device. [Figure 94B] Figures 85A to 88E show various embodiments of the anchor / foam interface that can be used with the LAA occlusion device. [Figure 94C] Figures 85A to 88E show various embodiments of the anchor / foam interface that can be used with the LAA occlusion device. [Figure 95A] This is a schematic diagram showing one embodiment of the inlet and the external shape of the LAA. [Figure 95B] Figures 95A and 85A to 88E are schematic diagrams of LAA occlusion devices that are implanted in the LAA and are shown in the inlet and LAA sections of Figure 85A to 88E, illustrating the device's shape conformability. [Figure 96A] Figures 85A to 88E are schematic diagrams of LAA occlusion devices illustrating the radial compression capacity of the devices. [Figure 96B] Figures 85A to 88E are schematic diagrams of LAA occlusion devices illustrating the axial compression capacity of the devices. [Figure 97] This is a top view showing one embodiment of a laser-cut tube frame, shown in a flat configuration, which can be used as a frame for the LAA occlusion device in Figures 85A to 88E. [Modes for carrying out the invention]

[0059] The drawings above illustrate the currently disclosed embodiments, but other embodiments are contemplated, as noted in the description. This disclosure presents exemplary embodiments to express, not to limit. Numerous other modifications and embodiments that fall within the scope and spirit of the principles of the currently disclosed embodiments can be devised by those skilled in the art.

[0060] The following detailed description is directed to several specific embodiments of this invention. Throughout this description, for clarity, drawings are referenced where similar parts or steps may be designated by similar numbers. Wherever the terms “one embodiment,” “an embodiment,” or “in several embodiments” are used herein, this means that a particular feature, structure, or characteristic described in relation to that embodiment is included in at least one embodiment of the invention. The phrases “one embodiment,” “an embodiment,” or “in several embodiments” appearing in various places throughout this specification do not necessarily all refer to the same embodiment, nor are different or alternative embodiments necessarily mutually exclusive with other embodiments. Furthermore, various features shown in some embodiments but not in other embodiments are described. Similarly, various requirements that may be requirements for some embodiments but not for other embodiments are described. Next, embodiments of the invention are referenced in detail, with examples shown in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or similar parts.

[0061] Devices and related methods relating to use in occluding, i.e., eliminating LAA (LAA) are described. Various figures illustrate various embodiments of LAA occluding devices, systems and methods for delivering LAA occluding devices, and / or methods for occluding LAA using the devices. Various systems, devices, and methods described herein may have the same or similar features and / or functions as other LAA occluding systems, devices, and methods, such as those described in, for example, U.S. Application No. 14 / 203,187, filed March 10, 2014, titled "DEVICES AND METHODS FOR EXCLUDING THE LAA," and / or U.S. Provisional Application No. 62 / 240,124, filed October 12, 2015, titled "DEVICES AND METHODS FOR EXCLUDING THE LAA," and each of their entire disclosures is incorporated herein by reference and forms part herein for all purposes.

[0062] Some embodiments of the LAA occlusion device 3000 comprise a foam body 3002, a deployable compliant frame 3040, and a proximal cover 3100, as illustrated and described primarily with respect to Figures 85A to 90D, for example. Other features and functions of the device 3000 that may be available are illustrated and described with respect to Figures 1 to 84 and Figures 91 to 93B.

[0063] Figure 1 shows a heart 100 with a left atrial appendage (LAA) 102, which is a cavity arising from the left atrium (LA) 104. The LAA 102 is extremely diverse in shape for all dimensions. When the heart beats abnormally, a condition called atrial fibrillation, blood stagnates in the LAA, promoting clot formation. When blood clots in the LAA, the clot travels from LAA 102 to LA 104, then to the left ventricle 106, and finally out of the heart 100 into the aorta. The blood vessels that carry blood to the brain branch off from the aorta. If the clot travels to the brain through these vessels, it can become blocked, obstructing small blood vessels in the brain and subsequently causing an ischemic stroke. Strokes have associated severe morbidity. The opening from LAA 102 to LA 104 is called the ostium 110. The ostium 110 is oval-shaped, extremely diverse, and depends on the load conditions, i.e., left atrial pressure. The purpose of the LAA occlusion device described herein is to occlude the inlet 110, thereby sealing LA104 from LAA102.

[0064] One embodiment of the LAA occlusion device is shown in Figure 2. The occlusion device or plug 204 is implanted in the LAA 200 at the opening to the LA 202. Plugs as described herein, such as plug 204, may have the same or similar characteristics as other implantable "devices" or "implants" described herein, such as device 10, device 1020, device 3000, and foam body 3002, and vice versa. Plug 204 comprises an expandable medium, such as an open-cell foam, which allows for folding and expansion of plug 204 and enhances tissue growth and penetration into the foam body. The foam plug 204 is at least partially encapsulated within a strong thin layer 206, such as ePTFE (stretched polytetrafluoroethylene), polyolefin, or polyester. Layer 206 may be referred to herein as the "skin" or "cover," etc. Alternatively, bioabsorbable materials such as PLA, PGA, PCL, PHA, or collagen may be used. This thin sealing layer 206 may be oriented to be elastic in at least one direction, such as radially, or may be modified in other ways. Layer 206 may have the same or similar characteristics and / or functions as the cover 3100, and vice versa.

[0065] Plug 204 can be made from polyurethane, polyolefin, PVA, collagen foam, or a blend thereof. One preferred material is polycarbonate polyurethane urea foam with a pore size of 100 μm to 250 μm or ~250 μm to 500 μm and a void ratio of 90 to 95%. The foam can be non-degradable or degradable materials such as PLA, PGA, PCL, PHA, and / or collagen can be used. If degradable, tissue from LAA will grow and invade the foam plug, replacing the foam over time. Plug 204 may be cylindrical in shape with unrestricted expansion, but may also be conical, for example, with its distal end smaller than its proximal end, or vice versa. It may also be possible to have an oval cross-section to better fit the opening of the LAA.

[0066] The foam plug 204 is radially oversized with unrestricted expansion to fit snugly into the LAA, and may have a diameter of 5 to 50 mm depending on the diameter of the target LAA. In a free and unrestricted state, the axial length "L" of the plug is smaller 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 to press against the LAA wall with sufficient force to hold the plug 204 in place, but without excessively stretching the LAA wall. The foam and / or skin also conform to the irregular surface of the LAA when expanded, providing a complementary surface structure to the natural LAA wall to reinforce fixation and facilitate sealing. Thus, the expandable foam plant described herein conforms to the natural constituent shape of the LAA. In one embodiment, the foam structure may be processed so that the diameter of the foam is increased by strongly compressing the opposing ends of the foam in the axial direction.

[0067] The ePTFE or foam material may be filled with or impregnated with a radiopaque filler such as barium sulfate, bismuth subcarbonate, or tungsten, which may have one or more radiopaque markers such as radiopaque thread 210, or which may allow an operator to verify under X-ray whether the plug is properly positioned within the anatomical structure. An X-ray image is shown in Figure 3, where the foam plug 300 is not visible, but the thread 302 and crimp 304 (described below) are clearly visible. The thread 302 or ribbon may be made from a radiopaque metal wire or tube such as platinum, platinum-iridium, or tungsten or polymer, containing a radiopaque filler such as barium, bismuth, tantalum, tungsten, titanium, or platinum.

[0068] The outer ePTFE layer may be formed from a tube having a diameter and wall thickness ranging from approximately 0.0001" to approximately 0.001" that is roughly the same as the diameter of the foam plug, and serves to allow the plug 204 to be folded and pulled without rupturing the foam material. The ePTFE material also serves as the blood contact surface facing LA202, having pores or nodules on which blood components coagulate and tissue intima or neointima covering grows on the surface and is firmly fixed to the material. The pore size is in the range of approximately 4μ to approximately 110μ, but ideally 5–35μ is useful for neointima formation and adhesion.

[0069] The outer covering 206 may be made from a non-ePTFE material such as a woven fabric, mesh, or perforated film made from FEP, polypropylene, polyethylene, polyester, or nylon. The covering 206 should have low compliance (inelasticity) at least in the longitudinal direction, sufficient strength to allow the plug to be removed, a low coefficient of friction, and coagulation resistance. The outer covering 206 acts as a matrix that allows the plug to be removed, as most foams do not have sufficient strength to resist tearing when pulled. The plug 204 may also be coated with or contain a material such as PTFE. Such a material may enhance the ultrasound echobrightness profile, coagulation resistance, and / or lubricity of the plug 204. The plug 204 may also be coated with or contain a material to facilitate echocardiographic visualization and promote cell growth, invasion, and covering.

[0070] The outer covering 206 has pores therein that allow LAA tissue to come into contact with the foam plug 204, promoting tissue growth and intrusion into the foam plug pores and / or allowing blood flow to pass through. These pores may be 1 to 5 mm in diameter or oval, with their long axis aligned with the axis of the foam plug, their length being 80% of the length of the foam plug, and their width being 1 to 5 mm. The pores may be as large as possible so that the outer covering maintains sufficient strength to transmit the tension required for removal. The pores may be preferably positioned along the device. In one embodiment, the pores are positioned distally enough to enhance tissue growth intrusion from the LAA wall.

[0071] In one implementation configuration, the implant comprises a proximal and / or distal end cap of ePTFE, joined together by two, three, or four or more axially extending elongated segments of ePTFE. The axially extending elongated segments are spaced apart on the circumferential surface and form at least two, three, or four or more transverse windows through which the open-cell foam body passes when it comes into direct contact with the tissue wall of the LAA. This outer covering can also be a mesh or netting. As shown in Figure 20, the covering 2004 is present only on the proximal and distal surfaces of the plug 2000. These can be glued to the foam plug and then crimped onto the central tube 2002.

[0072] The implantable plugs 204 or devices 10, 1020, 3000 (as described below) can be fixed in place and securely secured within the LAA by tissue growth penetration and / or by additional fixation features. In some embodiments, the plugs 204 or devices 10, 1020, 3000 can be fixed by tissue growth penetration alone.

[0073] In some embodiments, other fixation means may also be implemented. One means of adhering the foam plug in place within the LAA is to use an adhesive such as a low-viscosity cyanoacrylate (1-200 cps). The adhesive is injected in place along the side wall near the distal end of the foam plug 208. The pores in the ePTFE coating allow the adhesive to interact between the foam plug 204 and the LAA wall 200. The injection of the adhesive can be achieved by several means, one of which is to inject it into the central lumen 212 through a catheter. The passage 214 serves to guide the adhesive to the correct location. The distal end of the foam plug may be confined at that point to prevent the adhesive from coming out of the distal crimp 216. Alternatively, Figure 21 shows a tube 2104 that is pre-positioned through a guide catheter 2102 through the central lumen of the plug 2106, and then curves backward within the LAA to reach the distal end of the plug 2100. These tubes 2104 extend to the proximal end of the guide catheter 2102, where a fitting is attached to allow for the injection of adhesive, which then exits the smaller tubes 2104 at the desired position in the plug. These tubes are made from polyethylene, polypropylene, or FEP to prevent the adhesive from adhering to the tubes. After the adhesive is injected through the guide catheter from within the patient's body, the tubes 2104 are withdrawn.

[0074] Other one-component adhesives containing water-soluble crosslinking adhesives, polyurethane, PEG, PGA, PLA, polycaprolactone, or lysine-derived urethane may be used. In addition, these adhesives may be made of two components, with one component adhering to the foam and the second component being injected into the body. These two-component adhesives may also be injected simultaneously and mixed in the body to prevent fouling of the injection tube.

[0075] An alternative means of fixation for the plug 400 or device 3000 is one or more distal anchors, as shown in Figure 4. The wire 404 is passed through the central lumen 410 and fed into the LAA, where it is attached to the distal wall of the LAA. In this case, the screw wire 408 is screwed into the wall of the LAA 406. A more detailed view of this is shown in Figure 5, where the screw 502 is embedded in the LAA wall 504 but does not pass through the entire epicardial surface 506.

[0076] Additional means of fixation include the step of grasping the distal wall and the basket, Maleco, distal foam plug, and Nitinol wire bird nest using multiple hooks or barbs or grippers to open within the LAA and push outward against the wall or engage with projections of the LAA. It may be desirable as a secondary step to place the plug and then engage it with the anchor. One such embodiment may include multiple Nitinol wires with balls or catches welded proximal to the tip of the anchor. These can be collected by a delivery catheter and then released when the ideal plug position is confirmed.

[0077] A cross-section of one embodiment is shown in Figure 6 with the foam plug 600 and the LA surface 602 and LAA surface 610. The ePTFE material 604 encapsulates the foam plug 600, and its open end is connected to an attachment structure such as a wire, suture, or tubular crimp 606 on the inner tube 608. The inner tube 608 may be made of implant-grade stainless steel such as 304 or 316 grade or a cobalt-chromium alloy such as MP35n, and the crimp 606 may be made of annealed 304 or 316 stainless steel or a cobalt-chromium alloy such as MP35n. This crimp also serves as an element that can be grasped if the device needs to be removed.

[0078] Referring to Figure 6, the tubular ePTFE layer 604 extends along the inner layer 612, which is aligned in a line with the guidewire lumen, and flips over around the left atrial surface 602 to form the outer layer 614. In some embodiments, the layer 604 may cover the entire and / or portion of the proximal surface of the sidewall, such as a cover 3100 or a cover on the proximal surface 1064', as further described herein. As further shown in Figure 6, the first end 616 of the inner layer 612 is concentrically positioned within the second end 618 of the outer layer 614. The first end 616 and the second end 618 are clamped between the inner tube 608 and the outer clamp 606. In this way, the implant can be encapsulated in such a manner that it exposes the seamless left atrial surface 602 and maintains the integrity of the guidewire lumen and the inner tube 608.

[0079] One embodiment of the technique for implanting an LAA occlusion device is shown in Figures 7 to 15. To close the LAA, the LA is first accessed from the venous system. One approach is to puncture the atrial septum using a Brockenbrough-style needle and access the LA from the right atrium (RA). The basic needle puncture technique is typically performed after obtaining venous access via the right femoral vein. A Mullins sheath and dilator are then tracked on a 0.025" or 0.032" guidewire already placed in the superior vena cava (SVC). Fluoroscopy and echocardiography techniques, such as transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE), are typically utilized. If echocardiography is not available, it is common practice to place a pigtail catheter in the aortic origin to locate the aortic valve, a step that is not necessary when using echocardiography.

[0080] After the Mullins sheath and dilator are inserted into the SVC, the guidewire is removed and the transseptal needle is placed through the dilator. The needle houses a stylet to prevent polymer material from being stripped from the dilator lumen as it traverses to the tip. After the needle approaches the tip of the dilator, the stylet is removed and the needle is connected to a manifold and flushed. The Mullins sheath / dilator set and needle (positioned within the tip of the dilator) are retracted into the SVC toward the RA as a single unit. The system is pulled down the wall of the SVC and positioned within the fossa ovalis to the preferred puncture position.

[0081] After the correct position within the fossa ovalis is observed, the needle is advanced over the fossa ovalis and enters the LA. Successful transseptal puncture can be confirmed by ultrasound, pressure measurement, O2 saturation, and contrast agent injection. After confirmation that the needle position is within the LA, the sheath and dilator may be advanced over it and enter the LA. In some cases, the user first passes a guidewire through the needle into the LA and then into the superior pulmonary vein (typically left) before crossing it. Alternative options include the use of a high-frequency transseptal needle, which is useful for crossing very thick or hypertrophied septa, or the use of a safety wire that is placed through the needle and used for initial puncture.

[0082] Referring to Figures 8 through 15, the guide catheter 802 is placed in the right atrium of the heart via the femoral vein and enters the LA across the intraatrial septum, as described above and positioned near the LAA inlet 804. A guidewire 902, typically 0.035" in diameter, is threaded through the guide catheter 900 and placed in the LAA 904. This guidewire 1002 may be attached to the distal end of a balloon 1006 that is inflated in the LAA and acts as a buffer to prevent the guide catheter 1100 from perforating the wall of the LAA. The guide catheter 1100 is then advanced along the guidewire 1108 and delivered into the LAA 1104. A radiopaque marker 1102 is used to guide catheter placement under fluoroscopy.

[0083] Next, the foam plug 1204 is pushed into the guide catheter 1200 with the pusher 1202 and slowly exits the guide catheter 1300 in Figure 13 until it is fully deployed as shown in Figure 14. The position of the foam plug 1404 can then be adjusted in place by using the distal balloon 1408 and the guide catheter 1400, by sliding the foam plug proximal by pulling the balloon 1408 through the shaft 1412, or by sliding it distal by pushing the guide catheter 1400 distally. The guidewire may also contain a pressure sensor so that the sealing of the LAA is monitored and sufficient sealing is confirmed. After satisfactory placement, adhesive 1514 may be injected and / or a mechanical anchor may be deployed to fix the plug 1404 to the wall. The guidewire balloon 1508 is deflated, and then the guidewire is removed. In one alternative embodiment, a two-component adhesive system may be used, where one component of the two-component system is bonded to the outer surface of the skin covering the foam plug. The second component may be injected at the interface between the foam plug and the LAA wall, such that adhesion occurs only at the interface, minimizing the risk of adhesive embolism. In some embodiments, the adhesive and balloon may or may not be used, for example, with device 3000, which is further described herein.

[0084] An alternative step to the step of pushing the plug through the entire length of the guide catheter is to allow the plug 1204 to be initially positioned at the distal end of the guide catheter 1200, as shown in Figure 12. The guidewire 1210 passes through the center of the plug 1204, and in this mode, the pusher 1202 only needs to push the plug a short distance to deploy it into the LAA.

[0085] For alternative anchors, these can be deployed and the shafts can be cut and removed. The cutting mechanism may be of several types, such as screw-in, electrolytic desorption, or others known in the art. In some embodiments, suture attachments may be implemented as described, for example, with respect to Figure 24.

[0086] As shown in Figure 16, in some embodiments, a metal frame such as a foam body 1600 and a stent 1602 may be included. The foam body 1600 and the stent 1602 may have the same or similar features and / or functions as the foam body 3002 and the tubular body 3080 (see Figures 85A to 90D), and vice versa. The foam 1600 is designed to allow tissue growth intrusion and to provide the buffer of the metal stent 1602 on the tissue of the LAA. The proximal surface 1604' of the plug is covered with ePTFE, polyester, or another antithrombotic tissue scaffolding material to facilitate sealing with the desired pore size and promote overgrowth.

[0087] Stent 1602 may be made from nitinol to allow it to be packed into a 10, 12, 14, 16, 18, or 20F delivery catheter and expand to its desired diameter. Stent 1602 may be braided, laser-cut, or wire-formed. Depending on the desired outcome, any of the various stent wall patterns may be available. Stent 1602 may be a balloon-expandable stent or a self-expanding stent. In the embodiment shown, the self-expanding stent 1602 comprises multiple proximal vertices 1608 and distal vertices 1610 connected by multiple zigzag struts 1612. A hole 1606 allows a guidewire to pass through for delivery. This design may be advantageous in that the expansion force applied to the LAA by the plug can be controlled independently of the foam properties. It may also be easier to pack this concept into a smaller geometric shape. For example, the plug can be packed into a smaller geometric shape by reducing the amount of foam that must be compressed into the delivery catheter while maintaining sufficient expansion force.

[0088] Alternatively, the foam plug can be made from two foams. One denser core provides force, for example, radial force, while the outer, softer foam engages with the unevenness of the tissue. The softer foam may also be placed on the proximal and / or distal ends to facilitate removal.

[0089] Another means of adding rigidity to the foam plug is shown in Figure 17, where a cavity 1704 is formed within the foam plug 1700, and a coil of wire 1702 can be advanced at its proximal end 1706 and fed from the guide catheter into the cavity 1704. Once the wire enters the cavity, it expands to a predetermined size, applying a radially outward force to the foam. The type and amount of wire may be determined in vivo using an X-ray guide, thereby examining the radial expansion of the foam into the LAA.

[0090] Instead of a wire as shown in Figure 17, a balloon may be introduced into the foam and inflated to generate radial force while the outer foam engages with the tissue irregularities and tissue growth intrusions. Following inflation, the balloon can be detached from the deployment catheter, and the deployment catheter can be withdrawn. The balloon preferably includes a valve to prevent leakage of the inflation medium. The inflation medium may be any of a variety of media that can be converted between a first flowable state and a second hardened state by in-situ crosslinking or polymerization, etc.

[0091] Another LAA plug is illustrated in Figure 18 as a spring-like implant wire 1800 covered with foam 1802 to promote growth penetration. The proximal surface of the implant is covered with a sheet of ePTFE or other tissue scaffolding material. This implant can be stretched for delivery and released in place.

[0092] Instead of using foam, it is also possible to place a non-perforated, low-porosity outer bag within the LAA and then fill it with a material to induce radial expansion. This material may be a hydrogel, cellulose, or polyvinyl acetate.

[0093] Rather than requiring the use of a separate expansion device to cross the septum, the distal crimp element 1902 may be formed with a taper, so as to extend from the distal end of the catheter 1200 and act as an expansion tip as the catheter is advanced to expand the opening in the septum. See Figure 19.

[0094] The alternative plug design uses a foam, such as a dehydrated cellulose sponge material, which can be packed into a guide catheter. The foam material 2202 can be packed into the guide catheter as shown in Figure 22. The foam plug 2202 is then advanced from the distal end of the guide catheter 2204, which has a plunger 2206, and delivered into the LAA. The plug exits the guide catheter and opens, becoming a disc shape 2210. As the foam absorbs fluid from the blood, its length expands to form a cylinder 2220 that fills the LAA. The expansion ratio to compressed cellulose material is high at 17:1, and it can expand to its compressed length.

[0095] It may be advantageous to further engage the plug 2304 within the LAA using the small barb 2302 in Figure 23. The barb may be unidirectional or bidirectional to resist movement in either the proximal or distal direction. These barbs are embedded within the foam plug and may be 0.1 to 1 mm in height. It may be desirable to place the plug as a secondary step and then engage the barbs. One such embodiment may comprise a number of nitinol barb wires with balls or catches welded proximal to the barb tips. These can be collected by a delivery catheter in a sleeve or released when the sutures are then confirmed to be in the ideal plug position.

[0096] One means of removing a malfunctioning device is to attach a removal suture 2400 to the implant in a releasable manner, such as a proximal cap 2402 that extends further proximally along the entire length of the guide catheter 2404 in Figure 24. If the device is to be removed, pulling both ends of the suture 2400 pulls the outer covering into the guide catheter 2404, and the guide catheter can then be removed from the patient. If the device is properly positioned, the suture 2400 can be cut and removed, leaving the plug in place.

[0097] The deployment of the occlusion device has been described primarily in the context of transvascular access. However, the implant may alternatively be deployed via direct surgical access or various minimally invasive access routes (e.g., the jugular vein). For example, the area above the xiphoid and adjacent costal cartilages may be prepared using standard techniques and covered with cloth. A local anesthetic is administered, and a skin incision may be made, typically over a length of about 2 cm. The percutaneous penetration passes beneath the costal cartilage, and the sheath may be introduced into the pericardial cavity. The pericardial cavity may be perfused with saline, preferably a saline-lidocaine solution, to provide additional anesthesia and reduce the risk of stimulating the heart. The occlusion device may then be introduced through the sheath and through the access route formed through the wall of the LAA. Closure of the wall and access route may then be achieved using techniques understood in the art.

[0098] Depending on the desired clinical outcome, any of the LAA occlusion devices described herein may be supplied with drugs or other bioactive agents, which may be injected via a deployment catheter, impregnated within a continuous-cell foam, or coated onto the implant. The bioactive agents may be eluted from the implant into adjacent tissue over a delivery period appropriate to the specific agent as understood in the art, or released in any other way. Useful bioactive agents may include agents that modulate thrombosis, agents that promote cell growth entry, penetration growth, and endothelialization, and potentially agents that provide resistance to infection. For example, agents that may promote endothelial, smooth muscle, fibroblast, and / or other cell growth within the implant include collagen (type I or II), heparin, combinations of collagen and heparin, extracellular matrix (ECM), fibronectin, laminin, vitronectin, peptides or other biomolecules that act as chemoattractants, molecules MCP-1, VEGF, FGF-2 and TGF-beta, recombinant human growth factors, and / or plasma treatment with various gases.

[0099] Antithrombotic drugs can typically be divided into anticoagulants and antiplatelet agents. Anticoagulants include inhibitors of factors in the coagulation cascade, including heparin, heparin fractions and fractions, as well as thrombin inhibitors, including hirudin, hirudin derivatives, dabigatran, argatroban and vivalurdin, and factor X inhibitors such as low molecular weight heparin, rivaroxaban and apixaban.

[0100] Antiplatelet agents include GP 2b / 3a inhibitors such as epifibitide and absiximab, thienopyridines such as ticlovidin, clopidogrel, and prasugrel, and ADP receptor agonists (P2 / Y12) including ticagrelor, as well as aspirin. Other agents include urokinases and streptokinases, their homologs, analogs, fragments, derivatives and pharmaceutical salts, and prostaglandin inhibitors, as well as solvents.

[0101] Antibiotic preparations may include, but are not limited to, penicillin, cephalosporins, vancomycin, aminoglycosides, quinolones, polymyxins, erythromycin, tetracyclines, chloramphenicol, clindamycin, lincomycin, sulfonamides, their homologs, analogs, derivatives, pharmaceutical salts, and combinations thereof.

[0102] The biological agents outlined above may also be added to the implant 204 and injected through a delivery catheter into the space between the proximal cap 206 and the foam plug 204. This acts as a reservoir to minimize thrombus formation during initial implantation and may reduce the need for systemic anticoagulation after device implantation.

[0103] An electronic pressure sensor may be implanted within the proximal end of a foam plug, which can be used to transmit LA pressure to a receiver located remotely outside the body for monitoring LA pressure, useful for monitoring cardiac function. In addition, a cardiac pacemaker or defibrillator may be implanted within the foam plug and electrically attached to a distal anchor. A drug delivery reservoir may be implanted connected to the LA for controlled delivery of biological agents, as outlined above.

[0104] Another means of fixation is shown in Figure 25A with the foam plug 2500 placed within the LAA. The distal screw lead 2502 is advanced and screwed into the LAA wall. Guide 2506 is pulled proximal as shown in Figure 25B. As this guide 2506 is pulled back, the screw lead wire, made of nitinol, is gathered in one place within the "bird's nest" 2508 or forms a coil inside the foam plug 2500. The screw lead wire 2502 is pushed distally from the guide catheter 2504 by the pusher 2510, continuing to gather in one place within the foam. The catheter system 2504, 2506, and 2510 are then removed.

[0105] Another means of securing the distal anchor element to the foam is shown in Figure 26. Two barbed leads 2604 are attached to anchor 2602 so that the barbs 2604 dig into the foam plug when they are advanced to the appropriate position within the foam plug 2600.

[0106] Figures 27A to 27G show various diagrams of one embodiment of device 10 for occluding LAA (LAA). Device 10 may include the same or similar features as other devices for occluding LAA described herein, such as plug 204, device 1020, and device 3000, and vice versa. Device 10 comprises an internal locking system 101 for securing device 10 within the LAA. In some embodiments, device 10 may not include the internal locking system 101 or other fixing features, and for example, device 10 may be secured by tissue growth intrusion alone. The occluding device 10 comprises an expandable medium, such as an open-cell foam body 15, for example, a plug. The body 15 allows for folding and expanding of device 10 and also enhances tissue growth intrusion into the foam.

[0107] The main body 15 of the device 10 shown in Figures 27A to 27F takes on its expanded configuration shape. The main body 15 takes on the compressed configuration shape shown in Figure 27G. The device 10 comprises a foamed main body 15, a skin 20, a central lumen 25, a finial 30, and a dynamic internal locking system 101 that secures the device 10 within the LAA. Figure 27A is a side cross-sectional view of the device 10 showing the main body 15 and internal locking system 101 in their expanded configuration shapes. Figure 27B is an end face of the proximal end of the device 10 showing the main body 15 and internal locking system 101 in their expanded configuration shapes. Figure 27C is a side view of the device 10 showing the main body 15 and internal locking system 101 in their expanded configuration shapes. Figure 27D is a side cross-sectional view of the device 10 showing the main body 15 in its expanded configuration shape and the internal locking system 101 in its constrained configuration shape. Figure 27E is an end face of the distal end of the device 10 showing the main body 15 and internal locking system 101 in their unfolded configuration. Figure 27F is a cross-sectional view of the device 10 cut along the straight line 1F-1F as shown in Figure 27C. Figure 27G shows the main body 15 and internal locking system 101 loaded and compressed within the delivery sheath 1. The device 10 can be delivered via a delivery catheter in the configuration shown in Figure 27G. The main body 15 of the device 10 can then be expanded with the internal locking system 101 still constrained, as shown in Figure 27D. The internal locking system 101 can then be expanded into its unfolded configuration, as shown in Figure 27A.

[0108] Figure 27G shows the main body 15 and internal locking system 101 loaded and compressed within one embodiment of the delivery sheath 1. In some embodiments, the delivery sheath 1 may be an external delivery catheter. The main body 15 and internal locking system 101 are loaded and compressed within the delivery catheter 5. The device 10 may be entirely or partially inside the delivery catheter 5. In some embodiments, the delivery catheter 5 may be an internal delivery catheter. The device 10 can be loaded and compressed within the delivery catheter 5 inside the delivery sheath 1. The main body 15 of the device 10 may be expanded by removing the delivery sheath 1, for example, by retracting the delivery sheath 1 proximal. The main body 15 expands while the internal locking system 101 remains constrained, for example, by the delivery catheter 5. Figure 27D shows the main body 15 in an expanded state, with the internal locking system 101 in a configuration that is constrained within the delivery catheter 5. This shows the first step in the deployment process, in particular the implantation of the device 10 within the LAA, where the body 15 is expanded, the internal locking system 101 is constrained, and therefore the anchors are not deployed. The second step in the deployment process is shown in Figure 27A, where the internal locking system 101 has already been deployed through the body 15. In some embodiments, this second step is reversed to retract the anchors, for example, if the implantation of the device 10 within the LAA is not acceptable. The internal locking system 101, for example, a fixed component or system as further described herein, is deployed from within the body 15, thereby deploying at least one, and in some implementations at least two, four, or six or more, anchors of the internal locking system 101 outside the body 15 to engage with adjacent anatomical structures of the LAA.

[0109] The internal locking system 101 can be controlled to deploy after a certain period of time has elapsed since the main body 15 expanded. For example, the positioning and orientation of the device 10 can be verified by various imaging techniques, such as fluorescence fluoroscopy by injecting a contrast medium through the central lumen, before the internal locking system 101 is deployed and the anchor securely holds the device 10 within the LAA. In some embodiments, even after the internal locking system 101 and its anchor have been deployed, the anchor can be repositioned within the LAA and / or retracted into its position within the main body 15 for the removal of the device 10 from the LAA.

[0110] Figure 27F shows one embodiment of a device having a slot 17. The slot 17 is formed within the foam body 15. For example, the material of the foam body 15 may be removed to facilitate the deployment of the internal locking system 101, such as the outward expansion of anchors that engage with the tissue.

[0111] Device 10 may have any or all of the same or similar features and / or functions as other plugs described herein, such as plug 204. For example, device 10 is at least partially encapsulated within a skin 20. In some embodiments, the skin 20 may cover the proximal end of the main body 15. The skin 20 may be a thin, strong outer layer. The skin 20 may be a thin encapsulation layer. The skin 20 may be fabricated from ePTFE (stretched polytetrafluoroethylene), polyolefin, polyester, other suitable materials, or combinations thereof. In some embodiments, the skin 20 may be fabricated from bioabsorbable materials, such as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), PHA, collagen, other suitable bioabsorbable materials, or combinations thereof. The skin 20 may be oriented to be elastic in at least one direction, such as radially, or otherwise modified.

[0112] The main body 15 may be made from polyurethane, polyolefin, PVA, collagen foam, or a blend thereof. One preferred material is polycarbonate polyurethane urea foam with a pore size of 100-250 μm and a void ratio of 90-95%. The main body 15 may be non-degradable or may use degradable materials such as PLA, PGA, PCL, PHA, and / or collagen. If degradable, tissue from the LAA will grow and invade the foam main body 15, replacing the foam over time. The main body 15 may be cylindrical in shape with unrestricted expansion, but its distal end may be smaller than its proximal end, or it may be inverted cone-shaped. The main body 15 may also have an oval cross-section to better fit the opening of the LAA.

[0113] Device 10 is radially oversized with unconstrained expansion to fit snugly within the LAA. Device 10 is 5 to 50 millimeters (mm) in its unconstrained configuration shape, for example, depending on the diameter of the target LAA, and generally the diameter can be at least about 10 mm or 15 mm. The length "L" of device 10 can be small, similar to, or large than its diameter "D", such that the L / D ratio is less than 1.0, approximately or about 1.0, greater than about 1.5, or greater than about 2.0. The L / D ratio may be greater than 1.0 to maximize its stability. However, in some embodiments, the L / D ratio may be less than 1.0, for example, about 0.2 to about 0.9, or about 0.3 to about 0.8, or about 0.4 to about 0.6. The material compliance of device 10 is designed to push against the wall of the LAA with sufficient force to keep the plug in place, but without excessively stretching the LAA wall. The foam body 15 and / or skin 20 also conform to the irregular surface of the LAA when expanded, providing a complementary surface structure to the natural LAA wall, further reinforcing fixation and facilitating sealing. Thus, the expandable foam body 15 conforms to the natural irregular structural shape of the LAA. In some embodiments, the structure of the foam body 15 can be processed to increase the diameter of the foam by compressing the opposing ends of the body 15 axially, such as by retracting a pull wire or an inner concentric tube proximal to it.

[0114] The main body 15 and / or skin 20, for example, made of foam material and / or ePTFE, may be filled with or impregnated with one or more radiopaque markers, such as radiopaque threads 210 (see Figure 2), or with radiopaque fillers such as barium sulfate, bismuth subcarbonate, or tungsten, which allow the operator to visualize under X-rays that the device 10 is properly positioned within the anatomical structure. Visualization of the device 10 may be used to verify the position of the device 10 before deploying the anchor to firmly secure the device 10 in place.

[0115] The skin 20, such as an outer ePTFE layer, may have a thickness ranging from about 0.0001 inches to about 0.0030 inches. In some embodiments, the thickness of the skin 20 may be in the range of about 0.0003 inches to about 0.0020 inches. In some embodiments, the thickness of the skin 20 may be in the range of about 0.0005 inches to about 0.0015 inches. The thickness of the skin 20 may be uniform, for example, the same or approximately the same regardless of where the thickness is measured. In some embodiments, the thickness of the skin 20 may be non-uniform, for example, the thickness may vary in different parts of the skin 20.

[0116] The skin 20, such as an outer ePTFE layer, can also act as a blood contact surface on the proximal end of the device 10 facing the LA. The skin 20 may have pores or nodules such that blood components coagulate on the surface and tissue intima or neointebral covering grows on the surface and is firmly fixed to the skin material. The pore size may be in the range of about 4 μm to about 110 μm. In some embodiments, the pore size is in the range of about 30 μm to about 90 μm. In some embodiments, the pore size is in the range of about 30 μm to about 60 μm. Such a range of pore size is useful for the formation and adhesion of neointebral covering. In some embodiments, the skin 20, such as an outer ePTFE layer, may be formed from a tube having a diameter approximately the same as the diameter of the foam body 15, allowing the body 15 to be folded and stretched without tearing the foam material.

[0117] The skin 20 may be made from a non-ePTFE material such as a woven fabric, mesh, or perforated film made from FEP, polypropylene, polyethylene, polyester, or nylon. The skin 20 may have low compliance (e.g., inelastic), for example, low compliance in the longitudinal direction, may have sufficient strength to allow the plug to be removed, may have a low coefficient of friction, and / or have coagulation resistance. The skin 20 acts as a matrix that allows the plug to be removed because most foams do not have sufficient strength to resist tearing when pulled. The main body 15 may be coated with or contain a material to enhance the ultrasound echobrightness profile, coagulation resistance, lubricity, and / or to facilitate echocardiographic visualization and promote cell growth, invasion, and coating.

[0118] The skin 20 may have holes that allow contact between the LAA tissue and the foam body 15. Exposure of the foam 15 to the LAA or other tissue has the advantage of encouraging, for example, tissue growth and intrusion into the foam plug pores and / or increasing friction to hold the body 15 in place. These holes may be 1 to 5 mm in diameter or oval, with their long axis aligned with the axis of the foam plug, their length being 80% of the length of the foam plug, and their width being 1 to 5 mm. The holes may be as large as possible so that the outer covering maintains sufficient strength to transmit the tension required for removal. The holes may be preferably positioned along the device 10. In some embodiments, the holes are positioned distally enough to enhance tissue growth intrusion from the distal LAA wall.

[0119] In some embodiments, the device 10 comprises an occlusion region and a fixation region. The proximal portion of the device 10 facing the LA after implantation in the LAA may comprise an occlusion region. The occlusion region may be a blood-contacting surface on the proximal end of the device 10 that is antithrombotic while promoting the formation of neointima in the occlusion region. The occlusion zone promotes antithrombotic and endothelialization from the blood and adjacent tissue. The fixation zone promotes rapid and robust tissue growth penetration into the device 10 from adjacent nonvascular tissue. The fixation zone may be the outer surface of the device 10 adjacent to and / or in contact with tissue within the LAA. The fixation zone may also include the distal end of the device 10 facing the distal wall of the LAA after implantation.

[0120] Figures 28A to 28D are various diagrams showing one embodiment of an internal locking system 101 that may be used with device 10. In some embodiments, multiple internal locking systems 101 may be used with device 10. Figure 28A is a side view showing the internal locking system in its unfolded configuration. Figure 28B is an end view showing the distal end of the internal locking system 101 in its unfolded configuration. Figure 28C is a side view showing the internal locking system 101 in its constrained configuration. Figure 28D is a side view showing one embodiment of an anchor 120 of the internal locking system 101.

[0121] Various structures may be used as a dynamic internal locking system 101 in conjunction with the device 10. Generally, at least approximately two, four, or six or more tissue anchors 120 can be actively or passively advanced from the implantable device 10 into the adjacent tissue surrounding the implantation site. Following the deployment of the device 10 and the expansion of the main body 15, the tissue engagement segments 121 of the tissue anchors 120 extend beyond the skin by at least approximately 1 mm, and in some implementations, at least approximately 2 or 4 mm or more. The tissue engagement segments 121 are carried by support segments 122 of the tissue anchors 120 that penetrate the foam main body 15 and can be attached to a deployment control unit such as a pull wire, push wire, tubular support, or other control structure, depending on the desired configuration.

[0122] The locking system 101 described herein is a passively deployable structure. Upon release of the constraint, the tissue anchor 120 can laterally self-expand and deploy into the adjacent tissue. Self-expanding can be achieved by fabricating the tissue anchor 120 using Nitinol, Elgiloy, stainless steel, or other shape memory or spring-bias material. Depending on the structure of the locking system 101, the constraint can be released by proximal retraction or distal advancement until the tissue anchor 120 is no longer engaged by the constraint.

[0123] Alternatively, the tissue anchor 120 may be actively deployed by distal advancement, proximal retraction or rotation of a control unit, or by inflation of a balloon positioned within the device 10, thereby actively feeding the anchor 120 into the tissue through the skin 20 or a corresponding opening on the skin 20. For example, multiple support segments 122, such as struts, may be connected at their distal ends to a central hub 111 and inclined radially outward and proximal. Proximal retraction of the hub 111 advances the tissue engagement segments 121 along the axis beyond the skin 20 and into adjacent tissue. The inclination angle of the support segments 122, for example, struts, may be reversed in other structures, and distal advancement of the hub 111 deploys the tissue engagement segments 121 beyond the skin 20. Proximal or distal advancement of the hub 111 may be achieved by proximal or distal advancement of a control unit, such as a control wire or inner tube, which is releasably engaged with the hub 111.

[0124] Depending on the desired clinical outcome, the tissue anchor 120 may be retractable by distal or proximal axial movement of the control unit, depending on the inclination angle of the anchor 120. In embodiments exclusively illustrated herein, the step of reinserting the anchor 120 into the sheath may be achieved by advancing the tubular constraint along the inclined surface of the tissue anchor 120, thereby moving the anchor 120 radially inward toward the central longitudinal axis of the device 10. In the case of an anchor 120 that deploys by advancing along its own longitudinal axis, the anchor 120 may be retracted by advancing the control unit in the opposite direction from the direction in which the anchor 120 is advanced to deploy it.

[0125] Referring to Figures 28A to 28D, the internal locking system 101 comprises a central tubular element or hub 111 and anchors 120. The anchors 120 may be arms, segments, or other members extending from the hub 111. Each anchor 120 may comprise a tissue engagement segment 121 and a support segment 122 extending to the hub 111 or other control unit. The internal locking system 101 has a single central tubular hub 111 and a number of anchors 120. As shown, there are four anchors 120. There may be two, three, four, five, six, seven, eight or more anchors 120. The anchors 120 may be rotatably coupled to the hub 111 by hinges or in any other movable manner. Thus, the anchors 120 may be released from restraints that hold the anchors 120 in a constrained configuration shape, and after being deployed to an expanded configuration shape, they may move relative to the hub 111. As a further example, the anchor 120 may move from an expanded configuration to a retracted position, as further described herein. The anchor 120 may be curved, as illustrated, and may take the geometric shape shown in Figure 28A when the anchor 120 is unconstrained.

[0126] The illustrated anchor 120 may have a distal region 130, a hinge region 135, and / or a proximal region 125. The distal region 130 interacts with the hub element 111. The hinge region 135 and the curved geometric shape as illustrated allow the end of the proximal region 125 to extend beyond the body 15, for example, beyond the sidewall of the body 15. The proximal region 125 includes a tissue engagement segment 121 configured to engage with adjacent tissue. The tissue engagement segment 121 may be the entire proximal region 125 or a portion thereof, for example, the tip. Thus, the proximal region 125 may include a sharpened tissue engagement segment 121, a shaped tissue engagement segment 121, an angled tissue engagement segment 121, a thickness configured to make tissue engagement, and / or other preferred features. In some embodiments, the proximal region 125 may be retracted back into the body 15, as further described herein. In the illustrated embodiment, the anchor 120 and the central tube 111 are clearly distinguishable elements that are attached to each other as shown. In other embodiments, the anchor 120 and the tube 111 are a single, integrated unit.

[0127] The internal locking system 101 is made from an implant-grade stainless steel such as Nitinol, 304, or 316, or a biocompatible metal wire such as a cobalt-chromium alloy such as MP35N or Elgiloy. In some embodiments, the internal locking system 101 is cut from a single tubular piece of metal processed by machining or laser cutting, followed by a step of secondary forming or annealing using a similar material.

[0128] The internal locking system 101 can take on a constrained configuration shape when the device 10 is secured in the appropriate position within the LAA and the main body 15 expands therein. Then, in a secondary step, the internal locking system 101 locks the device 10 within the LAA by engaging with the anchor 120 or otherwise securely fastens it. If the position is not considered optimal, or if the device 10 needs to be repositioned within the LAA and / or removed from the LAA by any other means, the internal locking system 101 and its anchor 120 can be released, and the device 10 can be repositioned and / or removed.

[0129] Figures 29A and 29B are side views, in order, showing an axially movable loop-type release mechanism that may be used with device 10 to release a tissue anchor. Figure 29A is a side cross-sectional view of device 10 showing a tissue anchor of the internal locking system 101 in an deployed configuration. Figure 29B is a side cross-sectional view of device 10 showing a tissue anchor in a retracted configuration. One embodiment of a release system 140 is illustrated. The release system 140 comprises a ring 145. The ring 145 may be moved over the anchor 120 to move the anchor 120 into a retracted configuration. The ring 145 may be moved by a pull rod 147. The ring 145 may be releasably attached to the pull rod 147. The pull rod 147 may penetrate a catheter and engage with the ring 145. The release system 140 may be used when it is desirable to release the device 10 from within the LAA in order to reposition and / or remove the device 10 after the internal locking system 101 has been deployed.

[0130] In the illustrated structure, the distal advancement of the restraint device allows for the deployment of the tissue anchor, which is then retracted by the subsequent proximal retraction of the restraint device. Alternatively, the tissue anchor can be irreversibly released by retracting the restraint device proximal to release it.

[0131] Figure 30 is a side view showing one embodiment of device 10 having a flexible anchor 401. The device 10 shown in Figure 30 may have the same or similar features and / or functions as other devices for removing LAA described herein, and vice versa. Device 10 may take the configuration shown in Figure 30 adjacent to or within the LA201. Device 10 in Figure 30 comprises an expandable body 15, such as an open-cell foam body, which allows for the folding and expansion of device 10, and is at least partially enclosed within a skin 20, which may be a strong thin layer processed from ePTFE (stretched polytetrafluoroethylene), polyolefin, or polyester, to aid in healing, fixation, and removal. Device 10 may also be unfolded, and if desired, repositioned, and / or removed, or device 10 may be permanently fixed within the LAA by engaging with a fixation system, such as an internal locking system 101, as described herein. The anchor 401 may be made of metal and may be processed from nitinol. The anchor 401 may be a small-diameter nitinol wire with a diameter of approximately 0.001 inches to approximately 0.010 inches. In some embodiments, the anchor 401 may have a diameter of approximately 0.0005 inches to approximately 0.020 inches. The anchor 401 can be deployed after the main body 15 has expanded. For example, the anchor 401 may be self-deploying after the device 10 has been deployed from the delivery catheter. The anchor 401 may be relatively short and extremely bendable. The anchor 401 may penetrate tissue or may not be able to provide fixation immediately after the deployment of the device 10.

[0132] Figure 31 is a side view showing one embodiment of a device 10 for occluding an LAA, having an anchor 401 together with a tube 500. The device 10 may be positioned adjacent to or within the LA201. The anchor 401 may be a flexible anchor, or in some embodiments, the anchor 410 may be relatively rigid, as will be further described. The tube 500 may be a stationary or movable tube, as will be further described. In some embodiments, the tube 500 is a hypo tube. The tube 500 may be stainless steel, polyamide, or other suitable material. The tube 500 may surround the corresponding anchor 401, as will be further described.

[0133] In some embodiments, the anchor 401 may be fixed so as not to move axially. For example, the anchor 401 may have a portion such as a fixed-length tissue engagement segment 121 that extends outside the main body 15. The portion of the anchor 401 extending outside the main body 15 may be bent when compressed within the delivery catheter and / or sheath, and these portions of the anchor 401 may then extend straight into the configuration shape shown in Figures 31 and 32 after the deployment of the main body 15. The fixed-length portion of the anchor 401 extending beyond the main body 15 may be about 1 mm to about 5 mm, or about 1.5 mm to about 4 mm, or about 2 mm to about 3 mm. This length of the exposed anchor 401 outside the main body 15 may be effectively shortened by the deployment of the corresponding tube 500, as will be further described. The deployment of the corresponding tube 500 around the corresponding anchor 401 can reduce the effective length of the exposed anchor 401, i.e., the length of the anchor 401 extending beyond the end of the tube 500 after the deployment of the tube 500, by approximately 0.5 mm to approximately 1 mm. These are merely examples of different lengths of the anchor 401, and other suitable lengths may be implemented.

[0134] In some embodiments, the anchor 401 may be axially movable. For example, the anchor 401 cannot extend outside the body 15 immediately after the body 15 is deployed or otherwise extend in any way. Following the acceptable positioning of the device 10 within the LAA, the flexible anchor 401 can be advanced and passed through the corresponding tube 500. The anchor 401 may move axially in a preferred manner, including as described elsewhere in this specification. The anchor 401 may move through the tube 500 either before or after the tube 500 is moved and deployed outside the body 15, as described below.

[0135] In some embodiments, the tube 500 is movable and extends outside the main body 15. The tube 500 may be movable in embodiments having either a fixed or movable anchor 401. The tube 500 may be pre-loaded on the corresponding wire anchor 401, for example, one tube 500 per anchor 401, as shown in Figure 31. The tube 500 may then be moved over the corresponding anchor 401, as shown in Figure 32. The tube 500 may straighten the anchor 401 and add mechanical integrity. The tube 500 may also act as a puncture protector to prevent the anchor 401 from puncturing the wall of the LAA. As described, the movement of the tube 500 over the corresponding anchor 401 may shorten the exposed length of the anchor 401. This may result in a more rigid tissue engagement segment of the anchor 401 due to the shortened exposed length.

[0136] In some embodiments, the tube 500 extends from the delivery catheter to or near the outer surface of the main body 15, but does not extend outside the main body 15. Instead, the tube 500 simply guides the anchor 401, for example, around a curve, and supports the wire 401 until it penetrates the tissue. The tube 500 may set the launch angle so that the anchor 401 does not buckle and strikes the tissue perpendicularly. In this embodiment, the anchor 401 may have relatively high rigidity compared to embodiments in which the anchor 401 is relatively flexible in order to provide more secure fixation of the device 10 to the tissue. The tube 500 may impart this guiding function to the corresponding anchor in any of the embodiments described herein having a movable anchor, such as the movable anchor 401, anchor 120, etc.

[0137] The flexible anchor 401 and / or external reinforcing tube 500 may be made from biocompatible metallic materials such as implant-grade stainless steel such as Nitinol, 304V, or 316LVM, cobalt-chromium alloys such as MP35N or Elgiloy, other suitable materials, or combinations thereof. The anchor 401 may vary in length from 0.1 mm to 5 mm, and the external reinforcing tube 500 covers 10% to 90% of the exposed length of the anchor 401.

[0138] The skin 20 encloses the main body 15 at least partially, and a portion of the skin 20 may or may not be attached to the main body 15. In the various devices 10 described herein, the main body 15 may be at least partially enclosed within the skin 20, which may be fabricated from a material such as ePTFE (extended polytetrafluoroethylene), polyolefin, or polyester, to aid in healing, fixation, and removal. Figure 33 is a side view showing one embodiment of the device 10 for LAA occlusion having individual attachment points 700 of the skin 20 to the internal foam main body 15. For clarity, the attachment points 700 are shown as dots in the figure. The attachment points 700 may not be visible from the outside of the device 10, for example, the skin 20 may be bonded to the main body 15 at the attachment points 700. In some embodiments, in addition to or alternative to bonding, the skin 20 may be securely fastened to the main body 15 at the attachment points 700, for example with sutures, and thus some or all of the attachment points 700 may be visible from the outside of the device 10. The device 10 may have a configuration shape as shown in Figure 33, adjacent to or within the LA201. The skin 20 may be attached to the main body 15 at various separate attachment points 700. As shown in Figure 33, the skin 20 may be partially attached to the main body 15, with a portion of it not attached at all. This may allow, for example, the skin 20 to move during the expansion of the main body 15 that occurs after the device 10 is deployed from the delivery catheter. In some embodiments, the skin 20 may be attached at attachment points 700 located near the proximal side of the device 10 to help facilitate closure of the entrance to the LAA, for example, by a rim 800 as described below. The skin 20 may be attached in place at one or more attachment points 700 near the proximal surface, for example, so that bundling the skin 20 at implantation occurs near the entrance but within the LAA. This may be achieved using sutures, adhesives, heat bonding, other preferred approaches, or a combination thereof.

[0139] Selective placement of the attachment points 700 can facilitate the formation of a rim 800 around the skin 20. The rim 800 is schematically shown as a triangle in Figure 34 for clarity. The rim 800 can take on various different shapes depending on the configuration shape of the device 10, the shape of the LAA, etc. Furthermore, the rim 800 can extend completely or partially around the device 10. The rim 800 can surround the inlet of the LAA. The formation of the rim 800 can help completely seal the inlet to the LAA around the device 10, thereby preventing leakage. The attachment points 700 between the skin 20 and the main body 15, as shown in Figure 34, prevent the formation of irregular bundles of fabric and instead guide excess material to form a sealing rim 800 around or near the proximal surface of the device 10. The rim 800 can be formed when the main body 15 expands after deployment from the delivery catheter, as described herein. Alternatively, the mounting point 700 may be designed to prevent the fabric from becoming tangled and to provide a smooth surface, such as a smooth proximal surface.

[0140] Figures 35-36 are side views showing an embodiment of a device 10 having an anchor 120, with the V-shaped tip 901 shown in an unfolded configuration. As described herein, the V-shaped tip may be positioned within the proximal region 125 and / or may form all or part of the tissue engagement segment 121 of the anchor 120. The V-shaped tip 901 forms a V-shaped point. The V-shaped tip 901 generally takes the shape of a "V" or any other angled segmented shape. The V-shaped tip 901 may be a sharp barb or hook. The V-shaped tip 901 may be formed from wire or laser-cut tubing or other preferred method. As shown in Figure 35, one or more of the V-shaped tips 901 are attached to the main body 15 which is confined within the skin 20. The V-shaped tips 901 may be attached to the main body 15 and / or the skin 20. In some embodiments, the V-shaped tip 901 is the end of the anchor 1000. For example, the V-shaped tip 901 may be part of the anchor 1000 located within the body 15 and skin 20, as shown in Figure 36. The distal end of the V-shaped tip 901 may be free to slide, fold, or expand. The distal end of the V-shaped tip 901 may be attached to the body 15, skin 20, and / or anchor 1000, thereby allowing the V-shaped tip 901 to be folded and retracted. When withdrawn into a catheter or sheath, the V-shaped tip 901 may flatten when engaging with the inner diameter of the catheter or sheath. The V-shaped tip 901 may be formed from implant-grade stainless steel such as Nitinol, 304, or 316, cobalt-chromium alloys such as MP35N or Elgiloy, other suitable materials, or a combination thereof. Subsequently, the V-shaped tip 901 can be restored to its preset shape after deployment or re-deployment.

[0141] Figures 37A to 37C are side views illustrating various embodiments of V-shaped tips that may be used with the anchors described herein. Figure 37A is a side view of one embodiment of a V-shaped tip 901. The V-shaped tip 901 comprises two angled segments. The segments can form their angles freely. The angles may have a variety of angular amounts. In some embodiments, the angles formed by the V-shaped tip 901 are approximately 170°, 160°, 150°, 140°, 130°, 120°, 110°, 100°, 90°, 80°, 70°, 60°, or less than, greater than, or intermediate angular amounts. Figure 37B is a side view of one embodiment of a wavy V-shaped tip 1101. The wavy V-shaped tip 1101 may comprise a curved segment and an angled straight segment. Figure 37C is a side view of one embodiment of the double-wave V-shaped tip 1103. The double-wave V-shaped tip 1103 may comprise two curved segments. The curved segments may facilitate engagement between the tip and the inner wall of the LAA. The ends of various V-shaped tips may be smooth and rounded or sharp to facilitate tissue penetration. In some embodiments, all V-shaped tips may have the same shape. In some embodiments, some V-shaped tips may have a first shape, and other V-shaped tips may have a second shape different from the first shape. In some embodiments, some V-shaped tips may be attached to the skin 20 and / or body 15. In some embodiments, some V-shaped tips may be attached to the anchor 1000.

[0142] Figure 38 is a side view showing another embodiment of device 10 for occlusion of an LAA implanted inside an LAA 1201. Device 10 comprises a main body 15 in which a skin 20 and a finial 30 are implanted within the LAA 1201. The LAA has a proximal portion 1203 that is thicker closer to the entrance. An internal locking system 101, for example, its anchor, may be configured to engage with the thicker proximal portion 1203 of the LAA. Various anchors, V-shaped tips, etc., which are deliberately described herein for various embodiments of device 10, may be used to securely fasten the anchor within the thicker proximal portion 1203. In some embodiments, device 10 may be deployed from a catheter so that the main body 15 expands. The arrangement, orientation, etc., of the expanded main body 15 within the LAA may be verified by imaging, for example, as described herein. The arrangement, orientation, etc., of the extended body portion 15 within the LAA may be verified to ensure engagement of the internal locking system 101, for example, its anchor, with the thicker proximal portion 1203. The internal locking system 101, for example, its anchor, may then be deployed to engage with the thicker proximal portion 1203. If, after deployment of the internal locking system 101, for example, its anchor, it is determined that the anchor did not engage with the thicker proximal portion 1203, the anchor may be retracted, as described herein, to reposition and / or remove the device 10.

[0143] In some embodiments, the internal locking system 101, for example, its anchor, may be a pre-loaded surface element that is releasably constrained in a folded or constrained position or configuration shape, or otherwise locked down in some other way. The internal locking system 101, for example, its anchor, may be constrained using a restraint. The restraint may be a soluble polymer, a lasso, or a wire that can be retracted to release the anchor. The restraint may be similar to a deadbolt. Other fixed concepts include ePTFE-integrated Velcro®, electrically oriented / ratcheted fastening elements, unidirectional Gecko tape, or a wire pre-attached to the finial 30. In some embodiments, the body portion 15 with skin 20 is securely retained within the LAA by weaving the body portion 15 and exposing the body portion 15 to the tissue through holes in the skin 20, thereby increasing friction with the cardiac surface to a sufficiently high level to prevent implant migration.

[0144] Figures 39A and 39B are perspective views of one embodiment of a deployable anchor 1302, activated by a pull wire 1301, which can be used with various devices 10, 1020, 3000, etc., for occlusion of LAA as described herein, and shown in constrained and deployed configurations, respectively. The two-stage fixation system allows for the deployment of the anchor 1302 after implantation and expansion of the main body 15. This embodiment incorporates one or more hinged anchors 1302. The anchor 1302, which may be a barb or other fixation element, may be flattened during delivery and deployment of the main body 15. Then, when pulled or pushed, the anchor 1302 bends at the hinge 1306 and penetrates outward into the LAA tissue from the surface of the main body 15. The anchor 1302 can bend at a hinge 1306 using a thin, metal, round or rectangular box-shaped hollow constraint element 1304, such as a round or rectangular tube, and a pull wire 1301, which can be a wire or suture, for example, a sliding element. The pull wire 1301 is attached to the proximal end of the anchor 1302 and returns through a delivery catheter or sheath. When the pull wire 1301 is retracted, the anchor 1302 slides back through a slot 1308 in the tube 1304 and bends at a pre-formed hinge 1306. A portion of the anchor 1302 then extends outward and penetrates the slot 1308.

[0145] Figures 40A and 40B are perspective views of one embodiment of a deployable anchor 1405, activated by a lock wire 1401, which can be used with various devices 10, 1020, 3000, etc., for occlusion of LAA as described herein, and shown in a constrained configuration shape and an expanded configuration shape, respectively. The anchor 1405, which may be a barb or other fastening element, is formed from a wire or flat sheet of nitinol or other shape memory material and can be thermocured to an expanded configuration shape. One or more of the anchors 1405 can be fixed along the skin 20 or in any other way along the outer surface of the body 15. One or more corresponding guides 1402, such as loops, can be positioned along the skin 20 or the body 15. The guides 1402 may be positioned on both sides of the anchor 1405 as shown. The guides 1402 on the first side of the anchor 1405 can fix the anchor 1405 in place. The second opposing guide 1402 of the anchor 1405 may act as a guide for the lock wire 1401, which may be a restraint wire, suture, etc. The lock wire 1401 may be used to restrain the anchor 1405 in a constrained configuration shape, for example, in a flat position as shown in Figure 40A. When the lock wire 1401 is retracted, the anchor 1405 unfolds as shown in Figure 40B. The anchor 1405 may extend perpendicular to the main body 15 or at a certain angle.

[0146] Figures 41A and 41B are perspective views of one embodiment of a deployable anchor 1506, activated by a sheath 1502 and shown in a constrained configuration and an expanded configuration, respectively, which can be used with various devices 10, 1020, 3000, etc., for occlusion of LAA as described herein. The anchor 1506, which may be a barb or other fastening element, is formed from a wire or flat sheet of nitinol or other shape memory material and can be thermocured to an expanded configuration.

[0147] One or more of the anchors 1506 may be fixed along the skin 20 or in some other way along the outer surface of the main body 15. One or more corresponding guides 1500 and locking loops 1504 may be positioned along the skin 20 or the main body 15. The guides 1500 may be positioned on a first side of the anchor 1506, and the locking loops 1504 may be positioned on a second opposing side of the anchor 1506, as shown. The anchors 1506 are held in a configuration shape or position constrained or restrained by the sheath cover 1502. The sheath cover 1502 may be tubular or rectangular in shape. The sheath cover 1502 constrains the anchors 1506. The sheath cover 1502 may constrain the anchors 1506 to a flat position, as shown in Figure 41A. When the sheath cover 1502 is retracted, the anchors 1506 unfold, as shown in Figure 41B. The anchor 1506 may extend at an angle to the main body 15, or vertically.

[0148] Figures 42A to 42D illustrate various embodiments of a device 10 for LAA occlusion having externally deployable anchors 1601, 1604 that can be folded and expanded by retracting into or out of a sheath or external catheter. Figure 42A is a side view of the device 10 having anchor 1601 constrained by a delivery sheath 1603. Figure 42B is a side view of the device 10 with anchor 1601 deployed and not constrained by the delivery sheath 1603. Figure 42C is a side view of the device 10 having anchor 1604 constrained by the delivery sheath 1603. Figure 42D is a side view of the device 10 with anchor 1604 deployed and not constrained by the delivery sheath 1603. As shown in Figures 42B and 42D, the main body 15 comprising a skin 20 can accommodate anchors 1601 or 1604 fixed to the surface of the skin 20 and unconstrained, and therefore expandable in a free state. A delivery sheath 1603, such as a catheter, may be used to constrain anchors 1601 or 1604. Anchors 1601 or 1604 can then expand when the main body 15 is not constrained by the delivery sheath 1603, for example, when the main body 15 is released from the delivery sheath 1603. Anchor 1601 may unfold into a curved shape as shown in Figure 42B. Anchor 1604 may unfold into an angled shape as shown in Figure 42D. After deployment, anchors 1603 or 1604 may face either the proximal or distal side of the main body 15.

[0149] Figures 43A to 43C are sequential side views showing one embodiment of the illustrated LAA occlusion device 10, which is deployed and adjusted on a mount 1705 and constrained by a lasso 1707, respectively. One or more anchors 1709 may be pre-mounted within the main body 15 and attached distal to the mount 1705. The mount 1705 may be a ring-shaped member having an opening through it. The mount 1705 is positioned on a rod 1701 having an end 1711. The mount 1705 may move on the rod 1701, for example, in the proximal direction, for example, it may slide. In some embodiments, the mount 1705 may be pulled proximal, for example, by a pull wire. In some embodiments, the mount 1705 may move when the rod 1701 is rotated. In some embodiments, the end 1711 of the mount 1705 and / or the rod 1701 may be screwed in. As the mount 1705 moves, the anchors 1705 move. The device may include a tapered cone 1708. The cone 1708 may be attached to the end of the rod 1701. The mount 1705 may be moved toward the cone 1708 to adjust the height of the anchor 1709. Thus, the anchor 1709 can be angled more in Figure 17C with respect to Figure 17B. The anchor 1709 may move through the main body 15 and enter the tissue. The anchor 1709 may be adjusted to increase or decrease the amount of tissue penetration by moving the mount 1705, for example, as described. For removal, this process can be reversed. In some embodiments, a lasso 1707 attached to the wire 1703 may pass through the threaded rod 1701, for example, screw in, and be fixed around the anchor 1709 in order to pull the anchor 1709 into the main body 15. In some embodiments, the lasso 1707 may be used to first restrain the anchor 1709 and then retract to allow the anchor 1709 to unfold.

[0150] Figures 44A–44C are side views showing one embodiment of a device 10 for occlusion of a laparoscopic artery (LAA) having an adjustable two-stage anchoring system with an anchor 1801 activated by moving a mount 1803 along a rod 1804. The anchor 1801 may be an internal hook-type structure that is residing within the body 15 and skin 20. The anchor 1801 may be introduced through a central lumen 1003 penetrating the body 15, as shown in Figure 43A. The anchor 1801 can then pass through the body 15 and skin 20 and engage with tissue, as shown in Figure 43B. The anchor 1801 may be adjusted to increase or decrease the amount of tissue penetration. The anchor 1801 is attached distally to a movable mount 1803. The mount 1803 is prevented from rotating, and for example, the mount 1803 may be provided with a notch to prevent rotation of the mount 1830 within the finial 30, as shown in Figure 43C. Mount 1803 is screwed onto a threaded rod 1804, which can be rotated clockwise or counterclockwise to change the linear position of mount 1803. The distal end of rod 1804 may be coupled to a cap 1807. The cap 1807 may rotate with the rotation of rod 1804. Mount 1803 may move proximal to allow anchor 1801 to pass through the surface of body 15 and skin 20, as shown in Figure 43B. Mount 1803 may move distal to pull anchor 1801 back in or under the surface of skin 20. The depth of penetration of anchor 1801 may be controlled, for example, to account for the non-circular cross-section of LAA. In some embodiments, anchor 1801 may be deployed individually. Another option is to deploy anchor 1801 distal to body 15 together with skin 20 and control the stiffness of anchor 1801 to apply a sufficiently uniform penetrating force to the contacting tissue.

[0151] Each of the disclosures described herein, which are expressly incorporated by reference and form part of this specification for all purposes, for example, U.S. Patent Application No. 15 / 290,692, filed October 11, 2016, titled "DEVICES AND METHODS FOR EXCLUDING THE LAA" (reference number: CNFRM.001P1), U.S. Patent Application No. 14 / 203,187, filed March 10, 2014, titled "DEVICES AND METHODS FOR EXCLUDING THE LAA" (reference number: CNFRM.001A), and European Patent Application No. EP14779640.3, filed August 24, 2015, titled "DEVICES AND METHODS FOR EXCLUDING THE Various features for LAA (LAA) occlusion may be included, such as those described in PCT Patent Application No. PCT / US2014 / 022865, filed on March 10, 2014, titled "DEVICES AND METHODS FOR EXCLUDING THE LAA" (CNFRM.001WO). Further additions and improvements to these and other concepts are described below. Unless otherwise noted or indicated in the context, embodiments described in the following sections may have the same or similar features and / or functions as those described above, and vice versa.

[0152] A. Basic plug design components and improvements Various occlusion devices and associated features are described with respect to Figures 45A to 77. The same or similar features and / or functions of the various devices illustrated and described with respect to Figures 45A to 77 may be present in the various devices illustrated and described with respect to Figures 1 to 44C and Figures 78 to 93B, and vice versa.

[0153] As shown in Figures 45A–45C, the device 1020 (sometimes referred to herein as the “implant”) may utilize a foam “cup” with the interior removed. In some embodiments, this may be similar to the foam 1600 design illustrated and described with respect to Figure 16 and / or the foam body 3002 described with respect to Figures 85A–93B. The “cup” design may be in contrast to a solid or generally solid tubular foam plug, such as those described and shown in Figures 2 and 6. With respect to the cup design in Figures 45A–45C, the approximate thickness of the foam may be about 2.5 mm, but may range from about 0.25 mm to about 10 mm. Note that the thickness may be significantly thicker than typical stent coatings or coverings used in other applications (e.g., coronary stents, peripheral stents, AAA liners, etc.). In this application, which is performing occlusion, the thickness of the foam adds some desirable structure between the gaps of the internal support structure 1032, such as a stent. In some embodiments, the thickness is at least about 0.25 mm, in some embodiments, at least about 0.50 mm, 0.75 mm, 1.0 mm, or 2.0 mm or more in an unconstrained state, and in one mounting configuration, it may be about 2.5 mm, and the thickness is selected according to the desired performance.

[0154] Figure 45A is a cross-sectional view of a preferred embodiment showing the components of an implant 1020 having a proximal (atrial) end 1022, a distal (LAA) end 1024, and an internal cavity 1026 in an expanded configuration. An expandable tubular wall 1028 defines the internal cavity 1026, which, after deployment, may be surrounded at the proximal end 1022 by a tissue scaffold 1030 or other barrier configured to engage the entry point and separate the LAA from the atrium. The proximal edge of the tubular wall 1030 preferably has an inclined re-entry or recapture surface, such as an annular chamfer 1031, which extends continuously around or in some other way on the circumferential edge of the proximal edge of the implant 1020, and may facilitate the proximal retraction of the implant into the deployment sheath to allow repositioning or removal as desired. The distal extension 1029 of the tubular wall 1028 extends distally beyond the internal support (described below) and forms a non-invasive anterior edge.

[0155] The tissue scaffold 1030 may be integrally formed with or bonded to the tubular wall 1028. The tissue scaffold 1030 and the tubular wall 1028 may have approximately the same thickness and porosity, as described below. Alternatively, the tissue scaffold may comprise a material such as ePTFE, PTFE, Dacron, or other material known in the art, which is thinner than the tubular wall 1028 and is configured to support tissue growth intrusion and isolate LAA.

[0156] An expandable internal support structure 1032, such as a corrugated stent 1034 or other frame, may be provided. The illustrated corrugated stent 1034 comprises a plurality of struts 1038, where adjacent pairs of struts are coupled to form a plurality of proximal vertices 1041 and distal vertices 1042. The stent 1034 may be laser-cut from a tube stock as is known in the art. Each of at least three, preferably at least four, six, eight, or more proximal-facing vertices 1040, comprises a re-entry or recapture strut 1044 that inclins radially inward in the proximal direction relative to a central hub 1046. The recapture struts may be cut from the same tube stock as the stent. The hub 1046 may have a central lumen, such as for delivery on a guidewire or for releasable engagement with a deployment device (not shown). Alternatively, the hub 1046 may have attachments such as a small hole 1048 for receiving a suture loop. The suture or other retaining element may extend distally from the deployment catheter, pass through the tissue scaffold 1028, through the hole 1048, return proximal through the tissue scaffold 1028, and enter the deployment catheter. After satisfactory positioning of the implant 1020, the suture may be removed, freeing the implant 1020 from the deployment catheter, leaving a homogeneous tissue scaffold 1030 when the material's elasticity closes the suture marks. In one preferred implementation, the implant 1020 is deployed from the delivery catheter without advancing along a wire, and the hub lacks a central lumen. In one embodiment, the implant is secured to the delivery system using any of the various means known in the art, including a screw mechanism or ball in a socket mounting mechanism that can also pivot.

[0157] The tubular wall 1028 can be attached to the stent 1034 by adhesive, suture, or other bonding techniques known in the art. In the embodiment shown, the tubular wall 1028 is sutured to the stent 1034, the tissue scaffold 1030 is sutured to the recapture strut 1044, and the support structure 1032 is supported within the cavity 1026. Alternatively, at least a portion of the support structure 1032 may be supported on the outer surface of the tubular wall 1028 or the tissue scaffold 1030. The corrugated stent may be embedded within the tubular wall 1028, for example, by sandwiching the stent between inner and outer layers of foam which are then bonded together. Similarly, the recapture strut may be encapsulated between inner and outer polymer layers. The polymer material may also form a foam around the stent so that a secondary attachment process is not required.

[0158] Figure 45B is a distal end view of one embodiment of implant 1020 showing an internal metallic structure having a central hub 1046 and eight recapture struts 1044 that are radially inclined inward relative to the hub 1046. Multiple suture holders, such as openings 1050, are attached to or formed within the struts 1044 to receive sutures used to secure the tissue scaffold 1030. This reduces the tendency for the tissue scaffold material to slide distally along the struts 1044 when the implant 1020 is retracted proximal to the deployment catheter.

[0159] The frame may be expandable from a shrunk delivery configuration to an expanded deployed configuration. The frame may be retractable from an expanded deployed configuration to a shrunk delivery configuration. In an unconstrained expanded configuration, the frame is generally tubular, e.g., circular, round, segmented, polygonal, other shapes, or a combination thereof, preferably compressed foam to conform to the shape of the inner surface of the LAA. This allows the deployed implant to have minimal leakage, with a maximum size of approximately 4 mm or less, or 3 mm or 2 mm or less, and is essentially leak-free when viewed by color Doppler in some deployments.

[0160] Figure 45C is an external proximal end perspective view of one embodiment of implant 1020 in unconstrained expansion, having a single foam shell and showing a proximal chamfer 1028. The anchor deployed near the distal end of the frame will be described in more detail below.

[0161] Some advantages of a foam "cup" with the interior removed compared to a solid foam plug are as follows: It still behaves like a full foam plug in terms of shape conformity and sealing. It allows for the incorporation of an internal metal frame that can be optimized to provide the desired amount of expansion for sealing and anchoring by giving the optimal radial force and mounting point to the anchor, as well as an inner front of the proximal surface that helps fold the foam for removal. By sizing the metal frame to be shorter in length than the foam cup, a non-invasive distal buffer, which is entirely foam and can be pushed out from the tip of the sheath, is formed when the tip is advanced within the LAA. And the reduction in the overall volume of the material makes it easier to: significantly reduce the delivery outline, make it easier to flush to remove air before delivery into the vascular system, and increase porosity to blood so that more blood can flow into it if an embolism occurs in the cardiovascular system.

[0162] In one embodiment, the proximal edge of the foam plug 1040 is chamfered to facilitate loading and unloading. While central orientation may still be possible to allow tracking of the implant 1020 on a guidewire-type device, in some embodiments, there is either no lumen or only a slit within the foam plug 1040, as it is undesirable to have a significant residual central hole that could cause thrombus formation or allow leakage. The slit may be a single slit, a double cruciate slit, or multiple slits. The objective is to still allow tracking on the guidewire but ensure that the hole closes completely after the guidewire is removed. In the case of a solid surface, the implant 1020 cannot be tracked on the guidewire and instead can be delivered, for example, through a long transseptal sheath.

[0163] The term “guidewire” may refer to an actual medical device sold as a guidewire, as used above, or it may refer to a catheter such as a pigtail catheter, which is initially placed within the LAA to which the LAAC (LAA closure) implant 1020 is tracked.

[0164] Diameter: The LAA may be in the range of approximately 15 mm to 33 mm in diameter, and as such, the diameter of implant 1020 must be able to accommodate this variation in size. The more the implant 1020 can accommodate a wide range of diameters, the fewer predetermined sizes are required, thereby simplifying the implantation procedure. The structure of this implant 1020 is such that it can accommodate diameters less than 50% of the fully expanded diameter. Preferred plug 1040 diameters may be approximately 27 mm, 33 mm, and 35 mm. Ideally, only one or two sizes are needed to cover a wide range of LAA diameters. This is a significant advantage of the foam plug 1040 concept compared to metal cage-type devices that use fabric tissue scaffolds.

[0165] Depth: The preferred length of plug 1040 (generally the depth of the occluder within the LAA along the proximal-distal direction) is 20 mm, independent of the diameter of implant 1020. This allows it to accommodate most anatomical structures while also providing good stability for implant 1020. The distal tip of foam plug 1040 is very soft, making it a non-invasive tip when entering the LAA, when the distal tip of implant 1020 is allowed to protrude beyond the distal recess of the delivery catheter or sheath. Because of this short depth, the placement of plug 1040 is more secure, as there is less need to align the delivery catheter with the LAA as required with longer devices.

[0166] Foam and Porosity: The average pore size of the foam is 250–500 microns. The foam has a very high porosity (90–95%) to promote rapid and thorough tissue growth penetration. The open-cell foam allows blood to flow through it. If plug 1040 is to cause embolism, it should be opened wide enough to allow sufficient blood flow to remain safe until it can be removed. In addition, the high porosity will be beneficial for properly flushing implant 1020 to prevent air from entering the vascular system. The porosity and cell size may be as described with respect to the foam body 3002 of device 3000, which are illustrated and described in example with respect to Figures 85A–90D.

[0167] The foam's compliance and thickness are designed to form a good seal against the tissue with minimal compression. While other devices require significant oversizing to achieve a seal, the Implant 1020 requires less than 1 mm of oversizing.

[0168] LA contact surface: As described above, ePTFE (stretched polytetrafluoroethylene) or PTFE as a skin / layer over the plug 1040 or partially over the plug 1040 may be ideal for supporting neointima formation without thrombus formation. Embodiments may be described with respect to ePTFE, but it is understood that PTFE may also be used. However, even if blood flow can be made available around the outer surface of the cup, the low porosity of ePTFE may not allow blood flow through the surface of the embolused implant 1020, or may reduce its ability to do so, thus compromising safety. The porosity of ePTFE is considerably lower than that of open-cell foam, and therefore blood flow across the membrane may be negligibly small. However, this is hydrophobic, which is beneficial for antithrombotic properties. One option to maintain the desired open porosity of the foam structure while adding the antithrombotic properties of ePTFE and / or PTFE is to add a PTFE coating via vapor deposition to the foam. The antithrombotic coating may contain ePTFE or PTFE. This forms a highly porous surface that simulates the ePTFE morphology. The mounting method may include vapor deposition as described above, or elastomer adhesive (although this may eliminate porosity at the mounting point). If ePTFE is preferred, it may also be mounted by wrapping the metal frame with ePTFE, then wrapping it around the OD through the center, and securing it via sutures.

[0169] As further described herein, it may be desirable to reduce the pore size of the foam to a range of approximately 30 to 200 μm.

[0170] Barb / Anchor: There are several options or types of barb designs that can be implemented to secure implant 1020 within the LAA. Some examples are given below: 1) Static: The plug always engages with the tissue when deployed. This makes it difficult to reinsert and reposition implant 1020 into the sheath. 2) Constrained: Implant 1020 can be deployed with the barb constrained. Implant 1020 can be repositioned as needed. The barb is then released when plug 1040 is in its final position. 3) Dynamic: The barb can be deployed or retracted as desired without moving the plug. A dynamic barb may allow deployment and retraction, for example, to reposition and / or remove implant 1020.

[0171] In some embodiments, implant 1020 may have features that differ from other implants described herein. In some embodiments, implant 1020 may include any or all of the following features: namely, it has no central lumen, has a spoked element that contacts the proximal surface on the inside of the cup in addition to a corrugated stent, has an anchor / barb that can preferably be actuated as a secondary step after the placement of the plug itself, and has a layer on the proximal surface, which may be similar to the proximal surface 1604' shown in Figure 16 or the layer 3100 shown in Figure 85A, although in some embodiments, PTFE may be applied via a vapor deposition coating, as opposed to stretched PTFE (ePTFE) which is attached as a secondary material.

[0172] B. Endoskeletal system with proximal spokes The implant 1020 may comprise a foam plug 1040 having a central endoskeleton with a proximal spoke surface 1080 having several radial struts. This configuration improves the ability to remove (reinsert into the sheath) the foam implant 1020. The stent versions shown in Figures 45A and 45B may be laser-cut from a superelastic nitinol tube, but a number of other biocompatible metallic materials such as shape-memory nitinol, stainless steel, MP35N, or Elgiloy may be used. This embodiment is self-expandable, but a balloon-expandable design is also possible. In addition, the frame may be fabricated from drawn wire, as opposed to being laser-cut from a tube. Loops can be formed along each strut and thereby attached to the foam via sutures, but other attachment processes such as adhesive bonding may also be available. Loops located in the middle of the struts are oval-shaped and staggered, which may make them easier to load into a delivery catheter and easier to fabricate. In addition, loops may be omitted, as shown in Figure 46. The embodiment shown in Figure 45A has eight struts, but four to thirty-two struts can be used anywhere. Generally, it is preferable that the foam be attached to the frame at multiple points, including the center. This facilitates removal of the foam without damaging it, and suture loops are beneficial for this purpose. In other embodiments, the foam can be formed around the endoskeleton so that it is inside the foam, thereby eliminating the need for a secondary attachment step. As shown in Figure 45A, it is preferable that the proximal foam surface has a chamfer at the edge to minimize the bulk of the material in this area and help to reinsert it into the sheath.

[0173] Figures 47A and 47B are perspective and side views, respectively, of one embodiment of an LAA occlusion device 1020 having an internal frame 1032, which may be a single molded unit. The design shown in Figure 45B is machined from two separate parts—a proximal spoke surface 1080 having eight struts and a corrugated stent—but in some embodiments, there may be a single molded unit frame 1032, such as those shown in Figures 47A and 47B. In some embodiments, the proximal spoke surface 1080 may support reinsertion into the sheath, and eight crown-shaped corrugated cage stents 1060 support a foam cylinder plug 1040, with eight to sixteen, or fewer or more, barbs or anchors 1100 positioned within the cylinder to anchor and withstand embolization. The anchors 1100 may be positioned proximal, distal, and / or centrally along the length of the cylinder. The size of the anchor 1100 can preferably be in the range of about 0.003" to about 0.009" in thickness and about 0.007" to about 0.015" in width when fabricated from a nitinol tube. In some embodiments, the anchor 1100 may extend about 1 mm from the surface of the implant 1020, but may extend in the range of about 0.5 mm to about 2 mm, or shorter or longer, from the surface of the implant 1020. The anchor 1100 may be in a single location along the length of the cylinder, as shown in Figure 48, or arranged alternately. The in vitro anchor fixation movement resistance with these designs may be in the range of forces from 0.51b to 1.51b. As illustrated, the anchor 1100 may be in a single row. There may be multiple rows.

[0174] Figure 49 shows an implant 1020 having a central endoskeleton with a proximal spoke surface 1080 that takes on a fully expanded configuration when attached to a delivery catheter. Figure 50 shows implant 1020 in one embodiment of a folded configuration. Modified forms include an outer sheath component of the delivery catheter that may be expandable or expandable, or a slit at the tip to assist in tapering and folding. Reducing the coefficient of friction of the foam surface can reduce the force required to fold the implant and insert it into the catheter. This can be done, for example, by applying a layer of PTFE to the foam via vapor deposition or other processes, or by a layer of stretched PTFE (ePTFE) attached to the proximal surface using adhesive or other mechanical methods such as sutures. Secure attachment of the foam surface to the spoke system may be achieved by suture attachment including adhesive bonding or by other methods, which can result in increased force and potentially cause the foam to tear, preventing the foam from clumping together in one place during removal. If secure attachment with distributed force is not achieved, the metal spoke elements may pull the foam through during sheathing reinsertion, potentially destroying the implant.

[0175] C. Proximal (blood contact) surface of the foam The foam implant 1020 may be composed of a porous, open-cell foam. The foam may be any of the various currently available materials, including polyurethane, polycarbonate polyurethane, or polyvinyl acetal (PVA) (Ivalon®), which are polyurethane-based biocompatible materials. The foam may also be in the form of a mesh, such as a net. One embodiment utilizes a non-reabsorbable mesh polyurethane-based biocompatible material. In addition, reabsorbable foams containing poly-4-hydroxybutyrate (P4HB) or polyhydroxyalkanoates (PHA), such as cross-linked reabsorbable polyester urethane urea scaffolding materials, are also available.

[0176] The pore size in the material may be approximately 50 to 800 microns, preferably approximately 250 to 500 microns. Materials with such high porosity (e.g., approximately 90% to 95%) promote rapid and tenacious tissue growth penetration and effectively mimic the extracellular matrix. While such high porosity materials are desirable for tissue growth penetration, they may not be ideal for the antithrombotic properties required for the left atrium (LA) surface. An antithrombotic surface is desirable for the surface facing the LA. If modifications are made to the LA surface to promote blood compatibility, these modifications may be extended laterally to the implant 1020 by approximately 1 mm to 20 mm, preferably approximately 1 mm to 5 mm, to ensure antithrombotic properties when the implant 1020 is deployed and a portion of its side protrudes outside the LAA and enters the blood environment. If there is a hole, such as a guidewire lumen, in the proximal surface, the antithrombotic surface may at least partially penetrate into that lumen. In addition, the antithrombotic layer will promote tissue growth, invasion, and endothelialization.

[0177] Various methods may be used to form the antithrombotic proximal surface of implant 1020, including, but not limited to, the following: For example, a stretched PTFE (ePTFE) skin or layer may be applied to the outer surface of the foam implant as described elsewhere herein. This may also be attached by wrapping the metal frame with ePTFE and then wrapping it around the OD through the center and attaching it to the frame. This may be done using various methods including adhesion with sutures or adhesives, including the use of elastomer adhesives (although this may eliminate porosity at the attachment point). If there is one ePTFE layer, it may penetrate into the lumen of the guidewire. In addition to ePTFE, electrospun, melted, nonwoven, knitted or woven fibers of PTFE, polyester, PGA, PLA, poly-4-hydroxybutyrate (P4HB) or other biocompatible fiber materials may be used to form a porous biocompatible surface.

[0178] In some embodiments, a hydrophobic material coating, such as PTFE, is applied to the proximal surface using one of a number of processes known to those skilled in the art, including vapor deposition coating. Ideally, this coated layer also partially extends over the lateral portion of the implant. Some embodiments may not include a guidewire lumen, but if a central lumen is present, the coating preferably penetrates into it at least partially (e.g., about 1 mm). To promote antithrombotic properties, this coated layer reduces the porosity of the blood-contact surface from about 30 microns to about 200 microns, preferably from about 100 microns to about 150 microns. Materials that can be used for this include conformal coatings such as PTFE, polyurethane spray or dipping coatings, albumin, polyethylene glycol (PEG), or poly(ethylene oxide) (PEO), applied to a thickness of about 50–100 microns, all of which may or may not incorporate heparin or nitric oxide. PEG or PEO is ideally attached via a grafting process. In a preferred embodiment, the outer layer is also smooth to facilitate re-sheathing of the implant. This can be achieved with both hydrophobic materials such as ePTFE and PTFE, and hydrophilic materials such as PEO and PEG. A two-step process is often utilized to create a desirable combination of porosity and hemocompatibility, in which the foam is first coated with a base layer such as a polyurethane biocompatible material, and then in a second step, PTFE, PEG, or PEO is used to form a smoother surface with higher antithrombotic properties. Heparin or other anticoagulants may be added to the final blood-contact surface.

[0179] Another option for creating smaller pore sizes with ePTFE-like materials is to attach an electrospun layer of PTFE to the surface of the foam using sutures. A very thin layer (<1 mm) can be formed and attached via sutures or adhesive bonding.

[0180] Another desirable property of the foam plug 1040 is to impart echogenicity to the implant 1020, which enables visualization by echocardiography. To promote echogenicity, a porous surface may suffice in some cases, but in some cases, a hydrophilic surface may be beneficial. To promote blood compatibility and a hydrophilic surface, a preferred embodiment is a foam implant having a surface grafted with PEO or PEG.

[0181] D. Static barb (anchor) design The static barb engages with the tissue when the plug 1040 is deployed, for example, when it is expanded. This simplifies the fabrication process but makes it difficult to reposition the implant by reinserting it into the sheath.

[0182] In some embodiments, as shown in Figure 51, the barb 2000 may be fabricated from a wire and crimped onto the stent 1034, in this example a corrugated stent. The barb may be made from nitinol wire of any diameter, preferably in the range of about 0.005" to about 0.012" in diameter. The tip may be sharpened to allow for easy penetration into tissue. It may be attached to the stent frame using a crimp sleeve made from stainless steel, nitinol, or titanium tubing. This may require a filler wire inside the crimp tube to prevent rotation of the barb. It may also be attached by welding using a laser or other energy source.

[0183] Referring to FIG. 52, in some embodiments, a laser cut double barb 2000 system may be utilized. This may be fabricated from a nitinol tube 2002 that is cut to allow two crimped ends with one barb 2000 near each crimp 2004 having a continuous nitinol connection following the curvature of the stent 1034, which in this example is a waveform stent. The advantages of this embodiment are that it requires relatively little effort to fabricate and shape the barbs, it is easy to form sharp tips, and the barbs become rigid as a result of the curvature of the tube wall. FIG. 53 shows one embodiment of the laser cut portion of FIG. 52 before forming the crown-shaped curvature.

[0184] Referring to FIG. 54, in some embodiments, the wireform follows the curvature of the waveform support cage 1034 (stent) and terminates in two barbs 2000. This may be crimped to the waveform cage or stitched, welded, or adhered in place on the waveform cage (stent) with a suture. The advantage of this is that crimping is not required to prevent rotation of the barbs.

[0185] Referring to FIG. 55, in some embodiments of static barbs, a laser cut waveform support cage (stent) may be fabricated with an integrated barb 2000. The advantage of this concept is that no secondary attachment step is required to attach the barbs to the cage. Also, it may be relatively easy to add more barbs. The limitation is that it may be difficult to provide eight crowns (waveforms) with barbs on all struts as the material may not be readily available, and thus six crowns may be preferred in some cases.

[0186] E. Constraint Barb (Anchor) Design In the case of the constraint barb 2010, the implant 1020 may be deployed into the LAA with the barb 2010 constrained and thus, prior to barb release, may be repositioned as necessary. The barb 2010 is released when the implant 1020 is in its final position.

[0187] In one embodiment, as shown in FIG. 56, a throw-rope style restraint system is added to the static barb, thereby forming a constrained deployable barb 2010. A suture material may be tucked between the barb 2010 and the strut to prevent post-deployment fraying. Removal of the throw rope can release a plurality of barbs in a circular array.

[0188] As shown in FIG. 57, the barb may be formed as a loop approximately midway along the barb 2010, which allows a suture or thread to be looped through and retained to form a throw rope. This prevents full expansion of the barb 2010 until the body of the implant reaches its final desired position within the LAA.

[0189] A flipping-barb option is shown in FIG. 58. In this embodiment, the barb 2010 may be an elongated design that is folded back inside a foam opening with its interior removed prior to loading into the delivery system. This may require a pull cord or other locking element to hold the barb in a constrained configuration. After the implant 1020 is placed in its final desired position, the restraint is removed and the barb is no longer constrained, flipping to seat properly and engage the tissue.

[0190] F. Dynamic barb (anchor) design The dynamic barb 2020 can be deployed or retracted as desired without moving the implant. The dynamic barb 2020 may be a preferred option for several procedures, such as recapturing the implant 102 within a delivery catheter and / or sheath.

[0191] One embodiment is a tube-in-tube. In this embodiment, as shown in Figure 59, the laser-cut tube 1030 may be used to form an integrated front spoke surface 1080 and corrugated stent 1032 from a single molded product of preferably superelastic nitinol piping. Other materials, including shape memory nitinol, stainless steel, MP35N, or Elgiloy, may also be used. A second, smaller laser-cut tube 1040 may be used to form an inner spoke barb array, as shown in Figure 60.

[0192] As shown in Figure 61, during the deployment of the foam implant, the anterior spoke surface and corrugated stent may be deployed while the spoke barb array remains in a constrained position. The implant 1020 may be repositioned as needed, and then, as the inner tube 1040 moves distally with respect to the outer tube 1030, the barbs 2020 may expand and engage as shown in Figure 62. The inner spoke barb array may be repeatedly re-constrained and re-released until it is detached from the transmission line of the delivery catheter.

[0193] In another embodiment, as shown in Figure 63, an example is provided of a design for a dynamic barb 2020 which may preferably be fabricated from a single component. This embodiment may be laser-cut tube 1045, preferably cut from superelastic nitinol, with the front half of the spoke connecting to the wave point of the stent cage 1032 and the other half of the spoke supporting sheathing while it forms within the barb 2020.

[0194] Recapture or resheathing of implant 1020 may be initiated by folding the anterior spoke face, as shown in Figure 64, thereby simultaneously retracting barb 2020 from the tissue. This allows for safe repositioning of implant 1020 with the minimum amount of sheath repositioning required (limiting the length of the implant needed to fully retract into the sheath).

[0195] In another embodiment, a dynamic hinged barb system is illustrated, as shown in Figure 65. This is a laser-cut corrugated integrated barb 2020 with a living hinge and a constraint body. Once the constrained end is thermoset, it may curl inward and rest on or under the corrugated strut. When positioned on the corrugated strut, its sharp barb end may face the inner diameter of the assembly. When flicked into place under the strut, the opposing barb end moves upward like a seesaw and can engage with the tissue. The operation of the hinged barb 2020 can be achieved through the use of a lasso sewn in a circular array between each barb and the corresponding strut. By tightening the lasso inward, the retaining constraint body is moved to flick from above the strut to below the strut, thereby lifting the opposing barb end above the surface of the strut and allowing it to engage with the tissue surface.

[0196] G. Embodiments using foam cups, corrugated stents, and ePTFE layers As shown in Figures 66A–66C, a foam cup plug 1040 with an internal corrugated or zigzag anchor (for example, as shown and described in relation to Figure 16) can be modified to be completely covered on its outer surface by an ePTFE layer 2060. This layer 2060 can be attached to the distal end 1024 of the foam via suture or adhesive bonding, as opposed to relying solely on the proximal surface 1022. This can enclose the entire outer surface, enter the central lumen on the proximal surface, and be attached to the proximal portion of the corrugated stent by lamination or adhesive bonding. Other biocompatible materials or coatings, including but not limited to PTFE or polyurethane, may also be used.

[0197] H. Concepts of dynamic and static anchors Embodiments of implant 2300 shown in the side section and end view of Figure 67 each include an anchor 2310 that can be tied, welded, or crimped at the proximal end. The anchor 2310 may be made from nitinol wire to allow loading into the delivery system without bending or distorting. Eight to sixteen wires can be formed in the curved portion. The anchor may act like a “hook.” The assembly is loaded into the delivery catheter in a straightened position. As they are pushed out of the delivery catheter, they take the shape shown in Figure 67 and penetrate into the tissue through the foam 2320. The foam 2320 is pressed into the delivery system and its interior is removed as shown to reduce the amount of foam needed to maintain sufficient radial force to seal the tissue.

[0198] Embodiments of the implant 2350 shown in Figures 68A and 68B include a corrugated stent internal anchor with a barb in a foam plug that is removed from the interior and thickened at the distal end, which collapses and penetrates into the delivery catheter, but when partially unfolded from the delivery catheter it forms a larger non-invasive foam tip buffer 2360. The proximal surface 2363 may have an internal lumen 2365 as shown in Figure 68A, but may not have an internal lumen as shown in Figure 68B.

[0199] I. Constraint anchors unfolded in the second step The embodiment of implant 2370 shown in Figure 69 has a barb / anchor 2371 pre-attached to the corrugated stent 2372 inside the foam 2374. A suture 2375 forms a loop around the distal end of the corrugated stent 2372, compressing the stent 2372 and pulling the barb 2371 inward. The suture 2375 is tied with a pull knot. After the device 2370 is delivered in place, one end of the suture 2375 is pulled, the knot is released, and the suture is removed, thereby allowing the stent 2372 to open radially and the barb 2371 to engage with the tissue. The barb 2371 may be positioned distal to the foam 2370 as shown, or it may be pre-engaged with the foam 2374 and penetrate the foam 2374.

[0200] J. Internal stent with enhanced embolism resistance A metal stent-like frame 2380, comprising a distal static barb 2381 and a proximal "deceleration bump" 2382, is disclosed as shown in Figures 70–72. This can also be a zigzag stent (as shown) or a corrugated stent or other similar expandable embodiment. The bump 2382, which is placed on the exterior of the metal stent frame 2380, can be rounded or pointed in design. Its purpose is to increase resistance and stability to the implant when deployed in the LAA to prevent embolization. In a preferred embodiment, a foam "cup" 2384 can be shaped as shown in Figure 71 to provide an additional material 2385 on the distal end relative to the non-invasive buffer when the distal end of the implant is partially deployed from the delivery catheter. This may or may not have an internal lumen for a guidewire.

[0201] K. Constrained non-invasive anchors As shown in Figures 73 and 74, the corrugated, zigzag, or other stent shapes 2390 can be fabricated with distally positioned loops 2391 that engage with the tissue within the LAA to secure the implant in place and prevent migration resistance. These are rounded and blunt, which limits the risk of perforation; however, perfectly rounded loops do not provide sufficient migration resistance, so the tips may be modified to incorporate sharp features. Since loop anchors 2391 can be placed on or very slightly on each stent end, 4 to 16 anchors may be placed somewhere.

[0202] As the implant is delivered through the vascular system into the heart and LAA, loop 2291 folds toward the center of the constrained stent, as shown in Figure 75, and aligns adjacent to each other. The inner catheter is placed through loop 2391 to maintain constrainment. When the system is in the LAA, the outer catheter / sheath is retracted to deploy the proximal portion of the implant. If the positioning appears acceptable, the inner catheter is removed, allowing the distal portion of the implant to fully expand and the loop anchor to engage with the LAA tissue.

[0203] L. Perfusion element & barb options If the implant moves after being deployed within the LAA, the device is expected to move into the LA, cross the mitral valve, enter the left ventricle, then exit the left ventricular outflow tract, cross the aortic valve, and enter the aorta and distal circulatory system. Along this path, the device may become trapped in any of the aforementioned structures, obstructing flow and potentially causing distal ischemia and, in some cases, hemodynamic collapse. Therefore, it is desirable that the implant 2392 have design features that allow distal perfusion, such as those shown in Figures 76 and 77, for example.

[0204] Figure 76 is a top view of one embodiment of an implant showing the left atrial surface. A valve is visible within the surface, but in the illustrated embodiment, this is a simple cut section (A) that opens when sufficient pressure is applied, allowing flow to pass through device 2392. This flow may be bidirectional or unidirectional and may depend on specific conditions that allow a flow rate of 10 mL / min to 5 L / min. In embodiments such as those shown, this is achieved without loss of structural integrity, and as a result of the loading conditions, device 2392 is divided into multiple subsections, each of which can be removed using standard techniques. It is also possible that a particular device has a single valve element or an array (as shown).

[0205] As shown in Figure 77, in some embodiments, a series of lateral ports (B) may be cut into the lateral wall of the foam 2393 of the implant 2932 to allow blood flow in the event of migration and distal embolism. These can vary in size and number, with port diameters ranging from approximately 0.1 mm to approximately 5 mm, and the number of ports ranging from 1 to 20. They can also vary in shape, including, but not limited to, circular, oval, and rectangular.

[0206] Regarding barb designs as described herein, in addition to having an array of barbs deployed at different distances from the LA surface, barbs that penetrate to different depths within the tissue can be incorporated. In one embodiment, the most proximally positioned barb on the implant is longer and thus penetrates deeper into the thicker proximal LAA tissue, while the most distally positioned one on the implant is shorter and thus does not penetrate as deeply into the delicate distal tissue, maximizing plugging resistance while minimizing the risk of perforation. In another embodiment, the proximal and distal barbs may be of the same length but can be fabricated from wires of different diameters or cut from tubing material at different thicknesses, such that the barb engaging the more delicate distal LAA tissue has greater flexibility or is designed to engage only the internal trabeculation formation within the LAA, while the proximally positioned barb penetrates the tissue. Alternatively, the two barbs can be positioned at each crown point of the stent, opposite one another.

[0207] M. Multi-functional Occlusion Device Figures 78-84 show various features that can be used with, used alone, or used in combination with any of the LAA occlusion devices and methods described herein. In some embodiments, the features of Figures 78-84 can be incorporated into the device 3000 and associated features and methods shown and described with respect to Figures 85A-94B.

[0208] Figure 78 is a side view of one embodiment of an LAA occlusion device 3000 having an ablation feature. The LAA occlusion device 3000 has an array of ablation elements 3005. The ablation elements 3005 deliver energy to the tissue in and around the LAA inlet, electrically isolating the LAA. In the illustrated embodiment, the array of ablation elements 3005 is positioned at the proximal end 3004 of the main body 3002. The ablation elements 3005 may be electrically connected to an energy source through a deployment catheter. Energy may be supplied via radiofrequency, ultrasound, electricity, or other preferred methods. An internal lumen 3003 penetrates the main body 3002. In some embodiments, the lumen 3003 may be omitted.

[0209] Figure 79 is a side view of one embodiment of an LAA occlusion device 3000 having a pressure-sensing feature section. The device 3000 has a pressure sensor 3007 on its proximal surface 3008. In some embodiments, the sensor 3007 may be located on the proximal surface 3102 of the proximal cover 3100 (see Figure 85A). In some embodiments, the sensor 3007 does not protrude into the LAA, such as a flat sensor on the proximal surface 3008 or 3102. The sensor 3007 is electrically connected to an electronic element 3011 via a wire 3009. The electronic element 3011 has the function of converting and storing the signal generated by the sensor 3007. This information can be transmitted to a remote by signal 3013. The electronic element 3011 can be powered remotely or by an internal battery.

[0210] Figure 80 is a side view of one embodiment of an LAA occlusion device 3000 having a drug elution feature. The device 3000 has a sensor 3007 on its proximal surface 3008. The sensor 3007 may be located on the proximal surface 3102 of a proximal cover 3100 (see Figure 85A). The sensor 3007 is electrically connected to an electronic element 3011 via a first wire 3009. The electronic element 3011 is electrically connected via a second wire 3015 to a drug reservoir 3017 which is fluidically connected to a drug outlet port 3021 via a conduit 3019. This allows for the delivery of drugs into the LA, as well as monitoring of the concentration and / or state of specific chemicals, and, in response, delivery of drugs, for example, in blood glucose-driven insulin delivery. The sensor 3007 may be for detecting levels of various chemicals, and the reservoir 3017 may be controlled, for example, by the electronic element 3011 to elute drugs via the port 3021 in response.

[0211] Figure 81 is a side view of one embodiment of an LAA occlusion device 3000 having a pacing / defibrillation feature. The device 3000 has an electrical pacing element 3025, such as an electrode. The pacing element 3025 extends around the main body 3002. The pacing element 3025 may have other configurations. The pacing element 3025 is connected to a pace generator 3029 via a wire 3027. The generator 3029 is attached to a battery 3033 by a wire 3031. This pacing system may be used to tune the atria in the event of atrial fibrillation and to halt atrial fibrillation. The generator 3029 and / or battery 3033 may include components for control, communication, commands, etc.

[0212] In some embodiments, the LAA may be electrically isolated. The LAA may be electrically isolated by an occlusion device incorporating one or more ablation elements, as illustrated and described with reference to Figures 78–81, to guide the ablation to electrically isolate the LAA, and then the occlusion device 3000 may be engaged and disengaged to leave it in place in the heart. In some embodiments, the LAA may be electrically isolated first, and then the device 3000 may be implanted, as described herein, for example with reference to Figures 82–84. In some embodiments, shape-adjustable circumferential ablation via a foam plug with ablation elements may be incorporated.

[0213] Figures 82–84 illustrate various systems and methods for electrically isolating the LAA, which may be used with device 3000. In some embodiments, the LAA may be electrically isolated and then closed. For example, the systems and methods shown in Figures 82–84 may be used to induce isolation, after which LAA occlusion may be performed using various LAA occlusion devices described herein, such as device 3000.

[0214] Figure 82 is a side view showing one embodiment of an over-the-wire circumferential ablation balloon system. The over-the-wire balloon catheter 3035 is placed on a guidewire 3037 and inserted into the LAA (Laser Adhesive Anterior Organ). The balloon 3039 may have one or more circumferential ablation elements 3041, such as juxtaposed RF elements, to electrically isolate the LAA using radiofrequency (RF) to treat atrial fibrillation. The ablation elements 3041 extend circumferentially around the balloon 3039. The ablation elements 3041 may have other configurations. The guidewire 3037 may be inflated within the LAA and attached to the distal end of the balloon 3043, which acts as a buffer to prevent the guide catheter 1100 from perforating the wall of the LAA. These features may be similar to those described with respect to Figures 8 to 11.

[0215] Figure 83 is a side view showing one embodiment of an over-the-wire circumferential ablation ultrasound balloon system. The over-the-wire balloon catheter 3035 is placed on a guidewire 3037 and inserted into the laryngeal atrial fibrillation (LAA). A balloon 3045, such as a circumferential ablation ultrasound balloon, is used to treat atrial fibrillation by electrically isolating the LAA using ultrasound (US). The guidewire 3037 may have a balloon 3043 attached to its distal end, as described with respect to Figure 82.

[0216] Figure 84 is a side view showing one embodiment of an over-the-wire circumferential ablation helical wire system with ablation elements. An over-the-wire circumferential ablation helical wire 3047, having one or more ablation elements, is implanted within the LAA (LAA). The wire 3047 may be used to electrically isolate the LAA using radiofrequency and treat atrial fibrillation.

[0217] N. Embodiment comprising a compressible foam body having a proximal recapture strut and a distal tubular body, a proximal cover, and a compliant frame. Figures 85A to 93B illustrate another embodiment of the LAA occlusion device 3000. The device 3000 described herein may have the same or similar features and / or functions as other LAA occlusion devices described herein, and vice versa. Thus, any feature of the device 3000 described with respect to Figures 85 to 93B may apply to the features of devices described with respect to Figures 1 to 84, such as implant 1020, and vice versa.

[0218] Figures 85A to 85C show an LAA occlusion device 3000 having a foam body 3002, an expandable support or frame 3040, and a proximal cover 3100. Figure 85D shows an LAA occlusion device 3000 having an inner cover 3101 and a proximal marker 3023A in addition to the foam body 3002. Figures 86A to 86C show the foam body 3002, the body 3002 of which is shown in cross-section in Figures 86B and 86C. Figure 86C also includes a full view (i.e., not a cross-sectional view) of the frame 3040. The device 3000 is shown in an expanded configuration in these figures. The device 3000 has a longitudinal axis as shown, which can be defined by the foam body 3002, as further described.

[0219] 1. Compressible foam body The main body 3002 is formed from a compressible material, such as foam. The main body 3002 may be a foam formed from a mesh-like (e.g., net-like) polycarbonate polyurethane urea. The main body 3002 may be cut, formed, or assembled into a cup shape, as further described. The main body 3002 may have sufficient thickness and compressibility to engage with the surrounding tissue under radial forces applied by the inner frame and to conform to anatomically irregular shapes, as further described. As further described, using a compressible material such as foam for the main body 3002 forms a complete seal of the LAA, resulting in superior performance against LAA occlusion compared to existing devices. The foam structure of the main body 3002 comprises a three-dimensional network of interconnected meshes arranged in phases to form a network of interconnected open pores, as further described. The mesh can carry a coating such as PTFE while preserving the open pores, as further described.

[0220] The foam material of the main body 3002 has high porosity. “Porosity” as used herein has its usual, conventional meaning and refers to the percentage of open voids between the interconnected mesh of the foam. The porosity of the main body 3002 may 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 higher. The porosity may be in the range of about 90–95%. The porosity may be about 90%. The porosity may be about 95%. The porosity may be 90%, 91%, 92%, 93%, 94%, or 95%. Among the other advantages of high porosity are that it promotes rapid and tenacious tissue growth and invasion, that it can be compressed and pushed into a small catheter, and / or that it allows blood to pass through if an embolism occurs in the implant.

[0221] The foam body 3002 has pores or cells formed between the interconnected network of foam material. The foam body 3002 has cells ranging in size from about 250 μm to about 500 μm. The foam may have cell sizes of about 125 μm to about 750 μm, about 175 μm to about 650 μm, about 200 μm to about 600 μm, about 225 μm to about 550 μm, about 275 μm to about 450 μm, less than 125 μm, or greater than 750 μm. These sizes may refer to the cell size before application of any coating, such as PTFE. The cell size may therefore change after application of the coating, for example, it may decrease. The desired porosity and / or cell size may be determined on the basis of allowing blood to pass through while blocking debris of a size that could potentially cause ischemic stroke. The acceptable size of such debris may drive the selection of a particular porosity and / or cell size. For example, a cell size of about 250 μm to about 500 μm may be based on preventing debris of a particular size from passing through the main body 3002.

[0222] In one embodiment, the foam body 3002 is made of a non-reabsorbable, reticular, cross-linked, polycarbonate polyurethane urea matrix, structurally designed to support fibrous vascular tissue growth and invasion, with a fully interconnected macroporous morphology having a porosity of over 90-95%, and a cell size in the range of 250 to 500 μm.

[0223] The main body 3002 has a proximal end 3004 and a distal end 3006. In some embodiments, the axial length of the device 3000 from the proximal end to the distal end in a free and unconstrained state is 20 mm. As used herein, “free and unconstrained” state, and similar, refers to a state in which no external force other than the normal force or reaction force from the surface on which the device 3000 is implanted is applied to the device 3000. In some embodiments, this axial length may be about 10 mm to about 30 mm, about 12 mm to about 28 mm, about 14 mm to about 26 mm, about 16 mm to about 24 mm, about 18 mm to about 22 mm, or about 20 mm. The main body 3002 may have any of these lengths regardless of the outer diameter of the main body 3002.

[0224] The proximal end 3004 of the main body 3002 has a proximal end wall or surface 3008. The proximal surface 3008 is generally oriented toward the LA when the device 3000 is implanted in the LAA. The device 3000 may be implanted off-axis, as further described, in which case the proximal surface 3008 may not remain perpendicular to the longitudinal axis of the LA. Thus the proximal surface 3008 gives the main body 3002 a closed proximal end 3004. The closed proximal end 3004 is configured to overlap the inlet, but the porosity is large enough to allow blood to pass through while blocking debris of a size that could potentially cause ischemic stroke, as further described. This membrane may be formed by the main body 3002 and / or cover 3100. In some embodiments, the proximal surface 3008 or a portion thereof may be open. For example, there may be no proximal surface 3008, there may be a partial proximal surface 3008, or there may be a proximal surface 3008 with part removed. In some embodiments, the proximal surface 3008 or any part thereof is not included, and one or more openings are covered by the cover 3100. The determination of the size of any such openings in the proximal surface 3008 may be driven by the desired size of the fragments that cause embolization so as to be prevented from leaking out of the LAA, as further described.

[0225] The proximal surface 3008 is flat or generally flat and generally perpendicular to the longitudinal axis of the device 3000. The proximal surface 3008 is circular or generally has a circular shape when viewed from the proximal end 3004 in an unrestricted extension. In some embodiments, the proximal surface 3008 may be flat, round, segmented, angled with respect to the longitudinal axis, have other shapes, or a combination thereof. The proximal surface 3008 may have non-circular, polygonal, other round shapes, other shapes, or a combination thereof when viewed from the proximal end 3004.

[0226] The proximal surface 3008 has an outer surface 3010 and an opposing inner surface 3012. The outer surface 3010 faces proximally away from the device 3000, and the inner surface 3012 faces distally towards the frame 3040. Surfaces 3010 and 3012 may define the outer and inner surfaces of the proximal surface 3008. The thickness of the proximal surface 3008 may be measured axially between the outer surface 3010 and the inner surface 3012. In a free and unconstrained state (e.g., uncompressed and expanded), this thickness may be about 0.5 mm to about 5 mm, about 1 mm to about 4 mm, 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 surface 3008 may be uniform or non-uniform. Therefore, the thickness may vary in different regions of the proximal plane 3008.

[0227] The main body 3002 comprises a side wall 3014 extending distally from the proximal surface 3008. The side wall 3014 extends circumferentially around the proximal surface 3008 and forms a closed section (i.e., extends circumferentially 360 degrees around the axis). The side wall 3014 extends axially so as to define a tubular main body concentrically around the longitudinal axis of the device 3000. The longitudinal axis passes through the geometric center of the tubular main body defined by the side wall 3014. The side wall 3014 is tubular or generally tubular, for example, cylindrical, along the axis. In some embodiments, the side wall 3014 may be conical or frustoconical, for example, when the proximal end is wider than the distal end or vice versa. The side wall 3014 may have an outer contour at its proximal end, when viewed from the proximal or distal end, and may coincide with the outer contour of the proximal surface 3008.

[0228] In some embodiments, the cross-section of the side wall 3014 may not be closed, for example, if the side wall 3014 has an opening. Therefore, cross-sections taken in various arrangements along the longitudinal axis may or may not show a closed section. In some embodiments, the side wall 3014 may be non-tubular, non-cylindrical, non-circular, polygonal, other round shapes, other shapes, or a combination thereof. In some embodiments, as illustrated, the side wall 3014 may extend continuously along its entire length from the proximal end 3004 to the distal end 3006. In some embodiments, the side wall 3014 may not extend continuously along its entire length from the proximal end 3004 to the distal end 3006. For example, the side wall 3014 may comprise a plurality of unconnected sections, such as an annular portion of the side wall, which are arranged and separated along the longitudinal axis and connected to the frame 3040.

[0229] The sidewall 3014 has an outer surface 3016 and an opposing inner surface 3018. The outer surface 3016 faces radially outward from the axis. The inner surface 3018 faces radially inward toward the axis. The thickness of the sidewall 3014 may be measured radially between the outer surface 3016 and the inner surface 3018. In a free and unconstrained state (e.g., uncompressible), this thickness may be about 0.5 mm to about 5 mm, about 1 mm to about 4 mm, 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 sidewall 3014 may be uniform or non-uniform. Thus, the thickness may be thicker or thinner in different regions of the sidewall 3014. The thickness of the sidewall 3014 may be the same as or different from the thickness of the proximal surface 3008. In some embodiments, the thickness of the proximal surface 3008 is 2.5 mm, and the thickness of the side wall 3014 is 2.5 mm. In some embodiments, the thickness of the proximal surface 3008 is approximately 2.5 mm, and the thickness of the side wall 3014 is approximately 2.5 mm.

[0230] The side wall 3014 has a distal free end 3020 having a distal surface 3022. The distal surface 3022 is flat or generally flat and perpendicular to the longitudinal axis of the device 3000. In some embodiments, the distal surface 3022 is not flat, or is angled with respect to the axis of the device 3000, curved, rounded, segmented, or of other shapes, or a combination thereof.

[0231] The main body 3002 may have a distal opening 3024. The opening 3024 is formed by the distal free end 3020 of the side wall 3014. The opening 3024 is at the distal end of the internal central volume or cavity 3028 of the main body 3002, which is at least partially formed by the side wall 3014, the proximal surface 3008, and / or the stepped portion 3030. The frame 3040 may be placed inside the cavity 3028, as further described. The distal opening 3024 may be fully open. In some embodiments, the distal opening 3024 may be mostly open, partially open, or closed, for example, if the main body 3002 has a distal surface similar to the proximal surface 3008 so as to surround or partially surround the cavity 3028.

[0232] The main body 3002 has a stepped portion 3030, indicated as a bevel, extending between the proximal surface 3008 and the side wall 3014. The stepped portion 3030 may be at the intersection of the proximal end of the side wall 3014 and the proximal surface 3008. The stepped portion 3030 extends over the entire circumference of the intersection. The stepped portion 3030 has an outer surface 3032. The outer surface 3032 may be a chamfered surface. The outer surface 3032 is axially flat or generally flat. The outer surface 3032 extends over the entire circumference of the stepped portion 3030. In some embodiments, the stepped portion 3030 and / or the outer surface 3032 may be non-flat, rounded, have other shapes in the axial direction, or a combination thereof. The stepped portion 3030 and / or the outer surface 3032 may extend over a portion of the entire circumference of the stepped portion 3030. The thickness of the stepped portion 3030 may be measured perpendicular to the outer surface 3032 in an inward direction. The thickness of the stepped portion 3030 may be the same as the thickness of the proximal surface 3008 and / or the side wall 3014, as described herein. In some embodiments, the thickness of the stepped portion 3030 may be different from the thickness of the proximal surface 3008 and / or the side wall 3014. The stepped portion 3030 may function as a recapture ramp to facilitate the proximal retraction of the implant into the deployment catheter.

[0233] The compressibility of the main body 3002 contributes to the excellent sealing ability of the device 3000. The foam may be compressible to form a larger radial "footprint" and spread radial forces from the struts on the frame 3040, as further described. The foam main body 3002 may have a compressive strength of at least 1 pound (psi) per square inch or in the range of about 1 psi to about 2 psi, or less than about 2 psi. "Compressive strength" here refers to the pressure at which the foam is compressed to produce a 50% strain. With any foam material relative to the main body 3002, the pressure cannot vary from a 50% strain to at least an 80% strain, and the pressure-to-strain relationship is flat or generally flat. Therefore, even if the foam is thicker relative to the main body 3002, the main body 3002 does not exert a significantly larger outward force on the structure due to its own increase in thickness. In one embodiment, the foam body 3002 is a mesh-like crosslinked matrix having a porosity of at least about 90%, an average cell size in the range of about 250 to 500 microns, a wall thickness of at least about 2 mm, and a compressive strength of at least 1 psi. In one embodiment, the body 3002 is formed from a foam material having, or substantially having, the material properties shown in Table 1. In some embodiments, the body 3002 is formed from a material described, for example, in U.S. Patent No. 7,803,395, issued September 28, 2010, titled "Reticulated elastomeric matrices, their manufacture and use in implantable devices," or U.S. Patent No. 8,337,487, issued December 25, 2012, titled "Reticulated elastomeric matrices, their manufacture and use in implantable devices," the entire disclosure of which is incorporated herein by reference.

[0234] [Table 1]

[0235] The device 3000 may be equipped with markers 3023 (see Figures 85B and 87D; for clarity, only some of the markers 3023 are labeled in the figures) for visual identification during delivery. The markers 3023 may be radiopaque marker bands sewn into the distal free end 3020 of the main body 3002. The markers 3023 may be for visualization using fluoroscopic imaging of the distal end 3006 of the device 3000 during delivery. A series of markers 3023 may be arranged circumferentially along the distal surface 3022 of the main body 3002 (for clarity, only some of the markers 3023 are labeled in Figure 85B). In some embodiments, the markers 3023 may be located in addition to, or alternatively to, the cover 3100 or frame 3040, or other areas of the main body 3002 or other parts of the device.

[0236] In some embodiments, four platinum-iridium (PtIr) radiopaque (RO) tubular markers 3023 are sewn onto the distal end 3006 of the foam body 3002, allowing visualization of the distal edge of the device 3000 under fluoroscopy. In some embodiments, the PtIr markers 3023 are attached to the foam body 3002 in the arrangement of a proximal step 3030 to be used as a marker during recapture of the device 3000. Visualization of the proximal and / or distal markers 3023 can facilitate identification of the amount of recapture. If the device 3000 is recaptured up to the proximal 3090 of the anchor inside the access sheath, but is not limited thereto, the device 3000 can be redeployed and reused. If the proximal anchor 3090 is recaptured inside the access sheath, the device 3000 can be removed and discarded due to permanent deformation of the anchor 3090. In some embodiments, other materials, such as gold or other suitable materials, may be used for the marker 3023.

[0237] As shown in Figures 85D and 87D, the device 3000 may comprise one or more markers 3023A. Three markers 3023A are illustrated as an example. In some embodiments, there may be one marker 3023A. There may be two, four, five, or more markers 3023A. In some embodiments, there is one proximal marker 3023A and ten distal markers 3023. Unless otherwise noted, marker 3023A may have the same or similar features and / or functions as other markers described herein, e.g., marker 3023, and vice versa. Marker 3023A may be located at or near the proximal end of the device 3000. As shown, marker 3023A is located on the inner surface 3012 of the proximal end 3004 of the foam body portion 3002. The markers 3023A may be located on or near the inner surface of the stepped portion 3030 (see Figure 86B) of the foam body 3002. The markers 3023A may be distributed circumferentially, for example, at equidistant or equiangled points with respect to each other, or they may be at different relative distances from each other. They may be arranged radially in the same or different arrangements with respect to each other. In some embodiments, there may be only one marker 3023A. There may be one proximal marker 3023A and four distal markers 3023. One or more markers 3023A may be located inside, outside, or within the foam body 3002, or a combination thereof. One or more markers 3023A may be located on or near the distal surface 3022 of the foam body 3002. The markers 3023A may be elongated circumferentially as shown. In some embodiments, the marker 3023A may be such that the device 3000 is linear when viewed from a specific angle, such as a side view. The markers 3023a may be aligned or oriented in the same or similar orientation, or in different orientations.Some or all of the markers 3023 may be oriented in the circumferential, transverse, axial (for example, along the inner surface 3018 of the side wall 3014), other orientations, or combinations thereof, or may not be oriented in any of these directions.

[0238] There may be one or more markers 3023B, as further shown in Figure 87D. Unless otherwise noted, one or more markers 3023B may have the same or similar features and / or functions as other markers described herein, such as marker 3023 or 3023A, and vice versa. Markers 3023B may be positioned along the side wall 3014 of the main body 3002. There may be one or more markers 3023B positioned along the inner surface 3018 of the side wall 3014.

[0239] As illustrated, the two markers 3023B are visible on either side inside the foam body 3002. The markers 3023B are attached around the frame 3040 through the foam. The markers 3023B are attached around members of the proximal surface 3060 of the frame 3040, such as one of the struts 3061, for example, by stitching. The markers 3023B may be attached to the frame 3040 very close to one of the proximal vertices 3084 of the frame 3040, for example, at the outer curved portion 3066 of the strut 3061. There may be just one marker 3023B, or two, three, four, or more markers 3023B. There may be one marker 3023B for each strut 3061. In addition, the markers 3023B may be used to connect the frame 3040 to the foam body 3002. Marker 3023B may be a suture as described herein.

[0240] One or more markers 3023A and / or 3023B at or near the proximal end of device 3000 provide various desirable features. For example, marker 3023A at the stepped portion 3030 facilitates visualization of device 3000 during and after implantation. The typical non-circular shape of the opening (entrance) of the LAA can compress the proximal end 3004 of the device, causing it to protrude slightly in the proximal direction. However, the stepped portion 3030 can provide an arrangement for marker 3023A that reduces or prevents the linear proximal bulging of the foam body portion 3002. Thus, marker 3023A in that arrangement can provide a more useful visualization of the positioning of device 3000 and reduce complexity. For example, in some embodiments, a marker 3023A at the stepped portion 3030 (e.g., on the inner surface as shown) can be delivered using only fluorescence imaging without requiring echo or other ultrasound imaging, which may be particularly useful during delivery. One or more markers 3023B may provide similar advantages.

[0241] As further shown in Figures 85D and 87D, the device 3000 may include an inner cover 3101. Unless otherwise noted, the inner cover 3101 may have the same or similar features and / or functions as the cover 3100 (described in further detail below, see the section “Proximal Cover”). The inner cover 3101 may also be a cover for the hub 3050 (see, for example, Figures 86C and 89A–90C). The inner cover 3101 may be formed from stretched polytetrafluoroethylene ("ePTFE"). The inner cover 3101 may be a separate part of the same material as the proximal cover 3100.

[0242] The inner cover 3101 may be positioned between the foam body 3002 and the frame 3040. As shown, the inner cover 3101 is positioned between the inner surface 3012 of the foam body 3002 and the proximal end of the hub 3050 of the frame 3040. The inner cover 3101 may be circular or of other shapes. The inner cover 3101 may have a sufficient area to provide a barrier between the hub 3050 and the proximal end 3004 of the foam body 3002. In some embodiments, the inner cover 3101 may extend radially outward from the hub 3050 or to the side wall 3014, such as the inner surface 3018 of the foam body 3002, or to any radial position between them. The inner cover 3101 may have a diameter of about 4 mm to about 22 mm, about 5 mm to about 15 mm, about 6 mm to about 10 mm, about 8 mm, or 8 mm. The inner cover 3101 is flat or may be generally flat. The inner cover 3101 may have a thickness of about 0.0001" to about 0.0020", about 0.0002" to about 0.0010", about 0.0005", or 0.0005". The inner cover 3101 may have one or more openings 3103, such as holes that go through it. The inner cover 3101 may have two holes 3103 for passing through and receiving a tether 3240 (see, for example, Figures 93A to 93B). The two holes 3103 of the cover 3101 may align a tether 3240, such as a suture, which penetrates distally into the hub 3050 through one hole 3103 in the inner cover 3101 and exits proximal from the hub 3050 through the other hole 3103 in the inner cover 3101.

[0243] The inner cover 3101 may prevent the hub 3050 and / or other feature parts of the frame 3040 from directly contacting the foam material. The cover 3101 may protect the integrity of the foam body 3002 from stress that may be applied to the foam material by the hub 3050. This protection may be desirable, for example, during loading, deployment, removal, and redeployment of the device 3000. The inner cover 3101 may prevent or reduce damage to the foam body 3002 from the hub 3050.

[0244] The foam body portion 3002 can be attached to various feature portions of the device 3000. The body portion 3002 can be attached to the frame 3040 at various points, including, for example, the center of the proximal end of the frame 3040, as further described. Attachment may be performed using sutures such as polypropylene monofilament sutures, but other methods known in the art, such as adhesive bonding, are also available. To prevent relative movement between the foam body portion 3002 and the frame 3040, the proximal rows of proximal anchors 3090 may be individually attached to (e.g., inserted through) the foam body portion 3002. In other embodiments, the foam body portion 3002 can be formed around an endoskeleton such that the metal frame is inside the foam body portion 3002, thereby eliminating the need for a secondary attachment step. An advantage of attaching the body portion 3002 to the frame 3040 is, among other advantages, that it facilitates removal of the foam body portion 3002 without damaging it. This mounting also ensures that the buffer 3026, as further described herein, extends beyond the frame 3040 at all points in time, including during the initial exposure of the device 3000 after the proximal retraction of the delivery sheath.

[0245] As shown in Figure 87D, the device 3000 may comprise one or more fasteners 3001. The fasteners 3001 may connect the frame 3040 to the foam body 3002. The fasteners 3001 may be sutures. Other suitable fastening sutures may be used, including staples, ties, wires, components of the frame 3040, other mechanical fasteners, adhesives, other suitable means, or combinations thereof. The fasteners 3100 may extend around the frame 3040, penetrate the foam body 3002, and, for example, penetrate the side wall 3014.

[0246] As illustrated, four mounting fixtures 3001 are shown in Figure 87D. Two proximal mounting fixtures 3001 and two distal mounting fixtures 3001 are visible. Each proximal mounting fixture 3001 is positioned at the base of each proximal anchor 3090. Each distal mounting fixture 3001 is positioned at the base of each distal anchor 3094. There may be one, two, three, four, five, six, seven, eight, or more mounting fixtures 3001. There may be 20 mounting fixtures 3001. There may be one mounting fixture 3001 for each anchor 3090, 3094 of device 3000. Each mounting fixture 3001 may be positioned at the proximal vertex 3084 or distal vertex 3088 of frame 3040, for example with respect to Figure 89A, as further described herein. For example, the fastener 3001 may be wrapped around one or more of the struts 3082, 3086, as further described herein. The fastener 3001 may locally compress the foam body 3002 at and / or around the fastener, for example with respect to Figure 95C, as further described herein. The fastener 3001, such as a suture, may extend from within the cavity 3028 through the foam body 3002, out of the foam body 3002, along the outer surface 3016 of the foam body 3002, penetrate into the foam body 3002, penetrate back through the foam body 3002 into the cavity 3028, and be tied around the frame 3040 or otherwise connected together. In some embodiments, similar mounting paths for the fixture 3001 may be used to tie the fixture 3001 around and outside the foam body 3002, or to connect them together in other ways. In some embodiments, the fixture 3001 may also penetrate the cover 3300, or other covers as described herein. The fixture 3001 may penetrate the material of the cover 3300. The fixture 3001 may penetrate openings in the cover 3300, such as the side opening 3324, or the window 3177 (see, for example, Figures 88B–88E).As shown in the diagram, the proximal attachment 3001 may penetrate the foam body portion 3002 and the opening in the cover 3300, while the distal attachment 3001 may not penetrate the cover 3300 but only penetrate the foam body portion 3002.

[0247] The foam body 3002 may be coated. In some embodiments, the coating is optional. In embodiments with a coating, the coating is applied to the interconnected mesh of the foam material. The body 3002 may be coated with pure polytetrafluoroethylene (PTFE). The PTFE coating reduces friction of the foam body 3002 against the delivery system, facilitating deployment and removal, while minimizing thrombus formation on the LA surface. The body 3002 may be coated with shape-conforming, vacuum-deposited pure PTFE. In addition to or alternatively, the body 3002 may be coated with a coating other than PTFE. The coating, whether PTFE or another material, may be about 0.5 μm thick and cover at least a portion of the surface of the interconnected mesh of the foam without blocking the pores. The coating may be applied to part or all of the foam body 3002. The coating may be applied to part or all of the outer surface of the foam body 3002.

[0248] In some embodiments, the coating thickness is approximately 0.1 μm to approximately 1 μm, approximately 0.2 μm to approximately 0.9 μm, approximately 0.3 μm to approximately 0.8 μm, approximately 0.4 μm to approximately 0.7 μm, approximately 0.4 μm to approximately 0.6 μm, or approximately 0.5 μm. In some embodiments, the thickness of the applied coating may be greater or less. The coating has a uniform or substantially uniform thickness. In some embodiments, the coating may have a non-uniform thickness. For example, a portion of the body portion 3002 that faces the LA when implanted, such as the proximal surface 3008 and / or the stepped portion 3030, may have a thicker coating than the coating along the side wall 3014 of the body portion 3002. In some embodiments, the outer surface 3010 of the proximal surface 3008 has a PTFE coating, and the proximal surface 3008 also has an ePTFE cover 3100.

[0249] The coating is applied using a vapor deposition process. In some embodiments, the coating is applied through coating, vapor deposition, plasma deposition, grafting, other preferred processes, or a combination thereof. The coating is applied to the outer surfaces 3010, 3032, and 3016 of the proximal surface 3008, the stepped portion 3030, and the side wall 3014, respectively. In some embodiments, the coating is applied to the outer surfaces 3010 and 3032, and only partially to the outer surface 3016. In some embodiments, the coating is applied to the outer and inner surfaces of the main body portion 3002.

[0250] In some embodiments, other biocompatible, antithrombotic, and / or lubricating materials may be applied to the surface of the foam body 3002 and / or cover 3100. These materials may promote tissue growth penetration. Such materials may include, for example, heparin, albumin, collagen, polyethylene oxide (PEO), hydrogels, hyaluronic acid, nitric oxide, oxygen, nitrogen, amines, bioabsorbable polymers, and other biomaterial-releasing materials, pharmacologically active substances, and surface-modifying materials. In addition, the surface of the body 3002 may be roughened, textured, or otherwise modified or coated in some way to promote healing or enhance echobrightness generation.

[0251] 2. Proximal coverage Device 3000 may comprise a cover 3100, which may be an ePTFE cover as further described herein. Other embodiments of this outer cover 3100 are described herein and include, for example, covers 3101, 3300, 3150, 3151, etc. The various embodiments of this cover may have the same or similar features and / or functions as, unless otherwise noted. Cover 3100 may have a series of openings. In some embodiments, cover 3100 may be solid and have no openings. In some embodiments, cover 3100 may have only openings for receiving anchors and / or tethers through, as further described herein. In some embodiments, device 3000 may comprise an inner cover, such as an inner cover 3101, as illustrated and described with respect to Figure 85D.

[0252] The outer cover 3100 is a generally flat material that is applied to and covers at least a portion of the main body 3002. The cover 3100 is located on the proximal end 3004 of the device 3000. The cover 3100 covers the proximal surface 3008 of the main body 3002 and at least a portion of the side wall 3014. The cover 3100 covers the proximal portion of the side wall 3014. The cover 3100 has a proximal surface 3102 that at least a portion faces the LA when implanted. The cover 3100 has an outer edge 3104 that forms the outer vertex 3106 (for clarity, only the outer edge 3104 and a portion of the outer vertex 3106 are labeled in the figure). In some embodiments, the cover 3100 may cover only the proximal surface 3008 or a portion thereof. In some embodiments, the cover 3100 may extend over a large portion of the side wall 3014, for example, its middle or distal portion, or the entire side wall 3014.

[0253] The cover 3100 may have a thickness measured perpendicularly from the proximal surface 3102 to the opposing distal surface of the cover 3100 facing the main body 3002. The cover 3100 may have a thickness of 0.001 inches. In some embodiments, the cover 3100 may have a thickness of about 0.00025 to about 0.005, about 0.0003 to about 0.004, about 0.0004 to about 0.003, about 0.0006 to about 0.002, about 0.0008 to about 0.0015, or about 0.001. In some embodiments, the cover 3100 may have a thickness of 0.0005"; in some embodiments, the cover 3100 may have a thickness of about 0.0002" to about 0.0008", about 0.0003" to about 0.0007", about 0.0004" to about 0.0006", or about 0.0005";

[0254] The cover 3100 may be attached to the frame 3040 through the foam body 3002. The cover 3100 may be attached to the body 3002 in addition to, or alternatively to. The cover 3100 may be attached at at least two, four, six, or more of the outer vertices 3106. The cover 3100 may be attached to the frame 3040 and / or the body 3002 in various arrangements, including at the outer vertices 3106, through the proximal surface 3100, the proximal surface 3008 of the body 3002, other arrangements, or combinations thereof. The cover 3100 is attached using mechanical fasteners, such as sutures. In some embodiments, polypropylene 6-0 sutures are used throughout the device to attach the foam body 3002, the proximal cover 3100, and the RO marker 3023 to the foam body 3002 and / or the frame 3040. In some embodiments, the cover 3100 is attached to the frame 3040 via standard braided or monofiber suture material such as polypropylene, ePTFE, or polyester. In some embodiments, polypropylene monofiber is used. Proximal anchors 3090 of the frame 3040 (further described herein) may penetrate the outer apex 3106 of the cover 3100. Such penetrating anchors 3090 may further secure the cover 3100 in place with respect to the main body 3002. In some embodiments, the cover 3100 may be attached to various parts of the device 3000 by mechanical fasteners, crutches, adhesives, chemical bonds, other preferred techniques, or a combination thereof.

[0255] As illustrated, the cover 3100 is formed from stretched polytetrafluoroethylene ("ePTFE"). The ePTFE cover 3100 offers several advantages. For example, the ePTFE cover 3100 can enhance the ability to recapture the in vivo device 3000 by dispersing the proximal retraction force applied by the catheter. The cover 3100 may be an ePTFE material with a thickness of approximately 0.001" having appropriate porosity to promote healing and minimize thrombus formation, similar to the underlying PTFE coated foam.

[0256] The ePTFE cover 3100 can help recapture the implant within the access sheath while providing a smooth, antithrombotic surface that promotes tissue covering and integration. The ePTFE may cover the entire proximal surface and partially cover the lateral portion, as shown in Figure 85C. The ePTFE cover 3100 is fabricated from a pre-laminated sheet consisting of two or more sheets of oriented material that are offset to form a biaxially oriented material. Alternatively, a tube, preferably a biaxially oriented tube, may be used, which is then cut to form a sheet. The thickness of the final structure may be 0.0005" to 0.005", but preferably about 0.001".

[0257] In some embodiments, the cover 3100 is fabricated from other antithrombotic, high-strength, biocompatible materials such as knitted or woven polyester cloth, polypropylene, polyethylene, nonwoven vascular scaffolds, porous films, or bioabsorbable scaffolds such as polylactic acid, polyglycolic acid, and copolymers. The shape of the cover before attachment to the device 3000, as shown in Figures 88A and 88B, minimizes wrinkling and results in a smooth surface after attachment to the implant. This shape may be star-shaped, outwardly pointed, or other shapes.

[0258] The cover 3100 may be perforated with a series of openings 3120 (for clarity, only some of the openings 3120 are labeled in the figure). The openings 3120 are perforations or holes formed in the cover 3100 by laser or mechanical cutting. The openings 3120 comprise proximal openings 3122 and lateral openings 3124 (for clarity, only some of the proximal openings 3122 and lateral openings 3124 are labeled in the figure). When the cover 3100 is assembled with the main body 3002, the proximal openings 3122 are positioned on the proximal surface 3008 and / or the stepped portion 3030, and the lateral openings 3124 are positioned on the side wall 3014. In some embodiments, the cover 3100 comprises 40 proximal openings 3122. In some embodiments, the cover 3100 comprises 40 lateral openings 3124. The number of openings 3120 located on the proximal surface 3008 and / or the stepped portion 3030 when assembled with the main body 3002 may be in the range of 10 to 80, 20 to 70, 30 to 60, 35 to 50, or 40 openings 3120. The number of openings 3120 located on the side wall 3014 may be in the range of 10 to 80, 20 to 70, 30 to 60, 35 to 50, or 40 openings 3120.

[0259] The opening 3120 can have various sizes. The width of the opening 3120, for example, the minor axis, or the diameter of a circular opening, is 0.070". The width of the opening 3120 may be about 0.010" to about 0.200", about 0.020" to about 0.150", about 0.030" to about 0.110", about 0.040" to about 0.100", about 0.050" to about 0.090", 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", for example, 0.25", 0.5", or more. These widths may apply to circular, and even non-circular, openings 3120.

[0260] In some embodiments, the openings 3120 can take on various shapes. The openings 3120 may be elongated slots. The openings 3120 may extend radially along the cover 3100 from or near the central portion of the proximal surface 3102 toward and / or to the outer edge 3104. The openings 3120 may be annular openings that extend circumferentially along the cover 3100 and have different radial positions. The openings 3120 may be of uniform size and shape. Some of the openings 3120 may have different sizes and / or shapes with respect to others. The openings 3120 may have varying distributions or concentrations around the cover 3100. For example, the openings 3120 may be more densely arranged in various regions, such as along the proximal surface 3102 facing LA, along the stepped portion 3030, etc.

[0261] The opening 3120 allows blood to flow through the device 3000. The opening 3120 may allow blood to flow properly through the device 3000, thereby reducing the risk of occlusion in the bloodstream if the device 3000 causes an embolism within the vascular system. In some embodiments, if the device 3000 causes an embolism, it may act as a stationary filter at low pressures but allow blood to pass through at higher pressures. In some embodiments, the device 3000 allows blood to pass through at a pressure drop of <30 mmHg at a rate of about 2 to 14 liters per minute, about 4 to 12 liters, about 6 to 10 liters, or about 8 liters per minute, preventing shock in the event of embolism in the device. In some embodiments, there are 40 circular openings 3120, each with a diameter of 0.070" and allowing approximately 8 liters of blood per minute to pass through with a pressure drop of <30 mmHg. In some embodiments, the proximal end of the device 3000 may be a foam layer such as a foam proximal surface 3008 or a membrane such as a cover 3100, or both, surrounding a cavity 3028 defined within the tubular sidewall 3014 of the main body 3002. In one implementation having both a foam proximal surface 3008 and a cover 3100, the foam main body 3002 has a continuous-cell structure, further described herein, which allows blood to pass through but blocks the leakage of debris that could cause embolism. The cover 3100 may be occludable to blood flow and is present to provide structural integrity and friction reduction for drawing the expanded main body 3002 back into the deployment catheter.

[0262] In one implementation, the cover 3100 is ePTFE in a form that is substantially occludable to blood flow, as described. Thus, in this embodiment, the cover 3100 is provided with a plurality of perfusion windows or openings 3120, so that blood can pass through the open-cell foam and the cover 3100, but the device 3000 still benefits from other properties of the cover 3100.

[0263] In some embodiments, device 3000 may tolerate a specific flow rate of water under specified conditions to test the perfusion performance of device 3000. Device 3000 may have a foam body 3002 and a cover 3100 configured to tolerate a flow rate of water passing axially through device 3000 of at least 4 liters per minute. The water may be 68 degrees Fahrenheit (F) or about 68°F, and its upstream pressure may be 25 milliliters of mercury (mmHg) or about 25 mmHg. In some embodiments, device 3000 may be configured to tolerate a flow rate of water from about 1 liter to about 7 liters per minute, from about 2 liters to about 6 liters per minute, from about 3 liters to about 5 liters per minute, more than 2 liters, more than 3 liters, or more than 4 liters per minute under such conditions. The specific flow rate may depend on the porosity of the foam body 3002 and the open area of ​​the cover 3100. The specific flow rate may also depend on the features of the inner cover 3101. The cover 3100 may have a specific percentage of coverage area with a series of openings, as further described herein, to achieve a specific desired flow rate. The flow rate of water under specified conditions may be used to extrapolate or otherwise calculate the corresponding expected flow rate of blood in the body passing through the device 3000, in case it causes embolism, as further described herein. The device 3000 may tolerate cardiac indexes of about 1.6–2.4, about 1.7–2.3, about 1.8–2.2, about 1.9–2.1, about 2.0, or 2.0 liters per square meter per minute. The device 3000 may have these and other flow capabilities, being aligned, nearly aligned, or off-axis in the direction of fluid flow, as further described herein, for example, in the section “Off-axis delivery and deployment”, and the device 3000 may be angled with respect to the direction of fluid flow (flow axis).

[0264] Figures 87A to 87C show one embodiment of the LAA occlusion device 3000 having another embodiment of the cover 3300. The device 3000 comprises a foam body 3002 and a frame 3040, as described herein, and its feature parts, in addition to a cover 3300. The cover 3300 may have the same or similar features and / or functions as the cover 3100, and vice versa. The cover 3300 is located on the proximal end 3004 of the device 3000. The cover 3300 covers the proximal surface 3008 of the body 3002 and the proximal portion of the side wall 3014. The cover 3300 has a proximal surface 3302. The cover 3300 has an outer edge 3304 that forms a plurality of at least two, four, six, eight, ten or more outer vertices 3306 (for clarity, only some of the outer vertices 3306 are labeled in the figure). The cover 3300 is attached to the main body 3002 at the outer apex 3306. The proximal anchor 3090 passes through the side opening 3324 at the outer apex 3106 of the cover 3100.

[0265] The cover 3300 comprises a series of openings 3320. The openings 3320 include a proximal opening 3322, a stepped opening 3323, and a side opening 3324. The proximal opening 3322 is located on the proximal end 3004 of the main body 3002. The stepped opening 3323 is located on a stepped portion 3030 of the main body 3002, for example, a bevel. The side opening 3324 is located on the proximal portion of the side wall 3014 of the main body 3002. The proximal anchor 3090 may penetrate the side opening 3324 located at the outer apex 3106. The openings 3320 may have the same or similar features and / or functions as the opening 3120, and vice versa. In some embodiments, the proximal anchor 3090 may penetrate the cover 3300 at or near the outer apex 3106.

[0266] Figure 88A shows another embodiment of a cover 3150 that may be used with device 3000. Cover 3150 may have the same or similar features and / or functions as cover 3100 and / or cover 3300, and vice versa. Cover 3150 may be used to cover the proximal surface 3008 of the main body 3002 and a portion of the side wall 3014. Cover 3150 has a proximal surface 3152. Cover 3150 has an outer edge 3154 that forms an outer apex 3156. Cover 3150 may be attached to the main body 3002 at the outer apex 3156. A proximal anchor 3090 may penetrate the outer apex 3156 of cover 3100. Cover 3150 has a series of openings 3170. The opening 3170 comprises a proximal opening 3172 and a lateral opening 3174 (for clarity, only portions of the openings 3170, 3172, and 3174 are labeled in the figure). When the cover 3150 is assembled with the main body 3002, the proximal opening 3172 is positioned above the proximal end 3004 and the lateral opening 3174 is positioned above the side wall 3014. As shown, the openings 3174 may be distributed substantially uniformly along the cover 3150 except in the central region of the proximal surface 3152.

[0267] Figure 88B is a top view showing another embodiment of the proximal cover 3151 that may be used with the various LAA occlusion devices described herein. Figure 88C is a top view showing the cover 3151 assembled with the device 3000. Unless otherwise noted, the cover 3151 has the same or similar features and / or functions as the other covers described herein, such as the cover 3100 and / or cover 3300, and vice versa. For example, the cover 3151 may comprise a proximal surface 3152 and an outer edge 3154 that forms an outer apex 3156.

[0268] The cover 3151 further comprises another embodiment of a series of openings 3171. The openings 3171 comprise a smaller opening 3175 and a larger opening 3173. The openings 3175, 3173 have the same or similar features and / or functions as other cover openings such as openings 3120, 3122, 3124, 3320, 3322, 3324, 3170, 3172, and / or 3174, and vice versa. The smaller opening 3175 is relatively smaller in terms of width and / or area compared to the larger opening 3173. There may be openings with widths or areas of any size smaller than the smaller opening 3175, or larger than the larger opening 3173, or in between. As illustrated, the openings 3173, 3175 may generally be uniformly distributed around the proximal surface 3152 of the cover 3151. The openings 3173 and 3175 may be arranged at equal intervals or approximately evenly on the circumference around the cover 3151.

[0269] Each of the openings 3173 and 3175 can have a variety of different quantities. Of the series of openings 3171, there may be 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 150, 200, 300, 400 or more openings, or fewer, more, or in between. The series of openings 3171 may be holes as shown in the illustration. They may have a circular shape. They may have other shapes, including non-circular shapes, segmented shapes, other shapes, or combinations thereof. All the openings 3171 may have the same general shape or different shapes. In some embodiments, the cover 3151 may not have holes.

[0270] When the cover 3151 is assembled with the foam body 3002, the larger opening 3173 and the smaller opening 3175 may be located on the proximal end 3004 and / or side wall 3014 of the foam body 3002. When assembled with the foam body 3002, there may be a total of 140 or approximately 140 openings 3173, 3175 on the proximal-facing portion of the cover 3151. On this proximal-facing portion of the cover 3151, there may be a total of approximately 10 to approximately 300, approximately 50 to approximately 215, approximately 110 to approximately 170, approximately 120 to approximately 160, approximately 130 to approximately 150, or approximately 135 to approximately 155 openings 3173, 3175. There may be approximately 30 to approximately 50, approximately 35 to approximately 45, approximately 40, or 40 large openings 3173 on this proximal-facing portion of cover 3151. There may be approximately 60 to approximately 140, approximately 80 to approximately 120, approximately 90 to approximately 110, approximately 100, or 100 small openings 3175 on this proximal-facing portion of cover 3151.

[0271] When assembled with the foam body 3002, there may be about 5 to about 80, about 10 to about 40, about 15 to about 30, about 20, or 20 smaller openings 3175 on the portion of the cover 3151 located on and / or near the stepped portion 3030, such as on the outer surface 3032 of the foam body 3002 (see, for example, Figure 86B). In some embodiments, there may be about 5 to about 80, about 10 to about 40, about 15 to about 30, about 20, or 20 larger openings 3173 in this same portion of the cover 3151.

[0272] When assembled with the foam body 3002, there may be about 5 to about 80, about 10 to about 40, about 15 to about 30, about 20, or 20 larger openings 3173 on the portion of the cover 3151 located on and / or near the side wall 3014, such as on the outer surface 3016 of the foam body 3002 (see, for example, Figure 86B). In some embodiments, there may be about 5 to about 80, about 10 to about 40, about 15 to about 30, about 20, or 20 smaller openings 3175 in this same portion of the cover 3151.

[0273] The larger opening 3173 and the smaller opening 3175 may have a variety of different sizes, as described herein, for example, with respect to opening 3122. In some embodiments, the openings 3173 and 3175 may have diameters ranging from about 0.025 inches to about 0.040 inches. In some embodiments, the larger opening 3173 may have a diameter of 0.040 inches or about 0.040 inches. The larger opening 3173 may have a diameter of about 0.030 inches to about 0.050 inches, or about 0.035 inches to about 0.045 inches. These values ​​may refer to the width of the non-circular larger opening 3173, for example, the maximum width. In some embodiments, the smaller opening 3175 may have a diameter of 0.025 inches or about 0.025 inches. The smaller openings 3175 may have a diameter of approximately 0.015 inches to approximately 0.035 inches, or approximately 0.020 inches to approximately 0.030 inches. These values ​​may also refer to the width of the non-circular smaller openings 3175, for example, the maximum width.

[0274] A series of openings 3171 may be configured to form an open area of ​​a desired size through the cover 3151. This open area refers to the total area of ​​a particular opening within the cover 3151. The cover 3151 may cover the proximal surface 3008 of the proximal end 3004 of the foam body 3002. The open area may refer to the openings through the portion of the cover that is above the proximal surface 3008 of the foam body 3002 when assembled with the foam body 3002. A series of openings within various covers described herein may collectively form an open area. For example, a series of openings 3171 in the cover 3151 above the proximal surface of the foam may collectively form an open area. This is the sum of the areas of the openings within the cover 3151 above the proximal surface. As a further example, this open area may be the sum of the proximal openings 3122 of the cover 3100. As a further example, this open area may be the sum of the proximal openings 3322 of the cover 3300.

[0275] The open area may be at least 5% of the area of ​​the proximal surface 3008 of the foam body 3002. The open area may be at least 6%, at least 7%, at least 8%, at least 9%, at least 10%, at least 11%, at least 12%, at least 13%, at least 14%, at least 15%, at least 16%, at least 17%, at least 18%, at least 19%, at least 20%, at least 25%, at least 30%, at least 40%, or at least 50% of the area of ​​the proximal surface 3008. The open area may be about 1 to about 50%, about 5 to about 20%, about 8 to about 15%, about 10 to about 12%, or about 11% of the area of ​​the proximal surface 3008. Here, the "area" of the proximal surface 3008 is Pi × R 2 It is understood that R refers to an area equal to , where R is the radius of the proximal surface 3008 and extends perpendicularly from the longitudinal axis of the device 3000. Furthermore, "R" may be measured to the inner boundary of the stepped portion 3030, the outer boundary of the stepped portion 3030, or the outer surface 3016 of the side wall 3014. Furthermore, as mentioned above, some embodiments may not have a cover at all.

[0276] The cover 3151 may have one or more windows 3177. As shown, there may be 10 windows 3177. There may be one window 3177 for each proximal anchor 3090. There may be 4, 6, 8, 12, 14 or more windows 3177, or fewer or in between. The windows 3177 may be openings in the cover 3151. The windows 3177 may be located at or near the outer edge 3154 of the cover 3151. The windows 3177 may be located along a portion of the outer edge 3154, for example, at or near the outer vertex 3156. The windows 3177 may have a shape that conforms to the shape of the cover 3151 at each portion of the outer edge 3154. As shown, the windows 3177 may be diamond-shaped or generally diamond-shaped. The window 3177 may be square, rectangular, triangular, round, circular, arched, flattened diamond, other polygonal shapes, other shapes, or combinations thereof. The cover 3150 may be attached to the main body 3002 at the outer vertex window 3177. The window 3177 may have the same or similar features and / or functions as the side opening 3324 described and illustrated in Figure 87B. A proximal anchor 3090 may pass through the window 3177 of the cover 3151 to hold the cover 3151 on the device 3000.

[0277] Figures 88D to 88E are side and perspective views, respectively, of another embodiment of the proximal cover 3153, shown assembled with the device, which may be used with the various LAA occlusion devices described herein. Unless otherwise noted, the cover 3153 has the same or similar features and / or functions as the other covers described herein, such as covers 3100, 3151 and / or cover 3300, and vice versa. For example, the cover 3151 may comprise a proximal surface 3152, an outer edge 3154 forming an outer apex 3156, and a window 3177.

[0278] A device 3000 comprising a cover 3151 may have proximal anchors 3090 penetrating windows 3177. The proximal anchors 3090 may penetrate the openings of each window 3177. The proximal anchors 3090 may penetrate the distal portion of the window 3177, contributing, for example, to securing the cover 3151 to the device 3000. The proximal anchors 3090 may penetrate the window 3177 at its distal edge or distal apex. In some embodiments, the proximal anchors 3090 may penetrate the material of the cover 3151, for example, material adjacent to (distal to, for example) the window 3177. In some embodiments, the proximal anchors 3090 may penetrate various other arrangements within the window 3177, adjacent to the window 3177, or near the window 3177. A portion of the proximal anchor 3090 may penetrate the first arrangement, while other portions of the proximal anchor 3090 may penetrate a second arrangement of the cover 3153 that differs from the first arrangement. For example, one or more anchors 3090 may penetrate a first area of ​​the window 3177, one or more other anchors 3090 may penetrate a second area of ​​the window 3177, and one or more further other anchors 3090 may penetrate other areas, such as the material of the cover 3153.

[0279] The cover 3153 may have a proximal vertex 3155. The proximal vertex 3155 may be formed by an outer edge 3154. The proximal vertex 3155 may be a recess along the outer edge 3154 of the cover 3153, and may be angled, for example, as shown, or have other shapes, configurations, etc. The proximal vertex 3155 may define a region 3106A on the outer surface 3106 of the side wall 3104. Region 3016A may be partially enclosed by the outer edge 3154 of the cover 3153. Region 3016A may be designed to receive one or more distal anchors 3094 through it. The distal anchors 3094 may penetrate the distal portion of region 3106A or penetrate into other arrangements within region 3106A, adjacent to region 3106A, or near region 3106A. In some embodiments, the distal anchor 3094 does not need to penetrate or extend near region 3016. There may be multiple such regions 3016A of the foam body portion 3002 defined circumferentially around the device 3000 by the cover 3153.

[0280] The cover 3153 may comprise a series of openings 3320, for example, as described with respect to Figure 87A. The series of openings 3320 may comprise a proximal opening 3172, a stepped opening 3323, and / or a side opening 3174. The cover 3153 may include different patterns, sizes, distributions, etc., of the openings 3320, for example, as illustrated and described with respect to Figures 88B to 88C.

[0281] 3. Compliant Frame An expandable compliant support or frame 3040 is shown, for example, in Figures 85B, 85D, 86C, and 87C–87E. Figures 89A and 89B are a side view and a proximal perspective view, respectively, of the frame 3040 in an unfolded configuration, separated from the rest of the device 3000. The frame 3040 comprises a compliant structure having anchors to facilitate delivery, anchoring, and removal, and to facilitate the compression and sealing of the LAA tissue by the foam body 3002, among other things, as will be further described. The frame 3040 is located inside the cavity 3028 formed by the foam body 3002. In some embodiments, the frame 3040 may be located inside one or more portions of the body 3002, partially or as a whole, for example, within the proximal surface 3008 and / or side wall 3014, as will be further described. For example, the frame 3040 may be partially positioned within the side wall 3014, as shown in Figure 87C.

[0282] The frame 3040 has a proximal end 3042 and a distal end 3004 opposite to it. In a free and unconstrained state, the frame 3040 may be tubular, for example, cylindrical. Therefore, the width of the proximal end 3042 may be the same as or similar to the width of the distal end 3004 in a free and unconstrained state. In some embodiments, the frame 3040 or a part thereof may be conical or frustoconical, for example, if in a free and unconstrained state the width of the proximal end 3042 is wider than the width of the distal end 3004 or vice versa.

[0283] At the proximal end 3042, the frame 3040 has a proximal hub 3050, illustrated as a cylindrical nipple. The hub 3050 is a round structural end piece. The hub 3050 may have a tubular, for example, circular, cylindrical shape as illustrated, or it may be rounded, non-circular, segmented, other shapes, or a combination thereof. The hub 3050 extends axially and may have a central lumen. The hub 3050 may be wider than or equal to its length. The hub 3050 is hollow and has side walls that define a space through which to pass, such as a longitudinal opening. In some embodiments, the hub 3050 may be partially hollow, solid, or otherwise configured. The hub 3050 facilitates the delivery and removal of the device 3000, as further described herein. The hub 3050 may include a central structural mounting section, as further described herein. The hub 3050 may be located within the cavity 3028 at the proximal end. In some embodiments, the hub 3050 may be located partially or completely within the foam body 3002, for example, within the proximal surface 3008.

[0284] Pin 3051 may be positioned within the hub 3050 (as shown in Figures 89A and 89B). Pin 3051 is an elongated, rounded structural element extending laterally across the central lumen. "Lateral" refers to a direction perpendicular to, or generally perpendicular to, the longitudinal axis. Pin 3051 has a cylindrical shape. Pin 3051 has a rounded outer surface configured to form a smooth engaging surface for the tether, as further described. Pin 3051 provides a high-strength connection with the frame 3040, allowing the device 3000 to be pulled with sufficient force and the device 3000 to be re-sheathed. Pin 3051 may be formed from nitinol. Pin 3051 is fixed across the width, e.g., diameter, of the proximal hub 3050. Pin 3051 may be fixed at the sidewalls of the hub and at two opposing ends. Pin 3051 is configured to be engaged by a tether 3240, which is wrapped around pin 3051 in a sliding engagement for temporary attachment to a delivery catheter, as further described. In some embodiments, pin 3051 is assembled with a cap 3180, as further described herein, for example with respect to Figures 90A-90C.

[0285] The frame 3040 at the proximal end 3042 includes a proximal surface 3060. The proximal surface 3060 may be located within the cavity 3028 at its proximal end. In some embodiments, the proximal surface 3060 may be located partially or completely within the foam body 3002, for example, within the proximal surface 3008 and / or the side wall 3014. The proximal surface 3060 includes a series of recapture or reentry struts 3061. The struts 3061 are located at the proximal end of the cavity 3028. In some embodiments, the struts 3061 or a portion thereof may be located partially or completely within the foam body 3002, for example, within the proximal surface 3008 and / or the side wall 3014.

[0286] The strut 3061 is an elongated structural member. The strut 3061 may have a rectangular, circular, or other shaped cross-sectional shape. In some embodiments, the strut 3061 has a cross-sectional shape, for example, a rectangular shape, with a width greater than its thickness, such that the strut 3061 is more rigid in one direction than in another. This width may be in a direction that is generally perpendicular to the lateral or longitudinal axis of the device 3000 when the device 3000 is in an extended configuration, and the thickness is perpendicular to the width. The strut 3061 may be less rigid in the bending or flexing direction, for example, to facilitate the contraction and expansion of the device 3000 in a delivery and extended configuration. The strut 3061 may be an elongated pin. The strut 3061 may, for example, extend from the hub 3050 and inclined radially outward distally from the hub 3050. The strut 3061 may be attached to the inside, outside, and / or end of the sidewall of the hub 3050. The strut 3061 may be a separate component subsequently attached to the hub 3050, for example, by welding, bonding, fastening, other preferred means, or a combination thereof. In some embodiments, some or all of the strut 3061 and the hub 3050 may be a single continuous structure formed from the same raw material, such as laser-cut hypo tubing. Some or all of the strut 3061 may be attached to the body 3002 and / or cover 3100 at one or more mounting positions, for example, by sutures as described herein.

[0287] Each recapture strut 3061 may comprise an inner curved portion 3062, a middle straight portion 3064, and / or an outer curved portion 3066 connected to the distal end of the hub 3050 (for clarity, only some of portions 3062, 3064, and 3066 are labeled in the figure). In the deployed configuration, the inner curved portion 3062 extends exclusively distally from the hub 3050 and then curves further outward radially. The middle straight portion 3064 extends exclusively radially, but also slightly distally, from the inner curved portion 3062. The outer curved portion 3066 extends exclusively radially from the middle straight portion 3064 and then curves distally. These portions may have different shapes in the delivery configuration inside the delivery catheter. In the delivery configuration, these portions may extend exclusively distally. These portions may then take on an unfolded configuration as described after being unfolded from the delivery catheter. In some embodiments, strut 3061 may contain fewer or more portions than portions 3062, 3064, and 3066.

[0288] The device 3000 may include 10 of the proximal recapture struts 3061. Such a configuration may involve the device 3000 having a foam body 3002 with an outer diameter of 27 mm in a free, unconstrained state. Such a configuration may involve the device 3000 having a foam body 3002 with an outer diameter of 35 mm in a free, unconstrained state. In some embodiments, the device 3000 may have a number of struts 3061 ranging from about 2 to about 30, about 4 to about 20, about 6 to about 18, about 8 to about 16, about 10 to about 14, or any other number.

[0289] In the deployed configuration, each strut 3061 may extend distally radially outward at an angle to the axis. This angle may be approximately 60° to approximately 89.9°, approximately 65° to approximately 88.5°, approximately 70° to approximately 85°, approximately 72.5° to approximately 82.5°, approximately 75° to approximately 80°, or other angular amounts when measured with respect to the portion of the axis extending distally from the device 3000. This angle may be considerably smaller when the device 3000 is within the delivery catheter. The strut 3061 may bend or bend when transitioning between the delivery configuration and the expanded configuration, or when positioned therein. The strut 3061 may bend or bend at the inner curved portion 3062, the middle straight portion 3064, and / or the outer curved portion 3066.

[0290] Therefore, the proximal end 3042 of the frame 3040, such as the proximal surface 3060, may have a conical shape in the expanded configuration. A conical proximal surface 3060 can facilitate the recapture of the device 3000 into the delivery catheter. For example, the orientation of the strut 3061, which is inclined distally and radially outward from the hub 3050 in the expanded configuration, results in a conical shape that is advantageous to the proximal surface 3008, as distal movement of the delivery sheath on the device 3000 biases the strut 3061 inward, allowing the device 3000 to be repacked into the delivery configuration and size for removal into the catheter.

[0291] The proximal surface 3060 shortens considerably after expansion of the device 3000 with respect to the delivery configuration. “Shortened” here refers to the difference in axial length of the proximal surface 3060 between the shortened delivery configuration and the expanded configuration (expanded either freely or when implanted). This length may be measured axially from the distal or proximal end of the hub 3050 to the distal end of the outer curved portion 3066 of the recapture strut 3061. The proximal surface 3060 may shorten by 50%, 60%, 70%, 80%, 90%, or more. The post-expansion shortening of the proximal surface 3060 is significantly greater than that of the tubular body portion 3080, the latter of which may be referred to as the “working length” or “landing zone.” The landing zone is further described herein in relation to the tubular body portion 3080.

[0292] As illustrated, the struts 3061 are arranged at a constant angle around the axis in even-numbered angular increments. That is, the angles between the struts may be equal when the frame 3040 is viewed from the distal or proximal end. In some embodiments, the struts 3061 may not be arranged at equal angles around the axis as described. The struts 3061 may or may not be arranged symmetrically around the axis or around a plane containing the axis.

[0293] In some embodiments, a portion of the frame 3040 may be at various distances from the proximal end of the foam body 3002, for example, at the proximal end wall having the proximal surface 3008. As shown in Figure 87D, there may be an axial gap of size Z between the proximal surface 3060 of the frame 3040 and the inner surface 3012 of the proximal surface 3008. The length of Z may be 1 millimeter, 2 millimeters, 3 millimeters, 4 millimeters, 5 millimeters, 6 millimeters, 7 millimeters, 8 millimeters, 9 millimeters, 10 millimeters, or more. The length of Z may vary depending on the radial distance over which it is measured. For example, the length of Z may decrease, increase, or be a combination of these changes when measured along the length of the strut 3061. In some embodiments, the length of Z may be zero at more points along the length of the strut 3061. As shown in Figure 87E, the proximal surface 3060 or a portion thereof may be in contact with the proximal inner surface 3012 of the foam body 3002. The inner curved portion 3062, the straight portion 3064, and / or the outer curved portion 3066 may contact the proximal end wall, such as the inner surface 3012 and / or other portions of the foam body 3002. The hub 3050 may slightly compress the proximal surface 3008 or proximal end wall of the foam body 3002 in the proximal direction, as shown. Thus, the proximal surface 3008 may have a smaller thickness in this compressed region compared to other portions of the proximal surface 3008, for example, portions adjacent to this compressed portion. The hub 3050 may be positioned based on the axial position connecting the anchors 3090, 3094 to the side wall 3014, as described herein. In some embodiments, the hub 3000 does not need to compress the foam body 3002, as shown. In some embodiments, the proximal surface 3060 may extend radially outward, as shown. For example, the strut 3061, or a part thereof, such as a straight section 3064, may extend radially outward perpendicular to the longitudinal axis of the device 3000, or generally perpendicularly.The proximal surface 3060 may extend radially outward and be inclined distally or proximally, as described herein. The device 3000 may have any of these features in a constrained configuration, an unconstrained configuration, and / or an implanted configuration.

[0294] The frame 3040 comprises a tubular body portion 3080. The body portion 3080 comprises a mechanical base structure for the device 3000, as further described. The tubular body portion 3080 is attached to the distal end of the proximal surface 3060 of the frame 3040. The tubular body portion 3080 extends to the distal end 3044 of the frame 3040. The tubular body portion 3080 is attached to the distal end of the proximal surface 3060 of the frame 3040. The tubular body portion 3080 extends to the distal end 3044 of the frame 3040. The tubular body portion 3080 is attached at its proximal end to the outer curved portion 3066 of the recapture strut 3061, as further described. The tubular body portion 3080 may be attached to other parts of the recapture strut 3061. The tubular body portion 3080 of the frame 3040 may be attached to the body portion 3002 and / or cover 3100 in one or more mounting arrangements, for example, using sutures as described herein. The tubular body portion 3080 may be located within the cavity 3028. In some embodiments, the tubular body portion 3080 may be located partially or completely within the foam body portion 3002, for example, within the side wall 3014.

[0295] The tubular body portion 3080 comprises a series of proximal struts 3082 and distal struts 3086 (for clarity, only some of the struts 3082 and 3086 are labeled in the figure). The proximal struts 3082 and / or distal struts 3086 may have rectangular, circular, or other shaped cross-sectional shapes. In some embodiments, the proximal struts 3082 and / or distal struts 3086 have a width that is greater than their thickness, or vice versa, such as a rectangular cross-section, so that the struts 3061 are more rigid in one direction than in another. The struts 3061 may be less rigid in the bending or flexing direction, for example, to facilitate the contraction and expansion of the device 3000 in delivery and expansion configurations. The proximal ends of a pair of adjacent proximal struts 3082 are joined at the proximal apex 3084. Each proximal strut 3082 connects to the outer curved portion 3066 of one of the recapture struts 3061 at its respective proximal vertex 3084. Each distal end of a proximal strut 3082 connects to the distal end of an adjacent proximal strut 3082, and to the proximal ends of two distal struts 3086 at the intermediate vertex 3087. A pair of adjacent distal struts 3086 extend distally and join at their respective distal vertices 3088. The repeating pattern 3089, shown as a rhombus, may be formed by adjacent pairs of proximal struts 3082 and adjacent pairs of distal struts 3086. Some or all of the proximal struts 3082 and / or distal struts 3086 may be attached to the main body 3002 and / or cover 3100 at one or more attachment positions, for example, with sutures as described herein. Some or all of the proximal struts 3082 and / or distal struts 3086 may be located within the cavity 3028. In some embodiments, some or all of the proximal struts 3082 and / or distal struts 3086 may be located partially or completely within the foam body 3002, for example, within the side wall 3014.

[0296] There are as many proximal vertices 3084 as there are distal vertices 3088. As shown, there are 11 proximal vertices 3084 and 11 distal vertices 3088. The number of proximal vertices 3084 and distal vertices 3088 can be at least 7, at least 8, at least 9, at least 10, at least 11, at least 12, at least 13, at least 14, at least 15, at least 16, or fewer or more vertices, respectively. In some embodiments, there are not as many proximal vertices 3084 as there are distal vertices 3088. In some embodiments, multiple rows of the pattern, for example, a rhombus pattern, can be formed by proximal struts 3082 and distal struts 3086. There may be two, three, four, or more rows of the pattern. Some or all of the proximal vertices 3084 and / or distal vertices 3088 may be attached to the main body 3002 and / or cover 3100 at one or more attachment points, for example, with sutures as described herein.

[0297] The main body 3080 in the extended configuration may be tubular, for example, cylindrical or generally cylindrical. The tubular main body 3080 may be cylindrical, round, segmented, polygonal, tubular, other shapes, or combinations thereof, all of which are non-exclusively included under the category of “tubular”. The tubular shape is formed in the extended configuration by the proximal strut 3082 and the distal strut 3086. The tubular shape may also be formed in the extended configuration by the outer curved portion 3066 of the recapture strut 3061. The tubular shape may also be formed by the foam main body 3002 which applies radially outward forces onto the frame 3040. Thus, the frame 3040 may have a proximal conical section and a cylindrical working length. In some embodiments, the main body 3080 may be conical or frustoconical, for example, when the distal end is wider than the proximal end or vice versa.

[0298] The tubular body portion 3080 may be referred to as the “landing zone” as described. This landing zone may refer to the axial length of the body portion 3080 from the most distal end to the most proximal end at the transition point to the recapture strut 3061 in the expanded configuration. The landing zone may have the axial length as measured from the proximal apex 3084 to the distal apex 3088. The length of the landing zone may be 10 mm or about 10 mm. The landing zone may have lengths of about 5 mm to about 15 mm, about 6 mm to about 14 mm, about 7 mm to about 13 mm, about 8 mm to about 12 mm, about 9 mm to about 11 mm, or other lengths. The tubular body portion 3080 may be slightly shortened after expansion of the device 3000 with respect to the delivery configuration. The shortening of the tubular body portion 3080 after expansion is significantly smaller than the length of the proximal surface 3060. The tubular main body portion 3080 can be shortened by approximately 5% or less, 10%, 15%, 20%, or 30%.

[0299] The frame 3040 self-expands after delivery from the sheath. The proximal surface 3060 and the tubular body portion 3080 self-expand. After expansion, the radially outward portion of the tubular body portion 3080 contacts the tissue of the LAA wall, pressing the foam body portion 3002 against the tissue of the LAA wall. The tubular body portion 3080, for example, the proximal strut 3082 and distal strut 3086, contact the inner surface 3018 of the side wall 3014 and compress the side wall 3014, and the outer surface 3016 of the side wall 3014 contacts and compresses the LAA wall.

[0300] When pressed against the LAA wall, the foam body 3002 provides a larger "footprint" than the components of the skeletal frame 3040, forming a complete seal. Thus, the sidewall 3014 acts as a force dissipation layer, spreading the radial forces from the struts 3082, 3086 of the frame 3040 over a larger area compared to the area of ​​each of the struts 3082, 3086 alone (for example, a larger area compared to the area of ​​the radially outward-facing surfaces of the struts 3082, 3086 alone). The use of foam material in the body 3002 and its thickness, such as 2.5 mm, provides an advantage over devices that use thinner, less elastic materials compared to foam in this respect. For example, a thin cloth or similar material pressed against the LAA wall by the skeletal frame would not spread the radial forces, but would sag or even bend in some other way, creating gaps and forming unsealed portions of the LAA wall. The foam body 3002 as described herein takes the shape of an LAA wall, forms a complete circumferential seal, spreads radial forces from the frame 3040, forms a stronger seal with the foam body 3002, and maintains retention force.

[0301] Furthermore, the device 3000 described herein, together with the compressible body 3002, allows for a compliant structural frame 3040 because the radial force required from the frame 3040 is small. For example, existing devices made of incompressible fabric material have less effective seals, and therefore the structural elements of those devices must provide larger radial forces to compensate for and ensure an effective seal, resulting in less compliant devices. In contrast, the device 3000 of the present invention is advantageous in this respect by having a compressible foam body 3002, and among other advantages, it can provide smaller radial forces from the frame 3040 and therefore better compliance while forming an effective seal. This structural configuration has a cascading effect in terms of performance advantages. For example, the compliance of device 3000 allows for off-axis delivery while forming an effective seal, among other advantages, as described further herein.

[0302] The frame 3040 comprises a series of proximal anchors 3090. Each proximal anchor 3090 extends from its respective intermediate vertex 3087. The proximal anchors 3090 may extend from other parts of the tubular body 3080. As shown in the diagram, in the deployed configuration, the proximal anchors 3090 extend radially and proximal from the tubular body 3080. The proximal anchors 3090 may penetrate into adjacent areas of the side wall 3014. The proximal anchors 3090 may penetrate the outer surface 3106 of the side wall 3014 and penetrate tissue adjacent to the device 3000.

[0303] The frame 3040 comprises a series of distal anchors 3094. Each distal anchor 3094 extends from its respective distal vertex 3088. The distal anchors 3094 may extend from other portions of the tubular body 3080. As shown in the diagram, in the deployed configuration, the distal anchors 3094 extend radially and proximal from the tubular body 3080. The distal anchors 3094 may penetrate into adjacent areas of the side wall 3014. The distal anchors 3094 may penetrate the outer surface 3106 of the side wall 3014 and penetrate tissue adjacent to the device 3000. Anchors 3090, 3094 may be inclined radially outward in the proximal direction to engage with tissue and resist proximal movement of the device 3000.

[0304] Anchors 3090 and 3094 are elongated structural members. The tips of anchors 3090 and 3094 may be sharpened to facilitate tissue engagement and penetration. Anchors 3090 and 3094 may be straight and generally extend along their local axis. Anchors 3090 and 3094 may have a curved or other non-straight proximal portion that attaches to the tubular body portion 3080. In some embodiments, anchors 3090 and 3094, or a portion thereof, may be non-straight, curved, rounded, segmented, other trajectories, or a combination thereof. In some embodiments, the tips of the tissue engagements may be curved. In some embodiments, anchors 3090 and 3094 may have engagement features, such as barbs, hooks, or other features, that extend radially away from anchors 3090 and 3094.

[0305] The cross-section of anchors 3090 and 3094 may be rectangular. In some embodiments, the cross-section may be circular, round, non-round, square, rectangular, polygonal, other shapes, or a combination thereof. The cross-section may be uniform or uneven along the length of anchors 3090 and 3094. Anchors 3090 and 3094 may have a thickness of about 0.006" and a width of about 0.008". Anchors 3090 and 3094 may have a thickness ranging from about 0.003" to about 0.009" and a width ranging from about 0.003" to about 0.015". The cross-section of anchors 3090 and 3094 may taper, for example, by decreasing in size towards the distal tip.

[0306] In some embodiments, anchors 3090, 3094 in the deployed configuration are tilted at an angle of about 30° with respect to a portion of the central axis extending proximal to device 3000. This tilt angle may be about 10° to about 50°, about 15° to about 45°, about 20° to about 40°, about 25° to about 35°, or about 30°. This tilt angle of anchors 3090, 3094 in the delivery configuration may be smaller than that in the deployed configuration. Anchors 3090, 3094 may have an angle B, as illustrated and described with respect to Figures 94A to 94C.

[0307] Anchors 3090 and 3094 may have a variety of lengths. The length of anchors 3090 and 3094 is measured from the proximal end connected to the tubular body portion 3080 to the distal tissue-engaging tip of the anchor. In some embodiments, the length of anchors 3090 and 3094 may be about 0.5 mm to about 10 mm, about 1 mm to about 9 mm, about 2 mm to about 8 mm, about 3 mm to about 7 mm, about 4 mm to about 6 mm, about 5 mm, or other longer or shorter lengths. In some embodiments, anchors 3090 and 3094 are 5 mm long. In some embodiments, anchors 3090 and 3094 are about 5 mm long. In some embodiments, anchors 3090 and 3094 have 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. Anchors 3090 and 3094 may each have the same or similar lengths. In some embodiments, anchors 3090 and 3094 do not have to be the same length. In some embodiments, some or all of the proximal anchors 3090 may have a length shorter or longer than some or all of the lengths of the distal anchors 3094. Anchors 3090 and 3094 may have a length L, as illustrated and described with respect to Figures 94A to 94C. Furthermore, the outer tips of anchors 3090 and 3094 may extend to an outer radial arrangement smaller than, the same as, or greater than, the outermost surface of the foam body 3002 in the radial direction, as illustrated and described with respect to Figures 94A to 94C.

[0308] In the extended configuration, anchors 3090 and 3094 extend only as far as the length outside the uncompressed side wall 3014. This length of anchors 3090 and 3094 is measured along the local longitudinal axis of the anchor from the outer surface 3016 of the main body 3002 to the distal tip of the anchor. Anchors 3090 and 3094 may penetrate the side wall 3014 and / or cover 3100, and then be cut so that anchors 3090 and 3094 extend beyond the side wall 3014 and / or cover 3100 by a desired length. In a free and unconstrained state, anchors 3090 and 3094 extend approximately 0.5 mm beyond the outer surface 3016 of the side wall 3014. In some embodiments, in a free and unconstrained state, anchors 3090, 3094 extend beyond the outer surface 3016 of the side wall 3014 for about 0.1 mm to about 1.5 mm, about 0.2 mm to about 1.25 mm, about 0.3 mm to about 1.0 mm, about 0.4 mm to about 0.8 mm, about 0.5 mm to about 0.6 mm, or other longer or shorter lengths. In a compressed state, such as in a delivery configuration or after implantation, anchors 3090, 3094 extend only about 1.0 mm beyond the outer surface 3016 of the side wall 3014. In some embodiments, in a compressed state, anchors 3090, 3094 extend beyond the outer surface 3016 of the side wall 3014 over lengths of approximately 0.25 mm to approximately 2.5 mm, approximately 0.5 mm to approximately 2 mm, approximately 0.75 mm to approximately 1.5 mm, approximately 0.875 mm to approximately 1.125 mm, or other longer or shorter lengths.

[0309] The geometric shapes of anchors 3090 and 3094 offer several advantages. For example, at relatively long lengths, anchors 3090 and 3094 can be made flexible. This can potentially minimize damage to LAA tissue when device 3000 needs to be unanchored and / or removed. Anchors 3090 and 3094 are less susceptible to loss of strength due to off-axis orientation within the LAA. Furthermore, anchors 3090 and 3094 provide high resistance to pull-out. For example, device 3000 can provide a force of at least about 0.5 lb in resistance to movement from the LAA. Such pull-out tests can be simulated in vitro or on a benchtop model, as further described below.

[0310] In the illustrated embodiments, the anchors 3090, 3094 are arranged in two circumferential rows. One row is positioned proximal to the other distal row. Each row has 10 anchors. This configuration can be incorporated into, for example, a device 3000 having a foam body 3002 with a free and unrestricted outer diameter of 27 mm. Each row may have 14 anchors. This configuration can be incorporated into, for example, a device 3000 having a foam body 3002 with a free and unrestricted outer diameter of 35 mm. In some embodiments, a single row of anchors 3090, 3094 may have 2 to 24, 4 to 22, 5 to 20, 6 to 18, 7 to 16, 8 to 15, 9 to 14, 10 to 13 anchors, or more or fewer anchors 3090 or 3094. In some embodiments, there may be only one column or more than two columns of anchors. Anchors 3090, 3094 may be separated from each other on the perimeter in a single column.

[0311] In embodiments having multiple rows of anchors 3090, 3094, the rows may be offset circumferentially, as shown. That is, when viewed from the proximal or distal end of device 3000, the anchors 3090, 3094 are aligned at a constant angle from each other around the axis. The anchors 3090, 3094 do not have to be offset circumferentially, and may be aligned at equal angles when viewed, for example, as described. The anchors 3090, 3094 are positioned axially at or near the middle portion of the side wall 3014. The anchors 3090, 3094 may be positioned such that their tips extend to adjacent tissue at the middle portion of the side wall 3014. The offset and middle positioning of the anchors 3090, 3094 can ensure engagement with the LAA tissue distal to the inlet. The stability of device 3000 is increased by positioning anchors 3090 and 3094 at their maximum width. By using a cylindrical or generally cylindrical device 3000, anchors 3090 and 3094 effectively rest on the maximum diameter of device 3000. The cylindrical shape has advantages over typical LAA occluders, which taper distally and thereby reduce implant stability, and where anchors are positioned at a diameter smaller than the inlet diameter of the occludation surface. In addition to stability, the cylindrical shape of device 3000 along its axial length assists resistance to movement by allowing anchors 3090 and 3094 to be placed in the maximum diameter section of device 3000. In some embodiments, anchors 3090 and 3094 may be positioned proximal, distal, or centrally along the length of the frame body 3080. In some embodiments, anchors 3090 and 3094 do not need to be offset and / or aligned at equal angles.

[0312] Anchors 3090 and 3094 can offer advantageous flexibility compared to existing devices, as demonstrated by draw-out tests. For example, device 3000 was tested to determine the force required to move device 3000 by pulling it proximal outward from a simulated tissue model. Low-durometer silicone tubing with a circular inner diameter (ID) was used as the model. For device 3000, which has a foam body 3002 with an outer diameter of 27 mm in a free, unconstrained state, tubing with IDs of 16.5 mm, 21 mm, and 25 mm was tested. The draw-out force for existing devices decreased significantly and increased up to the 21 mm model, but the force for device 3000 decreased only slightly.

[0313] In the maximum diameter (25mm) model, assuming little interference with the mating, the force on the existing device approaches zero as the anchors rest on the trailing edge of the device with a smaller diameter, causing the device to no longer engage with the model wall. Device 3000 consistently resists movement with a force of approximately 0.7 lbs. The friction resisting the pull-out is so small that this force is almost entirely offset by the resistance from anchors 3090 and 3094. When examining the failure modes, all devices eventually begin to slide out of the model. After failure, anchors 3090 and 3094 either fold back or bend sideways before slippage begins. Assuming that a force of 0.7 lbs is required to fold back all 20 anchors 3090 and 3094, the force per anchor is estimated to be approximately 0.035 lbs.

[0314] The frame 3040 may be laser-cut. The tubular body portion 3080 may be laser-cut from a single tube. The body portion 3080 may be cut from a tube having a thickness of about 0.002" to about 0.014" or about 0.008". The tube may have an outer diameter (OD) of about 0.05" to about 0.30". The tube may have an outer diameter (OD) of 0.124" for a 27mm device 3000 (i.e., an embodiment of device 3000 has a foam body portion 3002 with an OD of 27mm in an unrestricted free state). The tube may have an OD of 0.163" for a 35mm device 3000 (i.e., an embodiment of device 3000 has a foam body portion 3002 with an OD of 35mm in an unrestricted free state).

[0315] In some embodiments, the main body 3080 is laser-cut from a superelastic nitinol tube, but a number of other biocompatible metallic materials such as shape-memory nitinol, stainless steel, MP35N, or Elgiloy may be used. The frame 3040 is self-expandable. In some embodiments, a balloon-expandable frame 3040 may also be used. In addition, the main body 3080 can also be processed from drawn wire, as opposed to being laser-cut from a tube.

[0316] As shown in the illustration, one embodiment of device 3000 comprises a frame 3040 having 10 proximal recapture struts 3061 and a total of 20 anchors 3090, 3094, with the foam body 3002 having an outer diameter of 27 mm. In some embodiments, device 3000 may comprise a frame 3040 having 14 proximal recapture struts 3061 and a total of 28 anchors 3090, 3094, with the foam body 3002 having an outer diameter of 35 mm.

[0317] In one embodiment, the frame 3040 comprises a proximal hub 3050, a tether pin 3051, a front surface with 10 or 14 recapture struts 3061, a rhombic-patterned cylindrical body 3080, and 20 or 28 anchors 3090, 3094. The proximal surface 3060 of the frame supports the recapture, the frame body 3080 supports the foam cylindrical body 3002, and the anchors 3090, 3094 positioned on the cylinder provide resistance to embolus formation.

[0318] The design of Device 3000 offers numerous advantages, some of which have already been described. As further examples, Frame 3040 offers many advantages, including, but is not limited to, 1) radial stiffness / compliance of the implant—Frame 3040 enhances radial stiffness while remaining sufficiently compliant to allow for off-axis implantation, recapture, etc.; 2) resistance to movement—Frame 3040 provides high pull-out strength, as described; 3) transcatheter delivery—Frame 3040 can be compressed and pushed into the delivery catheter and then fully expanded upon delivery; 4) recapture—Frame 3040 allows for recapture / removal into the delivery catheter even after deployment or implantation in the LAA; and 5) mechanical integrity—Frame 3040 possesses sharp and long-term structural integrity, such as the ability to withstand loading into the delivery catheter, deployment from the catheter, and repeated loading / fatigue. The frame 3040 also includes a shape-conforming structure that allows the foam body 3002 to compress the LAA structure, facilitating sealing and anchoring with minimal compression (oversizing). The resulting compliance of the frame 3040 provides better anchoring than existing solutions, as described.

[0319] As a further example, device 3000 seals against irregularly shaped LAA inlet and neck portions. For instance, the combination of a nitinol frame 3040 and a foam body 3002 having a PTFE coating and an ePTFE cover 3100 contributes to device 3000's ability to conform to anatomical structures and seal against irregular protrusions and shapes while forming a smooth antithrombotic LAA surface.

[0320] As a further example, device 3000 provides controlled, safe delivery. The design of the combined frame 3040 and foam body 3002 facilitates delivery in a controlled manner by slowing the rate of expansion. The buffer 3026 acts as a non-invasive anterior portion when delivering the implant into the LAA, reducing the risk of injury. The user can recapture and redeploy device 3000 if necessary. The flexible tether 3240 attachment from the delivery catheter to device 3000, as further described, allows device 3000 to be taut immediately after implantation, thereby enabling the user to ensure final proper positioning before releasing device 3000.

[0321] As a further example, Device 3000 performs simplified implantation. The foam-covered cylindrical design aligns Device 3000 with the central axis of the LAA during non-critical delivery (for example, by allowing off-axis deployment up to 45 degrees), which is designed to simplify the implantation procedure as described further.

[0322] As a further example, Device 3000 performs simple sizing. Thanks to its foam and frame design, only two diameters (e.g., 27mm and 35mm) are needed to accommodate the expected LAA configuration and diameter range (e.g., target LAA diameters from 16 to 33mm). The morphological conformability of the foam and frame allows a 20mm long implant to be fitted into the LAA to a short depth of 10mm. This short landing zone requirement (LAA depth) of Device 3000, combined with the fact that only two implant diameters are needed, enables treatment of a wide range of LAA anatomical structures with minimal need for cumbersome ultrasound and CT sizing. Implant morphological conformability is crucial in facilitating the easy use of a product platform that can adapt to various anatomical structures.

[0323] As a further example, Device 3000 provides antithrombotic materials and design. The removable tether leaves a smooth, metal-free surface within the LA. The antithrombotic materials (PTFE-coated foam and ePTFE cover) form a smooth LA surface (without metal mounting connections), reducing the need for anticoagulation, enhancing antithrombotic properties, and promoting endothelialization.

[0324] As a further example, device 3000 incorporates thin, low-profile anchors 3090 and 3094 around the midpoint of device 3000 to achieve secure yet non-invasive anchor fixation.

[0325] 4. Distal buffer The foam body 3002 has a distal buffer 3026. The buffer 3026 may be a distal region of the foam body 3002, such as the distal portion of the side wall 3014. The buffer 3026 may be a part of the foam body 3002 that extends beyond the distal end 3044 of the frame 3040. The buffer 3026 may extend beyond the distal end 3044 of the frame 3040 in the delivery configuration and the deployed configuration. The body 3002 may be attached to the frame 3040 in various configurations so that the body 3002 can extend, for example in the delivery configuration, in some embodiments, thereby ensuring that the buffer 3026 extends beyond the frame 3040 after initially retracting the sheath during delivery.

[0326] The device 3000 can be adapted in terms of both length and diameter due to the shape compatibility of both the foam body 3002 and the frame 3040. This allows the device 3000 to be adapted to most patient LAA anatomical structures having only two, three or some different sizes of the device 3000, such as the body 3002 with outer diameters of 27 mm and 35 mm as described herein, and one length such as 20 mm. The frame 3040 may therefore be shorter than the foam body 3002, and as a result, in some embodiments, about 5 mm of the foam buffer 3026 is distal to the most distal end of the frame 3040. The distal buffer 3026 acts as a non-invasive tip during delivery of the device 3000 and is compressed after implantation, thereby allowing the device 3000 to be adapted to appendages with a short depth (landing zone) of 10 mm. The ability to accommodate both length and diameter is due to the shape compatibility of both the foam body 3002 and the frame 3040.

[0327] The length of the buffer 3026 can be measured axially from the most distal end of the frame 3040 to the distal surface 3022 of the main body 3002. For example, the buffer 3026 may extend from the distal apex 3088 to the distal surface 3022. The buffer 3026 may have a length of 5 mm or about 5 mm. The buffer 3026 may 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 buffer 3026 may have a length of about 2.5 mm to about 7.5 mm, about 3 mm to about 7 mm, about 3.5 mm to about 6.5 mm, about 4 mm to about 6 mm, or about 4.5 mm to about 5.5 mm.

[0328] In some embodiments, the buffer 3026 may fold in response to axial and / or radial compression of the device 3000. The buffer 3026 may fold inward, for example, radially inward. The fold may be axial or approximately axial. The fold may be circumferential or approximately circumferential. The fold may be a combination of radial and circumferential, or angled thereto. The folding of the buffer 3026 is discussed further herein, for example, in the section "Device Compliance".

[0329] 5. Cap & Pin Figures 90A–90C are proximal perspective views of the frame 3040 having the cap 3180. Figure 90D is a distal perspective view showing the cap 3180. In some embodiments, a pin 3051 is positioned on the diameter of the proximal hub 3050 and serves to engage with the tether 3240 (e.g., a suture) of the delivery catheter, which is wrapped around the pin 3051 for temporary attachment to the delivery catheter 3220, as further described herein with respect to, for example, Figures 89A–89B. As illustrated, the hub 3050 has a pair of opposing lateral openings 3053 that penetrate the side wall of the hub 3050. The cap 3180 has a corresponding pair of opposing lateral openings 3190 that penetrate the side wall 3184 of the cap 3180. When the cap 3180 is assembled with the hub 3050, the pin 3051 can be inserted through the aligned pair of openings 3053, 3182. The assembly can be further secured by welding the end of pin 3051 to hub 3050.

[0330] As shown in Figure 90D, the cap 3180 comprises a proximal end 3182 and a distal end 3184. The cap 3180 includes a rounded side wall 3186 extending from the proximal end 3182 to the distal end 3184. The side wall 3186 defines a longitudinal opening 3188 passing through the cap 3180. The side wall 3186 includes a pair of lateral openings 3190 positioned opposite each other. The cap 3180 includes a flange 3192 at the proximal end 3182, which extends radially outward.

[0331] The cap 3180 is formed from titanium, and the pin 3051 is formed from nitinol or superelastic nitinol. In some embodiments, the cap 3180 and / or the pin 3051 may be formed from other materials, such as shape memory nitinol, stainless steel, MP35N, Elgiloy, polycarbonate, polysulfone, polyetheretherketone (PEEK), or polymethyl methacrylate (PMMA), or a number of other biocompatible metallic or polymer materials.

[0332] The cap 3180 facilitates attachment to the tether 3240. The cap 3180 and pin 3051 also reduce damage to the foam body 3002 during recapture of the device 3000. The cap 3180 also forms a non-invasive surface on the frame 3040 relative to the hub 3050. For example, the cap 3180 can prevent the hub 3050 from cutting through the foam body 3002 when the device 3000 is folded into the access sheath. Without the cap 3180, the sharp edges of the hub 3050 would shear the foam body 3002 during recapture of the device 3000 into the access sheath.

[0333] 6. Loading System Figure 91 is a side view showing one embodiment of a loading system 3200 for loading device 3000 into delivery catheter 3220. The system 3200 comprises a loading tool 3210. The loading tool 3210 has a conical portion 3212 with a distal opening 3213 and a cylindrical portion 3214. The delivery catheter 3220 passes through the cylindrical portion 3214, and the distal end 3222 of the delivery catheter 3220 is positioned within the cylindrical portion 3214. A pusher 3230, such as a pusher catheter, passes through the delivery catheter 3220. A tether 3240 (see Figures 92A to 92C) is attached to device 3000 and passes through the loading tool 3210, delivery catheter 3220, and pusher 3230. The tether 3240 and pusher 3230 are retracted proximal while the delivery catheter 3220 and loading tool 3210 are held in place. The device 3000 is compressed laterally by the conical portion 3212 as it is retracted proximal by the tether 3240 through the loading tool 3210. The distal end 3232 of the pusher 3230 remains adjacent to the proximal end 3004 of the device 3000 as it is loaded into the delivery catheter 3220. The removable tether 3240 is often fabricated from ultra-high molecular weight polyethylene (UHMWPE) and is used to attach the implant to the delivery catheter. The UHMWPE material for the tether 3240 provides high strength to the device 3000 and also enables low friction for smooth delivery of the device 3000.

[0334] In some embodiments, the conical portion 3212 of the loading tool 3210 has a chamfered distal edge of about 45° to 75°, preferably 60°. In some embodiments, the conical portion 3212 has a distal inner diameter (ID) greater than the outer diameter (OD) of the device 3000, ideally between 15° and 25°, and in one mounting configuration, an angle A of about 20°, which may be used to fold anchors 3090, 3094 that protrude from the surface of the foam body portion 3002 at an angle of 30° or about 30°. The distal opening of the conical portion 3210, for example, its diameter or maximum width, may be greater than the proximal opening of the conical portion 3210 that connects with the cylindrical portion 3214, for example, its diameter or maximum width. The cylindrical portion 3214 may have an opening, such as a diameter or maximum width, that is smaller than the distal opening of the conical portion 3210 and / or the same size as or similar to the opening at the proximal end of the conical portion 3210.

[0335] The decreasing width of the loading tool 3210, for example, a gradually changing taper, ensures that, for example, the frame 3040 folds evenly without crossing or extra distortion. The angled conical portion 3212 may ensure that the anchors 3090, 3094 fold or rotate proximal rather than distal. The sidewalls of the conical portion 3212 may extend to a “total” angle A measured between two opposing portions of the sidewall, as shown in Figure 91. Angle A may be about 12° to about 35°, about 15° to about 30°, about 17° to about 25°, about 18° to about 22°, about 20°, or 20°. Angle A may be at least 10°, at least 15°, at least 20°, at least 25°, or at least 30°. Angle A may be constant along the axial length of the conical portion 3212. The angle of the conical portion 3212 may be described with respect to the longitudinal geometric centroid axis defined by the conical portion 3212 and / or cylindrical portion 3214. The sidewalls may extend in a direction that forms an angle with respect to such a longitudinal axis and is half the value of the total angle A. Thus, this “half angle” may be at least 5°, at least 7.5°, at least 10°, at least 12.5°, or at least 15°, etc. The conical portion 3212 may have a frustoconical shape. The cross-sectional shape of the conical portion 3212 perpendicular to the longitudinal axis may be circular or substantially circular. In some embodiments, this cross-section may be round, non-circular, arcuate, other shapes, or a combination thereof. The cross-sectional shape of the conical portion 3212 may be constant along its axis or may be different along its axis. In some embodiments, angle A may vary along the axial length of the conical portion 3212, for example, the inner surface may be curved in the axial direction.

[0336] The loading tool 3210 may be smooth or generally smooth on its inner surface or multiple surfaces. The inner surfaces 3211, 3215 of the conical portion 3212 and / or cylindrical portion 3214 are smooth or generally smooth. In some embodiments, these inner surfaces 3211, 3215 or parts thereof may not be smooth. In some embodiments, these inner surfaces 3211, 3215 or parts thereof may be smooth, rough, etched, scratched, grooved, having varying degrees of roughness or smoothness, having other features, or a combination thereof.

[0337] In one example, the tool 3210 may be used by positioning the proximal end of the loading body, such as the tool 3210, adjacent to the distal end 3222 of the delivery catheter 3220. The loading body may have side walls defining a channel through which the distal opening 3213 at the distal end is larger than the proximal opening at the proximal end. The left atrial appendage occlusion device 3000 is fed proximally and passed through the loading body, thereby allowing the device 3000 to be compressed radially. The retraction step may include pulling the tether 3240 proximally and passing it through the delivery catheter 3220. The device can then be received within the distal end 3222 of the delivery catheter 3220. The device 3000 can be compressed radially within the delivery catheter 3220 having an outer diameter of 15 French or less. In some embodiments, the device 3000 can be radially compressed within a delivery catheter 3220 having an outer diameter of 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 French or less. The proximal end of the loading tool 3210 may have an inner diameter configured to result in an interlocking fit with the distal end 3222 of the delivery catheter 3220. The proximal end 3210 of the loading tool, such as a cylindrical portion 3214, may have an inner diameter slightly larger than the outer diameter of the delivery catheter 3220, for example, slightly larger than 5 mm for a delivery catheter 3220 having an outer diameter of 15 French. The device 3000 can be radially compressed to a restricted compression width smaller than 50%, 40%, 30%, 20%, 10%, and / or 5% of the unrestricted radial uncompressed width of the device. Here, the radial width can be measured perpendicular to the longitudinal axis of the device 3000, as defined by the tubular foam body portion 3002.

[0338] The loading tool 3210 may be formed from a material that is biocompatible, strong, transparent, and can be molded smoothly to minimize friction, such as polycarbonate. In some embodiments, the loading tool 3210 may be formed from rigid plastics such as Delrin, UHMWPE, Ultem®, polyetherimide, acrylic, metal, such as stainless steel, aluminum, other materials, or combinations thereof. In some embodiments, the loading tool 3210 may have one or more coatings. Such coatings may be applied to reduce friction and therefore load force. The coatings may be silicone, hydrophilic substances, various oils, other suitable coatings, or combinations thereof.

[0339] 7. Delivery System Figure 92A is a schematic side view of a delivery system 3201 for delivering device 3000. Figures 92B to 92C are additional drawings of system 3201. As shown in Figure 92A, the delivery system 3201 comprises a delivery catheter 3220 having a distal end 3222 and a proximal end 3224. The delivery system 3201 comprises a pusher 3230, such as a pusher catheter, having a distal end 3232 and a proximal end 3234. A tether 3240 comprises a first end 3242 and a second end 3244. A restraint 3246 secures the first en...

Claims

1. A left atrial appendage occlusion device, A foam body having a tubular side wall whose thickness is uncompressed in the radial direction, An expandable support connected to the main body, A left atrial appendage occlusion device comprising: at least one anchor bonded to the support and penetrating the side wall when the foam of the side wall is compressed, the at least one anchor having a radial height in the radial direction of the side wall that is less than or equal to the uncompressed thickness.

2. The left atrial appendage occlusion device according to claim 1, wherein the device defines a central axis, and the at least one anchor is angled with respect to the central axis.

3. The left atrial appendage occlusion device according to claim 2, wherein the at least one anchor extends radially outward in the proximal direction at an angle of at least 20 degrees with respect to a portion of the central axis extending proximal to the device.

4. The left atrial appendage occlusion device according to claim 3, wherein the angle is at least 30 degrees.

5. The left atrial appendage occlusion device according to claim 1, wherein the at least one anchor penetrates a radially compressed portion of the side wall having a radial thickness smaller than the radially uncompressed thickness.

6. The left atrial appendage occlusion device according to claim 5, further comprising a mounting device for connecting the support to the side wall and for radially compressing the side wall at the radially compressed portion.

7. A left atrial appendage occlusion device, A foam body having a tubular side wall comprising at least one first portion having a first radial thickness and at least one second portion having a second radial thickness smaller than the first radial thickness, An expandable support connected to the main body, A left atrial appendage occlusion device comprising the support and at least one anchor that is coupled to at least one second portion of the side wall and at least partially penetrates it.

8. The left atrial appendage occlusion device according to claim 7, wherein the device defines a central axis, and the at least one anchor is angled with respect to the central axis.

9. The left atrial appendage occlusion device according to claim 8, wherein the at least one anchor extends radially outward in the proximal direction at an angle of at least 20 degrees with respect to a portion of the central axis extending proximal to the device.

10. The left atrial appendage occlusion device according to claim 9, wherein the angle is at least 30 degrees.

11. The left atrial appendage occlusion device according to claim 8, wherein the at least one anchor penetrates the at least one second portion of the side wall such that a portion of the at least one anchor extends outward beyond the outer surface of the at least one second portion of the side wall.

12. The left atrial appendage occlusion device according to claim 8, wherein the at least one anchor has an axial length equal to the first radial thickness.

13. The left atrial appendage occlusion device according to claim 7, wherein the support comprises a tubular frame portion configured to expand radially outward after implantation of the device, compressing the side walls and pressing against the wall of the left atrial appendage.

14. The left atrial appendage occlusion device according to claim 7, further comprising a proximal cover that covers at least a portion of the proximal surface of the foam body.

15. A left atrial appendage occlusion device, A tubular foam body having a compressible side wall comprising at least one first portion having a first radial thickness and at least one second portion having a second radial thickness smaller than the first radial thickness, The system comprises an expandable support connected to the main body, The device described above, Inserting into the non-cylindrical opening of the rigid test body having a non-cylindrical outer shape, Expanding radially within the non-cylindrical opening, A left atrial appendage occlusion device configured to conform in shape to the non-cylindrical outer shape at least at the opening of the test body.

16. The left atrial appendage occlusion device according to claim 15, wherein the compressible side wall extends between the proximal and distal ends and defines a central cavity.

17. The left atrial appendage occlusion device according to claim 16, wherein the expandable support is configured to compress the side wall and press against the inner surface of the test body.

18. The left atrial appendage occlusion device according to claim 15, wherein the device, after being shaped to a non-cylindrical outer shape, leaves no radial gap between the device and the test body having a maximum radius dimension of more than 5 millimeters.

19. The left atrial appendage occlusion device according to claim 18, wherein the device, after being shaped to a non-cylindrical outer shape, leaves no radial gap between the device and the test body having a maximum radius dimension of more than 3 millimeters.

20. The left atrial appendage occlusion device according to claim 15, further comprising at least one anchor coupled to the frame and at least partially penetrating the tubular foam body portion.

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