CN112367929A - Device and method for excluding left atrial appendage - Google Patents

Abstract

Devices and methods for occluding the Left Atrial Appendage (LAA) are described. The device excludes the LAA from the bloodstream to prevent clotting and subsequent embolization of blood within the LAA, particularly in atrial fibrillation patients. The implantable device is delivered into the LAA and secured within the LAA by transcatheter delivery. The implant includes an expandable and conformable frame and an expandable and conformable tubular foam. The device may have an anti-thrombotic coating on the proximal end. The frame may have a retrieval support that is inclined radially outward from the central hub. The frame may have axially extending sidewall supports, with adjacent pairs of sidewall supports joined at one or more vertices. Anchors extend from the frame and into the foam to engage tissue.

Description

Device and method for excluding left atrial appendage

Incorporation by reference of any related application

The present application is an international application entitled "apparatus and method FOR EXCLUDING the left atrial appendage (DEVICES AND METHODS FOR EXCLUDING THE LEFT ATRIAL APPENDAGE)" filed on 2.5.2018 and claiming priority thereto, the disclosure of which is incorporated by reference in its entirety FOR all purposes and forms a part of this specification.

Technical Field

The present development relates generally to systems, devices and methods for excluding the Left Atrial Appendage (LAA). In particular, described herein are systems, devices, and methods for excluding LAAs using expandable foam implants having expandable and compliant frames.

Background

Atrial fibrillation (Afib) is a condition in which the normal beating of the Left Atrium (LA) is disorganized and ineffective. The Left Atrial Appendage (LAA) is the blind pocket (blid pouch) that emerges from the LA. In Afib patients, blood stagnates in the LAA and clots are easily formed. These clots (or clot fragments) have a tendency to embolize or exit the LAA and enter the systemic circulation. A stroke occurs when the clot/clot fragment embolises and blocks one of the arteries that perfuse the brain. Anticoagulants, such as, for example, coumarine sodium acetylacetonate, have been shown to significantly reduce the risk of stroke in patients with Afib, these drugs reduce clot formation, but also increase bleeding complications, including hemorrhagic stroke, subdural hematoma, and gastrointestinal bleeding.

In the US and EU, there are approximately eight million people with Afib. Of these patients, about 460 million are at high risk for stroke and would benefit from anticoagulation. A large number of these patients are unable to take anticoagulants due to the increased risk of bleeding, thereby defeating their stroke risk. The incidence of Afib increases with age.

Existing devices for occluding the LAA have drawbacks. Existing devices are provided in a variety of sizes and they must closely fit the anatomy of the vas that is changing dramatically. This is difficult to use with fluoroscopy and usually requires assisted imaging in the form of transesophageal echocardiography (TEE), cardiac CT and MRI, all using three-dimensional reconstruction. If the device is significantly oversized, the LAA ostium may be overstretched, resulting in tearing and leakage into the pericardial space. If the device is too small, it will not adequately seal the ostium and may be susceptible to embolization. Even if sized correctly, the device will force the oval LAA ostium to take on the circular shape of the device, which often results in residual leakage at the edges due to poor sealing.

Existing devices require sufficient spring force or stiffness to seal and anchor to the surrounding tissue. If too stiff, these devices may cause blood to leak through the tissue into the pericardial space, which may result in pericardial tamponade. In addition, the geometry of these devices limits the reduction of the implant when it is fully expanded. Existing devices also complicate delivery by requiring coaxial positioning in the LAA with the axis of the LAA.

Accordingly, there is a need for improved LAA occlusion devices.

Disclosure of Invention

The embodiments disclosed herein each have several aspects, no single one of which is solely responsible for its desirable attributes. Without limiting the scope of this disclosure, its more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section entitled "detailed description of certain embodiments" one will understand how the features of the embodiments described herein will provide advantages over existing systems, devices, and methods for Left Atrial Appendage (LAA) occlusion.

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

Devices and methods are described for occluding the LAA (LAA) to exclude the LAA from the blood stream, thereby preventing blood from clotting within the LAA and subsequently embolizing, particularly in atrial fibrillation patients. The LAA occlusion device is delivered to the LAA by transcatheter delivery and anchored using a compliant (compliant) frame and foam. Among other advantages, the device conforms to the elliptical shape of the LAA with excellent sealing effect, does not require excessive size and therefore does not require extensive preoperative imaging, and can be delivered off-axis, thereby making the delivery procedure simpler.

A foam body that can be in a tubular shape and a compliant frame inside or within the foam body are described that contract when delivered and then expand when in place within the LAA. The foam may have a coating at least partially on an outer surface of the foam. The coating may be a Polytetrafluoroethylene (PTFE) layer. The device is anchored by structural anchors of the frame and/or by tissue ingrowth from the Left Atrium (LA) and LAA into the foam. Additionally or alternatively, some embodiments are anchored by a separate or integrated repositionable anchor, by barbs, and/or by a distal anchoring member. For example, anchors extending from a compliant frame are described that deploy through a compressible foam plug (foam plug). In some embodiments, repositionable atraumatic anchoring system embodiments are also disclosed, which may be separate structures or integrated into the foam plug and/or skin.

The foam may be at least partially covered by a proximal cover (cover, lid, covering). The cover layer may be an expanded polytetrafluoroethylene (ePTFE) cover layer. The cover layer provides several advantages as follows: sufficient strength to enable handling of the plug without tearing; allowing the plug to be reset and retrieved; providing an antithrombotic (antithrombotic, thromboresistant, anticoagulant) surface within the LA, which will promote neointimal formation; helping to create an occlusion zone designed to promote anti-thrombosis and endothelialization from blood and adjacent tissue and an anchoring zone designed to promote rapid and firm ingrowth of tissue from adjacent non-blood tissue to the compressible implant; and may assist in closure of the opening. Cover layers, e.g., layers, jackets, skins, etc., may be separate or may be attached to the foam, e.g., by stitching, adhesives, etc. In some embodiments, a retrieval tip may be attached at one or more points to aid in retrieval of the embolic device and to improve radiopacity.

Some embodiments move relative to the guide wire track and have a guide wire lumen within the expandable foam to enable placement of the guide wire and then self-seal once the guide wire is removed. Some embodiments do not require a guidewire lumen. Further, some embodiments may be multifunctional and include functions for resection, pressure sensing, drug-elution, pacing, electrical isolation, and the like.

In one aspect, a left atrial appendage occlusion device includes a tubular foam body and a cover layer. The tubular foam body extends axially from a proximal end to a distal end. The covering layer includes a portion covering at least the proximal end. The portion covering the proximal end comprises a series of through openings. The foam and cover layer are configured such that the flow rate of water axially through the device is at least four liters per minute, the water is about sixty-eight degrees fahrenheit (F) and the upstream pressure is about twenty-five millimeters of mercury (mmHg).

Various embodiments of the aspects may be implemented. In some embodiments, the body may include a compressible sidewall extending between the proximal end and the distal end and defining a central lumen. The left atrial appendage occlusion device can further include an expandable support coupled to the body and configured to compress the sidewall against the wall of the left atrial appendage. The foam body may include a proximal face having an area, and the series of openings in the cover layer may collectively provide at least five percent of the open area of the proximal face. The open area may be at least ten percent of the area of the proximal end face. The open area may be at least fifteen percent of the area of the proximal end face. The water stream may flow along a 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 thirty degrees relative to the flow axis. The device may be configured such that the off-axis flow rate of water through the device is at least four liters per minute, the water is about sixty-eight degrees fahrenheit (F) and the upstream pressure is about twenty-five millimeters of mercury (mmHg). The off-axis flow may have at least thirty degrees relative to the axial flow.

In another aspect, a left atrial appendage occlusion device includes a tubular foam body and a cover layer. The tubular foam body extends axially from a proximal end to a distal end. The covering layer includes a portion covering at least the proximal end. The portion covering the proximal end comprises a series of through openings. The foam body includes a proximal face having an area located proximally. The series of openings in the cover layer collectively provide an open area of at least five percent of the area of the proximal end face.

Various embodiments of the aspects may be implemented. In some embodiments, the open area may be at least ten percent of the area of the proximal face. The open area may be at least fifteen percent of the area of the proximal end face. The foam and cover layer may be configured such that the flow rate of water axially through the device is at least four liters per minute, the water is about sixty-eight degrees fahrenheit (F) and the upstream pressure is about twenty-five millimeters of mercury (mmHg). The body may include compressible sidewalls extending between the proximal and distal ends and defining a central lumen. The left atrial appendage occlusion device can further include an expandable support coupled to the body and configured to compress the sidewall against the wall of the left atrial appendage.

In another aspect, a method of loading a left atrial appendage occlusion device into a delivery catheter is described. The method includes positioning a proximal end of a loading body adjacent to a distal end of a delivery catheter, the loading body having a sidewall defining a through-channel having a distal opening at a distal end larger than a proximal opening at the proximal end. The method further includes proximally withdrawing the left atrial appendage occlusion device by adding a carrier to thereby radially compress the device, the device comprising a foam, and placing the device back into the distal end of the delivery catheter.

Various embodiments of the aspects may be implemented. In some embodiments, the loading body may comprise a frustoconical portion. The loading body may define a central longitudinal axis, and the sidewall may extend at an angle of at least five degrees relative to the longitudinal axis. The sidewall may extend at an angle of at least ten degrees relative to the longitudinal axis. The sidewall may extend at an angle of at least fifteen degrees relative to the longitudinal axis. The sidewalls may define a total angle of at least ten degrees, at least twenty degrees, or at least thirty degrees. The advancing step may include pulling the tether proximally through the delivery catheter. The device may be radially compressible within a delivery catheter having an outer diameter of no more than fifteen Fr. The inner surface of the loading body may be substantially smooth. The method may include radially compressing the device within the delivery catheter to a radially compressed width of no more than twenty percent of a radially uncompressed width of the device. The radially compressed width within the delivery catheter may be no more than fifteen percent of the radially uncompressed width of the device.

In another aspect, a left atrial appendage occlusion device includes a foam body, an expandable support, and at least one anchor. The foam body has a tubular sidewall having a radially uncompressed thickness. An expandable support is coupled to the body. At least one anchor is coupled to the support and extends through the sidewall when the sidewall foam is compressed and when a radial height of the at least one anchor is not greater than a radial uncompressed thickness of the sidewall.

Various embodiments of the aspects may be implemented. In some embodiments, the device may define a central axis and the at least one anchor may be angled relative to the central axis. The at least one anchor may extend radially outward in the proximal direction at an angle of at least twenty degrees relative to a portion of a central axis extending proximally of the device (proximally extending to the device from the proximal end to the device). The angle may be at least thirty degrees. The at least one anchor may extend through a radially compressed portion of the sidewall having a radial thickness less than the radially uncompressed thickness. The left atrial appendage occlusion device can further include an attachment (attachment, connector) that connects the buttress to the sidewall and radially compresses the sidewall at the radially compressed portion. The device may further include a proximal cover layer covering at least a portion of the proximal face of the foam body.

In another aspect, a left atrial appendage occlusion device includes a foam body, an expandable support, and at least one anchor. The foam body has a tubular sidewall including 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. An expandable support is coupled to the body. At least one anchor is coupled to the support and extends at least partially through the at least one second portion of the sidewall.

Various embodiments of the aspects may be implemented. In some embodiments, the device may define a central axis and the at least one anchor may be angled relative to the central axis. The at least one anchor may extend radially outward in a proximal direction at an angle of at least twenty degrees relative to the central axis. The angle may be at least thirty degrees. The at least one anchor may extend through the at least one second portion of the sidewall such that a portion of the at least one anchor extends outwardly beyond an outer surface of the at least one second portion of the sidewall. The at least one anchor may have a length equal to the radial uncompressed thickness of the tubular sidewall. The buttress may include a tubular frame portion configured to expand radially outward to compress the sidewall against the left atrial appendage wall after implantation of the device. The device may further include a proximal cover layer covering at least a portion of the proximal face of the foam body.

In another aspect, a left atrial appendage occlusion device includes a tubular foam body and an expandable support coupled to the body. The device is configured to be inserted into a non-cylindrical opening of a test body having a non-cylindrical profile, radially expand within the non-cylindrical opening and conform to the non-cylindrical profile at least at the opening of the test body.

Various embodiments of the aspects may be implemented. In some embodiments, the device may be configured to conform to a non-cylindrical profile at least at the opening of the test body and leave no radial gap between the device and the test body opening of greater than five millimeters. The device may not leave a radial gap of more than four, three, two and/or one millimeter. The device may be configured to be inserted into a non-cylindrical opening of a test body having a non-cylindrical profile substantially similar in size and shape to a native left atrial appendage. The device may be configured to be inserted into a non-cylindrical opening of a test body having a radial stiffness substantially similar to a native left atrial appendage and to exhibit a non-cylindrical profile at least at the opening of the test body after a period of at least thirty days, at least sixty days, and/or at least one hundred twenty days. The device may further include at least one anchor coupled with the frame and extending at least partially into the tubular foam.

In some embodiments, the foam body may include compressible sidewalls extending between the proximal and distal ends and defining a central cavity. The left atrial appendage closure device can also include an expandable support coupled with the foam and configured to compress the sidewall against an inner surface of the test body.

In another aspect, a left atrial appendage occlusion device includes a tubular foam body and an expandable support coupled to the body. The device has a radially uncompressed width. The device is configured to be radially compressed to a radially compressed width of no more than fifty percent of the radially uncompressed width.

Various embodiments of the aspects may be implemented. In some embodiments, the radially compressed width may be no more than forty percent of the radially uncompressed width. The tubular foam body may extend along a longitudinal axis and the radially uncompressed width may extend along a diameter of the foam body perpendicular to the longitudinal axis.

In another aspect, a left atrial appendage occlusion device includes a tubular foam body and an expandable support coupled to the body. The device extends axially from a proximal end to a distal end, and the proximal end has a radially uncompressed width. The distal end is configured to be radially compressed to a radially compressed width of no more than fifty percent of a radially uncompressed width of the proximal end.

Various embodiments of the aspects may be implemented. In some embodiments, the distal end may be configured to be radially compressed to a radially compressed width of no more than forty percent of the radially uncompressed width of the proximal end. The radially compressed width may be no more than thirty percent, no more than twenty percent, no more than ten percent, and/or no more than five percent of the proximal radially uncompressed width.

In another aspect, a left atrial appendage occlusion device includes a tubular foam body and an expandable support coupled to the body. The device has an axially uncompressed length. The device is configured to be axially compressed to an axially compressed length of no more than fifty percent of the axially uncompressed length.

Various embodiments of the aspects may be implemented. In some embodiments, the axially compressed length may be no more than forty percent of the axially uncompressed length. The axially uncompressed length may extend from a proximal end of the foam body to a distal end of the foam body.

In another aspect, a left atrial appendage occlusion device is described. The device includes a conformable tubular foam, a compressible sidewall, and an expandable support. The conformable tubular foam has closed proximal and distal ends. The compressible sidewall extends between the proximal end and the distal end and defines a central lumen. An expandable support is positioned within the body and configured to compress the sidewall against the wall of the left atrial appendage.

In some embodiments, the sidewall can have an uncompressed thickness of at least about 0.5 mm. The compressible sidewall can have an uncompressed thickness of at least about 1.5 mm. The compressible side wall may have an uncompressed thickness of about 2.5 mm. The compressible sidewall can extend in an unconstrained, expanded state in a distal direction at least about 2mm beyond the distal end of the buttress. The compressible sidewall may extend in an unconstrained, expanded state in a distal direction about 5mm beyond the distal end of the buttress. The compressible sidewall may include a foam having a plurality of interconnected cells and voids, and further including a PTFE coating on at least some of the interconnected cells. The closed proximal end may include a foam end wall. The foam end wall may also include a cover layer. The cover layer may comprise ePTFE. The expandable support may be self-expandable. The expandable support may be in the central lumen. The tubular foam body may be substantially cylindrical in an unconstrained, expanded state.

In another aspect, a self-expandable, non-invasive occluding device is described. The device is configured to fit the left atrial appendage sidewall. The device includes a compressible open cell foam, a self-expandable support, and a proximal end wall. The compressible open-cell foam has tubular foam sidewalls and a central cavity. An expandable support is located within the cavity. The proximal end wall is located on the foam body. The proximal end wall is positioned proximally of the support and the foam sidewall extends distally beyond the distal end of the support to form a distal atraumatic bumper for preventing contact between the support and the left atrial appendage wall in implants in which the central longitudinal axis of the occluding device is not parallel to the major longitudinal axis of the left atrial appendage.

In another aspect, a left atrial appendage occlusion device is described. The device includes an expandable tubular foam cup and an expandable frame. The expandable tubular foam cup has a proximal end, a distal end, a tubular sidewall, and a proximal end wall. The sidewall has a thickness of at least about 1.0mm and a porosity of at least about 85% open void content (void content, porosity). The expandable frame is configured to press the side wall into conformal contact with the left atrial appendage wall.

In some embodiments, the tubular sidewall can have a thickness of at least about 2 mm. The tubular sidewall can have a void content of at least about 90%. The tubular sidewall can have an average pore size of at least about 100 microns. The tubular sidewall can have an average pore size of at least about 200 microns. The tubular sidewall may be provided with an anti-thrombogenic coating. The anti-thrombogenic coating may comprise PTFE. The proximal end wall may be provided with an anti-thrombotic coating. The frame may also include at least three retrieval struts that slope radially inward toward the hub in a proximal direction. The frame may comprise a plurality of axially extending sidewall supports, wherein adjacent pairs of sidewall supports are joined at an apex. The frame may comprise at least six proximally facing vertices and at least six distally facing vertices. Each retrieval support may be attached to a unique proximally facing apex on the frame. The recovery support may be integrally formed with the frame. The device may also contain a lumen through the hub. The device may also contain anchors to secure the device to tissue. The anchor may be a flexible anchor configured to extend through the foam sidewall at an oblique angle.

In another aspect, a conformable LAA occlusion device is described. The device includes a compressible tubular foam wall. The wall comprises a reticulated, crosslinked matrix having a void volume of at least about 90%, an average cell size (cell size) in the range of about 250-500 microns, a wall thickness of at least about 2mm, and a compressive strength of at least about 1 psi. In some embodiments, the compressive strength is in the range of about 1psi to about 2 psi. In some embodiments, the device may have an expandable support configured to compress the sidewall against the wall of the left atrial appendage.

In another aspect, a 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. After implantation in the LAA, the proximal end is configured to face the left atrium and the distal end is configured to face the LAA. The body may be compressed for delivery within the delivery catheter and may self-expand when removed from the delivery catheter. An internal locking system is coupled to the body and includes at least one deployable tissue anchor. The deployable anchor is configured to deploy from a constrained configuration to a deployed configuration in vivo, wherein the tissue-engaging portion of the anchor extends beyond the body to secure the body within the LAA. The deployable anchor is configured to deploy into a deployed configuration after the body is expanded within the LAA. The deployable anchor may be retractable in vivo from a deployed configuration to a retracted configuration.

In some embodiments, the internal locking system further comprises a plurality of deployable anchors rotatably coupled to the body, wherein the plurality of anchors are configured to rotate to a deployed and retracted configuration. The internal locking system may comprise four deployable anchors. In some embodiments, the body further comprises a plurality of axially extending slots corresponding to the plurality of anchors, wherein each of the plurality of anchors is configured to be deployed and retracted through the respective axial slot.

In some embodiments, the internal locking system further comprises a restraint that restrains the anchor in the restrained configuration and deploys the anchor from the restrained configuration to the deployed configuration by removing the restraint from the anchor. The restraint may be a shroud that restrains the anchor in a restrained configuration by covering the anchor, wherein the anchor is deployed from the restrained configuration to a deployed configuration by removing the shroud covering the anchor. The restraint may be a lasso that restrains the anchor in the restrained configuration by surrounding the anchor, and deploys the anchor from the restrained configuration to the deployed configuration by removing the lasso surrounding the anchor.

In some embodiments, the internal locking system further comprises a movable mount coupled to the distal end of the anchor, and the anchor is deployed from the constrained configuration to the deployed configuration by axially moving the mount.

In some embodiments, the internal locking system further comprises a restriction configured to move the anchor apart to cause retraction of the anchor. The constraint may be a loop configured to slide over the anchor to cause the anchor to retract.

In some embodiments, the skin layer comprises ePTFE.

In some embodiments, the device further comprises at least one tissue ingrowth surface on the sidewall of the body.

In some embodiments, the device further comprises a plurality of openings in the skin to allow tissue ingrowth into the open cell foam. The plurality of superficial openings may be located in an anchoring region of the device at least between the proximal and distal ends of the device, and the device may further comprise an occlusion region located at the proximal end of the device and configured to promote anti-thrombosis and endothelialization from blood and adjacent tissue.

In another aspect, a LAA closure system is described. The system includes a delivery catheter and a LAA occlusion device. The delivery catheter includes an elongate flexible tubular body having proximal and distal ends and at least one lumen extending therethrough. The LAA occlusion device is configured to be compressed within a delivery catheter and to self-expand from the delivery catheter upon deployment. The device comprises a self-expandable open-cell foam body coupled with an internal locking system. The internal locking system includes a deployable anchor configured to deploy from a constrained configuration to a deployed configuration after the body is expanded within the LAA and configured to be retracted from the deployed configuration to a retracted position within the body.

In some embodiments, the system further comprises a lumen extending through the body, an axially movable deployment controller for deploying the deployable anchor. The system may further include a lumen extending through the body, an axially movable deployment controller for deploying the foam body from the closed system distal end. The internal locking system may further include a restraint that restrains the anchor in the restrained configuration and actively deploys the anchor from the restrained configuration to the deployed configuration by removing the restraint from the anchor using an axially moveable deployment controller extending through the lumen of the body. The internal locking system may also include a movable carriage coupled to the distal end of the anchor and actively deploying the anchor from the constrained configuration to the deployed configuration by axially moving the carriage using an axially movable deployment controller extending through the lumen of the body.

In another aspect, a method of excluding LAA is described. The method includes advancing a guidewire into the LAA, advancing a distal end of a delivery catheter over the guidewire and into the LAA, and deploying the LAA occlusion device from the distal end of the delivery catheter. The device includes an expandable foam body coupled with an internal locking system having a deployable anchor, and once deployed from the distal end of the delivery catheter, the body expands within the LAA. The method further includes actively deploying the deployable anchor after the body is expanded within the LAA. The deployable anchor is configured to be retracted from a deployed configuration to a retracted position within the body. In some embodiments, the method further comprises retracting the deployable anchor from the deployed configuration to the retracted position.

In another aspect, a LAA occlusion device is described. The device includes an expandable foam body and an internal locking system. The body may be compressed for delivery within the delivery catheter and may self-expand when removed from the delivery catheter. An internal locking system is coupled to the body and includes a deployable anchor configured to deploy from a constrained configuration to a deployed configuration in vivo, wherein the anchor extends outside the body to secure the body within the LAA. The body is configured to expand upon removal from the delivery catheter, and the deployable anchor is configured to deploy into a deployed configuration upon expansion of the body.

In another aspect, a LAA occlusion device is described. The device includes 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. An internal locking system is coupled to the body and includes a deployable anchor configured to deploy from a constrained configuration to a deployed configuration in vivo, wherein the anchor extends outside the body to secure the body within the LAA. The deployable anchor is configured to be retracted within the body from the deployed configuration to a retracted configuration such that the body can be repositioned within the LAA.

In another aspect, a LAA occlusion device is described. The device includes 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. An expandable tubular foam layer is carried by the frame, and the foam layer has a thickness of at least about 0.5 mm. An embolic retention layer is carried by the frame and surrounds the lumen proximally.

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 void content of at least about 80%. The foam layer may have a void content 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 through the proximal end of the frame to form a tissue scaffold. The tissue scaffold may be provided with an anti-thrombogenic coating. The tissue scaffold may be provided with an anti-thrombotic layer. The anti-thrombotic coating or layer may comprise PTFE. The anti-thrombogenic coating or layer may comprise ePTFE. The frame may further comprise at least three retrieval supports angled radially inward toward the hub in the proximal direction.

In some embodiments, the foam layer extends through a proximal end of the frame to form a tissue skeleton, and the frame may include a plurality of axially extending sidewall supports, wherein adjacent pairs of sidewall supports are joined at an apex. The device may comprise at least six proximally facing apices and at least six distally facing apices. The device may include at least three retrieval supports coupled at a proximal hub, wherein each retrieval support has a distal end coupled to the frame. Each retrieval support may be attached to a unique proximally facing apex on the frame. The recovery support may be integrally formed with the frame. The device may also contain a lumen through the hub.

In some embodiments, the device may include an anchor to secure the device to tissue. The anchor may be a static anchor configured to deploy when the device is deployed from the delivery catheter. The anchor may be a constrained anchor configured for controlled release to a deployed configuration upon expansion of the foam. The anchor may be a dynamic anchor configured to be deployed from a retracted configuration to a deployed configuration, and further configured to be retracted from the deployed configuration back to the retracted configuration. The anchor may be further configured to retract from the deployed configuration back to the retracted configuration.

Drawings

The above and other features of the present disclosure will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. Understanding that these drawings depict only several embodiments in accordance with the disclosure and are not therefore to be considered to be limiting of its scope, the disclosure will be described with additional specificity and detail through use of the accompanying drawings. In the following detailed description, reference is made to the accompanying drawings, which form a part hereof. In the drawings, like numerals generally refer to like components unless context dictates otherwise. The illustrative embodiments in the detailed description, drawings, and claims are not meant to be limiting. Other embodiments may be utilized, and other changes may be made, without departing from the spirit or scope of the subject matter provided herein. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, and designed in a wide variety of different configurations, all of which are explicitly contemplated and make part of this disclosure.

Fig. 1 shows the anatomy of the Left Atrium (LA) and Left Atrial Appendage (LAA).

Fig. 2 shows the LAA with an embodiment of the LAA occluding device implanted in the LAA and using an adhesive.

Figure 3 shows an x-ray image of an embodiment of a LAA occlusion device.

Fig. 4 shows an LAA with an embodiment of the LAA occluding device and distal anchor implanted in the LA.

Figure 5 illustrates an embodiment of a helical anchor that may be used with the various LAA occlusion devices described herein.

Figure 6 shows a longitudinal cross section of an embodiment of the LAA occlusion device.

Fig. 7-15 are sequential schematic cross-sectional views of embodiments of LAAs and delivery systems, illustrating delivery and anchoring techniques that may be used with the various LAA occluding devices described herein, including but not limited to the devices of fig. 85A-90D.

Figure 16 is a side cross-sectional view of an embodiment of a LAA occlusion device having a foam body, a frame, and a proximal cover layer.

Figure 17 is a side cross-sectional view of an embodiment of an LAA occlusion device having a metal coil and foam.

Figure 18 is a side view of an embodiment of a LAA occlusion device having a single metal coil.

Figure 19 is a side view of an embodiment of a LAA occluding device having an enlarged distal tip.

Figure 20 is a side cross-sectional view of an embodiment of a LAA occlusion device having proximal and distal end caps.

Fig. 21 is a schematic view of an embodiment of an implant delivery system that can be used with the various LAA occlusion devices described herein, including but not limited to the devices of fig. 85A-90D.

Fig. 22 is a schematic view of an embodiment of the delivery of an expanded foam system that may be used with the various LAA occlusion devices described herein, including but not limited to the devices of fig. 85A-90D.

Fig. 23 is a side view of a barbed plug that may be used with the various LAA occluding devices described herein, including but not limited to the devices of fig. 85A-90D.

Fig. 24 shows an embodiment of a LAA occlusion device having a retrieval suture attachment that may be used with various LAA occlusion devices described herein, including but not limited to the devices of fig. 85A-90D.

Fig. 25A-26 illustrate embodiments of distal anchoring systems that may be used with the various LAA occluding devices described herein, including but not limited to the devices of fig. 85A-90D.

Fig. 27A-27G are various views of embodiments of LAA occlusion devices with internal locking systems that may be used with the various LAA occlusion devices described herein, including but not limited to the devices of fig. 85A-90D.

FIGS. 28A-28D are various views of an embodiment of an internal locking system that may be used with the device of FIGS. 27A-27G.

Fig. 29A-29B are sequential side views of an unlocking mechanism that may be used with the device of fig. 27A-27G.

Fig. 30 is a side view of an embodiment of a LAA occluding device with flexible anchors that may be used with the various LAA occluding devices described herein, including but not limited to the devices of fig. 85A-90D.

Fig. 31-32 are side views of embodiments of LAA occluding devices having flexible anchor and stiff tubular member configurations that may be used with the various LAA occluding devices described herein, including but not limited to the devices of fig. 85A-90D.

Fig. 33 is a side view of an embodiment of a LAA occlusion device having discrete attachments of an outer skin layer with an inner foam that may be used with the various LAA occlusion devices described herein, including but not limited to the devices of fig. 85A-90D.

Fig. 34 is a side view of the device of fig. 34, including the outer edge.

Fig. 35 is a side view of an embodiment of a LAA occlusion device having an anchor with a deployed V-shaped tip that may be used with the various LAA occlusion devices described herein, including but not limited to the devices of fig. 85A-90D.

Fig. 36 is a side view of an embodiment of a LAA occlusion device having a deployed anchor with a V-shaped tip that may be used with the various LAA occlusion devices described herein, including but not limited to the devices of fig. 85A-90D.

Fig. 37A-37C are side views of various embodiments of anchors that may be used with the various LAA occluding devices described herein, including but not limited to the devices of fig. 85A-90D.

Fig. 38 is a side view of an embodiment of a LAA occluding device implanted within a LAA.

Figures 39A-39B are perspective views of embodiments of deployable anchors that may be used with the various LAA occlusion devices described herein, including but not limited to the devices of figures 85A-90D.

Figures 40A-40B are perspective views of embodiments of deployable anchors that may be used with the various LAA occlusion devices described herein, including but not limited to the devices of figures 85A-90D.

Figures 41A-41B are perspective views of embodiments of deployable anchors that may be used with the various LAA occlusion devices described herein, including but not limited to the devices of figures 85A-90D.

Figures 42A-42D are various views of embodiments of an outer deployable anchor that may be used with the various LAA occlusion devices described herein, including but not limited to the devices of figures 85A-90D.

Figures 43A-43C are sequential side views of embodiments of deployment limits that may be used with the various LAA occlusion devices described herein, including but not limited to the devices of figures 85A-90D.

Fig. 44A-44C are side views of embodiments of adjustable dual-stage anchoring systems that may be used with the various LAA occlusion devices described herein, including but not limited to the devices of fig. 85A-90D.

Figure 45A is a cross-sectional view of an embodiment of an LAA occlusion device shown in an expanded configuration and having a foam cup, a proximal cover, and a deployable frame including a hinge, a retrieval support, and a tubular body.

Fig. 45B and 45C are distal and proximal perspective views, respectively, of the device of fig. 45A.

Figure 46 is a distal end view of the LAA occlusion device of figure 45A.

Figures 47A-47B are a perspective view and a side view, respectively, of the LAA occlusion device of figure 45A with a single piece inner frame.

Fig. 48 is a perspective view of the device of fig. 45A.

Fig. 49-50 are side views of the device of fig. 45A attached to a delivery catheter shown in an expanded configuration and a partially collapsed configuration, respectively, as in embodiments.

Fig. 51-55 are schematic diagrams showing various embodiments of static barbs that may be used with the various occlusion devices described herein, such as the devices of fig. 45A or 85A.

Figures 56-58 are schematic diagrams showing various embodiments of constrained barbs that may be used with the various occlusion devices described herein, such as the devices of figures 45A or 85A.

Fig. 59-65 are schematic diagrams showing various embodiments of dynamic barbs that may be used with the various occlusion devices described herein, such as the devices of fig. 45A or 85A.

Fig. 66A-66C are side views of the implant of fig. 45A with a proximal covering layer.

Fig. 67 shows side and end views of an embodiment of an implant with a grapple anchor.

68A-68B are side and end views, respectively, of an embodiment of an implant having a thicker distal bumper.

FIG. 69 is a side view of an embodiment of an implant with constrained anchors deployed in a second step.

Fig. 70-72 show an embodiment of an implant having a distal anchor and a proximal deceleration strip.

Fig. 73-75 illustrate an embodiment of an implant having a distal ring.

Fig. 76-77 illustrate an embodiment of an implant having an infusion member.

Fig. 78 is a side view of an embodiment of a LAA occlusion device having an ablation device (ablation features) that may incorporate the various LAA occlusion devices described herein.

Fig. 79 is a side view of an embodiment of a LAA occlusion device having a pressure sensing device that may incorporate various LAA occlusion devices described herein.

Fig. 80 is a side view of an embodiment of a LAA occlusion device having a drug eluting device that may incorporate a plurality of LAA occlusion devices as described herein.

Figure 81 is a side view of an embodiment of a LAA occlusion device having a pacing/defibrillation device that may incorporate the various LAA occlusion devices described herein.

Fig. 82-84 illustrate various systems and methods for electrically separating LAAs that may be used with the various LAA occlusion devices described herein.

Fig. 85A-85C are proximal, distal, and side views, respectively, of an embodiment of a LAA occlusion device having a compressible foam, an expandable frame, and a proximal cover layer.

Fig. 85D is a distal end view of the embodiment of the LAA occlusion device of fig. 85A-85C additionally having an inner covering layer and proximal markers.

FIGS. 86A-86B are side and cross-sectional views, respectively, of the compressible foam of FIGS. 85A-85C.

FIG. 86C is a cross-sectional view of the foam of FIGS. 85A-85C with an expandable frame.

Figures 87A-87C are top perspective, side, and cross-sectional views of another embodiment of a LAA occlusion device.

Fig. 87D-87E are side cross-sectional views of various embodiments of the LAA occlusion device of fig. 85D.

Figure 88A is a top view of an embodiment of a proximal cover layer shown in a flat configuration that may be used with the various LAA occlusion devices described herein.

Fig. 88B-88C are top views of another embodiment of the proximal cover layer, shown in a flat configuration and assembled with a LAA occluding device, respectively.

Fig. 88D-88E are side and perspective views, respectively, of another embodiment of a proximal cover layer shown in assembled form with a LAA occlusion device.

Fig. 89A and 89B are a side perspective view and a proximal perspective view, respectively, of the frame of fig. 85B and 86C, shown in an expanded configuration.

Fig. 90A-90C are sequential proximal perspective views of an embodiment of a frame showing an assembly of a cover and a pin with a frame that may be used with the LAA occlusion device of fig. 85A-88E.

Fig. 90D is a distal perspective view of the closure of fig. 90A-90C.

Fig. 91 is a side view of an embodiment of a loading system for loading the device of fig. 85A-88E into a delivery catheter.

Fig. 92A is a side view of a schematic of a transcatheter delivery system for delivering the device of fig. 85A-88E through an artery or vein.

Fig. 92B-92C are proximal and distal perspective views, respectively, of the delivery system of fig. 92A showing an associated tether release mechanism and method.

Fig. 93A and 93B are proximal and distal perspective views, respectively, of another embodiment of a tether release system that may be used with the device of fig. 85A-88E.

Fig. 94A-94C illustrate various embodiments of anchor/foam interfaces that may be used with the LAA occlusion device of fig. 85A-88E.

Fig. 95A is a schematic diagram showing an embodiment of the contour of the ostium and LAA.

Figure 95B is a schematic view of the LAA occluding device of figures 85A-88E implanted in the ostium and LAA of figure 95A, showing the conformability of the device.

Figure 96A is a schematic view of a LAA occlusion device showing the radial compression capabilities of the device of figures 85A-88E.

Figure 96B is a schematic view of a LAA occlusion device showing the axial compression capability of the device of figures 85A-88E.

Figure 97 is a plan view of an embodiment of a laser-cut tube frame, shown in a flat configuration, that may be used as a frame for the LAA occlusion device of figures 85A-88E.

While the above-identified drawing figures set forth embodiments of the disclosure, other embodiments are also contemplated, as noted in the discussion. The present disclosure provides illustrative embodiments by way of illustration and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the embodiments of this disclosure.

Detailed Description

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

Devices and related methods are described herein in connection with use in occlusion, i.e., excluding laa (laa). The various figures illustrate various embodiments of LAA occlusion devices, systems, and methods of delivery of LAA occlusion devices and/or methods of occluding the LAA using the devices. The various systems, devices, and methods described herein may include features and/or functionality identical or similar to other LAA occlusion systems, devices, and methods such as, for example, U.S. application No. 14/203,187 entitled "devices and methods for excluding LAA" filed 3/10/2014 and/or U.S. provisional application No. 62/240,124 entitled "devices and methods for excluding LAA" filed 2015 10/12, the entire disclosure of each of which is incorporated herein by reference for all purposes and forms a part of this specification.

Some embodiments of theLAA occlusion device 3000 include afoam body 3002, a deployable andconformable frame 3040, and aproximal cover layer 3100, as shown and described primarily, for example, with respect to fig. 85A-90D. Other features and functionality that theapparatus 3000 may include and use are shown and described with respect to fig. 1-84 and 91-93B.

Fig. 1 shows aheart 100 having a Left Atrial Appendage (LAA)102, the leftatrial appendage 102 being the cavity emanating from a Left Atrium (LA) 104. The shape of theLAA 102 in various dimensions is very variable. If the heart does not beat abnormally (a condition known as atrial fibrillation), the blood within the LAA becomes stagnant, which promotes clot formation. If blood clots within the LAA, the clots may travel from theLAA 102 into theLA 104, to theleft ventricle 106 and out of theheart 100 into the aorta. The blood vessels that carry the blood to the brain bifurcate in the aorta. If the clot is delivered to the brain through these blood vessels, it may become lodged in the brain and occlude small blood vessels, which then leads to ischemic stroke. Stroke has a serious morbidity associated with it. The opening of theLAA 102 to theLA 104 is referred to as theostium 110. Theostium 110 is elliptical, varies dramatically and depends on the loading condition, i.e., left atrial pressure. The LAA occlusion device described herein is aimed at occluding theostium 110, thereby sealing theLA 104 from theLAA 102.

Figure 2 illustrates one embodiment of a LAA occlusion device. An occluding device or plug 204 is placed within the LAA 200 at the opening of the LAA 200 to the LA 202. It is to be understood that a "plug" as described herein, such asplug 204, can have the same or similar features as other implantable "devices" or "implants" as described herein, such asdevice 10,device 1020,device 3000,foam 3002, and the like, and vice versa. Theplug 204 includes an expandable medium, such as an open-cell foam, that enables theplug 204 to contract and expand, and also improves tissue ingrowth into the foam. Thefoam plug 204 is at least partially encapsulated within a thin,strong layer 206, such as ePTFE (expanded polytetrafluoroethylene), polyolefin, or polyester.Layer 206 may be referred to herein as a "skin layer" or "cover layer" or the like. Alternatively, a bioabsorbable material, such as PLA, PGA, PCL, PHA, or collagen, may be used. Such athin encapsulation layer 206 may be oriented or otherwise modified to be elastomeric in at least one direction, such as radially. Thelayer 206 may have the same or similar features and/or functionality as theoverlay layer 3100, and vice versa.

Theplug 204 may be made of polyurethane, polyolefin, PVA, collagen foam, or blends thereof. One suitable material is a polycarbonate-polyurethaneurea foam having pore sizes of 100 μm to 250 μm or 250 μm to 500 μm and a void content of 90 to 95%. The foam may be non-degradable or use degradable materials such as PLA, PGA, PCL, PHA and/or collagen. If degradable, tissue from the LAA will grow into the foam plug and replace the foam over time. Theplug 204 may be in a cylindrical shape during unconstrained expansion, but it may also be tapered, for example, with its distal end smaller than the proximal end (or vice versa). Its cross-section may also be elliptical to better match the LAA opening.

Thefoam plug 204 is oversized in the radial direction in an unlimited expansion to fit snugly to the LAA, and may be 5-50mm in diameter based on the diameter of the target LAA. In the free, unconstrained state, the axial length "L" of the plug is less than its outer diameter "D", so that the L/D ratio is less than 1.0. In some embodiments, the ratio may be greater than 1.0. The conformability of the foam material is designed so that it presses against the LAA wall with sufficient force to maintain theplug 204 in place, but without overstretching the LAA wall. When expanded, the foam and/or skin also conforms to the irregular surface of the LAA to provide a surface structure complementary to the natural LAA wall to further improve anchoring and promote sealing. Thus, the expandable foam implants described herein conform to the natural configuration of LAA. In one embodiment, the foam structure may be manufactured such that axial compression on opposite ends of the foam causes the foam to increase in diameter.

One or two or more radiopaque markers may be provided to the ePTFE or foam material, such asradiopaque wire 210, or filled or infused with radiopaque fillers, such as barium sulfate, bismuth subcarbonate, or tungsten, which allow the operator to view the plug under x-rays for proper positioning in the anatomy. In fig. 3, an x-ray image is shown in which the foam plug 300 is not observable, but thelines 302 and curl (crimp)304 (as discussed below) are clearly observable. Such awire 302 or ribbon may be made of a radiopaque wire or tube, such as platinum, platinum-iridium or tungsten, or a polymer with a radiopaque filler, such as barium, bismuth, tantalum, tungsten, titanium or platinum.

The outer ePTFE layer can be formed of a tube having a diameter approximately the same as the diameter of the foam plug and a wall thickness between about 0.0001 "to about 0.001" thick and is used to allow it to collapse and press onto theplug 204 without tearing the foam material. The ePTFE material also serves as the blood contactsurface facing LA 206 and has pores or knots so that blood components coagulate on the surface and the intima or neointima covering of the tissue grows through it and is tightly anchored to the material. Pore sizes in the range of about 4 μ to about 110 μ, desirably 5-35 μ, are useful for neointimal formation and attachment.

Outer cover 206 may be constructed of materials other than ePTFE, such as woven fabrics, screens, or perforated films made of FEP, polypropylene, polyethylene, polyester, or nylon. Thecover layer 206 should have low compliance (inelastic), be strong enough in at least the longitudinal direction to allow removal of the plug, have a low coefficient of friction and be anti-thrombotic.Outer cover 206 serves as a matrix to allow plug removal because most foams are not strong enough to withstand tearing when pulled. Theplug 204 may also be coated with or contain a material, such as PTFE. These materials may improve the ultrasound echo spectrum, thrombus prevention, and/or smoothness of theplug 204. Theplug 204 may also be coated with or contain a material to facilitate echocardiography, promote cellular ingrowth and coverage.

Theouter cover 206 has holes therein to allow LAA tissue to contact thefoam plug 204 to promote tissue ingrowth into the foam plug hole and/or to allow blood to flow therethrough. The holes may be 1 to 5mm in diameter or may be oval, with the major axis aligned with the axis of the foam plug, may be 80% of the length of the foam plug and may be 1-5mm wide. The apertures may be as large as possible so that the outer cover layer maintains sufficient strength to transmit the pulling force required for removal. The holes may preferably be arranged along the device. In one embodiment, the aperture is distally disposed to enhance tissue ingrowth from the LAA wall.

In one implementation, the implant is provided with proximal and/or distal ePTFE covers that are joined together by two or three or four or more axially extending ePTFE strips. The axially extending strips are circumferentially spaced from one another to provide at least two or three or four or more laterally facing windows through which the open-cell foam body will be in direct contact with the LAA tissue wall. The outer cover may also be a screen or mesh. As shown in fig. 20, the coveringlayers 2004 are only on the proximal and distal faces of theplug 2000. They may be glued to the foam plug and then crimped to thecenter tube 2002.

Theimplantable plug 204 ordevice 10, 1020, 3000 (described below) may be anchored and fixed in place in the LAA by tissue ingrowth and/or by additional anchoring means. In some embodiments, the anchoringplug 204 or thedevice 10, 1020, 3000 may be tissue ingrowth alone.

In some embodiments, other anchoring means may be implemented. One way to adhere 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 into a location along the sidewall near the distal end of thefoam plug 208. The pores in the ePTFE cover allow the adhesive to interact between thefoam plug 204 and the LAA wall 200. Injection of the adhesive may be accomplished in several ways, one of which is via a catheter intocentral lumen 212. Thechannel 214 is used to direct the adhesive to the correct location. At this point, the distal end of the foam plug may be restrained to prevent the adhesive from curling away from thedistal end 216. Alternatively, fig. 21 showstube 2104 preplaced throughguide catheter 2102, through the central lumen ofplug 2106 and bent back in the LAA to the distal end ofplug 2100. Thesetubes 2104 lead all the way to the proximal end of the guidingcatheter 2102, where a fitting allowing for the injection of adhesive is attached, which then leaves thetubes 2104 at the desired plug position. These tubes are composed of polyethylene, polypropylene or FEP so that the adhesive does not adhere to the tubes. After injection, thetube 2104 is withdrawn from the patient through a guide catheter.

Another part of the adhesive may be used which includes an aqueous cross-linked adhesive, polyurethane, PEG, PGA, PLA, polycaprolactone or betaine derived urethane. Alternatively, these adhesives may be made in two components, whereby one component adheres to the foam and the second component is injected into the body. In addition, these two-part adhesives may be injected simultaneously for in vivo mixing to prevent contamination of the injection tube.

An alternative anchoring means for theplug 400 ordevice 3000, etc., is one or two or more distal anchors, as shown in fig. 4. Thewire 404 is passed through thecentral lumen 410, into the LAA and attached to the distal wall of the LAA. In this case, thespiral wire 408 is inserted into the wall of theLAA 406. More detailed information of this is shown in fig. 5, where thescrew 502 is shown embedded in the LAA wall 504, but not all the way through theepicardial surface 506.

Other anchoring means include the use of various hooks or barbs or graspers to grasp the distal wall and basket that open within the LAA and press outward on the wall and engage the LAA protrusion, the malecot (malecot), the distal foam plug, and the nitinol wire bird nest. It may be desirable to place the plug and then, as a second step, engage the anchor. One such embodiment may include a large number of nitinol wires with a ball or clip (catch) welded proximally to the anchor tip. These may be gathered with the delivery catheter and then released when the desired plug location is confirmed.

FIG. 6 shows a cross-section of one embodiment having afoam plug 600 and LA and LAA faces 602 and 610. TheePTFE material 604 encapsulates thefoam plug 600 and its open ends are connected to attachment structures, such as wires, sutures, ortubular crimps 606, on theinner tube 608.Inner tube 608 may be made of an implant grade stainless steel, such asgrade 304 or 316, or a cobalt chrome alloy, such as MP35n, and crimp 606 may be made of quenchedgrade 304 or 316 stainless steel or a cobalt chrome alloy, such as MP35 n. This crimping also serves as a component of the device that may be a snare that should need to be removed.

Referring to fig. 6,tubular ePTFE layer 604 extends alonginner layer 612 lining the guidewire lumen and is turned out around leftatrial surface 602 to formouter layer 614. In some embodiments, thelayer 604 may cover the entire proximal face and/or a portion of the sidewall, such as a cover layer on thecover layer 3100 or the proximal face 1064', as further described herein. As further shown in fig. 6, thefirst end 616 of theinner layer 612 is concentrically disposed within thesecond end 618 of theouter layer 614. Thefirst end 616 and thesecond end 618 are sandwiched between theinner tube 608 and theouter coil 606. In this manner, the implant may be encapsulated in a manner that provides a seamless leftatrial surface 602 and maintains the integrity of the guidewire lumen andinner tube 608.

An embodiment of a technique for placing a LAA occluding device is shown in fig. 7 to 15. To occlude the LAA, the LA is first accessed from the venous line. One method is to use a Brockenbrough type needle to penetrate the interatrial septum to access the LA from the Right Atrium (RA). A basic needle-piercing technique is performed, whereby venous access is obtained, typically through the right femoral vein. The Mullins cuff and dilator track are then moved over the 0.025 "or 0.032" guidewire previously placed in the Superior Vena Cava (SVC). Fluorescence and echocardiography are commonly used, such as esophageal ultrasound (TEE) or intracardiac ultrasound (ICE). If no echo is used, a pigtail catheter is also typically placed in the aortic root to define the position of the aortic valve, a step that is not needed when using echo.

Once the Mullins cuff and the stent are in the SVC, the guidewire is removed and a transseptal needle is placed through the stent. The needle contains a stylet (stylette) to prevent the polymer material from escaping from the stent lumen when it traverses to the tip. Once the needle is near the spreader tip, the probe is removed and the needle is connected to a manifold and flushed. As a unit, the Mullins sleeve/dilator set and needle (positioned within the dilator tip) are retracted into the SVC toward the RA. This is the preferred puncture location when the system is withdrawn down the SVC wall into the RA and positioned in the fossa ovalis.

Once proper positioning in the fossa ovalis observed, the needle is advanced through the fossa ovalis into the LA. Can be measured by echo, pressure, O₂Saturation and contrast injection to confirm successful transseptal puncture. Once the needle position is confirmed within the LA, the sheath and dilator may be advanced into the LA in an upward direction. In some cases, prior to threading, the user will first thread a guidewire through the needle into the LA and into the superior pulmonary vein (typically the left superior pulmonary vein). Alternatives include the use of a radio frequency transseptal needle, which is useful for crossing very thick or overgrown septa, or the use of a safety wire placed through the needle and used for initial puncture.

Referring to fig. 8-15, aguide catheter 802 is placed through the femoral vein in the right atrium of the heart and, as described above, through the intra-atrial septum into the LA and positioned adjacent theostium 804 of the LAA. A guidewire 902, typically 0.035 "in diameter, is passed through the guide catheter 900 and placed in the LAA 904. Such aguidewire 1002 may be attached to its distal end, inflated in the LAA and used as aballoon 1006 of a bumper to prevent theguide catheter 1100 from perforating the LAA wall. Theguide catheter 1100 is then advanced over theguidewire 1108 to access theLAA 1104. Radiopaque markers 1102 are used to guide catheter placement under fluoroscopy.

Thefoam plug 1204 is then pushed through theguide catheter 1200 by thepusher 1202 and is shown slowly exiting theguide catheter 1300 in fig. 13 until it is fully deployed as shown in fig. 14. Thefoam plug 1404 may then be adjusted in position using thedistal balloon 1408 and guidecatheter 1400, sliding the foam plug proximally by pushing theballoon 1408 via theshaft 1412 or distally by pushing theguide catheter 1400 distally. The guidewire may also contain a pressure sensor therein to monitor the sealing of the LAA and confirm that the sealing is adequate. Once satisfactory for placement, adhesive 1514 can be injected and/or the mechanical anchor deployed to anchor theplug 1404 to the wall. Theguidewire balloon 1508 is deflated and the guidewire is then removed. In an alternative embodiment, a two-part adhesive system may be used, wherein one component of the two-part 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 so that bonding occurs only at the interface to minimize the risk of adhesive embolism. In some embodiments, adhesives and balloons may or may not be used with, for example, thedevice 3000 described further herein.

Instead of pushing the plug through the entire length of the guide catheter, as shown in fig. 12, aplug 1204 may be initially disposed at the distal end of theguide catheter 1200. Theguidewire 1210 passes through the center of theplug 1204 and in this mode, thepusher 1202 need only push the plug a short distance to deploy it in the LAA.

For alternative anchors, they may be deployed, the shaft disconnected and removed. The disconnect mechanism may be of any of several types, such as threaded disengagement, electrical disengagement, or other mechanisms known in the art. In some embodiments, suture attachment may be implemented, for example, as described for fig. 24.

As shown in fig. 16, in some embodiments, afoam body 1600 and a metal frame, such as abracket 1602, may be included.Foam body 1600 andstent 1602 may have the same or similar features and/or functionality asfoam body 3002 andtubular body 3080, respectively (see fig. 85A-90D), and vice versa. Thefoam 1600 is designed to provide tissue ingrowth and also provides a cushion ofmetallic stents 1602 on the LAA tissue. Theproximal face 1604' of the plug is covered with ePTFE, polyester, or another anti-thrombogenic tissue scaffolding material to facilitate sealing at a desired pore size to promote overgrowth.

Thestent 1602 may be made of nitinol so that it can be loaded into a 10, 12, 14, 16, 18 or 20F delivery catheter and expanded to its desired diameter. Thestent 1602 may be braided, laser cut, or wire formed. Any of a variety of stent wall patterns may be used, based on the desired properties. Thestent 1602 may be a balloon expandable stent or a self-expanding stent. In the illustrated embodiment, the self-expandable stent 1602 includes a plurality ofproximal apices 1608 anddistal apices 1610 connected by a plurality of zigzag supports 1612.Hole 1606 allows a guidewire to pass through for delivery. Such a design may be advantageous where the expansion force exerted by the plug on the LAA can be controlled individually depending on the foam properties. In addition, it may be easier to fit this concept into smaller geometries. For example, the plug may be loaded into a smaller geometry by reducing the amount of foam that must be compressed into the delivery catheter while maintaining sufficient expansion force.

Alternatively, the foam plug may be constructed of two foams. A denser core to provide forces, e.g., radial forces, and an outer softer foam to engage tissue irregularities. Softer foam may also be located on the proximal and/or distal ends to facilitate retrieval.

Another way to increase the stiffness of the foam plug is shown in fig. 17, where acavity 1704 is prepared in thefoam plug 1700 and a roll ofwire 1702 can be advanced from the guide catheter into thecavity 1704 at theproximal end 1706. As the filament enters the cavity, it expands to its predetermined size and exerts a force radially outward on the foam. The type and amount of filament can be determined in the body using an x-ray guide to check for radial expansion of the foam into the LAA.

Instead of filaments as shown in fig. 17, a balloon may be fed into the foam and inflated to provide radial force, while the outer foam serves to engage tissue irregularities and tissue ingrowth. After inflation, the balloon may be detached from the deployment catheter and the deployment catheter withdrawn. Preferably, the balloon is provided with a valve to prevent escape of the inflation medium. The inflation vehicle can be any of a variety of vehicles that are convertible between a first flowable state and a second hardened state, such as by in situ crosslinking or polymerization.

Another LAA plug is shown in fig. 18 as a spring-like implant wire 1800 covered withfoam 1802 to promote ingrowth. The proximal face of the implant is covered with a sheet of ePTFE or other tissue scaffold material. Such implants may be stretched out for delivery and release in situ.

A low porosity, non-perforated outer bag may be placed in the LAA and then filled with a substance to provide radial expansion without the use of foam. Such materials may be hydrogels, cellulose or polyvinyl acetate.

The distal crimpingelement 1902 may be formed in a tapered form such that it extends out of the distal end of thecatheter 1200 and acts as an enlarged tip to enlarge the opening in the septum as the catheter is advanced, without requiring the use of a separate enlarging device to pass through the septum. See fig. 19.

An alternative plug design uses a foam, such as a cellulose sponge material, that is compacted and dewatered so that it can be loaded into a guide catheter. Such foam 2202 may be loaded into a guide catheter as shown in fig. 22. The foam plug 2202 is then advanced into the LAA from the distal end of theguide catheter 2204 with thepiston 2206. The plug exits the guide catheter and opens into a disk shape 2210. As the foam absorbs fluid from the blood, its length expands to form acylinder 2220, filling the LAA. The compressed cellulosic material may have an expansion ratio of up to 17:1, to a compressed length.

Small barbs 2302 in fig. 23 can be advantageously used to further engage theplug 2204 into the LAA. The barbs may be unidirectional or bidirectional to resist movement in the proximal or distal direction. These barbs are embedded in the foam plug and may be.1 to 1mm high. It may be desirable to place the plug and then, as a second step, engage the barbs. One such embodiment may include a plurality of nitinol barbed wires having a ball or catch (catch) welded proximally to the barb tip. These may be gathered with the delivery catheter within the cannula or suture and then released when the desired plug location is confirmed.

One way to remove the malfunctioning device is to releasably attach theretrieval suture 2400 to the implant to reach a proximal closure 2402 (fig. 24) that also extends proximally beyond the entire length of theguide catheter 2404. If the device is to be removed, pulling on both ends ofsuture 2400 pulls the outer cover intoguide catheter 2404, which can then be removed from the patient. If the device is properly in place, thesuture 2400 can be cut and removed, thereby holding the plug in place.

Deployment of the occluding device is discussed primarily in the context of transvascular access. Alternatively, however, the implant may be deployed by direct surgical access or by a variety of minimally invasive access routes (e.g., the jugular vein). For example, areas covering the xiphoid process and adjacent costal cartilage can be prepared and coated using standard techniques. Local anesthetics can be administered and superficial incisions can be made, typically about 2cm long. Percutaneous penetration is passed under the costal cartilage and a cuff may be introduced into the pericardial space. The pericardial space may be flushed with saline, preferably with a saline-lidocaine solution, to provide additional anesthesia and reduce the risk of stimulating the heart. Thereafter, the occluding device may be introduced through the sheath and through the access pathway created through the LAA wall. Thereafter, closure of the wall and access pathway can be accomplished using techniques understood in the art.

Based on the desired clinical presentation, any of the LAA occlusion devices described herein may be provided with a drug or other bioactive agent that may be injected through a deployment catheter or impregnated within an open-cell foam or coated on an implant. As understood in the art, the bioactive agent may be eluted or otherwise released from the implant into the adjacent tissue over a delivery period appropriate for the particular agent. Useful bioactive agents may include those that modulate thrombosis, those that promote cellular ingrowth, through growth, and endothelialization, and those that are potentially resistant to infection. For example, agents that may promote the growth of endothelial, smooth muscle, fibroblasts, and/or other cells into an 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, the molecules MCP-1, VEGF, FGF-2, and TGF- β, recombinant human growth factors, and/or plasma therapy using various gases.

Anti-thrombotic agents can generally be divided into anticoagulant and anti-platelet agents. Anticoagulants include inhibitors of factors within the coagulation cascade, including heparin, heparin fragments and fractions, and inhibitors of thrombin, including hirudin, hirudin derivatives, dabigatran (dabigatran), argatroban and bivalirudin, and factor X inhibitors such as low molecular weight heparin, rivaroxaban, apixaban.

Antiplatelet agents include GP 2b/3a inhibitors such as eptifibatide (epifinide) and abciximab, ADP receptor agonists (P2/Y12) including thienopyridines such as ticlopidine, clopidogrel, prasugrel and ticagrelor, and aspirin. Other agents include lytic agents, including urokinase and streptokinase, their homologs, analogs, fragments, derivatives, and pharmaceutical salts thereof, and prostaglandin inhibitors.

Antibiotic agents may include, but are not limited to, penicillins, cephalosporins, vancomycin, aminoglycosides, quinolones, polymyxins, erythromycin, tetracyclines, chloramphenicol, clindamycin, lincomycin, sulfonamides, their homologs, analogs, derivatives, salts of drugs, and combinations thereof.

Biological agents as listed above may be added to theimplant 204 and may be injected through a delivery catheter into the space between theproximal cap 206 and thefoam plug 204. This can serve as a reservoir to minimize thrombus formation during initial implantation and reduce the need for systemic anticoagulation after device implantation.

An electronic pressure sensor may be embedded at the proximal end of the foam plug, which may be used to transmit the LA pressure to a remote receiver outside the body for monitoring the LA pressure useful for monitoring cardiac function. Additionally, a cardiac pacemaker or defibrillator may be embedded in the foam plug and electrically connected to the distal anchor. A LA-embedded drug delivery reservoir may be incorporated for controlled delivery of biological agents as listed above.

Another anchoring means is shown in fig. 25A, in which a foam plug 2500 is placed in the LAA. The distal coiledwire 2502 is advanced and screwed into the wall of the LAA. As shown in fig. 25B, theguide 2506 is pulled proximally. When theguide 2506 is pulled back, the helical wires made of nitinol alloy gather into a "bird nest" 2508 or form a coil inside the foam plug 2500. Thehelical wire 2502 is pushed distally from theguide catheter 2504 with apusher 2510 and continues to accumulate in the foam.Catheter systems 2504, 2506, and 2510 are then removed.

Another way of anchoring the distal anchor element to the foam is shown in fig. 26. Twobarbed wires 2604 are attached to theanchor 2602 so that when advanced into position in thefoam plug 2600, thebarbs 2604 dig into the foam plug.

Fig. 27A-27G are various views of an embodiment of thedevice 10 for occluding laa (laa). Thedevice 10 may include the same or similar features as the other devices for occluding the LAA described herein, such as theplug 204, thedevice 1020, thedevice 3000, and the like, and vice versa. Thedevice 10 includes aninternal locking system 101 for securing thedevice 10 within the LAA. In some embodiments, thedevice 10 may not include aninternal locking system 101 or other anchoring means, e.g., thedevice 10 may be anchored by tissue ingrowth alone. Theocclusion device 10 includes an expandable medium, such as anopen cell foam 15, e.g., a plug.Body 15 enablesdevice 10 to contract and expand, and also improves tissue ingrowth into the foam.

Thebody 15 of thedevice 10 shown in fig. 27A-27F is in its expanded configuration. In fig. 27G,body 15 is in its compressed configuration. Thedevice 10 includes afoam body 15, askin 20, acentral lumen 25, an apex 30, and a dynamicinternal locking system 101 that anchors thedevice 10 within the LAA. FIG. 27A is a side cross-sectional view ofdevice 10 showingbody 15 andinternal locking system 101 in a deployed configuration. FIG. 27B is an end view of the proximal end ofdevice 10 showingbody 15 andinternal locking system 101 in a deployed configuration. FIG. 27C is a side view ofdevice 10 showingbody 15 andinternal locking system 101 in a deployed configuration. FIG. 27D is a side cross-sectional view ofdevice 10 showingbody 15 in a deployed configuration andinternal locking system 101 in a constrained configuration. FIG. 27E is an end view of the distal end ofdevice 10 showingbody 15 andinternal locking system 101 in a deployed configuration. FIG. 27F is a cross-sectional view of thedevice 10 taken along line 1F-1F as shown in FIG. 27C. Fig. 27G shows thebody 15 andinternal locking system 101 loaded and compressed within the delivery sheath 1. Thedevice 10 may be delivered through a delivery catheter in the configuration shown in fig. 27G. Thebody 15 of thedevice 10 may then be expanded with theinternal locking system 101 still constrained, as shown in fig. 27D. Theinternal locking system 101 can then be deployed into the deployed configuration, as shown in FIG. 27A.

Fig. 27G shows thebody 15 andinternal locking system 101 loaded and compressed within an embodiment of the delivery sheath 1. In some embodiments, the delivery sheath 1 may be an outer delivery catheter.Body 15 andinternal locking system 101 are loaded and compressed within delivery catheter 5. Thedevice 10 may be located wholly or partially within the delivery catheter 5. In some embodiments, the delivery catheter 5 may be an internal delivery catheter. Thedevice 10 may be loaded and compressed inside the delivery sheath 1 by the delivery catheter 5. For example, removal of the delivery sheath 1 may expand thebody 15 of thedevice 10 by retracting the delivery sheath 1 in a proximal direction.Body 15 expands whileinternal locking system 101 remains constrained, for example, by delivery catheter 5. Fig. 27D showsbody 15 in its deployed state, withinternal locking system 101 in a constrained configuration within delivery catheter 5. This shows the first step in the deployment process, specifically the placement of thedevice 10 within the LAA, where thebody 15 is expanded and theinternal locking system 101 is constrained and therefore the anchor is not deployed. The second step of the deployment process is shown in FIG. 27A, where theinner locking system 101 has been deployed tobody 15. In some embodiments, this second step is reversible to retract the anchor, for example, if placement of thedevice 10 within the LAA is unacceptable. Theinternal locking system 101 is deployed from within thebody 15, for example, an anchor assembly or system as further described herein to deploy at least one, and in some embodiments, at least 2 or 4 or 6 or more anchors of theinternal locking system 101 to engage adjacent anatomical structures of the LAA, outside of thebody 15.

Internal locking system 101 can be controllably deployed for a period of time after expansion ofbody 15. For example, the position, orientation, etc. of thedevice 10 may be verified by a variety of imaging techniques, such as fluoroscopy with contrast injected through the central lumen, prior to deployment of theinternal locking system 101 and anchor to secure thedevice 10 within the LAA. In some embodiments, even after deployment of theinternal locking system 101 and its anchors, the anchors may be retracted to a position within thebody 15 for repositioning and/or retrieval of thedevice 10 from, within, the LAA.

Fig. 27F shows an embodiment of the device with aslot 17. Agroove 17 is formed in thefoam 15. For example, the material of thefoam 15 may be removed to facilitate deployment of theinternal locking system 101, such as the anchor expanding outward to engage tissue.

Thedevice 10 can have any or all of the same or similar features and/or functionality as another plug described herein (e.g., plug 204, etc.). For example,device 10 is at least partially encapsulated withinskin 20. In some embodiments,skin layer 20 may cover the proximal end ofbody 15.Skin layer 20 may be a thin, strong outer layer. Theskin layer 20 may be a thin encapsulation layer.Skin layer 20 may be made from ePTFE (expanded polytetrafluoroethylene), polyolefin, polyester, other suitable materials, or combinations thereof. In some embodiments,skin layer 20 may be fabricated from a bioabsorbable material, for example, polylactic acid (PLA), polyglycolic acid (PGA), Polycaprolactone (PCL), PHA, collagen, other suitable bioabsorbable materials, or combinations thereof. Theskin layer 20 may be oriented or otherwise modified to be elastomeric in at least one direction, such as radially.

Body 15 may be made of polyurethane, polyolefin, PVA, collagen foam, or blends thereof. One suitable material is a polycarbonate-polyurethaneurea foam with pore sizes of 100-250 μm and a void content of 90-95%.Body 15 may be non-degradable or use degradable materials such as PLA, PGA, PCL, PHA and/or collagen. If degradable, tissue from the LAA will grow into thefoam 15 and replace the foam over time.Body 15 may be in a cylindrical shape during unconstrained expansion, but it may also be tapered with its distal end smaller than the proximal end (or vice versa). The cross-section of thebody 15 may also be oval to better match the LAA opening.

Thedevice 10 is oversized in the radial direction in an unlimited expansion to fit snugly into the LAA. For example, based on the diameter of the target LAA, thedevice 10 in its non-limiting configuration may be 5-50 millimeters (mm) in diameter and is generally at least about 10mm or 15 mm. The length "L" of thedevice 10 may be less than, similar to, or greater than its diameter "D" such that the L/D ratio is less than 1.0, about or greater than 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, from about 0.2 to about 0.9, or from about 0.3 to about 0.8, or from about 0.4 to about 0.6. The compliant design of the material of thedevice 10 allows it to be pressed against the wall of the LAA with sufficient force to maintain the plug in place, but without overstretching the LAA wall. When expanded, thefoam 15 and/or theskin 20 also conform to the irregular surface of the LAA to provide a surface structure complementary to the natural LAA wall to further improve anchoring and promote sealing. Thus, theexpandable foam 15 conforms to the natural irregular configuration of the LAA. In some embodiments, the structure offoam body 15 may be manufactured such that axial compression (e.g., by wire drawing or proximal retraction of internal concentric tubes) on opposite ends ofbody 15 results in an increase in foam diameter.

Body 15 and/orsurface layer 20, e.g., foam and/or ePTFE, may be provided with one, two or more radiopaque markers, such as radiopaque wire 210 (see fig. 2) or filled or infused with radiopaque fillers, such as barium sulfate, bismuth subcarbonate or tungsten, that allow the operator to visualizedevice 10 under x-rays for proper positioning in the anatomy. Visualization of thedevice 10 may be used to verify the position of thedevice 10 prior to deployment of the anchors that secure thedevice 10 in place.

Theskin layer 20, such as the outer ePTFE layer, can have a thickness between about 0.0001 inches to about 0.0030 inches. In some embodiments, theskin layer 20 may have a thickness of between about 0.0003 inches and about 0.0020 inches. In some embodiments,skin layer 20 may have a thickness of between about 0.0005 inches to about 0.0015 inches. The thickness of theskin layer 20 may be uniform, e.g., the same or approximately the same wherever the thickness is measured. In some embodiments, the thickness ofskin layer 20 may be non-uniform, e.g., the thickness may be different in different portions ofskin layer 20.

Thesurface layer 20, such as an outer ePTFE layer, may also serve as a blood contact surface on the proximal end of thedevice 10 facing the LA. Thesurface layer 20 may have pores or knots such that blood components coagulate on the surface and the intimal or neointimal covering of the tissue grows through it and is tightly anchored to the epidermal material. The pore size may be in the range of about 4 μ to about 110 μ. In some embodiments, the pore size is in the range of about 30 μ to about 90 μ. In some embodiments, the pore size is in the range of about 30 μ to about 60 μ. These pore size ranges are useful for neointimal formation and attachment. In some embodiments,skin layer 20, such as an outer ePTFE layer, may be formed from a tube having a diameter approximately the same as the diameter offoam 15 and allowed to contract and press onbody 15 without tearing the foam material.

Skin layer 20 may be constructed of materials other than ePTFE, such as woven fabrics, screens, or perforated films made of FEP, polypropylene, polyethylene, polyester, or nylon. Thesurface layer 20 may have a low compliance (e.g., inelastic), e.g., a longitudinally low compliance, may be strong enough to allow removal of the plug, may have a low coefficient of friction, and/or may be thromboresistant. Theskin layer 20 serves as a matrix to allow plug removal because most foams are not strong enough to resist tearing when pulled.Body 15 may also be coated with or contain materials to enhance its ultrasound echo spectrum, antithrombosis, smoothness and/or to facilitate echocardiography, promote cellular ingrowth and coverage.

Theskin 20 may include pores to allow contact of LAA tissue with thefoam 15. Exposure of thefoam body 15 to LAA or other tissue has benefits, such as promoting tissue ingrowth into the foam cells and/or increased friction to hold thebody 15 in place. The holes may be 1 to 5mm in diameter or may be oval, with the major axis aligned with the axis of the foam plug, may be 80% of the length of the foam plug and may be 1-5mm wide. The apertures may be as large as possible so that the outer cover layer maintains sufficient strength to transmit the pulling force required for removal. The holes may preferably be arranged along thedevice 10. In some embodiments, the aperture is distally disposed to enhance tissue ingrowth from the distal LAA wall.

In some embodiments, thedevice 10 includes an occlusion zone and an anchoring zone. After implantation of the device in the LAA, the proximal portion of thedevice 10 facing the LA may include an occlusion zone. The occlusion region may be a blood contacting surface on the proximal end of thedevice 10 that is thromboresistant while promoting neointimal formation at the occlusion region. The occlusion region promotes anti-thrombosis and endothelialization from the blood and adjacent tissues. The anchor region promotes rapid and secure tissue ingrowth from adjacent non-blood tissue into thedevice 10. The anchoring zone may be a side surface of thedevice 10 that interfaces with tissue adjacent to and/or within the LAA. The anchoring zone may also include the distal end of thedevice 10 that is implanted facing the distal wall of the LAA.

Figures 28A-28D are various views of an embodiment of aninternal locking system 101 that may be used withdevice 10. In some embodiments, multipleinternal locking systems 101 may be used with thedevice 10. Figure 28A is a side view of the internal locking system shown in an expanded configuration. Figure 28B is an end view of the distal end of theinternal locking system 101 shown in a deployed configuration. Figure 28C is a side view of the internal locking system 201101 in a restrained configuration. Fig. 28D is a side view of an embodiment of ananchor 120 of theinternal locking system 101.

Any of a variety of structures may be used as the dynamicinternal locking system 101 with thedevice 10. Generally, at least about two or four or six or more tissue anchors 120 can be actively or passively advanced from theimplantable device 10 into adjacent tissue surrounding the implantation site. Upon deployment ofdevice 10 and expansion ofbody 15,tissue engaging portion 121 oftissue anchor 120 will extend at least about one, and in some embodiments, at least about two or four 4mm or more beyond the skin. Thetissue engaging portion 121 is carried by asupport portion 122 of thetissue anchor 120 based on the desired configuration by extending through thefoam body 15 and may be attached to a deployment controller such as a pull wire, push wire, tubular support, or other control structure.

Thelocking system 101, discussed primarily herein, is in a passive deployed configuration. Removal of the restraint enables thetissue anchor 120 to self-expand laterally to deploy into adjacent tissue. Self-expansion may be achieved by constructing thetissue anchor 120 using nitinol, elgiloy, stainless steel, or other shape memory or spring-biased material. Depending on the configuration of thelocking system 101, the limiter may be removed by proximal retraction or distal advancement until thetissue anchor 120 is no longer engaged with the limiter.

Alternatively, thetissue anchor 120 may be actively deployed, such as by the distal end of a controller being advanced, proximally retracted or rotated, or by inflation of a balloon located within thedevice 10 to actively drive theanchor 120 through the corresponding hole in theskin 20 orskin 20 and into the tissue. For example, a plurality ofsupport portions 122, such as struts, may be joined to the central hub 111 at the distal end and angled radially outward in the proximal direction. Proximal retraction of hinge 111 will advancetissue engaging portion 121 axially beyondsurface 20 and into the adjacent tissue. In another configuration, the angle of inclination of thesupport portion 122, e.g., a strut, can be reversed such that advancing the distal end of the hinge 111 will deploy thetissue engaging portion 121 out of theskin 20. Proximal or distal advancement of the hinge 111 may be accomplished by a controller releasably engaged with the hinge 111, such as controlling the proximal or distal advancement of a wire or tube.

Thetissue anchor 120 may be retractable based on the desired clinical presentation, such as by axial distal or proximal movement of a controller based on the tilt angle of theanchor 120. In the embodiment primarily illustrated herein, re-entry of theanchor 120 into the sheath can be accomplished by advancing the tubular restraint along the inclined surface of thetissue anchor 120 to move theanchor 120 radially inward toward the central longitudinal axis of thedevice 10. In the case of ananchor 120 that is deployed by advancing it along its own longitudinal axis, theanchor 120 may be retracted by advancing the controller in a direction opposite to the direction in which theanchor 120 is deployed by advancing it.

Referring to fig. 28A-28D, theinternal locking system 101 includes a central tubular element or hub 111 and ananchor 120. Theanchor 120 can be an arm, portion, or other member extending from the hub 111. Eachanchor 120 can include atissue engaging portion 121 and asupport portion 122 extending to the hub 111 or other controller. Theinternal locking system 101 has a single central tubular hub 111 and a large number ofanchors 120. As shown, there are fouranchors 120. There may be two, three, four, five, six, seven, eight, or more anchors 120. Theanchor 120 may be rotatably, hingedly, or otherwise movably coupled with the hub 111. Thus, theanchor 120 can move relative to the hinge 111, for example, after being released from the restraint holding theanchor 120 in the restrained configuration to expand into the deployed configuration. As a further example, theanchor 120 may be moved from the deployed configuration to the retracted position, as further described herein. As shown, theanchor 120 may be curvilinear, e.g., when not limited, allowing theanchor 120 to adopt the geometry shown in fig. 28A.

The illustratedanchor 120 can have adistal region 130, ahinge region 135, and/or aproximal region 125. Thedistal region 130 interacts with the hinge element 111. As shown, hingeregion 135 and the curvilinear geometry are such that the end ofproximal region 125 extends beyondbody 15, e.g., beyond the sidewalls ofbody 15. Theproximal region 125 includes atissue engaging portion 121 configured to engage adjacent tissue. Thetissue engaging portion 121 may be the entireproximal region 125 or a portion thereof, e.g., a tip, etc. Theproximal region 125 may thus include a pointedtissue engaging portion 121, a shapedtissue engaging portion 121, an angledtissue engaging portion 121, a thickness configured for tissue engagement, and/or other suitable features. In some embodiments,proximal region 125 may be retracted back intobody 15, as further described herein. In the illustrated embodiment, theanchor 120 and the central tube 111 are distinct elements that are secured to one another, as shown. In other embodiments,anchor 120 and tube 111 are a single, integrated unit.

Theinternal locking system 101 is made of a biocompatible wire such as nitinol, implant grade stainless steel such as 304 or 316, or a cobalt-chromium based alloy such as MP35N or elgiloy. In some embodiments, theinternal locking system 101 may be cut from a single piece of tubular metal that is manufactured by machining or laser cutting, and then by a secondary forming or annealing step using similar materials.

When thedevice 10 is placed in position in the LAA and thebody 15 is expanded therein, theinternal locking system 101 may be in a constrained configuration. Then, in a second step, theinternal locking system 101 locks or otherwise secures thedevice 10 in the LAA by engaging theanchor 120. If the location is not deemed optimal, or if thedevice 10 otherwise needs to be reset and/or removed within the LAA, theinternal locking system 101 and itsanchor 120 may be unlocked and thedevice 10 reset and/or removed.

Fig. 29A-29B are sequential side views of an axially movable ring-type unlocking mechanism that may be used withdevice 10 to release tissue anchors. Fig. 29A is a side cross-sectional view ofdevice 10 showing the tissue anchor ofinternal locking system 101 in a deployed configuration. Fig. 29B is a side cross-sectional view of thedevice 10 showing the tissue anchor in a retracted configuration. An embodiment of anunlocked system 140 is shown.Unlocked system 140 includesring 145. Theloop 145 may be moved over theanchor 120 to move theanchor 120 to the retracted configuration. Thering 145 can be moved by apull rod 147. Thering 145 may be releasably attached to thepull rod 147. Apull rod 147 may extend through the conduit to engage thering 145. If it is desired to open thedevice 10 from within the LAA to reset and/or remove thedevice 10 after deployment of theinternal locking system 101, the unlockingsystem 140 may be used.

In the illustrated construction, the reversible deployment is enabled by the deployment of the tissue anchor forward of the distal end of the restrictor, such that subsequent proximal retraction of the restrictor will retract the tissue anchor. Alternatively, proximal withdrawal of the restrictor, which releases the tissue anchor, will irreversibly release the tissue anchor.

Fig. 30 is a side view of an embodiment of thedevice 10 having aflexible anchor 401. Thedevice 10 shown in fig. 30 may have the same or similar features and/or functionality as another device for excluding LAAs described herein, and vice versa.Device 10 may be in the configuration shown in fig. 30 adjacent to or withinLA 201. Thedevice 10 of fig. 30 includes anexpandable body 15, such as an open cell foam, that enables thedevice 10 to contract and expand and at least partially encase within askin layer 20, which may be a thin, strong layer made of ePTFE (expanded polytetrafluoroethylene), polyolefin or polyester that aids in healing, anchoring and retrieval. Thedevice 10 may also be deployed, and if desired, repositioned and/or retrieved, or thedevice 10 may be permanently secured within the LAA by engaging an anchoring system as described herein, such as aninternal locking system 101. Theanchor 401 may be metallic and may be fabricated from nitinol. Theanchor 401 may be a small diameter nitinol wire having a diameter of about 0.001 inches to about 0.010 inches. In some embodiments, theanchor 401 may have a diameter of about 0.0005 inches to about 0.020 inches. Theanchor 401 may be deployed by expansion of thebody 15. For example, theanchor 401 may be self-deployed by deployment of thedevice 10 from a delivery catheter. Theanchor 401 may be relatively short and extremely flexible. Theanchor 401 may not penetrate tissue or cause any anchoring immediately after deployment of thedevice 10.

Fig. 31 is a side view of an embodiment of thedevice 10 having ananchor 401 and atube 500 for occluding a LAA.Device 10 may be disposed adjacent to or withinLA 201. Theanchor 401 may be a flexible anchor, or in some embodiments, theanchor 410 may be relatively stiffer, as further described. Thetube 500 may be a fixed tube or a movable tube, as further described. In some embodiments, thetube 500 is a shaft tube (hypotube). Thetube 500 may be stainless steel, polyamide, or other suitable material. Thetube 500 may surround arespective anchor 401, as further described.

In some embodiments, theanchors 401 may be fixed so that they do not move axially. For example,anchor 401 may have a fixed length portion extending to the exterior ofbody 15, such astissue engaging portion 121. Portions ofanchor 401 that extendoutside body 15 may bend when compressed within a delivery catheter and/or sheath, and then, afterbody 15 is deployed, these portions ofanchor 401 may straighten out to the configuration shown in fig. 31 and 32. The fixed length portion ofanchor 401 extending beyondbody 15 may be about 1mm to about 5mm, or about 1.5mm to about 4mm, or about 2mm to about 3 mm. This length ofanchor 401 exposed outsidebody 15 can be effectively shortened by deploying arespective tube 500, as further described. Deployment of therespective tube 500 around therespective anchor 400 may shorten the effective length of the exposedanchor 401, i.e., the length of theanchor 401 extending beyond the end of thetube 500 is about 0.5mm to about 1mm after deployment of thetube 500. These are merely examples of different lengths of theanchor 401 and other suitable lengths may be implemented.

In some embodiments, theanchor 401 may be axially movable. For example,anchor 401 may not deploy immediately after expansion ofbody 15 or otherwise extend outside ofbody 15. After acceptable positioning of thedevice 10 within the LAA, theflexible anchors 401 may then be advanced through therespective tubes 500. Theanchor 401 may be axially moved in any suitable manner, including those described elsewhere herein. Theanchor 401 may be moved through thetube 500 before or after thetube 500 has been moved and deployed outside thebody 15, as described below.

In some embodiments,tube 500 is movable and is deployed outsidebody 15. Thetube 500 may be movable, in embodiments, with a fixed ormovable anchor 401. Thetubes 500 may be preloaded on the respective wire anchors 401 as shown in fig. 31, e.g., onetube 500 peranchor 401. Thetube 500 can then be moved over therespective anchor 401 as shown in fig. 32. Thetube 500 may straighten theanchor 401 and increase mechanical integrity. Thetube 500 may also act as a puncture protector to prevent theanchor 401 from piercing the LAA wall. Movement of thetube 500 over therespective anchor 401 may shorten the exposed length of theanchor 401, as described. This may provide a stiffer tissue engaging portion of theanchor 401 due to the shortened exposed length.

In some embodiments,tube 500 extends from the delivery catheter to at or near the outer surface ofbody 15, but does not extend outside ofbody 15. Instead, thetube 500 merely guides theanchor 401, e.g., around an arc, and supports thewire 401 until tissue penetration. Thetube 500 may fix the launch angle so that theanchor 401 does not buckle and reach the tissue at the correct angle. In this embodiment, theanchor 401 may have a relatively stronger stiffness than embodiments in which theanchor 401 is relatively flexible to provide a more secure anchoring of thedevice 10 to tissue. It is understood thattube 500 may provide such a guiding function for the respective anchors in any of the embodiments described herein having a moveable anchor, such asmoveable anchor 401,anchor 120, etc.

Theflexible anchor 401 and/or theouter stiffening tube 500 may be made of a biocompatible metallic material, such as nitinol, implant grade stainless steel, such as 304V or 316LVM, cobalt-chromium based alloy, such as MP35N or elgiloy, other suitable material, or combinations thereof. The length of theanchor 401 may vary between 0.1mm to 5mm with the outer reinforcingtube 500 covering 10% to 90% of the exposed length of theanchor 401.

Skin 20 at least partially surroundsbody 15 and portions ofskin 20 may or may not be attached tobody 15.Various devices 10 described herein may have abody 15 at least partially encased within askin 20, which may be made from a material that aids healing, anchoring, and retrieval, such as ePTFE (expanded polytetrafluoroethylene), polyolefin, or polyester. Fig. 33 is a side view of an embodiment of thedevice 10 for occluding the LAA having discrete attachment points 700 of theskin 20 to theinner foam 15. For clarity, the attachment points 700 are shown as dots in the figure. It should be understood thatattachment point 700 may not be visible fromoutside device 10, for example,skin 20 may be bonded tobody 15 atattachment point 700, or the like. In some embodiments,skin 20 may be secured tobody 15 at attachment points 700, such as by stitching, in addition to or as an alternative to bonding, and thus some or all of attachment points 700 may be visible fromoutside device 10. Thedevice 10 may be in a configuration adjacent to or withinLA 201 as shown in fig. 33.Skin 20 may be attached tobody 15 at a plurality of separate attachment points 700. As shown in fig. 33,skin 20 may be partially attached tobody 15, with portions thereof completely unattached. This may allow, for example,skin 20 to move during expansion ofbody 15 that occurs afterdevice 10 is deployed from a delivery catheter. In some embodiments, theskin 20 may be attached at attachment points 700 located near the proximal side of thedevice 10, e.g., to help facilitate the ostial closure of the LAA, as by theedges 800, as described below. Theskin 20 may be sutured into place, for example, at one or more attachment points 700 near the proximal face, so that any bundles of theskin 20 that occur during implantation occur near the ostium, but within the LAA. This may be accomplished using stitching, adhesive, thermal bonding, other suitable methods, or combinations thereof.

The selected location of attachment points 700 may facilitate the formation ofcircumferential edge 800 ofskin layer 20. For clarity, theedge 800 is shown schematically in FIG. 34 as a triangular edge. It should be understood that theedge 800 may be a variety of different shapes depending on the configuration of thedevice 10, the shape of the LAA, etc. Further, therim 800 may extend completely or partially around thedevice 10. Therim 800 may surround the ostium of the LAA. The formation of therim 800 may help to completely seal the entrance to the LAA around thedevice 10 and thereby prevent leakage. Attachment points 700 betweenskin 20 andbody 15 may prevent the creation of irregular fabric bundles and, instead, direct any excess material around or near the proximal face ofdevice 10 to form a sealededge 800, as shown in fig. 34.Edge 800 may be formed by expansion ofbody 15 after deployment from a delivery catheter, as described herein. Alternatively, theattachment point 700 may be designed to completely prevent any fabric bunches and provide a smooth surface, such as a smooth proximal surface.

Fig. 35-36 are side views of an embodiment of thedevice 10 havinganchors 120 with V-shapedtips 901 shown in an expanded configuration. The V-shaped tip may be located at theproximal end region 125 and/or may form all or part of thetissue engaging portion 121 of theanchor 120, as described herein. The V-shapedtip 901 forms a V-shaped point. The V-shapedtip 901 is generally in the shape of a "V" or otherwise in the shape of an angled segment. The V-shapedtip 901 may be a sharp barb or hook. The V-shapedtip 901 may be formed from a wire or laser cut tube or by other suitable methods. As shown in fig. 35, one or more V-shapedtips 901 are attached to thebody 15 encased in theskin 20. V-tip 901 may be attached tobody 15 and/orskin 20. In some embodiments, V-shapedtip 901 is the end ofanchor 1000. For example, V-shapedtip 901 may be part ofanchor 1000 withinbody 15 andskin 20, as shown in FIG. 36. The distal end of the V-shapedtip 901 is free to slide and contract or expand. The distal end of V-shapedtip 901 may be attached tobody 15,skin 20, and/oranchor 1000 to allow V-shapedtip 901 to retract and retract. During retrieval to the catheter or sheath, the V-shapedtip 901 may flatten out when engaging the catheter or sheath inner diameter. V-tip 901 may be made of nitinol, an implant grade stainless steel such as 304 or 316, a cobalt-chromium based alloy such as MP35N or elgiloy, other suitable materials, or combinations thereof. The V-shapedtips 901 may then resume their predetermined shape after deployment or redeployment.

37A-37C are side views of various embodiments of V-shaped tips that may be used with the anchors described herein. Fig. 37A is a side view of an embodiment of a V-shapedtip 901. The V-shapedtip 901 includes two angled portions. The portions may form an angle in a free state. The angle may be a variety of angular quantities. In some embodiments, the angle formed by the V-shapedtip 901 is no more than about 170 °, 160 °, 150 °, 140 °, 130 °, 120 °, 110 °, 100 °, 90 °, 80 °, 70 °, 60 °, or any smaller, larger, or intermediate angle amount. FIG. 37B is a side view of an embodiment of a wavy V-shaped tip 1101. The undulating chevron 1101 may include an arcuate portion and an angled linear portion. Figure 37C is a side view of an embodiment of a double wave V-shapedtip 1103. The double-wavy V-shapedtip 1103 may include two curved portions. The curved portion may promote engagement of the tip with the inner wall of the LAA. The ends of the various V-shaped points may be smooth and rounded or sharpened 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 toskin 20 and/orbody 15. In some embodiments, some V-shaped tips may be attached toanchor 1000.

Fig. 38 is a side view of another embodiment of thedevice 10 implanted within theLAA 1201 for occluding the LAA. Thedevice 10 includes abody 15 disposed within theLAA 1201 and acover 20 andtip 30. The LAA includes a thickerproximal portion 1203 closer to the ostium. Theinternal locking system 101, e.g., an anchor thereof, may be configured to engage the thickerproximal portion 1203 of the LAA. Various anchors, V-shaped tips, etc., as described herein for various embodiments of thedevice 10, may be used to secure the anchors in the thickerproximal portion 1203. In some embodiments,device 10 may be deployed from a catheter, thereby expandingbody 15. As described herein, the position, orientation, etc. of the expandedbody 15 within the LAA may be verified, for example, by imaging. The position, orientation, etc. of the expandedbody 15 within the LAA may be verified to ensure engagement of theinternal locking system 101, e.g. its anchor, with the thickerproximal portion 1203. Theinternal locking system 101 may then be deployed, such as with its anchor to engage the thickerproximal portion 1203. If after deployment of theinternal locking system 101, e.g., its anchor, it is determined that the anchor is not engaged with the thickerproximal portion 1203, the anchor may be retracted to reposition and/or retrieve thedevice 10 as described herein.

In some embodiments, theinternal locking system 101, e.g., an anchor thereof, may be a preloaded surface element that is releasably restrained or otherwise locked in a contracted or restrained position or configuration. Theinternal locking system 101, e.g. its anchors, can be restrained using a restraint. The restraint may be a dissolvable polymer, a lasso or a wire that can be withdrawn to release the anchor. The limiter may be similar to a deadbolt. Other anchoring concepts include Velcro (Velcro) integrated into the ePTFE, electrically orientable/ratchetable anchoring elements, unidirectional gecko tape, or filaments pre-attached to the apex 30. In some embodiments, thebody 15 and theskin 20 may be secured within the LAA by texturing thebody 15 and exposing thebody 15 to tissue through-holes in theskin 20 to increase friction with the surface of the heart to a level high enough to prevent migration of the implant.

Fig. 39A-39B are perspective views of embodiments of adeployable anchor 1302 activated by apull wire 1301 and shown in constrained and deployed configurations, respectively, that may be used withvarious devices 10, 1020, 3000, etc. for occluding an LAA as described herein. The two-stage anchoring system allows theanchor 1302 to be deployed after implantation and expansion of thebody 15. This embodiment introduces one or more hinge anchors 1302. Theanchor 1302, which is a barb or other anchoring element, may lie flat during delivery and during deployment of thebody 15. Then, when pulled or pushed, theanchor 1302 bends at thehinge 1306 and extends outward from the surface of thebody 15 and into the LAA tissue. Theanchor 1302 may be bent at thehinge 1306 using ahollow restraining element 1304, which may be a thin, metal, circular, or rectangular box, such as a circular or rectangular tube, and apull wire 1301, which may be a wire or suture, e.g., a sliding element.Pull wire 1301 is attached to the proximal end ofanchor 1302 and extends back through the delivery catheter or sheath. When thepull wire 1301 is retracted, theanchor 1302 slides back through theslot 1308 in thetube 1304 and bends at the preformedhinge 1306. Portions of theanchor 1302 then extend out through theslot 1308.

Fig. 40A-40B are perspective views of embodiments of adeployable anchor 1405 activated by alocking wire 1401 and shown in constrained and deployed configurations, respectively, as described herein that may be used with a variety ofdevices 10, 1020, 3000, etc. to occlude an LAA. Theanchor 1405, which is a barb or other anchoring element, may be formed from a wire or flat sheet of nitinol or other shape memory material and heat set to a shape in an expanded configuration. One ormore anchors 1405 may be disposed alongskin 20 or otherwise along the outer surface ofbody 15. One or morecorresponding guides 1402, such as rings, may be disposed alongskin 20 orbody 15. Theguides 1402 may be located on both sides of theanchor 1405, as shown. Aguide 1402 on a first side of theanchor 1405 may secure theanchor 1405 in place. Theguide 1402 on the second, opposite side of theanchor 1405 may function as a guide for thelocking wire 1401, which may be a restraining wire, suture, or the like. Thelocking wire 1401 may be used to restrain theanchor 1405 in a restrained configuration, for example, in a flat position as shown in fig. 40A. When thelocking wire 1401 is retracted, theanchor 1405 is deployed, as shown in FIG. 40B. Theanchor 1405 may extend perpendicular to thebody 15 or at an angle.

Fig. 41A-41B are perspective views of embodiments of adeployable anchor 1506 activated through asheath 1502 and shown in constrained and deployed configurations, respectively, that may be used withvarious devices 10, 1020, 3000, etc. described herein to occlude the LAA. Theanchor 1506, which is a barb or other anchoring element, may be formed from a wire or flat sheet of nitinol or other shape memory material and heat set to a shape in an expanded configuration.

One ormore anchors 1506 may be disposed alongskin 20 or otherwise along an outer surface ofbody 15. One or morecorresponding guides 1500 and lockingrings 1504 may be disposed alongskin 20 orbody 15. Theguide 1500 can be located on a first side of theanchor 1506, while thelocking ring 1504 can be located on a second, opposite side of theanchor 1506, as shown. Theanchors 1506 are held in a constrained or restricted configuration or position by theshroud cover 1502. Theshroud cover 1502 may be tubular or rectangular in shape. Theshroud cover 1502 constrains theanchors 1506. Theshroud cover 1502 may restrain theanchor 1506 in a flat position, as shown in fig. 41A. When theshroud cover 1502 is retracted, theanchors 1506 deploy as shown in FIG. 41B.Anchor 1506 may extend at an angle or perpendicular tobody 15.

Fig. 42A-42D are various views of an embodiment of thedevice 10 for occluding a LAA having an externallydeployable anchor 1601, 1604 that contracts and expands by retracting into or out of a sheath or outer catheter. Fig. 42A is a side view ofdevice 10 withanchor 1601 constrained bydelivery sleeve 1603. Fig. 42B is a side view ofdevice 10 withanchor 1601 deployed but not constrained bydelivery sheath 1603. Fig. 42C is a side view ofdevice 10 withanchor 1604 constrained bydelivery sheath 1603. Fig. 42D is a side view of thedevice 10 with theanchor 1604 deployed, but not constrained by thedelivery sheath 1603.Body 15 andskin 20 may containanchors 1601 or 1604 secured to the surface ofskin 20 and are unconstrained and therefore expand in a free state, as shown in fig. 42B and 42D. Adelivery sleeve 1603, such as a catheter, may be used to restrain theanchor 1601 or 1604.Anchors 1601 or 1604 may expand whenbody 15 is not restrained bydelivery sheath 1603, for example, whenbody 15 is released fromdelivery sheath 1603.Anchor 1601 may be expanded into an arc shape as shown in fig. 42B. Theanchor 1604 may be deployed in an angled shape as shown in fig. 42D. Upon deployment, anchors 1603 or 1604 may be directed toward the proximal or distal side ofbody 15.

Fig. 43A-43C are sequential side views of an embodiment of thedevice 10 for occluding a LAA shown constrained, deployed, and adjusted by anoose 1707 by amount 1705, respectively. One ormore anchors 1709 may be pre-loaded withinbody 15 and attached distally toseat 1705. Theseat 1705 may be a ring-like member having a through opening. Themount 1705 is positioned on arod 1701 having adistal end 1711. Theseat 1705 may move, e.g., slide, in a proximal direction on therod 1701. In some embodiments, thehub 1705 may be pulled proximally, for example, by a pull wire. In some embodiments, theseat 1705 may be moved when therod 1701 is rotated. In some embodiments, theseat 1705 and/or theend 1711 of therod 1701 may be threaded. Movement of themount 1705 causes theanchor 1705 to move. The device may include acone 1708. Acone 1708 may be attached to the end of therod 1701.Seat 1705 may be moved towardcone 1708 to adjust the height ofanchor 1709. Thus, theanchor 1709 in fig. 17C is at a greater angle relative to fig. 17B.Anchor 1709 can be moved throughbody 15 and into tissue. Theanchor 1709 may be adjusted to increase or decrease the amount of tissue penetration, for example, by moving theseat 1705. For retrieval, the process may be reversed. In some embodiments, alasso 1707 attached to awire 1703 may extend, for example, through thescrew 1701 and disposed around theanchor 1709 to retract theanchor 1709 back into thebody 15. In some embodiments, alasso 1707 may be used to initially restrainanchor 1709 and then retracted to deployanchor 1709.

Fig. 44A-44C are side views of an embodiment of thedevice 10 for occluding a LAA with an adjustable dual-stage anchoringsystem having anchors 1801 activated by moving theanchors 1803 along therods 1804.Anchors 1801 may be an internal grab hook type structure disposed withinbody 15 andskin 20.Anchor 1801 may be introduced throughcentral lumen 1003 extending throughbody 15, as shown in FIG. 43A.Anchor 1801 may then be passed throughbody 15 andskin 20 to engage tissue, as shown in FIG. 43B. Theanchor 1801 may be adjusted to increase or decrease the amount of tissue penetration. Ananchor 1801 is distally attached to themovable seat 1803. Theseat 1803 is prevented from rotating, for example, theseat 1803 may be notched to prevent theseat 1803 from rotating within thetip 30, as shown in fig. 43C. Theseat 1803 may be threaded onto thescrew 1804 and thescrew 1804 may be rotated clockwise or counterclockwise to change the linear position of theseat 1803. The distal end of therod 1804 may be coupled with acap 1807. Thecap 1807 may rotate as therod 1804 rotates.Seat 1803 may be moved proximally so thatanchor 1801 extends beyond the surface ofbody 15 andskin 20, as shown in fig. 43B.Seat 1803 may be moved distally to pullanchor 1801 back within or below the surface ofskin 20. The penetration depth of theanchor 1801 may be controlled, for example, to account for the non-circular cross-section of the LAA. In some embodiments, theanchors 1801 may be deployed individually. Another option is to deployanchors 1801 at the distal end ofbody 15 withskin 20 and control the stiffness ofanchors 1801 so that they exert a fairly uniform penetrating force on the tissue when in contact.

Various features for LAA (LAA) occlusion may be included, such as those described in, for example, U.S. patent application No. 15/290,692 filed on day 11/10/2016 and entitled apparatus and method for excluding LAA (attorney docket No.: cnfrm.001p1), U.S. patent application No. 14/203,187 filed onday 10/3/2014 and entitled apparatus and method for excluding LAA (attorney docket No.: cnfrm.001a), european patent application nos. EP14779640.3 filed on day 24/8/2015 and entitled apparatus and method for excluding LAA (attorney docket No.: cnfrm.001ep), and PCT patent application No. PCT/US2014/022865 filed onday 10/2014 and entitled apparatus and method for excluding LAA (attorney docket No.: cnfrm.001wo), the entire disclosure of each of the above patent applications is expressly incorporated by reference herein for all purposes and forms a part of this specification. Further additions and improvements to these and other concepts are described below. Unless otherwise indicated or indicated by context, the embodiments described in the following sections may include the same or similar features and/or functionality as the embodiments described above, and vice versa.

A.Foundation plug design assembly and improvements

Various occlusion devices and related devices are described with respect to fig. 45A-77. The same or similar features and/or functionality for the various devices shown and described with respect to fig. 45A-77 may be present in the various devices shown and described with respect to fig. 1-44C and 78-93B, and vice versa.

As shown in fig. 45A-45C, a device 1020 (sometimes referred to herein as an "implant") may use a foam "cup" that emerges from the center (ground-out). In some embodiments, this may be similar to thefoam 1600 design shown and described with respect to fig. 16 and/or thefoam body 3002 described with respect to fig. 85A-93B. The design of the "cup" may be contrasted with solid or generally solid tubular foam plugs, such as those described and illustrated in fig. 2 and 6. For the cup design of FIGS. 45A-45C, the approximate thickness of the foam may be about 2.5mm, but may range from about 0.25mm 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 linings, etc.). In this application, the thickness of the foam adds some desired structure between the gaps of theinternal support structure 1032, such as a shelf, when we are plugging. In some embodiments, the thickness may be at least about 0.25 mm; in some embodiments, in an unlimited state, at least about 0.50mm, 0.75mm, 1.0mm, or 2.0mm or greater, and in one implementation, about 2.5mm, with the thickness selected depending on the desired properties.

Fig. 45A is a cross-sectional view of a preferred embodiment showing the assembly of theimplant 1020 in an expanded configuration with a proximal (atrial)end 1022, a distal (LAA)end 1024, and aninternal cavity 1026. Theexpandable tubular wall 1028 defines aninterior cavity 1026 that may be surrounded at itsproximal end 1022 by atissue scaffold 1030 or other barrier configured to cover the ostium and separate the LAA from the atrium when deployed. The proximal edge of thetubular wall 1030 may be provided with a beveled re-entry and retrieval surface, such as anannular chamfer 1031 extending circumferentially or otherwise (preferably continuously) around the proximal edge of theimplant 1020 to facilitate proximal retraction of the implant into the deployment sleeve to allow repositioning or removal, if desired. Adistal extension 1029 oftubular wall 1028 extends distally beyond internal supports (discussed below) to form an atraumatic leading edge.

Thetissue scaffold 1030 may be integrally formed with thetubular wall 1028 or may be bonded thereto. Thetissue scaffold 1030 and thetubular wall 1028 can have substantially the same thickness and aperture characteristics, as discussed below. Alternatively, the tissue scaffold may comprise a different material, such as ePTFE, PTFE, dacron, or other materials known in the art, configured to support tissue ingrowth and separate LAAs, but which is thinner than thetubular wall 1028.

An expandableinternal support structure 1032 may be provided, such as awave bracket 1034 or other frame. The illustratedwave bracket 1034 includes a plurality ofsupport members 1038, with adjacent pairs of support members coupled together to form a plurality ofproximal vertices 1041 anddistal vertices 1042. Thestandoffs 1034 may be laser cut from the tube blank, as is known in the art. Each of at least three, and preferably at least 4 or 6 or 8 or more proximally facingapices 1040 is provided with a reentrant orretrieval support 1044 that is inclined radially inward in a proximal direction toward thecentral hub 1046. The recovery support can be cut from the same tube stock as the bracket. Thehub 1046 may be provided with a central lumen, such as for delivery over a guidewire, or for releasable engagement with a deployment device (not shown). Alternatively, thehub 1046 may be provided with an attachment for receiving a sewing ring, such as aneyelet 1048. A suture or other retention element may extend distally from the deployment catheter through thetissue scaffold 1028, through theeyelet 1048 and proximally back through thetissue scaffold 1028 and into the deployment catheter. After satisfactory positioning of theimplant 1020, the sutures can be removed, releasing theimplant 1020 from the deployment catheter, and leaving auniform tissue scaffold 1030 due to the elastic closure of the suture trajectory by the material. In a preferred implementation, theimplant 1020 is deployed from the delivery catheter without advancing over the wire, and the hub lacks a central lumen. In one embodiment, the implant is secured to the delivery system using any of a variety of means known in the art, including a screw mechanism or a ball in socket attachment mechanism (ball in socket attachment mechanism) that can also pivot.

Tubular wall 1028 may be attached tobracket 1034 by adhesive, sutures, or other bonding techniques known in the art. In the embodiment shown,tubular wall 1028 is sutured to ascaffold 1034 and atissue scaffold 1030 is sutured to aretrieval support 1044, withsupport structure 1032 carried withincavity 1026. Alternatively, at least a portion of thesupport structure 1032 may be carried on an exterior surface of thetubular wall 1028 or thetissue scaffold 1030. The undulating stent may be embedded within thetubular wall 1028, such as by sandwiching the stent between inner and outer layers of foam, and then bonding the inner and outer layers together. Similarly, a recycling support may be enclosed between the inner and outer polymer layers. The polymeric material may also be foamed around the stent, thereby eliminating the need for a second attachment process.

Fig. 45B is a distal end view of an embodiment of animplant 1020 showing an inner metal structure with acentral hub 1046 and eightretrieval supports 1044 angled radially inward toward thehub 1046. A plurality of suture retainers, such as holes 1050, are attached to or formed in thesupport 1044 to receive sutures for securing thetissue scaffold 1030. This reduces the tendency of thetissue scaffold 1030 material to slide distally along thesupport 1044 if theimplant 1020 is retracted proximally into the deployment catheter.

The frame is expandable from a retracted delivery configuration to an expanded deployed configuration. The frame may be retractable from an expanded deployed configuration to a retracted delivery configuration. In an unlimited expanded configuration, the frame may be generally tubular, e.g., circular, segmented, polygonal, other shapes, or combinations thereof, and preferably squeezes the foam to conform to the shape of the interior surface of the LAA. This allows the leakage of the deployed implant to be minimal, up to a maximum of about 4mm or 3mm or 2mm or less, and in some deployments, substantially leak-free as viewed by color doppler.

Fig. 45C is a proximal perspective view of the exterior of an embodiment of animplant 1020 having a single foam shell and showing aproximal chamfer 1028 in an unconstrained expansion. Anchors deployed near the distal end of the frame are discussed in further detail below.

Some of the advantages of a foam "cup" emerging from the center compared to a solid foam plug are as follows: it still behaves like a full foam plug for consistency and sealing; it allows the introduction of an inner metal frame that can be optimized to provide the desired amount of expansion for sealing and anchoring by providing optimal radial force and anchor attachment points, and a frontal surface inside the proximal face that helps the foam to contract for retrieval; by sizing the metal frame so that it is shorter in length than the foam cup, an atraumatic distal bumper is formed that is completely foam and can be extruded from the catheter hub tip as the tip advances within the LAA; and the reduction of the total volume of material contributes to the following: it significantly reduces the delivery profile, it is easier to flush to remove air prior to delivery to the vasculature, and it makes the plug more porous to blood, allowing more blood to flow therethrough if embolized within the cardiovascular system.

In one embodiment, the proximally facing edge of thefoam plug 1040 is chamfered to aid in loading and retrieval. Additionally, while there may still be a central location that allows theimplant 1020 to orbit over a guidewire-type device, in some embodiments, there is no cavity or only a crack in thefoam plug 1040 because it is not desirable to have a significant residual central hole that could cause thrombosis or allow leakage. The slit may be a single slit, a double cross slit, or a plurality of slits. The goal would be to still allow orbital movement over the guide wire, but once the guide wire is removed, determine that the aperture is completely closed. With a solid face,implant 1020 may not track over a guidewire and instead may be delivered, for example, through a long transseptal sheath.

Note that as used above, the term "guidewire" may refer to the actual medical device sold as a guidewire, or it may be a catheter, such as a pigtail catheter, that is initially placed in the LAA and over which the LAAC (LAA closure)implant 1020 orbits.

Diameter: the diameter of the LAA may vary from about 15mm to about 33mm, and as such, the diameter of theimplant 1020 must be able to accommodate this dimensional change. The more theimplant 1020 can accommodate a variety of large diameter ranges, the fewer predetermined sizes are required, thereby simplifying the implantation procedure. Thisimplant 1020 is configured such that it can accommodate diameters less than 50% of the fully expanded diameter. Preferred plugs 1040 may have diameters of about 27mm, 33mm, and 35 mm. Ideally, only 1-2 sizes would be needed to enclose the large diameter range of the LAA. This is an important advantage of thefoam plug 1040 concept compared to metal cage-type devices with fabric skeletal supports.

Depth: thepreferred plug 1040 has a length (the depth of the occluding device within the LAA is generally in the proximal-distal direction) of 20mm and is independent of the diameter of theimplant 1020. This allows for superior stability of theimplant 1020 while still accommodating most anatomical structures. The distal tip of thefoam plug 1040 is very flexible, providing an atraumatic tip as it enters the LAA while allowing the distal tip of theimplant 1020 to protrude beyond the distal tip of the delivery catheter or sheath. The short depth makes placement of theplug 1040 more robust, as it is less necessary to align the delivery catheter with the LAA, as is required when using longer devices.

Foam and porosity: the average pore size of the foam was 250-500 microns. The foam has a high void content (90-95%) to promote rapid and thorough tissue ingrowth. The open cell foam allows blood to flow therethrough. If theplug 1040 should be plugged, it will open sufficiently to allow sufficient safe blood flow until it can be retrieved. In addition, a large void volume should be beneficial for proper flushing of theimplant 1020 to prevent the introduction of air into the vasculature. The porosity and pore size can be as described forfoam 3002 ofdevice 3000, for example, as shown and described for fig. 85A-90D.

The conformability and thickness of the foam is designed to provide an excellent seal against tissue with minimal compression. Such animplant 1020 may only need to be oversized ≦ 1mm when other devices need to be significantly oversized to achieve a seal.

LA facing surface: as noted above, ePTFE (expanded polytetrafluoroethylene) or PTFE as a skin/layer of theimplant 1020, as on theplug 1040 or partially on theplug 1040, may be desirable to support neointimal formation in the absence of thrombus formation. While embodiments may be described with respect to ePTFE, it is understood that PTFE may also be used. However, because ePTFE's low porosity does not allow blood flow through the surface of theembolic implant 1020 or has a reduced ability, it can reduce safety, although blood flow can be made to surround the outer surface of the cup. The porosity of ePTFE is much lower than open-cell foam, so blood flow through the membrane is negligible. However, it is hydrophobic, which is beneficial for anti-thrombosis. One option for maintaining the desired open porosity of the foam structure while increasing the antithrombotic properties of ePTFE and/or PTFE is to add a PTFE coating to the foam by vapor deposition. The anti-thrombogenic coating may comprise ePTFE or PTFE. This creates a highly porous surface that mimics the morphology of ePTFE. Attachment methods may include vapor deposition or elastomeric glue as mentioned above (although such methods may eliminate porosity at the attachment points). If ePTFE is preferred, attachment can be made by wrapping a metal frame in ePTFE, then around the OD, through a center wrap, and by stitch attachment.

It may be desirable to reduce the foam cell size to between about 30-200 μm, as further described herein.

Barb/anchor: there are several barb design options or types that may be implemented for anchoring theimplant 1020 within the LAA. The following are some examples: 1) static state: when the plug is deployed, tissue is always engaged. This makes re-entry and repositioning of theimplant 1020 more difficult. 2) Limited: theimplant 1020 may be deployed with the barbs restrained. Theimplant 1020 may then be repositioned as desired. The barbs are then released when theplug 1040 is in its final position. 3) Dynamic state: the barbs can be deployed or retracted as needed without removing the plug. The dynamic barbs may allow deployment and retraction, for example, to reposition and/or remove theimplant 1020.

In some embodiments,implant 1020 may have different features than other implants described herein. In some embodiments, theimplant 1020 may include any or all of the following features: does not have a central lumen; in addition to the undulating support, there are spoke elements which rest on the proximal face of the cup interior; having anchors/barbs that can be activated as a second step, preferably after placement of the plug itself; there is a layer on the proximal face that may be similar toproximal face 1604' shown in fig. 16 orlayer 3100 shown in fig. 85A, although in some embodiments, PTFE may be applied by vapor deposition coating, as opposed to expanded PTFE (eptfe) attached as the second material.

B.Endoskeleton system with proximal spokes

Theimplant 1020 may include afoam plug 1040 having a central endoskeleton including aproximal spoke face 1080 having several radial supports. This configuration improves the ability to retrieve (re-enter the sleeve) thefoam implant 1020. The stent form shown in fig. 45A and 45B may be laser cut from a superelastic nitinol tube, however, a variety of other biocompatible metallic materials may be used, such as shape memory nitinol, stainless steel, MP35N, or elgiloy. Although this embodiment is self-expandable, balloon expansion designs may be used. Additionally, the frame may be fabricated from drawn wire as opposed to laser cutting from a tube. Loops may be provided along each support to allow attachment with the foam by stitching, although other attachment methods, such as adhesive, may be used. The loops at the intermediate support may be oval in shape and staggered to allow for easier loading into the delivery catheter and ease of manufacture. In addition, as shown in fig. 46, no ring may be present. Although the embodiment shown in fig. 45A has 8 struts, any of 4 to 32 struts may be used. Generally, it is preferred to attach the foam to the frame at multiple points, including the center. This facilitates retrieval without damaging the foam, and the sewing ring is beneficial for this. In other embodiments, the foam may be formed around the endoskeleton so that it is within the foam, eliminating the need for a second attachment step. As shown in fig. 45A, the proximal foam face preferably has a chamfer at the edge to minimize the volume of material in this region to aid in re-entry into the cuff.

Figures 47A-47B are perspective and side views, respectively, of an embodiment of aLAA occlusion device 1020 having aninner frame 1032 that may be a single piece. While the design shown in fig. 45B is made from two separate sheets, aproximal spoke face 1080 with eight struts and a wave-like support, in some embodiments, there may be a single-pieceintegral frame 1032, as shown in fig. 47A and 47B. In some embodiments, the proximal spokeface 1080 may support re-entry into the cuff, the eight crown shaped undulating cage supports 1060 support thefoam cylindrical plug 1040, and the eight to sixteen barbs or fewer ormore anchors 1100 located within the cylinder provide anchoring against emboli. Theanchor 1100 may be located proximally, distally, and/or centrally along the cylindrical length. When fabricated from a nitinol alloy tube, theanchor 1100 may preferably be in a size range of about 0.003 "to about 0.009" thick and about 0.007 "to about 0.015" wide. In some embodiments,anchor 1100 may extend about 1mm from the surface ofimplant 1020, but may range from about 0.5mm to about 2mm or less or more from the surface ofimplant 1020.Anchors 1100 may be in a single position along the length of the cylinder or staggered, as shown in fig. 48. With these designs, the resistance to in vitro anchor removal can be in the range of 0.5lb to 1.5lb force. There may be a single row ofanchors 1100, as shown. There may be multiple rows.

Fig. 49 shows animplant 1020 having a central endoskeleton with aproximal spoke face 1080 attached to a delivery catheter in its fully expanded configuration. Fig. 50 shows animplant 1020 having, in one embodiment, its collapsed configuration. The modification includes an outer sheath assembly that can be stretched or split at the tip to assist in conically constricting the delivery catheter. The reduction in the coefficient of friction on the foam side may reduce the force required to retract the implant into the catheter. This may be accomplished by applying a layer of PTFE to the foam, for example by vapor deposition or other methods, or by attaching a layer of expanded PTFE (eptfe) to the proximal face using adhesives or mechanical methods, such as stitching. The fixed attachment of the foam face to the spoke system may be obtained by a sewn attachment or other methods, including adhesion, which will prevent the foam from bunching up during retrieval, which may result in elevated forces and potentially tearing the foam. If the attachment is not secured by a dispersed force, the metal spoke elements can be pulled through the foam during re-entry into the cuff, thereby destroying the implant.

C.Proximal (blood-contacting) face of foam

Thefoam implant 1020 may be comprised of porous open cell foam. The foam may be any of a variety of currently available materials, including polyurethane-based biomaterials, such as polyurethane or polycarbonate-polyurethane or polyvinyl acetal (PVA)

The foam may also be reticulated, such as a mesh. Embodiments utilize non-absorbable mesh polyurethane-based biomaterials. In addition, absorbable foams may also be used, including Polyhydroxyalkanoates (PHAs), such as poly-4-hydroxybutyrate (P4HB) or a cross-linked absorbable polyester urethane-urea backbone.

The pore size in the material may be from about 50 microns to about 800 microns, preferably from about 250 microns to about 500 microns. This high amount of void (e.g., about 90% to about 95%) material promotes rapid and robust tissue ingrowth and effectively mimics the extracellular matrix. While such a high amount of void space material is desirable for tissue ingrowth, it may not be desirable for the anti-thrombosis required of the Left Atrial (LA) surface. On the side facing the LA, an anti-thrombotic surface is desirable. If the LA-facing surface is modified to promote hemocompatibility, then in the event that theimplant 1020 has a portion of the side surface of theimplant 1020 that protrudes outside the LAA and into the blood environment when deployed, those modifications may extend about 1mm to about 20mm, preferably about 1mm to about 5mm, onto the side of theimplant 1020 to ensure thromboresistance. If an aperture is present in the proximal face, such as in a guidewire lumen, the anti-thrombotic surface may extend at least partially within the lumen. In addition, the antithrombotic layer should promote tissue ingrowth and endothelialization.

A variety of methods may be used to create the anti-thrombotic proximal face of theimplant 1020, including, but not limited to, the following. For example, an expanded ptfe (eptfe) skin or layer may be applied to the outer surface of the foam implant, as described elsewhere herein. It can be attached by wrapping a metal frame in ePTFE, then wrapping through the center, surrounding the OD and attaching to the frame. This may be done using a variety of methods, including stitching or gluing, including the use of elastomeric glues (although this may eliminate porosity at the attachment points). The ePTFE layer may extend into the guidewire lumen (if one is present). In addition to ePTFE, electrospun, meltblown, non-woven, braided, or woven fibers of PTFE, polyester, PGA, PLA, poly-4-hydroxybutyrate (P4HB), or other biocompatible fibrous materials may be used to create a porous biocompatible surface.

In some embodiments, a hydrophobic material, such as a PTFE coating, is applied to the proximal face using any of a variety of methods known to those skilled in the art, including vapor deposition coating. Ideally, the coating layer will also extend partially onto the sides of the implant. Although some embodiments may not include a guidewire lumen, if a central lumen is present, the coating preferably will extend at least partially (e.g., about 1mm) into it. To promote anti-thrombosis, the coating reduces the porosity of the blood-contacting surface to a porosity of about 30 microns to about 200 microns, preferably about 100 microns to about 150 microns. Materials that may be used for this include conformal coatings such as PTFE, polyurethane spray or dip coatings applied at a thickness of about 50-100 microns, albumin, polyethylene glycol (PEG) or poly (ethylene oxide) (PEO), all with or without heparin or nitric oxide incorporation. PEG or PEO will ideally be attached by grafting. In a preferred embodiment, the outer layer will also be lubricious to help the implant re-enter the sleeve. This can be achieved by both hydrophobic materials, such as ePTFE and PTFE, and hydrophilic materials, such as PEO and PEG. To create the desired combination of porosity and blood compatibility, a two-step process may be used in which the foam is first coated with a substrate layer, such as a polyurethane-based biomaterial, and then in a second step, PTFE, PEG or PEO is used to create a more thrombogenic and lubricious surface. Heparin or other anticoagulant may be added to the final blood-contacting surface.

Another option for using ePTFE-like materials to create smaller pore sizes would be to attach an electrospun layer of PTFE to the foam face using stitching. Very thin layers (<1mm) can be prepared and attached by stitching or adhesive.

Another desirable property of the foam of theplug 1040 is to provide echogenicity of theimplant 1020, which enables visualization by echocardiography. To promote echogenicity, a porous surface may be sufficient; however, in some cases, a hydrophilic surface may be beneficial. To promote hemocompatibility and a hydrophilic surface, a preferred embodiment would be a foam implant with a surface grafted with PEO or PEG.

D.Static barb (anchor) design

When theplug 1040 is deployed, e.g., expanded, the static barbs engage the tissue. While this simplifies manufacture, it makes re-entry and repositioning of the implant more difficult.

In some embodiments, as shown in fig. 51,barbs 2000 may be made from wire and crimped onto astent 1034, in this example, a wavy stent. The barbs may be made from nitinol wires having any diameter (preferably in the range of about 0.005 "to about 0.012"). May be sharpened to facilitate penetration into tissue. It may be attached to the stent frame using a crimp sleeve made of stainless steel, nitinol or titanium tubing. It may be desirable for the filler wire to be located inside the crimp tube to prevent the barbs from rotating. It may also be attached by welding using a laser or other energy source.

Referring to fig. 52, in some embodiments, a laser cutdouble barb 2000 system may be used. This may be made fromnitinol tube 2002 cut to allow two crimped ends to have onebarb 2000 near eachcrimp 2004, and the continuous nitinol connection is followed by a curved portion ofstent 1034, in this example, in the form of a wave. An advantage of this embodiment is that it requires less labor to make and shape the barbs, it is more prone to produce sharp points, and the curved portion of the tube wall causes the barbs to harden. Fig. 53 shows an embodiment of the laser cut portion of fig. 52 prior to the formation of the crown curve.

Referring to fig. 54, in some embodiments, the filaments form a curved portion that conforms to the corrugated support cage 1034 (stent), which terminates in twobarbs 2000. It may be crimped to the undulating cage or may be stitched, welded or glued in place on the undulating cage (stent) by sutures. The advantage is that crimping does not require the barbs to be prevented from rotating.

Referring to fig. 55, in some static barb embodiments, a laser-cut undulating support cage (stent) may be fabricated withintegrated barbs 2000. The advantage of this concept is that no second attachment step is required to attach the barb to the cage. It may also be easier to add more barbs. The limitation is that it may be difficult to have 8 crowns (undulations) with barbs on each strut, since there may be insufficient material available, so 6 crowns may be preferred.

E.Constrained barb (anchor) design

With the constrainedbarbs 2010, theimplant 1020 may be deployed in the LAA while thebarbs 2010 are constrained and thus theimplant 1020 may be repositioned as desired before the barbs are released. When theimplant 1020 is in its final position, thebarbs 2010 are released.

In one embodiment, as shown in fig. 56, a lasso-type restraining system may be added to the static barbs to create restraining,deployable barbs 2010. The suture material may be tucked between thebarbs 2010 and the support to prevent rotation when deployed. Removal of the noose may release the plurality of barbs in a circular array.

As shown in fig. 57, barbs may be formed with the loop at approximately midway along thebarbs 2010, which enables sutures or threads to be placed through the loop, forming a lasso. This prevents thebarbs 2010 from fully expanding until the implant is in its final desired position within the LAA.

Figure 58 shows the flip-barb option. In this embodiment, thebarbs 2010 may be of an elongated design that fold back inside the centrally emerging foam opening prior to loading into the delivery system. This may require a pull cord or other locking element to hold the barbs in a restricted configuration. Once theimplant 1020 is in its final desired position, the constraint is removed and the barbs are no longer constrained and everted into place, thereby engaging the tissue.

F.Dynamic barb (anchor) design

Dynamic barb 2020 may be deployed or retracted as desired without removal of the implant.Dynamic barbs 2020 may be a preferred option for some procedures, such as, for example, retrieval of theimplant 102 into a delivery catheter and/or sheath.

One embodiment is a tube positioned within a tube. In this embodiment, as shown in fig. 59, alaser cut tube 1030 may be used to construct the integral front spokeface 1080 and the undulatingstent 1032 from a preferably single piece of superelastic nitinol alloy tube. Other materials may be used, including shape memory nitinol, stainless steel, MP35N, or elgiloy. A second smallerlaser cut tube 1040 may be used, as shown in fig. 60, to form an internal spoke barb array.

As shown in fig. 61, during deployment of the foam implant, the front spoke face and the undulating stent may be deployed while the array of spoke barbs remains in a constrained position. If desired,implant 1020 can be repositioned and then the distal movement ofinner tube 1040 relative toouter tube 1030 causesbarbs 2020 to expand and engage, as shown in FIG. 62. The inner spoke barb array can be repeatedly re-constrained and re-released until detached from the delivery catheter transmission line.

In another embodiment, shown in fig. 63, adynamic barb 2020 design is shown that may preferably be manufactured from a single component. Such an embodiment may be cut from alaser cut tube 1045, preferably a superelastic nitinol alloy, wherein one half of the front spokes connect to the wave-like points of thestent cage 1032 to support re-entry into the cuff, while the other half of the spokes formbarbs 2020.

Retraction or re-entry ofimplant 1020 into the sleeve may cause retraction of the barbs by contracting the front spoke faces as shown in fig. 64, thereby simultaneously retractingbarbs 2020 from the tissue. This allows safe repositioning of theimplant 1020 with a minimum amount of re-entry into the sheath required (limiting the length of implant required to be fully retracted into the sheath).

In another embodiment, as shown in FIG. 65, a dynamic hinge barb system is shown. This is a laser cutwave integrating barb 2020 with living hinges and restrictions. When the constrained end is heat set, it may be curled inward to sit above or below the undulating support. When disposed on the undulating support, the sharp barbed ends thereof may be directed toward the inner diameter of the assembly. When snapped into place under the buttress, the opposing barb tips may be tipped upward to engage the tissue. Activation of thehinge barbs 2020 may be accomplished by using a noose threaded in an annular array between each barb and the respective support. Grasping inwardly on the noose can transfer retention limits from above the support to below the support, causing the opposing barb ends to rise above the support surface where it can engage the tissue surface.

G.Embodiments using foam cups, undulating stents and ePTFE layers

As shown in fig. 66A-66C, afoam cup plug 1040 with an internal undulating or serrated anchor (e.g., as shown and described with respect to fig. 16) can be modified to completely cover the outer surface with anePTFE layer 2060. Thelayer 2060 may be attached to the foamdistal end 1024 by stitching or adhesive, as opposed to theproximal end face 1022. It may wrap around the entire outer surface and enter the central lumen on the proximal face to attach to the proximal portion of the undulating stent by lamination or adhesive. Other biomaterials or coatings may be used including, but not limited to, PTFE or polyurethane.

H.Dynamic and static anchor concepts

The embodiment ofimplant 2300 shown in side cross-sectional and end views in fig. 67 includesanchors 2310, respectively, that may be tied, welded, or crimped together at their proximal ends. Theanchor 2310 may be made of nitinol alloy wire to allow loading into the delivery system without taking the form of a set. There may be 8-16 filaments formed in an arc. The anchor may act like a "grapple". 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 fig. 67 and penetrate the tissue through thefoam 2320. As shown, thefoam 2320 is centrally generated to reduce the volume of foam required to compress into the delivery system while maintaining sufficient radial force to seal tissue.

The embodiment ofimplant 2350 shown in fig. 68A and 68B includes a wavy stent inner anchor with barbs located within a foam plug that is centrally grown to be thicker at the distal end, thus creating a larger atraumaticfoam tip bumper 2360 when collapsed within a delivery catheter, but partially deployed from the delivery catheter. Theproximal face 2363 may have aninternal cavity 2365 as shown in fig. 68A, but may not include an internal cavity as shown in fig. 68B.

I.Constrained anchors deployed in a second step

The embodiment ofimplant 2370 shown in fig. 69 has barbs/anchors 2371 that are pre-attached to undulatingstruts 2372 insidefoam 2374.Sutures 2375 are looped around the distal end of undulatingstent 2372 to compressstent 2372 and pullbarbs 2371 inward. Thesuture 2375 is tied in a slip knot. After thedevice 2370 is delivered into place, one end of thesuture 2375 is pulled and the knot is disengaged and the suture is removed, causing thestent 2372 to open radially and thebarbs 2371 to engage the tissue.Barbs 2371 may be located at the distal end offoam 2374 as shown, or may be pre-engaged withfoam 2374 and penetratefoam 2374.

J.Internal stent with increased embolic resistance

As shown in fig. 70-72, a metal stent-like frame 2380 with distalstatic barbs 2381 and proximal "speed bumps" 2382 is disclosed. It may be a zig-zag shaped stent (as shown) or a wave-like stent or other similar expandable embodiments. Deceleration strips 2382 placed on the outer portion ofmetal support frame 2380 may be of circular or point-like design. Their purpose is to provide additional tolerance and stability to the implant when deployed in the LAA to prevent embolization. In a preferred embodiment, a foam "cup" 2384 may be shaped as shown in fig. 71, providingadditional material 2385 on the distal end for an atraumatic bumper when the distal end of the implant is partially deployed from the delivery catheter. It may or may not have an internal lumen for a guidewire.

K.Restrained damage-proof anchor

As shown in fig. 73 and 74, a wave or saw-tooth orother support 2390 may be made with aring 2391 at the distal end that engages the tissue in the LAA to anchor the implant in place and prevent resistance to removal. This limits the risk of perforation since they are rounded rather than pointed, however, if a fully rounded ring does not provide sufficient resistance to removal, the point may be modified to introduce a sharp feature. The loop anchors 2391 may be placed at the end of each stent or only on some so that any of 4-16 anchors may be deployed.

During delivery of the implant through the vasculature and into the heart and LAA, theloops 2391 are folded toward the center of the constrained scaffold and aligned next to each other as shown in fig. 75. The inner catheters are placed through theloop 2391 to keep them constrained. When the system is in the LAA, the outer catheter/sheath is retracted, thereby deploying the proximal portion of the implant. If the positioning performance is acceptable, the inner catheter can be removed, allowing the distal portion of the implant to fully expand and the loop anchor to engage the LAA tissue.

L.Irrigation element and barb selection

If the implant is removed after deployment in the LAA, it is expected that the device will move into the LA, through the mitral valve and into the left ventricle, and then out the left ventricular outflow tract, through the aortic valve and into the aorta and distal circulation. During this procedure, it is possible that the device may become occluded in any of the above-described structures, interrupting blood flow and causing distal ischemia and possible hemodynamic collapse. Thus, forimplant 2392, it would be desirable to have design features that would allow distal perfusion, for example, as shown in fig. 76 and 77.

FIG. 76 is a top view of an embodiment of an implant showing a left atrial surface. The valve is seen in the surface, which in the embodiment shown is a single cut (a), which will open when sufficient pressure is applied, allowing flow through thedevice 2392. The fluid may be bi-directional or unidirectional and allows a flow rate of 10ml/min to 5L/min based on the specific conditions. In the embodiment as shown, which will be achieved without loss of structural integrity, the loading conditions will result in thedevice 2392 being divided into a plurality of sub-portions, each of which will be retrievable using standard techniques. A particular device may have a single petal element or array (as shown).

As shown in fig. 77, in some embodiments, a series of side holes (B) can be cut in the side wall of thefoam 2393 of theimplant 2392 to allow blood flow with dislodgement and distal embolization. These may vary in the size and number of 1-20 valve ports having a diameter of about 0.1mm to about 5 mm. They may also change shape including, but not limited to, circular, oval, and rectangular.

For barb designs, barbs penetrating tissue at different depths can be introduced, as well as having a series of barbs that spread out at different distances from the LA surface, such as those described herein. In one embodiment, the barbs disposed most proximally on the implant may be longer so that they penetrate deeper into the thicker proximal LAA tissue, while those disposed most distally on the implant are shorter so that they penetrate shallower into the delicate distal tissue, thereby maximizing embolic resistance with minimal risk of perforation. In another embodiment, the proximal and distal barbs may be of the same length, but may be made from wires of different diameters or may be cut from different thicknesses of the tube material so that the barbs that engage the more delicate distal LAA tissue are more flexible, or they may be designed to primarily engage the internal trabecular formation within the LAA, while the barbs located proximally penetrate the tissue. Alternatively, two barbs may be placed at each coronal point of the stent.

M.Multifunctional plugging device

Fig. 78-84 illustrate various devices and methods described herein that may be used alone or in combination with any LAA occlusion device. In some embodiments, the devices shown in fig. 78-84, as well as the related devices and methods shown and described with respect to fig. 85A-94B, may be incorporated intoapparatus 3000.

Figure 78 is a side view of an embodiment of aLAA occlusion device 3000 with an ablation device. TheLAA occlusion device 3000 has a series ofablation elements 3005. Theablation element 3005 delivers energy to tissue in and around the ostium of the LAA to electrically separate the LAA. In the illustrated embodiment, a series ofablation elements 3005 are disposed at theproximal end 3004 of thebody 3002. Theablation elements 3005 may be electrically connected to an energy source via a deployment catheter. The energy may be provided by radio frequency, ultrasound, electrical or other suitable means.Lumen 3003 extends throughbody 3002. In some embodiments,cavity 3003 may not be present.

Figure 79 is a side view of an embodiment of anLAA occlusion device 3000 with a pressure sensing device.Device 3000 has apressure sensor 3007 on itsproximal surface 3008. In some embodiments, thesensor 3007 may be located on theproximal surface 3102 of the proximal cover layer 3100 (see fig. 85A). In some embodiments, thesensor 3007 does not protrude into the LAA, such as a flat sensor on theproximal surface 3008 or 3102. Thesensor 3007 is electrically connected to theelectronic component 3011 bywires 3009. Theelectronic component 3011 has the ability to conduct and store signals generated by thesensor 3007. This information may be transmitted remotely viasignal 3013. Theelectronic component 3011 may be powered remotely or by an internal battery.

Figure 80 is a side view of an embodiment of aLAA occlusion device 3000 having a drug eluting device.Device 3000 hassensor 3007 on itsproximal surface 3008. Thesensor 3007 may be located on theproximal surface 3102 of the proximal overlay 3100 (see fig. 85A). Thesensor 3007 is electrically connected to theelectronic component 3011 by afirst wire 3009. Theelectronics 3011 are electrically connected to adrug reservoir 3017 by asecond lead 3015, the reservoir being fluidly connected to adrug outlet port 3021 by aconduit 3019. This enables drug delivery to the LA and for monitoring the concentration and or status of specific chemicals and insulin delivery driven by response to the delivery agent, e.g., blood glucose levels. Thesensor 3007 may detect the levels of a variety of chemicals and may control thereservoir 3017, for example by theelectronics 3011, to elute the drug via theoutlet 3021 in response.

Figure 81 is a side view of an embodiment of aLAA occlusion device 3000 with a pacing/defibrillation device.Device 3000 has anelectrical pacing element 3025, such as an electrode.Pacing element 3025 extends circumferentially aroundbody 3002.Pacing element 3025 may be in other configurations.Pacing element 3025 is connected topacing generator 3029 throughlead 3027.Generator 3029 is attached tobattery 3033 bywire 3031. When in atrial fibrillation, the pacing system may pace and defibrillate the atrium.Generator 3029 and/orbattery 3033 may include components for control, communication, instructions, and the like.

In some embodiments, the LAAs may be electrically separated. The LAA may be electrically separated from the occluding device incorporating one or more ablation elements, such as those shown and described with respect to fig. 78-81, ablation is performed to electrically separate the LAA, and then theoccluding device 3000 is detached to be in place within the heart. In some embodiments, the LAA may be first electrically isolated and then thedevice 3000 implanted, such as, for example, described herein with respect to fig. 82-84. In some embodiments, integrated circumferential ablation through a foam plug using an ablation element may be introduced.

Fig. 82-84 illustrate various systems and methods for electrically isolating a LAA that may be used with thedevice 3000. In some embodiments, the LAA may be electrically isolated and then the LAA occluded. For example, the systems and methods shown in fig. 82-84 can be used to perform detachment followed by LAA occlusion using various LAA occlusion devices described herein, such asdevice 3000.

FIG. 82 is a side view of an embodiment of an over the wire circumferential ablation balloon system. The over-the-wire balloon catheter 3035 is placed over theguide wire 3037 and in the laa (laa). Theballoon 3039 may have one or morecircumferential ablation elements 3041, such as apposed Radio Frequency (RF) elements, to electrically isolate the LAA using RF to treat atrial fibrillation. Theablation element 3041 extends circumferentially about theballoon 3039. Theablation element 3041 may be in other configurations. Such aguidewire 3037 may be attached to its distal end, inflated in the LAA and used as aballoon 3043 of a bumper that prevents theguide catheter 1100 from perforating the LAA wall. These devices may be similar to those for fig. 8-11.

FIG. 83 is a side view of an embodiment of an over the wire circumferential ablation ultrasonic balloon system. The over-the-wire balloon catheter 3035 is placed over theguide wire 3037 and in the laa (laa). Aballoon 3045, such as a circumferential ablation ultrasound balloon, is used to electrically isolate the LAA using Ultrasound (US) to treat atrial fibrillation. Aguidewire 3037 may be attached to itsdistal balloon 3043 as described for fig. 82.

FIG. 84 is a side view of an embodiment of a circumferential ablation spiral wire system on a wire having an ablation element. An over-the-wire circumferentialablation spiral wire 3047 having one or more ablation elements is placed in the laa (laa). Thewire 3047 may be used to electrically separate LAAs using radio frequency to treat atrial fibrillation.

N.Compliant article having compressible foam, proximal cover layer, and proximal retrieval support and distal tubular bodyEmbodiments of the sexual frame

Fig. 85A-93B illustrate another embodiment of aLAA occluding device 3000. Thedevices 3000 described herein may have the same or similar features and/or functionality as the other LAA occlusion devices described herein, and vice versa. Accordingly, any of the features of thedevice 3000 described with respect to fig. 85A-93B may be applied to the features of the device described with respect to fig. 1-84, such as theimplant 1020, and vice versa.

Fig. 85A-85C show aLAA occlusion device 3000 having afoam 3002, an expandable support orframe 3040, and aproximal cover layer 3100. Figure 85D shows aLAA occlusion device 3000 additionally having aninner cover layer 3101 and aproximal marker 3023A. Fig. 86A-86C show afoam 3002, withbody 3002 shown in cross-section in fig. 86B and 86C. Fig. 86C additionally includes a full view (i.e., non-cross-section) of theframe 3040. Thedevice 3000 is shown in an expanded configuration in these figures.Device 3000 has a longitudinal axis as shown, which may be defined byfoam 3002, as further described.

1.Compressible foam

Body 3002 is comprised of a compressible material, such as foam.Body 3002 can be a foam formed from a reticulated (e.g., web-like) polycarbonate polyurethane-urea.Body 3002 may be cut, formed, or assembled into a cup shape, as further described.Body 3002 may have a thickness and compressibility sufficient to engage surrounding tissue and conform to anatomical irregularities under radial forces applied by the inner frame, as further described. The use of a compressible material, such as foam, forbody 3002 provides a complete seal of the LAA and provides superior performance over prior devices for LAA occlusion, as further described. The structure of the foam ofbody 3002 includes a three-dimensional network of interconnected cells that are spaced apart to form an interconnected open-cell network, as further described. The mesh may have a coating, such as PTFE, while remaining open-celled, as further described.

The foam material ofbody 3002 has a high porosity. As used herein, "porosity" has its usual and customary meaning and refers to the amount of open voids between the interconnected cells of the foam. Thebody 3002 can have a porosity of at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 95%, or more. The porosity may be 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%. High porosity has the advantage of promoting rapid and firm tissue ingrowth, compressing it into a small vessel, and/or allowing blood to pass if the implant embolizes.

Thefoam 3002 has pores or cells formed between interconnected cells of the foam. Thefoam 3002 has pores with a size in the range of about 250 μm to about 500 μm. The foam may have a cell size 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 dimensions may refer to the pore size prior to application of any coating, such as PTFE. The pore size may thus be changed, e.g. reduced, after application of the coating. The desired porosity and/or pore size may be determined based on allowing blood to pass while blocking debris having a size that can potentially lead to an ischemic stroke. The allowable size of these fragments may drive the selection of a particular porosity and/or pore size. For example, a pore size of about 250 μm to about 500 μm may be based on the prevention of passage of debris having a particular size through thebody 3002.

In one embodiment,foam 3002 is made of a non-absorbable, reticulated, cross-linked polycarbonate polyurethane-urea matrix structurally designed to support fibrovascular ingrowth, with complete interconnection, with a large pore morphology with a void content in excess of 90-95%, and a small pore size in the range of 250 to 500 μm.

Body 3002 has aproximal end 3004 and adistal end 3006. In some embodiments, thedevice 3000 has an axial length from the proximal end to the distal end of 20mm in the free, unconstrained state. As used herein, a "free, unconstrained" state or the like refers to a state of thedevice 3000 when no external force is applied to thedevice 3000, other than a normal or reactive force from a surface (e.g., a desktop) on which thedevice 3000 is placed. In some embodiments, the axial length may be from about 10mm to about 30mm, from about 12mm to about 28mm, from about 14mm to about 26mm, from about 16mm to about 24mm, from about 18mm to about 22mm, or about 20 mm.Body 3002 may have any of these lengths regardless of the outer diameter ofbody 3002.

Theproximal end 3004 ofbody 3002 has a proximal end wall orface 3008. When thedevice 3000 is implanted in the LAA, theproximal face 3008 generally faces the LA. Thedevice 3000 may be implanted off-axis, as further described, in which case theproximal face 3008 may not be placed perpendicular to the longitudinal axis of the LA. Theproximal face 3008 thus provides a closedproximal end 3004 of thebody 3002. Closedproximal end 3004 is configured to cover the ostium, but as further described, porosity is sufficient to allow blood to pass through while blocking debris of a size that could potentially lead to an ischemic stroke. The membrane may be formed bybody 3002 and/orcover layer 3100. In some embodiments,proximal face 3008, or a portion thereof, may be open. For example, there may be noproximal end face 3008, there may be a partial removal ofproximal end face 3008, and so on. In some embodiments, theproximal face 3008 or a portion thereof is not included and any one or more openings are covered by theoverlay layer 3100. The size of any of these openings in theproximal face 3008 may be driven by the desired size of embolic debris that will prevent escape from the LAA, as further described.

Proximal face 3008 is planar or substantially planar and is generally perpendicular to the longitudinal axis ofdevice 3000. Theproximal face 3008 has a circular or substantially circular shape as viewed from theproximal end 3004 in an unconstrained expansion. In some embodiments, theproximal face 3008 may be planar, circular, segmented, angled with respect to the longitudinal axis, other shapes, or combinations thereof. Theproximal face 3008 may have a non-circular shape, a polygonal shape, other circular shapes, other shapes, or combinations thereof, as viewed from theproximal end 3004.

Theproximal face 3008 has anouter surface 3010 and an opposinginner surface 3012. Theouter surface 3010 faces proximally away from thedevice 3000 and theinner surface 3012 faces distally toward theframe 3040. Thesurfaces 3010, 3012 may define an outer side and an inner side of theproximal face 3008. The thickness of theproximal face 3008 may be measured axially between theouter surface 3010 to theinner surface 3012. Such thickness in a free, unconstrained (e.g., uncompressed and expanded) state can be about 0.5mm to about 5mm, about 1mm to about 4mm, about 2mm to about 3mm, about 2.5mm, or 2.5 mm. In some embodiments, the thickness may be less than 0.5mm or greater than 5 mm. The thickness of theproximal face 3008 may be uniform or non-uniform. Thus, the thickness may be greater or less in different regions of theproximal face 3008.

Body 3002 includes asidewall 3014 extending distally fromproximal face 3008. Thesidewall 3014 extends circumferentially around the perimeter of theproximal face 3008 to form a closed cross-section (i.e., extends 360 degrees circumferentially around the shaft). Thesidewall 3014 extends axially to define a concentric tubular body about the longitudinal axis of thedevice 3000. The longitudinal axis extends through the geometric center of the tubular body defined by theside wall 3014. Theside wall 3014 is tubular or substantially tubular, e.g., cylindrical, along a shaft. In some embodiments, thesidewall 3014 can be conical or frustoconical, e.g., where the proximal end is wider than the distal end or vice versa. Thesidewall 3014 may have an outer profile at its proximal end and, as viewed from the proximal or distal end, to match the outer perimeter of theproximal face 3008.

In some embodiments, the cross-section of theside wall 3014 may not be closed, for example, where there is an opening in theside wall 3014. Thus, sections taken at different positions along the longitudinal axis may or may not exhibit a closed section. In some embodiments, thesidewall 3014 can be non-tubular, non-cylindrical, non-circular, polygonal, other circular shapes, other shapes, or a combination thereof. In some embodiments, as shown, thesidewall 3014 may extend continuously the entire length from theproximal end 3004 to thedistal end 3006. In some embodiments, thesidewall 3014 may not continuously extend the entire length from theproximal end 3004 to thedistal end 3006. For example, thesidewall 3014 may include a plurality of break-off portions, such as annular portions of the sidewall, disposed and spaced apart along the longitudinal axis and connected to theframe 3040.

Theside wall 3014 has anouter surface 3016 and an opposinginner surface 3018. Theouter surface 3016 faces radially outward from the shaft. Theinner surface 3018 faces radially inward toward the shaft. The thickness of thesidewall 3014 may be measured radially between theouter surface 3016 to theinner surface 3018. Such thickness in a free, unconstrained (e.g., uncompressed) state can be about 0.5mm to about 5mm, about 1mm to about 4mm, about 2mm to about 3mm, about 2.5mm, or 2.5 mm. In some embodiments, the thickness may be less than 0.5mm or greater than 5 mm. The thickness of theside wall 3014 may be uniform or non-uniform. Thus, the thickness may be greater or less in different regions of thesidewall 3014. The thickness of thesidewall 3014 may be the same as or different than the thickness of theproximal face 3008. In some embodiments,proximal face 3008 has a thickness of 2.5mm andsidewall 3014 has a thickness of 2.5 mm. In some embodiments, the thickness ofproximal face 3008 is about 2.5mm and the thickness ofsidewall 3014 is about 2.5 mm.

Theside wall 3014 has a freedistal end 3020 with adistal surface 3022.Distal surface 3022 is planar or substantially planar and perpendicular to the longitudinal axis ofdevice 3000. In some embodiments,distal surface 3022 is non-planar, angled with respect to the axis ofdevice 3000, curved, rounded, segmented, other shapes, or combinations thereof.

Body 3002 may have adistal opening 3024. Anopening 3024 is formed through the freedistal end 3020 of thesidewall 3014.Opening 3024 is located at a distal end of an interior central volume orcavity 3028 ofbody 3002 formed at least in part byside wall 3014,proximal face 3008, and/orshoulder 3030. Theframe 3040 may be present within thecavity 3028, as further described.Distal opening 3024 may be fully open. In some embodiments,distal opening 3024 may be mostly open, partially open, or closed, for example, whenbody 3002 has a distal face similar toproximal face 3008 to enclose or partially enclosecavity 3028.

Body 3002 has a shoulder 3030 (shown as a bevel) extending betweenproximal face 3008 toside wall 3014.Shoulder 3030 may be the intersection of the proximal end ofsidewall 3014 andproximal face 3008. Theshoulder 3030 extends circumferentially around the entire intersection periphery. Theshoulder 3030 has anouter surface 3032. Theouter surface 3032 may be beveled. Theouter surface 3032 is planar or substantially planar in the axial direction. Theouter surface 3032 extends circumferentially around the entire periphery of theshoulder 3030. In some embodiments, theshoulder 3030 and/or theouter surface 3032 may be non-planar, circular, other shapes, or a combination thereof in the axial direction. Theshoulder 3030 and/or theouter surface 3032 may extend circumferentially less than the entire circumference of theshoulder 3030. The thickness of theshoulder 3030 may be measured inwardly perpendicular to theouter surface 3032. The thickness ofshoulder 3030 may be the same as the thickness ofproximal face 3008 and/orsidewall 3014, as described herein. In some embodiments, theshoulder 3030 can have a thickness that is different than the thickness of theproximal face 3008 and/or thesidewall 3014. Theshoulder 3030 may act as a retrieval ramp to facilitate pulling the implant proximally into the deployment catheter.

The compressibility ofbody 3002 contributes to the superior sealing capability ofdevice 3000. The foam may be compressible to provide a larger radial "footprint" and transmit radial forces outward from the support on theframe 3040, as further described. Thefoam 3002 may have a compressive strength in a range of at least 1 pound per square inch (psi), or about 1psi, to about 2psi, or no more than about 2 psi. "compressive strength" herein refers to the pressure that compresses the foam to 50% strain. With some foam materials forbody 3002, pressure may not vary from 50% strain to at least 80% strain, and the relationship of pressure versus strain may be planar or substantially planar. Thus, even if a thicker foam is used forbody 3002,body 3002 will not exert a greater outward force on the tissue due to the increased thickness itself. In one embodiment,foam 3002 is a reticulated, crosslinked matrix having a void volume of at least about 90%, an average cell size in the range of about 250 and 500 microns, a wall thickness of at least about 2mm, and a compressive strength of at least about 1 psi. In one embodiment,body 3002 is comprised of a foam material having or substantially having the material properties shown in table 1. In some embodiments,body 3002 is composed of materials described in, for example, U.S. patent No. 7,803,395 entitled "Reticulated elastomeric matrix, their manufacture and use in implantable devices (polymeric matrices, the third manufacture and use in implantable devices)" or U.S. patent No. 7,803,395 entitled "Reticulated elastomeric matrix, their manufacture and use in implantable devices (polymeric matrices, the third manufacture and use in implantable devices)", the entire disclosure of which is incorporated herein by reference.

TABLE 1 example material properties of embodiments of foam materials that may be used for thefoam 3002.

Thedevice 3000 may include markers 3023 (see fig. 85B and 87D; only some of themarkers 3023 are labeled in the figures for clarity) to facilitate visualization during delivery. Themarker 3023 may be a radio-opaque marker band sutured into the freedistal end 3020 of thebody 3002. Themarker 3023 may be used during delivery for visualization of thedistal end 3006 of thedevice 3000 using fluorescence imaging. A series ofmarkers 3023 may be circumferentially disposed along thedistal surface 3022 of the body 3002 (only some of themarkers 3023 are labeled in fig. 85B for clarity). In some embodiments, themarker 3023 may additionally or alternatively be located in other areas of thebody 3002 and/or on other components of the device, such as thecover layer 3100 or theframe 3040.

In some embodiments, four platinum iridium (PtIr) Radiopaque (RO)tubular markers 3023 are sutured to thedistal end 3006 of thefoam 3002 to enable visualization of the distal edge of thedevice 3000 under fluoroscopy. In some embodiments, aPtIr marker 3023 is attached to thefoam 3002 at the location of theproximal shoulder 3030 to serve as a marker during recovery of thedevice 3000. Visualization of the proximal and/ordistal markers 3023 may be advantageous to identify the amount recovered. If thedevice 3000 is retracted as far into the interior of the sleeve, but does not include the anchorproximal end 3090, thedevice 3000 can be re-deployed and reused. Ifproximal anchor 3090 is retrieved into the access sheath,device 3000 can be removed and discarded due to the permanent deformation ofanchor 3090. In some embodiments, other materials may be used formarker 3023, such as gold or other suitable materials.

As shown in fig. 85D and 87D, thedevice 3000 may include one ormore markers 3023A. As just one example, there are threemarkers 3023A shown. In some embodiments, onemarker 3023A may be present. Two, four, five ormore markers 3023A may be present. In some embodiments, there is oneproximal marker 3023A and tendistal markers 3023. Unless otherwise specified,marker 3023A can have the same or similar features and/or functionality as other markers described herein (e.g., marker 3023), and vice versa.Marker 3023A may be located at or near the proximal end ofdevice 3000. As shown, themarker 3023A is located on theinner surface 3012 of theproximal end 3004 of thefoam 3002. Themarker 3023A may be located at or near an inner surface of a shoulder 3030 (see fig. 86B) of thefoam 3002. Themarkers 3023A may be circumferentially distributed, e.g., equidistant or equiangular to each other, or they may be at different distances from each other. They may be located radially at the same or different positions relative to each other. In some embodiments, only onemarker 3023A is present. There may be oneproximal marker 3023A and fourdistal markers 3023. One ormore markers 3023A may be located inside, outside, or within thefoam 3002, or a combination thereof. One ormore markers 3023A may be located on or at thedistal surface 3022 of thefoam 3022. Themarker 3023A may be circumferentially elongated, as shown. In some embodiments, themarker 3023A may be linear when thedevice 3000 is viewed from a particular angle, such as a side view. Themarkers 3023A may be arranged or oriented in the same or similar orientation or in different orientations. Some, none, or all of themarkers 3023A may be oriented in a circumferential, transverse, axial (e.g., along theinner surface 3018 of the sidewall 3014), other direction, or combinations thereof.

As further shown in fig. 87D, one ormore markers 3023B may be present. Unless otherwise specified, one or more ofmarkers 3023B may have the same or similar features and/or functionality as the other markers described herein, such asmarkers 3023 or 3023A, and vice versa. Themarker 3023B can be positioned along thesidewall 3014 of thebody 3002. One ormore markers 3023B may be disposed along theinner surface 3018 of thesidewall 3014.

As shown, twomarkers 3023B are visible on either side inside thefoam 3002. Themarker 3023B is attached through the foam and around theframe 3040. Themarker 3023B may be attached, e.g., sutured, around aproximal face 3060 member of theframe 3040, such as one of thesupports 3061. Themarker 3023B may be attached to theframe 3040 at a location immediately proximal to one of theproximal apices 3084 of theframe 3040, e.g., at theouter arc portion 3066 of thesupport 3061. There may be only onemarker 3023B, or two, three, four, ormore markers 3023B. For eachstrut 3061, there may be one of themarkers 3023B. Themarker 3023B may additionally be used to connect theframe 3040 with thefoam 3002. As described herein,marker 3023B can be a suture.

One ormore markers 3023A and/or 3023B located at or near the proximal end of thedevice 3000 provide a variety of desirable features. For example, themarker 3023A at theshoulder 3030 facilitates visualization of thedevice 3000 during and after implantation. The generally non-circular shape of the LAA opening (ostium) may compress theproximal end 3004 of the device and cause theproximal end 3004 to extend slightly in a proximal direction. However, theshoulder 3030 may provide a location for themarker 3023A where linear bulging of thefoam 3002 in the proximal direction is reduced or prevented. Thus, themarker 3023A in this position may provide a more useful visualization of the location of theapparatus 3000 and reduce complexity. For example, in some embodiments, themarker 3023A at the shoulder 3030 (e.g., on the inner surface as shown) may be particularly useful during delivery, allowing delivery using fluorescence imaging only without echo or other ultrasound imaging. One ormore markers 3023B may provide similar benefits.

As further shown in fig. 85D and 87D,device 3000 may include aninner cover layer 3101. Theinner cover layer 3101 may have the same or similar features and/or functionality ascover layer 3100, unless otherwise described (see "proximal cover layer" section, as described in further detail below). Theinner cover layer 3101 can be a cover layer of hinges 3050 (see, e.g., fig. 86C and 89A-90C). Theinner cover layer 3101 may be formed from expanded polytetrafluoroethylene ("ePTFE"). Theinner cover layer 3101 may be a separate part of the same material as theproximal cover layer 3100.

Theinner cover layer 3101 may be positioned between thefoam 3002 and theframe 3040. As shown, theinner cover layer 3101 is located between theinner surface 3012 of thefoam body 3002 and the proximal ends of thehinges 3050 of theframe 3040. Theinner cover layer 3101 may be circular or other shape. Theinner cover layer 3101 may have an area sufficient to provide a barrier between thehinge 3050 and theproximal end 3004 of thefoam 3002. In some embodiments, theinner cover layer 3101 may extend radially to the outer perimeter of thehinge 3050, or it may extend radially to theside wall 3014, reaching theinner surface 3018 of thefoam body 3002 or any radial position therebetween. Theinner cover layer 3101 may have a diameter of about 4mm to about 22mm, about 5mm to about 15mm, about 6mm to about 10mm, about 8mm, or 8 mm. Theinner cover layer 3101 may be planar or substantially planar.Inner cover layer 3101 may have a thickness of about.0001 "-. 0020", about.0002 "-. 0010", about 0.0005 ", or 0.0005" thick.Inner cover layer 3101 may include one ormore openings 3103, such as through holes. Theinner cover layer 3101 may include twoholes 3103 to receive thetether 3240 therethrough (see, e.g., fig. 93A-93B). Twoholes 3103 in thecover layer 3101 may be aligned with atether 3240, such as a suture, thetether 3240 extending distally through onehole 3103 in theinner cover layer 3101 to thehub 3050 and proximally out of thehub 3050 through theother hole 3103 of theinner cover layer 3101.

Theinner cover layer 3101 may prevent thehinges 3050 and/or other features of theframe 3040 from directly contacting the foam material. Thecover layer 3101 may protect the integrity of thefoam 3002 against stresses that may be exerted on the foam by thehinges 3050. Such protection may be desirable during, for example, loading, deployment, retrieval, re-deployment, etc. ofdevice 3000. Theinner cover layer 3101 may prevent or reduce damage to thefoam 3002 by thehinges 3050.

Foam 3002 may be attached to multiple components ofdevice 3000.Body 3002 may be attached to frame 3040 at a plurality of points, including, for example, the proximal center offrame 3040, as further described herein. The attachment may be made using sutures, such as polypropylene monofilament sutures, although other methods known in the art, such as gluing, may be used. The proximal row ofproximal anchors 3090 may be individually attached to (e.g., inserted through) thefoam 3002 to prevent relative movement between thefoam 3002 and theframe 3040. In other embodiments, thefoam body 3002 may be formed around the endoskeleton such that the metal frame is located within thefoam body 3002, thereby eliminating the need for a second attachment step. The attachment of thebody 3002 to theframe 3040 has the advantage of facilitating retrieval without damaging thefoam 3002. The attachment also ensures thatbumper 3026, described further herein, always extends out of theframe 3040, including during initial exposure of thedevice 3000 upon proximal retraction of the delivery sheath.

As shown in fig. 87D,device 3000 can include one ormore attachments 3001.Attachment 3001 may connectframe 3040 withfoam 3002.Attachment 3001 may be a suture. Other suitable attachment structures may be used, including staples, knots, threads, components of theframe 3040, other mechanical attachments, adhesives, other suitable means, or combinations thereof.Attachment 3001 may extend aroundframe 3040 and throughfoam 3002, e.g., throughsidewall 3014.

As shown, fourattachments 3001 are visible in fig. 87D. There are twoproximal attachments 3001 and twodistal attachments 3001 visible.Proximal attachments 3001 are located at the base of eachproximal anchor 3090, respectively.Distal attachment 3001 is located at the base of eachdistal anchor 3094, respectively. There may be 1, 2, 3, 4, 5, 6, 7, 8, ormore attachments 3001. There may be 20attachments 3001. For eachanchor 3090, 3094 ofdevice 3000, there may be one of theattachments 3001. Theattachment 3001 may be located at aproximal apex 3084 or adistal apex 3088, respectively, of theframe 3040 as further described herein, e.g., as described with respect to fig. 89A. For example,attachment 3001 may be wrapped around one ormore supports 3082, 3086, as further described herein.Attachment 3001 may locally compressfoam 3002 at and/or around the attachment location, as further described herein, e.g., as described with respect to fig. 95C.Attachment 3001, such as sutures, may extend from within thecavity 3028 through thefoam 3002, exit thefoam 3002 and extend along theouter surface 3016 of thefoam 3002, extend back into and through thefoam 3002 into thecavity 3028, and be tied or otherwise connected together around theframe 3040. In some embodiments, asimilar attachment 3001 trajectory may be used withattachments 3001 knotted or otherwise wrapped and connected together outside offoam 3002. In some embodiments,attachment 3001 may also extend throughcovering layer 3300 or other covering layers as described herein.Attachment 3001 may extend through the material of coveringlayer 3300. Theattachment 3001 may extend through an opening in thecovering layer 3300, such as aside opening 3324 or a window 3177 (see, e.g., fig. 88B-88E). As shown,proximal attachment 3001 may extend throughfoam 3002 and through an opening in coveringlayer 3300, anddistal attachment 3001 may not extend throughcovering layer 3300, but only throughfoam 3002.

Thefoam 3002 may include a coating. In some embodiments, no coating may be present. In embodiments having a coating, the coating is applied to the interconnected cells of the foam.Body 3002 may be coated with pure Polytetrafluoroethylene (PTFE). The PTFE coating minimizes the procoagulant properties of the LA surface while also reducing the friction of thefoam 3002 against the delivery system to facilitate deployment and retrieval. Thebody 3002 may be coated with pure PTFE that is conformable, vacuum deposited. Additionally or alternatively,body 3002 can be coated with a coating other than PTFE. Whether a PTFE or other coating, the coating may be about 0.5 μm thick and cover at least a portion of the surface of the interconnected cells of the foam without plugging the cells. A coating may be applied to some or all of thefoam 3002. A coating may be applied to some or all of the exterior surface of thefoam 3002.

In some embodiments, the coating thickness is from about 0.1 μm to about 1 μm, from about 0.2 μm to about 0.9 μm, from about 0.3 μm to about 0.8 μm, from about 0.4 μm to about 0.7 μm, from about 0.4 μm to about 0.6 μm, or about 0.5 μm thick. In some embodiments, greater or lesser coating thicknesses may be applied. The coating has a uniform or substantially uniform thickness. In some embodiments, the coating may have a non-uniform thickness. For example, when implanted, portions ofbody 3002 facing the LA, such asproximal face 3008 and/orshoulder 3030 may have a thicker coating than the coating alongside wall 3014 ofbody 3002. In some embodiments, theouter surface 3010 of theproximal face 3008 has a PTFE coating, and theproximal face 3008 also has anePTFE cover 3100.

The coating is applied using a vapor deposition process. In some embodiments, the coating is applied by coating, vapor deposition, plasma deposition, grafting, other suitable methods, or combinations thereof. A coating is applied to theouter surfaces 3010, 3032, and 3016 ofproximal face 3008,shoulder 3030, andsidewall 3014, respectively. In some embodiments, the coating is applied to theouter surfaces 3010, 3032 and is only partially coated on theouter surface 3016. In some embodiments, a coating is applied to the outer and inner surfaces ofbody 3002.

In some embodiments, other biocompatible, anti-thrombogenic and/or lubricious materials may be applied to the surface of thefoam 3002 and/or theoverlay 3100. These materials may promote tissue ingrowth. These materials may include, for example, heparin, albumin, collagen, polyethylene oxide (PEO), hydrogels, hyaluronic acid, nitric oxide, oxygen, nitrogen, amine-releasing materials, bioabsorbable polymers and other biomaterials, pharmacological agents, and surface modifying materials. Additionally, the surface ofbody 3002 may be roughened, textured, or otherwise modified or coated to promote healing or to make it more echogenic.

2.Proximal cover layer

Device 3000 may include acover layer 3100, which may be an ePTFE cover layer as further described. Other embodiments of theouter cover layer 3100 are described herein, for example,cover layers 3101, 3300, 3150, 3151, and the like. Unless otherwise specified, various embodiments of the cover layer may have the same or similar features and/or functionality as one another. Thecover layer 3100 may have a series of openings. In some embodiments, theoverlay 3100 may be solid and not have any openings. In some embodiments, theoverlay 3100 may have only openings to accommodate anchors and/or through tethers, as further described herein. In some embodiments,device 3000 may include an inner cover layer, such asinner cover layer 3101, as shown and described with respect to fig. 85D.

Outer cover layer 3100 is a substantially planar material applied overbody 3002 and covers at least a portion ofbody 3002.Overlay 3100 is located on theproximal end 3004 ofdevice 3000. Theoverlay 3100 covers theproximal face 3008 and at least a portion of thesidewall 3014 of thebody 3002. Thecover layer 3100 covers a proximal portion of thesidewall 3014. When implanted, theoverlay 3100 has aproximal surface 3102 that at least partially faces the LA. Theoverlay 3100 has anouter edge 3104 that forms outer vertices 3106 (only some of theouter edge 3104 andouter vertices 3106 are labeled in the figure for clarity). In some embodiments, theoverlay 3100 may cover only theproximal face 3008 or a portion thereof. In some embodiments, theoverlay 3100 may extend over a greater extent of theside wall 3014, such as a medial or distal portion thereof, or theentire side wall 3014.

Thecovering layer 3100 may have a thickness measured perpendicularly from aproximal surface 3102 of thecovering layer 3100 facing thebody 3002 to an opposite distal surface. Theoverlay 3100 may have a thickness of 0.001 "(inches). In some embodiments, theoverlay layer 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, theoverlay layer 3100 may have a thickness of 0.0005 ". In some embodiments, theoverlay layer 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 ".

Theoverlay 3100 may be attached to theframe 3040 by afoam 3002. Theoverlay 3100 may additionally or alternatively be attached to thebody 3002. Theoverlay 3100 may attach at least 2 or 4 or 6 or moreouter vertices 3106. Theoverlay 3100 may be attached to theframe 3040 and/or thebody 3002 at various locations, including at theouter apex 3106, by theproximal surface 3100, at theproximal face 3008 of thebody 3002, other locations, or combinations thereof. Thecover layer 3100 is attached using a mechanical attachment, such as a suture. In some embodiments, polypropylene 6-0 sutures are used throughout the device to attach thefoam 3002,proximal cover layer 3100, andRO marker 3023 to thefoam 3002 and/or theframe 3040. In some embodiments, thecover layer 3100 is attached to theframe 3040 by a standard braided or monofilament suture material, such as polypropylene, ePTFE, or polyester. In some embodiments, polypropylene monofilaments are used. Theproximal anchor 3090 of the frame 3040 (described further herein) may extend through theouter apex 3106 of theoverlay 3100. These penetratinganchors 3090 may also secure theoverlay 3100 in place relative tobody 3002. In some embodiments, theoverlay 3100 may be attached to the various components of thedevice 3000 by mechanical attachment, fasteners, adhesives, chemical bonding, other suitable techniques, or combinations thereof.

As shown, thecover layer 3100 is formed from expanded polytetrafluoroethylene ("ePTFE"). TheePTFE overlay 3100 provides a number of advantages. For example, theePTFE overlay 3100 may enhance the ability of the invivo recovery device 3000 by distributing the proximal withdrawal force applied by the catheter. Thecover layer 3100 may be an approximately 0.001 "thick ePTFE material, similar to the underlying PTFE-coated foam, with appropriate porosity to promote healing and minimize thrombosis.

TheePTFE overlay 3100 may facilitate the retrieval of the implant into the sheath while providing a smooth, anti-thrombotic surface that promotes tissue coverage and integration. The ePTFE may cover the entire proximal face and partially cover the side edges as shown in fig. 85C. TheePTFE overlay 3100 is made from a previous laminate formed from two or more sheets of oriented material, offset to form a biaxially oriented material. Alternatively, a tube, preferably biaxially oriented, may be used, and then cut to form a sheet. The thickness of the final construction may be in the range of 0.0005 "to 0.005", but is preferably about 0.001 ".

In some embodiments, theoverlay 3100 is fabricated from other anti-thrombogenic, high strength, biocompatible materials, such as woven or woven polyester fabrics, polypropylene, polyethylene, non-woven vascular scaffolds, porous membranes, or bioabsorbable scaffolds, such as polylactic acid, polyglycolic acid, and copolymers. As shown in fig. 88A and 88B, the shape of the covering before attachment to thedevice 3000 minimizes wrinkling and provides a smooth surface after attachment to the implant. Such shapes may be star-shaped, pointed or otherwise.

Thecover layer 3100 may be perforated by a series of openings 3120 (only some of theopenings 3120 are labeled in the figures for clarity). Theopening 3120 is a perforation or hole formed in theoverlay 3100 by a laser or mechanical cutting. Theopenings 3120 includeproximal openings 3122 and side openings 3124 (only some of theproximal openings 3122 andside openings 3124 are labeled in the figures for clarity). When thecovering layer 3100 is assembled with thebody 3002, theproximal opening 3122 is located on theproximal face 3008 and/or theshoulder 3030, and theside opening 3124 is located on theside wall 3014. In some embodiments, thecover layer 3100 includes 40proximal openings 3122. In some embodiments, theoverlay 3100 includes 40side openings 3124. The number ofopenings 3120 on theproximal face 3008 and/or theshoulder 3030 may range from 10 to 80, 20 to 70, 30 to 60, 35 to 50, or 40openings 3120 when assembled with thebody 3002. The number ofopenings 3120 located on theside wall 3014 may be in the range of 10 to 80, 20 to 70, 30 to 60, 35 to 50, or 40openings 3120.

Theopening 3120 can have a variety of sizes. The width of theopening 3120 is 0.070 ", for example, the minor axis or the diameter of a circular opening. Theopening 3120 may have a width of 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 can be less than 0.010 "or greater than 0.200", such as 0.25 ", 0.5", or greater. These widths may be suitable for circular as well asnon-circular openings 3120.

In some embodiments, theopening 3120 can be a variety of shapes. Theopening 3120 may be an elongated slot. Theopening 3120 may extend radially along thecover layer 3100 from at or near a central portion of theproximal surface 3102 to theouter edge 3104 and/or radially to theouter edge 3104. Theopening 3120 may be an annular opening extending circumferentially along theoverlay 3100 and having a different radial position. Theopening 3120 may have a uniform size and shape. Someopenings 3120 may have different sizes and/or shapes thanother openings 3120. Theopenings 3120 may have various distributions or concentrations around thecover layer 3100. For example, theopenings 3120 may be more densely arranged in regions, such as along theproximal surface 3102 facing the LA, along theshoulder 3030, and so forth.

Theopening 3120 enables blood to flow through thedevice 3000. Theopening 3120 can allow blood to flow sufficiently through thedevice 3000 and thereby mitigate the risk of occlusion in the blood flow if thedevice 3000 is to be embolized within the vasculature. In some embodiments, if thedevice 3000 is to be embolized, it may act to stabilize the filter at low pressures, but pass through the blood stream at high pressures. In some embodiments, thedevice 3000 allows about 2 to about 14 liters, about 4 to about 12 liters, about 6 to about 10 liters, or about 8 liters per minute of blood to pass through at a pressure drop of <30mmHg to prevent shock in the event of a device embolism. In some embodiments, there are 40circular openings 3120 that each have a diameter of 0.070 "and allow about 8 liters per minute of blood to pass with a pressure drop of <30 mmHg. In some embodiments, the proximal end of thedevice 3000 may be a foam layer, such as the foamproximal face 3008 or a membrane, such as thecover layer 3100, or both, that surrounds thecavity 3028 defined within thetubular sidewall 3014 of thebody 3002.

In one implementation, by having both a foamproximal face 3008 and acover layer 3100, thefoam body 3002 has an open cell structure as discussed further herein that can allow blood to pass through, but prevent embolic debris from escaping. Thecovering layer 3100 may be sealed to blood flow and present to provide structural integrity and reduce friction of the expandedbody 3002 retracting back into the deployment catheter. In one implementation, theoverlay 3100 is ePTFE in a substantially closed form to blood flow, as described. In this embodiment, thecover layer 3100 is thus provided with a plurality of irrigation windows oropenings 3120 so that blood can pass through the open cell foam and thecover layer 3100, but thedevice 3000 still benefits from the other properties of thecover layer 3100.

In some embodiments, thedevice 3000 may allow a specific flow rate of water under specified conditions to detect the perfusion performance of thedevice 3000. Thedevice 3000 may have afoam 3002 and acover layer 3100 configured to allow water to pass axially through thedevice 3000 at a flow rate of at least 4 liters per minute. The water may be at 68 degrees fahrenheit (F) or about 68 ° F and an upstream pressure of 25 millimeters of mercury (mmHg) or about 25 mmHg. In some embodiments, thedevice 3000 may be configured to allow a flow rate of about 1 liter to about 7 liters, about 2 liters to about 6 liters, about 3 liters to about 5 liters, greater than 2 liters, greater than 3 liters, or greater than 4 liters of water per minute under these conditions. The specific flow rate may depend on the porosity of thefoam 3002 and the open area of thecover layer 3100. The specific flow rate may also depend on the characteristics of theinner cover layer 3101. Theoverlay 3100 may have a certain percentage of overlay opening area with a series of openings, as further described herein, to achieve a particular desired flow rate. As described herein, the flow rate of water under specified conditions may be used to extrapolate or otherwise calculate a corresponding expected flow rate of blood through thedevice 3000 in vivo (if it were to embolize). Thedevice 3000 may allow for a cardiac index 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 minute per square meter. Thedevice 3000 may have these and other flow rate capabilities that are consistent or approximately consistent with the direction of fluid flow, or off-axis flow rate capabilities in which thedevice 3000 is at an angle relative to the direction of fluid flow (the flow axis), such as, for example, discussed further herein in the section "off-axis delivery and deployment".

Fig. 87A-87C show an embodiment of anLAA occlusion device 3000 having another embodiment of acover layer 3300. Theapparatus 3000 includes thefoam 3002 and theframe 3040 and their components, as described herein, and additionally includes acover layer 3300. Theoverlay 3300 may have the same or similar features and/or functionality as theoverlay 3100, and vice versa. Coveringlayer 3300 is located onproximal end 3004 ofdevice 3000. Coveringlayer 3300 coversproximal end face 3008 ofbody 3002 and proximal portions ofsidewalls 3014. Coveringlayer 3300 has aproximal surface 3302.Overlay layer 3300 has anouter edge 3304 that forms a plurality of outer vertices 3306 (only some of theouter vertices 3306 are labeled in the figures for clarity) of at least 2 or 4 or 6 or 8 or 10 or more.Overlay 3300 is attached tobody 3002 atouter apex 3306. Theproximal anchor 3090 extends through theside opening 3324 in theouter apex 3106 of theoverlay 3100.

Overlay layer 3300 includes a series ofopenings 3320.Opening 3320 includes aproximal opening 3322, ashoulder opening 3323, and aside opening 3324.Proximal opening 3322 is located atproximal end 3004 ofbody 3002.Shoulder opening 3323 is located onshoulder 3030 ofbody 3002, e.g., at a bevel.Side opening 3324 is located on a proximal portion ofside wall 3014 ofbody 3002. Theproximal anchor 3090 may extend through theside opening 3324 located in theouter apex 3106.Opening 3320 may have the same or similar features and/or functionality as opening 3120, and vice versa. In some embodiments, theproximal anchor 3090 can extend through thecovering layer 3300 material at or near theouter apex 3106.

Fig. 88A shows another embodiment of acover layer 3150 that may be used with thedevice 3000. Thecover layer 3150 may have the same or similar features and/or functionality as thecover layer 3100 and/or thecover layer 3300, and vice versa. Thecover layer 3150 may be used to cover theproximal face 3008 and a portion of thesidewall 3014 of thebody 3002. Thecover layer 3150 has aproximal surface 3152. Thecover layer 3150 has anouter edge 3154 that forms anouter apex 3156. Thecover layer 3150 may be attached to thebody 3002 at anouter vertex 3156. Theproximal anchor 3090 may extend through theouter apex 3156 of theoverlay 3100. Thecover layer 3150 includes a series ofopenings 3170. Theopenings 3170 include aproximal opening 3172 and side openings 3174 (only some of theopenings 3170, 3172, 3174 are labeled in the figures for clarity). When thecover layer 3150 is assembled with thebody 3002, theproximal opening 3172 is located on theproximal end 3004 and theside opening 3174 is located on theside wall 3014. As shown, theopenings 3174 may be substantially uniformly arranged along thecover layer 3150, except for a central region of theproximal surface 3152.

Fig. 88B is a top view of another embodiment of aproximal cover layer 3151 that may be used with the various LAA occlusion devices described herein. Fig. 88C is a top view showing thecover layer 3151 assembled with thedevice 3000. Unless otherwise specified, theoverlay layer 3151 may have the same or similar features and/or functionality as the other overlay layers described herein, such as theoverlay layer 3100 and/or theoverlay layer 3300, and vice versa. For example, thecover layer 3151 may include aproximal surface 3152 and anouter edge 3154 that forms anouter apex 3156.

Thecover layer 3151 also includes another embodiment of a series ofopenings 3171. Theopening 3171 includes asmaller opening 3175 and alarger opening 3173. Theopenings 3175, 3173 may have the same or similar features and/or functionality as the other cover layer openings described herein, such asopenings 3120, 3122, 3124, 3320, 3322, 3324, 3170, 3172, and/or 3174, and vice versa. Thesmaller openings 3175 may be relatively smaller in width and/or area than thelarger openings 3173. There may be openings that are smaller in width or area than thesmaller openings 3175, larger than thelarger openings 3173, or have any size in between. As shown, theopenings 3173, 3175 may be substantially uniformly distributed around theproximal surface 3152 of thecover layer 3151. Theopenings 3173, 3175 may be evenly spaced or substantially evenly spaced circumferentially around thecover layer 3151.

There may be a variety of different amounts of eachopening 3173, 3175. There may be openings that total 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 150, 200, 300, 400 or more series ofopenings 3171, or any fewer, greater, or intermediate number of openings. The series ofopenings 3171 may be holes as shown. They may have a circular shape. They may have other shapes including non-circular, segmented, other shapes, or combinations thereof. Theopenings 3171 may all have the same general shape or different shapes. In some embodiments, there may not be any holes in thecover layer 3151.

The large andsmall openings 3173, 3175 may be located on theproximal end 3004 and/or theside wall 3014 of thefoam 3002 when thecover layer 3151 is assembled with thefoam 3002. When assembled with thefoam body 3002, there may be a total of 140 or about 140openings 3173, 3175 on the proximal facing portion of thecover layer 3151. On the proximal facing portion of thecover layer 3151, there may be a total of about 10 to about 300, about 50 to about 215, about 110 to about 170, about 120 to about 160, about 130 to about 150, about 135 to about 145openings 3173, 3175. On the proximal facing portion of thecover layer 3151, there may be about 30 to about 50, about 35 to about 45, about 40, or 40larger openings 3173. On the proximal facing portion of thecover layer 3151, there may be about 60 to about 140, about 80 to about 120, about 90 to about 110, about 100, or 100smaller openings 3175.

When assembled with thefoam 3002, there may be about 5 to about 80, about 10 to about 40, about 15 to about 30, about 20, or 20smaller openings 3175 on the portion of thecover layer 3151 disposed on and/or near theshoulder 3030, such as on theouter surface 3032 of the foam 3002 (see, e.g., fig. 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 20larger openings 3173 in this same portion of thecap layer 3151.

When assembled with thefoam 3002, there may be about 5 to about 80, about 10 to about 40, about 15 to about 30, about 20, or 20larger openings 3173 on portions of thecover layer 3151 disposed on and/or near theside wall 3014, such as on theouter surface 3016 of the foam 3002 (see, e.g., fig. 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 20smaller openings 3175 in this same portion of thecap layer 3151.

The larger andsmaller openings 3173, 3175 may have a variety of different sizes, for example, as described herein with respect toopening 3122. In some embodiments, theopenings 3173, 3175 may have a diameter range of about 0.025 inches to about 0.040 inches. In some embodiments, thelarger opening 3173 may be 0.040 inches in diameter or about 0.040 inches in diameter. Thelarger opening 3173 may be about 0.030 inches to about 0.050 inches in diameter or about 0.035 inches to about 0.045 inches in diameter. These values may also represent the width, e.g., maximum width, of the non-circularlarger opening 3173. In some embodiments, thesmaller opening 3175 may be 0.025 inches or about 0.025 inches in diameter. Thesmaller opening 3175 is about 0.015 inches to about 0.035 inches or about 0.020 inches to about 0.030 inches in diameter. These values may also represent the width, e.g., maximum width, of the non-circularsmaller opening 3175.

The series ofopenings 3171 may be configured to provide a desired amount of open area through thecover layer 3151. The open area refers to the total area of the particular opening in thecover layer 3151. Thecover layer 3151 may cover theproximal face 3008 at theproximal end 3004 of thefoam body 3002. The open area may represent an opening through a portion of the cover layer located on theproximal face 3008 of thefoam 3002 when assembled with thefoam 3002. A series of openings in multiple cover layers as described herein may collectively provide an open area. For example, a series ofopenings 3171 in thecover layer 3151 on the proximal face of the foam may collectively provide an open area. This is the sum of the areas of the openings in the proximal face overlying thecover layer 3151. As another example, the open area may be the sum of theproximal openings 3122 of thecover layer 3100. As another example, the open area may be the sum of theproximal openings 3322 of thecover layer 3300.

The open area may be at least 5% of the area of theproximal end face 3008 of thefoam 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 theproximal end face 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 theproximal end face 3008. It should be understood herein that the "area" of theproximal face 3008 is meant to be equal to Pi R²Where R is the radius of theproximal face 3008 and extends perpendicularly from the longitudinal axis of thedevice 3000. Further, "R" may be measured to the inner boundary of theshoulder 3030, to the outer boundary of theshoulder 3030 or to theouter surface 3016 of thesidewall 3014. Further, as mentioned, aSome embodiments may not include a cover layer at all.

Thecover layer 3151 may include one ormore windows 3177. As shown, there may be 10windows 3177. There may be 1window 3177 for eachproximal anchor 3090. There may be 4, 6, 8, 12, 14 ormore windows 3177 or any fewer or between number. Thewindow 3177 may be an opening in thecover layer 3151. Thewindow 3177 may be located at or near theouter edge 3154 of thecover layer 3151. Thewindow 3177 may be disposed along a portion of theouter edge 3154, e.g., at or near theouter vertex 3156. Thewindow 3177 may have a shape that conforms to the shape of thecover layer 3151 at various portions of theouter edge 3154. As shown, thewindows 3177 may be diamond shaped or substantially diamond shaped. Thewindow 3177 may be square, rectangular, triangular, round, circular, segmented, flat diamond, other polygonal shapes, other shapes, or combinations thereof. Thecover layer 3150 may be attached to thebody 3002 at theouter vertex window 3177. Thewindow 3177 may have the same or similar features and/or functionality as theside opening 3324, as described and illustrated in fig. 87B. Theproximal anchor 3090 may extend through thewindow 3177 of thecover layer 3151 to retain thecover layer 3151 on thedevice 3000.

Fig. 88D-88E are side and perspective views, respectively, of another embodiment of aproximal cover layer 3153 shown assembled with the device, theproximal cover layer 3153 being usable with various LAA occlusion devices described herein. Unless otherwise specified, thecover layer 3153 may have the same or similar features and/or functionality as the other cover layers described herein, such ascover layers 3100, 3151, and/or 3300, and vice versa. For example, thecover layer 3151 may include aproximal surface 3152, anouter edge 3154 forming anouter apex 3156, and awindow 3177.

Thedevice 3000 having acovering layer 3151 may have aproximal anchor 3090 extending through thewindow 3177. Theproximal anchor 3090 may extend through the opening of eachwindow 3177. Theproximal anchor 3090 may extend through a distal portion of thewindow 3177, for example, to help secure thecovering layer 3153 to thedevice 3000. Theproximal anchor 3090 may extend through thewindow 3177 at the distal edge or distal apex of thewindow 3177. In some embodiments, theproximal anchor 3090 may extend through thecovering layer 3151 material, e.g., through the material adjacent (e.g., distal)window 3177. In some embodiments, theproximal anchor 3090 may extend through a variety of other locations within, adjacent to, or near thewindow 3177. Some of theproximal anchors 3090 may extend through a first location and otherproximal anchors 3090 may extend through a second location of thecovering layer 3153 that is different from the first location. For example, one ormore anchors 3090 may extend through a first region ofwindow 3177, one or moreother anchors 3090 may extend through a second region ofwindow 3177, one or moreother anchors 3090 may extend through other regions, such as through thecover layer 3153 material, and the like.

Thecover layer 3153 may include aproximal apex 3155. Theproximal apex 3155 may be formed by theouter rim 3154. Theproximal apex 3155 may be a depression, e.g., a corner as shown or other shape, configuration, etc., along theouter edge 3154 of thecover layer 3153. Theproximal apex 3155 may define aregion 3016A of theouter surface 3016 of thesidewall 3014. Theregion 3016A may be partially encapsulated by theouter edge 3154 of thecover layer 3153. Theregion 3016A can receive one or moredistal anchors 3094 therethrough. Thedistal anchor 3094 may extend through a distal portion of theregion 3016A or other location within, adjacent to, or near theregion 3016A. In some embodiments, thedistal anchor 3094 may not extend through theregion 3016 or extend near theregion 3016. There may be a plurality of theseregions 3016A of thefoam 3002 defined circumferentially around thedevice 3000 by thecover layer 3153.

Thecover layer 3153 may include a series ofopenings 3320, for example, as described with respect to fig. 87A. The series ofopenings 3320 may include aproximal opening 3172, ashoulder opening 3323, and/or aside opening 3174. Thecover layer 3153 may include different patterns, sizes, distributions, etc. ofopenings 3320, e.g., as shown and described with respect to fig. 88B-88C.

3.Compliant frame

For example, an expandable and compliant support orframe 3040 is shown in FIGS. 85B, 85D, 86C, and 87C-E. Fig. 89A and 89B are side and proximal perspective views, respectively, of theframe 3040 shown in an expanded configuration and separated from the remainder of thedevice 3000. Theframe 3040 provides a compliant structure with anchors to facilitate delivery, anchoring, retrieval, and to enable thefoam 3002 to compress over LAA tissue to facilitate sealing, etc., as further described. Theframe 3040 is positioned inside acavity 3028 formed by thefoam 3002. In some embodiments, theframe 3040 can be partially or completely located inside one or more portions of thebody 3002, e.g., within theproximal face 3008 and/or thesidewall 3014, as further described. For example, as shown in fig. 87C, theframe 3040 may be partially located within thesidewall 3014.

Theframe 3040 has aproximal end 3042 and an oppositedistal end 3004. Theframe 3040 may be tubular, e.g., cylindrical, in a free, unconstrained state. Thus, the width of theproximal end 3042 can be the same as or similar to the width of thedistal end 3004 in the free, unconstrained state. In some embodiments, theframe 3040, or portion thereof, can be conical or frustoconical, e.g., where the width of theproximal end 3042 is greater than the width of thedistal end 3004 in a free, unconstrained state, or vice versa.

At theproximal end 3042, theframe 3040 has aproximal hub 3050, which is shown as a cylindrical nipple. Thehinge 3050 is a circular structural end piece. Thehinge 3050 can be tubular, e.g., circular and have a cylindrical shape as shown, or can be round, non-circular, segmented, other shapes, or a combination thereof. Thehub 3050 extends axially and may have a central cavity. Thehinge 3050 can be wider than it is long, or vice versa. Thehinge 3050 is hollow and has sidewalls that define a through space, such as a longitudinal opening. In some embodiments, thehinge 3050 can be partially hollow, solid, or otherwise constructed. Thehinge 3050 facilitates delivery and retrieval of thedevice 3000, as further described. Thehinge 3050 can provide for central structural attachment, as further described herein. Thehinge 3050 can be located within thecavity 3028 at its proximal end. In some embodiments, thehinge 3050 can be partially or completely located within thefoam body 3002, e.g., within theproximal face 3008.

Pin 3051 is located within hinge 3050 (as shown in fig. 89A and 89B). Thepin 3051 is an elongated, circular structural member extending laterally through the central lumen. "transverse" herein refers to a direction perpendicular or substantially perpendicular to the longitudinal axis. Thepin 3051 has a cylindrical shape. Thepin 3051 provides a rounded outer surface configured to provide a smooth engagement surface with a tether, as further described. Thepin 3051 provides a strong connection to theframe 3040 to enable thedevice 3000 to be pulled with sufficient force to re-enter thedevice 3000 into the socket (re-shear). Thepin 3051 can be formed of nitinol. Thepin 3051 is fastened across the width, e.g., diameter, of theproximal hub 3050. Thepin 3050 can be fastened to the side wall of the hinge at its two opposite ends.Pin 3051 is configured to be engaged bytether 3240,tether 3240 being slidably engaged aroundpin 3051 for temporary attachment with a delivery catheter, as further described. In some embodiments, thepin 3051 is assembled with thecap 3180 as further described herein, e.g., as described with respect to fig. 90A-90C.

Theframe 3040 at theproximal end 3042 includes aproximal face 3060. Theproximal face 3060 may be located within thecavity 3028 at its proximal end. In some embodiments, theproximal face 3060 may be partially or completely located within thefoam 3002, for example, within theproximal face 3008 and/or theside wall 3014. Theproximal face 3060 includes a series of retrieval or reentering supports 3061. Asupport 3061 is located at the proximal end ofcavity 3028. In some embodiments, thesupport 3061 or portions thereof may be partially or completely located within thefoam 3002, e.g., within theproximal face 3008 and/or theside wall 3014.

Thesupport 3061 is an elongated structural member. Thesupport 3061 may have a rectangular, circular, or other shaped cross-section. In some embodiments, thesupport 3061 has a cross-section, e.g., a rectangle, with a width greater than a thickness, making thesupport 3061 stiffer in one direction than in another. The width may be in a direction transverse or substantially perpendicular to the longitudinal axis of thedevice 3000, with the thickness perpendicular to the width when thedevice 3000 is in the expanded configuration. Thesupport 3061 may be less stiff in the flexing or bending direction, e.g., to facilitate retraction and expansion of thedevice 3000 in the delivery and expanded configurations. Thesupport 3061 may be an elongated pin. Thesupport 3061 can extend from thehinge 3050, e.g., and slope radially outward from thehinge 3050 in a distal direction. Thesupport 3061 can be attached inside, outside, and/or at the end of the side wall of thehinge 3050. Thesupport 3061 can be a separate component that is subsequently attached to thehub 3050, for example, by welding, gluing, fastening, other suitable methods, or a combination thereof. In some embodiments, some or all of thesupports 3061 and hinges 3050 can be a single, continuous structure formed from the same raw material, such as a laser cut shaft tube (hypotube). Some or all of thestruts 3061 may be attached to thebody 3002 and/or thecovering layer 3100 at one or more attachment locations, for example, by sutures as described herein.

Eachretrieval support 3061 can include aninner arc portion 3062, an intermediatestraight portion 3064, and/or anouter arc portion 3066 connected to the distal end of the hinge 3050 (only some of theportions 3062, 3064, 3066 are labeled in the figures for clarity). In the deployed configuration, theinner arc portion 3062 extends from thehinge 3050 substantially in a distal direction and then curves radially outward further to the face. The intermediatelinear portion 3064 extends substantially radially, but also slightly distally from the innerlinear portion 3062. The outercurved portion 3066 extends in a generally radial direction from the intermediatelinear portion 3064 and then curves in a distal direction. The portions may have different shapes when in the delivery configuration inside the delivery catheter. In the delivery configuration, the portion may extend substantially distally. The portion may then assume the deployed configuration as described once deployed from the delivery catheter. In some embodiments, thesupport 3061 may include fewer or more portions than theportions 3062, 3064, 3066.

Thedevice 3000 may include 10 proximal retrieval supports 3061. This configuration can be accompanied by adevice 3000 having afoam 3002 with an outer diameter of 27mm when in a free, unconstrained state. This configuration can be accompanied by adevice 3000 having afoam 3002 with an outer diameter of 35mm when in a free, unconstrained state. In some embodiments, thedevice 3000 may have from about 2 to about 30, from about 4 to about 20, from about 6 to about 18, from about 8 to about 16, from about 10 to about 14, or other number ofstruts 3061.

In the deployed configuration, eachsupport 3061 may extend radially outward and distally at an angle to the shaft. The angle may be about 60 ° to about 89.9 °, about 65 ° to about 88.5 °, about 70 ° to about 85 °, about 72.5 ° to about 82.5 °, about 75 ° to about 80 °, or other amount of tilt, measured relative to the shaft portion extending distally from thedevice 3000. This angle can be much smaller when thedevice 3000 is in a delivery catheter. Thestruts 3061 may bend or flex when transitioning between the delivery and expanded configurations or when positioned in the delivery and expanded configurations. Thesupport 3061 can be curved or flexed within the innercurved portion 3062, the intermediatelinear portion 3064, and/or the outercurved portion 3066.

In the expanded configuration, theproximal end 3042 of theframe 3040, such as theproximal face 3060, may thus have a conical shape. The conicalproximal face 3060 may facilitate retrieval of thedevice 3000 into a delivery catheter. For example, in the expanded configuration, the orientation of thestruts 3061 that are angled distally and radially outward from thehub 3050 provides an advantageous conical shape to theproximal face 3008, such that distal advancement of the delivery sleeve over thedevice 3000 will deflect thestruts 3061 inward and load thedevice 3000 back to the delivery configuration and size for retrieval within the catheter.

Once thedevice 3000 is expanded relative to the delivery configuration, theproximal face 3060 is significantly shortened. By "shortened" is meant herein the difference in axial length of theproximal face 3060 between the reduced delivery configuration and the expanded configuration (free expansion or expansion upon implantation). The length can be measured axially from the distal or proximal end of thehinge 3050 to the distal end of theouter arc portion 3066 of theretrieval support 3061. Theproximal face 3060 may be shortened by 50%, 60%, 70%, 80%, 90% or more. Once expanded, theproximal face 3060 shortens significantly more than thetubular body 3080, which may be referred to as a "working length" or "landing zone". The landing zone is further described with respect to thetubular body 3080 herein.

As shown, thesupports 3061 are arranged at angular intervals about the shaft at uniform angular increments. That is, the angles between the supports may be equal when viewing theframe 3040 from either the distal or proximal end. In some embodiments, thesupports 3061 may not be evenly angularly spaced about the shaft as described. Thesupports 3061 may or may not be symmetrically arranged about the shaft or about a plane that includes the shaft.

In some embodiments, portions of theframe 3040 may be at different distances from the proximal end of thefoam 3002, such as the proximal wall of theproximal face 3008. As shown in fig. 87D, there may be a gap of dimension Z in the axial direction between theproximal face 3060 of theframe 3040 and theinner surface 3012 of theproximal face 3008. The length of Z may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 millimeters or more. The length of Z may vary based on the radial distance at which it is measured. For example, the length of Z may be lowered, raised, or a combination thereof, as measured along the length of thesupport 3061. In some embodiments, the length of Z may be 0 or greater at points along the length of thesupport 3061. As shown in fig. 87E, theproximal face 3060 or portions thereof may contact the proximalinner surface 3012 of thefoam 3002. Theinner arc portions 3062, thelinear portions 3064, and/or theouter arc portions 3066 may contact a proximal wall of thefoam 3002, such as theinner surface 3012 and/or other portions. As shown, thehinge 3050 can slightly compress theproximal face 3008 or proximal wall of thefoam 3002 in the proximal direction. Thus, theproximal face 3008 may have a lesser thickness in the compressed region than other portions of theproximal face 3008, e.g., portions adjacent to the compressed portion. As described herein, thehub 3050 can be arranged based on the axial location of the connection of theanchors 3090, 3094 with thesidewall 3014. In some embodiments, as shown, the hinge 300 may not compress thefoam 3002. In some embodiments, as shown, theproximal face 3060 may extend radially outward. For example, thesupport 3061 or portions thereof, e.g., thelinear portions 3064, may extend radially outward perpendicular or substantially perpendicular to the longitudinal axis of theapparatus 3000. Theproximal face 3060 may extend radially outward and be sloped in the distal direction, as described herein, or it may be sloped in the proximal direction.Device 3000 may have any of these features in a constrained, unconstrained, and/or implanted configuration.

Theframe 3040 includes atubular body 3080.Body 3080 provides a mechanical infrastructure fordevice 3000, as further described. Thetubular body 3080 is attached to a distal end of theproximal face 3060 of theframe 3040. Thetubular body 3080 extends to thedistal end 3044 of theframe 3040. Thetubular body 3080 is attached at a proximal end to theouter arc portion 3066 of theretrieval support 3061, as further described. Thetubular body 3080 may be attached to other portions of theretrieval support 3061. Thetubular body 3080 of theframe 3040 may be attached to thebody 3002 and/or thecovering layer 3100 at one or more attachment locations, e.g., by sutures as described herein. Thetubular body 3080 may be located within thecavity 3028. In some embodiments, thetubular body 3080 may be partially or completely located within thefoam body 3002, e.g., within thesidewall 3014.

Thetubular body 3080 includes a series of proximal anddistal support members 3082, 3086 (only some of thesupport members 3082, 3086 are labeled in the figures for clarity). Theproximal support 3082 and/or thedistal support 3086 may have a rectangular, circular, or other shaped cross-section. In some embodiments, the proximal 3082 and/or distal 3086 supports have a cross-section, e.g., a rectangle, with a width greater than a thickness (or vice versa), making thesupport 3061 stiffer in one direction than in the other. Thesupport 3061 may be less stiff in the flexing or bending direction, e.g., to facilitate retraction and expansion of thedevice 3000 in the delivery and expanded configurations. The proximal ends of a pair of adjacent end supports 3082 are joined at aproximal apex 3084. Eachproximal support 3082 is connected to theouter arc portion 3066 of a respective one of the retrieval supports 3061 at a respectiveproximal apex 3084. Each distal end of theproximal support 3082 is connected to a distal end of an adjacentproximal support 3082 and to the proximal ends of twodistal supports 3086 at amedial apex 3087. A pair of adjacentdistal support members 3086 extend distally to join at respectivedistal apices 3088. A repeatingpattern 3089, shown as a diamond shape, may be formed by an adjacent pair ofproximal support members 3082 and an adjacent pair ofdistal support members 3086. Some or all ofproximal support 3082 and/ordistal support 3086 may be attached tobody 3002 and/orcovering layer 3100 at one or more attachment locations, e.g., by sutures as described herein. Some or all of theproximal support 3082 and/or thedistal support 3086 may be located within thecavity 3028. In some embodiments, some or all of theproximal support 3082 and/or thedistal support 3086 may be partially or completely located within thefoam body 3002, e.g., within theside wall 3014.

There are the same number ofproximal apices 3084 asdistal apices 3088. As shown, there are 11proximal apices 3084 and 11distal apices 3088. The number of proximal anddistal apices 3084, 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 apices, respectively. In some embodiments, there may be noproximal apices 3084 in the same number as thedistal apices 3088. In some embodiments, there may be more than one row of patterns formed by the proximal anddistal supports 3082, 3086, e.g., a diamond pattern. There may be 2, 3, 4 or more rows of patterns. Some or all of theproximal apices 3084 and/or thedistal apices 3088 may be attached to thebody 3002 and/or thecovering layer 3100 at one or more attachment locations, for example, by sutures as described herein.

Thebody 3080 in the expanded configuration can be tubular, e.g., cylindrical or substantially cylindrical. Thetubular body 3080 can be cylindrical, circular, segmented, polygonal, tube-like, other shapes, or combinations thereof, all of which are non-exhaustive in the category of "tubular". In the expanded configuration, a tubular shape is formed by the proximal anddistal supports 3082, 3086. In the expanded configuration, a tubular shape may also be formed by theouter arc portion 3066 of theretrieval support 3061. The tubular shape may also be formed by thefoam 3002 applying an outward radial force to theframe 3040. Thus, theframe 3040 may have a proximal conical cross-section and a cylindrical working length. In some embodiments,body 3080 can be conical or frustoconical, e.g., where the distal end is wider than the proximal end or vice versa.

As noted, thetubular body 3080 may be referred to as a "landing zone". The landing zone may represent the axial length of thebody 3080 from the most distal to the most proximal in the transition to theretrieval support 3061 in the expanded configuration. The landing zone may have an axial length measured from theproximal apex 3084 to thedistal apex 3088. The length of the landing zone may be 10mm or about 10 mm. The landing zone may have a length of about 5mm to about 15mm, about 6mm to about 14mm, about 7mm to about 13mm, about 8mm to about 12mm, about 9mm to about 11mm, or other lengths. Once thedevice 3000 is expanded relative to the delivery configuration, thetubular body 3080 can be slightly shortened. Once expanded, thetubular body 3080 has a significantly less shortening of its length than theproximal face 3060. Thetubular body 3080 may be shortened by no more than about 5%, 10%, 15%, 20%, or 30%.

Theframework 3040 self-expands by delivery from a cuff. Theproximal face 3060 and thetubular body 3080 will self-expand. Once expanded, the radially outward portion of thetubular body 3080 will contact and compress thefoam 3002 against the tissue of the LAA wall. Thetubular body 3080, e.g., theproximal support 3082 and thedistal support 3086, will contact theinner surface 3018 of thesidewall 3014 and compress thesidewall 3014 such that theouter surface 3016 of thesidewall 3014 contacts and compresses the LAA wall.

Thefoam 3002 provides a larger "footprint" than theskeletal frame 3040 assembly and forms a complete seal when the LAA walls are compressed. Thus, thesidewall 3014 functions as a force dissipation layer that transfers radial forces from thesupports 3082, 3086 of theframe 3040 over a larger area than the area of theindividual supports 3082, 3086 (e.g., a larger area than the area of the radially outer surfaces of thesupports 3082, 3086). In this regard, the use of foam material inbody 3002 and the thickness of the foam (e.g., 2.5mm) provide advantages over devices that use a material that is thinner and less resilient than foam. For example, a thin fabric or similar material that is squeezed against the LAA wall by the skeletal frame will not transmit radial forces out and may even sag or otherwise bend, creating gaps and unsealed LAA wall portions. Thefoam 3002 as described herein will take the shape of the LAA wall to create a complete circumferential seal and will also transmit radial forces away from theframe 3040 to create a stronger seal and retention by thefoam 3002.

In addition, theapparatus 3000 with thecompressible body 3002 described herein makes thestructural frame 3040 compliant due to the smaller radial forces required from theframe 3040. For example, existing devices having incompressible fabric materials will have less effective seals and therefore the structural elements of those devices must provide greater radial force to compensate for and ensure an effective seal, resulting in a less compliant device. In contrast, in this regard, by having acompressible foam 3002, theprior device 3000 provides advantages that, among other things, allow for less radial force from theframe 3040 and thus better compliance, while still providing an effective seal. This structural configuration has a cascading effect in terms of performance advantage. For example, the compliance of thedevice 3000 allows for off-axis delivery while still providing the advantages of effective sealing, as further described herein.

Theframe 3040 includes a series ofproximal anchors 3090. Eachproximal anchor 3090 extends from a respectiveintermediate apex 3087. Theproximal anchor 3090 can extend from other portions of thetubular body 3080. As shown, in the deployed configuration, theproximal anchor 3090 extends radially and proximally from thetubular body 3080. Theproximal anchor 3090 may extend into adjacent regions of thesidewall 3014. Theproximal anchor 3090 can extend through theouter surface 3016 of thesidewall 3014 to penetrate tissue adjacent thedevice 3000.

Theframe 3040 includes a series ofdistal anchors 3094. Eachdistal anchor 3094 extends from a respectivedistal apex 3088. Thedistal anchor 3094 can extend from other portions of thetubular body 3080. As shown, in the deployed configuration, thedistal anchor 3094 extends radially and proximally from thetubular body 3080. Thedistal anchor 3094 may extend into adjacent regions of theside wall 3014. Thedistal anchor 3094 can extend through theouter surface 3016 of thesidewall 3014 to penetrate tissue adjacent thedevice 3000. Theanchors 3090, 3094 can be angled radially outward in the proximal direction to engage tissue to resist proximal movement of thedevice 3000.

Anchors 3090, 3094 are elongated structural members. The tips ofanchors 3090, 3094 can be sharpened to facilitate tissue engagement and penetration.Anchors 3090, 3094 may be straight, extending substantially along their partial axes.Anchors 3090, 3094 can have curved or other non-linear proximal portions where they are attached to thetubular body 3080. In some embodiments, theanchors 3090, 3094 or portions thereof can be non-straight lines, arcs, circles, segments, other parabolas, or combinations thereof. In some embodiments, the tissue engaging the tip may be curved. In some embodiments, anchors 3090, 3094 can have engagement means, such as barbs, hooks, or other means, extending radially away fromanchors 3090, 3094.

Anchors 3090, 3094 can be rectangular in cross-section. In some embodiments, the cross-section may be circular, round, non-round, square, rectangular, polygonal, other shapes, or combinations thereof. The cross-section may or may not be uniform along the length of theanchors 3090, 3094.Anchors 3090, 3094 may be about 0.006 "thick and about 0.008" wide.Anchors 3090, 3094 may be in the range of about 0.003 "to about 0.009" thick and about 0.003 "to about 0.015" wide. The cross-section of theanchors 3090, 3094 can decrease in size, e.g., taper, toward the distal tip.

In some embodiments, theanchors 3090, 3094 in the deployed configuration are inclined at an inclination angle of about 30 ° relative to a central axial portion extending proximally from thedevice 3000. The angle of inclination may be from about 10 ° to about 50 °, from about 15 ° to about 45 °, from about 20 ° to about 40 °, from about 25 ° to about 35 °, or about 30 °. This angle of inclination foranchors 3090, 3094 in the delivery configuration can be less than the angle of inclination in the deployed configuration.Anchors 3090, 3094 can have an angle B, as shown and described with respect to fig. 94A-94C.

Anchors 3090, 3094 may have different lengths. The length of theanchors 3090, 3094 is measured from the proximal end attached to thetubular body 3080 to the distal tissue engaging tip of the anchor. In some embodiments, theanchors 3090, 3094 can have a length of about 0.5mm to about 10mm, about 1mm to about 9mm, about 2mm to about 8mm, about 3mm to about 7mm, about 4mm to about 6mm, about 5mm, or other greater or lesser lengths. In some embodiments, anchors 3090, 3094 are 5mm long. In some embodiments, theanchors 3090, 3094 are about 5mm long. In some embodiments, theanchors 3090, 3094 have a length of at least 2.5mm, at least 3mm, at least 3.5mm, at least 4mm, at least 4.5mm, at least 5mm or more.Anchors 3090, 3094 may each have the same or similar length. In some embodiments, theanchors 3090, 3094 may not be the same length. In some embodiments, some or all of theproximal anchors 3090 can have a length that is less than or greater than the length of some or all of thedistal anchors 3094.Anchors 3090, 3094 can have a length L, as shown and described with respect to fig. 94A-94C. In addition, the outer tips of theanchors 3090, 3094 can extend to an outer radial position that is less than, equal to, or greater than the radially outermost surface of thefoam 3002, as shown and described with respect to fig. 94A-94C.

In the expanded configuration, theanchors 3090, 3094 extend a length outside theuncompressed side wall 3014. This length of theanchors 3090, 3094 is measured along the local longitudinal axis of the anchor from theouter surface 3016 of thebody 3002 to the distal tip of the anchor.Anchors 3090, 3094 can extend throughside wall 3014 and/oroverburden 3100 and then be trimmed so thatanchors 3090, 3094 extend a desired length beyondside wall 3014 and/oroverburden 3100. In the free, unconstrained state, theanchors 3090, 3094 extend about 0.5mm beyond theouter surface 3016 of thesidewall 3014. In some embodiments, in the free, unconstrained state, theanchors 3090, 3094 extend beyond theouter surface 3016 of thesidewall 3014 for a length of about 0.1mm to about 1.5mm, about 0.2mm to about 1.25mm, about 0.3mm to about 1.0mm, about 0.4mm to about 0.8mm, about 5mm to about 0.6mm, or other greater or lesser lengths. In a compressed state, such as in a delivery configuration or after implantation, theanchors 3090, 3094 extend about 1.0mm beyond theouter surface 3016 of thesidewall 3014. In some embodiments, in the compressed state, theanchors 3090, 3094 extend a length of about 0.25mm to about 2.5mm, about 0.5mm to about 2mm, about.75 mm to about 1.5mm, about.875 mm to 1.125mm, or other greater or lesser lengths beyond theouter surface 3016 of thesidewall 3014.

The geometry of theanchors 3090, 3094 provides several advantages. For example, the relatively long length allows theanchors 3090, 3094 to be flexible. This provides the LAA tissue with potentially less trauma required to thedevice 3000 when it is being un-anchored and/or retrieved. Theanchors 3090, 3094 are less sensitive to loss of intensity in off-axis directions within the LAA. In addition, theanchors 3090, 3094 provide high resistance to pullout. For example, thedevice 3000 may provide a removal resistance from the LAA of at least about 0.5lb force. These pull-out tests may be simulated by in vitro or bench-top models, as described further below.

Theanchors 3090, 3094 in the illustrated embodiment are located in two circumferential rows. One row is located proximal to the other distal row. Each row has 10 anchors. This configuration can be incorporated into adevice 3000 such as afoam 3002 having a free, unconstrained outer diameter of 27 mm. Each row may have 14 anchors, respectively. This configuration can be incorporated into adevice 3000 such as afoam 3002 having a free, unconstrained outer diameter of 35 mm. In some embodiments, the single row ofanchors 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 or more orless anchors 3090 or 3094. In some embodiments, there may be only one row or more than two rows of anchors. Theanchors 3090, 3094 can be circumferentially spaced in a single row.

In an embodiment, by having multiple rows ofanchors 3090, 3094, the rows may be circumferentially offset, as shown. That is, theanchors 3090, 3094 are angularly spaced from one another about the shaft, as viewed from the proximal or distal end of thedevice 3000.Anchors 3090, 3094 may not be circumferentially offset, e.g., they may be evenly spaced at an angle when viewed as described.Anchors 3090, 3094 are positioned axially at or near a middle portion ofsidewall 3014. Theanchors 3090, 3094 can be positioned such that the tips of theanchors 3090, 3094 extend to adjacent tissue at the mid-portion of theside wall 3014. The offset and neutral position of theanchors 3090, 3094 may ensure engagement with LAA tissue distal to the ostium. The stability of thedevice 3000 is improved by theanchors 3090, 3094 being located at the maximum width. With a cylindrical or substantiallycylindrical device 3000, theanchors 3090, 3094 are effectively disposed on the largest diameter of thedevice 3000. The cylindrical shape provides advantages over typical LAA occluders, which are tapered distally, thus reducing implant stability and locating the anchor on a smaller diameter than the caliber of the occluding surface. In addition to increasing stability, the cylindrical shape ofdevice 3000 along the axial length facilitates resistance to removal by allowing placement ofanchors 3090, 3094 on the largest diameter portion ofdevice 3000. In some embodiments, theanchors 3090, 3094 can be disposed proximally, distally, or centrally along the length of theframe body 3080. In some embodiments, theanchors 3090, 3094 may not be offset and/or may not be evenly spaced at an angle.

Anchors 3090, 3094 can provide advantageous flexibility, as evidenced by pull-out tests and comparisons to existing devices. For example, thedevice 3000 may be tested to determine the force required to remove thedevice 3000 from the simulated tissue phantom by pulling thedevice 3000 proximally out of the phantom. A low durometer silicone tube with a circular Inner Diameter (ID) was used as a model. For thedevice 3000 with thefoam 3002 having an outer diameter of 27mm in a free, unconstrained state, 16.5mm, 21mm and 25mm ID tubes were tested. The pull-out force of the prior device was significantly reduced when proceeding to the 21mm model, whereas the force of thedevice 3000 was only slightly reduced.

In the largest diameter (25mm) model where there is no substantial mating hindrance, the force of the prior devices is close to zero because the devices do not engage the model walls because the anchors are on the smaller diameter of the device trailing edge. Thedevice 3000 continues to resist removal with a force of about 0.7 lbs. Since there is little friction against pullout, the force is almost completely resisted by theanchors 3090, 3094. When the failure mode is checked, all devices eventually start to slide out of the model. Once broken, theanchors 3090, 3094 are folded back or laterally before beginning to slide off. Assuming a 0.7lbs force is required to cause the entire 20anchors 3090, 3094 to fold back, the force per anchor is estimated to be about 0.035 lbs.

Theframe 3040 may be laser cut. Thetubular body 3080 can be laser cut from a single tube.Body 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". For a 27mm device 3000 (i.e., an embodiment of thedevice 3000 having afoam 3002 of 27mm OD in an unconstrained, free state), the tube may have an Outer Diameter (OD) of 0.124 ". For a 35mm device 3000 (i.e., an embodiment of thedevice 3000 having afoam 3002 of 35mm OD in an unconstrained, free state), the tube may have an OD of 0.163 ".

In some embodiments,body 3080 is laser cut from a superelastic nitinol tube, however, a variety of other biocompatible metallic materials may be used, such as shape memory nitinol, stainless steel, MP35N, or Elgiloy (Elgiloy). Theframe 3040 is self-expandable. In some embodiments, aballoon expansion frame 3040 may be used. Additionally,body 3080 can be made from drawn wire as opposed to laser cutting from a tube.

As shown, an embodiment of thedevice 3000 includes aframe 3040 having 10 proximal retrieval supports 3061 and a total of 20anchors 3090, 3094, withfoam 3002 having an outer diameter of 27 mm. In some embodiments, thedevice 3000 may include aframe 3040 having 14 proximal retrieval supports 3061 and a total of 28anchors 3090, 3094, with thefoam 3002 having an outer diameter of 35 mm.

In one embodiment, theframe 3040 includes aproximal hub 3050,tether pin 3051, a front face with 10 or 14 retrieval supports 3061,diamond pattern cylinders 3080 and 20 or 28anchors 3090, 3094. Theproximal face 3060 of the frame supports retrieval, thebody 3080 supports thefoam cylinder 3002, and thecylindrical anchors 3090, 3094 provide resistance to embolization.

The design of thedevice 3000 provides a number of advantages, some of which have been described. As a further example, theframe 3040 provides a number of advantages, including but not limited to: 1) implant radial stiffness/compliance, theframe 3040 provides increased radial stiffness while being compliant enough to allow off-axis implantation, retrieval, etc.; 2) removal resistance, as noted, theframe 3040 provides high pull-out strength; 3) delivered transcatheter, theframe 3040 can be compressed into a delivery catheter and then fully expanded when delivered; 4) retrieval, theframe 3040 allowing retrieval/retrieval into a delivery catheter after deployment in the LAA or even after implantation; and 5) mechanical integrity, theframework 3040 having acute and long-term structural integrity, e.g., the ability to withstand loading into the delivery catheter, deployment from the catheter, and cyclic loading/fatigue. Theframe 3040 also provides a conformable structure to enable thefoam 3002 to compress over LAA tissue to facilitate sealing and anchoring with minimal compression (oversizing). As noted, the resulting compliance of theframe 3040 provides better anchoring than prior solutions.

As a further example, thedevice 3000 seals against irregularly shaped LAA ostia and necks. For example, the combination of thenitinol alloy frame 3040 and thefoam 3002 with the PTFE coating andePTFE cover layer 3100 facilitates the conformability of thedevice 3000 to the anatomy and sealing to irregular protrusions and shapes while providing a smooth, anti-thrombogenic LA surface.

As a further example, thedevice 3000 provides controlled and safe delivery. The design of the combinedframe 3040 andfoam 3002 facilitates delivery in a controlled manner by slowing the rate of expansion. When delivering the implant to the LAA, thebumper 3026 acts as an atraumatic leading edge portion, which reduces the risk of injury. The user has the ability to retrieve and re-deploy thedevice 3000 if necessary. As further described, theflexible tether 3240 attachment from the delivery catheter to thedevice 3000 allows thedevice 3000 to be placed in place without tension immediately after implantation so that the user can ensure final proper positioning before thedevice 3000 is released.

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

As a further example, thedevice 3000 provides simple resizing. The design of the foam and frame facilitates the ability to seal only two diameters (e.g., 27mm and 35mm) to the desired LAA configuration and diameter range (e.g., for a LAA diameter of 16 to 33 mm). The conformability of the foam and frame allows a 20mm long implant to fit in a LAA as short as 10mm deep. The short landing zone requirement (LAA depth) of thedevice 3000 in combination with only two implant diameters enables treatment of a wide range of LAA anatomies while minimizing the need for cumbersome echo and CT sizing. The conformal nature of the implant is important to facilitate a simple, easy to use product platform that fits a wide variety of anatomical structures.

As a further example, thedevice 3000 provides an anti-thrombotic material and design. The removable tether leaves a smooth, metal-free surface in the LA. The anti-thrombotic materials (PTFE-coated foam and ePTFE overlay) create a smooth LA surface (no metal attachment) to reduce the need for anticoagulation, improve anti-thrombosis and promote endothelialization.

As a further example, thedevice 3000 provides thin, low-profile anchors 3090, 3094 around the midpoint of thedevice 3000 to provide secure and atraumatic anchoring.

4.Remote buffer

Foam 3002 has adistal bumper 3026.Bumper 3026 may be a foamed distal region ofbody 3002, such as a distal portion ofside wall 3014. Thebumper 3026 may be a portion of thefoam 3002 that extends beyond thedistal end 3044 of theframe 3040.Bumper 3026 may extend beyond thedistal end 3044 of theframe 3040 in the delivery configuration and in the deployed configuration.Body 3002 may be attached to frame 3040 at a variety of locations such that in some embodiments, for example, in a delivery configuration, once the cuff is initially retracted during delivery,body 3002 may stretch to ensure thatbumper 3026 extends beyondframe 3040.

Due to the consistency of both thefoam 3002 and theframe 3040, thedevice 3000 can conform to both length and diameter aspects. This enables the use of only some or a small number of differentsized devices 3000, such as 27mm and 35mmouter diameter bodies 3002 and one length, such as 20mm, as described herein to accommodate most patients' LAA anatomy. Thus, theframe 3040 may be shorter than thefoam 3002, resulting in, in some embodiments, afoam bumper 3026 of about 5mm at the distal end relative to the distal-most end of theframe 3040. Thedistal bumper 3026 acts as an atraumatic tip during delivery of thedevice 3000 and may compress after implantation to allow thedevice 3000 to conform to atrial appendages as short as 10mm in depth (land area). This ability to conform to both length and diameter is due to the consistency of both thefoam 3002 and theframe 3040.

The length ofbumper 3026 may be measured axially from the distal-most end offrame 3040 todistal surface 3022 ofbody 3002. For example,bumper 3026 may extend from distal apex 3088 todistal surface 3022.Buffer 3026 may have a length of 5mm or about 5 mm.Buffer 3026 may have a length of about 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, or more.Bumper 3026 may have a length of about 2.5mm to about 7.5mm, about 3mm to about 7mm, about 3.5mm to about 6.5mm, about 4mm to about 6mm, about 4.5mm to about 5.5 mm.

In some embodiments,bumper 3026 may collapse in response to axial and/or radial compression ofdevice 3000.Bumper 3026 may be folded inward, e.g., radially inward. The fold may be axial or substantially axial. The folding may be circumferential or substantially circumferential. The folds may be a combination of radial and circumferential directions, or at an angle thereto. Folding ofbuffer 3026 is discussed further herein, for example, in the "device compliance" section.

5.Closure and pin

Fig. 90A-90C are proximal perspective views of theframe 3040 with thecover 3180. Fig. 90D is a distal perspective view of theclosure 3180. In some embodiments,pin 3051 is placed diametrically throughproximal hub 3050 and is used to engage delivery catheter tether 3240 (e.g., a suture), which wraps aroundpin 3051 for temporary attachment withdelivery catheter 3220, as further described herein, e.g., with respect to fig. 89A-89B. As shown, thehinge 3050 has a pair of opposingside openings 3053 extending through the side walls of thehinge 3050. Thelid 3180 has a corresponding pair of opposingside openings 3190 extending through theside walls 3184 of thelid 3180. When thelid 3180 is assembled with thehinge 3050, thepins 3051 can be inserted into the alignedopenings 3053, 3182. The assembly may be further secured by welding the end of thepin 3051 to thehinge 3050.

As shown in fig. 90D, thecap 3180 includes aproximal end 3182 and adistal end 3184. Theclosure 3180 includes acircular sidewall 3186 extending from aproximal end 3182 to adistal end 3184. Thesidewall 3186 defines alongitudinal opening 3188 through thelid 3180. Thesidewall 3186 includes a pair ofside openings 3190 disposed opposite each other. Theclosure 3180 includes a radially outwardly extendingflange 3192 at theproximal end 3182.

Thecap 3180 is formed of titanium and thepin 3051 is formed of nitinol or superelastic nitinol. In some embodiments, thecap 3180 and/or thepin 3051 can be formed from other materials, for example, a variety of biocompatible metal or polymer materials, such as shape memory nitinol, stainless steel, MP35N, elgiloy, polycarbonate, polysulfone, Polyetheretherketone (PEEK), or Polymethylmethacrylate (PMMA), or other materials.

Thelid 3180 andpin 3051 facilitate attachment to thetether 3240. Thelid 3180 andpin 3051 also mitigate damage to thefoam 3002 during recycling of thedevice 3000. Thecover 3180 also creates an atraumatic surface for thehinge 3050 of theframe 3040. For example, thecover 3180 may prevent thehinge 3050 from cutting through thefoam 3002 when thedevice 3000 is retracted into the sleeve. Without thecover 3180, the sharp edge of thehinge 3050 can shear through thefoam 3002 during recovery of thedevice 3000 into the shroud.

6.Loading system

Fig. 91 is a side view of an embodiment of aloading system 3200 for loading adevice 3000 into adelivery catheter 3220. Thesystem 3200 includes aloading tool 3210.Loading tool 3210 has a taperedportion 3212 with adistal opening 3213 and acylindrical portion 3214.Delivery conduit 3220 extends throughcylindrical portion 3214 withdistal end 3222 ofdelivery conduit 3220 located withincylindrical portion 3214. Apusher 3230, such as a pusher catheter, extends through thedelivery catheter 3220. A tether 3240 (see fig. 92A-92C) is attached to thedevice 3000 and extends through theloading tool 3210,delivery catheter 3220, andpusher 3230. Thetether 3240 andpusher 3230 are pulled in a proximal direction while thedelivery catheter 3220 andloading tool 3210 remain stationary. As thedevice 3000 is pulled proximally through theloading tool 3210 by thetether 3240, thedevice 3000 is laterally compressed by the taperedportion 3212. Upon loading thedevice 3000 into thedelivery catheter 3220, thedistal end 3232 of thepusher 3230 remains adjacent to theproximal end 3004 of thedevice 3000. Aremovable tether 3240, which may be fabricated from ultra-high molecular weight polyethylene (UHMWPE), is used to attach the implant to the delivery catheter. UHMWPE, the material used fortether 3240, may provide high strength and low friction to facilitate delivery ofdevice 3000.

In some embodiments, the taperedportion 3212 of theloading tool 3210 has a chamfered distal edge of about 45 ° -75 ° (degrees), preferably 60 °. In some embodiments, the distal Inner Diameter (ID) of the taperedportion 3212 is greater than the Outer Diameter (OD) of thedevice 3000, and the angle a is desirably between 15 ° and 25 °, and in one implementation, about 20 °, to allow for proper constriction ofanchors 3090, 3094 that may protrude from the surface of thefoam 3002 at an angle of 30 ° or about 30 °. The distal opening, e.g., diameter or maximum width, of taperedportion 3210 may be larger than the proximal opening, e.g., diameter or maximum width, of taperedportion 3210 to whichcylindrical portion 3214 is coupled.Cylindrical portion 3214 may have a distal opening that is smaller than taperedportion 3210 and/or an opening that is the same or similar in size, e.g., diameter or maximum width, as the opening at the proximal end of taperedportion 3210.

Reducing the width of theloading tool 3210, e.g., tapering, ensures, for example, that theframe 3040 folds evenly without crossing or having additional tension. Theangled taper 3212 may ensure that theanchors 3090, 3094 fold or rotate proximally rather than distally. The sidewalls of the taperedsection 3212 may extend at an "overall" angle a, as measured between two opposing sidewall portions, as shown in fig. 91. Angle a may be from about 12 ° to about 35 °, from about 15 ° to about 30 °, from about 17 ° to about 25 °, from about 18 ° to about 22 °, from about 20 ° or 20 °. The 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 taperedsection 3212. The angle of taperedportion 3212 defined by taperedportion 3212 and/orcylindrical portion 3214 may also be described with respect to a longitudinal geometric central axis. The side wall may extend in a direction that is at an angle relative to the longitudinal axis and is half the value of the total angle a. The "half angle" may thus be at least 5 °, at least 7.5 °, at least 10 °, at least 12.5 °, or at least 15 °, etc. The taperedportion 3212 may have a frustoconical shape. The cross-sectional shape of the taperedportion 3212 perpendicular to its longitudinal axis may be circular or substantially circular. In some embodiments, the cross-section may be circular, non-circular, segmented, other shapes, or combinations thereof. The cross-sectional shape of the taperedportion 3212 may be constant along its axis or may have a different shape along the axis. In some embodiments, the angle a may vary along the axial length of the taperedportion 3212, for example, when the inner surface is curved in the axial direction.

Theloading tool 3210 may be smooth or generally smooth on its interior surface or surfaces. Theinner surfaces 3211, 3215 of the taperedportion 3212 and/or thecylindrical portion 3214 may be smooth or generally smooth. In some embodiments, theseinner surfaces 3211, 3215, or portions thereof, may not be smooth. In some embodiments, theseinterior surfaces 3211, 3215, or portions thereof, may be smooth, non-smooth, rough, etched, scored, grooved, have different degrees of roughness or smoothness, other features, or combinations thereof.

In one example, thetool 3210 may be used by positioning a proximal end of a loading body, such astool 3210, adjacent thedistal end 3222 of thedelivery catheter 3220. The loading body may have sidewalls defining a through channel having adistal opening 3213 at the distal end that is larger than the proximal opening at the proximal end. The left atrialappendage occlusion device 3000 may be advanced proximally through the loading body to thereby radially compress thedevice 3000. The retracting step may include pullingtether 3240 proximally throughdelivery catheter 3220. The device may then be housed in thedistal end 3222 of thedelivery catheter 3220.Device 3000 may be radially compressed within adelivery catheter 3220 having an outer diameter of no more than 15 Fr. In some embodiments, thedevice 3000 may be radially compressed within adelivery catheter 3220 having an outer diameter no greater than 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 Fr. The proximal end of theloading tool 3210 may have an inner diameter configured to provide an interference fit with thedistal end 3222 of thedelivery catheter 3220. The proximal end ofloading tool 3210, such ascylindrical portion 3214, may have an inner diameter that is slightly larger than the outer diameter ofdelivery catheter 3220, e.g., slightly larger than 5mm for adelivery catheter 3220 having an outer diameter of 15 Fr.Device 3000 may be radially compressed to a compressed width in the constrained state that is less than 50, 40, 30, 20, 10, and/or 5% of the radially uncompressed width of the device in the unconstrained state. The radial width herein may be measured perpendicular to the longitudinal axis of thedevice 3000 as defined by thetubular foam body 3002.

Theloading tool 3210 may be formed from a material that is biocompatible, strong, transparent, and may be smoothly molded to minimize friction, such as polycarbonate. In some embodiments, the material may be selected from hard plastics, such as Delrin, UHMWPE,

Polyetherimide, acrylic, metals such as stainless steel, aluminum, other materials, or combinations thereof form theloading tool 3210. In some embodiments, theloading tool 3210 may have one or more coatings. These coatings may be applied to reduce friction and thus reduce loading forces. The coating may be a silicone, a hydrophilic coating, various oils, other suitable coatings, or combinations thereof.

7.Delivery system

Fig. 92A is a side view of a schematic of adelivery system 3201 for adelivery device 3000. Fig. 92B-92C are other views of thesystem 3201. As shown in fig. 92A, thedelivery system 3201 includes adelivery catheter 3220 having adistal end 3222 and aproximal end 3224.Delivery system 3201 includes apusher 3230, such as a pusher catheter, having adistal end 3232 and aproximal end 3234.Tether 3240 includes afirst end 3242 and asecond end 3244. Alimiter 3246 secures the first andsecond ends 3242, 3244.

To deliver thedevice 3000 to the LAA, an access sheath is placed through the atrial septum into the LAA, and adelivery catheter 3220 containing thedevice 3000 is placed through the access sheath. Using theloading tool 3210, thedevice 3000 is loaded to thedistal end 3222 of thedelivery catheter 3220 at the time of manufacture or at the treatment site. To load theimplant device 3000, thepusher 3230 andtether 3240 are pulled proximally, thereby retracting theimplant device 3000 as it enters the distal tip of thedelivery catheter 3220. Once the loadeddelivery catheter 3220 is placed in the LAA through the sheath, thepusher 3230, such as a catheter or a shaft, is axially stabilized while thedelivery catheter 3220 is simultaneously proximally withdrawn and advanced into the sheath, thereby deploying theimplant device 3000.

Tether 3220 passes from the proximal end ofdelivery catheter 3220, through opening 3221 ofcatheter pusher 3230, aroundimplant tether pin 3051 and back throughdelivery catheter 3220. When the two ends oftether 3240 are pulled (held together at the catheter proximal end by limiter 3246),device 3000 is pulled intodelivery catheter 3220. Once thedevice 3000 is anatomically properly placed, one end of theends 3242, 3244 of thetether 3240 is cut and theentire tether 3240 can be removed from the system by pulling proximally on the uncut end and sliding the cut end distally into the system and around thepin 3051, disengaging from thepin 3051. Thedistal end 3232 of thepusher 3230 and/or thedistal end 3222 of thedelivery catheter 3220 may contact, e.g., press against, the proximal end of thedevice 3000, as in the relative position shown in fig. 92A. For example, thedistal end 3232 of thepusher 3230 can contact and prevent proximal movement of thedevice 3000 during retrieval of thetether 3240, as further described herein. For example, with respect to fig. 92B-93B, additional details of tether release are provided herein.

In some embodiments, thedelivery system 3201 may include other devices. For example, thedelivery catheter 3220 may include an injection lumen. The injection lumen may allow for injection of radiopaque dye to the distal end of thedevice 3000 after implantation to check for leaks using fluoroscopy.

8.Tether release system

Fig. 92B and 92C are proximal and distal perspective views of thedelivery system 3201. Additional features of the method and system for releasing a tether are described in this section. For clarity, some of the components, such as thecover 3100, thefoam 3002, and theframe 3040 are not shown.

Thesystem 3201 as shown in fig. 92B and 92C shows thedelivery catheter 3220,pusher 3230, andhub 3050 at different axial positions relative to each other. In some embodiments, during release, thedistal end 3222 of thedelivery catheter 3220 may be coextensive with, or otherwise extend adjacent to, or near thedistal end 3232 of thepusher 3230. Additionally, the distal ends 3222 and/or 3232 may contact or be adjacent to theproximal end 3004 of thedevice 3000, such as thecover layer 3100 and/or thefoam 3002. In some embodiments, thedistal end 3232 of the pusher can be disposed distally relative to thedistal end 3222 of thedelivery catheter 3220 during release of thetether 3240.

Tether 3240 can extend from a proximal end ofpusher 3230, through opening 3221 ofpusher 3230, wrap aroundpin 3051 and extend proximally back throughopening 3221 ofpusher 3230 and out of a proximal end ofpusher 3230, as described with respect to fig. 92A.Tether 3240 may extend throughcover layer 3100 andfoam 3002.Tether 3240 may extend distally through a first alignment path incover layer 3100 andfoam 3002, aroundpin 3051 and proximally back through a second alignment path incover layer 3100 andfoam 3002.Tether 3240 may extend through an opening ininner cover layer 3101, such as, for example, described with respect to fig. 85D and 87D.Tether 3240 may only extend around the distal surface or surface ofpin 3051, as shown.Tether 3240 can extend distally and wrap aroundpin 3051 and extend distally at 180 ° or about 180 ° relative to the proximal extension. In some embodiments,tether 3240 can be wrapped aroundpin 3051 one or more times, e.g., 2, 3, or more times. In some embodiments,tether 3240 may be located on a spool aroundpin 3051. In some embodiments,tether 3240 can be partially, fully, or multiple wound around a bushing (bushing) rotatably coupled aboutpin 3051.

System 3201 may facilitate removal oftether 3240 whilepusher catheter 3230 is in contact withdevice 3000. Such contact may assist, for example, in preventing or reducing accidental removal of thedevice 3000 from the LAA after implantation and anchoring. For example, during release of thetether 3240, thepusher 3230 may have a position relative to thedevice 3000 as shown in fig. 92A. Thepusher 3230 may contact thedevice 3000 on theproximal end 3002 of the device to prevent or reduce any proximal movement of thedevice 3000 upon removal of thetether 3240. For example, whentether 3240 opens aroundpin 3051, there may be friction betweentether 3240 andpin 3051. The distal end ofpusher 3230 may prevent this friction or other force from removing or otherwise movingdevice 3000 proximally. In some embodiments, thedelivery catheter 3220 may also be in contact with, adjacent to, etc. thedevice 3000. In some embodiments, the distal ends of thedelivery catheter 3220 andpusher 3230 may be axially coextensive, adjacent or contiguous with one another, etc., during tether release and removal, as described. Further, before thedelivery catheter 3220 and/orpusher 3230 is removed from the patient, thetether 3240 may be pulled proximally to be pulled completely out of thedelivery catheter 3220 and/orpusher 3230. In some embodiments, thetether 3240 may be removed from the patient with thedelivery catheter 3220 and/or thepusher 3230, for example, while thetether 3240 is still fully or partially within thepusher 3230.

Fig. 93A and 93B are proximal and distal perspective views, respectively, of another embodiment of atether release system 3400. Therelease system 3400 includes atube 3420 and alock 3402. Thetube 3420 has aproximal end 3422 and adistal end 3424.Opening 3426 extends throughtube 3420. Unless otherwise noted, thesystem 3400 may be similarly used as described with respect to thesystem 3201. For example,pusher 3230 and/ortube 3420 may contactdevice 3000 during tether removal, as described.

Lock 3402 includes aproximal end 3404 and adistal end 3406. Anopening 3408 defined by asidewall 3409 extends through thelock 3402 from theproximal end 3404 to thedistal end 3406. Thetube 3420 extends through theopening 3408 at theproximal end 3404 of thelock 3402 and to thedistal end 3406 of theopening 3408. Theside wall 3409 of thelock 3402 has afirst groove 3410 extending longitudinally from theproximal end 3404 to thedistal end 3406 and extending radially partially through the thickness of theside wall 3409. Theside wall 3409 of thelock 3402 has asecond groove 3412 extending longitudinally from theproximal end 3404 portion along theside wall 3409 to thedistal end 3406 and extending radially partially through the thickness of theside wall 3409.

Tether 3240 includes afirst end 3243 and asecond end 3245.Tether 3240 extends distally fromfirst end 3243 within opening 3426 oftube 3240 and exits throughdistal end 3424 oftube 3420 to cap 3180.Tether 3240 extends distally into opening 3188 ofclosure 3180 and aroundpin 3051 and back in a proximal direction.Tether 3240 then extends proximally intofirst groove 3410 oflock 3402, aroundproximal end 3404 oflock 3402, and then distally into and throughsecond groove 3412.Tether 3240 terminates at asecond end 3245 in aknot 3247.

In use,knot 3247 can be secured due to the relative positions oflock 3402 andpusher catheter 3230 within the interior ofdelivery catheter 3220.Knot 3247 prevents distal advancement because the distal inner diameter ofpusher 3230 closely matches the outer diameter oflock 3402. Whenlock 3402 engagespusher 3230,grooves 3410 and/or 3412 inlock 3402 may holdtether 3240 in an orientation that preventstether 3240 from slipping (e.g., if pulled with sufficient force).Pusher 3230 can be advanced distally to exposelock 3402, e.g., the full length f oflock 3402 or a portion thereof. As the proximal end oftether 3240 is pulled proximally,knot 3247 deflects off ofsecond groove 3412, advances aroundproximal end 3404 oflock 3402, distally by deflecting off offirst groove 3410, enterscover 3180 and aroundpin 3051, then passes distally through opening 3408 oflock 3402 and may be retrieved bypusher 3230. In some embodiments, the distal end oflock 3402 may be positioned axially proximally relative to the distal end oftube 3420, e.g., to bringdevice 3000 into contact withtube 3420 to preventdevice 3000 from moving proximally after implantation, as described above.

9.Off-axis delivery and deployment

Thedevice 3000 may be deployed off-axis within the LAA while still providing a complete, stable, and atraumatic seal. In some embodiments, thedevice 3000 may be deployed at an angle of, for example, at least about 15 ° or 25 ° relative to the longitudinal axis of the central LAA, and in some embodiments, up to 35 ° or 45 ° and still provide an effective seal. The LAA axis is defined herein as the geometric center of the ostium to the LAA, and the best-fit geometric center of the LAA cavity is tracked.

This off-axis deployment capability of thedevice 3000 is due in part to the relatively thick,compressible foam 3002 material, the cylindrical shape of thecompliant frame 3040 anddevice 3000, and thefoam bumper 3026. Thedevice 3000 is stable within the LAA despite having a length less than the diameter or having an L/D < 1. As noted, for adevice 3000 having an OD of both 27mm and 35mm, the length may be 20 mm. Thus, by having a length, not only is the production method flexible and simple, but the device is also stable and efficient in use. Furthermore, the axial compressibility of thebumper 3026, in combination with the axiallycompliant frame 3040, enables a 20mmlong device 3000 to be placed within a 10mm deep LAA, whereas existing LAA closure devices require a longer landing zone, or at least a landing zone equal to the length dimension of the metal frame.

In some embodiments, thedevice 3000 may be configured to allow sufficient blood flow in the event of an accidental embolism, as described herein. Further, thedevice 3000 may be configured to allow sufficient blood flow even if thedevice 3000 is occluded and not aligned with the blood flow direction. For example, thedevice 3000 may define a longitudinal axis and the blood flow direction may define a flow axis. The device longitudinal axis may be angled with respect to the flow axis and still provide adequate blood flow through thedevice 3000 in the event of an embolism or blockage within the patient's circulatory system. Thus, the ability of thedevice 3000 to blood flow through the device may also be applied todevices 3000 in such off-axis configurations or orientations with the systemic system, in the case of an embolism, or in tests where water is used under controlled conditions (e.g., as for the "proximal cover" segment). The device axis may be at an angle of 5, 10, 20, 30 or more degrees relative to the flow axis and still provide sufficient blood flow through thedevice 3000.

10.Anchor/foam interface

As noted, theframe 3040 with theanchors 3090, 3094 andfoam 3002 can have a variety of geometries, such as length, thickness, and the like. This section discusses some embodiments of theframe 3040, specifically, theanchors 3090, 3094 and thefoam 3002. Fig. 94A-94C show various embodiments of an anchor/foam interface 3500 usinganchor 3090 as an illustrative example. Fig. 94A-94C are side cross-sectional views of a portion of anapparatus 3000 displaying an embodiment of aninterface 3500. In some embodiments, even in an unlimited configuration, the outer tip of theanchor 3090, 3094 may or may not extend radially beyond a portion of theouter surface 3016 of thefoam body 3002, as further described herein.

Theinterface 3500 includes a portion of thetubular body 3080 of theframe 3040 having aproximal support 3082 and adistal support 3086, as described in further detail herein, e.g., with respect to fig. 89A. Theanchors 3090 extend radially outward from theframe 3040 in a proximal direction, e.g., from thetubular body 3080. The same or similar features and/or functionality in this section with respect tointerface 3500 withanchor 3090 may be applicable to other anchor/foam interfaces with other anchors, such as an anchor/foam interface withdistal anchor 3094. For example, theframe 3080 can have a distal end at the base of theanchor 3094, where adistal apex 3088 is disposed (see, e.g., fig. 89A).

As shown in fig. 94A-94C, anchors 3090 extend outwardly and proximally from theframe 3040, which may be fromproximal apices 3084 as described herein.Anchor 3090 has an axial length L. The length L extends from the distal base of theanchor 3090 to theproximal tip 3091 of theanchor 3090 at theframe 3040. The length L may include only a straight portion of theanchor 3090, for example, if the base of theanchor 3090 is curved. In some embodiments, length L may include anintact anchor 3090, such that L extends axially alonganchor 3090 from atip 3091 ofanchor 3090 toframe 3040. Thedisplay anchor 3090 has a flat end, but it may be pointed, angled, etc. The length L may extend proximally along the length of theanchor 3090 to a distal-most point, such as to atip 3091. In some embodiments, L is 2.5mm, about 2.5mm, or about 2.25mm to about 2.75 mm. Length L may have a variety of other lengths or be within other lengths ranges, for example, as described in further detail herein in the "compliant frame" section foranchors 3090, 3094.

Theanchors 3090 extend at an angle B relative to theproximal support 3082. In some embodiments, the protrusion of theproximal support 3082 onto a vertical plane that intersects the longitudinal axes of thedevice 3000 and theanchor 3090 may be considered for theproximal support 3082 as shown. Thus, angle B may be relative to the plane and/or relative to support 3082. For simplicity, angle B will be described with respect tosupport 3082. Angle B may be 30 ° or about 30 °. Angle B may have a variety of other angles or be within a range of angles, for example, as described in further detail herein in the "compliant frame" section foranchors 3090, 3094. The anchor also has a radial height H. The radial height H can be the radially outermost extent of theanchor 3090, such as theproximal tip 3091 of theanchor 3090. The length L and angle B can define a radial height H of theanchor 3090. The height H may be in a direction perpendicular to the longitudinal axis of the device 3000 (see, e.g., fig. 87B).

Theside wall 3014 of thefoam 3002 is also shown. Thesidewall 3014 has a thickness T. Thickness T extends radially outward frominner surface 3018 toouter surface 3016 ofsidewall 3014. The thickness T may extend radially outward perpendicular to the longitudinal axis of thedevice 3000. The thickness T may be equal to a distance from a radially outer portion of theframe 3040 to anouter surface 3016 of thesidewall 3014, e.g., when aninner surface 3018 of thesidewall 3014 contacts an outer portion of theframe support 3082, 3086. The thickness T may be the thickness of thesidewall 3014 in an unconstrained configuration, in a compressed configuration while inside the delivery catheter, or in a compressed configuration after implantation within the LAA, as further described. The thickness T of thesidewall 3014 can be measured in the same direction as the height H of theanchor 3090. The thickness T of theside wall 3014 may be 2.5mm or about 2.5 mm. The thickness T of thesidewall 3014 can be other values or ranges of values, for example, as described in further detail herein in the section "compressible foam".

As shown in fig. 94A, in some embodiments, the height H of theanchor 3090 can be greater than the thickness T of thefoam sidewall 3014. The difference may be equal to Δ d (delta d). Thedevice 3000 may have such a configuration in an unconstrained configuration, for example, as resting on a countertop as herein. Δ D may be from about 0.05mm to about 5mm, from about 0.075mm to about 4mm, from about 0.1mm to about 3mm, from about 0.2mm to about 2mm, from about 0.3mm to about 1.5mm, from about 0.4mm to about 1mm, about 0.5mm or 0.5 mm. In some embodiments, these example values of Δ D may be negative, where T is greater than H. In some embodiments, Δ D may be zero, as described for fig. 94B.

As shown in fig. 94B, in some embodiments, the height H of theanchor 3090 can be the same or about the same as the thickness T of thefoam sidewall 3014. Thus, Δ D may be zero or about zero. Thedevice 3000 may have such a configuration in an unconstrained configuration, for example, as resting on a countertop as herein. In an unlimited configuration, theanchors 3090, 3094 may extend through thefoam body 3002 to theouter surface 3016 and then extend radially outward beyond theouter surface 3016 when loaded for delivery and/or after implantation in a LAA. In other embodiments, thefoam 3002 is locally compressed such that the anchor extends beyond theouter surface 3016, as further described.

As shown in fig. 94C,device 3000 can include one or more attachments, such as sutures, e.g.,attachment 3001 described in further detail herein with respect to fig. 87D.Attachment 3001 may connectfoam 3002 toframe 3040. As shown,attachment 3001 may extend throughsidewall 3014 away from and aroundouter surface 3016, back into throughsidewall 3014 and aroundframe 3040, e.g., aroundproximal support 3082.Attachment 3001 may partially compressside wall 3014 as shown. Thesidewall 3014 may have a local radial thickness R. The thickness R may be less than the thickness T. The thickness R may be a local minimum in the thickness of thefoam 3002. The thickness T may be adjacent to or otherwise surrounding the location of the thickness R. The thickness of thesidewall 3014 may increase from the location of the thickness R to the surrounding thickness T. The increase may be gradual or abrupt.

The partial compression of theside walls 3014 may cause theanchors 3090 to extend proximally and outwardly beyond theouter surface 3016 of thefoam body 3002. As shown, theattachment 3001 may locally compress the thickness of thesidewall 3014 such that theproximal tip 3091 of theanchor 3090 extends a length L beyond theouter surface 3016 of thefoam 3002 at anangle B. Attachment 3001 may be proximally located onanchor 3090 as shown or at other locations, such as distally located onanchor 3090, adjacent the base ofanchor 3090, proximally/distally remote from the base ofanchor 3090, etc. Theattachment 3090 can be positioned and configured to cause thesidewall 3014 to partially compress, allowing thetip 3091 of theanchor 3090 to extend directly radially inward beyond theouter surface 3016 of the foam of thetip 3091 of theanchor 3090. In some embodiments,attachment 3001 can be located directly radially inward oftip 3091 of anchor 3090 (e.g., directly "below"tip 3091 ofanchor 3090, as oriented in the figures). In some embodiments, there may bemultiple attachments 3001 distributed axially along theframe 3040, and each of them facilitates a single localized compression of thefoam 3002 about a particular one of theanchors 3090.

Thefoam sidewall 3014 can be compressed into a configuration in an unconstrained configuration as shown in fig. 94C. Thefoam sidewall 3014 can be compressed into a configuration in a constrained configuration as shown in fig. 94C, e.g., within a delivery catheter or after deployment from a delivery catheter. Thefoam sidewall 3014 may be compressed from the configuration shown or described with respect to fig. 94A or 94B to the configuration shown in fig. 94C. Thus, in fig. 94C, the height H may be equal to or approximately equal to the thickness T, or the height H may be greater than or less than the thickness T. In some embodiments, in a non-limiting configuration, length L is 2.5mm or about 2.5mm, angle B is 30 ° or about 30 °, and thickness T is 2.5mm or about 2.5 mm.

The design of the anchor length may be based on a balance between a longer length that provides flexibility to aid removal and a shorter length that does not penetrate the LAA wall.Anchors 3090, 3094 may be flexible and, due to their length, capable of bending in a distal direction. Thus, theanchors 3090, 3094 are less likely to tear tissue during reduction and are therefore less traumatic. Theanchors 3090, 3094 may be longer than other tissue engaging devices of existing LAA occlusion solutions. In some embodiments of thedevice 3000, theanchors 3090, 3094 are designed to be long enough to be effectively anchored into the LAA wall. The thickness of thefoam 3002 andcorresponding side wall 3014 allows theanchors 3090, 3094 to have a longer length. An advantage of makinganchors 3090, 3094 longer is to increase their flexibility, thereby making them less damaging to tissue during removal and reduction. However, anchors 3090, 3094 outside of a particular length may penetrate the LAA wall, which is undesirable. Thefoam 3002 and its thickness help maintain the advantageously longer length of theanchors 3090, 3094, while reducing the risk of theanchors 3090, 3094 penetrating the LAA wall. For example, thefoam sidewall 3014 between the support of theframe 3040 and thetips 3091 of theanchors 3090, 3094 limits the depth to which theanchors 3090, 3094 will penetrate, allowing for longer and therefore moreflexible anchors 3090, 3094.

For example, with a 2.5mm foam sidewall 3014 thickness, theanchors 3090, 3094 may have an axial length of 2.5mm and be formed at an angle of 30-40 degrees or 25-45 degrees from the support. In some embodiments, as discussed, when theframe 3040 is first placed in thefoam 3002 and theanchors 3090, 3094 penetrate thefoam sidewall 3014, thetips 3091 of theanchors 3090, 3094 may not extend all the way through the foam because theanchors 3090, 3094 may be too short radially. In some embodiments, theframe 3040 has an OD of about 24mm and thefoam 3002, such as a foam cup shape, has sidewalls 3014 with an ID of about 22 mm. Thus, there may be an interference fit where theframe 3040 expands into thefoam sidewall 3014. By the length and angle of theanchors 3090, 3094, thetip 3091 of theanchors 3090, 3094 is about 27mm in diameter, which corresponds to just touching theouter surface 3016 of thesidewall 3014. As discussed, the assembly may be attached by sewing thefoam 3002 and the frame 3040 (and in some locations the cover layer 3100) together at each anchor-frame interface location. This may result in thefoam 3002 being indented locally at therespective anchor 3090, 3094, thereby exposing a length of theanchor 3090, 3094 at theouter surface 3016. The exposed length ofanchors 3090, 3094 can be a fraction of the overall length ofanchors 3090, 3094. In addition, the length of theanchors 3090, 3094 and the radial height of thefoam sidewall 3014 surrounding theanchors 3090, 3094 can be adjusted to expose a desired amount of theanchors 3090, 3094.

In some embodiments, thetip 3091 may be exposed outside of thefoam body 3002 when the foam is compressed, but thetip 3091 may be positioned within the foam below theouter surface 3016 when the foam is uncompressed. Thus, with uncompressed foam, thetips 3091 may not be positioned radially outward relative to theouter surface 3016, but with compressed foam, thetips 3091 may be positioned radially outward relative to adjacent portions of theouter surface 3016. Thus, in an uncompressed configuration,tip 3091 may not be exposed by "H" being less than "T", while in a compressed configuration,tip 3091 may be exposed by "H" being greater than "T".

11.Device compliance

Thedevice 3000 is able to conform to the geometry of the LAA. Thedevice 3000 is designed to be conformable such that it can conform to the LAA and reduce or minimize remodeling of the LAA. For example, thedevice 3000 may be implanted into the LAA and after a period of time, the ostium or the opening of the LAA may have the same or similar profile as before thedevice 3000 was implanted. In addition, thedevice 3000 may exhibit these properties while conforming to an extremely non-circular shape at the opening of and within the LAA. Due to conformability and other advantages, a single size of thedevice 3000 may be used for all or a wide range of patients having different geometries.

Fig. 95A is a schematic diagram showing an embodiment of the contour of a portal 110. The view shown allows viewing of the LAA, for example, in a plane perpendicular to the geometric central axis at the ostium. As described herein, for example, with respect to fig. 1, the geometry of theostium 110 can vary greatly. As shown in fig. 95A, the ostium may be approximated by an ellipse or ellipse having a relatively short minor axis a1 and a relatively long major axis a 2. Theheart door 110 is shown as being generally symmetrical about axis a1, a2, but theheart door 110 may have asymmetries, other local grooves, discontinuities, etc. Accordingly, the portal 110 is shown schematically for illustrative purposes only to describe the increased conformability capabilities of thedevice 3000. In some embodiments, minor axis a1 may represent the maximum width ofostium 110 in a first direction, while major axis a2 may represent the maximum width in a second direction. The first direction may be perpendicular to the second direction.

The length of the axes a1, a2 may have a variety of values or ranges of values. The minor axis a1 may be about 5mm to about 30mm, about 7.5mm to about 20mm, about 10mm to about 17.5mm, about 12mm to about 15mm, about 14mm or 14 mm. The major axis a2 may be about 10mm to about 40mm, about 15mm to about 37mm, about 20mm to about 35mm, about 22mm to about 32mm, about 25mm to about 30mm, about 27mm, or 27 mm.

Fig. 95B shows theostium 110 from the same perspective, but with thedevice 3000 implanted in the LAA. Theoverlay 3100 is visible showing theproximal surface 3102 with theproximal opening 3122. Other cover layers, such ascover layer 3150, etc., as described herein, may be included. The portal in 110 withdevice 3000 may have the same or similar shape and size as the portal shown in fig. 95A withoutdevice 3000. Another portion of the LAA may also have the same shape and size before and after implantation of thedevice 3000. Thedevice 3000 may thus conform to the shape of a LAA, such as theostium 110. Due to the configuration of thefoam 3002 and theframe 3040 as described herein, thedevice 3000 may conform to anatomical shapes. Thedevice 3000 may exhibit sufficient conformability to assume an anatomical shape that provides adequate occlusion functionality without requiring reshaping or otherwise deforming the shape of the LAA (e.g., the ostium 110).

The LAA may retain the same or similar original size and shape of the LAA immediately after implantation of thedevice 3000 and for a period of time thereafter. In some embodiments, the anatomical geometry, e.g., size and shape, of the LAA will still be the same or substantially the same after a period of 24 hours or more, 7 days or more, 30 days or more, 6 months or more, 1 year or more, 5 years or more or longer after implantation of thedevice 3000. Test structures having substantially the same geometry, stiffness, etc. may be constructed to confirm minimal secular variation in the structure due to thedevice 3000. A construct having an opening with a minor axis of about 14mm and a major axis of about 27mm and having a stiffness generally found in a patient's normal LAA ostium may have the same or similar size and shape after implantation of thedevice 3000 for the period of time described above. As further described, thedevice 3000 may also allow for the same or similar geometry along the length of the LAA (e.g., distal to the ostium 110) for these time periods.

In one example use,device 3000 may be configured to be inserted into a non-cylindrical opening of a test body having a non-cylindrical profile. The test body may be rigid so that the test body does not deform in response to thedevice 3000 to be implanted therein. The test body may be formed of hard plastic, metal, or the like. The opening and contour may have a size and shape substantially similar to a natural left atrial appendage. Thedevice 3000 may expand radially within a non-cylindrical opening and conform to a non-cylindrical contour, which may be located at least at the opening of the test body. Thedevice 3000 may conform to an opening with no visible gaps between thedevice 3000 and the opening. There may be one or more radial gaps of no more than 5, 4, 3, 2 and/or 1 mm at their widest part, respectively. These indentations may be measured radially or perpendicular to a longitudinal axis extending through the geometric center of the opening of the test body. A gap may be measured between the outer surface ofdevice 3000 and the inner surface of the test body opening. The notch may be measured at the location of maximum separation between thedevice 3000 and the test body. The device may conform to this shape after a period of at least 30 days, at least 60 days, and/or at least 120 days after implantation. In another example use, thedevice 3000 may be configured to be inserted into a non-cylindrical opening of a test body having a size and radial stiffness substantially similar to a native left atrial appendage, radially expand within the non-cylindrical opening, and assume a non-cylindrical profile 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.

Fig. 96A shows a side view of thedevice 3000 in a radially constrained configuration. Thedevice 3000 may have the illustrated configuration after implantation in the LAA, e.g., after the above-described time period. Adevice 3000 is shown having aproximal end 3004 with a width D1 and a distal end with a width D2. The widths D1, D2 may be diameters, or they may be the maximum width of the respective ends of thedevice 3000. Width D1 is greater than width D2. In some embodiments, width D1 may be less than width D2. In some embodiments, width D1 may be equal or approximately equal to width D2. In some embodiments, width D2 may be about 15% of width D1. The width D2 may be 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, 40% or less, 35% or less, 30% or less, 25% or less, 20% or less, 19% or less, 18% or less, 17% or less, 16% or less, 15% or less, 14% or less, 13% or less, 12% or less, 11% or less, or 10% or less of the width D1. In some embodiments, width D2 may alternatively or in addition to the distal end ofdevice 3000 be at other locations alongdevice 3000, e.g., at and adjacent to or near the distal end ofdevice 3000, the proximal end of the medial portion. In some embodiments, theentire device 3000 or a majority of thedevice 3000 may have a width D2. For example, when constrained within a delivery catheter, the entire device may have a width D2, as for example in the "loading system" section herein.

Fig. 96B shows a side view of thedevice 3000 in an axially constrained configuration relative to an axially unconstrained configuration.Device 3000 has an axial length L1 in an unconstrained state, and an axial length L2 in a constrained state. The length L1, L2 between theproximal end 3004 and thedistal end 3006 of thedevice 3000 in each configuration. Thedevice 3000 may have the configuration shown, having a length L2 after implantation in the LAA, e.g., after the period of time described above. Length L2 is less than length L1. Length L2 may be 95% or less, 90% or less, 85% or less, 80% or less, 75% or less, 70% or less, 65% or less, 60% or less, 55% or less, 50% or less, 45% or less, or 40% or less of length L1. In some embodiments, L2 may be equal or approximately equal to L1.

In some embodiments, thebuffer 3026 may allow thedistal end 3006 of the device to be extremely shortened. In some embodiments,bumper 3026 may fold inward to accommodate the radial and/or axial constraints ofdevice 3000.Bumper 3026 may be folded radially inward and/or folded proximally inward. In addition, theconformable frame 3040 within thefoam 3002 may allow for further axial shortening beyond the length of thebumper 3026. Theframe 3040 may be folded radially and/or axially inward.

In addition, the cylindrical shape of thedevice 3000 facilitates sealing of the LAA, even with atypical LAA anatomical geometries. The cylindrical shape ensures that the anchor is at the maximum width of thedevice 3000. As used herein, thetubular body 3080 can provide a cylindrical base for theanchors 3090, 3094, such that the anchors are located at the radially outer most portion of thedevice 3000. This cylindrical shape of the device along its longitudinal axis helps thedevice 3000 perform the necessary sealing even in the constrained configuration shown in fig. 96A and 96B. In some embodiments, thedevice 3000 may be constrained axially and radially, for example, by two variations shown in fig. 96A and 96B. Thedevice 3000 and the conformability of the cylindrical shape may ensure superior sealing performance compared to typical LAA occlusion devices currently in use.

Fig. 97 is a side view of an embodiment of a lasercut tube frame 3040 shown in a flat configuration. Theframe 3040 can have a variety of sizes, expressed in inches. The dimensions are for one embodiment only, and some or all of the dimensions may be different in other embodiments. Ahinge 3050 is located at the proximal end with theaperture 3053. Extending distally from thehinge 3050 is asupport 3061 having an arcuate (when assembled)proximal portion 3062, alinear portion 3064, and an outer arcuate (when assembled)portion 3066. Thesupport 3061 is connected to aproximal support 3082 at aproximal apex 3084. Aproximal anchor 3090 extends proximally from thecentral apex 3087. Adistal support 3086 extends from the apex 3087 to form a distal apex 3088 from which adistal anchor 3094 extends proximally. Theframes 3040 may have the dimensions generally shown, or they may be different. The illustratedframe 3040 can be used with adevice 3000 having a width of 27mm or about 27 mm.

Thedevice 3000 provides a number of advantages over existing LAA occlusion solutions, as described herein. An important advantage is that the device is highly conformable while still providing excellent resistance to emboli. This unique feature of being more conformable while anchoring better is counterintuitive. Thedevice 3000 is more conformable than prior solutions and therefore can take on the oval shape of the LAA ostium, e.g., while also providing superior removal resistance, in some embodiments, with an extraction force of greater than 0.8 pounds (lbs) in bench testing.

Various modifications to the disclosed implementations will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other implementations without departing from the spirit or scope of the present disclosure. Thus, the present disclosure is not intended to be limited to the implementations shown herein but is to be accorded the widest scope consistent with the claims, the principles and the novel features disclosed herein. The word "example" is used herein to mean "used as an example, instance, or illustration. Any implementation described herein as an "example" is not necessarily to be construed as preferred or advantageous over other implementations, unless otherwise specified.

In the context of separate implementations, certain features are in the description that may also be implemented in combination in a single implementation. Conversely, various features that are, for brevity, described in the context of a single implementation, may also be provided separately or in any suitable subcombination. Furthermore, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features of a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

Similarly, while operations are shown in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In addition, other implementations are within the scope of the smaller claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results.

Those skilled in the art will understand that the terms used herein are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including, but not limited to," the term "having" should be interpreted as "having at least," the term "includes" should be interpreted as "includes, but is not limited to," etc.). It will be further understood by those within the art that if a specific number of an introduced claim recitation is intended, such an intent will be explicitly recited in the claim, and in the absence of such recitation no such intent is present. For example, as an aid to understanding, the following appended claims may contain usage of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, the use of such phrases should not be construed to imply that the introduction of a claim recitation by the indefinite articles "a" or "an" limits any particular claim containing such introduced claim recitation to embodiments containing only one such recitation, even when the same claim includes the introductory phrases "one or more" or "at least one" and indefinite articles such as "a" or "an" (e.g., "a" and/or "an" should typically be interpreted to mean "at least one" or "one or more"); this also applies to the use of definite articles used to introduce claim recitations. In addition, even if a specific number of an introduced claim recitation is explicitly recited, those skilled in the art will recognize that such recitation should typically be interpreted to mean at least the recited number (e.g., the bare recitation of "two recitations," without other modifiers, typically means at least two recitations, or two or more recitations). Further, in those instances where a convention analogous to "at least one of A, B and C, etc." is used, in general such a construction is intended to indicate that one skilled in the art would understand the meaning of the convention (e.g., "a system having at least one of A, B and C" would include, but not be limited to, systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B and C together, etc.). In those instances where a convention analogous to "A, B or at least one of C, etc." is used, in general such a construction is intended to indicate that one of ordinary skill in the art would understand the meaning of the convention (e.g., "a system having at least one of A, B or C" would include, but not be limited to, systems that have A alone, B alone, C alone, A and B together, A and C together, B and C together, and/or A, B and C together, etc.). It will be further understood by those within the art that virtually any synonym or phrase representing two or more alternative terms, whether in the description, claims or drawings, should be understood to contemplate the possibilities of including one of the terms, either of the terms or both terms. For example, the phrase "a or B" will be understood to include the possibility of "a" or "B" or "a and B".

The claims (modification according to treaty clause 19)

1. A left atrial appendage occlusion device comprising:

a foam body having a tubular sidewall, the tubular sidewall having a radial uncompressed thickness;

an expandable support coupled to the body; and

at least one anchor coupled with the support and extending through the sidewall when the foam of the sidewall is compressed, wherein a radial height of the at least one anchor is no greater than the radial uncompressed thickness of the sidewall.

2. A left atrial appendage occlusion device as in claim 1, wherein the device defines a central axis and the at least one anchor is angled relative to the central axis.

3. A left atrial appendage occlusion device as in claim 2, wherein the at least one anchor extends radially outward in a proximal direction at an angle of at least twenty degrees relative to a portion of the central axis extending proximally of the device.

4. A left atrial appendage occlusion device as inclaim 3, wherein the angle is at least thirty degrees.

5. A left atrial appendage occlusion device as in claim 1, wherein the at least one anchor extends through a radially compressed portion of the sidewall, the radially compressed portion having a radial thickness that is less than the radial uncompressed thickness.

6. A left atrial appendage occlusion device as in claim 5, further comprising an attachment member connecting the buttress to the sidewall and radially compressing the sidewall at the radially compressed portion.

7. A left atrial appendage occlusion device comprising:

a foam body having a tubular sidewall, the tubular sidewall including 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;

an expandable support coupled to the body; and

at least one anchor coupled with the support and extending at least partially through the at least one second portion of the sidewall.

8. A left atrial appendage occlusion device as in claim 7, wherein the device defines a central axis and the at least one anchor is angled relative to the central axis.

9. A left atrial appendage occlusion device as in claim 8, wherein the at least one anchor extends radially outward in a proximal direction at an angle of at least twenty degrees relative to a portion of the central axis extending proximally of the device.

10. A left atrial appendage occlusion device as in claim 9, wherein the angle is at least thirty degrees.

11. A left atrial appendage occlusion device as in claim 8, wherein the at least one anchor extends through the at least one second portion of the sidewall such that a portion of the at least one anchor extends outwardly beyond an outer surface of the at least one second portion of the sidewall.

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

13. A left atrial appendage occlusion device as in claim 7, wherein the support comprises a tubular frame portion configured to expand radially outward to compress the sidewall against a left atrial appendage wall upon implantation of the device.

14. The left atrial appendage closure device of claim 7, further comprising a proximal cover layer covering at least a portion of a proximal face of the foam.

15. A left atrial appendage occlusion device comprising:

a tubular foam body having a compressible sidewall, the compressible sidewall including 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; and

an expandable support coupled to the body,

Wherein the apparatus is configured to:

inserted into a non-cylindrical opening of a rigid test body having a non-cylindrical profile,

radially expand within the non-cylindrical opening, and

the non-cylindrical contour is conformed at least at the opening of the test body.

16. A left atrial appendage occlusion device as inclaim 15, wherein the compressible sidewall extends between a proximal end and a distal end and defines a central lumen.

17. A left atrial appendage occlusion device as in claim 16, wherein the expandable support is configured to compress the sidewall against an inner surface of the test body.

18. A left atrial appendage occlusion device as inclaim 15, wherein the device leaves no radial gap between the device and the test body having a maximum radial dimension greater than five millimeters after conforming to the non-cylindrical profile.

19. A left atrial appendage occlusion device as in claim 18, wherein the device leaves no radial gap having a maximum radial dimension greater than three millimeters between the device and the test body after conforming to the non-cylindrical profile.

20. The left atrial appendage occlusion device ofclaim 15, further comprising at least one anchor coupled with the frame and extending at least partially into the tubular foam body.

Claims (20)

1. A left atrial appendage occlusion device comprising:

a foam body having a tubular sidewall, the tubular sidewall having a radial uncompressed thickness;

an expandable support coupled to the body; and

at least one anchor coupled with the support and extending through the sidewall when the foam of the sidewall is compressed, wherein a radial height of the at least one anchor is no greater than the radial uncompressed thickness of the sidewall.

2. A left atrial appendage occlusion device as in claim 1, wherein the device defines a central axis and the at least one anchor is angled relative to the central axis.

3. A left atrial appendage occlusion device as in claim 2, wherein the at least one anchor extends radially outward in a proximal direction at an angle of at least twenty degrees relative to a portion of the central axis extending proximally of the device.

4. A left atrial appendage occlusion device as in claim 3, wherein the angle is at least thirty degrees.

5. A left atrial appendage occlusion device as in claim 1, wherein the at least one anchor extends through a radially compressed portion of the sidewall, the radially compressed portion having a radial thickness that is less than the radial uncompressed thickness.

6. A left atrial appendage occlusion device as in claim 5, further comprising an attachment member connecting the buttress to the sidewall and radially compressing the sidewall at the radially compressed portion.

7. A left atrial appendage occlusion device comprising:

a foam body having a tubular sidewall, the tubular sidewall including 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;

an expandable support coupled to the body; and

at least one anchor coupled with the support and extending at least partially through the at least one second portion of the sidewall.

8. A left atrial appendage occlusion device as in claim 7, wherein the device defines a central axis and the at least one anchor is angled relative to the central axis.

9. A left atrial appendage occlusion device as in claim 8, wherein the at least one anchor extends radially outward in a proximal direction at an angle of at least twenty degrees relative to a portion of the central axis extending proximally of the device.

10. A left atrial appendage occlusion device as in claim 9, wherein the angle is at least thirty degrees.

11. A left atrial appendage occlusion device as in claim 8, wherein the at least one anchor extends through the at least one second portion of the sidewall such that a portion of the at least one anchor extends outwardly beyond an outer surface of the at least one second portion of the sidewall.

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

13. A left atrial appendage occlusion device as in claim 7, wherein the support comprises a tubular frame portion configured to expand radially outward to compress the sidewall against a left atrial appendage wall upon implantation of the device.

14. The left atrial appendage closure device of claim 7, further comprising a proximal cover layer covering at least a portion of a proximal face of the foam.

15. A left atrial appendage occlusion device comprising:

a tubular foam body; and

an expandable support coupled to the body,

wherein the apparatus is configured to:

inserted into a non-cylindrical opening of a rigid test body having a non-cylindrical profile,

radially expand within the non-cylindrical opening, and

The non-cylindrical contour is conformed at least at the opening of the test body.

16. A left atrial appendage occlusion device as in claim 15, wherein the foam body comprises compressible sidewalls extending between a proximal end and a distal end and defining a central lumen.

17. A left atrial appendage occlusion device as in claim 16, wherein the expandable support is configured to compress the sidewall against an inner surface of the test body.

18. A left atrial appendage occlusion device as in claim 15, wherein the device leaves no radial gap between the device and the test body having a maximum radial dimension greater than five millimeters after conforming to the non-cylindrical profile.

19. A left atrial appendage occlusion device as in claim 18, wherein the device leaves no radial gap having a maximum radial dimension greater than three millimeters between the device and the test body after conforming to the non-cylindrical profile.

20. The left atrial appendage occlusion device of claim 15, further comprising at least one anchor coupled with the frame and extending at least partially into the tubular foam body.

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